Lawrence E. Stewart, M.D.; Decision and Order, 54822-54848 [2016-19595]

Download as PDF 54822 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices By order of the Commission. Issued: August 10, 2016. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2016–19560 Filed 8–16–16; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 16–14] Lawrence E. Stewart, M.D.; Decision and Order mstockstill on DSK3G9T082PROD with NOTICES On June 1, 2016, Administrative Law Judge (ALJ) Charles Wm. Dorman issued the attached Recommended Decision. Therein, the ALJ found that on multiple occasions, Respondent issued prescriptions outside of the usual course of professional practice and which lacked a legitimate medical purpose for schedule II controlled substances such as Norco 10/325mg (hydrocodone/ acetaminophen) and Hycodan (hydrocodone/homatropine cough syrup),1 the schedule III controlled substance phentermine, and the schedule IV controlled substance alprazolam, in violation of 21 CFR 1306.04(a). See R.D. at 34–60.2 More specifically, the evidence showed that Respondent prescribed the controlled substances to his girlfriend knowing that she was seeking the drugs to abuse them. The evidence also showed that while some of the prescriptions were issued in the name of Respondent’s girlfriend, in multiple instances, Respondent issued prescriptions, including multiple prescriptions for Hycodan, listing his girlfriend’s two children, who were then three and five years old respectively, as the patients, and that Respondent did so knowing that his girlfriend intended to use the cough syrup because she enjoyed drinking it. The evidence further showed that on multiple occasions, Respondent issued prescriptions for Norco 3 to undercover agents who posed as acquaintances of 1 Effective October 6, 2014, combination hydrocodone products including both Norco and Hycodan were transferred from schedule III to schedule II of the Controlled Substances Act. See Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II, 79 FR 49661. Thus, at the time Respondent issued some of the Norco and Hycodan prescriptions, the drug was a schedule III controlled substance. This, however, has no consequence for my decision. 2 All citations to the Recommended Decision are to the slip opinion as issued by the ALJ. 3 The evidence also showed that at one of the undercover agent’s visits, Respondent also gave her a prescription for Hycodan cough syrup. VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 his girlfriend, knowing that the drugs would then be provided to his girlfriend and that Respondent further instructed his girlfriend as to how her purported acquaintances should present as having headaches so that he could document a reason in the their charts for having issued the prescriptions. The ALJ also found that on multiple occasions, Respondent violated Rule 1.4 of the Mississippi State Board of Medical Licensure’s Rules by failing to document in his girlfriend’s chart the diagnosis or justification for issuing the prescription, as well as required information including the drug’s name, the dose, strength and quantity. R.D. at 37–39 (citing Miss. Code R. § 30–17– 2640:1.4; also citing id. § 30–17– 2640:1.16; Miss. Code §§ 73–25–29(3) and (13)). The ALJ also made a similar finding with respect to four hydrocodone cough syrup prescriptions Respondent issued in the names of his girlfriend’s children. R.D. at 46–47 (Rx’s issued on 6/17/14, 7/23/14, 11/19/14); id. at 49 (Rx 11/3/14). With respect to the phentermine prescriptions Respondent issued to his girlfriend, the ALJ found that he ‘‘completely failed to comply’’ with the Board’s Rule 1.5 because he did not prescribe ‘‘adjunctively with caloric restriction,’’ ‘‘never conducted and recorded an initial comprehensive evaluation’’ including ‘‘a thorough patient history or physical examination,’’ and never recorded required histories, nor her height, weight, BMI, body measurements, and vital signs. R.D. 43. The ALJ also found that Respondent did not conduct a reevaluation of his girlfriend every 30 days as required by Rule 1.5. Id. Finally, noting that Rule 1.5 generally requires that the patient have a BMI greater than 30 in order to justify prescribing phentermine, the ALJ observed that Respondent’s girlfriend testified that she had gone from 135 to 121 pounds and that she presented at the hearing ‘‘with a slender body type.’’ Id. The ALJ thus explained that ‘‘[a]fter observing [her] appearance,’’ he found ‘‘it difficult to comprehend . . . how Respondent could have possibly believed that [she] has a high enough BMI to justify’’ prescribing weight-loss medication. Id. The ALJ thus found that Respondent violated 21 CFR 1306.04(a), the Board’s Rule 1.5, and Mississippi Code sections 73–25–29(3) and (13) when he prescribed phentermine to his girlfriend. Id. at 44. Based on these findings, the ALJ concluded that Respondent had engaged in ‘‘an egregious level of intentional diversion’’ and that the Government had satisfied its prima facie burden of PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 showing that ‘‘Respondent’s continued registration would be inconsistent with the public interest.’’ R.D. at 61. Because ‘‘Respondent offered no evidence that he accepted responsibility for his misconduct or reformed his ways,’’ the ALJ found that he ‘‘failed to rebut the Government’s prima facie case.’’ Id. The ALJ thus recommended that I revoke Respondent’s registration and deny any application to renew or modify his registration. Id. Respondent filed Exceptions to the ALJ’s Recommended Decision. Thereafter, the ALJ forwarded the record to me for Final Agency Action. Having considered the record in its entirety, including Respondent’s Exceptions, I have decided to adopt the ALJ findings of fact, conclusions of law, and recommended Order. However, before I address Respondent’s Exceptions, I deem it necessary to address the ALJ’s ruling on the admissibility of the FDA package insert for Hycodan (GX 4). On motion of Respondent’s counsel, the ALJ ruled inadmissible Government Exhibit 4, which the Government represented was the FDA package insert for Hycodan.4 Tr. 422, 427. The basis of Respondent’s objection was that the exhibit contains ‘‘little more than generalizations and medical opinions’’ and that the ALJ’s prehearing statement required the parties to disclose ‘‘the names and credentials and opinions of medical experts . . . who would be offering medical opinions in this case.’’ Id. at 420. Respondent’s counsel further argued that ‘‘[t]he government did not identify any expert capable of being cross-examined on any of these opinions’’ and that ‘‘[t]here is no reason to believe that [the Exhibit was] authored by a physician, much less do we know whether the author had credentials to offer these opinions.’’ Id. After the Government argued that the document was the FDA package insert, which is included ‘‘with every drug purchased or sold,’’ id. at 422, Respondent argued that the copyright of the document was the manufacturer and that ‘‘we don’t know who authored it, or what their credentials were, but it’s a self-interested marketing pharmaceutical company’’ that is ‘‘trying to sell their [sic] medicine’’ and while the company has a ‘‘self-interest[] to comply with a federal regulation . . . ‘‘[i]t doesn’t mean that the content is government-sanctioned.’’ Id. at 422–23. Respondent thus asserted that the 4 There is no dispute that the Exhibit was what the Government represented it to be—a copy of the package insert. Nor is there any dispute as to how the document was obtained. E:\FR\FM\17AUN1.SGM 17AUN1 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES document was ‘‘just not reliable enough.’’ Id. at 426. The ALJ sustained the objection but provided no explanation as to his reason for doing so. I conclude, however, that the Exhibit was admissible. As the FDA has explained, the package insert ‘‘is part of the FDA-approved labeling,’’ and ‘‘[t]he FDA approved label is the official description of a drug product, which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnant women, children, and other populations; and safety information for the patient.’’ See U.S. Food and Drug Administration, Drugs@ FDA Instructions: Health Information, available at www.fda.gov/Drugs/ InformationOnDrugs/ucm079450.htm (accessed August 4, 2016). The FDA’s approval of a drug label follows extensive clinical trials, including trials which examine the safety and effectiveness of a drug and are part of the process for approving the drug for marketing. See Food and Drug Administration, Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 FR 3922 (2006) (Final Rule) (‘‘A prescription drug product’s FDA-approved labeling (also known as ‘professional labeling,’ ‘package insert,’ ‘direction circular,’ or ‘package circular’) is a compilation of information about the product, approved by FDA, based on the agency’s thorough analysis of the new drug application (NDA) . . . submitted by the applicant. This labeling contains information necessary for safe and effective use.’’). Under the Food, Drug and Cosmetic Act, a drug ‘‘shall be deemed to be misbranded . . . [u]nless its labeling bears . . . such adequate warning against use . . . by children where its use may be dangerous to health.’’ 21 U.S.C. 352(f). Moreover, introducing a misbranded drug into interstate commerce is a violation of 21 U.S.C. 331(a). Thus, there are ample incentives for drug manufacturers to provide reliable information in the package insert. Based on the foregoing, I find that there are sufficient indicia of reliability to support the admission of the document into evidence and make it a part of the record.5 I further find that 5 Hearsay evidence is admissible in administrative proceedings, provided it is relevant and material and supported by sufficient indicia of reliability. See, e.g., Mireille Lalanne, 78 FR 47750 (2013). As further noted above, in opposing the admission of the package insert, Respondent represented that it contained expert opinions from unidentified persons whom he could not cross- VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 this evidence is probative on the issue of whether the Hycodan prescriptions issued by Respondent in the name of his girlfriend’s children were for a legitimate medical purpose. See, e.g., Medicine Shoppe-Jonesborough v. DEA, 300 Fed. Appx. 409, 413 (6th Cir. 2008) (holding that dispensing contraindicated controlled substance is evidence of 21 CFR 1306.04(a) violation). Notably, the Hycodan package insert’s safety information includes the following warning: ‘‘The use of HYCODAN is not recommended for use in children less than 6 years of age because of the risk of fatal respiratory depression.’’ GX 4, at 2. Notably, Respondent’s girlfriend’s daughter was not even five years old when he wrote the first Hycodan prescription in her name. GE 55, at 1–2. Respondent also wrote Hycodan prescriptions in the name of his girlfriend’s son who was then three years old. Id. at 3–4; 11–12. In short, neither of the children who were listed as the patients on the Hycodan prescriptions was six years of age when Respondent wrote the prescriptions. Thus, I consider this as additional evidence which supports the conclusion that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice when he issued the Hycodan prescriptions in the names of his girlfriend’s children. 21 CFR 1306.04(a). I now turn to Respondent’s Exceptions. Exception I—The Government Failed ‘‘to Prove Violations of State or Local Laws Sufficient to Demonstrate Danger to the Public Interest.’’ Respondent argues that the ALJ failed to give proper weight to the decision of Dr. Craig, the Medical Board’s Executive Director, to close the Board’s investigation of his prescribing practices examine and thus was being offered in violation of the ALJ’s Prehearing Order. However, in its prehearing statement, the Government provided notice that it intended to offer the Exhibit and pursuant to the ALJ’s Prehearing Ruling, the Government was required to provide the document to Respondent by 2 p.m. on February 12, 2016. ALJ Ex. 9, at 2. No claim is made that the Government failed to comply with the ALJ’s ruling. While Respondent asserts that he was unable to cross-examine the persons who wrote the package insert, he made no attempt to subpoena either an FDA official involved in reviewing the document or an employee from the manufacturer who was involved in preparing it. Moreover, Respondent could have sought to challenge the reliability of the document by producing evidence (whether through expert testimony or studies) disputing the package insert’s statement regarding the risks of prescribing the drug to children less than six years of age. Respondent, however, produced no evidence which calls into question the reliability of the statements contained in the insert. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 54823 without recommending the initiation of a formal action against his medical license. Exceptions, at 1–2. According to Respondent, the Board reviewed ‘‘all such clinical and prescription records’’ for his girlfriend and her children, and it ‘‘decided that there was no evidence of any breach of any medical standard of care sufficient to bring any administrative charge against [him] related to any such prescription.’’ Id. at 2. He also asserts that Dr. Craig ‘‘determined that there was not even sufficient professional reason to issue [him] an informal warning as to any such prescription for pain medication.’’ Id. Respondent then argues that ‘‘[r]ather than . . . defer[] to the professional judgments made by [Dr. Craig as to] whether State laws were violated by [him], the ALJ[’s] Recommendation proceeds to interpret and apply those State laws without the benefit of any medical evidence, or any medical opinion in any form, anywhere in the record of this case.’’ Id. And noting the ALJ’s discussion that ‘‘‘DEA has not required expert testimony to establish a violation of 21 CFR 1306.04(a) in cases where a prescriber engaged in drug deals, where there were notable differences between patients’ medical records and diagnoses, and where a prescriber falsified patients’ charts,’ ’’ Respondent contends that the Government did not allege that he engaged in any such conduct. Id. at n.1. I reject the Exception. As for the contention that Dr. Craig reviewed the medical records and prescriptions and did not find the evidence sufficient to initiate a proceeding against his license, Respondent ignores the credited testimony that the Board terminated its investigation upon the request of the Mississippi Bureau of Narcotics (MBN) after the latter informed the Board that it was conducting a criminal investigation. Tr. 60 (testimony of MBN agent); GE 3, at 2 (Board Complaint form entry dated ‘‘3–20–15’’ stating ‘‘MBN has asked that we hold off on doing anything to this doctor because they are working a criminal case on him’’).6 A Board investigator also testified that ‘‘it’s customary for [the Board] to back off [of an investigation] and let a criminal agency pursue their [sic] case’’ and that Dr. Craig was aware of the criminal investigation. Tr. 210. Moreover, even then the Board’s letter cautioned Respondent ‘‘that authorizing 6 The Board’s investigation involved interviewing Respondent, as well as reviewing his girlfriend’s patient file and a PMP report of her controlled substance prescriptions. GE 3, at 4–6. Notably, the Board’s investigator testified that the Board did not interview Respondent’s girlfriend. Tr. 196. E:\FR\FM\17AUN1.SGM 17AUN1 mstockstill on DSK3G9T082PROD with NOTICES 54824 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices refills for Phentermine/Adipex without the benefit of a medical examination is strictly prohibited by the Board’s Rules and Regulations’’ and specifically quoted the Board’s Rule 1.5(E), which states that: ‘‘[a] patient continued on a controlled substance in schedule III, IV, V for the purpose of weight reduction or the treatment of obesity should undergo an in-person re-evaluation once every 30 days.’’ GE 3, at 1. Finally, as the evidence shows, subsequent to the Board’s closing of its investigation, Respondent again issued multiple controlled substance prescriptions to purported acquaintances of his girlfriend knowing that the drugs would subsequently be provided to his girlfriend. Accordingly, I reject Respondent’s contention that the Board’s closing of its investigation reflects its ‘‘professional judgments’’ that Respondent acted within the bounds of accepted professional practice when he prescribed to Respondent and the undercover officers. Under both this and his subsequent exception, Respondent argues that the ALJ’s decision is unprecedented because the Government put forward no expert testimony to support the conclusion that he violated 21 CFR 1306.04(a) in issuing the various prescriptions. However, contrary to Respondent’s understanding, numerous decisions of both the federal courts in criminal cases and this Agency have held that expert testimony is not necessarily required to prove that a physician acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing a controlled substance prescription. See United States v. Pellman, 668 F.3d 918, 924 (7th Cir. 2012) (quoting United States v. Armstrong, 550 F.3d 382, 388–89 (5th Cir. 2008) (‘‘While expert testimony may be both permissible and useful, a jury can reasonably find that a doctor prescribed controlled substances not in the usual course of professional practice or for other than a legitimate medical purpose from adequate lay witness evidence surrounding the facts and circumstances of the prescriptions.’’)); Armstrong, 550 F.3d at 389 (‘‘Jurors have had a wide variety of their own experiences in doctors’ care over their lives, thus and expert testimony is not necessarily required for jurors to rationally conclude that seeing patients for as little as two or three minutes before prescribing powerful narcotics is not in the usual course of professional conduct.’’).7 See also T.J. McNichol, 77 7 See also United States v. Word, 806 F.2d 658, 663 (6th Cir. 1986); United States v. Larson, 507 VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 FR 57133, 57147–49 (2012), pet. for rev. denied, 537 Fed. Appx. 905 (11th Cir. 2013); Morris W. Cochran, 77 FR 17505, 17519–20 (2011) (holding, without expert testimony, that prescriptions lacked a legitimate medical purpose where physician noted in patient medical records that patients had no pain, did not document any findings to support a diagnosis, and yet diagnosed patients as having chronic pain); Robert F. Hunt, 75 FR 49995, 50003 (2010) (holding, without expert testimony, that physician lacked a legitimate medical purpose based on statements made during undercover visits and falsification of chart). See also Jack A. Danton, 76 FR 60900, 60904 (2011). Thus, while expert testimony is typically necessary to establish a violation of 21 CFR 1306.04(a) ‘‘ ‘where a physician ma[kes] some attempt to comply with various state medical practice standards and the adequacy of those efforts is at issue,’ . . . the facts and circumstances surrounding the issuance of the prescription may nonetheless establish a violation even without expert testimony.’’ McNichol, 77 FR 57147–48 (quoting Danton, 76 FR at 60904 & n.13). Accordingly, in McNichol, the Agency found a violation proved, notwithstanding that the ALJ had rejected the testimony of the Government’s Expert, because while the physician had gone through the motions of a physical exam, the physician’s ‘‘comments manifest[ed] that he knew that [the patient] was an abuser of controlled substances.’’ Id. at 57148. See also Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (‘‘[T]he prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.’’) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)). Here, as the ALJ found, Respondent issued multiple prescriptions to his girlfriend while failing to document the performance of a physical exam, as well as findings and diagnoses that would support the issuance of the prescriptions. Moreover, with respect to the hydrocodone cough syrup prescriptions Respondent issued to his girlfriend which listed her children as the patients, the ALJ credited her testimony that she told Respondent that she wanted the big bottle of hydrocodone cough syrup and he F.2d 385, 387 (9th Cir. 1974); United States v. Bartee, 479 F.2d 484, 488–89 (10th Cir. 1973); State v. Moody, 393 So.2d 1212, 1215 (La. 1981). PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 ‘‘knew I would drink it too.’’ R.D. 7; 11 (citing Tr. 216, 251–52, 268, 273); see also Tr. 298 (girlfriend’s testimony that the Norco prescriptions were ‘‘not for a headache’’ but were ‘‘[j]ust for fun’’). Likewise, with respect to the prescriptions Respondent provided in March and April 2015 to his girlfriend’s purported acquaintances, the undercover recordings clearly establish that Respondent knew that the acquaintances were not seeking the prescriptions to treat legitimate medical conditions but to provide the drugs to his girlfriend. Given the evidence that clearly shows that Respondent issued the prescriptions to support his girlfriend’s abuse of controlled substances, the Government was not required to put forward expert testimony to prove its case. Exception II—The Government ‘‘Fail[ed] to Prove ‘Past Experience in the Distribution of Controlled Substances.’ ’’ Respondent further argues that the ALJ erred when he refused ‘‘to allow Respondent to seek clinical evidence about [his girlfriend’s] medical history through third-party document subpoenas.’’ Exceptions, at 2. Prior to the hearing, Respondent requested that the ALJ issue eight subpoenas to health care providers for their medical records ‘‘which reflect, relate to, or explain the clinical or medical basis for prescribing’’ controlled substances (primarily hydrocodone with acetaminophen) to his girlfriend. See, e.g., ALJ Ex. 13, at 6. In seeking the subpoenas, Respondent maintained that ‘‘[i]n order for the truth about [his girlfriend’s] medical condition and needs to be revealed . . . the clinical findings and judgment of all such health care providers should be available to the Court in order to allow a comparison between Dr. Stewart’s judgment and the judgments of a substantial number of other health care professionals in the same community.’’ ALJ Ex. 13, at 3. On the various subpoenas, Respondent explained that because one of the Government’s Exhibits (the PMP report, GE 49) shows that the other health care providers had also issued hydrocodone prescriptions to his girlfriend, ‘‘[t]he presumed legitimacy of the particular clinical findings which caused [the] other health care professionals in the same community to prescribe the same medication to [her] could be strongly probative of the medical inaccuracy of the . . . core allegations against’’ him. See, e.g., GE 13, at 6. The Government opposed the issuance of the subpoenas. It argued that E:\FR\FM\17AUN1.SGM 17AUN1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices the information Respondent sought was irrelevant because the only allegations it raised as to the unlawful prescribing of hydrocodone with acetaminophen to his girlfriend involved the four Norco prescriptions which were identified in paragraph 4 of the Show Cause Order.8 ALJ Ex. 14, at 2–3. The Government also argued that ‘‘[i]n each of those instances,’’ it was ‘‘alleg[ing] that Respondent prescribed to [her] either without conducting any examination of her or without noting those prescriptions in her chart.’’ Id. at 3. And it further argued that none of the records would address the ‘‘actual charges against’’ Respondent. Id. The ALJ agreed with the Government and denied Respondent’s request. ALJ Ex. 16. The ALJ explained that having reviewed the allegations of the Show Cause Order, he agreed with ‘‘the Government’s assessment that the question of whether [Respondent’ girlfriend] needed a particular medication is not an issue before me.’’ Id. at 1. And noting that ‘‘Respondent has not produced a summary of [his] expected testimony,’’ the ALJ then reasoned that ‘‘there is no information in the record that the Respondent based his decision to prescribe a particular medication to [his girlfriend] based upon his knowledge of what some other treating physician had prescribed for’’ her. Id. at 1–2. Concluding that the information sought by Respondent was irrelevant, the ALJ denied the request. Id. at 2. I conclude that the ALJ properly denied Respondent’s request. I do not, however, read the Government’s Opposition as expressing the position that his girlfriend’s need for the Norco prescriptions was not at issue. While the Government alleged that these particular prescriptions were unlawful because: (1) Respondent did not ‘‘conduct[] an examination of’’ of his girlfriend or ‘‘document[] such in her file,’’ or (2) Respondent did not note the prescriptions in her chart and thus violated the Board’s Rules 1.4, 1.11(b) and 1.16, the Government also cited 21 CFR 1306.04(a)). Because ‘‘[a] prescription for a controlled substance to be effective must be issued for a legitimate medical purpose,’’ 21 CFR 1306.04(a), a patient’s need for the drug is invariably at issue when a violation of this provision is alleged. See also Miss. Code R. § 30–17–2640:1.4 (‘‘No physician shall prescribe, administer or dispense any controlled substance . . . 8 The Show Cause Order alleged that the prescriptions were issued on May 22, June 17, September 11, and October 29, 2014. ALJ Ex. 1, at 2. VerDate Sep<11>2014 17:38 Aug 16, 2016 Jkt 238001 without a good faith prior examination and medical indication therefore.’’). Indeed, assessing whether a patient needs a controlled substance to treat a medical condition is the reason why the usual course of professional practice generally requires that a physician take a detailed history and conduct an appropriate examination of the patient to make a proper diagnosis and treatment plan.9 See id. I nonetheless agree with the ALJ’s conclusion that the information sought by the subpoenas was irrelevant. Notably, Respondent made no proffer that he had obtained and reviewed the records maintained by these other providers and had based his decisions to prescribe hydrocodone to his girlfriend on those records. Nor did Respondent proffer that he was acting as a covering physician for any of these other physicians (or any other authorized prescriber) when he prescribed the hydrocodone to his girlfriend. Respondent further contends that the prescriptions issued by the other providers ‘‘strongly support a conclusion that [his] own prescriptions for [h]ydrocodone for use by [his girlfriend] were within the bounds of the medical standard of care practiced in that community.’’ Exceptions, at 4. However, were it the case that Respondent’s prescribing of hydrocodone was within the bounds of professional practice, he could have put on an expert to testify as such.10 Yet Respondent chose not do so. 9 As Rule 1.4 further states: Standards of proper medical practice require that, upon any encounter with a patient, in order to establish proper diagnosis and regimen of treatment, a physician must take three steps: (a) Take and record an appropriate medical history, (b) carry out an appropriate physical examination, and (c) record the results. The observance of these principles as a function of the ‘‘course of legitimate professional practice’’ is particularly of importance in cases in which controlled substances are to play a part in the course of treatment. It is the responsibility of the physician to dispense, prescribe or administer such drugs with proper regard for the actual and potential dangers. Miss. Code R. § 30–17–2640:1.4. 10 Respondent initially proposed to call a physician and professor from the University of Mississippi Medical Center who would testify that the prescriptions he issued ‘‘were for legitimate medical purposes’’ and ‘‘were in the usual course of and consistent with [his] own standard professional practices [and] were consistent with the standard of care in the medical community in which they lived.’’ ALJ Ex. 17, at 2–3. While the Government moved to exclude the proffered testimony, the ALJ denied the Government’s motion and specifically ruled that the expert could testify to the above subjects. ALJ Ex. 28, 3–4. Respondent did not, however, call this witness. Of further note, even if Respondent had put on testimony that the prescriptions were ‘‘consistent with [his] own standard professional practices,’’ that testimony would have been unavailing because PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 54825 Respondent also contends that the evidence is insufficient to show that the hydrocodone prescriptions lacked a legitimate medical purpose because ‘‘it is clear that during the months relevant to this case [his girlfriend] was in fact suffering from a chronic migraine condition and associated headache pain, and that [he] was treating her for that condition.’’ Exceptions, at 3. Respondent points to the testimony of his girlfriend that she was hospitalized for migraines ‘‘[t]hree times prior to the beginning of his treatment of her in February 2014, and a fourth time during that treatment in August of 2014.’’ Id. He further maintains that his charts ‘‘specified that she complained of, and in fact suffered from, a chronic migraine condition.’’ Id. It is true that in two of the visit notes for his girlfriend (April 21 and Sept. 2, 2014), Respondent listed Maxalt, a noncontrolled drug, and Norco (hydrocodone with acetaminophen), as the drugs he prescribed to her for this condition. GE 2, at 12. Yet prior to Respondent’s issuance of the first Norco prescription to her, she had ‘‘asked him to write the big bottle’’ of hydrocodone cough syrup ‘‘so that [she] could have some too’’ and ‘‘told him I like to drink it’’ because she ‘‘like[d] the way it made [her] feel.’’ Tr. 251–52; 273. Thus, Respondent already knew that his girlfriend was a drug abuser.11 The evidence also shows that Respondent told his girlfriend that taking hydrocodone could itself ‘‘cause migraines.’’ Id. at 283; see also id. at 299. Respondent’s girlfriend testified that he told her that taking hydrocodone ‘‘would not help’’ her migraines. Id. at 300. She further testified that ‘‘[t]he hydrocodone was not for a headache,’’ but for ‘‘[e]xtracurricular activities,’’ i.e., the standard of professional practice is not defined by a physician’s subjective belief as to the propriety of his practices but on the application of the standards of practice in the State where he practices. United States v. Tobin, 676 F.3d 1264, 1290 (11th Cir. 2012). For similar reasons, evidence as to the standard of care in the medical community in which Respondent lived would also be unavailing. 11 Respondent points to the testimony of his girlfriend that she never told him that she was addicted to hydrocodone, dependent on the drug, or taking it ‘‘for no reason.’’ Exceptions, at 3. As discussed above, Respondent’s girlfriend subsequently clarified that she took the Norco ‘‘just for fun.’’ Tr. 298. To the extent Respondent believes that his misconduct in writing the Norco prescriptions should be excused because his girlfriend did not tell him why she was taking the Norco, the evidence is clear that she had previously asked him to prescribe the big bottle of cough syrup so that she ‘‘could have some too’’ and had told him that she ‘‘like[d] to drink it’’ because of ‘‘the way it made [her] feel.’’ Thus, Respondent clearly knew that his girlfriend was a drug abuser at the time he wrote her the first Norco prescription. E:\FR\FM\17AUN1.SGM 17AUN1 mstockstill on DSK3G9T082PROD with NOTICES 54826 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices ‘‘just for fun.’’ Id. at 298. Moreover, Respondent issued the first of the Norco prescriptions to her without even taking a history and conducting a physical examination of her. GE 2, at 12; see Miss. Code R. § 30–17–2640:1.4. He also failed to document several of the hydrocodone prescriptions in his girlfriend’s chart.12 Compare GE 2, at 12, with GE 3, at 9–10. Thus, the evidence strongly supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed Norco to his girlfriend. 21 CFR 1306.04(a). Respondent also appears to argue that the alprazolam prescription he issued to his girlfriend was not unlawful because she suffered from anxiety and he referred her to a psychiatrist who had prescribed the drug to her. Exceptions, at 4. While Respondent acknowledges that he did not ‘‘diagnose [her] himself as to anxiety,’’ he argues that he issued the prescription ‘‘in reliance on that psychiatrist’s independent clinical judgment’’ and gave her a refill so that she could ‘‘avoid[] further one-hour trips to the psychiatrist to obtain a refill.’’ Id. I am not persuaded. Notably, the psychiatrist prescribed only a seven-day supply of alprazolam extended release in the .5 mg dosage. GE 49, at 1. Respondent, however, prescribed a stronger dosage of alprazolam and greater quantity, providing her with a prescription for 40 tablets of the 1mg immediate release dosage form, with a refill for an additional 40 tablets. Id. This was not a refill of the psychiatrist’s prescription at all, but a substantially different and stronger prescription. Yet the medical record contains no evidence that Respondent coordinated his prescribing with the psychiatrist. As for Respondent’s explanation that he wrote the prescription so that his girlfriend would not have to make the one-hour trip to obtain a refill, this begs the question as to why the psychiatrist would not be willing to call in a refill. I thus reject Respondent’s Exception to the extent it challenges the ALJ’s findings as to the alprazolam prescription. As for the phentermine prescriptions, Respondent again invokes Dr. Craig’s letter in which he stated that the Board was closing its investigation while cautioning Respondent about the need 12 Indeed, Respondent wrote the first Norco prescription for her on February 21, 2014. The note in her patient file simply states: ‘‘2–21–14 Hc 7.5/ 325 (#40, 1)—may be picked up at desk.’’ GE 2, at 12. Thus, Respondent issued the prescription without taking a history of his girlfriend’s migraines and without conducting a physical exam. VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 to conduct an in-person re-evaluation every 30 days. Exceptions, at 4. Respondent revisits his argument that Dr. Craig ‘‘determined that there was no sufficient medical basis for alleging any violation . . . of any medical standard in Mississippi.’’ Id. However, as previously explained, the Board terminated its investigation because Respondent was the subject of a criminal investigation. Moreover, the ALJ thoroughly explained the basis for his conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he issued the phentermine prescriptions to his girlfriend.13 Finally, Respondent argues that ‘‘[t]he DEA, through the CI [his girlfriend], effectively caused [him] to engage in conduct, which, according to the record . . . he apparently had never engaged in on any other occasion.’’ Exceptions, at 5. Continuing, Respondent argues that his ‘‘conduct, in issuing prescriptions for pain medications to third parties in an effort to provide the CI with continuing relief from her migraine conditions, arose from the peculiar combination of his personal relationship and familiarity with the CI and the CI’s insistence that her ‘friends’ were seeking medication for’’ her use. Id. Respondent thus maintains that this ‘‘peculiar circumstance . . . provides no significant medical or other evidence sufficient to justify any conclusion that [his] conduct . . . poses, or is likely to pose in the future, any danger to the public health or safety.’’ Id. I disagree. To the extent Respondent’s argument sounds in the entrapment defense, I reject it as there is ample evidence that he was predisposed to issue the unlawful prescriptions given the multiple unlawful prescriptions he wrote for his girlfriend in 2014, prior to the involvement of the MBN and DEA. See United States v. Sumlin, 271 F.3d 274 (D.C. Cir. 2001). As for the assertion that he wrote the prescriptions to the undercover agents to provide his girlfriend ‘‘with continuing relief from her migraine conditions,’’ this is simply counterfactual as the record abounds with evidence that Respondent knew she was seeking the drugs to abuse them. Tr. 345; GE15; 16; GE 17, at 2–4, 6–8; GE 18, at 3. I therefore reject Respondent’s contention that there is no ‘‘significant medical or other evidence’’ to support the conclusion that he poses a danger to public health and safety.14 Exceptions, at 5. To the contrary, the evidence shows that on multiple occasions, Respondent issued prescriptions outside of the usual course of professional practices and which lacked a legitimate medical purpose to feed his girlfriend’s abuse of controlled substances. This conduct amply supports the conclusion that he has committed such as acts as to render his registration ‘‘inconsistent with the public interest.’’ 21 U.S.C. 824(a)(4). 13 Respondent points to the evidence that on March 27, 2015, he declined to prescribe weight loss medication to one of the undercover agents. Exceptions, at 4 (citing GE 10, at 1–2). However, several weeks earlier, Respondent had been visited by a State Board Investigator who had told him that his documentation for the phentermine prescriptions that he issued to his girlfriend was inadequate and he may have already received the letter from Dr. Craig by the date of the first undercover visit. In any event, while Respondent may have taken to heart the warning he received from Dr. Craig regarding the prescribing of weight loss medications, this obviously had no impact on his prescribing of narcotics, as evidenced by his prescribing of Norco and Hycodan to the undercover agents. 14 In arguing that he does not ‘‘pose . . . any danger to public health or safety,’’ Respondent cites 21 U.S.C. 823(e), the provision which governs the registration of distributors of schedule III through V controlled substances and not practitioners, who are registered under section 823(f). However, to the extent Respondent argues that the Government is required to put forward such proof in seeking the revocation of his registration, the Government is not required to do so even though one of the section 823(f) factors is ‘‘such other conduct which may threaten the public health and safety.’’ 21 U.S.C. 823(f). While this factor encompasses conduct which is not otherwise embraced by the other section 823(f) factors, it is indisputable that issuing prescriptions to feed a person’s drug abuse is conduct which threatens public health and safety. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Exception III—The ALJ Violated Respondent’s Fifth Amendment Rights When He Denied His Request To Delay the Hearing Until the End of His Criminal Trial Respondent’s final contention is that the ALJ violated his Fifth Amendment privilege against self-incrimination when he denied his request to reschedule the hearing until after his criminal trial concluded. Exceptions, at 5–6. Notably, the Government did not call Respondent to testify and the ALJ declined to draw an adverse inference from his failure to testify on his own behalf even though doing so would have been warranted. See Keating v. Office of Thrift Supervision, 45 F.3d 322, 326 (9th Cir. 1995) (‘‘Not only is it permissible to conduct a civil proceeding at the same time as a related criminal proceeding, even if that necessitates invocation of the Fifth Amendment privilege, but it is even permissible for the trier of fact to draw adverse inferences from the invocation of the Fifth Amendment in a civil proceeding.’’) (citing Baxter v. Palmigiano, 425 U.S. 308, 318 (1976)). ‘ Here, Respondent does not contend that the need to preserve his Fifth Amendment privilege prevented him E:\FR\FM\17AUN1.SGM 17AUN1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices from providing testimony refuting the allegations that he unlawfully prescribed various controlled substances to his girlfriend and the undercover officers. Rather, he argues that ‘‘[b]ecause he desired understandably to preserve and not to waive his Fifth Amendment privileges with respect to his criminal trial, [he] was prohibited from ‘rebutting’ any prima facie Government case through his own hearing testimony, which was the only practical way he had to ‘accept responsibility’’ or to affirm that he ‘will not engage in future misconduct.’’’ Id. at 6. I reject Respondent’s contention. See Grider Drug 1 & 2, 77 FR 44069, 44104 (2012). In Grider, the respondents argued that the Agency should reject an ALJ’s conclusions that the pharmacies had failed to rebut the Government’s prima facie case because their owner, who was under indictment in two state criminal cases, did not testify and thus offered no evidence to show that he had accepted responsibility and implemented corrective measures. Invoking SEC v. Dresser Industries, Inc., 628 F.2d 1368, 1375–76 (D.C. Cir.1980), the Grider respondents further argued that because their owner was under indictment, the ALJ should have stayed the proceeding until the state criminal cases were concluded so as not to ‘‘undermine the party’s Fifth Amendment privilege against selfincrimination.’’ 77 FR at 44104. The Agency rejected Grider’s arguments. As the Agency explained, ‘‘‘as a general matter, due process is not infringed merely because an accused person is subjected, without his consent, to an administrative hearing concerning matters involved in a pending criminal proceeding.’’’ Id. (quoting 628 F.2d at 1376 n.21). As Dresser Industries noted, ‘‘[t]he civil and regulatory laws of the United States frequently overlap with the criminal laws creating the possibility of parallel [administrative] and criminal proceedings, either successive or simultaneous’’ and that ‘‘[i]n the absence of substantial prejudice to the rights of the parties involved, such parallel proceedings are unobjectionable.’’ 628 F.2d at 1374. Thus, in Dresser Industries, the D.C. Circuit observed that ‘‘[t]he Constitution . . . does not ordinarily require a stay of civil proceedings pending the outcome of criminal proceedings.’’ Id. at 1375. To be sure, in Dresser Industries, the D.C Circuit further explained that ‘‘the strongest case for deferring civil proceedings is where a party under indictment for a serious offense is VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 required to defend a civil or administrative action involving the same matter.’’ Id. However, the court further explained that the potential harm to a party’s Fifth Amendment privilege is just one of the factors to be considered in determining whether to stay the noncriminal proceeding. Id. at 1376. Continuing, the court explained that ‘‘[i]f delay of the noncriminal proceedings would not seriously injure the public interest, a court may be justified in deferring it.’’ Id. (emphasis added). That decision is, however, committed to the discretion of the trial court. See, e.g., Keating, 45 F.3d at 325 (setting forth multiple factors). Here, I find no reason to conclude that the ALJ abused his discretion when he declined to continue the proceeding until the conclusion of Respondent’s criminal trial. Notably, in his request for a continuance, Respondent provided no information to the ALJ as to when that trial would commence.15 That trial— and a subsequent appeal were Respondent convicted of the charges— could go on for several years. The ALJ was not required to withhold conducting the hearing while Respondent litigates in other forums. See 45 F.3d at 325 (noting that ‘‘convenience of the court in the management of its cases’’ is a factor). So too, the Government has a strong interest in proceeding expeditiously with this litigation, and indeed, under the Constitution, the Agency has an obligation to provide prompt postdeprivation process where the Government immediately suspends a registration. Id.; see also Barry v. Barchi, 443 U.S. 56, 64 (1979). As for the burden on Respondent, it is true that courts have held that the prejudice to a respondent’s Fifth Amendment privilege may be substantial where there are parallel administrative and criminal proceedings. Keating, 45 F.3d at 326. However, while ‘‘the extent to which the defendant’s Fifth Amendment rights are implicated is a significant factor . . . to consider . . . it is only one consideration to be weighed against others.’’ Id. (citation omitted). Notably, Respondent was not otherwise foreclosed from putting on a defense. Indeed, in its pre-hearing statement, Respondent proposed to call an expert witness who would testify that the prescriptions were lawfully issued but ultimately chose not to call this witness. Notably, in his Exceptions, Respondent does not maintain that 15 In opposing the request, the Government noted that Respondent had also sought a continuance of the criminal case. ALJ Ex. 6, at 1 n.1. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 54827 because he invoked the privilege, he was precluded from refuting the factual basis of the allegations. Instead, Respondent now contends that my consideration of the ALJ’s recommendation ‘‘should await the disposition of the criminal case . . . following which he should be given an opportunity promptly and succinctly to tell his side of the story and express his complete remorse.’’ Exceptions, at 6. However, as discussed above, in his Exceptions, Respondent continues to dispute the allegations (as well as the ALJ’s factual findings and legal conclusions) that he issued prescriptions outside of the usual course of professional practice and which lacked a legitimate medical purpose for each of the different drugs (i.e., the hydrocodone cough syrup, the Norco tablets, the alprazolam, and the phentermine). Thus, his argument begs the question of which allegations he now would admit to. The Fifth Amendment privilege is not ‘‘a sword whereby a claimant asserting the privilege [is] freed from adducing proof in support of a burden which would otherwise have been his.’’ United States v. Rylander, 460 U.S. 752, 758 (1983). See also MacKay v. DEA, 664 F.3d 808, 820 (10th Cir. 2011) (quoting Keating v. Office of Thrift Supervision, 45 F.3d 322, 326 (9th Cir. 1995)). Indeed, the misconduct established on this record is so egregious and occurred over such a lengthy period, that even were I to remand to allow Respondent to express his ‘‘complete remorse’’ and the ALJ was to find this credible, I would still find his registration to be inconsistent with the public interest. See Hatem M. Attaya, 81 FR 8221, 8244 (2016); Fred Samimi, 79 FR 18698, 18714 (2014) (denying applications noting that notwithstanding ALJ’s finding that physician ‘‘credibly accept responsibility for his misconduct, this is a case where actions speak louder than words’’). Thus, I find that Respondent has failed to establish that the ALJ abused his discretion when he denied Respondent’s request to continue the proceeding until his criminal trial concluded.16 16 It is, of course, commonplace that matters involving DEA registrants will lead to both a revocation proceeding and a criminal investigation and subsequent charges at either the federal or state level. However, the very purpose of a proceeding brought under 21 U.S.C. 823(f) and 824(a)(4) is to protect the public interest, and, in the Controlled Substances Act, Congress directed that these ‘‘proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter.’’ Thus, I conclude that the fifth Keating factor (‘‘the interest of the public in the pending . . . litigation’’) also supports the ALJ’s denial of Respondent’s stay request. E:\FR\FM\17AUN1.SGM Continued 17AUN1 54828 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices Accordingly, I reject Respondent’s third exception and will adopt the ALJ’s recommended sanction of revocation. ORDER Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 823(f), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration AS2286311 issued to Lawrence E. Stewart, M.D., be, and it hereby is, revoked. I further order that any application of Lawrence E. Stewart, M.D., to renew or modify the above registration, or for any additional registration be, and it hereby is, denied. This Order is effectively immediately.17 Dated: August 9, 2016. Chuck Rosenberg, Acting Administrator. Paul A. Dean, Esq. for the Government. J. Brad Pigott, Esq. for the Respondent. mstockstill on DSK3G9T082PROD with NOTICES RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION Administrative Law Judge Charles Wm. Dorman. On December 9, 2015, the Drug Enforcement Administration (‘‘DEA’’ or ‘‘Government’’) served Lawrence E. Stewart, M.D. (‘‘Respondent’’), with an Order to Show Cause and Immediate Suspension of Registration (‘‘OSC/ISO’’), which immediately suspended the Respondent’s DEA Certificate of Registration (‘‘COR’’), Number AS2286311. Administrative Law Judge Exhibit (‘‘ALJ-’’) 1–2. The Respondent’s COR has remained suspended throughout these proceedings. In response to the OSC/ISO, the Respondent requested a hearing before an Administrative Law Judge. ALJ–3. That hearing was held in New Orleans, Louisiana on March 22 and 23, 2016. The issue currently before the Administrator is whether the Respondent’s COR should be revoked, and applications for renewal or modification denied, because continued registration would be inconsistent with the public interest under 21 U.S.C. 823(f) and 824(a)(4). The following recommendations are based on my consideration of the entire administrative record, including all of the testimony, admitted exhibits, and the oral and written arguments of counsel. As for the fourth Keating factor, ‘‘the interests of persons not parties to the [administrative] litigation,’’ 45 F.3d at 326, Respondent puts forward no argument as to why this factor supports the requested stay or a remand at this juncture. 17 For the same reasons that led me to immediately suspend Respondent’s registration, I find that the public interest necessitates that this Order be effective immediately. See 21 CFR 1316.67. VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 ALLEGATIONS 1. From February 2014 to May 2015, the Respondent prescribed controlled substances, including hydrocodone and alprazolam, to a confidential informant (‘‘CI’’) 1 without conducting and/or documenting a physical examination, and without recording the controlled substance prescriptions in CI’s chart, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, Rules 1.4, 1.11(b), and 1.16, Mississippi Code §§ 73–25–29(3) and (13), and 21 CFR § 1306.04(a). ALJ–1, at 2. 2. On four occasions, the Respondent prescribed phentermine to CI without adequate documentation, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, Rule 1.5, Mississippi Code §§ 73–25– 29(3) and (13), and 21 CFR § 1306.04(a). ALJ–1, at 3. 3. From February 7, 2014 to November 19, 2014, the Respondent prescribed hydrocodone products to CI’s children 2 without conducting examinations of them, and for CI’s personal use, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, Rules 1.4, 1.10, 1.11(b), and 1.16, and Mississippi Code §§ 73–25–29(3) and (13), and 21 CFR § 1306.04(a) and 1306.05(a). ALJ–1, at 2–3. The Respondent prescribed hydrocodone-homatropine syrup to these children, who were under the age of six. ALJ–1, at 3. Hydrocodonehomatropine syrup is not recommended for children under the age of six because of a risk of death. ALJ–1, at 3. The Respondent also prescribed adult dosages of hydrocodone-homatropine to these children, even though the recommended dosage for children ages six to eleven is half of the adult dosage. ALJ–1, at 2–3. 4. On five occasions between March and October 2015, the Respondent prescribed controlled substances to undercover agents when he knew or should have known that the agents’ prescription requests were fraudulent, in violation of 21 U.S.C. 841(a) and 842(a), and 21 CFR § 1306.04(a). ALJ–1, at 3. In total, the Respondent wrote seven prescriptions on five occasions to undercover agents, for a total of 190 1 The Prehearing Ruling and Protective Order directed that the confidential informant would be referred to as ‘‘CI.’’ ALJ–9, at 5. Accordingly, in this Recommended Decision, the confidential informant will be referred to as ‘‘CI.’’ 2 The Prehearing Ruling and Protective Order directed that CI’s children would be referred to as ‘‘Kid 1’’ and ‘‘Kid 2.’’ ALJ–9, at 5. Accordingly, in this Recommended Decision, CI’s son will be referred to as ‘‘Kid 1,’’ and CI’s daughter will be referred to as ‘‘Kid 2.’’ PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 dosage units of hydrocodone tablets and 72 dosage units of hydrocodone syrup. ALJ–1, at 11. On at least four of those occasions, the Respondent knew that CI would receive a portion of the prescribed controlled substances. ALJ– 1, at 3–4. The Respondent also knew that CI had attempted to commit suicide using controlled substances that the Respondent had prescribed to her. ALJ– 1, at 3–4. 5. From February 2014 to October 2015, the Respondent unlawfully prescribed controlled substances in violation of 21 U.S.C. 841(a) and 842(a). ALJ–1, at 2. Specifically, the Respondent prescribed controlled substances when he knew or should have known that the prescriptions were not for legitimate medical purposes and were not made in the usual course of professional practice, in violation of 21 CFR § 1306.04(a) and Mississippi Code §§ 41–29–137(a)(1) and 41–29–141(1). ALJ–1, at 2. 6. On September 2, 2014, the Respondent prescribed meperidine to CI. ALJ–1, at 3. The Respondent was the only practitioner to prescribe meperidine to CI. ALJ–1, at 3. CI used meperidine to attempt to commit suicide in December 2014. ALJ–1, at 3. STIPULATIONS OF FACT 3 The Government and the Respondent stipulated to the following facts: 1. Respondent is registered with the DEA as a practitioner to handle controlled substances in Schedules II–V under DEA COR AS2286311 at 405 Marion Avenue, P.O. Box 666, McComb, Mississippi 39648–2709. 2. DEA COR AS2286311 will expire by its terms on February 28, 2018. 3. Respondent is presently licensed in Mississippi as a medical doctor (M.D.) with Medical License 11503. 4. CI is the mother of Kid 1 and Kid 2. 5. Hydrocodone-Acetaminophen 10– 325 (Norco), HydrocodoneAcetaminophen 7.5–325 (Norco), Hydrocodone-Acetaminophen 5–325 (Norco), and Hydrocodone-Homatropine Syrup (Hycodan) are all classified as Hydrocodone Combination Products. 6. Hydrocodone Combination Products are classified by DEA as Schedule II Controlled Substances and have been so classified since October 6, 2014. Before October 6, 2014, Hydrocodone Combination Products were classified by DEA as Schedule III Controlled Substances. 7. Alprazolam is classified by DEA as a Schedule IV Controlled Substance. 3 See E:\FR\FM\17AUN1.SGM ALJ–9, 20; Tr. 9. 17AUN1 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices The Government presented its case through the testimony of nine 4 witnesses. First, the Government called Kendrick Lewis (‘‘Lewis’’). Tr. 24. Lewis is an employee of the Mississippi Bureau of Narcotics (‘‘MBN’’). Tr. 25. Lewis received a complaint against the Respondent on January 18, 2015. Tr. 25. Lewis spoke with CI and her husband, who had made the complaint together. Tr. 25, 29–31. Other than this conversation, Lewis had no further contact with CI. Tr. 28. Based on the nature of the complaint, Lewis contacted MBN’s diversion unit, which began investigating the Respondent. Tr. 26–27, 31. During 2015, Lewis participated in the investigation by assisting with surveillance on March 27, April 8, April 29, and October 16. Tr. 27. Lewis’s testimony was thorough, detailed, and internally consistent. Therefore, I merit it as credible in this Recommended Decision. Second, the Government called Mary Flinchum (‘‘Flinchum’’). Tr. 33. Flinchum is a lieutenant for the MBN and a task force officer for the DEA’s Tactical Diversion Squad. Tr. 33–34. Flinchum received an intelligence report about the Respondent from MBN. Tr. 35. Flinchum interviewed CI and her husband, separately and together, about their complaint to MBN. Tr. 36, 82. Flinchum helped decide that MBN should investigate the Respondent. Tr. 36–37. Flinchum also communicated with the Mississippi State Board of Medical Licensure (‘‘Mississippi Board’’), which was conducting an independent investigation concerning the Respondent. Tr. 58–59. Flinchum was familiar with an undercover investigation of the Respondent during March, April, and October of 2015. Tr. 77–81. Later, Flinchum was recalled to offer further testimony concerning the October 2015 undercover operation. Tr. 449–50. Through Flinchum’s testimony, the Government authenticated and successfully offered into evidence Government Exhibits (‘‘GE-’’) 13 through 21, 27 through 29, 38 through 40, and 53. Tr. 38–57. I find all of these exhibits to be accurate, authentic, and meriting credibility. On cross- examination, the Respondent authenticated and successfully offered into evidence GE–2. Tr. 62–63. I find that Flinchum’s testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision. Third, the Government called Undercover Agent #1 5 (‘‘Agent 1’’). Tr. 89. Agent 1 is a female DEA task force officer and former MBN Agent. Tr. 89– 90. Agent 1 participated in an undercover investigation of the Respondent. Tr. 90–91. Agent 1 attended undercover medical appointments with the Respondent on four occasions in 2015: March 27, April 8, April 29, and October 16. Tr. 91, 102, 111, 119. Agent 1 also accompanied CI to a rendezvous with the Respondent at a Walmart before the second undercover appointment on April 8, 2015. Tr. 128– 29. Through Agent 1’s testimony, the Government authenticated and successfully offered into evidence GE–9 through 12, 24 through 26, 30 through 33, 42 through 47, and 54. Tr. 91–128. I find all of these exhibits to be accurate, authentic, and meriting credibility. I also find that Agent 1’s testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision. Fourth, the Government called Undercover Agent #2 (‘‘Agent 2’’). Tr. 141. Agent 2 is a female MBN agent. Tr. 141. Agent 2 participated in the undercover investigation of the Respondent. Tr. 142. Agent 2 attended an undercover medical appointment with the Respondent on April 29, 2015. Tr. 143. Through Agent 2’s testimony, the Government authenticated and successfully offered into evidence GE– 34 through 37. Tr. 143–51. I find these exhibits to be accurate, authentic, and meriting full credibility. I also find that Agent 2’s testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision. Fifth, the Government called MBN Agent Charles Causey (‘‘Causey’’). Tr. 159. In 2015, Causey assisted with audiovisual surveillance for the DEA and MBN’s undercover investigation of the Respondent on March 27, April 8, April 29, and October 16. Tr. 162–63. Causey testified that the video recordings of these undercover operations may contain incorrect internal date/time stamps, and that the 4 Although the Government also called Antoine Battle to the stand, the Government did not elicit any testimony from Mr. Battle, and he was excused without testifying. Tr. 155–58. 5 Pursuant to the Prehearing Ruling and Protective Order, the identities of the undercover agents are not disclosed in this Recommended Decision. ALJ–9. 8. Phentermine (Adipex) is classified by DEA as a Schedule IV Controlled Substance. 9. Meperidine (Demerol) is classified by DEA as a Schedule II Controlled Substance. mstockstill on DSK3G9T082PROD with NOTICES WITNESSES VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 54829 dates and times on the video recordings do not necessarily correspond to the actual dates and times on which the video recordings were made. Tr. 165– 66. I find that Causey’s testimony was thorough, detailed, and internally consistent. Therefore, I merit his testimony as credible in this Recommended Decision. Sixth, the Government called Leslie Ross (‘‘Ross’’). Tr. 168. Ross is an investigations supervisor for the Mississippi Board and a task force officer for the DEA’s Tactical Diversion Squad. Tr. 168–69. The Mississippi Board reviews and issues medical licenses, promulgates rules and regulations for the practice of medicine in Mississippi, investigates complaints about Mississippi licensees, and imposes disciplinary action when necessary. Tr. 170. Several days before the Mississippi Board closed its investigation concerning the Respondent, Ross received a call from Agent Flinchum, advising Ross that the DEA and the MBN were investigating the Respondent. Tr. 194–95, 210. Ross explained that the phone call influenced the Mississippi Board’s decision to close its case because it was the Mississippi Board’s custom ‘‘to back off and let a criminal agency pursue their case.’’ Tr. 210. Without interviewing CI, the Mississippi Board closed its investigation. Tr. 196. Ross also helped author part of Mississippi Administrative Rule 1.5, which regulates diet medication prescriptions in Mississippi. Tr. 172. Ross established the foundation for the Court to take official notice of Mississippi Administrative Rules 1.1, 1.2, 1.4, 1.10, and 1.16. Tr. 188–93. Additionally, while Ross did not conduct the Mississippi Board’s investigation of the Respondent, she supervised Todd Pohnert, who conducted the investigation. Tr. 170, 173. Ross served administrative subpoenas for information about the Respondent to two Mississippi pharmacies, one in McComb and one in Brookhaven. Tr. 185. I find that Ross’ testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision. Through Ross’ testimony, the Government authenticated and successfully offered into evidence GE–3 and 8. Tr. 171–78. I find these exhibits to be accurate, authentic, and meriting credibility. Furthermore, through Ross’ testimony, the Government established some foundation for GE–7 and 55. Tr. 185–88. Seventh, the Government called CI. Tr. 212. CI testified about her relationship with the Respondent and E:\FR\FM\17AUN1.SGM 17AUN1 54830 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES how and why she obtained controlled substance prescriptions from him. Tr. 212–31.6 Through CI’s testimony, the Respondent admitted GE–49, 56, and 57. Tr. 284, 300–03, 335–38. I find these exhibits to be generally accurate, authentic, and meriting credibility. I also find that CI’s testimony was generally forthright, internally consistent, and generally merited credibility 7 in this Recommended Decision. Eighth, the Government called James Pacheco (‘‘Pacheco’’). Tr. 385. Pacheco is an agent for the MBN and a task force officer for the DEA’s Tactical Diversion Squad. Tr. 386. Pacheco participated in the undercover investigation of the Respondent by coordinating the surveillance aspect of the investigation. Tr. 388. Pacheco assisted with physical surveillance of the Respondent and CI during an undercover operation at a Walmart on April 8, 2015. Tr. 388–89. Pacheco personally observed most of the operation at Walmart. Tr. 389. Pacheco also testified that he listened to the undercover operation conducted at the Respondent’s clinic in October 2015. Tr. 406–07. Through Pacheco’s testimony, the Government authenticated and successfully offered into evidence GE– 22 and 23. Tr. 387–93. I find these exhibits to be accurate, authentic, and meriting credibility. I also find that Pacheco’s testimony was thorough, detailed, and internally consistent. Therefore, I merit his testimony as credible in this Recommended Decision. The Government’s ninth witness was Maria Gilbert (‘‘Gilbert’’). Tr. 409. Gilbert is a DEA diversion investigator, and was a case agent in the investigation 6 The Respondent asked CI extensively about an exhibit, pre-marked for identification as Respondent’s Exhibit (‘‘RE-’’) 1. See generally Tr. 231–73. However, the Respondent never offered RE–1 into evidence. Therefore, the contents of RE– 1 are not considered in this Recommended Decision. 7 There were some inconsistencies in CI’s lengthy testimony. First, when asked if she paid cash for prescriptions from the Respondent, CI answered that she believed she always used insurance. Tr. 360. However, CI’s Prescription Monitoring Program report shows that, in 2014, CI paid for prescriptions from the Respondent with cash 15 times, and used her insurance only 5 times. See GE–49, at 1–3. Second, CI suggested that it was the Respondent’s idea for CI to send a friend into his office to get prescriptions for her. Tr. 345–47. However, audio recordings of the Respondent’s telephone calls with CI suggest that it was CI’s idea for her to send a friend into the Respondent’s office to get prescriptions for CI. See GE–16, file 2015–03– 16_18–51–48_EDT, at 20–21; GE–16, file 2015–03– 18_11–03–33_EDT, at 2. Third, CI testified that the Respondent only conducted a physical examination of her one time. Tr. 322. The Respondent’s patient file for CI seems to indicate, however, that the Respondent gave CI some sort of examination on both April 21 and September 2 of 2014. GE–2, at 12. In these three instances, I do not find CI’s testimony credible. VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 of the Respondent. Tr. 409–10. Gilbert helped submit the evidence acquired by the undercover agents into a DEA evidence locker. Tr. 440. Gilbert also directed DEA personnel to obtain Prescription Monitoring Program (‘‘PMP’’) reports during the investigation. Tr. 438. Gilbert created the administrative subpoenas issued to pharmacies to obtain information about the Respondent. Tr. 412. Gilbert helped conduct an administrative search of the Respondent’s office. Tr. 427–28. Through Gilbert’s testimony, the Government authenticated and successfully offered into evidence GE–7, 41, 48, 50 through 52, 55, and 58 through 60. Tr. 411–18, 427–39. I find these exhibits to be accurate, uncontested, and meriting credibility. I also find that Gilbert’s testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision. The Respondent did not call any witnesses or offer any of his proposed exhibits into evidence. Tr. 458. The factual findings below are based on a preponderance of the evidence, including the detailed, credible, and competent testimony of the aforementioned witnesses, the exhibits entered into evidence, and the record before me. FACTUAL FINDINGS 1. The Respondent has not previously been convicted of any crime related to controlled substances. GE–1, at 1. The Respondent has never had his state medical license revoked, suspended, denied, restricted, or placed on probation. GE–1, at 1. The Respondent’s Relationship with CI 2. The Respondent and CI became Facebook friends and began talking with each other in January 2014. Tr. 213, 237. CI asked the Respondent questions about the health of Kid 1.8 Tr. 213–14, 246–47, 261–62. The Respondent performed a tonsillectomy on Kid 1 and placed tubes in his ears on January 30, 2014. GE–57, at 13, 19–20; Tr. 219, 235, 285. Following Kid 1’s tonsillectomy, CI asked the Respondent for medication for Kid 1’s medical condition; the Respondent was willing to write prescriptions for Kid 1. GE–57, at 5–6; Tr. 246–47, 249. Around that time, CI and the Respondent became friends and began texting and talking on the phone. Tr. 213–14, 240. 3. In the spring of 2014, CI and the Respondent began to have a consensual sexual relationship. Tr. 213, 218–19, 8 See PO 00000 Stipulation (‘‘Stip.’’) 4; see also ALJ–9, at 5. Frm 00045 Fmt 4703 Sfmt 4703 290–92, 296, 359. During the summer of 2014, CI and the Respondent saw each other very often. Tr. 324. CI and the Respondent communicated frequently by texting and calling each other on their cell phones. Tr. 355–56. 4. CI engaged in a sexual affair with the Respondent because she was infatuated with him and because she wanted to obtain controlled substances for her recreational use. Tr. 291–92. The controlled substances, however, were not a prerequisite for sexual relations. Tr. 289. 5. The sexual relationship between CI and the Respondent ended in November 2014. Tr. 219. A. The Respondent’s Medical Treatment of CI and Her Children 6. The Respondent provided medical treatment to CI several times, beginning in 2010. GE–2, at 12–13; Tr. 215, 277. Specifically, the Respondent treated CI for a sinus infection, vertigo, and migraines. GE–2, at 12–13; Tr. 215, 277– 78, 287, 321. CI had a serious migraine condition that caused her to seek treatment in emergency rooms on four occasions. Tr. 278–80, 347. CI discussed her migraines and hospitalizations with the Respondent, who gave her information about migraines. Tr. 282, 287. The Respondent prescribed Maxalt 9 to CI to treat her migraines. GE–2, at 12; Tr. 215–16, 283. 7. The Respondent had a patient file for CI and wrote notes therein about her treatment. See GE–2, at 12–13. The Respondent conducted two physical examinations of CI, once when he was treating her for a sinus infection, and again when he was treating her for a migraine headache.10 GE–2, at 12–13; Tr. 322. The Respondent also requested a CT 11 sinus scan for CI in 2014. GE– 2, at 12, 14. A CT scan showed that CI’s sinuses were ‘‘clear [and] scant thickening in LNF duct.’’ GE–2, at 14. 8. CI took Kid 1 and Kid 2 to appointments with the Respondent. Tr. 219, 261–62, 285–86, 335–36, 338; see, e.g., GE–56, at 3–4; GE–57, at 6, 9–10. The Respondent conducted legitimate medical procedures on both children and saw the children for follow-up appointments. GE–56, at 3–4; GE–57, at 5–6; Tr. 219, 261–62. 9. CI sent the Respondent at least one message via social media requesting his medical advice about Kid 1’s condition. Tr. 262–63. CI communicated with the Respondent about the physical 9 Maxalt, or rizatriptan benzoate, is not a federally controlled substance. See generally 21 CFR §§ 1308.11–1308.15 (2015). 10 See supra note 7. 11 Computerized tomography. E:\FR\FM\17AUN1.SGM 17AUN1 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES condition of her children to get his medical advice. Tr. 263–65. 10. Near a date stamp reading ‘‘February 4, 2014,’’ the Respondent recorded in Kid 1’s medical file that CI had migraines, that she may call in for a prescription if needed, and that he discussed phentermine 12 with her. GE– 57, at 6; see Tr. 286. The Respondent’s patient file for CI also contains a telephone request form, dated July 18, 2014, and signed by the Respondent, which states that CI requested a phentermine refill. GE–2, at 15. CI’s patient file, however, does not note any reasons that the Respondent prescribed phentermine to CI. See GE–2, at 12–13. B. CI’s Drug Use 11. Prior to her relationship with the Respondent, CI took controlled substances, including hydrocodone, which were prescribed by numerous other doctors to help treat pain resulting from four lithotripsies, kidney stones, a broken tailbone, a root canal, and TMJ 13. GE–49, at 2; Tr. 214, 275–76, 304–09. CI told the Respondent about these prescriptions. Tr. 309. 12. CI occasionally used Adderall for nonmedicinal purposes. Tr. 215. CI had not used cough syrup for nonmedicinal purposes prior to her relationship with the Respondent. Tr. 215. 13. After Kid 1 had his tonsils removed on January 30, 2014, CI took some of Kid 1’s pain medication. Tr. 273–74, 276. As a result of the tonsillectomy, the Respondent prescribed two different forms of hydrocodone for Kid 1. GE–51, at 1; GE– 57, at 6, 14, 22. 14. The Respondent first prescribed cough syrup for Kid 2 on January 24, 2014. GE–50, at 1; GE–56, at 4. The Respondent again prescribed cough syrup for Kid 2 in February 2014. Tr. 216, 258–59; GE–50, at 1; GE–56, at 4. The Respondent did not examine Kid 2 before he prescribed cough syrup for her. Tr. 217, 251; see GE–56, at 4. 15. CI talked with the Respondent about prescribing a ‘‘big bottle’’ of cough syrup so that CI could drink it. Tr. 216, 251–52, 268, 273. CI thought that the Respondent knew she did not have a cough. Tr. 216, 251–52, 268. In February 2014, CI asked the Respondent to prescribe 14 a ‘‘big bottle’’ of hydrocodone cough syrup for Kid 2. Tr. 216–17, 250, 252–53, 259. At that time, 12 CI denied asking the Respondent for phentermine in February 2014. Tr. 286–88. Phentermine is another name for Adipex. See Stip. 8; Tr. 288. 13 Temporomandibular joint dysfunction, or lockjaw. 14 CI later testified that this was a refill of a prescription written by the Respondent. Tr. 272–73. VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 CI told the Respondent that Kid 2 had a cough. Tr. 250–51, 253–55. On February 7, 2014, the Respondent doubled the size of Kid 2’s prescription for cough syrup. GE–50, at 1; GE–55, at 1–2. 16. CI told the Respondent when Kid 1 or Kid 2 had a cough. Tr. 250. CI, however, did not bring her children to see the Respondent regarding a cough; she requested cough syrup from the Respondent because she liked drinking it. Tr. 220, 273; see generally GE–56, at 3–4; GE–57, at 5–6. 17. The Respondent prescribed Norco, Xanax, and Adipex to CI on multiple occasions. Tr. 26; GE–49. The Respondent prescribed Norco 15 to CI, which she took daily instead of as needed. Tr. 297. CI took hydrocodone ‘‘[j]ust for fun.’’ Tr. 298. CI would tell the Respondent when she ran low on a prescription, and he would give her another prescription.16 Tr. 298–99. He advised her that hydrocodone could cause migraines. Tr. 298–99. 18. On several occasions, the Respondent provided prescriptions to CI while he was at CI’s house. Tr. 217–18; see Tr. 26. On those occasions, the Respondent did not communicate a diagnosis to CI or perform a physical examination of CI. Tr. 218. Sometimes, CI took her children to appointments with the Respondent as an excuse to see the Respondent, who would then occasionally give prescriptions to CI. Tr. 219–20. On one occasion, the Respondent met CI in the garden section of a Walmart, where he gave her prescriptions for cough syrup and pain medication. Tr. 218. 19. At times, CI told the Respondent about her children’s pain or physical conditions to get prescriptions for her own personal use. Tr. 267. CI would occasionally administer the prescribed medication to her children. Tr. 270–72. 20. CI requested that the Respondent write a prescription for Adderall for her, but he declined to do so. Tr. 223. In the spring of 2014, CI asked the Respondent to write her a prescription for Adipex, a weight loss drug. Tr. 223–24, 288–89. The Respondent wrote prescriptions and refills for Adipex to CI. GE–49, at 1–2; Tr. 223–24. CI used Adipex for 15 Norco is a hydrocodone combination product. See Stip. 5. 16 Specifically, CI testified that when she ran low on a prescription, the Respondent would refill it. Tr. 298–99. Refills are not authorized for hydrocodone combination products, such as Norco. Compare 21 U.S.C. § 829(a), with Stip. 6. The record does not contain any evidence that the Respondent attempted to give CI a refill on a hydrocodone combination product. Therefore, I interpret CI’s statement as meaning that whenever she ran low on a prescription, she would tell the Respondent, and he would issue another prescription to her. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 54831 approximately three months. Tr. 224. The Respondent did not conduct a physical examination of CI focused on weight issues at any point before or while CI took Adipex, and the Respondent did not discuss alternative weight loss treatments with CI. Tr. 224– 25; see GE–2, at 12–13. 21. CI had anxiety, which she discussed with the Respondent. Tr. 322. The Respondent told her to visit a certain psychiatrist. Tr. 225, 295. CI visited that psychiatrist twice. Tr. 225. The psychiatrist prescribed a low dosage of time-release Xanax 17. Tr. 225, 295, 304; see GE–49, at 1. The Respondent then prescribed 18 a stronger dosage of Xanax to CI. Tr. 226; see GE–49, at 1. 22. The Respondent wrote nine prescriptions 19 to CI, contained in GE– 7 and 41, which are not documented in the Respondent’s patient file for CI. Compare GE–2, at 12–13 (containing the Respondent’s patient file for CI), with GE–7, at 1–2 (containing a prescription written by the Respondent to CI), and GE–41 (containing prescriptions written by the Respondent and filled by CI), and GE–49 (containing CI’s PMP report); see Tr. 364–77. The Respondent’s patient file for CI does not include any notes from any examinations on the dates on which the Respondent wrote these nine prescriptions. GE–2, at 12–13. CI did not have a physical examination or receive counseling before the Respondent gave her any of these prescriptions. Tr. 384; see GE–2, at 12–13.20 17 Xanax is a brand name for alprazolam, which is a benzodiazepine and a Schedule IV controlled substance. Stip. 7; see 21 CFR § 1308.14(c)(2); Tr. 304. 18 CI testified that this prescription was a refill prescription, but that it was for a different dosage. Tr. 295–96. 19 Seven of these prescriptions, written to CI in 2014, were as follows: May 19 for Adipex; May 22 for Norco; June 17 for Norco; July 24 for Adipex; September 8 for Adipex; September 11 for Norco; and October 6 for Xanax. Compare GE–2, at 12–13, with GE–41, at 1–7, 12–13, and 18–23, and GE–49. The Respondent wrote another prescription for Adipex to CI on April 9, 2014. Compare GE–2, at 12–13, with GE–7, at 1–2, and GE–49. The Respondent also wrote a prescription for Hycodan to CI, dated December 3, 2014, but CI’s PMP report said that the prescription was written on December 4, 2014. Compare GE–41, at 28–29, with GE–49. Regardless of when this prescription was actually written, it was not documented in CI’s patient file. See GE–2, at 12–13. 20 CI testified about a prescription that is not in GE–41. Tr. 364, 369–70. The prescription allegedly was written in her name by the Respondent. Tr. 369–70. The prescription allegedly was dated October 29, 2014. Tr. 369–70. The Respondent’s PMP report likewise lists a prescription for hydrocodone-acetaminophen (Norco) prescribed by the Respondent on October 29, 2014. GE–49, at 1. However, neither of the two copies of GE–41 submitted to me includes this prescription. Examination of both submitted copies of GE–41 E:\FR\FM\17AUN1.SGM Continued 17AUN1 54832 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices 23. Two prescriptions written by the Respondent to Kid 1 are not documented in Kid 1’s medical chart. Compare GE–51 (containing Kid 1’s PMP report and listing prescriptions from June 17 and November 19 of 2014), and GE–55, at 3–4, 11–12 (containing prescriptions from June 17 and November 19 of 2014), with GE–57 (containing Kid 1’s medical file, which does not include any examination or prescription notes for June 17 or November 19 of 2014); see also Tr. 377– 81. Likewise, a prescription written by the Respondent to Kid 2 is not documented in Kid 2’s medical chart. Compare GE–50 (containing Kid 2’s PMP report and listing a prescription written on July 23, 2014), and GE–55, at 5–6 (containing a prescription dated July 23, 2014), with GE–56 (containing Kid 2’s medical file, which does not include any examination notes or prescription notes for July 23, 2013). 24. On one occasion in early fall of 2014, following CI’s complaint of a severe migraine, the Respondent prescribed Demerol to CI. Tr. 222, 296– 97, 317–18, 382. Next to the date ‘‘September 2, 2014’’ in CI’s medical chart, the Respondent wrote that he refilled her prescription of phentermine, looked at her ears and nose, and counselled her. GE–2, at 12; Tr. 323. He also wrote that he prescribed Demerol and Xanax to CI. GE–2, at 12. CI did not ask the Respondent for Demerol. Tr. 296, 318. 25. CI’s husband discovered that CI was having an affair with the Respondent. Tr. 26, 320. Sometime after the discovery, in December 2014, CI attempted suicide using the Demerol the Respondent prescribed to her. Tr. 222, 314–17. CI went to a mental institution for a week following her suicide attempt. Tr. 227, 309. In January 2015, CI told the Respondent that she had tried to kill herself. Tr. 226–27, 309–11. mstockstill on DSK3G9T082PROD with NOTICES C. The MBN Complaint 26. After CI’s husband discovered the affair and CI attempted to commit reveals that no pages of GE–41 are missing. At the hearing, however, Government counsel provided CI with an excerpt of what he said was ‘‘part of Exhibit 41,’’ and he provided the Respondent and the ALJ with a copy of what was handed to the witness. Tr. 364. That excerpt has now been included in the administrative record as ALJ–29. Comparing ALJ– 29 with GE–41, I have determined that the witness did, in fact, examine a prescription dated October 29, 2014. That prescription, however, was never offered into evidence. Furthermore, the witness was never asked if the prescription, dated October 29, 2014, refreshed her memory of having received the prescription. Accordingly, I decline to find that the Government presented sufficient evidence to establish that the Respondent wrote a prescription to CI on October 29, 2014. Following the hearing, the parties were provided with copies of ALJ–29. VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 suicide, CI and her husband made a complaint against the Respondent to the MBN. Tr. 25, 29–31, 71, 228–29, 339– 40. CI told MBN investigators that she got medications from the Respondent for nonmedicinal purposes because she enjoyed using them. Tr. 84. D. The Anonymous Letter 27. The Mississippi Board received an unsigned letter, allegedly from CI’s husband, which complained about the extramarital affair between CI and the Respondent. GE–3, at 3; Tr. 58, 66. The Mississippi Board and MBN both received a copy of the letter. Tr. 66–67, 70–71, 398–99. Several witnesses testified that CI’s husband was not the author of this letter. Tr. 67–70, 326, 394, 396. The author of the letter is unknown. Tr. 67–70, 201, 326, 394–95. 28. The letter was written in the first person, and CI’s husband’s name was typewritten on the bottom of the letter, along with CI’s date of birth and social security number. GE–3, at 3. The letter said that the author’s wife, CI, had an affair with the Respondent for over a year, and that the author did not know about it until he found a box of empty pill bottles that the Respondent had prescribed to CI, even though CI was not his patient. GE–3, at 3. The letter was stamped as received by the Mississippi Board on February 19, 2015. GE–3, at 3. 29. By the time the MBN received a copy of the letter, it had already begun its investigation of the Respondent because of the complaint made by CI and her husband. Tr. 71, 74–76. After receiving a copy of the letter, the Mississippi Board began conducting an independent investigation of the Respondent. Tr. 58, 61, 203. E. The Mississippi Board Investigation 30. A Mississippi Board investigator met with the Respondent regarding the anonymous letter. GE–3, at 4–6. At that time, the Mississippi Board was unaware that the DEA was conducting a simultaneous investigation of the Respondent. Tr. 180. 31. In response to the investigator’s inquiry, the Respondent said that he only saw CI when she or her children had appointments, and had not seen CI outside of his office. GE–3, at 5; Tr. 179, 202. The Respondent suggested that he had not engaged in sexual misconduct with CI. GE–3, at 5; Tr. 180, 207. The Respondent also suggested that he was not aware that CI had attempted to commit suicide or had been committed to a mental hospital. GE–3, at 5, 7. 32. The investigator made copies of CI’s patient charts and found several shortcomings with CI’s medical records. GE–3, at 4–5; Tr. 180, 197. First, the PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 investigator found seven prescriptions in CI’s PMP report that were not documented in the Respondent’s patient file for CI. GE–3, at 5. The Respondent explained that he might have documented the missing prescriptions in his patient files for CI’s children instead. GE–3, at 5. 33. Second, the investigator found that CI’s patient file did not include any notes about CI’s vitals, height/weight, BMI, or alternative weight control treatment plans, and did not indicate that CI received any counseling about other weight loss options. GE–3, at 5; Tr. 180. 34. Following the investigator’s visit, the Mississippi Board sent the Respondent a copy of the anonymous letter purportedly from CI’s husband.21 See GE–2, at 6–8. The investigator told the Respondent that he should send a letter to the Mississippi Board as a follow-up from the investigator’s visit. GE–3, at 5; Tr. 179. 35. The Respondent sent a letter to the Mississippi Board. GE–3, at 7–8; Tr. 179–80. Therein, the Respondent denied knowing that CI had overdosed.22 GE– 3, at 7; Tr. 180. The Respondent stated that he was ‘‘appalled, outraged, and disgusted’’ by the anonymous letter’s allegations. GE–3, at 7; Tr. 208. The Respondent wrote that the medications CI used to overdose ‘‘were legitimately prescribed for valid medical problems.’’ GE–3, at 7. The Respondent wrote that he was unaware that CI had received controlled substances from other prescribers and that CI did not show ‘‘any hint of drug-seeking behavior.’’ GE–3, at 7. The Respondent acknowledged that he should not refill medications for a parent during a child’s visit without pulling the parent’s chart, and said that he would not do so in the future. GE–3, at 7. The Respondent stated that he would not refill diet drugs for patients in the future without completing the appropriate documentation. GE–3, at 7. 36. The Mississippi Board contemplated closing its investigation of the Respondent because it did not have enough evidence supporting the allegations of the Respondent’s sexual misconduct. Tr. 181, 184, 194–95, 197, 209–10. Throughout the course of its investigation, however, the Mississippi Board never interviewed CI. Tr. 196. 37. On March 20, 2015, while the Mississippi Board was contemplating closing its investigation, Flinchum 21 The handwritten notation on the bottom of the letter was likely added by a Mississippi Board investigator. Tr. 87; see GE–2, at 6. 22 Specifically, the Respondent wrote that he was ‘‘sorry to learn that [CI] may have deliberately taken an overdose.’’ GE–3, at 7. E:\FR\FM\17AUN1.SGM 17AUN1 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES contacted the Mississippi Board and requested, on the DEA’s behalf, that the Mississippi Board discontinue its investigation of, and communication with, the Respondent. GE–3, at 2; Tr. 60–61, 181, 209. The Mississippi Board customarily will discontinue an investigation to allow a criminal agency to pursue a case. Tr. 210. 38. The Mississippi Board closed its investigation of the Respondent on March 23, 2015. GE–3, at 1; Tr. 181. A letter from the Mississippi Board to the Respondent terminated the Board’s investigation. GE–3 at 1; Tr. 183. The letter stated that the Mississippi Board concluded its investigation and that, after a thorough review of the information and facts from the investigation, it decided not to recommend any formal action. GE–3, at 1. This letter was a truthful and accurate reflection of the Board’s reasons for terminating the investigation. Tr. 64–65, 86, 195–97. 39. The letter also cautioned the Respondent against ‘‘authorizing refills for Phentermine/Adipex without benefit of a medical examination.’’ GE–3, at 1 (discussing Mississippi Administrative Rule 1.5(E)). 40. The letter told the Respondent that the Mississippi Board had found some deficiencies with his medical records. Tr. 181, 183–84, 203. The letter did not exonerate the Respondent, but warned him about his inadequate documentation of weight loss prescriptions. Tr. 184, 203. F. DEA Undercover Operations 41. The DEA began undercover operations concerning the Respondent in March 2015. Tr. 77–78. 42. CI was told that if she cooperated with law enforcement, she would not be in any trouble. Tr. 342–43. CI signed a confidential informant agreement with the DEA. Tr. 343–44, 394. 43. The DEA instructed CI not to have any contact 23 with the Respondent unless the DEA supervised the contact. Tr. 350. CI did not comply with this instruction and met the Respondent one time without DEA’s supervision. Tr. 353, 358. 44. With CI’s consent, the DEA gave CI a telephone number that recorded all calls and text messages exchanged between CI and the Respondent. Tr. 37– 38, 84–85, 230. This telephone number operated through an application that the DEA installed on CI’s cellular phone. Tr. 382. This application automatically 23 The DEA did not ask CI to attend an undercover appointment with the Respondent because CI had a physical relationship with the Respondent, and because CI said that she was addicted to cough syrup. Tr. 400. VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 recorded all calls, conversations, and multimedia messages exchanged between CI and the Respondent. Tr. 37– 38, 85–86. 45. CI called and texted the Respondent outside of the presence of MBN and DEA agents. Tr. 85–86. The DEA did not tell CI what to say to the Respondent. Tr. 85–86. i. Interactions Between the Respondent and CI Before the First Undercover Appointment 46. The DEA agents asked CI to contact the Respondent by phone or by text message and ask him for Norco and cough syrup. Tr. 346, 348–49. 47. On March 16, 2015, at approximately 6:51 p.m., the Respondent and CI spoke on the phone. GE–15–16. CI asked the Respondent to meet her at Walmart and give her a prescription for something. GE–16, file 2015–03–16_18–51–48_EDT, at 19; see Tr. 345. The Respondent said he could not do that because the Mississippi Board was watching him and he could go to jail or lose his license. GE–16, file 2015–03–16_18–51–48_EDT, at 19–20; see Tr. 230, 345–47. He said that everything he had prescribed to CI was legitimate and written in her chart. GE– 16, file 2015–03–16_18–51–48_EDT, at 20. After CI again asked the Respondent several times to give her a prescription, CI asked him instead to write a prescription for someone else.24 Id. The Respondent said he could prescribe to anyone who came into his office, and what they did with their prescriptions was ‘‘their business,’’ but that it had ‘‘to be a legitimate thing.’’ Id. at 21. CI asked him multiple times to write prescriptions for her, but in different names, and the Respondent said he could not do so without someone coming for a visit and having a chart. Id. The Respondent said he could ‘‘probably pilfer’’ some medication from his wife for CI. Id. at 22. CI repeatedly asked the Respondent to get her some controlled substances, and the Respondent repeatedly said he would see what he could do. Id. at 24–26. 48. On March 17, 2015, at approximately 1:07 p.m., the Respondent and CI spoke on the phone. GE–15–16. CI asked the Respondent to slip ‘‘a couple Lorcets’’ into her mailbox. GE–16, file 2015–03–17_13– 07–36_EDT, at 4. The Respondent joked, ‘‘I need to learn to play the guitar so you could be getting sex, drugs and rock and roll, you know.’’ Id. CI asked the Respondent to ‘‘sneak [her] some meds.’’ Id. at 7. The Respondent said, 24 Contra PO 00000 Tr. 346; see supra note 7. Frm 00048 Fmt 4703 Sfmt 4703 54833 ‘‘I’ve got your request and I’m telling you that is highly, highly dangerous for me.’’ Id. 49. On March 18, 2015, at approximately 11:03 a.m., the Respondent and CI spoke on the phone. GE–15–16. CI suggested that the Respondent could write a prescription in Kid 1’s name. GE–16, file 2015–03– 18_11–03–33_EDT, at 1. The Respondent responded sarcastically and attempted to change the subject. Id. at 1–2. CI said that she really needed him to find a way to write her a prescription. Id. at 2. The Respondent said he did not know how to do that. Id. CI suggested that he could write a prescription in someone else’s name. Id. The Respondent said he would ‘‘have to have somebody that’s legitimate’’ and ‘‘what they did with the medicine[,] that was up to them . . . somebody that’s trustworthy.’’ Id. at 3. The Respondent indicated that it was like a ‘‘federal crime when you write medicine to—that are diverted to somebody else.’’ Id. CI said that the Respondent used to write her prescriptions ‘‘all the time.’’ Id. The Respondent said, ‘‘Yeah, but I wrote it for you.’’ Id. CI recalled that the Respondent ‘‘used to bring [his] prescription pad over and a bottle of vodka,’’ and that she ‘‘miss[ed] those days.’’ Id. The Respondent replied, ‘‘I know, me too.’’ Id. The Respondent joked with CI that it was good to have a boyfriend with a prescription pad. Id. at 4. 50. On March 25, 2015, at approximately 10:36 a.m., the Respondent and CI spoke on the phone. GE–17, at 1–5.25 CI asked the Respondent if he would write a prescription to another person. GE–17, at 2. The Respondent remarked that it was dangerous and it would have to be to an established patient; he suggested that she get another doctor to write a prescription for her. GE–17, at 2. CI insisted, and the Respondent said ‘‘it has to be legitimate’’ and for a ‘‘legitimate patient’’ because the Mississippi Board was watching him. GE–17, at 2. The Respondent said he could treat a patient for CI if the patient had headaches and anxiety. GE–17, at 3. The Respondent said, ‘‘what he does with ’em is his business.’’ GE–17, at 3. CI asked the Respondent if he would write something to her friend who came in with a headache; the Respondent said, ‘‘Yeah, I could write him something.’’ GE–17, at 3. CI clarified that the prescription would really be for her, and requested that he prescribe ‘‘Lorcet or something;’’ the Respondent said, ‘‘Yeah, I could write him some— 25 See E:\FR\FM\17AUN1.SGM GE–16, file 2015–03–25_10–36–40_EDT. 17AUN1 mstockstill on DSK3G9T082PROD with NOTICES 54834 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices yeah, some stuff like that.’’ GE–17, at 3. The Respondent cautioned CI that taking too many Lorcet or Demerol would be harmful and painful to her. GE–17, at 4. CI said she just wanted ‘‘some pain pills from [her] boyfriend.’’ GE–17, at 4. 51. On March 25, 2015, at approximately 11:43 a.m., the Respondent texted CI, ‘‘I won’t be in the office tomorrow. I could see her Friday.’’ GE–53, file 2015–03–25_11– 43–42_EDT. CI texted back, ‘‘Ok:) she is a real cool girl. I use [sic] to party with her.’’ GE–53, file 2015–03–25_11–47– 23_EDT; see Tr. 349. 52. On March 25, 2015, at approximately 2:36 p.m., the Respondent and CI spoke on the phone. GE–17, at 6–8.26 The Respondent asked CI for her friend’s name. GE–17, at 6– 8. CI told the Respondent the alias first name of Agent 1. GE–17, at 6–7. The Respondent said, ‘‘If she’s coming in for what I think she’s coming in, tell her not to tell me that. That needs to be your secret. I don’t wanna know that. She needs to have a headache and I will treat her for a headache, and so [I] don’t mind giving her prescriptions to treat a headache.’’ GE–17, at 7. The Respondent discussed the medications he could prescribe to Agent 1 and told CI that they ‘‘would be perfectly appropriate for you to take.’’ GE–17, at 7; see Tr. 349 (noting that the Respondent knew that Agent 1 was not a real patient and that medication prescribed to Agent 1 would be given to CI). 53. On March 26, 2015, at approximately 11:18 a.m., the Respondent and CI spoke on the phone. GE–18.27 CI told the Respondent that Agent 1 had an appointment with him ‘‘tomorrow at 2:00—2:10, I think.’’ GE– 18, at 3. The Respondent replied, ‘‘Okay. We’ll see if we can’t get my girlfriend fixed up.’’ GE–18, at 3. The Respondent said CI should remind Agent 1 to ‘‘play it straight’’ and tell the Respondent what he to needed to write on a chart to ‘‘keep the medical examiners at bay . . . .’’ GE–18, at 3. CI asked him if he would prescribe Norco to Agent 1. GE–18, at 3. The Respondent said, ‘‘Yeah, I’ll write her Norco and some more Maxalt, and then you can have some Maxalt also. Just remember to hide it.’’ GE–18, at 3. 54. Based on Findings of Fact 47 through 53 and the transcript at pages 91, 230, and 349, I find that, by the time the Respondent met with Agent 1 on March 27, 2015, the Respondent knew that Agent 1 was not a legitimate patient 26 See 27 See GE–16, file 2015–03–25_14–36–02_EDT. GE–16, file 2015–03–26_11–18–28_EDT. VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 and that any medication he prescribed to her at that appointment would be given to and used by CI. ii. Undercover Appointment #1: March 27, 2015 55. Agent 1’s first appointment with the Respondent was on March 27, 2015. GE–10; Tr. 91. Upon arriving at the Respondent’s clinic, Agent 1 signed in, completed paperwork, and waited in the Respondent’s waiting room. GE–9; Tr. 92. The Respondent’s nurse called Agent 1 back into an examination room and spoke briefly with her. GE–9; Tr. 92, 94. 56. Agent 1 met with the Respondent. GE–9–10; Tr. 91; see GE–59 (containing the Respondent’s patient file for Agent 1). The appointment lasted approximately seven minutes. GE–9. When the Respondent asked Agent 1 what her problem was, she told him, ‘‘Just kind of a whole head thang [sic].’’ GE–10, at 1; Tr. 94. The Respondent asked Agent 1 how long her head had been bothering her, and she indicated just a few days. GE–9–10. The Respondent quickly looked into Agent 1’s ears, nose, and throat. GE–9–10; Tr. 94, 132. The Respondent asked her if she was dizzy, nauseous, or taking other medication. GE–9–10. He advised her that Maxalt works well for sinus headaches and gave her instructions for taking her prescriptions. GE–9–10. The Respondent did not communicate any diagnosis to Agent 1, nor did he record a diagnosis in her patient file.28 GE–9– 10; GE–59, at 4. 57. Agent 1 asked the Respondent if he could help her with her weight loss. GE–9–10. The Respondent declined to prescribe anything for weight loss to Agent 1; he said that it was not his area of expertise and it was heavily regulated by the Mississippi Board. GE–10, at 2. He recommended that she could go to a licensed diet center for assistance. GE– 10, at 3. 58. The Respondent wrote two prescriptions for Agent 1: one nonrefillable prescription for Norco, and one refillable prescription for Maxalt. GE–11–12; Tr. 95. The Respondent told Agent 1 that he would give her ‘‘lots of refills’’ on the Maxalt. GE–10, at 1. 59. That same day, CI and the Respondent had a phone conversation about the Respondent’s meeting with CI’s ‘‘friend,’’ Agent 1. GE–13–14; GE– 20, file Post Buy CI Call With STEWART 3–27–2015. The Respondent 28 The Respondent’s March 27, 2015 notes in Agent 1’s patient file mention photophobia. GE–59, at 4. The transcript and recording of the office visit, however, contain no mention of photophobia or any discussion of the symptoms of photophobia. GE–9– 10. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 said he enjoyed meeting Agent 1 and that he was ‘‘hopeful that that helps’’ CI. GE–14, at 1. CI said that she could get through because the Respondent ‘‘hooked’’ her up. GE–14, at 1. The Respondent responded, ‘‘absolutely that needs to be about as discreet as [unintelligible].’’ GE–14, at 1. The Respondent told CI to ‘‘not take that other stuff but one at a time.’’ GE–14, at 1. He said that, during Agent 1’s appointment, he ‘‘talked about headaches and pretty much left it exactly at that.’’ GE–14, at 1. The Respondent told CI, ‘‘[s]o um you got refills on that Maxalt. Um she does,’’ and noted that he could not give refills ‘‘on the other one . . ..’’ GE–14, at 2. iii. Interactions Between the Respondent and CI Between the First and Second Undercover Appointments 60. On April 1, 2015, at approximately 8:28 p.m., the Respondent and CI spoke on the phone. GE–19.29 CI said that she spent time with Agent 1. GE–19, at 1. The Respondent asked her, ‘‘So that all went smooth with getting your medicine and all that?’’ GE–19, at 1; see Tr. 230–31. CI said she might need some more. GE– 19, at 1. The Respondent said he was glad he could help and that it was ‘‘just because of’’ the Mississippi Board complaint that ‘‘it just has to be straight up and clean.’’ GE–19, at 1. 61. On April 2, 2015, at approximately 2:15 p.m., the Respondent and CI spoke on the phone. GE–16, file 2015–04–02_14–15–50_EDT. CI told the Respondent that Agent 1 would come back and that she ‘‘took all’’ after CI ‘‘halved some with her.’’ Id. CI asked the Respondent if he could ‘‘give her a little bit more if she’d come back in.’’ Id. at 1. The Respondent replied, ‘‘I can do that.’’ Id. at 2. The Respondent asked if ‘‘she’’ really had migraines. Id. CI said ‘‘no’’ and laughed. Id. The Respondent laughed too and said he was just wondering because there were a lot of refills. Id. The Respondent said, ‘‘[l]ong as we don’t get outta hand. Just be sure to keep ’em really hidden.’’ Id. 62. On April 2, 2015, at approximately 3:04 p.m., the Respondent and CI spoke on the phone. GE–16, file 2015–04–02_15–04–43_EDT. CI asked the Respondent whether he could write her ‘‘80’’ if someone came in to see him. Id. at 1. The Respondent said he could not because it would be a red flag, and that ‘‘40 is a pretty substantial number.’’ Id. at 1–2. The Respondent joked that CI should tell her husband that he messed up CI’s ‘‘drug 29 See E:\FR\FM\17AUN1.SGM GE–16, file 2015–04–01_20–28–54_EDT. 17AUN1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices connection’’ when he filed the complaint. Id. at 2. 63. On April 6, 2015, at approximately 8:59 p.m., the Respondent and CI spoke on the phone. GE–16, file 2015–04–06_20–59–35_EDT. CI told the Respondent that she had talked to Agent 1, who was coming on Wednesday. Id. at 2. The Respondent said, ‘‘I’m glad to help her and take care of her.’’ Id. He commented that he had to follow the rules when taking care of her. Id. CI asked the Respondent to help her out when he saw Agent 1. Id. at 3. The Respondent said he would take care of Agent 1’s headaches ‘‘like any other patient’’ and that he had to follow the rules, treating her ‘‘like anybody else.’’ Id. 64. On April 7, 2015, at approximately 1:29 p.m., the Respondent and CI spoke on the phone. GE–16, file 2015–04–07_13–29–34_EDT. CI asked the Respondent if she could attend Agent 1’s appointment. Id. at 2. The Respondent said it was ‘‘a little bit on the risky side.’’ Id. 65. On April 7, 2015, at approximately 6:28 p.m., the Respondent and CI spoke on the phone. GE–16, file 2015–04–07_18–28–45_EDT. CI asked the Respondent if he wanted her to come with Agent 1 to her appointment the next day. Id. at 7. The Respondent said that he was nervous about it and had to treat Agent 1 the way he treated everyone else. Id. CI thanked the Respondent and said she knew he was seeing Agent 1 for her. Id. at 8. The Respondent said that he was treating her as a patient, and that it was dangerous. Id. 66. On April 7, 2015, at approximately 7:04 p.m., CI texted the Respondent and asked if he would meet her at Walmart the next day around lunch. GE–20, file 2015–05– 06_141328_601–904– 1188_FROM_2015–04–01_TO_2015– 04–30_ALL.30 67. On April 8, 2015, at approximately 8:59 a.m., CI again texted the Respondent and asked him to go to Walmart on his lunch break so that she could ‘‘run into’’ him. GE–21, at 3. CI texted the Respondent that Agent 1 would be there and that Agent 1 knew about their relationship, but was ‘‘cool’’ and would ‘‘cover’’ for CI. GE–21, at 5– 6. 68. On April 8, 2015, at approximately 10:16 a.m., the Respondent and CI spoke on the phone. GE–16, file 2015–04–08_10–16–03_EDT. The Respondent said he would love to see CI at Walmart at noon that day. Id. at 1. CI again said Agent 1 knew that the 30 Contra Tr. 129. VerDate Sep<11>2014 16:39 Aug 16, 2016 Respondent was CI’s boyfriend. Id. CI said she was fat because she was not taking Adipex anymore. Id. at 3. The Respondent said that she worried too much and that she was beautiful. Id.31 The Respondent and CI agreed to meet in Walmart that day. Id. at 7–8. 69. On April 8, 2015, at approximately 12:31 p.m., CI texted the Respondent and said, if he wanted to save Agent 1 some money, he could bring a prescription for her with him to Walmart. GE–21, at 8. At 12:37 p.m., the Respondent replied that he ‘‘MUST see her in the office. You know why.’’ GE– 21, at 9. iv. Undercover Operation at Walmart: April 8, 2015 70. On April 8, 2015, Agent 1 accompanied CI to Walmart at approximately 12:45 p.m. GE–22–23; Tr. 128–29, 133–34. The Respondent met CI in the home furnishings department. GE–22; Tr. 389. CI wore a video and audio recording device. Tr. 347–48, 389; see GE–22. The Respondent spoke with CI. Tr. 129; see GE–22. The video recording did not capture an image of the Respondent’s face, and much of the recording is inaudible. GE–22. 71. The Respondent told CI to tell Agent 1 to space out her appointments more. Tr. 129–30. The Respondent said, ‘‘[w]e will be good now, so but you can’t come back like every week for a prescription cause they keep up, it’s like every 4 weeks.’’ GE–23. CI asked the Respondent how she was ‘‘supposed to last that long.’’ GE–23. The Respondent told her to ‘‘go buy a bottle of Vodka . . . .’’ GE–23. 72. At approximately 3:29 p.m., CI texted the Respondent that she really felt fat and asked him to write Agent 1 ‘‘something for that too.’’ GE–21, at 13. 73. Based on Findings of Fact 47 through 53, Findings of Fact 56 through 72, and the transcript at pages 91, 230, and 349, I find that, by the time the Respondent met with Agent 1 on April 8, 2015, the Respondent knew that Agent 1 was not a legitimate patient and that at least some of the medication he prescribed at that appointment would be given to and used by CI. v. Undercover Appointment #2: April 8, 2015 74. Agent 1 had a second appointment with the Respondent that took place on April 8, 2015. GE–24–25; Tr. 102. The Respondent’s nurse asked Agent 1 why she was back so soon after her first visit and if she was taking her medication correctly. GE–24; GE–25, at 1; Tr. 103. Agent 1 said she just ‘‘ran out’’ of 31 See Jkt 238001 PO 00000 GE–27, at 1; contra Tr. 225. Frm 00050 Fmt 4703 Sfmt 4703 54835 medication and was taking it twice a day. GE–25, at 1. The nurse told her that she did not need to take pain medication ‘‘every day all year long.’’ GE–25, at 1. 75. The Respondent met with Agent 1 and asked her what she had going on. GE–25, at 1. Agent 1 said, ‘‘Same thing. Same stuff.’’ GE–25, at 1. The Respondent asked if the medicine had helped. GE–25, at 1. Agent 1 said it helped ‘‘a little bit.’’ GE–25, at 1. The Respondent began writing almost immediately after he entered the room without conducting any sort of examination of Agent 1. GE–24–25; Tr. 103–04, 132. The appointment lasted approximately seven minutes. GE–24. 76. The Respondent and Agent 1 talked casually about boating and skiing. GE–25, at 2–3. The Respondent took out his prescription pad and wrote prescriptions for Agent 1. GE–25, at 3. The Respondent said, ‘‘[w]e need to kinda stretch this out [to] make it last a month.’’ GE–25, at 3. 77. The Respondent wrote two prescriptions 32 to Agent 1: one for 40 Norco, and one for Maxalt. GE–24–26; Tr. 104. The Respondent told Agent 1 that he gave her refills for Maxalt but could not for ‘‘the other.’’ GE–25, at 1. The Respondent again told her to ‘‘spread it out a little bit longer.’’ GE– 25, at 2. He said that ‘‘the other ones are not really intended for . . . daily use,’’ but that he would ‘‘go ahead and give [her] a refill.’’ GE–25, at 2. vi. Interactions Between the Respondent and CI Between the Second and Third Undercover Appointments 78. On April 8, 2015, at approximately 5:01 p.m., CI texted the Respondent and said ‘‘[t]hank u sweetheart for hooking me up again :).’’ GE–20, file 2015–05–06_141328_601– 904–1188_FROM_2015–04– 01_TO_2015–04–30_ALL. 79. On April 8, 2015, at approximately 6:15 p.m., the Respondent and CI spoke on the phone. GE–27.33 CI asked how things went with Agent 1. GE–27, at 1. The Respondent said he thought they went okay. GE–27, at 1. The Respondent and CI discussed their encounter in Walmart. GE–27, at 3. The Respondent asked CI what Agent 1 said to CI, and she told him that Agent 1 said that they had talked about the 32 In GE–26, the Government only provided a copy of the prescription for Norco. However, the Respondent’s discussion of Maxalt, preserved in GE–24 and 25, indicates that the Respondent also prescribed Maxalt to Agent 1. Additionally, Agent 1’s testimony that she received two prescriptions at this appointment was credible and uncontested. Tr. 104. 33 See GE–16, file 2015–04–08_18–15–44_EDT. E:\FR\FM\17AUN1.SGM 17AUN1 mstockstill on DSK3G9T082PROD with NOTICES 54836 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices Respondent’s boat. GE–27, at 5. The Respondent said that he talked with Agent 1 about a boat because ‘‘we had to be in there more than ten seconds’’ so that his ‘‘nosy nurse’’ would not think, ‘‘[d]ang, why is this appointment over with in ten seconds?’’ GE–27, at 5. 80. On April 14, 2015, at approximately 3:48 p.m., CI texted the Respondent and asked him how many friends she could ‘‘send in ur office for ‘headaches’ lol?’’ GE–20, file 2015–04– 14_15–48–52_EDT. 81. On April 14, 2015, at approximately 6:47 p.m., the Respondent and CI spoke on the phone. GE–38.34 CI again asked the Respondent how many friends she could send to him with a headache. GE–38, at 2. The Respondent said they had to be really careful about it. Id. The Respondent told CI that if she had a friend who was ‘‘willing to help’’ her, she should not tell him about it and should just ask the friend to come by and ‘‘mention that they’ve got headaches.’’ GE–38, at 2. The Respondent said he was nervous about it because he knew he was being watched. GE–38, at 2. The Respondent said that, but for CI’s husband, CI could ‘‘have all the sex, drugs, and rock and roll’’ that she needed. GE–38, at 2. CI told the Respondent that she was ‘‘running low’’ and needed ‘‘some more pills or something.’’ GE–38, at 3. The Respondent suggested she drink vodka. GE–38, at 3. CI asked if he would treat Agent 1 for a cough if Agent 1 came in for a cough, and if he would give Agent 1 cough medicine. GE–38, at 3. The Respondent said he could give her cough medicine for something legitimate, and warned CI that the state monitors drug-seeking behavior. GE–38, at 3–4. CI asked the Respondent to prescribe her a ‘‘big bottle,’’ like he used to prescribe to her. GE–38, at 4. The Respondent said he could give her about eight ounces. GE–38, at 4. The Respondent told CI that he could not prescribe Adipex to her and explained why. GE–38, at 6. The Respondent told CI that he could help her feel happier if he did not get ‘‘busted by the . . . drug police.’’ GE–38, at 8. 82. On April 14, 2015, at approximately 7:02 p.m., CI texted the Respondent and asked if he had any Adipex left over from a prescription to his wife. GE–20. 83. On April 15, 2015, at approximately 9:30 p.m., the Respondent and CI spoke on the phone. GE–20, 28. CI talked about being severely depressed. GE–28, file 2015– 04–15_21–30–59_EDT, at 9. The 34 See GE–20, file 2015–04–14_18–47–34_EDT; GE–28, file 2015–04–14_18–47–34_EDT. VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 Respondent talked about how CI’s husband would not let her ‘‘have drugs.’’ Id. at 10. 84. On April 22, 2015, at approximately 10:28 a.m., the Respondent and CI spoke on the phone. GE–20, 28. CI told the Respondent that Agent 1 and some of her friends were coming next week to see the Respondent. GE–28, file 2015–04– 22_10–28–41_EDT, at 3. The Respondent warned CI that he had to be careful because it was ‘‘super serious.’’ Id. CI laughed and said that they had headaches. Id. The Respondent told CI that prescribing frequently to people from out of town was a ‘‘big’’ red flag. Id. The Respondent said he could not ‘‘do it on any kind of regular basis.’’ Id. at 4. 85. On April 22, 2015, at approximately 12:10 p.m., the Respondent texted CI that he ‘‘CANNOT do anything other than legitimate medical stuff’’ because it was risky and CI’s husband had everyone ‘‘on high alert.’’ GE–20. CI texted back and asked if he would see Agent 1 next week, and that Agent 1 and her friends would not ‘‘tell.’’ GE–20. CI asked him to ‘‘write in their chart it’s for migraines like u always do.’’ GE–20. The Respondent texted back that he would see Agent 1 and treat her in a medically appropriate way. GE–20. The Respondent also texted that his usual prescription for Lorcet (40) ‘‘should last more than a month.’’ GE–20. The Respondent texted that his feelings for CI needed to be ‘‘totally separate from [his] medical practice.’’ GE–20. 86. On April 22, 2015, at approximately 1:03 p.m., the Respondent and CI spoke on the phone. GE–20, 28. The Respondent said that they had to be really careful because the Mississippi Board was watching him. GE–28, file 2015–04–22_13–03–23_EDT, at 1–2. He compared their situation to going to ‘‘buy drugs at a crack house.’’ Id. at 2. The Respondent said everything needed to be ‘‘straight’’ and ‘‘above the board.’’ Id. The Respondent said that his normal prescription dosage of headache medicine should last more than 30 days, and that it would raise alarm if he saw people more than once a month or every other month for headaches. Id. CI said that it had been a month since he saw Agent 1; the Respondent said he did not remember. Id. CI asked him how he got ‘‘away with it’’ when he was seeing her; he replied that ‘‘they weren’t watching nearly as close’’ and that CI had legitimate headaches and he ‘‘was writing it down every time.’’ Id. at 3. The Respondent said he was not giving her prescriptions ‘‘super often.’’ Id. The Respondent discussed headaches, PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Maxalt, and Lorcet with CI. Id. at 3–4. CI asked the Respondent if he would see ‘‘them’’ next week. Id. at 4. The Respondent said that he would see anybody that came in to his office. Id. CI asked him to ‘‘write ’em Lorcet.’’ Id. The Respondent said that ‘‘[i]t would even be better if I don’t even know who they are’’ and instructed CI to not tell him their names. Id. The Respondent said that he treats everyone the same. Id. at 5. The Respondent said that he liked to be nice to Agent 1, who he identified as CI’s friend. Id. 87. On April 22, 2015, at approximately 2:32 p.m., CI texted the Respondent, ‘‘[w]hat I wouldn’t do for an aipex [sic] right now ! Omg :/.’’ GE– 20, file 2015–04–22_14–32–41_EDT. 88. On April 27, 2015, at approximately 2:45 p.m., the Respondent and CI spoke on the phone. GE–20, 28. CI said she spoke to Agent 1, who was going to see the Respondent that Wednesday. GE–20, file 2015–04– 27_14–45–16_EDT. The Respondent said he would be glad to see her. Id. CI said that Agent 1 would give CI all of Agent 1’s prescriptions. Id. CI said Agent 1 and Agent 2 would split Agent 2’s prescriptions. GE–28, file 2015–04– 27_14–45–16_EDT, at 1. The Respondent said he did not ‘‘know anything about that and [did not] want to know anything about that.’’ Id. CI discussed previously taking ‘‘like 20’’ of the Demerol that the Respondent prescribed to her. Id. at 7. 89. On April 28, 2015, at approximately 8:23 p.m., the Respondent and CI spoke on the phone. GE–20, 28. CI told the Respondent to not forget that Agent 1 and Agent 2 were coming tomorrow. GE–28, file 2015–04– 28_20–23–38_EDT, at 1. The Respondent acknowledged that he knew they were coming and said he would see them then. Id. CI told the Respondent to ‘‘[h]ook her up good. Give her some cough medicine.’’ Id. 90. On April 29, 2015, at approximately 9:38 a.m., the Respondent and CI spoke on the phone. GE–20, 28, 29. CI told the Respondent not to forget that Agent 1 was coming that day. GE–29, at 7. The Respondent replied that he would not forget and would ‘‘take care of her.’’ GE–29, at 7. CI told him to give her cough medicine. GE–29, at 7. The Respondent said he would see what he could do, but that CI was ‘‘really pushing [his] envelope.’’ GE–29, at 7. 91. On April 29, 2015, at approximately 3:40 p.m., CI texted the Respondent that Agent 1 said that Agent 2 ‘‘ ‘has a cough too’ if u could hook her up with some cough med . . . Please :) .’’ GE–39, at 5. E:\FR\FM\17AUN1.SGM 17AUN1 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices Agent 2. GE–34. Meanwhile, the Respondent talked casually with Agent 2 about sports, Birmingham, and restaurants. GE–35, at 2–3. 99. The Respondent wrote two prescriptions for Agent 2: one for 40 Norco 10/325, and one for Maxalt with unlimited refills. GE–35, at 3; GE–36– 37; Tr. 144. vii. Undercover Appointment #3: April 29, 2015, with Agent 1 93. Agent 1 had a third appointment with the Respondent, which occurred on April 29, 2015. GE–30–31; Tr. 111. 94. The Respondent met with Agent 1 and asked her, ‘‘Headaches for you?’’ GE–31, at 1. Agent 1 responded, ‘‘Yep.’’ GE–31, at 1. The Respondent performed a brief examination of Agent 1, checking her ears and nose. GE–30–31; Tr. 112, 132. The Respondent observed that Agent 1 still had ‘‘refills on the other.’’ GE–31, at 1. 95. Agent 1 told the Respondent that she talked on the phone with a friend of hers, who told her that she was coughing a lot and needed to get something for her cough; Agent 1 also told the Respondent that she had not paid it much attention to it. GE–31, at 1; Tr. 133, 138–39. The Respondent immediately told Agent 1 that he would give her some cough syrup. GE–30; Tr. 133, 139–40. Agent 1 was not coughing during the appointment. GE–30; Tr. 138. Agent 1 did not tell the Respondent that she had a cough. GE–30–31; Tr. 113, 132. Agent 1 did not directly request cough syrup from the Respondent. GE– 30–31; Tr. 113. 96. The Respondent wrote two prescriptions to Agent 1: one for 40 Norco 10/325, and one for eight ounces of Hycodan. GE–32–33; Tr. 113. mstockstill on DSK3G9T082PROD with NOTICES 92. Based on Findings of Fact 47 through 53, 56 through 72, and 75 through 91, and the transcript at pages 91, 136, 230, and 349, I find that, by the time the Respondent met with Agents 1 and 2 on April 29, 2015, the Respondent knew that Agent 1 and Agent 2 were not legitimate patients and that at least some of the medications that he prescribed to them during their appointments that day would be given to and used by CI and/or shared by the Agents. 100. On April 29, 2015, at approximately 1:48 p.m., the Respondent and CI spoke on the phone. GE–29, at 9. CI asked the Respondent if he had seen Agent 1. GE–29, at 9. The Respondent said he had. GE–29, at 9. CI asked him what he gave her. GE–29, at 9. The Respondent said, ‘‘appropriate medicine,’’ and laughed. GE–29, at 9. He said that he gave her something for her headache and cough. GE–29, at 9. CI thanked the Respondent. GE–29, at 9. 101. On April 30, 2015, at approximately 9:19 a.m., the Respondent and CI spoke on the phone. GE–40; see GE–20, 28. CI told the Respondent that she got her medication. GE–40, at 1. The Respondent said he was ‘‘glad all that worked out.’’ GE–40, at 1; see Tr. 230–31. The Respondent asked CI who Agent 2 was and if she was Agent 1’s friend. GE–40, at 1. CI told the Respondent that Agent 1 gave all of hers to CI, and that Agent 1 and Agent 2 split Agent 2’s prescription. GE–40, at 2. The Respondent said he was glad he could help, and that both agents were ‘‘very appropriate’’ because they went ‘‘through the motions.’’ GE– 40, at 2. The Respondent said that during the appointment with Agent 2, he was thinking, ‘‘I’m not mentioning [CI] and I’m not mentioning [Agent 1].’’ GE–40, at 2. 102. The DEA’s investigation was suspended while the Respondent campaigned for political office. Tr. 78. The DEA contacted CI in October 2015 and asked her to talk to the Respondent again to try to get him to write another prescription. Tr. 358. CI said no. Tr. 358. viii. Undercover Appointment #4: April 29, 2015, with Agent 2 97. Agent 2 also had an appointment with the Respondent on April 29, 2015. GE–34–35; Tr. 143. 98. The Respondent met with Agent 2. GE–34–35; Tr. 144; see also GE–58 (containing the Respondent’s patient file for Agent 2). The Respondent asked her what he could do for her. Agent 2 she said she had ‘‘a little headache,’’ but noted that it had not been going on for a long time. GE–35, at 1; Tr. 144. The Respondent briefly looked into Agent 2’s ears, nose, and mouth. GE–34–35; Tr. 144. The Respondent asked her a few questions about allergies, blood pressure, and smoking. GE–35, at 2. The Respondent then wrote prescriptions to VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 ix. Interactions Between the Respondent and CI Between the Fourth and Fifth Undercover Appointments x. Undercover Appointment #5: October 16, 2015 103. Agent 1 had a fourth appointment with the Respondent, which took place on October 16, 2015. Tr. 78, 119. The purpose of this appointment was to refresh the investigation concerning the Respondent. Tr. 78. Upon arriving at the Respondent’s clinic, the Respondent’s receptionist told Agent 1 that her chart PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 54837 had been misplaced,35 so Agent 1 filled out new paperwork and sat in the Respondent’s waiting room. GE–42–43; Tr. 119–20, 137. Agent 1 waited for about an hour and twenty minutes before she was called into an exam room. GE–42; Tr. 406. 104. Agent 1 met with the Respondent. GE–42; see GE–60 (containing Agent 1’s October 16, 2015 patient file). The Respondent examined Agent 1’s ears, nose, and throat. GE–60, at 4; Tr. 120, 132.36 The Respondent asked Agent 1 what her symptoms were and what he had treated her for in the past. GE–43, at 2; Tr. 135. Agent 1 thought the Respondent was acting as though he did not know who she was. Tr. 120, 135, 452; see GE–42–43. 105. The Respondent discussed the most effective medication for Agent 1 to take for headaches. GE–43, at 2–3. Agent 1 asked the Respondent if he remembered Agent 2. GE–43, at 3. The Respondent stopped, thought about it, and said he did not. GE–42, 43. 106. Agent 1’s recording device partially failed and did not record the last few minutes of Agent 1’s appointment with the Respondent. Tr. 79, 451. 107. While the Respondent was writing prescriptions for Agent 1, she asked the Respondent if he had spoken with CI lately. Tr. 122, 135, 452–53. The Respondent paused and looked surprised, then continued writing the prescriptions and stated that he had not heard from CI lately. Tr. 122–23. 108. The Respondent wrote Agent 1 prescriptions for 30 Norco 5/325, four ounces of Hycodan, Maxalt, Zyrtec, and dexamethasone. GE–44–47, 54; Tr. 120, 126–27, 452. The Respondent discussed these prescriptions with Agent 1 during the appointment. Tr. 452–53, 455–56. 109. During this visit, Agent 1 did not say that she had a cough. GE–42–43; Tr. 126, 138–39, 454. Agent 1 only stated at the outset of the appointment that she needed the ‘‘same as before,’’ and did not tell the Respondent that she had any specific complaints. GE–42–43; Tr. 454. The Respondent nonetheless prescribed cough syrup to Agent 1. GE–45; Tr. 139. 35 After the Respondent was arrested, Agent 1’s original file, GE–59, was found in the Respondent’s desk, along with the files for CI and CI’s children. Tr. 428. 36 The audiovisual recording of Agent 1’s appointment did not record any physical examination by the Respondent during this appointment. See GE–42. However, because the audiovisual recording was incomplete, and because Agent 1 testified that the Respondent examined her ears, nose, and throat, I find as a matter of fact that the Respondent conducted a physical examination of Agent 1 at this appointment. E:\FR\FM\17AUN1.SGM 17AUN1 54838 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices G. Search of the Respondent’s Office 110. The Respondent was arrested on December 9, 2015. Tr. 427, 432. That same day, the DEA searched the Respondent’s office and examined his records and patient files. Tr. 427, 432. The Respondent’s office kept patient files in a general population of files. Tr. 433. 111. The DEA unlocked the Respondent’s desk drawer and discovered several patient files that had not been kept in the general population of patient files. Tr. 428, 432. In the Respondent’s desk, the DEA found one patient file for Agent 1, one file for CI, one file for Kid 1, and one file for Kid 2. Tr. 428; see GE–2, 56–57, 59. 112. The DEA found a second patient file for Agent 1 within the general population of the Respondent’s patient files. Tr. 433; see GE–60. The DEA also found a patient file for Agent 2 in the general population of the Respondent’s patient files. Tr. 434; see GE–58. Additional facts required to resolve the issues in this case are included below in the Analysis section of this Recommended Decision. mstockstill on DSK3G9T082PROD with NOTICES ANALYSIS To revoke a respondent’s registration, the Government must prove, by a preponderance of the evidence, that the regulatory requirements for revocation are satisfied. Steadman v. SEC, 450 U.S. 91, 100–02 (1981); 21 CFR § 1301.44(e) (2015). Under 21 U.S.C. § 824(a)(4), the DEA may revoke a registrant’s COR if the registrant acted in a way that renders continued registration ‘‘inconsistent with the public interest.’’ The DEA considers the following five factors to determine whether continued registration is in the public interest: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The [registrant’s] experience in dispensing, or conducting research with respect to controlled substances. (3) The [registrant’s] conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (4) Compliance with applicable State, Federal, or local laws relating to controlled substances. (5) Such other conduct which may threaten the public health and safety. 21 U.S.C. 823(f) (2012). These public interest factors are considered separately. See Robert A. Leslie, M.D., 68 Fed. Reg. 15227, 15230 (2003). Each factor is weighed on a caseby-case basis. Morall v. DEA, 412 F.3d 165, 173–74 (D.C. Cir. 2005). Any one factor, or combination of factors, may be VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 decisive. David H. Gillis, M.D., 58 Fed. Reg. 37507, 37508 (1993). Thus, there is no need to enter findings on each of the factors. Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Further, there is no requirement to consider a factor in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76–77 (4th Cir. 1988). When deciding whether registration is in the public interest, the totality of the circumstances must be considered. See generally Joseph Gaudio, M.D., 74 Fed. Reg. 10083, 10094–95 (2009). The Government bears the initial burden of proof, and must justify revocation by a preponderance of the evidence. Steadman, 450 U.S. at 100– 03. If the Government makes a prima facie case for revocation, the burden of proof shifts to the registrant to show that revocation would be inappropriate. Med. Shoppe–Jonesborough, 73 Fed. Reg. 364, 387 (2008). A registrant may prevail by successfully attacking the veracity of the Government’s allegations or evidence. Alternatively, a registrant may rebut the Government’s prima facie case for revocation by accepting responsibility for wrongful behavior and by taking remedial measures to ‘‘prevent the re-occurrence of similar acts.’’ Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8236 (2010). In addition, when assessing the appropriateness and extent of sanctioning, the DEA considers the egregiousness of the offenses and the DEA’s interest in specific and general deterrence. David A. Ruben, M.D., 78 Fed. Reg. 38363, 38385 (2013). Factor One: The Recommendation of the Appropriate State Licensing Board or Professional Disciplinary Authority Neither party directly advanced an argument under Factor One. However, a substantial portion of the Respondent’s post-hearing brief (‘‘ALJ–34’’) argues that the DEA should give significant deference to the Mississippi Board’s termination of its investigation against the Respondent. ALJ–34, at 3–6. Therefore, by inference, the Respondent advanced a theory under Factor One that his license should not be revoked because the Mississippi Board declined to take formal disciplinary action against him. Although the Mississippi Board did not make a formal recommendation to the DEA in this matter, the DEA interprets a state licensing board’s ‘‘recommendation’’ broadly. See Kenneth Harold Bull, M.D., 78 Fed. Reg. 62666, 62672 (2013) (considering disciplinary actions taken by a state board under Factor One).37 A state 37 But see George R. Smith, M.D., 78 FR 44972, 44979 (2013) (finding that the absence of a state PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 board’s disciplinary actions can provide evidence of what a state licensing board would recommend. Id. For example, when a state board puts a registrant on probation, the DEA views the probation as a recommendation from the state board. E.g., Tyson D. Quy, M.D., 78 Fed. Reg. 47412, 47417 (2013). Here, the Mississippi Board has not revoked, suspended, or restricted the Respondent’s license. GE–1, at 1; GE–3, at 1. The Mississippi Board investigated the Respondent in March 2015. See GE– 3. This investigation was limited to reviewing an anonymous letter, interviewing the Respondent, and visiting the Respondent’s office. See GE–3, at 1–2, 4–6. The Mississippi Board neither exonerated the Respondent nor took any formal action against him. GE–3; Tr. 184, 203. The Mississippi Board only issued a warning letter to the Respondent to conclude its investigation. GE–3, at 1. Consistent with the findings of Investigator Pohnert, the Mississippi Board warned the Respondent that doctors are only permitted to refill phentermine prescriptions if they first conduct and document medical examinations. GE–3, at 1, 5. The fact ‘‘that a state has not acted against a registrant’s medical license is not dispositive in this administrative determination as to whether continuation of a registration is consistent with the public interest.’’ Carlos Gonzalez, M.D., 76 Fed. Reg. 63118, 63140 (2011) (citing Patrick W. Stodola, M.D., 74 Fed. Reg. 20727, 20730 (2009); Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 461 (2009)). Rather, the DEA, apart from the Mississippi Board, has its own independent responsibility to determine whether the Respondent’s continued registration is in the public interest. See Edmund Chein, M.D., 72 Fed. Reg. 6580, 6590 (2007), aff’d, Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008). Accordingly, the Mississippi Board’s warning letter does not weigh either for or against the Respondent under Factor One. Factors Two and Four: The Respondent’s Experience in Dispensing Controlled Substances and Compliance with Applicable State, Federal, or Local Laws Relating to Controlled Substances Allegations 1 through 5 all claim that the Respondent illegitimately prescribed controlled substances outside the course of his professional practice. See supra pp. 2–3. Regarding these allegations, the licensing board’s direct recommendation weighs neither for nor against a respondent); Paul Weir Battershell, N.P., 76 FR 44359, 44365–66 (2011) (same); Gilbert Eugene Johnson, M.D., 75 FR 65663, 65666 n.3 (2010) (same). E:\FR\FM\17AUN1.SGM 17AUN1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices Government endeavored to show that the Respondent knowingly diverted, or attempted to divert, controlled substances. This evidence is properly analyzed under Factors Two and Four because ‘‘[p]roof that a physician knowingly diverted controlled substances is the best evidence for assessing his experience in dispensing controlled substances, although it is also relevant in assessing his compliance with applicable laws related to controlled substances.’’ Syed Jawed Akhtar-Zaidi, M.D., 80 Fed. Reg. 42961, 42968 n.17 (2015). Under the Controlled Substances Act (‘‘CSA’’), it is unlawful for a person to distribute controlled substances, except as authorized under the CSA. 21 U.S.C. 841(a)(1). To combat drug abuse and trafficking of controlled substances, ‘‘Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.’’ Gonzales v. Raich, 545 U.S. 1, 13 (2005). To maintain this closed regulatory system, controlled substances may only be prescribed if a DEA registrant writes a valid prescription. Gonzalez, 76 FR at 63141. As the Supreme Court explained, ‘‘the prescription requirement . . . ensures that patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.’’ Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)). A controlled substance prescription is not valid unless it is ‘‘issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.’’ 21 CFR § 1306.04(a). Federal regulations further provide that ‘‘[a]n order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of [21 U.S.C. § 829] and . . . the person issuing it, shall be subject to the penalties provided for violations of [controlled substance laws].’’ Id.; see 21 U.S.C. § 842(a)(1) (establishing that, under the CSA, it is illegal for a person to distribute or dispense controlled substances without a prescription, as is required under 21 U.S.C. § 829). Much like the federal regulations, the Mississippi Code provides that it is illegal to dispense Schedule II 38 38 These sections of the Mississippi Code only apply to the Respondent’s Schedule II controlled VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 controlled substances except upon a valid prescription written by a practitioner. Miss. Code §§ 41–29– 137(a)(1), 41–29–141(1). The Mississippi Code further provides that a registrant’s license may be revoked if the registrant prescribes narcotics outside of the course of legitimate professional practice, id. § 73–25–29(3), or if the registrant violates the Mississippi Board’s administrative rules, id. § 73–25–29(13). The DEA recognizes several methods to show that a registrant wrote prescriptions without a legitimate medical purpose and outside of the usual course of professional practice. See Jack A. Danton, D.O., 76 FR 60900, 60901 (2011). The Respondent, however, incorrectly suggests that the Government must provide ‘‘medical literature’’ or a ‘‘medical opinion’’ in order to establish that a registrant acted outside the usual course of professional practice and lacked a legitimate medical purpose. ALJ–34, at 5. Typically, the Government uses expert testimony to establish a violation of 21 CFR 1306.04(a). T.J. McNichol, M.D., 77 FR 57133, 57147–48 (2012). However, ‘‘whether expert testimony is needed is necessarily dependent on the nature of the allegations and the other evidence in the case.’’ Beau Boshers, M.D., 76 FR 19401, 19402 n.4 (2011). Numerous state and federal courts have found in criminal cases, which require a higher standard of proof than is required in these proceedings, that expert testimony is not required to establish a violation of 21 U.S.C. § 841 or 21 CFR § 1306.04(a). McNichol, 77 FR at 57147.39 For example, the DEA has not required expert testimony to establish a violation of 21 CFR § 1306.04(a) in cases where a prescriber engaged in drug deals,40 where there were notable differences between patients’ medical records and diagnoses,41 and where a prescriber substance prescriptions. Notably, hydrocodone combination products, such as Norco and Hycodan, were re-classified by the federal government as Schedule II controlled substances on October 6, 2014. See Stip. 5–6. The parties made no argument, and presented no evidence, regarding the classification of hydrocodone combination products in the state of Mississippi. 39 E.g., United States v. Pellman, 668 F.3d 918, 924 (7th Cir. 2012); United States v. Armstrong, 550 F.3d 382, 389 (5th Cir. 2008); United States v. Word, 806 F.2d 658, 663 (6th Cir. 1986); United States v. Larson, 507 F.2d 385, 387 (9th Cir. 1974); United States v. Bartee, 479 F.2d 484, 488–89 (10th Cir. 1973); State v. Moody, 393 So.2d 1212, 1215 (La. 1981). 40 Boshers, 76 Fed. Reg. at 19402 n.4. 41 Morris W. Cochran, M.D., 77 Fed. Reg. 17505, 17519–20 (2011). PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 54839 falsified patients’ charts.42 Simply put, whether the Government must present expert testimony is dependent on the facts of each case. McNichol, 77 FR at 57147–48. In the Government’s post-hearing brief (‘‘ALJ–35’’), it advanced two theories regarding how the Respondent violated 21 CFR § 1306.04(a): (1) the Respondent knowingly diverted controlled substances to CI, and (2) the Respondent violated state medical practice standards. ALJ–35, at 18–24. The Government can prove that a registrant acted outside of the usual course of professional practice and lacked a legitimate medical purpose by ‘‘providing evidence showing that [the registrant] knowingly diverted drugs.’’ Danton, 76 Fed. Reg. at 60901. Additionally, the Government can prove that a registrant acted outside of the usual course of professional practice and lacked a legitimate medical purpose by providing evidence showing that the registrant violated a state medical practice standard ‘‘which has a substantial relationship to the CSA’s purpose of preventing substance abuse and diversion.’’ Id. Neither of these methods of proof requires the presentation of expert testimony. Id. Allegation 1: Hydrocodone and Alprazolam Prescriptions to CI In Allegation 1, the Government claimed that the Respondent prescribed hydrocodone and alprazolam to CI from February 2014 to May 2015 43 without conducting and/or documenting a physical examination, and without recording the prescriptions in CI’s patient file, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, (‘‘Mississippi Administrative Rules’’) 1.4, 1.11(b),44 and 1.16, Mississippi Code §§ 73–25– 29(3) and (13), and 21 CFR § 1306.04(a). ALJ–1, at 2. Specifically, the Government alleged that the Respondent issued improper 42 Robert F. Hunt, D.O., 75 Fed. Reg. 49995, 50003 (2010). 43 The record does not contain any evidence that the Respondent prescribed controlled substances directly to CI in 2015. The 2015 prescriptions that the Government alluded to under Allegation 1 were the Respondent’s 2015 prescriptions to Agent 1 and Agent 2. Those prescriptions are discussed at length under Allegation 4, infra pp. 50–58. 44 Rule 1.11(b) requires that ‘‘[e]very written prescription delivered to a patient, or delivered to any other person on behalf of a patient, must be manually signed on the date of issuance by the physician.’’ Miss. Code R. § 30–17–2640:1.11(b). Although the Government alleged a violation of this provision in its OSC/ISO, the Government did not advance a theory or offer evidence to establish a violation of this specific rule. I therefore find that the Government’s allegation that the Respondent violated Rule 1.11(b) is NOT SUSTAINED. E:\FR\FM\17AUN1.SGM 17AUN1 54840 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices prescriptions to CI: (a) on May 22, 2014, for 40 units of a hydrocodone combination product; (b) on June 17, 2014, for 40 units of a hydrocodone combination product; (c) on September 11, 2014, for 40 units of a hydrocodone combination product; (d) on October 6, 2014, for 40 units of alprazolam with one refill for 40 units; (e) on October 29, 2014, for 40 units of a hydrocodone combination product; and (f) on December 4, 2014, for 180 units of a hydrocodone combination product. ALJ–1, at 2. Under the Mississippi Administrative Code, the Mississippi Board requires that a prescribing physician must: mstockstill on DSK3G9T082PROD with NOTICES maintain a complete record of his or her examination, evaluation and treatment of the patient which must include documentation of the diagnosis and reason for prescribing, dispensing or administering any controlled substance; the name, dose, strength, quantity of the controlled substance and the date that the controlled substance was prescribed, dispensed or administered. Miss. Code R. § 30–17–2640:1.4.45 This record must ‘‘be maintained in the patient’s medical records.’’ Id. Further, the Mississippi Board requires that a physician cannot prescribe a controlled substance ‘‘without a good faith prior examination and medical indication therefore.’’ Id. This obligation is a continuing one; ‘‘upon any encounter with a patient, in order to establish proper diagnosis and regimen of treatment, a physician must take three steps: (a) take and record an appropriate medical history, (b) carry out an appropriate physical examination, and (c) record the results.’’ Id. (emphasis added). A physician’s failure to complete these three steps is conduct outside the ‘‘course of legitimate professional practice.’’ Id. In fact, any violation of these rules is considered conduct outside of the course of legitimate professional practice, in violation of Section 73–25– 29(3) of the Mississippi Code. Miss. Code R. § 30–17–2640:1.16. The evidence establishes that, on four occasions, the Respondent prescribed controlled substances to CI without writing any notes about any prescriptions or examinations in CI’s patient file. On May 22, 2014, the Respondent prescribed 40 units of Norco 10/325 to CI. GE–41, at 4; GE–49, at 2. On June 17, 2014, the Respondent 45 I find that the documentation requirements of Mississippi Administrative Rule 1.4 share a substantial relationship with the CSA’s purpose of preventing drug abuse and diversion. VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 prescribed 40 units of Norco 7.5/325 46 to CI. GE–41, at 6; GE–49, at 2. On September 11, 2014, the Respondent prescribed 40 units of Norco 10/325 to CI. GE–41, at 20; GE–49, at 2. On December 4, 2014, the Respondent prescribed 180 units, or six ounces, of Hycodan to CI.47 GE–41, at 28; GE–49, at 1. None of these four prescriptions were recorded in CI’s medical file. See GE–2, at 12–13. The Respondent did not document a diagnosis or reason for prescribing to CI on any of these dates. The Respondent did not write the names, doses, strengths, or quantities of these prescriptions to CI in CI’s medical record. The Respondent did not record the dates of these prescriptions in CI’s medical record. The Respondent did not record any notes in CI’s medical record about any physical examinations on these dates. Because of the complete absence of this required information in CI’s patient file, the prescriptions that the Respondent wrote to CI on these four dates were improper under Mississippi Administrative Rule 1.4. The Government’s allegations that these four prescriptions to CI violated Mississippi Administrative Rule 1.4 are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. Because these prescriptions violated Mississippi Administrative Rule 1.4, these prescriptions were issued outside of the course of the Respondent’s legitimate professional practice under Mississippi Administrative Rule 1.16. Further, there is no evidence that the Respondent even saw CI on May 22, June 17, September 11, or December 4 of 2014. Even absent expert testimony, the DEA has held that a prescriber does not act in the usual course of professional practice if the prescriber writes prescriptions to a patient without first seeing the patient. Armando B. Figueroa, M.D., 73 Fed. Reg. 40380, 40381–82 (2008). Therefore, the Government’s allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73–25–29(3) and (13), and 21 CFR § 1306.04(a) on these four occasions are SUSTAINED by a preponderance of the evidence, and 46 Originally, the Government alleged that the Respondent prescribed Norco 10/325 on June 17, 2014. See ALJ–1, at 2. However, as the Government correctly noted in its post-hearing brief, the Respondent prescribed Norco 7.5/325 on June 17, 2014. ALJ–35, at 6 n.1; see GE–41, at 6. 47 The record reflects some confusion concerning the date of this prescription. GE–41, at 21, indicates it was written on December 3, 2014, while GE–49, at 1, indicates it was written on December 4, 2014. See supra note 19. Regardless of the one day variance, the analysis is the same. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 weigh in favor of the revocation sought by the Government. On October 6, 2014, the Respondent prescribed 40 units of alprazolam 1 mg, with one refill, to CI. GE–41, at 22; GE– 49, at 1. In CI’s medical file, near a date stamp reading September 2, 2014, the Respondent noted ‘‘Xanax 1mg (#40, 1),’’ but did not write any justification for this prescription, as is required by Mississippi Administrative Rule 1.4. See GE–2, at 12–13. The Respondent did not write any notes anywhere in CI’s patient file about a diagnosis of anxiety or any of CI’s alleged symptoms. See GE–2, at 12–13. Additionally, CI’s testimony and her PMP report indicate that, although CI’s psychiatrist prescribed a smaller dosage of alprazolam to her, the Respondent increased CI’s dosage without any noted justification. GE–49, at 1; Tr. 225–26, 295, 304; see GE–2 (failing to justify an increased dosage of alprazolam); see also GE–2, at 21 (documenting that another registrant prescribed 7 units of alprazolam ER 0.5 mg to CI on September 30, 2014, and that the Respondent then prescribed 40 units of alprazolam 1 mg on October 6, 2014). Because the Respondent never documented a reason for prescribing alprazolam to CI in her patient file, the Government’s allegation that the October 6, 2014 prescription violated Mississippi Administrative Rule 1.4 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, this prescription was issued outside of the course of the Respondent’s legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government’s allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73–25–29(3) and (13), and 21 CFR § 1306.04(a) by issuing the October 6, 2014 prescription are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. The Government also alleged that the Respondent prescribed 40 units of a hydrocodone product to CI on October 29, 2014. ALJ–1, at 2. Although this alleged prescription is noted on CI’s PMP report, see GE–49, as Government counsel stated, ‘‘PMPs are not without their flaws’’ and are not ‘‘necessarily accurate.’’ Tr. 302–03. The Government offered testimony from CI related to this alleged prescription. Tr. 369–70. CI was presented with a copy of this alleged prescription, which she reviewed. Tr. 369–70. At the hearing, CI did not testify about the prescription from her E:\FR\FM\17AUN1.SGM 17AUN1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices personal recollection; she only looked at and read off of the copy of the prescription presented to her. Tr. 369– 70. I do not find that CI’s testimony proved the existence of the October 29 prescription. This copy of the prescription was not offered into evidence.48 In sum, the Government failed to offer substantial evidence that the Respondent did, in fact, prescribe hydrocodone to CI on October 29, 2014 outside of the course of his professional practice. Therefore, the Government’s allegations that the Respondent violated Mississippi Administrative Rules 1.4 and 1.16, Mississippi Code §§ 73–25– 29(3) and (13), and 21 CFR § 1306.04(a) by issuing an October 29, 2014 prescription are NOT SUSTAINED. Beyond the above-mentioned specific prescribing events, the Government provided ample evidence that, throughout 2014, the Respondent prescribed controlled substances to CI outside of the usual course of his professional practice and without a legitimate medical purpose. The DEA has held, even without the benefit of expert testimony, that a controlled substance prescription based on a patient’s request ‘‘rather than the result of the application of the physician’s medical judgment’’ lacks a medical purpose. Robert M. Golden, M.D., 61 Fed. Reg. 24808, 24812 (1996) (citing Robert L. Dougherty, Jr., M.D., 60 Fed. Reg. 55047 (1995); Harland J. Borcherding, D.O., 60 Fed. Reg. 28796 (1995)). Likewise, the Mississippi Administrative Rules state that a prescriber lacks good faith when he ‘‘permit[s] the patient to name the drug desired’’ or ‘‘dispens[es] drugs to patients having no medical need, when the physician knew or should have known that the patients were addicts.’’ Miss. Code R. § 30–17–2640:1.4. It is true that, at times, the Respondent intended to treat CI’s medical conditions. GE–2, at 12–13; Tr. 215, 277–78, 287, 321. However, even if the Respondent subjectively intended to provide legitimate medical treatment to CI, ‘‘[t]he appropriate focus is not on the subjective intent of the doctor, but rather . . . whether the physician prescribe[d] medicine ‘in accordance with [the accepted] standard of medical practice.’ ’’ United States v. Merrill, 513 F.3d 1293, 1306 (11th Cir. 2008) (quoting United States v. Moore, 423 U.S. 122, 139 (1975)). The Respondent’s failure to perform and document physical examinations of CI, and his failure to document his prescriptions to CI, constitutes a significant failure to comply with Mississippi medical 48 See supra note 20. VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 standards, regardless of the Respondent’s subjective intent. Here, CI took Norco daily and recreationally, and the Respondent gave prescriptions to CI upon her request. Tr. 297–99. The Respondent gave prescriptions to CI at her house, at her children’s appointments, and in the garden section of Walmart. Tr. 26, 217– 20. The Respondent did not provide CI with a diagnosis or perform physical examinations before giving these prescriptions to CI. See Tr. 217–18; see also GE–2, at 12–13. Importantly, the Respondent only made three entries in CI’s patient file in 2014, on February 21, April 21, and September 2, and he made no entries in CI’s patient chart in 2015. See GE–2, at 12–13. Neither party presented any standard to evaluate the adequacy of the patient file entries.49 Assuming that the file entries on those dates are adequate, under Mississippi Administrative Rule 1.4, any prescriptions that the Respondent issued to CI in 2014, other than on February 21, April 21, and September 2, were issued outside of the Respondent’s professional practice. CI’s PMP report indicates that CI may have filled prescriptions written by the Respondent on 13 dates in 2014.50 I do not find that the PMP report, standing alone, constitutes substantial evidence that these prescriptions existed, as discussed supra. However, CI’s credible, confident, and uncontested testimony that she simply requested prescriptions from the Respondent ‘‘for fun,’’ and that he would give them to her, considered in conjunction with the PMP report, constitutes substantial evidence that the Respondent prescribed controlled substances to CI in 2014 based on CI’s request rather than in the proper exercise of sound medical judgment. On these grounds, the Government’s allegations that the Respondent violated Mississippi Administrative Rules 1.4 and 1.16, Mississippi Code §§ 73–25– 49 CI’s patient file is not entirely legible. See GE– 2, at 12–13. The February 21, 2014 entry reads: ‘‘HC 7.5/325 (#40, 1)—may be picked up at desk.’’ GE– 2, at 12. The April 21, 2014 entry reads: ‘‘Headaches ? ‘Sinuses’ Motion sickness Occasional vertigo Ears clear OC/OP clear Nose mildly inflamed CT → clear and thickening in L NF duct Rx Maxalt (one given) HC 10/325 (#40) (refill).’’ GE–2, at 12. The September 2, 2014 entry reads: ‘‘Lexapro Maxalt ¯ prn has anxiety c migraines Migraine—usually ¯ responsive to Maxalt, now c brea[illegible] Ears clean; [illegible] in ® EAC @[illegible] Nose clear OC/OP clear Counseled [illegible] Rx Zofran Demerol 50 (#30) HC 10/325 (#40, 1) Phentermine (refilled) Xanax 1mg (#40, 1).’’ GE–2, at 12. These three notations are the only entries in the Respondent’s patient file for CI during 2014. 50 Specifically, these dates are as follows: February 21, April 9, May 19, May 22, June 17, July 19, July 24, September 2, September 8, September 11, October 6, October 29, and December 4. See GE– 2, at 21–23; GE–49, at 1–3. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 54841 29(3) and (13), and 21 CFR § 1306.04(a) are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. Allegation 2: Phentermine Prescriptions to CI In Allegation 2, Government claimed that the Respondent prescribed phentermine 51 to CI without adequate documentation, in violation of Mississippi Administrative Rule 1.5, Mississippi Code §§ 73–25–29(3) and (13), and 21 CFR § 1306.04(a). ALJ–1, at 3. The Government specifically alleged that this inappropriate prescribing occurred on four occasions in 2014: April 9, for 30 dosage units; May 19, for 30 dosage units with one refill; July 24, for 30 dosage units; and September 8, for 30 dosage units with two refills. ALJ–1, at 3. The administration of weight loss medication is regulated by state medical standards. See generally Wesley G. Harline, M.D., 65 Fed. Reg. 5665 (2000) (discussing, at length, general practice and state medical standards for legitimately prescribing controlled substances for weight loss). The Mississippi Board has a special standard of care for practitioners who prescribe diet medication. See Miss. Code R. § 30– 17–2640:1.5; see also GE–8; Tr. 171–72. Specifically, Rule 1.5 requires a doctor prescribing weight loss drugs to: (1) only prescribe adjunctively with caloric restriction; (2) conduct and thoroughly record an initial comprehensive evaluation; (3) record a thorough patient history and physical exam; (4) conduct an in-person re-evaluation of the patient once every 30 days, recording the patient’s weight, BMI, blood pressure, pulse, and the results of all tests to monitor adverse effects of the medication; and (5) maintain records about the patient’s weight loss efforts, dedication, responses, contraindications, and adverse effects during treatment. Miss. Code R. § 30– 17–2640:1.5. The patient’s history and physical exam must, at a minimum, document: 1. Past medical history, past surgical history, social history, family history, weight history, dietary history, gynecological (GYN) history if female, review of systems, allergies and medications. 2. Height, weight, Body Mass Index (BMI), blood pressure, pulse, % body fat or waist circumference/weight hip ratio, HEENT, chest, heart, abdomen, extremities. 51 Phentermine, or Adipex, is a Schedule IV controlled substance. See Stip. 8. E:\FR\FM\17AUN1.SGM 17AUN1 mstockstill on DSK3G9T082PROD with NOTICES 54842 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices 3. Appropriate testing related to medical weight loss . . . . Id. The Government presented evidence that the Respondent wrote four prescriptions for phentermine to CI. On April 9, 2014, the Respondent prescribed 30 units of Adipex 37.5 to CI. GE–7, at 1–2; GE–49, at 2. On May 19, 2014, the Respondent prescribed 30 units of Adipex 37.5, with one refill to CI. GE–7, at 3–4; GE–41, at 2–3; GE–49, at 2. On July 24, 2014, the Respondent prescribed 30 units of Adipex 37.5 to CI. GE–7, at 5–6; GE–41, at 12–13; GE–49, at 2. On September 8, 2014, the Respondent prescribed 30 units of phentermine 37.5 with two refills to CI. GE–7, at 7–8; GE–41, at 18–19; GE–49, at 2. During 2014, CI filled these prescriptions seven times. GE–49, at 1– 2. In the administrative record, there are only four notations in the Respondent’s files related to phentermine, Adipex, or weight loss prescriptions. The first mention of phentermine is in the Respondent’s patient file for Kid 1 near a date stamp reading February 4, 2014. GE–57, at 6; Tr. 286. That note reads, ‘‘Mother has migraines ? in children May call in Rx if needed. Discussed ¯ phentermine c mother May consider this as well.’’ GE–57, at 6. The second time phentermine was mentioned was in a March 19, 2014 entry in Kid 1’s patient file. That note reads, ‘‘Discussed ¯ [illegible] medications c mother Rx [illegible] Phentermine 37.5.’’ GE–57, at 5; Tr. 286. The third mention of phentermine, and the first in the Respondent’s patient file for CI, is dated July 18, 2014. GE–2, at 15. This third mention is on a patient telephone request form, which indicated that CI called the Respondent to ask about a refill of ‘‘phentermine 37.5 (#30, 2)’’ for her to ‘‘pick up at front.’’ GE–2, at 15. The final mention of phentermine, and the only one contained in the Respondent’s treatment notes of CI, is dated September 2, 2014. GE–2, at 12. This last entry simply reads, ‘‘Phentermine (refilled).’’ GE–2, at 12. Accordingly, while prescribing phentermine to CI on April 9, May 19, July 24, and September 8, the Respondent completely failed to comply with the requirements of Mississippi Administrative Rule 1.5. The Respondent never prescribed phentermine adjunctively with caloric restriction. He never conducted and recorded an initial comprehensive evaluation. He never recorded a thorough patient history or physical examination. He never conducted an inperson re-evaluation of CI once every 30 VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 days. He never recorded CI’s, BMI, blood pressure, pulse, past medical history, social history, family history, dietary history, gynecological history, height, weight, or body measurements. He did not document CI’s efforts to lose weight or note her response to treatment. A prescriber lacks good faith if he prescribes controlled substances to a patient who the prescriber knew or should have known had no legitimate medical need for the controlled substances prescribed. Miss. Code R. § 30–17–2640:1.4. It is concerning that the Respondent wholly failed to document any justification whatsoever for CI’s supposed need for weight loss medication. During 2014, CI went from 135 pounds down to 121 pounds. Tr. 224. At the hearing, CI presented with a slender body type. After observing CI’s appearance, I find it difficult to comprehend, from even a layman’s perspective, how the Respondent could have possibly believed that CI had a high enough BMI 52 to justify the administration of weight loss medication. The Respondent displayed a complete disregard for Mississippi’s weight loss prescription requirements. He prescribed weight loss drugs to CI without any documented medical justification. GE–2, at 12–13. ‘‘[W]here a medical record contains no findings that support a diagnosis, . . . expert testimony is not necessary to conclude that a prescription lacked a legitimate medical purpose.’’ McNichol, 77 Fed. Reg. at 57151 (citations omitted). Therefore, the Government’s allegations that the Respondent violated Mississippi Administrative Rule 1.5, Mississippi Code §§ 73–25–29(3) and (13), and 21 CFR § 1306.04(a), by prescribing phentermine to CI on April 9, May 19, July 24, and September 8 of 2014 are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. The Respondent argued in his posthearing brief that, after receiving the Mississippi Board’s warning letter, he refused to prescribe weight loss medication to an undercover agent. ALJ–34, at 6. The Respondent argued that this refusal showed that he ‘‘came promptly into conformity’’ with 52 See Miss. Code R. § 30–17–2640:1.5(A)(4) (requiring generally a BMI of greater than 30.0 in a normal, otherwise healthy patient to justify prescribing weight loss drugs); see also Minnix v. Colvin, No. 2:12CV00038, 2014 WL 618688, at *3 n.3 (W.D. Va. Feb. 18, 2014) (defining a BMI of 30 or higher as obesity) (citing Nat’l Inst. of Health, Calculate Your Body Mass Index, http:// www.nhlbi.nih.gov/guidelines/obesity/BMI/ bmicalc.htm (last visited May 18, 2016)). PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Mississippi’s weight loss medication prescribing standards. ALJ–34, at 6. However, even if the Respondent took remedial measures, those measures, standing alone, cannot rebut the Government’s prima facie case for revocation unless the Respondent also accepted responsibility for his actions. See Michael S. Moore, M.D., 76 Fed. Reg. 45867, 45868 (2011); Hassman, 75 Fed. Reg. at 8236. The Respondent did not testify and did not accept responsibility. Accordingly, the Respondent failed to rebut the Government’s prima facie case for revocation based upon his violation of state regulations that detail the requirements for prescribing weight loss medication. Allegation 3: Prescribing to CI’s Children: Physical Examinations, Propriety of Prescriptions, and True Intended Recipient In Allegation 3, the Government claimed that, from February 7 to November 19 of 2014, the Respondent prescribed hydrocodone products to CI’s children without conducting examinations, and that the prescriptions were for CI’s personal use, in violation of Mississippi Administrative Rules 1.4, 1.10, 1.11(b),53 and 1.16, Mississippi Code §§ 73–25–29(3) and (13), and 21 CFR § 1306.04(a) and 1306.05(a). ALJ–1, at 2–3. Mississippi Administrative Rule 1.10 requires that a prescription for a controlled substance contain ‘‘the complete name and address of the patient to whom the physician is prescribing the controlled substance.’’ Miss. Code R. § 30–17–2640:1.10. Likewise, 21 CFR § 1306.05(a) requires that a controlled substance prescription must ‘‘bear the full name and address of the patient.’’ Additionally, the Government alleged that the Respondent prescribed hydrocodone-homatropine (‘‘cough’’) syrup, or Hycodan, to CI’s children, who were under the age of six, even though cough syrup is not recommended for children under the age of six because of a risk of death. ALJ–1, at 3. The Government alleged that the Respondent prescribed adult dosages of this cough syrup to these children, even though the recommended dosage for children aged six to eleven is half of the adult dosage. ALJ–1, at 2–3. The Government further alleged that the Respondent issued the following improper prescriptions for hydrocodone combination products to CI’s children in 53 For the reasons previously discussed, supra note 44, the Government’s allegation that the Respondent violated Mississippi Administrative Rule 1.11(b) is NOT SUSTAINED. E:\FR\FM\17AUN1.SGM 17AUN1 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES 2014: (a) to Kid 2 on February 7, for 150 dosage units, with one refill; (b) to Kid 1 on June 17, for 180 dosage units, with one refill; (c) to Kid 2 on July 23, for 480 dosage units; (d) to Kid 2 on September 2, for 120 dosage units; (e) to Kid 2 on November 3, for 180 dosage units; and (f) to Kid 1 on November 19, for 115 dosage units. ALJ–1, at 2–3. A. The February 7 Prescription On February 7, 2014, the Respondent wrote a prescription for 240 units of Hycodan to Kid 2. GE–50, at 1; GE–55, at 1–2. The Respondent’s medical file for Kid 2 appeared to contain a notation from 2014, possibly from February 7, documenting a Hycodan prescription. See GE–56, at 4. The copy of the medical file partially cut off this notation because it was at the bottom of a copied page. See GE–56, at 4. The only legible part of the notation appears to read, ‘‘Hycodan (8 oz, 2 refills) to Brookhaven Walmart.’’ See GE–56 at 4. CI testified that the Respondent did not examine Kid 2 before prescribing cough syrup to her in February. Tr. 217, 251. The Respondent’s patient file for Kid 2 does not include any notes about any physical examination on that date. The Respondent did not document a diagnosis for Kid 2 on that date. Because this required information was not recorded prior to prescribing controlled substances to Kid 2, the Government’s allegation that the Respondent violated Mississippi Administrative Rule 1.4 by failing to conduct a physical examination of Kid 2 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, it was issued outside of the course of the Respondent’s legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government’s allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73–25–29(3) and (13), and 21 CFR § 1306.04(a) on February 7, 2014, are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. Just 15 days before the February 7, 2014 prescription, the Respondent prescribed 120 units (or 24 days’ worth) of Hycodan syrup to Kid 2. See GE–50, at 1; GE–56, at 4. Thus, Kid 2 still should have had approximately nine days of Hycodan syrup remaining from her last prescription and should not have needed additional Hycodan syrup on February 7, much less double the original dosage. See GE–50, at 1 VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 (showing that the January 24, 2014 prescription was a 24-day supply). CI discussed the real reason that the Respondent wrote this prescription. CI testified that, in February 2014, the Respondent prescribed a big bottle of cough syrup to Kid 2 so that CI could drink it as well, even though the Respondent knew that CI did not have a cough. Tr. 216–17, 250–53, 259, 268, 273. While Kid 2 did have a cough at that time, Tr. 250–51, 253–55, I give full credit to CI’s testimony that the Respondent knew that CI intended to consume some of Kid 2’s Hycodan prescription. Considering the timing of the February 7 prescription and its large dosage, I find, based on a totality of the circumstances, that a preponderance of evidence supports the conclusion that the Respondent knew that CI would consume at least part of Kid 2’s February 7, 2014 prescription. It is a violation of 21 CFR § 1306.05 for a registrant to prescribe controlled substances to a patient knowing that someone other than the patient named on the prescription would receive the medication. Golden, 61 FR at 24811. Therefore, the Government’s allegations that the February 7, 2014 prescription violated Mississippi Administrative Rule 1.10 and 21 CFR § 1306.05(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. B. The June 17, July 23, and November 19 Prescriptions The Respondent wrote three prescriptions to CI’s children without recording the prescriptions in the children’s medical records. First, on June 17, 2014, the Respondent wrote a prescription for six ounces (or 180 units) of Hycodan syrup to Kid 1. GE– 51, at 1; GE–55, at 3–4. The Respondent’s patient file for Kid 1 does not contain any notes dated on or about 54 June 17, 2014. See GE–57. The Respondent did not document a diagnosis for Kid 1 at this time. Then, on July 23, 2014, the Respondent wrote a prescription for 16 ounces (or 480 units) of Hycet liquid to Kid 2. GE–50, at 1; GE–55, at 5–6. The Respondent’s patient file for Kid 2 does not contain any notes dated on or about July 23, 2014. See GE–56. Finally, on November 19, 2014, the Respondent wrote a prescription for eight ounces (or 115 units) of Hycodan for Kid 1. GE–51, at 1; GE–55, at 11. The Respondent’s patient file for Kid 1 does not contain 54 Although the Respondent’s patient file for Kid 1 includes notes from examinations on March 19, 2014, and June 9, 2014, the notes next to these dates do not contain any notations about a Hycodan prescription. See GE–57. PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 54843 any notes on or about November 19, 2014. See GE–56. The Respondent did not write the name, dose, strength, or quantity of any of these prescriptions in the medical records of CI’s children. The Respondent did not record the dates of the prescriptions or the reasons for the prescriptions. The Respondent did not record any notes about any physical examinations on these dates. There is no evidence in the record before me indicating that the Respondent ever saw CI’s children on the dates that he wrote these prescriptions to them. Even absent any expert testimony, failure to see a patient before prescribing medications to the patient is outside of the legitimate practice of medicine. Figueroa, 73 FR at 40381. Therefore, the Government’s allegations that the June 17, 2014, and November 19, 2014 prescriptions to Kid 1, and July 23, 2014 prescription to Kid 2, violated Mississippi Administrative Rule 1.4 are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. Because these prescriptions violated Mississippi Administrative Rule 1.4, they were issued outside of the course of the Respondent’s legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government’s allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73–25–29(3) and (13), and 21 CFR § 1306.04(a) by issuing the June 17, July 23, and November 19 prescriptions are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. The Government further alleged that these prescriptions were issued for CI’s personal use. The Government bears the burden of proof on this point. The administrative record in this case supports the conclusion that the Government established, by a preponderance of the evidence, that the Respondent knew that CI would consume at least part of the cough syrup he prescribed to CI’s children on June 17, July 23, and November 19. In this regard, CI testified that: (1) she would tell the Respondent when her child would have a cough; (2) she never brought her children to see the Respondent regarding a cough; (3) she requested cough syrup from the Respondent because she enjoyed drinking it; and (4) she would request a big bottle of cough syrup. Tr. 220, 265– 66, 273. In addition, the administrative record supports CI’s testimony that she did not bring her children to see the Respondent regarding a cough, as evidenced by their medical charts. GE– E:\FR\FM\17AUN1.SGM 17AUN1 54844 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES 56, at 2–4; GE–57, at 5–6. I find that CI’s testimony, when considered cumulatively and in conjunction with other evidence of record, establishes that, at the time the Respondent wrote the June 17, July 23, and November 19 prescriptions, he knew that CI would drink at least some of the cough syrup, though there was no medical reason for her to do so. Therefore, the Government’s allegations that these three prescriptions violated Mississippi Administrative Rule 1.10 and 21 CFR § 1306.05(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. C. The September 2 and November 3 Prescriptions On September 2, 2014, the Respondent wrote a prescription for four ounces (or 120 units) of Hycodan for Kid 2. GE–50, at 1; GE–55, at 7–8. The Respondent’s patient file for Kid 2 included some notes dated September 2, 2014. GE–56, at 3. These notes stated, ‘‘URI Ears clear Nose, OC/OP mildly inflamed Lungs clear Rx [illegible] 15 Hycodan.’’ GE–56, at 3. Because these notes indicate that the Respondent examined Kid 2, and because the Government did not enter any evidence contesting the accuracy of these notes, I find that the Government failed to show by substantial evidence that the Respondent did not conduct a physical examination of Kid 2 on September 2, and the Government’s allegation to that effect is NOT SUSTAINED. However, Kid 2’s medical record did not include any diagnosis or reason for prescribing Hycodan to Kid 2, as required by Mississippi Administrative Rule 1.4. Additionally, the medical record did not clearly include the dose, strength, or quantity of Hycodan prescribed to Kid 2, as required by Mississippi Administrative Rule 1.4. Because the medical record did not contain this information, the Government’s allegation that the September 2, 2014 prescription to Kid 2 violated Mississippi Administrative Rule 1.4 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, it was issued outside of the course of the Respondent’s legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government’s allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73–25–29(3) and (13), and 21 CFR § 1306.04(a) by issuing the September 2, 2014 prescription are also VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. Similarly, on November 3, 2014, the Respondent wrote a prescription for six ounces (or 180 units) of Hycodan for Kid 2. GE–50, at 1; GE–55, at 9–10. The Respondent wrote a note near a date stamp reading November 4, 2014, in Kid 2’s file. GE–56, at 2. This note said, ‘‘[illegible] 5 problems Rx Hycodan (6 oz) (requested).’’ GE–56, at 2. The medical record did not include documentation of a diagnosis and reason for prescribing controlled substances, other than the fact that it was ‘‘requested.’’ Moreover, the medical record did not include the dosage or strength of the Hycodan prescribed, as is required by Mississippi Administrative Rule 1.4. Further, the notes near the November 3, 2014 date stamp did not indicate that the Respondent conducted any examination prior to prescribing Hycodan to Kid 2, as is required by Mississippi Administrative Rule 1.4. Therefore, the Government’s allegation that the November 3, 2014 prescription to Kid 2 violated Mississippi Administrative Rule 1.4 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, it was issued outside of the course of the Respondent’s legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government’s allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73–25–29(3) and (13), and 21 CFR § 1306.04(a) by issuing the November 3, 2014 prescription are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. The Government also alleged that the September 2 and November 3 prescriptions were issued for CI’s personal use. The Government bears the burden of proof on this point. The administrative record in this case supports the conclusion that the Government established, by a preponderance of the evidence, that the Respondent knew that CI would consume at least part of the cough syrup he prescribed to CI’s children on September 2 and November 3. In this regard, CI testified that: (1) she would tell the Respondent when her child would have a cough: (2) she never brought her children to see the Respondent regarding a cough; (3) she requested cough syrup from the Respondent because she enjoyed PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 drinking it; and (4) she would request a big bottle of cough syrup. Tr. 220, 266, 273. In addition, the administrative record supports CI’s testimony that she did not bring her children to see the Respondent regarding a cough, as evidenced by their medical charts. GE– 56, at 2–4; GE–57, at 5–6. I find that CI’s testimony, when considered cumulatively and in conjunction with other evidence of record, establishes that, at the time the Respondent wrote the September 2 and November 3 prescriptions, he knew that CI would drink at least some of the cough syrup, though there was no medical reason for her to do so. Therefore, the Government’s allegations that these two prescriptions violated Mississippi Administrative Rule 1.10 and 21 CFR 1306.05(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. D. Dangerous Prescriptions The Government alleged that the Respondent prescribed cough syrup to CI’s children, who were under the age of six, even though cough syrup is not recommended for children under the age of six because of a risk of death. ALJ–1, at 3. The Government also alleged that the Respondent prescribed adult dosages of cough syrup to these children, even though the recommended dosage for children aged six to eleven is half of the adult dosage. ALJ–1, at 2–3. There is no evidence on the record before me 55 that indicates that it is improper to prescribe cough syrup to children. There is no evidence on the record before me that indicates that the dosages of cough syrup that the Respondent prescribed to CI’s children were improper dosages. The Government did not offer an authentic, well-founded medical opinion that the quantities and types of prescriptions to CI’s children were improper. The Government had the burden of proving that the prescriptions were unlawful. See Ruben, 78 FR at 38384. The Government failed to meet this burden. Accordingly, the Government’s allegations regarding the propriety of the Respondent’s prescriptions to CI’s children are NOT SUSTAINED. 55 The Government offered into evidence three printouts from Web sites, allegedly obtained from the FDA’s Web site, WebMD, and Drugs.com. See Gov’t Proposed Exs. 4–6. Upon the Respondent’s timely objection, I rejected these three exhibits because they were improper opinion testimony, lacked adequate foundation, and were not properly authenticated. See Tr. 418–26. E:\FR\FM\17AUN1.SGM 17AUN1 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices Allegation 4: Fraudulent Prescriptions for CI through Undercover Agents 56 In Allegation 4, the Government claimed that, on five occasions between March and October 2015, the Respondent prescribed controlled substances to undercover agents when he knew or should have known that the agents’ prescription requests were fraudulent, in violation of 21 U.S.C. §§ 841(a) and 842(a) and 21 CFR § 1306.04(a). ALJ–1, at 3. The Government alleged that the Respondent wrote seven hydrocodone prescriptions on five occasions to undercover agents, for 190 total dosage units of hydrocodone tablets and 72 total dosage units of hydrocodone syrup. ALJ–1, at 11. The Government alleged that, on four of those occasions, the Respondent knew that CI would receive a portion of the prescribed medications. ALJ–1, at 3–4. mstockstill on DSK3G9T082PROD with NOTICES A. Undercover Appointments 1 through 4 The evidence against the Respondent regarding the first four undercover appointments is significant, conclusive, and uncontested. The Respondent compared his diversion of drugs to CI with going to ‘‘buy drugs at a crack house.’’ GE–28, file 2015–04–22_13–03–23_EDT, at 2. In some sense, this was an apt description. Whenever CI asked the Respondent for drugs, he would attempt to convey them to her. Prior to each of the first four undercover appointments, CI clearly and repeatedly asked the Respondent for controlled substances.57 CI specifically named certain controlled substances that she wanted the Respondent to prescribe to Agent 1 and Agent 2 to divert to her.58 Although the 56 In its post-hearing brief, the Government argued that this conduct should be analyzed under Factor Five. ALJ–35, at 21–24. However, in the Government’s OSC/ISO and its presentation of evidence at the hearing, the Government made a strong argument that the Respondent’s prescriptions to the undercover agents violated state and federal laws, and were acts of knowing diversion which reflected poorly on the Respondent’s experience in dispensing controlled substances. Therefore, analysis of this conduct under Factors Two and Four is appropriate. 57 GE–16, file 2015–03–16_18–51–48_EDT, at 20– 21, 24–26 (expressing that CI was seeking drugs before the first undercover appointment); GE–16, file 2015–03–18_11–03–33_EDT, at 2 (same); GE– 17, at 4 (same); see GE–16, file 2015–04–02_14–15– 50_EDT, at 1 (expressing that CI was seeking drugs before the second undercover appointment, and indicating that she had taken all of the drugs from the first appointment too quickly); see also GE–28, file 2015–04–13_20–26–31_EDT, at 7 (expressing that CI was seeking more drugs before the third and fourth undercover appointments); GE–28, file 2015– 04–28_20–23–38_EDT, at 1 (same); GE–38, at 2–3 (same). 58 GE–16, file 2015–03–17_13–07–36_EDT, at 4 (asking for Lorcet/Norco before the first undercover VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 Respondent wanted to be ignorant about the identities of CI’s ‘‘friends,’’ 59 the Respondent knew that Agent 1 and Agent 2 were ‘‘friends’’ of CI 60 and that they would give CI at least some of the drugs he prescribed to them.61 The Respondent had reason to know that Agent 1 and Agent 2 did not legitimately need medication for themselves.62 The Respondent had reason to know that Agent 1, Agent 2, and CI were splitting their appointment); GE–17, at 3 (same); GE–18, at 3 (asking for Norco before the first undercover appointment); see GE–16, file 2015–04–02_15–04– 43_EDT, at 1–2 (asking for a double dosage, presumably of Norco, before the second undercover appointment); see also GE–28, file 2015–04–28_20– 23–38_EDT, at 1 (asking for cough medicine before the third and fourth undercover appointments); GE– 29, at 7 (same); GE–38, at 3–4 (asking for a ‘‘big bottle’’ of cough syrup before the third and fourth undercover appointments); GE–39, at 5 (asking for cough medicine before the third and fourth undercover appointments). 59 GE–28, file 2015–04–22_13–03–23_EDT, at 4– 5 (expressing his desire to remain ignorant before the third and fourth undercover appointments); GE– 28, file 2015–04–27_14–45–16_EDT, at 1 (same); GE–38, at 2 (same). The Respondent even stated at one point, ‘‘if [Agent 1 is] coming in for what I think she’s coming in, tell her not to tell me that. That needs to be your secret. I don’t wanna know that. She needs to have a headache and I will treat her for a headache, and so don’t mind giving her prescriptions to treat a headache.’’ GE–17, at 7. 60 GE–16, file 2015–04–07_13–29–34_EDT, at 2 (discussing CI accompanying Agent 1 to her appointment); GE–16, file 2015–04–07_18–28–45_ EDT, at 7–8 (same); GE–16, file 2015–04–08_10–16– 03_EDT, at 1 (saying that Agent 1 knew about their relationship); GE–17, at 6–7 (identifying Agent 1 before the first undercover appointment); GE–21, at 5–6 (identifying Agent 1 before the second undercover appointment); see GE–21, at 8 (asking the Respondent to bring Agent 1’s prescriptions to his rendezvous with CI at Walmart to save her money); see also GE–28, file 2015–04–22_13–03– 23_EDT, at 4–5 (recognizing Agent 1 as CI’s friend before the third and fourth undercover appointments); GE–28, file 2015–04–28_20–23–38_ EDT, at 1 (identifying Agent 1 and Agent 2 as CI’s friends before the third and fourth undercover appointments); GE–40, at 2 (recognizing that, at the time of Agent 2’s appointment, the Respondent knew that Agent 2 was affiliated with CI and Agent 1). 61 GE–16, file 2015–03–18_11–03–33_EDT, at 2– 4 (suggesting that CI could send a friend in to get prescriptions before the first undercover appointment); GE–17, at 3 (same, and acknowledging, before the first undercover appointment, that any prescriptions to CI’s friends would be diverted to CI); GE–17, at 7 (advising that the prescriptions he gave to Agent 1 would be fine for CI to take); GE–18, at 3 (stating, before the first undercover appointment, that the Respondent would write prescriptions for Agent 1 so CI could have the medication); see GE–14, at 1 (identifying Agent 1 as CI’s friend, and discussing how the Respondent ‘‘hooked [CI] up,’’ before the second undercover appointment); GE–16, file 2015–04–02_ 14–15–50_EDT, at 1–2 (same); GE–21, at 13 (thanking the Respondent for ‘‘hooking’’ her up before the second undercover appointment); GE–28, file 2015–04–28_20–23–38_EDT, at 1 (asking the Respondent to ‘‘[h]ook’’ up CI’s friend before the third and fourth undercover appointments). 62 E.g., GE–16, file 2015–04–02_14–15–50_EDT, at 2; GE–16, file 2015–04–02_15–04–43_EDT, at 1–2. PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 54845 prescriptions.63 Therefore, based on the communications exchanged between the Respondent and CI, I find that the Respondent knew that Agent 1 and Agent 2 were ‘‘not seeking treatment for a legitimate medical condition but [were] engaged in . . . diversion.’’ See McNichol, 77 FR at 57148. Despite circumstances that plainly and unambiguously indicated diversion, the Respondent nonetheless prescribed drugs to Agent 1 and Agent 2 during the first four undercover appointments. Even beyond this, the Respondent took extra efforts to facilitate the diversion of drugs to CI. The Respondent discussed the scheduling of Agent 1 and Agent 2’s appointments with CI, and CI reminded him about the timing of those appointments.64 The Respondent asked CI to tell her friends to pretend they had headaches and act like legitimate patients.65 After the third and fourth undercover appointments, the Respondent praised Agent 1 and Agent 2 for acting very appropriately by going ‘‘through the motions.’’ GE–40, at 2. After each of the first four appointments, CI told the Respondent that she had received the drugs prescribed to Agent 1 and Agent 2; in response, the Respondent stated that he was happy to help get drugs to CI.66 It is true that the Respondent conducted appointments with Agents 1 and 2, and wrote notes in their medical files. In that aspect, this case is similar to Robert F. Hunt, D.O., 75 FR 49995 (2010). Dr. Hunt had said that he wrote information on a patient’s chart ‘‘just to cover [his] ass.’’ Id. at 50003. The DEA held that this statement made it ‘‘clear that [Dr. Hunt] knew that he lacked a legitimate medical purpose for prescribing’’ controlled substances. Id. Similarly, although the Respondent 63 GE–28, file 2015–04–27_14–45–16_EDT, at 1. at 3 (discussing the first undercover appointment); GE–23 (discussing, before the second undercover appointment, the need to space out the appointments more); see GE–16, file 2015–04–06_ 20–59–35_EDT, at 2 (discussing the second undercover appointment); see also GE–28, file 2015–04–22_10–28–41_EDT, at 3–4 (discussing the third and fourth undercover appointments); GE–28, file 2015–04–22_13–03–23_EDT, at 4 (same); GE– 28, file 2015–04–28_20–23–38_EDT, at 1 (same); GE–29, at 7 (same). 65 GE–18, at 3 (instructing CI to tell Agent 1 to ‘‘play it straight’’ and tell him what he needed to write in his chart at the first undercover appointment). 66 GE–14, at 1 (telling CI, after the first undercover appointment, that he was happy to meet Agent 1 and hoped it helped, and receiving thanks from CI for ‘‘hooking’’ her up); GE–14, at 2 (acknowledging that the prescriptions that he gave to Agent 1 went to CI); GE–19, at 1 (asking CI if everything ‘‘went smooth with getting your medication’’ and expressing that he was happy to help); GE–40, at 1–2 (asking CI if she got the medication and expressing that he was ‘‘glad all that worked out’’). 64 GE–18, E:\FR\FM\17AUN1.SGM 17AUN1 mstockstill on DSK3G9T082PROD with NOTICES 54846 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices conducted appointments with Agents 1 and 2 and wrote notes in their medical files, the Respondent’s statements to CI before and after each of the first four appointments made it clear that the Respondent was unquestionably prescribing controlled substances to Agents 1 and 2 to intentionally divert drugs to CI. His statements also make clear that the records he was keeping concerning Agents 1 and 2 were merely to keep the Mississippi Board investigators at bay. E.g., GE–18, at 3. Moreover, the fact that a registrant conducted a medical appointment before prescribing controlled substances does not, standing by itself, validate the prescriptions issued; rather, an appointment may be used by a prescriber as ‘‘a sham justification to support an unlawful prescription.’’ McNichol, 77 Fed. Reg. at 57148. An appointment can constitute a perfunctory, sham examination if the registrant ‘‘already agreed to issue’’ certain prescriptions to a patient. Darryl J. Mohr, M.D., 77 Fed. Reg. 34998, 35000 (2012). This is precisely what happened here. Before each of the first four undercover appointments, the record unambiguously shows that the Respondent knew exactly what he would prescribe to Agents 1 and 2 before they ever walked through his door, because he knew what drugs CI had requested. For example, the Respondent prescribed Hycodan to Agent 1, even though she was not coughing during her appointment, because he had told CI that he would get eight ounces of cough syrup to her. GE– 33, at 1; GE–38, at 3–4, 8; Tr. 113. Following the second appointment, the Respondent himself acknowledged the sham nature of the appointment; he stated that he had made small talk with Agent 1 because ‘‘we had to be in there more than ten seconds’’ so that his ‘‘nosy nurse’’ would not think, ‘‘[d]ang, why is this appointment over with in ten seconds?’’ GE–27, at 1, 5. It is not surprising that, during Agent 1’s second appointment, the Respondent did not bother to conduct even a sham physical examination. See GE–24–25; Tr. 103–04, 132. The facts of this case present an appalling and flagrant disregard of a registrant’s duty to prescribe controlled substances only to legitimate patients. While the Respondent told CI that his feelings for her needed to be ‘‘totally separate from [his] medical practice,’’ GE–20, he was unable to follow his own internal guidance. In fact, the size of the Respondent’s diversion was significant: during the first four undercover appointments, the Respondent VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 prescribed a total of 160 units of Norco and eight ounces of Hycodan to the undercover agents, who he believed would divert those drugs to CI.67 The Respondent repeatedly joked about providing CI access to all the drugs that she wanted.68 Even though the Respondent did not take his responsibilities as a registrant seriously, he did understand the potential legal consequences of his actions. The Respondent repeatedly expressed a fear of getting in trouble for diverting drugs to CI.69 This reflects that the Respondent undoubtedly knew that his actions were wrong.70 I find that, during the first four undercover appointments, the Respondent knew that Agent 1 and Agent 2 were not real patients and that at least some of the medications he prescribed to them would be given to CI. I find that the Respondent prescribed medications to Agent 1 and Agent 2 upon CI’s request for those medications. I further find that, when the Respondent wrote prescriptions to Agent 1 and Agent 2 during those four appointments, the Respondent intended to divert drugs to CI. Thus, by ‘‘providing evidence showing that [the Respondent] knowingly diverted drugs,’’ the Government proved that the Respondent acted outside of the usual course of his 67 GE–11, at 1 (prescribing 40 units of Norco 10/ 325 to Agent 1 at the first undercover appointment); GE–26, at 1 (prescribing 40 units of Norco 10/325 to Agent 1 at the second undercover appointment); GE–32 (prescribing 40 units of Norco 10/325 to Agent 1 at the third undercover appointment); GE– 33, at 1 (prescribing eight ounces of Hycodan to Agent 1 at the third undercover appointment); GE– 36, at 1 (prescribing 40 units of Norco 10/325 to Agent 2 at the fourth undercover appointment). 68 GE–16, file 2015–03–17_13–07–36_EDT, at 7 (joking before the first undercover appointment); GE–16, file 2015–03–18_11–03–33_EDT, at 4 (same); GE–16, file 2015–04–02_15–04–43_EDT, at 1–2 (joking before the second undercover appointment); GE–29, at 9 (joking after the third and fourth undercover appointments); GE–38, at 2 (joking before the third and fourth undercover appointments). 69 GE–16, file 2015–03–17_13–07–36_EDT, at 7 (admitting fear before the first undercover appointment); GE–16, file 2015–04–02_14–15–50_ EDT, at 2 (instructing CI to keep things hidden); GE–17, at 2 (expressing fear before the first undercover appointment); see GE–14, at 1 (expressing fear after the first undercover appointment); GE–16, file 2015–04–02_15–04–43_ EDT, at 2 (discussing avoiding detection before the second undercover appointment); GE–16, file 2015– 04–07_13–29–34_EDT, at 2 (same); GE–16, file 2015–04–07_18–28–45_EDT, at 7–8 (same); see also GE–28, file 2015–04–22_10–28–41_EDT, at 3–4 (expressing concern about getting caught before the third and fourth undercover appointments); GE–28, file 2015–04–22_13–03–23_EDT, at 4 (same); GE– 38, at 2 (same). 70 See GE–16, file 2015–03–18_11–03–33_EDT, at 2–3 (reflecting his knowledge that his actions were wrongful before the first undercover appointment); GE–38, at 8 (expressing his fear that he might be ‘‘busted’’ by the ‘‘drug police’’). PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 professional practice and lacked a legitimate medical purpose. See Danton, 76 Fed. Reg. at 60901. Therefore, the Government’s allegations that the first four undercover appointments violated 21 U.S.C. §§ 841(a) and 842(a), and 21 CFR § 1306.04(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. To the extent that the Respondent’s actions are interpreted as prescribing controlled substances to CI indirectly,71 his prescriptions are grave violations of 21 CFR 1306.04(a). On this point, this case bears a striking similarity to Annicol Marrocco, M.D., 80 FR 28695 (2015). In that case, Dr. Marrocco prescribed controlled substances to her lover, but did not physically see her lover for three to six months while he was using those prescriptions. Id. at 28703. The DEA found that Dr. Marrocco lacked a legitimate purpose for her prescriptions because she was unable to supervise her lover’s use of his medication, which reflected ‘‘a stunning disregard for [Dr. Marrocco’s] obligations as a prescriber of controlled substances.’’ Id.; see Figueroa, 73 FR at 40381 (noting that failure to see a patient before prescribing medication deviates from the legitimate practice of medicine). Similarly, other than two brief interactions in public places, the Respondent never saw CI while he was prescribing controlled substances to Agent 1 and Agent 2 to divert to CI. Therefore, the Respondent could not monitor CI’s use of controlled substances. Additionally, prescribing controlled substances based on a patient’s request, ‘‘rather than the result of the application of the physician’s medical judgment,’’ lacks a legitimate medical purpose. Golden, 61 FR at 24812 (citing Dougherty, 60 FR 55047; Borcherding, 60 FR 28796). The Respondent’s prescriptions to Agent 1 and Agent 2 were based only on CI’s request for certain controlled substances, not on any physical examination or medical evaluation. Under Mississippi Administrative Rule 1.4(a), such prescribing establishes that the Respondent lacked good faith in issuing these prescriptions. For these reasons, to the extent that the Respondent’s 2015 prescriptions to Agent 1 and Agent 2 are perceived as indirect prescriptions to CI, they clearly violate Mississippi Administrative Rules 1.4 and 1.16, Mississippi Code §§ 73–25–29(3) and (13), and 21 CFR 1306.04(a), and the Government’s allegations to that effect are 71 See E:\FR\FM\17AUN1.SGM supra note 43. 17AUN1 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. In addition, the Respondent diverted controlled substances to CI through the undercover agents after he knew that CI attempted to commit suicide. Such actions reflect an astonishing level of irresponsibility in the Respondent’s prescribing activity. In McNichol, the DEA held under Factors Two and Four that a prescriber’s statement, which reflected concern about putting a patient potentially ‘‘in jeopardy of overdose,’’ made it ‘‘clear that [the prescriber] believed that [the patient] was a drug abuser.’’ 77 FR at 57149. Similarly, in Jayam Krishna-Iyer, the DEA held that ‘‘[a] practitioner who ignores the warning signs that [his] patients are either personally abusing or diverting controlled substances commits ‘acts inconsistent with the public interest,’ 21 U.S.C. 824(a)(4), even if [he] is merely ¨ gullible or naıve.’’ 74 FR at 460 n.3. Additionally, it is ‘‘relevant that [a registrant], knowing that the CI had been treated for drug abuse, facilitated her access to controlled substances.’’ Golden, 61 FR at 24812. Here, the facts indicate that the Respondent knew his prescribing actions put CI’s health in danger. The Respondent knew that CI previously had attempted to commit suicide using drugs he prescribed to her. He knew she was still depressed. GE–28, file 2015– 04–15_21–30–59_EDT, at 9. He expressed fear and concern that she would take too many pills, resulting in ‘‘unfixably bad’’ damage and a ‘‘long, agonizing, painful way to go.’’ GE–14, at 1; GE–17, at 4. In spite of all of this, the Respondent continued to divert controlled substances to CI and said he was ‘‘glad’’ to do so. GE–19, at 1; GE– 40, at 1; Tr. 230–31. Under these circumstances, the Respondent’s continued prescribing controlled of substances to CI reflects negatively on the Respondent’s experience in dispensing controlled substances. B. Undercover Appointment #5 Although the Government did not allege that the Respondent’s prescriptions to Agent 1 during the fifth undercover appointment were knowing attempts to divert drugs to CI, the Government alleged that the October 2015 prescriptions violated 21 U.S.C. 841(a) and 842(a) and 21 CFR 1306.04(a) because the Respondent knew or should have known that Agent 1’s prescription requests were fraudulent. See ALJ–1, at 3–4. The Government presented no evidence of any communications between the Respondent and CI or VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 Agent 1 immediately preceding Agent 1’s October 2015 appointment. At the appointment, Agent 1 met with the Respondent, who examined her ears, nose, and throat. Tr. 120, 132. The Respondent appeared to not remember Agent 1. Tr. 120, 135, 452; see GE–42– 43. Only the first portion of the appointment was recorded, and no witnesses were able to confidently recall the whole conversation between Agent 1 and the Respondent. In response to Agent 1’s inquiry, the Respondent indicated during the appointment that he did not remember Agent 2. GE–42– 43. When Agent 1 asked the Respondent if he had heard from CI lately, the Respondent paused, and looked surprised, before saying that he had not. Tr. 122–23, 135, 452–53. Agent 1 said that she needed the ‘‘same as before,’’ but did not tell the Respondent that she had any specific complaints. GE–42–43; Tr. 454. The Respondent discussed the efficacy of medication with Agent 1. GE–43, at 2–3. Agent 1 never said she had a cough. GE–42–43; Tr. 126, 454. Nonetheless, the Respondent prescribed cough syrup, among other things, to Agent 1. GE–45; Tr. 139. The Respondent’s medical file for Agent 1 indicated that Agent 1 had ‘‘migraine headaches, as before Weather changes may make it worse Maxalt helps most of the time Norco works okay as a backup Dry [illegible] cough; no [illegible] to be allergy related Allergy symptoms Ears clear OC/OP ¯ clear Nose c somewhat [illegible] Lungs clear.’’ GE–60, at 4. The Respondent also recorded that he wrote five prescriptions to CI, including 30 units of Norco 5/325 and four ounces of Hycodan. GE–60, at 4. These facts summarize the totality of the evidence before me concerning the October 2015 undercover appointment. Based on these facts, I find that there is not substantial evidence that the Respondent knew or should have known that Agent 1’s prescription requests were fraudulent. The recordings and testimony do not clearly indicate that Agent 1 was presenting sham symptoms to the Respondent. Agent 1’s patient file indicated that the Respondent examined Agent 1, recorded her complaints, and recorded the prescriptions he gave to her. Importantly, the Government did not allege that the Respondent’s medical record for Agent 1 from the October appointment was deficient; it only alleged that he knew or should have known that Agent 1’s prescription requests were fraudulent. The Government bears the burden of proof on this point. ‘‘[U]nder the substantial PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 54847 evidence test, the evidence must ‘do more than create a suspicion of the existence of the fact to be established.’’’ Alvin Darby, M.D., 75 FR 26993, 26999 n.31 (2010) (citing NLRB v. Columbian Enameling & Stamping Co., 306 U.S. 292, 300 (1939)). The Government failed to meet this burden. The Government offered insufficient evidence to support a conclusion that the Respondent knew or should have known that, five and a half months after last seeing Agent 1, and while reviewing a new medical chart, her requests during the October 2015 appointment were fraudulent. Therefore, the Government’s allegations that the fifth undercover appointment violated 21 U.S.C. 841(a) and 842(a), and 21 CFR 1306.04(a), because the Respondent knew or should have known that Agent 1’s prescription requests were fraudulent are NOT SUSTAINED. Allegation 5: Prescriptions Issued in 2014 and 2015 The Government alleged that, from February 2014 to October 2015, the Respondent unlawfully prescribed controlled substances in violation of 21 U.S.C. 841(a) and 842(a). ALJ–1, at 2. Specifically, the Government alleged that the Respondent prescribed controlled substances when he knew or should have known that they were not prescribed for legitimate medical purposes, and were not written in the usual course of professional practice, in violation of 21 CFR 1306.04(a) and Mississippi Code §§ 41–29–137(a)(1) and 41–29–141(1). ALJ–1, at 2. Those sections of the Mississippi Code provide that it is illegal for practitioners to dispense Schedule II controlled substances without a valid written prescription. Miss. Code §§ 41–29– 137(a)(1), 41–29–141(1). Under Allegation 1, I sustained the Government’s allegations that the Respondent’s 2014 prescriptions to CI on May 22, June 17, September 11, October 6, and December 4 were outside the usual course of his professional practice and were illegitimate prescriptions that violated 21 CFR 1306.04(a). Under Allegation 2, I sustained the Government’s allegations that the Respondent’s 2014 prescriptions to CI on April 9, May 19, July 24, and September 8 were outside the usual course of his professional practice and were illegitimate prescriptions that violated 21 CFR 1306.04(a). Under Allegation 3, I sustained the Government’s allegations that the Respondent’s 2014 prescriptions to Kid 2 on February 7, July 23, September 2, and November 3, and the Respondent’s prescriptions to E:\FR\FM\17AUN1.SGM 17AUN1 54848 Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices Kid 1 on June 17 and November 19, were outside the usual course of his professional practice and were illegitimate prescriptions that violated 21 CFR 1306.04(a). Finally, under Allegation 4, I sustained the Government’s allegations that the Respondent’s prescriptions written during the first four undercover appointments in 2015 were fraudulent and violated 21 CFR 1306.04(a). I have held that all of these prescriptions were issued outside of the Respondent’s usual course of professional practice and were not issued for legitimate medical purposes. Therefore, the Government’s allegation that the Respondent violated 21 CFR 1306.04(a) is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. The Government also established that some prescriptions were invalid because CI, rather than the named patient, was the actual intended recipient of several prescriptions. The Government’s allegations that the Respondent’s six prescriptions to CI’s children, identified supra, and 2015 hydrocodone combination product prescriptions to the undercover agents at the first four undercover appointments violated Mississippi Code §§ 41–29–137(a)(1) and 41–29–141(1) are SUSTAINED.72 Because the Respondent issued illegitimate prescriptions, the Government’s allegations that the Respondent violated 21 U.S.C. 841(a) and 842(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. mstockstill on DSK3G9T082PROD with NOTICES Allegation 6: Meperidine Used in Suicide Attempt The Government alleged that the Respondent prescribed 30 dosage units of meperidine 50 mg to CI, which she used to try to kill herself. ALJ–1, at 3. The evidence shows that the Respondent prescribed Demerol to CI on September 2, 2014. GE–2, at 12; GE–49, at 2; Tr. 222, 296–97, 317–18, 382. The Respondent appears to have been the only person to prescribe Demerol to CI. See GE–49. CI used the Demerol to attempt to commit suicide in December 2014. Tr. 222, 315–17. The Government, however, did not specify or argue why 72 Hydrocodone combination products were reclassified by the federal government as Schedule II controlled substances as of October 6, 2014. Stip. 6. The Government has not shown how hydrocodone combination products are scheduled in the state of Mississippi. The Government’s allegations that the Respondent’s prescriptions predating October 6, 2014, violated Mississippi Code §§ 41–29–137(a)(1) and 41–29–141(1), which only address Schedule II controlled substances, are NOT SUSTAINED. VerDate Sep<11>2014 16:39 Aug 16, 2016 Jkt 238001 this Demerol prescription was improper. The Government did not allege or argue that the Respondent failed to conduct a physical examination of CI, or failed to maintain proper medical charts, when he prescribed Demerol to CI. The Government did not allege or argue that the Respondent knew or anticipated that CI would attempt to commit suicide using the Demerol he prescribed to her. The Government did not even allege or argue that the Respondent possessed anything other than a legitimate intent to treat CI’s physical symptoms when he prescribed Demerol to her. Therefore, to the extent that the Government alleged that the Respondent’s Demerol prescription to CI merits revocation of his COR, the Government’s allegation is NOT SUSTAINED. Under Factors Two and Four,73 the Respondent’s prescribing conduct indicates that his continued registration is not in the public interest. Therefore, Factors Two and Four militate strongly in favor of revocation of the Respondent’s COR. RECOMMENDATION Even if the Respondent had knowingly attempted to divert controlled substances to CI only one time, that alone would have been sufficient to make a prima facie case for revocation of the Respondent’s license. See MacKay v. DEA, 664 F.3d 808, 819 (10th Cir. 2011). ‘‘[P]roof of a single act of intentional or knowing diversion is sufficient to satisfy the Government’s prima facie burden of showing that a practitioner’s continued registration is inconsistent with the public interest, and if unrebutted by a showing that the practitioner accepts responsibility for his misconduct and will not engage in future misconduct, warrants the revocation of a registration.’’ McNichol, 77 FR at 57145 (internal citations omitted); see also Krishna-Iyer, 74 FR at 462–64; Alan H. Olefsky, 57 FR 928, 928–29 (1992). In cases of knowing diversion, ‘‘the [DEA] has an interest in deterring [the Respondent] and others from engaging in similar egregious behavior.’’ Michael A. White, M.D., 79 FR 62957, 62967 (2014). Here, the Government has proven far more than one act of knowing diversion. The Government has proven that the Respondent repeatedly and continually 73 Both parties specifically discussed Factor Five in their post-hearing briefs. Factor Five considers conduct not otherwise addressed under Factors One through Four. 21 U.S.C. 823(f)(5). As discussed supra, the Respondent’s actions in this case are most appropriately analyzed under Factors Two and Four. Therefore, consideration of this conduct under Factor Five, the ‘‘catch-all’’ factor, is inappropriate. PO 00000 Frm 00063 Fmt 4703 Sfmt 9990 issued illegitimate prescriptions to CI and others for multiple types of drugs based solely on CI’s request. The Government has proven that, on multiple occasions, the Respondent knowingly issued fraudulent prescriptions with the intent to divert drugs to CI. The Respondent’s improper prescribing constituted an egregious level of intentional diversion. Accordingly, Factors Two and Four weigh heavily against the Respondent, and the Government has established a prima facie case supporting revocation of the Respondent’s registration. Further, after evaluating all of the above established facts, I find that considerations of both specific and general deterrence also weigh in favor of revocation in this case. Because the Government has made a prima facie case that the Respondent’s continued registration would be inconsistent with the public interest, the Respondent had the burden of production to ‘‘present[] sufficient mitigating evidence’’ to show why he can be entrusted with a registration. See Med. Shoppe—Jonesborough, 73 FR at 387 (quoting Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)). Specifically, to rebut the Government’s prima facie case, the Respondent must have both accepted responsibility for his actions and demonstrated that he would not engage in future misconduct. Stodola, 74 FR at 20734–35. However, the Respondent offered no evidence 74 that he accepted responsibility for his misconduct or reformed his ways. Therefore, the Respondent failed to rebut the Government’s prima facie case. Because the Government proved that the Respondent’s registration is inconsistent with the public interest, and because the Respondent failed to rebut the Government’s prima facie case, I RECOMMEND that the Respondent’s DEA Certificate of Registration be REVOKED and any applications for renewal or modification of his license be DENIED. Dated: June 1, 2016 s/Charles Wm. Dorman Administrative Law Judge [FR Doc. 2016–19595 Filed 8–16–16; 8:45 am] BILLING CODE 4410–09–P 74 The Government requested that I draw an adverse inference against the Respondent because of his failure to testify at the hearing. ALJ–35, at 27– 28. However, I decline to do so because an adverse inference is unnecessary in light of the overwhelming evidence against the Respondent. E:\FR\FM\17AUN1.SGM 17AUN1

Agencies

[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Pages 54822-54848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19595]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 16-14]

Lawrence E. Stewart, M.D.; Decision and Order

On June 1, 2016, Administrative Law Judge (ALJ) Charles Wm. Dorman
issued the attached Recommended Decision. Therein, the ALJ found that
on multiple occasions, Respondent issued prescriptions outside of the
usual course of professional practice and which lacked a legitimate
medical purpose for schedule II controlled substances such as Norco 10/
325mg (hydrocodone/acetaminophen) and Hycodan (hydrocodone/homatropine
cough syrup),\1\ the schedule III controlled substance phentermine, and
the schedule IV controlled substance alprazolam, in violation of 21 CFR
1306.04(a). See R.D. at 34-60.\2\
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\1\ Effective October 6, 2014, combination hydrocodone products
including both Norco and Hycodan were transferred from schedule III
to schedule II of the Controlled Substances Act. See Schedules of
Controlled Substances: Rescheduling of Hydrocodone Combination
Products from Schedule III to Schedule II, 79 FR 49661. Thus, at the
time Respondent issued some of the Norco and Hycodan prescriptions,
the drug was a schedule III controlled substance. This, however, has
no consequence for my decision.
\2\ All citations to the Recommended Decision are to the slip
opinion as issued by the ALJ.
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More specifically, the evidence showed that Respondent prescribed
the controlled substances to his girlfriend knowing that she was
seeking the drugs to abuse them. The evidence also showed that while
some of the prescriptions were issued in the name of Respondent's
girlfriend, in multiple instances, Respondent issued prescriptions,
including multiple prescriptions for Hycodan, listing his girlfriend's
two children, who were then three and five years old respectively, as
the patients, and that Respondent did so knowing that his girlfriend
intended to use the cough syrup because she enjoyed drinking it. The
evidence further showed that on multiple occasions, Respondent issued
prescriptions for Norco \3\ to undercover agents who posed as
acquaintances of his girlfriend, knowing that the drugs would then be
provided to his girlfriend and that Respondent further instructed his
girlfriend as to how her purported acquaintances should present as
having headaches so that he could document a reason in the their charts
for having issued the prescriptions.
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\3\ The evidence also showed that at one of the undercover
agent's visits, Respondent also gave her a prescription for Hycodan
cough syrup.
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The ALJ also found that on multiple occasions, Respondent violated
Rule 1.4 of the Mississippi State Board of Medical Licensure's Rules by
failing to document in his girlfriend's chart the diagnosis or
justification for issuing the prescription, as well as required
information including the drug's name, the dose, strength and quantity.
R.D. at 37-39 (citing Miss. Code R. Sec. 30-17-2640:1.4; also citing
id. Sec. 30-17-2640:1.16; Miss. Code Sec. Sec. 73-25-29(3) and (13)).
The ALJ also made a similar finding with respect to four hydrocodone
cough syrup prescriptions Respondent issued in the names of his
girlfriend's children. R.D. at 46-47 (Rx's issued on 6/17/14, 7/23/14,
11/19/14); id. at 49 (Rx 11/3/14).
With respect to the phentermine prescriptions Respondent issued to
his girlfriend, the ALJ found that he ``completely failed to comply''
with the Board's Rule 1.5 because he did not prescribe ``adjunctively
with caloric restriction,'' ``never conducted and recorded an initial
comprehensive evaluation'' including ``a thorough patient history or
physical examination,'' and never recorded required histories, nor her
height, weight, BMI, body measurements, and vital signs. R.D. 43. The
ALJ also found that Respondent did not conduct a re-evaluation of his
girlfriend every 30 days as required by Rule 1.5. Id. Finally, noting
that Rule 1.5 generally requires that the patient have a BMI greater
than 30 in order to justify prescribing phentermine, the ALJ observed
that Respondent's girlfriend testified that she had gone from 135 to
121 pounds and that she presented at the hearing ``with a slender body
type.'' Id. The ALJ thus explained that ``[a]fter observing [her]
appearance,'' he found ``it difficult to comprehend . . . how
Respondent could have possibly believed that [she] has a high enough
BMI to justify'' prescribing weight-loss medication. Id. The ALJ thus
found that Respondent violated 21 CFR 1306.04(a), the Board's Rule 1.5,
and Mississippi Code sections 73-25-29(3) and (13) when he prescribed
phentermine to his girlfriend. Id. at 44.
Based on these findings, the ALJ concluded that Respondent had
engaged in ``an egregious level of intentional diversion'' and that the
Government had satisfied its prima facie burden of showing that
``Respondent's continued registration would be inconsistent with the
public interest.'' R.D. at 61. Because ``Respondent offered no evidence
that he accepted responsibility for his misconduct or reformed his
ways,'' the ALJ found that he ``failed to rebut the Government's prima
facie case.'' Id. The ALJ thus recommended that I revoke Respondent's
registration and deny any application to renew or modify his
registration. Id.
Respondent filed Exceptions to the ALJ's Recommended Decision.
Thereafter, the ALJ forwarded the record to me for Final Agency Action.
Having considered the record in its entirety, including
Respondent's Exceptions, I have decided to adopt the ALJ findings of
fact, conclusions of law, and recommended Order. However, before I
address Respondent's Exceptions, I deem it necessary to address the
ALJ's ruling on the admissibility of the FDA package insert for Hycodan
(GX 4).
On motion of Respondent's counsel, the ALJ ruled inadmissible
Government Exhibit 4, which the Government represented was the FDA
package insert for Hycodan.\4\ Tr. 422, 427. The basis of Respondent's
objection was that the exhibit contains ``little more than
generalizations and medical opinions'' and that the ALJ's prehearing
statement required the parties to disclose ``the names and credentials
and opinions of medical experts . . . who would be offering medical
opinions in this case.'' Id. at 420. Respondent's counsel further
argued that ``[t]he government did not identify any expert capable of
being cross-examined on any of these opinions'' and that ``[t]here is
no reason to believe that [the Exhibit was] authored by a physician,
much less do we know whether the author had credentials to offer these
opinions.'' Id.
---------------------------------------------------------------------------

\4\ There is no dispute that the Exhibit was what the Government
represented it to be--a copy of the package insert. Nor is there any
dispute as to how the document was obtained.
---------------------------------------------------------------------------

After the Government argued that the document was the FDA package
insert, which is included ``with every drug purchased or sold,'' id. at
422, Respondent argued that the copyright of the document was the
manufacturer and that ``we don't know who authored it, or what their
credentials were, but it's a self-interested marketing pharmaceutical
company'' that is ``trying to sell their [sic] medicine'' and while the
company has a ``self-interest[] to comply with a federal regulation . .
. ``[i]t doesn't mean that the content is government-sanctioned.'' Id.
at 422-23. Respondent thus asserted that the

[[Page 54823]]

document was ``just not reliable enough.'' Id. at 426.
The ALJ sustained the objection but provided no explanation as to
his reason for doing so. I conclude, however, that the Exhibit was
admissible. As the FDA has explained, the package insert ``is part of
the FDA-approved labeling,'' and ``[t]he FDA approved label is the
official description of a drug product, which includes indication (what
the drug is used for); who should take it; adverse events (side
effects); instructions for uses in pregnant women, children, and other
populations; and safety information for the patient.'' See U.S. Food
and Drug Administration, Drugs@FDA Instructions: Health Information,
available at www.fda.gov/Drugs/InformationOnDrugs/ucm079450.htm
(accessed August 4, 2016). The FDA's approval of a drug label follows
extensive clinical trials, including trials which examine the safety
and effectiveness of a drug and are part of the process for approving
the drug for marketing. See Food and Drug Administration, Requirements
on Content and Format of Labeling for Human Prescription Drug and
Biological Products, 71 FR 3922 (2006) (Final Rule) (``A prescription
drug product's FDA-approved labeling (also known as `professional
labeling,' `package insert,' `direction circular,' or `package
circular') is a compilation of information about the product, approved
by FDA, based on the agency's thorough analysis of the new drug
application (NDA) . . . submitted by the applicant. This labeling
contains information necessary for safe and effective use.'').
Under the Food, Drug and Cosmetic Act, a drug ``shall be deemed to
be misbranded . . . [u]nless its labeling bears . . . such adequate
warning against use . . . by children where its use may be dangerous to
health.'' 21 U.S.C. 352(f). Moreover, introducing a misbranded drug
into interstate commerce is a violation of 21 U.S.C. 331(a). Thus,
there are ample incentives for drug manufacturers to provide reliable
information in the package insert. Based on the foregoing, I find that
there are sufficient indicia of reliability to support the admission of
the document into evidence and make it a part of the record.\5\ I
further find that this evidence is probative on the issue of whether
the Hycodan prescriptions issued by Respondent in the name of his
girlfriend's children were for a legitimate medical purpose. See, e.g.,
Medicine Shoppe-Jonesborough v. DEA, 300 Fed. Appx. 409, 413 (6th Cir.
2008) (holding that dispensing contraindicated controlled substance is
evidence of 21 CFR 1306.04(a) violation).
---------------------------------------------------------------------------

\5\ Hearsay evidence is admissible in administrative
proceedings, provided it is relevant and material and supported by
sufficient indicia of reliability. See, e.g., Mireille Lalanne, 78
FR 47750 (2013).
As further noted above, in opposing the admission of the package
insert, Respondent represented that it contained expert opinions
from unidentified persons whom he could not cross-examine and thus
was being offered in violation of the ALJ's Prehearing Order.
However, in its pre-hearing statement, the Government provided
notice that it intended to offer the Exhibit and pursuant to the
ALJ's Prehearing Ruling, the Government was required to provide the
document to Respondent by 2 p.m. on February 12, 2016. ALJ Ex. 9, at
2. No claim is made that the Government failed to comply with the
ALJ's ruling.
While Respondent asserts that he was unable to cross-examine the
persons who wrote the package insert, he made no attempt to subpoena
either an FDA official involved in reviewing the document or an
employee from the manufacturer who was involved in preparing it.
Moreover, Respondent could have sought to challenge the reliability
of the document by producing evidence (whether through expert
testimony or studies) disputing the package insert's statement
regarding the risks of prescribing the drug to children less than
six years of age. Respondent, however, produced no evidence which
calls into question the reliability of the statements contained in
the insert.
---------------------------------------------------------------------------

Notably, the Hycodan package insert's safety information includes
the following warning: ``The use of HYCODAN is not recommended for use
in children less than 6 years of age because of the risk of fatal
respiratory depression.'' GX 4, at 2. Notably, Respondent's
girlfriend's daughter was not even five years old when he wrote the
first Hycodan prescription in her name. GE 55, at 1-2. Respondent also
wrote Hycodan prescriptions in the name of his girlfriend's son who was
then three years old. Id. at 3-4; 11-12. In short, neither of the
children who were listed as the patients on the Hycodan prescriptions
was six years of age when Respondent wrote the prescriptions. Thus, I
consider this as additional evidence which supports the conclusion that
Respondent lacked a legitimate medical purpose and acted outside of the
usual course of professional practice when he issued the Hycodan
prescriptions in the names of his girlfriend's children. 21 CFR
1306.04(a). I now turn to Respondent's Exceptions.

Exception I--The Government Failed ``to Prove Violations of State or
Local Laws Sufficient to Demonstrate Danger to the Public Interest.''

Respondent argues that the ALJ failed to give proper weight to the
decision of Dr. Craig, the Medical Board's Executive Director, to close
the Board's investigation of his prescribing practices without
recommending the initiation of a formal action against his medical
license. Exceptions, at 1-2. According to Respondent, the Board
reviewed ``all such clinical and prescription records'' for his
girlfriend and her children, and it ``decided that there was no
evidence of any breach of any medical standard of care sufficient to
bring any administrative charge against [him] related to any such
prescription.'' Id. at 2. He also asserts that Dr. Craig ``determined
that there was not even sufficient professional reason to issue [him]
an informal warning as to any such prescription for pain medication.''
Id.
Respondent then argues that ``[r]ather than . . . defer[] to the
professional judgments made by [Dr. Craig as to] whether State laws
were violated by [him], the ALJ['s] Recommendation proceeds to
interpret and apply those State laws without the benefit of any medical
evidence, or any medical opinion in any form, anywhere in the record of
this case.'' Id. And noting the ALJ's discussion that ```DEA has not
required expert testimony to establish a violation of 21 CFR 1306.04(a)
in cases where a prescriber engaged in drug deals, where there were
notable differences between patients' medical records and diagnoses,
and where a prescriber falsified patients' charts,' '' Respondent
contends that the Government did not allege that he engaged in any such
conduct. Id. at n.1.
I reject the Exception. As for the contention that Dr. Craig
reviewed the medical records and prescriptions and did not find the
evidence sufficient to initiate a proceeding against his license,
Respondent ignores the credited testimony that the Board terminated its
investigation upon the request of the Mississippi Bureau of Narcotics
(MBN) after the latter informed the Board that it was conducting a
criminal investigation. Tr. 60 (testimony of MBN agent); GE 3, at 2
(Board Complaint form entry dated ``3-20-15'' stating ``MBN has asked
that we hold off on doing anything to this doctor because they are
working a criminal case on him'').\6\ A Board investigator also
testified that ``it's customary for [the Board] to back off [of an
investigation] and let a criminal agency pursue their [sic] case'' and
that Dr. Craig was aware of the criminal investigation. Tr. 210.
---------------------------------------------------------------------------

\6\ The Board's investigation involved interviewing Respondent,
as well as reviewing his girlfriend's patient file and a PMP report
of her controlled substance prescriptions. GE 3, at 4-6. Notably,
the Board's investigator testified that the Board did not interview
Respondent's girlfriend. Tr. 196.
---------------------------------------------------------------------------

Moreover, even then the Board's letter cautioned Respondent ``that
authorizing

[[Page 54824]]

refills for Phentermine/Adipex without the benefit of a medical
examination is strictly prohibited by the Board's Rules and
Regulations'' and specifically quoted the Board's Rule 1.5(E), which
states that: ``[a] patient continued on a controlled substance in
schedule III, IV, V for the purpose of weight reduction or the
treatment of obesity should undergo an in-person re-evaluation once
every 30 days.'' GE 3, at 1. Finally, as the evidence shows, subsequent
to the Board's closing of its investigation, Respondent again issued
multiple controlled substance prescriptions to purported acquaintances
of his girlfriend knowing that the drugs would subsequently be provided
to his girlfriend. Accordingly, I reject Respondent's contention that
the Board's closing of its investigation reflects its ``professional
judgments'' that Respondent acted within the bounds of accepted
professional practice when he prescribed to Respondent and the
undercover officers.
Under both this and his subsequent exception, Respondent argues
that the ALJ's decision is unprecedented because the Government put
forward no expert testimony to support the conclusion that he violated
21 CFR 1306.04(a) in issuing the various prescriptions. However,
contrary to Respondent's understanding, numerous decisions of both the
federal courts in criminal cases and this Agency have held that expert
testimony is not necessarily required to prove that a physician acted
outside of the usual course of professional practice and lacked a
legitimate medical purpose in issuing a controlled substance
prescription. See United States v. Pellman, 668 F.3d 918, 924 (7th Cir.
2012) (quoting United States v. Armstrong, 550 F.3d 382, 388-89 (5th
Cir. 2008) (``While expert testimony may be both permissible and
useful, a jury can reasonably find that a doctor prescribed controlled
substances not in the usual course of professional practice or for
other than a legitimate medical purpose from adequate lay witness
evidence surrounding the facts and circumstances of the
prescriptions.'')); Armstrong, 550 F.3d at 389 (``Jurors have had a
wide variety of their own experiences in doctors' care over their
lives, thus and expert testimony is not necessarily required for jurors
to rationally conclude that seeing patients for as little as two or
three minutes before prescribing powerful narcotics is not in the usual
course of professional conduct.'').\7\ See also T.J. McNichol, 77 FR
57133, 57147-49 (2012), pet. for rev. denied, 537 Fed. Appx. 905 (11th
Cir. 2013); Morris W. Cochran, 77 FR 17505, 17519-20 (2011) (holding,
without expert testimony, that prescriptions lacked a legitimate
medical purpose where physician noted in patient medical records that
patients had no pain, did not document any findings to support a
diagnosis, and yet diagnosed patients as having chronic pain); Robert
F. Hunt, 75 FR 49995, 50003 (2010) (holding, without expert testimony,
that physician lacked a legitimate medical purpose based on statements
made during undercover visits and falsification of chart). See also
Jack A. Danton, 76 FR 60900, 60904 (2011).
---------------------------------------------------------------------------

\7\ See also United States v. Word, 806 F.2d 658, 663 (6th Cir.
1986); United States v. Larson, 507 F.2d 385, 387 (9th Cir. 1974);
United States v. Bartee, 479 F.2d 484, 488-89 (10th Cir. 1973);
State v. Moody, 393 So.2d 1212, 1215 (La. 1981).
---------------------------------------------------------------------------

Thus, while expert testimony is typically necessary to establish a
violation of 21 CFR 1306.04(a) `` `where a physician ma[kes] some
attempt to comply with various state medical practice standards and the
adequacy of those efforts is at issue,' . . . the facts and
circumstances surrounding the issuance of the prescription may
nonetheless establish a violation even without expert testimony.''
McNichol, 77 FR 57147-48 (quoting Danton, 76 FR at 60904 & n.13).
Accordingly, in McNichol, the Agency found a violation proved,
notwithstanding that the ALJ had rejected the testimony of the
Government's Expert, because while the physician had gone through the
motions of a physical exam, the physician's ``comments manifest[ed]
that he knew that [the patient] was an abuser of controlled
substances.'' Id. at 57148. See also Gonzales v. Oregon, 546 U.S. 243,
274 (2006) (``[T]he prescription requirement . . . ensures patients use
controlled substances under the supervision of a doctor so as to
prevent addiction and recreational abuse. As a corollary, [it] also
bars doctors from peddling to patients who crave the drugs for those
prohibited uses.'') (citing United States v. Moore, 423 U.S. 122, 135,
143 (1975)).
Here, as the ALJ found, Respondent issued multiple prescriptions to
his girlfriend while failing to document the performance of a physical
exam, as well as findings and diagnoses that would support the issuance
of the prescriptions. Moreover, with respect to the hydrocodone cough
syrup prescriptions Respondent issued to his girlfriend which listed
her children as the patients, the ALJ credited her testimony that she
told Respondent that she wanted the big bottle of hydrocodone cough
syrup and he ``knew I would drink it too.'' R.D. 7; 11 (citing Tr. 216,
251-52, 268, 273); see also Tr. 298 (girlfriend's testimony that the
Norco prescriptions were ``not for a headache'' but were ``[j]ust for
fun''). Likewise, with respect to the prescriptions Respondent provided
in March and April 2015 to his girlfriend's purported acquaintances,
the undercover recordings clearly establish that Respondent knew that
the acquaintances were not seeking the prescriptions to treat
legitimate medical conditions but to provide the drugs to his
girlfriend. Given the evidence that clearly shows that Respondent
issued the prescriptions to support his girlfriend's abuse of
controlled substances, the Government was not required to put forward
expert testimony to prove its case.

Exception II--The Government ``Fail[ed] to Prove `Past Experience in
the Distribution of Controlled Substances.' ''

Respondent further argues that the ALJ erred when he refused ``to
allow Respondent to seek clinical evidence about [his girlfriend's]
medical history through third-party document subpoenas.'' Exceptions,
at 2. Prior to the hearing, Respondent requested that the ALJ issue
eight subpoenas to health care providers for their medical records
``which reflect, relate to, or explain the clinical or medical basis
for prescribing'' controlled substances (primarily hydrocodone with
acetaminophen) to his girlfriend. See, e.g., ALJ Ex. 13, at 6.
In seeking the subpoenas, Respondent maintained that ``[i]n order
for the truth about [his girlfriend's] medical condition and needs to
be revealed . . . the clinical findings and judgment of all such health
care providers should be available to the Court in order to allow a
comparison between Dr. Stewart's judgment and the judgments of a
substantial number of other health care professionals in the same
community.'' ALJ Ex. 13, at 3. On the various subpoenas, Respondent
explained that because one of the Government's Exhibits (the PMP
report, GE 49) shows that the other health care providers had also
issued hydrocodone prescriptions to his girlfriend, ``[t]he presumed
legitimacy of the particular clinical findings which caused [the] other
health care professionals in the same community to prescribe the same
medication to [her] could be strongly probative of the medical
inaccuracy of the . . . core allegations against'' him. See, e.g., GE
13, at 6.
The Government opposed the issuance of the subpoenas. It argued
that

[[Page 54825]]

the information Respondent sought was irrelevant because the only
allegations it raised as to the unlawful prescribing of hydrocodone
with acetaminophen to his girlfriend involved the four Norco
prescriptions which were identified in paragraph 4 of the Show Cause
Order.\8\ ALJ Ex. 14, at 2-3. The Government also argued that ``[i]n
each of those instances,'' it was ``alleg[ing] that Respondent
prescribed to [her] either without conducting any examination of her or
without noting those prescriptions in her chart.'' Id. at 3. And it
further argued that none of the records would address the ``actual
charges against'' Respondent. Id.
---------------------------------------------------------------------------

\8\ The Show Cause Order alleged that the prescriptions were
issued on May 22, June 17, September 11, and October 29, 2014. ALJ
Ex. 1, at 2.
---------------------------------------------------------------------------

The ALJ agreed with the Government and denied Respondent's request.
ALJ Ex. 16. The ALJ explained that having reviewed the allegations of
the Show Cause Order, he agreed with ``the Government's assessment that
the question of whether [Respondent' girlfriend] needed a particular
medication is not an issue before me.'' Id. at 1. And noting that
``Respondent has not produced a summary of [his] expected testimony,''
the ALJ then reasoned that ``there is no information in the record that
the Respondent based his decision to prescribe a particular medication
to [his girlfriend] based upon his knowledge of what some other
treating physician had prescribed for'' her. Id. at 1-2. Concluding
that the information sought by Respondent was irrelevant, the ALJ
denied the request. Id. at 2.
I conclude that the ALJ properly denied Respondent's request. I do
not, however, read the Government's Opposition as expressing the
position that his girlfriend's need for the Norco prescriptions was not
at issue.
While the Government alleged that these particular prescriptions
were unlawful because: (1) Respondent did not ``conduct[] an
examination of'' of his girlfriend or ``document[] such in her file,''
or (2) Respondent did not note the prescriptions in her chart and thus
violated the Board's Rules 1.4, 1.11(b) and 1.16, the Government also
cited 21 CFR 1306.04(a)). Because ``[a] prescription for a controlled
substance to be effective must be issued for a legitimate medical
purpose,'' 21 CFR 1306.04(a), a patient's need for the drug is
invariably at issue when a violation of this provision is alleged. See
also Miss. Code R. Sec. 30-17-2640:1.4 (``No physician shall
prescribe, administer or dispense any controlled substance . . .
without a good faith prior examination and medical indication
therefore.''). Indeed, assessing whether a patient needs a controlled
substance to treat a medical condition is the reason why the usual
course of professional practice generally requires that a physician
take a detailed history and conduct an appropriate examination of the
patient to make a proper diagnosis and treatment plan.\9\ See id.
---------------------------------------------------------------------------

\9\ As Rule 1.4 further states:
Standards of proper medical practice require that, upon any
encounter with a patient, in order to establish proper diagnosis and
regimen of treatment, a physician must take three steps: (a) Take
and record an appropriate medical history, (b) carry out an
appropriate physical examination, and (c) record the results. The
observance of these principles as a function of the ``course of
legitimate professional practice'' is particularly of importance in
cases in which controlled substances are to play a part in the
course of treatment. It is the responsibility of the physician to
dispense, prescribe or administer such drugs with proper regard for
the actual and potential dangers.
Miss. Code R. Sec. 30-17-2640:1.4.
---------------------------------------------------------------------------

I nonetheless agree with the ALJ's conclusion that the information
sought by the subpoenas was irrelevant. Notably, Respondent made no
proffer that he had obtained and reviewed the records maintained by
these other providers and had based his decisions to prescribe
hydrocodone to his girlfriend on those records. Nor did Respondent
proffer that he was acting as a covering physician for any of these
other physicians (or any other authorized prescriber) when he
prescribed the hydrocodone to his girlfriend.
Respondent further contends that the prescriptions issued by the
other providers ``strongly support a conclusion that [his] own
prescriptions for [h]ydrocodone for use by [his girlfriend] were within
the bounds of the medical standard of care practiced in that
community.'' Exceptions, at 4. However, were it the case that
Respondent's prescribing of hydrocodone was within the bounds of
professional practice, he could have put on an expert to testify as
such.\10\ Yet Respondent chose not do so.
---------------------------------------------------------------------------

\10\ Respondent initially proposed to call a physician and
professor from the University of Mississippi Medical Center who
would testify that the prescriptions he issued ``were for legitimate
medical purposes'' and ``were in the usual course of and consistent
with [his] own standard professional practices [and] were consistent
with the standard of care in the medical community in which they
lived.'' ALJ Ex. 17, at 2-3. While the Government moved to exclude
the proffered testimony, the ALJ denied the Government's motion and
specifically ruled that the expert could testify to the above
subjects. ALJ Ex. 28, 3-4. Respondent did not, however, call this
witness.
Of further note, even if Respondent had put on testimony that
the prescriptions were ``consistent with [his] own standard
professional practices,'' that testimony would have been unavailing
because the standard of professional practice is not defined by a
physician's subjective belief as to the propriety of his practices
but on the application of the standards of practice in the State
where he practices. United States v. Tobin, 676 F.3d 1264, 1290
(11th Cir. 2012). For similar reasons, evidence as to the standard
of care in the medical community in which Respondent lived would
also be unavailing.
---------------------------------------------------------------------------

Respondent also contends that the evidence is insufficient to show
that the hydrocodone prescriptions lacked a legitimate medical purpose
because ``it is clear that during the months relevant to this case [his
girlfriend] was in fact suffering from a chronic migraine condition and
associated headache pain, and that [he] was treating her for that
condition.'' Exceptions, at 3. Respondent points to the testimony of
his girlfriend that she was hospitalized for migraines ``[t]hree times
prior to the beginning of his treatment of her in February 2014, and a
fourth time during that treatment in August of 2014.'' Id. He further
maintains that his charts ``specified that she complained of, and in
fact suffered from, a chronic migraine condition.'' Id.
It is true that in two of the visit notes for his girlfriend (April
21 and Sept. 2, 2014), Respondent listed Maxalt, a non-controlled drug,
and Norco (hydrocodone with acetaminophen), as the drugs he prescribed
to her for this condition. GE 2, at 12. Yet prior to Respondent's
issuance of the first Norco prescription to her, she had ``asked him to
write the big bottle'' of hydrocodone cough syrup ``so that [she] could
have some too'' and ``told him I like to drink it'' because she
``like[d] the way it made [her] feel.'' Tr. 251-52; 273. Thus,
Respondent already knew that his girlfriend was a drug abuser.\11\
---------------------------------------------------------------------------

\11\ Respondent points to the testimony of his girlfriend that
she never told him that she was addicted to hydrocodone, dependent
on the drug, or taking it ``for no reason.'' Exceptions, at 3. As
discussed above, Respondent's girlfriend subsequently clarified that
she took the Norco ``just for fun.'' Tr. 298.
To the extent Respondent believes that his misconduct in
writing the Norco prescriptions should be excused because his
girlfriend did not tell him why she was taking the Norco, the
evidence is clear that she had previously asked him to prescribe the
big bottle of cough syrup so that she ``could have some too'' and
had told him that she ``like[d] to drink it'' because of ``the way
it made [her] feel.'' Thus, Respondent clearly knew that his
girlfriend was a drug abuser at the time he wrote her the first
Norco prescription.
---------------------------------------------------------------------------

The evidence also shows that Respondent told his girlfriend that
taking hydrocodone could itself ``cause migraines.'' Id. at 283; see
also id. at 299. Respondent's girlfriend testified that he told her
that taking hydrocodone ``would not help'' her migraines. Id. at 300.
She further testified that ``[t]he hydrocodone was not for a
headache,'' but for ``[e]xtracurricular activities,'' i.e.,

[[Page 54826]]

``just for fun.'' Id. at 298. Moreover, Respondent issued the first of
the Norco prescriptions to her without even taking a history and
conducting a physical examination of her. GE 2, at 12; see Miss. Code
R. Sec. 30-17-2640:1.4. He also failed to document several of the
hydrocodone prescriptions in his girlfriend's chart.\12\ Compare GE 2,
at 12, with GE 3, at 9-10. Thus, the evidence strongly supports the
conclusion that Respondent acted outside of the usual course of
professional practice and lacked a legitimate medical purpose when he
prescribed Norco to his girlfriend. 21 CFR 1306.04(a).
---------------------------------------------------------------------------

\12\ Indeed, Respondent wrote the first Norco prescription for
her on February 21, 2014. The note in her patient file simply
states: ``2-21-14 Hc 7.5/325 (#40, 1)--may be picked up at desk.''
GE 2, at 12. Thus, Respondent issued the prescription without taking
a history of his girlfriend's migraines and without conducting a
physical exam.
---------------------------------------------------------------------------

Respondent also appears to argue that the alprazolam prescription
he issued to his girlfriend was not unlawful because she suffered from
anxiety and he referred her to a psychiatrist who had prescribed the
drug to her. Exceptions, at 4. While Respondent acknowledges that he
did not ``diagnose [her] himself as to anxiety,'' he argues that he
issued the prescription ``in reliance on that psychiatrist's
independent clinical judgment'' and gave her a refill so that she could
``avoid[] further one-hour trips to the psychiatrist to obtain a
refill.'' Id.
I am not persuaded. Notably, the psychiatrist prescribed only a
seven-day supply of alprazolam extended release in the .5 mg dosage. GE
49, at 1. Respondent, however, prescribed a stronger dosage of
alprazolam and greater quantity, providing her with a prescription for
40 tablets of the 1mg immediate release dosage form, with a refill for
an additional 40 tablets. Id. This was not a refill of the
psychiatrist's prescription at all, but a substantially different and
stronger prescription. Yet the medical record contains no evidence that
Respondent coordinated his prescribing with the psychiatrist. As for
Respondent's explanation that he wrote the prescription so that his
girlfriend would not have to make the one-hour trip to obtain a refill,
this begs the question as to why the psychiatrist would not be willing
to call in a refill. I thus reject Respondent's Exception to the extent
it challenges the ALJ's findings as to the alprazolam prescription.
As for the phentermine prescriptions, Respondent again invokes Dr.
Craig's letter in which he stated that the Board was closing its
investigation while cautioning Respondent about the need to conduct an
in-person re-evaluation every 30 days. Exceptions, at 4. Respondent
revisits his argument that Dr. Craig ``determined that there was no
sufficient medical basis for alleging any violation . . . of any
medical standard in Mississippi.'' Id. However, as previously
explained, the Board terminated its investigation because Respondent
was the subject of a criminal investigation. Moreover, the ALJ
thoroughly explained the basis for his conclusion that Respondent acted
outside of the usual course of professional practice and lacked a
legitimate medical purpose when he issued the phentermine prescriptions
to his girlfriend.\13\
---------------------------------------------------------------------------

\13\ Respondent points to the evidence that on March 27, 2015,
he declined to prescribe weight loss medication to one of the
undercover agents. Exceptions, at 4 (citing GE 10, at 1-2). However,
several weeks earlier, Respondent had been visited by a State Board
Investigator who had told him that his documentation for the
phentermine prescriptions that he issued to his girlfriend was
inadequate and he may have already received the letter from Dr.
Craig by the date of the first undercover visit. In any event, while
Respondent may have taken to heart the warning he received from Dr.
Craig regarding the prescribing of weight loss medications, this
obviously had no impact on his prescribing of narcotics, as
evidenced by his prescribing of Norco and Hycodan to the undercover
agents.
---------------------------------------------------------------------------

Finally, Respondent argues that ``[t]he DEA, through the CI [his
girlfriend], effectively caused [him] to engage in conduct, which,
according to the record . . . he apparently had never engaged in on any
other occasion.'' Exceptions, at 5. Continuing, Respondent argues that
his ``conduct, in issuing prescriptions for pain medications to third
parties in an effort to provide the CI with continuing relief from her
migraine conditions, arose from the peculiar combination of his
personal relationship and familiarity with the CI and the CI's
insistence that her `friends' were seeking medication for'' her use.
Id. Respondent thus maintains that this ``peculiar circumstance . . .
provides no significant medical or other evidence sufficient to justify
any conclusion that [his] conduct . . . poses, or is likely to pose in
the future, any danger to the public health or safety.'' Id.
I disagree. To the extent Respondent's argument sounds in the
entrapment defense, I reject it as there is ample evidence that he was
predisposed to issue the unlawful prescriptions given the multiple
unlawful prescriptions he wrote for his girlfriend in 2014, prior to
the involvement of the MBN and DEA. See United States v. Sumlin, 271
F.3d 274 (D.C. Cir. 2001). As for the assertion that he wrote the
prescriptions to the undercover agents to provide his girlfriend ``with
continuing relief from her migraine conditions,'' this is simply
counterfactual as the record abounds with evidence that Respondent knew
she was seeking the drugs to abuse them. Tr. 345; GE15; 16; GE 17, at
2-4, 6-8; GE 18, at 3. I therefore reject Respondent's contention that
there is no ``significant medical or other evidence'' to support the
conclusion that he poses a danger to public health and safety.\14\
Exceptions, at 5. To the contrary, the evidence shows that on multiple
occasions, Respondent issued prescriptions outside of the usual course
of professional practices and which lacked a legitimate medical purpose
to feed his girlfriend's abuse of controlled substances. This conduct
amply supports the conclusion that he has committed such as acts as to
render his registration ``inconsistent with the public interest.'' 21
U.S.C. 824(a)(4).
---------------------------------------------------------------------------

\14\ In arguing that he does not ``pose . . . any danger to
public health or safety,'' Respondent cites 21 U.S.C. 823(e), the
provision which governs the registration of distributors of schedule
III through V controlled substances and not practitioners, who are
registered under section 823(f). However, to the extent Respondent
argues that the Government is required to put forward such proof in
seeking the revocation of his registration, the Government is not
required to do so even though one of the section 823(f) factors is
``such other conduct which may threaten the public health and
safety.'' 21 U.S.C. 823(f). While this factor encompasses conduct
which is not otherwise embraced by the other section 823(f) factors,
it is indisputable that issuing prescriptions to feed a person's
drug abuse is conduct which threatens public health and safety.
---------------------------------------------------------------------------

Exception III--The ALJ Violated Respondent's Fifth Amendment Rights
When He Denied His Request To Delay the Hearing Until the End of His
Criminal Trial

Respondent's final contention is that the ALJ violated his Fifth
Amendment privilege against self-incrimination when he denied his
request to reschedule the hearing until after his criminal trial
concluded. Exceptions, at 5-6. Notably, the Government did not call
Respondent to testify and the ALJ declined to draw an adverse inference
from his failure to testify on his own behalf even though doing so
would have been warranted. See Keating v. Office of Thrift Supervision,
45 F.3d 322, 326 (9th Cir. 1995) (``Not only is it permissible to
conduct a civil proceeding at the same time as a related criminal
proceeding, even if that necessitates invocation of the Fifth Amendment
privilege, but it is even permissible for the trier of fact to draw
adverse inferences from the invocation of the Fifth Amendment in a
civil proceeding.'') (citing Baxter v. Palmigiano, 425 U.S. 308, 318
(1976)).
` Here, Respondent does not contend that the need to preserve his
Fifth Amendment privilege prevented him

[[Page 54827]]

from providing testimony refuting the allegations that he unlawfully
prescribed various controlled substances to his girlfriend and the
undercover officers. Rather, he argues that ``[b]ecause he desired
understandably to preserve and not to waive his Fifth Amendment
privileges with respect to his criminal trial, [he] was prohibited from
`rebutting' any prima facie Government case through his own hearing
testimony, which was the only practical way he had to `accept
responsibility'' or to affirm that he `will not engage in future
misconduct.''' Id. at 6.
I reject Respondent's contention. See Grider Drug 1 & 2, 77 FR
44069, 44104 (2012). In Grider, the respondents argued that the Agency
should reject an ALJ's conclusions that the pharmacies had failed to
rebut the Government's prima facie case because their owner, who was
under indictment in two state criminal cases, did not testify and thus
offered no evidence to show that he had accepted responsibility and
implemented corrective measures. Invoking SEC v. Dresser Industries,
Inc., 628 F.2d 1368, 1375-76 (D.C. Cir.1980), the Grider respondents
further argued that because their owner was under indictment, the ALJ
should have stayed the proceeding until the state criminal cases were
concluded so as not to ``undermine the party's Fifth Amendment
privilege against self-incrimination.'' 77 FR at 44104.
The Agency rejected Grider's arguments. As the Agency explained,
```as a general matter, due process is not infringed merely because an
accused person is subjected, without his consent, to an administrative
hearing concerning matters involved in a pending criminal
proceeding.''' Id. (quoting 628 F.2d at 1376 n.21). As Dresser
Industries noted, ``[t]he civil and regulatory laws of the United
States frequently overlap with the criminal laws creating the
possibility of parallel [administrative] and criminal proceedings,
either successive or simultaneous'' and that ``[i]n the absence of
substantial prejudice to the rights of the parties involved, such
parallel proceedings are unobjectionable.'' 628 F.2d at 1374. Thus, in
Dresser Industries, the D.C. Circuit observed that ``[t]he Constitution
. . . does not ordinarily require a stay of civil proceedings pending
the outcome of criminal proceedings.'' Id. at 1375.
To be sure, in Dresser Industries, the D.C Circuit further
explained that ``the strongest case for deferring civil proceedings is
where a party under indictment for a serious offense is required to
defend a civil or administrative action involving the same matter.''
Id. However, the court further explained that the potential harm to a
party's Fifth Amendment privilege is just one of the factors to be
considered in determining whether to stay the noncriminal proceeding.
Id. at 1376. Continuing, the court explained that ``[i]f delay of the
noncriminal proceedings would not seriously injure the public interest,
a court may be justified in deferring it.'' Id. (emphasis added). That
decision is, however, committed to the discretion of the trial court.
See, e.g., Keating, 45 F.3d at 325 (setting forth multiple factors).
Here, I find no reason to conclude that the ALJ abused his
discretion when he declined to continue the proceeding until the
conclusion of Respondent's criminal trial. Notably, in his request for
a continuance, Respondent provided no information to the ALJ as to when
that trial would commence.\15\ That trial--and a subsequent appeal were
Respondent convicted of the charges--could go on for several years. The
ALJ was not required to withhold conducting the hearing while
Respondent litigates in other forums. See 45 F.3d at 325 (noting that
``convenience of the court in the management of its cases'' is a
factor). So too, the Government has a strong interest in proceeding
expeditiously with this litigation, and indeed, under the Constitution,
the Agency has an obligation to provide prompt post-deprivation process
where the Government immediately suspends a registration. Id.; see also
Barry v. Barchi, 443 U.S. 56, 64 (1979).
---------------------------------------------------------------------------

\15\ In opposing the request, the Government noted that
Respondent had also sought a continuance of the criminal case. ALJ
Ex. 6, at 1 n.1.
---------------------------------------------------------------------------

As for the burden on Respondent, it is true that courts have held
that the prejudice to a respondent's Fifth Amendment privilege may be
substantial where there are parallel administrative and criminal
proceedings. Keating, 45 F.3d at 326. However, while ``the extent to
which the defendant's Fifth Amendment rights are implicated is a
significant factor . . . to consider . . . it is only one consideration
to be weighed against others.'' Id. (citation omitted).
Notably, Respondent was not otherwise foreclosed from putting on a
defense. Indeed, in its pre-hearing statement, Respondent proposed to
call an expert witness who would testify that the prescriptions were
lawfully issued but ultimately chose not to call this witness. Notably,
in his Exceptions, Respondent does not maintain that because he invoked
the privilege, he was precluded from refuting the factual basis of the
allegations.
Instead, Respondent now contends that my consideration of the ALJ's
recommendation ``should await the disposition of the criminal case . .
. following which he should be given an opportunity promptly and
succinctly to tell his side of the story and express his complete
remorse.'' Exceptions, at 6. However, as discussed above, in his
Exceptions, Respondent continues to dispute the allegations (as well as
the ALJ's factual findings and legal conclusions) that he issued
prescriptions outside of the usual course of professional practice and
which lacked a legitimate medical purpose for each of the different
drugs (i.e., the hydrocodone cough syrup, the Norco tablets, the
alprazolam, and the phentermine). Thus, his argument begs the question
of which allegations he now would admit to.
The Fifth Amendment privilege is not ``a sword whereby a claimant
asserting the privilege [is] freed from adducing proof in support of a
burden which would otherwise have been his.'' United States v.
Rylander, 460 U.S. 752, 758 (1983). See also MacKay v. DEA, 664 F.3d
808, 820 (10th Cir. 2011) (quoting Keating v. Office of Thrift
Supervision, 45 F.3d 322, 326 (9th Cir. 1995)). Indeed, the misconduct
established on this record is so egregious and occurred over such a
lengthy period, that even were I to remand to allow Respondent to
express his ``complete remorse'' and the ALJ was to find this credible,
I would still find his registration to be inconsistent with the public
interest. See Hatem M. Attaya, 81 FR 8221, 8244 (2016); Fred Samimi, 79
FR 18698, 18714 (2014) (denying applications noting that
notwithstanding ALJ's finding that physician ``credibly accept
responsibility for his misconduct, this is a case where actions speak
louder than words''). Thus, I find that Respondent has failed to
establish that the ALJ abused his discretion when he denied
Respondent's request to continue the proceeding until his criminal
trial concluded.\16\
---------------------------------------------------------------------------

\16\ It is, of course, commonplace that matters involving DEA
registrants will lead to both a revocation proceeding and a criminal
investigation and subsequent charges at either the federal or state
level. However, the very purpose of a proceeding brought under 21
U.S.C. 823(f) and 824(a)(4) is to protect the public interest, and,
in the Controlled Substances Act, Congress directed that these
``proceedings shall be independent of, and not in lieu of, criminal
prosecutions or other proceedings under this subchapter.'' Thus, I
conclude that the fifth Keating factor (``the interest of the public
in the pending . . . litigation'') also supports the ALJ's denial of
Respondent's stay request.
As for the fourth Keating factor, ``the interests of persons
not parties to the [administrative] litigation,'' 45 F.3d at 326,
Respondent puts forward no argument as to why this factor supports
the requested stay or a remand at this juncture.

---------------------------------------------------------------------------

[[Page 54828]]

Accordingly, I reject Respondent's third exception and will adopt
the ALJ's recommended sanction of revocation.

ORDER

Pursuant to the authority vested in me by 21 U.S.C. 824(a) and
823(f), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration AS2286311 issued to Lawrence E. Stewart, M.D., be, and it
hereby is, revoked. I further order that any application of Lawrence E.
Stewart, M.D., to renew or modify the above registration, or for any
additional registration be, and it hereby is, denied. This Order is
effectively immediately.\17\
---------------------------------------------------------------------------

\17\ For the same reasons that led me to immediately suspend
Respondent's registration, I find that the public interest
necessitates that this Order be effective immediately. See 21 CFR
1316.67.

Dated: August 9, 2016.
Chuck Rosenberg,
Acting Administrator.

Paul A. Dean, Esq. for the Government.
J. Brad Pigott, Esq. for the Respondent.

RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION

Administrative Law Judge Charles Wm. Dorman. On December 9, 2015,
the Drug Enforcement Administration (``DEA'' or ``Government'') served
Lawrence E. Stewart, M.D. (``Respondent''), with an Order to Show Cause
and Immediate Suspension of Registration (``OSC/ISO''), which
immediately suspended the Respondent's DEA Certificate of Registration
(``COR''), Number AS2286311. Administrative Law Judge Exhibit (``ALJ-
'') 1-2. The Respondent's COR has remained suspended throughout these
proceedings. In response to the OSC/ISO, the Respondent requested a
hearing before an Administrative Law Judge. ALJ-3. That hearing was
held in New Orleans, Louisiana on March 22 and 23, 2016. The issue
currently before the Administrator is whether the Respondent's COR
should be revoked, and applications for renewal or modification denied,
because continued registration would be inconsistent with the public
interest under 21 U.S.C. 823(f) and 824(a)(4). The following
recommendations are based on my consideration of the entire
administrative record, including all of the testimony, admitted
exhibits, and the oral and written arguments of counsel.

ALLEGATIONS

1. From February 2014 to May 2015, the Respondent prescribed
controlled substances, including hydrocodone and alprazolam, to a
confidential informant (``CI'') \1\ without conducting and/or
documenting a physical examination, and without recording the
controlled substance prescriptions in CI's chart, in violation of
Mississippi Medical Board Administrative Rules Part 2640, Chapter 1,
Rules 1.4, 1.11(b), and 1.16, Mississippi Code Sec. Sec. 73-25-29(3)
and (13), and 21 CFR Sec. 1306.04(a). ALJ-1, at 2.
---------------------------------------------------------------------------

\1\ The Prehearing Ruling and Protective Order directed that the
confidential informant would be referred to as ``CI.'' ALJ-9, at 5.
Accordingly, in this Recommended Decision, the confidential
informant will be referred to as ``CI.''
---------------------------------------------------------------------------

2. On four occasions, the Respondent prescribed phentermine to CI
without adequate documentation, in violation of Mississippi Medical
Board Administrative Rules Part 2640, Chapter 1, Rule 1.5, Mississippi
Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a). ALJ-
1, at 3.
3. From February 7, 2014 to November 19, 2014, the Respondent
prescribed hydrocodone products to CI's children \2\ without conducting
examinations of them, and for CI's personal use, in violation of
Mississippi Medical Board Administrative Rules Part 2640, Chapter 1,
Rules 1.4, 1.10, 1.11(b), and 1.16, and Mississippi Code Sec. Sec. 73-
25-29(3) and (13), and 21 CFR Sec. 1306.04(a) and 1306.05(a). ALJ-1,
at 2-3. The Respondent prescribed hydrocodone-homatropine syrup to
these children, who were under the age of six. ALJ-1, at 3.
Hydrocodone-homatropine syrup is not recommended for children under the
age of six because of a risk of death. ALJ-1, at 3. The Respondent also
prescribed adult dosages of hydrocodone-homatropine to these children,
even though the recommended dosage for children ages six to eleven is
half of the adult dosage. ALJ-1, at 2-3.
---------------------------------------------------------------------------

\2\ The Prehearing Ruling and Protective Order directed that
CI's children would be referred to as ``Kid 1'' and ``Kid 2.'' ALJ-
9, at 5. Accordingly, in this Recommended Decision, CI's son will be
referred to as ``Kid 1,'' and CI's daughter will be referred to as
``Kid 2.''
---------------------------------------------------------------------------

4. On five occasions between March and October 2015, the Respondent
prescribed controlled substances to undercover agents when he knew or
should have known that the agents' prescription requests were
fraudulent, in violation of 21 U.S.C. 841(a) and 842(a), and 21 CFR
Sec. 1306.04(a). ALJ-1, at 3. In total, the Respondent wrote seven
prescriptions on five occasions to undercover agents, for a total of
190 dosage units of hydrocodone tablets and 72 dosage units of
hydrocodone syrup. ALJ-1, at 11. On at least four of those occasions,
the Respondent knew that CI would receive a portion of the prescribed
controlled substances. ALJ-1, at 3-4. The Respondent also knew that CI
had attempted to commit suicide using controlled substances that the
Respondent had prescribed to her. ALJ-1, at 3-4.
5. From February 2014 to October 2015, the Respondent unlawfully
prescribed controlled substances in violation of 21 U.S.C. 841(a) and
842(a). ALJ-1, at 2. Specifically, the Respondent prescribed controlled
substances when he knew or should have known that the prescriptions
were not for legitimate medical purposes and were not made in the usual
course of professional practice, in violation of 21 CFR Sec.
1306.04(a) and Mississippi Code Sec. Sec. 41-29-137(a)(1) and 41-29-
141(1). ALJ-1, at 2.
6. On September 2, 2014, the Respondent prescribed meperidine to
CI. ALJ-1, at 3. The Respondent was the only practitioner to prescribe
meperidine to CI. ALJ-1, at 3. CI used meperidine to attempt to commit
suicide in December 2014. ALJ-1, at 3.

STIPULATIONS OF FACT \3\
---------------------------------------------------------------------------

\3\ See ALJ-9, 20; Tr. 9.
---------------------------------------------------------------------------

The Government and the Respondent stipulated to the following
facts:
1. Respondent is registered with the DEA as a practitioner to
handle controlled substances in Schedules II-V under DEA COR AS2286311
at 405 Marion Avenue, P.O. Box 666, McComb, Mississippi 39648-2709.
2. DEA COR AS2286311 will expire by its terms on February 28, 2018.
3. Respondent is presently licensed in Mississippi as a medical
doctor (M.D.) with Medical License 11503.
4. CI is the mother of Kid 1 and Kid 2.
5. Hydrocodone-Acetaminophen 10-325 (Norco), Hydrocodone-
Acetaminophen 7.5-325 (Norco), Hydrocodone-Acetaminophen 5-325 (Norco),
and Hydrocodone-Homatropine Syrup (Hycodan) are all classified as
Hydrocodone Combination Products.
6. Hydrocodone Combination Products are classified by DEA as
Schedule II Controlled Substances and have been so classified since
October 6, 2014. Before October 6, 2014, Hydrocodone Combination
Products were classified by DEA as Schedule III Controlled Substances.
7. Alprazolam is classified by DEA as a Schedule IV Controlled
Substance.

[[Page 54829]]

8. Phentermine (Adipex) is classified by DEA as a Schedule IV
Controlled Substance.
9. Meperidine (Demerol) is classified by DEA as a Schedule II
Controlled Substance.

WITNESSES

The Government presented its case through the testimony of nine \4\
witnesses. First, the Government called Kendrick Lewis (``Lewis''). Tr.
24. Lewis is an employee of the Mississippi Bureau of Narcotics
(``MBN''). Tr. 25. Lewis received a complaint against the Respondent on
January 18, 2015. Tr. 25. Lewis spoke with CI and her husband, who had
made the complaint together. Tr. 25, 29-31. Other than this
conversation, Lewis had no further contact with CI. Tr. 28. Based on
the nature of the complaint, Lewis contacted MBN's diversion unit,
which began investigating the Respondent. Tr. 26-27, 31. During 2015,
Lewis participated in the investigation by assisting with surveillance
on March 27, April 8, April 29, and October 16. Tr. 27. Lewis's
testimony was thorough, detailed, and internally consistent. Therefore,
I merit it as credible in this Recommended Decision.
---------------------------------------------------------------------------

\4\ Although the Government also called Antoine Battle to the
stand, the Government did not elicit any testimony from Mr. Battle,
and he was excused without testifying. Tr. 155-58.
---------------------------------------------------------------------------

Second, the Government called Mary Flinchum (``Flinchum''). Tr. 33.
Flinchum is a lieutenant for the MBN and a task force officer for the
DEA's Tactical Diversion Squad. Tr. 33-34. Flinchum received an
intelligence report about the Respondent from MBN. Tr. 35. Flinchum
interviewed CI and her husband, separately and together, about their
complaint to MBN. Tr. 36, 82. Flinchum helped decide that MBN should
investigate the Respondent. Tr. 36-37. Flinchum also communicated with
the Mississippi State Board of Medical Licensure (``Mississippi
Board''), which was conducting an independent investigation concerning
the Respondent. Tr. 58-59. Flinchum was familiar with an undercover
investigation of the Respondent during March, April, and October of
2015. Tr. 77-81. Later, Flinchum was recalled to offer further
testimony concerning the October 2015 undercover operation. Tr. 449-50.
Through Flinchum's testimony, the Government authenticated and
successfully offered into evidence Government Exhibits (``GE-'') 13
through 21, 27 through 29, 38 through 40, and 53. Tr. 38-57. I find all
of these exhibits to be accurate, authentic, and meriting credibility.
On cross-examination, the Respondent authenticated and successfully
offered into evidence GE-2. Tr. 62-63. I find that Flinchum's testimony
was thorough, detailed, and internally consistent. Therefore, I merit
her testimony as credible in this Recommended Decision.
Third, the Government called Undercover Agent #1 \5\ (``Agent 1'').
Tr. 89. Agent 1 is a female DEA task force officer and former MBN
Agent. Tr. 89-90. Agent 1 participated in an undercover investigation
of the Respondent. Tr. 90-91. Agent 1 attended undercover medical
appointments with the Respondent on four occasions in 2015: March 27,
April 8, April 29, and October 16. Tr. 91, 102, 111, 119. Agent 1 also
accompanied CI to a rendezvous with the Respondent at a Walmart before
the second undercover appointment on April 8, 2015. Tr. 128-29. Through
Agent 1's testimony, the Government authenticated and successfully
offered into evidence GE-9 through 12, 24 through 26, 30 through 33, 42
through 47, and 54. Tr. 91-128. I find all of these exhibits to be
accurate, authentic, and meriting credibility. I also find that Agent
1's testimony was thorough, detailed, and internally consistent.
Therefore, I merit her testimony as credible in this Recommended
Decision.
---------------------------------------------------------------------------

\5\ Pursuant to the Prehearing Ruling and Protective Order, the
identities of the undercover agents are not disclosed in this
Recommended Decision. ALJ-9.
---------------------------------------------------------------------------

Fourth, the Government called Undercover Agent #2 (``Agent 2'').
Tr. 141. Agent 2 is a female MBN agent. Tr. 141. Agent 2 participated
in the undercover investigation of the Respondent. Tr. 142. Agent 2
attended an undercover medical appointment with the Respondent on April
29, 2015. Tr. 143. Through Agent 2's testimony, the Government
authenticated and successfully offered into evidence GE-34 through 37.
Tr. 143-51. I find these exhibits to be accurate, authentic, and
meriting full credibility. I also find that Agent 2's testimony was
thorough, detailed, and internally consistent. Therefore, I merit her
testimony as credible in this Recommended Decision.
Fifth, the Government called MBN Agent Charles Causey (``Causey'').
Tr. 159. In 2015, Causey assisted with audiovisual surveillance for the
DEA and MBN's undercover investigation of the Respondent on March 27,
April 8, April 29, and October 16. Tr. 162-63. Causey testified that
the video recordings of these undercover operations may contain
incorrect internal date/time stamps, and that the dates and times on
the video recordings do not necessarily correspond to the actual dates
and times on which the video recordings were made. Tr. 165-66. I find
that Causey's testimony was thorough, detailed, and internally
consistent. Therefore, I merit his testimony as credible in this
Recommended Decision.
Sixth, the Government called Leslie Ross (``Ross''). Tr. 168. Ross
is an investigations supervisor for the Mississippi Board and a task
force officer for the DEA's Tactical Diversion Squad. Tr. 168-69. The
Mississippi Board reviews and issues medical licenses, promulgates
rules and regulations for the practice of medicine in Mississippi,
investigates complaints about Mississippi licensees, and imposes
disciplinary action when necessary. Tr. 170. Several days before the
Mississippi Board closed its investigation concerning the Respondent,
Ross received a call from Agent Flinchum, advising Ross that the DEA
and the MBN were investigating the Respondent. Tr. 194-95, 210. Ross
explained that the phone call influenced the Mississippi Board's
decision to close its case because it was the Mississippi Board's
custom ``to back off and let a criminal agency pursue their case.'' Tr.
210. Without interviewing CI, the Mississippi Board closed its
investigation. Tr. 196. Ross also helped author part of Mississippi
Administrative Rule 1.5, which regulates diet medication prescriptions
in Mississippi. Tr. 172. Ross established the foundation for the Court
to take official notice of Mississippi Administrative Rules 1.1, 1.2,
1.4, 1.10, and 1.16. Tr. 188-93. Additionally, while Ross did not
conduct the Mississippi Board's investigation of the Respondent, she
supervised Todd Pohnert, who conducted the investigation. Tr. 170, 173.
Ross served administrative subpoenas for information about the
Respondent to two Mississippi pharmacies, one in McComb and one in
Brookhaven. Tr. 185. I find that Ross' testimony was thorough,
detailed, and internally consistent. Therefore, I merit her testimony
as credible in this Recommended Decision. Through Ross' testimony, the
Government authenticated and successfully offered into evidence GE-3
and 8. Tr. 171-78. I find these exhibits to be accurate, authentic, and
meriting credibility. Furthermore, through Ross' testimony, the
Government established some foundation for GE-7 and 55. Tr. 185-88.
Seventh, the Government called CI. Tr. 212. CI testified about her
relationship with the Respondent and

[[Page 54830]]

how and why she obtained controlled substance prescriptions from him.
Tr. 212-31.\6\ Through CI's testimony, the Respondent admitted GE-49,
56, and 57. Tr. 284, 300-03, 335-38. I find these exhibits to be
generally accurate, authentic, and meriting credibility. I also find
that CI's testimony was generally forthright, internally consistent,
and generally merited credibility \7\ in this Recommended Decision.
---------------------------------------------------------------------------

\6\ The Respondent asked CI extensively about an exhibit, pre-
marked for identification as Respondent's Exhibit (``RE-'') 1. See
generally Tr. 231-73. However, the Respondent never offered RE-1
into evidence. Therefore, the contents of RE-1 are not considered in
this Recommended Decision.
\7\ There were some inconsistencies in CI's lengthy testimony.
First, when asked if she paid cash for prescriptions from the
Respondent, CI answered that she believed she always used insurance.
Tr. 360. However, CI's Prescription Monitoring Program report shows
that, in 2014, CI paid for prescriptions from the Respondent with
cash 15 times, and used her insurance only 5 times. See GE-49, at 1-
3. Second, CI suggested that it was the Respondent's idea for CI to
send a friend into his office to get prescriptions for her. Tr. 345-
47. However, audio recordings of the Respondent's telephone calls
with CI suggest that it was CI's idea for her to send a friend into
the Respondent's office to get prescriptions for CI. See GE-16, file
2015-03-16_18-51-48_EDT, at 20-21; GE-16, file 2015-03-18_11-03-
33_EDT, at 2. Third, CI testified that the Respondent only conducted
a physical examination of her one time. Tr. 322. The Respondent's
patient file for CI seems to indicate, however, that the Respondent
gave CI some sort of examination on both April 21 and September 2 of
2014. GE-2, at 12. In these three instances, I do not find CI's
testimony credible.
---------------------------------------------------------------------------

Eighth, the Government called James Pacheco (``Pacheco''). Tr. 385.
Pacheco is an agent for the MBN and a task force officer for the DEA's
Tactical Diversion Squad. Tr. 386. Pacheco participated in the
undercover investigation of the Respondent by coordinating the
surveillance aspect of the investigation. Tr. 388. Pacheco assisted
with physical surveillance of the Respondent and CI during an
undercover operation at a Walmart on April 8, 2015. Tr. 388-89. Pacheco
personally observed most of the operation at Walmart. Tr. 389. Pacheco
also testified that he listened to the undercover operation conducted
at the Respondent's clinic in October 2015. Tr. 406-07. Through
Pacheco's testimony, the Government authenticated and successfully
offered into evidence GE-22 and 23. Tr. 387-93. I find these exhibits
to be accurate, authentic, and meriting credibility. I also find that
Pacheco's testimony was thorough, detailed, and internally consistent.
Therefore, I merit his testimony as credible in this Recommended
Decision.
The Government's ninth witness was Maria Gilbert (``Gilbert''). Tr.
409. Gilbert is a DEA diversion investigator, and was a case agent in
the investigation of the Respondent. Tr. 409-10. Gilbert helped submit
the evidence acquired by the undercover agents into a DEA evidence
locker. Tr. 440. Gilbert also directed DEA personnel to obtain
Prescription Monitoring Program (``PMP'') reports during the
investigation. Tr. 438. Gilbert created the administrative subpoenas
issued to pharmacies to obtain information about the Respondent. Tr.
412. Gilbert helped conduct an administrative search of the
Respondent's office. Tr. 427-28. Through Gilbert's testimony, the
Government authenticated and successfully offered into evidence GE-7,
41, 48, 50 through 52, 55, and 58 through 60. Tr. 411-18, 427-39. I
find these exhibits to be accurate, uncontested, and meriting
credibility. I also find that Gilbert's testimony was thorough,
detailed, and internally consistent. Therefore, I merit her testimony
as credible in this Recommended Decision.
The Respondent did not call any witnesses or offer any of his
proposed exhibits into evidence. Tr. 458.
The factual findings below are based on a preponderance of the
evidence, including the detailed, credible, and competent testimony of
the aforementioned witnesses, the exhibits entered into evidence, and
the record before me.

FACTUAL FINDINGS

1. The Respondent has not previously been convicted of any crime
related to controlled substances. GE-1, at 1. The Respondent has never
had his state medical license revoked, suspended, denied, restricted,
or placed on probation. GE-1, at 1.
The Respondent's Relationship with CI
2. The Respondent and CI became Facebook friends and began talking
with each other in January 2014. Tr. 213, 237. CI asked the Respondent
questions about the health of Kid 1.\8\ Tr. 213-14, 246-47, 261-62. The
Respondent performed a tonsillectomy on Kid 1 and placed tubes in his
ears on January 30, 2014. GE-57, at 13, 19-20; Tr. 219, 235, 285.
Following Kid 1's tonsillectomy, CI asked the Respondent for medication
for Kid 1's medical condition; the Respondent was willing to write
prescriptions for Kid 1. GE-57, at 5-6; Tr. 246-47, 249. Around that
time, CI and the Respondent became friends and began texting and
talking on the phone. Tr. 213-14, 240.
---------------------------------------------------------------------------

\8\ See Stipulation (``Stip.'') 4; see also ALJ-9, at 5.
---------------------------------------------------------------------------

3. In the spring of 2014, CI and the Respondent began to have a
consensual sexual relationship. Tr. 213, 218-19, 290-92, 296, 359.
During the summer of 2014, CI and the Respondent saw each other very
often. Tr. 324. CI and the Respondent communicated frequently by
texting and calling each other on their cell phones. Tr. 355-56.
4. CI engaged in a sexual affair with the Respondent because she
was infatuated with him and because she wanted to obtain controlled
substances for her recreational use. Tr. 291-92. The controlled
substances, however, were not a prerequisite for sexual relations. Tr.
289.
5. The sexual relationship between CI and the Respondent ended in
November 2014. Tr. 219.

A. The Respondent's Medical Treatment of CI and Her Children

6. The Respondent provided medical treatment to CI several times,
beginning in 2010. GE-2, at 12-13; Tr. 215, 277. Specifically, the
Respondent treated CI for a sinus infection, vertigo, and migraines.
GE-2, at 12-13; Tr. 215, 277-78, 287, 321. CI had a serious migraine
condition that caused her to seek treatment in emergency rooms on four
occasions. Tr. 278-80, 347. CI discussed her migraines and
hospitalizations with the Respondent, who gave her information about
migraines. Tr. 282, 287. The Respondent prescribed Maxalt \9\ to CI to
treat her migraines. GE-2, at 12; Tr. 215-16, 283.
---------------------------------------------------------------------------

\9\ Maxalt, or rizatriptan benzoate, is not a federally
controlled substance. See generally 21 CFR Sec. Sec. 1308.11-
1308.15 (2015).
---------------------------------------------------------------------------

7. The Respondent had a patient file for CI and wrote notes therein
about her treatment. See GE-2, at 12-13. The Respondent conducted two
physical examinations of CI, once when he was treating her for a sinus
infection, and again when he was treating her for a migraine
headache.\10\ GE-2, at 12-13; Tr. 322. The Respondent also requested a
CT \11\ sinus scan for CI in 2014. GE-2, at 12, 14. A CT scan showed
that CI's sinuses were ``clear [and] scant thickening in LNF duct.''
GE-2, at 14.
---------------------------------------------------------------------------

\10\ See supra note 7.
\11\ Computerized tomography.
---------------------------------------------------------------------------

8. CI took Kid 1 and Kid 2 to appointments with the Respondent. Tr.
219, 261-62, 285-86, 335-36, 338; see, e.g., GE-56, at 3-4; GE-57, at
6, 9-10. The Respondent conducted legitimate medical procedures on both
children and saw the children for follow-up appointments. GE-56, at 3-
4; GE-57, at 5-6; Tr. 219, 261-62.
9. CI sent the Respondent at least one message via social media
requesting his medical advice about Kid 1's condition. Tr. 262-63. CI
communicated with the Respondent about the physical

[[Page 54831]]

condition of her children to get his medical advice. Tr. 263-65.
10. Near a date stamp reading ``February 4, 2014,'' the Respondent
recorded in Kid 1's medical file that CI had migraines, that she may
call in for a prescription if needed, and that he discussed phentermine
\12\ with her. GE-57, at 6; see Tr. 286. The Respondent's patient file
for CI also contains a telephone request form, dated July 18, 2014, and
signed by the Respondent, which states that CI requested a phentermine
refill. GE-2, at 15. CI's patient file, however, does not note any
reasons that the Respondent prescribed phentermine to CI. See GE-2, at
12-13.
---------------------------------------------------------------------------

\12\ CI denied asking the Respondent for phentermine in February
2014. Tr. 286-88. Phentermine is another name for Adipex. See Stip.
8; Tr. 288.
---------------------------------------------------------------------------

B. CI's Drug Use

11. Prior to her relationship with the Respondent, CI took
controlled substances, including hydrocodone, which were prescribed by
numerous other doctors to help treat pain resulting from four
lithotripsies, kidney stones, a broken tailbone, a root canal, and TMJ
\13\. GE-49, at 2; Tr. 214, 275-76, 304-09. CI told the Respondent
about these prescriptions. Tr. 309.
---------------------------------------------------------------------------

\13\ Temporomandibular joint dysfunction, or lockjaw.
---------------------------------------------------------------------------

12. CI occasionally used Adderall for nonmedicinal purposes. Tr.
215. CI had not used cough syrup for nonmedicinal purposes prior to her
relationship with the Respondent. Tr. 215.
13. After Kid 1 had his tonsils removed on January 30, 2014, CI
took some of Kid 1's pain medication. Tr. 273-74, 276. As a result of
the tonsillectomy, the Respondent prescribed two different forms of
hydrocodone for Kid 1. GE-51, at 1; GE-57, at 6, 14, 22.
14. The Respondent first prescribed cough syrup for Kid 2 on
January 24, 2014. GE-50, at 1; GE-56, at 4. The Respondent again
prescribed cough syrup for Kid 2 in February 2014. Tr. 216, 258-59; GE-
50, at 1; GE-56, at 4. The Respondent did not examine Kid 2 before he
prescribed cough syrup for her. Tr. 217, 251; see GE-56, at 4.
15. CI talked with the Respondent about prescribing a ``big
bottle'' of cough syrup so that CI could drink it. Tr. 216, 251-52,
268, 273. CI thought that the Respondent knew she did not have a cough.
Tr. 216, 251-52, 268. In February 2014, CI asked the Respondent to
prescribe \14\ a ``big bottle'' of hydrocodone cough syrup for Kid 2.
Tr. 216-17, 250, 252-53, 259. At that time, CI told the Respondent that
Kid 2 had a cough. Tr. 250-51, 253-55. On February 7, 2014, the
Respondent doubled the size of Kid 2's prescription for cough syrup.
GE-50, at 1; GE-55, at 1-2.
---------------------------------------------------------------------------

\14\ CI later testified that this was a refill of a prescription
written by the Respondent. Tr. 272-73.
---------------------------------------------------------------------------

16. CI told the Respondent when Kid 1 or Kid 2 had a cough. Tr.
250. CI, however, did not bring her children to see the Respondent
regarding a cough; she requested cough syrup from the Respondent
because she liked drinking it. Tr. 220, 273; see generally GE-56, at 3-
4; GE-57, at 5-6.
17. The Respondent prescribed Norco, Xanax, and Adipex to CI on
multiple occasions. Tr. 26; GE-49. The Respondent prescribed Norco \15\
to CI, which she took daily instead of as needed. Tr. 297. CI took
hydrocodone ``[j]ust for fun.'' Tr. 298. CI would tell the Respondent
when she ran low on a prescription, and he would give her another
prescription.\16\ Tr. 298-99. He advised her that hydrocodone could
cause migraines. Tr. 298-99.
---------------------------------------------------------------------------

\15\ Norco is a hydrocodone combination product. See Stip. 5.
\16\ Specifically, CI testified that when she ran low on a
prescription, the Respondent would refill it. Tr. 298-99. Refills
are not authorized for hydrocodone combination products, such as
Norco. Compare 21 U.S.C. Sec. 829(a), with Stip. 6. The record does
not contain any evidence that the Respondent attempted to give CI a
refill on a hydrocodone combination product. Therefore, I interpret
CI's statement as meaning that whenever she ran low on a
prescription, she would tell the Respondent, and he would issue
another prescription to her.
---------------------------------------------------------------------------

18. On several occasions, the Respondent provided prescriptions to
CI while he was at CI's house. Tr. 217-18; see Tr. 26. On those
occasions, the Respondent did not communicate a diagnosis to CI or
perform a physical examination of CI. Tr. 218. Sometimes, CI took her
children to appointments with the Respondent as an excuse to see the
Respondent, who would then occasionally give prescriptions to CI. Tr.
219-20. On one occasion, the Respondent met CI in the garden section of
a Walmart, where he gave her prescriptions for cough syrup and pain
medication. Tr. 218.
19. At times, CI told the Respondent about her children's pain or
physical conditions to get prescriptions for her own personal use. Tr.
267. CI would occasionally administer the prescribed medication to her
children. Tr. 270-72.
20. CI requested that the Respondent write a prescription for
Adderall for her, but he declined to do so. Tr. 223. In the spring of
2014, CI asked the Respondent to write her a prescription for Adipex, a
weight loss drug. Tr. 223-24, 288-89. The Respondent wrote
prescriptions and refills for Adipex to CI. GE-49, at 1-2; Tr. 223-24.
CI used Adipex for approximately three months. Tr. 224. The Respondent
did not conduct a physical examination of CI focused on weight issues
at any point before or while CI took Adipex, and the Respondent did not
discuss alternative weight loss treatments with CI. Tr. 224-25; see GE-
2, at 12-13.
21. CI had anxiety, which she discussed with the Respondent. Tr.
322. The Respondent told her to visit a certain psychiatrist. Tr. 225,
295. CI visited that psychiatrist twice. Tr. 225. The psychiatrist
prescribed a low dosage of time-release Xanax \17\. Tr. 225, 295, 304;
see GE-49, at 1. The Respondent then prescribed \18\ a stronger dosage
of Xanax to CI. Tr. 226; see GE-49, at 1.
---------------------------------------------------------------------------

\17\ Xanax is a brand name for alprazolam, which is a
benzodiazepine and a Schedule IV controlled substance. Stip. 7; see
21 CFR Sec. 1308.14(c)(2); Tr. 304.
\18\ CI testified that this prescription was a refill
prescription, but that it was for a different dosage. Tr. 295-96.
---------------------------------------------------------------------------

22. The Respondent wrote nine prescriptions \19\ to CI, contained
in GE-7 and 41, which are not documented in the Respondent's patient
file for CI. Compare GE-2, at 12-13 (containing the Respondent's
patient file for CI), with GE-7, at 1-2 (containing a prescription
written by the Respondent to CI), and GE-41 (containing prescriptions
written by the Respondent and filled by CI), and GE-49 (containing CI's
PMP report); see Tr. 364-77. The Respondent's patient file for CI does
not include any notes from any examinations on the dates on which the
Respondent wrote these nine prescriptions. GE-2, at 12-13. CI did not
have a physical examination or receive counseling before the Respondent
gave her any of these prescriptions. Tr. 384; see GE-2, at 12-13.\20\
---------------------------------------------------------------------------

\19\ Seven of these prescriptions, written to CI in 2014, were
as follows: May 19 for Adipex; May 22 for Norco; June 17 for Norco;
July 24 for Adipex; September 8 for Adipex; September 11 for Norco;
and October 6 for Xanax. Compare GE-2, at 12-13, with GE-41, at 1-7,
12-13, and 18-23, and GE-49. The Respondent wrote another
prescription for Adipex to CI on April 9, 2014. Compare GE-2, at 12-
13, with GE-7, at 1-2, and GE-49. The Respondent also wrote a
prescription for Hycodan to CI, dated December 3, 2014, but CI's PMP
report said that the prescription was written on December 4, 2014.
Compare GE-41, at 28-29, with GE-49. Regardless of when this
prescription was actually written, it was not documented in CI's
patient file. See GE-2, at 12-13.
\20\ CI testified about a prescription that is not in GE-41. Tr.
364, 369-70. The prescription allegedly was written in her name by
the Respondent. Tr. 369-70. The prescription allegedly was dated
October 29, 2014. Tr. 369-70. The Respondent's PMP report likewise
lists a prescription for hydrocodone-acetaminophen (Norco)
prescribed by the Respondent on October 29, 2014. GE-49, at 1.
However, neither of the two copies of GE-41 submitted to me includes
this prescription. Examination of both submitted copies of GE-41
reveals that no pages of GE-41 are missing. At the hearing, however,
Government counsel provided CI with an excerpt of what he said was
``part of Exhibit 41,'' and he provided the Respondent and the ALJ
with a copy of what was handed to the witness. Tr. 364. That excerpt
has now been included in the administrative record as ALJ-29.
Comparing ALJ-29 with GE-41, I have determined that the witness did,
in fact, examine a prescription dated October 29, 2014. That
prescription, however, was never offered into evidence. Furthermore,
the witness was never asked if the prescription, dated October 29,
2014, refreshed her memory of having received the prescription.
Accordingly, I decline to find that the Government presented
sufficient evidence to establish that the Respondent wrote a
prescription to CI on October 29, 2014. Following the hearing, the
parties were provided with copies of ALJ-29.

---------------------------------------------------------------------------

[[Page 54832]]

23. Two prescriptions written by the Respondent to Kid 1 are not
documented in Kid 1's medical chart. Compare GE-51 (containing Kid 1's
PMP report and listing prescriptions from June 17 and November 19 of
2014), and GE-55, at 3-4, 11-12 (containing prescriptions from June 17
and November 19 of 2014), with GE-57 (containing Kid 1's medical file,
which does not include any examination or prescription notes for June
17 or November 19 of 2014); see also Tr. 377-81. Likewise, a
prescription written by the Respondent to Kid 2 is not documented in
Kid 2's medical chart. Compare GE-50 (containing Kid 2's PMP report and
listing a prescription written on July 23, 2014), and GE-55, at 5-6
(containing a prescription dated July 23, 2014), with GE-56 (containing
Kid 2's medical file, which does not include any examination notes or
prescription notes for July 23, 2013).
24. On one occasion in early fall of 2014, following CI's complaint
of a severe migraine, the Respondent prescribed Demerol to CI. Tr. 222,
296-97, 317-18, 382. Next to the date ``September 2, 2014'' in CI's
medical chart, the Respondent wrote that he refilled her prescription
of phentermine, looked at her ears and nose, and counselled her. GE-2,
at 12; Tr. 323. He also wrote that he prescribed Demerol and Xanax to
CI. GE-2, at 12. CI did not ask the Respondent for Demerol. Tr. 296,
318.
25. CI's husband discovered that CI was having an affair with the
Respondent. Tr. 26, 320. Sometime after the discovery, in December
2014, CI attempted suicide using the Demerol the Respondent prescribed
to her. Tr. 222, 314-17. CI went to a mental institution for a week
following her suicide attempt. Tr. 227, 309. In January 2015, CI told
the Respondent that she had tried to kill herself. Tr. 226-27, 309-11.

C. The MBN Complaint

26. After CI's husband discovered the affair and CI attempted to
commit suicide, CI and her husband made a complaint against the
Respondent to the MBN. Tr. 25, 29-31, 71, 228-29, 339-40. CI told MBN
investigators that she got medications from the Respondent for
nonmedicinal purposes because she enjoyed using them. Tr. 84.

D. The Anonymous Letter

27. The Mississippi Board received an unsigned letter, allegedly
from CI's husband, which complained about the extramarital affair
between CI and the Respondent. GE-3, at 3; Tr. 58, 66. The Mississippi
Board and MBN both received a copy of the letter. Tr. 66-67, 70-71,
398-99. Several witnesses testified that CI's husband was not the
author of this letter. Tr. 67-70, 326, 394, 396. The author of the
letter is unknown. Tr. 67-70, 201, 326, 394-95.
28. The letter was written in the first person, and CI's husband's
name was typewritten on the bottom of the letter, along with CI's date
of birth and social security number. GE-3, at 3. The letter said that
the author's wife, CI, had an affair with the Respondent for over a
year, and that the author did not know about it until he found a box of
empty pill bottles that the Respondent had prescribed to CI, even
though CI was not his patient. GE-3, at 3. The letter was stamped as
received by the Mississippi Board on February 19, 2015. GE-3, at 3.
29. By the time the MBN received a copy of the letter, it had
already begun its investigation of the Respondent because of the
complaint made by CI and her husband. Tr. 71, 74-76. After receiving a
copy of the letter, the Mississippi Board began conducting an
independent investigation of the Respondent. Tr. 58, 61, 203.

E. The Mississippi Board Investigation

30. A Mississippi Board investigator met with the Respondent
regarding the anonymous letter. GE-3, at 4-6. At that time, the
Mississippi Board was unaware that the DEA was conducting a
simultaneous investigation of the Respondent. Tr. 180.
31. In response to the investigator's inquiry, the Respondent said
that he only saw CI when she or her children had appointments, and had
not seen CI outside of his office. GE-3, at 5; Tr. 179, 202. The
Respondent suggested that he had not engaged in sexual misconduct with
CI. GE-3, at 5; Tr. 180, 207. The Respondent also suggested that he was
not aware that CI had attempted to commit suicide or had been committed
to a mental hospital. GE-3, at 5, 7.
32. The investigator made copies of CI's patient charts and found
several shortcomings with CI's medical records. GE-3, at 4-5; Tr. 180,
197. First, the investigator found seven prescriptions in CI's PMP
report that were not documented in the Respondent's patient file for
CI. GE-3, at 5. The Respondent explained that he might have documented
the missing prescriptions in his patient files for CI's children
instead. GE-3, at 5.
33. Second, the investigator found that CI's patient file did not
include any notes about CI's vitals, height/weight, BMI, or alternative
weight control treatment plans, and did not indicate that CI received
any counseling about other weight loss options. GE-3, at 5; Tr. 180.
34. Following the investigator's visit, the Mississippi Board sent
the Respondent a copy of the anonymous letter purportedly from CI's
husband.\21\ See GE-2, at 6-8. The investigator told the Respondent
that he should send a letter to the Mississippi Board as a follow-up
from the investigator's visit. GE-3, at 5; Tr. 179.
---------------------------------------------------------------------------

\21\ The handwritten notation on the bottom of the letter was
likely added by a Mississippi Board investigator. Tr. 87; see GE-2,
at 6.
---------------------------------------------------------------------------

35. The Respondent sent a letter to the Mississippi Board. GE-3, at
7-8; Tr. 179-80. Therein, the Respondent denied knowing that CI had
overdosed.\22\ GE-3, at 7; Tr. 180. The Respondent stated that he was
``appalled, outraged, and disgusted'' by the anonymous letter's
allegations. GE-3, at 7; Tr. 208. The Respondent wrote that the
medications CI used to overdose ``were legitimately prescribed for
valid medical problems.'' GE-3, at 7. The Respondent wrote that he was
unaware that CI had received controlled substances from other
prescribers and that CI did not show ``any hint of drug-seeking
behavior.'' GE-3, at 7. The Respondent acknowledged that he should not
refill medications for a parent during a child's visit without pulling
the parent's chart, and said that he would not do so in the future. GE-
3, at 7. The Respondent stated that he would not refill diet drugs for
patients in the future without completing the appropriate
documentation. GE-3, at 7.
---------------------------------------------------------------------------

\22\ Specifically, the Respondent wrote that he was ``sorry to
learn that [CI] may have deliberately taken an overdose.'' GE-3, at
7.
---------------------------------------------------------------------------

36. The Mississippi Board contemplated closing its investigation of
the Respondent because it did not have enough evidence supporting the
allegations of the Respondent's sexual misconduct. Tr. 181, 184, 194-
95, 197, 209-10. Throughout the course of its investigation, however,
the Mississippi Board never interviewed CI. Tr. 196.
37. On March 20, 2015, while the Mississippi Board was
contemplating closing its investigation, Flinchum

[[Page 54833]]

contacted the Mississippi Board and requested, on the DEA's behalf,
that the Mississippi Board discontinue its investigation of, and
communication with, the Respondent. GE-3, at 2; Tr. 60-61, 181, 209.
The Mississippi Board customarily will discontinue an investigation to
allow a criminal agency to pursue a case. Tr. 210.
38. The Mississippi Board closed its investigation of the
Respondent on March 23, 2015. GE-3, at 1; Tr. 181. A letter from the
Mississippi Board to the Respondent terminated the Board's
investigation. GE-3 at 1; Tr. 183. The letter stated that the
Mississippi Board concluded its investigation and that, after a
thorough review of the information and facts from the investigation, it
decided not to recommend any formal action. GE-3, at 1. This letter was
a truthful and accurate reflection of the Board's reasons for
terminating the investigation. Tr. 64-65, 86, 195-97.
39. The letter also cautioned the Respondent against ``authorizing
refills for Phentermine/Adipex without benefit of a medical
examination.'' GE-3, at 1 (discussing Mississippi Administrative Rule
1.5(E)).
40. The letter told the Respondent that the Mississippi Board had
found some deficiencies with his medical records. Tr. 181, 183-84, 203.
The letter did not exonerate the Respondent, but warned him about his
inadequate documentation of weight loss prescriptions. Tr. 184, 203.

F. DEA Undercover Operations

41. The DEA began undercover operations concerning the Respondent
in March 2015. Tr. 77-78.
42. CI was told that if she cooperated with law enforcement, she
would not be in any trouble. Tr. 342-43. CI signed a confidential
informant agreement with the DEA. Tr. 343-44, 394.
43. The DEA instructed CI not to have any contact \23\ with the
Respondent unless the DEA supervised the contact. Tr. 350. CI did not
comply with this instruction and met the Respondent one time without
DEA's supervision. Tr. 353, 358.
---------------------------------------------------------------------------

\23\ The DEA did not ask CI to attend an undercover appointment
with the Respondent because CI had a physical relationship with the
Respondent, and because CI said that she was addicted to cough
syrup. Tr. 400.
---------------------------------------------------------------------------

44. With CI's consent, the DEA gave CI a telephone number that
recorded all calls and text messages exchanged between CI and the
Respondent. Tr. 37-38, 84-85, 230. This telephone number operated
through an application that the DEA installed on CI's cellular phone.
Tr. 382. This application automatically recorded all calls,
conversations, and multimedia messages exchanged between CI and the
Respondent. Tr. 37-38, 85-86.
45. CI called and texted the Respondent outside of the presence of
MBN and DEA agents. Tr. 85-86. The DEA did not tell CI what to say to
the Respondent. Tr. 85-86.

i. Interactions Between the Respondent and CI Before the

First Undercover Appointment

46. The DEA agents asked CI to contact the Respondent by phone or
by text message and ask him for Norco and cough syrup. Tr. 346, 348-49.
47. On March 16, 2015, at approximately 6:51 p.m., the Respondent
and CI spoke on the phone. GE-15-16. CI asked the Respondent to meet
her at Walmart and give her a prescription for something. GE-16, file
2015-03-16_18-51-48_EDT, at 19; see Tr. 345. The Respondent said he
could not do that because the Mississippi Board was watching him and he
could go to jail or lose his license. GE-16, file 2015-03-16_18-51-
48_EDT, at 19-20; see Tr. 230, 345-47. He said that everything he had
prescribed to CI was legitimate and written in her chart. GE-16, file
2015-03-16_18-51-48_EDT, at 20. After CI again asked the Respondent
several times to give her a prescription, CI asked him instead to write
a prescription for someone else.\24\ Id. The Respondent said he could
prescribe to anyone who came into his office, and what they did with
their prescriptions was ``their business,'' but that it had ``to be a
legitimate thing.'' Id. at 21. CI asked him multiple times to write
prescriptions for her, but in different names, and the Respondent said
he could not do so without someone coming for a visit and having a
chart. Id. The Respondent said he could ``probably pilfer'' some
medication from his wife for CI. Id. at 22. CI repeatedly asked the
Respondent to get her some controlled substances, and the Respondent
repeatedly said he would see what he could do. Id. at 24-26.
---------------------------------------------------------------------------

\24\ Contra Tr. 346; see supra note 7.
---------------------------------------------------------------------------

48. On March 17, 2015, at approximately 1:07 p.m., the Respondent
and CI spoke on the phone. GE-15-16. CI asked the Respondent to slip
``a couple Lorcets'' into her mailbox. GE-16, file 2015-03-17_13-07-
36_EDT, at 4. The Respondent joked, ``I need to learn to play the
guitar so you could be getting sex, drugs and rock and roll, you
know.'' Id. CI asked the Respondent to ``sneak [her] some meds.'' Id.
at 7. The Respondent said, ``I've got your request and I'm telling you
that is highly, highly dangerous for me.'' Id.
49. On March 18, 2015, at approximately 11:03 a.m., the Respondent
and CI spoke on the phone. GE-15-16. CI suggested that the Respondent
could write a prescription in Kid 1's name. GE-16, file 2015-03-18_11-
03-33_EDT, at 1. The Respondent responded sarcastically and attempted
to change the subject. Id. at 1-2. CI said that she really needed him
to find a way to write her a prescription. Id. at 2. The Respondent
said he did not know how to do that. Id. CI suggested that he could
write a prescription in someone else's name. Id. The Respondent said he
would ``have to have somebody that's legitimate'' and ``what they did
with the medicine[,] that was up to them . . . somebody that's
trustworthy.'' Id. at 3. The Respondent indicated that it was like a
``federal crime when you write medicine to--that are diverted to
somebody else.'' Id. CI said that the Respondent used to write her
prescriptions ``all the time.'' Id. The Respondent said, ``Yeah, but I
wrote it for you.'' Id. CI recalled that the Respondent ``used to bring
[his] prescription pad over and a bottle of vodka,'' and that she
``miss[ed] those days.'' Id. The Respondent replied, ``I know, me
too.'' Id. The Respondent joked with CI that it was good to have a
boyfriend with a prescription pad. Id. at 4.
50. On March 25, 2015, at approximately 10:36 a.m., the Respondent
and CI spoke on the phone. GE-17, at 1-5.\25\ CI asked the Respondent
if he would write a prescription to another person. GE-17, at 2. The
Respondent remarked that it was dangerous and it would have to be to an
established patient; he suggested that she get another doctor to write
a prescription for her. GE-17, at 2. CI insisted, and the Respondent
said ``it has to be legitimate'' and for a ``legitimate patient''
because the Mississippi Board was watching him. GE-17, at 2. The
Respondent said he could treat a patient for CI if the patient had
headaches and anxiety. GE-17, at 3. The Respondent said, ``what he does
with 'em is his business.'' GE-17, at 3. CI asked the Respondent if he
would write something to her friend who came in with a headache; the
Respondent said, ``Yeah, I could write him something.'' GE-17, at 3. CI
clarified that the prescription would really be for her, and requested
that he prescribe ``Lorcet or something;'' the Respondent said, ``Yeah,
I could write him some--

[[Page 54834]]

yeah, some stuff like that.'' GE-17, at 3. The Respondent cautioned CI
that taking too many Lorcet or Demerol would be harmful and painful to
her. GE-17, at 4. CI said she just wanted ``some pain pills from [her]
boyfriend.'' GE-17, at 4.
---------------------------------------------------------------------------

\25\ See GE-16, file 2015-03-25_10-36-40_EDT.
---------------------------------------------------------------------------

51. On March 25, 2015, at approximately 11:43 a.m., the Respondent
texted CI, ``I won't be in the office tomorrow. I could see her
Friday.'' GE-53, file 2015-03-25_11-43-42_EDT. CI texted back, ``Ok:)
she is a real cool girl. I use [sic] to party with her.'' GE-53, file
2015-03-25_11-47-23_EDT; see Tr. 349.
52. On March 25, 2015, at approximately 2:36 p.m., the Respondent
and CI spoke on the phone. GE-17, at 6-8.\26\ The Respondent asked CI
for her friend's name. GE-17, at 6-8. CI told the Respondent the alias
first name of Agent 1. GE-17, at 6-7. The Respondent said, ``If she's
coming in for what I think she's coming in, tell her not to tell me
that. That needs to be your secret. I don't wanna know that. She needs
to have a headache and I will treat her for a headache, and so [I]
don't mind giving her prescriptions to treat a headache.'' GE-17, at 7.
The Respondent discussed the medications he could prescribe to Agent 1
and told CI that they ``would be perfectly appropriate for you to
take.'' GE-17, at 7; see Tr. 349 (noting that the Respondent knew that
Agent 1 was not a real patient and that medication prescribed to Agent
1 would be given to CI).
---------------------------------------------------------------------------

\26\ See GE-16, file 2015-03-25_14-36-02_EDT.
---------------------------------------------------------------------------

53. On March 26, 2015, at approximately 11:18 a.m., the Respondent
and CI spoke on the phone. GE-18.\27\ CI told the Respondent that Agent
1 had an appointment with him ``tomorrow at 2:00--2:10, I think.'' GE-
18, at 3. The Respondent replied, ``Okay. We'll see if we can't get my
girlfriend fixed up.'' GE-18, at 3. The Respondent said CI should
remind Agent 1 to ``play it straight'' and tell the Respondent what he
to needed to write on a chart to ``keep the medical examiners at bay .
. . .'' GE-18, at 3. CI asked him if he would prescribe Norco to Agent
1. GE-18, at 3. The Respondent said, ``Yeah, I'll write her Norco and
some more Maxalt, and then you can have some Maxalt also. Just remember
to hide it.'' GE-18, at 3.
---------------------------------------------------------------------------

\27\ See GE-16, file 2015-03-26_11-18-28_EDT.
---------------------------------------------------------------------------

54. Based on Findings of Fact 47 through 53 and the transcript at
pages 91, 230, and 349, I find that, by the time the Respondent met
with Agent 1 on March 27, 2015, the Respondent knew that Agent 1 was
not a legitimate patient and that any medication he prescribed to her
at that appointment would be given to and used by CI.

ii. Undercover Appointment #1: March 27, 2015

55. Agent 1's first appointment with the Respondent was on March
27, 2015. GE-10; Tr. 91. Upon arriving at the Respondent's clinic,
Agent 1 signed in, completed paperwork, and waited in the Respondent's
waiting room. GE-9; Tr. 92. The Respondent's nurse called Agent 1 back
into an examination room and spoke briefly with her. GE-9; Tr. 92, 94.
56. Agent 1 met with the Respondent. GE-9-10; Tr. 91; see GE-59
(containing the Respondent's patient file for Agent 1). The appointment
lasted approximately seven minutes. GE-9. When the Respondent asked
Agent 1 what her problem was, she told him, ``Just kind of a whole head
thang [sic].'' GE-10, at 1; Tr. 94. The Respondent asked Agent 1 how
long her head had been bothering her, and she indicated just a few
days. GE-9-10. The Respondent quickly looked into Agent 1's ears, nose,
and throat. GE-9-10; Tr. 94, 132. The Respondent asked her if she was
dizzy, nauseous, or taking other medication. GE-9-10. He advised her
that Maxalt works well for sinus headaches and gave her instructions
for taking her prescriptions. GE-9-10. The Respondent did not
communicate any diagnosis to Agent 1, nor did he record a diagnosis in
her patient file.\28\ GE-9-10; GE-59, at 4.
---------------------------------------------------------------------------

\28\ The Respondent's March 27, 2015 notes in Agent 1's patient
file mention photophobia. GE-59, at 4. The transcript and recording
of the office visit, however, contain no mention of photophobia or
any discussion of the symptoms of photophobia. GE-9-10.
---------------------------------------------------------------------------

57. Agent 1 asked the Respondent if he could help her with her
weight loss. GE-9-10. The Respondent declined to prescribe anything for
weight loss to Agent 1; he said that it was not his area of expertise
and it was heavily regulated by the Mississippi Board. GE-10, at 2. He
recommended that she could go to a licensed diet center for assistance.
GE-10, at 3.
58. The Respondent wrote two prescriptions for Agent 1: one non-
refillable prescription for Norco, and one refillable prescription for
Maxalt. GE-11-12; Tr. 95. The Respondent told Agent 1 that he would
give her ``lots of refills'' on the Maxalt. GE-10, at 1.
59. That same day, CI and the Respondent had a phone conversation
about the Respondent's meeting with CI's ``friend,'' Agent 1. GE-13-14;
GE-20, file Post Buy CI Call With STEWART 3-27-2015. The Respondent
said he enjoyed meeting Agent 1 and that he was ``hopeful that that
helps'' CI. GE-14, at 1. CI said that she could get through because the
Respondent ``hooked'' her up. GE-14, at 1. The Respondent responded,
``absolutely that needs to be about as discreet as [unintelligible].''
GE-14, at 1. The Respondent told CI to ``not take that other stuff but
one at a time.'' GE-14, at 1. He said that, during Agent 1's
appointment, he ``talked about headaches and pretty much left it
exactly at that.'' GE-14, at 1. The Respondent told CI, ``[s]o um you
got refills on that Maxalt. Um she does,'' and noted that he could not
give refills ``on the other one . . ..'' GE-14, at 2.

iii. Interactions Between the Respondent and CI Between the First and
Second Undercover Appointments

60. On April 1, 2015, at approximately 8:28 p.m., the Respondent
and CI spoke on the phone. GE-19.\29\ CI said that she spent time with
Agent 1. GE-19, at 1. The Respondent asked her, ``So that all went
smooth with getting your medicine and all that?'' GE-19, at 1; see Tr.
230-31. CI said she might need some more. GE-19, at 1. The Respondent
said he was glad he could help and that it was ``just because of'' the
Mississippi Board complaint that ``it just has to be straight up and
clean.'' GE-19, at 1.
---------------------------------------------------------------------------

\29\ See GE-16, file 2015-04-01_20-28-54_EDT.
---------------------------------------------------------------------------

61. On April 2, 2015, at approximately 2:15 p.m., the Respondent
and CI spoke on the phone. GE-16, file 2015-04-02_14-15-50_EDT. CI told
the Respondent that Agent 1 would come back and that she ``took all''
after CI ``halved some with her.'' Id. CI asked the Respondent if he
could ``give her a little bit more if she'd come back in.'' Id. at 1.
The Respondent replied, ``I can do that.'' Id. at 2. The Respondent
asked if ``she'' really had migraines. Id. CI said ``no'' and laughed.
Id. The Respondent laughed too and said he was just wondering because
there were a lot of refills. Id. The Respondent said, ``[l]ong as we
don't get outta hand. Just be sure to keep 'em really hidden.'' Id.
62. On April 2, 2015, at approximately 3:04 p.m., the Respondent
and CI spoke on the phone. GE-16, file 2015-04-02_15-04-43_EDT. CI
asked the Respondent whether he could write her ``80'' if someone came
in to see him. Id. at 1. The Respondent said he could not because it
would be a red flag, and that ``40 is a pretty substantial number.''
Id. at 1-2. The Respondent joked that CI should tell her husband that
he messed up CI's ``drug

[[Page 54835]]

connection'' when he filed the complaint. Id. at 2.
63. On April 6, 2015, at approximately 8:59 p.m., the Respondent
and CI spoke on the phone. GE-16, file 2015-04-06_20-59-35_EDT. CI told
the Respondent that she had talked to Agent 1, who was coming on
Wednesday. Id. at 2. The Respondent said, ``I'm glad to help her and
take care of her.'' Id. He commented that he had to follow the rules
when taking care of her. Id. CI asked the Respondent to help her out
when he saw Agent 1. Id. at 3. The Respondent said he would take care
of Agent 1's headaches ``like any other patient'' and that he had to
follow the rules, treating her ``like anybody else.'' Id.
64. On April 7, 2015, at approximately 1:29 p.m., the Respondent
and CI spoke on the phone. GE-16, file 2015-04-07_13-29-34_EDT. CI
asked the Respondent if she could attend Agent 1's appointment. Id. at
2. The Respondent said it was ``a little bit on the risky side.'' Id.
65. On April 7, 2015, at approximately 6:28 p.m., the Respondent
and CI spoke on the phone. GE-16, file 2015-04-07_18-28-45_EDT. CI
asked the Respondent if he wanted her to come with Agent 1 to her
appointment the next day. Id. at 7. The Respondent said that he was
nervous about it and had to treat Agent 1 the way he treated everyone
else. Id. CI thanked the Respondent and said she knew he was seeing
Agent 1 for her. Id. at 8. The Respondent said that he was treating her
as a patient, and that it was dangerous. Id.
66. On April 7, 2015, at approximately 7:04 p.m., CI texted the
Respondent and asked if he would meet her at Walmart the next day
around lunch. GE-20, file 2015-05-06_141328_601-904-1188_FROM_2015-04-
01_TO_2015-04-30_ALL.\30\
---------------------------------------------------------------------------

\30\ Contra Tr. 129.
---------------------------------------------------------------------------

67. On April 8, 2015, at approximately 8:59 a.m., CI again texted
the Respondent and asked him to go to Walmart on his lunch break so
that she could ``run into'' him. GE-21, at 3. CI texted the Respondent
that Agent 1 would be there and that Agent 1 knew about their
relationship, but was ``cool'' and would ``cover'' for CI. GE-21, at 5-
6.
68. On April 8, 2015, at approximately 10:16 a.m., the Respondent
and CI spoke on the phone. GE-16, file 2015-04-08_10-16-03_EDT. The
Respondent said he would love to see CI at Walmart at noon that day.
Id. at 1. CI again said Agent 1 knew that the Respondent was CI's
boyfriend. Id. CI said she was fat because she was not taking Adipex
anymore. Id. at 3. The Respondent said that she worried too much and
that she was beautiful. Id.\31\ The Respondent and CI agreed to meet in
Walmart that day. Id. at 7-8.
---------------------------------------------------------------------------

\31\ See GE-27, at 1; contra Tr. 225.
---------------------------------------------------------------------------

69. On April 8, 2015, at approximately 12:31 p.m., CI texted the
Respondent and said, if he wanted to save Agent 1 some money, he could
bring a prescription for her with him to Walmart. GE-21, at 8. At 12:37
p.m., the Respondent replied that he ``MUST see her in the office. You
know why.'' GE-21, at 9.

iv. Undercover Operation at Walmart: April 8, 2015

70. On April 8, 2015, Agent 1 accompanied CI to Walmart at
approximately 12:45 p.m. GE-22-23; Tr. 128-29, 133-34. The Respondent
met CI in the home furnishings department. GE-22; Tr. 389. CI wore a
video and audio recording device. Tr. 347-48, 389; see GE-22. The
Respondent spoke with CI. Tr. 129; see GE-22. The video recording did
not capture an image of the Respondent's face, and much of the
recording is inaudible. GE-22.
71. The Respondent told CI to tell Agent 1 to space out her
appointments more. Tr. 129-30. The Respondent said, ``[w]e will be good
now, so but you can't come back like every week for a prescription
cause they keep up, it's like every 4 weeks.'' GE-23. CI asked the
Respondent how she was ``supposed to last that long.'' GE-23. The
Respondent told her to ``go buy a bottle of Vodka . . . .'' GE-23.
72. At approximately 3:29 p.m., CI texted the Respondent that she
really felt fat and asked him to write Agent 1 ``something for that
too.'' GE-21, at 13.
73. Based on Findings of Fact 47 through 53, Findings of Fact 56
through 72, and the transcript at pages 91, 230, and 349, I find that,
by the time the Respondent met with Agent 1 on April 8, 2015, the
Respondent knew that Agent 1 was not a legitimate patient and that at
least some of the medication he prescribed at that appointment would be
given to and used by CI.

v. Undercover Appointment #2: April 8, 2015

74. Agent 1 had a second appointment with the Respondent that took
place on April 8, 2015. GE-24-25; Tr. 102. The Respondent's nurse asked
Agent 1 why she was back so soon after her first visit and if she was
taking her medication correctly. GE-24; GE-25, at 1; Tr. 103. Agent 1
said she just ``ran out'' of medication and was taking it twice a day.
GE-25, at 1.
The nurse told her that she did not need to take pain medication
``every day all year long.'' GE-25, at 1.
75. The Respondent met with Agent 1 and asked her what she had
going on. GE-25, at 1. Agent 1 said, ``Same thing. Same stuff.'' GE-25,
at 1. The Respondent asked if the medicine had helped. GE-25, at 1.
Agent 1 said it helped ``a little bit.'' GE-25, at 1. The Respondent
began writing almost immediately after he entered the room without
conducting any sort of examination of Agent 1. GE-24-25; Tr. 103-04,
132. The appointment lasted approximately seven minutes. GE-24.
76. The Respondent and Agent 1 talked casually about boating and
skiing. GE-25, at 2-3. The Respondent took out his prescription pad and
wrote prescriptions for Agent 1. GE-25, at 3. The Respondent said,
``[w]e need to kinda stretch this out [to] make it last a month.'' GE-
25, at 3.
77. The Respondent wrote two prescriptions \32\ to Agent 1: one for
40 Norco, and one for Maxalt. GE-24-26; Tr. 104. The Respondent told
Agent 1 that he gave her refills for Maxalt but could not for ``the
other.'' GE-25, at 1. The Respondent again told her to ``spread it out
a little bit longer.'' GE-25, at 2. He said that ``the other ones are
not really intended for . . . daily use,'' but that he would ``go ahead
and give [her] a refill.'' GE-25, at 2.
---------------------------------------------------------------------------

\32\ In GE-26, the Government only provided a copy of the
prescription for Norco. However, the Respondent's discussion of
Maxalt, preserved in GE-24 and 25, indicates that the Respondent
also prescribed Maxalt to Agent 1. Additionally, Agent 1's testimony
that she received two prescriptions at this appointment was credible
and uncontested. Tr. 104.
---------------------------------------------------------------------------

vi. Interactions Between the Respondent and CI Between the Second and
Third Undercover Appointments

78. On April 8, 2015, at approximately 5:01 p.m., CI texted the
Respondent and said ``[t]hank u sweetheart for hooking me up again
:).'' GE-20, file 2015-05-06_141328_601-904-1188_FROM_2015-04-
01_TO_2015-04-30_ALL.
79. On April 8, 2015, at approximately 6:15 p.m., the Respondent
and CI spoke on the phone. GE-27.\33\ CI asked how things went with
Agent 1. GE-27, at 1. The Respondent said he thought they went okay.
GE-27, at 1. The Respondent and CI discussed their encounter in
Walmart. GE-27, at 3. The Respondent asked CI what Agent 1 said to CI,
and she told him that Agent 1 said that they had talked about the

[[Page 54836]]

Respondent's boat. GE-27, at 5. The Respondent said that he talked with
Agent 1 about a boat because ``we had to be in there more than ten
seconds'' so that his ``nosy nurse'' would not think, ``[d]ang, why is
this appointment over with in ten seconds?'' GE-27, at 5.
---------------------------------------------------------------------------

\33\ See GE-16, file 2015-04-08_18-15-44_EDT.
---------------------------------------------------------------------------

80. On April 14, 2015, at approximately 3:48 p.m., CI texted the
Respondent and asked him how many friends she could ``send in ur office
for `headaches' lol?'' GE-20, file 2015-04-14_15-48-52_EDT.
81. On April 14, 2015, at approximately 6:47 p.m., the Respondent
and CI spoke on the phone. GE-38.\34\ CI again asked the Respondent how
many friends she could send to him with a headache. GE-38, at 2. The
Respondent said they had to be really careful about it. Id. The
Respondent told CI that if she had a friend who was ``willing to help''
her, she should not tell him about it and should just ask the friend to
come by and ``mention that they've got headaches.'' GE-38, at 2. The
Respondent said he was nervous about it because he knew he was being
watched. GE-38, at 2. The Respondent said that, but for CI's husband,
CI could ``have all the sex, drugs, and rock and roll'' that she
needed. GE-38, at 2. CI told the Respondent that she was ``running
low'' and needed ``some more pills or something.'' GE-38, at 3. The
Respondent suggested she drink vodka. GE-38, at 3. CI asked if he would
treat Agent 1 for a cough if Agent 1 came in for a cough, and if he
would give Agent 1 cough medicine. GE-38, at 3. The Respondent said he
could give her cough medicine for something legitimate, and warned CI
that the state monitors drug-seeking behavior. GE-38, at 3-4. CI asked
the Respondent to prescribe her a ``big bottle,'' like he used to
prescribe to her. GE-38, at 4. The Respondent said he could give her
about eight ounces. GE-38, at 4. The Respondent told CI that he could
not prescribe Adipex to her and explained why. GE-38, at 6. The
Respondent told CI that he could help her feel happier if he did not
get ``busted by the . . . drug police.'' GE-38, at 8.
---------------------------------------------------------------------------

\34\ See GE-20, file 2015-04-14_18-47-34_EDT; GE-28, file 2015-
04-14_18-47-34_EDT.
---------------------------------------------------------------------------

82. On April 14, 2015, at approximately 7:02 p.m., CI texted the
Respondent and asked if he had any Adipex left over from a prescription
to his wife. GE-20.
83. On April 15, 2015, at approximately 9:30 p.m., the Respondent
and CI spoke on the phone. GE-20, 28. CI talked about being severely
depressed. GE-28, file 2015-04-15_21-30-59_EDT, at 9. The Respondent
talked about how CI's husband would not let her ``have drugs.'' Id. at
10.
84. On April 22, 2015, at approximately 10:28 a.m., the Respondent
and CI spoke on the phone. GE-20, 28. CI told the Respondent that Agent
1 and some of her friends were coming next week to see the Respondent.
GE-28, file 2015-04-22_10-28-41_EDT, at 3. The Respondent warned CI
that he had to be careful because it was ``super serious.'' Id. CI
laughed and said that they had headaches. Id. The Respondent told CI
that prescribing frequently to people from out of town was a ``big''
red flag. Id. The Respondent said he could not ``do it on any kind of
regular basis.'' Id. at 4.
85. On April 22, 2015, at approximately 12:10 p.m., the Respondent
texted CI that he ``CANNOT do anything other than legitimate medical
stuff'' because it was risky and CI's husband had everyone ``on high
alert.'' GE-20. CI texted back and asked if he would see Agent 1 next
week, and that Agent 1 and her friends would not ``tell.'' GE-20. CI
asked him to ``write in their chart it's for migraines like u always
do.'' GE-20. The Respondent texted back that he would see Agent 1 and
treat her in a medically appropriate way. GE-20. The Respondent also
texted that his usual prescription for Lorcet (40) ``should last more
than a month.'' GE-20. The Respondent texted that his feelings for CI
needed to be ``totally separate from [his] medical practice.'' GE-20.
86. On April 22, 2015, at approximately 1:03 p.m., the Respondent
and CI spoke on the phone. GE-20, 28. The Respondent said that they had
to be really careful because the Mississippi Board was watching him.
GE-28, file 2015-04-22_13-03-23_EDT, at 1-2. He compared their
situation to going to ``buy drugs at a crack house.'' Id. at 2. The
Respondent said everything needed to be ``straight'' and ``above the
board.'' Id. The Respondent said that his normal prescription dosage of
headache medicine should last more than 30 days, and that it would
raise alarm if he saw people more than once a month or every other
month for headaches. Id. CI said that it had been a month since he saw
Agent 1; the Respondent said he did not remember. Id. CI asked him how
he got ``away with it'' when he was seeing her; he replied that ``they
weren't watching nearly as close'' and that CI had legitimate headaches
and he ``was writing it down every time.'' Id. at 3. The Respondent
said he was not giving her prescriptions ``super often.'' Id. The
Respondent discussed headaches, Maxalt, and Lorcet with CI. Id. at 3-4.
CI asked the Respondent if he would see ``them'' next week. Id. at 4.
The Respondent said that he would see anybody that came in to his
office. Id. CI asked him to ``write 'em Lorcet.'' Id. The Respondent
said that ``[i]t would even be better if I don't even know who they
are'' and instructed CI to not tell him their names. Id. The Respondent
said that he treats everyone the same. Id. at 5. The Respondent said
that he liked to be nice to Agent 1, who he identified as CI's friend.
Id.
87. On April 22, 2015, at approximately 2:32 p.m., CI texted the
Respondent, ``[w]hat I wouldn't do for an aipex [sic] right now ! Omg
:/.'' GE-20, file 2015-04-22_14-32-41_EDT.
88. On April 27, 2015, at approximately 2:45 p.m., the Respondent
and CI spoke on the phone. GE-20, 28. CI said she spoke to Agent 1, who
was going to see the Respondent that Wednesday. GE-20, file 2015-04-
27_14-45-16_EDT. The Respondent said he would be glad to see her. Id.
CI said that Agent 1 would give CI all of Agent 1's prescriptions. Id.
CI said Agent 1 and Agent 2 would split Agent 2's prescriptions. GE-28,
file 2015-04-27_14-45-16_EDT, at 1. The Respondent said he did not
``know anything about that and [did not] want to know anything about
that.'' Id. CI discussed previously taking ``like 20'' of the Demerol
that the Respondent prescribed to her. Id. at 7.
89. On April 28, 2015, at approximately 8:23 p.m., the Respondent
and CI spoke on the phone. GE-20, 28. CI told the Respondent to not
forget that Agent 1 and Agent 2 were coming tomorrow. GE-28, file 2015-
04-28_20-23-38_EDT, at 1. The Respondent acknowledged that he knew they
were coming and said he would see them then. Id. CI told the Respondent
to ``[h]ook her up good. Give her some cough medicine.'' Id.
90. On April 29, 2015, at approximately 9:38 a.m., the Respondent
and CI spoke on the phone. GE-20, 28, 29. CI told the Respondent not to
forget that Agent 1 was coming that day. GE-29, at 7. The Respondent
replied that he would not forget and would ``take care of her.'' GE-29,
at 7. CI told him to give her cough medicine. GE-29, at 7. The
Respondent said he would see what he could do, but that CI was ``really
pushing [his] envelope.'' GE-29, at 7.
91. On April 29, 2015, at approximately 3:40 p.m., CI texted the
Respondent that Agent 1 said that Agent 2 `` `has a cough too' if u
could hook her up with some cough med . . . Please :) .'' GE-39, at 5.

[[Page 54837]]

92. Based on Findings of Fact 47 through 53, 56 through 72, and 75
through 91, and the transcript at pages 91, 136, 230, and 349, I find
that, by the time the Respondent met with Agents 1 and 2 on April 29,
2015, the Respondent knew that Agent 1 and Agent 2 were not legitimate
patients and that at least some of the medications that he prescribed
to them during their appointments that day would be given to and used
by CI and/or shared by the Agents.

vii. Undercover Appointment #3: April 29, 2015, with Agent 1

93. Agent 1 had a third appointment with the Respondent, which
occurred on April 29, 2015. GE-30-31; Tr. 111.
94. The Respondent met with Agent 1 and asked her, ``Headaches for
you?'' GE-31, at 1. Agent 1 responded, ``Yep.'' GE-31, at 1. The
Respondent performed a brief examination of Agent 1, checking her ears
and nose. GE-30-31; Tr. 112, 132. The Respondent observed that Agent 1
still had ``refills on the other.'' GE-31, at 1.
95. Agent 1 told the Respondent that she talked on the phone with a
friend of hers, who told her that she was coughing a lot and needed to
get something for her cough; Agent 1 also told the Respondent that she
had not paid it much attention to it. GE-31, at 1; Tr. 133, 138-39. The
Respondent immediately told Agent 1 that he would give her some cough
syrup. GE-30; Tr. 133, 139-40. Agent 1 was not coughing during the
appointment. GE-30; Tr. 138. Agent 1 did not tell the Respondent that
she had a cough. GE-30-31; Tr. 113, 132. Agent 1 did not directly
request cough syrup from the Respondent. GE-30-31; Tr. 113.
96. The Respondent wrote two prescriptions to Agent 1: one for 40
Norco 10/325, and one for eight ounces of Hycodan. GE-32-33; Tr. 113.

viii. Undercover Appointment #4: April 29, 2015, with Agent 2

97. Agent 2 also had an appointment with the Respondent on April
29, 2015. GE-34-35; Tr. 143.
98. The Respondent met with Agent 2. GE-34-35; Tr. 144; see also
GE-58 (containing the Respondent's patient file for Agent 2). The
Respondent asked her what he could do for her. Agent 2 she said she had
``a little headache,'' but noted that it had not been going on for a
long time. GE-35, at 1; Tr. 144. The Respondent briefly looked into
Agent 2's ears, nose, and mouth. GE-34-35; Tr. 144. The Respondent
asked her a few questions about allergies, blood pressure, and smoking.
GE-35, at 2. The Respondent then wrote prescriptions to Agent 2. GE-34.
Meanwhile, the Respondent talked casually with Agent 2 about sports,
Birmingham, and restaurants. GE-35, at 2-3.
99. The Respondent wrote two prescriptions for Agent 2: one for 40
Norco 10/325, and one for Maxalt with unlimited refills. GE-35, at 3;
GE-36-37; Tr. 144.

ix. Interactions Between the Respondent and CI Between the Fourth and
Fifth Undercover Appointments

100. On April 29, 2015, at approximately 1:48 p.m., the Respondent
and CI spoke on the phone. GE-29, at 9. CI asked the Respondent if he
had seen Agent 1. GE-29, at 9. The Respondent said he had. GE-29, at 9.
CI asked him what he gave her. GE-29, at 9. The Respondent said,
``appropriate medicine,'' and laughed. GE-29, at 9. He said that he
gave her something for her headache and cough. GE-29, at 9. CI thanked
the Respondent. GE-29, at 9.
101. On April 30, 2015, at approximately 9:19 a.m., the Respondent
and CI spoke on the phone. GE-40; see GE-20, 28. CI told the Respondent
that she got her medication. GE-40, at 1. The Respondent said he was
``glad all that worked out.'' GE-40, at 1; see Tr. 230-31. The
Respondent asked CI who Agent 2 was and if she was Agent 1's friend.
GE-40, at 1. CI told the Respondent that Agent 1 gave all of hers to
CI, and that Agent 1 and Agent 2 split Agent 2's prescription. GE-40,
at 2. The Respondent said he was glad he could help, and that both
agents were ``very appropriate'' because they went ``through the
motions.'' GE-40, at 2. The Respondent said that during the appointment
with Agent 2, he was thinking, ``I'm not mentioning [CI] and I'm not
mentioning [Agent 1].'' GE-40, at 2.
102. The DEA's investigation was suspended while the Respondent
campaigned for political office. Tr. 78. The DEA contacted CI in
October 2015 and asked her to talk to the Respondent again to try to
get him to write another prescription. Tr. 358. CI said no. Tr. 358.

x. Undercover Appointment #5: October 16, 2015

103. Agent 1 had a fourth appointment with the Respondent, which
took place on October 16, 2015. Tr. 78, 119. The purpose of this
appointment was to refresh the investigation concerning the Respondent.
Tr. 78. Upon arriving at the Respondent's clinic, the Respondent's
receptionist told Agent 1 that her chart had been misplaced,\35\ so
Agent 1 filled out new paperwork and sat in the Respondent's waiting
room. GE-42-43; Tr. 119-20, 137.
---------------------------------------------------------------------------

\35\ After the Respondent was arrested, Agent 1's original file,
GE-59, was found in the Respondent's desk, along with the files for
CI and CI's children. Tr. 428.
---------------------------------------------------------------------------

Agent 1 waited for about an hour and twenty minutes before she was
called into an exam room. GE-42; Tr. 406.
104. Agent 1 met with the Respondent. GE-42; see GE-60 (containing
Agent 1's October 16, 2015 patient file). The Respondent examined Agent
1's ears, nose, and throat. GE-60, at 4; Tr. 120, 132.\36\ The
Respondent asked Agent 1 what her symptoms were and what he had treated
her for in the past. GE-43, at 2; Tr. 135. Agent 1 thought the
Respondent was acting as though he did not know who she was. Tr. 120,
135, 452; see GE-42-43.
---------------------------------------------------------------------------

\36\ The audiovisual recording of Agent 1's appointment did not
record any physical examination by the Respondent during this
appointment. See GE-42. However, because the audiovisual recording
was incomplete, and because Agent 1 testified that the Respondent
examined her ears, nose, and throat, I find as a matter of fact that
the Respondent conducted a physical examination of Agent 1 at this
appointment.
---------------------------------------------------------------------------

105. The Respondent discussed the most effective medication for
Agent 1 to take for headaches. GE-43, at 2-3. Agent 1 asked the
Respondent if he remembered Agent 2. GE-43, at 3. The Respondent
stopped, thought about it, and said he did not. GE-42, 43.
106. Agent 1's recording device partially failed and did not record
the last few minutes of Agent 1's appointment with the Respondent. Tr.
79, 451.
107. While the Respondent was writing prescriptions for Agent 1,
she asked the Respondent if he had spoken with CI lately. Tr. 122, 135,
452-53. The Respondent paused and looked surprised, then continued
writing the prescriptions and stated that he had not heard from CI
lately. Tr. 122-23.
108. The Respondent wrote Agent 1 prescriptions for 30 Norco 5/325,
four ounces of Hycodan, Maxalt, Zyrtec, and dexamethasone. GE-44-47,
54; Tr. 120, 126-27, 452. The Respondent discussed these prescriptions
with Agent 1 during the appointment. Tr. 452-53, 455-56.
109. During this visit, Agent 1 did not say that she had a cough.
GE-42-43; Tr. 126, 138-39, 454. Agent 1 only stated at the outset of
the appointment that she needed the ``same as before,'' and did not
tell the Respondent that she had any specific complaints. GE-42-43; Tr.
454. The Respondent nonetheless prescribed cough syrup to Agent 1. GE-
45; Tr. 139.

[[Page 54838]]

G. Search of the Respondent's Office

110. The Respondent was arrested on December 9, 2015. Tr. 427, 432.
That same day, the DEA searched the Respondent's office and examined
his records and patient files. Tr. 427, 432. The Respondent's office
kept patient files in a general population of files. Tr. 433.
111. The DEA unlocked the Respondent's desk drawer and discovered
several patient files that had not been kept in the general population
of patient files. Tr. 428, 432. In the Respondent's desk, the DEA found
one patient file for Agent 1, one file for CI, one file for Kid 1, and
one file for Kid 2. Tr. 428; see GE-2, 56-57, 59.
112. The DEA found a second patient file for Agent 1 within the
general population of the Respondent's patient files. Tr. 433; see GE-
60. The DEA also found a patient file for Agent 2 in the general
population of the Respondent's patient files. Tr. 434; see GE-58.
Additional facts required to resolve the issues in this case are
included below in the Analysis section of this Recommended Decision.

ANALYSIS

To revoke a respondent's registration, the Government must prove,
by a preponderance of the evidence, that the regulatory requirements
for revocation are satisfied. Steadman v. SEC, 450 U.S. 91, 100-02
(1981); 21 CFR Sec. 1301.44(e) (2015). Under 21 U.S.C. Sec.
824(a)(4), the DEA may revoke a registrant's COR if the registrant
acted in a way that renders continued registration ``inconsistent with
the public interest.'' The DEA considers the following five factors to
determine whether continued registration is in the public interest:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(3) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.

21 U.S.C. 823(f) (2012).

These public interest factors are considered separately. See Robert
A. Leslie, M.D., 68 Fed. Reg. 15227, 15230 (2003). Each factor is
weighed on a case-by-case basis. Morall v. DEA, 412 F.3d 165, 173-74
(D.C. Cir. 2005). Any one factor, or combination of factors, may be
decisive. David H. Gillis, M.D., 58 Fed. Reg. 37507, 37508 (1993).
Thus, there is no need to enter findings on each of the factors. Hoxie
v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Further, there is no
requirement to consider a factor in any given level of detail. Trawick
v. DEA, 861 F.2d 72, 76-77 (4th Cir. 1988). When deciding whether
registration is in the public interest, the totality of the
circumstances must be considered. See generally Joseph Gaudio, M.D., 74
Fed. Reg. 10083, 10094-95 (2009).
The Government bears the initial burden of proof, and must justify
revocation by a preponderance of the evidence. Steadman, 450 U.S. at
100-03. If the Government makes a prima facie case for revocation, the
burden of proof shifts to the registrant to show that revocation would
be inappropriate. Med. Shoppe-Jonesborough, 73 Fed. Reg. 364, 387
(2008). A registrant may prevail by successfully attacking the veracity
of the Government's allegations or evidence. Alternatively, a
registrant may rebut the Government's prima facie case for revocation
by accepting responsibility for wrongful behavior and by taking
remedial measures to ``prevent the re-occurrence of similar acts.''
Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8236 (2010). In addition, when
assessing the appropriateness and extent of sanctioning, the DEA
considers the egregiousness of the offenses and the DEA's interest in
specific and general deterrence. David A. Ruben, M.D., 78 Fed. Reg.
38363, 38385 (2013).

Factor One: The Recommendation of the Appropriate State Licensing Board
or Professional Disciplinary Authority

Neither party directly advanced an argument under Factor One.
However, a substantial portion of the Respondent's post-hearing brief
(``ALJ-34'') argues that the DEA should give significant deference to
the Mississippi Board's termination of its investigation against the
Respondent. ALJ-34, at 3-6. Therefore, by inference, the Respondent
advanced a theory under Factor One that his license should not be
revoked because the Mississippi Board declined to take formal
disciplinary action against him.
Although the Mississippi Board did not make a formal recommendation
to the DEA in this matter, the DEA interprets a state licensing board's
``recommendation'' broadly. See Kenneth Harold Bull, M.D., 78 Fed. Reg.
62666, 62672 (2013) (considering disciplinary actions taken by a state
board under Factor One).\37\ A state board's disciplinary actions can
provide evidence of what a state licensing board would recommend. Id.
For example, when a state board puts a registrant on probation, the DEA
views the probation as a recommendation from the state board. E.g.,
Tyson D. Quy, M.D., 78 Fed. Reg. 47412, 47417 (2013).
---------------------------------------------------------------------------

\37\ But see George R. Smith, M.D., 78 FR 44972, 44979 (2013)
(finding that the absence of a state licensing board's direct
recommendation weighs neither for nor against a respondent); Paul
Weir Battershell, N.P., 76 FR 44359, 44365-66 (2011) (same); Gilbert
Eugene Johnson, M.D., 75 FR 65663, 65666 n.3 (2010) (same).
---------------------------------------------------------------------------

Here, the Mississippi Board has not revoked, suspended, or
restricted the Respondent's license. GE-1, at 1; GE-3, at 1. The
Mississippi Board investigated the Respondent in March 2015. See GE-3.
This investigation was limited to reviewing an anonymous letter,
interviewing the Respondent, and visiting the Respondent's office. See
GE-3, at 1-2, 4-6. The Mississippi Board neither exonerated the
Respondent nor took any formal action against him. GE-3; Tr. 184, 203.
The Mississippi Board only issued a warning letter to the Respondent to
conclude its investigation. GE-3, at 1. Consistent with the findings of
Investigator Pohnert, the Mississippi Board warned the Respondent that
doctors are only permitted to refill phentermine prescriptions if they
first conduct and document medical examinations. GE-3, at 1, 5.
The fact ``that a state has not acted against a registrant's
medical license is not dispositive in this administrative determination
as to whether continuation of a registration is consistent with the
public interest.'' Carlos Gonzalez, M.D., 76 Fed. Reg. 63118, 63140
(2011) (citing Patrick W. Stodola, M.D., 74 Fed. Reg. 20727, 20730
(2009); Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 461 (2009)).
Rather, the DEA, apart from the Mississippi Board, has its own
independent responsibility to determine whether the Respondent's
continued registration is in the public interest. See Edmund Chein,
M.D., 72 Fed. Reg. 6580, 6590 (2007), aff'd, Chein v. DEA, 533 F.3d 828
(D.C. Cir. 2008). Accordingly, the Mississippi Board's warning letter
does not weigh either for or against the Respondent under Factor One.

Factors Two and Four: The Respondent's Experience in Dispensing
Controlled Substances and Compliance with Applicable State, Federal, or
Local Laws Relating to Controlled Substances

Allegations 1 through 5 all claim that the Respondent
illegitimately prescribed controlled substances outside the course of
his professional practice. See supra pp. 2-3. Regarding these
allegations, the

[[Page 54839]]

Government endeavored to show that the Respondent knowingly diverted,
or attempted to divert, controlled substances. This evidence is
properly analyzed under Factors Two and Four because ``[p]roof that a
physician knowingly diverted controlled substances is the best evidence
for assessing his experience in dispensing controlled substances,
although it is also relevant in assessing his compliance with
applicable laws related to controlled substances.'' Syed Jawed Akhtar-
Zaidi, M.D., 80 Fed. Reg. 42961, 42968 n.17 (2015).
Under the Controlled Substances Act (``CSA''), it is unlawful for a
person to distribute controlled substances, except as authorized under
the CSA. 21 U.S.C. 841(a)(1). To combat drug abuse and trafficking of
controlled substances, ``Congress devised a closed regulatory system
making it unlawful to manufacture, distribute, dispense, or possess any
controlled substance except in a manner authorized by the CSA.''
Gonzales v. Raich, 545 U.S. 1, 13 (2005). To maintain this closed
regulatory system, controlled substances may only be prescribed if a
DEA registrant writes a valid prescription. Gonzalez, 76 FR at 63141.
As the Supreme Court explained, ``the prescription requirement . . .
ensures that patients use controlled substances under the supervision
of a doctor so as to prevent addiction and recreational abuse. As a
corollary, [it] also bars doctors from peddling to patients who crave
the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S.
243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143
(1975)).
A controlled substance prescription is not valid unless it is
``issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of his professional practice.'' 21 CFR Sec.
1306.04(a). Federal regulations further provide that ``[a]n order
purporting to be a prescription issued not in the usual course of
professional treatment . . . is not a prescription within the meaning
and intent of [21 U.S.C. Sec. 829] and . . . the person issuing it,
shall be subject to the penalties provided for violations of
[controlled substance laws].'' Id.; see 21 U.S.C. Sec. 842(a)(1)
(establishing that, under the CSA, it is illegal for a person to
distribute or dispense controlled substances without a prescription, as
is required under 21 U.S.C. Sec. 829).
Much like the federal regulations, the Mississippi Code provides
that it is illegal to dispense Schedule II \38\ controlled substances
except upon a valid prescription written by a practitioner. Miss. Code
Sec. Sec. 41-29-137(a)(1), 41-29-141(1). The Mississippi Code further
provides that a registrant's license may be revoked if the registrant
prescribes narcotics outside of the course of legitimate professional
practice, id. Sec. 73-25-29(3), or if the registrant violates the
Mississippi Board's administrative rules, id. Sec. 73-25-29(13).
---------------------------------------------------------------------------

\38\ These sections of the Mississippi Code only apply to the
Respondent's Schedule II controlled substance prescriptions.
Notably, hydrocodone combination products, such as Norco and
Hycodan, were re-classified by the federal government as Schedule II
controlled substances on October 6, 2014. See Stip. 5-6. The parties
made no argument, and presented no evidence, regarding the
classification of hydrocodone combination products in the state of
Mississippi.
---------------------------------------------------------------------------

The DEA recognizes several methods to show that a registrant wrote
prescriptions without a legitimate medical purpose and outside of the
usual course of professional practice. See Jack A. Danton, D.O., 76 FR
60900, 60901 (2011). The Respondent, however, incorrectly suggests that
the Government must provide ``medical literature'' or a ``medical
opinion'' in order to establish that a registrant acted outside the
usual course of professional practice and lacked a legitimate medical
purpose. ALJ-34, at 5.
Typically, the Government uses expert testimony to establish a
violation of 21 CFR 1306.04(a). T.J. McNichol, M.D., 77 FR 57133,
57147-48 (2012). However, ``whether expert testimony is needed is
necessarily dependent on the nature of the allegations and the other
evidence in the case.'' Beau Boshers, M.D., 76 FR 19401, 19402 n.4
(2011). Numerous state and federal courts have found in criminal cases,
which require a higher standard of proof than is required in these
proceedings, that expert testimony is not required to establish a
violation of 21 U.S.C. Sec. 841 or 21 CFR Sec. 1306.04(a). McNichol,
77 FR at 57147.\39\ For example, the DEA has not required expert
testimony to establish a violation of 21 CFR Sec. 1306.04(a) in cases
where a prescriber engaged in drug deals,\40\ where there were notable
differences between patients' medical records and diagnoses,\41\ and
where a prescriber falsified patients' charts.\42\ Simply put, whether
the Government must present expert testimony is dependent on the facts
of each case. McNichol, 77 FR at 57147-48.
---------------------------------------------------------------------------

\39\ E.g., United States v. Pellman, 668 F.3d 918, 924 (7th Cir.
2012); United States v. Armstrong, 550 F.3d 382, 389 (5th Cir.
2008); United States v. Word, 806 F.2d 658, 663 (6th Cir. 1986);
United States v. Larson, 507 F.2d 385, 387 (9th Cir. 1974); United
States v. Bartee, 479 F.2d 484, 488-89 (10th Cir. 1973); State v.
Moody, 393 So.2d 1212, 1215 (La. 1981).
\40\ Boshers, 76 Fed. Reg. at 19402 n.4.
\41\ Morris W. Cochran, M.D., 77 Fed. Reg. 17505, 17519-20
(2011).
\42\ Robert F. Hunt, D.O., 75 Fed. Reg. 49995, 50003 (2010).
---------------------------------------------------------------------------

In the Government's post-hearing brief (``ALJ-35''), it advanced
two theories regarding how the Respondent violated 21 CFR Sec.
1306.04(a): (1) the Respondent knowingly diverted controlled substances
to CI, and (2) the Respondent violated state medical practice
standards. ALJ-35, at 18-24. The Government can prove that a registrant
acted outside of the usual course of professional practice and lacked a
legitimate medical purpose by ``providing evidence showing that [the
registrant] knowingly diverted drugs.'' Danton, 76 Fed. Reg. at 60901.
Additionally, the Government can prove that a registrant acted outside
of the usual course of professional practice and lacked a legitimate
medical purpose by providing evidence showing that the registrant
violated a state medical practice standard ``which has a substantial
relationship to the CSA's purpose of preventing substance abuse and
diversion.'' Id. Neither of these methods of proof requires the
presentation of expert testimony. Id.
Allegation 1: Hydrocodone and Alprazolam Prescriptions to CI
In Allegation 1, the Government claimed that the Respondent
prescribed hydrocodone and alprazolam to CI from February 2014 to May
2015 \43\ without conducting and/or documenting a physical examination,
and without recording the prescriptions in CI's patient file, in
violation of Mississippi Medical Board Administrative Rules Part 2640,
Chapter 1, (``Mississippi Administrative Rules'') 1.4, 1.11(b),\44\ and
1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR
Sec. 1306.04(a). ALJ-1, at 2. Specifically, the Government alleged
that the Respondent issued improper

[[Page 54840]]

prescriptions to CI: (a) on May 22, 2014, for 40 units of a hydrocodone
combination product; (b) on June 17, 2014, for 40 units of a
hydrocodone combination product; (c) on September 11, 2014, for 40
units of a hydrocodone combination product; (d) on October 6, 2014, for
40 units of alprazolam with one refill for 40 units; (e) on October 29,
2014, for 40 units of a hydrocodone combination product; and (f) on
December 4, 2014, for 180 units of a hydrocodone combination product.
ALJ-1, at 2.
---------------------------------------------------------------------------

\43\ The record does not contain any evidence that the
Respondent prescribed controlled substances directly to CI in 2015.
The 2015 prescriptions that the Government alluded to under
Allegation 1 were the Respondent's 2015 prescriptions to Agent 1 and
Agent 2. Those prescriptions are discussed at length under
Allegation 4, infra pp. 50-58.
\44\ Rule 1.11(b) requires that ``[e]very written prescription
delivered to a patient, or delivered to any other person on behalf
of a patient, must be manually signed on the date of issuance by the
physician.'' Miss. Code R. Sec. 30-17-2640:1.11(b). Although the
Government alleged a violation of this provision in its OSC/ISO, the
Government did not advance a theory or offer evidence to establish a
violation of this specific rule. I therefore find that the
Government's allegation that the Respondent violated Rule 1.11(b) is
NOT SUSTAINED.
---------------------------------------------------------------------------

Under the Mississippi Administrative Code, the Mississippi Board
requires that a prescribing physician must:

maintain a complete record of his or her examination, evaluation
and treatment of the patient which must include documentation of the
diagnosis and reason for prescribing, dispensing or administering any
controlled substance; the name, dose, strength, quantity of the
controlled substance and the date that the controlled substance was
prescribed, dispensed or administered.

Miss. Code R. Sec. 30-17-2640:1.4.\45\ This record must ``be
maintained in the patient's medical records.'' Id.
---------------------------------------------------------------------------

\45\ I find that the documentation requirements of Mississippi
Administrative Rule 1.4 share a substantial relationship with the
CSA's purpose of preventing drug abuse and diversion.
---------------------------------------------------------------------------

Further, the Mississippi Board requires that a physician cannot
prescribe a controlled substance ``without a good faith prior
examination and medical indication therefore.'' Id. This obligation is
a continuing one; ``upon any encounter with a patient, in order to
establish proper diagnosis and regimen of treatment, a physician must
take three steps: (a) take and record an appropriate medical history,
(b) carry out an appropriate physical examination, and (c) record the
results.'' Id. (emphasis added). A physician's failure to complete
these three steps is conduct outside the ``course of legitimate
professional practice.'' Id. In fact, any violation of these rules is
considered conduct outside of the course of legitimate professional
practice, in violation of Section 73-25-29(3) of the Mississippi Code.
Miss. Code R. Sec. 30-17-2640:1.16.
The evidence establishes that, on four occasions, the Respondent
prescribed controlled substances to CI without writing any notes about
any prescriptions or examinations in CI's patient file. On May 22,
2014, the Respondent prescribed 40 units of Norco 10/325 to CI. GE-41,
at 4; GE-49, at 2. On June 17, 2014, the Respondent prescribed 40 units
of Norco 7.5/325 \46\ to CI. GE-41, at 6; GE-49, at 2. On September 11,
2014, the Respondent prescribed 40 units of Norco 10/325 to CI. GE-41,
at 20; GE-49, at 2. On December 4, 2014, the Respondent prescribed 180
units, or six ounces, of Hycodan to CI.\47\ GE-41, at 28; GE-49, at 1.
None of these four prescriptions were recorded in CI's medical file.
See GE-2, at 12-13. The Respondent did not document a diagnosis or
reason for prescribing to CI on any of these dates. The Respondent did
not write the names, doses, strengths, or quantities of these
prescriptions to CI in CI's medical record. The Respondent did not
record the dates of these prescriptions in CI's medical record. The
Respondent did not record any notes in CI's medical record about any
physical examinations on these dates.
---------------------------------------------------------------------------

\46\ Originally, the Government alleged that the Respondent
prescribed Norco 10/325 on June 17, 2014. See ALJ-1, at 2. However,
as the Government correctly noted in its post-hearing brief, the
Respondent prescribed Norco 7.5/325 on June 17, 2014. ALJ-35, at 6
n.1; see GE-41, at 6.
\47\ The record reflects some confusion concerning the date of
this prescription. GE-41, at 21, indicates it was written on
December 3, 2014, while GE-49, at 1, indicates it was written on
December 4, 2014. See supra note 19. Regardless of the one day
variance, the analysis is the same.
---------------------------------------------------------------------------

Because of the complete absence of this required information in
CI's patient file, the prescriptions that the Respondent wrote to CI on
these four dates were improper under Mississippi Administrative Rule
1.4. The Government's allegations that these four prescriptions to CI
violated Mississippi Administrative Rule 1.4 are SUSTAINED by a
preponderance of the evidence, and weigh in favor of the revocation
sought by the Government. Because these prescriptions violated
Mississippi Administrative Rule 1.4, these prescriptions were issued
outside of the course of the Respondent's legitimate professional
practice under Mississippi Administrative Rule 1.16. Further, there is
no evidence that the Respondent even saw CI on May 22, June 17,
September 11, or December 4 of 2014. Even absent expert testimony, the
DEA has held that a prescriber does not act in the usual course of
professional practice if the prescriber writes prescriptions to a
patient without first seeing the patient. Armando B. Figueroa, M.D., 73
Fed. Reg. 40380, 40381-82 (2008). Therefore, the Government's
allegations that the Respondent violated Mississippi Administrative
Rule 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR
Sec. 1306.04(a) on these four occasions are SUSTAINED by a
preponderance of the evidence, and weigh in favor of the revocation
sought by the Government.
On October 6, 2014, the Respondent prescribed 40 units of
alprazolam 1 mg, with one refill, to CI. GE-41, at 22; GE-49, at 1. In
CI's medical file, near a date stamp reading September 2, 2014, the
Respondent noted ``Xanax 1mg (#40, 1),'' but did not write any
justification for this prescription, as is required by Mississippi
Administrative Rule 1.4. See GE-2, at 12-13. The Respondent did not
write any notes anywhere in CI's patient file about a diagnosis of
anxiety or any of CI's alleged symptoms. See GE-2, at 12-13.
Additionally, CI's testimony and her PMP report indicate that, although
CI's psychiatrist prescribed a smaller dosage of alprazolam to her, the
Respondent increased CI's dosage without any noted justification. GE-
49, at 1; Tr. 225-26, 295, 304; see GE-2 (failing to justify an
increased dosage of alprazolam); see also GE-2, at 21 (documenting that
another registrant prescribed 7 units of alprazolam ER 0.5 mg to CI on
September 30, 2014, and that the Respondent then prescribed 40 units of
alprazolam 1 mg on October 6, 2014). Because the Respondent never
documented a reason for prescribing alprazolam to CI in her patient
file, the Government's allegation that the October 6, 2014 prescription
violated Mississippi Administrative Rule 1.4 is SUSTAINED by a
preponderance of the evidence, and weighs in favor of the revocation
sought by the Government. Because this prescription violated
Mississippi Administrative Rule 1.4, this prescription was issued
outside of the course of the Respondent's legitimate professional
practice under Mississippi Administrative Rule 1.16. Therefore, the
Government's allegations that the Respondent violated Mississippi
Administrative Rule 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and
(13), and 21 CFR Sec. 1306.04(a) by issuing the October 6, 2014
prescription are also SUSTAINED by a preponderance of the evidence, and
weigh in favor of the revocation sought by the Government.
The Government also alleged that the Respondent prescribed 40 units
of a hydrocodone product to CI on October 29, 2014. ALJ-1, at 2.
Although this alleged prescription is noted on CI's PMP report, see GE-
49, as Government counsel stated, ``PMPs are not without their flaws''
and are not ``necessarily accurate.'' Tr. 302-03. The Government
offered testimony from CI related to this alleged prescription. Tr.
369-70. CI was presented with a copy of this alleged prescription,
which she reviewed. Tr. 369-70. At the hearing, CI did not testify
about the prescription from her

[[Page 54841]]

personal recollection; she only looked at and read off of the copy of
the prescription presented to her. Tr. 369-70. I do not find that CI's
testimony proved the existence of the October 29 prescription. This
copy of the prescription was not offered into evidence.\48\ In sum, the
Government failed to offer substantial evidence that the Respondent
did, in fact, prescribe hydrocodone to CI on October 29, 2014 outside
of the course of his professional practice. Therefore, the Government's
allegations that the Respondent violated Mississippi Administrative
Rules 1.4 and 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13),
and 21 CFR Sec. 1306.04(a) by issuing an October 29, 2014 prescription
are NOT SUSTAINED.
---------------------------------------------------------------------------

\48\ See supra note 20.
---------------------------------------------------------------------------

Beyond the above-mentioned specific prescribing events, the
Government provided ample evidence that, throughout 2014, the
Respondent prescribed controlled substances to CI outside of the usual
course of his professional practice and without a legitimate medical
purpose. The DEA has held, even without the benefit of expert
testimony, that a controlled substance prescription based on a
patient's request ``rather than the result of the application of the
physician's medical judgment'' lacks a medical purpose. Robert M.
Golden, M.D., 61 Fed. Reg. 24808, 24812 (1996) (citing Robert L.
Dougherty, Jr., M.D., 60 Fed. Reg. 55047 (1995); Harland J.
Borcherding, D.O., 60 Fed. Reg. 28796 (1995)). Likewise, the
Mississippi Administrative Rules state that a prescriber lacks good
faith when he ``permit[s] the patient to name the drug desired'' or
``dispens[es] drugs to patients having no medical need, when the
physician knew or should have known that the patients were addicts.''
Miss. Code R. Sec. 30-17-2640:1.4.
It is true that, at times, the Respondent intended to treat CI's
medical conditions. GE-2, at 12-13; Tr. 215, 277-78, 287, 321. However,
even if the Respondent subjectively intended to provide legitimate
medical treatment to CI, ``[t]he appropriate focus is not on the
subjective intent of the doctor, but rather . . . whether the physician
prescribe[d] medicine `in accordance with [the accepted] standard of
medical practice.' '' United States v. Merrill, 513 F.3d 1293, 1306
(11th Cir. 2008) (quoting United States v. Moore, 423 U.S. 122, 139
(1975)). The Respondent's failure to perform and document physical
examinations of CI, and his failure to document his prescriptions to
CI, constitutes a significant failure to comply with Mississippi
medical standards, regardless of the Respondent's subjective intent.
Here, CI took Norco daily and recreationally, and the Respondent
gave prescriptions to CI upon her request. Tr. 297-99. The Respondent
gave prescriptions to CI at her house, at her children's appointments,
and in the garden section of Walmart. Tr. 26, 217-20. The Respondent
did not provide CI with a diagnosis or perform physical examinations
before giving these prescriptions to CI. See Tr. 217-18; see also GE-2,
at 12-13.
Importantly, the Respondent only made three entries in CI's patient
file in 2014, on February 21, April 21, and September 2, and he made no
entries in CI's patient chart in 2015. See GE-2, at 12-13. Neither
party presented any standard to evaluate the adequacy of the patient
file entries.\49\ Assuming that the file entries on those dates are
adequate, under Mississippi Administrative Rule 1.4, any prescriptions
that the Respondent issued to CI in 2014, other than on February 21,
April 21, and September 2, were issued outside of the Respondent's
professional practice. CI's PMP report indicates that CI may have
filled prescriptions written by the Respondent on 13 dates in 2014.\50\
I do not find that the PMP report, standing alone, constitutes
substantial evidence that these prescriptions existed, as discussed
supra. However, CI's credible, confident, and uncontested testimony
that she simply requested prescriptions from the Respondent ``for
fun,'' and that he would give them to her, considered in conjunction
with the PMP report, constitutes substantial evidence that the
Respondent prescribed controlled substances to CI in 2014 based on CI's
request rather than in the proper exercise of sound medical judgment.
On these grounds, the Government's allegations that the Respondent
violated Mississippi Administrative Rules 1.4 and 1.16, Mississippi
Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a) are
also SUSTAINED by a preponderance of the evidence, and weigh in favor
of the revocation sought by the Government.
---------------------------------------------------------------------------

\49\ CI's patient file is not entirely legible. See GE-2, at 12-
13. The February 21, 2014 entry reads: ``HC 7.5/325 (#40, 1)--may be
picked up at desk.'' GE-2, at 12. The April 21, 2014 entry reads:
``Headaches ? `Sinuses' Motion sickness Occasional vertigo Ears
clear OC/OP clear Nose mildly inflamed CT [rarr] clear and
thickening in L NF duct Rx Maxalt (one given) HC 10/325 (#40)
(refill).'' GE-2, at 12. The September 2, 2014 entry reads:
``Lexapro Maxalt prn has anxiety c migraines Migraine--usually
responsive to Maxalt, now c brea[illegible] Ears clean; [illegible]
in [supreg] EAC @[illegible] Nose clear OC/OP clear Counseled
[illegible] Rx Zofran Demerol 50 (#30) HC 10/325 (#40, 1)
Phentermine (refilled) Xanax 1mg (#40, 1).'' GE-2, at 12. These
three notations are the only entries in the Respondent's patient
file for CI during 2014.
\50\ Specifically, these dates are as follows: February 21,
April 9, May 19, May 22, June 17, July 19, July 24, September 2,
September 8, September 11, October 6, October 29, and December 4.
See GE-2, at 21-23; GE-49, at 1-3.
---------------------------------------------------------------------------

Allegation 2: Phentermine Prescriptions to CI
In Allegation 2, Government claimed that the Respondent prescribed
phentermine \51\ to CI without adequate documentation, in violation of
Mississippi Administrative Rule 1.5, Mississippi Code Sec. Sec. 73-25-
29(3) and (13), and 21 CFR Sec. 1306.04(a). ALJ-1, at 3. The
Government specifically alleged that this inappropriate prescribing
occurred on four occasions in 2014: April 9, for 30 dosage units; May
19, for 30 dosage units with one refill; July 24, for 30 dosage units;
and September 8, for 30 dosage units with two refills. ALJ-1, at 3.
---------------------------------------------------------------------------

\51\ Phentermine, or Adipex, is a Schedule IV controlled
substance. See Stip. 8.
---------------------------------------------------------------------------

The administration of weight loss medication is regulated by state
medical standards. See generally Wesley G. Harline, M.D., 65 Fed. Reg.
5665 (2000) (discussing, at length, general practice and state medical
standards for legitimately prescribing controlled substances for weight
loss). The Mississippi Board has a special standard of care for
practitioners who prescribe diet medication. See Miss. Code R. Sec.
30-17-2640:1.5; see also GE-8; Tr. 171-72. Specifically, Rule 1.5
requires a doctor prescribing weight loss drugs to: (1) only prescribe
adjunctively with caloric restriction; (2) conduct and thoroughly
record an initial comprehensive evaluation; (3) record a thorough
patient history and physical exam; (4) conduct an in-person re-
evaluation of the patient once every 30 days, recording the patient's
weight, BMI, blood pressure, pulse, and the results of all tests to
monitor adverse effects of the medication; and (5) maintain records
about the patient's weight loss efforts, dedication, responses,
contraindications, and adverse effects during treatment. Miss. Code R.
Sec. 30-17-2640:1.5. The patient's history and physical exam must, at
a minimum, document:
1. Past medical history, past surgical history, social history,
family history, weight history, dietary history, gynecological (GYN)
history if female, review of systems, allergies and medications.
2. Height, weight, Body Mass Index (BMI), blood pressure, pulse, %
body fat or waist circumference/weight hip ratio, HEENT, chest, heart,
abdomen, extremities.

[[Page 54842]]

3. Appropriate testing related to medical weight loss . . . .

Id.

The Government presented evidence that the Respondent wrote four
prescriptions for phentermine to CI. On April 9, 2014, the Respondent
prescribed 30 units of Adipex 37.5 to CI. GE-7, at 1-2; GE-49, at 2. On
May 19, 2014, the Respondent prescribed 30 units of Adipex 37.5, with
one refill to CI. GE-7, at 3-4; GE-41, at 2-3; GE-49, at 2. On July 24,
2014, the Respondent prescribed 30 units of Adipex 37.5 to CI. GE-7, at
5-6; GE-41, at 12-13; GE-49, at 2. On September 8, 2014, the Respondent
prescribed 30 units of phentermine 37.5 with two refills to CI. GE-7,
at 7-8; GE-41, at 18-19; GE-49, at 2. During 2014, CI filled these
prescriptions seven times. GE-49, at 1-2.
In the administrative record, there are only four notations in the
Respondent's files related to phentermine, Adipex, or weight loss
prescriptions. The first mention of phentermine is in the Respondent's
patient file for Kid 1 near a date stamp reading February 4, 2014. GE-
57, at 6; Tr. 286. That note reads, ``Mother has migraines ? in
children May call in Rx if needed. Discussed phentermine c mother May
consider this as well.'' GE-57, at 6. The second time phentermine was
mentioned was in a March 19, 2014 entry in Kid 1's patient file. That
note reads, ``Discussed [illegible] medications c mother Rx [illegible]
Phentermine 37.5.'' GE-57, at 5; Tr. 286. The third mention of
phentermine, and the first in the Respondent's patient file for CI, is
dated July 18, 2014. GE-2, at 15. This third mention is on a patient
telephone request form, which indicated that CI called the Respondent
to ask about a refill of ``phentermine 37.5 (#30, 2)'' for her to
``pick up at front.'' GE-2, at 15. The final mention of phentermine,
and the only one contained in the Respondent's treatment notes of CI,
is dated September 2, 2014. GE-2, at 12. This last entry simply reads,
``Phentermine (refilled).'' GE-2, at 12.
Accordingly, while prescribing phentermine to CI on April 9, May
19, July 24, and September 8, the Respondent completely failed to
comply with the requirements of Mississippi Administrative Rule 1.5.
The Respondent never prescribed phentermine adjunctively with caloric
restriction. He never conducted and recorded an initial comprehensive
evaluation. He never recorded a thorough patient history or physical
examination. He never conducted an in-person re-evaluation of CI once
every 30 days. He never recorded CI's, BMI, blood pressure, pulse, past
medical history, social history, family history, dietary history,
gynecological history, height, weight, or body measurements. He did not
document CI's efforts to lose weight or note her response to treatment.
A prescriber lacks good faith if he prescribes controlled
substances to a patient who the prescriber knew or should have known
had no legitimate medical need for the controlled substances
prescribed. Miss. Code R. Sec. 30-17-2640:1.4. It is concerning that
the Respondent wholly failed to document any justification whatsoever
for CI's supposed need for weight loss medication. During 2014, CI went
from 135 pounds down to 121 pounds. Tr. 224. At the hearing, CI
presented with a slender body type. After observing CI's appearance, I
find it difficult to comprehend, from even a layman's perspective, how
the Respondent could have possibly believed that CI had a high enough
BMI \52\ to justify the administration of weight loss medication.
---------------------------------------------------------------------------

\52\ See Miss. Code R. Sec. 30-17-2640:1.5(A)(4) (requiring
generally a BMI of greater than 30.0 in a normal, otherwise healthy
patient to justify prescribing weight loss drugs); see also Minnix
v. Colvin, No. 2:12CV00038, 2014 WL 618688, at *3 n.3 (W.D. Va. Feb.
18, 2014) (defining a BMI of 30 or higher as obesity) (citing Nat'l
Inst. of Health, Calculate Your Body Mass Index, http://www.nhlbi.nih.gov/guidelines/obesity/BMI/bmicalc.htm (last visited
May 18, 2016)).
---------------------------------------------------------------------------

The Respondent displayed a complete disregard for Mississippi's
weight loss prescription requirements. He prescribed weight loss drugs
to CI without any documented medical justification. GE-2, at 12-13.
``[W]here a medical record contains no findings that support a
diagnosis, . . . expert testimony is not necessary to conclude that a
prescription lacked a legitimate medical purpose.'' McNichol, 77 Fed.
Reg. at 57151 (citations omitted). Therefore, the Government's
allegations that the Respondent violated Mississippi Administrative
Rule 1.5, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR
Sec. 1306.04(a), by prescribing phentermine to CI on April 9, May 19,
July 24, and September 8 of 2014 are SUSTAINED by a preponderance of
the evidence, and weigh in favor of the revocation sought by the
Government.
The Respondent argued in his post-hearing brief that, after
receiving the Mississippi Board's warning letter, he refused to
prescribe weight loss medication to an undercover agent. ALJ-34, at 6.
The Respondent argued that this refusal showed that he ``came promptly
into conformity'' with Mississippi's weight loss medication prescribing
standards. ALJ-34, at 6. However, even if the Respondent took remedial
measures, those measures, standing alone, cannot rebut the Government's
prima facie case for revocation unless the Respondent also accepted
responsibility for his actions. See Michael S. Moore, M.D., 76 Fed.
Reg. 45867, 45868 (2011); Hassman, 75 Fed. Reg. at 8236. The Respondent
did not testify and did not accept responsibility. Accordingly, the
Respondent failed to rebut the Government's prima facie case for
revocation based upon his violation of state regulations that detail
the requirements for prescribing weight loss medication.
Allegation 3: Prescribing to CI's Children: Physical Examinations,
Propriety of Prescriptions, and True Intended Recipient
In Allegation 3, the Government claimed that, from February 7 to
November 19 of 2014, the Respondent prescribed hydrocodone products to
CI's children without conducting examinations, and that the
prescriptions were for CI's personal use, in violation of Mississippi
Administrative Rules 1.4, 1.10, 1.11(b),\53\ and 1.16, Mississippi Code
Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec. 1306.04(a) and
1306.05(a). ALJ-1, at 2-3. Mississippi Administrative Rule 1.10
requires that a prescription for a controlled substance contain ``the
complete name and address of the patient to whom the physician is
prescribing the controlled substance.'' Miss. Code R. Sec. 30-17-
2640:1.10. Likewise, 21 CFR Sec. 1306.05(a) requires that a controlled
substance prescription must ``bear the full name and address of the
patient.''
---------------------------------------------------------------------------

\53\ For the reasons previously discussed, supra note 44, the
Government's allegation that the Respondent violated Mississippi
Administrative Rule 1.11(b) is NOT SUSTAINED.
---------------------------------------------------------------------------

Additionally, the Government alleged that the Respondent prescribed
hydrocodone-homatropine (``cough'') syrup, or Hycodan, to CI's
children, who were under the age of six, even though cough syrup is not
recommended for children under the age of six because of a risk of
death. ALJ-1, at 3. The Government alleged that the Respondent
prescribed adult dosages of this cough syrup to these children, even
though the recommended dosage for children aged six to eleven is half
of the adult dosage. ALJ-1, at 2-3.
The Government further alleged that the Respondent issued the
following improper prescriptions for hydrocodone combination products
to CI's children in

[[Page 54843]]

2014: (a) to Kid 2 on February 7, for 150 dosage units, with one
refill; (b) to Kid 1 on June 17, for 180 dosage units, with one refill;
(c) to Kid 2 on July 23, for 480 dosage units; (d) to Kid 2 on
September 2, for 120 dosage units; (e) to Kid 2 on November 3, for 180
dosage units; and (f) to Kid 1 on November 19, for 115 dosage units.
ALJ-1, at 2-3.

A. The February 7 Prescription

On February 7, 2014, the Respondent wrote a prescription for 240
units of Hycodan to Kid 2. GE-50, at 1; GE-55, at 1-2. The Respondent's
medical file for Kid 2 appeared to contain a notation from 2014,
possibly from February 7, documenting a Hycodan prescription. See GE-
56, at 4. The copy of the medical file partially cut off this notation
because it was at the bottom of a copied page. See GE-56, at 4. The
only legible part of the notation appears to read, ``Hycodan (8 oz, 2
refills) to Brookhaven Walmart.'' See GE-56 at 4.
CI testified that the Respondent did not examine Kid 2 before
prescribing cough syrup to her in February. Tr. 217, 251. The
Respondent's patient file for Kid 2 does not include any notes about
any physical examination on that date. The Respondent did not document
a diagnosis for Kid 2 on that date. Because this required information
was not recorded prior to prescribing controlled substances to Kid 2,
the Government's allegation that the Respondent violated Mississippi
Administrative Rule 1.4 by failing to conduct a physical examination of
Kid 2 is SUSTAINED by a preponderance of the evidence, and weighs in
favor of the revocation sought by the Government. Because this
prescription violated Mississippi Administrative Rule 1.4, it was
issued outside of the course of the Respondent's legitimate
professional practice under Mississippi Administrative Rule 1.16.
Therefore, the Government's allegations that the Respondent violated
Mississippi Administrative Rule 1.16, Mississippi Code Sec. Sec. 73-
25-29(3) and (13), and 21 CFR Sec. 1306.04(a) on February 7, 2014, are
also SUSTAINED by a preponderance of the evidence, and weigh in favor
of the revocation sought by the Government.
Just 15 days before the February 7, 2014 prescription, the
Respondent prescribed 120 units (or 24 days' worth) of Hycodan syrup to
Kid 2. See GE-50, at 1; GE-56, at 4. Thus, Kid 2 still should have had
approximately nine days of Hycodan syrup remaining from her last
prescription and should not have needed additional Hycodan syrup on
February 7, much less double the original dosage. See GE-50, at 1
(showing that the January 24, 2014 prescription was a 24-day supply).
CI discussed the real reason that the Respondent wrote this
prescription. CI testified that, in February 2014, the Respondent
prescribed a big bottle of cough syrup to Kid 2 so that CI could drink
it as well, even though the Respondent knew that CI did not have a
cough. Tr. 216-17, 250-53, 259, 268, 273. While Kid 2 did have a cough
at that time, Tr. 250-51, 253-55, I give full credit to CI's testimony
that the Respondent knew that CI intended to consume some of Kid 2's
Hycodan prescription. Considering the timing of the February 7
prescription and its large dosage, I find, based on a totality of the
circumstances, that a preponderance of evidence supports the conclusion
that the Respondent knew that CI would consume at least part of Kid 2's
February 7, 2014 prescription. It is a violation of 21 CFR Sec.
1306.05 for a registrant to prescribe controlled substances to a
patient knowing that someone other than the patient named on the
prescription would receive the medication. Golden, 61 FR at 24811.
Therefore, the Government's allegations that the February 7, 2014
prescription violated Mississippi Administrative Rule 1.10 and 21 CFR
Sec. 1306.05(a) are SUSTAINED by a preponderance of the evidence, and
weigh in favor of the revocation sought by the Government.

B. The June 17, July 23, and November 19 Prescriptions

The Respondent wrote three prescriptions to CI's children without
recording the prescriptions in the children's medical records. First,
on June 17, 2014, the Respondent wrote a prescription for six ounces
(or 180 units) of Hycodan syrup to Kid 1. GE-51, at 1; GE-55, at 3-4.
The Respondent's patient file for Kid 1 does not contain any notes
dated on or about \54\ June 17, 2014. See GE-57. The Respondent did not
document a diagnosis for Kid 1 at this time. Then, on July 23, 2014,
the Respondent wrote a prescription for 16 ounces (or 480 units) of
Hycet liquid to Kid 2. GE-50, at 1; GE-55, at 5-6. The Respondent's
patient file for Kid 2 does not contain any notes dated on or about
July 23, 2014. See GE-56. Finally, on November 19, 2014, the Respondent
wrote a prescription for eight ounces (or 115 units) of Hycodan for Kid
1. GE-51, at 1; GE-55, at 11. The Respondent's patient file for Kid 1
does not contain any notes on or about November 19, 2014. See GE-56.
---------------------------------------------------------------------------

\54\ Although the Respondent's patient file for Kid 1 includes
notes from examinations on March 19, 2014, and June 9, 2014, the
notes next to these dates do not contain any notations about a
Hycodan prescription. See GE-57.
---------------------------------------------------------------------------

The Respondent did not write the name, dose, strength, or quantity
of any of these prescriptions in the medical records of CI's children.
The Respondent did not record the dates of the prescriptions or the
reasons for the prescriptions. The Respondent did not record any notes
about any physical examinations on these dates. There is no evidence in
the record before me indicating that the Respondent ever saw CI's
children on the dates that he wrote these prescriptions to them. Even
absent any expert testimony, failure to see a patient before
prescribing medications to the patient is outside of the legitimate
practice of medicine. Figueroa, 73 FR at 40381. Therefore, the
Government's allegations that the June 17, 2014, and November 19, 2014
prescriptions to Kid 1, and July 23, 2014 prescription to Kid 2,
violated Mississippi Administrative Rule 1.4 are SUSTAINED by a
preponderance of the evidence, and weigh in favor of the revocation
sought by the Government. Because these prescriptions violated
Mississippi Administrative Rule 1.4, they were issued outside of the
course of the Respondent's legitimate professional practice under
Mississippi Administrative Rule 1.16. Therefore, the Government's
allegations that the Respondent violated Mississippi Administrative
Rule 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR
Sec. 1306.04(a) by issuing the June 17, July 23, and November 19
prescriptions are SUSTAINED by a preponderance of the evidence, and
weigh in favor of the revocation sought by the Government.
The Government further alleged that these prescriptions were issued
for CI's personal use. The Government bears the burden of proof on this
point. The administrative record in this case supports the conclusion
that the Government established, by a preponderance of the evidence,
that the Respondent knew that CI would consume at least part of the
cough syrup he prescribed to CI's children on June 17, July 23, and
November 19. In this regard, CI testified that: (1) she would tell the
Respondent when her child would have a cough; (2) she never brought her
children to see the Respondent regarding a cough; (3) she requested
cough syrup from the Respondent because she enjoyed drinking it; and
(4) she would request a big bottle of cough syrup. Tr. 220, 265-66,
273. In addition, the administrative record supports CI's testimony
that she did not bring her children to see the Respondent regarding a
cough, as evidenced by their medical charts. GE-

[[Page 54844]]

56, at 2-4; GE-57, at 5-6. I find that CI's testimony, when considered
cumulatively and in conjunction with other evidence of record,
establishes that, at the time the Respondent wrote the June 17, July
23, and November 19 prescriptions, he knew that CI would drink at least
some of the cough syrup, though there was no medical reason for her to
do so. Therefore, the Government's allegations that these three
prescriptions violated Mississippi Administrative Rule 1.10 and 21 CFR
Sec. 1306.05(a) are SUSTAINED by a preponderance of the evidence, and
weigh in favor of the revocation sought by the Government.

C. The September 2 and November 3 Prescriptions

On September 2, 2014, the Respondent wrote a prescription for four
ounces (or 120 units) of Hycodan for Kid 2. GE-50, at 1; GE-55, at 7-8.
The Respondent's patient file for Kid 2 included some notes dated
September 2, 2014. GE-56, at 3. These notes stated, ``URI Ears clear
Nose, OC/OP mildly inflamed Lungs clear Rx [illegible] 15 Hycodan.''
GE-56, at 3. Because these notes indicate that the Respondent examined
Kid 2, and because the Government did not enter any evidence contesting
the accuracy of these notes, I find that the Government failed to show
by substantial evidence that the Respondent did not conduct a physical
examination of Kid 2 on September 2, and the Government's allegation to
that effect is NOT SUSTAINED. However, Kid 2's medical record did not
include any diagnosis or reason for prescribing Hycodan to Kid 2, as
required by Mississippi Administrative Rule 1.4. Additionally, the
medical record did not clearly include the dose, strength, or quantity
of Hycodan prescribed to Kid 2, as required by Mississippi
Administrative Rule 1.4. Because the medical record did not contain
this information, the Government's allegation that the September 2,
2014 prescription to Kid 2 violated Mississippi Administrative Rule 1.4
is SUSTAINED by a preponderance of the evidence, and weighs in favor of
the revocation sought by the Government. Because this prescription
violated Mississippi Administrative Rule 1.4, it was issued outside of
the course of the Respondent's legitimate professional practice under
Mississippi Administrative Rule 1.16. Therefore, the Government's
allegations that the Respondent violated Mississippi Administrative
Rule 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR
Sec. 1306.04(a) by issuing the September 2, 2014 prescription are also
SUSTAINED by a preponderance of the evidence, and weigh in favor of the
revocation sought by the Government.
Similarly, on November 3, 2014, the Respondent wrote a prescription
for six ounces (or 180 units) of Hycodan for Kid 2. GE-50, at 1; GE-55,
at 9-10. The Respondent wrote a note near a date stamp reading November
4, 2014, in Kid 2's file. GE-56, at 2. This note said, ``[illegible] 5
problems Rx Hycodan (6 oz) (requested).'' GE-56, at 2. The medical
record did not include documentation of a diagnosis and reason for
prescribing controlled substances, other than the fact that it was
``requested.'' Moreover, the medical record did not include the dosage
or strength of the Hycodan prescribed, as is required by Mississippi
Administrative Rule 1.4. Further, the notes near the November 3, 2014
date stamp did not indicate that the Respondent conducted any
examination prior to prescribing Hycodan to Kid 2, as is required by
Mississippi Administrative Rule 1.4. Therefore, the Government's
allegation that the November 3, 2014 prescription to Kid 2 violated
Mississippi Administrative Rule 1.4 is SUSTAINED by a preponderance of
the evidence, and weighs in favor of the revocation sought by the
Government. Because this prescription violated Mississippi
Administrative Rule 1.4, it was issued outside of the course of the
Respondent's legitimate professional practice under Mississippi
Administrative Rule 1.16. Therefore, the Government's allegations that
the Respondent violated Mississippi Administrative Rule 1.16,
Mississippi Code Sec. Sec. 73-25-29(3) and (13), and 21 CFR Sec.
1306.04(a) by issuing the November 3, 2014 prescription are also
SUSTAINED by a preponderance of the evidence, and weigh in favor of the
revocation sought by the Government.
The Government also alleged that the September 2 and November 3
prescriptions were issued for CI's personal use. The Government bears
the burden of proof on this point. The administrative record in this
case supports the conclusion that the Government established, by a
preponderance of the evidence, that the Respondent knew that CI would
consume at least part of the cough syrup he prescribed to CI's children
on September 2 and November 3. In this regard, CI testified that: (1)
she would tell the Respondent when her child would have a cough: (2)
she never brought her children to see the Respondent regarding a cough;
(3) she requested cough syrup from the Respondent because she enjoyed
drinking it; and (4) she would request a big bottle of cough syrup. Tr.
220, 266, 273. In addition, the administrative record supports CI's
testimony that she did not bring her children to see the Respondent
regarding a cough, as evidenced by their medical charts. GE-56, at 2-4;
GE-57, at 5-6. I find that CI's testimony, when considered cumulatively
and in conjunction with other evidence of record, establishes that, at
the time the Respondent wrote the September 2 and November 3
prescriptions, he knew that CI would drink at least some of the cough
syrup, though there was no medical reason for her to do so. Therefore,
the Government's allegations that these two prescriptions violated
Mississippi Administrative Rule 1.10 and 21 CFR 1306.05(a) are
SUSTAINED by a preponderance of the evidence, and weigh in favor of the
revocation sought by the Government.

D. Dangerous Prescriptions

The Government alleged that the Respondent prescribed cough syrup
to CI's children, who were under the age of six, even though cough
syrup is not recommended for children under the age of six because of a
risk of death. ALJ-1, at 3. The Government also alleged that the
Respondent prescribed adult dosages of cough syrup to these children,
even though the recommended dosage for children aged six to eleven is
half of the adult dosage. ALJ-1, at 2-3.
There is no evidence on the record before me \55\ that indicates
that it is improper to prescribe cough syrup to children. There is no
evidence on the record before me that indicates that the dosages of
cough syrup that the Respondent prescribed to CI's children were
improper dosages. The Government did not offer an authentic, well-
founded medical opinion that the quantities and types of prescriptions
to CI's children were improper. The Government had the burden of
proving that the prescriptions were unlawful. See Ruben, 78 FR at
38384. The Government failed to meet this burden. Accordingly, the
Government's allegations regarding the propriety of the Respondent's
prescriptions to CI's children are NOT SUSTAINED.
---------------------------------------------------------------------------

\55\ The Government offered into evidence three printouts from
Web sites, allegedly obtained from the FDA's Web site, WebMD, and
Drugs.com. See Gov't Proposed Exs. 4-6. Upon the Respondent's timely
objection, I rejected these three exhibits because they were
improper opinion testimony, lacked adequate foundation, and were not
properly authenticated. See Tr. 418-26.

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[[Page 54845]]

Allegation 4: Fraudulent Prescriptions for CI through Undercover Agents
\56\
---------------------------------------------------------------------------

\56\ In its post-hearing brief, the Government argued that this
conduct should be analyzed under Factor Five. ALJ-35, at 21-24.
However, in the Government's OSC/ISO and its presentation of
evidence at the hearing, the Government made a strong argument that
the Respondent's prescriptions to the undercover agents violated
state and federal laws, and were acts of knowing diversion which
reflected poorly on the Respondent's experience in dispensing
controlled substances. Therefore, analysis of this conduct under
Factors Two and Four is appropriate.
---------------------------------------------------------------------------

In Allegation 4, the Government claimed that, on five occasions
between March and October 2015, the Respondent prescribed controlled
substances to undercover agents when he knew or should have known that
the agents' prescription requests were fraudulent, in violation of 21
U.S.C. Sec. Sec. 841(a) and 842(a) and 21 CFR Sec. 1306.04(a). ALJ-1,
at 3. The Government alleged that the Respondent wrote seven
hydrocodone prescriptions on five occasions to undercover agents, for
190 total dosage units of hydrocodone tablets and 72 total dosage units
of hydrocodone syrup. ALJ-1, at 11. The Government alleged that, on
four of those occasions, the Respondent knew that CI would receive a
portion of the prescribed medications. ALJ-1, at 3-4.

A. Undercover Appointments 1 through 4

The evidence against the Respondent regarding the first four
undercover appointments is significant, conclusive, and uncontested.
The Respondent compared his diversion of drugs to CI with going to
``buy drugs at a crack house.'' GE-28, file 2015-04-22_13-03-23_EDT, at
2. In some sense, this was an apt description. Whenever CI asked the
Respondent for drugs, he would attempt to convey them to her. Prior to
each of the first four undercover appointments, CI clearly and
repeatedly asked the Respondent for controlled substances.\57\ CI
specifically named certain controlled substances that she wanted the
Respondent to prescribe to Agent 1 and Agent 2 to divert to her.\58\
Although the Respondent wanted to be ignorant about the identities of
CI's ``friends,'' \59\ the Respondent knew that Agent 1 and Agent 2
were ``friends'' of CI \60\ and that they would give CI at least some
of the drugs he prescribed to them.\61\ The Respondent had reason to
know that Agent 1 and Agent 2 did not legitimately need medication for
themselves.\62\ The Respondent had reason to know that Agent 1, Agent
2, and CI were splitting their prescriptions.\63\ Therefore, based on
the communications exchanged between the Respondent and CI, I find that
the Respondent knew that Agent 1 and Agent 2 were ``not seeking
treatment for a legitimate medical condition but [were] engaged in . .
. diversion.'' See McNichol, 77 FR at 57148. Despite circumstances that
plainly and unambiguously indicated diversion, the Respondent
nonetheless prescribed drugs to Agent 1 and Agent 2 during the first
four undercover appointments.
---------------------------------------------------------------------------

\57\ GE-16, file 2015-03-16_18-51-48_EDT, at 20-21, 24-26
(expressing that CI was seeking drugs before the first undercover
appointment); GE-16, file 2015-03-18_11-03-33_EDT, at 2 (same); GE-
17, at 4 (same); see GE-16, file 2015-04-02_14-15-50_EDT, at 1
(expressing that CI was seeking drugs before the second undercover
appointment, and indicating that she had taken all of the drugs from
the first appointment too quickly); see also GE-28, file 2015-04-
13_20-26-31_EDT, at 7 (expressing that CI was seeking more drugs
before the third and fourth undercover appointments); GE-28, file
2015-04-28_20-23-38_EDT, at 1 (same); GE-38, at 2-3 (same).
\58\ GE-16, file 2015-03-17_13-07-36_EDT, at 4 (asking for
Lorcet/Norco before the first undercover appointment); GE-17, at 3
(same); GE-18, at 3 (asking for Norco before the first undercover
appointment); see GE-16, file 2015-04-02_15-04-43_EDT, at 1-2
(asking for a double dosage, presumably of Norco, before the second
undercover appointment); see also GE-28, file 2015-04-28_20-23-
38_EDT, at 1 (asking for cough medicine before the third and fourth
undercover appointments); GE-29, at 7 (same); GE-38, at 3-4 (asking
for a ``big bottle'' of cough syrup before the third and fourth
undercover appointments); GE-39, at 5 (asking for cough medicine
before the third and fourth undercover appointments).
\59\ GE-28, file 2015-04-22_13-03-23_EDT, at 4-5 (expressing his
desire to remain ignorant before the third and fourth undercover
appointments); GE-28, file 2015-04-27_14-45-16_EDT, at 1 (same); GE-
38, at 2 (same). The Respondent even stated at one point, ``if
[Agent 1 is] coming in for what I think she's coming in, tell her
not to tell me that. That needs to be your secret. I don't wanna
know that. She needs to have a headache and I will treat her for a
headache, and so don't mind giving her prescriptions to treat a
headache.'' GE-17, at 7.
\60\ GE-16, file 2015-04-07_13-29-34_EDT, at 2 (discussing CI
accompanying Agent 1 to her appointment); GE-16, file 2015-04-07_18-
28-45_EDT, at 7-8 (same); GE-16, file 2015-04-08_10-16-03_EDT, at 1
(saying that Agent 1 knew about their relationship); GE-17, at 6-7
(identifying Agent 1 before the first undercover appointment); GE-
21, at 5-6 (identifying Agent 1 before the second undercover
appointment); see GE-21, at 8 (asking the Respondent to bring Agent
1's prescriptions to his rendezvous with CI at Walmart to save her
money); see also GE-28, file 2015-04-22_13-03-23_EDT, at 4-5
(recognizing Agent 1 as CI's friend before the third and fourth
undercover appointments); GE-28, file 2015-04-28_20-23-38_EDT, at 1
(identifying Agent 1 and Agent 2 as CI's friends before the third
and fourth undercover appointments); GE-40, at 2 (recognizing that,
at the time of Agent 2's appointment, the Respondent knew that Agent
2 was affiliated with CI and Agent 1).
\61\ GE-16, file 2015-03-18_11-03-33_EDT, at 2-4 (suggesting
that CI could send a friend in to get prescriptions before the first
undercover appointment); GE-17, at 3 (same, and acknowledging,
before the first undercover appointment, that any prescriptions to
CI's friends would be diverted to CI); GE-17, at 7 (advising that
the prescriptions he gave to Agent 1 would be fine for CI to take);
GE-18, at 3 (stating, before the first undercover appointment, that
the Respondent would write prescriptions for Agent 1 so CI could
have the medication); see GE-14, at 1 (identifying Agent 1 as CI's
friend, and discussing how the Respondent ``hooked [CI] up,'' before
the second undercover appointment); GE-16, file 2015-04-02_14-15-
50_EDT, at 1-2 (same); GE-21, at 13 (thanking the Respondent for
``hooking'' her up before the second undercover appointment); GE-28,
file 2015-04-28_20-23-38_EDT, at 1 (asking the Respondent to
``[h]ook'' up CI's friend before the third and fourth undercover
appointments).
\62\ E.g., GE-16, file 2015-04-02_14-15-50_EDT, at 2; GE-16,
file 2015-04-02_15-04-43_EDT, at 1-2.
\63\ GE-28, file 2015-04-27_14-45-16_EDT, at 1.
---------------------------------------------------------------------------

Even beyond this, the Respondent took extra efforts to facilitate
the diversion of drugs to CI. The Respondent discussed the scheduling
of Agent 1 and Agent 2's appointments with CI, and CI reminded him
about the timing of those appointments.\64\ The Respondent asked CI to
tell her friends to pretend they had headaches and act like legitimate
patients.\65\ After the third and fourth undercover appointments, the
Respondent praised Agent 1 and Agent 2 for acting very appropriately by
going ``through the motions.'' GE-40, at 2. After each of the first
four appointments, CI told the Respondent that she had received the
drugs prescribed to Agent 1 and Agent 2; in response, the Respondent
stated that he was happy to help get drugs to CI.\66\
---------------------------------------------------------------------------

\64\ GE-18, at 3 (discussing the first undercover appointment);
GE-23 (discussing, before the second undercover appointment, the
need to space out the appointments more); see GE-16, file 2015-04-
06_20-59-35_EDT, at 2 (discussing the second undercover
appointment); see also GE-28, file 2015-04-22_10-28-41_EDT, at 3-4
(discussing the third and fourth undercover appointments); GE-28,
file 2015-04-22_13-03-23_EDT, at 4 (same); GE-28, file 2015-04-
28_20-23-38_EDT, at 1 (same); GE-29, at 7 (same).
\65\ GE-18, at 3 (instructing CI to tell Agent 1 to ``play it
straight'' and tell him what he needed to write in his chart at the
first undercover appointment).
\66\ GE-14, at 1 (telling CI, after the first undercover
appointment, that he was happy to meet Agent 1 and hoped it helped,
and receiving thanks from CI for ``hooking'' her up); GE-14, at 2
(acknowledging that the prescriptions that he gave to Agent 1 went
to CI); GE-19, at 1 (asking CI if everything ``went smooth with
getting your medication'' and expressing that he was happy to help);
GE-40, at 1-2 (asking CI if she got the medication and expressing
that he was ``glad all that worked out'').
---------------------------------------------------------------------------

It is true that the Respondent conducted appointments with Agents 1
and 2, and wrote notes in their medical files. In that aspect, this
case is similar to Robert F. Hunt, D.O., 75 FR 49995 (2010). Dr. Hunt
had said that he wrote information on a patient's chart ``just to cover
[his] ass.'' Id. at 50003. The DEA held that this statement made it
``clear that [Dr. Hunt] knew that he lacked a legitimate medical
purpose for prescribing'' controlled substances. Id. Similarly,
although the Respondent

[[Page 54846]]

conducted appointments with Agents 1 and 2 and wrote notes in their
medical files, the Respondent's statements to CI before and after each
of the first four appointments made it clear that the Respondent was
unquestionably prescribing controlled substances to Agents 1 and 2 to
intentionally divert drugs to CI. His statements also make clear that
the records he was keeping concerning Agents 1 and 2 were merely to
keep the Mississippi Board investigators at bay. E.g., GE-18, at 3.
Moreover, the fact that a registrant conducted a medical
appointment before prescribing controlled substances does not, standing
by itself, validate the prescriptions issued; rather, an appointment
may be used by a prescriber as ``a sham justification to support an
unlawful prescription.'' McNichol, 77 Fed. Reg. at 57148. An
appointment can constitute a perfunctory, sham examination if the
registrant ``already agreed to issue'' certain prescriptions to a
patient. Darryl J. Mohr, M.D., 77 Fed. Reg. 34998, 35000 (2012).
This is precisely what happened here. Before each of the first four
undercover appointments, the record unambiguously shows that the
Respondent knew exactly what he would prescribe to Agents 1 and 2
before they ever walked through his door, because he knew what drugs CI
had requested. For example, the Respondent prescribed Hycodan to Agent
1, even though she was not coughing during her appointment, because he
had told CI that he would get eight ounces of cough syrup to her. GE-
33, at 1; GE-38, at 3-4, 8; Tr. 113. Following the second appointment,
the Respondent himself acknowledged the sham nature of the appointment;
he stated that he had made small talk with Agent 1 because ``we had to
be in there more than ten seconds'' so that his ``nosy nurse'' would
not think, ``[d]ang, why is this appointment over with in ten
seconds?'' GE-27, at 1, 5. It is not surprising that, during Agent 1's
second appointment, the Respondent did not bother to conduct even a
sham physical examination. See GE-24-25; Tr. 103-04, 132.
The facts of this case present an appalling and flagrant disregard
of a registrant's duty to prescribe controlled substances only to
legitimate patients. While the Respondent told CI that his feelings for
her needed to be ``totally separate from [his] medical practice,'' GE-
20, he was unable to follow his own internal guidance. In fact, the
size of the Respondent's diversion was significant: during the first
four undercover appointments, the Respondent prescribed a total of 160
units of Norco and eight ounces of Hycodan to the undercover agents,
who he believed would divert those drugs to CI.\67\ The Respondent
repeatedly joked about providing CI access to all the drugs that she
wanted.\68\ Even though the Respondent did not take his
responsibilities as a registrant seriously, he did understand the
potential legal consequences of his actions. The Respondent repeatedly
expressed a fear of getting in trouble for diverting drugs to CI.\69\
This reflects that the Respondent undoubtedly knew that his actions
were wrong.\70\
---------------------------------------------------------------------------

\67\ GE-11, at 1 (prescribing 40 units of Norco 10/325 to Agent
1 at the first undercover appointment); GE-26, at 1 (prescribing 40
units of Norco 10/325 to Agent 1 at the second undercover
appointment); GE-32 (prescribing 40 units of Norco 10/325 to Agent 1
at the third undercover appointment); GE-33, at 1 (prescribing eight
ounces of Hycodan to Agent 1 at the third undercover appointment);
GE-36, at 1 (prescribing 40 units of Norco 10/325 to Agent 2 at the
fourth undercover appointment).
\68\ GE-16, file 2015-03-17_13-07-36_EDT, at 7 (joking before
the first undercover appointment); GE-16, file 2015-03-18_11-03-
33_EDT, at 4 (same); GE-16, file 2015-04-02_15-04-43_EDT, at 1-2
(joking before the second undercover appointment); GE-29, at 9
(joking after the third and fourth undercover appointments); GE-38,
at 2 (joking before the third and fourth undercover appointments).
\69\ GE-16, file 2015-03-17_13-07-36_EDT, at 7 (admitting fear
before the first undercover appointment); GE-16, file 2015-04-02_14-
15-50_EDT, at 2 (instructing CI to keep things hidden); GE-17, at 2
(expressing fear before the first undercover appointment); see GE-
14, at 1 (expressing fear after the first undercover appointment);
GE-16, file 2015-04-02_15-04-43_EDT, at 2 (discussing avoiding
detection before the second undercover appointment); GE-16, file
2015-04-07_13-29-34_EDT, at 2 (same); GE-16, file 2015-04-07_18-28-
45_EDT, at 7-8 (same); see also GE-28, file 2015-04-22_10-28-41_EDT,
at 3-4 (expressing concern about getting caught before the third and
fourth undercover appointments); GE-28, file 2015-04-22_13-03-
23_EDT, at 4 (same); GE-38, at 2 (same).
\70\ See GE-16, file 2015-03-18_11-03-33_EDT, at 2-3 (reflecting
his knowledge that his actions were wrongful before the first
undercover appointment); GE-38, at 8 (expressing his fear that he
might be ``busted'' by the ``drug police'').
---------------------------------------------------------------------------

I find that, during the first four undercover appointments, the
Respondent knew that Agent 1 and Agent 2 were not real patients and
that at least some of the medications he prescribed to them would be
given to CI. I find that the Respondent prescribed medications to Agent
1 and Agent 2 upon CI's request for those medications. I further find
that, when the Respondent wrote prescriptions to Agent 1 and Agent 2
during those four appointments, the Respondent intended to divert drugs
to CI. Thus, by ``providing evidence showing that [the Respondent]
knowingly diverted drugs,'' the Government proved that the Respondent
acted outside of the usual course of his professional practice and
lacked a legitimate medical purpose. See Danton, 76 Fed. Reg. at 60901.
Therefore, the Government's allegations that the first four undercover
appointments violated 21 U.S.C. Sec. Sec. 841(a) and 842(a), and 21
CFR Sec. 1306.04(a) are SUSTAINED by a preponderance of the evidence,
and weigh in favor of the revocation sought by the Government.
To the extent that the Respondent's actions are interpreted as
prescribing controlled substances to CI indirectly,\71\ his
prescriptions are grave violations of 21 CFR 1306.04(a). On this point,
this case bears a striking similarity to Annicol Marrocco, M.D., 80 FR
28695 (2015). In that case, Dr. Marrocco prescribed controlled
substances to her lover, but did not physically see her lover for three
to six months while he was using those prescriptions. Id. at 28703. The
DEA found that Dr. Marrocco lacked a legitimate purpose for her
prescriptions because she was unable to supervise her lover's use of
his medication, which reflected ``a stunning disregard for [Dr.
Marrocco's] obligations as a prescriber of controlled substances.''
Id.; see Figueroa, 73 FR at 40381 (noting that failure to see a patient
before prescribing medication deviates from the legitimate practice of
medicine). Similarly, other than two brief interactions in public
places, the Respondent never saw CI while he was prescribing controlled
substances to Agent 1 and Agent 2 to divert to CI. Therefore, the
Respondent could not monitor CI's use of controlled substances.
---------------------------------------------------------------------------

\71\ See supra note 43.
---------------------------------------------------------------------------

Additionally, prescribing controlled substances based on a
patient's request, ``rather than the result of the application of the
physician's medical judgment,'' lacks a legitimate medical purpose.
Golden, 61 FR at 24812 (citing Dougherty, 60 FR 55047; Borcherding, 60
FR 28796). The Respondent's prescriptions to Agent 1 and Agent 2 were
based only on CI's request for certain controlled substances, not on
any physical examination or medical evaluation. Under Mississippi
Administrative Rule 1.4(a), such prescribing establishes that the
Respondent lacked good faith in issuing these prescriptions.
For these reasons, to the extent that the Respondent's 2015
prescriptions to Agent 1 and Agent 2 are perceived as indirect
prescriptions to CI, they clearly violate Mississippi Administrative
Rules 1.4 and 1.16, Mississippi Code Sec. Sec. 73-25-29(3) and (13),
and 21 CFR 1306.04(a), and the Government's allegations to that effect
are

[[Page 54847]]

SUSTAINED by a preponderance of the evidence, and weigh in favor of the
revocation sought by the Government.
In addition, the Respondent diverted controlled substances to CI
through the undercover agents after he knew that CI attempted to commit
suicide. Such actions reflect an astonishing level of irresponsibility
in the Respondent's prescribing activity. In McNichol, the DEA held
under Factors Two and Four that a prescriber's statement, which
reflected concern about putting a patient potentially ``in jeopardy of
overdose,'' made it ``clear that [the prescriber] believed that [the
patient] was a drug abuser.'' 77 FR at 57149. Similarly, in Jayam
Krishna-Iyer, the DEA held that ``[a] practitioner who ignores the
warning signs that [his] patients are either personally abusing or
diverting controlled substances commits `acts inconsistent with the
public interest,' 21 U.S.C. 824(a)(4), even if [he] is merely gullible
or na[iuml]ve.'' 74 FR at 460 n.3. Additionally, it is ``relevant that
[a registrant], knowing that the CI had been treated for drug abuse,
facilitated her access to controlled substances.'' Golden, 61 FR at
24812.
Here, the facts indicate that the Respondent knew his prescribing
actions put CI's health in danger. The Respondent knew that CI
previously had attempted to commit suicide using drugs he prescribed to
her. He knew she was still depressed. GE-28, file 2015-04-15_21-30-
59_EDT, at 9. He expressed fear and concern that she would take too
many pills, resulting in ``unfixably bad'' damage and a ``long,
agonizing, painful way to go.'' GE-14, at 1; GE-17, at 4. In spite of
all of this, the Respondent continued to divert controlled substances
to CI and said he was ``glad'' to do so. GE-19, at 1; GE-40, at 1; Tr.
230-31. Under these circumstances, the Respondent's continued
prescribing controlled of substances to CI reflects negatively on the
Respondent's experience in dispensing controlled substances.

B. Undercover Appointment #5

Although the Government did not allege that the Respondent's
prescriptions to Agent 1 during the fifth undercover appointment were
knowing attempts to divert drugs to CI, the Government alleged that the
October 2015 prescriptions violated 21 U.S.C. 841(a) and 842(a) and 21
CFR 1306.04(a) because the Respondent knew or should have known that
Agent 1's prescription requests were fraudulent. See ALJ-1, at 3-4.
The Government presented no evidence of any communications between
the Respondent and CI or Agent 1 immediately preceding Agent 1's
October 2015 appointment. At the appointment, Agent 1 met with the
Respondent, who examined her ears, nose, and throat. Tr. 120, 132. The
Respondent appeared to not remember Agent 1. Tr. 120, 135, 452; see GE-
42-43.
Only the first portion of the appointment was recorded, and no
witnesses were able to confidently recall the whole conversation
between Agent 1 and the Respondent. In response to Agent 1's inquiry,
the Respondent indicated during the appointment that he did not
remember Agent 2. GE-42-43. When Agent 1 asked the Respondent if he had
heard from CI lately, the Respondent paused, and looked surprised,
before saying that he had not. Tr. 122-23, 135, 452-53. Agent 1 said
that she needed the ``same as before,'' but did not tell the Respondent
that she had any specific complaints. GE-42-43; Tr. 454. The Respondent
discussed the efficacy of medication with Agent 1. GE-43, at 2-3. Agent
1 never said she had a cough. GE-42-43; Tr. 126, 454. Nonetheless, the
Respondent prescribed cough syrup, among other things, to Agent 1. GE-
45; Tr. 139.
The Respondent's medical file for Agent 1 indicated that Agent 1
had ``migraine headaches, as before Weather changes may make it worse
Maxalt helps most of the time Norco works okay as a backup Dry
[illegible] cough; no [illegible] to be allergy related Allergy
symptoms Ears clear OC/OP clear Nose c somewhat [illegible] Lungs
clear.'' GE-60, at 4. The Respondent also recorded that he wrote five
prescriptions to CI, including 30 units of Norco 5/325 and four ounces
of Hycodan. GE-60, at 4.
These facts summarize the totality of the evidence before me
concerning the October 2015 undercover appointment. Based on these
facts, I find that there is not substantial evidence that the
Respondent knew or should have known that Agent 1's prescription
requests were fraudulent. The recordings and testimony do not clearly
indicate that Agent 1 was presenting sham symptoms to the Respondent.
Agent 1's patient file indicated that the Respondent examined Agent 1,
recorded her complaints, and recorded the prescriptions he gave to her.
Importantly, the Government did not allege that the Respondent's
medical record for Agent 1 from the October appointment was deficient;
it only alleged that he knew or should have known that Agent 1's
prescription requests were fraudulent. The Government bears the burden
of proof on this point. ``[U]nder the substantial evidence test, the
evidence must `do more than create a suspicion of the existence of the
fact to be established.''' Alvin Darby, M.D., 75 FR 26993, 26999 n.31
(2010) (citing NLRB v. Columbian Enameling & Stamping Co., 306 U.S.
292, 300 (1939)). The Government failed to meet this burden. The
Government offered insufficient evidence to support a conclusion that
the Respondent knew or should have known that, five and a half months
after last seeing Agent 1, and while reviewing a new medical chart, her
requests during the October 2015 appointment were fraudulent.
Therefore, the Government's allegations that the fifth undercover
appointment violated 21 U.S.C. 841(a) and 842(a), and 21 CFR
1306.04(a), because the Respondent knew or should have known that Agent
1's prescription requests were fraudulent are NOT SUSTAINED.
Allegation 5: Prescriptions Issued in 2014 and 2015
The Government alleged that, from February 2014 to October 2015,
the Respondent unlawfully prescribed controlled substances in violation
of 21 U.S.C. 841(a) and 842(a). ALJ-1, at 2. Specifically, the
Government alleged that the Respondent prescribed controlled substances
when he knew or should have known that they were not prescribed for
legitimate medical purposes, and were not written in the usual course
of professional practice, in violation of 21 CFR 1306.04(a) and
Mississippi Code Sec. Sec. 41-29-137(a)(1) and 41-29-141(1). ALJ-1, at
2. Those sections of the Mississippi Code provide that it is illegal
for practitioners to dispense Schedule II controlled substances without
a valid written prescription. Miss. Code Sec. Sec. 41-29-137(a)(1),
41-29-141(1).
Under Allegation 1, I sustained the Government's allegations that
the Respondent's 2014 prescriptions to CI on May 22, June 17, September
11, October 6, and December 4 were outside the usual course of his
professional practice and were illegitimate prescriptions that violated
21 CFR 1306.04(a). Under Allegation 2, I sustained the Government's
allegations that the Respondent's 2014 prescriptions to CI on April 9,
May 19, July 24, and September 8 were outside the usual course of his
professional practice and were illegitimate prescriptions that violated
21 CFR 1306.04(a). Under Allegation 3, I sustained the Government's
allegations that the Respondent's 2014 prescriptions to Kid 2 on
February 7, July 23, September 2, and November 3, and the Respondent's
prescriptions to

[[Page 54848]]

Kid 1 on June 17 and November 19, were outside the usual course of his
professional practice and were illegitimate prescriptions that violated
21 CFR 1306.04(a). Finally, under Allegation 4, I sustained the
Government's allegations that the Respondent's prescriptions written
during the first four undercover appointments in 2015 were fraudulent
and violated 21 CFR 1306.04(a).
I have held that all of these prescriptions were issued outside of
the Respondent's usual course of professional practice and were not
issued for legitimate medical purposes. Therefore, the Government's
allegation that the Respondent violated 21 CFR 1306.04(a) is SUSTAINED
by a preponderance of the evidence, and weighs in favor of the
revocation sought by the Government. The Government also established
that some prescriptions were invalid because CI, rather than the named
patient, was the actual intended recipient of several prescriptions.
The Government's allegations that the Respondent's six prescriptions to
CI's children, identified supra, and 2015 hydrocodone combination
product prescriptions to the undercover agents at the first four
undercover appointments violated Mississippi Code Sec. Sec. 41-29-
137(a)(1) and 41-29-141(1) are SUSTAINED.\72\ Because the Respondent
issued illegitimate prescriptions, the Government's allegations that
the Respondent violated 21 U.S.C. 841(a) and 842(a) are SUSTAINED by a
preponderance of the evidence, and weigh in favor of the revocation
sought by the Government.
---------------------------------------------------------------------------

\72\ Hydrocodone combination products were reclassified by the
federal government as Schedule II controlled substances as of
October 6, 2014. Stip. 6. The Government has not shown how
hydrocodone combination products are scheduled in the state of
Mississippi. The Government's allegations that the Respondent's
prescriptions predating October 6, 2014, violated Mississippi Code
Sec. Sec. 41-29-137(a)(1) and 41-29-141(1), which only address
Schedule II controlled substances, are NOT SUSTAINED.
---------------------------------------------------------------------------

Allegation 6: Meperidine Used in Suicide Attempt
The Government alleged that the Respondent prescribed 30 dosage
units of meperidine 50 mg to CI, which she used to try to kill herself.
ALJ-1, at 3. The evidence shows that the Respondent prescribed Demerol
to CI on September 2, 2014. GE-2, at 12; GE-49, at 2; Tr. 222, 296-97,
317-18, 382. The Respondent appears to have been the only person to
prescribe Demerol to CI. See GE-49. CI used the Demerol to attempt to
commit suicide in December 2014. Tr. 222, 315-17. The Government,
however, did not specify or argue why this Demerol prescription was
improper. The Government did not allege or argue that the Respondent
failed to conduct a physical examination of CI, or failed to maintain
proper medical charts, when he prescribed Demerol to CI. The Government
did not allege or argue that the Respondent knew or anticipated that CI
would attempt to commit suicide using the Demerol he prescribed to her.
The Government did not even allege or argue that the Respondent
possessed anything other than a legitimate intent to treat CI's
physical symptoms when he prescribed Demerol to her. Therefore, to the
extent that the Government alleged that the Respondent's Demerol
prescription to CI merits revocation of his COR, the Government's
allegation is NOT SUSTAINED.
Under Factors Two and Four,\73\ the Respondent's prescribing
conduct indicates that his continued registration is not in the public
interest. Therefore, Factors Two and Four militate strongly in favor of
revocation of the Respondent's COR.
---------------------------------------------------------------------------

\73\ Both parties specifically discussed Factor Five in their
post-hearing briefs. Factor Five considers conduct not otherwise
addressed under Factors One through Four. 21 U.S.C. 823(f)(5). As
discussed supra, the Respondent's actions in this case are most
appropriately analyzed under Factors Two and Four. Therefore,
consideration of this conduct under Factor Five, the ``catch-all''
factor, is inappropriate.
---------------------------------------------------------------------------

RECOMMENDATION

Even if the Respondent had knowingly attempted to divert controlled
substances to CI only one time, that alone would have been sufficient
to make a prima facie case for revocation of the Respondent's license.
See MacKay v. DEA, 664 F.3d 808, 819 (10th Cir. 2011). ``[P]roof of a
single act of intentional or knowing diversion is sufficient to satisfy
the Government's prima facie burden of showing that a practitioner's
continued registration is inconsistent with the public interest, and if
unrebutted by a showing that the practitioner accepts responsibility
for his misconduct and will not engage in future misconduct, warrants
the revocation of a registration.'' McNichol, 77 FR at 57145 (internal
citations omitted); see also Krishna-Iyer, 74 FR at 462-64; Alan H.
Olefsky, 57 FR 928, 928-29 (1992). In cases of knowing diversion, ``the
[DEA] has an interest in deterring [the Respondent] and others from
engaging in similar egregious behavior.'' Michael A. White, M.D., 79 FR
62957, 62967 (2014).
Here, the Government has proven far more than one act of knowing
diversion. The Government has proven that the Respondent repeatedly and
continually issued illegitimate prescriptions to CI and others for
multiple types of drugs based solely on CI's request. The Government
has proven that, on multiple occasions, the Respondent knowingly issued
fraudulent prescriptions with the intent to divert drugs to CI. The
Respondent's improper prescribing constituted an egregious level of
intentional diversion. Accordingly, Factors Two and Four weigh heavily
against the Respondent, and the Government has established a prima
facie case supporting revocation of the Respondent's registration.
Further, after evaluating all of the above established facts, I find
that considerations of both specific and general deterrence also weigh
in favor of revocation in this case.
Because the Government has made a prima facie case that the
Respondent's continued registration would be inconsistent with the
public interest, the Respondent had the burden of production to
``present[] sufficient mitigating evidence'' to show why he can be
entrusted with a registration. See Med. Shoppe--Jonesborough, 73 FR at
387 (quoting Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)).
Specifically, to rebut the Government's prima facie case, the
Respondent must have both accepted responsibility for his actions and
demonstrated that he would not engage in future misconduct. Stodola, 74
FR at 20734-35. However, the Respondent offered no evidence \74\ that
he accepted responsibility for his misconduct or reformed his ways.
Therefore, the Respondent failed to rebut the Government's prima facie
case.
---------------------------------------------------------------------------

\74\ The Government requested that I draw an adverse inference
against the Respondent because of his failure to testify at the
hearing. ALJ-35, at 27-28. However, I decline to do so because an
adverse inference is unnecessary in light of the overwhelming
evidence against the Respondent.
---------------------------------------------------------------------------

Because the Government proved that the Respondent's registration is
inconsistent with the public interest, and because the Respondent
failed to rebut the Government's prima facie case, I RECOMMEND that the
Respondent's DEA Certificate of Registration be REVOKED and any
applications for renewal or modification of his license be DENIED.
Dated: June 1, 2016
s/Charles Wm. Dorman
Administrative Law Judge
[FR Doc. 2016-19595 Filed 8-16-16; 8:45 am]
BILLING CODE 4410-09-P