Michael A. White, M.D.; Decision and Order, 62957-62968 [2014-25025]

Download as PDF Federal Register / Vol. 79, No. 203 / Tuesday, October 21, 2014 / Notices treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.5 This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.8(c) of the Commission’s Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)). By order of the Commission. Issued: October 16, 2014. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2014–24972 Filed 10–20–14; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 13–16] Michael A. White, M.D.; Decision and Order On April 16, 2014, Administrative Law Judge (ALJ) Gail A. Randall issued the attached Recommended Decision (R.D.).1 Respondent filed Exceptions to the Recommended Decision. Having reviewed the entire record including Respondent’s Exceptions, I have decided to adopt the ALJ’s findings of fact, conclusions of law, and recommended sanction except as explained below.2 A discussion of Respondent’s Exceptions follows. mstockstill on DSK4VPTVN1PROD with NOTICES Respondent’s Exceptions In his Exceptions, Respondent raises five different contentions. Notably, however, Respondent does not challenge any of the ALJ’s factual findings (including her findings that were based on the testimony of the Government’s Expert) regarding his prescribing of phentermine to the sixteen patients at issue in this proceeding. See generally Exceptions, at 1–4. Nor does he challenge the ALJ’s 5 Electronic Document Information System (EDIS): https://edis.usitc.gov. 1 All citations to the Recommended Decision are to the slip opinion as issued by the ALJ. 2 I decline to publish the ALJ’s discussion of the substantial evidence standard. It suffices to say that in reviewing the factual findings of a recommended decision, this Agency adheres to the principles set forth in Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951). VerDate Sep<11>2014 18:05 Oct 20, 2014 Jkt 235001 legal conclusion ‘‘that Respondent failed to establish a bona-fide doctorpatient relationship before prescribing [p]hentermine to the sixteen patients at issue here, thus violating 21 CFR 1306.04(a).’’ R.D. at 33; see also Exceptions, at 1–4. The ALJ also made extensive findings based on the results of a January 19, 2012 hearing conducted by the Mississippi State Board of Medical Licensure regarding Respondent’s prescribing of phentermine to five other persons. GX 5. Following the hearing, at which Respondent was represented by counsel, the Board found him guilty of violating various provisions of both state law and the Board’s rules. More specifically, with respect to each of the five persons, the Board found that Respondent failed to obtain a thorough history or complete a thorough physical examination prior to initiating treatment utilizing a Schedule IV controlled substance.3 Id. at 49 (citing Miss. Code Ann. § 73–25–29(13); 25 Miss. Code R. § 501(2)). The Board further found that Respondent had violated its rule prohibiting the continued prescribing of controlled substances classified as amphetamine like anorectics and/or central nervous system stimulants to a patient who had failed to lose weight after taking the controlled substances over a period of thirty days. Id. (citing Miss. Code Ann. § 73–25–29(13)). Most significantly, with respect to each of the five patients at issue in the proceeding, the Board found Respondent ‘‘guilty of dispensing drugs having addiction-forming or addictionsustaining liability otherwise than in the course of legitimate professional practice.’’ Id. at 16 (citing Miss. Code Ann. § 73–25–29(3)). This finding is equivalent to a finding that Respondent violated 21 CFR 1306.04(a), which requires that a controlled-substance prescription ‘‘be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.’’ Here again, Respondent did not challenge the ALJ’s findings of fact and conclusions of law which were based on the Board’s findings. Indeed, nowhere 3 The Board also found that he had ‘‘initiated treatment utilizing a Schedule IV controlled substance without having performed a review of the patient’s prior medical and weight-loss program records to determine that the patient had made a substantial good-faith effort to lose weight in a treatment program utilizing a regimen of weight reduction based on caloric restriction, nutritional counseling, behavior modification and exercise, without the utilization of controlled substances, and that said treatment had been ineffective, all in violation of Miss. Code Ann. § 73–25–29(13).’’ GX 5, at 49 (citing 25 Miss. Code R. § 501(1)). PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 62957 in his Exceptions does he dispute the ALJ’s legal conclusions that he violated the Controlled Substance Act’s prescription requirement with respect to some twenty-one patients. Instead, he argues that the denial of his application is unwarranted because there is no evidence that any person he prescribed to has been injured or died as a result of his unlawful prescribing of controlled substances. Exceptions, at 1–2. The short answer to Respondent’s contention is that proving injury is not an element of an allegation that a physician violated 21 CFR 1306.04(a). Rather, proof of such a violation is established by showing that in issuing the prescription, the physician acted outside of the usual course of professional practice and lacked a legitimate medical purpose, and such proof establishes that a physician knowingly or intentionally diverted a controlled substance. Respondent also argues that the ALJ’s findings and recommendation are erroneous because he was found not guilty in a criminal proceeding ‘‘after the exact evidence was presented and the same witness testimony[ ] that was presented’’ at the DEA hearing. Exceptions, at 2. Putting aside whether the exact same evidence was presented at both his criminal trial and the DEA proceeding (the latter appearing to include evidence of his misconduct in prescribing to far more patients than were at issue in the former), Respondent ignores that the State Board also found him guilty of dispensing controlled substances other than in the course of legitimate professional practice (i.e., without a legitimate medical purpose). See GX 5, at 50. As for his related argument that ‘‘[t]he irony is overwhelming that the public who he could potentially harm did not buy the DEA’s assertions while sitting in the jury box,’’ Exceptions, at 2–3; Respondent ignores that because of the greater consequences that attach upon a criminal conviction, a higher standard of proof applies in a criminal trial than in an administrative proceeding. Indeed, given that Respondent does not challenge any of the ALJ’s findings with respect to whether he violated the CSA’s prescription requirement and diverted controlled substances, there is more than ample evidence to support the conclusion that he poses a potential danger to the public. See Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (‘‘the 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 E:\FR\FM\21OCN1.SGM 21OCN1 62958 Federal Register / Vol. 79, No. 203 / Tuesday, October 21, 2014 / Notices crave the drugs for those prohibited uses’’) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)). As further support for his contention that he ‘‘poses no threat or risk’’ to the public, Respondent points to the fact that the State Board has allowed him to continue to practice medicine.4 Exceptions, at 3. Contrary to Respondent’s understanding, the denial of his application for a DEA registration does not prevent him from practicing medicine. It only prevents him from dispensing controlled substances, a remedy which is more than warranted considering the extensiveness of his misconduct and his failure to accept responsibility for it. See R.D. at 37 (noting that Respondent’s ‘‘acceptance of responsibility was tenuous at best,’’ that ‘‘not once during the hearing did Respondent unequivocally admit fault for his improper [p]hentermine prescriptions,’’ and that his ‘‘purported admission of guilt was also undermined by his tendency to blame others and make excuses for his misconduct’’). As the Tenth Circuit has recognized: The DEA may properly consider whether a physician admits fault in determining if the physician’s registration should be revoked. When faced with evidence that a doctor has a history of distributing controlled substances unlawfully, it is reasonable for the [Agency] to consider whether that doctor will change his or her behavior in the future. And that consideration is vital to whether continued registration is in the public interest. mstockstill on DSK4VPTVN1PROD with NOTICES MacKay v. DEA, 664 F.3d 808, 820 (10th Cir. 2011) (citing Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005)); see also Jayam Krishna-Iyer, 74 FR 459, 462 (2009) (holding that even where the evidence shows that an applicant or registrant has committed only a few acts of intentional diversion, ‘‘this Agency will not grant or continue the practitioner’s registration unless he accepts responsibility for his misconduct’’). As for his contention that this proceeding ‘‘is nothing more than a vindictive act by’’ the Agency because he was acquitted in his criminal case, Exceptions at 3, here again, Respondent ignores that two separate bodies have found that he knowingly diverted 4 While in exercising its sovereign power to regulate the medical profession within the State, the Mississippi Board may have chosen to allow Respondent to continue to practice medicine, this ‘‘Agency has long held that ‘the Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.’ ’’ David A. Ruben, 78 FR 38363, 38379 n.35 (2013) (quoting Mortimer Levin, 57 FR 8680, 8681 (1992)). VerDate Sep<11>2014 18:05 Oct 20, 2014 Jkt 235001 controlled substances, and the ALJ’s findings, which he does not challenge, establish that he diverted controlled substances to more than twenty patients. Because his misconduct is egregious and Respondent has failed to accept responsibility for it, I reject his exceptions and will adopt the ALJ’s recommended order that I deny his application.5 Order Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well as 28 CFR 0.100(b) and 0.104, I order that the application of Michael A. White, M.D., for a DEA Certificate of Registration as a practitioner be, and it hereby is, denied. This Order is effective immediately. Dated: October 10, 2014. Thomas M. Harrigan, Deputy Administrator. Michelle F. Gillice, Esq., and Frank W. Mann, Esq., for the Government Rodney A. Ray, Esq., for the Respondent RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE Gail A. Randal, Administrative Law Judge. I. INTRODUCTION This proceeding is an adjudication pursuant to the Administrative Procedure Act, 5 U.S.C. § 551 et seq., to determine whether the Drug Enforcement Administration (‘‘DEA’’ or ‘‘Government’’) should deny a physician’s application for a DEA Certificate of Registration pursuant to 21 U.S.C. § 823(f) (2006). Without his registration, the physician, Michael A. White, M.D. (‘‘Respondent’’ or ‘‘Dr. White’’), would be unable to lawfully prescribe, dispense or otherwise handle controlled substances in the course of his medical practice. II. PROCEDURAL HISTORY The Deputy Assistant Administrator, Drug Enforcement Administration (‘‘DEA’’ or ‘‘Government’’), issued an Order to Show Cause (‘‘OTSC’’) dated July 2, 2013, proposing to deny the 5 I have also considered his final contention, which takes issue with the ALJ’s finding that Respondent took a ‘‘hostile tone’’ during the hearing and argues that this finding establishes that the ALJ was not impartial. R.D. at 38; Exceptions, at 3–4. He cites no authority for the contention that a trier of fact cannot consider a witness’s tone in assessing his credibility, and because the ALJ was in the best position to observe Respondent’s demeanor during the hearing, I reject the contention. PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 Respondent’s application for a DEA Certificate of Registration, as a practitioner, pursuant to 21 U.S.C. §§ 824(a)(4) and 823(f) because the Respondent’s registration would be inconsistent with the public interest, as that term is defined in 21 U.S.C. § 823(f). [Administrative Law Judge Exhibit (‘‘ALJ Exh.’’) 1 at 1]. Specifically, the OTSC stated that according to a January 19, 2012 order (‘‘Board Order’’ or ‘‘Order’’) from the Mississippi State Board of Medical Licensure (‘‘Board’’), Respondent violated several state laws relating to controlled substances. [Id. at 2]. First, the OTSC alleged that, according to the Board Order, Respondent violated title 73, chapter 25, section 29(3) of the Mississippi Code by dispensing drugs having addiction-forming or addictionsustaining liability outside of the course of legitimate professional practice. [Id.]. Second, the OTSC alleged that, according to the Board Order, Respondent violated Chapter 25, Section 501 of the Board’s Rules and Regulations by prescribing a Schedule IV controlled substance without first reviewing the patient’s records to determine if the patient had made a good-faith effort to lose weight using caloric restriction, nutritional counseling, behavior modification, and exercise. [Id.]. Third, the OTSC alleged that, according to the Board Order, Respondent violated Chapter 25, Section 501(2) of the Board’s Rules and Regulations by prescribing a Schedule IV controlled substance without first obtaining a thorough history or completing a thorough physical examination of the patient. [Id.]. Fourth, the OTSC alleged that, according to the Board Order, Respondent violated Chapter 25, Section 501(5)(a) of the Board’s Rules and Regulations by continuing to prescribe a Schedule IV controlled substance to patients who failed to lose weight over a thirty day period. [Id.]. Finally, the OTSC alleged that, according to the Board Order, Respondent’s improper prescribing of a Schedule IV controlled substance constituted unprofessional conduct under Mississippi Code Ann. 73–24– 83(a). Additionally, the Order alleged that Respondent failed to obey the Board Order’s requirement that Respondent submit proof that he completed 40 hours of continuing medical education (‘‘CME’’). [Id. at 2–3]. The OTSC alleged that as a result of these violations, the Board suspended Respondent’s medical license for six months and permanently prohibited Respondent from treating patients for E:\FR\FM\21OCN1.SGM 21OCN1 Federal Register / Vol. 79, No. 203 / Tuesday, October 21, 2014 / Notices weight loss with controlled substances. [Id.at 2]. The OTSC further alleged that Respondent’s issuing of prescriptions for Schedule IV controlled substances without a legitimate medical purpose and outside the usual course of business violated 21 C.F.R. § 1306.04(a). [Id.]. On July 31, 2013, the Respondent, through counsel, timely filed a request for a hearing. [ALJ Exh. 2]. The hearing in this case took place on January 29, 2014 in Oxford, Mississippi. [ALJ Exh. 7; Transcript (‘‘Tr.’’) 1]. Respondent and the Government were each represented by counsel. At the hearing, the Government introduced documentary evidence and called three witnesses and Respondent called one witness, himself. [Tr. 3]. After the hearing, the Government and the Respondent submitted proposed findings of fact, conclusions of law, and argument. III. ISSUE The issue in this proceeding is whether or not the record as a whole establishes by a preponderance of the evidence that the Drug Enforcement Administration should deny the application for a DEA Certificate of Registration (‘‘COR’’) of Dr. Michael A. White, as a practitioner, pursuant to 21 U.S.C. § 823(f), because to grant his application would be inconsistent with the public interest, as that term is defined in 21 U.S.C. § 823(f). [Tr. 6; ALJ Exh. 4 at 1]. IV. FINDINGS OF FACT mstockstill on DSK4VPTVN1PROD with NOTICES A. Stipulated Facts The parties have stipulated to the following facts: 1. Respondent applied for a DEA COR as a practitioner in Schedules II–V at the Pain Clinic LLC, 3499 Bluecutt Road, Suite 1, Columbus, Mississippi, 39701 on March 21, 2012. 2. Respondent was previously registered with DEA as a practitioner in Schedules II–V under DEA COR number BW3923009 at 3499 Bluecutt Road, Suite 1, P.O. Box 7757, Columbus, Mississippi, 39705. 3. On September 22, 2011, DEA issued an Order to Show Cause to Respondent seeking revocation of his DEA COR BW3923009. 4. Phentermine is a Schedule IV controlled substance pursuant to 21 C.F.R. § 1308.14(e)(9). 5. Respondent voluntarily surrendered his COR BW3923009 on March 16, 2012. 6. On June 21, 2011, DEA and other law enforcement officials executed a search warrant at Respondent’s medical VerDate Sep<11>2014 19:38 Oct 20, 2014 Jkt 235001 practice which was also his registered address and seized among other items, Respondent’s patient files. 7. Government Exhibit #12 is a true and accurate copy of the Respondent’s patient file of patient [C.H.] 6 seized during the execution of a search warrant at Respondent’s registered address on June 21, 2011. 8. Government Exhibit #13 is a true and accurate copy of the Respondent’s patient file of patient [R.G.] seized during the execution of a search warrant at Respondent’s registered address on June 21, 2011. 9. Government Exhibit #14 is a true and accurate copy of the Respondent’s patient file of patient [C.B.] seized during the execution of a search warrant at Respondent’s registered address on June 21, 2011. 10. Government Exhibit #15 is a true and accurate copy of the Respondent’s patient file of patient [A.G.] seized during the execution of a search warrant at Respondent’s registered address on June 21, 2011. 11. Government Exhibit #16 is a true and accurate copy of the Respondent’s patient file of patient [J.H.] seized during the execution of a search warrant at Respondent’s registered address on June 21, 2011. 12. Government Exhibit #17 is a true and accurate copy of the Respondent’s patient file of patient [T.H.] seized during the execution of a search warrant at Respondent’s registered address on June 21, 2011. 13. Government Exhibit #18 is a true and accurate copy of the Respondent’s patient file of patient [K.H.] seized during the execution of a search warrant at Respondent’s registered address on June 21, 2011. [ALJ Exh. 4 at 1–2; ALJ Exh. 5]. B. Respondent’s Background Respondent earned his undergraduate degree in Chemistry and Biology from the University of California, Irvine. [Tr. 186]. Thereafter, he earned his medical degree from the California College of Medicine at Irvine in 1981 and later completed his residency in anesthesiology at Emory University in Atlanta, Georgia. [Tr. 186–87]. He obtained DEA COR BW3923009 on March 4, 1994. [Gov’t Exh. 1 at 1]. On March 20, 2012, the Respondent surrendered this registration for cause. [Id.]. Respondent practiced anesthesiology in Mississippi until 2008 when, due to 6 Before the hearing, I issued a Protective Order which protects the identities of third parties in these proceedings. [ALJ Exh. 3]. Thus, in this recommended decision, I will refer to all parties protected by the Protective Order by their initials. PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 62959 his hearing beginning to deteriorate, he felt he could not properly perform his job function and might pose a danger in the surgery room. [Tr. 187]. Drawing on his experience in pain management as an anesthesiologist, Respondent then opened a pain management clinic in Columbus, Mississippi. [Tr. 188]. Respondent started the practice ‘‘from scratch,’’ and most of his patients sought relief from neck or back pain and were referred by another physician. [Tr. 188–89]. In the Fall of 2008, Respondent agreed to treat the patients of a weight loss physician, ‘‘Dr. Burtman,’’ who, in Respondent’s words, ‘‘was shut down by . . . the DEA and the Medical Board.’’ [Tr. 189]. Respondent testified that he did not intend his weight loss practice to be permanent, but that he maintained the weight loss patients because it was a financial buoy for his developing pain management practice. [Tr. 190]. C. Law Enforcement’s Investigation of Respondent The DEA investigation into Respondents’ weight loss practice began when the Lowndes County Narcotics Task Force notified DEA that Respondent and another doctor may be ‘‘running pill mills’’ and that ‘‘there were some concerns about some overdose deaths.’’ 7 [Tr. 15–16]. DEA investigators worked together with the Lowndes County Narcotics Task Force, Mississippi Bureau of Narcotics, and the Mississippi State Board of Medical Licensure to conduct the investigation of Respondent’s practice. [Tr. 15]. During the course of the investigation, law enforcement officers interviewed Respondent’s patients and sent undercover informants to book appointments with Respondent’s practice. [Gov’t Exh. 5 at 36; Tr. 17]. The informants first attempted to book appointments with Respondent for pain management, but were turned away.8 7 On cross examination, Diversion Investigator Sean Baudier admitted that although the investigation began because of ‘‘initial complaints’’ about overdose deaths, no such overdoses were ever substantiated during the investigation. [Tr. 26–27]. In fact, DI Baudier testified that DEA did not even seriously investigate the reported drug overdose deaths because ‘‘a lot of times in overdose deaths, there are—there are poly drugs or alcohol involved.’’ [Tr. 26]. Moreover, the president of the Board testified that he is not aware of any injuries or deaths resulting from Respondent’s practice. [Tr. 70]. Therefore, because the Government did not establish that any deaths occurred due to misconduct by Respondent, my recommendation to the Administrator does not take into account DI Baudier’s mention of deaths by overdose. 8 There is some dispute as to why Respondent turned away the informants on the pain management side of his practice. On direct E:\FR\FM\21OCN1.SGM Continued 21OCN1 62960 Federal Register / Vol. 79, No. 203 / Tuesday, October 21, 2014 / Notices enforcement. [Gov’t Exh. 5 at 36–48]. Regarding those patients, the Board made the following factual and legal findings, which are binding on this Court under the principles of collateral estoppel. See David A. Ruben, 78 Fed. Reg. 38,363, 38,365 (DEA 2013); Robert L. Dougherty, M.D., 76 Fed. Reg. 16,823, 16,830 (DEA 2011). measurements such as BMI or waist circumference, conducting any laboratory testing, or verifying that J.B. had made good-faith efforts to lose weight without the aid of controlled substances. [Gov’t Exh. 5 at 39–41]. In total, Respondent prescribed 150 doses of Phentermine to A.S. [Gov’t Exh. 5 at 39]. D. The Board Hearings and Board Order The investigation of Respondent resulted in the Board issuing a Summons and Affidavit in November of 2011, formally charging Respondent with twenty three counts of misconduct. [Gov’t Exh. 5 at 1–33]. Respondent, represented by counsel, attended a hearing before the Board on January 19, 2012. [Gov’t Exh. 5 at 35; Gov’t Exh. 6 at 1–2; Tr. 51, 58–59]. Respondent did not testify at that hearing because criminal charges related to the same facts were pending. [Tr. 66–67]. The Board issued its decision orally and in writing on the day of the hearing. [Gov’t Exh. 5 at 35–52; Gov’t Exh. 6 at 215– 218]. The Board considered Respondent’s misconduct with respect to five patients, J.B., A.S., T.S., C.R., and T.S., three of whom were confidential informants employed by law 1. J.B. J.B., referred to in the Board Order as ‘‘Patient #1,’’ was one of Respondent’s patients who was interviewed by law enforcement during the course of its investigation. [Gov’t Exh. 5 at 36–37]. At the time she first came to see Respondent for weight loss on February 2, 2009, J.B. was 5′7″ tall and weighed 148 pounds, ‘‘which the Board determine[d] is not obese.’’ [Gov’t Exh. 5 at 37]. On the initial visit, Respondent issued a prescription for 30 doses of Phentermine and subsequently issued eight more prescriptions for 30 doses of Phentermine between March 9, 2009 and September 27, 2010. [Gov’t Exh. 5 at 37]. Additionally, Respondent prescribed to J.B. 90 doses of Sibutramine, a Schedule IV controlled substance. [Gov’t Exh. 5 at 37]. Respondent issued these prescriptions without performing a physical examination, properly documenting J.B.’s medical history, recording adiposity measurements such as BMI or waist circumference, conducting an EKG, conducting any laboratory testing, or verifying that J.B. had made goodfaith efforts to lose weight without the aid of controlled substances. [Gov’t Exh. 5 at 37–38]. Furthermore, Respondent continued to prescribe controlled substances to J.B. despite the patient’s failure to lose weight after six months of treatment. [Gov’t Exh. 5 at 39]. In fact, after the nineteen month-long treatment, J.B. actually gained twenty pounds. [Gov’t Exh. 5 at 39]. 3. T.S. T.S., referred to in the Board Order as ‘‘Patient #3,’’ was a confidential informant employed by law enforcement to gather information about Respondent’s practice. [Gov’t Exh. 5 at 41]. She was thirty four years old, 5′4″ tall, and weighed 225 pounds at the time of her initial visit to Respondent’s practice. [Gov’t Exh. 5 at 41–42]. Law enforcement chose her to participate in the investigation because she is not only obese, but has a number of other medical conditions as well. [Gov’t Exh. 5 at 41]. As with the other patients, Respondent prescribed controlled substances to T.S. without performing an adequate physical examination, properly documenting her medical history, recording adiposity measurements such as BMI or waist circumference, conducting any laboratory testing, or verifying that T.S had made good faith efforts to lose weight without the aid of controlled substances. [Gov’t Exh. 5 at 42–43]. In total, Respondent prescribed 150 doses of Phentermine to T.S. [Gov’t Exh. 5 at 41]. examination, DI Baudier testified that the informants were turned away on the pain management side because Respondent was ‘‘not taking any patients.’’ [Tr. 16–17]. He clarified this testimony on cross examination, testifying that Respondent turned the informants away because he ‘‘[w]asn’t accepting new patients.’’ [Tr. 41]. Respondent’s counsel suggested while cross examining DI Baudier that the informants were turned away because Respondent only accepted new patients with referrals, not because Respondent was not taking new patients. [Tr. 41–42]. DI Baudier responded that because he did not personally make the phone calls to book the appointments, he could not dispute Respondent’s explanation. [Tr. 41, 42]. Respondent himself testified that all of his pain management patients were referred by physicians and that ‘‘[y]ou couldn’t walk off the street into my clinic.’’ [Tr. 188–89]. To the extent that it is relevant, I find that the Government has failed to establish that Respondent turned the informants away because he was not accepting new pain patients. 2. A.S. A.S., referred to in the Board Order as ‘‘Patient #2,’’ was also one of Respondent’s patients who cooperated with the law enforcement investigation. [Gov’t Exh. 5 at 39]. A.S. was 5′6″ tall and weighed 180 pounds when she first saw Respondent for weight loss. [Gov’t Exh. 5 at 39]. She told Respondent that she had previously received ‘‘diet medication’’ from another doctor, Dr. Burtman, but Respondent did not include Dr. Burtman’s charts in A.S.’s file. [Gov’t Exh. 5 at 40]. Respondent prescribed controlled substances to A.S. without performing an adequate physical examination, properly documenting her medical history, recording adiposity mstockstill on DSK4VPTVN1PROD with NOTICES [Tr. 16–17; 41–42]. When the informants were able to get appointments with Respondent for weight loss, DEA centered its investigation on the weight loss side of Respondent’s practice. [Tr. 17, 48]. Diversion Investigator Sean Baudier testified that the informants obtained Phentermine from Respondent ‘‘[e]very time’’ they visited Respondent’s practice. [Tr. 17]. Phentermine, also called Adipex, is a Schedule IV controlled substance. [Tr. 52; ALJ Exh. 4 at 2]; 21 C.F.R. § 1308.14(e)(9). DEA executed a warrant to search and seize evidence from Respondent’s practice on June 21, 2011 and obtained all patient files kept by Respondent. [Tr. 17–18, 191; ALJ Exh. 5 at 1; Gov’t Exhs. 12–27]. Respondent credibly testified, and the Government did not refute, that he ceased treating weight loss patients on the day the warrant was executed. [Tr. 192]. VerDate Sep<11>2014 19:38 Oct 20, 2014 Jkt 235001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 4. C.R. C.R., referred to in the Board Order as ‘‘Patient #4,’’ was another confidential law enforcement informant. [Gov’t Exh. 5 at 43]. At the time of her initial visit with Respondent, she was twenty two years old, 5′3″ tall, and weighed 139 pounds. [Gov’t Exh. 5 at 43–44]. The Board found that although she was not obese, Respondent noted in C.R.’s chart that she was ‘‘overweight.’’ [Gov’t Exh. 5 at 44]. As with the other patients, Respondent prescribed controlled substances to C.R. without performing an adequate physical examination, properly documenting her medical history, recording adiposity measurements such as BMI or waist circumference, conducting any laboratory testing, or verifying that C.R. had made good faith efforts to lose weight without the aid of controlled substances. [Gov’t Exh. 5 at 43–45]. Additionally, Respondent did not document an individualized treatment plan for C.R. Rather, under ‘‘Plan of Care’’ in the chart, Respondent merely E:\FR\FM\21OCN1.SGM 21OCN1 Federal Register / Vol. 79, No. 203 / Tuesday, October 21, 2014 / Notices wrote ‘‘Weight Loss Program Month #1,’’ which apparently included prescriptions for Phentermine and a ‘‘Low carb Diet.’’ [Gov’t Exh. 5 at 45]. Respondent prescribed C.R. a total of 120 doses of Phentermine. [Gov’t Exh. 5 at 43]. 5. T.S.1 T.S.1, referred to in the Board Order as ‘‘Patient #5,’’ was another confidential informant who visited Respondent for weight loss. [Gov’t Exh. 5 at 46]. At the time of her initial visit, she was twenty nine years old, 5′8″ tall, and weighed 125 pounds. [Gov’t Exh. 5 at 46]. The Board found that she was not obese. [Gov’t Exh. 5 at 46]. As with the other patients, Respondent prescribed controlled substances to T.S.1 without performing an adequate physical examination, properly documenting her medical history, recording adiposity measurements such as BMI or waist circumference, conducting any laboratory testing, or verifying that T.S.1 had made good faith efforts to lose weight without the aid of controlled substances. [Gov’t Exh. 5 at 46–47]. Additionally, Respondent continued to prescribe Phentermine to T.S.1 even though she actually gained nine pounds while being on the weight loss program. [Gov’t Exh. 5 at 48]. In total, Respondent prescribed 120 doses of Phentermine to T.S.1. [Gov’t Exh 5 at 46]. mstockstill on DSK4VPTVN1PROD with NOTICES 6. The Board’s Conclusions of Law Based on these factual findings, the Board concluded that Respondent violated a number of rules and regulations. First, it found that Respondent’s failure to verify that these five patients made a good-faith effort to lose weight without the aid of controlled substances violated Chapter 25, Section 501(1) of the Rules and Regulations of the Board, as well as title 73, Chapter 25, section 29(13) of the Mississippi Code. [Gov’t Exh. 5 at 49]. Second, the Board found that Respondent’s failure to obtain full medical histories and perform adequate physical examinations of the five patients violated Chapter 25, Section 501(2) of the Rules and Regulations of the Board, as well as title 73, Chapter 25, section 29(13) of the Mississippi Code. [Gov’t Exh. 5 at 49]. Third, the Board found that Respondent’s continued prescribing of controlled substances to patients who failed to lose weight after thirty days of taking the controlled substances violated Chapter 25, Section 501(5)(a) of the Rules and Regulations of the Board, as well as title 73, Chapter 25, section VerDate Sep<11>2014 18:05 Oct 20, 2014 Jkt 235001 29(13) of the Mississippi Code. [Gov’t Exh. 5 at 49]. Fourth, the Board found that Respondent dispensed ‘‘drugs having addition-forming or addition-sustaining liability otherwise than in the course of legitimate professional practice, all in violation of Miss. Code Ann. 73–25– 29(3).’’ [Gov’t Exh. 5 at 50]. Finally, the Board found that Respondent’s actions constituted ‘‘dishonorable or unethical conduct likely to deceive, defraud, or harm the public in violation of Miss. Code Ann. 73–25–29(8)(d) and 73–24–83(a).’’ [Gov’t Exh. 5 at 50]. Having made these findings, the Board suspended Respondent’s medical license for six months, but stayed the suspension contingent on certain conditions. [Gov’t Exh. 5 at 50–51]. Namely, the Board ordered Respondent to complete certain continuing medical education courses within six months of the Board Order and to report such completion to the Board. [Gov’t Exh. 5 at 50–51]. The Board also permanently prohibited Respondent from treating patients for weight loss and ordered Respondent to reimburse the Board for its costs in adjudicating the matter. [Gov’t Exh. 5 at 51]. Additionally, the Board stated that it would monitor Respondent’s compliance with the Board Order by periodically reviewing Respondent’s patient charts. [Gov’t Exh. 5 at 51]. 7. The Second Board Hearing In November of 2013, the Board held another hearing to determine why Respondent had not complied with the Board Order. [Tr. 60; Gov’t Exh. 32]. At that hearing, Respondent testified that he had not taken the CME courses because he could not afford them.9 [Tr. 60]. The Board found that Respondent ‘‘failed to comply with the . . . conditions as set forth in the January 19, 2012 Determination Order. Specifically, [Respondent] failed to submit proof of successful completion of Continuing Medical Education (CME) hours; failed to communicate with the Board as to the status of same; and failed to reimburse the Board for all costs. . . .’’ [Gov’t Exh. 32 at 5]. Thereafter, the Board allowed Respondent more time to complete the CME courses and reimburse the Board for its expenses. Specifically, the Board ordered Respondent to complete the 9 The transcripts for the second Board hearing were not entered into the record, but Dr. Van Craig testified that Respondent told the Board at the hearing that he could not afford the CME courses. [Tr. 60]. This testimony is corroborated by Respondent’s own testimony in these proceedings. [Tr. 205–06]. PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 62961 courses and pay the Board within six months of this DEA hearing. [Gov’t Exh. 32 at 5]. The Board also ordered Respondent to notify the Board ‘‘when the DEA hearing is scheduled and conducted.’’ [Gov’t Exh. 32 at 5]. At the hearing in these proceedings, the Board’s executive director, Dr. Harris Van Craig, testified that Respondent, to date, had not notified the Board of the scheduled date for the DEA hearing. [Tr. 63]. He also testified regarding Respondent’s ‘‘demeanor’’ in the second Board hearing. [Tr. 60–61]. Specifically, Dr. Van Craig testified that Respondent appeared ‘‘angry with the Board for . . . disciplining him’’ and that Respondent thought he had received ‘‘rather harsh treatment from the Board because of what he was doing.’’ [Tr. 60, 61; see also Tr. 66]. Dr. Van Craig also testified that Respondent felt he was being ‘‘singled out’’ by law enforcement because ‘‘other practitioners in his area were doing the same thing as he was.’’ [Tr. 60; see also Tr. 61]. E. Respondent’s Criminal Charges A month or two 10 after the Board handed down its Order, federal criminal charges were brought against Respondent for ‘‘knowingly and intentionally dispensing and distributing phentermine, which is a Schedule IV controlled substance[,] without a legitimate medical purpose and outside the usual course of medical practice.’’ [Gov’t Exh. 10 at 6; see also Tr. 21, 192]. A jury trial was conducted on October 22 and October 23, 2012, resulting in Respondent being acquitted of all charges. [Gov’t Exh. 10 at 1; Gov’t Exh. 11 at 1, 224; Tr. 33]. Respondent credibly testified, and the Government did not refute, that he stopped practicing medicine altogether on the day he was indicted. [Tr. 192]. F. The Standard of Care for Prescribing Phentermine At the hearing in these proceedings, the Government offered, and I certified, Dr. Stephen Sudderth as an expert in weight loss medicine and the medical use of Phentermine for weight loss. [Tr. 77–78]. Dr. Sudderth is a general surgeon, a bariatric surgeon, and a bariatric physician, licensed to practice in Mississippi. [Tr. 72, 73]. His bariatric specialty means he ‘‘specializes in the field of metabolic and obesity disease.’’ [See Tr. 72–73]. He has been practicing weight-loss medicine for twelve years. 10 The record is not clear as to exactly when Respondent was indicted. Respondent testified that he was indicted four to six weeks after the Board issued its Order on January 19, 2012, [Tr. 192], but the indictment itself is not in evidence. E:\FR\FM\21OCN1.SGM 21OCN1 mstockstill on DSK4VPTVN1PROD with NOTICES 62962 Federal Register / Vol. 79, No. 203 / Tuesday, October 21, 2014 / Notices [Tr. 73]. He attended medical school at Louisiana State University Medical School, completed his internship at Yale University-affiliated hospitals in New Haven, Connecticut, and completed his general surgery residency at the University of Nevada, Las Vegas. [Tr. 74–75; Gov’t Exh. 28]. He is boardcertified in bariatric medicine and general surgery. [Tr. 75]. He is a fellow of the American College of Surgeons and a diplomat to the American Board of Bariatric Medicine, which is an honor denoting ‘‘that you are at the top of your field.’’ [Tr. 75]. Dr. Sudderth testified that he has treated ‘‘[t]housands’’ of patients for weight loss in his career and regularly prescribes Phentermine. [Tr. 76]. In fact, he helped draft the recent changes to the regulations regarding the prescription of Phentermine for weight loss. [Tr. 76]. As such, he is familiar with the regulations and standards both as they are now and as they were when Respondent’s misconduct occurred. [Tr. 76–77]. Dr. Sudderth credibly testified regarding the standard of care when prescribing Phentermine. He testified that physicians should document the patient’s history of diet, weight, exercise, and controlled substance use ‘‘to determine if they had gone through other programs or used drugs for the purpose of weight loss by a prescription.’’ [Tr. 83, 84]. Dr. Sudderth also testified that the patient’s medical history should be noted in the chart, including allergies and other medical conditions the patient may have. [Tr. 85]. The physician should also note any medications the patient is taking, the patient’s primary care physician, the patient’s gynecological history, and the patient’s family medical history. [Tr. 85]. This information should all be noted in the patient’s chart. [Tr. 84]. According to Dr. Sudderth, documenting this information is necessary for a physician to meet the standard of care when prescribing Phentermine. [Tr. 87]. Dr. Sudderth testified that a physical examination is also necessary to meet the standard of care. [Tr. 87, 103]. This means that before prescribing Phentermine, the physician should measure and document the patient’s vital signs, including temperature, pulse, blood pressure, height, and weight. [Tr. 87]. In addition, the physician should measure the patient’s body mass index (‘‘BMI’’), waist circumferences, or body fat percentage, each of which give ‘‘some indication of the patient’s fat content.’’ [Tr. 87, 93]. BMI, which is a ‘‘common standard used in most states and certainly in Mississippi’’ to measure adiposity, is VerDate Sep<11>2014 18:05 Oct 20, 2014 Jkt 235001 calculated by dividing the patient’s weight by the patient’s height squared. [Tr. 88–90]. A BMI of 18 to 24 is considered ‘‘normal weight,’’ 25 to 29.9 is considered ‘‘overweight,’’ 30 to 39 is considered ‘‘obese,’’ 40 to 49 is considered ‘‘morbidly obese,’’ and anything over 50 is considered ‘‘super morbid obese.’’ [Tr. 90]. To be prescribed Phentermine for weight loss, a patient must have a BMI of 27 or greater and have at least one ‘‘comorbid medical problem,’’ which Dr. Sudderth testified is ‘‘[a]nother medical problem that’s related directly to the weight.’’ [Tr. 91]. Common comorbid conditions include high blood pressure, diabetes, sleep apnea, arthritis, lower back pain, heartburn, urinary incontinence, breast cancer, and prostate cancer. [Tr. 91]. A patient without a comorbid condition must have a BMI of at least 30 to be prescribed Phentermine for weight loss. [Tr. 91]. Dr. Sudderth also testified that although these are the customary standards, a physician has some ‘‘latitude’’ to prescribe Phentermine to a patient with a slightly lower BMI if the physician believes the patient’s weight is significantly aggravating a medical condition. [Tr. 92–93]. Measuring vital signs and adiposity, however, is not the only important part of the physical exam. Dr. Sudderth testified that various observations made during a routine physical exam might indicate the patient has medical conditions that are contributing to the patient’s weight or would make controlled substances unsafe to prescribe. [Tr. 94–98]. Dr. Sudderth also testified that lab work is ‘‘essential’’ in determining whether to prescribe Phentermine because it uncovers things that a physical examination typically does not. [Tr. 99]. Specifically, lab work can identify conditions that may hinder weight loss or make prescribing certain controlled substances improper, such as anemia, liver disease, hypothyroidism, and high cholesterol. [Tr. 99–101]. Dr. Sudderth testified that in Mississippi, the standard of care is to perform blood work and to document the results before or at the visit when prescribing Phentermine for weight loss occurs.11 [Tr. 101–02]. 11 On cross examination, counsel for Respondent suggested that cost sometimes prohibits lab work. [Tr. 170–71]. However, Respondent offered no evidence, expert or otherwise, to contradict Dr. Sudderth’s credible testimony that lab work is essential before prescribing Phentermine. Therefore, I find that lab work is required before prescribing Phentermine under the standard of care in Mississippi, regardless of the cost. PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 G. The Sixteen Additional Patient Files Dr. Sudderth also testified that he reviewed the patient files of sixteen of Respondent’s patients not included in the Board Order and concluded that Respondent did not meet the standard of care when he prescribed Phentermine to all sixteen patients. [Tr. 80; Gov’t Exhs. 12–27; Tr. 79–80, 106, 117, 123, 127, 128, 133, 138, 140–41, 145, 146, 150, 151, 152, 153]. The Government questioned Dr. Sudderth on only six of the sixteen patients whose files were entered into evidence: C.H., R.G., A.G., J.G., K.C., and P.H. 1. C.H. C.H.’s height and weight at the initial visit were recorded in the chart as 5′6″, 150 pounds. [Gov’t Exh. 12 at 13; Tr. 107–08]. No BMI was recorded, however, and Dr. Sudderth testified that he calculated C.H.’s BMI to be 24.2 using the patient’s recorded height and weight. [Tr. 109, 111; Gov’t Exh. 31]. Based on this BMI calculation, Dr. Sudderth testified that C.H. did not qualify for Phentermine prescriptions. [Tr. 111]. Dr. Sudderth further testified that Respondent’s ‘‘impression’’ that C.H. is ‘‘overweight,’’ recorded in the chart, is an incorrect diagnosis, and that there are no co-morbid conditions recorded in C.H.’s chart that would justify prescribing Phentermine. [Tr. 115]. As such, Dr. Sudderth testified that, in his opinion, Respondent did not ‘‘take a thorough history of [C.H.] as contemplated by the State regulations.’’ [Tr. 115]. Dr. Sudderth further testified that while Respondent recorded C.H.’s blood pressure and heart rate in the chart, he failed to record C.H.’s weight, diet, and gynecological history. [Tr. 111–12]. Additionally, on the chart, Respondent had drawn ‘‘squiggly lines’’ through all of the spaces designed to notate that the various organs were ‘‘normal.’’ [Tr. 112– 13; Gov’t Exh. 12 at 14]. The chart also had no indication that any lab work was conducted on C.H. [Tr. 114]. Thus, Dr. Sudderth testified that Respondent did not conduct a ‘‘thorough physical examination as contemplated under the regulations.’’ [Tr. 115–16]. Dr. Sudderth concluded that Respondent did not meet the standard of care when he prescribed C.H. Phentermine on her initial visit. [Tr. 117]. He noted that the chart does not reflect any legitimate medical justification for prescribing Phentermine to C.H. [Tr. 123–24]. Additionally, Dr. Sudderth testified that Respondent failed to meet the standard of care for prescribing Phentermine at each of C.H.’s follow-up E:\FR\FM\21OCN1.SGM 21OCN1 Federal Register / Vol. 79, No. 203 / Tuesday, October 21, 2014 / Notices visits. [Tr. at 123]. He reached this conclusion partly because in each of the seven follow-up visits notated in the chart, neither Respondent nor C.H. had any questions or concerns about the weight loss plan. [Tr. 120–23; Gov’t Exh. 12 at 11]. Dr. Sudderth testified that this is ‘‘very significant because I haven’t seen that in my 12-year career of doing weight loss, that there are no problems at any follow-up visit ever.’’ [Tr. 122]. mstockstill on DSK4VPTVN1PROD with NOTICES 2. R.G. R.G.’s initial height and weight were recorded in the chart as 5′4″, 141 pounds. [Tr. 125; Gov’t Exh. 13 at 13]. R.G.’s body fat and BMI were not measured, however, but Dr. Sudderth calculated R.G.’s BMI to be approximately 24, which is ‘‘normal.’’ [Tr. 125; Gov’t Exh. 31]. Thus, Dr. Sudderth testified that R.G. did not qualify for weight loss treatment with Phentermine. [Tr. 125]. Dr. Sudderth testified that R.G.’s weight, diet, exercise, and gynecological history were not recorded in the chart, except to note that R.G. is not pregnant.12 [Tr. 125; Gov’t Exh. 13 at 13–14]. Like in C.H.’s chart, the ‘‘Physical Examination’’ section of R.G.’s chart contained ‘‘squiggly lines’’ through all of the spaces designed to notate that the various organs were ‘‘normal.’’ [Tr. 126; Gov’t Exh. 13 at 14]. Because the chart contained a line through the part marked ‘‘Laboratory Findings,’’ Dr. Sudderth testified that he assumed no labs were conducted. [Tr. 126; Gov’t Exh. 13 at 14]. Dr. Sudderth testified that because R.G. has no co-morbid conditions and a BMI of 24, it was not appropriate to prescribe Phentermine to the patient. [Tr. 126, 127]. Also, similar to C.H.’s chart, Dr. Sudderth noted that the follow-up visits uncovered no questions or concerns about the weight loss program. [Tr. 127–28; Gov’t Exh 13 at 11]. Thus, Dr. Sudderth concluded that Respondent did not meet the standard of care in prescribing R.G. Phentermine during the seven follow-up visits. [Tr. 128; Gov’t Exh. 13 at 4–10]. In sum, Dr. Sudderth testified that ‘‘[t]here is no justification’’ for prescribing Phentermine to R.G. [Tr. 128]. 3. A.G. A.G.’s height and weight at the initial visit were 5′1″, 141 pounds. [Tr. 129, Gov’t Exh. 15 at 8]. A.G.’s BMI was not in the chart, but Dr. Sudderth calculated it to be 26.6. [Tr. 129; Gov’t Exh 31]. Respondent recorded his ‘‘impression’’ 12 Dr. Sudderth testified that simply noting the pregnancy status of a female patient does not constitute an adequate gynecological history report. [Tr. 136]. VerDate Sep<11>2014 18:05 Oct 20, 2014 Jkt 235001 of A.G. as ‘‘obesity.’’ [Tr. 129; Gov’t Exh 15 at 9]. Dr. Sudderth testified, however, that A.G. was not ‘‘obese,’’ but ‘‘overweight’’ according to the standard in Mississippi. [Tr. 129–30]. Dr. Sudderth further testified that A.G.’s diet, weight, exercise, and gynecological history were not noted in the file except that A.G. is not pregnant and that ‘‘she is on a Depo shot for birth control.’’ [Tr. 130; Gov’t Exh. 15 at 8]. In physical examination section of the chart, there were lines through all of the spaces designed to notate that the various organs were ‘‘normal.’’ [Tr. 130– 31; Gov’t Exh. 15 at 9]. The only organ with a notation other than the line was the abdomen, which had ‘‘obese’’ written in the ‘‘normal’’ column.13 [Tr. 130–31; Gov’t Exh. 15 at 9]. No lab work or co-morbid conditions were indicated on the chart. [Tr. 131; Gov’t Exh. 15 at 9]. Thus, Dr. Sudderth ultimately concluded that Respondent did not meet the standard of care when he prescribed A.G. Phentermine. [Tr. 133; Gov’t Exh. 15 at 4–5, 7]. 4. J.G. According to the chart, J.G. weighed 282 pounds and was 5′4″ tall when she first visited Respondent for weight loss. [Tr. 134; Gov’t Exh 20 at 12]. Her BMI was not included in the chart, but Dr. Sudderth calculated it to be approximately 48, which is high enough to qualify for a Phentermine prescription. [Tr. 134; Gov’t Exh. 31]. Respondent recorded three co-morbid conditions for J.G.: High blood pressure, high cholesterol, and diabetes. [Tr. 134– 35; Gov’t Exh. 20 at 12]. Dr. Sudderth testified that he would have ‘‘done a thorough history and physical’’ and ‘‘gotten labs on this patient and an EKG’’ before prescribing Phentermine, which can aggravate the co-morbid conditions reported by J.G. [Tr. 135]. J.G.’s chart had no lab findings recorded. [Tr. 136–37; Gov’t Exh. 20 at 13]. No weight, diet, exercise, or gynecological history was recorded on the chart except that J.G. is not pregnant. [Tr. 135–36; Gov’t Exh. 20 at 12]. J.G.’s chart included heart rate and blood pressure measurements, but the section for organ examinations, like in the other charts, had a ‘‘squiggly line’’ through the ‘‘normal’’ boxes. [Tr. 136; Gov’t Exh. 20 at 13]. Respondent recorded his ‘‘impression’’ of J.G. as ‘‘overweight,’’ which Dr. Sudderth 13 Dr. Sudderth noted that describing an abdomen as ‘‘obese’’ is inaccurate. ‘‘You may characterize it as protuberant, large. It may be described in many different ways, but you wouldn’t describe an abdomen as obese. You may describe a person as obese but not an abdomen.’’ [Tr. 131]. PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 62963 testified is an inappropriate diagnosis— Respondent should have diagnosed J.G. as ‘‘morbidly obese.’’ [Tr. 137; Gov’t Exh. 20 at 13]. Dr. Sudderth testified that Respondent did not meet the standard of care when he prescribed Phentermine to J.G. on her first visit because Respondent did not conduct and record an adequately thorough physical examination and history. [Tr. 138]. Respondent prescribed J.G. Phentermine in each of six follow-up visits. [Tr. 139, 140; Gov’t Exh 20 at 4– 9, 11]. Dr. Sudderth testified that a visit on August 9, 2010 was particularly troubling, since J.G.’s blood pressure was especially high that day, apparently because J.G. had not taken her blood pressure medication. [Tr. 138–39; Gov’t Exh. 20 at 10]. Dr. Sudderth testified that, given J.G.’s unregulated blood pressure, prescribing J.G. Phentermine on that visit fell below the standard of care. [Tr. 139]. Similarly, J.G.’s blood pressure was even higher on her next visit, and Respondent once again prescribed Phentermine. [Tr. 139–40]. Dr. Sudderth thus concluded that Respondent fell below the standard of care by prescribing Phentermine to J.G. at each follow-up visit because he failed to perform adequate histories and physicals, he ignored contraindications such as high blood pressure, and ‘‘he has no follow-up visit that is of any substance, whatsoever.’’ [Tr. 141]. 5. K.C. K.C. was sixteen years old, weighed 142 pounds, and was 5′4″ tall when she first visited Respondent for weight loss. [Tr. 141–42; Gov’t Exh 21 at 9]. Her BMI was not recorded in her file, but Dr. Sudderth calculated it to be approximately 24, which classifies her weight as ‘‘normal.’’14 [Tr. 142, 144; Gov’t Exh. 31]. The patient chart included no weight, diet, or gynecological history recorded except that K.C. is not pregnant. [Tr. 143–44; Gov’t Exh. 21 at 9]. Notably, K.C.’s chart did not include any physical examination; in fact, the patient file did not even include the form Respondent normally used to record physical examinations. [Tr. 144; Gov’t Exh. 21]. Dr. Sudderth testified that Respondent fell below the standard of care by prescribing Phentermine on the 14 Dr. Sudderth explained that there is a slightly different standard for determining whether Phentermine is appropriate to prescribe to pediatric patients such as K.C. Specifically, children must be ‘‘in the 99th percentile or greater’’ in relation to ‘‘other kids their age’’ to qualify for a Phentermine prescription. [Tr. 144]. He testified that K.C. is a ‘‘normal 16-year-old girl who falls in the normal percentile of girls.’’ [Tr. 143–44]. E:\FR\FM\21OCN1.SGM 21OCN1 62964 Federal Register / Vol. 79, No. 203 / Tuesday, October 21, 2014 / Notices initial visit. [Tr. 144–45; Gov’t Exh. 21 at 8]. He also testified that Respondent fell below the standard of care by prescribing Phentermine to K.C. during three follow-up visits, where no problems or concerns were reported or discussed. [Tr. 145–46]. Dr. Sudderth testified that nowhere in the file was a legitimate medical reason or justification for prescribing K.C. Phentermine recorded. [Tr. 146; Gov’t Exh. 21]. mstockstill on DSK4VPTVN1PROD with NOTICES 6. P.H P.H. weighed 162 pounds and was 5′5″ tall on her initial visit to Respondent. [Gov’t Exh. 27 at 22]. No body fat or BMI were recorded, but Dr. Sudderth calculated it to be 26.9, which is classified as ‘‘overweight.’’ [Tr. 147; Gov’t Exh. 31]. No weight, diet, or gynecological history were recorded except that P.H. is not pregnant. [Tr. 147–48; Gov’t Exh. 27 at 22]. P.H.’s heart rate and blood pressure were recorded in the chart, and Dr. Sudderth testified that P.H. had high blood pressure. [Tr. 148; Gov’t Exh. 27 at 23]. Dr. Sudderth also testified that P.H.’s high blood pressure is probably ‘‘controlled’’ because ‘‘it’s high, but it’s not excessively high.’’ [Tr. 149]. No lab work was recorded in the file. [Tr. 148]. Respondent recorded his ‘‘impression’’ of P.H. as ‘‘desires weight loss,’’ which Dr. Sudderth testified was an inappropriate diagnosis. [Tr. 149]. Dr. Sudderth noted that P.H.’s BMI, combined with her co-morbid condition of high blood pressure, qualified her for Phentermine. [Tr. 150]. Dr. Sudderth concluded, however, that the physical examination and history of P.H. fell below the standard of care for prescribing Phentermine on the initial visit. [Tr. 150]. Respondent treated P.H. for about three years, prescribing Phentermine at each of fifteen follow-up visits. [Tr. 150–51, 152; Gov’t Exh. 27 at 4–23]. As with the other patients, Respondent noted no problems at any of the followup visits. [Tr. 151; Gov’t Exh 27 at 19– 20]. Dr. Sudderth testified that P.H.’s blood pressure was high at every followup visit, and ‘‘was worsening by the time she finished with Dr. White.’’ [Tr. 151; Gov’t Exh. 27 at 19–20]. Notably, Respondent did not diagnose or record P.H’s blood pressure as being high at any time during her treatment. [Tr. 151; Gov’t Exh. 27]. Dr. Sudderth concluded that Respondent fell below the standard of care each time he prescribed P.H. Phentermine at a follow-up visit. [Tr. 152]. VerDate Sep<11>2014 18:05 Oct 20, 2014 Jkt 235001 7. The Sixteen Patient Files Generally Outside the six patient files about which he specifically testified, Dr. Sudderth also testified generally that he reviewed all of the sixteen patient files the Government entered into evidence and that none of them included adequate histories, physicals, or lab work. [Tr. 106–07, 120, 152]. He thus concluded that Respondent fell below the standard of care in prescribing Phentermine to ‘‘[a]ll sixteen’’ of those patients’’ both in their initial visits, and in all follow-up visits. [Tr. 153]. He additionally testified that seven of the sixteen patients did not qualify for Phentermine based on their BMIs, which Dr. Sudderth calculated himself since they were not documented in the charts. [Tr. 110–11; Gov’t Exh. 31]. Dr. Sudderth also testified that in the sixteen patient files he reviewed, ‘‘there was no follow-up visit to speak of, of any substance that would qualify these patients to receive more Phentermine.’’ [Tr. 106–07]. H. Letters from Respondent’s Patients At the hearing, the Government offered into evidence hundreds of letters written by Respondent’s patients, vouching for the quality of care Respondent provided them. [Gov’t Exh. 30; Tr. 54]. To the extent that Respondent relies on these letters to prove that denying his registration would impose a burden on his patients, I find the letters irrelevant. The Agency has consistently held that so-called ‘‘community impact evidence’’ is not relevant in these proceedings. See Linda Sue Cheek, M.D., 76 Fed. Reg. 66,972, 66,973 (DEA 2011); Steven M. Abbadessa, D.O., 74 Fed. Reg. 10,077, 10,078 (DEA 2009); Mark De La Lama, P.A., 76 Fed. Reg. 20,011, 20,020 n.20 (DEA 2011); Bienvenido Tan, M.D., 76 Fed. Reg. 17,673, 17,694 n.58 (DEA 2011); Gregory D. Owens, D.D.S, 74 Fed. Reg. 36,751, 36,757 & n.22 (DEA 2009); Kwan Bo Jin, M.D., 77 Fed. Reg. 35,021, 35,021 (DEA 2012). V. STATEMENT OF LAW AND DISCUSSION A. Positions of the Parties 1. Government’s Position The Government timely filed Government’s Proposed Findings of Fact and Conclusions of Law (‘‘Government’s Brief’’) with this Court on April 2, 2014. The bulk of the Government’s argument is that Respondent deviated from the standard of care by performing ‘‘woefully inadequate’’ physical examinations, failing to obtain patient’s medical histories, and failing to measure PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 patients’ BMI before prescribing Phentermine to the sixteen patients at issue in these proceedings and to the five patients at issue in the Board Order. [Gov’t Br. at 36–39]. In addition, the Government argues that Respondent violated the Board’s order to complete certain CME courses within six months of the Order. [Gov’t Br. at 39]. According to the Government, these facts, which are largely undisputed, prove that Respondent’s registration would be inconsistent with the public interest. [Gov’t Br. at 39–40]. The Government also argues that Respondent failed to prove that he has taken responsibility for his actions and therefore failed to rebut the Government’s prima facie case. [Gov’t Br. at 42]. The Government points out various portions of Respondents’ testimony where Respondent attempted to minimize his misconduct and criticized the laws, standards, rules, and regulations concerning the prescription of Phentermine. [Gov’t Br. at 42–45]. This testimony, the Government argues, shows that Respondent has failed to take responsibility for his actions. [Gov’t Br. at 44]. Moreover, the Government argues that Respondent failed to take responsibility for his actions in the criminal trial, where he testified that he had done nothing improper. [Gov’t Br. at 44]. Accordingly, the Government argues that Respondent has failed to rebut the Government’s prima facie case because any acceptance of responsibility—which is minimal—is not credible. [Gov’t Br. at 44–45]. 2. Respondent’s Position Respondent timely filed Respondent’s Proposed Findings of Fact and Conclusions of Law (‘‘Respondent’s Brief’’) on April 2, 2014. Therein, Respondent makes three arguments. First, Respondent argues that his registration would be consistent with the public interest because he has never harmed any of his patients and has never been the subject of any medical malpractice complaint. [Resp’t Br. at 7]. In Respondent’s view, the fact that law enforcement investigated Respondent for months before taking any action supports the conclusion that Respondent’s misconduct was not seriously harmful or egregious. [Resp’t Br. at 8–9]. Second, Respondent argues that he has taken responsibility for his actions, as evidenced by his voluntary relinquishment of his DEA registration and his agreement to forego treating patients for weight loss. [Resp’t Br. at 7]. Lastly, Respondent argues that his registration is consistent with the public interest because, after a criminal trial E:\FR\FM\21OCN1.SGM 21OCN1 Federal Register / Vol. 79, No. 203 / Tuesday, October 21, 2014 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES and two hearings before the Board, the Board still saw fit to permit Respondent to practice medicine. [Resp’t Br. at 9– 10]. B. Statement of Law and Analysis Pursuant to 21 U.S.C. § 823(f), the Deputy Administrator may deny an application for a DEA COR if he determines that such registration would be inconsistent with the public interest.15 In determining the public interest, the following factors are considered: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant’s experience in dispensing, or conducting research with respect to controlled substances. (3) The applicant’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). These factors are to be considered in the disjunctive; the Deputy Administrator may rely on any one or a combination of factors and may give each factor the weight he deems appropriate in determining whether a registration should be revoked or an application for registration be denied. See Robert A. Leslie, M.D., 68 Fed. Reg. 15,227, 15,230 (DEA 2003) (citing Henry J. Schwartz, Jr. M.D., 54 Fed. Reg. 16,422, 16,424 (DEA 1989)). Moreover, the Deputy Administrator is ‘‘not required to make findings as to all of the factors.’’ Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173–74 (D.C. Cir. 2005). Thus, ‘‘this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor’’ each party. Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 462 (DEA 2009). ‘‘Rather, it is an inquiry which focuses on protecting the public interest. . . .’’ Id. The Government bears the ultimate burden of proving that the requirements for registration are not satisfied. 21 C.F.R. § 1301.44(d) (2014). Specifically, the Government must show that Respondent has committed acts that are inconsistent with the public interest. 21 U.S.C. § 823(f); Jeri Hassman, M.D., 75 Fed. Reg. 8,194, 8,227 (DEA 2010). However, where the Government has 15 The Deputy Administrator has the authority to make such a determination pursuant to 28 C.F.R. §§ 0.100(b), 0.104 (2013). VerDate Sep<11>2014 18:05 Oct 20, 2014 Jkt 235001 made out a prima facie case that Respondent’s application would be ‘‘inconsistent with the public interest,’’ the burden of production shifts to the applicant to ‘‘present[ ] sufficient mitigating evidence’’ to show why he can be trusted with a new registration. See Medicine Shoppe—Jonesborough, 73 Fed. Reg. 364, 387 (DEA 2008). To this point, the Agency has repeatedly held that the ‘‘registrant must accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct.’’ Id.; see also Samuel S. Jackson, D.D.S., 72 Fed. Reg. 23,848, 23,853 (DEA 2007). The Respondent must produce sufficient evidence that he can be trusted with the authority that a registration provides by demonstrating that he accepts responsibility for his misconduct and that the misconduct will not reoccur. See id.; see also Samuel S. Jackson, D.D.S., 72 Fed. Reg. at 23,853. The DEA has consistently held the view that ‘‘past performance is the best predictor of future performance.’’ Alra Laboratories, 59 Fed. Reg. 50,620 (DEA 1994), aff’d, Alra Laboratories, Inc. v. DEA, 54 F.3d 450, 451 (7th Cir 1995). Factor One: Recommendation of Appropriate State Licensing Board Recommendations of state licensing boards are relevant, but not dispositive, in determining whether a respondent should be permitted to maintain a registration. See Gregory D. Owens, D.D.S., 74 Fed. Reg. 36,751, 36,755 (DEA 2009); see also Martha Hernandez, M.D., 62 Fed. Reg. 61,145, 61,147 (DEA 1997). According to clear agency precedent, a ‘‘state license is a necessary, but not a sufficient condition for registration.’’ Robert A. Leslie, M.D., 68 Fed. Reg. at 15,230; John H. Kennedy, M.D., 71 Fed. Reg. 35,705, 35,708 (DEA 2006). DEA possesses ‘‘a separate oversight responsibility with respect to the handling of controlled substances,’’ which requires the Agency to make an ‘‘independent determination as to whether the granting of [a registration] would be in the public interest.’’ Mortimer B. Levin D.O., 55 Fed. Reg. 8,209, 8,210 (DEA 1990); see also Jayam Krishna-Iyer, 74 Fed. Reg. at 461. Even the reinstatement of a state medical license does not affect this Agency’s independent responsibility to determine whether a DEA registration is in the public interest. Levin, 55 Fed. Reg. at 8,210. The ultimate responsibility to determine whether a registration is consistent with the public interest has been delegated exclusively to the DEA, not to entities within state government. Edmund Chein, M.D., 72 Fed. Reg. PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 62965 6,580, 6,590 (DEA 2007), aff’d Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008). Thus, Agency precedent holds that even where a respondent is licensed to practice medicine by a state licensing agency, factor one weighs neither for nor against registration unless the state licensing agency makes a direct recommendation regarding the respondent’s DEA registration. Mark G. Medinnus, D.D.S., 78 Fed. Reg. 62,683, 62,692–93 (DEA 2013); George R. Smith, M.D., 78 Fed. Reg. 44,972, 44,979 (DEA 2013); Robert M. Brodkin, D.P.M., 77 Fed. Reg. 73,678, 73,681 n.5 (DEA 2012); Jeffrey J. Becker, D.D.S., 77 Fed. Reg. 72,387, 72,403 (DEA 2012); Scott D. Fedosky, M.D., 76 Fed. Reg. 71,375, 71,377 (DEA 2011); Paul W. Battershell, 76 Fed. Reg. 44,359, 44,365 (DEA 2011); Robert L. Dougherty, 76 Fed. Reg. 16,823, 16,833 n.13 (DEA 2011); Gilbert Eugene Johnson, 75 Fed. Reg. 65,663, 65,666 n.3 (DEA 2010). Although it is undisputed in this case that Respondent’s state license is valid, [ALJ Exh. 4 at 4], the Board has not given a recommendation on whether Respondent’s application for a DEA registration should be granted. Therefore, factor one weighs neither for nor against Respondent’s registration.16 16 The Government argues that because Mississippi law prohibits physicians who have been the subject of a disciplinary action for improper prescribing practices from operating pain management clinics, the Board’s prohibition against Respondent operating a weight loss clinic ‘‘is the equivalent to a Board recommendation against Respondent handling controlled substances for pain management.’’ [Gov’t Br. at 31]. This argument, however, does not square with the Board Order, which allowed Respondent to practice medicine with full knowledge that Respondent owned a pain management clinic. Had the Board wished to restrict Respondent’s ability to practice pain management, it could have done so. Moreover, Agency precedent strongly suggests that anything less than a specific, direct recommendation from a state board to DEA regarding respondent’s suitability for DEA registration does not constitute a ‘‘recommendation’’ under factor one of the public interest analysis. See Mark G. Medinnus, D.D.S., 78 Fed. Reg. 62,683, 62,692–93 (DEA 2013) (holding that factor one weighed neither for nor against granting a registration because the state board ‘‘has not made a specific recommendation concerning the granting of a DEA registration to the Respondent’’); George R. Smith, M.D., 78 Fed. Reg. 44,972, 44,979 (DEA 2013) (holding that factor one weighed neither for nor against granting a registration because the state board ‘‘did not directly recommend that the Respondent’s DEA application for registration should be granted’’). I therefore decline to construe the Board’s findings as a recommendation by the Board that Respondent’s registration should be denied. E:\FR\FM\21OCN1.SGM 21OCN1 mstockstill on DSK4VPTVN1PROD with NOTICES 62966 Federal Register / Vol. 79, No. 203 / Tuesday, October 21, 2014 / Notices Factors Two and Four: Applicant’s Experience with Controlled Substances and Applicant’s Compliance with Applicable State, Federal, or Local Laws Relating to Controlled Substances Respondent’s experiences with handling controlled substances, as well as his compliance with laws related to controlled substances, are relevant considerations under the public interest analysis. Pursuant to the Controlled Substances Act, ‘‘[p]ersons registered by the Attorney General under this subchapter to . . . dispense controlled substances . . . are authorized to possess . . . or dispense such substances . . . to the extent authorized by their registration and in conformity with the other provisions of this subchapter.’’ 21 U.S.C. § 822(b); Leonard E. Reaves, III, M.D., 63 Fed. Reg. 44,471, 44,473 (DEA 1998); see also 21 C.F.R. § 1301.13(a) (providing that ‘‘[n]o person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Administrator to such person.’’). As such, the DEA properly considers practitioners’ past compliance with CSA requirements and DEA regulations in determining whether registering such a practitioner would be in the public interest. The first regulation applicable here is DEA’s long-standing requirement that a prescription be issued for ‘‘a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.’’ 21 C.F.R. § 1306.04(a). DEA precedent establishes that ‘‘a practitioner must establish and maintain a bona-fide doctor-patient relationship in order to be acting ‘in the usual course of . . . professional practice’ and to issue a prescription for a ‘legitimate medical purpose.’ ’’ Paul H. Volkman, 73 Fed. Reg. 30,630, 30,642 (DEA 2008). Whether a valid doctorpatient relationship was established is determined by looking to state law. Id. Here, Dr. Sudderth credibly testified regarding the steps physicians must take to create a doctor-patient relationship before legitimately prescribing Phentermine. Specifically, he testified that in Mississippi, before prescribing Phentermine, a physician must (1) document the patient’s history of diet, weight, exercise, and use of controlled substances for weight loss [Tr. 83–84]; (2) document the patient’s medical and family history [Tr. 85]; (3) perform and document a physical examination of the patient, including vital signs and some VerDate Sep<11>2014 18:05 Oct 20, 2014 Jkt 235001 form or adiposity measurement (BMI, waist circumference, or body fat) [Tr. 87–98]; and (4) perform lab work such as blood tests and an EKG [Tr. 99–102]. Dr. Sudderth further testified that to be prescribed Phentermine for weight loss, a patient must either (1) have a BMI of at least 30; or (2) have a BMI of at least 27 and have at least one comorbid condition. [Tr. 91, 105]. Some of these standards, including the requirement to perform physicals, document histories, and investigate prior weight loss efforts, are found in Chapter 25, Section 501(1) and (2) of the Rules and Regulations of the Board.17 [Gov’t Exh. 29]. Dr. Sudderth testified that Respondent fell below this standard of care for each of the sixteen patient files he reviewed. [Tr. 80, 106]. Specifically, Dr. Sudderth testified that Respondent failed to document the patients’ histories, conduct or document adequate physical exams, measure patients’ BMI, or do any lab work on the patients. [Tr. 114, 115–16, 120, 125, 126, 129, 130, 131, 137, 138, 142, 147, 148]. Additionally, Dr. Sudderth testified that seven of the sixteen patients had BMIs too low to justify prescribing Phentermine. [Tr. 110–11; see also Gov’t Exh. 31]. Further, Dr. Sudderth testified that Respondent failed to conduct any follow-up visit ‘‘of substance’’ that would justify the continued prescription of Phentermine to the patients. [Tr. 106– 07]. I find Dr. Sudderth’s testimony credible because his credentials are impeccable, his testimony was internally and externally consistent, and the testimony itself was largely unrebutted by Respondent. Indeed, when asked at the hearing if he disputes Dr. Sudderth’s testimony, Respondent replied, ‘‘Why would I dispute his testimony? He’s an expert.’’ [Tr. 219]. Accordingly, I find that Respondent failed to establish a bona-fide doctorpatient relationship before prescribing Phentermine to the sixteen patients at issue here, thus violating 21 C.F.R. § 1306.04(a).18 I also find that Respondent’s improper prescriptions of Phentermine to the sixteen patients at issue in these proceedings violated Chapter 25, Section 501(1) and (2) of the Rules and Regulations of the Board, which 17 The standards set forth in the Rules and Regulations of the Board for prescribing anorectics were revised in 2012. [Tr. 76]. The Government entered into evidence the version of the regulations that was in place during the time in question. [Tr. 81–82; Gov’t Exh. 29]. 18 21 C.F.R. § 1306.04(a) provides, in relevant part, ‘‘A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.’’ PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 requires documentation of a thorough physical examination, medical history, and a good-faith effort by the patient to lose weight without controlled substances before prescribing anorectics. [Gov’t Exh. 29 at 1–2]. Moreover, as noted supra, the Board found that Respondent violated multiple rules, regulations, and statutes by improperly prescribing Phentermine to five additional patients. Specifically, the Board found that Respondent violated Chapter 25, Section 501 of the Rules and Regulations of the Board by (1) failing to verify that the five patients made a good-faith effort to lose weight without the aid of controlled substances; (2) failing to obtain full medical histories and perform adequate physical examinations of the five patients; and (3) continuing to prescribe controlled substances to patients who failed to lose weight after thirty days of taking the controlled substances. [Gov’t Exh. 5 at 49–50]. Additionally, the Board found that Respondent violated title 73, chapter 25, section 29(3) of the Mississippi Code by dispensing ‘‘drugs having addiction-forming or addictionsustaining liability otherwise than in the course of legitimate professional practice.’’ [Gov’t Exh. 5 at 50]. Finally, the Board found that Respondent’s actions constituted ‘‘dishonorable or unethical conduct likely to deceive, defraud, or harm the public, in violation of Miss. Code Ann. 73–25–29(8)(d) and 73–24–83(a).’’ [Gov’t Exh. 5 at 50]. These findings of fact and law are binding on the Agency. David A. Ruben, M.D., 78 Fed. Reg. at 38,365–66; Dougherty, 76 Fed. Reg. at16,830–31. Respondent also failed to attend the CME courses required by the Board Order. Although Respondent offered an explanation for this failure—that he could not afford the courses 19—such explanations do not alter the fact that failing to attend the courses within six month of the Board Order constituted a violation of the Order. Therefore, because Respondent violated multiple rules, regulations, and statutes by prescribing Phentermine to twenty-one patients without a legitimate medical purpose and outside the usual course of professional practice, and because Respondent violated the Board Order by failing to attend the required CME courses, I find that factors two and four clearly weigh against Respondent’s registration. 19 I find this reason incredible, since the Respondent also testified that he has a monthly income of $15,000. [Tr. 207]. E:\FR\FM\21OCN1.SGM 21OCN1 Federal Register / Vol. 79, No. 203 / Tuesday, October 21, 2014 / Notices would be inconsistent with the public interest. Factor Three: Applicant’s Conviction Record Relating to Controlled Substances Pursuant to 21 U.S.C. § 823(f)(3), the Deputy Administrator may deny a pending application for a certificate of registration upon a finding that the applicant has been convicted 20 of a felony related to controlled substances under state or federal law. See Thomas G. Easter II, M.D., 69 Fed. Reg. 5,579, 5,580 (DEA 2004); Barry H. Brooks, M.D., 66 Fed. Reg. 18,305, 18,307 (DEA 2001); John S. Noell, M.D., 56 Fed. Reg. 12,038, 12,039 (DEA 1991). Here, it is undisputed that Respondent has not been convicted of any crimes relating to controlled substances. However, DEA precedent clearly holds that because there are ‘‘a number of reasons why a person may never be convicted of an offense falling under this factor, let alone be prosecuted for one, the absence of such a conviction is of considerably less consequence in the public interest inquiry.’’ Ruben, 78 Fed. Reg. at 38,379 n.35 (quoting Dewey C. MacKay, M.D., 75 Fed. Reg. 49,956, 49,973 (DEA 2010), pet. for rev. denied, MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011)). I therefore find that factor three weighs neither for nor against Respondent’s registration. Factor Five: Such Other Conduct Which May Threaten the Public Health and Safety mstockstill on DSK4VPTVN1PROD with NOTICES Under the fifth public interest factor, the Agency considers ‘‘[s]uch other conduct which may threaten the public health and safety.’’ 21 U.S.C. § 823(f)(5). Because the facts of this case do not implicate this factor,21 I find that factor five weighs neither for nor against Respondent’s registration. Therefore, because the Government proved by a preponderance of the evidence that Respondent violated multiple statutes, rules, and regulations relating to dispensing controlled substances, I find that the Government met its burden to prove its prima facie case that Respondent’s registration 20 The Administrator interprets the term ‘‘conviction’’ by affording it the ‘‘broadest possible meaning.’’ Donald Patsy Rocco, D.D.S., 50 Fed. Reg. 34,210, 34,211 (DEA 1985). Thus, evidence of a guilty plea is probative under the third factor of the public interest analysis. See, e.g., Farmacia Ortiz, 61 Fed. Reg. 726, 728 (DEA 1996); Roger Pharmacy, 61 Fed. Reg. 65,079, 65,080 (DEA 1996). 21 Under the heading of factor five, the Government’s Brief makes a host of arguments about Respondent’s credibility and his failure to accept responsibility. [Gov’t Br. at 40–45]. These arguments, however, are more properly asserted in the context of Respondent’s rebuttal case. See, e.g., Jeri Hassman, M.D., 75 Fed. Reg. 8,194, 8,235–36 (DEA 2010). I therefore address these arguments infra in the ‘‘Sanction’’ discussion. VerDate Sep<11>2014 18:05 Oct 20, 2014 Jkt 235001 Sanction Where the Government has made out a prima facie case that Respondent’s registration would be inconsistent with the public interest, the burden of production shifts to the applicant to ‘‘present[] sufficient mitigating evidence’’ to show why he can be trusted with a new registration. See Medicine Shoppe—Jonesborough, 73 Fed. Reg. at 387. To this point, the Agency has repeatedly held that the registrant must ‘‘accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct. Id.; see also Samuel S. Jackson, D.D.S., 72 Fed. Reg. 23,848, 23,853 (DEA 2007). Specifically, to rebut the Government’s prima facie case, the respondent is required ‘‘to accept responsibility for [the established] misconduct, [and] also to demonstrate what corrective measures [have been] undertaken to prevent the re-occurrence of similar acts.’’ Jeri Hassman, M.D., 75 Fed. Reg. 8,194, 8,236 (DEA 2010) (citing Jayam KrishnaIyer, M.D., 74 Fed. Reg. 459, 464 n.8 (DEA 2009)). In determining whether a respondent has accepted responsibility and whether misconduct will reoccur, the Agency has historically looked to a number of considerations, including genuine remorse and admission of wrongdoing, Lawrence C. Hill, M.D., 64 Fed. Reg. 30,060, 30,062 (DEA 1999), lapse of time since the wrongdoing, Norman Alpert, M.D., 58 Fed. Reg. 67,420, 67,421 (DEA 1993), candor with the court and DEA investigators, Jeri Hassman, M.D., 75 Fed. Reg. 8,194, 8,236 (DEA 2010), and attempts to minimize misconduct, Ronald Lynch, M.D., 75 Fed. Reg. 78,745, 78,754 (DEA 2010). The Agency has placed special emphasis on the need to deter intentional diversion of controlled substances, which includes issuing prescriptions ‘‘outside of the usual course of professional practice and [without] a legitimate medical purpose.’’ David A. Ruben, M.D., 78 Fed. Reg. at 38,386–87; see also Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,094–95 (DEA 2009). ‘‘Indeed, this Agency has revoked a practitioner’s registration upon proof of as few as two acts of intentional diversion and has further explained that proof of a single act of intentional diversion is sufficient to support the revocation of a registration.’’ David A. Ruben, M.D., 78 Fed. Reg. at 38,386 (citing Dewey C. MacKay, M.D., 75 Fed. Reg. 49,956, 49,977 (DEA 2010)). PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 62967 Here, Respondent’s improper prescribing methods clearly constituted intentional diversion. See David A. Ruben, M.D., 78 Fed. Reg. at 38,386–87 (defining intentional diversion as prescribing controlled substances ‘‘outside of the usual course of professional practice and [without] a legitimate medical purpose’’). The Agency thus has an interest in deterring Respondent and others from engaging in similar egregious behavior. That no one was injured as a result of Respondent’s misconduct is irrelevant; Agency precedent is clear that in light of the prescription drug abuse epidemic, even a single act of intentional diversion justifies revocation. David A. Ruben, M.D., 78 Fed. Reg. at 38,386. Moreover, Respondent’s purported acceptance of responsibility was tenuous at best. When asked on direct examination whether his weight loss prescribing practices were improper, he responded equivocally: ‘‘When I got busted, I realized it, yeah. I didn’t know—I had no idea that there was a strict rule on BMI.’’ [Tr. 193]. When asked on cross-examination whether he admits to prescribing controlled substances without medical justification, Respondent responded that he had ‘‘never given anything to somebody without a medical justification, in my opinion.’’ [Tr. 214]. But when pressed on the same question, Respondent quickly changed his tune and answered, ‘‘According to the rules, I guess, yes.’’ [Tr. 214]. Similarly, when asked whether his weight-loss practice was ‘‘improperly run,’’ Respondent replied, ‘‘I said I broke some rules and regulations. I didn’t say it was anything improper.’’ [Tr. 221–22]. Indeed, not once during the hearing did Respondent unequivocally admit fault for his improper Phentermine prescriptions. Respondent’s purported admission of guilt was also undermined by his tendency to blame others and make excuses for his misconduct. For example, he testified several times that in his weight loss practice he was ‘‘just doing the same practice that I know other physicians do.’’ [Tr. 217; see also Tr. 190 (‘‘. . . there were a lot of doctors doing it in town, and I followed what they did.’’)]. Indeed, when Respondent was asked on cross examination whether he believed he was ‘‘picked on by the DEA,’’ he responded, ‘‘I don’t believe it. I know it.’’ [Tr. 222]. In addition, Respondent admitted that his practices were ‘‘less than desirable,’’ and then, practically in the same breath, blamed the undesirable practices on his staff: ‘‘I didn’t know that [my histories and physicals] were that less than desirable because they were all done by E:\FR\FM\21OCN1.SGM 21OCN1 62968 Federal Register / Vol. 79, No. 203 / Tuesday, October 21, 2014 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES my nurse practitioners.’’ 22 [Tr. 197]. In short, Respondent blamed other physicians, the DEA, and his own staff for his current predicament rather than take the responsibility himself. Respondent also minimized the severity of his misconduct by suggesting that he thinks the requirements for prescribing Phentermine are too strict. For example, Respondent testified in these proceedings and at his criminal trial, ‘‘I mean, you can get a tummy tuck, a facelift, whatever you want, but you can’t get a—you can’t get a diet pill. Come on.’’ [Tr. 193; see also Tr. 198–99; Gov’t Exh. 11 at 115]. In his criminal trial, Respondent testified, ‘‘You can get phentermine over the internet from Canada. Nurses can write for it. It’s a Schedule IV drug like cough syrup. I mean, it’s so safe. The addiction potential is so low.’’ [Gov’t Exh. 11 at 119]. Additionally, Respondent testified in his criminal trial that BMI measurements are ‘‘worthless.’’ [Tr. 216; Gov’t Exh. 11 at 117]. In other words, rather than acknowledging his faults, Respondent opted to criticize the standards put in place by the medical community, the Board, and the DEA. I also find it significant that Dr. Van Craig, the executive director of the Board, remembered Respondent as being ‘‘angry with the Board for disciplining him’’ and felt that Respondent believed he had received ‘‘rather harsh treatment from the Board because of what he was doing.’’ [Tr. 60, 61; see also Tr. 66]. Indeed, Respondent’s demeanor described by Dr. Van Craig is consistent with the hostile tone Respondent took during the hearings in these proceedings.23 The above-noted examples do not reflect someone who feels remorse for his misconduct or understands the gravity of his mistakes. Rather, they illustrate that Respondent takes no responsibility for his actions, blames others for his improper prescribing methods, and disagrees with the rules regarding the dispensing of Phentermine. Additionally, other than a 22 I note that immediately following this remark, Respondent purported to take responsibility by saying, ‘‘Although, I’m responsible, so I take the cold blame for them myself.’’ [Tr. 197]. In context, however, I find this acceptance of responsibility to be disingenuous; he made this statement only after clearly placing blame on someone else. 23 Respondent’s counsel, at the hearing, suggested that Respondent’s ‘‘loud and obnoxious’’ tone is a result of his hearing impairment rather than his lack of remorse or hostility toward the Board or the DEA. [Tr. 66]. During the hearing in these proceedings, I certainly noticed that Respondent’s hearing disability affected him. [E.g., Tr. 225, 226]. But Respondent’s hearing did not appear to be what motivated his tone or his statements, discussed supra, which gave cause for concern regarding his remorse and acceptance of responsibility. VerDate Sep<11>2014 18:05 Oct 20, 2014 Jkt 235001 promise to comply with the Board’s order to refrain from treating weight loss patients, Respondent has offered no evidence of remedial measures he has taken to ensure that future violations will not occur. As such, I find that Respondent has not taken responsibility for his misconduct and therefore has failed to rebut the Government’s prima facie case. VI. CONCLUSION AND RECOMMENDATION Because the Government met its burden to prove that Respondent’s registration would be inconsistent with the public interest, and because Respondent failed to rebut the Government’s case, I recommend that the Deputy Administrator deny Respondent’s application. Dated: April 16, 2014 s/Gail A. Randall, Administrative Law Judge CERTIFICATE OF SERVICE This is to certify that the undersigned, on llllll, 2013, caused a copy of the foregoing to be faxed and placed in the interoffice mail addressed to DEA Headquarters, Attn: Office of Chief Counsel/Michelle Gillice, Esq., 8701 Morrissette Drive, Springfield, VA 22152, Fax: (202) 307–4946, and a copy to be faxed and mailed to Respondent’s Counsel, Rodney A. Ray, Esq., P. O. Box 1018, Columbus, MS 39703, Fax: (662) 329–3522. Carlene R. Thomas, Secretary to The Honorable Gail A. Randall [FR Doc. 2014–25025 Filed 10–20–14; 8:45 am] BILLING CODE 4410–09–P The APB will meet in open session from 8:30 a.m. until 5 p.m., on December 3–4, 2014. DATES AND TIMES: DEPARTMENT OF JUSTICE Federal Bureau of Investigation Meeting of the CJIS Advisory Policy Board Federal Bureau of Investigation (FBI), DOJ. ACTION: Meeting notice. AGENCY: The purpose of this notice is to announce the meeting of the Federal Bureau of Investigation’s Criminal Justice Information Services (CJIS) Advisory Policy Board (APB). The FBI CJIS APB is a federal advisory committee established pursuant to the Federal Advisory Committee Act (FACA). This meeting announcement is being published as required by Section 10 of the FACA. The FBI CJIS APB is responsible for reviewing policy issues and appropriate technical and operational issues related SUMMARY: PO 00000 Frm 00029 Fmt 4703 to the programs administered by the FBI’s CJIS Division, and thereafter, making appropriate recommendations to the FBI Director. The programs administered by the CJIS Division are the Next Generation Identification, Interstate Identification Index, Law Enforcement Enterprise Portal, National Crime Information Center, National Instant Criminal Background Check System, National Incident-Based Reporting System, National Data Exchange, and Uniform Crime Reporting. This meeting is open to the public. All attendees will be required to checkin at the meeting registration desk. Registrations will be accepted on a space available basis. Interested persons whose registrations have been accepted may be permitted to participate in the discussions at the discretion of the meeting chairman and with approval of the Designated Federal Officer (DFO). Any member of the public may file a written statement with the Board. Written comments shall be focused on the APB’s current issues under discussion and may not be repetitive of previously submitted written statements. Written comments should be provided to Mr. R. Scott Trent, DFO, at least seven (7) days in advance of the meeting so that the comments may be made available to the APB for their consideration prior to the meeting. Anyone requiring special accommodations should notify Mr. Trent at least seven (7) days in advance of the meeting. Sfmt 9990 The meeting will take place at Hyatt Regency Jacksonville, 225 E. Coastline Drive, Jacksonville, Florida, 32202, telephone (904) 588–1234. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Inquiries may be addressed to Ms. Skeeter J. Murray; Management and Program Analyst; CJIS Training and Advisory Process Unit, Resources Management Section; FBI CJIS Division, Module C2, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306–0149; telephone (304) 625–3518, facsimile (304) 625–5090. Dated: October 14, 2014. R. Scott Trent, CJIS Designated Federal Officer, Criminal Justice Information Services Division, Federal Bureau of Investigation. [FR Doc. 2014–24966 Filed 10–20–14; 8:45 am] BILLING CODE 4410–02–P E:\FR\FM\21OCN1.SGM 21OCN1

Agencies

[Federal Register Volume 79, Number 203 (Tuesday, October 21, 2014)]
[Notices]
[Pages 62957-62968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25025]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 13-16]


Michael A. White, M.D.; Decision and Order

    On April 16, 2014, Administrative Law Judge (ALJ) Gail A. Randall 
issued the attached Recommended Decision (R.D.).\1\ Respondent filed 
Exceptions to the Recommended Decision. Having reviewed the entire 
record including Respondent's Exceptions, I have decided to adopt the 
ALJ's findings of fact, conclusions of law, and recommended sanction 
except as explained below.\2\ A discussion of Respondent's Exceptions 
follows.
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    \1\ All citations to the Recommended Decision are to the slip 
opinion as issued by the ALJ.
    \2\ I decline to publish the ALJ's discussion of the substantial 
evidence standard. It suffices to say that in reviewing the factual 
findings of a recommended decision, this Agency adheres to the 
principles set forth in Universal Camera Corp. v. NLRB, 340 U.S. 
474, 496 (1951).
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Respondent's Exceptions

    In his Exceptions, Respondent raises five different contentions. 
Notably, however, Respondent does not challenge any of the ALJ's 
factual findings (including her findings that were based on the 
testimony of the Government's Expert) regarding his prescribing of 
phentermine to the sixteen patients at issue in this proceeding. See 
generally Exceptions, at 1-4. Nor does he challenge the ALJ's legal 
conclusion ``that Respondent failed to establish a bona-fide doctor-
patient relationship before prescribing [p]hentermine to the sixteen 
patients at issue here, thus violating 21 CFR 1306.04(a).'' R.D. at 33; 
see also Exceptions, at 1-4.
    The ALJ also made extensive findings based on the results of a 
January 19, 2012 hearing conducted by the Mississippi State Board of 
Medical Licensure regarding Respondent's prescribing of phentermine to 
five other persons. GX 5. Following the hearing, at which Respondent 
was represented by counsel, the Board found him guilty of violating 
various provisions of both state law and the Board's rules.
    More specifically, with respect to each of the five persons, the 
Board found that Respondent failed to obtain a thorough history or 
complete a thorough physical examination prior to initiating treatment 
utilizing a Schedule IV controlled substance.\3\ Id. at 49 (citing 
Miss. Code Ann. Sec.  73-25-29(13); 25 Miss. Code R. Sec.  501(2)). The 
Board further found that Respondent had violated its rule prohibiting 
the continued prescribing of controlled substances classified as 
amphetamine like anorectics and/or central nervous system stimulants to 
a patient who had failed to lose weight after taking the controlled 
substances over a period of thirty days. Id. (citing Miss. Code Ann. 
Sec.  73-25-29(13)).
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    \3\ The Board also found that he had ``initiated treatment 
utilizing a Schedule IV controlled substance without having 
performed a review of the patient's prior medical and weight-loss 
program records to determine that the patient had made a substantial 
good-faith effort to lose weight in a treatment program utilizing a 
regimen of weight reduction based on caloric restriction, 
nutritional counseling, behavior modification and exercise, without 
the utilization of controlled substances, and that said treatment 
had been ineffective, all in violation of Miss. Code Ann. Sec.  73-
25-29(13).'' GX 5, at 49 (citing 25 Miss. Code R. Sec.  501(1)).
---------------------------------------------------------------------------

    Most significantly, with respect to each of the five patients at 
issue in the proceeding, the Board found Respondent ``guilty of 
dispensing drugs having addiction-forming or addiction-sustaining 
liability otherwise than in the course of legitimate professional 
practice.'' Id. at 16 (citing Miss. Code Ann. Sec.  73-25-29(3)). This 
finding is equivalent to a finding that Respondent violated 21 CFR 
1306.04(a), which requires that a controlled-substance prescription 
``be issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his professional practice.''
    Here again, Respondent did not challenge the ALJ's findings of fact 
and conclusions of law which were based on the Board's findings. 
Indeed, nowhere in his Exceptions does he dispute the ALJ's legal 
conclusions that he violated the Controlled Substance Act's 
prescription requirement with respect to some twenty-one patients.
    Instead, he argues that the denial of his application is 
unwarranted because there is no evidence that any person he prescribed 
to has been injured or died as a result of his unlawful prescribing of 
controlled substances. Exceptions, at 1-2. The short answer to 
Respondent's contention is that proving injury is not an element of an 
allegation that a physician violated 21 CFR 1306.04(a). Rather, proof 
of such a violation is established by showing that in issuing the 
prescription, the physician acted outside of the usual course of 
professional practice and lacked a legitimate medical purpose, and such 
proof establishes that a physician knowingly or intentionally diverted 
a controlled substance.
    Respondent also argues that the ALJ's findings and recommendation 
are erroneous because he was found not guilty in a criminal proceeding 
``after the exact evidence was presented and the same witness 
testimony[ ] that was presented'' at the DEA hearing. Exceptions, at 2. 
Putting aside whether the exact same evidence was presented at both his 
criminal trial and the DEA proceeding (the latter appearing to include 
evidence of his misconduct in prescribing to far more patients than 
were at issue in the former), Respondent ignores that the State Board 
also found him guilty of dispensing controlled substances other than in 
the course of legitimate professional practice (i.e., without a 
legitimate medical purpose). See GX 5, at 50.
    As for his related argument that ``[t]he irony is overwhelming that 
the public who he could potentially harm did not buy the DEA's 
assertions while sitting in the jury box,'' Exceptions, at 2-3; 
Respondent ignores that because of the greater consequences that attach 
upon a criminal conviction, a higher standard of proof applies in a 
criminal trial than in an administrative proceeding. Indeed, given that 
Respondent does not challenge any of the ALJ's findings with respect to 
whether he violated the CSA's prescription requirement and diverted 
controlled substances, there is more than ample evidence to support the 
conclusion that he poses a potential danger to the public. See Gonzales 
v. Oregon, 546 U.S. 243, 274 (2006) (``the 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

[[Page 62958]]

crave the drugs for those prohibited uses'') (citing United States v. 
Moore, 423 U.S. 122, 135, 143 (1975)).
    As further support for his contention that he ``poses no threat or 
risk'' to the public, Respondent points to the fact that the State 
Board has allowed him to continue to practice medicine.\4\ Exceptions, 
at 3. Contrary to Respondent's understanding, the denial of his 
application for a DEA registration does not prevent him from practicing 
medicine. It only prevents him from dispensing controlled substances, a 
remedy which is more than warranted considering the extensiveness of 
his misconduct and his failure to accept responsibility for it. See 
R.D. at 37 (noting that Respondent's ``acceptance of responsibility was 
tenuous at best,'' that ``not once during the hearing did Respondent 
unequivocally admit fault for his improper [p]hentermine 
prescriptions,'' and that his ``purported admission of guilt was also 
undermined by his tendency to blame others and make excuses for his 
misconduct'').
---------------------------------------------------------------------------

    \4\ While in exercising its sovereign power to regulate the 
medical profession within the State, the Mississippi Board may have 
chosen to allow Respondent to continue to practice medicine, this 
``Agency has long held that `the Controlled Substances Act requires 
that the Administrator . . . make an independent determination [from 
that made by state officials] as to whether the granting of 
controlled substance privileges would be in the public interest.' '' 
David A. Ruben, 78 FR 38363, 38379 n.35 (2013) (quoting Mortimer 
Levin, 57 FR 8680, 8681 (1992)).
---------------------------------------------------------------------------

    As the Tenth Circuit has recognized:

    The DEA may properly consider whether a physician admits fault 
in determining if the physician's registration should be revoked. 
When faced with evidence that a doctor has a history of distributing 
controlled substances unlawfully, it is reasonable for the [Agency] 
to consider whether that doctor will change his or her behavior in 
the future. And that consideration is vital to whether continued 
registration is in the public interest.

MacKay v. DEA, 664 F.3d 808, 820 (10th Cir. 2011) (citing Hoxie v. DEA, 
419 F.3d 477, 483 (6th Cir. 2005)); see also Jayam Krishna-Iyer, 74 FR 
459, 462 (2009) (holding that even where the evidence shows that an 
applicant or registrant has committed only a few acts of intentional 
diversion, ``this Agency will not grant or continue the practitioner's 
registration unless he accepts responsibility for his misconduct'').

    As for his contention that this proceeding ``is nothing more than a 
vindictive act by'' the Agency because he was acquitted in his criminal 
case, Exceptions at 3, here again, Respondent ignores that two separate 
bodies have found that he knowingly diverted controlled substances, and 
the ALJ's findings, which he does not challenge, establish that he 
diverted controlled substances to more than twenty patients. Because 
his misconduct is egregious and Respondent has failed to accept 
responsibility for it, I reject his exceptions and will adopt the ALJ's 
recommended order that I deny his application.\5\
---------------------------------------------------------------------------

    \5\ I have also considered his final contention, which takes 
issue with the ALJ's finding that Respondent took a ``hostile tone'' 
during the hearing and argues that this finding establishes that the 
ALJ was not impartial. R.D. at 38; Exceptions, at 3-4. He cites no 
authority for the contention that a trier of fact cannot consider a 
witness's tone in assessing his credibility, and because the ALJ was 
in the best position to observe Respondent's demeanor during the 
hearing, I reject the contention.
---------------------------------------------------------------------------

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well 
as 28 CFR 0.100(b) and 0.104, I order that the application of Michael 
A. White, M.D., for a DEA Certificate of Registration as a practitioner 
be, and it hereby is, denied. This Order is effective immediately.

    Dated: October 10, 2014.
Thomas M. Harrigan,
Deputy Administrator.

Michelle F. Gillice, Esq., and
Frank W. Mann, Esq., for the Government
Rodney A. Ray, Esq., for the Respondent

RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION 
OF THE ADMINISTRATIVE LAW JUDGE

Gail A. Randal, Administrative Law Judge.

I. INTRODUCTION

    This proceeding is an adjudication pursuant to the Administrative 
Procedure Act, 5 U.S.C. Sec.  551 et seq., to determine whether the 
Drug Enforcement Administration (``DEA'' or ``Government'') should deny 
a physician's application for a DEA Certificate of Registration 
pursuant to 21 U.S.C. Sec.  823(f) (2006). Without his registration, 
the physician, Michael A. White, M.D. (``Respondent'' or ``Dr. 
White''), would be unable to lawfully prescribe, dispense or otherwise 
handle controlled substances in the course of his medical practice.

II. PROCEDURAL HISTORY

    The Deputy Assistant Administrator, Drug Enforcement Administration 
(``DEA'' or ``Government''), issued an Order to Show Cause (``OTSC'') 
dated July 2, 2013, proposing to deny the Respondent's application for 
a DEA Certificate of Registration, as a practitioner, pursuant to 21 
U.S.C. Sec. Sec.  824(a)(4) and 823(f) because the Respondent's 
registration would be inconsistent with the public interest, as that 
term is defined in 21 U.S.C. Sec.  823(f). [Administrative Law Judge 
Exhibit (``ALJ Exh.'') 1 at 1].
    Specifically, the OTSC stated that according to a January 19, 2012 
order (``Board Order'' or ``Order'') from the Mississippi State Board 
of Medical Licensure (``Board''), Respondent violated several state 
laws relating to controlled substances. [Id. at 2]. First, the OTSC 
alleged that, according to the Board Order, Respondent violated title 
73, chapter 25, section 29(3) of the Mississippi Code by dispensing 
drugs having addiction-forming or addiction-sustaining liability 
outside of the course of legitimate professional practice. [Id.]. 
Second, the OTSC alleged that, according to the Board Order, Respondent 
violated Chapter 25, Section 501 of the Board's Rules and Regulations 
by prescribing a Schedule IV controlled substance without first 
reviewing the patient's records to determine if the patient had made a 
good-faith effort to lose weight using caloric restriction, nutritional 
counseling, behavior modification, and exercise. [Id.]. Third, the OTSC 
alleged that, according to the Board Order, Respondent violated Chapter 
25, Section 501(2) of the Board's Rules and Regulations by prescribing 
a Schedule IV controlled substance without first obtaining a thorough 
history or completing a thorough physical examination of the patient. 
[Id.]. Fourth, the OTSC alleged that, according to the Board Order, 
Respondent violated Chapter 25, Section 501(5)(a) of the Board's Rules 
and Regulations by continuing to prescribe a Schedule IV controlled 
substance to patients who failed to lose weight over a thirty day 
period. [Id.]. Finally, the OTSC alleged that, according to the Board 
Order, Respondent's improper prescribing of a Schedule IV controlled 
substance constituted unprofessional conduct under Mississippi Code 
Ann. 73-24-83(a). Additionally, the Order alleged that Respondent 
failed to obey the Board Order's requirement that Respondent submit 
proof that he completed 40 hours of continuing medical education 
(``CME''). [Id. at 2-3]. The OTSC alleged that as a result of these 
violations, the Board suspended Respondent's medical license for six 
months and permanently prohibited Respondent from treating patients for

[[Page 62959]]

weight loss with controlled substances. [Id.at 2].
    The OTSC further alleged that Respondent's issuing of prescriptions 
for Schedule IV controlled substances without a legitimate medical 
purpose and outside the usual course of business violated 21 C.F.R. 
Sec.  1306.04(a). [Id.].
    On July 31, 2013, the Respondent, through counsel, timely filed a 
request for a hearing. [ALJ Exh. 2].
    The hearing in this case took place on January 29, 2014 in Oxford, 
Mississippi. [ALJ Exh. 7; Transcript (``Tr.'') 1]. Respondent and the 
Government were each represented by counsel. At the hearing, the 
Government introduced documentary evidence and called three witnesses 
and Respondent called one witness, himself. [Tr. 3].
    After the hearing, the Government and the Respondent submitted 
proposed findings of fact, conclusions of law, and argument.

III. ISSUE

    The issue in this proceeding is whether or not the record as a 
whole establishes by a preponderance of the evidence that the Drug 
Enforcement Administration should deny the application for a DEA 
Certificate of Registration (``COR'') of Dr. Michael A. White, as a 
practitioner, pursuant to 21 U.S.C. Sec.  823(f), because to grant his 
application would be inconsistent with the public interest, as that 
term is defined in 21 U.S.C. Sec.  823(f). [Tr. 6; ALJ Exh. 4 at 1].

IV. FINDINGS OF FACT

A. Stipulated Facts

    The parties have stipulated to the following facts:
    1. Respondent applied for a DEA COR as a practitioner in Schedules 
II-V at the Pain Clinic LLC, 3499 Bluecutt Road, Suite 1, Columbus, 
Mississippi, 39701 on March 21, 2012.
    2. Respondent was previously registered with DEA as a practitioner 
in Schedules II-V under DEA COR number BW3923009 at 3499 Bluecutt Road, 
Suite 1, P.O. Box 7757, Columbus, Mississippi, 39705.
    3. On September 22, 2011, DEA issued an Order to Show Cause to 
Respondent seeking revocation of his DEA COR BW3923009.
    4. Phentermine is a Schedule IV controlled substance pursuant to 21 
C.F.R. Sec.  1308.14(e)(9).
    5. Respondent voluntarily surrendered his COR BW3923009 on March 
16, 2012.
    6. On June 21, 2011, DEA and other law enforcement officials 
executed a search warrant at Respondent's medical practice which was 
also his registered address and seized among other items, Respondent's 
patient files.
    7. Government Exhibit #12 is a true and accurate copy of the 
Respondent's patient file of patient [C.H.] \6\ seized during the 
execution of a search warrant at Respondent's registered address on 
June 21, 2011.
---------------------------------------------------------------------------

    \6\ Before the hearing, I issued a Protective Order which 
protects the identities of third parties in these proceedings. [ALJ 
Exh. 3]. Thus, in this recommended decision, I will refer to all 
parties protected by the Protective Order by their initials.
---------------------------------------------------------------------------

    8. Government Exhibit #13 is a true and accurate copy of the 
Respondent's patient file of patient [R.G.] seized during the execution 
of a search warrant at Respondent's registered address on June 21, 
2011.
    9. Government Exhibit #14 is a true and accurate copy of the 
Respondent's patient file of patient [C.B.] seized during the execution 
of a search warrant at Respondent's registered address on June 21, 
2011.
    10. Government Exhibit #15 is a true and accurate copy of the 
Respondent's patient file of patient [A.G.] seized during the execution 
of a search warrant at Respondent's registered address on June 21, 
2011.
    11. Government Exhibit #16 is a true and accurate copy of the 
Respondent's patient file of patient [J.H.] seized during the execution 
of a search warrant at Respondent's registered address on June 21, 
2011.
    12. Government Exhibit #17 is a true and accurate copy of the 
Respondent's patient file of patient [T.H.] seized during the execution 
of a search warrant at Respondent's registered address on June 21, 
2011.
    13. Government Exhibit #18 is a true and accurate copy of the 
Respondent's patient file of patient [K.H.] seized during the execution 
of a search warrant at Respondent's registered address on June 21, 
2011.

[ALJ Exh. 4 at 1-2; ALJ Exh. 5].

B. Respondent's Background

    Respondent earned his undergraduate degree in Chemistry and Biology 
from the University of California, Irvine. [Tr. 186]. Thereafter, he 
earned his medical degree from the California College of Medicine at 
Irvine in 1981 and later completed his residency in anesthesiology at 
Emory University in Atlanta, Georgia. [Tr. 186-87]. He obtained DEA COR 
BW3923009 on March 4, 1994. [Gov't Exh. 1 at 1]. On March 20, 2012, the 
Respondent surrendered this registration for cause. [Id.].
    Respondent practiced anesthesiology in Mississippi until 2008 when, 
due to his hearing beginning to deteriorate, he felt he could not 
properly perform his job function and might pose a danger in the 
surgery room. [Tr. 187]. Drawing on his experience in pain management 
as an anesthesiologist, Respondent then opened a pain management clinic 
in Columbus, Mississippi. [Tr. 188]. Respondent started the practice 
``from scratch,'' and most of his patients sought relief from neck or 
back pain and were referred by another physician. [Tr. 188-89].
    In the Fall of 2008, Respondent agreed to treat the patients of a 
weight loss physician, ``Dr. Burtman,'' who, in Respondent's words, 
``was shut down by . . . the DEA and the Medical Board.'' [Tr. 189]. 
Respondent testified that he did not intend his weight loss practice to 
be permanent, but that he maintained the weight loss patients because 
it was a financial buoy for his developing pain management practice. 
[Tr. 190].

C. Law Enforcement's Investigation of Respondent

    The DEA investigation into Respondents' weight loss practice began 
when the Lowndes County Narcotics Task Force notified DEA that 
Respondent and another doctor may be ``running pill mills'' and that 
``there were some concerns about some overdose deaths.'' \7\ [Tr. 15-
16]. DEA investigators worked together with the Lowndes County 
Narcotics Task Force, Mississippi Bureau of Narcotics, and the 
Mississippi State Board of Medical Licensure to conduct the 
investigation of Respondent's practice. [Tr. 15].
---------------------------------------------------------------------------

    \7\ On cross examination, Diversion Investigator Sean Baudier 
admitted that although the investigation began because of ``initial 
complaints'' about overdose deaths, no such overdoses were ever 
substantiated during the investigation. [Tr. 26-27]. In fact, DI 
Baudier testified that DEA did not even seriously investigate the 
reported drug overdose deaths because ``a lot of times in overdose 
deaths, there are--there are poly drugs or alcohol involved.'' [Tr. 
26]. Moreover, the president of the Board testified that he is not 
aware of any injuries or deaths resulting from Respondent's 
practice. [Tr. 70]. Therefore, because the Government did not 
establish that any deaths occurred due to misconduct by Respondent, 
my recommendation to the Administrator does not take into account DI 
Baudier's mention of deaths by overdose.
---------------------------------------------------------------------------

    During the course of the investigation, law enforcement officers 
interviewed Respondent's patients and sent undercover informants to 
book appointments with Respondent's practice. [Gov't Exh. 5 at 36; Tr. 
17]. The informants first attempted to book appointments with 
Respondent for pain management, but were turned away.\8\

[[Page 62960]]

[Tr. 16-17; 41-42]. When the informants were able to get appointments 
with Respondent for weight loss, DEA centered its investigation on the 
weight loss side of Respondent's practice. [Tr. 17, 48]. Diversion 
Investigator Sean Baudier testified that the informants obtained 
Phentermine from Respondent ``[e]very time'' they visited Respondent's 
practice. [Tr. 17]. Phentermine, also called Adipex, is a Schedule IV 
controlled substance. [Tr. 52; ALJ Exh. 4 at 2]; 21 C.F.R. Sec.  
1308.14(e)(9).
---------------------------------------------------------------------------

    \8\ There is some dispute as to why Respondent turned away the 
informants on the pain management side of his practice. On direct 
examination, DI Baudier testified that the informants were turned 
away on the pain management side because Respondent was ``not taking 
any patients.'' [Tr. 16-17]. He clarified this testimony on cross 
examination, testifying that Respondent turned the informants away 
because he ``[w]asn't accepting new patients.'' [Tr. 41]. 
Respondent's counsel suggested while cross examining DI Baudier that 
the informants were turned away because Respondent only accepted new 
patients with referrals, not because Respondent was not taking new 
patients. [Tr. 41-42]. DI Baudier responded that because he did not 
personally make the phone calls to book the appointments, he could 
not dispute Respondent's explanation. [Tr. 41, 42]. Respondent 
himself testified that all of his pain management patients were 
referred by physicians and that ``[y]ou couldn't walk off the street 
into my clinic.'' [Tr. 188-89]. To the extent that it is relevant, I 
find that the Government has failed to establish that Respondent 
turned the informants away because he was not accepting new pain 
patients.
---------------------------------------------------------------------------

    DEA executed a warrant to search and seize evidence from 
Respondent's practice on June 21, 2011 and obtained all patient files 
kept by Respondent. [Tr. 17-18, 191; ALJ Exh. 5 at 1; Gov't Exhs. 12-
27]. Respondent credibly testified, and the Government did not refute, 
that he ceased treating weight loss patients on the day the warrant was 
executed. [Tr. 192].

D. The Board Hearings and Board Order

    The investigation of Respondent resulted in the Board issuing a 
Summons and Affidavit in November of 2011, formally charging Respondent 
with twenty three counts of misconduct. [Gov't Exh. 5 at 1-33]. 
Respondent, represented by counsel, attended a hearing before the Board 
on January 19, 2012. [Gov't Exh. 5 at 35; Gov't Exh. 6 at 1-2; Tr. 51, 
58-59]. Respondent did not testify at that hearing because criminal 
charges related to the same facts were pending. [Tr. 66-67]. The Board 
issued its decision orally and in writing on the day of the hearing. 
[Gov't Exh. 5 at 35-52; Gov't Exh. 6 at 215-218].
    The Board considered Respondent's misconduct with respect to five 
patients, J.B., A.S., T.S., C.R., and T.S., three of whom were 
confidential informants employed by law enforcement. [Gov't Exh. 5 at 
36-48]. Regarding those patients, the Board made the following factual 
and legal findings, which are binding on this Court under the 
principles of collateral estoppel. See David A. Ruben, 78 Fed. Reg. 
38,363, 38,365 (DEA 2013); Robert L. Dougherty, M.D., 76 Fed. Reg. 
16,823, 16,830 (DEA 2011).

1. J.B.

    J.B., referred to in the Board Order as ``Patient #1,'' was one of 
Respondent's patients who was interviewed by law enforcement during the 
course of its investigation. [Gov't Exh. 5 at 36-37]. At the time she 
first came to see Respondent for weight loss on February 2, 2009, J.B. 
was 5'7'' tall and weighed 148 pounds, ``which the Board determine[d] 
is not obese.'' [Gov't Exh. 5 at 37]. On the initial visit, Respondent 
issued a prescription for 30 doses of Phentermine and subsequently 
issued eight more prescriptions for 30 doses of Phentermine between 
March 9, 2009 and September 27, 2010. [Gov't Exh. 5 at 37]. 
Additionally, Respondent prescribed to J.B. 90 doses of Sibutramine, a 
Schedule IV controlled substance. [Gov't Exh. 5 at 37].
    Respondent issued these prescriptions without performing a physical 
examination, properly documenting J.B.'s medical history, recording 
adiposity measurements such as BMI or waist circumference, conducting 
an EKG, conducting any laboratory testing, or verifying that J.B. had 
made good-faith efforts to lose weight without the aid of controlled 
substances. [Gov't Exh. 5 at 37-38]. Furthermore, Respondent continued 
to prescribe controlled substances to J.B. despite the patient's 
failure to lose weight after six months of treatment. [Gov't Exh. 5 at 
39]. In fact, after the nineteen month-long treatment, J.B. actually 
gained twenty pounds. [Gov't Exh. 5 at 39].

2. A.S.

    A.S., referred to in the Board Order as ``Patient #2,'' was also 
one of Respondent's patients who cooperated with the law enforcement 
investigation. [Gov't Exh. 5 at 39]. A.S. was 5'6'' tall and weighed 
180 pounds when she first saw Respondent for weight loss. [Gov't Exh. 5 
at 39]. She told Respondent that she had previously received ``diet 
medication'' from another doctor, Dr. Burtman, but Respondent did not 
include Dr. Burtman's charts in A.S.'s file. [Gov't Exh. 5 at 40].
    Respondent prescribed controlled substances to A.S. without 
performing an adequate physical examination, properly documenting her 
medical history, recording adiposity measurements such as BMI or waist 
circumference, conducting any laboratory testing, or verifying that 
J.B. had made good-faith efforts to lose weight without the aid of 
controlled substances. [Gov't Exh. 5 at 39-41]. In total, Respondent 
prescribed 150 doses of Phentermine to A.S. [Gov't Exh. 5 at 39].

3. T.S.

    T.S., referred to in the Board Order as ``Patient #3,'' was a 
confidential informant employed by law enforcement to gather 
information about Respondent's practice. [Gov't Exh. 5 at 41]. She was 
thirty four years old, 5'4'' tall, and weighed 225 pounds at the time 
of her initial visit to Respondent's practice. [Gov't Exh. 5 at 41-42]. 
Law enforcement chose her to participate in the investigation because 
she is not only obese, but has a number of other medical conditions as 
well. [Gov't Exh. 5 at 41].
    As with the other patients, Respondent prescribed controlled 
substances to T.S. without performing an adequate physical examination, 
properly documenting her medical history, recording adiposity 
measurements such as BMI or waist circumference, conducting any 
laboratory testing, or verifying that T.S had made good faith efforts 
to lose weight without the aid of controlled substances. [Gov't Exh. 5 
at 42-43]. In total, Respondent prescribed 150 doses of Phentermine to 
T.S. [Gov't Exh. 5 at 41].

4. C.R.

    C.R., referred to in the Board Order as ``Patient #4,'' was another 
confidential law enforcement informant. [Gov't Exh. 5 at 43]. At the 
time of her initial visit with Respondent, she was twenty two years 
old, 5'3'' tall, and weighed 139 pounds. [Gov't Exh. 5 at 43-44]. The 
Board found that although she was not obese, Respondent noted in C.R.'s 
chart that she was ``overweight.'' [Gov't Exh. 5 at 44].
    As with the other patients, Respondent prescribed controlled 
substances to C.R. without performing an adequate physical examination, 
properly documenting her medical history, recording adiposity 
measurements such as BMI or waist circumference, conducting any 
laboratory testing, or verifying that C.R. had made good faith efforts 
to lose weight without the aid of controlled substances. [Gov't Exh. 5 
at 43-45]. Additionally, Respondent did not document an individualized 
treatment plan for C.R. Rather, under ``Plan of Care'' in the chart, 
Respondent merely

[[Page 62961]]

wrote ``Weight Loss Program Month #1,'' which apparently included 
prescriptions for Phentermine and a ``Low carb Diet.'' [Gov't Exh. 5 at 
45]. Respondent prescribed C.R. a total of 120 doses of Phentermine. 
[Gov't Exh. 5 at 43].

5. T.S.1

    T.S.1, referred to in the Board Order as ``Patient #5,'' was 
another confidential informant who visited Respondent for weight loss. 
[Gov't Exh. 5 at 46]. At the time of her initial visit, she was twenty 
nine years old, 5'8'' tall, and weighed 125 pounds. [Gov't Exh. 5 at 
46]. The Board found that she was not obese. [Gov't Exh. 5 at 46].
    As with the other patients, Respondent prescribed controlled 
substances to T.S.1 without performing an adequate physical 
examination, properly documenting her medical history, recording 
adiposity measurements such as BMI or waist circumference, conducting 
any laboratory testing, or verifying that T.S.1 had made good faith 
efforts to lose weight without the aid of controlled substances. [Gov't 
Exh. 5 at 46-47]. Additionally, Respondent continued to prescribe 
Phentermine to T.S.1 even though she actually gained nine pounds while 
being on the weight loss program. [Gov't Exh. 5 at 48]. In total, 
Respondent prescribed 120 doses of Phentermine to T.S.1. [Gov't Exh 5 
at 46].

6. The Board's Conclusions of Law

    Based on these factual findings, the Board concluded that 
Respondent violated a number of rules and regulations. First, it found 
that Respondent's failure to verify that these five patients made a 
good-faith effort to lose weight without the aid of controlled 
substances violated Chapter 25, Section 501(1) of the Rules and 
Regulations of the Board, as well as title 73, Chapter 25, section 
29(13) of the Mississippi Code. [Gov't Exh. 5 at 49].
    Second, the Board found that Respondent's failure to obtain full 
medical histories and perform adequate physical examinations of the 
five patients violated Chapter 25, Section 501(2) of the Rules and 
Regulations of the Board, as well as title 73, Chapter 25, section 
29(13) of the Mississippi Code. [Gov't Exh. 5 at 49].
    Third, the Board found that Respondent's continued prescribing of 
controlled substances to patients who failed to lose weight after 
thirty days of taking the controlled substances violated Chapter 25, 
Section 501(5)(a) of the Rules and Regulations of the Board, as well as 
title 73, Chapter 25, section 29(13) of the Mississippi Code. [Gov't 
Exh. 5 at 49].
    Fourth, the Board found that Respondent dispensed ``drugs having 
addition-forming or addition-sustaining liability otherwise than in the 
course of legitimate professional practice, all in violation of Miss. 
Code Ann. 73-25-29(3).'' [Gov't Exh. 5 at 50].
    Finally, the Board found that Respondent's actions constituted 
``dishonorable or unethical conduct likely to deceive, defraud, or harm 
the public in violation of Miss. Code Ann. 73-25-29(8)(d) and 73-24-
83(a).'' [Gov't Exh. 5 at 50].
    Having made these findings, the Board suspended Respondent's 
medical license for six months, but stayed the suspension contingent on 
certain conditions. [Gov't Exh. 5 at 50-51]. Namely, the Board ordered 
Respondent to complete certain continuing medical education courses 
within six months of the Board Order and to report such completion to 
the Board. [Gov't Exh. 5 at 50-51]. The Board also permanently 
prohibited Respondent from treating patients for weight loss and 
ordered Respondent to reimburse the Board for its costs in adjudicating 
the matter. [Gov't Exh. 5 at 51]. Additionally, the Board stated that 
it would monitor Respondent's compliance with the Board Order by 
periodically reviewing Respondent's patient charts. [Gov't Exh. 5 at 
51].

7. The Second Board Hearing

    In November of 2013, the Board held another hearing to determine 
why Respondent had not complied with the Board Order. [Tr. 60; Gov't 
Exh. 32]. At that hearing, Respondent testified that he had not taken 
the CME courses because he could not afford them.\9\ [Tr. 60]. The 
Board found that Respondent ``failed to comply with the . . . 
conditions as set forth in the January 19, 2012 Determination Order. 
Specifically, [Respondent] failed to submit proof of successful 
completion of Continuing Medical Education (CME) hours; failed to 
communicate with the Board as to the status of same; and failed to 
reimburse the Board for all costs. . . .'' [Gov't Exh. 32 at 5].
---------------------------------------------------------------------------

    \9\ The transcripts for the second Board hearing were not 
entered into the record, but Dr. Van Craig testified that Respondent 
told the Board at the hearing that he could not afford the CME 
courses. [Tr. 60]. This testimony is corroborated by Respondent's 
own testimony in these proceedings. [Tr. 205-06].
---------------------------------------------------------------------------

    Thereafter, the Board allowed Respondent more time to complete the 
CME courses and reimburse the Board for its expenses. Specifically, the 
Board ordered Respondent to complete the courses and pay the Board 
within six months of this DEA hearing. [Gov't Exh. 32 at 5]. The Board 
also ordered Respondent to notify the Board ``when the DEA hearing is 
scheduled and conducted.'' [Gov't Exh. 32 at 5].
    At the hearing in these proceedings, the Board's executive 
director, Dr. Harris Van Craig, testified that Respondent, to date, had 
not notified the Board of the scheduled date for the DEA hearing. [Tr. 
63]. He also testified regarding Respondent's ``demeanor'' in the 
second Board hearing. [Tr. 60-61]. Specifically, Dr. Van Craig 
testified that Respondent appeared ``angry with the Board for . . . 
disciplining him'' and that Respondent thought he had received ``rather 
harsh treatment from the Board because of what he was doing.'' [Tr. 60, 
61; see also Tr. 66]. Dr. Van Craig also testified that Respondent felt 
he was being ``singled out'' by law enforcement because ``other 
practitioners in his area were doing the same thing as he was.'' [Tr. 
60; see also Tr. 61].

E. Respondent's Criminal Charges

    A month or two \10\ after the Board handed down its Order, federal 
criminal charges were brought against Respondent for ``knowingly and 
intentionally dispensing and distributing phentermine, which is a 
Schedule IV controlled substance[,] without a legitimate medical 
purpose and outside the usual course of medical practice.'' [Gov't Exh. 
10 at 6; see also Tr. 21, 192]. A jury trial was conducted on October 
22 and October 23, 2012, resulting in Respondent being acquitted of all 
charges. [Gov't Exh. 10 at 1; Gov't Exh. 11 at 1, 224; Tr. 33]. 
Respondent credibly testified, and the Government did not refute, that 
he stopped practicing medicine altogether on the day he was indicted. 
[Tr. 192].
---------------------------------------------------------------------------

    \10\ The record is not clear as to exactly when Respondent was 
indicted. Respondent testified that he was indicted four to six 
weeks after the Board issued its Order on January 19, 2012, [Tr. 
192], but the indictment itself is not in evidence.
---------------------------------------------------------------------------

F. The Standard of Care for Prescribing Phentermine

    At the hearing in these proceedings, the Government offered, and I 
certified, Dr. Stephen Sudderth as an expert in weight loss medicine 
and the medical use of Phentermine for weight loss. [Tr. 77-78]. Dr. 
Sudderth is a general surgeon, a bariatric surgeon, and a bariatric 
physician, licensed to practice in Mississippi. [Tr. 72, 73]. His 
bariatric specialty means he ``specializes in the field of metabolic 
and obesity disease.'' [See Tr. 72-73]. He has been practicing weight-
loss medicine for twelve years.

[[Page 62962]]

[Tr. 73]. He attended medical school at Louisiana State University 
Medical School, completed his internship at Yale University-affiliated 
hospitals in New Haven, Connecticut, and completed his general surgery 
residency at the University of Nevada, Las Vegas. [Tr. 74-75; Gov't 
Exh. 28]. He is board-certified in bariatric medicine and general 
surgery. [Tr. 75]. He is a fellow of the American College of Surgeons 
and a diplomat to the American Board of Bariatric Medicine, which is an 
honor denoting ``that you are at the top of your field.'' [Tr. 75]. Dr. 
Sudderth testified that he has treated ``[t]housands'' of patients for 
weight loss in his career and regularly prescribes Phentermine. [Tr. 
76]. In fact, he helped draft the recent changes to the regulations 
regarding the prescription of Phentermine for weight loss. [Tr. 76]. As 
such, he is familiar with the regulations and standards both as they 
are now and as they were when Respondent's misconduct occurred. [Tr. 
76-77].
    Dr. Sudderth credibly testified regarding the standard of care when 
prescribing Phentermine. He testified that physicians should document 
the patient's history of diet, weight, exercise, and controlled 
substance use ``to determine if they had gone through other programs or 
used drugs for the purpose of weight loss by a prescription.'' [Tr. 83, 
84]. Dr. Sudderth also testified that the patient's medical history 
should be noted in the chart, including allergies and other medical 
conditions the patient may have. [Tr. 85]. The physician should also 
note any medications the patient is taking, the patient's primary care 
physician, the patient's gynecological history, and the patient's 
family medical history. [Tr. 85]. This information should all be noted 
in the patient's chart. [Tr. 84]. According to Dr. Sudderth, 
documenting this information is necessary for a physician to meet the 
standard of care when prescribing Phentermine. [Tr. 87].
    Dr. Sudderth testified that a physical examination is also 
necessary to meet the standard of care. [Tr. 87, 103]. This means that 
before prescribing Phentermine, the physician should measure and 
document the patient's vital signs, including temperature, pulse, blood 
pressure, height, and weight. [Tr. 87]. In addition, the physician 
should measure the patient's body mass index (``BMI''), waist 
circumferences, or body fat percentage, each of which give ``some 
indication of the patient's fat content.'' [Tr. 87, 93].
    BMI, which is a ``common standard used in most states and certainly 
in Mississippi'' to measure adiposity, is calculated by dividing the 
patient's weight by the patient's height squared. [Tr. 88-90]. A BMI of 
18 to 24 is considered ``normal weight,'' 25 to 29.9 is considered 
``overweight,'' 30 to 39 is considered ``obese,'' 40 to 49 is 
considered ``morbidly obese,'' and anything over 50 is considered 
``super morbid obese.'' [Tr. 90]. To be prescribed Phentermine for 
weight loss, a patient must have a BMI of 27 or greater and have at 
least one ``comorbid medical problem,'' which Dr. Sudderth testified is 
``[a]nother medical problem that's related directly to the weight.'' 
[Tr. 91]. Common comorbid conditions include high blood pressure, 
diabetes, sleep apnea, arthritis, lower back pain, heartburn, urinary 
incontinence, breast cancer, and prostate cancer. [Tr. 91]. A patient 
without a comorbid condition must have a BMI of at least 30 to be 
prescribed Phentermine for weight loss. [Tr. 91]. Dr. Sudderth also 
testified that although these are the customary standards, a physician 
has some ``latitude'' to prescribe Phentermine to a patient with a 
slightly lower BMI if the physician believes the patient's weight is 
significantly aggravating a medical condition. [Tr. 92-93].
    Measuring vital signs and adiposity, however, is not the only 
important part of the physical exam. Dr. Sudderth testified that 
various observations made during a routine physical exam might indicate 
the patient has medical conditions that are contributing to the 
patient's weight or would make controlled substances unsafe to 
prescribe. [Tr. 94-98].
    Dr. Sudderth also testified that lab work is ``essential'' in 
determining whether to prescribe Phentermine because it uncovers things 
that a physical examination typically does not. [Tr. 99]. Specifically, 
lab work can identify conditions that may hinder weight loss or make 
prescribing certain controlled substances improper, such as anemia, 
liver disease, hypothyroidism, and high cholesterol. [Tr. 99-101]. Dr. 
Sudderth testified that in Mississippi, the standard of care is to 
perform blood work and to document the results before or at the visit 
when prescribing Phentermine for weight loss occurs.\11\ [Tr. 101-02].
---------------------------------------------------------------------------

    \11\ On cross examination, counsel for Respondent suggested that 
cost sometimes prohibits lab work. [Tr. 170-71]. However, Respondent 
offered no evidence, expert or otherwise, to contradict Dr. 
Sudderth's credible testimony that lab work is essential before 
prescribing Phentermine. Therefore, I find that lab work is required 
before prescribing Phentermine under the standard of care in 
Mississippi, regardless of the cost.
---------------------------------------------------------------------------

G. The Sixteen Additional Patient Files

    Dr. Sudderth also testified that he reviewed the patient files of 
sixteen of Respondent's patients not included in the Board Order and 
concluded that Respondent did not meet the standard of care when he 
prescribed Phentermine to all sixteen patients. [Tr. 80; Gov't Exhs. 
12-27; Tr. 79-80, 106, 117, 123, 127, 128, 133, 138, 140-41, 145, 146, 
150, 151, 152, 153]. The Government questioned Dr. Sudderth on only six 
of the sixteen patients whose files were entered into evidence: C.H., 
R.G., A.G., J.G., K.C., and P.H.

1. C.H.

    C.H.'s height and weight at the initial visit were recorded in the 
chart as 5'6'', 150 pounds. [Gov't Exh. 12 at 13; Tr. 107-08]. No BMI 
was recorded, however, and Dr. Sudderth testified that he calculated 
C.H.'s BMI to be 24.2 using the patient's recorded height and weight. 
[Tr. 109, 111; Gov't Exh. 31]. Based on this BMI calculation, Dr. 
Sudderth testified that C.H. did not qualify for Phentermine 
prescriptions. [Tr. 111]. Dr. Sudderth further testified that 
Respondent's ``impression'' that C.H. is ``overweight,'' recorded in 
the chart, is an incorrect diagnosis, and that there are no co-morbid 
conditions recorded in C.H.'s chart that would justify prescribing 
Phentermine. [Tr. 115]. As such, Dr. Sudderth testified that, in his 
opinion, Respondent did not ``take a thorough history of [C.H.] as 
contemplated by the State regulations.'' [Tr. 115].
    Dr. Sudderth further testified that while Respondent recorded 
C.H.'s blood pressure and heart rate in the chart, he failed to record 
C.H.'s weight, diet, and gynecological history. [Tr. 111-12]. 
Additionally, on the chart, Respondent had drawn ``squiggly lines'' 
through all of the spaces designed to notate that the various organs 
were ``normal.'' [Tr. 112-13; Gov't Exh. 12 at 14]. The chart also had 
no indication that any lab work was conducted on C.H. [Tr. 114]. Thus, 
Dr. Sudderth testified that Respondent did not conduct a ``thorough 
physical examination as contemplated under the regulations.'' [Tr. 115-
16].
    Dr. Sudderth concluded that Respondent did not meet the standard of 
care when he prescribed C.H. Phentermine on her initial visit. [Tr. 
117]. He noted that the chart does not reflect any legitimate medical 
justification for prescribing Phentermine to C.H. [Tr. 123-24].
    Additionally, Dr. Sudderth testified that Respondent failed to meet 
the standard of care for prescribing Phentermine at each of C.H.'s 
follow-up

[[Page 62963]]

visits. [Tr. at 123]. He reached this conclusion partly because in each 
of the seven follow-up visits notated in the chart, neither Respondent 
nor C.H. had any questions or concerns about the weight loss plan. [Tr. 
120-23; Gov't Exh. 12 at 11]. Dr. Sudderth testified that this is 
``very significant because I haven't seen that in my 12-year career of 
doing weight loss, that there are no problems at any follow-up visit 
ever.'' [Tr. 122].

2. R.G.

    R.G.'s initial height and weight were recorded in the chart as 
5'4'', 141 pounds. [Tr. 125; Gov't Exh. 13 at 13]. R.G.'s body fat and 
BMI were not measured, however, but Dr. Sudderth calculated R.G.'s BMI 
to be approximately 24, which is ``normal.'' [Tr. 125; Gov't Exh. 31]. 
Thus, Dr. Sudderth testified that R.G. did not qualify for weight loss 
treatment with Phentermine. [Tr. 125].
    Dr. Sudderth testified that R.G.'s weight, diet, exercise, and 
gynecological history were not recorded in the chart, except to note 
that R.G. is not pregnant.\12\ [Tr. 125; Gov't Exh. 13 at 13-14]. Like 
in C.H.'s chart, the ``Physical Examination'' section of R.G.'s chart 
contained ``squiggly lines'' through all of the spaces designed to 
notate that the various organs were ``normal.'' [Tr. 126; Gov't Exh. 13 
at 14]. Because the chart contained a line through the part marked 
``Laboratory Findings,'' Dr. Sudderth testified that he assumed no labs 
were conducted. [Tr. 126; Gov't Exh. 13 at 14].
---------------------------------------------------------------------------

    \12\ Dr. Sudderth testified that simply noting the pregnancy 
status of a female patient does not constitute an adequate 
gynecological history report. [Tr. 136].
---------------------------------------------------------------------------

    Dr. Sudderth testified that because R.G. has no co-morbid 
conditions and a BMI of 24, it was not appropriate to prescribe 
Phentermine to the patient. [Tr. 126, 127]. Also, similar to C.H.'s 
chart, Dr. Sudderth noted that the follow-up visits uncovered no 
questions or concerns about the weight loss program. [Tr. 127-28; Gov't 
Exh 13 at 11]. Thus, Dr. Sudderth concluded that Respondent did not 
meet the standard of care in prescribing R.G. Phentermine during the 
seven follow-up visits. [Tr. 128; Gov't Exh. 13 at 4-10]. In sum, Dr. 
Sudderth testified that ``[t]here is no justification'' for prescribing 
Phentermine to R.G. [Tr. 128].

3. A.G.

    A.G.'s height and weight at the initial visit were 5'1'', 141 
pounds. [Tr. 129, Gov't Exh. 15 at 8]. A.G.'s BMI was not in the chart, 
but Dr. Sudderth calculated it to be 26.6. [Tr. 129; Gov't Exh 31]. 
Respondent recorded his ``impression'' of A.G. as ``obesity.'' [Tr. 
129; Gov't Exh 15 at 9]. Dr. Sudderth testified, however, that A.G. was 
not ``obese,'' but ``overweight'' according to the standard in 
Mississippi. [Tr. 129-30].
    Dr. Sudderth further testified that A.G.'s diet, weight, exercise, 
and gynecological history were not noted in the file except that A.G. 
is not pregnant and that ``she is on a Depo shot for birth control.'' 
[Tr. 130; Gov't Exh. 15 at 8]. In physical examination section of the 
chart, there were lines through all of the spaces designed to notate 
that the various organs were ``normal.'' [Tr. 130-31; Gov't Exh. 15 at 
9]. The only organ with a notation other than the line was the abdomen, 
which had ``obese'' written in the ``normal'' column.\13\ [Tr. 130-31; 
Gov't Exh. 15 at 9]. No lab work or co-morbid conditions were indicated 
on the chart. [Tr. 131; Gov't Exh. 15 at 9]. Thus, Dr. Sudderth 
ultimately concluded that Respondent did not meet the standard of care 
when he prescribed A.G. Phentermine. [Tr. 133; Gov't Exh. 15 at 4-5, 
7].
---------------------------------------------------------------------------

    \13\ Dr. Sudderth noted that describing an abdomen as ``obese'' 
is inaccurate. ``You may characterize it as protuberant, large. It 
may be described in many different ways, but you wouldn't describe 
an abdomen as obese. You may describe a person as obese but not an 
abdomen.'' [Tr. 131].
---------------------------------------------------------------------------

4. J.G.

    According to the chart, J.G. weighed 282 pounds and was 5'4'' tall 
when she first visited Respondent for weight loss. [Tr. 134; Gov't Exh 
20 at 12]. Her BMI was not included in the chart, but Dr. Sudderth 
calculated it to be approximately 48, which is high enough to qualify 
for a Phentermine prescription. [Tr. 134; Gov't Exh. 31].
    Respondent recorded three co-morbid conditions for J.G.: High blood 
pressure, high cholesterol, and diabetes. [Tr. 134-35; Gov't Exh. 20 at 
12]. Dr. Sudderth testified that he would have ``done a thorough 
history and physical'' and ``gotten labs on this patient and an EKG'' 
before prescribing Phentermine, which can aggravate the co-morbid 
conditions reported by J.G. [Tr. 135]. J.G.'s chart had no lab findings 
recorded. [Tr. 136-37; Gov't Exh. 20 at 13].
    No weight, diet, exercise, or gynecological history was recorded on 
the chart except that J.G. is not pregnant. [Tr. 135-36; Gov't Exh. 20 
at 12]. J.G.'s chart included heart rate and blood pressure 
measurements, but the section for organ examinations, like in the other 
charts, had a ``squiggly line'' through the ``normal'' boxes. [Tr. 136; 
Gov't Exh. 20 at 13]. Respondent recorded his ``impression'' of J.G. as 
``overweight,'' which Dr. Sudderth testified is an inappropriate 
diagnosis--Respondent should have diagnosed J.G. as ``morbidly obese.'' 
[Tr. 137; Gov't Exh. 20 at 13].
    Dr. Sudderth testified that Respondent did not meet the standard of 
care when he prescribed Phentermine to J.G. on her first visit because 
Respondent did not conduct and record an adequately thorough physical 
examination and history. [Tr. 138].
    Respondent prescribed J.G. Phentermine in each of six follow-up 
visits. [Tr. 139, 140; Gov't Exh 20 at 4-9, 11]. Dr. Sudderth testified 
that a visit on August 9, 2010 was particularly troubling, since J.G.'s 
blood pressure was especially high that day, apparently because J.G. 
had not taken her blood pressure medication. [Tr. 138-39; Gov't Exh. 20 
at 10]. Dr. Sudderth testified that, given J.G.'s unregulated blood 
pressure, prescribing J.G. Phentermine on that visit fell below the 
standard of care. [Tr. 139]. Similarly, J.G.'s blood pressure was even 
higher on her next visit, and Respondent once again prescribed 
Phentermine. [Tr. 139-40]. Dr. Sudderth thus concluded that Respondent 
fell below the standard of care by prescribing Phentermine to J.G. at 
each follow-up visit because he failed to perform adequate histories 
and physicals, he ignored contraindications such as high blood 
pressure, and ``he has no follow-up visit that is of any substance, 
whatsoever.'' [Tr. 141].

5. K.C.

    K.C. was sixteen years old, weighed 142 pounds, and was 5'4'' tall 
when she first visited Respondent for weight loss. [Tr. 141-42; Gov't 
Exh 21 at 9]. Her BMI was not recorded in her file, but Dr. Sudderth 
calculated it to be approximately 24, which classifies her weight as 
``normal.''\14\ [Tr. 142, 144; Gov't Exh. 31]. The patient chart 
included no weight, diet, or gynecological history recorded except that 
K.C. is not pregnant. [Tr. 143-44; Gov't Exh. 21 at 9]. Notably, K.C.'s 
chart did not include any physical examination; in fact, the patient 
file did not even include the form Respondent normally used to record 
physical examinations. [Tr. 144; Gov't Exh. 21].
---------------------------------------------------------------------------

    \14\ Dr. Sudderth explained that there is a slightly different 
standard for determining whether Phentermine is appropriate to 
prescribe to pediatric patients such as K.C. Specifically, children 
must be ``in the 99th percentile or greater'' in relation to ``other 
kids their age'' to qualify for a Phentermine prescription. [Tr. 
144]. He testified that K.C. is a ``normal 16-year-old girl who 
falls in the normal percentile of girls.'' [Tr. 143-44].
---------------------------------------------------------------------------

    Dr. Sudderth testified that Respondent fell below the standard of 
care by prescribing Phentermine on the

[[Page 62964]]

initial visit. [Tr. 144-45; Gov't Exh. 21 at 8]. He also testified that 
Respondent fell below the standard of care by prescribing Phentermine 
to K.C. during three follow-up visits, where no problems or concerns 
were reported or discussed. [Tr. 145-46]. Dr. Sudderth testified that 
nowhere in the file was a legitimate medical reason or justification 
for prescribing K.C. Phentermine recorded. [Tr. 146; Gov't Exh. 21].

6. P.H

    P.H. weighed 162 pounds and was 5'5'' tall on her initial visit to 
Respondent. [Gov't Exh. 27 at 22]. No body fat or BMI were recorded, 
but Dr. Sudderth calculated it to be 26.9, which is classified as 
``overweight.'' [Tr. 147; Gov't Exh. 31]. No weight, diet, or 
gynecological history were recorded except that P.H. is not pregnant. 
[Tr. 147-48; Gov't Exh. 27 at 22]. P.H.'s heart rate and blood pressure 
were recorded in the chart, and Dr. Sudderth testified that P.H. had 
high blood pressure. [Tr. 148; Gov't Exh. 27 at 23]. Dr. Sudderth also 
testified that P.H.'s high blood pressure is probably ``controlled'' 
because ``it's high, but it's not excessively high.'' [Tr. 149]. No lab 
work was recorded in the file. [Tr. 148]. Respondent recorded his 
``impression'' of P.H. as ``desires weight loss,'' which Dr. Sudderth 
testified was an inappropriate diagnosis. [Tr. 149].
    Dr. Sudderth noted that P.H.'s BMI, combined with her co-morbid 
condition of high blood pressure, qualified her for Phentermine. [Tr. 
150]. Dr. Sudderth concluded, however, that the physical examination 
and history of P.H. fell below the standard of care for prescribing 
Phentermine on the initial visit. [Tr. 150].
    Respondent treated P.H. for about three years, prescribing 
Phentermine at each of fifteen follow-up visits. [Tr. 150-51, 152; 
Gov't Exh. 27 at 4-23]. As with the other patients, Respondent noted no 
problems at any of the follow-up visits. [Tr. 151; Gov't Exh 27 at 19-
20]. Dr. Sudderth testified that P.H.'s blood pressure was high at 
every follow-up visit, and ``was worsening by the time she finished 
with Dr. White.'' [Tr. 151; Gov't Exh. 27 at 19-20]. Notably, 
Respondent did not diagnose or record P.H's blood pressure as being 
high at any time during her treatment. [Tr. 151; Gov't Exh. 27]. Dr. 
Sudderth concluded that Respondent fell below the standard of care each 
time he prescribed P.H. Phentermine at a follow-up visit. [Tr. 152].

7. The Sixteen Patient Files Generally

    Outside the six patient files about which he specifically 
testified, Dr. Sudderth also testified generally that he reviewed all 
of the sixteen patient files the Government entered into evidence and 
that none of them included adequate histories, physicals, or lab work. 
[Tr. 106-07, 120, 152]. He thus concluded that Respondent fell below 
the standard of care in prescribing Phentermine to ``[a]ll sixteen'' of 
those patients'' both in their initial visits, and in all follow-up 
visits. [Tr. 153]. He additionally testified that seven of the sixteen 
patients did not qualify for Phentermine based on their BMIs, which Dr. 
Sudderth calculated himself since they were not documented in the 
charts. [Tr. 110-11; Gov't Exh. 31]. Dr. Sudderth also testified that 
in the sixteen patient files he reviewed, ``there was no follow-up 
visit to speak of, of any substance that would qualify these patients 
to receive more Phentermine.'' [Tr. 106-07].

H. Letters from Respondent's Patients

    At the hearing, the Government offered into evidence hundreds of 
letters written by Respondent's patients, vouching for the quality of 
care Respondent provided them. [Gov't Exh. 30; Tr. 54]. To the extent 
that Respondent relies on these letters to prove that denying his 
registration would impose a burden on his patients, I find the letters 
irrelevant. The Agency has consistently held that so-called ``community 
impact evidence'' is not relevant in these proceedings. See Linda Sue 
Cheek, M.D., 76 Fed. Reg. 66,972, 66,973 (DEA 2011); Steven M. 
Abbadessa, D.O., 74 Fed. Reg. 10,077, 10,078 (DEA 2009); Mark De La 
Lama, P.A., 76 Fed. Reg. 20,011, 20,020 n.20 (DEA 2011); Bienvenido 
Tan, M.D., 76 Fed. Reg. 17,673, 17,694 n.58 (DEA 2011); Gregory D. 
Owens, D.D.S, 74 Fed. Reg. 36,751, 36,757 & n.22 (DEA 2009); Kwan Bo 
Jin, M.D., 77 Fed. Reg. 35,021, 35,021 (DEA 2012).

V. STATEMENT OF LAW AND DISCUSSION

A. Positions of the Parties

1. Government's Position

    The Government timely filed Government's Proposed Findings of Fact 
and Conclusions of Law (``Government's Brief'') with this Court on 
April 2, 2014. The bulk of the Government's argument is that Respondent 
deviated from the standard of care by performing ``woefully 
inadequate'' physical examinations, failing to obtain patient's medical 
histories, and failing to measure patients' BMI before prescribing 
Phentermine to the sixteen patients at issue in these proceedings and 
to the five patients at issue in the Board Order. [Gov't Br. at 36-39]. 
In addition, the Government argues that Respondent violated the Board's 
order to complete certain CME courses within six months of the Order. 
[Gov't Br. at 39]. According to the Government, these facts, which are 
largely undisputed, prove that Respondent's registration would be 
inconsistent with the public interest. [Gov't Br. at 39-40].
    The Government also argues that Respondent failed to prove that he 
has taken responsibility for his actions and therefore failed to rebut 
the Government's prima facie case. [Gov't Br. at 42]. The Government 
points out various portions of Respondents' testimony where Respondent 
attempted to minimize his misconduct and criticized the laws, 
standards, rules, and regulations concerning the prescription of 
Phentermine. [Gov't Br. at 42-45]. This testimony, the Government 
argues, shows that Respondent has failed to take responsibility for his 
actions. [Gov't Br. at 44]. Moreover, the Government argues that 
Respondent failed to take responsibility for his actions in the 
criminal trial, where he testified that he had done nothing improper. 
[Gov't Br. at 44]. Accordingly, the Government argues that Respondent 
has failed to rebut the Government's prima facie case because any 
acceptance of responsibility--which is minimal--is not credible. [Gov't 
Br. at 44-45].

2. Respondent's Position

    Respondent timely filed Respondent's Proposed Findings of Fact and 
Conclusions of Law (``Respondent's Brief'') on April 2, 2014. Therein, 
Respondent makes three arguments. First, Respondent argues that his 
registration would be consistent with the public interest because he 
has never harmed any of his patients and has never been the subject of 
any medical malpractice complaint. [Resp't Br. at 7]. In Respondent's 
view, the fact that law enforcement investigated Respondent for months 
before taking any action supports the conclusion that Respondent's 
misconduct was not seriously harmful or egregious. [Resp't Br. at 8-9].
    Second, Respondent argues that he has taken responsibility for his 
actions, as evidenced by his voluntary relinquishment of his DEA 
registration and his agreement to forego treating patients for weight 
loss. [Resp't Br. at 7].
    Lastly, Respondent argues that his registration is consistent with 
the public interest because, after a criminal trial

[[Page 62965]]

and two hearings before the Board, the Board still saw fit to permit 
Respondent to practice medicine. [Resp't Br. at 9-10].

B. Statement of Law and Analysis

    Pursuant to 21 U.S.C. Sec.  823(f), the Deputy Administrator may 
deny an application for a DEA COR if he determines that such 
registration would be inconsistent with the public interest.\15\ In 
determining the public interest, the following factors are considered:
---------------------------------------------------------------------------

    \15\ The Deputy Administrator has the authority to make such a 
determination pursuant to 28 C.F.R. Sec. Sec.  0.100(b), 0.104 
(2013).
---------------------------------------------------------------------------

    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The applicant'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. Sec.  823(f).

    These factors are to be considered in the disjunctive; the Deputy 
Administrator may rely on any one or a combination of factors and may 
give each factor the weight he deems appropriate in determining whether 
a registration should be revoked or an application for registration be 
denied. See Robert A. Leslie, M.D., 68 Fed. Reg. 15,227, 15,230 (DEA 
2003) (citing Henry J. Schwartz, Jr. M.D., 54 Fed. Reg. 16,422, 16,424 
(DEA 1989)). Moreover, the Deputy Administrator is ``not required to 
make findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 
482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. 
Cir. 2005). Thus, ``this is not a contest in which score is kept; the 
Agency is not required to mechanically count up the factors and 
determine how many favor'' each party. Jayam Krishna-Iyer, M.D., 74 
Fed. Reg. 459, 462 (DEA 2009). ``Rather, it is an inquiry which focuses 
on protecting the public interest. . . .'' Id.
    The Government bears the ultimate burden of proving that the 
requirements for registration are not satisfied. 21 C.F.R. Sec.  
1301.44(d) (2014). Specifically, the Government must show that 
Respondent has committed acts that are inconsistent with the public 
interest. 21 U.S.C. Sec.  823(f); Jeri Hassman, M.D., 75 Fed. Reg. 
8,194, 8,227 (DEA 2010). However, where the Government has made out a 
prima facie case that Respondent's application would be ``inconsistent 
with the public interest,'' the burden of production shifts to the 
applicant to ``present[ ] sufficient mitigating evidence'' to show why 
he can be trusted with a new registration. See Medicine Shoppe--
Jonesborough, 73 Fed. Reg. 364, 387 (DEA 2008). To this point, the 
Agency has repeatedly held that the ``registrant must accept 
responsibility for [his] actions and demonstrate that [he] will not 
engage in future misconduct.'' Id.; see also Samuel S. Jackson, D.D.S., 
72 Fed. Reg. 23,848, 23,853 (DEA 2007). The Respondent must produce 
sufficient evidence that he can be trusted with the authority that a 
registration provides by demonstrating that he accepts responsibility 
for his misconduct and that the misconduct will not reoccur. See id.; 
see also Samuel S. Jackson, D.D.S., 72 Fed. Reg. at 23,853. The DEA has 
consistently held the view that ``past performance is the best 
predictor of future performance.'' Alra Laboratories, 59 Fed. Reg. 
50,620 (DEA 1994), aff'd, Alra Laboratories, Inc. v. DEA, 54 F.3d 450, 
451 (7th Cir 1995).

Factor One: Recommendation of Appropriate State Licensing Board

    Recommendations of state licensing boards are relevant, but not 
dispositive, in determining whether a respondent should be permitted to 
maintain a registration. See Gregory D. Owens, D.D.S., 74 Fed. Reg. 
36,751, 36,755 (DEA 2009); see also Martha Hernandez, M.D., 62 Fed. 
Reg. 61,145, 61,147 (DEA 1997). According to clear agency precedent, a 
``state license is a necessary, but not a sufficient condition for 
registration.'' Robert A. Leslie, M.D., 68 Fed. Reg. at 15,230; John H. 
Kennedy, M.D., 71 Fed. Reg. 35,705, 35,708 (DEA 2006).
    DEA possesses ``a separate oversight responsibility with respect to 
the handling of controlled substances,'' which requires the Agency to 
make an ``independent determination as to whether the granting of [a 
registration] would be in the public interest.'' Mortimer B. Levin 
D.O., 55 Fed. Reg. 8,209, 8,210 (DEA 1990); see also Jayam Krishna-
Iyer, 74 Fed. Reg. at 461. Even the reinstatement of a state medical 
license does not affect this Agency's independent responsibility to 
determine whether a DEA registration is in the public interest. Levin, 
55 Fed. Reg. at 8,210. The ultimate responsibility to determine whether 
a registration is consistent with the public interest has been 
delegated exclusively to the DEA, not to entities within state 
government. Edmund Chein, M.D., 72 Fed. Reg. 6,580, 6,590 (DEA 2007), 
aff'd Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008). Thus, Agency 
precedent holds that even where a respondent is licensed to practice 
medicine by a state licensing agency, factor one weighs neither for nor 
against registration unless the state licensing agency makes a direct 
recommendation regarding the respondent's DEA registration. Mark G. 
Medinnus, D.D.S., 78 Fed. Reg. 62,683, 62,692-93 (DEA 2013); George R. 
Smith, M.D., 78 Fed. Reg. 44,972, 44,979 (DEA 2013); Robert M. Brodkin, 
D.P.M., 77 Fed. Reg. 73,678, 73,681 n.5 (DEA 2012); Jeffrey J. Becker, 
D.D.S., 77 Fed. Reg. 72,387, 72,403 (DEA 2012); Scott D. Fedosky, M.D., 
76 Fed. Reg. 71,375, 71,377 (DEA 2011); Paul W. Battershell, 76 Fed. 
Reg. 44,359, 44,365 (DEA 2011); Robert L. Dougherty, 76 Fed. Reg. 
16,823, 16,833 n.13 (DEA 2011); Gilbert Eugene Johnson, 75 Fed. Reg. 
65,663, 65,666 n.3 (DEA 2010).
    Although it is undisputed in this case that Respondent's state 
license is valid, [ALJ Exh. 4 at 4], the Board has not given a 
recommendation on whether Respondent's application for a DEA 
registration should be granted. Therefore, factor one weighs neither 
for nor against Respondent's registration.\16\
---------------------------------------------------------------------------

    \16\ The Government argues that because Mississippi law 
prohibits physicians who have been the subject of a disciplinary 
action for improper prescribing practices from operating pain 
management clinics, the Board's prohibition against Respondent 
operating a weight loss clinic ``is the equivalent to a Board 
recommendation against Respondent handling controlled substances for 
pain management.'' [Gov't Br. at 31]. This argument, however, does 
not square with the Board Order, which allowed Respondent to 
practice medicine with full knowledge that Respondent owned a pain 
management clinic. Had the Board wished to restrict Respondent's 
ability to practice pain management, it could have done so. 
Moreover, Agency precedent strongly suggests that anything less than 
a specific, direct recommendation from a state board to DEA 
regarding respondent's suitability for DEA registration does not 
constitute a ``recommendation'' under factor one of the public 
interest analysis. See Mark G. Medinnus, D.D.S., 78 Fed. Reg. 
62,683, 62,692-93 (DEA 2013) (holding that factor one weighed 
neither for nor against granting a registration because the state 
board ``has not made a specific recommendation concerning the 
granting of a DEA registration to the Respondent''); George R. 
Smith, M.D., 78 Fed. Reg. 44,972, 44,979 (DEA 2013) (holding that 
factor one weighed neither for nor against granting a registration 
because the state board ``did not directly recommend that the 
Respondent's DEA application for registration should be granted''). 
I therefore decline to construe the Board's findings as a 
recommendation by the Board that Respondent's registration should be 
denied.

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[[Page 62966]]

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

    Respondent's experiences with handling controlled substances, as 
well as his compliance with laws related to controlled substances, are 
relevant considerations under the public interest analysis. Pursuant to 
the Controlled Substances Act, ``[p]ersons registered by the Attorney 
General under this subchapter to . . . dispense controlled substances . 
. . are authorized to possess . . . or dispense such substances . . . 
to the extent authorized by their registration and in conformity with 
the other provisions of this subchapter.'' 21 U.S.C. Sec.  822(b); 
Leonard E. Reaves, III, M.D., 63 Fed. Reg. 44,471, 44,473 (DEA 1998); 
see also 21 C.F.R. Sec.  1301.13(a) (providing that ``[n]o person 
required to be registered shall engage in any activity for which 
registration is required until the application for registration is 
granted and a Certificate of Registration is issued by the 
Administrator to such person.''). As such, the DEA properly considers 
practitioners' past compliance with CSA requirements and DEA 
regulations in determining whether registering such a practitioner 
would be in the public interest.
    The first regulation applicable here is DEA's long-standing 
requirement that a prescription be issued for ``a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
professional practice.'' 21 C.F.R. Sec.  1306.04(a). DEA precedent 
establishes that ``a practitioner must establish and maintain a bona-
fide doctor-patient relationship in order to be acting `in the usual 
course of . . . professional practice' and to issue a prescription for 
a `legitimate medical purpose.' '' Paul H. Volkman, 73 Fed. Reg. 
30,630, 30,642 (DEA 2008). Whether a valid doctor-patient relationship 
was established is determined by looking to state law.

Id.

    Here, Dr. Sudderth credibly testified regarding the steps 
physicians must take to create a doctor-patient relationship before 
legitimately prescribing Phentermine. Specifically, he testified that 
in Mississippi, before prescribing Phentermine, a physician must (1) 
document the patient's history of diet, weight, exercise, and use of 
controlled substances for weight loss [Tr. 83-84]; (2) document the 
patient's medical and family history [Tr. 85]; (3) perform and document 
a physical examination of the patient, including vital signs and some 
form or adiposity measurement (BMI, waist circumference, or body fat) 
[Tr. 87-98]; and (4) perform lab work such as blood tests and an EKG 
[Tr. 99-102]. Dr. Sudderth further testified that to be prescribed 
Phentermine for weight loss, a patient must either (1) have a BMI of at 
least 30; or (2) have a BMI of at least 27 and have at least one 
comorbid condition. [Tr. 91, 105]. Some of these standards, including 
the requirement to perform physicals, document histories, and 
investigate prior weight loss efforts, are found in Chapter 25, Section 
501(1) and (2) of the Rules and Regulations of the Board.\17\ [Gov't 
Exh. 29].
---------------------------------------------------------------------------

    \17\ The standards set forth in the Rules and Regulations of the 
Board for prescribing anorectics were revised in 2012. [Tr. 76]. The 
Government entered into evidence the version of the regulations that 
was in place during the time in question. [Tr. 81-82; Gov't Exh. 
29].
---------------------------------------------------------------------------

    Dr. Sudderth testified that Respondent fell below this standard of 
care for each of the sixteen patient files he reviewed. [Tr. 80, 106]. 
Specifically, Dr. Sudderth testified that Respondent failed to document 
the patients' histories, conduct or document adequate physical exams, 
measure patients' BMI, or do any lab work on the patients. [Tr. 114, 
115-16, 120, 125, 126, 129, 130, 131, 137, 138, 142, 147, 148]. 
Additionally, Dr. Sudderth testified that seven of the sixteen patients 
had BMIs too low to justify prescribing Phentermine. [Tr. 110-11; see 
also Gov't Exh. 31]. Further, Dr. Sudderth testified that Respondent 
failed to conduct any follow-up visit ``of substance'' that would 
justify the continued prescription of Phentermine to the patients. [Tr. 
106-07].
    I find Dr. Sudderth's testimony credible because his credentials 
are impeccable, his testimony was internally and externally consistent, 
and the testimony itself was largely unrebutted by Respondent. Indeed, 
when asked at the hearing if he disputes Dr. Sudderth's testimony, 
Respondent replied, ``Why would I dispute his testimony? He's an 
expert.'' [Tr. 219]. Accordingly, I find that Respondent failed to 
establish a bona-fide doctor-patient relationship before prescribing 
Phentermine to the sixteen patients at issue here, thus violating 21 
C.F.R. Sec.  1306.04(a).\18\
---------------------------------------------------------------------------

    \18\ 21 C.F.R. Sec.  1306.04(a) provides, in relevant part, ``A 
prescription for a controlled substance to be effective must be 
issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his professional 
practice.''
---------------------------------------------------------------------------

    I also find that Respondent's improper prescriptions of Phentermine 
to the sixteen patients at issue in these proceedings violated Chapter 
25, Section 501(1) and (2) of the Rules and Regulations of the Board, 
which requires documentation of a thorough physical examination, 
medical history, and a good-faith effort by the patient to lose weight 
without controlled substances before prescribing anorectics. [Gov't 
Exh. 29 at 1-2].
    Moreover, as noted supra, the Board found that Respondent violated 
multiple rules, regulations, and statutes by improperly prescribing 
Phentermine to five additional patients. Specifically, the Board found 
that Respondent violated Chapter 25, Section 501 of the Rules and 
Regulations of the Board by (1) failing to verify that the five 
patients made a good-faith effort to lose weight without the aid of 
controlled substances; (2) failing to obtain full medical histories and 
perform adequate physical examinations of the five patients; and (3) 
continuing to prescribe controlled substances to patients who failed to 
lose weight after thirty days of taking the controlled substances. 
[Gov't Exh. 5 at 49-50]. Additionally, the Board found that Respondent 
violated title 73, chapter 25, section 29(3) of the Mississippi Code by 
dispensing ``drugs having addiction-forming or addiction-sustaining 
liability otherwise than in the course of legitimate professional 
practice.'' [Gov't Exh. 5 at 50]. Finally, the Board found that 
Respondent's actions constituted ``dishonorable or unethical conduct 
likely to deceive, defraud, or harm the public, in violation of Miss. 
Code Ann. 73-25-29(8)(d) and 73-24-83(a).'' [Gov't Exh. 5 at 50]. These 
findings of fact and law are binding on the Agency. David A. Ruben, 
M.D., 78 Fed. Reg. at 38,365-66; Dougherty, 76 Fed. Reg. at16,830-31.
    Respondent also failed to attend the CME courses required by the 
Board Order. Although Respondent offered an explanation for this 
failure--that he could not afford the courses \19\--such explanations 
do not alter the fact that failing to attend the courses within six 
month of the Board Order constituted a violation of the Order.
---------------------------------------------------------------------------

    \19\ I find this reason incredible, since the Respondent also 
testified that he has a monthly income of $15,000. [Tr. 207].
---------------------------------------------------------------------------

    Therefore, because Respondent violated multiple rules, regulations, 
and statutes by prescribing Phentermine to twenty-one patients without 
a legitimate medical purpose and outside the usual course of 
professional practice, and because Respondent violated the Board Order 
by failing to attend the required CME courses, I find that factors two 
and four clearly weigh against Respondent's registration.

[[Page 62967]]

Factor Three: Applicant's Conviction Record Relating to Controlled 
Substances

    Pursuant to 21 U.S.C. Sec.  823(f)(3), the Deputy Administrator may 
deny a pending application for a certificate of registration upon a 
finding that the applicant has been convicted \20\ of a felony related 
to controlled substances under state or federal law. See Thomas G. 
Easter II, M.D., 69 Fed. Reg. 5,579, 5,580 (DEA 2004); Barry H. Brooks, 
M.D., 66 Fed. Reg. 18,305, 18,307 (DEA 2001); John S. Noell, M.D., 56 
Fed. Reg. 12,038, 12,039 (DEA 1991).
---------------------------------------------------------------------------

    \20\ The Administrator interprets the term ``conviction'' by 
affording it the ``broadest possible meaning.'' Donald Patsy Rocco, 
D.D.S., 50 Fed. Reg. 34,210, 34,211 (DEA 1985). Thus, evidence of a 
guilty plea is probative under the third factor of the public 
interest analysis. See, e.g., Farmacia Ortiz, 61 Fed. Reg. 726, 728 
(DEA 1996); Roger Pharmacy, 61 Fed. Reg. 65,079, 65,080 (DEA 1996).
---------------------------------------------------------------------------

    Here, it is undisputed that Respondent has not been convicted of 
any crimes relating to controlled substances. However, DEA precedent 
clearly holds that because there are ``a number of reasons why a person 
may never be convicted of an offense falling under this factor, let 
alone be prosecuted for one, the absence of such a conviction is of 
considerably less consequence in the public interest inquiry.'' Ruben, 
78 Fed. Reg. at 38,379 n.35 (quoting Dewey C. MacKay, M.D., 75 Fed. 
Reg. 49,956, 49,973 (DEA 2010), pet. for rev. denied, MacKay v. DEA, 
664 F.3d 808 (10th Cir. 2011)). I therefore find that factor three 
weighs neither for nor against Respondent's registration.

Factor Five: Such Other Conduct Which May Threaten the Public Health 
and Safety

    Under the fifth public interest factor, the Agency considers 
``[s]uch other conduct which may threaten the public health and 
safety.'' 21 U.S.C. Sec.  823(f)(5). Because the facts of this case do 
not implicate this factor,\21\ I find that factor five weighs neither 
for nor against Respondent's registration.
---------------------------------------------------------------------------

    \21\ Under the heading of factor five, the Government's Brief 
makes a host of arguments about Respondent's credibility and his 
failure to accept responsibility. [Gov't Br. at 40-45]. These 
arguments, however, are more properly asserted in the context of 
Respondent's rebuttal case. See, e.g., Jeri Hassman, M.D., 75 Fed. 
Reg. 8,194, 8,235-36 (DEA 2010). I therefore address these arguments 
infra in the ``Sanction'' discussion.
---------------------------------------------------------------------------

    Therefore, because the Government proved by a preponderance of the 
evidence that Respondent violated multiple statutes, rules, and 
regulations relating to dispensing controlled substances, I find that 
the Government met its burden to prove its prima facie case that 
Respondent's registration would be inconsistent with the public 
interest.

Sanction

    Where the Government has made out a prima facie case that 
Respondent's registration would be inconsistent with the public 
interest, the burden of production shifts to the applicant to 
``present[] sufficient mitigating evidence'' to show why he can be 
trusted with a new registration. See Medicine Shoppe--Jonesborough, 73 
Fed. Reg. at 387. To this point, the Agency has repeatedly held that 
the registrant must ``accept responsibility for [his] actions and 
demonstrate that [he] will not engage in future misconduct. Id.; see 
also Samuel S. Jackson, D.D.S., 72 Fed. Reg. 23,848, 23,853 (DEA 2007). 
Specifically, to rebut the Government's prima facie case, the 
respondent is required ``to accept responsibility for [the established] 
misconduct, [and] also to demonstrate what corrective measures [have 
been] undertaken to prevent the re-occurrence of similar acts.'' Jeri 
Hassman, M.D., 75 Fed. Reg. 8,194, 8,236 (DEA 2010) (citing Jayam 
Krishna-Iyer, M.D., 74 Fed. Reg. 459, 464 n.8 (DEA 2009)).
    In determining whether a respondent has accepted responsibility and 
whether misconduct will reoccur, the Agency has historically looked to 
a number of considerations, including genuine remorse and admission of 
wrongdoing, Lawrence C. Hill, M.D., 64 Fed. Reg. 30,060, 30,062 (DEA 
1999), lapse of time since the wrongdoing, Norman Alpert, M.D., 58 Fed. 
Reg. 67,420, 67,421 (DEA 1993), candor with the court and DEA 
investigators, Jeri Hassman, M.D., 75 Fed. Reg. 8,194, 8,236 (DEA 
2010), and attempts to minimize misconduct, Ronald Lynch, M.D., 75 Fed. 
Reg. 78,745, 78,754 (DEA 2010).
    The Agency has placed special emphasis on the need to deter 
intentional diversion of controlled substances, which includes issuing 
prescriptions ``outside of the usual course of professional practice 
and [without] a legitimate medical purpose.'' David A. Ruben, M.D., 78 
Fed. Reg. at 38,386-87; see also Joseph Gaudio, M.D., 74 Fed. Reg. 
10,083, 10,094-95 (DEA 2009). ``Indeed, this Agency has revoked a 
practitioner's registration upon proof of as few as two acts of 
intentional diversion and has further explained that proof of a single 
act of intentional diversion is sufficient to support the revocation of 
a registration.'' David A. Ruben, M.D., 78 Fed. Reg. at 38,386 (citing 
Dewey C. MacKay, M.D., 75 Fed. Reg. 49,956, 49,977 (DEA 2010)).
    Here, Respondent's improper prescribing methods clearly constituted 
intentional diversion. See David A. Ruben, M.D., 78 Fed. Reg. at 
38,386-87 (defining intentional diversion as prescribing controlled 
substances ``outside of the usual course of professional practice and 
[without] a legitimate medical purpose''). The Agency thus has an 
interest in deterring Respondent and others from engaging in similar 
egregious behavior. That no one was injured as a result of Respondent's 
misconduct is irrelevant; Agency precedent is clear that in light of 
the prescription drug abuse epidemic, even a single act of intentional 
diversion justifies revocation. David A. Ruben, M.D., 78 Fed. Reg. at 
38,386.
    Moreover, Respondent's purported acceptance of responsibility was 
tenuous at best. When asked on direct examination whether his weight 
loss prescribing practices were improper, he responded equivocally: 
``When I got busted, I realized it, yeah. I didn't know--I had no idea 
that there was a strict rule on BMI.'' [Tr. 193]. When asked on cross-
examination whether he admits to prescribing controlled substances 
without medical justification, Respondent responded that he had ``never 
given anything to somebody without a medical justification, in my 
opinion.'' [Tr. 214]. But when pressed on the same question, Respondent 
quickly changed his tune and answered, ``According to the rules, I 
guess, yes.'' [Tr. 214]. Similarly, when asked whether his weight-loss 
practice was ``improperly run,'' Respondent replied, ``I said I broke 
some rules and regulations. I didn't say it was anything improper.'' 
[Tr. 221-22]. Indeed, not once during the hearing did Respondent 
unequivocally admit fault for his improper Phentermine prescriptions.
    Respondent's purported admission of guilt was also undermined by 
his tendency to blame others and make excuses for his misconduct. For 
example, he testified several times that in his weight loss practice he 
was ``just doing the same practice that I know other physicians do.'' 
[Tr. 217; see also Tr. 190 (``. . . there were a lot of doctors doing 
it in town, and I followed what they did.'')]. Indeed, when Respondent 
was asked on cross examination whether he believed he was ``picked on 
by the DEA,'' he responded, ``I don't believe it. I know it.'' [Tr. 
222]. In addition, Respondent admitted that his practices were ``less 
than desirable,'' and then, practically in the same breath, blamed the 
undesirable practices on his staff: ``I didn't know that [my histories 
and physicals] were that less than desirable because they were all done 
by

[[Page 62968]]

my nurse practitioners.'' \22\ [Tr. 197]. In short, Respondent blamed 
other physicians, the DEA, and his own staff for his current 
predicament rather than take the responsibility himself.
---------------------------------------------------------------------------

    \22\ I note that immediately following this remark, Respondent 
purported to take responsibility by saying, ``Although, I'm 
responsible, so I take the cold blame for them myself.'' [Tr. 197]. 
In context, however, I find this acceptance of responsibility to be 
disingenuous; he made this statement only after clearly placing 
blame on someone else.
---------------------------------------------------------------------------

    Respondent also minimized the severity of his misconduct by 
suggesting that he thinks the requirements for prescribing Phentermine 
are too strict. For example, Respondent testified in these proceedings 
and at his criminal trial, ``I mean, you can get a tummy tuck, a 
facelift, whatever you want, but you can't get a--you can't get a diet 
pill. Come on.'' [Tr. 193; see also Tr. 198-99; Gov't Exh. 11 at 115]. 
In his criminal trial, Respondent testified, ``You can get phentermine 
over the internet from Canada. Nurses can write for it. It's a Schedule 
IV drug like cough syrup. I mean, it's so safe. The addiction potential 
is so low.'' [Gov't Exh. 11 at 119]. Additionally, Respondent testified 
in his criminal trial that BMI measurements are ``worthless.'' [Tr. 
216; Gov't Exh. 11 at 117]. In other words, rather than acknowledging 
his faults, Respondent opted to criticize the standards put in place by 
the medical community, the Board, and the DEA.
    I also find it significant that Dr. Van Craig, the executive 
director of the Board, remembered Respondent as being ``angry with the 
Board for disciplining him'' and felt that Respondent believed he had 
received ``rather harsh treatment from the Board because of what he was 
doing.'' [Tr. 60, 61; see also Tr. 66]. Indeed, Respondent's demeanor 
described by Dr. Van Craig is consistent with the hostile tone 
Respondent took during the hearings in these proceedings.\23\
---------------------------------------------------------------------------

    \23\ Respondent's counsel, at the hearing, suggested that 
Respondent's ``loud and obnoxious'' tone is a result of his hearing 
impairment rather than his lack of remorse or hostility toward the 
Board or the DEA. [Tr. 66]. During the hearing in these proceedings, 
I certainly noticed that Respondent's hearing disability affected 
him. [E.g., Tr. 225, 226]. But Respondent's hearing did not appear 
to be what motivated his tone or his statements, discussed supra, 
which gave cause for concern regarding his remorse and acceptance of 
responsibility.
---------------------------------------------------------------------------

    The above-noted examples do not reflect someone who feels remorse 
for his misconduct or understands the gravity of his mistakes. Rather, 
they illustrate that Respondent takes no responsibility for his 
actions, blames others for his improper prescribing methods, and 
disagrees with the rules regarding the dispensing of Phentermine. 
Additionally, other than a promise to comply with the Board's order to 
refrain from treating weight loss patients, Respondent has offered no 
evidence of remedial measures he has taken to ensure that future 
violations will not occur. As such, I find that Respondent has not 
taken responsibility for his misconduct and therefore has failed to 
rebut the Government's prima facie case.

VI. CONCLUSION AND RECOMMENDATION

    Because the Government met its burden to prove that Respondent's 
registration would be inconsistent with the public interest, and 
because Respondent failed to rebut the Government's case, I recommend 
that the Deputy Administrator deny Respondent's application.

Dated: April 16, 2014

s/Gail A. Randall,
Administrative Law Judge

CERTIFICATE OF SERVICE

    This is to certify that the undersigned, on _____--, 2013, caused a 
copy of the foregoing to be faxed and placed in the interoffice mail 
addressed to DEA Headquarters, Attn: Office of Chief Counsel/Michelle 
Gillice, Esq., 8701 Morrissette Drive, Springfield, VA 22152, Fax: 
(202) 307-4946, and a copy to be faxed and mailed to Respondent's 
Counsel, Rodney A. Ray, Esq., P. O. Box 1018, Columbus, MS 39703, Fax: 
(662) 329-3522.

Carlene R. Thomas,
Secretary to The Honorable Gail A. Randall

[FR Doc. 2014-25025 Filed 10-20-14; 8:45 am]
BILLING CODE 4410-09-P

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