John O. Dimowo, M.D.; Decision and Order, 15800-15814 [2020-05751]

Download as PDF 15800 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices Controlled substance Drug code 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... Levomethorphan .............................................................................................................................................................. Levorphanol ..................................................................................................................................................................... Remifentanil ..................................................................................................................................................................... Fentanyl ........................................................................................................................................................................... The company plans to bulk manufacture API quantities of the listed controlled substances for validation purposes and FDA approval. Dated: March 5, 2020. William T. McDermott, Assistant Administrator. [FR Doc. 2020–05750 Filed 3–18–20; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration John O. Dimowo, M.D.; Decision and Order jbell on DSKJLSW7X2PROD with NOTICES On August 28, 2017, the Drug Enforcement Administration (hereinafter, DEA) Administrative Law Judge Charles Wm. Dorman (hereinafter, ALJ), issued a Recommended Rulings, Findings of Fact, Conclusions of Law and Decision (hereinafter, RD) on the action to revoke the DEA Certification of Registration of John O. Dimowo, M.D. Neither party filed exceptions to the RD. Having reviewed and considered the entire administrative record before me, I adopt the ALJ’s RD with minor modifications, where noted herein.*A Overall, with respect to this case, I appreciate Respondent’s efforts to limit DEA time and resources by stipulating to many of the Government’s fact allegations. However, as explained in the findings and conclusions below, his actions, including prescribing after a court’s restriction and prescribing in Texas after his convictions and settlement in California without a DEA registration, contradicted the credibility of his words. The Respondent must convince the Administrator that his acceptance of responsibility and remorse are sufficiently credible to demonstrate that the misconduct will not recur. Jeffrey Stein, M.D., 84 FR 46,968, 46,974 (2019). As described *A I have made minor modifications to the RD. I have substituted initials or titles for the names of witnesses and patients to protect their privacy and I have made minor, nonsubstantive, grammatical changes. Where I have made substantive changes, omitted language for brevity or relevance, or where I have added to or modified the ALJ’s opinion, I have noted the edits with an asterisk, and I have included specific descriptions of the modifications in brackets following the asterisk or in footnotes marked with an asterisk and a letter. VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 herein, Respondent did not convince me or the ALJ that he could be entrusted with a DEA registration. Order Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration BD3755571 issued to John O. Dimowo, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny any pending application of John O. Dimowo to renew or modify this registration, as well as any pending application of John O. Dimowo for registration in California. This Order is effective April 20, 2020. Dated: March 2, 2020. Uttam Dhillon, Acting Administrator. Paul E. Soeffing, Esq., for the Government Courtney E. Pilchman, Esq., for the Respondent Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge Charles Wm. Dorman, Administrative Law Judge. On July 21, 2016, the Drug Enforcement Administration (‘‘DEA’’ or ‘‘Government’’) served John O. Dimowo, M.D., (‘‘Respondent’’) with an Order to Show Cause (‘‘OSC’’), seeking to revoke his DEA Certificate of Registration (‘‘COR’’), Number BD3755571. Administrative Law Judge Exhibit (‘‘ALJ–’’) 1, 6. One of the allegations contained in the OSC was that the Respondent lacked state authority to handle controlled substances in California, where he was registered. In response to the OSC, the Respondent timely requested a hearing before an Administrative Law Judge. ALJ–2. On September 2, 2016, the Government filed a Motion for Summary Disposition. ALJ–7. Therein, the Government argued that the Respondent lacked state authority in California to handle controlled substances, the state where the Respondent was registered with the DEA. ALJ–7, at 2. The Government stated that an Interim Suspension Order was issued against the Respondent by the Medical Board of California (‘‘MBC’’) on June 10, 2016. ALJ–7, at 2– PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 8333 9210 9220 9739 9801 Schedule II II II II II 3. Attached to the Government’s Motion was a copy of the MBC’s Interim Order of Suspension. ALJ–7, Ex. 1. The Government also stated that on June 28, 2016, a hearing was held before a California administrative law judge. ALJ–7, at 3. Following that hearing, on July 1, 2016, the state continued the suspension of the Respondent’s medical license, and issued an Interim Order of Suspension. ALJ–7, Ex. 2. On September 16,*B 2016, the Respondent filed a Response to the Government Motion for Summary Disposition (‘‘Response’’). ALJ–8. Therein, the Respondent acknowledged that his California medical license had been suspended but asserted that he had ‘‘completed negotiation with the [MBC] to resolve the accusations that resulted in the temporary license suspension.’’ ALJ–8, at 1. Attached to the Response was a copy of a Stipulated Settlement and Disciplinary Order between the Respondent and the Attorney General of California. ALJ–8, Ex. 1. In the Response, the Respondent requested that ‘‘the hearing on this matter be stayed pending the final approval of the negotiated settlement stipulation by the Executive Director of the [MBC].’’ ALJ– 8,*C at 1. At that time, both parties agreed that the Respondent currently lacked state authority to handle controlled substances in California. Because there was no genuine question of fact, no adversarial hearing was required. See, e.g., Jesus R. Juarez, M.D., 62 FR 14,945, 14,945 (1997). Therefore, because DEA precedent requires that a practitioner be authorized to handle controlled substances in the jurisdiction in which the practitioner is registered, I granted the Government’s Motion for Summary Disposition on October 18, 2016. See ALJ–14. On November 15, 2016, I forwarded my October 18, 2016 Order Granting Summary Disposition and Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision (‘‘Recommended Decision’’) to the Acting Administrator of the DEA. ALJ– 15. Subsequent to the issuance of the Recommended Decision, the MBC restored a substantial portion of the *B Correction. *C Correction. E:\FR\FM\19MRN1.SGM 19MRN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices Respondent’s state authority to practice medicine and handle controlled substances in California, but did limit his ability to prescribe or handle drugs that are listed in Schedules II and III of the California Uniform Controlled Substances Act. In light of the action by the MBC, the Acting Administrator determined that revocation of the Respondent’s COR was no longer warranted based on a lack of state authority. ALJ–19, at 2. The OSC, however, contained other allegations, which the Government had alleged as grounds for revocation. Following input from the parties, ALJ–17, ALJ–18, the Acting Administrator issued an Order in this case on February 23, 2017. ALJ–19.*D That Order placed restrictions on the Respondent’s COR, prohibiting him from ‘‘prescribing, direct dispensing, purchasing and ordering any controlled substance in schedules II and III of the Controlled Substances Act.’’ ALJ–19, at 6. The Order further prohibited the Respondent ‘‘from administering any controlled substance in schedules II and III, except when such administration is for the purpose of providing anesthesia to a patient in a hospital or licensed surgery center.’’ Id. at 6. Finally, the Acting Administrator remanded this case to the Office of Administrative Law Judges for ‘‘further proceedings consistent with [his] decision.’’ Id. at 7. Following that remand, I issued an Order for Prehearing Statements. ALJ– 20. The parties filed Prehearing Statements, ALJ–22, ALJ–23, as well as Supplemental Prehearing Statements. ALJ–28, ALJ–29. Afterwards, a hearing in this matter was held in Santa Ana, California on June 27, 2017. The issue before the Administrator is whether the DEA should revoke the registration of John O. Dimowo, M.D., DEA Certificate of Registration, BD3755571, pursuant to 21 U.S.C. 824(a)(4), and deny any pending application 1* for renewal or modification of such registration, pursuant to 21 U.S.C. 823(f). This Recommended Decision is based on my consideration of the entire administrative record, including all of the testimony, admitted exhibits, and the oral and written arguments of counsel. *D Correction. 1* [RD footnote 1 omitted due to lack of relevance of the status of Respondent’s registration or application. See Jeffrey D. Olsen, M.D., 84 FR 68,474 (2019).] VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 The Remaining Allegations I. Unlawful Distribution of Controlled Substances to Three Undercover Agents on Five Separate Occasions in Violation of 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code § 11153(a); and Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), and 2242(a) 2 1. On March 30, 2012, an undercover law enforcement officer (‘‘UC1’’) met with the Respondent. GE–3. During an office visit that day, UC1 rated his pain as a two, on a scale of one to ten; explained that his only pain was caused by exercise and walking a lot; and stated that he was taking a friend’s Vicodin and Adderall to self-medicate. Id. The Respondent conducted little or no physical examination of UC1 and provided no diagnosis warranting a prescription for controlled substances, yet he prescribed Adderall 10 mg, a schedule II controlled substance, and Norco, a schedule III controlled substance, to UC1. ALJ–1, at 2; GE–4. 2. On May 4, 2012, UC1 again met with the Respondent. GE–5. During an office visit that day, UC1 stated his pain was good; asked for Opana, a schedule II controlled substance, which he said he had been obtaining from someone at a gym; said his pain was caused by exercise; and failed a urine screening for the drugs the Respondent had previously prescribed to him. Id. The Respondent conducted little or no physical examination of UC1 and provided no diagnosis warranting a prescription for controlled substances, yet he prescribed Adderall 10 mg, a schedule II controlled substance, and Vicodin, a schedule III controlled substance, to UC1. ALJ–1, at 2; GE–6. 3. On May 4, 2012, UC2 met with the Respondent. GE–7. During an office visit that day, UC2 stated she wanted something to treat her soreness after exercise and she asked for Adderall to stay alert with her children, and Xanax or Vicodin to relax at night. Id. The Respondent conducted little or no physical examination of UC2 and provided no diagnosis warranting a prescription for controlled substances, yet he prescribed Adderall 10 mg, Vicodin 5/500 mg, and Xanax 2 mg, all controlled substances in schedules II, III, and IV, respectively. ALJ–1, at 2–3; GE–8. 2 I have taken official notice of Cal. Health & Safety Code § 11153(a) (Westlaw, Current with all laws through Ch. 870 of 2019 Regular Session); and Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), and 2242(a) (Westlaw, Current with all laws through Ch. 870 of 2019 Regular Session); Tr. 7. *[See also GE 1 and GE 2.] PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 15801 4. On March 21, 2013, UC3 met with the Respondent. GE–9. During an office visit that day, UC3 complained of generalized pain from an old high school football accident and informed the Respondent that he did not have insurance, but he did what he needed to do to get oxycodone. Id. The Respondent conducted little or no physical examination of UC3 and provided no diagnosis warranting a prescription for controlled substances, yet he prescribed Percocet 10/325 mg, a schedule II controlled substance, to UC3. ALJ–1, at 3; GE–10. 5. On April 25, 2013, UC3 met with the Respondent. GE–11. The Respondent conducted little or no physical examination of UC3 and provided no diagnosis warranting a prescription for controlled substances, yet he prescribed Percocet 10/325 mg, to UC3. ALJ–1, at 3; GE–12. *[I am omitting RD Section II and renumbered subsequent sections for brevity due to the Government’s dismissal of the charge].3 II. State Convictions 6. On May 14, 2015,*E a Los Angeles County jury convicted the Respondent of seven felony counts of issuing unlawful controlled substance prescriptions for Adderall, hydrocodone, and alprazolam. On March 28, 2016, the presiding judge reduced the felony convictions to misdemeanors. Id. at 4. These convictions may be considered in determining whether the Respondent’s registration is inconsistent with the public interest under 21 U.S.C. 823(f)(3) and 824(a)(4). III. Writing Prescriptions in Texas Without a Valid DEA COR for a Texas Location 7. In March and April 2017, the Respondent issued three prescriptions for Lyrica, a schedule V controlled substance, from his medical practice in El Paso, Texas. In writing these three prescriptions, the Respondent listed his DEA COR for his registered address in California. At the time the Respondent wrote the prescriptions in Texas he did not have a DEA COR for a registered Texas location. Thus, the Respondent violated the separate registration requirements of 21 U.S.C. 822(e) and 21 CFR 1301.12(a) and (b)(3). ALJ–29, at 5– 6; GE–23, 24. 3 The Government withdrew* [the allegation of issuing prescriptions for office use or for personal use in violation of 21 CFR 1306.04(b)] at the hearing. Tr. 7. *E Correction. E:\FR\FM\19MRN1.SGM 19MRN1 15802 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices Witnesses jbell on DSKJLSW7X2PROD with NOTICES I. The Government’s Witnesses The Government presented no witness during its case-in-chief. Rather, the Government introduced 24 Exhibits, and relied upon the 83 stipulations of fact that the Respondent had entered into with the Government. Following the presentation of the Respondent’s case-in-chief, the Government presented two rebuttal witnesses. The Government’s first rebuttal witness was a Diversion Investigator (DI). Tr. 112–130. DI has been a diversion investigator with the DEA for five years and she is assigned to the Los Angeles Field Division, Tactical Diversion Squad. DI attended the basic 12-weeks of training for new diversion investigators at Quantico, VA, and two additional training courses at Quantico concerning financial investigations. As a diversion investigator, DI has conducted regulatory and criminal investigations of individuals and organizations holding DEA registrations to deal with controlled substances. As a member of the Tactical Diversion Squad, DI’s investigations primarily concern criminal matters involving doctors and pharmacies. DI became the lead investigator concerning the Respondent when the initial investigator left the Tactical Diversion Squad. As a rebuttal witness DI provided testimony concerning where the Respondent was registered to handle controlled substances; the prescriptions the Respondent wrote in Texas; and her interaction with the Respondent’s MBC probation officer. I find DI’s testimony to be thorough, detailed, and internally consistent with Government Exhibits 18, 23, and 24. Therefore, I merit it as credible in this Recommended Decision. The Government’s second rebuttal witness was M.D., who has been an investigator with the California Department of Consumer Affairs for over six years. M.D. is assigned to the Health Quality Investigation Unit of the Department. M.D.’s credentials are further detailed at GE–13, at 8. M.D. was the main investigator concerning the Respondent. Tr. 131. M.D. provided rather limited testimony concerning whether the Respondent had complied with terms of his stipulated settlement with the MBC and his familiarity with reporting requirements contained in such settlements. I find M.D.’s testimony to be thorough, detailed, and internally consistent with Government Exhibit 18. Therefore, I merit it as credible in this Recommended Decision. VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 II. The Respondent’s Witness The Respondent’s case-in-chief included the testimony of the Respondent, reliance upon the 83 stipulations of fact, and introduction of Respondent’s Exhibits A–CC. The overall tenor of the Respondent’s testimony was his acceptance of responsibility and detailing steps he has taken to ensure that his past violations are not repeated. Tr. 21–112. The Respondent testified about his medical training and background, as well as describing the various medical positions he has held since being licensed as a medical doctor in the United States and his impressive curriculum vitae. The Respondent testified about actions he took to divest himself of his pain management practice after the MBC visited his clinic in 2013, but before he was charged with any crimes. The Respondent testified concerning his conviction on seven felony counts, later reduced to misdemeanors by the trial judge, and the actions he took following the trial, including performing 353 hours of community service, even though he was only required to perform 130 hours. Tr. 45. During his community service, the Respondent shared his ‘‘story’’ with individuals dealing with substance abuse issues in an effort to allow them to learn from his own mistakes. He testified that if he is allowed to keep his COR he would restrict his practice to anesthesiology in a hospital or surgery center, using only the controlled substances those institutions had acquired. The Respondent testified in a very candid and straightforward manner. There were at least six portions of his testimony, however, that strained credulity. The Respondent testified that, in retrospect, he does not believe he was prepared to enter into a pain management practice in 2010 because he had not reviewed the requirements for substance control; he was not able to identify drug seeking patients; and he was too trusting of patients. Tr. 35–36. The Respondent, however, was board certified in pain management. The Respondent had also completed a twoyear pain management fellowship and was a Diplomate of the American Board of Pain Medicine. RE–A, at 1. The Respondent had also been practicing medicine in the United States for 17 years by the time he opened his pain clinic in 2007, and although the primary focus of his practice had been anesthesiology, he worked in a pain clinic before he opened his own pain clinic. I find that the Respondent’s assertion of being ill prepared to open PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 a pain clinic rings hollow given his training and experience, which included work in a pain clinic, where 70% of his work was pain management, prior to opening his own pain clinic. The Respondent testified that he intended to limit his medical practice to anesthesiology. Just this year, however, the Respondent opened a pain clinic in Texas.*F When asked to explain why he had failed to perform examinations of the three undercover patients, the Respondent testified that he had performed a short diagnosis, as he had been trained to do in Nigeria. The Respondent’s failure to perform the examinations, however, occurred in 2012, years after he had been trained in Nigeria, and after more than 20 years of medical practice in the United States. When describing the requirements of his stipulated settlement with the MBC, the Respondent either did not understand the terms of the settlement or he mischaracterized its terms to make it seem more onerous than it is. For example, he testified that he must have a physician to monitor his medical practice. Tr. 59. The settlement provided, however, that he need not have a monitor if he participates in a professional enhancement program. GE– 18, at 11. The Respondent testified that the stipulated settlement required that he practice medicine at least 40 hours a month in California. The stipulated settlement contains no such provision. As Respondent’s counsel stated, ‘‘the best reflection of the terms and conditions are contained in the stipulated settlement . . . .’’ Tr. 136. With respect to the Respondent’s ability to practice medicine following his conviction and sentencing by a California court, the Respondent testified that the sentencing judge did not restrict his ability to practice medicine, stating that the judge left that to the MBC. Tr. 56. That testimony stands in sharp contrast to the Finding of Fact contained in the MBC’s Interim Order of Suspension. In the MBC’s second finding of fact it states that the court ‘‘ordered Respondent ‘not to practice medicine until an order has been made by the Medical Board with respect to your ability to do so in the State of California.’ ’’ GE–17, at 2. Thus, it would appear that the trial judge did prohibit the Respondent from practicing medicine until the MBC had taken action. The Respondent also testified that when he wrote prescriptions for a *F I am omitting two sentences of the R.D., because they are superfluous and could be misinterpreted as conflicting with my February 23, 2017 Order. E:\FR\FM\19MRN1.SGM 19MRN1 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices schedule V controlled substance in Texas this year he thought he had authority to do so. He apparently based this belief upon the fact that he had requested a change of mailing address with the DEA and the DEA had acknowledged the new address. He also based it upon the fact that he had called a pharmacy in Texas, and the pharmacy had told him it was okay to issue the prescription. These prescriptions, however, were written after the Respondent had taken a ‘‘PACE’’ course on how to write prescriptions, after a motion had been filed to revoke the Respondent’s bail prior to his trial for violating a court order not to do so,4 and after he had been convicted of writing illegal prescriptions. Thus, it would appear that the Respondent’s belief that he had the authority to write prescriptions for controlled substances in Texas was an unreasonable belief. I find that the Respondent presented as a generally credible and sincere witness. The six examples detailed above, however, detract from the Respondent’s overall credibility. Thus, to the extent that the Respondent’s testimony is in conflict with other evidence of record, or it is based on illogical or unsound reasoning, I defer to that other evidence, logic and/or reasoning. jbell on DSKJLSW7X2PROD with NOTICES The Facts I. Stipulations of Fact The parties stipulated to the following facts. 1. Respondent is registered with DEA as an individual practitioner in Schedules II–V under DEA registration number BD3755571 at 5857 Pine Avenue, Chino Hills, CA 91709. This registration expires by its terms on June 30, 2017. *[Respondent filed for renewal in May 2017. See Tr. 116, 127.] 2. Norco is a hydrocodone combination product. Prior to October 6, 2014, hydrocodone combination products were classified as Schedule III controlled substances. After October 6, 2014, hydrocodone combination products were classified as Schedule II controlled substances. 3. Adderall is a brand name for generic amphetamine. Amphetamine is classified as a Schedule II controlled substance. 4. Vicodin is a hydrocodone combination product. Prior to October 6, 2014, hydrocodone combination products were classified as Schedule III controlled substances. After October 6, 2014, hydrocodone combination products were classified as Schedule II controlled substances. 4 See GE–16, at 4, para 13: GE–19, at 1170. VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 5. Xanax is a brand name for generic alprazolam. Alprazolam is classified as a Schedule IV controlled substance. 6. Percocet is a brand name for generic oxycodone. Oxycodone is classified as a Schedule II controlled substance. 7. On March 30, 2012, Respondent issued prescriptions to UC1 for 90 dosage units of Norco 10/325 mg and 30 dosage units of Adderall 10 mg. 8. On May 4, 2012, Respondent issued prescriptions to UC1 for 90 dosage units of Vicodin 5/500 mg and 30 dosage units of Adderall 10 mg. 9. On May 4, 2012, Respondent issued prescriptions to UC2 for 30 dosage units of Vicodin 5/500 mg, 60 dosage units of Xanax 2 mg, and 30 dosage units of Adderall 10 mg. 10. On March 21, 2013, Respondent issued a prescription to UC3 for 90 dosage units of Percocet 10/325 mg. 11. On April 25, 2013, Respondent issued a prescription to UC3 for 90 dosage units of Percocet 10/325 mg. 12. On March 22, 2013, investigators with the MBC, assisted by DEA investigators, executed a state search warrant at Respondent’s medical offices located at 1120 West La Palma #2, Anaheim, California 92801 and 218 East Anaheim St., Wilmington, California 90744, and seized materials, including all controlled substances from both locations and medical records of patients. 13. On May 14, 2015, a Los Angeles County jury convicted Respondent of seven state felony counts of issuing unlawful controlled substance prescriptions for hydrocodone and Adderall. 14. On March 28, 2016, Respondent was sentenced and the presiding judge, pursuant to the discretion afforded him under state law, reduced the convictions to misdemeanors and sentenced Respondent to probation. 15. On June 10, 2016, the MBC suspended Respondent’s medical license with the issuance of an ex parte Interim Order of Suspension. 16. On July 1, 2016,5 after a hearing, the MBC continued the suspension of Respondent’s medical license with the issuance of an Interim Order of Suspension. 17. On December 20, 2016, the MBC issued a Decision adopting a Stipulated Settlement and Disciplinary Order entered into by Respondent and the Attorney General for California on September 9, 2016. The Decision was effective January 19, 2017, and reinstated Respondent’s medical license, with restrictions. 5 See Tr. 6, lines 24–25 (correcting a typographical error in the Prehearing Ruling). PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 15803 18. The parties stipulate to the authenticity and admission of Government Exhibit 1: Cal. Health & Safety Code § 11153(a). 19. The parties stipulate to the authenticity and admission of Government Exhibit 2: Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), 2242(a). 20. The parties stipulate to the authenticity and admission of Government Exhibit 3: DVD recording and transcript of undercover visit by UC1 on March 30, 2012. (13 pages) 21. The parties stipulate to the authenticity and admission of Government Exhibit 4: Prescriptions written by John O. Dimowo for UC1 for 90 Norco 10/325 mg and 30 Adderall 10 mg dated March 30, 2012. 22. The parties stipulate to the authenticity and admission of Government Exhibit 5: DVD recording and transcript of undercover visit by UC1 on May 4, 2012. 23. The parties stipulate to the authenticity and admission of Government Exhibit 6: Prescriptions written by John O. Dimowo for UC1 for 90 Vicodin 5/500 mg and 30 Adderall 10 mg dated May 4, 2012. 24. The parties stipulate to the authenticity and admission of Government Exhibit 7: DVD recording and transcript of undercover visit by UC2 on May 4, 2012. 25. The parties stipulate to the authenticity and admission of Government Exhibit 8: Prescriptions written by John O. Dimowo for UC2 for 30 Vicodin 5/500 mg, 60 Xanax 2 mg and 30 Adderall 10 mg dated May 4, 2012. 26. The parties stipulate to the authenticity and admission of Government Exhibit 9: DVD recording and transcript of undercover visit by UC3 on March 21, 2013. 27. The parties stipulate to the authenticity and admission of Government Exhibit 10: Prescription written by John O. Dimowo for UC3 for 90 Percocet 10/325 mg dated March 21, 2013. 28. The parties stipulate to the authenticity and admission of Government Exhibit 11: DVD recording and transcript of undercover visit by UC3 on April 25, 2013. 29. The parties stipulate to the authenticity and admission of Government Exhibit 12: Prescription written by John O. Dimowo for UC3 for 90 Percocet 10/325 mg dated April 25, 2013. 30. The parties stipulate to the authenticity and admission of Government Exhibit 13: Search Warrant dated March 19, 2013. E:\FR\FM\19MRN1.SGM 19MRN1 jbell on DSKJLSW7X2PROD with NOTICES 15804 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices 31. The parties stipulate to the authenticity and admission of Government Exhibit 14: Patient File for UC1. 32. The parties stipulate to the authenticity and admission of Government Exhibit 15: Patient File for UC2. 33. The parties stipulate to the authenticity and admission of Government Exhibit 16: Certified copy of MBC’s Interim Order of Suspension (ex parte) dated June 10, 2016. 34. The parties stipulate to the authenticity and admission of Government Exhibit 17: Certified copy of MBC’s Interim Order of Suspension dated July 1, 2016. 35. The parties stipulate to the authenticity and admission of Government Exhibit 18: Certified copy of MBC’s Decision dated December 20, 2016, and Stipulated Settlement and Disciplinary Order dated September 9, 2016. 36. The parties stipulate to the authenticity and admission of Government Exhibit 19: California v. Dimowo, Case No. BA417100, Reporter’s Transcript of Proceedings (Cal. Sup. Ct. Los Angeles County, Apr. 24–May 14, 2015). 37. The parties stipulate to the authenticity and admission of Government Exhibit 20: California v. Dimowo, Case No. BA417100, Conviction Minute Order (Cal. Sup. Ct. Los Angeles County, May 14, 2015). 38. The parties stipulate to the authenticity and admission of Government Exhibit 21: California v. Dimowo, Case No. BA417100, Sentencing Minute Order (Cal. Sup. Ct. Los Angeles County, Mar. 28, 2016). 39. The parties stipulate to the authenticity and admission of Government Exhibit 22: Curriculum Vitae of W.S., M.D. 40. The parties stipulate to the authenticity and admission of Government Exhibit 23: Two prescriptions for Lyrica authorized by Respondent in Texas and filled by ASP Cares Pharmacy. 41. The parties stipulate to the authenticity and admission of Government Exhibit 24: One prescription for Lyrica authorized by Respondent in Texas and filled by Walgreens Pharmacy. 42. The parties stipulate that UC1 is a MBC Investigator who saw Respondent in an undercover capacity posing as UC1 on March 30, 2012, and May 4, 2012. 43. The parties stipulate that the prescription written by John O. Dimowo for UC1 for 90 Norco 10/325 mg, dated March 30, 2012, (Government Exhibit 4) VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 was issued for no legitimate medical purpose and outside the usual course of professional practice, in violation of 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code § 11153(a); and Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), 2242(a). 44. The parties stipulate that the prescription written by John O. Dimowo for UC1 for 30 Adderall 10 mg, dated March 30, 2012, (Government Exhibit 4) was issued for no legitimate medical purpose and outside the usual course of professional practice, in violation of 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code § 11153(a); and Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), 2242(a). 45. The parties stipulate that the prescription written by John O. Dimowo for UC1 for 90 Vicodin 5/500 mg, dated May 4, 2012, (Government Exhibit 6) was issued for no legitimate medical purpose and outside the usual course of professional practice, in violation of 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code § 11153(a); and Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), 2242(a). 46. The parties stipulate that the prescription written by John O. Dimowo for UC1 for 30 Adderall 10 mg, dated May 4, 2012, (Government Exhibit 6) was issued for no legitimate medical purpose and outside the usual course of professional practice, in violation of 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code § 11153(a); and Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), 2242(a). 47. The parties stipulate that UC2 was a MBC Investigator who saw Respondent posing in an undercover capacity as UC2 on May 4, 2012. 48. The parties stipulate that the prescription written by John O. Dimowo for UC2 for 30 Vicodin 5/500 mg, dated May 4, 2012, (Government Exhibit 8) was issued for no legitimate medical purpose and outside the usual course of professional practice, in violation of 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code § 11153(a); and Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), 2242(a). 49. The parties stipulate that the prescription written by John O. Dimowo for UC2 for 60 Xanax 2 mg, dated May 4, 2012, (Government Exhibit 8) was issued for no legitimate medical purpose and outside the usual course of professional practice, in violation of 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code § 11153(a); and Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), 2242(a). 50. The parties stipulate that the prescription written by John O. Dimowo for UC2 for 30 Adderall 10 mg, dated PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 May 4, 2012, (Government Exhibit 8) was issued for no legitimate medical purpose and outside the usual course of professional practice, in violation of 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code § 11153(a); and Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), 2242(a). 51. The parties stipulate that UC3 is a California Department of Health Care Services Investigator who saw Respondent in an undercover capacity posing as UC3 on March 21, 2013, and April 25, 2013. 52. The parties stipulate that the prescription written by John O. Dimowo for UC3 for 90 Percocet 10/325 mg, dated March 21, 2013, (Government Exhibit 10) was issued for no legitimate medical purpose and outside the usual course of professional practice, in violation of 21 CFR 1306.04(a); and Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), 2242(a).6 53. The parties stipulate that the prescription written by John O. Dimowo for UC3 for 90 Percocet 10/325 mg, dated April 25, 2013, (Government Exhibit 12) was issued for no legitimate medical purpose and outside the usual course of professional practice, in violation of 21 CFR 1306.04(a); and Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), 2242(a).7 54. The parties stipulate that during March and April 2017, Respondent maintained a principal place of business or professional practice in Texas from which he issued three prescriptions for Lyrica (Government Exhibits 23 and 24), which is a brand name for generic pregabalin a Schedule V controlled substance. The parties further stipulate that during March and April 2017, Respondent was not registered in Texas with DEA. 55. The parties stipulate to the authenticity and admission of Respondent’s Exhibit A: CV of Dr. Dimowo. 56. The parties stipulate to the authenticity and admission of Respondent’s Exhibit B: Character letter from P.B., D.O., dated December 3, 2013. 57. The parties stipulate to the authenticity and admission of Respondent’s Exhibit C: Character letter from R.B., M.D. 58. The parties stipulate to the authenticity and admission of Respondent’s Exhibit D: Character letter from S.B., D.P.M., dated November 26, 2013. 6 See Tr. 107–08 (deleting reference to 21 U.S.C. 841(a)(1), and Cal. Health & Safety Code § 11153(a)). 7 See Tr. 107–08 (deleting reference to 21 U.S.C. 841(a)(1), and Cal. Health & Safety Code § 11153(a)). E:\FR\FM\19MRN1.SGM 19MRN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices 59. The parties stipulate to the authenticity and admission of Respondent’s Exhibit E: Character letter from E.G., M.D., dated December 5, 2013. 60. The parties stipulate to the authenticity and admission of Respondent’s Exhibit F: Character letter from S.V., M.D., dated December 3, 2013. 61. The parties stipulate to the authenticity and admission of Respondent’s Exhibit G: Character letter from R.R., M.D., dated December 13, 2013. 62. The parties stipulate to the authenticity and admission of Respondent’s Exhibit H: Character letter from J.L., M.D., dated December 3, 2013. 63. The parties stipulate to the authenticity and admission of Respondent’s Exhibit I: Character letter from K.K., M.D., dated December 19, 2013. 64. The parties stipulate to the authenticity and admission of Respondent’s Exhibit J: Certificate of completion of Medical Record Keeping Course, UC San Diego PACE program, dated July 18–19, 2013. 65. The parties stipulate to the authenticity and admission of Respondent’s Exhibit K: Certificate of completion of Physician Prescribing Course, UC San Diego PACE program, dated July 15–17, 2013. 66. The parties stipulate to the authenticity and admission of Respondent’s Exhibit L: Certificate of attendance Medical Ethics and Professional Boundaries Program, April 8, 2017. 67. The parties stipulate to the authenticity and admission of Respondent’s Exhibit M: Certificate of completion Drug and Alcohol Awareness Class, dated November 3, 2015. 68. The parties stipulate to the authenticity and admission of Respondent’s Exhibit N: Chronic Pain Management, dated April 15, 2015. 69. The parties stipulate to the authenticity and admission of Respondent’s Exhibit O: Acute Pain Management, dated April 15, 2015. 70. The parties stipulate to the authenticity and admission of Respondent’s Exhibit P: Pain Review Course, dated August 20, 2015. 71. The parties stipulate to the authenticity and admission of Respondent’s Exhibit Q: Medical Ethics for Physicians, dated August 12, 2015. 72. The parties stipulate to the authenticity and admission of Respondent’s Exhibit R: Opioid Use Disorder, dated August 22, 2015. VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 73. The parties stipulate to the authenticity and admission of Respondent’s Exhibit S: Prescription Opioid: Risk Management and Strategies for Safe Use, dated August 22, 2015. 74. The parties stipulate to the authenticity and admission of Respondent’s Exhibit T: Family Healing Center community service, dated September 16, 2016, for 42 hours. 75. The parties stipulate to the authenticity and admission of Respondent’s Exhibit U: Chosen Few/ Thin Line Sober Living community service, dated September 8, 2016, for 70 hours. 76. The parties stipulate to the authenticity and admission of Respondent’s Exhibit V: Chosen Few/ Thin Line Sober Living community service, dated December 14, 2015, for 54 hours. 77. The parties stipulate to the authenticity and admission of Respondent’s Exhibit W: Chosen Few/ Thin Line Sober Living community service, dated March 22, 201,6 for 16 hours. 78. The parties stipulate to the authenticity and admission of Respondent’s Exhibit X: Recovery Can Conquer Home community service, dated September 18, 2015, for 24 hours. 79. The parties stipulate to the authenticity and admission of Respondent’s Exhibit Y: Recovery Can Conquer Home community service, dated December 12, 2015, for 36 hours. 80. The parties stipulate to the authenticity and admission of Respondent’s Exhibit Z: The House of Courage community service, dated August 25, 2015, for 2 hours. 81. The parties stipulate to the authenticity and admission of Respondent’s Exhibit AA: Jubilee House community service, dated September 25, 2015, for 13 hours. 82. The parties stipulate to the authenticity and admission of Respondent’s Exhibit BB: Jubilee House community service, dated December 16, 2015, for 12 hours. 83. The parties stipulate to the authenticity and admission of Respondent’s Exhibit CC: Jubilee House community service, dated March 23, 2016, for 48 hours. II. Findings of Fact Respondent’s Education, Training and Work Experience 1. The Respondent graduated from medical school in Nigeria in 1983. Tr. 21–22; RE–A, at 1. 2. Following medical school, the Respondent completed a one year rotating internship in one of the busiest hospitals in Nigeria. Tr. 22. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 15805 3. After completing his internship, the Respondent worked as a general practitioner for five years before he immigrated to the United States. Tr. 22; RE–A, at 2. 4. The Respondent took over a psychiatric medical practice for two years in Nigeria. Tr. 89–90. 5. The Respondent immigrated to the United States in 1989, and after he passed the exam for foreign medical graduates, he began an internship in pediatrics at the Medical College of Ohio. Tr. 22–23; RE–A, at 1. 6. Upon completion of his internship in Ohio, the Respondent began a threeyear residency in anesthesiology at Vanderbilt University Medical Center, completing the program in 1994. Tr. 23; RE–A, at 1–2. 7. The Respondent then obtained a fellowship at the University of Southern California Medical Center (‘‘USCMC’’) and completed a one-year obstetrical anesthesia fellowship. Tr. 23; RE–A, at 1. 8. Following his residency at USCMC, the Respondent was appointed as an instructor in anesthesiology and a consultant anesthesiologist at the Vanderbilt University Medical Center in 1995–96. Tr. 23–24; RE–A, at 1. 9. Between 1997 and 1999, the Respondent completed a pain management fellowship at Emory University Hospital. RE–A, at 1. 10. From the time that the Respondent was admitted to medical practice in the United States until 2007 his primary area of practice was anesthesiology. Tr. 26–30. 11. While practicing anesthesiology, the Respondent has never had any malpractice complaints filed against him nor had his employment as an anesthesiologist been terminated. Tr. 30–31. 12. The Respondent was a Diplomate of the American Board of Pain Medicine. RE–A, at 1. 13. The Respondent was board certified in pain management. GE–19, at 660, 894. 14. Beginning in April 2007 the Respondent was employed as a pain management specialist and staff anesthesiologist with the Las Vegas Pain Institute, where 70% of his practice was pain management. Tr. 31; RE–A, at 2. 15. In 2007, the Respondent started the California Advanced Pain Clinic Institute, which was located across the street from the Anaheim Memorial Medical Center. Tr. 72–73; RE–A, at 1. 16. From February 2008 to September 2010, the Respondent worked part-time as a staff anesthesiologist at the St. Bernadine Medical Center in San Bernardino, CA. The Respondent E:\FR\FM\19MRN1.SGM 19MRN1 15806 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES worked part-time at the St. Bernadine Medical Center because he was starting a solo practice in pain management at the same time. Tr. 32–33; RE–A, at 2. 17. The Respondent stopped working as an anesthesiologist in September 2010, because the patients he treated in his pain clinic occupied most of his time. Tr. 33. 18. The Respondent began to make changes in his medical practice in 2013 after the medical board sent some observers to his clinic to pick up patient charts. Tr. 36. At that time, the Respondent started looking for someone to take over his pain management practice, and by July 2013 he had found someone to do that. Tr. 37. 19. By July 2013, the Respondent was only doing interventional pain management in association with Dr. K., who had taken over the Respondent’s practice. Tr. 38, 98. By then, the Respondent had stopped writing new pain prescriptions, though he did fill prescriptions for about 10 patients who were already on morphine pumps. Tr. 38. 20. Also in July 2013, the Respondent completed a 48-hour continuing medical education course called Physician Assessment and Clinical Education Program (‘‘PACE’’), which has been adopted by the MBC. Tr. 39; RE–J–K; GE–18, at 9. 21. In the PACE course, the Respondent studied record keeping; how to write proper prescriptions; the essence of controlled substances; and prescription-writing ethics. Tr. 39; RE– J–K. 22. The PACE course also provided instruction in how to identify drug seeking patients. Tr. 41. Undercover Office Visits 23. The Respondent required each of his pain patients to sign a form swearing under penalty of perjury that, ‘‘I am not an undercover agent of any lawenforcement. I do no work for the DEA, the FBI, the police or any other law enforcement agency.’’ GE–14, at 12; GE– 15, at 12; GE–19, at 941. 24. With respect to the treatment the Respondent provided to the undercover patients, he believes he took adequate patient histories, but he did not perform appropriate physical exams. Tr. 35–36. The Respondent issued prescriptions to those patients based on what he thought was appropriate from the information the patients provided him in their patient history. Tr. 36. 25. Regarding UC1, the Respondent gave him a ‘‘short diagnosis,’’ as he was trained to do in medical school in Nigeria. Tr. 75. UC1 complained of pain in his arms and legs after exercise, but VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 to the Respondent’s observation there was nothing significantly wrong with his arms and legs. Tr. 76. Therefore, the Respondent did not think UC1 required a full body exam. Tr. 76. 26. During his first appointment with the Respondent, UC1 informed the Respondent that he was obtaining Vicodin and Adderall from a friend. GE–3, at 9. During his second appointment, UC1 informed the Respondent that he was obtaining Opana from someone at the gym. GE–5, at 5. 27. The Respondent acknowledged that he did not do a comprehensive exam on UC2. Tr. 78. 28. With respect to UC3, the Respondent testified that he did conduct some physical exam of that patient and ‘‘maybe that was why they acquitted me of that one.’’ Tr. 78. UC3 informed the Respondent that he did what he had to do to obtain oxycodone. GE–9, at 4. 29. At the Respondent’s criminal trial, UC3 testified that during his first office visit with the Respondent, when the Respondent asked him to walk on his toes, he did so in ‘‘the normal way you’d walk on your toes.’’ GE–19, at 626. UC3 did not walk in a manner to illustrate an injury. Id. UC3 testified that the Respondent did not do anything else to detect UC3’s range of movement or his difficulty with pain. Id. 30. The Respondent acknowledged that his treatment of UC3 fell below acceptable medical standards. Tr. 85. 31. The Respondent acknowledged that the prescriptions that he wrote to UC3 on March 21, 2013, and April 25, 2013, were issued for no legitimate medical purposes and were outside the usual course of professional practice. Tr. 111. The Respondent’s Convictions 32. On October 9, 2013, a Felony Complaint and Arrest Warrant was filed against the Respondent. GE–16, at 3. The Respondent was charged with eight felony counts regarding prescribing scheduled drugs. Tr. 44. 33. On October 15, 2013, the Respondent was arrested and his arrest was covered by the Los Angeles Times. Tr. 52; GE–16, at 3. 34. On May 14, 2015, the Respondent was convicted of seven of those original eight felony counts. Tr. 44; GE–19, at 1161–1167. 35. When the Respondent was sentenced on March 28, 2016, the trial judge reduced the felony charges to misdemeanors, and the Respondent was placed on 36 months of probation. Tr. 55; GE–21, at 1–2. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 36. The Respondent testified that the sentencing judge did not restrict the Respondent’s ability to practice medicine, stating that the judge left that to the MBC. Tr. 56. The Finding of Fact contained in the MBC’s Interim Order of Suspension, however, indicates that the court ‘‘ordered Respondent ‘not to practice medicine until an order has been made by the Medical Board with respect to your ability to do so in the State of California.’’’ GE–17, at 2. 37. The Respondent has taken several continuing medical education courses, to include: Pain management review courses; a course presented by the American Academy of Addiction Psychiatry; a 16-hour course concerning the problems of substance abuse; a medical ethics course; and a course prescribed by courts to alcohol and drug crime clients. Tr. 43. Most of these courses were completed in 2015 after the Respondent was convicted. RE–M, P, R–S. The Respondent completed two of these courses in 2015 prior to his conviction. RE–N–O, Q. 38. The Respondent was also sentenced to perform 130 hours of community work. Tr. 45. The Respondent chose to perform those hours working with patients who suffered from addiction problems. Tr. 45. 39. The Respondent performed 353 community service hours to show his remorse. Tr. 45–46. 40. Some of the Respondent’s community service hours were performed with a psychiatrist in an addiction medicine practice where the Respondent observed, educated, and talked to patients who came to the psychiatry addiction clinic. Tr. 46. The Respondent shared his story with those patients concerning his arrest. Tr. 46. 41. The Respondent also performed community service hours at sober living facilities where he counseled those with addictions and instructed on the dangers of addiction by using a PowerPoint presentation. Tr. 47–51. The Respondent also helped to maintain the cleanliness of the facilities. Tr. 47–51. 42. The physicians the Respondent worked with, to include those who wrote letters of recommendation on his behalf, are all aware that he was arrested. Tr. 52–54; RE–B–I. Most of these letters are dated in 2013. Id. 43. Representatives from the various organizations at which the Respondent performed his community service hours also wrote letters in support of the Respondent. RE–T–CC. 44. The Respondent’s probation *[with Superior Court was scheduled to expire] in March 2019. Tr. 56. E:\FR\FM\19MRN1.SGM 19MRN1 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES The Stipulated Settlement 45. The Respondent entered into a Stipulated Settlement (‘‘Settlement’’) with the MBC on December 20, 2016, with an effective date of January 19, 2017. Tr. 57–58; GE–18, at 1. The Settlement allows the Respondent to practice medicine, but prohibits him from writing prescriptions for Schedule II and Schedule III controlled substances. Tr. 57; GE–18, at 4. The Settlement, however, allows the Respondent to use controlled substances in any Schedule, including II and III, while practicing anesthesia in an operating room or surgical center. Tr. 57; GE–18, at 4. The Settlement placed the Respondent on probation for seven years. Tr. 58; GE–18, at 4. 46. The Respondent understands that if he were to write a prescription for a Schedule II or a Schedule III controlled substance his California medical license could be revoked. Tr. 62. 47. The State of California can run a ‘‘CURES’’ report anytime to monitor prescriptions the Respondent may write. Tr. 61. 48. The Respondent has not written any prescription for Schedule II or III drugs since he was placed on probation by the MBC. Tr. 61–62. 49. The Settlement does not state that the Respondent can only practice medicine in California. Tr. 119. 50. The Respondent testified that he is in compliance with his probation with the MBC, as well as with his probation with the Superior Court of California. Tr. 62. 51. The Settlement, however, requires the Respondent to report any practice of medicine outside of California to the MBC. Tr. 134; GE–18, at 13.* [It is noted that at hearing the Respondent’s attorney argued that the Settlement only required such notification to the MBC after a certain period of days. Tr. 136. The Settlement does include a thirtyday minimum time period for intent to move or travel to another state to trigger the notification requirement, and it is not entirely clear from the language in the Settlement whether or not that time period applies to practicing medicine in another state in the subsequent paragraph; however, the Respondent testified that he moved in February, when he changed his address with the DEA, and he prescribed in Texas on April 28, 2017, so it appears that the timeframe of both his stay and his practice of medicine in Texas exceeded thirty days, triggering the notification requirement to the MBC in the Settlement. Tr. 93, GE–23 and GE–24.] The Respondent did not report that he VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 had been practicing medicine outside of California. Tr. 119, 134. 52. The Respondent submitted a quarterly report to the MBC, but it arrived late. Tr. 119; GE–18, at 12. 53. The MBC required that the Respondent take a course concerning medical ethics, which he completed in April 2017. Tr. 92; GE–18, at 8; RE–L. 54. The Settlement requires that the Respondent either have a practice monitor, who would provide quarterly evaluations to the MBC of the Respondent’s medical practice or, in lieu of a monitor, the Respondent could participate in a sanctioned professional enhancement program. GE–18, at 11. 55. The Respondent is not currently practicing medicine because he had a stroke in January 2016, and he is waiting for a letter that says that he is medically qualified to resume his practice in anesthesiology. Tr. 60. The Respondent was informed by his neurologist that he could not find any residual deficits as a result of the stroke. Tr. 60. The Respondent does not currently have a practice manager assigned because he is not currently practicing medicine. Tr. 59–60. Texas Allegations 56. The Respondent has been licensed to practice medicine in Texas since 1998 and he went there in 2017 to find an anesthesiology job. Tr. 65–66. The Respondent found an anesthesia job in Texas, but once his employer learned of the Respondent’s background, the employer stopped inviting him to participate in the care of its patients. Tr. 65–66. 57. The Respondent requested that DEA change his mailing address in February 2017 from California to Texas. Tr. 95, 115. 58. The Respondent’s request to change his mailing address from California to Texas was approved by DEA. Tr. 115. 59. The Respondent opened a medical practice in Texas in March 2017. Tr. 95. The heading on the prescription pad for the Respondent’s office in Texas reads, ‘‘El Paso Advanced Pain Institute.’’ GE– 23, at 2. 60. The Respondent testified that he assumed that the DEA had approved his request to change the address of his COR to Texas, but that he has no plans to move to Texas. Tr. 68, 93. 61. Before the Respondent started issuing prescriptions in Texas, he called the pharmacy that would be filling the prescription and the pharmacy told the Respondent it was okay. Tr. 96. The Respondent testified that he believed that he successfully changed the address of his COR in February 2017, before he PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 15807 issued the prescriptions in Texas. Tr. 97–98, 103–07. 62. The Respondent wrote prescriptions for Lyrica, a Schedule V controlled substance, for three patients who had been on Schedule II controlled substances in an effort to get them off of Schedule II controlled substances. Tr. 66, 121, 125. These prescriptions were written in April and March* [correction] 2017. GE–23 and GE–24. 63. The pharmacist-in-charge of ASP Cares Pharmacy indicated that the prescription was written from a pain clinic across the street from the pharmacy. Tr. 117–18. 64. Lyrica is not the type of controlled substance that, by itself, would raise a red flag for a pharmacist. Tr. 128–129. 65. The Respondent requested a change in the registered location for his COR in May 2017 upon his application for renewal. Tr. 116, 127. 66. The Respondent’s request to change the location of his COR is still pending, and the Respondent does not have any DEA authority in Texas. Tr. 116. Additional facts required to resolve the issues in this case are included in the Analysis section of this Recommended Decision. Analysis To revoke a respondent’s registration, the Government must prove, by a preponderance of the evidence, that the regulatory requirements for revocation are satisfied. Steadman v. SEC, 450 U.S. 91, 100–02 (1981); 21 CFR 1301.44(e).*G Under 21 U.S.C. 824(a)(4), the DEA may revoke a registrant’s COR if the registrant acted in a way that renders continued registration ‘‘inconsistent with the public interest.’’ The DEA considers the following five factors to determine whether continued registration is in the public interest: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The [registrant’s] experience in dispensing, or conducting research with respect to controlled substances. (3) The [registrant’s] conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (4) Compliance with applicable State, Federal, or local laws relating to controlled substances. *G See also Director, Office of Workers’ Compensation Programs, Dep’t of Labor v. Greenwich Collieries, 512 U.S. 267, 277 (1994) (affirming Steadman’s interpretation of the Administrative Procedure Act standard of proof as the preponderance of evidence standard and clarifying that the ‘‘burden of proof’’ in 5 U.S.C. 556(d) refers to the burden of persuasion). E:\FR\FM\19MRN1.SGM 19MRN1 15808 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices (5) Such other conduct which may threaten the public health and safety.8 21 U.S.C. 823(f). These public interest factors are considered separately. See Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a case-by-case basis. Morall v. Drug Enf’t Admin., 412 F.3d 165, 173–74 (D.C. Cir. 2005). Any one factor, or combination of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508 (1993). Thus, there is no need to enter findings on each of the factors. Hoxie v. Drug Enf’t Admin., 419 F.3d 477, 482 (6th Cir. 2005). Further, there is no requirement to consider a factor in any given level of detail. Trawick v. Drug Enf’t Admin., 861 F.2d 72, 76–77 (4th Cir. 1988). When deciding whether registration is in the public interest, the totality of the circumstances must be considered. See generally Joseph Gaudio, M.D., 74 FR 10083, 10094–95 (2009). The Government bears the initial burden of proof, and must justify revocation by a preponderance of the evidence. See Steadman, 450 U.S. at 100–03. If the Government makes a prima facie case for revocation, the burden of proof shifts to the registrant to show that revocation would be inappropriate.*H Medicine Shoppe— Jonesborough, 73 FR 364387 (2008). A registrant may prevail by successfully attacking the veracity of the Government’s allegations or evidence. Alternatively, a registrant may rebut the Government’s prima facie case for revocation by accepting responsibility for wrongful behavior and by taking remedial measures to ‘‘prevent the reoccurrence of similar acts.’’ Jeri Hassman, M.D., 75 FR 8194, 8236 (2010) (citations omitted). In addition, when assessing the appropriateness and extent of sanctioning, the DEA considers the egregiousness of the offenses and the DEA’s interest in specific and general deterrence. David A. Ruben, M.D., 78 FR 38363, 38385 (2013). I. The Government’s Position The Government submitted its Proposed Findings of Fact and jbell on DSKJLSW7X2PROD with NOTICES 8 The Government has not made any Factor Five allegations against the Respondent. *H I am clarifying this statement slightly. DEA caselaw has stated that the burden shifts to the Respondent to ‘‘show why its continued registration would nonetheless be consistent with the public interest.’’ Medicine Shoppe—Jonesborough, 73 FR 364387 (2008) (collecting cases). DEA caselaw has further explained that where the Government has established grounds for revocation by a preponderance of the evidence, the Respondent must ‘‘present[ ] sufficient mitigating evidence’’ to show why he can be entrusted with a new registration. Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988)). VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 Conclusions of Law (‘‘Government’s Brief’’) on August 11, 2017.9 Of note, the Government’s proposed findings of fact are primarily based upon the stipulations the Respondent entered into prior to the hearing, which, the Government argues, established a prima facie case for revocation of the Respondent’s COR. ALJ–37, at 1–8. Based upon the evidence presented, the Government seeks to revoke the Respondent’s COR based upon Factors Two, Three, and Four. ALJ–37, at 8. Under Factors Two and Four, the Government argues that the unlawful prescriptions that the Respondent wrote to three undercover investigators and those he wrote in Texas, where he does not have a DEA registration warrant the revocation of the Respondent’s COR. ALJ–37, at 8–9. Under Factor Three, the Government argues that the Respondent’s California conviction of seven counts of unlawfully issuing prescriptions for controlled substances also serves as a basis for revocation and ‘‘adds to the gravity of the Respondent’s conduct.’’ 10 ALJ–37, at 9–10. The Government also argues that the Respondent has not unequivocally accepted responsibility for his conduct. ALJ–37, at 10–12. While acknowledging that the Respondent had generally accepted responsibility, the Government argued that the Respondent vacillated on whether the prescriptions he had written to UC3 were improper. ALJ–37, at 10. In addition, the Respondent testified that he believed he had authority to write the prescriptions he wrote in Texas. ALJ–37, at 11. In support of its position that a registrant’s acceptance of responsibility must be unequivocal the Government cited to numerous cases, to include: Daniel A. Glick, D.D.S., 80 FR 74800, 74801 (2015); Hatem M, Ataya, M.D., 81 FR 8221, 8242 (2016); and MacKay v. Drug Enf’t Admin., 664 F.3d 808, 820 (10th Cir. 2011). ALJ–37, at 11–12. Finally, the Government argues that, even if the Respondent were found to have accepted full responsibility, revocation would still be appropriate in this case to deter others. ALJ–37, at 12. In support of this position, the Government cites to Peter F. Kelly, D.P.M., 82 FR 28676, 28691 (2017). ALJ– 37, at 12. The Government also argues that ‘‘[i]n the midst of the current opioid crisis, violations of the prescribing 9 The Government’s Brief has been marked as ALJ–37. 10 The Respondent’s convictions are based upon the same conduct as is alleged in paragraphs 3a– 3e of the OSC. ALJ–1, at 2–3. Accordingly, I do not find that the Respondent’s convictions add ‘‘gravity’’ to his conduct. The allegations are essentially multiplicitous. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 requirements such as occurred here should result in revocation of the underlying registration.’’ 11 II. The Respondent’s Position The Respondent submitted his closing statement (‘‘Respondent’s brief’’) on August 25, 2017.12 The overall theme of the Respondent’s brief is that he has accepted responsibility for his actions and has taken numerous remedial steps to ensure he does not again violate the Controlled Substances Act (‘‘CSA’’). Noting that the Respondent’s medical practice since 1993 had centered around anesthesiology in a hospital setting, he argues that when it came to treating pain patients he ‘‘may have been a naı¨ve physician who was not fully prepared to deal with patients who may be drug seeking. He relied on what his patients told him, rather than conduct examinations to corroborate those statements.’’ ALJ–38, at 2. The Respondent correctly argues that revocation of a DEA certificate of registration is not mandatory for violations of 21 U.S.C. 824(a)(4). The Respondent then, incorrectly, argues that 21 U.S.C. 824(a)(4) is the only section that the Government is relying upon in its request for revocation. ALJ– 38, at 3–4. In fact, the Respondent goes on to analyze this case under the five factors of 21 U.S.C. 823(f). ALJ–38, at 4– 8. The Respondent suggests that Factor One weighs in his favor. He notes that after the MBC reviewed all the facts of his case it determined that ‘‘public safety would be met by allowing [the Respondent] to continue to practice medicine, specifically, anesthesiology . . . .’’ ALJ–38, at 4–5. With respect to Factor Two, the Respondent notes that he has not had ‘‘any discipline or issues with his practicing anesthesiology.’’ ALJ–38, at 5. The Respondent argues that the only legal issues he has dealt with related to his practice of outpatient pain management, asserting that he will no longer be practicing in that area. ALJ–38, at 5. 11 The Government’s position suggests that had the Respondent engaged in the same conduct, but there was no opioid crisis, that that same conduct might not merit revocation. For that reason, I reject the suggestion that a registrant should lose his or her registration based on whether the nation is in an opioid crisis or not. *[Although I agree with ALJ Dorman on this point, I do not wish to imply that the opioid crisis is never properly considered by DEA in enforcing the Controlled Substances Act.] 12 The Respondent’s Brief has been marked as ALJ–38. I note that the Respondent’s brief was filed nine days late and it is not in conformance with 21 CFR 1316.64, which requires ‘‘specific and complete citations of the pages of the transcript and exhibits.’’ Nevertheless, I have considered the Respondent’s Brief. E:\FR\FM\19MRN1.SGM 19MRN1 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES Under Factor Three, the Respondent argues that the reduction of his felony convictions to misdemeanors suggests that his ‘‘conduct and/or intention was not as aggravated as those of other physicians who are prosecuted.’’ 13 ALJ– 38, at 6. Again the Respondent notes that the convictions were the result of his practicing pain management and not anesthesiology. He argues that his ‘‘conduct was not one of greed or intentional wrongdoing rather inexperience and naı¨vete´ . . . .’’ ALJ– 38, at 6. With respect to Factor Four, the Respondent argues that he has been fully compliant with all state, federal, and local laws concerning the handling of controlled substances since he was arrested. The Respondent further argues that the allegation that he wrote prescriptions in Texas without authority from the DEA is ‘‘unclear at best . . . and not supported by any evidence.’’ ALJ–38, at 7. Finally, with respect to Factor Five, the Respondent asserts that there is no other evidence that he is a danger to the public. ALJ–38, at 8. The Respondent’s brief concludes with a discussion of acceptance of responsibility and mitigation. ALJ–38, at 8–10. He argues that he has taken full responsibility for his actions, noting the stipulations he entered into with the MBC and during these proceedings. ALJ–38, at 9. The Respondent argues that since his ‘‘arrest he has made strong and concerted efforts to show his remorse and take full responsibility for his actions.’’ 14 ALJ–38, at 8. With respect to mitigation, the Respondent ‘‘has performed over 300 hours of community service in sober living homes, he has completed continuing education in the area of substance abuse and prescribing and he has abided by all that has been asked of him.’’ ALJ–38, at 9. The Respondent argues that the evidence of record is sufficient to allow for the exercise of discretion to conclude that public safety would not be endangered by allowing him to retain his COR. ALJ–38, at 9–10. Significantly, the Respondent cites to the action of the MBC, which has allowed him to 13 This statement is not supported by any evidence in the record. Furthermore, even if true, it is irrelevant. 14 This is not an accurate statement. At his criminal trial, the Respondent pled not guilty and testified that the exams he conducted on the three undercover investigators were sufficient and that he had been betrayed by the undercover investigators. GE–19, at 905–07. That hardly seems like taking full responsibility for his actions after his arrest. Even at the hearing before me, the Respondent was reluctant to take responsibility for the unlawful prescriptions he issued to UC3 because he had been found not guilty of prescribing oxycodone to him. VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 continue practicing medicine as an anesthesiologist. ALJ–38, at 10. He notes that the function of the MBC is similar to that of the DEA, to ensure public safety. ALJ–38, at 10. III. Factor One: The Recommendation of the Appropriate State Licensing Board or Professional Disciplinary Authority The Respondent suggests that Factor One weighs in his favor because the MBC entered into a stipulated settlement wherein the Respondent has been allowed to continue his medical practice, but he may not prescribe schedule II or III controlled substances, and may only administer them while practicing anesthesiology in a hospital or licensed surgical center. ALJ–38, at 4; GE–18, at 5. In addition, the stipulated settlement placed the Respondent on probation for seven years. Id. *[I am omitting some language from the RD and adding the below until the end of this section, to clarify the analysis of Factor One. In determining the public interest, the ‘‘recommendation of the appropriate State licensing board or professional disciplinary authority . . . shall be considered.’’ 21 U.S.C. 823(f)(1). Two forms of recommendations appear in Agency decisions: (1) A recommendation to DEA directly from a state licensing board or professional disciplinary authority (hereinafter, appropriate state entity), which explicitly addresses the granting or retention of a DEA COR; and (2) the appropriate state entity’s action regarding the licensure under its jurisdiction on the same matter that is the basis for the DEA OSC.*I See, e.g., Vincent J. Scolaro, D.O., 67 FR 42,060, 42,065 (2002) (‘‘While the State Board did not affirmatively state that the Respondent could apply for a DEA registration, [the ALJ] found that the State Board by implication acquiesced to the Respondent’s application because the State Board has given state authority to the Respondent to prescribe controlled substances.’’). However, some more recent Agency decisions could be read to imply that Factor One should be more narrowly focused on recommendations from the appropriate state entity that specifically address the *I Regarding Factor One, I am distinguishing the fact findings of an appropriate state entity from the ultimate recommendation of such entity, the latter of which is relevant under Factor One. But see Ralph J. Chambers, M.D., 79 FR 4962, 4970 (2014) (stating that the possession of state ‘‘authority is not dispositive of the public interest’’ but then discussing under Factor One the rationale for not relying on the fact findings of the board). The fact findings themselves are more appropriately considered under other public interest factors. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 15809 registrant’s DEA COR; therefore, I am providing some clarification to the Agency’s consideration of Factor One below. See Garrett Howard Smith, M.D., 83 FR 18882 n.30 (2018). ‘‘Interpretation of a statute must begin with the statute’s language.’’ Mallard v. U.S. Dist. Court, 490 U.S. 296, 300–301 (1989) (citing e.g., United States v. Ron Pair Enterprises, Inc., 489 U.S. 235, 241 (1989); Landreth Timber Co. v. Landreth, 471 U.S. 681, 685 (1985)). The dictionary indicates a breadth of possible interpretations of ‘‘recommend,’’ the root word of ‘‘recommendation’’ in 21 U.S.C. 823(f)(1), including: ‘‘(1)(a) to present as worthy of acceptance or trial; (1)(b) to endorse as fit, worthy, or competent; (2) entrust, commit (3) to make acceptable; (4) to suggest an act or course of action.’’ ‘‘Recommend.’’ Merriam-Webster’s Online Dictionary. 2020. https:// www.merriam-webster.com/dictionary/ recommend (last visited Feb. 4, 2020). Most of the entries would appear to encompass the action of the appropriate state entity were it to present the practitioner as worthy of acceptance for a DEA COR, make the practitioner acceptable for a DEA COR in retaining the state authority or even to continue to entrust the practitioner with state controlled substance authority after considering the facts that provide the basis for DEA action. These definitions could easily encompass the actions of the appropriate state entity on the state licensure. Only the fourth entry would support a reading that would require the appropriate state entity to explicitly recommend a course of action regarding the DEA COR, and even that definition implies some latitude in specificity in using the term ‘‘suggest.’’ Additionally, if the agency were to limit consideration under Factor One to specific recommendations about DEA registrations, the practical implementation of such a narrow interpretation would likely read out the applicability of the Factor in its entirety, as very few cases contain such specific recommendations.*J See e.g., Tyson D. *J It is unclear whether many appropriate state entities would have the requisite authority to provide a specific recommendation regarding a DEA registration, and practically, how they would obtain a full view of the facts and legal bases underlying the OSC in order to provide such a specific recommendation. Additionally, a narrow interpretation of Factor One could present challenges across the wide variety of state statutory authorities. See Scott D. Fedosky, M.D., 76 FR 71375 (2011) (finding that the ‘‘vote[ ] to allow [the respondent] to apply for a new DEA registration’’ of the Arkansas State Medical Board did not constitute a specific ‘‘recommendation,’’ because it did not include any advice about whether DEA should grant the application). E:\FR\FM\19MRN1.SGM 19MRN1 15810 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES Quy, M.D., 78 FR 47,412, 47,417; Vincent J. Scolaro, D.O., 67 FR at 42,065; but see, John Porter Richards, D.O., 61 FR 13,878, 13,879 (1996) (wherein the West Virginia Board sent a letter supporting the respondent’s application for a DEA COR, which the Administrator considered under Factor One along with the actions of the disciplinary boards in two states). The available legislative history supports the Agency’s broader reading of ‘‘recommendation.’’ *K The public interest factors for practitioners’ applications for registration were added to Section 823 in 1984. Controlled Substances Penalties Amendments Act of 1984, Public Law 98–473, 511, 98 Stat. 1837, 2073 (1984) (codified at 21 U.S.C. 823(f)(1)–(5)). Prior to the addition of these public interest factors, practitioner applicants would be granted a registration if they were ‘‘authorized to dispense . . . [controlled substances] under the law of the State in which they practice[d].’’ Controlled Substances Act, Public Law 91–513, 303, 84 Stat. 1236, 1255 (1970) (codified at 21 U.S.C. 823(f)). The Senate Report explained that ‘‘because of a variety of legal, organizational, and resource problems, many states are unable to take effective or prompt action against violating registrants.’’ *L Senate Report, at 266, 1984 U.S.C.C.A.N., at 3448. After pointing out that the practitioner public interest factors are ‘‘similar to those applicable under current law to registration applications on the part of the manufacturers and distributors of controlled substances,’’ the Senate *K There is no conference report specifically for the Comprehensive Crime Control Act of 1984. It was passed as part of Public Law 98–473, the 1985 Continuing Appropriations Act. The controlled substances-related provisions of that law were taken from S. 1762 as reported by the Senate Judiciary Committee and addressed in Senate Report No. 98– 225 (1983), reprinted in 1984 U.S.C.C.A.N. 3182 (hereinafter, Senate Report). Part B of Title V of the Comprehensive Crime Control Act of 1984 is called the ‘‘Diversion Control Amendments.’’ According to the Senate Report’s discussion of Title V, between 60% and 70% of all drug-related deaths and injuries ‘‘involve drugs that were originally part of the legitimate drug production and distribution chain.’’ Senate Report, at 260, 1984 U.S.C.C.A.N., at 3442. In addition, according to the Senate Report, ‘‘diversion of legally produced drugs often evidences the same sort of large-scale trafficking more commonly associated with the trade in wholly illicit drugs.’’ Id. To illustrate this finding, the Senate Report cites ‘‘Operation Script’’ in which twenty-one practitioners registered to dispense controlled substances were ‘‘responsible for the diversion of approximately 21.6 million dosage units of controlled substances.’’ Senate Report, at 261, 1984 U.S.C.C.A.N., at 3443. *L The Senate Report also stated that the ‘‘limited grounds for revoking or denying a practitioner’s registration have been cited as contributing to the problem of diversion of dangerous drugs.’’ Senate Report, at 266, 1984 U.S.C.C.A.N., at 3448. VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 Report noted that ‘‘the amendment would continue to give deference to the opinions of the state licensing authorities,’’ because of the inclusion of Factor One. Senate Report, at 267, 1984 U.S.C.C.A.N., at 3449; see also Oregon v. Ashcroft, 368 F.3d 1118, 1122 (9th Cir. 2004) (quoting the Senate Report). The breadth of the intended meaning of ‘‘recommendation’’ is further explained in a Senate Report footnote describing Factor One: ‘‘it would no longer be necessary that the state authority have in fact revoked the practitioner’s license or registration before federal registration could be denied.’’ Senate Report, at 266 n.36, 1984 U.S.C.C.A.N., at 3448 n.36. In other words, the Senate Report acknowledges both that an appropriate state entity’s ‘‘recommendation’’ precedes the effective date of any revocation, and makes clear that the addition of Factor One directs the Agency’s focus to an existing ‘‘recommendation,’’ separate from any finalized revocation. Further, I agree with prior Agency decisions’ functional reading of ‘‘recommendation.’’ In Vincent J. Scolaro, D.O., for example, the Agency carefully analyzed the respondent’s interactions with the state licensing board, law enforcement, and other offices. 67 FR at 42060–65. Based on this analysis, my predecessor determined that the state licensing board ‘‘implicitly’’ agreed that respondent was ready for a DEA registration. 67 FR at 42065. In other words, it would be contrary to the amended language to not at least consider the actions of an appropriate state entity on the same matters, particularly where it rendered an opinion regarding the practitioner’s medical practice in the state due to the same facts alleged in the DEA OSC. Id.*M Although statutory analysis may not definitively settle this matter, the most impartial and reasonable course of action is to continue to take into consideration all actions indicating a recommendation from an appropriate *M It is noted that Agency decisions have long held that in considering Factor One, the appropriate state entity’s actions are distinct from its inactions—an interpretation which is supported by both a reading of the active word ‘‘recommend,’’ and the rationale given by the Senate Report for adding the public interest factors. See Ajay S. Ahuja, M.D., 84 FR 5479, 5490 (2019) (finding that ‘‘where the record contains no evidence of a recommendation by a state licensing board that absence does not weigh for or against revocation.’’); see also MacKay v. Drug Enf’t Admin., 664 F.3d 808, 817–819 (10th Cir. 2011) (noting that the Agency decision found that the lack of action from an appropriate state entity was not a recommendation under Factor One and holding that the Deputy Administrator did not misweigh the public interest factors). PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 state. See Volkman v. Drug Enf’t Admin., 567 F.3d 215, 222 (6th Cir. 2009) (the Administrator can ‘‘ ‘give each factor the weight [he] determines is appropriate.’ ’’ (quoting Hoxie v. Drug Enf’t Admin., 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. Drug Enf’t Admin., 412 F.3d 165, 173–74 (D.C. Cir. 2005). In this case, the MBC has not made a direct recommendation to the Agency regarding whether the Respondent’s COR should be suspended or revoked.*N As already discussed, after suspending the Respondent’s medical license and continuing the suspension after a hearing before a state Administrative Law Judge, the MBC entered into a stipulated settlement allowing Respondent to continue his medical practice and, regarding controlled substances, allowing Respondent to administer only schedule II or III controlled substances while practicing anesthesiology in a hospital or licensed surgical center. GE–18; ALJ– 38. Older Agency decisions can be read to give more than nominal weight in the public interest determination to a state’s decision to restore or maintain a practitioner’s authority to dispense controlled substances. Brian Thomas Nichol, M.D., 83 FR 47352, 47362 (collecting cases) (2018). However, these cases do not change longstanding federal law that it is the Administrator who makes a determination of whether granting a COR is in the public interest as defined by the CSA. Ajay S. Ahuja, M.D., 84 FR at 5490. It is noted that the Board’s reinstatement of Respondent’s medical license in California was severely limited in the stipulated settlement, including compliance with seven years of probation, which does not indicate a substantial amount of trust in the Respondent. See ALJ–38, at 5. Finally, the Board’s settlement on January 19, 2017, predated the March and April 2017 instances where the Respondent wrote prescriptions without a valid DEA COR for a Texas location, and therefore, the Board’s decision did not encompass all of the allegations and facts that are before this Agency. See GE–23 and GE– 24; GE 18. Accordingly, the terms of the MBC’s stipulated settlement with the Respondent are not dispositive of the public interest inquiry in this case, and although I have considered it in favor of the Respondent, it is also minimized by the circumstances described above. See *N The Government called an investigator for the California Department of Consumer Affairs to provide official testimony during the hearing. Tr. 129–35. That testimony, however, was not a recommendation from the Board. E:\FR\FM\19MRN1.SGM 19MRN1 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices Brian Thomas Nichol, M.D., 83 FR at 47,362–63.] jbell on DSKJLSW7X2PROD with NOTICES IV. Factors Two and Four: The Respondent’s Experience in Dispensing Controlled Substances and Compliance With Applicable State, Federal, or Local Laws Relating to Controlled Substances *O The Government alleges that revocation of the Respondent’s COR is appropriate under Factors Two and Four because the Respondent: (1) Issued unlawful prescriptions to three undercover investigators on five separate occasions; and (2) wrote three prescriptions for a controlled substance out of an office he maintained in Texas, even though he did not have a DEA COR for that office. The Government further alleges that by writing the prescriptions to the undercover investigators the Respondent violated 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code § 11153(a); and Cal. Bus. & Prof. Code §§ 725(a), 2241(b), 2241.5(c), and 2242(a). In addition, the Government alleges that by writing the three prescriptions in Texas the Respondent violated 21 U.S.C. 822(e) and 21 CFR 1301.12(a) and (b)(3). Under the CSA, it is unlawful for a person to distribute controlled substances, except as authorized under the CSA. 21 U.S.C. 841(a)(1). To combat drug abuse and trafficking of controlled substances, ‘‘Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.’’ Gonzales v. Raich, 545 U.S. 1, 13 (2005). To maintain this closed regulatory system, controlled substances may only be prescribed if a DEA registrant writes a valid prescription. Carlos Gonzalez, M.D., 76 FR 63118, 63141 (2011). As the Supreme Court explained, ‘‘the prescription requirement . . . ensures that patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.’’ Gonzales v. Oregon, 546 U.S. at 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)). A controlled substance prescription is not valid unless it is ‘‘issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.’’ 21 CFR 1306.04(a). Federal *O I have omitted the first paragraph of the ALJ’s analysis of Factors 2 and 4, because I found it unnecessary to my analysis of the factors under the caselaw. VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 regulations further provide that ‘‘[a]n order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of [21 U.S.C. 829] and . . . the person issuing it, shall be subject to the penalties provided for violations of [controlled substance laws].’’ Id.; see 21 U.S.C. 842(a)(1) (establishing that, under the CSA, it is illegal for a person to distribute or dispense controlled substances without a prescription, as is required under 21 U.S.C. 829). Much like the federal regulations, the California Health and Safety Code, Section 11153(a), provides, in part, that, ‘‘[a] prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice.’’ Further, Section 2242(a) of the California Business and Professions Code states that, ‘‘[p]rescribing, dispensing, or furnishing dangerous drugs . . . without an appropriate prior examination and a medical indication, constitutes unprofessional conduct.’’ Id. Section 725(a) provides that it is considered to be unprofessional conduct for a physician to engage in ‘‘repeated acts of clearly excessive prescribing.’’ Id. * [I am omitting the ALJ’s finding of a violation of state law under Cal. Bus. & Prof. Code § 2241(b). See Original RD, at 40. Section 2241 is generally permissive and sets forth the circumstances under which a practitioner may prescribe, dispense or administer to an addict for treatment of substance abuse. 2241(b) provides that ‘‘[n]othing in this subdivision shall authorize a physician and surgeon to prescribe, dispense, or administer dangerous drugs or controlled substances to a person he or she knows or reasonably believes is using or will use the drugs or substances for non medical purposes.’’ Cal. Bus. & Prof. Code § 2241(b) (Westlaw, current with all laws through Ch. 870 of 2019 Regular Session). I cannot find any evidence that this subdivision is intended to provide a separate violation of law. The underlying violation for prescribing ‘‘not in the course of professional treatment or as part of an authorized narcotic treatment program,’’ was already alleged in the OSC in Cal. Health & Safety Code § 11153(a). Therefore, I find that although Cal. Bus. & Prof. Code § 2241(b) is useful in determining whether a violation of Cal. Health & Safety Code § 11153(a) *P has *P It also appears that the Government could have alleged violations of Cal. Health & Safety Code § 11156, which states that ‘‘[e]xcept as provided in PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 15811 occurred, it does not provide for a separate violation in and of itself.] Additionally, Section 2241.5(c) of the Cal. Bus. & Prof. Code is merely an administrative provision concerning the authority of the MBC. Cal. Bus. & Prof. Code § 2242(a) (Westlaw, current with urgency legislation through Ch 706 of the 2019 Regular Session). *[Although I am not sustaining state law violations for Sections 2241.5(c) or 2241(b) of the Cal. Bus. & Prof. Code, the Respondent’s multiple blatant violations of Cal. Health & Safety Code § 11153(a), eight of which were the basis for his conviction in state court, are more than enough to demonstrate violations of state law and weigh heavily in favor of revocation. See GE–20 (Respondent’s Conviction).] * [Omitted sentences for brevity]. DEA recognizes several methods to show that a registrant wrote prescriptions without a legitimate medical purpose and outside of the usual course of professional practice. See Jack A. Danton, D.O., 76 FR 60900, 60901 (2011). In this case, however, the Respondent has admitted he did so. Stip. 42–53. In addition, a review of several of the Government exhibits reveals that at the time the Respondent wrote prescriptions to the undercover investigators he knew or had reason to believe they would be using the prescriptions for nonmedical reasons. For example, on March 30, 2012, UC1 informed the Respondent that he had been using Vicodin and Adderall, which he obtained from a friend. GE–3, at 9. Then when UC1 returned to see the Respondent on May 4, 2012, UC1 had none of the prescribed drugs in his urine. GE–5, at 5; GE–14, at 14. In addition, UC1 once again informed the Respondent that he was obtaining Opana from someone at his gym, and that his pain level was good. GE–5, at 5. Nevertheless, on each occasion, the Respondent issued UC1 prescriptions for controlled substances. GE–4, at 1; GE–6, at 1. With respect to UC2, the Respondent prescribed controlled substances to her on her first office visit with him after she told the Respondent that her pain was not bad,15 that she got sore from working out, and that she needed something to relax. GE–37, at 3–4; GE– 15, at 13. At that visit, the Respondent provided UC2 with prescriptions for Section 2241 of the Business and Professions Code, no person shall prescribe for, or administer, or dispense a controlled substance to, an addict, or to any person representing himself or herself as such.’’ See Daniel Brubaker, D.O., 77 FR 19322, 19328. 15 UC2 listed her pain level as a 1 out of 10 on her in-take form on May 4, 2012. GE–15, at 2. On her pain assessment form UC2 indicated that her pain was a 1 out of 10 at its worst. GE–15, at 3. E:\FR\FM\19MRN1.SGM 19MRN1 15812 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices Vicodin, Xanax, and Adderall. GE–8, at 1. The third undercover investigator presented to the Respondent on March 21, 2013, almost a year after the visits by UC1 and UC2. GE–9, at 1. UC3 informed the Respondent that he was taking oxycodone for an old injury he sustained playing high school football. Id.; GE–19, at 910. When the Respondent asked where UC3 was getting the oxycodone, UC3 replied, ‘‘I don’t know if you really want me to say where I’ve been getting it or not. I don’t have insurance you know, so I do what I gotta do.’’ GE–9, at 1. While the Respondent did have UC3 walk around on his heels and toes, he did not do so to assess UC3’s pain level. Rather, the Respondent was trying to determine if UC3 had a more severe problem that would require referral to a specialist. GE–19, at 911–12. At that first visit with the Respondent, the Respondent prescribed Percocet 10 mg to UC3 even though he knew that UC3 was obtaining oxycodone on the street. GE–10, at 1; GE–19, at 910. UC3 returned to see the Respondent on April 25, 2013. A review of the video recording of that visit reveals that the Respondent spent about ten minutes talking with UC3, but he did not conduct an examination. GE–11. On that date, the Respondent again prescribed Percocet for UC3. GE–12, at 1. [I am omitting the portion of the R.D. where the ALJ sustained the allegations related to the prescriptions to the undercover investigators. I agree with the ALJ’s findings and conclusions on these allegations *Q and incorporate them herein; however, it is unnecessary to repeat them considering that the Respondent stipulated to them and I am removing them to condense this opinion. All of the allegations related to prescribing beneath the standard of care and outside of the usual course of professional practice are sustained and weigh in favor of revocation of the Respondent’s Registration.] jbell on DSKJLSW7X2PROD with NOTICES The Texas Prescriptions In the Government Supplemental Prehearing Statement, the Government alleged that the Respondent wrote three prescriptions for a controlled substance in Texas in April and May 2017 without *Q It appears that the ALJ inadvertently left out one of the prescriptions in the stipulated facts for Xanax, a schedule IV controlled substance to UC2 on May 4, 2012. See Original RD, at 35–36; see also Stip. 48, 49, 50; RD, at 14, 15; GX 8. In addition to the ALJ’s findings, I find that this prescription was for no legitimate medical purpose and issued outside the usual course of professional practice, in violation of 21 U.S.C. 841(a)(1), 21 CFR 1306.04(a), Cal. Health & Safety Code § 11153(a), and the Cal. Bus. & Prof. Code §§ 725(a), and 2242(a). VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 having a valid DEA COR for Texas. ALJ– 29, at 5–6. The Government alleges that by writing these prescriptions the Respondent violated 21 U.S.C. 822(e), and 21 CFR 1301.12(a) and 1301.12(b)(3). ALJ–29, at 6. Title 21 of the U.S. Code, Section 822(e) requires a separate COR at each principal place of business where a registrant is prescribing controlled substances.16 21 CFR 1301.12(a) essentially reinforces the cited provision of the U.S. Code, 21 CFR 1301.12(b)(3) is not specifically applicable. Rather, it defines places that are deemed not to be places where controlled substances can be prescribed. In this case the Government has alleged that the Respondent issued three prescriptions for Lyrica, a schedule V controlled substance. ALJ–29, at 5–6; FF 62. Specifically, the Respondent wrote the first prescription for 30 tablets of Lyrica 50 mg for patient L.C. on March 15, 2017, and it was filled at a Walgreens Pharmacy in El Paso, Texas, on March 27. 2017. ALJ–29, at 5, GE– 24, at 2–3. The Respondent then called in a prescription to an ASP Cares Pharmacy in El Paso, Texas, for patient F.D. for 60 tablets of Lyrica 25 mg, on April 17, 2017, and it was filled the same day. ALJ–29, at 5; GE–23, at 4–5. The Respondent wrote his third Texas prescription on April 28, 2017. ALJ–29, at 5; GE–23, at 2. This third prescription was written for patient R.A. for 60 tablets of Lyrica 75 mg on a prescription pad containing the heading, ‘‘El Paso Advanced Pain Institute.’’ ALJ–29, at 5; GE–23, at 2. The prescription was filled at an ASP Cares Pharmacy in El Paso, Texas on May 1, 2017. ALJ–29, at 5; GE– 23, at 3. All three prescriptions contain the Respondent’s California COR number. GE–23, at 2–5, GE–24, at 2. That COR, however, lists the Respondent’s principal place of business as 5857 Pine Avenue, Chino Hills, California 91709. Stip. 1. Under 21 CFR 1306.05(a),*R a doctor is required to include his or her name, address, and registration number on any prescription the doctor writes. Here, the Respondent issued at least one prescription on a prescription pad bearing an El Paso address and phone number. GE–23, at 2, and the other two prescriptions contained the Respondent’s El Paso phone number. 16 21 U.S.C. 822(e) uses the terms ‘‘dispenses controlled substances.’’ 21 U.S.C § 802 (10) includes ‘‘prescribing’’ in the definition of the term ‘‘dispense.’’ *R The Government did not allege a violation of 21 CFR 1306.05(a), and therefore, I am only considering this requirement and the lack of the DEA registration number on the prescription pad as evidence that Respondent knew or should have known that he was not registered in Texas. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 GE–23, at 4–5; GE–24, at 2. Further, the Respondent acknowledged that he opened a medical practice in Texas in March 2017. FF 59; Stip. 54. During March and April 2017, the Respondent did not have a COR for his El Paso medical practice. FF 66; Stip. 54. Both the CSA and its implementing regulations require a ‘‘separate registration . . . at each principal place of business or professional practice where the applicant . . . dispenses controlled substances . . . .’’ 21 U.S.C. 822(e)(1); 21 CFR 1301.12(a); Clarification of Registration Requirements for Individual Practitioners, 71 FR 69,478 (2006); Joe W. Morgan, 78 FR 61,961 (2013); David Moon, D.O., 82 FR 19,385, 19,389 (2017). This requirement also applies where a doctor is merely prescribing controlled substances. 21 U.S.C. 802(10); Moon, 82 FR at 19,389. Accordingly, the Government’s allegation, contained in its Supplemental Prehearing Statement, that the Respondent violated 21 U.S.C. 822(e), and 21 CFR 1301.12(a) by issuing prescriptions in Texas without having a COR for his Texas office is sustained by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government.17 The allegation concerning the Respondent violating 21 CFR 1301.12(b)(3), however, is not sustained. V. Factor Three: Conviction Record Under Federal or State Laws Relating to the Manufacture, Distribution, or Dispensing of Controlled Substances In paragraph 6 of the OSC, the Government alleged that a Los Angeles County jury convicted the Respondent of seven felony counts of issuing unlawful controlled substance prescriptions for Adderall, hydrocodone, and alprazolam on March 28, 2016. ALJ–1, at 4. These felony convictions were reduced to misdemeanors upon sentencing. ALJ–1, at 4. The Government asserts that these convictions may be considered in determining whether the Respondent’s registration is inconsistent with the public interest under 21 U.S.C. 823(f)(3) and 824(a)(4). Id. As to Factor Three, the Respondent has been convicted of seven offenses violating California law ‘‘relating to the manufacture, distribution, or dispensing of controlled substances.’’ 21 U.S.C. 823(f)(3); FF 34–35. A review of GE–19 and GE–20 reveals that the Respondent’s convictions were directly 17 I reject the Respondent’s argument that this allegation is unclear and not supported by any evidence. ALJ–38, at 7. E:\FR\FM\19MRN1.SGM 19MRN1 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices related to the Respondent’s unlawful prescriptions the Respondent wrote to UC1, UC2, and UC3. Specifically, the Respondent was convicted of seven misdemeanor counts of issuing unlawful prescriptions for the controlled substances of Adderall, hydrocodone, and alprazolam. Stip. 13, 14; GE–20, at 6–9. The Government has proven the allegations contained in paragraph 6 of the OSC through the Stipulations and Government Exhibits 19 and 20. In addition, the Respondent testified that he had been convicted of seven counts involving the prescriptions he wrote for controlled substances. Tr. 44. Accordingly, the allegations, contained in paragraph 6 of the OSC, concerning the Respondent’s conviction of unlawfully writing prescriptions for controlled substances are sustained, and weigh in favor of the revocation sought by the Government. jbell on DSKJLSW7X2PROD with NOTICES Discussion and Conclusions of Law *[Although I have considered Factor One in favor of Respondent, it is minimized by the circumstances described above, and it is ultimately outweighed by the Factors weighing against him.] *S In its Brief, the Government asserted that it was only proceeding under Factors Two, Three, and Four. Accordingly, Factor Five does not weigh for or against revocation in this case. The Government has presented documents, testimony, and has relied on stipulations that establish by a preponderance of the evidence that the Respondent: Unlawfully prescribed controlled substances to three undercover agents on five separate occasions; was convicted in state court of seven misdemeanors for issuing unlawful prescriptions for controlled substances; and that he wrote three prescriptions in Texas without a valid DEA COR for a Texas location. After the Government presents a prima facie case for revocation, the Respondent has the burden of production to present ‘‘sufficient mitigating evidence’’ to show why he can be entrusted with a DEA registration. See Medicine Shoppe— Jonesborough, 73 FR at 387 (quoting Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)). To rebut the Government’s prima facie case, the Respondent must both accept responsibility for his actions and demonstrate that he will not engage in future misconduct. Stodola, 74 FR at 20734–35. *S I changed the first two sentences and third sentences based on my revised Factor One analysis. VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 The Respondent may accept responsibility by providing evidence of his remorse, his efforts at rehabilitation, and his recognition of the severity of his misconduct. See Leslie, 68 FR at 15228. To accept responsibility, a respondent must show ‘‘true remorse’’ for wrongful conduct. Michael S. Moore, M.D., 76 FR 45867, 45877 (2011). An expression of remorse includes acknowledgment of wrongdoing. See Wesley G. Harline, M.D., 65 FR 5665, 5671 (2000). A respondent must express remorse for all acts of documented misconduct, Jeffrey Patrick Gunderson, M.D., 61 FR 26208, 26211 (1996), and acknowledge the scope of his misconduct, Arvinder Singh, M.D., 81 FR 8247, 8250–51 (2016) *T [(calling for Respondent to acknowledge the ‘‘full scope of his criminal behavior and the risk of diversion it created’’). Additionally, ‘‘the Agency has previously weighed against a finding of acceptance of full responsibility’’ attempts to minimize the egregiousness of Respondent’s misconduct. Jeffrey Stein, M.D., 84 FR at 46,973 (collecting cases).] It is clear in this case that the Respondent attempted to accept full responsibility for his actions. It is clear because, prior to the hearing, the Respondent entered into extensive stipulations of fact, essentially relieving the Government of the need to present any evidence of the Respondent’s conduct that violated the CSA and its implementing regulations. The Record clearly demonstrates that the Respondent understood the importance of those stipulations. The Respondent acknowledged that by entering into the stipulations that essentially admitted to all the facts the Government would need to prove its allegations against him. Tr. 14. He also acknowledged that if no other evidence had been admitted in the case, that I could issue a well-founded recommendation that his COR be revoked. Tr. 14–15. The Respondent also acknowledged that the stipulations shifted the burden of proof to him to ‘‘demonstrate contrition and remedial actions that would convince me that in spite of the conduct [he] admitted to, that I should make a recommendation to . . . not revoke [his] certificate of registration.’’ Tr. 15. The Respondent has not met that burden. Here, the Government accurately argued in its Brief that while the Respondent ‘‘generally accepted responsibility for his improper prescribing to the three undercover investigators, his admission of *T I am tweaking the caselaw descriptions slightly and adding some additional caselaw that bolsters the ALJ’s position, with which I agree. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 15813 wrongdoing was not without some vacillation.’’ ALJ–37, at 10. To be accurate, the only vacillation concerned the Respondent’s testimony relative to the prescriptions the Respondent wrote for UC3, on March 21, 2013 and April 25, 2013. Indeed, the Respondent waivered on his acceptance of responsibility in writing those prescriptions. While he testified that he did do ‘‘some exam’’ of UC3, it seems that the only exam he conducted was to have UC3 perform a heel and toe walk on March 21, 2013. Tr. 78; GE–19, at 625–26. Further, the Respondent’s purpose in having UC3 perform a heel and toe walk was not to assess UC3’s pain level, but rather to determine if he needed to send UC3 to a specialist. GE– 19, at 911–12. No examination was conducted on April 25, 2013. See GE– 11. Clearly, at the hearing before me, the Respondent was reluctant to admit culpability for the prescriptions he wrote to UC3 because he had been acquitted of writing prescriptions for oxycodone.18 See Tr. 78, 110–11. In addition, during the hearing, the Respondent withdrew from the two stipulations he had originally entered into concerning the two prescriptions he wrote to UC3, and later entered into a modified stipulation, which did not address violations of 21 U.S.C. 841(a)(1), and Cal. Health & Safety Code § 11153(a). Tr. 80–81, 108. The Respondent also had problems in accepting responsibility for the three prescriptions he wrote in Texas. Initially, the Respondent stipulated that he had maintained a principal place of business in Texas, but he was not registered with the DEA in Texas. Stip. 54. During his testimony, however, he again ‘‘vacillated.’’ When asked if he had a certificate of registration for Texas, the Respondent testified that he had submitted a change of address and that he believed the DEA had approved the change. Tr. 92–93. The Respondent further testified that when he wrote the prescriptions in Texas, he believed he had the authority to do so. Tr. 105–107. The Respondent could have presented testimony that when he wrote the prescriptions in Texas he believed he had authority to do so, but now he realizes that he was wrong in that belief. But, the Respondent did not do so. 18 There are many reasons, however, why even a person who has engaged in criminal misconduct may never have been convicted of an offense or even prosecuted for one. Dewey C. MacKay, M.D., 75 FR 49956, 49973 (2010), pet. for rev. denied, MacKay v. Drug Enf’t Admin., 664 F.3d 808, 822 (10th Cir. 2011). The Agency has, therefore, held that ‘‘the absence of such a conviction is of considerably less consequence in the public interest inquiry’’ and is therefore not dispositive. Id. *[Omitted sentence]. E:\FR\FM\19MRN1.SGM 19MRN1 jbell on DSKJLSW7X2PROD with NOTICES 15814 Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices Through his testimony, the Respondent made clear that he has not accepted responsibility for the prescriptions he wrote in Texas without having a DEA COR for a place of business in Texas. In this case, the Government has established that the Respondent unlawfully wrote prescriptions for controlled substances to three undercover investigators on five separate occasions beginning in March 2012 and ending in April 2013. After the Respondent was arrested, the Government filed a motion to revoke his bail because he continued writing prescriptions. GE–16, at 4; GE–19, at 1170, 1173. Then, as a result of these unlawful prescriptions, in May 2015 the Respondent was convicted in the Superior Court of the State of California, County of Los Angeles, of seven counts concerning issuing unlawful prescriptions for Adderall, hydrocodone, and alprazolam. That court imposed a sentence in March 2016. Then in June 2016, the MBC suspended the Respondent’s medical license, a suspension which remained in effect until January 2017. In February 2017, the Acting Administrator of the DEA issued an Order restricting the Respondent’s COR, and remanded the Respondent’s case to the Office of Administrative Law Judges for further proceedings. Then in March and April of 2017, the Respondent wrote three prescriptions for Lyrica, a Schedule V controlled substance, in Texas, without having the authority to write such prescriptions from the DEA. At his hearing the Respondent accepted some responsibility for his actions. I find, however, that the Respondent’s limited acceptance of responsibility is outweighed by his prescribing transgressions detailed above, particularly considering the timeline and the fact that the Respondent’s acceptance of responsibility is equivocal. *[See Alra Labs, Inc. v. Drug Enf’t Admin., 54 F. 3d 450, 452 (7th Cir. 1995) (‘‘The DEA had to decide whether to believe [registrant’s] protestation that its problems are behind it. It did not have to accept that assertion.’’ (citations omitted).] *U When considering whether the Respondent’s continued registration is consistent with the public interest, an ALJ must consider both the egregiousness of the registrant’s violations and the DEA’s interest in deterring future misconduct by both the registrant as well as other registrants. Ruben, 78 FR at 38364. *[Omitted additional citations]. *U Replaced citation. VerDate Sep<11>2014 17:05 Mar 18, 2020 Jkt 250001 In this case, the Respondent’s numerous transgressions are sufficiently egregious to warrant revocation.19 See Dewey C. MacKay, M.D., 75 FR 49956, 49974 n.35 (2010) (‘‘[U]nder the public interest standard, DEA has authority to consider those prescribing practices of a physician, which, while not rising to the level of intentional or knowing misconduct, nonetheless create a substantial risk of diversion.’’). I find the Respondent’s transgressions egregious for several reasons. First, the Respondent issued prescriptions for controlled substances to UC1 even though he knew that UC1 was obtaining controlled substances on the street, and he reissued that prescription to UC1 even knowing that none of the controlled substances the Respondent prescribed to UC1 were detected in his urine test. Second, almost a year later, the Respondent again prescribed oxycodone, this time to UC3, knowing that UC3 had been obtaining oxycodone on the street. Finally, after being caught, convicted and sentenced for writing illegal prescriptions; after having had his medical license suspended by the MBC for writing illegal prescriptions; after taking courses on writing prescriptions through PACE; and then less than three months after he had his medical license reinstated; he wrote illegal prescriptions in Texas. This misconduct, particularly on this timeline, engenders absolutely no confidence that the Respondent can be entrusted with a DEA certificate of registration. Recommendation The Government established that the Respondent’s continued registration is inconsistent with the public interest because of his improper prescribing, and his state conviction relating to his unlawful prescribing of controlled substances. While the Respondent admitted to many of the Government’s 19 I acknowledge that the Respondent has taken some remedial steps to reduce the likelihood that his actions would result in future violations of the CSA and/or its implementing regulations. See, e.g., ALJ–38, at 8–9. Nevertheless, a registrant does not accept responsibility for its actions simply by taking remedial measures. Holiday CVS, L.L.C., d/b/a CVS/ Pharmacy Nos. 219 & 5195, 77 FR 62,316, 62,346 (2012). Further, where a registrant has not accepted responsibility it is not necessary to consider evidence of the registrant’s remedial measures. Jones Total Health Care Pharmacy, L.L.C. & SND Health Care, L.L.C., 81 FR 79,188, 79,202–03 (2016). *[In this case, Respondent has taken responsibility for most of the allegations related to his conduct related to his criminal conviction; however, through his vacillations, and as a result of his conduct in Texas, I have reason to doubt the sincerity of his words. Therefore, I agree with the ALJ that the egregiousness of his conduct even in the stipulated facts must be considered in determining whether sanction is appropriate.] PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 factual allegations, he failed to fully accept responsibility for his actions. Furthermore, even had the Respondent accepted full responsibility, the egregiousness of his violations may *T have outweighed his acceptance of responsibility and the remedial measures he has taken. Accordingly, I recommend that the Respondent’s DEA COR be revoked and that any application for renewal or modification of his registration be denied. Dated: August 28, 2017. Charles Wm. Dorman, U.S. Administrative Law Judge. [FR Doc. 2020–05751 Filed 3–18–20; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Ainistration [Docket No. DEA–591] Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before May 18, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on November 6, 2019, Siegfried USA, LLC, 33 Industrial Park Road, Pennsville, New Jersey 08070– 3244 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: DATES: Controlled substance Gamma Hydroxybutyric Acid. Dihydromorphine .......... Hydromorphinol ............ Methylphenidate ........... Amobarbital .................. Pentobarbital ................ Secobarbital .................. Codeine ........................ Oxycodone ................... Drug code Schedule 2010 I 9145 9301 1724 2125 2270 2315 9050 9143 I I II II II II II II *T I changed the word ‘‘would’’ to ‘‘may,’’ because I decline to foreclose definitively the ability of the Respondent to have convinced me that he could have been entrusted with a registration. Most importantly, in this case he did not E:\FR\FM\19MRN1.SGM 19MRN1

Agencies

[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15800-15814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05751]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


John O. Dimowo, M.D.; Decision and Order

    On August 28, 2017, the Drug Enforcement Administration 
(hereinafter, DEA) Administrative Law Judge Charles Wm. Dorman 
(hereinafter, ALJ), issued a Recommended Rulings, Findings of Fact, 
Conclusions of Law and Decision (hereinafter, RD) on the action to 
revoke the DEA Certification of Registration of John O. Dimowo, M.D. 
Neither party filed exceptions to the RD. Having reviewed and 
considered the entire administrative record before me, I adopt the 
ALJ's RD with minor modifications, where noted herein.*\A\
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    *\A\ I have made minor modifications to the RD. I have 
substituted initials or titles for the names of witnesses and 
patients to protect their privacy and I have made minor, 
nonsubstantive, grammatical changes. Where I have made substantive 
changes, omitted language for brevity or relevance, or where I have 
added to or modified the ALJ's opinion, I have noted the edits with 
an asterisk, and I have included specific descriptions of the 
modifications in brackets following the asterisk or in footnotes 
marked with an asterisk and a letter.
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    Overall, with respect to this case, I appreciate Respondent's 
efforts to limit DEA time and resources by stipulating to many of the 
Government's fact allegations. However, as explained in the findings 
and conclusions below, his actions, including prescribing after a 
court's restriction and prescribing in Texas after his convictions and 
settlement in California without a DEA registration, contradicted the 
credibility of his words. The Respondent must convince the 
Administrator that his acceptance of responsibility and remorse are 
sufficiently credible to demonstrate that the misconduct will not 
recur. Jeffrey Stein, M.D., 84 FR 46,968, 46,974 (2019). As described 
herein, Respondent did not convince me or the ALJ that he could be 
entrusted with a DEA registration.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration 
BD3755571 issued to John O. Dimowo, M.D. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby 
deny any pending application of John O. Dimowo to renew or modify this 
registration, as well as any pending application of John O. Dimowo for 
registration in California. This Order is effective April 20, 2020.

    Dated: March 2, 2020.
Uttam Dhillon,
Acting Administrator.
Paul E. Soeffing, Esq., for the Government
Courtney E. Pilchman, Esq., for the Respondent

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge

    Charles Wm. Dorman, Administrative Law Judge. On July 21, 2016, the 
Drug Enforcement Administration (``DEA'' or ``Government'') served John 
O. Dimowo, M.D., (``Respondent'') with an Order to Show Cause 
(``OSC''), seeking to revoke his DEA Certificate of Registration 
(``COR''), Number BD3755571. Administrative Law Judge Exhibit (``ALJ-
'') 1, 6. One of the allegations contained in the OSC was that the 
Respondent lacked state authority to handle controlled substances in 
California, where he was registered. In response to the OSC, the 
Respondent timely requested a hearing before an Administrative Law 
Judge. ALJ-2.
    On September 2, 2016, the Government filed a Motion for Summary 
Disposition. ALJ-7. Therein, the Government argued that the Respondent 
lacked state authority in California to handle controlled substances, 
the state where the Respondent was registered with the DEA. ALJ-7, at 
2. The Government stated that an Interim Suspension Order was issued 
against the Respondent by the Medical Board of California (``MBC'') on 
June 10, 2016. ALJ-7, at 2-3. Attached to the Government's Motion was a 
copy of the MBC's Interim Order of Suspension. ALJ-7, Ex. 1. The 
Government also stated that on June 28, 2016, a hearing was held before 
a California administrative law judge. ALJ-7, at 3. Following that 
hearing, on July 1, 2016, the state continued the suspension of the 
Respondent's medical license, and issued an Interim Order of 
Suspension. ALJ-7, Ex. 2.
    On September 16,*\B\ 2016, the Respondent filed a Response to the 
Government Motion for Summary Disposition (``Response''). ALJ-8. 
Therein, the Respondent acknowledged that his California medical 
license had been suspended but asserted that he had ``completed 
negotiation with the [MBC] to resolve the accusations that resulted in 
the temporary license suspension.'' ALJ-8, at 1. Attached to the 
Response was a copy of a Stipulated Settlement and Disciplinary Order 
between the Respondent and the Attorney General of California. ALJ-8, 
Ex. 1. In the Response, the Respondent requested that ``the hearing on 
this matter be stayed pending the final approval of the negotiated 
settlement stipulation by the Executive Director of the [MBC].'' ALJ-
8,*\C\ at 1.
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    *\B\ Correction.
    *\C\ Correction.
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    At that time, both parties agreed that the Respondent currently 
lacked state authority to handle controlled substances in California. 
Because there was no genuine question of fact, no adversarial hearing 
was required. See, e.g., Jesus R. Juarez, M.D., 62 FR 14,945, 14,945 
(1997). Therefore, because DEA precedent requires that a practitioner 
be authorized to handle controlled substances in the jurisdiction in 
which the practitioner is registered, I granted the Government's Motion 
for Summary Disposition on October 18, 2016. See ALJ-14. On November 
15, 2016, I forwarded my October 18, 2016 Order Granting Summary 
Disposition and Recommended Rulings, Findings of Fact, Conclusions of 
Law, and Decision (``Recommended Decision'') to the Acting 
Administrator of the DEA. ALJ-15.
    Subsequent to the issuance of the Recommended Decision, the MBC 
restored a substantial portion of the

[[Page 15801]]

Respondent's state authority to practice medicine and handle controlled 
substances in California, but did limit his ability to prescribe or 
handle drugs that are listed in Schedules II and III of the California 
Uniform Controlled Substances Act. In light of the action by the MBC, 
the Acting Administrator determined that revocation of the Respondent's 
COR was no longer warranted based on a lack of state authority. ALJ-19, 
at 2. The OSC, however, contained other allegations, which the 
Government had alleged as grounds for revocation.
    Following input from the parties, ALJ-17, ALJ-18, the Acting 
Administrator issued an Order in this case on February 23, 2017. ALJ-
19.*\D\ That Order placed restrictions on the Respondent's COR, 
prohibiting him from ``prescribing, direct dispensing, purchasing and 
ordering any controlled substance in schedules II and III of the 
Controlled Substances Act.'' ALJ-19, at 6. The Order further prohibited 
the Respondent ``from administering any controlled substance in 
schedules II and III, except when such administration is for the 
purpose of providing anesthesia to a patient in a hospital or licensed 
surgery center.'' Id. at 6. Finally, the Acting Administrator remanded 
this case to the Office of Administrative Law Judges for ``further 
proceedings consistent with [his] decision.'' Id. at 7.
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    *\D\ Correction.
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    Following that remand, I issued an Order for Prehearing Statements. 
ALJ-20. The parties filed Prehearing Statements, ALJ-22, ALJ-23, as 
well as Supplemental Prehearing Statements. ALJ-28, ALJ-29. Afterwards, 
a hearing in this matter was held in Santa Ana, California on June 27, 
2017.
    The issue before the Administrator is whether the DEA should revoke 
the registration of John O. Dimowo, M.D., DEA Certificate of 
Registration, BD3755571, pursuant to 21 U.S.C. 824(a)(4), and deny any 
pending application \1\* for renewal or modification of such 
registration, pursuant to 21 U.S.C. 823(f).
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    \1\* [RD footnote 1 omitted due to lack of relevance of the 
status of Respondent's registration or application. See Jeffrey D. 
Olsen, M.D., 84 FR 68,474 (2019).]
---------------------------------------------------------------------------

    This Recommended Decision is based on my consideration of the 
entire administrative record, including all of the testimony, admitted 
exhibits, and the oral and written arguments of counsel.

The Remaining Allegations

I. Unlawful Distribution of Controlled Substances to Three Undercover 
Agents on Five Separate Occasions in Violation of 21 U.S.C. 841(a)(1); 
21 CFR 1306.04(a); Cal. Health & Safety Code Sec.  11153(a); and Cal. 
Bus. & Prof. Code Sec. Sec.  725(a), 2241(b), 2241.5(c), and 2242(a) 
\2\
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    \2\ I have taken official notice of Cal. Health & Safety Code 
Sec.  11153(a) (Westlaw, Current with all laws through Ch. 870 of 
2019 Regular Session); and Cal. Bus. & Prof. Code Sec. Sec.  725(a), 
2241(b), 2241.5(c), and 2242(a) (Westlaw, Current with all laws 
through Ch. 870 of 2019 Regular Session); Tr. 7. *[See also GE 1 and 
GE 2.]
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    1. On March 30, 2012, an undercover law enforcement officer 
(``UC1'') met with the Respondent. GE-3. During an office visit that 
day, UC1 rated his pain as a two, on a scale of one to ten; explained 
that his only pain was caused by exercise and walking a lot; and stated 
that he was taking a friend's Vicodin and Adderall to self-medicate. 
Id. The Respondent conducted little or no physical examination of UC1 
and provided no diagnosis warranting a prescription for controlled 
substances, yet he prescribed Adderall 10 mg, a schedule II controlled 
substance, and Norco, a schedule III controlled substance, to UC1. ALJ-
1, at 2; GE-4.
    2. On May 4, 2012, UC1 again met with the Respondent. GE-5. During 
an office visit that day, UC1 stated his pain was good; asked for 
Opana, a schedule II controlled substance, which he said he had been 
obtaining from someone at a gym; said his pain was caused by exercise; 
and failed a urine screening for the drugs the Respondent had 
previously prescribed to him. Id. The Respondent conducted little or no 
physical examination of UC1 and provided no diagnosis warranting a 
prescription for controlled substances, yet he prescribed Adderall 10 
mg, a schedule II controlled substance, and Vicodin, a schedule III 
controlled substance, to UC1. ALJ-1, at 2; GE-6.
    3. On May 4, 2012, UC2 met with the Respondent. GE-7. During an 
office visit that day, UC2 stated she wanted something to treat her 
soreness after exercise and she asked for Adderall to stay alert with 
her children, and Xanax or Vicodin to relax at night. Id. The 
Respondent conducted little or no physical examination of UC2 and 
provided no diagnosis warranting a prescription for controlled 
substances, yet he prescribed Adderall 10 mg, Vicodin 5/500 mg, and 
Xanax 2 mg, all controlled substances in schedules II, III, and IV, 
respectively. ALJ-1, at 2-3; GE-8.
    4. On March 21, 2013, UC3 met with the Respondent. GE-9. During an 
office visit that day, UC3 complained of generalized pain from an old 
high school football accident and informed the Respondent that he did 
not have insurance, but he did what he needed to do to get oxycodone. 
Id. The Respondent conducted little or no physical examination of UC3 
and provided no diagnosis warranting a prescription for controlled 
substances, yet he prescribed Percocet 10/325 mg, a schedule II 
controlled substance, to UC3. ALJ-1, at 3; GE-10.
    5. On April 25, 2013, UC3 met with the Respondent. GE-11. The 
Respondent conducted little or no physical examination of UC3 and 
provided no diagnosis warranting a prescription for controlled 
substances, yet he prescribed Percocet 10/325 mg, to UC3. ALJ-1, at 3; 
GE-12. *[I am omitting RD Section II and renumbered subsequent sections 
for brevity due to the Government's dismissal of the charge].\3\
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    \3\ The Government withdrew* [the allegation of issuing 
prescriptions for office use or for personal use in violation of 21 
CFR 1306.04(b)] at the hearing. Tr. 7.
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II. State Convictions

    6. On May 14, 2015,*\E\ a Los Angeles County jury convicted the 
Respondent of seven felony counts of issuing unlawful controlled 
substance prescriptions for Adderall, hydrocodone, and alprazolam. On 
March 28, 2016, the presiding judge reduced the felony convictions to 
misdemeanors. Id. at 4. These convictions may be considered in 
determining whether the Respondent's registration is inconsistent with 
the public interest under 21 U.S.C. 823(f)(3) and 824(a)(4).
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    *\E\ Correction.
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III. Writing Prescriptions in Texas Without a Valid DEA COR for a Texas 
Location

    7. In March and April 2017, the Respondent issued three 
prescriptions for Lyrica, a schedule V controlled substance, from his 
medical practice in El Paso, Texas. In writing these three 
prescriptions, the Respondent listed his DEA COR for his registered 
address in California. At the time the Respondent wrote the 
prescriptions in Texas he did not have a DEA COR for a registered Texas 
location. Thus, the Respondent violated the separate registration 
requirements of 21 U.S.C. 822(e) and 21 CFR 1301.12(a) and (b)(3). ALJ-
29, at 5-6; GE-23, 24.

[[Page 15802]]

Witnesses

I. The Government's Witnesses

    The Government presented no witness during its case-in-chief. 
Rather, the Government introduced 24 Exhibits, and relied upon the 83 
stipulations of fact that the Respondent had entered into with the 
Government. Following the presentation of the Respondent's case-in-
chief, the Government presented two rebuttal witnesses.
    The Government's first rebuttal witness was a Diversion 
Investigator (DI). Tr. 112-130. DI has been a diversion investigator 
with the DEA for five years and she is assigned to the Los Angeles 
Field Division, Tactical Diversion Squad. DI attended the basic 12-
weeks of training for new diversion investigators at Quantico, VA, and 
two additional training courses at Quantico concerning financial 
investigations. As a diversion investigator, DI has conducted 
regulatory and criminal investigations of individuals and organizations 
holding DEA registrations to deal with controlled substances. As a 
member of the Tactical Diversion Squad, DI's investigations primarily 
concern criminal matters involving doctors and pharmacies. DI became 
the lead investigator concerning the Respondent when the initial 
investigator left the Tactical Diversion Squad.
    As a rebuttal witness DI provided testimony concerning where the 
Respondent was registered to handle controlled substances; the 
prescriptions the Respondent wrote in Texas; and her interaction with 
the Respondent's MBC probation officer. I find DI's testimony to be 
thorough, detailed, and internally consistent with Government Exhibits 
18, 23, and 24. Therefore, I merit it as credible in this Recommended 
Decision.
    The Government's second rebuttal witness was M.D., who has been an 
investigator with the California Department of Consumer Affairs for 
over six years. M.D. is assigned to the Health Quality Investigation 
Unit of the Department. M.D.'s credentials are further detailed at GE-
13, at 8. M.D. was the main investigator concerning the Respondent. Tr. 
131. M.D. provided rather limited testimony concerning whether the 
Respondent had complied with terms of his stipulated settlement with 
the MBC and his familiarity with reporting requirements contained in 
such settlements. I find M.D.'s testimony to be thorough, detailed, and 
internally consistent with Government Exhibit 18. Therefore, I merit it 
as credible in this Recommended Decision.

II. The Respondent's Witness

    The Respondent's case-in-chief included the testimony of the 
Respondent, reliance upon the 83 stipulations of fact, and introduction 
of Respondent's Exhibits A-CC. The overall tenor of the Respondent's 
testimony was his acceptance of responsibility and detailing steps he 
has taken to ensure that his past violations are not repeated. Tr. 21-
112.
    The Respondent testified about his medical training and background, 
as well as describing the various medical positions he has held since 
being licensed as a medical doctor in the United States and his 
impressive curriculum vitae. The Respondent testified about actions he 
took to divest himself of his pain management practice after the MBC 
visited his clinic in 2013, but before he was charged with any crimes. 
The Respondent testified concerning his conviction on seven felony 
counts, later reduced to misdemeanors by the trial judge, and the 
actions he took following the trial, including performing 353 hours of 
community service, even though he was only required to perform 130 
hours. Tr. 45. During his community service, the Respondent shared his 
``story'' with individuals dealing with substance abuse issues in an 
effort to allow them to learn from his own mistakes. He testified that 
if he is allowed to keep his COR he would restrict his practice to 
anesthesiology in a hospital or surgery center, using only the 
controlled substances those institutions had acquired. The Respondent 
testified in a very candid and straightforward manner. There were at 
least six portions of his testimony, however, that strained credulity.
    The Respondent testified that, in retrospect, he does not believe 
he was prepared to enter into a pain management practice in 2010 
because he had not reviewed the requirements for substance control; he 
was not able to identify drug seeking patients; and he was too trusting 
of patients. Tr. 35-36. The Respondent, however, was board certified in 
pain management. The Respondent had also completed a two-year pain 
management fellowship and was a Diplomate of the American Board of Pain 
Medicine. RE-A, at 1. The Respondent had also been practicing medicine 
in the United States for 17 years by the time he opened his pain clinic 
in 2007, and although the primary focus of his practice had been 
anesthesiology, he worked in a pain clinic before he opened his own 
pain clinic. I find that the Respondent's assertion of being ill 
prepared to open a pain clinic rings hollow given his training and 
experience, which included work in a pain clinic, where 70% of his work 
was pain management, prior to opening his own pain clinic.
    The Respondent testified that he intended to limit his medical 
practice to anesthesiology. Just this year, however, the Respondent 
opened a pain clinic in Texas.*\F\
---------------------------------------------------------------------------

    *\F\ I am omitting two sentences of the R.D., because they are 
superfluous and could be misinterpreted as conflicting with my 
February 23, 2017 Order.
---------------------------------------------------------------------------

    When asked to explain why he had failed to perform examinations of 
the three undercover patients, the Respondent testified that he had 
performed a short diagnosis, as he had been trained to do in Nigeria. 
The Respondent's failure to perform the examinations, however, occurred 
in 2012, years after he had been trained in Nigeria, and after more 
than 20 years of medical practice in the United States.
    When describing the requirements of his stipulated settlement with 
the MBC, the Respondent either did not understand the terms of the 
settlement or he mischaracterized its terms to make it seem more 
onerous than it is. For example, he testified that he must have a 
physician to monitor his medical practice. Tr. 59. The settlement 
provided, however, that he need not have a monitor if he participates 
in a professional enhancement program. GE-18, at 11. The Respondent 
testified that the stipulated settlement required that he practice 
medicine at least 40 hours a month in California. The stipulated 
settlement contains no such provision. As Respondent's counsel stated, 
``the best reflection of the terms and conditions are contained in the 
stipulated settlement . . . .'' Tr. 136.
    With respect to the Respondent's ability to practice medicine 
following his conviction and sentencing by a California court, the 
Respondent testified that the sentencing judge did not restrict his 
ability to practice medicine, stating that the judge left that to the 
MBC. Tr. 56. That testimony stands in sharp contrast to the Finding of 
Fact contained in the MBC's Interim Order of Suspension. In the MBC's 
second finding of fact it states that the court ``ordered Respondent 
`not to practice medicine until an order has been made by the Medical 
Board with respect to your ability to do so in the State of 
California.' '' GE-17, at 2. Thus, it would appear that the trial judge 
did prohibit the Respondent from practicing medicine until the MBC had 
taken action.
    The Respondent also testified that when he wrote prescriptions for 
a

[[Page 15803]]

schedule V controlled substance in Texas this year he thought he had 
authority to do so. He apparently based this belief upon the fact that 
he had requested a change of mailing address with the DEA and the DEA 
had acknowledged the new address. He also based it upon the fact that 
he had called a pharmacy in Texas, and the pharmacy had told him it was 
okay to issue the prescription. These prescriptions, however, were 
written after the Respondent had taken a ``PACE'' course on how to 
write prescriptions, after a motion had been filed to revoke the 
Respondent's bail prior to his trial for violating a court order not to 
do so,\4\ and after he had been convicted of writing illegal 
prescriptions. Thus, it would appear that the Respondent's belief that 
he had the authority to write prescriptions for controlled substances 
in Texas was an unreasonable belief.
---------------------------------------------------------------------------

    \4\ See GE-16, at 4, para 13: GE-19, at 1170.
---------------------------------------------------------------------------

    I find that the Respondent presented as a generally credible and 
sincere witness. The six examples detailed above, however, detract from 
the Respondent's overall credibility. Thus, to the extent that the 
Respondent's testimony is in conflict with other evidence of record, or 
it is based on illogical or unsound reasoning, I defer to that other 
evidence, logic and/or reasoning.

The Facts

I. Stipulations of Fact

    The parties stipulated to the following facts.
    1. Respondent is registered with DEA as an individual practitioner 
in Schedules II-V under DEA registration number BD3755571 at 5857 Pine 
Avenue, Chino Hills, CA 91709. This registration expires by its terms 
on June 30, 2017. *[Respondent filed for renewal in May 2017. See Tr. 
116, 127.]
    2. Norco is a hydrocodone combination product. Prior to October 6, 
2014, hydrocodone combination products were classified as Schedule III 
controlled substances. After October 6, 2014, hydrocodone combination 
products were classified as Schedule II controlled substances.
    3. Adderall is a brand name for generic amphetamine. Amphetamine is 
classified as a Schedule II controlled substance.
    4. Vicodin is a hydrocodone combination product. Prior to October 
6, 2014, hydrocodone combination products were classified as Schedule 
III controlled substances. After October 6, 2014, hydrocodone 
combination products were classified as Schedule II controlled 
substances.
    5. Xanax is a brand name for generic alprazolam. Alprazolam is 
classified as a Schedule IV controlled substance.
    6. Percocet is a brand name for generic oxycodone. Oxycodone is 
classified as a Schedule II controlled substance.
    7. On March 30, 2012, Respondent issued prescriptions to UC1 for 90 
dosage units of Norco 10/325 mg and 30 dosage units of Adderall 10 mg.
    8. On May 4, 2012, Respondent issued prescriptions to UC1 for 90 
dosage units of Vicodin 5/500 mg and 30 dosage units of Adderall 10 mg.
    9. On May 4, 2012, Respondent issued prescriptions to UC2 for 30 
dosage units of Vicodin 5/500 mg, 60 dosage units of Xanax 2 mg, and 30 
dosage units of Adderall 10 mg.
    10. On March 21, 2013, Respondent issued a prescription to UC3 for 
90 dosage units of Percocet 10/325 mg.
    11. On April 25, 2013, Respondent issued a prescription to UC3 for 
90 dosage units of Percocet 10/325 mg.
    12. On March 22, 2013, investigators with the MBC, assisted by DEA 
investigators, executed a state search warrant at Respondent's medical 
offices located at 1120 West La Palma #2, Anaheim, California 92801 and 
218 East Anaheim St., Wilmington, California 90744, and seized 
materials, including all controlled substances from both locations and 
medical records of patients.
    13. On May 14, 2015, a Los Angeles County jury convicted Respondent 
of seven state felony counts of issuing unlawful controlled substance 
prescriptions for hydrocodone and Adderall.
    14. On March 28, 2016, Respondent was sentenced and the presiding 
judge, pursuant to the discretion afforded him under state law, reduced 
the convictions to misdemeanors and sentenced Respondent to probation.
    15. On June 10, 2016, the MBC suspended Respondent's medical 
license with the issuance of an ex parte Interim Order of Suspension.
    16. On July 1, 2016,\5\ after a hearing, the MBC continued the 
suspension of Respondent's medical license with the issuance of an 
Interim Order of Suspension.
---------------------------------------------------------------------------

    \5\ See Tr. 6, lines 24-25 (correcting a typographical error in 
the Prehearing Ruling).
---------------------------------------------------------------------------

    17. On December 20, 2016, the MBC issued a Decision adopting a 
Stipulated Settlement and Disciplinary Order entered into by Respondent 
and the Attorney General for California on September 9, 2016. The 
Decision was effective January 19, 2017, and reinstated Respondent's 
medical license, with restrictions.
    18. The parties stipulate to the authenticity and admission of 
Government Exhibit 1: Cal. Health & Safety Code Sec.  11153(a).
    19. The parties stipulate to the authenticity and admission of 
Government Exhibit 2: Cal. Bus. & Prof. Code Sec. Sec.  725(a), 
2241(b), 2241.5(c), 2242(a).
    20. The parties stipulate to the authenticity and admission of 
Government Exhibit 3: DVD recording and transcript of undercover visit 
by UC1 on March 30, 2012. (13 pages)
    21. The parties stipulate to the authenticity and admission of 
Government Exhibit 4: Prescriptions written by John O. Dimowo for UC1 
for 90 Norco 10/325 mg and 30 Adderall 10 mg dated March 30, 2012.
    22. The parties stipulate to the authenticity and admission of 
Government Exhibit 5: DVD recording and transcript of undercover visit 
by UC1 on May 4, 2012.
    23. The parties stipulate to the authenticity and admission of 
Government Exhibit 6: Prescriptions written by John O. Dimowo for UC1 
for 90 Vicodin 5/500 mg and 30 Adderall 10 mg dated May 4, 2012.
    24. The parties stipulate to the authenticity and admission of 
Government Exhibit 7: DVD recording and transcript of undercover visit 
by UC2 on May 4, 2012.
    25. The parties stipulate to the authenticity and admission of 
Government Exhibit 8: Prescriptions written by John O. Dimowo for UC2 
for 30 Vicodin 5/500 mg, 60 Xanax 2 mg and 30 Adderall 10 mg dated May 
4, 2012.
    26. The parties stipulate to the authenticity and admission of 
Government Exhibit 9: DVD recording and transcript of undercover visit 
by UC3 on March 21, 2013.
    27. The parties stipulate to the authenticity and admission of 
Government Exhibit 10: Prescription written by John O. Dimowo for UC3 
for 90 Percocet 10/325 mg dated March 21, 2013.
    28. The parties stipulate to the authenticity and admission of 
Government Exhibit 11: DVD recording and transcript of undercover visit 
by UC3 on April 25, 2013.
    29. The parties stipulate to the authenticity and admission of 
Government Exhibit 12: Prescription written by John O. Dimowo for UC3 
for 90 Percocet 10/325 mg dated April 25, 2013.
    30. The parties stipulate to the authenticity and admission of 
Government Exhibit 13: Search Warrant dated March 19, 2013.

[[Page 15804]]

    31. The parties stipulate to the authenticity and admission of 
Government Exhibit 14: Patient File for UC1.
    32. The parties stipulate to the authenticity and admission of 
Government Exhibit 15: Patient File for UC2.
    33. The parties stipulate to the authenticity and admission of 
Government Exhibit 16: Certified copy of MBC's Interim Order of 
Suspension (ex parte) dated June 10, 2016.
    34. The parties stipulate to the authenticity and admission of 
Government Exhibit 17: Certified copy of MBC's Interim Order of 
Suspension dated July 1, 2016.
    35. The parties stipulate to the authenticity and admission of 
Government Exhibit 18: Certified copy of MBC's Decision dated December 
20, 2016, and Stipulated Settlement and Disciplinary Order dated 
September 9, 2016.
    36. The parties stipulate to the authenticity and admission of 
Government Exhibit 19: California v. Dimowo, Case No. BA417100, 
Reporter's Transcript of Proceedings (Cal. Sup. Ct. Los Angeles County, 
Apr. 24-May 14, 2015).
    37. The parties stipulate to the authenticity and admission of 
Government Exhibit 20: California v. Dimowo, Case No. BA417100, 
Conviction Minute Order (Cal. Sup. Ct. Los Angeles County, May 14, 
2015).
    38. The parties stipulate to the authenticity and admission of 
Government Exhibit 21: California v. Dimowo, Case No. BA417100, 
Sentencing Minute Order (Cal. Sup. Ct. Los Angeles County, Mar. 28, 
2016).
    39. The parties stipulate to the authenticity and admission of 
Government Exhibit 22: Curriculum Vitae of W.S., M.D.
    40. The parties stipulate to the authenticity and admission of 
Government Exhibit 23: Two prescriptions for Lyrica authorized by 
Respondent in Texas and filled by ASP Cares Pharmacy.
    41. The parties stipulate to the authenticity and admission of 
Government Exhibit 24: One prescription for Lyrica authorized by 
Respondent in Texas and filled by Walgreens Pharmacy.
    42. The parties stipulate that UC1 is a MBC Investigator who saw 
Respondent in an undercover capacity posing as UC1 on March 30, 2012, 
and May 4, 2012.
    43. The parties stipulate that the prescription written by John O. 
Dimowo for UC1 for 90 Norco 10/325 mg, dated March 30, 2012, 
(Government Exhibit 4) was issued for no legitimate medical purpose and 
outside the usual course of professional practice, in violation of 21 
U.S.C. 841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code Sec.  
11153(a); and Cal. Bus. & Prof. Code Sec. Sec.  725(a), 2241(b), 
2241.5(c), 2242(a).
    44. The parties stipulate that the prescription written by John O. 
Dimowo for UC1 for 30 Adderall 10 mg, dated March 30, 2012, (Government 
Exhibit 4) was issued for no legitimate medical purpose and outside the 
usual course of professional practice, in violation of 21 U.S.C. 
841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code Sec.  11153(a); 
and Cal. Bus. & Prof. Code Sec. Sec.  725(a), 2241(b), 2241.5(c), 
2242(a).
    45. The parties stipulate that the prescription written by John O. 
Dimowo for UC1 for 90 Vicodin 5/500 mg, dated May 4, 2012, (Government 
Exhibit 6) was issued for no legitimate medical purpose and outside the 
usual course of professional practice, in violation of 21 U.S.C. 
841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code Sec.  11153(a); 
and Cal. Bus. & Prof. Code Sec. Sec.  725(a), 2241(b), 2241.5(c), 
2242(a).
    46. The parties stipulate that the prescription written by John O. 
Dimowo for UC1 for 30 Adderall 10 mg, dated May 4, 2012, (Government 
Exhibit 6) was issued for no legitimate medical purpose and outside the 
usual course of professional practice, in violation of 21 U.S.C. 
841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code Sec.  11153(a); 
and Cal. Bus. & Prof. Code Sec. Sec.  725(a), 2241(b), 2241.5(c), 
2242(a).
    47. The parties stipulate that UC2 was a MBC Investigator who saw 
Respondent posing in an undercover capacity as UC2 on May 4, 2012.
    48. The parties stipulate that the prescription written by John O. 
Dimowo for UC2 for 30 Vicodin 5/500 mg, dated May 4, 2012, (Government 
Exhibit 8) was issued for no legitimate medical purpose and outside the 
usual course of professional practice, in violation of 21 U.S.C. 
841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code Sec.  11153(a); 
and Cal. Bus. & Prof. Code Sec. Sec.  725(a), 2241(b), 2241.5(c), 
2242(a).
    49. The parties stipulate that the prescription written by John O. 
Dimowo for UC2 for 60 Xanax 2 mg, dated May 4, 2012, (Government 
Exhibit 8) was issued for no legitimate medical purpose and outside the 
usual course of professional practice, in violation of 21 U.S.C. 
841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code Sec.  11153(a); 
and Cal. Bus. & Prof. Code Sec. Sec.  725(a), 2241(b), 2241.5(c), 
2242(a).
    50. The parties stipulate that the prescription written by John O. 
Dimowo for UC2 for 30 Adderall 10 mg, dated May 4, 2012, (Government 
Exhibit 8) was issued for no legitimate medical purpose and outside the 
usual course of professional practice, in violation of 21 U.S.C. 
841(a)(1); 21 CFR 1306.04(a); Cal. Health & Safety Code Sec.  11153(a); 
and Cal. Bus. & Prof. Code Sec. Sec.  725(a), 2241(b), 2241.5(c), 
2242(a).
    51. The parties stipulate that UC3 is a California Department of 
Health Care Services Investigator who saw Respondent in an undercover 
capacity posing as UC3 on March 21, 2013, and April 25, 2013.
    52. The parties stipulate that the prescription written by John O. 
Dimowo for UC3 for 90 Percocet 10/325 mg, dated March 21, 2013, 
(Government Exhibit 10) was issued for no legitimate medical purpose 
and outside the usual course of professional practice, in violation of 
21 CFR 1306.04(a); and Cal. Bus. & Prof. Code Sec. Sec.  725(a), 
2241(b), 2241.5(c), 2242(a).\6\
---------------------------------------------------------------------------

    \6\ See Tr. 107-08 (deleting reference to 21 U.S.C. 841(a)(1), 
and Cal. Health & Safety Code Sec.  11153(a)).
---------------------------------------------------------------------------

    53. The parties stipulate that the prescription written by John O. 
Dimowo for UC3 for 90 Percocet 10/325 mg, dated April 25, 2013, 
(Government Exhibit 12) was issued for no legitimate medical purpose 
and outside the usual course of professional practice, in violation of 
21 CFR 1306.04(a); and Cal. Bus. & Prof. Code Sec. Sec.  725(a), 
2241(b), 2241.5(c), 2242(a).\7\
---------------------------------------------------------------------------

    \7\ See Tr. 107-08 (deleting reference to 21 U.S.C. 841(a)(1), 
and Cal. Health & Safety Code Sec.  11153(a)).
---------------------------------------------------------------------------

    54. The parties stipulate that during March and April 2017, 
Respondent maintained a principal place of business or professional 
practice in Texas from which he issued three prescriptions for Lyrica 
(Government Exhibits 23 and 24), which is a brand name for generic 
pregabalin a Schedule V controlled substance. The parties further 
stipulate that during March and April 2017, Respondent was not 
registered in Texas with DEA.
    55. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit A: CV of Dr. Dimowo.
    56. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit B: Character letter from P.B., D.O., dated 
December 3, 2013.
    57. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit C: Character letter from R.B., M.D.
    58. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit D: Character letter from S.B., D.P.M., dated 
November 26, 2013.

[[Page 15805]]

    59. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit E: Character letter from E.G., M.D., dated 
December 5, 2013.
    60. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit F: Character letter from S.V., M.D., dated 
December 3, 2013.
    61. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit G: Character letter from R.R., M.D., dated 
December 13, 2013.
    62. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit H: Character letter from J.L., M.D., dated 
December 3, 2013.
    63. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit I: Character letter from K.K., M.D., dated 
December 19, 2013.
    64. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit J: Certificate of completion of Medical Record 
Keeping Course, UC San Diego PACE program, dated July 18-19, 2013.
    65. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit K: Certificate of completion of Physician 
Prescribing Course, UC San Diego PACE program, dated July 15-17, 2013.
    66. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit L: Certificate of attendance Medical Ethics and 
Professional Boundaries Program, April 8, 2017.
    67. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit M: Certificate of completion Drug and Alcohol 
Awareness Class, dated November 3, 2015.
    68. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit N: Chronic Pain Management, dated April 15, 2015.
    69. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit O: Acute Pain Management, dated April 15, 2015.
    70. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit P: Pain Review Course, dated August 20, 2015.
    71. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit Q: Medical Ethics for Physicians, dated August 12, 
2015.
    72. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit R: Opioid Use Disorder, dated August 22, 2015.
    73. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit S: Prescription Opioid: Risk Management and 
Strategies for Safe Use, dated August 22, 2015.
    74. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit T: Family Healing Center community service, dated 
September 16, 2016, for 42 hours.
    75. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit U: Chosen Few/Thin Line Sober Living community 
service, dated September 8, 2016, for 70 hours.
    76. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit V: Chosen Few/Thin Line Sober Living community 
service, dated December 14, 2015, for 54 hours.
    77. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit W: Chosen Few/Thin Line Sober Living community 
service, dated March 22, 201,6 for 16 hours.
    78. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit X: Recovery Can Conquer Home community service, 
dated September 18, 2015, for 24 hours.
    79. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit Y: Recovery Can Conquer Home community service, 
dated December 12, 2015, for 36 hours.
    80. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit Z: The House of Courage community service, dated 
August 25, 2015, for 2 hours.
    81. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit AA: Jubilee House community service, dated 
September 25, 2015, for 13 hours.
    82. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit BB: Jubilee House community service, dated 
December 16, 2015, for 12 hours.
    83. The parties stipulate to the authenticity and admission of 
Respondent's Exhibit CC: Jubilee House community service, dated March 
23, 2016, for 48 hours.

II. Findings of Fact

Respondent's Education, Training and Work Experience
    1. The Respondent graduated from medical school in Nigeria in 1983. 
Tr. 21-22; RE-A, at 1.
    2. Following medical school, the Respondent completed a one year 
rotating internship in one of the busiest hospitals in Nigeria. Tr. 22.
    3. After completing his internship, the Respondent worked as a 
general practitioner for five years before he immigrated to the United 
States. Tr. 22; RE-A, at 2.
    4. The Respondent took over a psychiatric medical practice for two 
years in Nigeria. Tr. 89-90.
    5. The Respondent immigrated to the United States in 1989, and 
after he passed the exam for foreign medical graduates, he began an 
internship in pediatrics at the Medical College of Ohio. Tr. 22-23; RE-
A, at 1.
    6. Upon completion of his internship in Ohio, the Respondent began 
a three-year residency in anesthesiology at Vanderbilt University 
Medical Center, completing the program in 1994. Tr. 23; RE-A, at 1-2.
    7. The Respondent then obtained a fellowship at the University of 
Southern California Medical Center (``USCMC'') and completed a one-year 
obstetrical anesthesia fellowship. Tr. 23; RE-A, at 1.
    8. Following his residency at USCMC, the Respondent was appointed 
as an instructor in anesthesiology and a consultant anesthesiologist at 
the Vanderbilt University Medical Center in 1995-96. Tr. 23-24; RE-A, 
at 1.
    9. Between 1997 and 1999, the Respondent completed a pain 
management fellowship at Emory University Hospital. RE-A, at 1.
    10. From the time that the Respondent was admitted to medical 
practice in the United States until 2007 his primary area of practice 
was anesthesiology. Tr. 26-30.
    11. While practicing anesthesiology, the Respondent has never had 
any malpractice complaints filed against him nor had his employment as 
an anesthesiologist been terminated. Tr. 30-31.
    12. The Respondent was a Diplomate of the American Board of Pain 
Medicine. RE-A, at 1.
    13. The Respondent was board certified in pain management. GE-19, 
at 660, 894.
    14. Beginning in April 2007 the Respondent was employed as a pain 
management specialist and staff anesthesiologist with the Las Vegas 
Pain Institute, where 70% of his practice was pain management. Tr. 31; 
RE-A, at 2.
    15. In 2007, the Respondent started the California Advanced Pain 
Clinic Institute, which was located across the street from the Anaheim 
Memorial Medical Center. Tr. 72-73; RE-A, at 1.
    16. From February 2008 to September 2010, the Respondent worked 
part-time as a staff anesthesiologist at the St. Bernadine Medical 
Center in San Bernardino, CA. The Respondent

[[Page 15806]]

worked part-time at the St. Bernadine Medical Center because he was 
starting a solo practice in pain management at the same time. Tr. 32-
33; RE-A, at 2.
    17. The Respondent stopped working as an anesthesiologist in 
September 2010, because the patients he treated in his pain clinic 
occupied most of his time. Tr. 33.
    18. The Respondent began to make changes in his medical practice in 
2013 after the medical board sent some observers to his clinic to pick 
up patient charts. Tr. 36. At that time, the Respondent started looking 
for someone to take over his pain management practice, and by July 2013 
he had found someone to do that. Tr. 37.
    19. By July 2013, the Respondent was only doing interventional pain 
management in association with Dr. K., who had taken over the 
Respondent's practice. Tr. 38, 98. By then, the Respondent had stopped 
writing new pain prescriptions, though he did fill prescriptions for 
about 10 patients who were already on morphine pumps. Tr. 38.
    20. Also in July 2013, the Respondent completed a 48-hour 
continuing medical education course called Physician Assessment and 
Clinical Education Program (``PACE''), which has been adopted by the 
MBC. Tr. 39; RE-J-K; GE-18, at 9.
    21. In the PACE course, the Respondent studied record keeping; how 
to write proper prescriptions; the essence of controlled substances; 
and prescription-writing ethics. Tr. 39; RE-J-K.
    22. The PACE course also provided instruction in how to identify 
drug seeking patients. Tr. 41.
Undercover Office Visits
    23. The Respondent required each of his pain patients to sign a 
form swearing under penalty of perjury that, ``I am not an undercover 
agent of any law-enforcement. I do no work for the DEA, the FBI, the 
police or any other law enforcement agency.'' GE-14, at 12; GE-15, at 
12; GE-19, at 941.
    24. With respect to the treatment the Respondent provided to the 
undercover patients, he believes he took adequate patient histories, 
but he did not perform appropriate physical exams. Tr. 35-36. The 
Respondent issued prescriptions to those patients based on what he 
thought was appropriate from the information the patients provided him 
in their patient history. Tr. 36.
    25. Regarding UC1, the Respondent gave him a ``short diagnosis,'' 
as he was trained to do in medical school in Nigeria. Tr. 75. UC1 
complained of pain in his arms and legs after exercise, but to the 
Respondent's observation there was nothing significantly wrong with his 
arms and legs. Tr. 76. Therefore, the Respondent did not think UC1 
required a full body exam. Tr. 76.
    26. During his first appointment with the Respondent, UC1 informed 
the Respondent that he was obtaining Vicodin and Adderall from a 
friend. GE-3, at 9. During his second appointment, UC1 informed the 
Respondent that he was obtaining Opana from someone at the gym. GE-5, 
at 5.
    27. The Respondent acknowledged that he did not do a comprehensive 
exam on UC2. Tr. 78.
    28. With respect to UC3, the Respondent testified that he did 
conduct some physical exam of that patient and ``maybe that was why 
they acquitted me of that one.'' Tr. 78. UC3 informed the Respondent 
that he did what he had to do to obtain oxycodone. GE-9, at 4.
    29. At the Respondent's criminal trial, UC3 testified that during 
his first office visit with the Respondent, when the Respondent asked 
him to walk on his toes, he did so in ``the normal way you'd walk on 
your toes.'' GE-19, at 626. UC3 did not walk in a manner to illustrate 
an injury. Id. UC3 testified that the Respondent did not do anything 
else to detect UC3's range of movement or his difficulty with pain. Id.
    30. The Respondent acknowledged that his treatment of UC3 fell 
below acceptable medical standards. Tr. 85.
    31. The Respondent acknowledged that the prescriptions that he 
wrote to UC3 on March 21, 2013, and April 25, 2013, were issued for no 
legitimate medical purposes and were outside the usual course of 
professional practice. Tr. 111.
The Respondent's Convictions
    32. On October 9, 2013, a Felony Complaint and Arrest Warrant was 
filed against the Respondent. GE-16, at 3. The Respondent was charged 
with eight felony counts regarding prescribing scheduled drugs. Tr. 44.
    33. On October 15, 2013, the Respondent was arrested and his arrest 
was covered by the Los Angeles Times. Tr. 52; GE-16, at 3.
    34. On May 14, 2015, the Respondent was convicted of seven of those 
original eight felony counts. Tr. 44; GE-19, at 1161-1167.
    35. When the Respondent was sentenced on March 28, 2016, the trial 
judge reduced the felony charges to misdemeanors, and the Respondent 
was placed on 36 months of probation. Tr. 55; GE-21, at 1-2.
    36. The Respondent testified that the sentencing judge did not 
restrict the Respondent's ability to practice medicine, stating that 
the judge left that to the MBC. Tr. 56. The Finding of Fact contained 
in the MBC's Interim Order of Suspension, however, indicates that the 
court ``ordered Respondent `not to practice medicine until an order has 
been made by the Medical Board with respect to your ability to do so in 
the State of California.''' GE-17, at 2.
    37. The Respondent has taken several continuing medical education 
courses, to include: Pain management review courses; a course presented 
by the American Academy of Addiction Psychiatry; a 16-hour course 
concerning the problems of substance abuse; a medical ethics course; 
and a course prescribed by courts to alcohol and drug crime clients. 
Tr. 43. Most of these courses were completed in 2015 after the 
Respondent was convicted. RE-M, P, R-S. The Respondent completed two of 
these courses in 2015 prior to his conviction. RE-N-O, Q.
    38. The Respondent was also sentenced to perform 130 hours of 
community work. Tr. 45. The Respondent chose to perform those hours 
working with patients who suffered from addiction problems. Tr. 45.
    39. The Respondent performed 353 community service hours to show 
his remorse. Tr. 45-46.
    40. Some of the Respondent's community service hours were performed 
with a psychiatrist in an addiction medicine practice where the 
Respondent observed, educated, and talked to patients who came to the 
psychiatry addiction clinic. Tr. 46. The Respondent shared his story 
with those patients concerning his arrest. Tr. 46.
    41. The Respondent also performed community service hours at sober 
living facilities where he counseled those with addictions and 
instructed on the dangers of addiction by using a PowerPoint 
presentation. Tr. 47-51. The Respondent also helped to maintain the 
cleanliness of the facilities. Tr. 47-51.
    42. The physicians the Respondent worked with, to include those who 
wrote letters of recommendation on his behalf, are all aware that he 
was arrested. Tr. 52-54; RE-B-I. Most of these letters are dated in 
2013. Id.
    43. Representatives from the various organizations at which the 
Respondent performed his community service hours also wrote letters in 
support of the Respondent. RE-T-CC.
    44. The Respondent's probation *[with Superior Court was scheduled 
to expire] in March 2019. Tr. 56.

[[Page 15807]]

The Stipulated Settlement
    45. The Respondent entered into a Stipulated Settlement 
(``Settlement'') with the MBC on December 20, 2016, with an effective 
date of January 19, 2017. Tr. 57-58; GE-18, at 1. The Settlement allows 
the Respondent to practice medicine, but prohibits him from writing 
prescriptions for Schedule II and Schedule III controlled substances. 
Tr. 57; GE-18, at 4. The Settlement, however, allows the Respondent to 
use controlled substances in any Schedule, including II and III, while 
practicing anesthesia in an operating room or surgical center. Tr. 57; 
GE-18, at 4. The Settlement placed the Respondent on probation for 
seven years. Tr. 58; GE-18, at 4.
    46. The Respondent understands that if he were to write a 
prescription for a Schedule II or a Schedule III controlled substance 
his California medical license could be revoked. Tr. 62.
    47. The State of California can run a ``CURES'' report anytime to 
monitor prescriptions the Respondent may write. Tr. 61.
    48. The Respondent has not written any prescription for Schedule II 
or III drugs since he was placed on probation by the MBC. Tr. 61-62.
    49. The Settlement does not state that the Respondent can only 
practice medicine in California. Tr. 119.
    50. The Respondent testified that he is in compliance with his 
probation with the MBC, as well as with his probation with the Superior 
Court of California. Tr. 62.
    51. The Settlement, however, requires the Respondent to report any 
practice of medicine outside of California to the MBC. Tr. 134; GE-18, 
at 13.* [It is noted that at hearing the Respondent's attorney argued 
that the Settlement only required such notification to the MBC after a 
certain period of days. Tr. 136. The Settlement does include a thirty-
day minimum time period for intent to move or travel to another state 
to trigger the notification requirement, and it is not entirely clear 
from the language in the Settlement whether or not that time period 
applies to practicing medicine in another state in the subsequent 
paragraph; however, the Respondent testified that he moved in February, 
when he changed his address with the DEA, and he prescribed in Texas on 
April 28, 2017, so it appears that the timeframe of both his stay and 
his practice of medicine in Texas exceeded thirty days, triggering the 
notification requirement to the MBC in the Settlement. Tr. 93, GE-23 
and GE-24.] The Respondent did not report that he had been practicing 
medicine outside of California. Tr. 119, 134.
    52. The Respondent submitted a quarterly report to the MBC, but it 
arrived late. Tr. 119; GE-18, at 12.
    53. The MBC required that the Respondent take a course concerning 
medical ethics, which he completed in April 2017. Tr. 92; GE-18, at 8; 
RE-L.
    54. The Settlement requires that the Respondent either have a 
practice monitor, who would provide quarterly evaluations to the MBC of 
the Respondent's medical practice or, in lieu of a monitor, the 
Respondent could participate in a sanctioned professional enhancement 
program. GE-18, at 11.
    55. The Respondent is not currently practicing medicine because he 
had a stroke in January 2016, and he is waiting for a letter that says 
that he is medically qualified to resume his practice in 
anesthesiology. Tr. 60. The Respondent was informed by his neurologist 
that he could not find any residual deficits as a result of the stroke. 
Tr. 60. The Respondent does not currently have a practice manager 
assigned because he is not currently practicing medicine. Tr. 59-60.
Texas Allegations
    56. The Respondent has been licensed to practice medicine in Texas 
since 1998 and he went there in 2017 to find an anesthesiology job. Tr. 
65-66. The Respondent found an anesthesia job in Texas, but once his 
employer learned of the Respondent's background, the employer stopped 
inviting him to participate in the care of its patients. Tr. 65-66.
    57. The Respondent requested that DEA change his mailing address in 
February 2017 from California to Texas. Tr. 95, 115.
    58. The Respondent's request to change his mailing address from 
California to Texas was approved by DEA. Tr. 115.
    59. The Respondent opened a medical practice in Texas in March 
2017. Tr. 95. The heading on the prescription pad for the Respondent's 
office in Texas reads, ``El Paso Advanced Pain Institute.'' GE-23, at 
2.
    60. The Respondent testified that he assumed that the DEA had 
approved his request to change the address of his COR to Texas, but 
that he has no plans to move to Texas. Tr. 68, 93.
    61. Before the Respondent started issuing prescriptions in Texas, 
he called the pharmacy that would be filling the prescription and the 
pharmacy told the Respondent it was okay. Tr. 96. The Respondent 
testified that he believed that he successfully changed the address of 
his COR in February 2017, before he issued the prescriptions in Texas. 
Tr. 97-98, 103-07.
    62. The Respondent wrote prescriptions for Lyrica, a Schedule V 
controlled substance, for three patients who had been on Schedule II 
controlled substances in an effort to get them off of Schedule II 
controlled substances. Tr. 66, 121, 125. These prescriptions were 
written in April and March* [correction] 2017. GE-23 and GE-24.
    63. The pharmacist-in-charge of ASP Cares Pharmacy indicated that 
the prescription was written from a pain clinic across the street from 
the pharmacy. Tr. 117-18.
    64. Lyrica is not the type of controlled substance that, by itself, 
would raise a red flag for a pharmacist. Tr. 128-129.
    65. The Respondent requested a change in the registered location 
for his COR in May 2017 upon his application for renewal. Tr. 116, 127.
    66. The Respondent's request to change the location of his COR is 
still pending, and the Respondent does not have any DEA authority in 
Texas. Tr. 116.
    Additional facts required to resolve the issues in this case are 
included in the Analysis section of this Recommended Decision.

Analysis

    To revoke a respondent's registration, the Government must prove, 
by a preponderance of the evidence, that the regulatory requirements 
for revocation are satisfied. Steadman v. SEC, 450 U.S. 91, 100-02 
(1981); 21 CFR 1301.44(e).*G Under 21 U.S.C. 824(a)(4), the 
DEA may revoke a registrant's COR if the registrant acted in a way that 
renders continued registration ``inconsistent with the public 
interest.'' The DEA considers the following five factors to determine 
whether continued registration is in the public interest:
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    *G See also Director, Office of Workers' Compensation 
Programs, Dep't of Labor v. Greenwich Collieries, 512 U.S. 267, 277 
(1994) (affirming Steadman's interpretation of the Administrative 
Procedure Act standard of proof as the preponderance of evidence 
standard and clarifying that the ``burden of proof'' in 5 U.S.C. 
556(d) refers to the burden of persuasion).

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The [registrant's] experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The [registrant's] conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.

[[Page 15808]]

    (5) Such other conduct which may threaten the public health and 
safety.\8\
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    \8\ The Government has not made any Factor Five allegations 
against the Respondent.

21 U.S.C. 823(f).
    These public interest factors are considered separately. See Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a 
case-by-case basis. Morall v. Drug Enf't Admin., 412 F.3d 165, 173-74 
(D.C. Cir. 2005). Any one factor, or combination of factors, may be 
decisive. David H. Gillis, M.D., 58 FR 37507, 37508 (1993). Thus, there 
is no need to enter findings on each of the factors. Hoxie v. Drug 
Enf't Admin., 419 F.3d 477, 482 (6th Cir. 2005). Further, there is no 
requirement to consider a factor in any given level of detail. Trawick 
v. Drug Enf't Admin., 861 F.2d 72, 76-77 (4th Cir. 1988). When deciding 
whether registration is in the public interest, the totality of the 
circumstances must be considered. See generally Joseph Gaudio, M.D., 74 
FR 10083, 10094-95 (2009).
    The Government bears the initial burden of proof, and must justify 
revocation by a preponderance of the evidence. See Steadman, 450 U.S. 
at 100-03. If the Government makes a prima facie case for revocation, 
the burden of proof shifts to the registrant to show that revocation 
would be inappropriate.*H Medicine Shoppe--Jonesborough, 73 
FR 364387 (2008). A registrant may prevail by successfully attacking 
the veracity of the Government's allegations or evidence. 
Alternatively, a registrant may rebut the Government's prima facie case 
for revocation by accepting responsibility for wrongful behavior and by 
taking remedial measures to ``prevent the re-occurrence of similar 
acts.'' Jeri Hassman, M.D., 75 FR 8194, 8236 (2010) (citations 
omitted). In addition, when assessing the appropriateness and extent of 
sanctioning, the DEA considers the egregiousness of the offenses and 
the DEA's interest in specific and general deterrence. David A. Ruben, 
M.D., 78 FR 38363, 38385 (2013).
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    *H I am clarifying this statement slightly. DEA 
caselaw has stated that the burden shifts to the Respondent to 
``show why its continued registration would nonetheless be 
consistent with the public interest.'' Medicine Shoppe--
Jonesborough, 73 FR 364387 (2008) (collecting cases). DEA caselaw 
has further explained that where the Government has established 
grounds for revocation by a preponderance of the evidence, the 
Respondent must ``present[ ] sufficient mitigating evidence'' to 
show why he can be entrusted with a new registration. Samuel S. 
Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 
21931, 21932 (1988)).
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I. The Government's Position

    The Government submitted its Proposed Findings of Fact and 
Conclusions of Law (``Government's Brief'') on August 11, 2017.\9\ Of 
note, the Government's proposed findings of fact are primarily based 
upon the stipulations the Respondent entered into prior to the hearing, 
which, the Government argues, established a prima facie case for 
revocation of the Respondent's COR. ALJ-37, at 1-8. Based upon the 
evidence presented, the Government seeks to revoke the Respondent's COR 
based upon Factors Two, Three, and Four. ALJ-37, at 8. Under Factors 
Two and Four, the Government argues that the unlawful prescriptions 
that the Respondent wrote to three undercover investigators and those 
he wrote in Texas, where he does not have a DEA registration warrant 
the revocation of the Respondent's COR. ALJ-37, at 8-9. Under Factor 
Three, the Government argues that the Respondent's California 
conviction of seven counts of unlawfully issuing prescriptions for 
controlled substances also serves as a basis for revocation and ``adds 
to the gravity of the Respondent's conduct.'' \10\ ALJ-37, at 9-10.
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    \9\ The Government's Brief has been marked as ALJ-37.
    \10\ The Respondent's convictions are based upon the same 
conduct as is alleged in paragraphs 3a-3e of the OSC. ALJ-1, at 2-3. 
Accordingly, I do not find that the Respondent's convictions add 
``gravity'' to his conduct. The allegations are essentially 
multiplicitous.
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    The Government also argues that the Respondent has not 
unequivocally accepted responsibility for his conduct. ALJ-37, at 10-
12. While acknowledging that the Respondent had generally accepted 
responsibility, the Government argued that the Respondent vacillated on 
whether the prescriptions he had written to UC3 were improper. ALJ-37, 
at 10. In addition, the Respondent testified that he believed he had 
authority to write the prescriptions he wrote in Texas. ALJ-37, at 11. 
In support of its position that a registrant's acceptance of 
responsibility must be unequivocal the Government cited to numerous 
cases, to include: Daniel A. Glick, D.D.S., 80 FR 74800, 74801 (2015); 
Hatem M, Ataya, M.D., 81 FR 8221, 8242 (2016); and MacKay v. Drug Enf't 
Admin., 664 F.3d 808, 820 (10th Cir. 2011). ALJ-37, at 11-12.
    Finally, the Government argues that, even if the Respondent were 
found to have accepted full responsibility, revocation would still be 
appropriate in this case to deter others. ALJ-37, at 12. In support of 
this position, the Government cites to Peter F. Kelly, D.P.M., 82 FR 
28676, 28691 (2017). ALJ-37, at 12. The Government also argues that 
``[i]n the midst of the current opioid crisis, violations of the 
prescribing requirements such as occurred here should result in 
revocation of the underlying registration.'' \11\
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    \11\ The Government's position suggests that had the Respondent 
engaged in the same conduct, but there was no opioid crisis, that 
that same conduct might not merit revocation. For that reason, I 
reject the suggestion that a registrant should lose his or her 
registration based on whether the nation is in an opioid crisis or 
not. *[Although I agree with ALJ Dorman on this point, I do not wish 
to imply that the opioid crisis is never properly considered by DEA 
in enforcing the Controlled Substances Act.]
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II. The Respondent's Position

    The Respondent submitted his closing statement (``Respondent's 
brief'') on August 25, 2017.\12\ The overall theme of the Respondent's 
brief is that he has accepted responsibility for his actions and has 
taken numerous remedial steps to ensure he does not again violate the 
Controlled Substances Act (``CSA''). Noting that the Respondent's 
medical practice since 1993 had centered around anesthesiology in a 
hospital setting, he argues that when it came to treating pain patients 
he ``may have been a na[iuml]ve physician who was not fully prepared to 
deal with patients who may be drug seeking. He relied on what his 
patients told him, rather than conduct examinations to corroborate 
those statements.'' ALJ-38, at 2.
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    \12\ The Respondent's Brief has been marked as ALJ-38. I note 
that the Respondent's brief was filed nine days late and it is not 
in conformance with 21 CFR 1316.64, which requires ``specific and 
complete citations of the pages of the transcript and exhibits.'' 
Nevertheless, I have considered the Respondent's Brief.
---------------------------------------------------------------------------

    The Respondent correctly argues that revocation of a DEA 
certificate of registration is not mandatory for violations of 21 
U.S.C. 824(a)(4). The Respondent then, incorrectly, argues that 21 
U.S.C. 824(a)(4) is the only section that the Government is relying 
upon in its request for revocation. ALJ-38, at 3-4. In fact, the 
Respondent goes on to analyze this case under the five factors of 21 
U.S.C. 823(f). ALJ-38, at 4-8.
    The Respondent suggests that Factor One weighs in his favor. He 
notes that after the MBC reviewed all the facts of his case it 
determined that ``public safety would be met by allowing [the 
Respondent] to continue to practice medicine, specifically, 
anesthesiology . . . .'' ALJ-38, at 4-5. With respect to Factor Two, 
the Respondent notes that he has not had ``any discipline or issues 
with his practicing anesthesiology.'' ALJ-38, at 5. The Respondent 
argues that the only legal issues he has dealt with related to his 
practice of outpatient pain management, asserting that he will no 
longer be practicing in that area. ALJ-38, at 5.

[[Page 15809]]

    Under Factor Three, the Respondent argues that the reduction of his 
felony convictions to misdemeanors suggests that his ``conduct and/or 
intention was not as aggravated as those of other physicians who are 
prosecuted.'' \13\ ALJ-38, at 6. Again the Respondent notes that the 
convictions were the result of his practicing pain management and not 
anesthesiology. He argues that his ``conduct was not one of greed or 
intentional wrongdoing rather inexperience and na[iuml]vet[eacute] . . 
. .'' ALJ-38, at 6.
---------------------------------------------------------------------------

    \13\ This statement is not supported by any evidence in the 
record. Furthermore, even if true, it is irrelevant.
---------------------------------------------------------------------------

    With respect to Factor Four, the Respondent argues that he has been 
fully compliant with all state, federal, and local laws concerning the 
handling of controlled substances since he was arrested. The Respondent 
further argues that the allegation that he wrote prescriptions in Texas 
without authority from the DEA is ``unclear at best . . . and not 
supported by any evidence.'' ALJ-38, at 7. Finally, with respect to 
Factor Five, the Respondent asserts that there is no other evidence 
that he is a danger to the public. ALJ-38, at 8.
    The Respondent's brief concludes with a discussion of acceptance of 
responsibility and mitigation. ALJ-38, at 8-10. He argues that he has 
taken full responsibility for his actions, noting the stipulations he 
entered into with the MBC and during these proceedings. ALJ-38, at 9. 
The Respondent argues that since his ``arrest he has made strong and 
concerted efforts to show his remorse and take full responsibility for 
his actions.'' \14\ ALJ-38, at 8. With respect to mitigation, the 
Respondent ``has performed over 300 hours of community service in sober 
living homes, he has completed continuing education in the area of 
substance abuse and prescribing and he has abided by all that has been 
asked of him.'' ALJ-38, at 9.
---------------------------------------------------------------------------

    \14\ This is not an accurate statement. At his criminal trial, 
the Respondent pled not guilty and testified that the exams he 
conducted on the three undercover investigators were sufficient and 
that he had been betrayed by the undercover investigators. GE-19, at 
905-07. That hardly seems like taking full responsibility for his 
actions after his arrest. Even at the hearing before me, the 
Respondent was reluctant to take responsibility for the unlawful 
prescriptions he issued to UC3 because he had been found not guilty 
of prescribing oxycodone to him.
---------------------------------------------------------------------------

    The Respondent argues that the evidence of record is sufficient to 
allow for the exercise of discretion to conclude that public safety 
would not be endangered by allowing him to retain his COR. ALJ-38, at 
9-10. Significantly, the Respondent cites to the action of the MBC, 
which has allowed him to continue practicing medicine as an 
anesthesiologist. ALJ-38, at 10. He notes that the function of the MBC 
is similar to that of the DEA, to ensure public safety. ALJ-38, at 10.

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

    The Respondent suggests that Factor One weighs in his favor because 
the MBC entered into a stipulated settlement wherein the Respondent has 
been allowed to continue his medical practice, but he may not prescribe 
schedule II or III controlled substances, and may only administer them 
while practicing anesthesiology in a hospital or licensed surgical 
center. ALJ-38, at 4; GE-18, at 5. In addition, the stipulated 
settlement placed the Respondent on probation for seven years. Id. *[I 
am omitting some language from the RD and adding the below until the 
end of this section, to clarify the analysis of Factor One.
    In determining the public interest, the ``recommendation of the 
appropriate State licensing board or professional disciplinary 
authority . . . shall be considered.'' 21 U.S.C. 823(f)(1). Two forms 
of recommendations appear in Agency decisions: (1) A recommendation to 
DEA directly from a state licensing board or professional disciplinary 
authority (hereinafter, appropriate state entity), which explicitly 
addresses the granting or retention of a DEA COR; and (2) the 
appropriate state entity's action regarding the licensure under its 
jurisdiction on the same matter that is the basis for the DEA 
OSC.*I See, e.g., Vincent J. Scolaro, D.O., 67 FR 42,060, 
42,065 (2002) (``While the State Board did not affirmatively state that 
the Respondent could apply for a DEA registration, [the ALJ] found that 
the State Board by implication acquiesced to the Respondent's 
application because the State Board has given state authority to the 
Respondent to prescribe controlled substances.''). However, some more 
recent Agency decisions could be read to imply that Factor One should 
be more narrowly focused on recommendations from the appropriate state 
entity that specifically address the registrant's DEA COR; therefore, I 
am providing some clarification to the Agency's consideration of Factor 
One below. See Garrett Howard Smith, M.D., 83 FR 18882 n.30 (2018).
---------------------------------------------------------------------------

    *I Regarding Factor One, I am distinguishing the fact 
findings of an appropriate state entity from the ultimate 
recommendation of such entity, the latter of which is relevant under 
Factor One. But see Ralph J. Chambers, M.D., 79 FR 4962, 4970 (2014) 
(stating that the possession of state ``authority is not dispositive 
of the public interest'' but then discussing under Factor One the 
rationale for not relying on the fact findings of the board). The 
fact findings themselves are more appropriately considered under 
other public interest factors.
---------------------------------------------------------------------------

    ``Interpretation of a statute must begin with the statute's 
language.'' Mallard v. U.S. Dist. Court, 490 U.S. 296, 300-301 (1989) 
(citing e.g., United States v. Ron Pair Enterprises, Inc., 489 U.S. 
235, 241 (1989); Landreth Timber Co. v. Landreth, 471 U.S. 681, 685 
(1985)). The dictionary indicates a breadth of possible interpretations 
of ``recommend,'' the root word of ``recommendation'' in 21 U.S.C. 
823(f)(1), including: ``(1)(a) to present as worthy of acceptance or 
trial; (1)(b) to endorse as fit, worthy, or competent; (2) entrust, 
commit (3) to make acceptable; (4) to suggest an act or course of 
action.'' ``Recommend.'' Merriam-Webster's Online Dictionary. 2020. 
https://www.merriam-webster.com/dictionary/recommend (last visited Feb. 
4, 2020). Most of the entries would appear to encompass the action of 
the appropriate state entity were it to present the practitioner as 
worthy of acceptance for a DEA COR, make the practitioner acceptable 
for a DEA COR in retaining the state authority or even to continue to 
entrust the practitioner with state controlled substance authority 
after considering the facts that provide the basis for DEA action. 
These definitions could easily encompass the actions of the appropriate 
state entity on the state licensure. Only the fourth entry would 
support a reading that would require the appropriate state entity to 
explicitly recommend a course of action regarding the DEA COR, and even 
that definition implies some latitude in specificity in using the term 
``suggest.'' Additionally, if the agency were to limit consideration 
under Factor One to specific recommendations about DEA registrations, 
the practical implementation of such a narrow interpretation would 
likely read out the applicability of the Factor in its entirety, as 
very few cases contain such specific recommendations.*\J\ See e.g., 
Tyson D.

[[Page 15810]]

Quy, M.D., 78 FR 47,412, 47,417; Vincent J. Scolaro, D.O., 67 FR at 
42,065; but see, John Porter Richards, D.O., 61 FR 13,878, 13,879 
(1996) (wherein the West Virginia Board sent a letter supporting the 
respondent's application for a DEA COR, which the Administrator 
considered under Factor One along with the actions of the disciplinary 
boards in two states).
---------------------------------------------------------------------------

    *\J\ It is unclear whether many appropriate state entities would 
have the requisite authority to provide a specific recommendation 
regarding a DEA registration, and practically, how they would obtain 
a full view of the facts and legal bases underlying the OSC in order 
to provide such a specific recommendation. Additionally, a narrow 
interpretation of Factor One could present challenges across the 
wide variety of state statutory authorities. See Scott D. Fedosky, 
M.D., 76 FR 71375 (2011) (finding that the ``vote[ ] to allow [the 
respondent] to apply for a new DEA registration'' of the Arkansas 
State Medical Board did not constitute a specific 
``recommendation,'' because it did not include any advice about 
whether DEA should grant the application).
---------------------------------------------------------------------------

    The available legislative history supports the Agency's broader 
reading of ``recommendation.'' *\K\ The public interest factors for 
practitioners' applications for registration were added to Section 823 
in 1984. Controlled Substances Penalties Amendments Act of 1984, Public 
Law 98-473, 511, 98 Stat. 1837, 2073 (1984) (codified at 21 U.S.C. 
823(f)(1)-(5)). Prior to the addition of these public interest factors, 
practitioner applicants would be granted a registration if they were 
``authorized to dispense . . . [controlled substances] under the law of 
the State in which they practice[d].'' Controlled Substances Act, 
Public Law 91-513, 303, 84 Stat. 1236, 1255 (1970) (codified at 21 
U.S.C. 823(f)). The Senate Report explained that ``because of a variety 
of legal, organizational, and resource problems, many states are unable 
to take effective or prompt action against violating registrants.'' 
*\L\ Senate Report, at 266, 1984 U.S.C.C.A.N., at 3448. After pointing 
out that the practitioner public interest factors are ``similar to 
those applicable under current law to registration applications on the 
part of the manufacturers and distributors of controlled substances,'' 
the Senate Report noted that ``the amendment would continue to give 
deference to the opinions of the state licensing authorities,'' because 
of the inclusion of Factor One. Senate Report, at 267, 1984 
U.S.C.C.A.N., at 3449; see also Oregon v. Ashcroft, 368 F.3d 1118, 1122 
(9th Cir. 2004) (quoting the Senate Report). The breadth of the 
intended meaning of ``recommendation'' is further explained in a Senate 
Report footnote describing Factor One: ``it would no longer be 
necessary that the state authority have in fact revoked the 
practitioner's license or registration before federal registration 
could be denied.'' Senate Report, at 266 n.36, 1984 U.S.C.C.A.N., at 
3448 n.36. In other words, the Senate Report acknowledges both that an 
appropriate state entity's ``recommendation'' precedes the effective 
date of any revocation, and makes clear that the addition of Factor One 
directs the Agency's focus to an existing ``recommendation,'' separate 
from any finalized revocation.
---------------------------------------------------------------------------

    *\K\ There is no conference report specifically for the 
Comprehensive Crime Control Act of 1984. It was passed as part of 
Public Law 98-473, the 1985 Continuing Appropriations Act. The 
controlled substances-related provisions of that law were taken from 
S. 1762 as reported by the Senate Judiciary Committee and addressed 
in Senate Report No. 98-225 (1983), reprinted in 1984 U.S.C.C.A.N. 
3182 (hereinafter, Senate Report).
    Part B of Title V of the Comprehensive Crime Control Act of 1984 
is called the ``Diversion Control Amendments.'' According to the 
Senate Report's discussion of Title V, between 60% and 70% of all 
drug-related deaths and injuries ``involve drugs that were 
originally part of the legitimate drug production and distribution 
chain.'' Senate Report, at 260, 1984 U.S.C.C.A.N., at 3442. In 
addition, according to the Senate Report, ``diversion of legally 
produced drugs often evidences the same sort of large-scale 
trafficking more commonly associated with the trade in wholly 
illicit drugs.'' Id. To illustrate this finding, the Senate Report 
cites ``Operation Script'' in which twenty-one practitioners 
registered to dispense controlled substances were ``responsible for 
the diversion of approximately 21.6 million dosage units of 
controlled substances.'' Senate Report, at 261, 1984 U.S.C.C.A.N., 
at 3443.
    *\L\ The Senate Report also stated that the ``limited grounds 
for revoking or denying a practitioner's registration have been 
cited as contributing to the problem of diversion of dangerous 
drugs.'' Senate Report, at 266, 1984 U.S.C.C.A.N., at 3448.
---------------------------------------------------------------------------

    Further, I agree with prior Agency decisions' functional reading of 
``recommendation.'' In Vincent J. Scolaro, D.O., for example, the 
Agency carefully analyzed the respondent's interactions with the state 
licensing board, law enforcement, and other offices. 67 FR at 42060-65. 
Based on this analysis, my predecessor determined that the state 
licensing board ``implicitly'' agreed that respondent was ready for a 
DEA registration. 67 FR at 42065. In other words, it would be contrary 
to the amended language to not at least consider the actions of an 
appropriate state entity on the same matters, particularly where it 
rendered an opinion regarding the practitioner's medical practice in 
the state due to the same facts alleged in the DEA OSC. Id.*\M\ 
Although statutory analysis may not definitively settle this matter, 
the most impartial and reasonable course of action is to continue to 
take into consideration all actions indicating a recommendation from an 
appropriate state. See Volkman v. Drug Enf't Admin., 567 F.3d 215, 222 
(6th Cir. 2009) (the Administrator can `` `give each factor the weight 
[he] determines is appropriate.' '' (quoting Hoxie v. Drug Enf't 
Admin., 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. Drug 
Enf't Admin., 412 F.3d 165, 173-74 (D.C. Cir. 2005).
---------------------------------------------------------------------------

    *\M\ It is noted that Agency decisions have long held that in 
considering Factor One, the appropriate state entity's actions are 
distinct from its inactions--an interpretation which is supported by 
both a reading of the active word ``recommend,'' and the rationale 
given by the Senate Report for adding the public interest factors. 
See Ajay S. Ahuja, M.D., 84 FR 5479, 5490 (2019) (finding that 
``where the record contains no evidence of a recommendation by a 
state licensing board that absence does not weigh for or against 
revocation.''); see also MacKay v. Drug Enf't Admin., 664 F.3d 808, 
817-819 (10th Cir. 2011) (noting that the Agency decision found that 
the lack of action from an appropriate state entity was not a 
recommendation under Factor One and holding that the Deputy 
Administrator did not misweigh the public interest factors).
---------------------------------------------------------------------------

    In this case, the MBC has not made a direct recommendation to the 
Agency regarding whether the Respondent's COR should be suspended or 
revoked.*\N\ As already discussed, after suspending the Respondent's 
medical license and continuing the suspension after a hearing before a 
state Administrative Law Judge, the MBC entered into a stipulated 
settlement allowing Respondent to continue his medical practice and, 
regarding controlled substances, allowing Respondent to administer only 
schedule II or III controlled substances while practicing 
anesthesiology in a hospital or licensed surgical center. GE-18; ALJ-
38. Older Agency decisions can be read to give more than nominal weight 
in the public interest determination to a state's decision to restore 
or maintain a practitioner's authority to dispense controlled 
substances. Brian Thomas Nichol, M.D., 83 FR 47352, 47362 (collecting 
cases) (2018). However, these cases do not change longstanding federal 
law that it is the Administrator who makes a determination of whether 
granting a COR is in the public interest as defined by the CSA. Ajay S. 
Ahuja, M.D., 84 FR at 5490.
---------------------------------------------------------------------------

    *\N\ The Government called an investigator for the California 
Department of Consumer Affairs to provide official testimony during 
the hearing. Tr. 129-35. That testimony, however, was not a 
recommendation from the Board.
---------------------------------------------------------------------------

    It is noted that the Board's reinstatement of Respondent's medical 
license in California was severely limited in the stipulated 
settlement, including compliance with seven years of probation, which 
does not indicate a substantial amount of trust in the Respondent. See 
ALJ-38, at 5. Finally, the Board's settlement on January 19, 2017, 
predated the March and April 2017 instances where the Respondent wrote 
prescriptions without a valid DEA COR for a Texas location, and 
therefore, the Board's decision did not encompass all of the 
allegations and facts that are before this Agency. See GE-23 and GE-24; 
GE 18. Accordingly, the terms of the MBC's stipulated settlement with 
the Respondent are not dispositive of the public interest inquiry in 
this case, and although I have considered it in favor of the 
Respondent, it is also minimized by the circumstances described above. 
See

[[Page 15811]]

Brian Thomas Nichol, M.D., 83 FR at 47,362-63.]

IV. Factors Two and Four: The Respondent's Experience in Dispensing 
Controlled Substances and Compliance With Applicable State, Federal, or 
Local Laws Relating to Controlled Substances *O
---------------------------------------------------------------------------

    *\O\ I have omitted the first paragraph of the ALJ's analysis of 
Factors 2 and 4, because I found it unnecessary to my analysis of 
the factors under the caselaw.
---------------------------------------------------------------------------

    The Government alleges that revocation of the Respondent's COR is 
appropriate under Factors Two and Four because the Respondent: (1) 
Issued unlawful prescriptions to three undercover investigators on five 
separate occasions; and (2) wrote three prescriptions for a controlled 
substance out of an office he maintained in Texas, even though he did 
not have a DEA COR for that office. The Government further alleges that 
by writing the prescriptions to the undercover investigators the 
Respondent violated 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a); Cal. Health 
& Safety Code Sec.  11153(a); and Cal. Bus. & Prof. Code Sec. Sec.  
725(a), 2241(b), 2241.5(c), and 2242(a). In addition, the Government 
alleges that by writing the three prescriptions in Texas the Respondent 
violated 21 U.S.C. 822(e) and 21 CFR 1301.12(a) and (b)(3).
    Under the CSA, it is unlawful for a person to distribute controlled 
substances, except as authorized under the CSA. 21 U.S.C. 841(a)(1). To 
combat drug abuse and trafficking of controlled substances, ``Congress 
devised a closed regulatory system making it unlawful to manufacture, 
distribute, dispense, or possess any controlled substance except in a 
manner authorized by the CSA.'' Gonzales v. Raich, 545 U.S. 1, 13 
(2005). To maintain this closed regulatory system, controlled 
substances may only be prescribed if a DEA registrant writes a valid 
prescription. Carlos Gonzalez, M.D., 76 FR 63118, 63141 (2011). As the 
Supreme Court explained, ``the prescription requirement . . . ensures 
that patients use controlled substances under the supervision of a 
doctor so as to prevent addiction and recreational abuse. As a 
corollary, [it] also bars doctors from peddling to patients who crave 
the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. at 
274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 
(1975)).
    A controlled substance prescription is not valid unless it is 
``issued for a legitimate medical purpose by an individual practitioner 
acting in the usual course of his professional practice.'' 21 CFR 
1306.04(a). Federal regulations further provide that ``[a]n order 
purporting to be a prescription issued not in the usual course of 
professional treatment . . . is not a prescription within the meaning 
and intent of [21 U.S.C. 829] and . . . the person issuing it, shall be 
subject to the penalties provided for violations of [controlled 
substance laws].'' Id.; see 21 U.S.C. 842(a)(1) (establishing that, 
under the CSA, it is illegal for a person to distribute or dispense 
controlled substances without a prescription, as is required under 21 
U.S.C. 829).
    Much like the federal regulations, the California Health and Safety 
Code, Section 11153(a), provides, in part, that, ``[a] prescription for 
a controlled substance shall only be issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
or her professional practice.'' Further, Section 2242(a) of the 
California Business and Professions Code states that, ``[p]rescribing, 
dispensing, or furnishing dangerous drugs . . . without an appropriate 
prior examination and a medical indication, constitutes unprofessional 
conduct.'' Id. Section 725(a) provides that it is considered to be 
unprofessional conduct for a physician to engage in ``repeated acts of 
clearly excessive prescribing.'' Id. * [I am omitting the ALJ's finding 
of a violation of state law under Cal. Bus. & Prof. Code Sec.  2241(b). 
See Original RD, at 40. Section 2241 is generally permissive and sets 
forth the circumstances under which a practitioner may prescribe, 
dispense or administer to an addict for treatment of substance abuse. 
2241(b) provides that ``[n]othing in this subdivision shall authorize a 
physician and surgeon to prescribe, dispense, or administer dangerous 
drugs or controlled substances to a person he or she knows or 
reasonably believes is using or will use the drugs or substances for 
non medical purposes.'' Cal. Bus. & Prof. Code Sec.  2241(b) (Westlaw, 
current with all laws through Ch. 870 of 2019 Regular Session). I 
cannot find any evidence that this subdivision is intended to provide a 
separate violation of law. The underlying violation for prescribing 
``not in the course of professional treatment or as part of an 
authorized narcotic treatment program,'' was already alleged in the OSC 
in Cal. Health & Safety Code Sec.  11153(a). Therefore, I find that 
although Cal. Bus. & Prof. Code Sec.  2241(b) is useful in determining 
whether a violation of Cal. Health & Safety Code Sec.  11153(a) *\P\ 
has occurred, it does not provide for a separate violation in and of 
itself.] Additionally, Section 2241.5(c) of the Cal. Bus. & Prof. Code 
is merely an administrative provision concerning the authority of the 
MBC. Cal. Bus. & Prof. Code Sec.  2242(a) (Westlaw, current with 
urgency legislation through Ch 706 of the 2019 Regular Session). 
*[Although I am not sustaining state law violations for Sections 
2241.5(c) or 2241(b) of the Cal. Bus. & Prof. Code, the Respondent's 
multiple blatant violations of Cal. Health & Safety Code Sec.  
11153(a), eight of which were the basis for his conviction in state 
court, are more than enough to demonstrate violations of state law and 
weigh heavily in favor of revocation. See GE-20 (Respondent's 
Conviction).]
---------------------------------------------------------------------------

    *\P\ It also appears that the Government could have alleged 
violations of Cal. Health & Safety Code Sec.  11156, which states 
that ``[e]xcept as provided in Section 2241 of the Business and 
Professions Code, no person shall prescribe for, or administer, or 
dispense a controlled substance to, an addict, or to any person 
representing himself or herself as such.'' See Daniel Brubaker, 
D.O., 77 FR 19322, 19328.
---------------------------------------------------------------------------

* [Omitted sentences for brevity].
    DEA recognizes several methods to show that a registrant wrote 
prescriptions without a legitimate medical purpose and outside of the 
usual course of professional practice. See Jack A. Danton, D.O., 76 FR 
60900, 60901 (2011). In this case, however, the Respondent has admitted 
he did so. Stip. 42-53. In addition, a review of several of the 
Government exhibits reveals that at the time the Respondent wrote 
prescriptions to the undercover investigators he knew or had reason to 
believe they would be using the prescriptions for nonmedical reasons. 
For example, on March 30, 2012, UC1 informed the Respondent that he had 
been using Vicodin and Adderall, which he obtained from a friend. GE-3, 
at 9. Then when UC1 returned to see the Respondent on May 4, 2012, UC1 
had none of the prescribed drugs in his urine. GE-5, at 5; GE-14, at 
14. In addition, UC1 once again informed the Respondent that he was 
obtaining Opana from someone at his gym, and that his pain level was 
good. GE-5, at 5. Nevertheless, on each occasion, the Respondent issued 
UC1 prescriptions for controlled substances. GE-4, at 1; GE-6, at 1.
    With respect to UC2, the Respondent prescribed controlled 
substances to her on her first office visit with him after she told the 
Respondent that her pain was not bad,\15\ that she got sore from 
working out, and that she needed something to relax. GE-37, at 3-4; GE-
15, at 13. At that visit, the Respondent provided UC2 with 
prescriptions for

[[Page 15812]]

Vicodin, Xanax, and Adderall. GE-8, at 1.
---------------------------------------------------------------------------

    \15\ UC2 listed her pain level as a 1 out of 10 on her in-take 
form on May 4, 2012. GE-15, at 2. On her pain assessment form UC2 
indicated that her pain was a 1 out of 10 at its worst. GE-15, at 3.
---------------------------------------------------------------------------

    The third undercover investigator presented to the Respondent on 
March 21, 2013, almost a year after the visits by UC1 and UC2. GE-9, at 
1. UC3 informed the Respondent that he was taking oxycodone for an old 
injury he sustained playing high school football. Id.; GE-19, at 910. 
When the Respondent asked where UC3 was getting the oxycodone, UC3 
replied, ``I don't know if you really want me to say where I've been 
getting it or not. I don't have insurance you know, so I do what I 
gotta do.'' GE-9, at 1. While the Respondent did have UC3 walk around 
on his heels and toes, he did not do so to assess UC3's pain level. 
Rather, the Respondent was trying to determine if UC3 had a more severe 
problem that would require referral to a specialist. GE-19, at 911-12. 
At that first visit with the Respondent, the Respondent prescribed 
Percocet 10 mg to UC3 even though he knew that UC3 was obtaining 
oxycodone on the street. GE-10, at 1; GE-19, at 910. UC3 returned to 
see the Respondent on April 25, 2013. A review of the video recording 
of that visit reveals that the Respondent spent about ten minutes 
talking with UC3, but he did not conduct an examination. GE-11. On that 
date, the Respondent again prescribed Percocet for UC3. GE-12, at 1.
    [I am omitting the portion of the R.D. where the ALJ sustained the 
allegations related to the prescriptions to the undercover 
investigators. I agree with the ALJ's findings and conclusions on these 
allegations *\Q\ and incorporate them herein; however, it is 
unnecessary to repeat them considering that the Respondent stipulated 
to them and I am removing them to condense this opinion. All of the 
allegations related to prescribing beneath the standard of care and 
outside of the usual course of professional practice are sustained and 
weigh in favor of revocation of the Respondent's Registration.]
---------------------------------------------------------------------------

    *\Q\ It appears that the ALJ inadvertently left out one of the 
prescriptions in the stipulated facts for Xanax, a schedule IV 
controlled substance to UC2 on May 4, 2012. See Original RD, at 35-
36; see also Stip. 48, 49, 50; RD, at 14, 15; GX 8. In addition to 
the ALJ's findings, I find that this prescription was for no 
legitimate medical purpose and issued outside the usual course of 
professional practice, in violation of 21 U.S.C. 841(a)(1), 21 CFR 
1306.04(a), Cal. Health & Safety Code Sec.  11153(a), and the Cal. 
Bus. & Prof. Code Sec. Sec.  725(a), and 2242(a).
---------------------------------------------------------------------------

The Texas Prescriptions
    In the Government Supplemental Prehearing Statement, the Government 
alleged that the Respondent wrote three prescriptions for a controlled 
substance in Texas in April and May 2017 without having a valid DEA COR 
for Texas. ALJ-29, at 5-6. The Government alleges that by writing these 
prescriptions the Respondent violated 21 U.S.C. 822(e), and 21 CFR 
1301.12(a) and 1301.12(b)(3). ALJ-29, at 6. Title 21 of the U.S. Code, 
Section 822(e) requires a separate COR at each principal place of 
business where a registrant is prescribing controlled substances.\16\ 
21 CFR 1301.12(a) essentially reinforces the cited provision of the 
U.S. Code, 21 CFR 1301.12(b)(3) is not specifically applicable. Rather, 
it defines places that are deemed not to be places where controlled 
substances can be prescribed.
---------------------------------------------------------------------------

    \16\ 21 U.S.C. 822(e) uses the terms ``dispenses controlled 
substances.'' 21 U.S.C Sec.  802 (10) includes ``prescribing'' in 
the definition of the term ``dispense.''
---------------------------------------------------------------------------

    In this case the Government has alleged that the Respondent issued 
three prescriptions for Lyrica, a schedule V controlled substance. ALJ-
29, at 5-6; FF 62. Specifically, the Respondent wrote the first 
prescription for 30 tablets of Lyrica 50 mg for patient L.C. on March 
15, 2017, and it was filled at a Walgreens Pharmacy in El Paso, Texas, 
on March 27. 2017. ALJ-29, at 5, GE-24, at 2-3. The Respondent then 
called in a prescription to an ASP Cares Pharmacy in El Paso, Texas, 
for patient F.D. for 60 tablets of Lyrica 25 mg, on April 17, 2017, and 
it was filled the same day. ALJ-29, at 5; GE-23, at 4-5. The Respondent 
wrote his third Texas prescription on April 28, 2017. ALJ-29, at 5; GE-
23, at 2. This third prescription was written for patient R.A. for 60 
tablets of Lyrica 75 mg on a prescription pad containing the heading, 
``El Paso Advanced Pain Institute.'' ALJ-29, at 5; GE-23, at 2. The 
prescription was filled at an ASP Cares Pharmacy in El Paso, Texas on 
May 1, 2017. ALJ-29, at 5; GE-23, at 3. All three prescriptions contain 
the Respondent's California COR number. GE-23, at 2-5, GE-24, at 2. 
That COR, however, lists the Respondent's principal place of business 
as 5857 Pine Avenue, Chino Hills, California 91709. Stip. 1.
    Under 21 CFR 1306.05(a),*\R\ a doctor is required to include his or 
her name, address, and registration number on any prescription the 
doctor writes. Here, the Respondent issued at least one prescription on 
a prescription pad bearing an El Paso address and phone number. GE-23, 
at 2, and the other two prescriptions contained the Respondent's El 
Paso phone number. GE-23, at 4-5; GE-24, at 2. Further, the Respondent 
acknowledged that he opened a medical practice in Texas in March 2017. 
FF 59; Stip. 54. During March and April 2017, the Respondent did not 
have a COR for his El Paso medical practice. FF 66; Stip. 54.
---------------------------------------------------------------------------

    *\R\ The Government did not allege a violation of 21 CFR 
1306.05(a), and therefore, I am only considering this requirement 
and the lack of the DEA registration number on the prescription pad 
as evidence that Respondent knew or should have known that he was 
not registered in Texas.
---------------------------------------------------------------------------

    Both the CSA and its implementing regulations require a ``separate 
registration . . . at each principal place of business or professional 
practice where the applicant . . . dispenses controlled substances . . 
. .'' 21 U.S.C. 822(e)(1); 21 CFR 1301.12(a); Clarification of 
Registration Requirements for Individual Practitioners, 71 FR 69,478 
(2006); Joe W. Morgan, 78 FR 61,961 (2013); David Moon, D.O., 82 FR 
19,385, 19,389 (2017). This requirement also applies where a doctor is 
merely prescribing controlled substances. 21 U.S.C. 802(10); Moon, 82 
FR at 19,389. Accordingly, the Government's allegation, contained in 
its Supplemental Prehearing Statement, that the Respondent violated 21 
U.S.C. 822(e), and 21 CFR 1301.12(a) by issuing prescriptions in Texas 
without having a COR for his Texas office is sustained by a 
preponderance of the evidence, and weighs in favor of the revocation 
sought by the Government.\17\ The allegation concerning the Respondent 
violating 21 CFR 1301.12(b)(3), however, is not sustained.
---------------------------------------------------------------------------

    \17\ I reject the Respondent's argument that this allegation is 
unclear and not supported by any evidence. ALJ-38, at 7.
---------------------------------------------------------------------------

V. Factor Three: Conviction Record Under Federal or State Laws Relating 
to the Manufacture, Distribution, or Dispensing of Controlled 
Substances

    In paragraph 6 of the OSC, the Government alleged that a Los 
Angeles County jury convicted the Respondent of seven felony counts of 
issuing unlawful controlled substance prescriptions for Adderall, 
hydrocodone, and alprazolam on March 28, 2016. ALJ-1, at 4. These 
felony convictions were reduced to misdemeanors upon sentencing. ALJ-1, 
at 4. The Government asserts that these convictions may be considered 
in determining whether the Respondent's registration is inconsistent 
with the public interest under 21 U.S.C. 823(f)(3) and 824(a)(4). Id.
    As to Factor Three, the Respondent has been convicted of seven 
offenses violating California law ``relating to the manufacture, 
distribution, or dispensing of controlled substances.'' 21 U.S.C. 
823(f)(3); FF 34-35. A review of GE-19 and GE-20 reveals that the 
Respondent's convictions were directly

[[Page 15813]]

related to the Respondent's unlawful prescriptions the Respondent wrote 
to UC1, UC2, and UC3. Specifically, the Respondent was convicted of 
seven misdemeanor counts of issuing unlawful prescriptions for the 
controlled substances of Adderall, hydrocodone, and alprazolam. Stip. 
13, 14; GE-20, at 6-9.
    The Government has proven the allegations contained in paragraph 6 
of the OSC through the Stipulations and Government Exhibits 19 and 20. 
In addition, the Respondent testified that he had been convicted of 
seven counts involving the prescriptions he wrote for controlled 
substances. Tr. 44. Accordingly, the allegations, contained in 
paragraph 6 of the OSC, concerning the Respondent's conviction of 
unlawfully writing prescriptions for controlled substances are 
sustained, and weigh in favor of the revocation sought by the 
Government.

Discussion and Conclusions of Law

    *[Although I have considered Factor One in favor of Respondent, it 
is minimized by the circumstances described above, and it is ultimately 
outweighed by the Factors weighing against him.] *\S\ In its Brief, the 
Government asserted that it was only proceeding under Factors Two, 
Three, and Four. Accordingly, Factor Five does not weigh for or against 
revocation in this case. The Government has presented documents, 
testimony, and has relied on stipulations that establish by a 
preponderance of the evidence that the Respondent: Unlawfully 
prescribed controlled substances to three undercover agents on five 
separate occasions; was convicted in state court of seven misdemeanors 
for issuing unlawful prescriptions for controlled substances; and that 
he wrote three prescriptions in Texas without a valid DEA COR for a 
Texas location.
---------------------------------------------------------------------------

    *\S\ I changed the first two sentences and third sentences based 
on my revised Factor One analysis.
---------------------------------------------------------------------------

    After the Government presents a prima facie case for revocation, 
the Respondent has the burden of production to present ``sufficient 
mitigating evidence'' to show why he can be entrusted with a DEA 
registration. See Medicine Shoppe--Jonesborough, 73 FR at 387 (quoting 
Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)). To rebut the 
Government's prima facie case, the Respondent must both accept 
responsibility for his actions and demonstrate that he will not engage 
in future misconduct. Stodola, 74 FR at 20734-35.
    The Respondent may accept responsibility by providing evidence of 
his remorse, his efforts at rehabilitation, and his recognition of the 
severity of his misconduct. See Leslie, 68 FR at 15228. To accept 
responsibility, a respondent must show ``true remorse'' for wrongful 
conduct. Michael S. Moore, M.D., 76 FR 45867, 45877 (2011). An 
expression of remorse includes acknowledgment of wrongdoing. See Wesley 
G. Harline, M.D., 65 FR 5665, 5671 (2000). A respondent must express 
remorse for all acts of documented misconduct, Jeffrey Patrick 
Gunderson, M.D., 61 FR 26208, 26211 (1996), and acknowledge the scope 
of his misconduct, Arvinder Singh, M.D., 81 FR 8247, 8250-51 (2016) 
*\T\ [(calling for Respondent to acknowledge the ``full scope of his 
criminal behavior and the risk of diversion it created''). 
Additionally, ``the Agency has previously weighed against a finding of 
acceptance of full responsibility'' attempts to minimize the 
egregiousness of Respondent's misconduct. Jeffrey Stein, M.D., 84 FR at 
46,973 (collecting cases).]
---------------------------------------------------------------------------

    *\T\ I am tweaking the caselaw descriptions slightly and adding 
some additional caselaw that bolsters the ALJ's position, with which 
I agree.
---------------------------------------------------------------------------

    It is clear in this case that the Respondent attempted to accept 
full responsibility for his actions. It is clear because, prior to the 
hearing, the Respondent entered into extensive stipulations of fact, 
essentially relieving the Government of the need to present any 
evidence of the Respondent's conduct that violated the CSA and its 
implementing regulations. The Record clearly demonstrates that the 
Respondent understood the importance of those stipulations. The 
Respondent acknowledged that by entering into the stipulations that 
essentially admitted to all the facts the Government would need to 
prove its allegations against him. Tr. 14. He also acknowledged that if 
no other evidence had been admitted in the case, that I could issue a 
well-founded recommendation that his COR be revoked. Tr. 14-15. The 
Respondent also acknowledged that the stipulations shifted the burden 
of proof to him to ``demonstrate contrition and remedial actions that 
would convince me that in spite of the conduct [he] admitted to, that I 
should make a recommendation to . . . not revoke [his] certificate of 
registration.'' Tr. 15. The Respondent has not met that burden.
    Here, the Government accurately argued in its Brief that while the 
Respondent ``generally accepted responsibility for his improper 
prescribing to the three undercover investigators, his admission of 
wrongdoing was not without some vacillation.'' ALJ-37, at 10. To be 
accurate, the only vacillation concerned the Respondent's testimony 
relative to the prescriptions the Respondent wrote for UC3, on March 
21, 2013 and April 25, 2013. Indeed, the Respondent waivered on his 
acceptance of responsibility in writing those prescriptions. While he 
testified that he did do ``some exam'' of UC3, it seems that the only 
exam he conducted was to have UC3 perform a heel and toe walk on March 
21, 2013. Tr. 78; GE-19, at 625-26. Further, the Respondent's purpose 
in having UC3 perform a heel and toe walk was not to assess UC3's pain 
level, but rather to determine if he needed to send UC3 to a 
specialist. GE-19, at 911-12. No examination was conducted on April 25, 
2013. See GE-11. Clearly, at the hearing before me, the Respondent was 
reluctant to admit culpability for the prescriptions he wrote to UC3 
because he had been acquitted of writing prescriptions for 
oxycodone.\18\ See Tr. 78, 110-11. In addition, during the hearing, the 
Respondent withdrew from the two stipulations he had originally entered 
into concerning the two prescriptions he wrote to UC3, and later 
entered into a modified stipulation, which did not address violations 
of 21 U.S.C. 841(a)(1), and Cal. Health & Safety Code Sec.  11153(a). 
Tr. 80-81, 108.
---------------------------------------------------------------------------

    \18\ There are many reasons, however, why even a person who has 
engaged in criminal misconduct may never have been convicted of an 
offense or even prosecuted for one. Dewey C. MacKay, M.D., 75 FR 
49956, 49973 (2010), pet. for rev. denied, MacKay v. Drug Enf't 
Admin., 664 F.3d 808, 822 (10th Cir. 2011). The Agency has, 
therefore, held that ``the absence of such a conviction is of 
considerably less consequence in the public interest inquiry'' and 
is therefore not dispositive. Id. *[Omitted sentence].
---------------------------------------------------------------------------

    The Respondent also had problems in accepting responsibility for 
the three prescriptions he wrote in Texas. Initially, the Respondent 
stipulated that he had maintained a principal place of business in 
Texas, but he was not registered with the DEA in Texas. Stip. 54. 
During his testimony, however, he again ``vacillated.'' When asked if 
he had a certificate of registration for Texas, the Respondent 
testified that he had submitted a change of address and that he 
believed the DEA had approved the change. Tr. 92-93. The Respondent 
further testified that when he wrote the prescriptions in Texas, he 
believed he had the authority to do so. Tr. 105-107. The Respondent 
could have presented testimony that when he wrote the prescriptions in 
Texas he believed he had authority to do so, but now he realizes that 
he was wrong in that belief. But, the Respondent did not do so.

[[Page 15814]]

Through his testimony, the Respondent made clear that he has not 
accepted responsibility for the prescriptions he wrote in Texas without 
having a DEA COR for a place of business in Texas.
    In this case, the Government has established that the Respondent 
unlawfully wrote prescriptions for controlled substances to three 
undercover investigators on five separate occasions beginning in March 
2012 and ending in April 2013. After the Respondent was arrested, the 
Government filed a motion to revoke his bail because he continued 
writing prescriptions. GE-16, at 4; GE-19, at 1170, 1173. Then, as a 
result of these unlawful prescriptions, in May 2015 the Respondent was 
convicted in the Superior Court of the State of California, County of 
Los Angeles, of seven counts concerning issuing unlawful prescriptions 
for Adderall, hydrocodone, and alprazolam. That court imposed a 
sentence in March 2016. Then in June 2016, the MBC suspended the 
Respondent's medical license, a suspension which remained in effect 
until January 2017. In February 2017, the Acting Administrator of the 
DEA issued an Order restricting the Respondent's COR, and remanded the 
Respondent's case to the Office of Administrative Law Judges for 
further proceedings. Then in March and April of 2017, the Respondent 
wrote three prescriptions for Lyrica, a Schedule V controlled 
substance, in Texas, without having the authority to write such 
prescriptions from the DEA.
    At his hearing the Respondent accepted some responsibility for his 
actions. I find, however, that the Respondent's limited acceptance of 
responsibility is outweighed by his prescribing transgressions detailed 
above, particularly considering the timeline and the fact that the 
Respondent's acceptance of responsibility is equivocal. *[See Alra 
Labs, Inc. v. Drug Enf't Admin., 54 F. 3d 450, 452 (7th Cir. 1995) 
(``The DEA had to decide whether to believe [registrant's] protestation 
that its problems are behind it. It did not have to accept that 
assertion.'' (citations omitted).] *\U\
---------------------------------------------------------------------------

    *\U\ Replaced citation.
---------------------------------------------------------------------------

    When considering whether the Respondent's continued registration is 
consistent with the public interest, an ALJ must consider both the 
egregiousness of the registrant's violations and the DEA's interest in 
deterring future misconduct by both the registrant as well as other 
registrants. Ruben, 78 FR at 38364. *[Omitted additional citations].
    In this case, the Respondent's numerous transgressions are 
sufficiently egregious to warrant revocation.\19\ See Dewey C. MacKay, 
M.D., 75 FR 49956, 49974 n.35 (2010) (``[U]nder the public interest 
standard, DEA has authority to consider those prescribing practices of 
a physician, which, while not rising to the level of intentional or 
knowing misconduct, nonetheless create a substantial risk of 
diversion.''). I find the Respondent's transgressions egregious for 
several reasons. First, the Respondent issued prescriptions for 
controlled substances to UC1 even though he knew that UC1 was obtaining 
controlled substances on the street, and he reissued that prescription 
to UC1 even knowing that none of the controlled substances the 
Respondent prescribed to UC1 were detected in his urine test. Second, 
almost a year later, the Respondent again prescribed oxycodone, this 
time to UC3, knowing that UC3 had been obtaining oxycodone on the 
street. Finally, after being caught, convicted and sentenced for 
writing illegal prescriptions; after having had his medical license 
suspended by the MBC for writing illegal prescriptions; after taking 
courses on writing prescriptions through PACE; and then less than three 
months after he had his medical license reinstated; he wrote illegal 
prescriptions in Texas. This misconduct, particularly on this timeline, 
engenders absolutely no confidence that the Respondent can be entrusted 
with a DEA certificate of registration.
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    \19\ I acknowledge that the Respondent has taken some remedial 
steps to reduce the likelihood that his actions would result in 
future violations of the CSA and/or its implementing regulations. 
See, e.g., ALJ-38, at 8-9. Nevertheless, a registrant does not 
accept responsibility for its actions simply by taking remedial 
measures. Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 & 5195, 
77 FR 62,316, 62,346 (2012). Further, where a registrant has not 
accepted responsibility it is not necessary to consider evidence of 
the registrant's remedial measures. Jones Total Health Care 
Pharmacy, L.L.C. & SND Health Care, L.L.C., 81 FR 79,188, 79,202-03 
(2016). *[In this case, Respondent has taken responsibility for most 
of the allegations related to his conduct related to his criminal 
conviction; however, through his vacillations, and as a result of 
his conduct in Texas, I have reason to doubt the sincerity of his 
words. Therefore, I agree with the ALJ that the egregiousness of his 
conduct even in the stipulated facts must be considered in 
determining whether sanction is appropriate.]
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Recommendation

    The Government established that the Respondent's continued 
registration is inconsistent with the public interest because of his 
improper prescribing, and his state conviction relating to his unlawful 
prescribing of controlled substances. While the Respondent admitted to 
many of the Government's factual allegations, he failed to fully accept 
responsibility for his actions. Furthermore, even had the Respondent 
accepted full responsibility, the egregiousness of his violations may 
*\T\ have outweighed his acceptance of responsibility and the remedial 
measures he has taken. Accordingly, I recommend that the Respondent's 
DEA COR be revoked and that any application for renewal or modification 
of his registration be denied.
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    \*T\ I changed the word ``would'' to ``may,'' because I decline 
to foreclose definitively the ability of the Respondent to have 
convinced me that he could have been entrusted with a registration. 
Most importantly, in this case he did not

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    Dated: August 28, 2017.

Charles Wm. Dorman,

U.S. Administrative Law Judge.

[FR Doc. 2020-05751 Filed 3-18-20; 8:45 am]
BILLING CODE 4410-09-P
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