Source: https://www.federalregister.gov/documents/2013/07/25/2013-17890/george-r-smith-md-decision-and-order
Timestamp: 2017-08-16 18:52:17
Document Index: 582940919

Matched Legal Cases: ['§\u2009823', '§\u2009843', '§\u2009823', '§\u2009823', '§\u2009823', '§\u20090']

Federal Register :: George R. Smith, M.D.; Decision and Order
A Notice by the Drug Enforcement Administration on 07/25/2013
44972-44980 (9 pages)
https://www.federalregister.gov/d/2013-17890 https://www.federalregister.gov/d/2013-17890
Gail A. Randall, Administrative Law Judge. This proceeding is an adjudication pursuant to the Administrative Procedure Act, 5 U.S.C. 551 et seq., to determine whether the Drug Enforcement Administration (“DEA” or “Government”) should deny a physician's application for a DEA Certificate of Registration pursuant to 21 U.S.C. 823(f) (2006). Without such registration, the physician, George R. Smith, M.D. (“Respondent” or “Dr. Smith”), would be unable to lawfully Start Printed Page 44973prescribe, dispense or otherwise handle controlled substances in the course of his medical practice.
The Deputy Assistant Administrator, Drug Enforcement Administration, issued an Order to Show Cause (“Order”) dated June 5, 2012, proposing to deny the application of George R. Smith, M.D. for a DEA Certificate of Registration pursuant to 21 U.S.C. 823(f) (2006), because Respondent's registration would be inconsistent with the public interest, as that term is used in 21 U.S.C. § 823(f). [Administrative Law Judge Exhibit (“ALJ Exh.”) 1 at 1]. The Order stated that on November 18, 2011, Respondent applied for a DEA registration as a practitioner in Schedules II-V at 4721 Bob White Road, Gilmer, Texas 75645. [Id.]. Additionally, the Order stated that Respondent had twice previously surrendered his DEA registrations for cause. [Id.]. Respondent first voluntarily surrendered his DEA registration, DEA number BS2388381, on March 6, 2002. [Id.]. Respondent then voluntarily surrendered his second DEA registration, DEA number FS0339817, on April 27, 2011. [Id.].
The Order alleged that between November 1998 and June 2001, Respondent issued prescriptions for large quantities of hydrocodone, a Schedule III controlled substance, to his family members for his own personal use for other than legitimate medical purposes. [Id.]. In relation to this allegation, the Order asserted that during this time period, Respondent obtained and filled prescriptions for hydrocodone from at least ten different doctors for his own personal use for other than legitimate medical purposes. [Id.]. Additionally, the Order asserted that between June 2001 and August 2001, Respondent issued prescriptions for hydrocodone and alprazolam to third-party non-patients in order for Respondent to obtain these controlled substances for his own personal use for other than legitimate medical purposes. [Id.]. As a result of issuing these unlawful prescriptions for controlled substances, Respondent pled guilty to one count of obtaining controlled substances by fraud, in violation of 21 U.S.C. § 843(a)(3), a felony, on November 26, 2001, before the United States District Court for the Eastern District of Texas. [Id. at 2].
After authorized delays, a hearing was held in Austin, Texas on December 12, 2012 through December 13, 2012, with the Government and Respondent each represented by counsel. [ALJ Exh. 3-4, 6-7]. At the hearing, counsel for the Government called one witness to testify and introduced documentary evidence. [Transcript (“Tr.”) Volume I-II]. Counsel for the Respondent called two witnesses to testify, including the Respondent, and introduced documentary evidence. [Id.].
After the hearing, the Government and the Respondent submitted Proposed Findings of Fact, Conclusions of Law and Argument (“Govt. Brief” and “Resp. Brief”).
The issue in this proceeding is whether or not the record as a whole establishes by a preponderance of the evidence that the Drug Enforcement Administration should deny the application of George R. Smith, M.D., for a DEA Certificate of Registration as a practitioner, pursuant to 21 U.S.C. § 823(f) (2006), because to grant Dr. Smith's application would be inconsistent with the public interest as that term is defined in 21 U.S.C. 823(f). [ALJ Exh. 3; Tr. 5].
1. Respondent holds Texas Medical license H-8411 (expiration February 28, 2013),[1] and Texas Department of Public Safety Controlled Substances Registration (Texas DPS Registration) Certificate 60184908 (expiration November 30, 2012) [2] which allows Respondent to issue prescriptions for controlled substances listed in Schedules II-V.
2. On March 4, 1995, the Texas State Board of Medical Examiners (Medical Board) suspended Respondent's medical license because Respondent had developed a drug addiction due to the self-administration of hydrocodone and codeine. The suspension was stayed and Respondent was placed on probation for five (5) years.
4. On October 24, 2001, Respondent's medical license was temporarily suspended because his “continuation in the practice of medicine would constitute a continuing threat to public welfare.”
8. By Medical Board Order dated June 2, 2006, Respondent was permitted to apply to the DEA and the Texas DPS for Certificates of Registration for Schedule V controlled substances only. Respondent was further limited to prescribing Schedule V controlled substances to hospital admission patients only.Start Printed Page 44974
15. The August 26, 2010 [3] Medical Order remains in effect until May 17, 2017, and is not eligible for early termination.
17. On November 18, 2011, Respondent applied for an unrestricted DEA Certificate of Registration.[4]
In 2000, the Respondent became Board Certified in Internal Medicine.[5] [Tr. 89]. Following his time in private practice and working as the critical care unit director at Titus Regional Medical Center, Respondent conducted pilot exams for American Airlines for a period of 6-8 months. [Tr. 113]. After this position was eliminated, the Respondent began working for a county hospital in Mineral Wells, Texas as the hospitalist. [Id.]. Next, the Respondent conducted routine pre-employment physicals for a company before becoming employed at Hugman-Kent Clinic, in Gladewater, Texas, in 2006.[6] [Tr. 113-115]. Respondent continues to practice at Hugman-Kent Clinic. [Tr. 114-115]. Approximately 85% of the Respondent's patients are Medicare patients. [Tr. 115]. The median age of the Respondent's patients is about 60-65 years old. [Tr. 119]. A significant number of the Respondent's patients have co-morbidities that require complex medical management. [Tr. 116-117].
After practicing medicine for only two and one half years, the Respondent entered into an Agreed Order with the Texas State Board of Medical Examiners (“the Board” or “the Texas Medical Board”) on March 4, 1995, in which his Texas medical license was suspended as a result of his addiction to hydrocodone; however, the Texas Medical Board stayed the suspension of Respondent's medical license and placed him on probation for a term of five years. [Govt. Exh. 3; Tr. 85]. As a result of the 1995 Agreed Order, restrictions were placed on the Respondent's ability to practice medicine. [Govt. Exh. 3; Tr. 88-89]. The Respondent was required to abstain from the consumption of alcohol and drugs unless prescribed by another physician for a legitimate purpose, submit to drug testing at the request of the Board, and continue under the care of Dr. Michael Healy. [Id.].
However, the Respondent started abusing controlled substances again in 1999, approximately one year after the Texas Medical Board had terminated the 1995 Agreed Order. [Tr. 185]. Around November of 1999, the Respondent suffered two compression fractures. [Tr. 92]. The Respondent then began taking hydrocodone for pain. [Id.]. Respondent Start Printed Page 44975initially began obtaining hydrocodone from physicians and then later started writing prescriptions for it himself. [Id.]. In addition to abusing hydrocodone, Respondent prescribed hydrocodone to family members and Respondent would consume the hydrocodone that he prescribed to family members a majority of the time. [Tr. 93, 185; Govt. Exh. 6]. Respondent also approached nurses and employees of the Titus Regional Medical Center, where he was working in 2001, and asked them to fill controlled substance prescriptions for him. [Govt. Exh. 6 at 2]. As a result of his addiction problems, the Titus Regional Medical Center suspended Respondent's hospital privileges. [Tr. 93; Govt. Exh. 6 at 3].
On October 24, 2001, the Texas Medical Board entered a Temporary Suspension Order, which temporarily suspended the Respondent's Texas medical license as a result of his return to addiction. [Govt. Exh. 6]. Following the 2001 Temporary Suspension, the Board entered an Agreed Order on May 17, 2002. [Govt. Exh. 7; Resp. Exh. 4]. The Order revoked the Respondent's Texas medical license; however, the Board stayed the revocation and placed the Respondent on probation for a term of ten years. [Govt. Exh. 7 at 4; Resp. Exh. 4 at 4]. The 2002 Agreed Order required the Respondent to abstain from the consumption of alcohol and controlled substances unless prescribed by a physician for a legitimate purpose, to report any prescription of controlled substances to the Board, to give a copy of the Agreed Order to all treating physicians, to submit to drug testing at the request of the Board, to remain under the care of Dr. Michael Healy,[7] to attend Alcoholics Anonymous (“AA”) meetings, to surrender all controlled substances registrations,[8] and to limit his medical practice to a group or institutional setting approved by the Board. [Govt. Exh. 7; Resp. Exh. 4]. Should the Respondent test positive for drug use, then his medical license could be automatically revoked without the need for further hearings. [Tr. 103; Govt. Exh. 7]. The agreement also prohibited the Respondent from applying for a controlled substances registration absent Board approval. [Govt. Exh. 7]. Further, the Respondent was only allowed to file a request to modify this order once a year thereafter. [Id.].
Respondent subsequently sought treatment for his relapse in addiction. [Tr. 94]. Respondent went to Baylor, in Dallas, where he underwent a three-month treatment program for his addiction. [Id.]. Respondent has been required to submit to over 600 drug tests as a result of the 2002 Agreed Order and has never failed to appear for a drug test nor has the Respondent tested positive.[9] [Tr. 103-108]. As a result of the Respondent's treatment and willingness to stay sober, the Respondent reports a sobriety date of October 22, 2001.[10] [Tr. 96; Govt. Exh. 7; Resp. Exh. 4]. Respondent admits that his return to addiction and his prescribing to family members, self-administration, and solicitation of colleagues was an abuse of the authority of his Texas medical license, his Texas DPS registration, and his DEA registration. [Tr. 92]. The 2002 Agreed Order was subsequently modified on October 10, 2003 and June 2, 2006. [Govt. Exh. 8 and 10; Resp. Exh. 3 and 2].
In late 2009, Respondent began prescribing Schedules III and IV controlled substances to his patients at the Hugman-Kent Clinic. [Tr. 139]. Respondent continued prescribing outside the scope of his Texas DPS and DEA registrations up until he was visited by Diversion Investigator (“DI”) Thomas McLaughlin [11] on April 6, 2011. [Tr. 23, 139]. Yet, the Respondent credibly testified that he prescribed these controlled substances to adequately treat his patients. [Tr. 130, 135].
DI McLaughlin first began investigating the Respondent after he received information from Sandra Atkins, a DEA registration technician, that Respondent was writing Schedule III and IV prescriptions when he was only authorized to write Schedule V prescriptions. [Tr. 10-11]. DI McLaughlin requested information from the Texas Prescription Monitoring Start Printed Page 44976Program (“PMP”) [12] from the time period of January 2010 through January 2011, and discovered through the report that Respondent prescribed 1,532 prescriptions in Schedules III, IV, and V to 335 patients. [Tr. 14-18; Govt. Exh. 2]. These prescriptions were issued to non-hospital admission patients. [Tr. 22]. Of the 1,532 prescriptions issued during this time period, over 1,400 were for Schedule III and IV controlled substances. [Tr. 18-19; Govt. Exh. 2]. DI McLaughlin also requested copies of original prescriptions from the pharmacies that filled Respondent's issued prescriptions. [Tr. 20-22; Govt. Exh. 2, 12]. He noted that there were no discrepancies between the Prescription Monitoring Program Data and the prescription slips that he received. [Id.].
Finding Respondent's testimony to be credible, it is probable that someone had in fact abused Respondent's DEA registration because neither the Respondent nor the Clinic have any records of these 41 patients being prescribed controlled substances.[13] [Tr. 173-178; Resp. Exh. 15]. However, Respondent acknowledges that his actions were still wrong and that he did prescribe outside the scope of his Texas DPS and DEA registrations. [Tr. 23, 59, 139, 174]. Regardless of the controversy concerning the 41 patients, he ceased prescribing Schedule III and IV controlled substances after a visit by DI McLaughlin in April of 2011. [Tr. 139].
Although, Respondent admitted his fault, he repeatedly gave justifications for his actions; these included: prescribing for the patient's best interest and patient care; and continuing prescriptions for patients of a retiring doctor out of the Hugman-Kent Clinic.[14] [Tr. 134-139, 168-172, 204, 206; Resp. Exh. 13]. The Respondent later admitted on cross-examination that he would have had fewer patients if he did not prescribe Schedule III and IV controlled substances, and the Clinic could therefore have lowered his salary. [Tr. 191]. Additionally, the Respondent admitted that there are hundreds of physicians located in Longview, Texas, which is about 20 miles away from the Respondent's place of business. [Tr. 202, 39-40]. Finally, there were other physicians in Gladewater, Texas, who had unrestricted DEA registrations at the time the Respondent was prescribing outside the scope of his registration. [Tr. 39-40]. Yet the Respondent credibly testified that other physicians working at the Hugman-Kent Clinic were not comfortable writing controlled substance prescriptions for the Respondent's patients because “they didn't know the patients.” [Tr. 138].
As a result of the Respondent's unauthorized prescribing of Schedule III and IV controlled substances, he voluntarily surrendered his DEA registration on April 27, 2011. [ALJ Exh. 5]. The Respondent also violated his modified 2002 Agreed Order.[15] [Govt. Exh. 11 at 4; Resp. Exh. 1 at 4]. Also, the Respondent had been reporting to his compliance officer that he was in full compliance with the 2002 Agreed Order, when in fact he admitted at the hearing that he had not been in compliance. [Resp. Exh. 5-6; Tr. 186-192].
On August 26, 2011, the Respondent again entered into an Agreed Order with the Texas Medical Board. [Govt. Exh. 11; Resp. Exh. 1; Tr. 162-165]. Pursuant to the 2011 Agreed Order, which was issued after the Respondent took part in an Informal Settlement and Show Cause Proceeding (“ISC”) [16] on July 28, 2011, the Respondent is to remain under the terms of the 2002 Agreed Order, as modified, without the right to seek an early termination. [Tr. 308; Govt. Exh. 11 at 5; Resp. Exh. 1 at 5]. The Board modified the 2002 Agreed Order to authorize the Respondent to reapply to the DEA and the Texas DPS to obtain registrations in Schedule II, III, IV, and V controlled substances. [Id.]. But, the decision to grant or deny the Respondent's application remains “a matter for appropriate determination by the DEA and DPS.” [Govt. Exh. 11 at 5-6; Resp. Exh. 1 at 5-6]. In addition, the Respondent was ordered to pay an administrative penalty of $10,000, which he has paid. [Tr. 164; Govt. Exh. 11 at 6; Resp. Exh. 1 at 6]. Thus, after the Respondent had been found to be in violation of both his Texas DPS and DEA registrations and his 2002 Agreed Order, the Respondent was permitted to reapply for unrestricted registrations, and he obtained an unrestricted Texas DPS registration in Schedules II through V in September 2011. [ALJ Exh. 5]. Now, in spite of his violations, the Respondent seeks a DEA registration for Schedules II through V. [ALJ Exh. 5; Govt. Exh. 1].
As a result of Respondent's addiction to hydrocodone and his self-administration of hydrocodone, he pled guilty to one count of obtaining a controlled substance by fraud, a felony, on November 26, 2001, before the United States District Court for the Eastern District of Texas. [ALJ Exh. 5; Tr. 99]. Respondent was then sentenced to a three year term of probation on March 21, 2002. [ALJ Exh. 5]. Start Printed Page 44977
The Government argues that the recommendation of the Texas Medical Board, which allows the Respondent to reapply for a DEA registration in Schedule II through V controlled substances, should be given “nominal weight.” [Id. at 12-13]. In support of its argument, the Government contends that the Respondent has “been the subject of Texas Medical Board orders from 1995 through 1998 and again from 2001 through the present day based on Respondent's misconduct involving controlled substances.” [Id. at 12].
In addition, the Government argues that the Respondent's experience in dispensing controlled substances, his conviction record, and his compliance with federal and state laws relating to controlled substances “all strongly weigh in favor of the denial of Respondent's application” for a DEA Certificate of Registration. [Id. at 13]. The Government argues that Respondent has had his Texas medical license revoked (although stayed) twice due to his addiction to hydrocodone and his prescribing hydrocodone to his family members. [Id. at 13-14]. Additionally, the Government argues that the Respondent has had two felony convictions related to controlled substances, one for issuing fraudulent prescriptions and another for prescribing controlled substances outside the scope of his prescriptive authority. He has twice surrendered his DEA registrations. [Id.]. The Government also argues that Respondent violated federal and local law on several occasions when he prescribed Schedule III and IV controlled substances to his non-hospital patients. [Id. at 14].
Lastly, the Government argues that the Respondent's application for a DEA registration is inconsistent with the public interest because Respondent has failed to be a compliant registrant in the past and will likely fail to be a compliant registrant in the future. [Id. at 15]. The Government also argues that the Respondent has failed to take full responsibility for his actions. [Id. at 16]. The Government additionally argues that the Respondent's excuses for his failure to be a compliant registrant, i.e. the need of the community and his patients, is not a viable argument and does not support the granting of Respondent's application for a DEA registration. [Id. at 17]. In conclusion, the Government asserts that “Respondent failed in his responsibilities as a DEA registrant, not once but two times. Both failures involved Respondent's knowing and willful violations of the Controlled Substances Act and resulted in criminal convictions.” [Id. at 18]. For these reasons, the Government concludes that the Respondent's application should be denied.
The Respondent asserts that his application for a DEA registration should be granted because granting his registration is consistent with the public interest.[17] [Resp. Brief at 13]. First, Dr. Smith argues that the Texas Medical Board has recommended that he be able to apply for an unrestricted DEA registration, in spite of his past disciplinary history with the Texas Medical Board. [Id. at 13-14]. Additionally, the Respondent notes that he has already obtained an unrestricted Texas DPS registration for controlled substances that weighs in favor of the DEA granting his registration. [Id. at 14].
The Respondent next argues that he has sufficient knowledge and experience in dispensing controlled substances. [Id.]. Respondent claims that he has “a good working knowledge of complex medical management.” [Id.].
Although the Respondent acknowledges that he has had two felony convictions and has not complied with state, federal, or local laws relating to controlled substances, he asserts that he has rehabilitated himself and thus, these factors do not warrant the denial of his DEA registration application. [Id. at 14-16]. Specifically, the Respondent asserts that he has been sober since October of 2001, and has submitted to over 600 drug tests, in which he has never tested positive. [Id. at 15]. Additionally, the Respondent argues that, although he prescribed outside the scope of his Start Printed Page 44978registration, he did so because it was in the best interest of his patients and he never “non-therapeutically prescribed drugs since his 2002 arrest.” [Id.]. Moreover, Respondent asserts that since his noncompliance was discovered in 2011, he has been in full compliance with his Texas Medical Board Orders, his Texas DPS registration and his DEA registration. [Id. at 15-16].
Pursuant to 21 U.S.C. 823(f) (2006), the Deputy Administrator may deny an application for a DEA Certificate of Registration if he determines that such registration would be inconsistent with the public interest.[18] In determining the public interest, the following factors are considered:
(5) Such other conduct which may threaten the public health and safety. 21 U.S.C. § 823(f) (2006).
These factors are to be considered in the disjunctive; the Deputy Administrator may rely on any one or a combination of factors and may give each factor the weight he deems appropriate in determining whether an application should be denied. See Robert A. Leslie, M.D., 68 Fed. Reg. 15,227, 15,230 (DEA 2003). Moreover, the Deputy Administrator is “not required to make findings as to all of the factors.” Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005).
The Government bears the ultimate burden of proving that the requirements for registration are not satisfied. 21 CFR 1301.44(d) (2012). However, where the Government has made out a prima facie case that Respondent's application would be “inconsistent with the public interest,” the burden of production shifts to the applicant to “present[] sufficient mitigating evidence” to show why he can be trusted with a new registration. See Medicine Shoppe—Jonesborough, 73 FR 364, 387 (DEA 2008). To this point, the Agency has repeatedly held that the “registrant must accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct. Id.; see also Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (DEA 2007). In short, after the Government makes its prima facie case, the Respondent must produce sufficient evidence that he can be trusted with the authority that a registration provides by demonstrating that he accepts responsibility for his misconduct and that the misconduct will not reoccur. Yet, the DEA has consistently held the view that “past performance is the best predictor of future performance.” Alra Laboratories, 59 FR 50,620 (DEA 1994), aff'd Alra Laboratories, Inc. v. DEA, 54 F.3d 450, 451 (7th Cir 1995).
Although the recommendation of the applicable state licensing board is probative to this factor, the Agency possesses “a separate oversight responsibility with respect to the handling of controlled substances” and therefore, must make an “independent determination as to whether the granting of [a registration] would be in the public interest.” Mortimer B. Levin, D.O., 55 Fed. Reg. 8,209, 8,210 (DEA 1990); see also Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 461 (DEA 2009). It is well-established Agency precedent that a “state license is a necessary, but not a sufficient condition for registration.” Leslie, 68 Fed. Reg. at 15,230; John H. Kennedy, M.D., 71 FR 35,705, 35,708 (DEA 2006). Even the reinstatement of a state medical license does not affect the DEA's independent responsibility to determine whether a registration is in the public interest. Levin, 55 FR at 8,210. The ultimate responsibility to determine whether a registration is consistent with the public interest has been delegated exclusively to the DEA, not to entities within a state government. Edmund Chein, M.D., 72 Fed. Reg. 6,580, 6,590 (DEA 2007), aff'd Chein v. DEA, 533 F.3d 828 (DC Cir. 2008). So while not dispositive, state board recommendations are relevant to the issue of granting a DEA registration. See Gregory D. Owens, D.D.S., 74 FR 36,751, 36,755 (DEA 2009); Martha Hernandez, M.D., 62 FR 61,145, 61,147 (DEA 1997).
In spite of the Respondent's past history, the most recent Texas Medical Board Order, dated August 26, 2011, permits Respondent to reapply to the DEA and the Texas DPS for controlled substance registrations in Schedules II through V. [Govt. Exh. 11; Resp. Exh. 1]. Start Printed Page 44979However, the 2011 Order notes that, although the Board will allow the Respondent to reapply for these registrations, the decision of whether to grant or deny the Respondent's application is reserved for the issuing agency. [Id.].
Respondent's experience with controlled substances and his compliance with applicable laws related to the handling of controlled substances are relevant to determining the public interest in this case. “Pursuant to 21 U.S.C. 822(b), `[p]ersons registered by the Attorney General under this subchapter to . . . dispense controlled substances . . . are authorized to possess . . . or dispense such substances . . . to the extent authorized by their registration and in conformity with the other provisions of this subchapter.' ” Leonard E. Reaves, III, M.D., 63 FR 44,471, 44,473 (DEA 1998) (registration revoked after physician was prescribing outside the scope of his DEA registration). Additionally, except as authorized, “it shall be unlawful for any person knowingly or intentionally to . . . dispense, or possess with intent to . . . dispense a controlled substance.” 21 U.S.C. 841(a)(1) (2006); see 21 U.S.C. 802(10) (“`dispense' means to deliver a controlled substance to an ultimate user . . . pursuant to the lawful order of, a practitioner, including the prescribing . . . of a controlled substance”); see also 21 CFR 1301.13(a) (providing that “[n]o person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Administrator to such person.”).
Under Factor Five, the Deputy Administrator is authorized to consider “other conduct which may threaten the public health and safety.” 21 U.S.C. 823(f)(5) (2006). This factor encompasses “conduct which creates a probable or possible threat (and not only an actual [threat]) to public health and safety.” Jacobo Dreszer, M.D., 76 FR 19,386, 19,401 FN2 (DEA 2011). The Agency has long held that a practitioner's self-abuse of controlled substances constitutes “conduct which may threaten public health and safety.” 21 U.S.C. § 823(f)(5) (2006); see also Tony T. Bui, M.D., 75 Fed. Reg. 49,979, 49,990 (DEA 2010); Kenneth Wayne Green, Jr., M.D., 59 FR 51,453 (DEA 1994); David E. Trawick, D.D.S., 53 Fed. Reg. 5,326 (DEA 1988). Additionally, the DEA has consistently held that “[c]andor during DEA investigations, regardless of the severity of the violations alleged, is considered by the DEA to be an important factor when assessing whether a . . . registration is consistent with the public interest” and noting that a registrant's “lack of candor and failure to take responsibility for his past legal troubles . . . provide substantial evidence that his registration is inconsistent with the public interest.” Jeri Hassman, M.D., 75 FR 8,194, 8,236 (DEA 2010); see also Prince George Daniels DDS, 60 FR 62,884, 62,887 (DEA 1995); see also Ronald Lynch, M.D., 75 FR 78,745, 78,749 (DEA 2010) Start Printed Page 44980(Respondent's attempts to minimize misconduct held to undermine acceptance of responsibility). Furthermore, the Agency is not required to “consider community impact evidence in exercising its authority.. . .” Linda Sue Cheek, M.D., 76 FR 66,972, 66,973 (DEA 2011); see also Steven M. Abbadessa, D.O., 74 FR 10,077, 10,078 (DEA 2009) (the hardship imposed because Respondent lacks a registration is not a relevant consideration under the Controlled Substances Act).
Here, Respondent self-abused and prescribed significant quantities of controlled substances to his family members, from approximately 1993 through October 22, 2001, which he reports as his sobriety date. [Govt. Exh. 3-10]. Such unlawful ingestion and prescribing of controlled substances clearly places the public health and safety in jeopardy. This unlawful conduct led to the temporary suspension of Respondent's Texas medical license, a felony conviction, the surrender of Respondent's DEA registration, and revocation of Respondent's Texas medical license.[19] [Govt. Exh. 3, 6-7; ALJ Exh. 5; Resp. Exh. 4].
Yet, I find that Respondent has successfully addressed his addiction problem and returned to the practice of medicine by regaining his medical license in 2002. [Govt. Exh. 7; Resp. Exh. 4]. At the hearing, Respondent proffered substantial and detailed evidence regarding his impressive recovery program, including numerous negative drug screens he has taken over the past eleven years. [Tr. 103-108]. As the Deputy Administrator has previously determined, “[t]he paramount issue is not how much time has elapsed since [the Respondent's] unlawful conduct, but rather, whether during that time [the] Respondent has learned from past mistakes and has demonstrated that he would handle controlled substances properly if entrusted with a DEA registration.” Leonardo V. Lopez, M.D., 54 FR 36,915 (DEA 1989). Even though it has been previously found that time, alone, is not dispositive in such situations, it is certainly an appropriate factor to be considered. See Robert G. Hallermeier, M.D., 62 FR 26,818 (DEA 1997) (four years); John Porter Richards, D.O., 61 FR 13,878 (DEA 1996) (ten years); Norman Alpert, M.D., 58 FR 67,420, 67,421 (DEA 1993) (seven years).
1. On January 31, 2013, the parties filed Joint Stipulations of Fact No. 2 with the Court. Therein, the parties stipulated “[a]fter the conclusion of the Hearing on the Merits Respondent submitted a renewal request to the Texas Medical Board (“TMB”) for his Texas Medical License H-8411 which was set to expire at the end of February 2013. The TMB renewed Respondent's medical license for the ordinary term of two years. Respondent's Texas Medical License is now current through February 28, 2015.”
2. On January 31, 2013, the parties filed Joint Stipulations of Fact No. 2 with the Court. Therein, the parties stipulated “[p]rior to the Hearing on the Merits the Respondent submitted a request to the Texas Department of Public Safety (“DPS”) to renew his Texas Controlled Substances Registration. The DPS renewed Respondent's DPS Controlled Substances Registration for the ordinary term of one year. Respondent's DPS Registration is now current through November 30, 2013.”
3. It appears that both counsel are referring to the August 26, 2011 Medical Order. See Government Exhibit (“Govt. Exh.”) 11 and Respondent Exhibit (“Resp. Exh.”) 1.
4. The November 18, 2011 application is the subject of this administrative hearing.
5. Respondent is no longer Board Certified in Internal Medicine because his certification expired December 31, 2010. He is not permitted to sit for recertification because he is currently under an Agreed Order with the Texas Medical Board. [Tr. 111-112, 217; Govt. Exh. 11; Resp. Exh. 1].
6. The reasoning for Respondent's constant movement from job to job will be discussed below. However, such job hopping was due in large part to his addiction problems and the restrictions placed on his medical license by the Texas Medical Board.
7. After the retirement of Dr. Michael Healy, the Respondent has been under the care of Dr. Jonathon Lockhart and continues to see Dr. Lockhart once a month per the 2002 Agreed Order. [Tr. 109].
8. Respondent voluntarily surrendered his Texas DPS and DEA registrations prior to the date of the 2002 Agreed Order. [Tr. 110].
9. The drug testing that Respondent must submit to as a result of his 2002 Agreed Order and subsequent modifications to this Agreed Order are intense. Respondent must call an automated mechanism every morning in order to determine if he must give a specimen on that particular day. If Respondent is required to give a specimen on a particular day, then he must report to give the specimen before the early afternoon. Respondent has never failed to call or failed to provide a specimen over the eleven year period that he has been required to submit to this drug testing. The Respondent pays the costs for the drug tests. [Tr. 103-108, 314-316].
10. The Government does not challenge this sobriety date. [Tr. 313-314].
11. DI McLaughlin is employed by the DEA at the Tyler Resident Office of the Dallas Field Division. [Tr. 8]. DI McLaughlin has been a Diversion Investigator for over 15 years. [Tr. 9]. Prior to being employed with DEA, DI McLaughlin served as a Correctional Officer for the Illinois Department of Corrections, served as an Investigator with the City of Chicago, and served a total of 21 years in the Air Force. [Id.]. As part of his training in being a Diversion Investigator, DI McLaughlin has attended the basic diversion investigator course in Quantico, Virginia, and has received continuing training throughout his tenure as a Diversion Investigator. [Tr. 9-10].
12. Under Texas law all pharmacies must submit prescription information on controlled substances to the PMP when the prescriptions are filled. The information includes the date, the drug, the practitioner's name and DPS registration numbers. [Tr. 12].
13. There was some testimony that implicated an employee of the Hugman-Kent Clinic, who was functioning as a nurse, had illegally used Respondent's prescriptive authority to help others obtain controlled substances. [Tr. 174-178]. But, there is no concrete evidence that this unidentified nurse had in fact used Respondent's prescriptive authority to help 41 people obtain controlled substances under the guise of Respondent's Texas DPS and DEA registrations. [Id.]. However, this unidentified nurse was later fired from the Clinic after it had been discovered that she had taken samples from the Clinic. [Tr. 177].
14. Respondent offered justifications as to why he prescribed Schedules III and IV controlled substances to five patients under his care. The Respondent found there was a medical need for each of the patients to be prescribed controlled substances. Yet, Respondent did not have the authority to prescribe these controlled substances to these patients. However, there is no dispute concerning the medical necessity for these prescriptions. [Resp. Exh. 13; Tr. 140-161].
15. The Respondent had been requesting modification of his 2002 Agreed Order through letters that he sent to the Texas Medical Board on four separate occasions. Yet each time that he requested modification, he was not in compliance with the 2002 Agreed Order. [Resp. Exh. 7-10; Tr. 188-192]. In fact, at the March 2011 modification hearing that the Respondent had with the Texas Medical Board, he represented that he was in compliance with the 2002 Agreed Order but, he was not. [Tr. 192].
16. The record contains testimony concerning the ISC process. [Tr. 308-311]. Since there is no dispute concerning this due process procedure, I do not explain this Medical Board process here.
17. Although the Respondent contends that granting his application for a DEA registration is in the public interest, he recognizes that restrictions could be placed on his registration, such as maintaining a log book and agreeing to inspections without the need for an administrative warrant. [Resp. Brief at 13].
18. The Deputy Administrator has the authority to make such a determination pursuant to 28 C.F.R. §§ 0.100(b), 0.104 (2012).
19. Although the Respondent's medical license was temporarily suspended and later revoked, both of these actions were stayed and the Respondent was placed on probation each time. See Govt. Exh. 3, 6, 7 and Resp. Exh. 4.