[Federal Register Volume 89, Number 179 (Monday, September 16, 2024)]
[Notices]
[Pages 75567-75573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20939]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 23-31]


Mary A. Vreeke, M.D.; Decision and Order

    On February 13, 2023, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause (OSC) to Mary A. Vreeke, M.D. 
(Respondent), of Oxnard, CA. OSC, at 1, 5. The OSC proposed the 
revocation of Respondent's DEA Certificate of Registration 
(Registration) No. FV3660037, alleging that Respondent's continued 
registration is inconsistent with the public interest. Id. at 1 (citing 
21 U.S.C. 823(g)(1), 824(a)(4)).
    A hearing was held before DEA Administrative Law Judge Paul E. 
Soeffing (the ALJ), who, on October 19, 2023, issued his Recommended 
Rulings, Findings of Fact, Conclusions of Law, and Decision 
(Recommended Decision or RD). The RD recommended that Respondent's 
Registration be suspended for six months, and then reinstated with 
restrictions to ensure that Respondent remains sober and continues with 
her current treatment program.\1\ RD, at 27. Neither party filed 
Exceptions to the RD. Having reviewed the entire record, the Agency 
adopts and hereby incorporates by reference the ALJ's credibility 
findings,\2\ findings of fact, and conclusions of law, and clarifies 
and expands upon portions thereof herein. However, the Agency has 
determined that revocation is the appropriate sanction based on the 
egregiousness of Respondent's conduct, her recidivism, and the Agency's 
interests in deterring intentional violations of the Controlled 
Substances Act (CSA).
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    \1\ The restrictions that the ALJ recommends imposing on 
Respondent's registration require her to: (1) limit her controlled 
substance administering, prescribing, and dispensing to the practice 
of anesthesiology; (2) comply with the terms of the Medical Board of 
California's (MBC's) Stipulated Interim Order imposing restrictions 
on her Registration; (3) comply with the terms of her probation with 
the MBC and refrain from seeking early termination of her probation; 
(4) notify DEA's Los Angeles Field Division of any action taken 
against her license and immediately surrender her Registration if 
her California medical license is suspended or revoked; (5) remain 
in monitoring for substance abuse and submit to regular urine drug 
screens; (6) provide DEA with copies of all quarterly reports issued 
by her practice monitor; (7) maintain a detailed record of 
controlled substances prescribed, administered, or dispensed; (8) 
report all activity involving Schedule II controlled substances to 
DEA on a monthly basis; (9) allow DEA personnel to enter her 
registered location during normal business hours without prior 
notice or a warrant. RD, at 42-43.
    \2\ The Agency adopts the ALJ's summary of each of the 
witnesses' testimonies as well as the ALJ's assessment with respect 
to each of the witnesses' credibility. RD, at 4-23.
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I. Findings of Fact

    Respondent is an anesthesiologist currently practicing at St. 
John's Hospital in Oxnard, California. Respondent testified that she 
has a substance abuse disorder that began with abusing alcohol in her 
mid-30s. RD, at 18; Tr. 234-35.\3\ Respondent later began abusing 
zolpidem \4\ and diazepam \5\ which she obtained without a prescription 
either from a friend or by going into Mexico. Tr. 235. Respondent was 
arrested and convicted in 2009 for

[[Page 75568]]

transporting zolpidem and diazepam across the United States border with 
Mexico. RD, at 18; Tr. 235-36. Respondent testified that she 
transported drugs across the border on approximately ten occasions. RD, 
at 18 n.25; Tr. 237. In 2013, Respondent was confronted by her employer 
regarding diversion of controlled substances, and she admitted to 
diverting fentanyl and midazolam for personal use. RD, at 18; Tr. 239-
40.
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    \3\ The Agency agrees with the ALJ that Respondent's testimony 
was ``genuine and generally consistent,'' despite Respondent having 
a significant personal interest in the outcome of these proceedings. 
RD, at 23. The ALJ found that ``to the extent that [Respondent's 
testimony] differs from the testimony of other testifying witnesses, 
[he would] consider her personal interest in this case, and [he 
would] give her testimony the weight that it deserves in light of 
other evidence and testimony presented during the hearing.'' Id. The 
Agency agrees with the amount of weight that the ALJ afforded 
Respondent's testimony.
    \4\ Zolpidem is a Schedule IV controlled substance sold under 
the brand name Ambien. The generic name (zolpidem) is used in this 
decision.
    \5\ Diazepam is a Schedule IV controlled substance sold under 
the brand name Valium. The generic name (diazepam) is used in this 
decision.
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    After admitting to diversion in 2013, Respondent entered treatment 
at the Loma Linda behavioral unit, and then moved to a 95-day inpatient 
program at the Betty Ford Center. RD, at 18; Tr. 240. The Medical Board 
of California (MBC) required Respondent to participate in a recovery 
program for one year before formally putting her on probation. RD, at 
18; Tr. 241-42. This program included undergoing monitoring with the 
Pacific Assistance Group (PAG),\6\ attending PAG support meetings twice 
weekly, attending Alcoholics Anonymous (AA) meetings, getting an AA 
sponsor, engaging in individual therapy, and attending meetings and 
programing through Betty Ford. RD, at 18; Tr. 240-41.
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    \6\ PAG is a support group for ``impaired healthcare 
professionals'' that is ``designed to help healthcare professionals 
provide treatment that is safe for the public [and] that is ethical 
and within the bounds of each of their practices.'' RD, at 6; Tr. 
55-56.
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    After a year of monitoring, the MBC and Respondent reached an 
agreement that resulted in restrictions being placed on Respondent's 
medical license for seven years. RD, at 18; Tr. 242-43. The conditions 
included ``all of the conditions that [she] was currently doing and 
then a few more.'' RD, at 18; Tr. 243, 246-47; RX 2. Respondent 
testified that she was ``100 percent'' compliant with the terms of her 
probation. RD, at 19; Tr. 247-48. After approximately four years on 
probation, her probation agent suggested that she apply for early 
termination. Id. Respondent testified that she delayed her application 
for early termination because she was very comfortable in the routine 
that she had developed with PAG and AA, and she felt safe having their 
support. RD, at 19; Tr. 250-51. However, Respondent eventually applied 
for early termination, and her probation terminated on December 31, 
2020. RD, at 19; Tr. 249, 252; RX 4.
    During the time that Respondent was on probation with the MBC, she 
also entered into a Memorandum of Agreement (MOA) with DEA that allowed 
her to retain authority in Schedules II-V as long as she abided by the 
MBC's restrictions, which included limiting her registration to 
prescribing and administering controlled substances in a perioperative 
or obstetric setting. RD, at 19; Tr. 252-53; RX 3. Respondent testified 
that she fully complied with the DEA restrictions, which terminated in 
December of 2020 along with her MBC probation. RD, at 19; Tr. 254-56.
    In January of 2021, less than 30 days after the MBC's and DEA's 
restrictions were lifted, Respondent relapsed and resumed diverting 
controlled substances from her employer for personal use.\7\ RD, at 19; 
Tr. 256-57. Respondent's relapse lasted from January 2021 to March 
2021, and she recalled diverting fentanyl, midazolam, and hydromorphone 
on at least ten occasions for intravenous use. RD, at 19; Tr. 257-58. 
Respondent testified that she diverted mostly ``waste'' controlled 
substances that were not used during a procedure and should have been 
discarded.\8\ Id. Respondent deceived the nurses by telling them that 
she was disposing of the ``waste'' substances, when instead she was 
disposing of saline. Id. On other occasions, Respondent overprescribed 
controlled substances to patients, or falsely documented that she had 
administered a controlled substance to a patient, and retained the 
excess for herself.\9\ RD, at 19-20; Tr. 300. Respondent used the 
diverted controlled substances at home or in the call room where she 
worked at St. John's hospital. RD, at 20; Tr. 258. On March 26, 2021, 
Respondent was found unconscious in the hospital bathroom after having 
unintentionally overdosed on fentanyl, midazolam, and propofol that she 
had falsely documented that she had given to a patient during her 
shift.\10\ RD, at 20-21; Tr. 298-300.
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    \7\ Respondent testified that the circumstances that 
precipitated her relapse included stress related to the second wave 
of the COVID-19 pandemic, wanting to spend more time with her 
family, sporadic shifts, and mounting anger and resentment towards 
her boss relating to his scheduling decisions. RD, at 20; Tr. 258-
59, 296-97. Respondent also testified that around the time of her 
relapse, she was attending AA meetings via Zoom video 
teleconferencing, not in person, due to COVID-related stress. RD, at 
20; Tr. 259. Respondent testified that she ``basically had no 
accountability'' with the lack of a ``solid'' AA program. RD, at 20; 
Tr. 259-60. Respondent testified that on the day of her overdose, 
she received a text message from her boss that he would not give her 
future shifts if she did not cancel a long-scheduled vacation. RD, 
at 20-21; Tr. 260-61, 298. Additionally, her last case of the day 
involved a ``code crimson,'' where hospital staff must engage in a 
hasty blood transfusion. RD, at 21; Tr. 299.
    \8\ Respondent testified that she never took medication that was 
necessary to treat a patient. RD, at 19; Tr. 300.
    \9\ Respondent admitted that overprescribing controlled 
substances to a patient and diverting the excess could have an 
impact on the actions of another doctor reviewing the patient's file 
at a later time. RD, at 20; Tr. 335-36. However, she testified that 
it is standard practice for anesthesiologists to titrate the dose 
until the desired respiratory rate is achieved, which would mitigate 
the potential harms of overprescribing. Id.
    \10\ DEA Diversion Investigator Yekaterina Blissard (DI) 
testified that DEA received an anonymous tip in August of 2022 
alleging that Respondent was found unconscious in a hospital 
bathroom in March of 2021 ``with an IV still attached to her hand'' 
and controlled substances on her person. RD, at 4; Tr. 16.
    DI's testimony primarily focused on the introduction of the 
Government's documentary evidence and her interactions with 
Respondent following the anonymous tip. RD, at 5. The Agency agrees 
that DI's testimony was ``generally consistent,'' that ``there was 
no indication that she harbors any animosity towards the 
Respondent,'' and that she has no personal stake in this proceeding. 
Id.
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    Respondent's testimony about the restrictions that the MBC placed 
on her registration after her 2021 relapse is summarized below. See 
infra III.B.

II. Discussion

A. The Five Public Interest Factors

    Under the CSA, ``[a] registration . . . to . . . dispense a 
controlled substance . . . may be suspended or revoked by the Attorney 
General upon a finding that the registrant . . . has committed such 
acts as would render his registration under section 823 of this title 
inconsistent with the public interest as determined under such 
section.'' 21 U.S.C. 824(a). In making the public interest 
determination, the CSA requires consideration of the following factors:

    (A) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (B) The [registrant's] experience in dispensing, or conducting 
research with respect to controlled substances.
    (C) The [registrant's] conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (D) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (E) Such other conduct which may threaten the public health and 
safety.

21 U.S.C. 823(g)(1).
    The Agency considers these public interest factors in the 
disjunctive. Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (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 37,507, 
37,508 (1993).
    The Government has the burden of proof in this proceeding. 21 CFR 
1301.44. While the Agency has considered all of the public interest 
factors in 21 U.S.C. 823(g)(1), the Government's evidence in support of 
its prima facie case for revocation of

[[Page 75569]]

Respondent's registration is confined to Factors B and D. RD, at 26-31; 
see also id. at 26 n.33 (finding that Factors A, C, and E do not weigh 
for or against revocation).\11\ Having reviewed the record and the RD, 
the Agency adopts the ALJ's analysis, and agrees that the Government's 
evidence satisfies its prima facie burden of showing that Respondent's 
continued registration would be ``inconsistent with the public 
interest.'' 21 U.S.C. 824(a)(4); RD, at 25-31.
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    \11\ Respondent argues that Factor A weighs in her favor because 
the MBC considered her misconduct and put her on probation rather 
than revoking her state medical license. ALJ Exhibit (ALJX) 29, at 
29. Prior Agency decisions have considered two forms of 
recommendations from state licensing entities: ``(1) A 
recommendation to DEA directly from a state licensing board or 
professional disciplinary authority . . . , which explicitly 
addresses the granting or retention of a [Registration]; 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.'' 
John O. Dimowo, M.D., 85 FR 15,800, 15,810 (2020). Here, the MBC has 
not made a direct recommendation to DEA, but the MBC has considered 
the same misconduct alleged in the OSC and entered into a Stipulated 
Interim Order (Interim Order) with Respondent substantially 
restricting her registration. The Interim Order is not a final 
decision by the MBC, it does not contain final legal conclusions or 
factual findings, and it clarifies that any admissions regarding 
Respondent's conduct are not admissible in administrative 
proceedings. RX 12, at 3 (``The parties stipulate that the 
admissions made by Respondent as to the alleged conduct . . . are 
solely for the purpose of this stipulated Interim Order Imposing 
License Restrictions only, and shall not be used in any other 
proceeding before the [MBC], and shall not be admissible in any 
other criminal, civil, and/or administrative proceeding.''). 
Moreover, the Order does not analyze whether Respondent's continued 
registration is consistent with the public interest under the CSA, 
which is a determination that the Agency must make in deciding 
whether to sanction a registrant. Id. at 15,810 (citing Ajay S. 
Ahuja, M.D., 84 FR 5479, 5490 (2019)). Thus, the Agency finds that 
this Order is not determinative.
    Regarding Factor C, the Agency does not consider Respondent's 
2009 felony conviction as part of the public interest analysis 
because the Government did not allege that the conviction was a 
basis for revocation. RD, at 26 n.33. Finally, regarding Factor E, 
the absence of evidence of ``other conduct which may threaten the 
public health and safety'' does not militate for or against a 
finding that Respondent's registration is inconsistent with the 
public interest. Id.
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B. Factors B and D

    Evidence is considered under Public Interest Factors B and D when 
it reflects compliance (or non-compliance) with laws related to 
controlled substances and experience dispensing controlled substances. 
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D., 
87 FR 21,156, 21,162 (2022). In the current matter, the Government has 
alleged that Respondent violated numerous federal and state laws 
regulating controlled substances. OSC, at 1-2. Specifically, federal 
law requires that ``[a] prescription for a controlled substance to be 
effective must be issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of his professional 
practice.'' 21 CFR 1306.04(a).\12\ California law provides that ``no 
person shall knowingly prescribe, administer, dispense, or furnish a 
controlled substance to or for any person . . . not under his or her 
treatment for a pathology or condition.'' Cal. Health & Safety Code 
Sec.  11154(a). California law also provides that ``no person shall 
prescribe, administer, or furnish a controlled substance for himself.'' 
Id. at Sec.  11170. Further, California law defines unprofessional 
conduct to include ``[p]rescribing, dispensing, or furnishing 
[controlled substances] without an appropriate prior examination and a 
medical indication'' and ``commi[ting] [ ] any act involving dishonesty 
or corruption that is substantially related to the qualifications, 
functions, or duties of a physician and surgeon.'' Cal. Bus. & Prof. 
Code Sec. Sec.  2242(a), 2234.
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    \12\ The Agency need not adjudicate the criminal violations 
alleged in the instant OSC. Ruan v. United States, 142 S. Ct. 2370 
(2022) (decided in the context of criminal proceedings).
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    In the current matter, Respondent admitted that she diverted 
controlled substances for her own personal use on at least ten 
occasions between January 2021 and March 2021. The parties stipulated 
that these acts of diversion occurred and that Respondent's conduct 
weighs against her under Factors B and D.\13\ As Respondent's conduct 
displays clear violations of the federal and state regulations 
described above, the Agency agrees with the ALJ and finds that 
Respondent repeatedly violated federal and state law relating to 
controlled substances. RD, at 41. Accordingly, the Agency agrees with 
the ALJ and finds that Factors B and D weigh in favor of revoking 
Respondent's registration, and thus finds Respondent's continued 
registration to be inconsistent with the public interest in balancing 
the factors of 21 U.S.C. 823(g)(1).
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    \13\ RD, at 2; Stipulation 3, 4 (``[Respondent] acknowledges 
that her conduct reflects negative experience in dispensing with 
respect to controlled substances in violation of 21 U.S.C. 
823(g)(1)(B).''), 5 (``[Respondent] failed to comply with applicable 
federal and state laws relating to controlled substances in 
violation of 21 U.S.C. 823(g)(1)(D).''), 6.
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III. Sanction

    Where, as here, the Government has established sufficient grounds 
to revoke Respondent's registration, the burden shifts to Respondent to 
show why she can be entrusted with the responsibility carried by a 
registration. Garret Howard Smith, M.D., 83 FR 18,882, 18,904 (2018). 
When a registrant has committed acts inconsistent with the public 
interest, she must both accept responsibility and demonstrate that she 
has undertaken remedial measures. Holiday CVS, L.L.C., dba CVS Pharmacy 
Nos 219 and 5195, 77 FR 62,316, 62,339 (2012). Trust is necessarily a 
fact-dependent determination based on individual circumstances; 
therefore, the Agency looks at factors such as the acceptance of 
responsibility, the credibility of that acceptance as it relates to the 
probability of repeat violations, the nature of the misconduct that 
forms the basis for sanction, and the Agency's interest in deterring 
similar acts. See, e.g., Robert Wayne Locklear, M.D., 86 FR 33,738, 
33,746 (2021).

A. Acceptance of Responsibility

    Here, the Agency agrees with the ALJ that Respondent unequivocally 
accepted responsibility for her conduct and expressed genuine remorse 
for her actions. RD, at 31-35. Respondent fully accepted responsibility 
for the allegations outlined in the OSC, as well as her misconduct in 
2009 and 2013, and agreed that she violated state and federal law. Id. 
at 22, 33; Tr. 332, 327. Respondent testified that, for her, accepting 
responsibility means making ``living amends'' and not ``minimizing'' 
her actions. RD, at 33; Tr. 345-46. She feels ``profound regret'' for 
her relapse, but she is ``trying to use [that regret] as a tool for 
good.'' RD, at 22; Tr. 326-27. Respondent testified that her actions 
were egregious because she was dishonest, she ``violated the trust of 
patients and nurses,'' she ``potentially'' hurt patients, she knew 
better, and she failed to use her available resources to get help. RD, 
at 23; Tr. 346. Respondent's willingness to reflect on her battle with 
addiction in a public forum is admirable, and the Agency agrees with 
the ALJ that Respondent unequivocally accepted responsibility for her 
misconduct. RD, at 31-35.

B. Remedial Measures

    Having found that Respondent has unequivocally accepted 
responsibility for her conduct, the Agency considers whether Respondent 
has implemented sufficient remedial measures to demonstrate that she 
will not engage in future misconduct and can be trusted with a 
registration. Jayam Krishna-Iyer, M.D., 74 FR 459, 463 (2009). The 
Agency has acknowledged that ``[i]n self-abuse cases, . . . successful 
rehabilitation efforts are an important consideration in determining 
whether a respondent can be trusted with a registration.'' Trenton F. 
Horst, D.O., 80 FR 41,079, 41,091 (2015); see also Abbas E. Sina, M.D., 
80 FR 53,191, 53,201

[[Page 75570]]

(2015) (``[T]he risk of relapse becomes critical in determining what 
steps are warranted when determining the public interest.'')
    Respondent testified at length about the measures that she has 
taken, and will continue to take, to remain sober. These measures were 
implemented after Respondent was caught diverting from her employer in 
2021, and they are mandatory under the terms of her agreements with the 
MBC and/or St. John's Hospital (her current employer), which diminishes 
their weight as remedial evidence.\14\ However, the Agency appreciates 
that the measures that Respondent is required to take under her 
agreements with the MBC and St. John's hospital are extensive, leaving 
little room for Respondent to implement additional voluntary measures. 
The Agency also appreciates that Respondent has made a sincere 
commitment to remaining sober for herself, and not just for her 
employer. Tr. 341. Thus, the Agency considers Respondent's remedial 
measures in determining whether Respondent can be trusted with a DEA 
registration.
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    \14\ The Agency has held that remedial measures are given 
``limited-to-no-weight'' when they are implemented after enforcement 
begins. See, e.g., Morris & Dickson Co., LLC, 88 FR 34,523 (2023) 
(citing Mireille Lalanne, M.D., 78 FR 47,750, 47,777 (2013) (``The 
Agency has recognized that a cessation of illegal behavior only when 
`DEA comes knocking at one's door,' can be afforded a diminished 
weight borne of its own opportunistic timing.''); Southwood 
Pharmaceuticals, Inc., 72 FR 36,487, 36,503 (2007) (giving no weight 
to respondent's ``stroke-of-midnight decision'' to cease supplying 
suspect pharmacies with controlled substances and to employ a 
compliance officer). This principle applies in even greater force 
here, where the remedial measures that Respondent has implemented 
appear to be mandatory under an agreement with the state medical 
board rather than voluntary.
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Summary of Respondent's Remedial Measures
    After her overdose in March of 2021, Respondent was put on a 
medical leave of absence and began a new 30-day inpatient treatment 
program at the Betty Ford Center. RD, at 21; Tr. 302-04. Following her 
discharge from Betty Ford in May of 2021, she completed another three-
month outpatient addiction program. RD, at 21; Tr. 304-05, 307-09.
    On August 2, 2023, Respondent entered into a restrictive agreement 
with the MBC (the 2023 MBC Agreement) that allows her to continue 
practicing anesthesia as long as she: (1) abstains from using drugs and 
alcohol, (2) enlists a licensed physician to monitor her at work, (3) 
remains enrolled in the PAG program, (4) attends weekly substance abuse 
support group meetings, (5) receives psychotherapy, (6) submits to 
regular biological fluid testing (drug testing), and (7) notifies all 
of her employers about the MBC Agreement. RD, at 21-22; Tr. 323-24; RX 
12, at 4-10. The MBC agreement allows Respondent to order, prescribe, 
and dispense controlled substances in a perioperative setting. RD, at 
22; Tr. 324; RX 12 at 4.
    Respondent testified that she currently attends AA meetings five 
times per week and PAG meetings twice per week (more than is required 
by the MBC Agreement). RD, at 21; Tr. 309. Respondent has completed the 
AA 12-Step Program and remains in the ``maintenance steps,'' 10, 11, 
and 12.\15\ RD, at 21; Tr. 309.
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    \15\ Respondent described the ``maintenance steps'' as steps to 
avoid complacency by focusing on recognition of present feelings and 
emotions, faith and meditation, and outreach to others in recovery 
and service. RD, at 21; Tr. 309-10.
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    Respondent's return to work following her relapse began in November 
of 2021 at UrgentMed urgent care, where she worked through the spring 
of 2023.\16\ RD, at 21; Tr. 168, 315. In August of 2022, Respondent 
resumed practicing as an anesthesiologist at St. John's Hospital, where 
her continued employment is conditioned upon compliance with a Return 
to Practice Agreement (the St. John's Practice Agreement). RD, at 21; 
Tr. 315-18; RX 9. In addition to the requirements outlined above in the 
2023 MBC Agreement, the St. John's Practice Agreement also requires 
Respondent to continue treatment with naltrexone (or an equivalent 
medication), to notify the hospital of any outside employment, and to 
maintain records of controlled substances ordered, prescribed, 
dispensed, administered, or possessed. RX 9, at 1-3. The St. John's 
Practice Agreement also included restrictions that remained in place 
for a limited period of time, including proctoring for at least three 
cases, limitations on the number of shifts and hours worked, and 
evaluation by a board-certified addiction physician.\17\ Id. Respondent 
is currently working a full 40-hour per week schedule. RD, at 21; Tr. 
318-19.
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    \16\ The Medical Director of UrgentMed, Dr. Peter Chung, 
testified that there were no complaints about Respondent's treatment 
of patients and she received only positive feedback from patients 
and colleagues. RD, at 14; Tr. 175. The Agency agrees with the ALJ 
that Dr. Chung's testimony was ``genuine and generally consistent, 
though the subject matter of his testimony is of limited relevance 
to these proceedings.'' RD, at 13. The ALJ stated that ``where 
relevant[,] [he would] give [Dr. Chung's] testimony the weight that 
it deserves in light of other evidence and testimony presented 
during the hearing.'' Id. The Agency agrees with the amount of 
weight that the ALJ afforded Dr. Chung's testimony.
    \17\ Dr. James Golden, a California-licensed physician who is 
Board certified in addiction medicine, evaluated Respondent 
following her relapse in 2021. RD, at 11-12; Tr. 124-26. Dr. Golden 
testified that he initially determined that Respondent was fit to 
work twenty or thirty hours a week, because she has a ``propensity 
to have problems when she [feels] overwhelmed.'' RD, at 12; Tr. 124-
29. After additional meetings with Respondent, Dr. Golden has 
increased his recommended limitation to forty hours per week. RD, at 
12; Tr. 130. Dr. Golden agreed that even physicians being monitored 
can relapse, but testified that relapse is less likely the longer a 
physician is in recovery and subject to monitoring. RD, at 12; Tr. 
132-33. Dr. Golden further testified that Respondent ``stands out 
[to him] as someone who is very committed'' to her recovery program 
with a ``willingness to continue with recovery.'' RD, at 12; Tr. 
135-36. Dr. Golden expressed support for the Respondent's continued 
DEA registration and medical practice ``so long as she is being 
monitored under the terms imposed by the Medical Board of 
California.'' RD, at 12; Tr. 137.
     The Agency agrees with the ALJ that Dr. Golden's testimony was 
``was genuine and generally consistent, though the bases for his 
recommendations and conclusions were not addressed in much detail.'' 
RD, at 12. The ALJ determined that Dr. Golden's testimony was 
``credible and [he would] give it appropriate weight.'' Id. The 
Agency agrees with the amount of weight that the ALJ afforded Dr. 
Golden's testimony.
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    Respondent offered eight witnesses to testify about Respondent's 
commitment to remaining sober, her success in remaining sober from 2013 
to 2020 while being monitored by PAG, and their belief that there is a 
high likelihood that Respondent will remain sober under her current 
monitoring program. RD, at 6-17; Tr. 50-217.
    Tracy Zemansky, Ph.D., is a clinical psychologist and one of seven 
practitioners who owns and operates PAG.\18\ RD, at 6; Tr. 50, 55-56. 
Dr. Zemansky was accepted as an expert in psychology, specializing in 
the field of physician impairment, evaluation, and recovery. RD, at 6; 
Tr. 57-58. Dr. Zemansky has known Respondent since November of 2013, 
when Respondent initially enrolled in PAG after being caught diverting 
drugs from her employer the first time. RD, at 6; Tr. 58, 61. Dr. 
Zemansky has also been involved in monitoring Respondent since her 
relapse in 2021.
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    \18\ The Agency agrees with the ALJ that Dr. Zemansky 
``presented credible testimony that was internally consistent and 
generally logically persuasive'' and that she ``presented an 
objective analysis'' despite her ``close therapeutic relationship 
with the Respondent.'' RD, at 11. The Agency also agrees with the 
ALJ that Dr. Zemansky's testimony is entitled to significant weight. 
Id.
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    Dr. Zemansky testified that, in her expert opinion, Respondent 
remains safe to practice as a physician and safe to prescribe 
controlled substances. RD, at 9; Tr. 84-85, 94, 107-08. Dr. Zemansky 
testified that the stressors that led to Respondent's relapse in 2021 
are a new focus of her recovery plan, and that her commitment to 
recovery is

[[Page 75571]]

sincere. RD, at 7-8, 11; Tr. 80, 101-04. Although Dr. Zemansky agreed 
that new and unforeseen stressors could cause a future relapse, she 
opined that having already gone through an extremely stressful 
situation resulting in relapse, Respondent now has additional tools 
that will help her remain sober. RD, at 11; Tr. 104-05. Dr. Zemansky 
testified that Respondent is being monitored closely by St. John's 
well-being committee, and that PAG provides St. John's with monthly 
compliance reports. RD, at 9; Tr. 81-82. Dr. Zemansky testified that 
Respondent has not had any positive drug tests or missed any 
appointments since resuming monitoring with PAG, and that Respondent 
has been sober since March of 2021. RD, at 7-8; Tr. 69-72, 74. Dr. 
Zemansky also highlighted that Respondent was fully compliant with her 
probation during her initial eight years of monitoring with PAG from 
2013 to 2020, and that she ``went above and beyond what was required in 
terms of her attitude . . . [and] involvement in outside recovery.'' 
RD, at 6-7, 9; Tr. 62-64; Tr. 84-85, 99-100.
    Dr. Zemansky opined that physicians in monitoring are ``actually 
safer than physicians'' who are not being monitored, because ``we don't 
know what [the unmonitored physicians] are doing.'' RD, at 9; Tr. 81-
82. However, Dr. Zemansky acknowledged that there is ``always'' a 
chance for relapse, and that relapse can occur even with monitoring, 
though rare. RD, at 9; Tr. 87-88.
    Dr. Zemansky testified that she supported Respondent's request for 
early termination of her probation in December of 2020. RD, at 9-10; 
Tr. 86-87, 105-06. At that time, Dr. Zemansky offered testimony on 
Respondent's behalf in front of the MBC stating that she believed that 
Respondent had an excellent prognosis for continued success and that 
she had no reservations about terminating Respondent's probation. Tr. 
86-87. At the DEA hearing, Dr. Zemansky acknowledged that she regrets 
her decision to support the removal of all monitoring requirements in 
December of 2020, and she characterized Respondent's relapse in January 
of 2021 as ``brief but quite severe.'' Tr. 87, 106-07. Dr. Zemansky 
testified that she ``wish[es] that [she] had been able to foresee 
differently.'' Tr. 107.
    Dr. W. Lee Wan,\19\ a California-licensed ophthalmologist and Chair 
of the Well-Being Committee at St. John's, testified that the Well-
Being Committee has assumed an active role in monitoring Respondent 
since her 2021 relapse.\20\ RD, at 16; Tr. 205-06. Dr. Wan testified 
that Respondent has remained compliant with the St. John's Practice 
Agreement. RD, at 17; Tr. 215. Dr. Wan supports Respondent's continued 
ability to practice as an anesthesiologist and continued DEA 
registration, and testified that he believes Respondent remains fit for 
duty. RD, at 17; Tr. 217, 221-22. However, Dr. Wan agreed that there is 
always a chance that an ``addicted physician'' will relapse. Tr. 217-
18.\21\
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    \19\ The Agency agrees with the ALJ that Dr. Wan's testimony was 
``generally credible and consistent.'' RD, at 17. The ALJ found 
that, ``where relevant [he would] give his testimony the weight that 
it deserves in light of other evidence and testimony presented 
during the hearing.'' Id. The Agency agrees with the amount of 
weight that the ALJ afforded Dr. Wan's testimony.
    \20\ Dr. Wan testified that Respondent was not being formally 
monitored by the Well-Being Committee when she relapsed in 2021. RD, 
at 16; Tr. 206-07. Dr. Wan is not aware of any patient complaints or 
other issues in the seven or eight years that Respondent worked at 
St. John's prior to relapsing. Id.
    \21\ Respondent offered the testimony of four additional 
colleagues and friends who support the continuation of her 
registration: Kathleen Van Daalen Wetter, Kimrae McDonald, Dr. Karen 
Simon, and Dr. Bahram Namdari. Ms. Wetter has been Respondent's AA 
sponsor for the past two years and interacts with her daily. RD, at 
13. Ms. Wetter believes that Respondent has the ``perfect attitude 
needed to continue to stay clean and sober,'' and ``[s]he remains 
open, willing, and honest about her recovery.'' Id.; Tr. 147. Ms. 
McDonald, a nurse who works with Respondent at St. John's, testified 
that Respondent has a stellar reputation and she unequivocally 
supports Respondent's ability to continue practicing as an 
anesthesiologist. RD, at 13; Tr. 150-159. Dr. Simon, another 
colleague at St. John's, testified that she has known Respondent for 
15 years, but was unaware of Respondent's substance abuse history 
until these proceedings. RD, at 15; Tr. 193-97. Dr. Simon testified 
that since 2021 she has not observed Respondent appear impaired 
while at work, and that she and Respondent have ``an excellent 
working relationship.'' RD, at 15; Tr. 198. Dr. Simon testified that 
Respondent's practice at St. John's is very busy and regularly 
involves emergency care, and that Respondent's performance is 
``excellent'' under those stressful conditions. RD, at 15-16; Tr. 
199. Dr. Namdari, a California-licensed anesthesiologist, testified 
that he has worked with Respondent at St. John's since 2015 and 
interacts with her nearly every workday as her workplace monitor. 
RD, at 15; Tr. 183-89. Dr. Namdari testified that since returning to 
work at St. John's following her relapse, Respondent has had no 
issues, she is ``doing a great job,'' and ``patients are happy.'' 
RD, at 15; Tr. 188. Dr. Namdari supported Respondent's ability to 
continue administering controlled substances with monitoring in 
place. RD, at 15; Tr. 189.
    The Agency agrees with the ALJ that the testimony of Ms. 
Wetters, Ms. McDonald, Dr. Simon, and Dr. Namdari was ``genuine and 
generally consistent[,] though the subject matter of [their] 
testimony is of minimal relevance to these proceedings.'' RD, at 13-
16. The Agency agrees with the amount of weight that the ALJ 
afforded these witnesses' testimony.
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    Based on this evidence, the ALJ found that Respondent had 
``produced significant, unrebutted evidence showing that she is capable 
of complying with the terms of licensing restrictions and monitoring,'' 
and concluded that the Agency can trust Respondent to handle controlled 
substances as long as these rehabilitative measures remain in place. 
RD, at 35, 38-39. The ALJ did observe, however, that the length of time 
between the end of Respondent's probation in December of 2020 and her 
relapse in January of 2021 was ``especially concerning.'' Id. at 39.
    The Agency agrees with the ALJ that the likelihood of Respondent 
relapsing is reduced if Respondent remains under strict monitoring. 
However, the record in this case establishes that relapse is always 
possible.\22\ Respondent's expert witness, Dr. Zemansky, acknowledged 
this, and even admitted that she did not foresee Respondent's severe 
relapse in 2021. Thus, in assessing the adequacy of Respondent's 
remedial measures, the Agency must weigh the reduced risk of relapse 
against the serious and unmitigable risk that Respondent poses to the 
public if she relapses on the job again. Respondent works with patients 
while they are heavily sedated or unconscious--in their most vulnerable 
state. The practice of anesthesia requires careful focus and continuous 
monitoring, as Respondent testified that medication is titrated during 
a procedure in small doses until the desired respiratory rate is 
achieved. RD, at 20 n.30; Tr. 335-39. During Respondent's previous 
episodes of abuse and diversion, she treated patients for months at a 
time while under the influence, deceiving her colleagues and falsifying 
patient records to obtain more drugs. Although there was no evidence 
demonstrating that Respondent harmed any patients during her previous 
relapses, Respondent concedes that her conduct put patients at risk and 
could have caused harm. RD, at 20; Tr. 327-28, 337.
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    \22\ Several of Respondent's witnesses acknowledged that relapse 
is possible (although rare) when physicians are being monitored for 
substance abuse. See RD, at 9-10; Tr. 87-88, 106-07 (Dr. Zemansky's 
testimony); see also RD, at 12; Tr. 132-33 (Dr. Golden's testimony); 
RD, at 17; Tr. 217-18 (Dr. Wan's testimony).
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    The Agency finds that Respondent has presented substantial evidence 
of remedial measures and acknowledges that Respondent has taken 
admirable steps towards continued sobriety; but continued sobriety is 
not guaranteed. Moreover, the agency has long held that ``past 
performance is the best predictor of future performance.'' ALRA Labs, 
Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995). Here, where Respondent 
had a ``severe'' relapse one month after the prior

[[Page 75572]]

restrictions to her controlled substances authority were lifted, the 
Agency is not confident that it can trust Respondent with the 
continuation of her registration even with the remedial measures in 
place.

C. Deterrent Effect and Egregiousness

    Acceptance of responsibility and remedial measures are assessed in 
the context of the ``egregiousness of the violations and the [DEA's] 
interest in deterring similar misconduct by [the] Respondent in the 
future as well as on the part of others.'' Daniel A. Glick, D.D.S., 80 
FR 74,800, 74,810 (2015); OakmontScript Limited Partnership, 87 FR 
21,546, 21,545 (2022). Here, although Respondent accepted 
responsibility and expressed a genuine commitment to ensuring that she 
does not relapse again, she has a long history of violating federal and 
state laws related to controlled substances. DEA has shown leniency in 
the past by allowing Respondent to retain her registration after her 
previous offenses, but Respondent reverted back to intentionally 
diverting from her employer less than 30 days after DEA's and the MBC's 
restrictions were lifted, and she continued diverting for several 
months until she was caught. Thus, the Agency finds that considerations 
of specific deterrence weigh in favor of revocation. The Agency also 
finds that the interests of general deterrence support revocation. A 
decision to maintain Respondent's registration after repeated behavior 
of intentionally diverting from her employer and violating other 
controlled substance laws would send a message to the registrant 
community that repeated acts of intentional diversion can be overlooked 
or excused as long as the Respondent accepts responsibility when 
confronted.
    The egregiousness of Respondent's conduct also supports a sanction 
of revocation.\23\ Respondent engaged in prolonged and repeated acts of 
intentional diversion, involving deception, theft, and falsifying 
patient records, that ``strike[] at the CSA's core purpose.'' Samuel 
Mintlow, M.D., 80 FR 3630, 3653 (2015). In this case, the Agency 
believes that revocation of Respondent's registration would encourage 
the general registrant community to seek help as soon as possible upon 
experiencing substance abuse problems, in order to avoid violating the 
Agency's trust by engaging in repeated and intentional diversion.
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    \23\ The ALJ concluded that Respondent's conduct was egregious, 
but found that there were two factors that mitigated the 
egregiousness: first, that Respondent's addiction problems ``greatly 
impacted her decision-making leading to her deceptive actions,'' and 
second, that the record is devoid of evidence that Respondent 
directly harmed her patients. RD, at 37-38. The Agency agrees that 
the first factor could be mitigating in certain circumstances, but 
finds that the weight of the evidence supports a sanction of 
revocation, as discussed throughout this Order. Regarding the second 
factor, the Agency does not consider the lack of evidence of harm to 
be a mitigating factor because of the significant risk to public 
health and safety that Respondent posed while treating patients 
under the influence. The Agency has repeatedly held that it is not 
necessary for the Agency to find patient harm to revoke a 
registration and has declined to consider a lack of harm as evidence 
of positive prescribing experience. See, e.g., Larry C. Daniels, 
M.D., 86 FR 61630, 61660-61 (2021) (``Waiting for a controlled 
substance to be found coursing through a person's bloodstream before 
holding the registrant accountable is wholly at odds with the DEA's 
responsibility to protect the public interest under 21 U.S.C. 
823(f).''); Jeanne E. Germeil, M.D., 85 FR 73786, 73799 n.32 (2020) 
(``I decline to consider that `no reported overdoses or deaths' is 
an indicator of positive dispensing experience and there is no legal 
authority for the proposition that I must find death or an overdose 
before I may suspend or revoke a registration.'').
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    Respondent agrees that her misconduct was egregious, but she cites 
in her Post-Hearing Brief to several cases where the Agency has allowed 
physicians to retain restricted registrations despite intentional and 
egregious violations of the CSA. ALJX 29, at 34-36. However, most of 
the cases that Respondent cites were decided more than 20 years ago, 
before the opioid epidemic surged.\24\ The Agency has since departed 
from some of its more lenient sanction policies, citing the need to 
protect the public from abuse and diversion. For example, in Jayam 
Krishna-Iyer, the Agency noted that ``[b]ecause of the grave and 
increasing harm to public health and safety caused by the diversion of 
prescription controlled substances,'' it would no longer allow 
registrants who intentionally diverted controlled substances to retain 
their registrations if they declined to accept responsibility. Jayam 
Krishna-Iyer, M.D., 74 FR 459, 463 (2009). In Southwood and Gaudio, the 
Agency further clarified that it would consider the deterrent effect of 
a potential sanction, in addition to requiring registrants to accept 
responsibility and demonstrate that they could be trusted with a 
registration. Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 
(2007); Joseph Gaudio, M.D., 74 FR 10083, 10094 (2009). Although the 
Agency has issued decisions within the past decade maintaining or 
granting restricted registrations notwithstanding intentional and 
egregious violations of the CSA,\25\ the Agency considers the unique 
facts of each case in determining the appropriate sanction. In this 
case, there are significant factors weighing against continuing 
Respondent's registration, including the recurrent nature of her 
misconduct, the severity of her relapse, the substantial danger that 
she will pose to the public if she relapses again, the high level of 
deception involved in her diversion, and the speed with which 
Respondent resumed her unlawful behavior after DEA and the MBC lifted 
their restrictions in December of 2020.
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    \24\ See ALJX 29, at 34-36 (citing Judy L. Henderson, D.V.M., 65 
FR 5672 (2000); Theodore Neujahr, D.V.M., 65 FR 5680 (2000); Jimmy 
H. Conway, Jr., M.D., 64 FR 32271 (DEA 1999); Robert G. Hallermeier, 
M.D., 62 FR 26,818 (1997); Karen A. Kruger, M.D., 69 FR 7016 (2004) 
Jeffrey Martin Ford, D.D.S., 68 FR 10750 (2003)).
    \25\ See, e.g., Abbas E. Sina, M.D., 80 FR 53191 (2015) 
(physician with a long history of abusing alcohol, controlled 
substances, and illicit drugs allowed to retain a restricted 
registration, despite repeated acts of issuing unlawful 
prescriptions, because he unequivocally accepted responsibility for 
his misconduct and demonstrated that he had successfully complied 
with substance abuse monitoring for four years); Trenton F. Horst, 
D.O., 80 FR 41079 (2015) (physician with a history of self-abuse 
granted a restricted registration, despite repeatedly issuing 
unlawful prescriptions and possessing methamphetamine without a 
prescription, after expressing true remorse for his actions and 
demonstrating compliance with a substance abuse treatment plan for 
seven months).
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    Respondent also argues that revocation is not necessary for 
purposes of deterrence, and that revoking Respondent's registration 
would ``send[ ] the wrong message to impaired physicians'' that ``if 
you are open, honest, and admit to abusing or diverting controlled 
substances and seek help, you may have your DEA registration revoked.'' 
ALJX 29, at 36. However, this record establishes that DEA did show 
leniency to Respondent previously, in 2013, which should give addicted 
registrants hope that by accepting responsibility and remediating their 
actions they too may be shown leniency for CSA violations. Rather, this 
decision is meant to encourage recovering registrants to continue to 
follow the CSA and avoid diversion even after DEA lifts any 
restrictions. Moreover, Respondent did not admit to abusing or 
diverting controlled substances and seek help until after she was 
confronted by her employer in both 2013 and 2021. If she had 
immediately sought help after relapsing in January of 2021, rather than 
diverting from her employer for several months until getting caught, 
Respondent's argument regarding deterrence may have been more 
persuasive.
    In sum, Respondent has not offered sufficient credible evidence on 
the record to rebut the Government's case for revocation and Respondent 
has not demonstrated that she can be entrusted

[[Page 75573]]

with the responsibility of registration. Accordingly, the Agency will 
order that Respondent's registration be revoked.

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 No. 
FV3660037 issued to Mary A. Vreeke, M.D. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I 
hereby deny any pending applications of Mary A. Vreeke, M.D. to renew 
or modify this registration, as well as any other pending application 
of Mary A. Vreeke, M.D., for additional registration in California. 
This Order is effective October 16, 2024.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
September 10, 2024, by Administrator Anne Milgram. That document with 
the original signature and date is maintained by DEA. For 
administrative purposes only, and in compliance with requirements of 
the Office of the Federal Register, the undersigned DEA Federal 
Register Liaison Officer has been authorized to sign and submit the 
document in electronic format for publication, as an official document 
of DEA. This administrative process in no way alters the legal effect 
of this document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-20939 Filed 9-13-24; 8:45 am]
BILLING CODE 4410-09-P