Notice2024-20939
Mary A. Vreeke, M.D.; Decision and Order
Primary source
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Published
September 16, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 89 Issue 179 (Monday, September 16, 2024)</title>
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[Federal Register Volume 89, Number 179 (Monday, September 16, 2024)]
[Notices]
[Pages 75567-75573]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
</pre></body>
</html>Indexed from Federal Register on September 16, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.