Notice2022-01838
Bradley H. Chesler, M.D.; Decision and Order
Primary source
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Published
January 31, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 87 Issue 20 (Monday, January 31, 2022)</title>
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[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4917-4941]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01838]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 20-07]
Bradley H. Chesler, M.D.; Decision and Order
On January 8, 2020, a former Assistant Administrator, Diversion
Control Division, of the Drug Enforcement Administration (hereinafter,
DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to
Bradley H. Chesler, M.D. (hereinafter, Respondent) of Escondido,
California. Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1,
(OSC) at 1. The OSC proposed the revocation of Respondent's DEA
Certificate of Registration No. BC1317165 (hereinafter, COR or
registration) and the denial of any pending application to modify or
renew the registration and any applications for any other DEA
registrations pursuant to 21 U.S.C. 824(a)(4) and 823(f), because
Respondent's ``registration is inconsistent with the public interest.''
Id. (citing 21 U.S.C. 824(a)(4) and 823(f)).
On January 28, 2020, counsel for the Respondent requested a
hearing, which, following a series of continuances due to the COVID-19
pandemic, was conducted August 25, 2020, through September 1, 2020, at
the DEA Hearing Facility in Arlington, Virginia with parties, counsel,
and witnesses participating by video teleconference (VTC). On November
5, 2020, Chief Administrative Law Judge John J. Mulrooney, II
(hereinafter, the Chief ALJ) issued his Recommended Rulings, Findings
of Fact, Conclusions of Law and Decision of the Administrative Law
Judge (hereinafter, Recommended Decision or RD). On December 2, 2020,
the Respondent filed exceptions to the Recommended Decision
(hereinafter, Resp't Exceptions) and on December 15, 2020, the
Government filed its Response to Government's Exceptions (hereinafter
Gov't Response). I address the Respondent's Exceptions in the
Recommendation Section, and throughout the relevant portions of the
record and I issue the final order in this case following the RD. The
ALJ transmitted the record to me on February 19, 2020. Having reviewed
the entire record, I adopt the ALJ's rulings, findings of fact, as
modified, conclusions of law and recommended sanction with minor
modifications, where noted herein. *\A\
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*\A\ I have made minor, nonsubstantive, grammatical changes to
the RD and nonsubstantive conforming edits. Where I have made
substantive changes, omitted language for brevity or relevance, or
where I have added to or modified the Chief ALJ's opinion, I have
noted the edits in brackets, and I have included specific
descriptions of the modifications in brackets or in footnotes marked
with an asterisk and a letter. Within those brackets and footnotes,
the use of the personal pronoun ``I'' refers to myself--the
Administrator.
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Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
*\B\ After carefully considering the testimony elicited at the
hearing, the admitted exhibits, the arguments of counsel, and the
record as a whole, I have set forth my recommendation findings of fact
and conclusions of law below.
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*\B\ I have omitted the RD's discussion of the procedural
history to avoid repetition with my introduction.
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The Allegations
Although, as discussed in greater detail, infra, much of the OSC in
this case is burdened with a drafting peculiarity, it is clear that the
Government's intent is to seek revocation of the Respondent's COR based
on the alleged commission of acts that would render the continuation of
his registration status as being inconsistent with the public interest.
See ALJ Ex. 1 at 1. At principal issue in the case is the Respondent's
controlled substance prescribing as it relates to ten patients. Four of
the patients (collectively, Board Patients) were the subject of
findings by the Medical Board of California, and charts of the other
six patients (collectively, Six Patients) were reviewed by the
Government's medical expert.\1\ On consent of the parties, the OSC in
this matter was amended in accordance with a post-hearing order
granting partial summary disposition. ALJ Ex. 25.
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\1\ Specific patients are referred to by their initials in this
Recommended Decision. The Board Patients include Patients A, B, D,
and E, ALJ Ex. 1 ] 31, while Patients AA, BB, JD, DD, SM, and ET
comprise the Six Patients, id. ]] 8-30. The Government does not
allege that there is any overlap between these two sets of patients.
Id. at 11 n.14.
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The Evidence
Stipulations
The parties entered into factual stipulations which were accepted
prior to the commencement of the hearing. Accordingly, the following
factual matters are deemed conclusively established in this case:
1. The Respondent currently possesses DEA COR No. BC1317165, which
expires by its own terms on August 31, 2020.\2\
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\2\ Inasmuch as the parties agree that the Respondent has
represented that he has made timely application for a renewal of his
COR (ALJ Exs. 39, 40), his registration remains intact pending the
conclusion of these proceedings. See 5 U.S.C. 558(c); 21 CFR
1301.36(i).
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2. The Respondent was issued California Physician and Surgeon
License No. A43963 on August 31, 1987.
3. Alprazolam is a Schedule IV Controlled Substance.
4. Carisoprodol is a Schedule IV Controlled Substance.
5. Fentanyl is a Schedule II Controlled Substance.
6. Hydrocodone is a Schedule II Controlled Substance.
7. Hydromorphone is a Schedule II Controlled Substance.
8. Lorazepam is a Schedule IV Controlled Substance.
9. Morphine is a Schedule II Controlled Substance.
10. Oxycodone is a Schedule II Controlled Substance.
11. Temazepam is a Schedule IV Controlled Substance.
The Government's Case
The Diversion Investigator
The Government presented the evidence of Diversion Investigator
(hereinafter, DI). DI testified that he has been a DI for two and a
half years, the majority of which has been in DEA's San Diego Field
Office. Tr. 45-46. DI was the lead investigator in the case that
culminated in the present charges. Tr. 46-47. He testified that the
investigation into the Respondent began when DEA received information,
around March 2019, from the Medical Board of California that an
accusation was filed against the Respondent for over-prescribing
controlled substances. Tr. 47. DI's testimony was used to authenticate
a number of Government Exhibits,\3\ consisting of documents
[[Page 4918]]
obtained during the course of the investigation. Among the exhibits
introduced through the testimony of DI was an order (Board Order)
issued by the Medical Board of California (MBC or the Board) regarding
the Respondent's treatment of the four Board Patients. See Gov't Ex.
30.
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\3\ Government Exhibit 1 is a print-out of the Respondent's COR.
Gov't Ex. 1. Government Exhibit 2 contains medical records for
Patient AA. Gov't Ex. 2. Government Exhibit 3 comprises
prescriptions for Patient AA, taken from Government Exhibit 2. Gov't
Ex. 3. Government Exhibit 4 contains medical records for Patient BB.
Gov't Ex. 4. Government Exhibit 5 comprises prescriptions for
Patient BB, taken from Government Exhibit 4. Gov't Ex. 5. Government
Exhibit 6 contains medical records for Patient JD. Gov't Ex. 6.
Government Exhibit 7 comprises prescriptions for Patient JD, taken
from Government Exhibit 6. Gov't Ex. 7. Government Exhibit 8
contains medical records for Patient DD. Gov't Ex. 8. Government
Exhibit 9 comprises prescriptions for Patient DD, taken from
Government Exhibit 8. Gov't Ex. 9. Government Exhibit 10 contains
medical records for Patient SM. Gov't Ex. 10. Government Exhibit 11
comprises prescriptions for Patient SM, taken from Government
Exhibit 10. Gov't Ex. 11. Government Exhibit 12 contains medical
records for Patient ET. Gov't Ex. 12. Government Exhibit 13
comprises prescriptions for Patient ET, taken from Government
Exhibit 12. Gov't Ex. 13. Government Exhibit 14 is a CURES report
for Patient AA. Gov't Ex. 14. Government Exhibit 15 is a CURES
report for Patient BB. Gov't Ex. 15. Government Exhibit 16 is a
CURES report for Patient JD. Gov't Ex. 16. Government Exhibit 17 is
a CURES report for Patient DD. Gov't Ex. 17. Government Exhibit 18
is a CURES report for Patient SM. Gov't Ex. 18. Government Exhibit
19 is a CURES report for Patient ET. Gov't Ex. 19. Government
Exhibit 30 is a decision by the California Board concerning the
Respondent. Gov't Ex. 30. Government Exhibit 31 is a report from the
Medical Examiner for Patient AA. Gov't Ex. 31. Government Exhibit 37
is a portion of a CURES report concerning the Respondent, from
November 2019 to August 2020 and pertaining to Patient SM. Gov't Ex.
37.
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DI presented as an objective regulator and investigator with no
discernable motive to fabricate or exaggerate. In addition to being
uncontroverted, the testimony of this witness was sufficiently
detailed, plausible, and internally consistent to be afforded full
credibility in this case.
Dr. Timothy Munzing, M.D.
The Government presented the expert testimony of Dr. Timothy
Munzing. Dr. Munzing's curriculum vitae (CV) \4\ reflects nearly four
decades of experience practicing primary care medicine,\5\ teaching,
and serving as a medical expert reviewer for various state and federal
agencies in cases involving controlled substance prescribing.\6\ Tr.
72; Gov't Ex. 20. The witness testified that he is (and for thirty-five
years has been) a clinical professor at the University of California,
Irvine,\7\ and among his published scholarly work is an article
published in a peer-reviewed publication regarding controlled substance
prescribing. Tr. 74-75, 81; Gov't Exs. 20, 35. Dr. Munzing was tendered
\8\ and accepted as an expert witness in the prescribing of controlled
substances in the State of California, including for the management of
pain. Tr. 89.
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\4\ Gov't Ex. 20.
\5\ Dr. Munzing testified that most pain management treatment in
the United States is conducted by primary care physicians. Tr. 88-
89.
\6\ Dr. Munzing testified that he has been compensated for his
professional work as an expert, including by DEA in this case. Tr.
83.
\7\ Tr. 80.
\8\ Tr. 76.
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Dr. Munzing agreed to confine his testimony to outlining the
standard of care for controlled substance prescribing in California,
and to avoid conflating the bedrock standards with any discussion of
best practices or his view of optimum treatment options. Id. at 93-94,
205-06. According to Dr. Munzing, under the applicable standard in
California, the process of controlled substance prescribing must
commence with the taking of a patient history. Id. at 94. The history
must include queries about the length, location, and duration of any
pain symptoms, as well as any comorbid medical or mental health
conditions, and what (if any) treatment modalities have been deployed
to date. Id. at 94-95. Any and all controlled and non-controlled
medications being taken by the patient must be factored into the
history. Id. at 96. In Dr. Munzing's view, where controlled substances
have been utilized, strong consideration must be given to any
indications of historical drug and/or alcohol abuse. Id. at 95.
A physical examination that includes the taking of vital signs and
a detailed, focused examination of the locus of any discomfort is also
a required element that must precede controlled medication prescribing.
Id. at 96-97. Comorbid physical conditions encountered in a physical
exam (e.g., breathing or cardiac issues) may impact prescribing
decisions. Id. at 97.
The third prescribing prerequisite, according to the witness, is
reaching a determination as to whether to order additional objective
testing of the patient. Id. at 98. Where controlled substances are
contemplated by the physician, he/she should query the state
prescription monitoring program (PMP), which in California is the
Controlled Substance Utilization Review and Evaluation System (CURES).
Id. at 98-99.
According to Dr. Munzing, the fourth step in the prescribing
process is to assess the patient based on the information acquired in
the other steps. Id. at 100. The physician must process available
information to formulate a differential diagnosis of the etiology of
the symptoms. Id. at 100-02. An important element of the assessment
stage is to stratify the patient's risks of opioid or other substance
abuse attendant upon utilizing controlled substances. Id. at 99, 102-
04. The risk stratification piece of the equation remains an ongoing
evaluation throughout the treatment of a patient as an aspect of
meeting the applicable standard of care. Id. at 108-10.
Once the assessment has been conducted, the next step in the
process is to individualize the treatment of the patient by setting
objectives and procuring informed consent for the designated treatment
modalities. Id. at 104-05. Informed consent includes ``[n]otifying the
patient about the common potential side effects or adverse effects,''
as well the additional risks posed by taking controlled substances as
prescribed, to include addiction or substance use disorder, overdose,
and death. Id. at 131-N; see also id. at 205-06.
Dr. Munzing stressed that throughout the process, ``clear[,] true,
and . . . appropriate documentation'' is a required element of the
standard of care for controlled substance prescribing in California.
Id. at 105-07. The witness explained the documentation requirements
this way:
Document . . . the history . . . , document the exam, document
the vital signs, document . . . how you came up with the risk
stratification, document the assessment. If you've done laboratory
imaging, document those, and then document an appropriate management
plan including either in the [progress] note or separate from the
[progress] note an informed consent, especially sharing the most
serious potential problems of the management figure.
Id. at 106-07.
Dr. Munzing's view is that treatment risk stratification, coupled
with periodic informed consent, is a process that must continue
throughout the treatment of the patient. Id. at 111. A high-risk
patient should be re-stratified and get renewed informed consent
annually, whereas a lower risk patient can be addressed less frequently
in this regard. Id. at 111, 204.
The Government's expert testified that he reviewed patient charts
corresponding to the Six Patients \9\ from the Respondent's practice
and determined that the Respondent's controlled substance prescribing
did not meet the applicable standard of care in California.\10\ Tr.
120. There were numerous observations that Dr. Munzing offered in
support of his position. For example, the progress notes showed no
indicia that the Respondent or his staff conducted a physical
examination, gauged heart or lung function, performed an abdomen check,
[on AA] or took any vital signs from the other patients [over the
majority of time period covered by the allegations].*\C\ Gov't Exs. 2,
4, 6, 8, 10; Tr. 165-66, 182, 191, 193, 231-32
[[Page 4919]]
(Patient AA); <SUP>11 </SUP>*<SUP>D</SUP> Tr. 407-08 (Patient BB); Tr.
384-89 (Patient JD); Tr. 477-79 (Patient DD); Tr. 329-31, 349-52
(Patient SM). Further, Dr. Munzing identified instances where the
Respondent's patients were maintained on doses of medications that far
exceeded the morphine milligram equivalent (MME) \12\ recommended by
the Centers for Disease Control and Prevention (CDC) \13\ guidance
without documentation that the patient was afforded an informed consent
that explained the risks inherent in such treatment. Tr. 120; Gov't
Exs. 2-8, 10-13; Tr. 132-37, 139, 141-43, 145, 148-49, 156-57, 164-65,
169, 179-84, 191-92, 204-05, 224-25, 231-32, 271, 306-07 (Patient AA);
Tr. 401-02, 406-07, 409-15, 417-22 (Patient BB); Tr. 384-89, 393-400
(Patient JD); Tr. 477-79, 481-84, 488, 490-95 (Patient DD); Tr. 314-17,
321-23, 328-32, 350-51, 353-56, 360-62, 365, 370-72, 377-82 (Patient
SM); *\E\ Tr. 424-29, 431-35, 437-38, 440-47, 450 (Patient ET).
Likewise, controlled substances were prescribed in high-risk
combinations \14\ that significantly elevated the risk of such things
as central nervous system (CNS)/respiratory depression, overdose, and
death \15\ without documented informed consent. Gov't Exs. 2-8, 10-13;
Tr. 157-58, 164-65, 167, 191-92, 224-26, 231-32, 276-78, 302-03
(Patient AA); Tr. 409-14, 418-22 (Patient BB); Tr. 387, 393-400
(Patient JD); Tr. 477-81, 483-84, 488, 490-94 (Patient DD); Tr. 321-23,
329-32, 351-56, 360-62, 365, 370-72, 377-82 (Patient SM); Tr. 424-29,
431-35, 437-38, 440-47, 450 (Patient ET). Dr. Munzing also identified
instances in the Respondent's patient charts where clear flags of
potential diversion were present but not resolved prior to controlled
substance prescribing. For example, the witness pointed to places in
the medical records where anomalous urine drug screens (UDSs) were
recorded, yet seemingly ignored,\16\ without documented patient
counseling or medication modification. Gov't Exs. 3, 11, 13; Tr. 149-
55, 180-82, 196, 198, 206-09, 224-26, 228-31, 271-75, 279-82, 289-302
(Patient AA); \17\ Tr. 362-64, 371-72 (Patient SM); Tr. 438-440
(Patient ET). Another category where the Government's expert found
prescribing that, in his view, was below the applicable standard was in
the area of early refill prescribing. According to Dr. Munzing, the
charts he reviewed showed many instances where the Respondent wrote
prescriptions refilling controlled substance prescriptions before the
prior medications should have been expended.\18\ Gov't Exs. 2-5, 8, 10,
11; Tr. 158-59, 169-72, 177-78, 180-81, 184-89, 224-26, 271 (Patient
AA); Tr. 409-17 (Patient BB); Tr. 486-89 (Patient DD); Tr. 338-47, 349-
50 (Patient SM).*\F\ Dr. Munzing testified that regarding Patients
AA,\19\ BB,\20\ JD,\21\ DD,\22\ SM,\23\ and ET,\24\ over 150 controlled
substance prescriptions were issued below the applicable standard in
California, and were thus not issued in the usual course of
professional practice by the Respondent.
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\9\ Patients AA, BB, JD, DD, SM, and ET.
\10\ Some of the prescriptions reviewed by the Government's
expert included those issued by physician assistants (PAs) who
worked within the Respondent's practice. Dr. Munzing's testimony
that the Respondent was responsible for the prescriptions issued by
these PAs, see Tr. 174, is in accord with California Business and
Professions Code Sec. 3502.1(d).
*\C\ I have amended this sentence based on Respondent's
Exceptions, which noted that Dr. Munzing's testimony regarding the
lack of physical examination and lack of heart and lung function and
abdomen check were limited to Patient AA--the patient who died of an
overdose, and which noted that Respondent began taking vital signs
from his patients in 2018. Resp't Exceptions at 12.
\11\ Although the chart maintained by the Respondent's practice
on Patient AA reflected a diagnosis of hypereosinophilic syndrome
(HES), it is Dr. Munzing's judgment that references in the record
that conflate this treatment with cancer are not accurate. Tr. 194.
Further, Dr. Munzing testified that the Respondent's progress notes
indicate that the pain medication prescribed for this patient by the
Respondent were to treat a lower back ailment, not HES. Id. at 194-
95. As discussed, supra, the San Diego Medical Examiner reached a
similar conclusion. Gov't Ex. 31 at 5.
*\D\ Dr. Munzing testified that there must be some exam even for
an established patient, because ``this patient is at much higher
risk. We don't know whether anyone is checking the patient's heart,
lung exam, vital signs, despite these levels. Because of that,
you're monitoring the patient to try to keep them as safe as
possible.'' Tr. 166. When asked if he could point to a source for
this statement, Dr. Munzing credibly stated, ``Do I know anywhere
where it says you must do exactly this? No, but I do know that one
needs to monitor and try to keep the patient as safe as possible.
That's part of trying to keep the patient as safe as possible.'' Id.
at 168. I credit Dr. Munzing's testimony.
\12\ Dr. Munzing testified that the MME is a protocol by which
medications can be compared by using an equivalent dosage of
morphine as a common denominator. Tr. 121-22. In California (and in
the present record), the term morphine equivalent dosage (MED) is
used interchangeably with MME. Id. at 22, 121-23. The record
contains MME conversion tables published by the Center for Medicare
and Medicaid Services (CMMS) and the Centers for Disease Control and
Prevention (CDC). Gov't Exs. 26, 27; Tr. 124-31.
\13\ The witness testified that the CDC set 90 MME as a high
dose. Tr. 131-L; see also Gov't Ex. 23 at 24-25. [However, Dr.
Munzing stated that there is no maximum MME because ``some patients
need a higher amount, and so there's--there's no written absolute
amount, but there's certainly--one certainly needs to look at the
risk to the patients, the potential benefits, and attempt to
mitigate the risks.'' Tr. 131-B.]
*\E\ For example, Dr. Munzing testified that on October 31,
2016, Respondent prescribed SM, Soma, diazepam, fentanyl patch,
oxycodone, and Norco, and the combined MME of the three opioids is
960 and included the trinity cocktail (see n.14). Tr. 353-55l; see
also, e.g., Tr. 389 (1,234 MME to JD); Tr. 407 (1,920 MME to BB).
\14\ Dr. Munzing testified that a particularly high-risk
combination includes an opioid, benzodiazepine, and muscle relaxer.
Tr. 324-26. This combination, colloquially known as ``the trinity,''
creates increased euphoria, which increases the risk of substance
use disorder, and elevates the risk for respiratory depression. Id.
at 323-26. [Respondent prescribed the trinity to Patient S.M. Tr.
323, e.g. GX 11 at 11 and 281. Dr. Munzing further opined that the
trinity prescription was a ``red flag'' of abuse or diversion. Tr.
324. He testified that it was not always outside the standard of
care to prescribe the trinity in 2016, but ``you are adding to the
risk for the patient, both the risk of addiction, the risk of
overdose, and the risk of death. And when you are increasing the
risk, one needs to really identify it, notify the patient, and
divulge to the patient that they are at increased risk.'' Tr. 395-
96.]
\15\ Tr. 167.
\16\ In some instances, in the face of obviously anomalous UDS
results, the chart incorrectly reflected that the results were
consistent with the patient's treating program. Tr. 198-200, 209,
216; Gov't Ex. 2 at 75 (Patient AA); [see also e.g., Tr. 364 (Gov't
Ex. 10 at 517 (UDS negative for opioids SM was prescribed and the
note says UDS is ``consistent with the medication program.'')]
\17\ According to Dr. Munzing, chart notes that indicate that
some of the medication was prescribed to be taken ``PRN'' (as
needed) do not resolve the conflict because the dosage level was
sufficiently high that declining to take the medication for the
three days or so it would take to produce a clean urine catch would
result in profound withdrawal symptoms. Tr. 151-53, 281-87.
Additionally, if the patient was taking the medication sporadically,
the refills would not have been as consistent as the records
indicate they were. Id. at 151-55, 209, 281-89.
\18\ Dr. Munzing acknowledged that on a very occasional basis,
to accommodate life contingencies such as weekends and vacations,
the standard of care can absorb one or two days of flexibility
regarding refill timing. Tr. 158. However, where the early
prescribing forms a pattern resulting in a significant potential
reservoir of extra medication, as is the case with the Respondent's
patients, the controlled substance prescribing falls below the
standard of care. Id. at 158-63. The standard of care requires that
early prescription fills have an annotated ``do not fill before''
note on the prescription. Id. at 162-63. Dr. Munzing's view is that
irrespective of the date the medication is ultimately dispensed to
the patient (a date which can be procured by a query to the CURES
system), it is the early prescribing of the drug that renders a
prescribing event below the applicable standard of care. Id. at 175-
76. [``When you repeatedly write it early then it's providing
opportunity for the patient to get more than what you're
prescribing.'' Tr. 176). Additionally, the] Government's expert
testified that the early refill phenomenon was confirmed by
consultation with CURES [demonstrating that the individuals had in
fact filled the prescriptions early on the dates that they were
prescribed]. Tr. 217-21; Gov't Ex. 2 at 14-15.
*\F\ Dr. Munzing testified that, for example, for Patient SM,
prescriptions were issued two days early for a year. Tr. 347 (e.g.
Gov't 11 at 45-46 (prescriptions for Valium, fentanyl patches,
oxycodone and Norco)). He stated that for SM there are ``over a
dozen times in a row where every time you're approximately two days
early or average two days early. Over time, you've ended up getting
a lot of extra medication. And either that medication is going and
used by the patient in addition to what was felt necessary by the
doctor. Or they may end up diverted in some other way.'' Tr. 348. He
concluded that although this might happen a few times and not cause
concern, ``after three or four times it arose, then it becomes a
pattern and becomes a problem that you are falling below the
standard of care.'' Id. at 348. Another example of early fills
occurred to Patient DD, who was prescribed high dosages of opioids
between 1-6 days early over sequential months. Tr. 486-491; Gov't
Ex. 9 at 189-198.
\19\ Tr. 164, 192-93, 195, 203-04, 210-12, 225, 232, 271-73,
275-76, 278-79, 292, 295, 300-01, 303-06.
\20\ Tr. 407-08, 415-16, 418, 421-22.
\21\ Tr. 388-89, 393-97, 400-01.
\22\ Tr. 486, 487-96.
\23\ Tr. 332, 352, 365, 369, 371.
\24\ Tr. 429-32, 435, 437-38, 442, 446, 450.
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One of the Six Patients merits additional discussion. On November
11, 2017, Patient AA died in his apartment
[[Page 4920]]
due to a drug overdose. Gov't Ex. 31 at 5. The San Diego Chief Deputy
Medical Examiner (ME) ruled the cause of death as ``fentanyl,
clonazepam, alprazolam, ketamine, hydrocodone, and morphine toxicity,''
and determined that the overdose was accidental. Id. Interestingly,
although the Medical Examiner's report (ME Report), like much of the
Respondent's progress notes, noted that Patient AA's ``medical history
was significant for `terminal blood and bone marrow cancer,' '' the
examination revealed that ``[n]o terminal malignancy was identified.''
Id. Thus, the Medical Examiner's conclusions in this regard are
consistent with Dr. Munzing's view that the HES that Patient AA was
afflicted with was not cancerous,*\G\ and that the Respondent's pain
protocols were directed at the patient's lower back ailments. Tr. 194-
95. Dr. Munzing testified that among the drugs listed in the ME Report
as toxicity causes of death, the Respondent's practice was prescribing
hydrocodone and morphine, and that the charts demonstrated awareness
that Patient AA was also taking a benzodiazepine.\25\ Tr. 310. [Dr.
Munzing testified that these two prescriptions, ``were felt to be
contributors to the death, the hydrocodone and the morphine,'' and that
it was not just one of the controlled substances that caused death, but
a ``multitude, it's toxicity, a multitude of drugs including a couple
[Respondent] prescribed.'' Id.]
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*\G\ I note that Respondent took Exception to the fact that the
Chief ALJ ``seems to insinuate that because no malignancy was found
during post mortem examination, that AA's HES was not cancerous.''
Resp't Exceptions at 17 (citing RD at 9). It is not relevant to this
case whether AA's malignancy ultimately was cancerous. It would only
be relevant if I were to credit Dr. Polston's testimony that there
is a different standard of care for cancer patients. I agree with
the Chief ALJ and do not credit that testimony. See infra n.87.
\25\ According to Dr. Munzing, alprazolam, a specific causal
medication cited in the ME Report, was one of the three
benzodiazepines that the Respondent was prescribing. Tr. 310-11. Dr.
Munzing also noted that the ME Report found evidence of oxycodone in
Patient AA's system (Gov't Ex. 31 at 11), but apparently did not
find the drug in a sufficient quantity that it was included among
the toxicity causes of death. Tr. 311-12.
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Overall, Dr. Munzing's testimony was authoritative, reasonable, and
supported by the admitted evidence of record. The witness presented as
a qualified, knowledgeable, and dispassionate expert evaluator of the
Respondent's controlled substance prescribing practices. Although,
unlike the Respondent and Dr. Polston, Dr. Munzing does not practice
pain medicine exclusively and does not hold a Board subspecialty in
pain management, his testimony was supportive, objective, and
convincing. Dr. Munzing's testimony was unburdened by the keen interest
that the Respondent has in the outcome of the case. Indeed, as
discussed elsewhere in this Recommended Decision, Dr. Munzing's
presentation was sufficiently persuasive that on several occasions the
Respondent accepted Dr. Munzing's conclusions and changed his practices
*\H\ as a result of what he heard at the hearing. As discussed, infra,
when confronted by the Respondent's agreement with Dr. Munzing's
testimony, Dr. Polston actually altered his view to conform with the
Respondent's version. This willingness to support the Respondent's
opinions based merely on being advised of them undermined the weight
that could be attached to Dr. Polston's presentation. Accordingly, in
this Recommended Decision, Dr. Munzing's opinions will be afforded
controlling weight.
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*\H\ Respondent argued in his Exceptions that he only changed
one practice as a result of the hearing. Resp't Exceptions at 18.
However, Respondent does argue that he changed other of his
practices before the hearing. Id. I take note of this discrepancy,
and to the extent Respondent finds it important, agree that the
record only demonstrates that he only changed one of his practices
as a result of the hearing. Respondent continues to adhere to his
position that the new practice regarding refills that he instituted
as a result of the hearing is not mandated by the standard of care,
in spite of his own actions and the Chief ALJ's finding herein that
the substantial evidence in the record demonstrates that it is. Id.
(``Physicians in the San Diego area prescribe in this fashion, and
Dr. Polston testified it is not below the standard of care to refill
medications two days early. [] Notwithstanding this, Respondent took
notice of what Dr. Munzing stated and immediately changed his
practice to remedy this issue.'') The Government points out that in
spite of similar arguments from Respondent in the MBC case, the MBC
found that it was a violation for Respondent to prescribe greater
than a 30 day supply, and yet, Respondent did not change this
practice until August of 2020. Gov't Response at 30 (citing Gov't
Ex. 30 at 134). Although Respondent changed this practice at the
hearing, I cannot be sure that he will continue to implement this
change in the future given his delay in recognizing the failure and
his continued arguments that the practice is not required.
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The Respondent's Case
The Respondent
The Respondent presented his own testimony at the hearing. He
testified that since his graduation from the University of Minnesota in
1985, and the completion of his residency at the University of
California, Irvine, he has been practicing medicine for over thirty-one
years, all in Escondido, California. Tr. 895-97. The Respondent's CV
\26\ reflects that he is Board Certified in Physical Medicine and
Rehabilitation and holds subspecialty certifications in Pain Medicine
and Neuromuscular and Electrodiagnostic Medicine. Resp't Ex. G; see
also Tr. 899. The Respondent reckons that he has treated over 20,000
patients in the course of his professional life, and that his current
patient base consists of adults between the ages of 18 and 97, each of
whom has ``a pain condition that causes some sort of functional
deficit.'' Tr. 900-01. According to the Respondent, the patients carry
``diagnoses from orthopedic, to neurology, to stroke, to debilitating
rheumatologic diseases.'' Id. The Respondent testified that as a pain
specialist, he routinely handles patients with high-impact pain
conditions,\27\ that 100% of his patient base is referrals, and that at
the outset of patient establishment he vets the patients for doctor
shopping, early refills, indicators of abuse and/or diversion, and on
some occasions has referred prospective patients to addictionologists.
Tr. 949-50. By his own account, he has never been sued for malpractice,
never settled any malpractice litigation, and other than his recent
entanglements with the California Board, his state medical license has
never been subjected to sanction or limitation. Id. at 901.
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\26\ The Respondent's CV was received into the record. Resp't
Ex. G; Tr. 898.
\27\ The Respondent testified that he employs the Stanford
definition of high-impact pain conditions, which he explained as
``somebody that's had pain greater than six months, with significant
functional deficits.'' Tr. 951. The Respondent further explained
that high-impact pain patients are a subset of chronic pain
patients, with the latter comprising 20% of all national pain
patients and the former representing 8%, with some ``affect [on]
function in some form, [that is,] standing, walking, sitting,
driving, sleeping, [and] self-care.'' Id. at 952.
---------------------------------------------------------------------------
During his testimony, the Respondent narrated those of the
Government's allegations which he accepts, elaborated on some areas
where he took issue, and in other areas he assumed a hybrid, more
nuanced stance.
Regarding the Government's allegation that ten \28\ aberrant UDS
results related to Patient AA were not adequately addressed and
documented by patient queries and resolution,\29\ the Respondent simply
confessed error without particular equivocation. Tr. 934. Regarding his
custom of simply marking aberrant UDS results with the letters PRN
(i.e., that the medication was written to be taken as needed), the
Respondent agreed that he ``needed to do more questioning of the
patient, more documentation of that questioning, and then more reaction
in terms of the patient reactions.'' Id.; see also id. at 1071.
---------------------------------------------------------------------------
\28\ This allegation was modified from 12 to 10 instances on the
unopposed motion from the Government. ALJ Ex. 25.
\29\ ALJ Ex. 1 ] 14.d.
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[[Page 4921]]
Similarly, the Respondent confessed error regarding the manner in
which he timed his prescriptions which, as the Government alleged,\30\
resulted in the potential for significant reservoirs of excess medicine
for Patient AA. Tr. 935-39. While commending himself for his practice
of seeing Patient AA every twenty-eight days, the Respondent testified
that he has now implemented corrections to his prescribing practice
which circumscribes future controlled substance prescriptions to
twenty-eight days.\31\ Tr. 936-39, 1071.
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\30\ ALJ Ex. 1 ] 14.e.
\31\ The Respondent later explained that he realized the
validity of this aspect of his prescribing while listening to Dr.
Munzing's testimony, and started to implement corrective actions
during the course of this hearing. Tr. 1311-12.
---------------------------------------------------------------------------
The Respondent also conceded that to the extent the Government
alleges \32\ that he failed to adequately document the basis for the
extremely high opioid dosage he prescribed to Patient AA, that is true.
Tr. 928-29. The Respondent refined his position in this way:
---------------------------------------------------------------------------
\32\ ALJ Ex. 1 ] 14.a.
I see in retrospect the documentation could be better, and I
respect [the Government expert's] criticism when he was saying that
the documents should show the next doctor what's going on. And I did
---------------------------------------------------------------------------
not feel that I was able to do that.
Id. at 929. While conceding the inadequacy of the documentation, the
Respondent did provide some explanatory details about the course of his
treatment of Patient AA's pain symptoms with controlled substances. The
Respondent explained that upon assuming his pain management care,
Patient AA ``had been a lobster fisherman in Boston, had gotten in car
wrecks, had a finger rotting, and also had had [sic] the onset of [HES,
and h]e was in quite a bit of hurt.'' Id. at 930. According to the
Respondent, he held his level of pain medication steady,
notwithstanding the patient's requests to the contrary, and
reemphasized his contention that he was treating this patient during
the evolution of professional pain management guidance. Id. at 930,
1068.
The Respondent took issue with the Government's contention that
chart entries regarding Patient AA ``indicate that [he] never discussed
the risks of opioids with'' the patient.\33\ Tr. 931. He testified
that, in his view, these risks were discussed with Patient AA, and
while agreeing that he has beefed up the quality of his documentation
based on the Government expert's testimony, his opinion is that the
level of the discussion that occurred in the pain contract executed
with the patient did meet the required standard, and the Government's
allegation to the contrary is not supported. Id. at 931-32. As an
example, the Respondent pushed back on the opinion of the Government's
expert that the failure to mention the risk of death is problematic.
Id. According to the Respondent, while true that the pain contract did
not precisely detail the risk of death, ``it did discuss respiratory
depression, which is usually the antecedence of that.'' Id. at 932.
Still, while not conceding fault in this regard, the Respondent
testified that [``it should be better'' and] he has developed an opioid
informed consent document that ``plug[s] that hole.'' Id. The
Respondent ultimately allowed that specific mention of death is
``important to mention to the patient, and . . . is something [that he]
want[s] to do better and need[s] to do.'' Id.
---------------------------------------------------------------------------
\33\ ALJ Ex. 1 ] 14.b.
---------------------------------------------------------------------------
The Government specifically alleges that the Respondent's
concurrent prescribing of opioids and benzodiazepines to Patient AA was
a ``red flag of abuse or diversion'' and ``represented a dangerous
combination, and constituted an extreme departure from the standard of
care for the practice of medicine.'' ALJ Ex. 1 ] 14.c. In his
testimony, the Respondent sidestepped the principal issues of this
allegation somewhat, by countering that, notwithstanding the absence of
documentation in this regard, the risks of benzodiazepines were
discussed with the patient and his standards for documenting such
discussions has been enhanced. Tr. 933. No mention was made about the
opinion of the Government's expert regarding whether the prescribing
combination fell below the standard, only that the issue of
benzodiazepine risks were discussed, if not pristinely documented. Id.
The Respondent was unequivocal in his view that, contrary to the
Government's allegation,\34\ the Government's expert,\35\ and the ME
Report,\36\ his prescribing was not a contributing factor in Patient
AA's untimely demise. Tr. 943. The way the Respondent sees it, Patient
AA would not have died had he not taken fentanyl and drank alcohol,
both of which the Respondent feels were covered in the patient advisals
set forth in the pain agreement and executed by the patient. Id. at
943-45. When pressed on the issue, the Respondent provided the
following elucidation on his own self-exoneration:
---------------------------------------------------------------------------
\34\ ALJ Ex. 1 ] 14.f.
\35\ Tr. 310-12.
\36\ Gov't Ex. 31 at 5. The ME Report, in pertinent part,
renders the following ultimate conclusion: ``Based on the [report's
integral] findings and the history and circumstances of [Patient
AA's] death as currently known, the cause of death is best listed as
`fentanyl, clonazepam, alprazolam, ketamine, hydrocodone, and
morphine toxicity' and the manner of death as `accident.''' Id.
[Patient AA] had been on a combination of medications for a long
time with no issues, and I feel badly that this event happened, but
I honestly saw no issue where what we were providing was a
significant component to someone who had so much additional
---------------------------------------------------------------------------
medication in his system.
Id. at 943. The Respondent testified that he had no sense, indication,
or warning that addiction or other substances were issues with Patient
AA, based upon the following observations: ``I never had him come early
for his appointments, [he] never asked for additional medication, no
exhibited behaviors, never was there alcohol.'' Id. at 944-45. Absent
from his consideration in this regard was the ever-growing reservoir of
extra medications the patient was receiving from refills that preceded
the anticipated medication exhaustion dates \37\ or the aberrant UDS
results that were never addressed and documented.\38\
---------------------------------------------------------------------------
\37\ Tr. 158-59, 169-72, 177-78, 180-81, 184-89, 224-26, 271.
\38\ Tr. 149-55, 180-82, 196, 198, 206-09, 224-26, 228-31, 271-
75, 279-82, 289-302. [Further, the Government highlighted that
Respondent did not test for Ketamine or fentanyl in the UDS on
September 19, 2017. Tr. 1098 (citing Gov't Ex. 2 at 535).]
---------------------------------------------------------------------------
The Respondent detailed his experience with the balance of the Six
Patients, much of it following the same pattern, notwithstanding a
nuance or two. He agreed that the Government was right with respect to
the potential reservoir of medication created by his temporally-
truncated prescribing practices.\39\ Tr. 960-62. By the Respondent's
account, the patients established with his office with painful medical
issues and high-dosage MMEs, and he either maintained the patients at
the pain medication levels they arrived at, notwithstanding their
protestations to the contrary, or in some cases, according to the
Respondent, he was able to effect some reductions.
---------------------------------------------------------------------------
\39\ ALJ Ex. 1 ] 18.d.
---------------------------------------------------------------------------
The Respondent testified that such was the case with Patient BB.
Id. at 946-49, 953-55, 957-58. The Respondent testified that Patient BB
resisted his attempts to taper her pain medication,\40\ and ultimately
left his practice as a
[[Page 4922]]
response to her frustrations.\41\ Tr. 947, 969-70. He took issue with
the Government's allegation that the MME level he prescribed for this
patient was ``extraordinarily high,'' \42\ opining that it was an
appropriate dose under the circumstances, and conceding only that he
``was not happy with [his] documentation at that point in time and
[that he] fixed it.'' Tr. 956; see also id. at 1068. In describing what
he thought could be improved with his level of documentation, the
Respondent allowed, in retrospect, that his documentation was ``basic''
and ``wasn't descriptive enough.'' Id. at 956. The Respondent also
resisted the Government's allegation that his medical records were
deficient in that they contained no discussion of the risks and
benefits of opioid therapy.\43\ The Respondent adhered to the view that
the pain contract that he executed with this patient was sufficient to
satisfy the requirement that the risks were discussed and true informed
consent was obtained. Tr. 957-58.*\I\ The Respondent likewise declined
to budge from his position that although his standard pain contract at
the time made no mention of death, language which included the risk of
respiratory depression was sufficient, contrary to the Government's
allegation and the position of its expert. Id. at 958-59.
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\40\ The Respondent testified that the patient resisted his
attempts to set her up with a behavioral health evaluation and
detoxification process, and that he made numerous (ultimately
fruitless) attempts to sort things out with her insurance provider
and her (concurrently prescribing) primary care physician. Tr. 969-
75.
\41\ The Respondent testified that other than the late Patient
AA and Patient BB, the other four of the Six Patients are still
under his care. Tr. 962.
\42\ ALJ Ex. 1 ] 18.a.
\43\ ALJ Ex. 1 ] 18.b.
*\I\ Respondent seemingly contradicted his previous testimony
that he always had the conversations with his patients on cross-
examination, when he stated: ``The--the informed consent document is
better than it was before. It's actually an informed consent
document. But, as you know, informed consent is more than just a
document. It's the discussions surrounding it, and I think that's
what we're doing much better with.'' Tr. 1070. This statement
undermines his previous testimony that true informed consent was
obtained, but just not documented. He also appeared to change his
position regarding whether his previous pain agreements met the
minimum standard of care with respect to informed consent--answering
that they did not. Id. Regardless, as explained herein, it is
unnecessary to conclude whether or to what extent he had these
discussions, because the documentary evidence does not demonstrate
that he did. Further, even if he had, he waivered on acknowledging
whether discussing the risk of death associated with the
medications, even if they are taken as prescribed, was essential to
the standard of care. So even if he did have conversations about the
risks, it is still unclear whether the content of those
conversations met the standard of care as Dr. Munzing described it.
Finally, I credit Dr. Munzing's testimony that the issue of
discussing risk is universal in medicine, because a lay person is
not expected to know what the consequence of respiratory depression
is. See also infra n.*S for further discussion of Respondent's
testimony regarding informed consent in the context of his purported
acceptance of responsibility.
---------------------------------------------------------------------------
Consistent with much of his presentation, the Respondent was
unwilling to agree with the Government's allegation that prescribing
the combination of opioids and benzodiazepines constituted an extreme
departure from the standard of care,\44\ but [] acknowledged that he
was unhappy with Patient BB's chart because it was ``not as acceptable
as [he would] like it to be with specific benzodiazepine
interactions.'' Tr. 960. The Respondent asserted that his standard
paperwork has now been improved to include such interactions. He also
testified that he has changed his practice to conform with certain
views expressed by the Government's expert witness. Id. at 957.
---------------------------------------------------------------------------
\44\ ALJ Ex. 1 ] 18.c.
---------------------------------------------------------------------------
The same testimonial pattern was present regarding Patient JD. The
patient came to the Respondent's practice on a referral with a dramatic
and acute set of pain etiologies \45\ and on a high dosage of
medication.\46\ In the Respondent's estimation, continuation of this
patient's high controlled substance dosing was not ``an extreme
departure from the standard of care for the practice of medicine,''
\47\ based on what he perceived as the best professional guidance
available at the time and the existing medication level the patient was
at when referred to his practice. Tr. 982-83, 1068. The Respondent
explained that in his view, the available guidance regarding the pain
management of patients has been the subject of considerable evolution
over the past fourteen years. Id. at 901-02; see also id. at 930. The
Respondent's handling of the issue contained a high level of nuance.
---------------------------------------------------------------------------
\45\ According to the Respondent, Patient JD was status post a
catastrophic vehicular/pedestrian strike, and had avascular necrosis
involving one shoulder and both hips, cervical radiculopathy with
osteophytes, ankylosing spondylitis affecting the lower spine, Lyme
disease, multiple lower extremity fractures, and complex regional
pain syndrome (RSD). Tr. 977-81.
\46\ Tr. 976, 986-87.
\47\ ALJ Ex. 1 ] 21.a.
At that time, we're just coming off of the decade of maybe 2000,
2010. Pain is a fifth vital sign. There's no limits to dosing. You
dose to function, you don't dose to milligram quantity. And that, I
believe that's how he got up to that level before he came to me. So
---------------------------------------------------------------------------
at that point, it was not an unheard-of dosage.
Id. at 982 (emphasis supplied). Unpacking this analysis is somewhat
instructive. Even accepting the Respondent's view that pain medication
guidance was evolving, it is difficult to assess the significance that
should be placed on his estimation of ``just coming off of the decade
of maybe 2000, 2010'' \48\ of a divergent approach. To the extent that
the decade the Respondent was referring to took place [ ] ended (as he
says) in 2000, Patient JD established with the Respondent's practice
ten years later, in 2010. There is no indication in the record or any
available source that expert guidance inexorably changed by the decade
or how long it would take to ``come off'' such a decade, even if there
were some logic to this statement. Likewise, the notation that any
decade had ``no limits to dosing'' \49\ dangerous controlled substances
strikes as inconsistent with the limits of human endurance and common
sense; and to justify the level at which he was medicating this patient
by saying ``it was not an unheard-of dosage'' \50\ is far from a
persuasive endorsement of his controlled substance prescribing
practices. Even taking the Respondent's testimony in the most indulgent
light possible, ``not unheard-of'' cannot be a meter that his actions
are measured by to gauge whether he complied with the applicable
controlled substance prescribing standard in California. When asked for
clarification as to whether he agreed with the Government's allegation
regarding his dosing, the Respondent supplied the following non
sequitur:
---------------------------------------------------------------------------
\48\ Tr. 982.
\49\ Tr. 982.
\50\ Id.
I don't. As I stated, I received him at the higher dose. That's
why it's coming to me, and I'm supposed to be the one who will
contain it, control it, and reduce it over time while trying to
---------------------------------------------------------------------------
increase function.
Tr. 983. The only self-criticism the Respondent offered was that his
``documentation should have been better at that point in time . . . and
[that he] wish[es he] had done a better job of documenting.'' Id.
Again, the Respondent clung to his view that the Government's
allegation that his records fail to indicate sufficient opioid risks
discussions with the patient \51\ is unfounded because his standard
pain contract language at the time (although improved since) was
sufficient to do the job. Tr. 984-85. While again confessing error \52\
regarding the 28-day visit vs. the 30-day early prescription
issuance,\53\ with respect to the Government's allegation that
prescribing a combination of opioids and benzodiazepines to Patient JD
fell below the standard of care,\54\ the
[[Page 4923]]
Respondent offered only that he engaged the patient with an ultimately
successful protocol to eventually wean him off the benzodiazepine. Tr.
985-86. In fact, the Respondent testified that during the course of his
treatment of Patient JD, he successfully weaned him off multiple
benzodiazepines and significantly reduced the overall MME of the
medications he was taking. Id. at 988-89.
---------------------------------------------------------------------------
\51\ ALJ Ex. 1 ] 21.b.
\52\ The Respondent testified, ``That was a very easy one to fix
with literally no fuss at all.'' Tr. 986; see also id. at 1071.
\53\ ALJ Ex. 1 ] 21.d.
\54\ ALJ Ex. 1 ] 21.c.
---------------------------------------------------------------------------
The pattern repeated itself with respect to Patient DD. The
Respondent owned up to the early refill allegation.\55\ Tr. 998-99,
1071. The Respondent testified that upon intake this patient had
complicated orthopedic problems \56\ that had been treated by another
pain doctor prior to the referral. Tr. 990. Consistent with his
description of the other Six Patients, the Respondent testified that
Patient DD arrived on a high MME level of controlled medications, which
was ultimately reduced through the Respondent's efforts. Id. at 991-95,
1001. The Respondent disputed the Government's allegation that the MME
levels of the medications he prescribed to Patient DD ``constituted an
extreme departure from the standard of care for the practice of
medicine,'' \57\ claiming that the medication levels were appropriate
because (in his view, at that time) level of function (not the dosage)
was the touchstone, and also because a review of prior medical records
gave the Respondent no indication of the patient requesting early
refills.\58\ Tr. 995, 1068. The only culpability the Respondent would
assume in this regard came from the quality of the templates in his
electronic medical record software. Id. at 995-96. Once again, as he
did in addressing the other Six Patients, the Respondent eschewed any
responsibility for documenting deficiencies related to explaining the
risks and benefits of opioid use by pointing to the language employed
by the standard pain contract he was using at the time. Id. at 996.
---------------------------------------------------------------------------
\55\ ALJ Ex. 1 ] 23.c (as amended, see ALJ Ex. 25 at 2, ] 7).
\56\ According to the Respondent, Patient DD had a catastrophic
lumbar spinal collapse, had endured multiple surgeries and an
infected pain pump, as well as an unsuccessful go at a dorsal cord
stimulator, and was presenting with surgically-placed titanium
spinal rods that had snapped. Tr. 991.
\57\ ALJ Ex. 1 ] 23.a.
\58\ [Omitted.]
---------------------------------------------------------------------------
The analysis presented in the Respondent's testimony about Patient
SM did not differ substantially from the manner in which he described
his treatment of the other members of the Six Patients group. According
to the Respondent, at the time of her referral to his practice, Patient
SM presented with pain from complex and serious etiologies,\59\ and was
being maintained on high-MME levels of pain medication combined with
benzodiazepines. Tr. 1003-05. The Respondent testified that he worked
to reduce the MME levels \60\ and eliminate the benzodiazepines \61\
from the treatment equation. Tr. 1005. The Respondent accepted error
regarding his early refill practices,\62\ but again defended his dosing
levels against the Government's allegation that the levels were
sufficiently high that they constituted ``an extreme departure from the
standard of care for the practice of medicine.'' \63\ Tr. 1005-06,
1068. His answer was once again that the only conceivable hiccup in the
prescribing \64\ was his level of documentation. Tr. 1006. The
Respondent explained it this way: ``Looking at it now, with the lens
that I have, I can see that the documentation should have been
better.'' Id. However, the documentation deficits the Respondent owned
up to regarding this patient, like the others, did not extend to the
Government's allegation regarding the failure to adequately document
risk warnings associated with opioid use,\65\ as he again explained
that, in his opinion, his standard pain contract covered this area
sufficiently.\66\ Tr. 1006-07. Similarly, the Respondent was resistant
to the concept that dual prescribing benzodiazepines with opioids fell
below the applicable standard as charged by the Government,\67\ but
offered instead that he ``should have done a better job of documenting
the risks of benzodiazepines.'' Tr. 1007-08.
---------------------------------------------------------------------------
\59\ According to the Respondent, Patient SM suffered from
cervical and lumbar issues, underwent multiple surgeries and other
procedures, and ultimately lost the ability to swallow. Tr. 1003-04.
\60\ Tr. 1010-12.
\61\ The Respondent testified that he ultimately discontinued
the trinity combination of medications for this patient. Tr. 1008.
\62\ Tr. 1008 (``I see that as a processing error, as we talked
about before. It's a very simple thing to correct, and it's already
been implemented.''); see also id. at 1071.
\63\ ALJ Ex. 1 ] 26.a.
\64\ According to the Respondent, ``The dosing was appropriate,
considering her medical condition, the fact that that's what she was
on previously. And, again, that's where we start, and then we move
down from there.'' Tr. 1006.
\65\ ALJ Ex. 1 ] 26.b.
\66\ Regarding this patient, and throughout the proceedings, the
Respondent suggests that his forms had room for some improvement,
but does not agree that utilization of this form to satisfy informed
consent regarding the risks of opioid therapy falls below the
standard. Tr. 1007 (``I am always in a state of continuous quality
improvement, and I recognize that as an issue. We have corrected
it.'').
\67\ ALJ Ex. 1 ] 26.c.
---------------------------------------------------------------------------
The Respondent adhered to a like pattern in his testimony regarding
Patient ET. This referred patient arrived at his practice with high MME
levels and sobering etiologies \68\ behind his symptoms. Tr. 1012-13.
The Respondent again confessed error on his unintended early refills
issue,\69\ and allowed that his documentation was inadequate,\70\ but
testified that, based on the science at the time and the medications
she was on when she came into his care, he stood behind his dosing
decisions,\71\ and that he reduced this patient's MME dosing. Tr. 1015-
22. The Respondent referenced a report \72\ (PMC Report) prepared
regarding Patient ET at the Respondent's request by the University of
California San Diego Pain Management Clinic (PMC). Tr. 1015.*\J\ The
Respondent's testimonial assessment of the PMC Report's conclusion is
that:
---------------------------------------------------------------------------
\68\ The Respondent testified that Patient ET carried diagnoses
of hemiplegic migraine, was status post cervical surgery, and had
cervical radiculopathy. Tr. 1012-13.
\69\ Tr. 1027-28.
\70\ Tr. 1024.
\71\ Tr. 1022-24, 1068.
\72\ Gov't Ex. 12 at 987.
*\J\ Respondent admitted that for this patient there was ``a
component of opiate use disorder'' and that she was weaned off all
of the pain medication and now, years later, being prescribed
Suboxone, which ``does have some pain implications and can reduce
the craving for patients who need to cut back with their
medication.'' Tr. 1020, 1021.
[PMC] said there was nothing more to offer from their
perspective, in terms of intervention. And they recommended we
---------------------------------------------------------------------------
continue the path, and that we continue to wean the patient.
Id. The PMC Report does indeed recommend continuation of physical
therapy and does state that it declines to recommend interventions, but
it also recommends the addition of conservative therapies such as
osteopathic manipulative medicine (OMM), acupuncture, and alternative
medicine modalities, and states: ``Continue medications per [the
Respondent], recommend weaning if possible.'' \73\ Gov't Ex. 12 at 992.
---------------------------------------------------------------------------
\73\ An undated, handwritten note in the margin of the PMC
Report reads: ``Noted wean attempt in progress.'' Gov't Ex. 12 at
992; Tr. 1016.
---------------------------------------------------------------------------
The Respondent, consistent with the view he espoused in his
Corrective Action Plan (CAP),\74\ initially maintained his uniform
position that the standard pain management contract he was employing at
the time satisfied the applicable standard of care regarding his
obligation to inform Patient ET about the risks associated with
prescribing opioids,\75\ but then, in
[[Page 4924]]
something of a departure from his prior assessments, testified that
``[o]n the issue of informed consent, the documents were not
adequate.'' Tr. 1026. The Respondent explained his unexpected change in
perspective this way:
---------------------------------------------------------------------------
\74\ Resp't Ex. M at 5, ] 4.
\75\ Tr. 1024-26.
I needed to talk more about the actual conversations I had with
the patient, the potential risks, including death, which was not
mentioned specifically. And I see that as a deficit in my reading,
---------------------------------------------------------------------------
documentation and my discussion with the patient.
Id.; see also id. at 1070. Oddly, this change of heart only apparently
applied to his treatment of Patient ET, but the Respondent also
testified that he has since introduced a specific opioid consent
contract. Id. at 1039-40. While the Respondent maintained that his pain
agreement was sufficient in all cases (other than Patient ET), he
testified that the opioid consent document ``was created specifically
to plug some of the gaps that the pain agreement was not fully
compliant [sic].'' Id. at 1040. The Respondent further testified that
he ``felt like [he] needed to expand [his] offerings in terms of
informed consent, to be fully compliant.'' Id. at 1041. Thus, the
Respondent testified (consistent with the position he took in his CAP)
\76\ that the pain contracts did meet the standard, then in the case of
Patient ET that they did not meet the standard, then he testified to
his creation of a separate opioid consent document ``to plug some of
the gaps'' in the aforementioned pain agreements that were ``not fully
compliant.'' \77\ See Tr. 1040-41. It would not be hyperbolic to
suggest that the Respondent's view on this issue in his testimony was
all over the place and did not enhance his credibility.
---------------------------------------------------------------------------
\76\ Resp't Ex. M at 5, ] 4.
\77\ In his CAP, the Respondent highlighted language he added to
his standard pain medication agreement, implicitly arguing that the
agreement, as modified, satisfies the standard without a separate
opioid consent agreement. Resp't Ex. M at 33, ] 15; Tr. 1061.
---------------------------------------------------------------------------
The Respondent resisted the Government's allegation that he failed
to appropriately respond to one of Patient ET's UDS results based on
his view that the result was not aberrant. Id. at 1028. Specifically,
the Respondent testified that although Patient ET supplied a urine
sample that tested positive for temazepam (a medication she was not
prescribed), temazepam, according to the Respondent, is a metabolizer
of diazepam (a medication that the Respondent had prescribed). Id. The
Respondent followed up by offering that he has enhanced his internal
office mechanisms for responding to UDS results that appear
inconsistent. Id. at 1028-29.
The Respondent described numerous improvements he has effected in
his electronic medical records software \78\ so that an increased level
of detail and analysis would be reflected in the future.\79\ Tr. 1029-
34, 1038-39, 1044, 1047-52; Resp't Ex. M at 4-7. When pressed as to why
a multitude of prior notes showed that no one in his office had been
taking weight measurements or other vital signs, the Respondent
conceded that he ``should have been doing it.'' Tr. 1034. The
Respondent explained some improvements he incorporated into his
practice, and explained that he now sees one less patient per hour
under his new protocol. Id. at 1041-43, 1053. He also testified that
his staff now takes blood pressure readings from his patients. Id. at
1039. The Respondent explained that all his office notes correspond to
his new, more detailed protocols, and offered that:
---------------------------------------------------------------------------
\78\ The Respondent testified that his medical records have been
electronically maintained since 2005. Tr. 924.
\79\ The Respondent testified that these enhancements were not
the result of the DEA investigation, but rather, his experience with
the Administrative Law Judge handling the state licensing
proceedings. Tr. 1052.
I'm much happier. The patients are better informed. And I feel
as though each of these notes, when I finish, we have all the facts,
whoever goes to the primary physician and anybody else in the circle
of care. And I just feel like I'm doing a much better job of inter-
---------------------------------------------------------------------------
operability and cooperation with the other physicians.
Id. at 1052. He also added that he ``always want[s] to improve'' \80\
and that he has ``never stepped down from a challenge.'' Id. at 1062.
---------------------------------------------------------------------------
\80\ The Respondent testified to completing two continuing
medical education (CME) courses in 2017 through the UCSD School of
Medicine. Tr. at 1057-59. The Respondent personally attended a two-
day course on physician prescribing and a two-day course on medical
record keeping. Id.; see Resp't M at 47, 49.
---------------------------------------------------------------------------
The Respondent made clear in his testimony that he only accepted
responsibility for the deficiencies he was willing to acknowledge at
the hearing. Id. In addition to his electronic recordkeeping
enhancements, the Respondent testified that he no longer prescribes the
trinity combination of medications,\81\ and has eliminated carisoprodol
from the medicines he prescribes. Tr. 1065. Throughout the hearing, the
Respondent adhered to his position that his prescribing did not fall
below the applicable standard of care, due to the available knowledge
at the time, the high MME levels the patients carried upon his first
encounter with them, and his eventual efforts to wean them down.\82\
Tr. 1068-69, 1073. By his reckoning, his only potential prescribing
missteps in this regard were the unintentional early refills and the
quality of his documentation, both of which he argues have since been
remedied.
---------------------------------------------------------------------------
\81\ The Respondent did not admit that his combination
prescribing fell below the standard of care, and pointed out that
the CDC qualified its admonition against combining opioids and
benzodiazepines as to be avoided ``whenever possible.'' Tr. 1072.
The Respondent maintains that the relative merits of prescribing the
trinity combination in the past ``was not clear.'' Id. at 1073.
\82\ The Government assisted the witness in highlighting the
fact that, notwithstanding progress notes expressing an intention to
wean, not all of his opioid medication titrations have pointed
downward. Tr. 1074-96. [For just one example, Respondent's notes for
SM stated that attempts at reducing the medication were met with
decreased function, but there were no substantial attempts to reduce
in the actual prescribing as demonstrated in the records from March
2014 until April 2018. Tr. 1080, 1084; Gov't Ex. 10 at 149.] The
Respondent offered that he encouraged some of his patients to reduce
their medications below the amounts he was prescribing, but
unpersuasively conceded that such a recommendation would not be
documented in his charting. Id. at 1103-04.
---------------------------------------------------------------------------
Surprisingly, although, as discussed, supra, the findings of the
California Board set forth in the Board Order are entitled to
preclusive effect in these proceedings,\83\ the Respondent devoted no
portion of his testimony to any of those issues. Thus, although the
Board Order established much of the Government's overall case, the
Respondent's testimony offered neither an acceptance of responsibility
nor a plan of remedial action concerning those issues.
---------------------------------------------------------------------------
\83\ See Robert L. Dougherty, M.D., 76 FR 16823, 16834 (2011).
---------------------------------------------------------------------------
As is always the case in these proceedings, among the witnesses who
testified at this hearing, the Respondent unarguably possesses the
greatest interest in the outcome, and hence, the greatest motivation to
enhance, modify, or even fabricate his testimony. However, even apart
from the risk of implicit bias, the Respondent's testimony presented a
robust array of other reasons to eschew accepting his version of events
without a significant level of skepticism. The Respondent initially
testified, as he argued in his CAP, that his standard pain medication
contracts satisfied the applicable standard of care relative to the
required appraisal of the risks of opioid use and combined prescribing
to his patients. However, when the identical issue arose regarding one
of his patients, Patient ET, the Respondent suddenly changed course and
claimed that his standard pain medication contracts did not meet the
standard, and even cited this as a reason that he changed his practice
and
[[Page 4925]]
introduced specific opioid consent documents and implemented changes to
his standard pain medication contracts. Additionally, although the
Respondent consistently defended his high-MME prescribing based on his
practice of titrating the medications down, a review of his progress
notes reflects that although this was a consistently-documented
intention that would presumably be understood by anyone reviewing his
charting, the reality was that in many instances weaning was not
effected, and later notes, instead of reflecting the failure to taper,
just continued to express the purported aspiration. The potential
inescapable inference here is that inexorably repeated comments
supposedly seeking to taper and failing to document no progress in that
regard was intentional window dressing to create a variety of plausible
deniability. Another aspect of the Respondent's presentation that was
unhelpful to his credibility was the manner in which he addressed his
perception that medical literature on the issue of opioid prescribing
presented an evolving landscape. As discussed, supra, the Respondent
depicted his prescribing decision point as ``just coming off of the
decade of maybe 2000, 2010[, where p]ain is a fifth vital sign[ and
t]here's no limits to dosing.'' Tr. 982. To be sure, scientific
guidance is rarely fixed in any field, much less medicine, and
controlled substance prescribing in the medical field has seen its fair
share of fluctuation. But even assuming the accuracy of this broad
reality, defending the prescribing of dangerous and powerful controlled
substances to his patients based on something as vague as what
``decade'' *\K\ he was ``coming off'' does not reflect a serious
analysis of the issue or any level of reflective circumspection.
Medical science does not adjust itself based on the inexorable flipping
of the calendar decades, and it would be impossible to even define when
a prescriber was ``coming off'' one decade and jumping into another,
even if this were a realistic concept--which it is not. Is a month
after a decade ``coming off''? Is three or five years? Suffice it to
say that this sort of glib dismissal of the proper standard to be
applied to controlled substance prescribing at the moment he was
writing prescription after prescription did not enhance the level of
credibility and reliability that can be reasonably assigned to the
Respondent's testimony.
---------------------------------------------------------------------------
*\K\ Respondent took exception to the Chief ALJ's comment that
Respondent was vague as to the exact decade. Resp't Exceptions at 23
n.6 (``[Respondent] states clearly the time is 2010. This means the
decade of pain occurred approximately between 2000-2010.''). Even if
the Respondent was clear in this statement, what remains unclear is
the issue that the Chief ALJ highlighted--how long after the decade
can Respondent still claim ignorance as to the dangers of
prescribing high levels of opioids? The prescribing activity in the
OSC allegations falls between 2014 and 2019, so if Respondent is
claiming that this ``decade of pain'' ended around 2010, it is not
credible that the decade would still be affecting the standard of
care four to nine years (almost an another entire decade) after it
ended. Respondent notably stretches the decade to around 2012 in his
Exceptions using Dr. Polston's declaration, but even taking this
expanded timeframe into account, he cannot cover the activity in
question. Resp't Exceptions at 24 (citing Ex. L). In fact, the
Government points out that the evidence demonstrates that
Respondent's prescribing behavior did not begin to change until
around the same time that the California Medical Board was preparing
to file an action against Respondent, which was ``ultimately filed
on October 5, 2017.'' Gov't Response at 33 (citing Gov't Ex. 30 at
4).
---------------------------------------------------------------------------
That is not to say that the Respondent is entirely incredible or
that his professional opinions are to be easily dispatched. The
Respondent is an experienced, knowledgeable, well-credentialed
physician with a considerable level of subject-matter expertise. There
were aspects of his biographical information, the progress of his
career, and even some aspects of his testimony regarding treatment that
were reliable and believable and should be relied upon and believed,
but where the Respondent's testimony conflicts with the testimony of
other witnesses and evidence of record (which is substantial), it must
be viewed with a heightened level of scrutiny.
Dr. Gregory Polston, M.D.
The Respondent presented the expert testimony of Dr. Gregory
Polston.\84\ Dr. Polston's CV reflects that he has been Board Certified
in Anesthesiology for over twenty years, has held a subspecialty
certification in Pain Medicine for nearly twenty years,\85\ and
completed a pain fellowship at the University of California, San Diego
(UCSD). Tr. 1140, 1142-43, 1146-47; Resp't Ex. K. The witness testified
that he is currently the Assistant Director of the Center for Pain
Management at UCSD, the Sector Chief for the Pain Service at the
Veteran's Affairs Medical Center in San Diego, and his current medical
practice is exclusively devoted to patients with acute or chronic pain.
Tr. 1141-42, 1148; Resp't Ex. K. Dr. Polston was tendered \86\ and
accepted \87\ as an expert witness in controlled substance prescribing
in California, including controlled substance prescribing for
intractable pain. Tr. 1153-54.
---------------------------------------------------------------------------
\84\ Dr. Polston testified that he has been compensated by the
Respondent for his professional work as an expert in this case. Tr.
1285.
\85\ Dr. Polston testified that there is no pain management
board certification available, and that the added pain management
qualification awarded by the American Board of Anesthesiologists is
the closest that a physician can get to a board certification in
pain management. Tr. 1146-47.
\86\ Tr. 1148-49.
\87\ During voir dire, Dr. Polston stated that his expert
opinion was influenced by statements the Respondent made during
preparation sessions with the Respondent's counsel. Tr. 1151-52. The
tribunal recognized Dr. Polston as an expert but directed the
witness to inform the tribunal at any point during his testimony if
his opinion was influenced by an explanation or elaboration that the
Respondent gave during a preparation session. Id. at 1153-54.
---------------------------------------------------------------------------
The Respondent's expert testified that he reviewed patient files
for the Six Patients from the Respondent's practice and (at least
initially) testified that the Respondent's controlled substance
prescribing did meet the standard of care in California. Id. at 1193,
1224-26, 1229-30, 1284. Specifically, the witness opined that the
amount of medication the Respondent prescribed for each of the Six
Patients was within the standard the care. Id. at 1167, 1192-93, 1199,
1204, 1211, 1217-18, 1224-26. To support his reasoning, Dr. Polston
identified patient records that stated the patients had a diagnosis
that could be painful and/or the patients' history contained evidence
of multiple pain, indicating the patients were candidates for opiate
therapy.\88\ Gov't Exs. 2-4, 6, 8, 10, 12; Tr. 1155-56, 1166-67
(Patient AA); Tr. 1186-88, 1190-93 (Patient BB); Tr. 1196-99, 1203
(Patient JD); Tr. 1206-10 (Patient DD); Tr. 1214-15 (Patient SM); Tr.
1222-24 (Patient ET). He also explained that, in determining whether to
prescribe controlled substances, a physician should consider subjective
input from patients and increased functionality, and then pointed to
instances in the record where subjective input and functionality were
identified. Tr. 1167, 1184 (Patient AA); Tr. 1191-92 (Patient BB); Tr.
1201, 1203-04 (Patient JD); Gov't Ex. 8; Tr. 1210-11 (Patient DD);
Gov't Ex. 10; Tr. 1215-17 (Patient SM). The Respondent's expert
explained his view of functionality analysis this way:
---------------------------------------------------------------------------
\88\ Dr. Polston explained that Patient AA's primary diagnosis
was HES, which he classifies as a form of cancer. Tr. 1155-56. In
Dr. Polston's opinion, it was important that Patient AA had a cancer
diagnosis because ``the guidelines are much different for chronic
benign pain versus cancer pain.'' Id. at 1156. Remarkably, the
witness explained that, in his view, a cancer diagnosis ``really
strips away nearly all guidelines'' for prescribing controlled
substances. Id. at 1157. It was clear from Dr. Polston's testimony
that his perception that the Respondent was treating this patient
for cancer essentially dissolved other constraints that might
otherwise be placed on his pain medication prescribing.
Initially physicians would consider the functional report of
pain or reduction in pain as being more important. As time evolved
we felt that function was more important and it's a balancing act.
There are some patients who
[[Page 4926]]
report less function as you reduce medicines because they say they
have more pain, they reduce their activity, and have more anxiety
and more difficulty. There are some patients that go the other way
and find more function as the medicines go down and that is
something that, you know, that you are always trying to use both of
---------------------------------------------------------------------------
those markers as a way to judge whether the therapy is appropriate.
Tr. 1202-03.
Dr. Polston also testified that the Respondent reduced the MME
levels for Patients JD,\89\ DD,\90\ SM,\91\ and ET,\92\ and that the
Respondent met the standard of care by virtue of the reductions he made
in these patients' MME levels. Tr. 1200, 1213, 1221, 1228-29. However,
according to Dr. Polston, reducing MMEs is not always necessary to meet
the standard of care,\93\ and the Respondent met the standard of care
when he did not reduce Patient AA's opioid dosage. Tr. 1284. After
being directed to the autopsy report for Patient AA, Dr. Polston opined
that the Respondent's prescriptions were not a contributing factor to
Patient AA's overdose death. Id. at 1182; see also Gov't Ex. 31.
According to Dr. Polston, ``[t]his patient, if he would not have taken
the fentanyl, added in the alcohol and the ketamine, . . . would be
still alive.'' Tr. 1182. [Dr. Polston later clarified his testimony on
cross-examination that the fentanyl, alcohol and ketamine ``are
contributing to his death,'' but that ``to say that those are precise
cause of death, no, I cannot go that far.'' Tr. 1280.]
---------------------------------------------------------------------------
\89\ Tr. 1200.
\90\ Tr. 1211-13; see Resp't Exs. D at 1051-55, L at 8-9, ] 27.
\91\ Tr. 1214, 1219-20; see Resp't Exs. E at 1494, L at 10, ]
29.
\92\ Tr. 1226-28; see Resp't Ex. L at 10-11, ] 32.
\93\ Tr. 1273-76, 1284.
---------------------------------------------------------------------------
Dr. Polston also testified that after reviewing all patient records
presented to him, it was his opinion that the Respondent met the
standard of care with respect to informed consent. Id. at 1229-30.
However, when asked if it would change his opinion if he learned that
the Respondent believed his care of the patients fell below the
standard of care in regards to informed consent, Dr. Polston answered
affirmatively; that is, learning that the Respondent's view that he
failed to meet the standard would change Dr. Polston's mind on the
issue. Id. at 1231-32. The witness explained his change in opinion this
way: ``[I]f he's reviewing his records and says that he did not meet
the standard of care then I would agree with that.'' Id. at 1232.
The witness initially testified that there was no evidence of early
refills in this case, and that the Respondent's practice of writing
prescriptions of thirty day dosages every twenty-eight days was within
the standard of care in California. Id. at 1232-33, 1236-38.*\L\
However, when Dr. Polston was asked if it would change his opinion if
he learned that the Respondent believed his prescribing every twenty-
eight days fell below the standard of care, he answered affirmatively.
Id. at 1239. The witness altered his expert opinion based on the
Respondent's alleged testimony, explaining that ``he alone will know
precisely what was going on at that appointment when he's writing it,
and if he . . . feels that he was below the standard of care then I
would say that, that would be below the standard of care.'' Id.
---------------------------------------------------------------------------
*\L\ I also found Dr. Polston's testimony about whether early
fills are outside the standard of care to be evasive. ``I don't
think that's good care. I'm not sure, you know, the--your argument
over time is concerning to me, but I can say that I know that that
occurs. The standard of care is what reasonable physicians in the
community would approve, and I have seen that in the community at
multiple different levels.'' When the Chief ALJ pressed him to
clarify, he said, ``I would say best practices is not to do that,
but I see reasonable physicians in the community doing that.'' Tr.
1237-38.
---------------------------------------------------------------------------
Dr. Polston also testified regarding medical records presented by
the Government that bore indicia of anomalous UDS results regarding
Patient AA. Tr. 1243-44, 1250-53. Dr. Polston identified Patient AA's
UDSs as inconsistent (not aberrant),*\M\ testifying that there was no
indication in the records that he reviewed of aberrant behavior by
Patient AA, and opining that the purported inconsistency could have
resulted from the patient being a rapid metabolizer.\94\ Tr. 1244-45,
1281-82. In his opinion, the Respondent's handling of the inconsistent
UDS results in the charts was rendered within the standard of care by
the act of the Respondent writing the letters PRN on some of the
screens and by seeing the patient on a regular basis. Id. at 1263-65.
However, when Dr. Polston was informed that the Respondent testified
that even he believed that he fell below the standard of care when he
dealt with the inconsistent UDSs, the witness again deserted the
opinion he had previously offered with conviction and (with equal
conviction) testified that it had become his (new) opinion that the
Respondent did in fact not meet the standard of care in this category.
Id. at 1265-66.
---------------------------------------------------------------------------
*\M\ I did not find Dr. Polston's argument about the difference
between aberrant and inconsistent urine screens to be credible. He
seemed to want to justify his stance that these drug screens did not
rise to what he deemed ``aberrant'' no matter what the circumstance.
Respondent's counsel asked if ``there [was] any indication in any of
the drug results or any of the records that [he] reviewed that this
patient was having aberrant behavior and not just inconsistent?''
Dr. Polston answered, ``Yes. These appeared to me inconsistent and
that those results were the same. I am concerned that there was
multiple times. But in some ways, multiple times also means that
there was something unusual about that.'' Tr. 1282. He first
references a concern that could make these UDS results ``aberrant,''
but then decides that that very concern is, in actuality, a reason
not to be concerned. This logic is circular and evasive. Regardless
of which term is used, the heart of the matter here is whether or
not there needed to be documentation of the resolution of the
aberrant or inconsistent UDS. Dr. Polston seemingly attempted to
evade and confuse this issue.
\94\ Neither the Patient AA charts nor the balance of this
record (including the Respondent's testimony) bore any indication
that this patient was a rapid metabolizer, or that the Respondent
believed he might be a rapid metabolizer.
---------------------------------------------------------------------------
Overall, Dr. Polston's unabashed willingness to forsake his
purported expert opinions at the first sign that the Respondent offered
testimony that conflicted with those opinions obviously created
internal inconsistencies that undermined the weight that can be
attached to his presentation. While there is no question that the
witness's credentials were impressive, Dr. Polston presented an overall
impression that he was present to support the Respondent's position,
even where the Respondent's position evolved. It was unhelpful that Dr.
Polston initially testified that the Respondent's controlled substance
prescribing did meet the standard of care in California, but when
confronted by the Respondent's agreement with Dr. Munzing's testimony
regarding informed consent, early refills, and anomalous UDSs, Dr.
Polston unhesitatingly changed his view to conform with the
Respondent's version. It was almost as if to say that his expert
opinion was whatever the Respondent may have said before, now, or
later, even if the Respondent's position toggled back and forth. To
offer ``whatever he said'' as an expert opinion is not a feature that
enhances the reliability that can be attached to the views expressed by
a purported expert. Suffice it to say that Dr. Polston's amenability to
instantly change course and support the Respondent's fluid opinions,
based merely on being advised of them, undermines the weight that can
be attached to his testimony. Additionally, at one point in his
testimony, the Respondent's expert testified that ``the guidelines are
much different for chronic benign pain versus cancer pain.'' Tr. 1156.
According to Dr. Polston, a cancer diagnosis ``really strips away
nearly all guidelines'' for prescribing controlled substances.\95\ Tr.
[[Page 4927]]
1157. The unique concept that a particular diagnosis would obliterate
any controlled substance prescribing standard was offered here without
any supporting sources and challenges common sense. Under a mild
extrapolation of this logic, a near-lethal, or even lethal dose of
controlled pain medication would not be excluded from Dr. Polston's
view of acceptable prescribing.
---------------------------------------------------------------------------
\95\ Even setting aside the relative merits of this view, [it is
unclear from the Medical examiner's report whether AA, in fact, had
cancer, and given that he died of an overdose, it certainly is not a
stretch to question whether he had other motivations for seeking
medication. Gov't Ex. 31 at 5; Tr. 194-95. However, I find that
whether or not AA had cancer is not relevant to my overall finding
that Respondent prescriptions to AA were issued beneath the
applicable standard of care and outside the usual course of
professional practice.]
---------------------------------------------------------------------------
That is not to say that Dr. Polston is entirely unreliable. Like
the Respondent, this is an extremely experienced and well-credentialed
professional. There were certainly aspects of his biographical
information, the progress of his career, and even some testimony
regarding treatment and prescribing that presented as sensible and
consistent with the record, and those opinions and information should
be relied upon. However, it is where Dr. Polston's testimony conflicts
with the testimony of other expert testimony and evidence of record
that reliance becomes problematic. Specifically, where Dr. Polston's
expert testimony conflicts with the testimony of Dr. Munzing, it is Dr.
Munzing's view that must control.
Other facts necessary for a disposition of this case are set forth
in the balance of this Recommended Decision.
The Analysis
Public Interest Determination: The Standard
Under 21 U.S.C. 824(a)(4), the Agency may revoke the COR of a
registrant if the registrant ``has committed such acts as would render
his registration . . . inconsistent with the public interest.'' 21
U.S.C. 824(a)(4). Congress has circumscribed the definition of public
interest in this context by directing consideration of the following
factors:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(3) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f).
``These factors are to be considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). Any one or a combination of
factors may be relied upon, and when exercising authority as an
impartial adjudicator, the Agency may properly give each factor
whatever weight it deems appropriate in determining whether a
registrant's COR should be revoked. Id.; see Morall v. DEA, 412 F.3d
165, 173-74 (D.C. Cir. 2005). Moreover, the Agency is ``not required to
make findings as to all of the factors,'' Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005); Morall, 412 F.3d at 173, and is not required to
discuss consideration of each factor in equal detail, or even every
factor in any given level of detail, Trawick v. DEA, 861 F.2d 72, 76
(4th Cir. 1988) (holding that the Administrator's obligation to explain
the decision rationale may be satisfied even if only minimal
consideration is given to the relevant factors, and that remand is
required only when it is unclear whether the relevant factors were
considered at all). The balancing of the public interest factors ``is
not a contest in which score is kept; the Agency is not required to
mechanically count up the factors and determine how many favor the
Government and how many favor the registrant. Rather, it is an inquiry
which focuses on protecting the public interest . . . .'' Jayam
Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
In adjudicating a revocation of a DEA COR, the Government has the
burden of proving that the requirements for the revocation it seeks are
satisfied. 21 CFR 1301.44(e). Where the Government has met this burden
by making a prima facie case for revocation of a registrant's COR, the
burden of production then shifts to the registrant to show that, given
the totality of the facts and circumstances in the record, revoking the
registrant's COR would not be appropriate. Med. Shoppe-Jonesborough, 73
FR 364, 387 (2008). Further, ``to rebut the Government's prima facie
case, a[] registrant is required not only to accept responsibility for
[the established] misconduct, but also to demonstrate what corrective
measures [have been] undertaken to prevent the re-occurrence of similar
acts.'' Jeri Hassman, M.D., 75 FR 8194, 8236 (2010); accord Krishna-
Iyer, 74 FR 464 n.8. In determining whether and to what extent a
sanction is appropriate, consideration must be given to both the
egregiousness of the offense established by the Government's evidence
and the Agency's interest in both specific and general deterrence.
David A. Ruben, M.D., 78 FR 38363, 38364, 38385 (2013).
Normal hardships to the registrant, and even to the surrounding
community, which are attendant upon lack of registration, are not a
relevant consideration. See Linda Sue Cheek, M.D., 76 FR 66972, 66972-
73 (2011); Gregory D. Owens, D.D.S., 74 FR 36751, 36757 (2009).
Further, the Agency's conclusion that ``past performance is the best
predictor of future performance'' has been sustained on review in the
courts, Alra Labs., Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as
has the Agency's consistent policy of strongly weighing whether a
registrant who has committed acts inconsistent with the public interest
has accepted responsibility and demonstrated that he or she will not
engage in future misconduct, Hoxie, 419 F.3d at 483.\96\
---------------------------------------------------------------------------
\96\ The Agency has repeatedly upheld this policy. See Ronald
Lynch, M.D., 75 FR 78745, 78754 (2010) (holding that the
respondent's attempts to minimize misconduct undermined acceptance
of responsibility); George Mathew, M.D., 75 FR 66138, 66140, 66145,
66148 (2010); George C. Aycock, M.D., 74 FR 17529, 17543 (2009);
Krishna-Iyer, 74 FR 463; Steven M. Abbadessa, D.O., 74 FR 10077,
10078 (2009); Med. Shoppe-Jonesborough, 73 FR 387.
---------------------------------------------------------------------------
Although the burden of proof at this administrative hearing is a
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S.
91, 100-03 (1981), the Agency's ultimate factual findings will be
sustained on review to the extent they are supported by ``substantial
evidence,'' Hoxie, 419 F.3d at 482. While ``the possibility of drawing
two inconsistent conclusions from the evidence'' does not limit the
Administrator's ability to find facts on either side of the contested
issues in the case, Shatz v. U.S. Dep't of Justice, 873 F.2d 1089, 1092
(8th Cir. 1989) (internal citation omitted), all ``important aspect[s]
of the problem,'' such as a respondent's defense or explanation that
runs counter to the Government's evidence, must be considered,
Wedgewood Vill. Pharmacy v. DEA, 509 F.3d 541, 549 (D.C. Cir. 2007);
see Humphreys v. DEA, 96 F.3d 658, 663 (3d Cir. 1996). The ultimate
disposition of the case ``must be `in accordance with' the weight of
the evidence, not simply supported by enough evidence `to justify, if
the trial were to a jury, a refusal to direct a verdict when the
conclusion sought to be drawn from it is one of fact for the jury.'''
Steadman, 450 U.S. at 99 (quoting Consolo v. FMC, 303 U.S. 607, 620
(1966)).
Regarding the exercise of discretionary authority, the courts have
recognized that gross deviations from past agency precedent must be
adequately supported, Morall, 412 F.3d at 183, but mere unevenness in
[[Page 4928]]
application does not, standing alone, render a particular discretionary
action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (D.C. Cir. 2008),
cert. denied, 555 U.S. 1139 (2009); cf. Dep't of Homeland Security v.
Regents of Univ. of Cal., 140 S. Ct. 1891, 1913 (2020) (holding that an
agency must carefully justify significant departures from prior policy
where reliance interests are implicated). It is well settled that,
because the Administrative Law Judge has had the opportunity to observe
the demeanor and conduct of hearing witnesses, the factual findings set
forth in this Recommended Decision are entitled to significant
deference, see Universal Camera Corp. v. NLRB, 340 U.S. 474, 496
(1951), and that this Recommended Decision constitutes an important
part of the record that must be considered in the Agency's final
decision, see Morall, 412 F.3d at 179. However, any recommendations set
forth herein regarding the exercise of discretion are by no means
binding on the Administrator and do not limit the exercise of that
discretion. See 5 U.S.C. 557(b); River Forest Pharmacy, Inc. v. DEA,
501 F.2d 1202, 1206 (7th Cir. 1974); Attorney General's Manual on the
Administrative Procedure Act Sec. 8(a) (1947).
[Factor One
In this case, it is undisputed that Respondent holds a valid state
medical license in California. However, possession of a state license
does not entitle a holder of that license to a DEA registration. Mark
De La Lama, P.A., 76 FR 20011, 20018 (2011). It is well established
that a ``state license is a necessary, but not a sufficient condition
for registration.'' Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003).
The ultimate responsibility to determine whether a DEA registration is
consistent with the public interest resides exclusively with the DEA,
not to entities within state government. Edmund Chien, M.D., 72 FR
6580, 6590 (2007), aff'd Chien v. DEA, 533 F.3d 828 (D.C. Cir. 2008).
In determining the public interest, the ``recommendation of the
appropriate State licensing board or professional disciplinary
authority . . . shall be considered.'' 21 U.S.C. 823(f)(1). Two forms
of recommendations appear in Agency decisions: (1) A recommendation to
DEA directly from a state licensing board or professional disciplinary
authority (hereinafter, appropriate state entity), which explicitly
addresses the granting or retention of a DEA COR; and (2) the
appropriate state entity's action regarding the licensure under its
jurisdiction on the same matter that is the basis for the DEA OSC. John
O. Dimowo, M.D., 85 FR 15800, 15810 (2020); see also Vincent J.
Scolaro, D.O., 67 FR 42060, 42065 (2002).
In this case, neither the MBC nor any other state entity has made a
direct recommendation to DEA regarding whether the Respondent's
controlled substances registration should be suspended or revoked.
There is evidence on the record that on October 29, 2019, the MBC found
that the Respondent violated state law by prescribing dangerous
controlled substances to the Board Patients. Gov't Ex. 30 at 147, 157-
61, 196-199. The MBC found in favor of revocation, but stayed the
revocation pending completion of probation. Id. at 168.
The evidence before me is different than the evidence that was
before the MBC. It demonstrates that Respondent engaged in additional
violations of state and federal law with respect to his prescribing
practices. The fact that the MBC chose to stay the revocation of
Respondent's state medical license carries minimal weight under Factor
One, because there is no evidence that the MBC would have made the same
decision in the face of the additional misconduct found herein
involving different patients.*\N\ Further, it is noted that, in spite
of the decision's stay, the Board actually found in favor of
revocation, which does not indicate a substantial amount of trust in
Respondent. For all of these reasons, the terms of the MBC Order have
been considered, but I find that they have little impact on the public
interest inquiry in this case. See Jeanne E. Germeil, 85 FR 73786,
73799 (2020); see also John O. Dimowo, M.D., 85 FR 15810. It ultimately
is the Administrator who makes a determination of whether maintaining a
COR is in the public interest as defined by the CSA, and the
Administrator's purview is focused on entrusting Respondent with a
controlled substances registration, which is a much more narrow inquiry
than a medical license generally. Ajay S. Ahuja, M.D., 84 FR 5479, 5490
(2019).
---------------------------------------------------------------------------
*\N\ In Dimowo, the Acting Administrator found that ``[a]lthough
statutory analysis [of the CSA] may not definitively settle . . .
[the breadth of the cognizable state `recommendation' referenced in
Factor One], the most impartial and reasonable course of action is
to continue to take into consideration all actions indicating a
recommendation from an appropriate state;'' however, Dimowo also
limited the ``recommendations'' DEA would consider to the ``actions
of an appropriate state entity on the same matters, particularly
where it rendered an opinion regarding the practitioner's medical
practice in the state due to the same facts alleged in the DEA
OSC.'' John O. Dimowo, 85 FR 15810. Although the same ``matters''
may include similar types of violations, in this case, I have no
indication that the MBC would have made a similar decision in the
face of these additional violations and misconduct.
---------------------------------------------------------------------------
In sum, while the terms of the MBC are not dispositive of the
public interest inquiry in this case and are minimized due to the
differences in the evidence in the MBC Order, the record evidence
before me and the severity of the sanctions ordered by the MBC, I
consider the stay of the MBC's revocation of Respondent's California
medical license and give it minimal weight in Respondent's favor,
because the charges could have immediately resulted in the revocation
of his medical license, instead of a stayed revocation. See Jennifer
St. Croix, 86 FR 19010, 19022 (2021). Even with this minimal weight in
his favor, I do not find Respondent's continued registration to be
within the public interest as explained below.]
Factors Two and Four: The Respondent's Experience Dispensing Controlled
Substances and Compliance With Federal, State, and Local Law
The Government has founded its theory for sanction exclusively on
Public Interest Factors Two (the Respondent's experience conducting
regulated activity) and Four (the Respondent's compliance with state
and federal laws related to controlled substances), and it is under
those two factors that the lion's share of the evidence of record
relates.\97\ In this case, the gravamen of the allegations in the OSC
as well as the factual concentration of much of the evidence presented,
share as a principal focus the manner in which the Respondent has
managed that
[[Page 4929]]
part of his practice relative to prescribing controlled substances and
acts allegedly committed in connection with that practice. Thus, it is
analytically logical to consider Public Interest Factors Two and Four
together. That being said, Factors Two and Four involve analysis of
both common and distinct considerations.
---------------------------------------------------------------------------
\97\ [Omitted the Chief ALJ's discussion of Factor One and added
it into the text above]. [T]here is no record evidence of a
conviction record relating to regulated activity (Factor Three).
Even apart from the fact that the plain language of this factor does
not appear to emphasize the absence of such a conviction record,
myriad considerations are factored into a decision to initiate,
pursue, and dispose of criminal proceedings by federal, state, and
local prosecution authorities which lessen the logical impact of the
absence of such a record. See Dougherty, 76 FR 16833 n.13; Dewey C.
MacKay, M.D., 75 FR 49956, 49973 (2010) (``[W]hile a history of
criminal convictions for offenses involving the distribution or
dispensing of controlled substances is a highly relevant
consideration, there are any number of reasons why a registrant may
not have been convicted of such an offense, and thus, the absence of
such a conviction is of considerably less consequence in the public
interest inquiry.''), aff'd, MacKay v. DEA, 664 F.3d 808 (10th Cir.
2011); Ladapo O. Shyngle, M.D., 74 FR 6056, 6057 n.2 (2009).
Therefore, the absence of criminal convictions militates neither for
nor against the revocation sought by the Government. Since the
Government's allegations and evidence fit squarely within the
parameters of Factors Two and Four and do not raise ``other conduct
which may threaten the public health and safety,'' 21 U.S.C.
823(f)(5), Factor Five considerations are inapplicable and militate
neither for nor against the sanction sought by the Government in
this case.
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Regarding Factor Two, it is beyond argument that the Respondent is
a well-credentialed, experienced medical practitioner who has been
treating many patients for many years. Resp't Ex. G; Tr. 898. There is
likewise no evidence of record that, prior to his present difficulties,
that the Respondent has been the subject of discipline by state or
federal authorities relative to his controlled substance prescribing.
[Omitted for brevity.] The Respondent's experience as a registrant is
lengthy, and there is no evidence to contradict his contention that he
has treated many, many patients, but the Agency has long held that
benign experience cannot overcome intentional misconduct, and that the
misconduct established by record evidence is considered under both
Factors Two and Four. See Roberto Zayas, M.D., 82 FR 21410, 21422 n.27
(2017) (announcing that ``misconduct is misconduct whether it is
relevant under Factor Two, Factor Four, or Factor Five, or multiple
factors''). Thus, the balance of the evidence related to Factor Two,
per the Agency's interpretation, will be considered below together with
Factor Four.
As discussed, supra, Factor Four compels consideration of the
Respondent's compliance with state and federal laws related to
controlled substances. The DEA regulations provide that to be
effective, a prescription must be issued for a legitimate medical
purpose by a practitioner acting in the usual course of professional
practice. 21 CFR 1306.04(a). The Supreme Court has opined that, ``the
prescription requirement . . . ensures patients use controlled
substances under the supervision of a doctor so as to prevent addiction
and recreational abuse.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
Further, the Agency's authority to revoke a registration is not limited
to instances where a practitioner has intentionally diverted controlled
substances. Bienvenido Tan, 76 FR 1763, 17689 (2011); see Dewey C.
MacKay, M.D., 75 FR 49956, 49974 n.35 (2010) (noting that revocation is
not precluded merely because the conduct was ``unintentional, innocent,
or devoid of improper motive'') (citation omitted).
To effectuate the dual goals of conquering drug abuse and
controlling both legitimate and illegitimate traffic in controlled
substances, ``Congress devised a closed regulatory system making it
unlawful to manufacture, distribute, dispense, or possess any
controlled substance except in a manner authorized by the [Controlled
Substance Act (CSA)].'' Gonzales v. Raich, 545 U.S. 1, 13 (2005).
Consistent with the maintenance of that closed regulatory system,
subject to limited exceptions not relevant here, a controlled substance
may only be dispensed upon a prescription issued by a practitioner, and
such a prescription is unlawful unless it is ``issued for a legitimate
medical purpose by an individual practitioner acting in the usual
course of his professional practice.'' 21 CFR 1306.04(a); see 21 U.S.C.
829. Furthermore, ``[a]n order purporting to be a prescription issued
not in the usual course of professional treatment . . . is not a
prescription within the meaning and intent of [21 U.S.C. 829] and the
person knowingly . . . issuing it, shall be subject to the penalties
provided for violations of the provisions of law relating to controlled
substances.'' 21 CFR 1306.04(a).
The prescription requirement is designed to ensure that controlled
substances are used under the supervision of a doctor, as a bulwark
against the risk of addiction and recreational abuse. George C. Aycock,
M.D., 74 FR 17529, 17541 (2009) (citing Gonzales, 546 U.S. at 274); see
also United States v. Moore, 423 U.S. 122, 135, 142-43 (1975) (noting
that evidence established that a physician exceeded the bounds of
professional practice when he gave inadequate examinations or none at
all, ignored the results of the tests he did make, and took no
precautions against misuse and diversion). The prescription requirement
likewise stands as a proscription against doctors ``peddling to
patients who crave the drugs for those prohibited uses.'' Gonzales, 546
U.S. at 274. A registered practitioner is authorized to dispense, which
the CSA defines as ``to deliver a controlled substance to an ultimate
user . . . by, or pursuant to the lawful order of a practitioner.'' 21
U.S.C. 802(10); see also Rose Mary Jacinta Lewis, 72 FR 4035, 4040
(2007). The courts have sustained criminal convictions based on the
issuing of illegitimate prescriptions where physicians conducted no
physical examinations or sham physical examinations. United States v.
Alerre, 430 F.3d 681, 690-91 (4th Cir. 2005), cert. denied, 574 U.S.
1113 (2006); United States v. Norris, 780 F.2d 1207, 1209 (5th Cir.
1986).
``Under the CSA, it is fundamental that a practitioner must
establish and maintain a [bona fide] doctor-patient relationship in
order to act in the usual course of . . . professional practice and to
issue a prescription for a legitimate medical purpose.'' Mackay, 75 FR
49973 (citation omitted); Patrick W. Stodola, M.D., 74 FR 20727, 20731
(2009); Ladapo O. Shyngle, M.D., 74 FR 6056, 6057-58 (2009). The CSA
generally looks to state law to determine whether a bona fide doctor-
patient relationship was established and maintained. Stodola, 74 FR
20731; Kamir Garces-Mejias, M.D., 72 FR 54931, 54935 (2007); United
Prescription Servs., Inc., 72 FR 50397, 50407 (2007).
While true that the CSA authorizes the ``regulat[ion of] medical
practice insofar as it bars doctors from using their prescription-
writing powers as a means to engage in illicit drug dealing and
trafficking as conventionally understood,'' Gonzales, 546 U.S. at 909-
10, and the agency also evaluates state standards. Joseph Gaudio, M.D.,
74 FR 10083, 10090 (2009); Garces-Mejias, 72 FR 54935; United
Prescription Servs., 72 FR 50407. In this adjudication, the evaluation
of the Respondent's prescribing practices must be consistent with the
CSA's recognition of state regulation of the medical profession and its
bar on physicians from engaging in unlawful prescribing. Aycock, 74 FR
17541.*\O\
---------------------------------------------------------------------------
*\O\ Omitted for clarity.
---------------------------------------------------------------------------
Here, the relevant state law provisions largely mirror the CSA
where they do not go beyond it. Compare Cal. Health & Safety Code Sec.
11153(a) with 21 CFR 1304.06(a). California Health and Safety Code
Sec. 1153(a), like its CSA counterpart,\98\ provides that ``[a]
prescription for a controlled substance shall only be issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his or her professional practice.'' California law
further provides that ``[r]epeated acts of clearly excessive
prescribing'' constitutes unprofessional conduct for a physician. Cal.
Bus. & Prof. Code Sec. 725(a). Additionally, gross negligence,
incompetence, and repeated negligent acts can subject a physician to
sanction by the state medical board. Cal. Bus. & Prof. Code Sec. 2234.
---------------------------------------------------------------------------
\98\ 21 U.S.C. 802(21), 823(f).
---------------------------------------------------------------------------
California has specifically classified two categories of controlled
substance prescriptions as per se illegal:
(1) an order purporting to be a prescription which is issued not
in the usual course of professional treatment or in legitimate and
authorized research; or (2) an order for an addict or habitual user
of controlled
[[Page 4930]]
substances, which is issued not in the course of professional
treatment or as part of an authorized narcotic treatment program,
for the purpose of providing the user with controlled substances,
sufficient to keep him or her comfortable by maintaining customary
use.
Cal. Health & Safety Code Sec. 11153(a). A practitioner in California
who knowingly issues such an illegal prescription faces criminal
exposure. Cal. Health & Safety Code Sec. 11153(b).
During the course of his testimony, the Government's expert, Dr.
Munzing, outlined six elements that compose the standard of care for
prescribing controlled substances in the usual course of professional
treatment in California. Dr. Munzing explained that a physician must
acquire a patient history, conduct a physical examination of the
patient, determine whether additional data is necessary, produce an
assessment of the patient that includes risk stratification, create an
individualized treatment plan and obtain informed consent, and have
proper documentation throughout each step. Tr. 94-111. These elements
laid out by Dr. Munzing are consistent with instructions provided by
the California Board in its publication, Guide to the Laws Governing
the Practice of Medicine by Physicians and Surgeons (the MBC Guide).
See Gov't Ex. 21 at 57-61. The MBC Guide also lays out six basic
components to assist practitioners in meeting the standard of care in
managing pain patients: History/physical examination; treatment plan,
objectives; informed consent; periodic review; consultation; and
records. Id. at 59-61. The California Board supplies the following
explanation for acquiring a patient history and conducting a physical
examination:
A medical history and physical examination must be accomplished.
This includes an assessment of the pain, physical and psychological
function; a substance abuse history; history of prior pain
treatment; an assessment of underlying or coexisting diseases or
conditions; and documentation of the presence of a recognized
medical indication for the use of a controlled substance.
Id. at 59. The California Board explains producing an assessment of the
patient, or the creation of a treatment plan, as follows:
The treatment plan should state objectives by which the
treatment plan can be evaluated, such as pain relief and/or improved
physical and psychosocial function, and indicate if any further
diagnostic evaluations or other treatments are planned. The
physician and surgeon should tailor pharmacological therapy to the
individual medical needs of each patient. Multiple treatment
modalities and/or a rehabilitation program may be necessary if the
pain is complex or is associated with physical and psychosocial
impairment.
Id. In clarifying informed consent, the California Board states that
physicians ``should discuss the risks and benefits of the use of
controlled substances and other treatment modalities with the patient,
caregiver, or guardian.'' Id. at 60.
The California Board also suggests that a physician ``should
periodically review the course of pain treatment of the patient and any
new information about the etiology of the pain or the patient's state
of health.'' Id. In addressing consultation, the California Board
advises that ``physicians should give special attention to those pain
patients who are at risk for misusing their medications including those
whose living arrangements pose a risk for medication misuse or
diversion.'' Id. Dr. Munzing emphasized the importance of the
documentation requirement to ensuring patient safety. Tr. 105-07. Dr.
Munzing's explanation of the documentation requirements mirrored the
California Board's guidelines.
The physician and surgeon should keep accurate and complete
records according to [the five other controlled substance
prescribing components], including the medical history and physical
examination, other evaluations and consultations, treatment plan
objectives, informed consent, treatments, medications, rationale for
changes in the treatment plan or medications, agreements with the
patient, and periodic reviews of the treatment plan.
Gov't Ex. 21 at 61.
The applicable California Code provisions are consistent with the
standards outlined by the Government's expert, Dr. Munzing. Further,
the Respondent (and ultimately his expert) acceded that his controlled
substance prescribing fell below the applicable standard of care in
California in regard to prescribing early refills, addressing
inconsistent UDSs, and (at least with respect to Patient ET) acquiring
adequate informed consent. Accordingly, on these issues, the testimony
of the Government's expert stands uncontroverted on the present record.
When an administrative tribunal elects to disregard the uncontradicted
opinion of an expert, it runs the risk of improperly declaring itself
as an interpreter of medical knowledge. Ross v. Gardner, 365 F.2d 554
(6th Cir. 1966). There is no shortage of reliable expert knowledge in
the present record, at least regarding these issues, it is
uncontroverted, and it is not favorable to the Respondent.
At issue in this case is the Respondent's controlled substance
prescribing to ten patients: The four Board Patients that were the
subject of findings by MBC, and the Six Patients that were evaluated by
Dr. Munzing. While the evidence of record is generally discernible, the
same cannot entirely be said of the allegations propounded by the
Government in its OSC relating to the Six Patients. While it is likely
that the Government's intention was to contend that the Respondent
issued prescriptions to the Six Patients for controlled substances
outside the usual course of professional practice, that is not entirely
reflected in the plain language of the Government's charging document.
As discussed, supra, the CSA authorizes the Agency to impose a
sanction upon a finding that a registrant ``has committed such acts as
would render his registration under [21 U.S.C. 823] inconsistent with
the public interest as determined under such section.'' 21 U.S.C.
824(a)(4). Thus, for the Government to satisfy its prima facie burden,
it must allege facts that, if sustained, would actually demonstrate
that the registrant committed such acts as would render his
registration inconsistent with the public interest. See id. Here, in a
subset of allegations relating to the Six Patients (the He-Opined
Allegations), the Government does not allege actions, conduct, or
omissions attributable to the Respondent, but rather conclusions or
observations made by its own medical expert. ALJ Ex. 1 ]] 14.a, c, d,
e, f; ]] 18.a, c, d; ]] 21.a, c, d; ]] 23.a, c; ]] 26.a, c, d; ]] 30.a,
c, d. The plain language of each of the He-Opined Allegations points
not to conduct or omissions made by the Respondent, but merely to the
fact that (at some unspecified point in time) the Government's expert
concluded that certain matters were true.\99\ [Omitted for brevity.]
---------------------------------------------------------------------------
\99\ [Omitted for relevance.]
---------------------------------------------------------------------------
In pursuing a sanction under the Administrative Procedure Act (APA)
the Government is obligated to provide timely notice to a respondent,
inter alia, of ``the matters of law and fact asserted.'' 5 U.S.C.
554(b)(3); see also 21 CFR 1301.37(c). The Agency is required to
provide a respondent with notice of those acts which the Agency intends
to rely upon in seeking a sanction so as to provide a full and fair
opportunity to challenge the factual and legal basis for the Agency's
action. CBS Wholesale Distribs., 74 FR 36746, 36749 (2009). An
administrative charging document is not subject to the same level of
formality as
[[Page 4931]]
required in a criminal indictment or a pleading filed in a civil case,
Clair L. Pettinger, M.D., 78 FR 61591, 61596 (2013); Roy E. Berkowitz,
M.D., 74 FR 36758, 36759-60 (2009), but neither is the requirement
meaningless or illusory. The notice must be adequate, but the
allegation as written, must also establish culpability if proved.
[Omitted for brevity.]
However, [ ] the Agency has embraced the concept of litigation by
consent. Grider Drug #1 and Grider Drug #2, 77 FR 36746, 44070 n.23
(2012). Where, as here, a respondent has been provided with adequate
notice of an allegation, was afforded a full and fair opportunity to
litigate the issue, and did fully litigate the issue without objection,
the Agency has applied the well-established principle of litigation by
consent to adjudicate that which was intentionally tried by the
parties. However, the analysis of litigation by consent is fact
specific and the Agency may not base its decision on an issue that was
inadvertently tried by the parties. See Farmacia Yani, 80 FR 29053,
29059 (2015). ``Implied consent is not established merely because one
party introduced evidence relevant to an unpleaded issue and the
opposing party failed to object to its introduction. It must appear
that the parties understood the evidence to be aimed at the unpleaded
issue.'' Id. (internal citations omitted).
It is beyond argument that the He-Opined Allegations are unartfully
pleaded, but it is likewise irrefutable that the parties mutually
understood that they were litigating the issue of whether the
controlled-substance prescribing issues set forth in a subset of those
allegations depicted conduct that fell below the applicable standard.
In fact, the Respondent, through his counsel, frequently tracked along
with the OSC allegations and phrased many of his queries on whether the
Government-expert's criticisms raised by the He-Opined Allegations were
valid. See, e.g., Tr. 535, 643, 929, 932-33, 962, 981, 983, 1005, 1182.
Additionally, this issue was not raised by the Respondent in his
closing brief. See ALJ Ex. 37. This case raises no realistic notice
issues, and the language related to the opinions of the Government's
expert will be treated here as surplusage that does not impact the
validity of the charges or the findings. Accordingly, based on the
conduct of the parties at the hearing, as well as their post-hearing
briefs, the He-Opined Allegations will be considered as if the
underlying actions are alleged, not as if the conclusions of the
Government's expert (at some unspecified time) are the single issue
(that is: as they were drafted and served on the Respondent and this
tribunal).\100\ *\P\
---------------------------------------------------------------------------
\100\ [Footnote omitted for clarity.]
*\P\ I agree with the Chief ALJ that the OSC's drafting was
imprecise. I note that the OSC did include overarching acts or
omissions in addition to the more-specific expert opinions. The OSC
stated that Respondent ``violated federal and California law by
issuing prescriptions for controlled substances outside the usual
course of profession practice and not for a legitimate medical
purpose, to more than six patients.'' See, e.g., OSC at 3; see also
id. at 2 (``a prescription for a controlled substance is legitimate
only if `issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional
practice.' '' (citing 21 CFR 1306.04(a))). Therefore, although I
agree with the Chief ALJ that the drafting could be improved, I also
agree with him that Respondent was adequately noticed of the
allegations against it in this case.
---------------------------------------------------------------------------
During the course of this case, Dr. Munzing delivered his expert
opinion that the Respondent's charts did not reflect that he adequately
discussed the risks attendant upon the opiate course of treatment he
was employing on the Six Patients. While the Respondent and Dr. Polston
held differing views of this perspective, Dr. Munzing's views on this
issue (and all the issues upon which he opined in this case) are
afforded controlling weight. Accordingly, OSC Allegations 14.b, 18.b,
21.b, 23.b, 26.b, and 30.b are sustained.
Similarly, Dr. Munzing's expert opinion, supported by the findings
of the San Diego Medical Examiner's Office in its ME Report \101\
(although in conflict with the views of the Respondent and Dr.
Polston), that controlled substances prescribed by the Respondent were
among the contributing factors to Patient AA's death,\102\ is likewise
afforded controlling weight. Accordingly, OSC Allegations 12 and 14.f
are sustained.
---------------------------------------------------------------------------
\101\ Gov't Ex. 31 at 5.
\102\ The Government did not allege, nor is it necessary for
this Recommended Decision to find, that the Respondent's prescribing
was the sole or even principal factor [or a ``significant
component,'' Tr. 943] in Patient AA's overdose death.
---------------------------------------------------------------------------
The Respondent's practice of refilling 30-day controlled substance
prescriptions every 28 days for the Six Patients, causing a reservoir
of extra medication, is an area where the Respondent, during the course
of his testimony, was able to agree with the expert opinion of Dr.
Munzing. Accordingly, as amended,\103\ OSC Allegations 14.e, 18.d,
21.d, 23.c, 26.d, and 30.c are sustained.
---------------------------------------------------------------------------
\103\ ALJ Ex. 25.
---------------------------------------------------------------------------
Although the Respondent remained convinced about the validity of
the controlled medications and dosages he prescribed to the Six
Patients, as well as the combinations of medicines in the context of
the time and the ailments he was treating, in general he did not resist
the Government's view, supported by the expert opinion of Dr. Munzing,
that the documentation generated in the Respondent's charting of the
Six Patients was inadequate to a point where it fell below the
applicable standard of care. Dr. Munzing's expert opinion has been
afforded controlling weight. Accordingly, OSC Allegations 14.a,
14.c,*\Q\ 18.a, 18.c, 21.a, 21.c, 23.a, 26.a, 26.c, and 30.a are
sustained.
---------------------------------------------------------------------------
*\Q\ In his Exceptions, Respondent claims that the Chief ALJ
recommended sustaining allegations 14c and 18c that Respondent's
concurrent prescribing of opioids and benzodiazepines was beneath
the standard of care ``without discussing the reasons why.'' Resp't
Exceptions at 10. Respondent claims, as he did many times in this
case, that the CDC Guidelines ``do not prohibit this combination.''
Id. Dr. Munzing testified that ``the fact that you prescribe a
benzodiazepine to [sic] an opioid, the risk of overdose goes up ten-
fold. That's a significant increase.'' Tr. 448. He stated that ``the
FDA and the CDC both came out with--one was a black box warning by
the FDA; the other is the CDC guidelines, but it was known before
that time. It was in literature by 2015, potentially earlier than
that.'' Tr. 449. Dr. Munzing further testified that because ``the
patient is being put at significantly increased risk,'' the standard
of care requires that ``[i]t certainly needs to be recognized,
addressed, and if the patient has conditions that the potential
benefit is outweighed by the potential risk, which it would be hard
to show that in this case. Doctors need to well document that and
show that alternatives are really not an option.'' Tr. 449.
Therefore, Respondent's testimony that he had discussions with these
patients regarding the risks, but simply did not document those
discussions ``as well as [he] should have,'' Tr. 933, does not
address the other issues that Dr. Munzing raised, such as
documenting that alternatives are not an option. The testimony
Respondent cites to in its Exceptions clearly only addresses
documenting the discussion of the risks with the patient, not
alternative treatments or the risks of the combination generally.
Resp't Exceptions at 11. Further, even if I found, in accordance
with Respondent and Dr. Polston, that ``in the year 2014,
prescribing opioids and benzodiazepines was not outside the standard
of care,'' the Government's allegations would still include several
years of prescribing to AA and BB, during which Respondent's
documentation did not address the concerns that the co-prescribing
of these substances raised. Resp't Exceptions at 11 (citing Ex. L at
10). Dr. Polston notably did not testify about this combination and
the only reference to it is in his report as the Respondent cited,
which is given limited weight given my inability to assess the
credibility of these statements. Ultimately, I find that the record
evidence clearly supports the Government allegations related to the
concurrent prescribing, and I do not find Respondent's Exception to
be meaningful in my overall assessment that Respondent issued
prescriptions beneath the standard of care and outside the usual
course of professional practice to AA and BB, particularly given the
multitude of other reasons why these prescriptions fell beneath the
standard.
---------------------------------------------------------------------------
The OSC contains allegations regarding controlled substances with
doses and amounts specific to each of the Six Patients. The record
contains sufficient evidence to preponderantly sustain the amounts
alleged for Patients
[[Page 4932]]
AA,\104\ BB,\105\ JD,\106\ and ET \107\ as charged. Accordingly OSC
Allegations 8, 15, 19, and 27 are sustained. However, the amounts
specified regarding Patients DD \108\ and SM \109\ are more
problematic, and it is at least possible that a greater investment on
the part of the Government in this regard could have been more
helpful.\110\ Although subsection (1) of the Patient DD OSC dosage/
amount allegation references ``patches,'' only lozenges were raised by
the evidence, and there is no evidence to support the subsection (4)
reference to eight fills of temazepam. Accordingly, OSC Allegation 22
is sustained in part to the extent that subsection (1) alleges ``a
quantity of fentanyl citrate,'' subsections (2) and (3) are sustained
as charged, and subsection (4) is not sustained. Similarly, the dosage/
amount allegation pertaining to Patient SM contains insufficient
quantitative evidence to support the amounts specified in subsections
(3), (4), and (5).\111\ Accordingly, OSC Allegation 24 is sustained in
part to the extent that subsection (3) alleges ``a quantity of
diazepam,'' subsection (4) alleges ``a quantity of fentanyl,'' and
subsection (5) alleges ``a quantity of oxycodone.'' Subsections (1) and
(2) are sustained as charged.*\R\
<SUP>112 113 114 115 116 117 118</SUP>
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\104\ ALJ Ex. 1 ] 8.
\105\ ALJ Ex. 1 ] 15.
\106\ ALJ Ex. 1 ] 19.
\107\ ALJ Ex. 1 ] 27.
\108\ ALJ Ex. 1 ] 22.
\109\ ALJ Ex. 1 ] 24.
\110\ See Gregg & Son Distributors, 74 FR 17517, 17517 n.1
(2009) (clarifying that ``it is the Government's obligation as part
of its burden of proof and not the ALJ's responsibility to sift
through the records and highlight that information which is
probative of the issues in the proceeding''). In addressing the
specifically-alleged amounts of medications prescribed to the Six
Patients, the Government's closing brief avers that the Respondent
issued ``numerous prescriptions'' of a particular controlled
substance to a patient and then provides a general reference to a
contemporaneously-filed attachment. ALJ Ex. 35 at 5-9. Not to put
too fine a point on the matter, but this methodology is less helpful
than it could have been in this case because the attachment is
regrettably hobbled by numerous entries that appear to be less than
entirely accurate. For instance, the chart attachment for Patient DD
contains no reference to patches of fentanyl citrate, modafinil, or
temazepam (although OSC Allegation 22 alleges specific amounts of
each), it lists only 58 prescription dates (while OSC Allegation 22
alleges 93 separate fills of fentanyl patches and 60 separate fills
of OxyContin), and it appears that it may even be missing a third
page. See id. at 41-42. The chart attachment for Patient BB includes
at least one prescription issued by the Respondent outside of the
timeframe alleged in OSC Allegation 15. See id. at 33-35. Further,
multiple prescriptions listed in the Patient SM chart attachment
contain inaccurate dosages and medications. See id. at 43-46.
\111\ See Gregg & Son Distributors, 74 FR 17517 n.1 (noting that
``it is the Government's obligation as part of its burden of proof .
. . to sift through the records and highlight that information which
is probative of the issues in the proceeding'').
*\R\ The Government allegations also included references to
``letters of concern'' from insurance companies that identified the
high level of MMEs that Respondent was prescribing. ALJ Ex. 1 ] 13,
16, 35, 29, 20; See e.g., Gov't Ex. 2 at 522-23, 542-44, 596-98,
672-74. The Chief ALJ sustained some of the allegations related to
the letters of concern, and in doing so, noted issues with the
Government's evidence. RD at 39. I am declining to consider these
letters as separate violations--they appear to more support the
overall notion that Respondent's prescribing was in violation 21 CFR
1306.04; however, there is little explanation on the record
supporting the direct relevance of the letters, and there is ample
evidence on the record to support finding a violation of 21 CFR
1306.04 without such letters. As such, I have omitted this section
of the RD.
\112\ Omitted. See n.*R supra.
\113\ Omitted. See n.*R supra.
\114\ Omitted. See n.*R supra.
\115\ Omitted. See n.*R supra.
\116\ Omitted. See n.*R supra.
\117\ Omitted. See n.*R supra.
\118\ Omitted. See n.*R supra.
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The Government alleges that the Respondent examined CURES reports
eight times regarding Patient BB, but presented no evidence that this
occurred (or why it would be relevant to the extent he had done
so).\119\ Accordingly, OSC Allegation 17 is not sustained.
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\119\ Again, see Gregg & Son Distributors, 74 FR 17517 n.1
(clarifying that ``it is the Government's obligation as part of its
burden of proof and not the ALJ's responsibility to sift through the
records and highlight that information which is probative of the
issues in the proceeding'').
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The Government alleges that on multiple occasions where the
Respondent encountered anomalous urine drug screen results relative to
two of the Six Patients,\120\ his medical charting failed to reflect
actions that would have been required to stay within the standard of
care. Dr. Munzing's expert opinion has been afforded controlling
weight, and although the Respondent pushed back regarding Patient
SM,\121\ in general, he accepted that his documentation in this regard
was lacking. Accordingly, OSC Allegations 9, 10, 14.d, 28, and 30.d are
sustained.
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\120\ ALJ Ex. 1 ]] 9, 10, 14.d (Patient AA); ]] 28, 30.d
(Patient ET).
\121\ The Respondent testified that he did not feel that Patient
ET's positive drug screen result for temazepam was truly aberrant
because, in his view, that result was consistent with a medication
(diazepam) that he had prescribed. Tr. 1028. Although the Government
did not present evidence to refute the Respondent's proposition in
this regard, Dr. Munzing's opinion has been afforded controlling
weight.
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The Government introduced an October 29, 2019 order (Board Order)
issued by the California Board regarding disciplinary action taken by
MBC against the Respondent. Gov't Ex. 30. In DEA administrative
proceedings, factual findings and legal conclusions based on state law
reached by state administrative tribunals are given preclusive effect.
Robert L. Dougherty, M.D., 76 FR 16823, 16830 (2011); Gilbert Eugene
Johnson, M.D., 75 FR 65663, 65666 (2010); see also James William
Eisenberg, M.D., 77 FR 45663, 45663-64 (2012) (holding that official
notice taken of findings in a state medical board censure order gives
those findings preclusive effect). State medical boards are presumed to
be the expert agency with the authority to determine whether one of its
practitioners has engaged in unprofessional conduct or provided
incompetent medical care, and ``[w]here . . . a state medical board has
determined that a practitioner's conduct violated the standard of care,
its findings of fact and conclusions of law are not subject to
relitigation before the Agency.'' Ruben, 78 FR 38369. The key inquiry
is not whether a full evidentiary hearing was conducted in the prior
proceedings, but whether the parties had a full and fair opportunity to
litigate the issues prior to the Agency's decision. Jose G. Zavaleta,
M.D., 78 FR 27431, 27434 (2013).
The Board Order introduced by the Government includes the following
findings related to MBC's decision that the Respondent violated state
and/or federal law and engaged in unprofessional conduct by prescribing
dangerous controlled substances to the Board Patients. Gov't Ex. 30 at
147, 157-61. MBC's findings regarding the Board Patients are herein
discussed in seriatim.
With respect to Board Patient A, MBC found that the Respondent
prescribed opioids to Patient A, between December 2011 and early 2013,
in an amount that exceeded 300 MEDs. Id. at 129-30. While prescribed
these large quantities of controlled substances, Patient A ``reported
lack of analgesia and continued chronic pain, and decreased function,
and [ ] displayed aberrant behaviors.'' Id. at 129. MBC found that the
Respondent ``committed gross negligence in his care and treatment of
Patient A'' by continuing to prescribe high dose opioids even though
her chronic pain was not effectively treated with the prescribed
medications and she displayed aberrant behaviors. Id. at 128-29, 157.
Accordingly, inasmuch as the California Board's findings are res
judicata in these proceedings, OSC Allegation 31.a, which pertains to
Patient A, must be and is sustained. See
[[Page 4933]]
Dougherty, 76 FR 16830; Johnson, 75 FR 65666.
Regarding Board Patient B, the California Board found that the
Respondent committed gross negligence when he failed to discuss the
attendant risks and benefits of controlled substances and failed to
enter into a pain management agreement with Patient B. Gov't Ex. 30 at
130, 146, 158. The Respondent additionally prescribed greater than 30-
day supplies of controlled substances to Patient B on multiple
occasions during 2013, which the Board found to constitute gross
negligence. Id. at 131, 144, 158. Accordingly, inasmuch as the
California Board's findings are res judicata in these proceedings, OSC
Allegations 31.b and 31.c, which pertain to Patient B, must be and are
sustained. See Dougherty, 76 FR 16830; Johnson, 75 FR 65666.
MBC found that the Respondent's treatment of Board Patient D was
grossly negligent in that he continued to prescribe her controlled
substances despite aberrant behaviors, possible addiction, and
noncompliance with her pain management agreement. Gov't Ex. 30 at 135,
158. In finding that the Respondent failed to adequately monitor his
treatment of Patient D, the Board identified that the Respondent could
have employed, but did not, UDSs and random pill counts as monitoring
methods. Id. at 136. Notably, the California Board found that, for at
least one prescription, the Respondent's conduct with respect to
Patient D was an ``extreme departure'' from the standard of care for
medical professionals in California. Id. at 98, 136-37. Accordingly,
inasmuch as the California Board's findings are res judicata in these
proceedings, OSC Allegation 31.d, which pertains to Patient D, must be
and is sustained. See Dougherty, 76 FR 16830; Johnson, 75 FR 65666.
With respect to Board Patient E, the California Board found the
Respondent's conduct to similarly be grossly negligent. Gov't Ex. 30 at
137, 158. MBC found that the Respondent prescribed controlled
substances to Patient E without ``taking a systematic and thorough
history including vitals, without periodically reviewing and
documenting efficacy of treatment, without regularly assessing for
possible diversion, and without discussing the risks, benefits, and
alternatives of pharmacological treatment.'' Id. at 137; see also id.
at 158. Moreover, MBC found that the Respondent further departed from
the standard of care in prescribing methadone to Patient E, a known
alcoholic, when methadone and alcohol are known to be contraindicated.
Id. at 139-40, 148, 158, 161. Inasmuch as the California Board's
findings are res judicata in these proceedings, OSC Allegations 31.e
and 31.f, which pertain to Patient E, must be and are sustained. See
Dougherty, 76 FR 16830; Johnson, 75 FR 65666.
All subsections of OSC Allegation 31(the Board Patient Allegations)
are sustained, and any one of these subsections, standing in isolation
is (and all, when considered collectively are) sufficient to satisfy
the Government's prima facie burden in this case.
OSC Allegations 1 and 2 (COR and state licensure status) are
sustained based on the evidence \122\ and stipulations \123\ of record.
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\122\ Gov't Ex. 30 at 5.
\123\ Stips 1,2.
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Accordingly, even in the face of the Respondent's lengthy
experience as a practitioner and registrant, a balancing of Factors Two
and Four militate strongly and powerfully in favor of the imposition of
the revocation sanction sought by the Government.
Recommendation
The evidence of record preponderantly establishes that the
Respondent has committed acts which render his continued registration
inconsistent with the public interest. See 21 U.S.C. 824(a)(4). Since
the Government has met its burden \124\ in demonstrating that the
revocation it seeks is authorized, to avoid sanction the Respondent
must show that, given the totality of the facts and circumstances, the
revocation sought by the Government is not warranted. See Med. Shoppe-
Jonesborough, 73 FR 387. In order to rebut the Government's prima facie
case, the Respondent must demonstrate not only an unequivocal
acceptance of responsibility but also a demonstrable plan of action to
avoid similar conduct in the future. See Hassman, 75 FR 8236. On the
present record he has accomplished neither objective.
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\124\ See 21 CFR 1301.44(e).
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Agency precedent is clear that a respondent must unequivocally
admit fault as opposed to a ``generalized acceptance of
responsibility.'' The Medicine Shoppe, 79 FR 59504, 59510 (2014); see
also Lon F. Alexander, M.D., 82 FR 49704, 49728 (2017). To satisfy this
burden, the respondent must show ``true remorse'' or an
``acknowledgment of wrongdoing.'' Michael S. Moore, M.D., 76 FR 45867,
45877 (2011). The Agency has made it clear that an unequivocal
acceptance of responsibility is an unwaivable condition precedent for
avoiding a sanction. Dougherty, 76 FR 16834 (citing Krishna-Iyer, 74 FR
464). This feature of the Agency's interpretation of its statutory
mandate on the exercise of its discretionary function under the CSA has
been sustained on review. Jones Total Health Care Pharmacy, LLC v. DEA,
881 F.3d 823, 830-31 (11th Cir. 2018); MacKay v. DEA, 664 F.3d 808, 822
(10th Cir. 2011); Hoxie, 419 F.3d at 483.
As discussed, supra, the findings of the California Board, which
are afforded preclusive effect here,\125\ preponderantly and
conclusively establish the Board Patient Allegations, and are
sufficient standing alone to satisfy the Government's prima facie case
for revocation. Yet beyond noting that MBC declined to impose greater
sanctions than it could have,\126\ the Respondent did not address those
charges in his testimony or accept responsibility for any of the
misconduct established therein. In his closing brief, the Respondent
addressed the Board Order only insofar that he argued that it did not
impact Public Interest Factor One (recommendation from an authorized
state licensing authority) to his detriment. ALJ Ex. 37 at 3-
4.<SUP>127 128</SUP> The Agency has consistently held that without
record evidence of both prongs (acceptance of responsibility and
remedial steps aimed at avoiding recurrence), neither is relevant. Ajay
S. Ahuja, M.D., 84 FR 5498 n.33; Jones Total Health Care, LLC, 81 FR
79188, 79202-03 (2016); Hassman, 75 FR 8236. Thus, as the record
stands, the Government has established OSC Allegations 31.a--31.f,
which collectively and separately make out the Government's prima facie
case for revocation, and the Respondent has offered no acceptance of
responsibility. Hence, on this posture, based exclusively on the Board
Patient Allegations and irrespective of the remainder of the analysis,
it would be impossible under the Agency's interpretation of the CSA for
the Respondent to avoid sanction.
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\125\ See Dougherty, 76 FR 16830; Johnson, 75 FR 65666.
\126\ Tr. 1064-65.
\127\ [omitted for relevance.]
\128\ [omitted for relevance.]
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The Respondent's defense fares no better regarding the balance of
the Government's case related to the Six Patients. During his
testimony, the Respondent accepted responsibility for a standard office
practice that yielded each of the Six Patients a bounty of extra
medicine, but not much else. In
[[Page 4934]]
fact, the Respondent was careful to limit his acceptance to the
deficiencies he was willing to acknowledge at the hearing.\129\ Tr.
1062. He agreed that most \130\ of the anomalous UDS results merited
additional patient queries and documentation in his charts, and, in
general, that the level of his medical record documentation could bear
some level of improvement in the future. But the Respondent stridently
adhered to the medical correctness of his controlled substance choices
and dosing, based primarily on the only mostly accurate premise that he
received the patient at a high dose, the somewhat accurate premise that
he was engaged in a taper,\131\ and the untenable premise that the
practice of pain management was ``just coming off of the decade'' where
there was ``no limits to dosing.'' Tr. 982. At one point in his
testimony, he described a high dosage to one of the Six Patients as
``not an unheard-of dosage.'' Id. The meaning (or timing) of ``coming
off of the decade'' \132\ was never clear, and the concept that there
was ever a point in time where there were ``no limits to dosing'' \133\
is unsupported in this record and dubious at best.
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\129\ Even in his closing brief, the Respondent's purported
acceptance of responsibility, which is limited to the Six Patients
allegations, reads this way: ``By way of mitigation/remediation,
[the Respondent] acknowledged and accepted responsibility for
deficiencies contained in the OSC.'' ALJ Ex. 37 at 32, ] 209 (record
citation omitted). The Respondent's carefully-worded closing-brief
assertions that he has ``unequivocally accepted responsibility for
his deficiencies, as stated herein,'' id. at 38 (emphasis added),
and that he ``admitted and took responsibility for numerous
deficiencies that happened in the past,'' id. at 39 (emphasis
added), strike as a trifle too layered to satisfy the Agency's
requirement of an unequivocal acceptance of responsibility. Indeed,
the Respondent's closing brief represents that ``he unequivocally
accepted responsibility with respect to most of the allegations
levied against him,'' id. at 41 (emphasis supplied), and lists five
areas where he reckons he got the acceptance job done, id. at 41-42.
No effort is made on any level to accept any responsibility
regarding the Board Patient Allegations.
\130\ Regarding a UDS for Patient ET that reflected a positive
result for temazepam, the Respondent testified that he does not feel
that this was anomalous because the patient had been prescribed
diazepam, which according to the Respondent, would metabolize into
yielding a positive temazepam result. Tr. 1028-29; see also ALJ Ex.
37 at 31.
\131\ Although the Respondent's progress notes frequently
referenced his intention to wean down medications, the record
evidence demonstrated that for extended periods of time these notes
were limited to aspirations, and the medication was not reduced. The
Respondent's post-hearing-brief argument that he was, in essence,
resisting the urge to ``abruptly taper'' or suddenly discontinue
opioid therapy, ALJ Ex. 37 at 8, ]] 49-50, is unpersuasive here, as
the Government has not ascribed fault to the failure to engage in
recklessly fast weaning of his patients' medications. No weaning
whatsoever took place regarding Patient AA, and no weaning for
extended periods was evident regarding the balance of the Six
Patients.
\132\ Tr. 982.
\133\ Id.
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Furthermore, during the hearing, the Respondent sporadically
persisted in his position that the standard pain management contracts
executed by each of the Six Patients constituted an adequate risks/
benefits discussion to support informed consent. Admittedly, he seemed
to acknowledge at some points that the opioid risks discussion would
have benefitted by adding more detail (e.g., such as the risk of death
\134\), but it would not be at all fair to say that this record paints
a picture that demonstrates that he understands that the standard pain
medication contract he employed did not meet the standard. It is clear
from the plain language of the pain management contracts that these
instruments were designed to advise patients of the consequences
associated with medication-related non-compliance, not to supply
adequate informed consent. Although the Respondent agreed that the pain
management contracts did not advise the patients, inter alia, that
death is a risk associated with the high dosage levels he was employing
(or continuing), the Respondent maintained that the contracts did the
job.\135\ By the Respondent's reckoning, the fact that the pain
management contract mentioned the potential for respiratory depression
was sufficient, because respiratory depression ``is usually the
antecedence of [death].'' Tr. 932. This tack was particularly puzzling
in light of the revelation that the Respondent ultimately did generate
an opioid informed consent document that ``plug[s] that hole.'' Id. The
Respondent's inconsistent approach to this issue seemed dependent upon
who was asking the questions and how the questions were framed. At one
point during his testimony, when pressed on the issue, the Respondent
seemed to offer a limited acknowledgement:
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\134\ Tr. 932, 1026.
\135\ The Respondent took a like position in the CAP he filed
with the Agency. Resp't Ex. M at 4-5.
I needed to talk more about the actual conversations I had with
the patient, the potential risks, including death, which was not
mentioned specifically. And I see that as a deficit in my reading,
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documentation and my discussion with the patient.
Id. at 1026. [Omitted. The Chief ALJ noted, and I agree, that
Respondent waivered on whether he had the level of detailed
conversations about risk that Dr. Munzing credibly testified were
required by the standard of care, to include the risk of death, with
his patients.]*\S\ \136\ On the present record it is far more plausible
that such detailed conversations with the Six Patients never occurred,
and that glossing over the issue by saying he wished he documented it
better is unhelpful to the credibility of his position. The Respondent
at once seemed to express understanding, even detailing a remedial step
to improve documentation, but simultaneously declined to accept
responsibility for the focus of the remedial step he implemented. The
Respondent took essentially the same approach regarding his prescribing
of dangerous combinations of drugs; to wit, that it was only the depth
of his documentation that was lacking. More fundamentally, the
Government's position is that the Respondent's high level of opioid
prescribing created a sufficient danger to his patients such that he
was required under the applicable standard of care in California to
provide a specific warning
[[Page 4935]]
to those patients about the risks associated with such high levels of
pain killers. The Government's expert reliably testified to that
standard of informed consent, and the Respondent never [clearly and
unequivocally] accepted responsibility for the absence of such a
[detailed] warning; whether documented in his charts or not.
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*\S\ Respondent argues in his Exceptions that Respondent
``unambiguously testified his pain agreement was not an adequate
document and it needed to be improved.'' Resp't Exceptions at 25.
Respondent did testify at times that he had conversations with his
patients about the risks and he did admit that his pain management
agreement ``should be, and has been improved.'' Tr. 25. I also agree
with the Chief ALJ that Respondent pushed back at one point about
whether he needed to include death, RD at 11-12 (citing Tr. 932).
Contrary to Respondent's contention, it is not clear from the record
whether he specifically discussed the risk of death with his
patients, which Dr. Munzing testified was necessary under the
standard of care. Regarding having ``words such as death,''
Respondent stated, ``I think it's important to mention to the
patient, and that is something I want to do better and need to do.''
Tr. 932. Nowhere did Respondent clearly testify that he discussed
the risks, including the risk of death with his patients. See also
n.136 and n.*I supra. Considering the fact that Respondent and the
Chief ALJ and myself had to pull strands of the record to try to eke
out an understanding of Respondent's position on whether he had
detailed discussions with his patients, including about the risk of
death, and whether he believed he needed to have these detailed
discussions to meet the standard of care, there is not enough on the
record to find that Respondent accepted responsibility
unequivocally, which necessarily includes a clear acknowledgement of
the wrongdoing.
\136\ The Respondent testified that he had an opioid risk
discussion with Patient AA, but only ``in the context of his
original pain agreement'' and supplied a vague reference to
``subsequent discussions.'' Tr. 931. In his closing brief, the
Respondent avers that the evidence evinces ``multiple discussions
with [Patient AA] regarding the pain treatment agreement and the
patient's medication program.'' ALJ Ex. 37 at 11, ] 74. Regrettably,
the record citations supplied by the Respondent in his closing brief
do not support the proposition that the risks associated with a high
opioid protocol were discussed with the patients. See, e.g., ALJ Ex.
37 at 17, ] 109; 21, ] 132; 25, ] 156. Even the few potential
exceptions do not address high-dosage opioids, but rather ``[t]he
risks and benefits of the medical program.'' See, e.g., Gov't Ex. 6
at 376, 390 (cited at ALJ Ex. 37 at 21, ] 132).
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The Respondent likewise declined to take any responsibility for any
role that his prescribed medications [or any of his misconduct] played
in the unfortunate death of Patient AA. Although this patient died from
an overdose of multiple medications, some of which were prescribed by
the Respondent, because Patient AA did not appear early for refills or
ask for additional medications,\137\ the Respondent, even in his
closing brief,\138\ adheres to the position that his prescribing played
no role in Patient AA's overdose death, notwithstanding the contrary
views held by the Government's expert \139\ and the San Diego Medical
Examiner.\140\
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\137\ Tr. 943-45.
\138\ ALJ Ex. 37 at 13, ] 86.
\139\ Tr. 310-12.
\140\ Gov't Ex. 31 at 5. The ME Report, in pertinent part,
renders the following ultimate conclusion: ``Based on the [report's
integral] findings and the history and circumstances of [Patient
AA's] death as currently known, the cause of death is best listed as
`fentanyl, clonazepam, alprazolam, ketamine, hydrocodone, and
morphine toxicity' and the manner of death as `accident.' '' Id.
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[Respondent notes in his Exceptions, that he believes that the
Chief ALJ did not adequately credit him for what he contends was
unequivocal acceptance of responsibility for failing to take vital
signs for his patients until 2018. Resp't Exceptions at 13 (citing Tr.
1034 ``When I consult with my orthopedist and surgeons and so on, whom
I was in the department with, and we'd look at their notes, they didn't
contain that. And quite honestly, looking back on it, it was really a
defect on my part that I wasn't collecting it, and I should have been
doing it.*\T\). Respondent is correct to point out that this statement
is much closer to accepting responsibility for found misconduct;
however, he is incorrect in characterizing this statement as
unequivocal. He begins his statement with a minimizing excuse--that no
one else in his Department was doing it, and he uses the pronoun ``we''
to make clear that he was acting with consensus of others of some
kind,*\U\ but most importantly, this statement is lacking in an
understanding of the gravity of his misconduct. Dr. Munzing testified
that vital signs are monitored ``to try to keep [the patients] as safe
as possible'' due the high risk of the high dosages being prescribed to
them. Tr. 166. I find Respondent's statement here, and elsewhere, where
he claims to accept responsibility, to be lacking in a complete
understanding and acknowledgment of these risks and the potential
consequences of his misconduct. ``[T]he degree of acceptance of
responsibility that is required does not hinge on the respondent
uttering `magic words' of repentance, but rather on whether the
respondent has credibly and candidly demonstrated that he will not
repeat the same behavior and endanger the public in a manner that
instills confidence in the Administrator.'' Stein, 84 FR 46973.
Respondent's statement acknowledges the mistake, but it lacks remorse,
and it lacks recognition or even acknowledgement of the impact. I agree
with the Chief ALJ that Respondent handled these issues with the
gravity that someone would apply to nitpicks--that he is now checking
boxes, as opposed to really changing his viewpoint. For all of these
reasons, although I credit Respondent for admitting some fault on the
vital signs violation, I cannot find that Respondent has unequivocally
accepted responsibility, even for something that was clearly found in
this case and in the MBC case against him.]
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*\T\ Respondent also notes that ``in response to criticism
elsewhere, [he] started using the Vital Signs.'' Although he did not
specifically reference it directly, in spite of arguing that he had
accepted responsibility for the MBC's findings, I am assuming that
he is referring to the California Medical Board complaint that was
alleged against him around the time when he started taking vital
signs. Tr. 1033.
*\U\ See Stein, 84 FR 46972 (finding that a registrant's
attempts to minimize his misconduct weigh against a finding of
unequivocal acceptance of responsibility); see also Ronald Lynch,
M.D., 75 FR 78745, 78754 (2010) (Respondent did not accept
responsibility noting that he ``repeatedly attempted to minimize his
[egregious] misconduct''); Michael White, M.D., 79 FR 62957, 62967
(2014) (finding that Respondent's ``acceptance of responsibility was
tenuous at best'' and that he ``minimized the severity of his
misconduct by suggesting that he thinks the requirements for
prescribing Phentermine are too strict.'').
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Although the Respondent testified that he has improved the detail
level of his electronic charting, [takes vital signs from his patients
to ensure their safety,] no longer prescribes dangerous combinations of
controlled substances, now eschews the prescribing of carisoprodol, and
has taken various courses to address controlled substance prescribing
and documenting, in light of his refusal to enter an unequivocal
acceptance of responsibility, his expressed, commendable plans further
his case not at all.
To be sure, the transgressions alleged and proved here are serious
and numerous, but it is at least arguable that a true, unequivocal
acceptance of responsibility, coupled with a thoughtful plan of
remedial action could have gone a long way to supporting a creditable
case for at least some level of sanction lenity. Indeed, while true
that Agency precedent holds that the lack of an unambiguous acceptance
of responsibility and remedial action plan are a cold bar to the
avoidance of a sanction,\141\ the wisdom of the Agency's policy is
vindicated in this case by the reality that the Respondent still
believes that the gravamen of his transgressions amount to little more
than documentation deficiencies and a numerical prescribing practice
error. He feels his dosing and medicine combinations were
appropriate,\142\ that the Six Patients received adequate informed
consent about the high opioid levels through their pain contracts, and
that although Patient AA died as a result of an overdose where his
drugs were irrefutably among the medications that precipitated the
fatality, that it was simply not his fault. The Respondent's message is
essentially that the Government is nitpicking a knowledgeable
practitioner, and to make the regulators happy he will clean up his
documentation and drop dangerous combinations of medications from his
treatment repertoire. And regarding the Board Patient Allegations, he
has offered no responsibility acceptance whatsoever [on the record of
this hearing.] It is not necessary or wise to conjecture whether an
unequivocal acceptance of responsibility would have yielded a different
result here. The fact is that it was not a part of the record.
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\141\ Hassman, 75 FR 8236.
\142\ Even in his closing brief, the Respondent highlights (with
italics for emphasis) the concept that the CDC does not prohibit
prescribing a combination of opioids and benzodiazepines. ALJ Ex. 37
at 12, 18.
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The Agency is thus faced with a choice of imposing a registration
sanction or imposing none and therein creating a fair likelihood that
it will be instituting new proceedings, charging the same conduct
against the same doctor, soon thereafter. To the extent the Respondent,
after being present at this hearing, does not see that he was not
acting as a reliable registrant, it is highly unlikely that he will see
the light in a month, a week, or a day from an Agency action that
affords him another chance.
In determining whether and to what extent imposing a sanction is
appropriate, consideration must also be given to the Agency's interest
in both specific and general deterrence and the
[[Page 4936]]
egregiousness *\V\ of the offenses established by the Government's
evidence. Ruben, 78 FR 38364, 38385. Considerations of specific and
general deterrence in this case militate in favor of revocation.
Specific deterrence is something of a mixed bag here. On one hand, the
Respondent has credibly related that he has deployed a prescribing
regimen that addresses the systemic early refill issue identified by
the Government, he has taken CME classes that address helpful
standards, and he credibly testified that he has cleaned up some of his
documentation. However, as discussed, supra, the Respondent has not
supplied any indication that, beyond picayune electronic documentation
complaints, and understandable early refills,\143\ that he has done
anything worthy of a sanction. The Respondent did not present as a
practitioner who intends to change the high level of his dosing, and
there is no real way to track whether the Respondent genuinely intends
to indefinitely limit the combination prescribing that he continues to
feel was warranted. On the whole, [ ]*\W\ the issue of specific
deterrence supports a sanction. [The Chief ALJ found that specific
deterrence supports a sanction, but that it was an ``admittedly close
case.'' *\X\ Although I agree that Respondent has made steps to improve
his practice, I am not convinced by his limited and equivocal
acceptance of responsibility that he will not repeat similar behavior
once his probation period in California has ended. Therefore, I find
that the issue of specific deterrence weighs in favor of revocation.]
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*\V\ The Administrator has noted that ``there may be some
instances in which the proven misconduct is not so egregious as to
warrant revocation . . . and a respondent, while offering a less
than unequivocal acceptance of responsibility[,] nonetheless offers
sufficient evidence of adequate remedial measures to rebut the
Government's proposed sanction.'' Roberto Zayas, M.D., 82 FR 21410,
21429 (2017). This is not such an instance. Although I do give
credit to Respondent's remedial measures, I do not find that I can
ultimately trust him to continue implementing them without constant
monitoring by this Agency, and as stated herein, he has not given me
reason to extend him such a benefit. Furthermore, the violations
herein are egregious and absolutely warrant revocation.
\143\ In fact, notwithstanding his seeming acknowledgement of
this below-standard activity, his closing brief reminds that his
expert witness, Dr. Polston, testified that this practice ``is NOT
below the standard of care and it is something that reasonable
physicians in the community have done.'' ALJ Ex. 37 at 13, ] 85
(emphasis in original).
*\W\ The Chief ALJ found that specific deterrence supports a
sanction and I strongly agree. Although Respondent has made steps to
improve his practice, I am not convinced by his limited and
equivocal acceptance of responsibility that he will not repeat
similar behavior once his probation period in California has ended.
It is unclear to me that he understands the gravity of the
misconduct alleged against him and that he has reacted appropriately
and with the amount of contrition and acceptance that would convince
me that he will not slip back into his old prescribing habits.
Therefore, I find that the issue of specific deterrence weighs
strongly in favor of revocation.
*\X\ Respondent takes this statement, which was evaluating one
of the many aspects that I consider when deciding a sanction, out of
context, arguing that ``it is clear that Judge Mulrooney had a
difficult time in deciding his recommendation.'' Resp't Exceptions
at 34 (citing RD at 48). I disagree that the Chief ALJ had a
difficult time deciding his recommendation. He stated clearly, and I
agree, that ``the conduct preponderantly established on this record
is extremely troubling, and warrants a substantial sanction.'' RD at
49.
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As the regulator in this field, the Agency bears the responsibility
to deter similar misconduct on the part of others for the protection of
the public at large. Ruben, 78 FR 38385. This record contains such a
high volume of errant prescribing and even an overdose death for which
the Respondent eschews responsibility. To continue the Respondent's DEA
registration privileges on the present record would send a message to
the regulated community that it is acceptable to keep prescribing
powerful drugs to multiple patients, in dangerous combinations, for
years, even contributing to the death of a patient, until you get
caught; and even then, it is not even required to admit your mistakes.
The interests of general deterrence militate convincingly in favor of a
sanction on this record.
Regarding the egregiousness of the Respondent's conduct, as
discussed, supra, the Respondent prescribed inordinately high levels of
medication to a host of patients, in dangerous combinations, with
inadequate documentation and informed consent for many years, and one
of his prescribed medications was a contributing factor in the death of
one of those patients. These actions were not borne of an
understandable misapprehension of his responsibilities, or an isolated
misstep taken in the midst of a busy medical practice. The conduct
preponderantly established on this record is extremely troubling, and
warrants a substantial sanction.
A balancing of the statutory public interest factors, coupled with
consideration of the Respondent's failure to unequivocally accept
responsibility, and the Agency's interest in deterrence, supports the
conclusion that the Respondent should not continue to be entrusted with
a registration.
Accordingly, it is respectfully recommended that the Respondent's
DEA COR should be revoked, and any pending applications for renewal
should be denied.
Dated: November 5, 2020.
John J. Mulrooney, II,
Chief Administrative Law Judge.
Respondent's Exceptions
On December 1, 2020, Respondent filed its Exceptions to the RD. I
find that Respondent's Exceptions are either without merit or
irrelevant to my Decision as explained below. Therefore, I reject
Respondent's Exceptions and affirm the RD's conclusion that
Respondent's continued registration is inconsistent with the public
interest, and that revocation is the appropriate sanction.
Exception 1
(I) Respondent first argues that Dr. Munzing should not have been
accepted as an expert in controlled substance prescribing for pain
management. Resp't Exceptions at 2. Respondent's argument is based on
his concern that his attorney raised at the hearing that ``the
credibility and weight'' given to the testimony of Dr. Munzing should
be limited due to the fact that he does not generally treat patients on
high dosages of opioids.*\Y\ Tr. 85. The Chief ALJ admitted Dr. Munzing
as an expert in ``the standard of care in prescribing controlled
substances in the State of California including for the management of
pain.'' Tr. 89.*\Z\ Dr. Munzing was not qualified as an expert in the
practice of pain management, which Government counsel specifically made
clear at the hearing. Tr. 84. For that matter, neither was Respondent's
Expert, Dr. Polston, who was tendered and accepted as an expert witness
in controlled substance prescribing in California, including controlled
substance prescribing for
[[Page 4937]]
intractable pain. Tr. 1153-54. In this Exception, Respondent reframes
the primary issue in this case to be about the practice of pain
management, when the underlying issue is actually whether Respondent's
prescribing of controlled substances was within the applicable standard
of care and usual course of professional practice in California.
Respondent also conveniently ignores the fact that the MBC found
specifically that Respondent's prescribing was beneath the standard of
care with respect to some of the patients at issue in this case (the
Board Patients). For the other patients (the Six Patients), Respondent
mischaracterizes Dr. Munzing's testimony. Dr. Munzing testified that
identified instances where the Respondent's patients were maintained on
doses of medications that far exceeded the morphine milligram
equivalent (MME) recommended by the Centers for Disease Control and
Prevention (CDC) guidance without documentation that the patient was
afforded an informed consent that explained the risks inherent in such
treatment. Tr. 120; Gov't Exs. 2-8, 10-13; Tr. 132-37, 139, 141-43,
145, 148-49, 156-57, 164-65, 169, 179-84, 191-92, 204-05, 224-25, 231-
32, 271, 306-07 (Patient AA); Tr. 401-02, 406-07, 409-15, 417-22
(Patient BB); Tr. 384-89, 393-400 (Patient JD); Tr. 477-79, 481-84,
488, 490-95 (Patient DD); Tr. 314-17, 321-23, 328-32, 350-51, 353-56,
360-62, 365, 370-72, 377-82 (Patient SM); Tr. 424-29, 431-35, 437-38,
440-47, 450 (Patient ET). Respondent argues that Dr. Munzing testified
that ``he does not know the precise amount of MMEs a patient should be
prescribed,'' and concludes that ``[i]t is appalling that credibility
is given to an expert who does not know the proper dose of MMEs, yet
opines the amounts Respondent prescribed are somehow incorrect.''
Resp't Exceptions at 3 (citing Tr. 704-06). A closer look at Dr.
Munzing's testimony demonstrates a much more measured and neutral
picture. Tr. 131-B (explaining that there is no maximum amount of MME
because ``some patients need a higher amount, and so there's--there's
no written absolute amount, but there's certainly--one certainly needs
to look at the risk to the patients, the potential benefits, and
attempt to mitigate the risks''); Tr. 704-05 (responding to the
question ``[s]o what's the exact dose that you should be receiving?''
with ``[w]ell, obviously, you know that one can't say--I mean, you
could have many people with the same symptoms and the dosage required
would be very different. Again, as I said before, you balance the
benefit of the treatments including prescribed medications and other
treatments with risk . . . and so you just can't say here's the number.
But what I can say is that the risk is incredibly high. We don't know
whether or not medications at one-half or one-third this dosage may
give the same level of benefit. Many times that is the case. And so
that we don't know because we haven't actually tried that as far as
what we can see here in the notes.'').
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*\Y\ Given the evidence, which Respondent repeatedly
highlighted, that he had successfully managed to reduce the MME of
his patients and the fact that the witnesses were largely in
agreement that reduction of the high dosages was important to the
applicable standard of care, I find this argument to be confusing.
See, e.g., Tr. 1204 (Dr. Polston opining that Respondent's dosing
was within the California standard of care, because ``in total, the
patient showed indications and the doses of opioids were being
reduced as the care was ongoing''); see also Resp't Exceptions at 10
(touting that ``[o]ver time, [Respondent] brought each one of them
down drastically. Today, he does not accept any patients who are on
daily MMEs over 90, and 93% of his current patients are at 90 MME or
below.'' (emphasis in original)). It seems that Respondent is
suggesting that the fact that Dr. Munzing has limited risk to his
patients by prescribing at lower MME levels somehow makes him less
of an expert. I cannot agree. It also seems a particularly odd
argument given Respondent's assertions that he, himself, no longer
prescribes at these levels to most of his patients.
*\Z\ Furthermore, it is noted that the Chief ALJ repeatedly
ensured that the experts stayed within the scope of their expertise.
See, e.g., Tr. 100 (``We are only talking about the standard of care
for controlled substance prescribing in California--the minimum
standard of care'').
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Contrary to Respondent's argument, I find Dr. Munzing's opinion to
be rational and to permit much more flexibility in prescribing than
Respondent would like to make it seem. The problem with Respondent's
prescribing of these high levels of MMEs is not the level itself--it is
the risk associated with that level, which has been objectively
established, and whether the Respondent adequately addressed that risk.
The record demonstrates that he repeatedly did not address the risk for
these patients over the course of many years, or at the very least did
not meet many of the documentation requirements for addressing the
risks.
I agree with the Chief ALJ that Dr. Munzing was qualified as an
expert in the standard of care in prescribing controlled substances in
the State of California including for the management of pain, and I
reject Respondent's Exception.
(II) Respondent next argues that Dr. Munzing's testimony should not
be given controlling weight over that of Dr. Polston for much of the
same reasons that underlie his arguments that Dr. Munzing should not
have been qualified as an expert. Respondent specifically picks apart
the Chief ALJ's rationale for finding Dr. Munzing more credible. In
particular, he highlights that Respondent ``only changed one thing in
response to Dr. Munzing's testimony, not many things.'' Resp't
Exceptions, at 4 (highlighting that Respondent only changed his early
prescribing practices as a result of Dr. Munzing's testimony).
Respondent also dedicates an entire Exception 6 to this issue, stating
``[w]hile it is accurate that Respondent agreed with Dr. Munzing's
criticisms on other issues, he did not change his practices with
respect to those issues after Dr. Munzing's testimony. In fact, the
bulk of the criticisms that Dr. Munzing had with Respondent's care
stemmed from care prior to April 2019.'' Respondent then emphasizes
that he is following the standard of care as described by Dr. Munzing
now, and in fact, he argues that the record demonstrates that he began
to do so after April 2019.*\AA\
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*\AA\ In doing so, Respondent opines that it ``is critical for
the Administrator's analysis because the Government's own expert is
testifying that as of April of 2019, Dr. Chesler had addressed the
issues with which he was concerned and was practicing within the
standard of care.'' Resp't Exceptions at 18 (citing Tr. 763-64 Dr.
Munzing opining that one progress note for Patient BB at the end of
the Government's allegations in April 2019 was more in line with the
standard of care as he had described it). The part of my analysis to
which this finding might be ``critical'' is whether Respondent has
accepted responsibility and instigated remedial measures such that I
can entrust him with a registration. I credit Respondent for
implementing practices that are more in line with meeting the
standard of care in California and I hope that he continues to
practice within the standard of care in the future, as I am sure
does the Medical Board of California. Even assuming all of his
current practices and all of his practices before and after the
allegations are completely beyond criticism, which I do, the record
still demonstrates that he prescribed beneath the applicable
standard of care and outside the usual course of professional
practice in California to many patients over the course of many
years and in violation of federal and state law. Further, the record
demonstrates that these violations were egregious and that,
regardless of whether Respondent contributed to the cause, a patient
died, and another patient had opiate use disorder (Supra n.*J), and
all of the Six Patients and Board Patients were at some amount of
risk due to the high dosages they were prescribed.
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I find Respondent's argument about disqualifying Dr. Munzing's
expert testimony on the applicable standard of care to be incongruous
with his argument that his practices now follow the standard of care as
described by Dr. Munzing. If he only changed one thing as a direct
result of Dr. Munzing's testimony at the hearing, that is noted, but
the record demonstrates, and Respondent actively argues, that he has
changed many of his practices since the time period covered by the
majority of the allegations in the OSC, and those practices clearly
comport with the standard of care described by Dr. Munzing. I find that
the standard of care as described by Dr. Munzing was supported by the
record in this case, by California laws and guidance and even by the
findings of the California Medical Board against the Respondent for the
Board Patients. Further, I agree with the Chief ALJ that Dr. Polston's
version of the standard of care was less credible in that it shifted,
was often vague and argumentative and that his testimony did not come
across as neutral (regardless of the noted objective issues with
neutrality for both paid experts).*\BB\ Therefore, I reject
Respondent's Exception.
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*\BB\ Again, Respondent's general medical decisionmaking is not
the basis for the allegations in the OSC--the OSC allegations are
focused on whether or not the identified prescriptions were issued
in accordance with the applicable standard of care and in the usual
course of professional practice and in accordance with state law.
See generally, OSC. The expert testimony in this case is necessary,
in conjunction with California law and guidelines, to understand the
applicable standard of care. Dr. Munzing clearly demonstrated his
expertise in how the standard of care applied to the facts in this
case and furthermore, his testimony regarding his expertise was
credible. In those places where Dr. Munzing's and Dr. Polston's
testimony differed regarding the standard of care, California law
and guidelines aligned more closely with Dr. Munzing's testimony.
Accordingly, I affirm the ALJ's decision to qualify Dr. Munzing as
an expert in this case and to credit his testimony over Dr.
Polston's.
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[[Page 4938]]
Exception 2
Respondent next takes Exception to the individual findings on the
allegations as sustained by the Chief ALJ. I have addressed some of
these in footnotes in the actual findings supra.
I note in particular here that Respondent took Exception to the
finding that a physician ``must avoid or carefully justify MMEs beyond
90 mg per day'' and those related to the combination of controlled
substances. Resp't Exceptions at 8, 10, 11. In sustaining these
allegations, the Chief ALJ stated the following:
Although the Respondent remained convinced about the validity of
the controlled medications and dosages he prescribed to the Six
Patients, as well as the combinations of medicines in the context of
the time and the ailments he was treating, in general he did not
resist the Government's view, supported by the expert opinion of Dr.
Munzing, that the documentation generated in the Respondent's
charting of the Six Patients was inadequate to a point where it fell
below the applicable standard of care.
RD at 38.
In taking Exception to these findings, Respondent once again tries
to reframe the question regarding whether his prescribing was beneath
the applicable standard of care and outside the usual course of
professional practice by attempting to make this question into a
determination about whether his patients ``demonstrated an etiology
consistent with a need for pain treatment.'' Resp't Exceptions at 9. He
emphasizes that the ``medical record shows a patient was receiving a
functional benefit and pain relief based on the medications
prescribed.'' Id. In support of Respondent's argument, I note that the
MBC Guide does include objectives in the treatment plan, such as ``pain
relief and/or improved physical and psychosocial function.'' MBC Guide
at 59. However, I credit Dr. Munzing, who testified, ``[W]ell, I mean,
it's good to get improved function. It's good to get reduced pain.
Nowhere is the issue that this person has extremely risky treatments.
And so in no way do we know whether or not this patient might get the
same benefits from having medication that's one-quarter or one-third,
one tenth the amount. We just don't know that.'' Tr. 719. Again, the
overarching issue with Respondent's prescriptions is whether or not
they were issued within the standard of care and usual course of
professional practice. The record clearly indicates that Respondent's
prescribing at dosages with high MMEs and combination prescribing put
his patients at risk, and his documentation clearly did not adequately
address those risks either with adequate informed consent or adequate
acknowledgements of the risks and formulation of a plan to reduce the
MME levels for many of the years of the allegations. Regardless of
whether the patients were transferred to Respondent at high levels of
MMEs or on dangerous, highly abused combinations of controlled
substances, and regardless of whether he eventually, after several
years, managed to reduce their MME levels or wean them off of the
combinations,*\CC\ the medical records do not demonstrate that he
adequately addressed these risks when they existed. Therefore, I reject
Respondent's Exception and sustain the Chief ALJ's finding that,
particularly given the high levels of MME and the combination of
controlled substances that Respondent was prescribing, ``the
documentation generated in the Respondent's charting of the Six
Patients was inadequate to a point where it fell below the applicable
standard of care.'' RD at 38.
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*\CC\ Respondent states that ``the Administrator should find
that Respondent's mere prescribing of these medications was not
below the standard of care.'' Resp't Exceptions at 11. I find
nowhere in the RD that makes such a statement. Respondent seems
again to be trying to reframe the violations. He seems intent on
limiting his violations to what he partially accepted responsibility
for--that ``his documentation should have been better,'' id., but he
does not seem to understand the serious implications of his failure
to document--that he was putting his patients at risk without
adequately addressing those risks in the medical records--without
demonstrating his planning and the thinking behind his prescribing
actions, which as found herein is required by the standard of care
and state law.
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Exception 3
Respondent takes Exception to the Chief ALJ's findings that he did
not conduct physical examinations on patients other than AA. I have
amended the RD where Respondent has asked for clarification supra and
have addressed Respondent's contention that he accepted responsibility
in the Recommendations Section supra. Respondent also took Exception to
the Chief ALJ's finding that Respondent did not take vital signs from
the patients, noting that ``[w]hile this is true in the beginning of
the time of review, Respondent made significant changes over time and
began taking vital signs in 2018.'' Id. Respondent states that he took
vital signs for all patients from that period on, id., however,
unfortunately, AA died on November 11, 2017, so he did not receive the
benefit of Respondent's improved practices. I have made an addition to
clarify the RD in accordance with Respondent's Exceptions. The fact
that Respondent only failed to take vital signs from his patients for
approximately four out of the five years covered by the Government's
allegations, during which he was issuing controlled substance
prescriptions at high levels of MMEs to his patients, who were at
increased risk for respiratory depression, does not alter my finding
that the prescriptions for controlled substances at issue in this case
were issued outside the standard of care.
Exception 4
I have addressed Respondent's Exception related to informed consent
in supra n.*I and *S.
Exception 5
Respondent takes Exception to the finding that the prescriptions he
issued to AA contributed to his death. Resp't Exceptions at 16. The OSC
alleged that Respondent's ``prescriptions to Patient AA were a
contributing factor to Patient AA's overdose death.'' OSC at 14.f. The
ME Report, in pertinent part, renders the following ultimate
conclusion: ``Based on the[report's integral] findings and the history
and circumstances of [Patient AA's] death as currently known, the cause
of death is best listed as `fentanyl, clonazepam, alprazolam, ketamine,
hydrocodone, and morphine toxicity' and the manner of death as
`accident.' '' Id. Dr. Munzing stated that based on this report,
``[t]wo of the medications that were prescribed were felt to be
contributors to the death, the hydrocodone and the morphine.'' Tr. 312.
``It's a multitude, it's toxicity, a multitude of drugs including a
couple he prescribed.'' Id. According to Dr. Polston, the controlled
substances prescribed did not contribute to A.A.'s death. He stated,
``[t]his patient, if he would not have taken the fentanyl, added in the
alcohol and the ketamine, . . . would be still alive.'' Tr. 1182. Dr.
Polston later clarified his testimony on cross-examination that the
fentanyl, alcohol and ketamine ``are contributing to his death,'' but
that ``to say that those are precise cause of death, no, I cannot go
that far.'' *\DD\ Tr. 1280.
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*\DD\ Based on Dr. Polston's clarification, I cannot
characterize Dr. Polston's testimony regarding the cause of AA's
death as ``unequivocal,'' as Respondent would suggest. Resp't
Exceptions at 16.
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[[Page 4939]]
I find that the substantial evidence on the record as described
above supports the Chief ALJ's finding that the controlled substances
prescribed by Respondent to AA were among the contributing factors to
his overdose. However, the overarching issue for Patient AA, and all of
the patients, is whether the alleged prescriptions were issued beneath
the applicable standard of care in California and outside the usual
course of professional practice, and the evidence clearly demonstrates
that Respondent did not issue the alleged prescriptions to AA within
the standard of care. I am not surprised by Respondent's adherence to
his position that his prescriptions did not contribute to AA's death,
considering the cascading implications that such a finding could have
on his liability, but I also find that his testimony on this issue did
not compel me to believe that he had more than a passing regret
regarding any of his prescribing decisions related to AA. Regardless of
whether the hydrocodone and the morphine actually contributed to his
death, the evidence demonstrates that AA was abusing controlled
substances, Respondent had been prescribing controlled substances to AA
for a considerable period of time and did not detect this, in spite of
several negative UDS for one of his prescriptions, and importantly,
Respondent's medical records for AA offer little-to-no ability for the
Agency to find out what was occurring. Furthermore, the fact is that
one of Respondent's patients died of an overdose. In light of such a
drastic occurrence, I would expect some sort of acknowledgement of the
wrongdoing surrounding this incident, even without taking fault for the
actual death. Instead, Respondent stated, ``[AA] had been on a
combination of medications for a long time with no issues, and I feel
badly that this event happened, but I honestly saw no issue where what
we were providing was a significant [*\EE\] component to someone who
had so much additional medication in his system.'' Tr. 943.*\FF\
Respondent's sole statement of regret related to AA's death was that he
``feels badly.'' This casual throw away statement does nothing to
acknowledge the magnitude of the situation and furthermore focuses the
entire attention of his remorse on himself and the way that he feels
about the death, which is apparently ``badly.'' See Nicholas Roussis
M.D., 86 FR 59190, 59194 (2021) (finding that ``remorse and acceptance
of responsibility are not the same thing and . . . Respondent's
consistent focus on his own suffering does not suggest an unequivocal
acceptance of responsibility, but rather, suggests regret for the
negative consequences that he has personally faced.''). Respondent
provided no acknowledgement that any of the wrongdoing, even the
conduct that he admitted to, related to his care of AA could have
played a small part in the patient's overdose. Had Respondent
documented informed consent that he had discussed the risk of death
with AA, had he documented that he conducted a physical examination or
vital signs, had he more completely addressed the negative UDS in the
records, had he addressed the high levels of MMEs he was prescribing
and shown that he was carefully assessing all of these risks, then I
doubt that AA's death would be an issue in this case. The questions
that are unanswered with respect to AA's death demonstrate the true
value of a prescribing practitioner's documented rationale.
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*\EE\ It is noted that Respondent used the term ``
[…truncated; see source link]Indexed from Federal Register on January 31, 2022.
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.