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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. 

*B I have omitted the RD’s discussion of the 

procedural history to avoid repetition with my 

introduction. 

1Specific 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. 

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). 

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 

Continued 

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

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

of the Administrative Law Judge 

*BAfter 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. 

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. 

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

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 overprescribing controlled substances. Tr. 

47. DI’s testimony was used to 

authenticate a number of Government 

Exhibits,3 consisting of documents 


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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. 

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. 

7Tr. 80. 

8Tr. 76. 

9Patients AA, BB, JD, DD, SM, and ET. 

10Some 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 § 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. 

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. 

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. 

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 noncontrolled 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 


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11Although 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. 

13The 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 highrisk 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.] 

15Tr. 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.’’)] 

17According 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. 

19Tr. 164, 192–93, 195, 203–04, 210–12, 225, 232, 

271–73, 275–76, 278–79, 292, 295, 300–01, 303–06. 

20Tr. 407–08, 415–16, 418, 421–22. 

21Tr. 388–89, 393–97, 400–01. 

22Tr. 486, 487–96. 

23Tr. 332, 352, 365, 369, 371. 

24Tr. 429–32, 435, 437–38, 442, 446, 450. 

(Patient AA); 11 *D 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. 

One of the Six Patients merits 

additional discussion. On November 11, 

2017, Patient AA died in his apartment 


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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. 

25According 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. 

*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. 

26The Respondent’s CV was received into the 

record. Resp’t Ex. G; Tr. 898. 

27The 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. 

28This allegation was modified from 12 to 10 

instances on the unopposed motion from the 

Government. ALJ Ex. 25. 

29ALJ Ex. 1 ¶ 14.d. 

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.] 

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. 

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 thirtyone 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. 

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. 


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30ALJ Ex. 1 ¶ 14.e. 

31The 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. 

32ALJ Ex. 1 ¶ 14.a. 

33ALJ Ex. 1 ¶ 14.b. 

34ALJ Ex. 1 ¶ 14.f. 

35Tr. 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. 

37Tr. 158–59, 169–72, 177–78, 180–81, 184–89, 

224–26, 271. 

38Tr. 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).] 

39ALJ Ex. 1 ¶ 18.d. 

40The 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. 

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. 

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: 

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. 

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 selfexoneration: 

[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

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. 

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 


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41The 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. 

42ALJ Ex. 1 ¶ 18.a. 

43ALJ Ex. 1 ¶ 18.b. 

*IRespondent seemingly contradicted his 

previous testimony that he always had the 

conversations with his patients on crossexamination, 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. 

44ALJ Ex. 1 ¶ 18.c. 

45According 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. 

46Tr. 976, 986–87. 

47ALJ Ex. 1 ¶ 21.a. 

48Tr. 982. 

49Tr. 982. 

50 Id. 

51ALJ Ex. 1 ¶ 21.b. 

52The Respondent testified, ‘‘That was a very 

easy one to fix with literally no fuss at all.’’ Tr. 986; 

see also id. at 1071. 

53ALJ Ex. 1 ¶ 21.d. 

54ALJ Ex. 1 ¶ 21.c. 

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. 

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. 

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. 

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: 

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 


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55ALJ Ex. 1 ¶ 23.c (as amended, see ALJ Ex. 25 

at 2, ¶ 7). 

56According 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 surgicallyplaced titanium spinal rods that had snapped. Tr. 

991. 

57ALJ Ex. 1 ¶ 23.a. 

58 [Omitted.] 

59According 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. 

60Tr. 1010–12. 

61The Respondent testified that he ultimately 

discontinued the trinity combination of 

medications for this patient. Tr. 1008. 

62Tr. 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. 

63ALJ Ex. 1 ¶ 26.a. 

64According 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. 

65ALJ Ex. 1 ¶ 26.b. 

66Regarding 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.’’). 

67ALJ Ex. 1 ¶ 26.c. 

68The Respondent testified that Patient ET 

carried diagnoses of hemiplegic migraine, was 

status post cervical surgery, and had cervical 

radiculopathy. Tr. 1012–13. 

69Tr. 1027–28. 

70Tr. 1024. 

71Tr. 1022–24, 1068. 

72 Gov’t Ex. 12 at 987. 

*JRespondent 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. 

73An undated, handwritten note in the margin of 

the PMC Report reads: ‘‘Noted wean attempt in 

progress.’’ Gov’t Ex. 12 at 992; Tr. 1016. 

74Resp’t Ex. M at 5, ¶ 4. 

75Tr. 1024–26. 

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. 

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. 

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. 

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: 

[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. 

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 


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76Resp’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. 

78The Respondent testified that his medical 

records have been electronically maintained since 

2005. Tr. 924. 

79The 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. 

80The 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 twoday course on medical record keeping. Id.; see 

Resp’t M at 47, 49. 

81The 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. 

82The 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. 

83See Robert L. Dougherty, M.D., 76 FR 16823, 

16834 (2011). 

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: 

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. 

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: 

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 interoperability 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. 

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. 

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. 

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 


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*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). 

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. 

86Tr. 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. 

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. 

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 consistentlydocumented 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. 

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, wellcredentialed 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. 

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: 

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 


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89Tr. 1200. 

90Tr. 1211–13; see Resp’t Exs. D at 1051–55, L at 

8–9, ¶ 27. 

91Tr. 1214, 1219–20; see Resp’t Exs. E at 1494, 

L at 10, ¶ 29. 

92Tr. 1226–28; see Resp’t Ex. L at 10–11, ¶ 32. 

93Tr. 1273–76, 1284. 

*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. 

*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. 

94Neither 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. 

95Even 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 

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 crossexamination 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.] 

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. 

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. 

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. 


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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.] 

96The 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. 

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. 

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. ShoppeJonesborough, 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 KrishnaIyer, 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

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 


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*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. 

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. 

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 § 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). 

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 


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*O Omitted for clarity. 

98 21 U.S.C. 802(21), 823(f). 

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. 

Regarding Factor Two, it is beyond 

argument that the Respondent is a wellcredentialed, 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 GarcesMejias, 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

Here, the relevant state law provisions 

largely mirror the CSA where they do 

not go beyond it. Compare Cal. Health 

& Safety Code § 11153(a) with 21 CFR 

1304.06(a). California Health and Safety 

Code § 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 § 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 § 2234. 

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 


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99 [Omitted for relevance.] 

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 § 11153(a). A 

practitioner in California who 

knowingly issues such an illegal 

prescription faces criminal exposure. 

Cal. Health & Safety Code § 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 HeOpined 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.] 

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 


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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. 

101 Gov’t Ex. 31 at 5. 

102The 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. 

103ALJ Ex. 25. 

*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. 

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 HeOpined 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 HeOpined 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

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. 

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. 

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. 

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 


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104ALJ Ex. 1 ¶ 8. 

105ALJ Ex. 1 ¶ 15. 

106ALJ Ex. 1 ¶ 19. 

107ALJ Ex. 1 ¶ 27. 

108ALJ Ex. 1 ¶ 22. 

109ALJ Ex. 1 ¶ 24. 

110See 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. 

111See 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. 

112Omitted. See n.*R supra. 

113Omitted. See n.*R supra. 

114Omitted. See n.*R supra. 

115Omitted. See n.*R supra. 

116Omitted. See n.*R supra. 

117Omitted. See n.*R supra. 

118Omitted. See n.*R supra. 

119Again, 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’’). 

120ALJ Ex. 1 ¶¶ 9, 10, 14.d (Patient AA); ¶¶ 28, 

30.d (Patient ET). 

121The 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. 

122 Gov’t Ex. 30 at 5. 

123Stips 1,2. 

124See 21 CFR 1301.44(e). 

125See Dougherty, 76 FR 16830; Johnson, 75 FR 

AA,104 BB,105 JD,106 and ET107 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 112 113 114 115 116 117 118

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. 

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. 

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 


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122 Gov’t Ex. 30 at 5. 

123Stips 1,2. 

124See 21 CFR 1301.44(e). 

125See Dougherty, 76 FR 16830; Johnson, 75 FR 

65666. 

126Tr. 1064–65. 

127 [omitted for relevance.] 

128 [omitted for relevance.] 

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. 

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. 

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 3–4.127 128

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. 

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 


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129Even 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. 

130Regarding 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. 

131Although 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. 

132Tr. 982. 

133 Id. 

134Tr. 932, 1026. 

135The Respondent took a like position in the 

CAP he filed with the Agency. Resp’t Ex. M at 4– 

5. 

*SRespondent 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. 136The 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). 

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. 

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 noncompliance, 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: 

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. 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 


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137Tr. 943–45. 

138ALJ Ex. 37 at 13, ¶ 86. 

139Tr. 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. 

*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.’’). 

141Hassman, 75 FR 8236. 

142Even 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. 

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. 

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

[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.] 

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. 

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 


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4936 Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices 

*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. 

*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’’). 

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.] 

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 


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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. 

*BBAgain, 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 

Continued 

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.’’). 

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

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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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. 

*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. 

*DD Based on Dr. Polston’s clarification, I cannot 

characterize Dr. Polston’s testimony regarding the 

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 onethird, 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. 

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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cause of AA’s death as ‘‘unequivocal,’’ as 

Respondent would suggest. Resp’t Exceptions at 16. 

*EE It is noted that Respondent used the term 

‘‘significant component,’’ which seems to 

acknowledge that the controlled substances he 

prescribed were a component of the death and 

contradicts his Exception to the Chief ALJ’s finding 

that these controlled substances were ‘‘among the 

contributing factors’’ to AA’s death. RD at 38. 

*FFRespondent also stated, ‘‘I feel badly because 

I know he was supposed to be and I’m still not sure 

what had him take this test.’’ Tr. 945. It is unclear 

from the record what test he is referring to or what 

AA was supposed to be doing—possibly exhibiting 

signs of addiction? But again, the testimony that 

Respondent felt ‘‘badly’’ did not amount to any sort 

of acceptance of responsibility for the prescriptions 

he issued to this patient beneath the standard of 

care. 

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. 

Additionally, I do not find that 

Respondent has adequately accepted 

responsibility for his misconduct related 

to this patient, even setting aside 

whether or not the two controlled 

substances he prescribed were among 

the contributing factors to his death. 

Furthermore, my finding that 

Respondent has not accepted 

responsibility for something so serious, 

has significant implications about 

whether I can entrust him with a 

controlled substances registration in the 

future. 

Exception 6 

I have addressed Exception 6 related 

to Respondent’s change in his practices 

in supra n.*H. 

Exception 7 

Respondent also takes Exception ‘‘to 

the conclusion he did not accept 

responsibility for misconduct in the 

Medical Board of California case.’’ 

Resp’t Exceptions at 19–20. In support 

of his argument, he cites to several 

findings in the MBC case where ‘‘he 

admitted he committed repeated 

negligent acts.’’ Id. (citing Gov’t Ex. 30 

at 150–51). Instead of diving into the 

MBC’s opinion on this issue, I will 

review the evidence to which the 

Respondent points that he accepted 

responsibility in that proceeding. 

Respondent himself states that ‘‘the 

MBC ALJ specifically made mention of 

this [Respondent’s acceptance of 

responsibility] with respect to Patients 

D and E and further ruled that 

Respondent believed the care provided 

to A, B and C was appropriate and that 

the fact that he did not admit to 

mistakes with those patients was not a 

factor in the outcome of the case.’’ Id. 

at 20. Essentially, Respondent is 

admitting that he did not fully accept 

responsibility in the MBC case, but 

arguing that because the MBC did not 

consider his non-acceptance as essential 

to its decision, I should not either. 

However, what matters to me in 

carrying out my responsibility under the 

CSA is whether Respondent can be 

entrusted with a registration. 

‘‘Respondent must convince the 

Administrator that his acceptance of 

responsibility and remorse are 

sufficiently credible to demonstrate that 

the misconduct will not recur.’’ Stein, 

84 FR 46974. 

Respondent did testify that he made 

changes to his medical practice 

‘‘regarding the Medical Board situation, 

which you know about, was 

highlighting some of the same—these 

are the same cases, the same era. It was 

my reaction to that, to show them that 

I was making a good faith effort to repair 

this.’’ Tr. 1052. It appears to me that this 

statement was very careful, stumbling 

almost, not to acknowledge that the 

MBC found many of the exact same type 

of violations of the standard of care as 

were at issue in this hearing. And in 

fact, even though Respondent brought it 

up in his testimony, he still did not take 

a moment to accept responsibility for 

the MBC findings on the record, but 

stated that his reasoning for the changes 

to his practice was to ‘‘show them’’—the 

MBC—that he was now complying with 

the standard of care. Id. I do credit 

Respondent for stating that he is 

‘‘happier’’ about these changes. Id. 

However, as further discussed below 

and herein, Respondent has not 

unequivocally accepted responsibility 

for the Board Patients or the Six 

Patients. 

Furthermore, I find it relevant to 

whether Respondent accepted 

responsibility for the MBC findings that 

Respondent continued to argue that his 

prescribing practices were historically 

within reason, given what he described 


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*GGWith a regulated community of nearly two 

million registrants, DEA must be able to rely on 

registrants to comply with the standard of care 

without constantly monitoring them. See DEA FY 

2020 Budget Request available at https://

www.justice.gov/jmd/page/file/1142431/download. 

*HH It is noted that the CSA’s core purposes are 

not, as Respondent suggests, limited to diversion, 

but also include abuse of controlled substances. See 

John O. Dimowo, M.D., 85 FR 15800, 15810 n.K, M 

(2020), Further, ‘‘it is axiomatic that another core 

purpose of the CSA is to protect patients from the 

drug-related deaths and injuries that may result 

from drug abuse and diversion.’’ Salman Akbar 

M.D, 86 Fed Reg. 52181, n.*O (2021). In this case, 

there is evidence that Respondent’s prescribing put 

his patients at risk and that he did not document 

informed consent surrounding that risk. Further, 

there is evidence on the record that a patient died 

of an overdose, and regardless of whether the 

controlled substances Respondent prescribed 

contributed to that death, the overdose itself 

indicates abuse. Additionally, there is evidence that 

another one of Respondent’s patients had opiate use 

disorder by Respondent’s admission. Supra n.*J. 

And finally, there is evidence that AA was possibly 

not taking his oxycodone and that patients were 

repeatedly receiving extra controlled substances 

beyond their prescriptions—all of which have the 

potential to contribute to diversion. Therefore, even 

though, contrary to Respondent’s assertion, I am not 

required to find evidence of abuse and diversion in 

order to find in favor of a sanction, I disagree with 

Respondent’s bold assertion that ‘‘there is no 

evidence of addiction or medication abuse.’’ Resp’t 

Exceptions at 33. 

as the end of a ‘‘decade of pain.’’ On 

October 29, 2019, the MBC had clearly 

stated: 

[A]s commented on earlier in this decision, 

the evaluation of respondent’s treatment of 

all of these patients needs to be looked at in 

terms of the risks to these patients and 

respondent’s efforts to size up and manage 

these risks using the tools available to him. 

By November 2011, when the CDC declared 

prescription drug abuse to be a nationwide 

epidemic, respondent as a pain specialist was 

on notice that he needed to use the tools 

available to him, whether UDTs, cup screens, 

pill counts, and/or CURES, and he also need 

to critically assess patients and what they 

told him. Respondent was slow to respond to 

this change in the opioid pain management 

landscape and did not consistently use the 

tools available to him. Even when he did use 

these tools and was put on notice of potential 

problems, he did not take actions to protect 

his patients from their risky aberrant 

behaviors. 

Gov’t Ex. 30 at 165. 

Respondent states on the one hand 

that he has addressed and accepted 

responsibility the issues that the MBC 

found, while still re-hashing arguments 

that the MBC discredited—that his 

prescribing practices were explained 

given the historical period that had just 

ended. The MBC found that 

‘‘Respondent was slow to respond to 

this change in the opioid pain 

management landscape and did not 

consistently use the tools available to 

him.’’ Id. Had Respondent really 

understood and accepted responsibility 

for the MBC findings, I find it doubtful 

that he would have attempted to excuse 

his behavior in his DEA hearing. 

Exception 8 

Respondent again argues that he has 

adequately responsibility. I have 

discussed some of these specific 

arguments in the Recommendation 

Section and throughout where relevant. 

The issue of trust is necessarily a factdependent determination based on the 

circumstances presented by the 

individual respondent; therefore, the 

Agency looks at factors, such as the 

acceptance of responsibility and the 

credibility of that acceptance as it 

relates to the probability of repeat 

violations or behavior and the nature of 

the misconduct that forms the basis for 

sanction, while also considering the 

Agency’s interest in deterring similar 

acts. See Arvinder Singh, M.D., 81 FR 

8247, 8248 (2016). 

Respondent argues that he ‘‘accepted 

full responsibility for deficiencies for 

which he agreed with Dr. Munzing. 

There were other allegations for which 

he provided a defense, as stated herein. 

Dr. Chesler should not be made to 

accept responsibility for allegations for 

which he does not believe are accurate. 

That would be disingenuous and not 

something he should do as an honorable 

and credible person.’’ Resp’t Exceptions 

at 28. I disagree, as explained in more 

detail supra that Respondent 

unequivocally and credibly accepted 

responsibility for the deficiencies for 

which he agreed with Dr. Munzing. 

With respect to his high dosing levels 

and combination prescribing, which 

seem to be primarily the focus of his 

continued disagreement with Dr. 

Munzing, I am confounded as to why he 

continues to argue these points, while 

also stating that he no longer prescribes 

these combinations or at these levels. 

Additionally, although Respondent 

repeatedly admitted that his 

documentation ‘‘could be better,’’ see, 

e.g., Tr. 929, he gives little weight or 

understanding to these statements. 

Respondent’s cavalier assumptions 

about his documentation 

responsibilities and the fact that he did 

not undertake this responsibility with 

seriousness weigh against my ability to 

entrust him with a registration. See 

Singh, M.D., 81 FR 8248 (‘‘[U]ntil . . . 

[a] Respondent can convincingly show 

he accepts the authority of the law and 

those bodies charged with enforcing it 

and regulating his activities, granting [ ] 

a DEA registration will gravely endanger 

the public.’’). The truth is that it is not 

possible to tell whether Respondent’s 

care was as appropriate as he claims 

because his recordkeeping did not 

support those claims. Nowhere is this 

more obvious than with Patient AA. 

With respect to the dosing levels, 

Respondent argues that I should now 

trust him because he has corrected 

something that he does not believe was 

a mistake. He then states that if DEA 

wants to ensure that he does not 

prescribe at high levels, ‘‘a CURES 

monitoring program could easily be set 

up between him and the DEA to track 

prescriptions for all patients.’’ Resp’t 

Exceptions at 32. DEA is responsible for 

regulating more than just Respondent 

and Respondent has already violated my 

trust through the multiple, egregious 

proven allegations. Ensuring that a 

registrant is trustworthy to comply with 

all relevant aspects of the CSA without 

constant oversight is crucial to the 

Agency’s ability to complete its mission 

of preventing diversion within such a 

large regulated population.*GG Jeffrey 

Stein, M.D., 84 FR 46974. I do not see 

how I can believe that Respondent has 

accepted responsibility for his actions 

and reformed, while arguing that the 

rationale underlying some of those 

reforms is superfluous. His acceptance 

of responsibility did not adequately 

convince me that he can be entrusted 

with a registration. Once his state 

probation ends and the scrutiny is off of 

him, I am not convinced that he will 

continue the practices that he put in 

place, when he does not believe that 

they are necessary in the first place or 

truly demonstrate a grasp of their 

gravity and importance. 

Exception 9 

Lastly, Respondent argues that 

‘‘[d]isciplining Respondent based upon 

findings of the deficiencies in the 

Recommended Decision is inconsistent 

with, and has no nexus to, the DEA’s 

stated goals of avoiding diversion.’’ *HH

Resp’t Exceptions at 33. The 

Government, however, is not required to 

prove that diversion resulted from the 

unauthorized issuance of prescriptions. 

Arvinder Singh, M.D., 81 FR 8247, 8249 

(2016). Rather, when a practitioner 

violates the CSA’s prescription 

requirement, set forth in 21 CFR 

1306.04(a), by issuing a prescription 

without a legitimate medical purpose 

and outside the course of professional 

practice, the DEA essentially considers 

the prescription to have been diverted. 

George Mathew, M.D., 75 FR 66146. 

Furthermore, the Agency is not, as 

Respondent suggests, required to find 

intentional misconduct in order to 

support a sanction. Resp’t Exceptions at 

33. DEA decisions have found that ‘‘just 

because misconduct is unintentional, 

innocent, or devoid of improper motive, 

[it] does not preclude revocation or 


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denial. Careless or negligent handling of 

controlled substances creates the 

opportunity for diversion and [can] 

justify the revocation of an existing 

registration . . .’’ Bobby D. Reynolds, 

N.P., Tina L. Killebrew, N.P., & David R. 

Stout, N.P., 80 FR 28643, 28662 (2015) 

(quoting Paul J. Caragine, Jr. 63 FR 

51592, 51601 (1998). In fact, the Agency 

has found in favor of revocation in cases 

where registrants have failed to 

document their prescribing decisions— 

a violation which has been clearly 

established in this case. The Agency has 

repeatedly emphasized that 

‘‘[c]onscientious documentation is . . . 

not just a ministerial act, but a key 

treatment tool and vital indicator to 

evaluate whether the physician’s 

prescribing practices are within the 

usual course of professional practice.’’ 

Cynthia M. Cadet, M.D., 76 FR 19,450, 

19,464 (2011) (internal citation and 

quotation omitted); see also Kaniz F. 

Khan-Jaffery, M.D., 85 FR 45,667, 45,686 

(2020) (‘‘DEA’s ability to assess whether 

controlled substances registrations are 

consistent with the public interest is 

predicated upon the ability to consider 

the evidence and rationale of the 

practitioner at the time that she 

prescribed a controlled substance— 

adequate documentation is critical to 

that assessment.’’). 

The case at hand demonstrates 

prescribing beneath the applicable 

standard of care and outside the usual 

course of professional practice in 

California to multiple patients over the 

course of many years. I agree with the 

Chief ALJ that this conduct was 

egregious and I agree with his rationale 

for sanction. As stated above, for many 

reasons, I cannot find that I can entrust 

Respondent with a registration. 

Accordingly, I reject Respondent’s 

Exceptions and affirm the RD’s 

conclusion that Respondent’s 

registration should be revoked. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

824(a)(4) and 21 U.S.C. 823(f), I hereby 

revoke DEA Certificate of Registration 

No. BC1317165 issued to Bradley H. 

Chesler, M.D. Pursuant to 28 CFR 

0.100(b) and the authority vested in me 

by 21 U.S.C. 824(a) and 21 U.S.C. 823(f), 

I further hereby deny any pending 

application of Bradley H. Chesler, M.D., 

to renew or modify this registration, as 

well as any other pending application of 

Bradley H. Chesler, M.D. for registration 

in California. This Order is effective 

March 2, 2022. 

Anne Milgram, 

Administrator. 

[FR Doc. 2022–01838 Filed 1–28–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–947] 

Bulk Manufacturer of Controlled 

Substances Application: Siegfried 

USA, LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Siegfried USA, LLC. has 

applied to be registered as a bulk 

manufacturer of basic class(es) of 

controlled substance(s). Refer to 

Supplementary Information listed below 

for further drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before April 1, 2022 Such persons 

may also file a written request for a 

hearing on the application on or before 

April 1, 2022. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on December 8, 2021, 

Siegfried USA, LLC., 33 Industrial Park 

Road, Pennsville, New Jersey 08070– 

3244, applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Gamma Hydroxybutyric Acid .. 2010 I 

Dihydromorphine ..................... 9145 I 

Hydromorphinol ....................... 9301 I 

Amphetamine .......................... 1100 II 

Lisdexamfetamine ................... 1205 II 

Methylphenidate ...................... 1724 II 

Amobarbital ............................. 2125 II 

Pentobarbital ........................... 2270 II 

Secobarbital ............................ 2315 II 

Phenylacetone ........................ 8501 II 

Codeine ................................... 9050 II 

Oxycodone .............................. 9143 II 

Hydromorphone ...................... 9150 II 

Hydrocodone ........................... 9193 II 

Methadone .............................. 9250 II 

Methadone intermediate ......... 9254 II 

Morphine ................................. 9300 II 

Oripavine ................................. 9330 II 

Controlled substance Drug 

code Schedule 

Thebaine ................................. 9333 II 

Opium tincture ........................ 9630 II 

Oxymorphone ......................... 9652 II 

Tapentadol .............................. 9780 II 

The company plans to manufacture 

the above-listed controlled substance in 

bulk for development of a new active 

pharmaceutical ingredient (API) and 

validation for a Drug Master File 

submission to the Food and Drug 

Administration. No other activity for 

this drug code is authorized for this 

registration. 

Brian S. Besser, 

Acting Assistant Administrator. 

[FR Doc. 2022–01816 Filed 1–28–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 22–4] 

Austin J. Kosier, M.D.; Decision and 

Order 

On September 30, 2021, the Acting 

Assistant Administrator, Diversion 

Control Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause (hereinafter, OSC) to Austin J. 

Kosier, M.D. (hereinafter, Respondent) 

of Zanesville, Ohio. OSC, at 1 and 3. 

The OSC proposed the revocation of 

Respondent’s Certificate of Registration 

No. FK6714504. It alleged that 

Respondent ‘‘[does] not have authority 

to dispense or prescribe controlled 

substances in the [s]tate of Ohio, the 

state in which [Respondent is] 

registered with DEA.’’ Id. at 1 (citing 21 

U.S.C. 824(a)(3)). 

Specifically, the OSC alleged that on 

or about May 12, 2021, the State 

Medical Board of Ohio issued an Order 

suspending Respondent’s state license 

to practice medicine and surgery. Id. at 

2. The Order was effective immediately 

and ordered that Respondent 

‘‘immediately cease the practice of 

medicine and surgery in Ohio.’’ Id. 

The OSC notified Respondent of the 

right to request a hearing on the 

allegations or to submit a written 

statement, while waiving the right to a 

hearing, the procedures for electing each 

option, and the consequences for failing 

to elect either option. Id. at 2 (citing 21 

CFR 1301.43). The OSC also notified 

Respondent of the opportunity to 

submit a corrective action plan. Id. at 3 

(citing 21 U.S.C. 824(c)(2)(C)). 


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