Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 16823 

1As the basis for rejecting the ALJ’s 

recommended sanction of a one-year suspension 

and revoking Respondent’s registration, the DA 

cited four findings: (1) Respondent’s ‘‘failure to 

acknowledge the need for adequate recordkeeping 

to insure [sic] that controlled substances are not 

diverted’’; (2) his ‘‘lack of remorse concerning his 

* * * unlawful recordkeeping and refill practices’’; 

(3) his ‘‘failure to act in a timely manner upon, and 

to take responsibility for, receipt of information 

given him or to his staff concerning the forged 

prescriptions of Patient #3’’; and (4) his ‘‘lack of 

acknowledgement that the inadequate treatment 

record of Patient #1 could have ultimately 

jeopardized that patient’s welfare.’’ 60 FR at 55051. 

A. Bergman, M.D., 70 FR 33,193 (DEA 

2005) (denying respondent’s request for 

temporary suspension and granting 

motion for summary disposition where 

respondent lacked state authority); see 

also Roy Chi Lung, 74 FR 20,346, 20,346 

(DEA 2009) (‘‘Respondent * * * lack[s] 

authority to handle controlled 

substances in California * * * 

Respondent is therefore not entitled to 

maintain his DEA registration.’’) 

(emphasis supplied); Sheran Arden 

Yeates, M.D., 71 FR 39,130, 39,131 (DEA 

2006) (‘‘DEA does not have statutory 

authority under the Controlled 

Substances Act to maintain a 

registration if the registrant is without 

state authority to handle controlled 

substances in the state in which he 

practices.’’). See generally 21 CFR 

1301.01(17) (2010) (defining ‘‘individual 

practitioner’’ as a person, other than a 

pharmacist, pharmacy or institutional 

practitioner, possessing state authority 

to dispense a controlled substance in 

the course of a professional practice). 

Under the circumstances discussed 

above, I conclude that further delay in 

ruling on the Government’s Motion for 

Summary Disposition is not warranted. 

Recommended Decision 

I grant the Government’s motion for 

summary disposition and recommend 

that Respondent’s DEA COR BS5109889 

be revoked and any pending 

applications denied. 

Dated: November 2, 2010 

Timothy D. Wing, 

Administrative Law Judge. 

[FR Doc. 2011–7016 Filed 3–24–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 09–35] 

Robert L. Dougherty, M.D.; Denial of 

Application 

On March 16, 2009, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Robert L. Dougherty, 

M.D. (Respondent), of Poway, 

California. ALJ Ex. 1. The Show Cause 

Order proposed the denial of 

Respondent’s pending application for a 

DEA Certificate of Registration as a 

practitioner, on the ground that his 

‘‘registration would be inconsistent with 

the public interest, as that term is used 

in 21 U.S.C. 823(f).’’ Id. at 1. 

The Show Cause Order alleged that on 

October 27, 1995, the DEA Deputy 

Administrator (DA) issued a Final Order 

revoking Respondent’s registration 

based on his prescribing of controlled 

substances to three patients. Id. (citing 

60 FR 55047). More specifically, the 

Show Cause Order alleged that the DA 

had ‘‘found that [Respondent’s] 

prescribing of controlled substances to 

Patient #1 ‘on demand,’ ‘virtually upon 

request,’ with ‘virtually no scrutiny’ and 

with ‘virtually no records or monitoring’ 

demonstrated a gross lack of judgment 

and showed that some of the 

prescriptions issued were outside the 

course of professional practice.’’ Id. 

With regard to Patient #2, the Show 

Cause Order alleged that the DA ‘‘found 

that * * * Respondent’s prescribing of 

controlled substances to an admitted 

drug abuser showed a disregard of the 

requirements for detailed attention to 

individual patient behavior necessary 

for the dispensing of controlled 

substances.’’ Id. With regard to Patient 

#3, the Show Cause Order alleged that 

the DA found that Respondent’s 

‘‘prescribing of an excessive number of 

refills of controlled substances over a 

six month period, without requiring a 

clinical examination or visit, 

demonstrated a reckless disregard for 

medical standards in dispensing 

controlled substances and violations of 

Federal regulations and state law[,]’’ and 

that he ‘‘had violated Federal and state 

record-keeping requirements for 

controlled substances.’’ Id. 

Finally, the Show Cause Order alleged 

that on June 25, 1997, the Medical 

Board of California (MBC) issued a 

decision which ‘‘severely criticized 

[Respondent’s] treatment of [P]atient 

#1.’’ Id. The Order alleged that the MBC 

had found that Respondent ‘‘had 

engaged in repeated negligent acts and 

had demonstrated incompetence in [his] 

treatment of the patient[,]’’ and that 

‘‘[t]his misconduct included prescribing 

controlled substances to an obvious 

drug addict.’’ Id. at 1–2. 

Respondent requested a hearing on 

the allegations, and the matter was 

placed on the docket of the Agency’s 

Administrative Law Judges (ALJ). 

Following pre-hearing procedures, on 

March 10, 2010, an ALJ conducted a 

hearing on the matter in San Diego, 

California, at which both parties called 

witnesses to testify and the Government 

introduced documentary evidence. 

Thereafter, both parties filed briefs 

containing their proposed findings of 

fact, conclusions of law, and argument. 

On June 9, 2010, the ALJ issued her 

recommended decision (also ALJ). 

Therein, the ALJ found that the 

Government had ‘‘met its prima facie 

burden.’’ ALJ at 22. However, the ALJ 

reasoned that all of the facts and 

circumstances should be considered 

including that Respondent’s ‘‘mistakes’’ 

involved only ‘‘a very small portion of 

his patients,’’ that one of the patients 

was a relative who has since died and 

that this ‘‘decreases the likelihood that 

similar circumstances would reoccur,’’ 

and that Respondent’s ‘‘mis-judgments 

were well intentioned.’’ Id. at 22–24. 

Next, the ALJ reasoned that ‘‘there was 

controversy in the medical community 

with regards to his prescribing practices, 

and that his methods have since been 

adopted by the FDA, though not 

necessarily DEA,’’ and that his 

prescribing methods, while ‘‘found to be 

objectionable over ten years ago * * * 

may, according to the record, arguably 

not be objectionable now.’’ Id. at 24. The 

ALJ thus concluded that ‘‘the 

circumstances surrounding his 

prescribing practices have changed.’’ Id. 

Finally, the ALJ noted that in the 1995 

Final Order, the Agency had made four 

summarized findings.1 Id. at 25. While 

the ALJ noted that Respondent did not 

‘‘completely acknowledge his past 

problems with refill practices with 

regards to Patient #2,’’ she found it 

relevant that the ALJ who conducted the 

earlier hearing had ‘‘recognized 

discrepancies in the Government’s 

evidence relating to how many refills 

were actually authorized.’’ Id. With 

respect to the Agency’s finding that 

Respondent failed ‘‘to act in a timely 

manner upon, and to take responsibility 

for, receipt of information given to him 

or to his staff concerning the forged 

prescriptions of Patient #3,’’ the ALJ 

reasoned that ‘‘the record demonstrates 

that [he] received information about 

possibly forged prescriptions, made 

inquiries, questioned the patient, was 

deceived, and ultimately stopped 

prescribing to the patient.’’ Id. at 26. 

Finally, with respect to Patient #1, the 

ALJ characterized the Agency’s finding 

as that he had maintained an 

‘‘inadequate treatment record.’’ Id. at 26. 

Reasoning that ‘‘[t]here is no question 

that the Respondent demonstrated 

remorse with regards to his recordkeeping,’’ and that the ‘‘DA’s 

summarized findings focused on recordkeeping,’’ the ALJ concluded that 


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Respondent had generally accepted 

responsibility.2 Id. 

The ALJ thus concluded that while 

she did not ‘‘condone or minimize the 

seriousness of * * * Respondent’s prior 

misconduct[,] * * * the circumstances, 

which existed at the time of the prior 

proceeding, have changed sufficiently to 

support a conclusion that Respondent’s 

registration would be in the public 

interest.’’ Id. at 28. While acknowledging 

that ‘‘Respondent failed to express 

remorse for the entirety of his 

prescribing practices,’’ she 

recommended that I grant him a 

restricted registration. Id. 

Thereafter, the Government filed 

Exceptions to the ALJ’s recommended 

decisions. The record was then 

forwarded to me for Final Agency 

Action. 

Having considered the record as a 

whole (including the ALJ’s 

recommended decision), I agree with 

the ALJ’s finding that the Government 

established a prima facie case to deny 

Respondent’s application. However, I 

reject the ALJ’s finding that Respondent 

has successfully rebutted the 

Government’s prima facie case and will 

deny his application. As ultimate fact 

finder, I make the following findings of 

fact. 

Findings 

Respondent is a physician licensed by 

the Medical Board of California, GX 1, 

at 2. Respondent, who has been licensed 

since 1957, is board certified in Family 

Practice. Tr. 89. Respondent has taught 

pain management to Army hospital 

corpsmen as well as to U.S. Park 

Rangers, and served at two MASH 

hospitals in Korea. Id. at 90–91, 97. 

The First DEA Proceeding 

Respondent previously held a DEA 

Certificate of Registration as a 

practitioner. Robert L. Dougherty, Jr., 

M.D., 60 FR 55047 (1995) (GX 7). 

However, on July 29, 1993, the Deputy 

Assistant Administrator, Office of 

Diversion Control, issued an Order to 

Show Cause which proposed the 

revocation of the registration he then 

held based on five separate allegations. 

Id. Respondent requested a hearing, and 

in July 1994, an Agency ALJ conducted 

a four-day hearing at which Respondent 

was represented by counsel and at 

which he testified and introduced 

documentary evidence. Id. Following 

the hearing, Respondent (and the 

Government) submitted briefs 

containing proposed findings of fact, 

conclusions of law, and argument. Id. 

Thereafter, the ALJ issued his decision, 

which found most of the allegations 

proved and recommended that 

Respondent’s registration be suspended 

for a period of one year. Id. The 

Government filed Exceptions and 

Respondent filed a Response to the 

Government’s Exceptions. Id. The 

record was then forwarded to the DA, 

who, on October 27, 1995, issued the 

Agency’s Decision and Final Order 

which contained extensive factual 

findings. Id. 

With respect to Patient #1, the DA 

credited the testimony of an expert in 

pain management who concluded that 

while Respondent’s initial treatment of 

the patient was medically appropriate, 

‘‘after Patient #1 moved into the 

Respondent’s home in early 1990, the 

notations in his chart became sporadic, 

ending on December 3, 1991.’’ 60 FR at 

55048. Based on the Expert’s testimony, 

the DA further found that ‘‘Respondent’s 

standard of care as to Patient #1, to 

include a lack of a medical record 

showing [his] treatment, and the 

excessive amounts of prescribed 

medication between January 1990 and 

February 1992, ‘fell below community 

standards for the average physician.’ ’’ 

Id. However, the DA also found ‘‘that the 

evidence ‘does not support that the 

doctor was prescribing for an 

illegitimate purpose,’ or that ‘he was 

doing something dishonest,’ but rather 

that such prescribing was not 

‘appropriate treatment’ in this case.’’ Id. 

With respect to Patient #1, the DA 

further noted Respondent’s testimony 

that ‘‘he altered his patient record 

practices in the case of Patient #1 after 

he moved into his home because he now 

saw him regularly and was able to 

closely observe him on a daily basis.’’ Id. 

Respondent also conceded that he had 

provided samples of Xanax to Patient 

#1, but did not record doing so in his 

chart. Id. Respondent further admitted 

that he had prescribed schedule II drugs 

between April 1991 and March 1992, 

but generally did not record this in his 

chart. Id. 

Finally, the DA found ‘‘that from midDecember 1991 to April 1992, Patient 

#1’’ would visit Respondent’s office ‘‘to 

pick up prescriptions’’ but ‘‘‘rarely ever’ 

went into an examination room,’’ and 

that ‘‘he would often call the 

Respondent’s office and leave a message 

telling the Respondent what controlled 

substances to bring home.’’ Id. The DA 

again credited the Expert’s testimony 

that ‘‘such patient and physician 

behavior concerned him, because the 

patient’s demands seemed to replace the 

physician’s judgment.’’ Id. 

Concluding that Respondent 

dispensed to Patient #1 ‘‘on demand, 

virtually upon request, with virtually no 

security, and with virtually no records 

or monitoring in the early 1990s,’’ as 

well as that it was his ‘‘practice of giving 

Patient #1 Xanax samples without 

documenting’’ this in his chart, the DA 

adopted the ALJ’s conclusion that 

‘‘Respondent’s prescribing and 

dispensing to Patient #1 was ‘outside 

the context of the Respondent’s usual 

professional practice.’ ’’ Id. at 55049. 

With respect to Patient #2, the DA 

found that ‘‘[o]n October 24, 1990, the 

Respondent issued [her] an original 

prescription for 30 dosage units of 

Vicodin, [that] he saw this patient again 

on November 14, 1990, and although 

[he] did not see this patient again until 

May 1, 1991, he authorized more than 

twenty refills from the October 24, 1990, 

prescription for Vicodin,’’ the latter 

being a schedule III controlled 

substance. Id. at 55048. The DA also 

found that on October 24, 1990, 

Respondent ‘‘issued Patient #2 an 

original prescription for Darvocet-N 100 

* * * and between that date and May 

1, 1991, he authorized more than twenty 

refills of Darvocet, a medication 

containing propoxyphene napsylate, a 

Schedule IV controlled substance.’’ Id. 

The DA thus concluded that ‘‘the 

excessive number of refills [Respondent] 

provided Patient #2 over a six-month 

period of time without requiring a 

clinical examination or visit, 

demonstrates a reckless disregard for 

medical standards in dispensing 

controlled substances.’’ Id. at 55049. 

Based on his finding that between 

October 24, 1990 and May 1, 1991, 

Respondent had authorized original 

prescriptions for both Vicodin and 

Darvocet-N, as well as more than twenty 

refills for each drug, the DA also 

concluded that Respondent had violated 

21 CFR 1306.22(a), which prohibited 

(then as now) both the filling or refilling 

of a prescription for a schedule III or IV 

controlled substance ‘‘more than six 

months after the date on which such 

prescription was issued,’’ as well as the 

refilling of a prescription ‘‘more than 

five times’’ during this period, after 

which a new prescription must be 

issued. Id. at 55050. The DA also 

concluded that Respondent violated Cal. 

Health and Safety Code § 11200, which 

provided that ‘‘[n]o person shall 

dispense or refill a controlled substance 

prescription more than six months after 

the date thereof or cause a prescription 

for a Schedule III or IV substance to be 

refilled in an amount in excess of a 120 

day supply, unless renewed by the 

prescriber.’’ Id. 

As for Patient #3, the DA found that 

Respondent and the Government had 

stipulated that Patient #3 had forged 

prescriptions under Respondent’s name 

on seven different dates between 

February 3 and April 21, 1992, resulting 


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2The ALJ also observed that the MBC’s decision, 

which found that Respondent’s prescribing to 

Patient #1 showed ‘‘a ‘pattern of excess’ resulting in 

‘irrational polypharmacy,’ * * * also states [that]: 

‘[t]he most powerful tool in reducing polypharmacy 

is an accurate medical record. It is thus easy to see 

why the out of control polypharmacy [] existed.’ ’’ 

ALJ at 26 (citation omitted). The ALJ thus reasoned 

that these statements ‘‘reflect primarily on the 

Respondent’s past-poor record-keeping[,]’’ for which 

he had demonstrated remorse. Id. 

in ‘‘a total of 396 dosage units of Lortab,’’ 

a schedule III controlled substance, 

being dispensed to Patient #3. Id. at 

55049. The DA also found that 

Respondent was notified that Patient #3 

was forging prescriptions on at least 

three occasions between January 1990 

and April 1992. Id. These included: (1) 

A January 1990 incident in which ‘‘a 

pharmacist contacted the Respondent’s 

office about a forged prescription from 

Patient #3,’’ (2) a February 6, 1992 letter 

‘‘written to * * * Respondent informing 

him of a suspicious prescription written 

to Patient #3 despite Respondent’s 

office’s verification of the prescriptions 

which the pharmacist had filled,’’ and 

(3) another pharmacist notifying 

Respondent in April 1992 ‘‘about forged 

prescriptions for a controlled substance 

for Patient #3.’’ Id. The DA found that 

notwithstanding that Respondent had 

received this information, he 

‘‘authorized the refills and continued to 

prescribe Lortab for Patient #3.’’ Id. 

The DA also found that Patient #3 had 

stated during an interview that ‘‘he had 

been a patient of the Respondent’s from 

July 1990 to about June 1992, that he 

had told the Respondent of his past drug 

addiction problems, but that the 

Respondent continued to prescribe 

Lortab’’ to him. Id. Patient #3 ‘‘also 

stated that the Respondent talked to him 

about forged prescriptions, that he had 

denied forging the prescriptions, but 

that the Respondent had told him that 

he did not believe his denial. However, 

the Respondent continued prescribing 

Lortab even after this conversation.’’ Id. 

Patient #3 further ‘‘stated that in June 

1992 he stopped receiving treatment 

from the Respondent and that he went 

into a rehabilitation treatment center for 

90 days to overcome his addiction to 

Lortab.’’ Id. 

The DA noted Respondent’s 

testimony that ‘‘he believed Patient #3 

had valid complaints of pain stemming 

from a history of back pain, that he 

never received a copy of a forged 

prescription regarding Patient #3, [and] 

that he did not see such a copy until 

June 1992, when he then realized 

Patient #3 had been deceiving him.’’ Id. 

The DA also noted the Expert’s opinion 

that ‘‘Respondent’s prescribing practices 

were excessive with poor 

documentation of the need for those 

narcotics, [and] demonstrate[d] a lack of 

usual care and precaution in dealing 

with these kinds of prescriptions.’’ Id. 

The DA concluded that ‘‘the 

dispensing of a controlled substance in 

the quantities prescribed to Patient #3, 

a patient known to the Respondent as an 

admitted drug abuser, even after 

receiving warnings of forged 

prescriptions, demonstrates at least a 

lack of precaution, and more probably a 

disregard of the requirements for 

detailed attention to individual patient 

behavior necessary for the dispensing of 

controlled substances.’’ Id. The DA 

further observed that this ‘‘create[d] 

grave doubt as to * * * Respondent’s 

prescription practices to known drug 

abusers,’’ and that while Respondent 

had been warned about Patient #3’s 

conduct, there was no evidence that he 

had ‘‘ceased prescribing controlled 

substances to this patient until he 

obtained and documented accurate 

information about the amounts of such 

substances actually received by Patient 

#3 through the use of these forged 

prescriptions.’’ Id. at 55051. 

In addition, the DA found that 

Respondent had violated various 

recordkeeping requirements of both 

Federal and State law. Id. at 55050. 

These included 21 U.S.C. 827(a)(3), 

which requires that ‘‘every registrant 

* * * dispensing a controlled substance 

or substances shall maintain, on a 

current basis, a complete and accurate 

record of each substance * * * 

received, sold, delivered, or otherwise 

disposed of by him’’; and subsection 

827(b), which requires that records 

‘‘contain such relevant information as 

may be required by, regulations of the 

Attorney General,’’ that the records for 

narcotics ‘‘be maintained separately 

from all other records of the registrant’’ 

and those for non-narcotic controlled 

substances ‘‘be in such form that 

information required by the Attorney 

General is readily retrievable from the 

ordinary business records of the 

registrant’’; and that records ‘‘be 

available for at least two years, for 

inspection and copying by officers or 

employees of the United States 

authorized by the Attorney General.’’ 21 

U.S.C. 827(b) (quoted at 60 FR 55050) 

(also citing 21 CFR 1304.04(a) and 

1304.24; Cal. Health and Safety Code 

§§ 11190–92).3 In addition, the DA 

found that between April 16 and July 

23, 1990, Respondent had ordered 

Demerol and morphine on ten 

occasions, which are schedule II 

controlled substances, from a local 

pharmacy, but on April 24, 1992, he 

‘‘was unable or unwilling to produce’’ 

the DEA Order Forms, even though 

under Federal regulations he was 

required to maintain these forms 

‘‘separately from all other records’’ and 

to keep them ‘‘available for inspection 

for a period of 2 years.’’ 60 FR at 55050. 

Summarizing his findings, the DA 

concluded that Respondent had shown 

‘‘a blatant disregard for statutory 

provisions’’ which exist ‘‘to prevent the 

diversion of controlled substances to 

unauthorized individuals.’’ Id. 

Finally, the DA found (again based on 

the Expert’s testimony) that Respondent 

had failed ‘‘to maintain accurate, 

current, and complete patient treatment 

records’’ for all three patients. Id. This 

was deemed actionable as ‘‘such other 

conduct which may threaten the public 

health or safety’’ (factor five), because if 

‘‘Respondent suddenly fell ill, [the] 

treatment [of his patients by another 

physician] could be seriously impaired 

by * * * Respondent’s shoddy 

documentation.’’ Id. at 55050–51 

(citation omitted). 

The Medical Board Proceeding 

On dates not established in the 

record, the MBC filed an Accusation, as 

well two Supplemental Accusations 

against Respondent. GX 8, at 3. The 

Accusation charged, inter alia, that he 

had violated California law by engaging 

in ‘‘repeated acts of clearly excessive 

prescribing,’’ as well as that he had 

‘‘dispen[sed] or furnish[ed] * * * 

dangerous drugs without a good-faith 

prior examination and medical 

indication therefor.’’ Id. at 3 (citing Cal. 

Bus. & Prof. Code §§ 725, 4211). The 

Accusation also charged Respondent 

with violating state record-keeping 

requirements for schedule II controlled 

substances, id. (citing Cal. Health & 

Safety Code § 11190), as well having 

violated ‘‘various sections of Federal 

law, contained in the Code of Federal 

Regulations (CFR) relating to dispensing 

controlled substances.’’ Id. All of the 

charges involved Respondent’s 

‘‘administration of certain drugs’’ to 

Patient #1. Id. at 4. 

In May 1997, a State ALJ conducted 

a hearing, which lasted seven days. Id. 

at 2. In his Decision, the State ALJ made 

extensive findings regarding 

Respondent’s prescribing practices 

between November 1991 and September 

1995, which he characterized as ‘‘a 

graphic illustration of a practice without 

a plan’’ and as ‘‘a pattern of excess.’’ Id. 

at 14–15. For example, the State ALJ 

found that ‘‘[d]uring January 1992, 

[R]espondent prescribed 360 Demerol 

100 mg tablets, 200 Valium 10 mg 

tablets, 500 Percocet tablets, and 220 

Xanax 2 mg tablets’’ to Patient #1. Id. at 

15. 

As other examples, the State ALJ 

found that between January and March 


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4The State ALJ also made findings regarding 

Respondent’s prescriptions to Patient #1 during the 

months of November and December 1991, as well 

as January through March 1993. See GX 8, at 14– 

15. 

5The State’s Expert also identified five ‘‘examples 

of gross negligence by [R]espondent’’ in his 

prescribing to Patient #1.’’ Id. at 20–21. These 

included that ‘‘the dose of [D]emerol * * * was 

dangerous and potentially toxic,’’ ‘‘the dose of 

acetaminophen,’’ which is contained in Lorcet, ‘‘was 

very excessive and toxic to the patient’s liver,’’ ‘‘the 

lack of record-keeping is virtually unheard of in 

terms of this degree of prescribing,’’ ‘‘the lack of 

monitoring given the patient’s condition and 

history of substance abuse,’’ and ‘‘the lack of use of 

other modalities besides narcotics to treat the 

patient’s pain.’’ Id. 

6The State ALJ also found that Respondent had 

committed unprofessional conduct under several 

provisions of California law. GX 8, at 26–27. 

1994, Respondent prescribed to Patient 

#1: 672 Lorcet 10/650, 240 diazepam 10 

mg, 56 Xanax 2 mg, 360 amitriptyline 50 

mg, and 56 alprazolam 2 mg; and that 

between January and March 1995, he 

prescribed to Patient #1: 672 Lorcet 10/ 

650, 240 diazepam 10 mg, 720 

amitriptyline 50 mg, 240 alprazolam 2 

mg, and 90 Prelu-2 105 mg 

(phendimetrazine). Id. The ALJ further 

found that between July and September 

1995, Respondent prescribed to Patient 

#1: 784 Lorcet 10/650, 360 diazepam 10 

mg, 720 amitriptyline 50 mg, 120 

alprazolam 2 mg, and 90 Prelu-2 105 

mg. Id. The ALJ also found that 

Respondent maintained no medical 

records on Patient #1 during 1993, and 

that he had a total of ten chart notes on 

him for the years 1994 through 

1996.4 Id. 

The State ALJ characterized 

Respondent’s prescribing practices ‘‘as 

irrational pharmacy,’’ further explaining 

that ‘‘[p]olypharmacy is the prescription, 

administration or use of more 

medications than are clinically 

indicated.’’ Id. at 16. While 

acknowledging that Respondent 

‘‘prescribed pain pills and the patient 

had pain,’’ as well as that ‘‘the patient 

was anxious and received anxiolytics,’’ 

the State ALJ observed that Patient #1 

‘‘really ceased being treated in a fully 

engaged professional manner long ago’’ 

as Respondent had ‘‘prescribed a 

mixture of narcotic, anti-depressant, 

anti-anxiety and anti-inflammatory 

medications without any serious 

attempt to discern efficacy, side effects 

or synergy.’’ Id. at 15–16. 

Noting that ‘‘[t]he most powerful tool 

in reducing polypharmacy is an 

accurate medical record,’’ the State ALJ 

reasoned that it was ‘‘easy to see why 

the out of control polypharmacy of the 

1990’s existed.’’ Id. at 16. The ALJ 

further found that ‘‘[t]otally absent from 

[Respondent’s] care and treatment of 

[Patient #1] was control, monitoring and 

periodic assessment,’’ and that ‘‘[f]rom 

1990 to 1996, almost all of [his] 

prescribing to [Patient #1] took place in 

the absence of a legitimate physical 

examination.’’ Id. 

The State ALJ made additional 

findings based on the expert testimony 

of a practitioner in pain management as 

to the standard of care in treating a 

chronic pain patient. Id. at 20–21. While 

the State’s Expert testified ‘‘that it is not 

necessarily a breach of the standard of 

care to prescribe potent narcotic 

analgesics to an addict,’’ he further 

explained that ‘‘[h]ow a physician goes 

about this and how such a plan is 

monitored is the key to whether the 

patient is engaged in improper drug 

seeking behavior or properly receiving 

medications for a medical condition.’’ 

Id. at 21. 

The State’s Expert testified and the 

ALJ found that ‘‘if a patient with serious 

and legitimate back pain admits to 

addiction to opioids,’’ the ‘‘treating 

physician should always have a 

psychiatrist or psychologist working 

with him for adjunctive evaluation and 

necessary treatment.’’ Id. at 21. 

Moreover, ‘‘[t]he patient should be 

required to sign a narcotic contract that 

specifically spells out the terms and 

conditions under which the physician 

agrees to provide pain medication to the 

patient and what is expected from the 

patient in return.’’ Id. The ALJ further 

found that ‘‘[t]he physician should 

explore other [treatment] modalities 

besides narcotics’’ to see if they will 

‘‘lessen the need for narcotics.’’ Id. While 

acknowledging that narcotics may still 

be necessary after trying other treatment 

modalities, the Expert testified that ‘‘the 

prescribing must be monitored 

extremely closely [and] [t]here must be 

very strict limitations placed on the 

patient to discourage drug seeking 

behavior.’’ Id. 

The State ALJ found that the Expert 

‘‘established that [R]espondent was 

guilty of excessive prescribing to 

[P]atient [#1] based on the extremely 

large quantity of drugs prescribed, the 

toxicity of the medications and the 

absence of good faith examinations.’’ 5

Id. The State ALJ further found that 

while Patient #1 ‘‘lived in pain,’’ ‘‘[t]he 

evidence is overwhelming that [Patient 

#1] abused prescription medication over 

an extended period of time, that his 

abuse was manifest and apparent to 

those around him and that [R]espondent 

could not have been ignorant of this.’’ 

Id. at 24. The State ALJ then noted that 

while ‘‘[i]t appears that [R]espondent 

was motivated by a desire to alleviate 

[Patient #1’s] suffering,’’ Respondent 

‘‘fail[ed] to acknowledge any errors.’’ Id.; 

see also id. at 33 (Respondent ‘‘fails to 

acknowledge any responsibility for any 

of his actions. He blames others or 

completely excuses his actions.’’). 

The State ALJ thus found that 

Respondent had violated numerous 

provisions of both state and Federal law 

including, inter alia, that ‘‘[h]e 

prescribed medication without a good 

faith examination and medical 

indication,’’ that ‘‘he excessively 

prescribed controlled substances,’’ and 

that he had violated 21 CFR 1306.04(a), 

which requires that ‘‘a prescription for a 

controlled substance ‘must be [issued] 

for a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice.’ ’’ 6 Id. at 27–28 (citing Cal. Bus. 

& Prof. Code § 2242, Cal. Health & Safety 

Code § 11153, and 21 CFR 1306.04(a)). 

The State ALJ further found that 

Respondent had violated DEA 

regulations requiring that he maintain a 

biennial inventory of controlled 

substances, that ‘‘he failed to maintain 

all required DEA 222 order forms’’ for 

schedule II controlled substances, and 

that ‘‘he failed to maintain all required 

controlled substances records.’’ Id. 

(citing 21 CFR 1304.11–1304.13; 

1305.03; 1305.13; 1304.21; 1304.24). 

Thereafter, the MBC adopted the 

ALJ’s decision. Id. at 1. Respondent’s 

license was revoked, but the revocation 

was stayed and he was placed on 

probation for ten years. Id. at 35. In 

addition, Respondent’s license was 

suspended ‘‘for 180 days’’ and he was 

ordered to take a course in prescribing 

practices; he was also ordered to take an 

additional Continuing Medical 

Education course for each year of his 

probation. Id. 

Respondent testified that he 

completed the probationary period 

imposed by the MBC and did not have 

any violations. Tr. 117–18. He further 

maintained that he had ‘‘substantially’’ 

improved his charting practices. Id. at 

118. 

The Current Proceeding 

At the hearing in this matter, 

Respondent testified as both a witness 

for the Government and himself. The 

Government asked him a series of 

questions regarding the findings of both 

the 1995 DEA Final Order and the MBC. 

With respect to Patient #1, the 

Government asked Respondent whether 

he agreed with the DA’s finding that his 

dispensing of controlled substances 

‘‘between January 1990 and February 

1992, was highly irregular in the 

medical profession and was excessive?’’ 


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Tr. 15. Respondent answered: ‘‘No, I do 

not.’’ Id. 

Next, the Government asked 

Respondent whether he agreed with the 

DA’s finding that his management of 

Patient #1 ‘‘demonstrated behavior such 

that the patient’s demands seemed to 

replace your judgment.’’ Tr. 15. 

Respondent answered: ‘‘No, I do not.’’ 

The Government then asked 

Respondent whether he agreed with the 

DA’s finding that he ‘‘dispensed 

controlled substances to Patient Number 

1 basically on demand?’’ Tr. 16. 

Respondent again answered: ‘‘No, I do 

not.’’ Id. at 16. 

Next, the Government asked 

Respondent whether he agreed with the 

DA’s finding that, during ‘‘the early 

1990’s,’’ he had ‘‘dispensed controlled 

substances to Patient Number 1 * * * 

with virtually no records or 

monitoring?’’ Id. at 17. Respondent 

answered: ‘‘My records were far less 

thorough than they should have been. I 

know that now and in the future will be 

much more cautious.’’ Id. 

With respect to Patient #3, the 

Government asked Respondent whether 

he agreed with the DA’s finding that his 

‘‘conduct in continuing to prescribe to 

[him], despite his use of forged 

prescriptions, showed a carelessness 

inappropriate for continued 

registration?’’ Id. at 17. Respondent 

answered: 

In the first place, this was not what I would 

call a forgery although it was close. What 

happened was the patient got a reasonable 

prescription from me, ran it through a copy 

machine, took both prescriptions to 

pharmacies so that both prescriptions looked 

extremely genuine, and yet I know I’d only 

written one. I don’t know if that is legally a 

forgery or not, but it’s very similar to that. 

* * * I did not think that it was a forgery. 

Forgeries are usually very obvious to 

pharmacists who are familiar with my 

prescriptions and signature. So I was 

blindsided on that. And I did subsequently 

dismiss that patient from my practice when 

there were increasing questions about what 

was going on. 

Id. at 17–18. 

The Government then asked 

Respondent if he agreed with the DA’s 

‘‘finding that [he was] careless in 

continuing to prescribe to * * * Patient 

Number 3?’’ Id. at 18. Respondent 

answered: ‘‘No, I do not, but I had not 

seen the prescription that is now being 

called a forgery until much later.’’ Id. 

As a follow-up, the Government asked 

Respondent if he agreed with the 

finding that his ‘‘continued prescribing 

to this patient showed more probably a 

disregard of the requirements for 

detailed attention to individual patient 

behavior necessary for the dispensing of 

controlled substances?’’ Id. at 19. 

Respondent answered: 

I find that rather strange. I don’t know 

what behavior is being referred to or conduct 

at that point. Quite simply, the patient came 

to me complaining of severe headaches, 

appeared to be having severe headaches, and 

was prescribed, but there became increasing 

questions about some things that were going 

on. And finally, I just terminated his 

treatment. 

Id. 

With respect to Patient #2, the 

Government noted the DA’s finding that 

‘‘over a six-month period of time, 

[Respondent’s] prescribed [an] excessive 

number of refills [and] showed a 

reckless disregard for medical standards 

in dispensing controlled substances.’’ Id. 

The Government then asked Respondent 

whether he agreed that he ‘‘showed a 

reckless disregard for medical standards 

in dispensing controlled substances 

with regard to Patient Number 2?’’ Id. at 

19–20. Respondent answered: ‘‘No, I do 

not.’’ Id. at 20. 

Testifying on his own behalf 

regarding Patient #2, Respondent stated 

that he understood that he could not 

‘‘legally write on the prescription itself 

more than five refills.’’ Id. at 121. He 

then testified: ‘‘I don’t think I ever did 

write more than five [refills] on Ms. [J.]’’ 

Id. 

The Government then objected that 

Respondent’s counsel was trying to relitigate the findings as to Patient #2. Id. 

Respondent’s counsel acknowledged 

that this was ‘‘true,’’ stating that ‘‘I am 

pointing out the discrepancy in the 

ALJ’s findings versus the final 

revocation order,’’ and that ‘‘[t]here are 

discrepancies that I think that need to 

be illuminated.’’ Id. at 121–22. 

While the ALJ initially expressed the 

opinion that Respondent was ‘‘trying to 

revisit these facts which are facts that 

have already been adjudicated,’’ id. at 

122, Respondent’s counsel replied that 

‘‘the conclusions [of the 1995 Order] 

aren’t support by the facts, and the facts 

are in the record,’’ and that his line of 

questioning was only being done to 

show that when Respondent answered 

the Government’s questions by stating 

‘‘that he disagreed with the conclusion,’’ 

this was ‘‘in fact, supported by the 

record.’’ Id. The ALJ then agreed to 

allow Respondent’s counsel to ask him 

questions to clarify ‘‘why he disagree[d] 

with the final order.’’ Id. at 123. 

Next, Respondent’s counsel read a 

portion of the prior DEA ALJ’s 

recommended decision which noted 

that there was ‘‘arguably * * * 

conflicting evidence’’ as to whether 

Respondent had issued more than five 

refills to Patient #2 between November 

14, 1990 and May 1, 1991. Id. at 125. 

Respondent’s counsel then asked 

Respondent whether he ‘‘agree[d] that 

the evidence that was presented and, in 

fact, the footnote here that the judge 

found conflicted with the conclusion 

that you had violated the prescription 

refill limits?’’ Id. at 126. After the 

Government again objected that 

Respondent’s counsel was trying to relitigate the findings of the earlier 

proceeding, and before the ALJ ruled on 

the objection, Respondent’s counsel 

rephrased his question ‘‘as simply 

asking is that the reason for your 

disagreement with [the Government 

counsel’s] question earlier?’’ Id. 

Respondent answered: 

The word ‘refill’ is perhaps ambiguous. 

When I write a prescription for a patient with 

an ongoing problem, * * * I would write in 

the number of refills, if any, and that’s a 

refill. On the other hand, if the patient calls 

me back a month later and says I need this 

medicine again, and I’m confident the patient 

still has that symptom, that problem, I call 

the pharmacy and say give Ms. Doe another 

30 tablets or whatever. Legally, I think it’s a 

new prescription. Some people would call it 

a refill, but I don’t think that the refill thing 

was intended to necessarily refer to 

situations in which a doctor phones in what 

the pharmacy considers a new prescription at 

that point[.] * * * [W]hether I use the word 

refill or say give the patient another 30 

tablets, basically, it means I’ve considered 

what to do, have hopefully a reason to do it, 

and go on from there. And it’s technically, I 

believe a new prescription. * * * Basically, 

* * * I did not believe I was violating any 

refill laws on this. 

Id. at 127. 

Next, Respondent’s counsel asked 

him if he ‘‘remember[ed] what the * * * 

main issue [was that] the Government 

* * * had with Patient Number 3?’’ Id. 

at 127–28. Respondent answered: ‘‘[t]he 

problem with Patient Number 3 was that 

there was a great deal of confusion from 

a lot of parties. It was * * * not until 

much later that I realized the problem.’’ 

Id. at 128. Following the Government’s 

objection (again, on the ground that 

Respondent was trying to re-litigate the 

findings of the first proceeding), which 

was overruled by the ALJ, Respondent 

testified that: 

There was a question about a pharmacy 

that called me and said, ‘We’ve got a 

prescription here, we think something is 

wrong with it.’ And I of course, they knew 

my signature and my handwriting, and I said, 

‘Well, you know, I did give the patient a 

prescription for this, I guess you might as 

well fill it.’ What actually happened and 

what * * * no one notices was that the 

patient had taken my prescriptions, run it 

through a copying machine, then used 

scissors and cut it to size, * * * took it to 

pharmacies, and each of them had what 

looked like a genuine prescription. And 

eventually, I got copies of both and sure 


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enough, it was a photocopy so that I think 

I was acting in innocence, and the 

pharmacist was right when he thought 

something was wrong with it, but it was not 

a prescription that the patient forged. He 

simply illegally copied a prescription. 

Id. at 128–29. 

Respondent was then asked whether 

at some point, he had ceased his 

relationship with Patient Number 3. Id. 

at 129–30. Respondent answered: 

Yes. There were too many suspicious 

things. I can’t remember the details, but not 

uncommonly a patient will say something 

like ‘my dog ate my pills’ or whatever, rather 

phony-sounding reason for wanting an [sic] 

new prescription. And believe me, if 

somebody drops a bottle in the bathroom, the 

pills always fall in the toilet. I mean it’s just, 

as a doctor, I’ve heard all these reasons, and 

I am extremely suspicious, especially now. I 

often, in fact, have the patient come into the 

office so I can eyeball the squirming when I 

start asking the embarrassing questions, so 

that when these things started happening 

with Mr. [F.], I finally said enough is enough, 

no more, no more medical care. 

Id. at 130. 

Respondent’s counsel then asked him 

‘‘[h]ow much time passed between 

* * * this issue with regard to the 

forgery and your ceasing the 

relationship?’’ Id. Respondent answered 

that he could not ‘‘remember the exact 

dates’’ and that he had ‘‘no memory of 

* * * what that time was.’’ Id. at 130– 

31. 

Respondent was then asked if ‘‘in any 

way, shape, or form do you take 

responsibility for * * * Patient Number 

3 regarding the forged prescriptions?’’ 

Id. at 131. Respondent answered: 

I wrote a prescription, patient apparently 

went to two pharmacies, and one of them 

* * * they was [sic] alert enough to notice 

that a ballpoint pen hadn’t indented it or 

anything and simply called and said, ‘‘I think 

I have a forged prescription.’’ And I simply 

said * * * yes * * * ‘‘That’s what I wrote, 

the quantity.’’ ‘‘You know my signature.’’ 

‘‘You might as well fill it, cause I did write 

that prescription for the patient.’’ I didn’t 

realize the patient had photocopied it and 

* * * had taken it, presumably, [to] two 

different places. 

Id. at 132. Respondent then 

maintained that if he had known the 

prescription had been forged, he ‘‘would 

not have done that,’’ but did not specify 

what ‘‘that’’ was. Id. 

Respondent further conceded that he 

did not have the required bi-annual 

inventory on hand because when he 

first started practicing in 1959, he had 

to take an inventory every year and mail 

it in, but that after ‘‘the doctors of the 

country were notified that they no 

longer needed to mail the DEA an 

inventory every two years, * * * we 

mistakenly believed that we didn’t need 

to do the inventory either, because no 

one would ever see it except ourselves 

or an investigator. So I stopped making 

an inventory. It was, I think, good faith.’’ 

Id. at 134–35. Respondent, however, 

acknowledged that he had to keep an 

inventory, receipts for any controlled 

substances he obtained from drug 

company representatives, and 

dispensing records. Id. at 135–37. 

The Government also asked 

Respondent a series of questions 

regarding the MBC’s Order. First, it 

asked Respondent whether he agreed 

with the Board’s finding that he was 

‘‘guilty of unprofessional conduct in 

[his] care and treatment of [Patient #1] 

both in terms of [his] prescribing 

practice and in terms of [his] 

recordkeeping?’’ Tr. 21. Respondent 

answered that he ‘‘agree[d] with the part 

on recordkeeping,’’ but that ‘‘[o]n the 

other things, I do not agree.’’ Id. 

Respondent then explained that ‘‘[t]his 

patient received textbook treatment in 

accordance with standards of the 

American Medical Association, and 

shortly after, the FDA adopted policies 

which indicated that [it] agreed with the 

AMA.’’ Id. at 21–22. 

The Government then asked 

Respondent whether he agreed with the 

Board’s finding that Patient #1 ‘‘was 

making the only therapeutic decision 

and that the patient was determining his 

need for drugs?’’ Id. at 22. Respondent 

answered: ‘‘No.’’ Id. Next, the 

Government asked Respondent whether 

he agreed with the Board’s finding that 

‘‘serious monitoring [of Patient #1] was 

non-existent?’’ Id. at 22–23. Respondent 

answered: ‘‘I was obviously in a position 

to observe him, that he was showing no 

evidence of drug overdose or problems. 

He was monitored but my 

recordkeeping was inadequate, to say 

the least.’’ Id. at 23. 

Next, the Government asked 

Respondent whether he agreed with the 

Board’s finding that his prescribing 

practices with respect Patient #1 ‘‘could 

be characterized as irrational 

polypharmacy?’’ Id. at 23. Respondent 

answered: ‘‘No, I do not, and the reason 

is that polypharmacy is, by definition, 

irrational.’’ Id. Continuing, Respondent 

explained ‘‘[t]o give more than one drug 

to a patient when there is a reasonably 

good reason for doing that is not 

considered polypharmacy in the 

medical profession, but it must be 

rational and there must be a good reason 

for using more than one drug in a class.’’ 

Id. at 24. 

The Government then asked 

Respondent whether he agreed with the 

Board’s finding that his ‘‘prescribing 

practices to [Patient #1] * * * made 

little sense?’’ Id. Respondent answered: 

‘‘Again, this patient needed more than 

one specific drug in his treatment 

depending on whether the problem was 

being awake and alert and reasonably 

pain free during the daytime and also 

something additional at night so that he 

could sleep as well. I do not consider 

that irrational or unreasonable.’’ Id. at 

24–25. 

Next, the Government asked whether 

Respondent agreed with the Board’s 

finding that ‘‘even though the drugs 

were given for conditions that [Patient 

#1] had, their manner of dispensing was 

totally irrational?’’ Id. at 25. Respondent 

answered: ‘‘No, I do not.’’ Id. 

The Government then asked whether 

he agreed with the Board’s finding that 

he ‘‘committed acts of clearly excessive 

prescribing or administering of drugs to’’ 

Patient #1? Id. at 26–27. Respondent 

answered: ‘‘No.’’ Id. at 27; see also id. at 

50. 

The Government also asked 

Respondent whether he agreed with the 

Board’s finding that he ‘‘had violated 

federal statutes and regulations 

regulating dangerous drugs or controlled 

substances?’’ Id. Respondent answered: 

‘‘In terms of recordkeeping, there’s some 

truth in it. In terms of following 

accepted guidelines, including those of 

the American Medical Association, and 

they’re still the guidelines of the Food 

and Drug Administration, although they 

were adopted after that, indicate that the 

treatment I gave was within national 

standards.’’ Id. 

Respondent further challenged the 

State Expert’s finding that the doses of 

Demerol he prescribed to Patient #1 

were potentially toxic, contending that 

there was uncertainty in medical texts 

as to whether metabolites of the drug 

accumulate and whether ‘‘they cause 

any significant harm.’’ Id. at 36. He 

testified that even today, there is still 

controversy over the appropriate dosing 

of Demerol, although not ‘‘as much 

* * * as there used to be’’ because most 

doctors are using oxycodone or 

morphine to treat patients with severe 

pain. Id. at 38. 

Respondent also maintained that 

Patient #1 had been ‘‘treated with all 

sorts of things other than controlled 

substances early in his course,’’ and that 

‘‘the more potent medications and 

narcotics were used only when the other 

modalities failed.’’ Id. at 32. Respondent 

asserted that he had tried antiinflammatories such as Aleve and 

Naproxen with Patient #1 to no avail, 

and that he had referred him to ‘‘a socalled pain clinic * * * at which they 

tried everything,’’ including ‘‘extensive 

physical therapy’’ but this ‘‘did not give 

him any relief.’’ Id. at 52. While 

Respondent admitted that he did not 


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obtain any of the charts that the pain 

clinic maintained on Patient #1, he 

maintained that he was aware of what 

modalities the clinic had tried because 

‘‘they’re pretty much standard.’’ Id. at 53. 

Respondent further testified that he 

‘‘frequently’’ would not document the 

use of non-prescription medicines 

‘‘because it’s over-the-counter,’’ and thus 

a physician reviewing his charts ‘‘could 

not have seen necessarily everything 

else that was tried.’’ Id. at 32. While 

Respondent agreed that he needed to 

closely monitor a patient, he admitted 

that he did not write down every time 

he saw Patient #1. Id. at 40. Respondent 

testified that Patient #1 had lived with 

him for a two-year period and that he 

had observed him on a daily basis. Id. 

at 42. 

Respondent’s counsel also asked him 

whether ‘‘a reasonable doctor looking at 

[Patient #1’s] history wouldn’t have 

enough information to * * * form a 

strong opinion except to the extent that 

the lack of information indicates that 

perhaps he wasn’t treated correct[ly], 

right?’’ Id. at 40. Respondent answered 

that he did not ‘‘agree quite with that 

because a person reviewing it with 

inadequate records would not know 

* * * [and] probably would not even 

[be able] to formulate a guess unless 

there was other evidence pointing in 

one particular direction.’’ Id. 

Respondent then testified that the 

Board’s decision used ‘‘strong language,’’ 

and that in his ‘‘opinion, there were not 

multiple violations or even violations of 

[the] standard of care, although there 

were in recordkeeping.’’ Id. at 40–41. 

Next, Respondent asserted that it was 

not true—as found by the State ALJ— 

that he had ceased treating Patient #1 

‘‘in a fully engaged professional manner 

long ago’’ and noted that he had refused 

to provide him with medication that he 

‘‘did not consider indicated.’’ Id. at 43. 

He then testified that the situation with 

Patient #1 was not likely to happen 

again because Patient #1 ‘‘was [a] 

slightly distant cousin,’’ whose family 

was close to his father’s relatives. Id. 

Respondent testified that while he 

agreed with the State ALJ statements 

that he ‘‘had a desire to alleviate [Patient 

#1’s] suffering,’’ he did not think that he 

had ‘‘lost sight * * * of [his] duty as a 

physician.’’ Id. at 47. He then testified 

that he did not think that the 

prescriptions ‘‘were in error,’’ and ‘‘other 

physicians also agreed that [Patient #1] 

needed relatively heavy medication.’’ Id. 

Respondent then stated that in his 

‘‘opinion, [Patient #1] was never an 

addict, and I certainly never gave him 

medications along those lines.’’ Id. at 48. 

Respondent then maintained that at 

some point ‘‘in the 1990’s, * * * the 

AMA recommended major changes in 

dosage as did the FDA * * *. [B]ut the 

FDA regulations were postponed at the 

request of the DEA, which felt that they 

were too high.’’ Id. at 51. Continuing, 

Respondent claimed that ‘‘[a]fter a year 

of discussion, the FDA decided that 

their proposal was correct, that the[y] 

* * * did not agree with the DEA, did 

agree with the American Medical 

Association and adopted those things, I 

would guess [in the] early 1990’s.’’ Id. 

Subsequently, Respondent testified 

that ‘‘[s]hortly after [his] Medical Board 

case,’’ the FDA changed its position and 

‘‘approved the higher dosage.’’ Id. at 55. 

Clarifying his testimony, Respondent 

stated that prior to the FDA action, ‘‘the 

highest number of milligrams in a tablet 

of oxycodone was 5 milligrams,’’ and 

that ‘‘after my Medical Board hearing, 

the FDA approved a * * * 20 milligram 

and 40 milligram tablet, [and] about a 

year and a half later, an 80 milligram 

tablet.’’ Id. at 55–56. In Respondent’s 

view, the FDA was ‘‘simply saying many 

patients need [a] higher dosage than 

doctors have necessarily been using and 

that * * * rather than have a patient 

take 4 or 8 tablets at a time or even 

eventually 16, a larger size tablet is 

relevant.’’ Id. at 56. Respondent then 

maintained that these ‘‘changes’’ were 

‘‘[e]xactly in line with the American 

Medical Association.’’ Id. 

Respondent then testified that as early 

1958, the AMA had published 

guidelines which ‘‘made it clear that 

much larger doses of oxycodone were 

relevant,’’ that the ‘‘milligram dosage 

and timing [of oxycodone] should be 

identical with [that of] morphine,’’ and 

that ‘‘morphine should be given, based 

on body weight, on the order of 15 

milligrams every 4 to 6 hours, which 

would be a whole lot of oxycodone 

tablets in a day.’’ Id. at 57. He then 

maintained that ‘‘[t]he FDA and DEA are 

taking opposite positions on oxycodone 

dosage * * * and the AMA is on the 

same side as the FDA.’’ Id. 

Later, Respondent’s counsel asked 

him if he was ‘‘remorseful at all for any 

of the problems that occurred?’’ Id. at 

138. Respondent answered: 

Remorseful, no, because in terms of the 

treatment I actually gave, I believed it was 

good treatment. And I can’t think of any 

patient who was damaged by my treatment. 

At the same time, of course, I certainly am 

sorry that this relative died while under the 

care of another physician. Basically, who was 

giving him narcotics and many other things. 

So remorse, no, but obviously, I regret many 

things that happened. 

Id. at 139–40. Respondent then 

explained that what he regretted was 

that he had ‘‘been unable to prescribe 

medications for people in severe pain.’’ 

Id. at 140. 

Respondent was then asked whether 

he felt that ‘‘a distinction [should] be 

drawn in [his] case’’ between his 

contention he had ‘‘performed and 

issued prescriptions that were medically 

necessary and the Government’s 

contention that [he] didn’t * * * 

properly keep track of [them] and follow 

the correct procedures in doing it?’’ Id. 

at 139. Respondent testified: 

I think it’s a major distinction. I prescribed 

in good faith what I thought the patient 

needed and was appropriate. And partly from 

my ignorance and partly from maybe being 

very busy, I did not keep the detailed records 

I now know I should have taken. The other 

thing is that there were so many 

consultations on [Patient #1] especially, nine 

consultations saying yes * * * your 

treatment is correct * * * the patient is 

getting good care. In the practice of medicine, 

there are enough uncertainties so that if a 

large group of physicians are almost 

unanimous in a patient’s need for a particular 

treatment, going back later and saying, well, 

maybe they were all or nearly all wrong is 

not very productive. In other words, there are 

enough uncertainties that going back [in] 

hindsight is 100 percent, but at the time, 

things look * * * like the right thing to do. 

Id. at 140. Respondent then claimed that 

‘‘two consultants testified for the 

Medical Board, but neither one of them, 

identified any problems in my care or 

with his medications. And they simply 

said, oh, if [Respondent] had only told 

me this or that, I would have decided 

differently.’’ Id. 

Discussion 

Section 303(f) of the Controlled 

Substances Act (CSA) provides that the 

Attorney General ‘‘may deny an 

application for [a practitioner’s] 

registration if he determines that the 

issuance of such a registration is 

inconsistent with the public interest.’’ 

21 U.S.C. 823(f). In making the public 

interest determination, the CSA directs 

that the following factors be considered: 

(1) The recommendation of the appropriate 

State licensing board or professional 

disciplinary authority. 

(2) The applicant’s experience in 

dispensing * * * controlled substances. 

(3) The applicant’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. 

Id. 

‘‘[T]hese factors are * * * considered 

in the disjunctive.’’ Robert A. Leslie, 68 

FR 15227, 15230 (2003). I may rely on 

any one or a combination of factors and 


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7There is no dispute that neither the 1995 DEA 

Order, nor the 1997 MBC Order, was vacated by a 

court. 

8See also City Drug, 69 FR at 1307 (denying 

application; noting that applicant had not 

‘‘present[ed] any persuasive evidence of meaningful 

procedural changes * * * that would ensure that it 

will not again fail to account for controlled 

substances or dispense [them] without 

authorization,’’ as well as its ‘‘lack of 

acknowledgement or explanation for previous 

shortages of large quantities of controlled 

substances’’); Turk, 62 FR at 19606 (denying 

application, noting that ‘‘while [r]espondent has 

stated that he has changed his inventory practices, 

there is more than sufficient evidence in the record 

to indicate that [r]espondent has not accepted 

responsibility for his prior actions as a DEA 

registrant, [and] has not significantly changed his 

inventory practices’’). 

may give each factor the weight I deem 

appropriate in determining whether to 

revoke an existing registration or to 

deny an application for a registration. 

Id. Moreover, I am ‘‘not required to make 

findings as to all of the factors.’’ Hoxie 

v. DEA, 419 F.3d 477, 482 (6th Cir. 

2005); see also Morall v. DEA, 412 F.3d 

165, 173–74 (DC Cir. 2005). 

Where the Government has met its 

prima facie burden of showing that 

issuing a new registration to the 

applicant would be inconsistent with 

the public interest, the burden then 

shifts to the applicant to ‘‘present 

sufficient mitigating evidence’’ to show 

why he can be entrusted with a new 

registration. Medicine ShoppeJonesborough, 73 FR 364, 387 (2008) 

(quoting Samuel S. Jackson, 72 FR 

23848, 23853 (2007) (quoting Leo R. 

Miller, 53 FR 21931, 21932 (1988))). 

‘‘Moreover, because ‘past performance is 

the best predictor of future 

performance,’ ALRA Labs, Inc. v. DEA, 

54 F.3d 450, 452 (7th Cir.1995), [DEA] 

has repeatedly held that where a 

registrant has committed acts 

inconsistent with the public interest, the 

registrant must accept responsibility for 

[his] actions and demonstrate that [he] 

will not engage in future misconduct.’’ 

Medicine Shoppe, 73 FR at 387; see also 

Jackson, 72 FR at 23853; John H. 

Kennedy, 71 FR 35705, 35709 (2006); 

Cuong Tron Tran, 63 FR 64280, 64283 

(1998); Prince George Daniels, 60 FR 

62884, 62887 (1995); Hoxie v. DEA, 419 

F.3d at 483 (‘‘admitting fault’’ is 

‘‘properly consider[ed]’’ by DEA to be an 

‘‘important factor[]’’ in the public 

interest determination). 

Where, as here, DEA has previously 

issued a Final Order which revoked an 

applicant’s former registration, ‘‘the 

critical issue in th[e] proceeding is 

whether the circumstances, which 

existed at the time of the prior 

proceeding, have changed sufficiently to 

support [the] conclusion that’’ granting 

the application would be consistent 

with the public interest. Ellis Turk, 

M.D., 62 FR 19603, 19604 (1997); 

Stanley Alan Azen, M.D., 61 FR 57893, 

57893–94 (1996). Contrary to the ALJ’s 

apparent understanding, this is not an 

invitation to relitigate the findings of the 

prior proceeding. Rather, where, as here, 

an applicant has previously been the 

subject of an Agency Final Order, the 

doctrine of res judicata bars the 

relitigation of the factual findings and 

conclusions of law of the prior 

proceeding absent the applicant’s 

establishing that he falls within one of 

the doctrine’s recognized exceptions. 

See City Drug Co., 69 FR 1304, 1306 

(2004); Turk, 62 FR at 19604; Azen, 61 

FR at 57894; see also Restatement 

(Second) of Judgments § 28 (2010). So 

too, the doctrine of res judicata bars the 

relitigation of the findings of the MBC’s 

final order. See Christopher Henry 

Lister, P.A., 75 FR 28068, 28069 (2010) 

(citing University of Tenn. v. Elliot, 478 

U.S. 788, 798–99 (1986)); Marie Y. v. 

General Star Indem. Co., 2 Cal. Rptr.3d 

135, 155 (Cal. Ct. App. 2003) (‘‘When an 

administrative agency acts in a judicial 

capacity to resolve disputed issues of 

fact properly before it which the parties 

have had an adequate opportunity to 

litigate, its decision will collaterally 

estop a party to the proceeding from 

relitigating those issues.’’); see also 

Misischia v. Pirie, 60 F.3d 626, 629–30 

(9th Cir. 1995); Restatement (Second) of 

Judgments, § 29. 

Accordingly, upon the Government’s 

establishing that the Agency has 

previously issued a Final Order 

revoking an applicant’s registration and 

absent the applicant’s establishing that 

he falls within a recognized exception to 

the application of res judicata,7 the 

Government has satisfied its prima facie 

burden of showing that granting the 

application would be inconsistent with 

the public interest. Moreover, the scope 

of the issues to be litigated is limited. As 

in any other proceeding, ‘‘an applicant 

must accept responsibility for [his] 

actions and demonstrate that [he] will 

not engage in future misconduct.’’ 

Medicine Shoppe, 73 FR at 387 (int. 

quotations and citations omitted). 

For example, in Robert A. Leslie, 

M.D., DEA denied the application of a 

practitioner whose registration had been 

previously revoked following his state 

court convictions for unlawfully 

prescribing or furnishing controlled 

substances. 60 FR 14004, 14005 (1995). 

While the practitioner attempted to 

relitigate his convictions, the thenDeputy Administrator, agreeing with the 

ALJ, held that ‘‘the conviction is res 

judicata, and that [r]espondent should 

not be allowed to relitigate the matter.’’ 

Id. Continuing, the Deputy 

Administrator noted that ‘‘although 

[r]espondent was free to offer new 

evidence that he would never again 

engage in the type of conduct that 

resulted in his conviction, he failed to 

do so. * * * [W]hile [r]espondent 

offered evidence and expended time 

arguing the invalidity of his criminal 

convictions, he offered no evidence of 

remorse for his prior conduct, that he 

has taken rehabilitative steps, or that he 

recognizes the severity of his actions.’’ 

Id. The Deputy Administrator thus 

denied the practitioner’s application. 

Likewise, when, several years later, 

Dr. Leslie re-applied for a registration, 

the Deputy Administrator held that the 

1995 Agency Order was res judicata; the 

Order specifically noted that the 

‘‘[r]espondent continued to blame others 

for his criminal convictions,’’ 

contending that his name had been 

forged on various prescriptions; that his 

criminal convictions had been affirmed 

because his counsel was ineffective; and 

that a Government witness in the earlier 

DEA proceeding had committed perjury. 

Robert A. Leslie, M.D., 64 FR 25908, 

25908–09 (1999). After again observing 

that both Dr. Leslie’s criminal 

convictions and the 1995 Agency Order 

were res judicata, the Deputy 

Administrator denied his application, 

stating that ‘‘[r]espondent continues to 

fail to acknowledge wrongdoing or 

accept responsibility for his actions. 

Therefore, the Deputy Administrator is 

not convinced that [r]espondent has 

been rehabilitated and would properly 

handle controlled substances in the 

future, even on a restricted basis.’’ Id. at 

25910; see also Robert A. Leslie, M.D., 

68 FR 15227, 15231 (2003) (revoking 

registration obtained through 

administrative error, noting that ‘‘[i]n 

the face of DEA’s repeated concerns 

regarding his lack of contrition, the 

[r]espondent remains steadfast in his 

insistence upon denying any previous 

wrongdoing. Despite previous findings 

that his criminal convictions were res 

judicata, the [r]espondent in his support 

of his most recent application * * * 

attempted yet again to re-litigate his 

criminal convictions’’).8

At the instant hearing, the 

Government objected to various 

questions asked of Respondent by his 

counsel on the ground that Respondent 

was attempting to relitigate the findings 

of the 1995 Agency Order. Tr. 121–22. 

Respondent’s counsel admitted that this 

was ‘‘true,’’ id., but justified doing so to 

show purported discrepancies between 

the record (and the ALJ’s decision) in 

the prior proceeding and the Agency’s 

Final Order. Id. at 122. The ALJ 

overruled the Government’s objection 


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and allowed Respondent to pursue this 

line of inquiry, id. at 123, 128; she also 

allowed Respondent to testify 

extensively as to why he disagreed with 

the MBC’s findings. Moreover, in her 

decision, the ALJ ignored many of the 

findings of the 1995 Agency Order 

regarding Respondent’s prescribing 

practices, and generally found proved 

only the various recordkeeping 

violations to which Respondent 

admitted. See generally ALJ. The ALJ 

also entirely ignored the MBC’s findings 

that Respondent violated California law 

by ‘‘prescrib[ing] medication without a 

good faith examination and medical 

indication,’’ that ‘‘he excessively 

prescribed controlled substances,’’ and 

that he violated Federal law because he 

issued prescriptions which lacked ‘‘a 

legitimate medical purpose’’ and which 

were issued outside of the usual course 

of professional practice. Compare ALJ at 

7–12, 19–27, with GX 8, at 27–28. 

Indeed, in her decision, the ALJ did not 

even acknowledge that DEA has long 

applied the doctrine of res judicata, let 

alone explain why the doctrine should 

not apply here. 

Factors Two and Four—The Applicant’s 

Experience in Dispensing Controlled 

Substances and Record of Compliance 

With Applicable Controlled Substance 

Laws 

In her discussion of these two factors, 

the ALJ found only that ‘‘[t]he 

Government has proven and the 

Respondent has admitted to various 

record-keeping violations.’’ ALJ at 19. 

Specifically, the ALJ found that 

Respondent did not keep receipts for the 

controlled substances he obtained, did 

not maintain the required biennial 

inventories, and that his records were 

not readily retrievable. Id. Noting that 

Respondent had ‘‘shown remorse for’’ 

these violations, the ALJ concluded 

‘‘that this factor falls in favor of granting 

Respondent’s application.’’ Id. 

It doesn’t. As noted above, the ALJ 

ignored many of the most significant 

findings of both the 1995 Agency Order 

and the 1997 MBC Decision, which are 

relevant under these factors. With 

respect to Patient #1, the ALJ ignored 

the DA’s findings that Respondent 

dispensed controlled substances to him 

‘‘on demand [and] virtually upon 

request,’’ with ‘‘virtually no records or 

monitoring,’’ and that the prescribing 

occurred ‘‘outside the context of the 

Respondent’s usual professional 

practice.’’ 60 FR at 55049 (emphasis 

added). These findings are res judicata 

and establish that Respondent violated 

the CSA in prescribing to Patient #1. See 

21 CFR 1306.04(a). 

Likewise, the MBC’s Decision and 

Order found that Respondent had 

committed numerous violations of 

California law. In addition to his failure 

to keep required records, the MBC 

found that Respondent had prescribed 

controlled substances to Patient #1 

‘‘without a good faith examination and 

medical indication,’’ in violation of Cal. 

Bus. & Prof. Code § 2242, and that ‘‘he 

excessively prescribed controlled 

substances,’’ in violation of Cal. Health 

& Safety Code § 11153. The MBC also 

found that Respondent violated 21 CFR 

1306.04 in that he issued prescriptions 

to Patient #1 outside of the usual course 

of professional practice and which 

lacked a legitimate medical purpose. 

While the MBC found that Patient #1 

‘‘lived in pain,’’ it nonetheless 

concluded that ‘‘the evidence [wa]s 

overwhelming that [Patient #1] abused 

prescription medication over an 

extended period of time, that his abuse 

was manifest and apparent to those 

around him and that [R]espondent 

could not have been ignorant of this.’’ 

GX 8, at 24. Of further significance, the 

MBC considered Respondent’s 

dispensing practices in periods beyond 

those at issue in the first DEA 

proceeding including his practices 

during the periods following both the 

issuance of the Show Cause Order and 

the ALJ’s recommended decision. 

With respect to Patient #1, 

Respondent testified that in his 

‘‘opinion, there were not multiple 

violations or even violations of [the] 

standard of care, although there were in 

recordkeeping.’’ Tr. 40–41. He further 

suggested that the MBC’s findings were 

flawed ‘‘because a person reviewing [his 

treatment of Patient #1] with inadequate 

records would not know’’ whether he 

was being treated appropriately, and 

‘‘probably would not even [be able] to 

formulate a guess unless there was other 

evidence pointing in one particular 

direction.’’ Id. at 40. Respondent also 

disagreed with the MBC’s findings that 

he had ceased treating Patient #1 ‘‘in a 

fully engaged professional manner long 

ago;’’ he asserted that Patient #1 ‘‘was 

never an addict,’’ that the prescriptions 

were not ‘‘in error,’’ and that ‘‘other 

physicians also agreed that [Patient #1] 

needed relatively heavy medication.’’ Id. 

at 43–48. He further claimed that ‘‘two 

consultants testified for the Medical 

Board, but neither one of them 

identified any problems in my care or 

with [Patient #1’s] medications,’’ and 

that these physicians said that if 

Respondent ‘‘had only told me this or 

that, I would have decided differently.’’ 

Id. at 140. 

All of Respondent’s testimony could 

have been, and should have been 

presented in the MBC proceeding. Here 

again, it is clear that Respondent is 

simply trying to relitigate the findings of 

the MBC proceeding. Having failed to 

establish that the MBC proceeding did 

not provide him with a full and fair 

opportunity to litigate these issues, the 

doctrine of res judicata precludes 

Respondent from relitigating them in 

this proceeding. GX 8, at 26. 

In her decision, the ALJ opined that 

‘‘the record * * * contains evidence of 

changes in acceptable prescribing 

practices that make for changed 

circumstances.’’ ALJ at 21. She noted 

that ‘‘at the previous [Agency] hearing, 

an expert witness testified to the 

controversy in the medical community 

at that time over prescribing practices 

for chronic pain.’’ Id. The ALJ then 

explained that Respondent ‘‘credibly 

testified that the AMA standards he 

applied in the past have now been 

adopted by the FDA, though arguably, 

the DEA disagrees.’’ Id. at 22. 

Several pages later, the ALJ repeated 

this observation, noting that Respondent 

in this proceeding and a government 

witness in the first proceeding ‘‘stated 

that there was a controversy in the 

medical community with regards to his 

prescribing practices, and that his 

methods have since been adopted by the 

FDA, though not necessarily the DEA.’’ 

Id. at 24. Observing that ‘‘[t]he 

Government did not rebut this 

testimony in any way,’’ the ALJ 

suggested that ‘‘his standard of care, 

though not accepted universally then or 

even now, has yet become more 

established,’’ and that his ‘‘methods of 

prescribing * * * may, according to the 

record, arguably not be objectionable 

now.’’ Id. The ALJ thus opined that ‘‘the 

circumstances surrounding his 

prescribing practices have changed.’’ Id. 

Contrary to the ALJ’s view, 

Respondent’s evidence is manifestly 

insufficient to support a finding of 

changed circumstances regarding the 

legitimacy of his prescribing practices. 

Indeed, the ALJ’s finding is quite 

strange given that for much of 

Respondent’s testimony on this issue, 

he maintained that his prescribing 

practices with respect to Patient #1 were 

consistent with then-accepted medical 

practices. 

For example, Respondent claimed 

that Patient #1 ‘‘received textbook 

treatment in accordance with standards 

of the AMA.’’ Tr. 21–22. He maintained 

‘‘that the treatment I gave was within 

national standards.’’ Id. at 27. 

Respondent further testified that as 

‘‘early as 1958,’’ the AMA had published 

guidelines which ‘‘made it clear that 

much larger doses of oxycodone were 

relevant,’’ that the ‘‘milligram dosage [of 


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9 Indeed, it appears that Respondent presented 

such evidence in the MBC proceeding as the State 

ALJ’s decision noted that he argued that ‘‘unless 

dosages exceed the range recommended by the 

American Medical Association, Drug Evaluations 

(6th Edition), no evidence should be admitted about 

drug dosages.’’ GX 8, at 26. The State ALJ rejected 

this argument, explaining that: 

[t]he text relied on by respondent is one small 

source of the standard of care for prescribing 

practices. * * * It provides information. The fact 

that respondent relied on [the AMA guidelines] to 

determine safe dosage does not establish 

compliance with the standard of care. Respondent 

fails to understand that his patient was not some 

representative abstraction. His patient was [L.S.] 

who presented over time with his own unique 

medical history. How respondent responded to the 

medical needs of this particular patient is what is 

relevant. 

GX 8, at 26. 

10 I reject the ALJ’s finding that ‘‘Respondent 

credibly testified that the AMA standards he 

applied in the past have now been adopted by the 

FDA.’’ ALJ at 22. As noted above, Respondent did 

not submit a copy of the purported guidelines or 

regulation, and other than his testimony, which 

appears to equate the FDA’s approval for marketing 

of greater strength tablets with that of a clinical 

guideline, there is no evidence that any such 

guidelines or regulation exist. Accordingly, the 

Government was not obligated to rebut this 

testimony. 

Beyond this, the ALJ should have some 

understanding of the FDA’s functions and should 

have carefully considered the inherent plausibility 

(or lack thereof) of an assertion regarding the scope 

of the FDA’s activities. I further note that whether 

FDA has adopted such guidelines or a regulation is 

an issue of legislative (and not historic) fact. See II 

Richard J. Pierce, Administrative Law Treatise 

§ 10.5, at 732 (4th ed. 2002). As such, I decline to 

defer to the ALJ’s credibility finding. See id. 

(quoting Concerned Citizens of So. Ohio, Inc., v. 

Pine Creek Conservancy Dist., 429 U.S. 651, 657 

(1977) (‘‘As Mr. Justice Holmes recognized, the 

determination of legislative facts does not 

necessarily implicate the same considerations as 

does the determination of adjudicative facts.’’)). 

11The ALJ’s use of the phrase ‘‘his standard of 

care’’ suggests a degree of confusion on her part as 

to what a standard of care is. The concept of the 

standard of care refers to a standard of medical 

practice which is generally recognized and accepted 

by the medical community. See Brown v. Colm, 11 

Cal.3d 639, 642–43 (1974) (‘‘It is settled that a 

doctor is required to apply that degree of skill, 

knowledge and care ordinarily exercised by other 

members of his profession under similar 

circumstances.’’). It is not personal to a physician. 

oxycodone] should be identical with 

morphine,’’ and that ‘‘morphine should 

be given * * * on the order of 15 

milligrams every 4 to 6 hours, which 

would be a whole lot of oxycodone 

tablets in a day.’’ Id. at 57. 

Notably, Respondent did not enter 

into evidence the AMA guidelines he 

referred to. Nor did he introduce the 

guidelines of any other body of medical 

professionals with expertise in treating 

chronic pain, nor excerpts from any 

recognized medical treatise. Indeed, 

given that Respondent maintained that 

as early as 1958—more than thirty years 

before the events at issue in the first 

Agency and MBC proceeding—the AMA 

had issued guidelines on oxycodone 

dosage which were consistent with his 

prescribing practices; this evidence also 

could have been, and should have been, 

presented in the prior proceedings.9

Indeed, it seems most unlikely that the 

MBC would have found that 

Respondent violated both State and 

Federal law if, as he contends, his 

prescribing practices with respect to 

Patient #1 had been consistent with the 

thirty-year old guidelines of one of, if 

not the largest, organization of 

physicians in the country, or if his 

dispensing practices constituted 

‘‘textbook treatment,’’ or treatment 

‘‘within national standards.’’ 

Respondent further asserted that 

while at the time of the MBC 

proceedings, five milligram tablets were 

the strongest oxycodone available, 

thereafter, the FDA had ‘‘adopted’’ the 

AMA guidelines because it approved 

twenty, forty and then eighty milligram 

strength tablets for marketing. 

Respondent did not, however, produce 

any guidelines or regulation which the 

FDA has purportedly adopted. 

Indeed, it appears that Respondent 

(and given her findings, the ALJ) 

fundamentally misunderstand the 

FDA’s role. The FDA’s approval of 

larger-strength tablets of oxycodone for 

marketing under the Food, Drug and 

Cosmetic Act does not mean that it is 

medically appropriate to prescribe those 

drugs to a particular patient. Rather, the 

daily dose of a controlled substance to 

be prescribed to any patient is a matter 

of a physician’s clinical judgment based 

on his use of accepted medical practices 

(such as performing a good faith 

medical examination as California law 

explicitly requires, see Cal. Bus. & Prof. 

Code § 2242) to diagnose his patient and 

determine that the patient has a medical 

indication warranting the prescription, 

followed by proper monitoring and 

periodic assessment of the patient to 

determine both whether the treatment is 

effective (or causing harmful side 

effects) and to prevent drug abuse and 

diversion. See GX 8, at 8 (noting the 

MBC’s ‘‘acknowledg[ment] that 

predetermined numerical limits on 

dosages or length of drug therapy cannot 

alone justify a claim of unprofessional 

conduct. Rather, the validity of a 

physician’s prescribing is to be judged 

on the basis of the diagnosis and 

treatment of the patient and whether the 

drugs prescribed are appropriate for the 

condition. There is a requirement that 

good faith prescribing requires a good 

faith history, physical examinations and 

documentation.’’). 

In short, the FDA does not regulate 

the practice of medicine; rather, it 

evaluates drugs to determine whether 

they are safe and effective for the 

treatment of particular medical 

conditions and illnesses. See BristolMyers Squib Co., v. Shalala, 91 F.3d 

1493, 1496 (DC Cir. 1996); Weaver v. 

Reagen, 886 F.2d 194,198 (8th Cir. 

1989); 21 U.S.C. 396. The regulation of 

the practice of medicine is primarily a 

function performed by state medical 

boards such as the MBC.10

In sum, the ALJ’s reasoning that ‘‘his 

[Respondent’s] standard of care 11 may 

have become more universally accepted, 

and * * * his methods of prescribing 

may, according to the record, arguably 

not be objectionable now,’’ ALJ at 24, 

has no credible support in the record. 

Indeed, it is flatly inconsistent with 

Respondent’s testimony that he 

provided Patient #1 with treatment that 

was—even at the time—consistent with 

accepted standards of medical practice. 

However, the MBC found otherwise, 

and I conclude that evidence does not 

support a finding of changed 

circumstances. 

As for Patient #2, the ALJ found it 

‘‘relevant that the prior ALJ recognized 

discrepancies in the Government’s 

evidence relating to how many refills 

were actually authorized (i.e., six or 

twenty).’’ ALJ at 25. The ALJ’s view 

reflects a fundamental 

misunderstanding of the relationship 

between the ALJ and the Agency. 

Contrary to her understanding, the prior 

ALJ’s findings are no longer relevant 

because the Agency—and not the ALJ— 

is the ultimate factfinder. Morall v. DEA, 

412 F.3d at 177; 5 U.S.C. 557(b). While 

the prior ALJ’s recommended decision 

was part of the record in that 

proceeding, and the Agency was 

required to consider it in making its 

findings in that proceeding, Morall, 412 

F.3d at 177, the appropriate forum to 

challenge whether the Agency’s 1995 

finding was supported by substantial 

evidence was by filing a Petition for 

Review in a United States Court of 

Appeals within the time allowed for 

doing so. Because Respondent did not 

seek judicial review of the Agency’s 

1995 Order, the findings of fact and 

conclusions of law made therein are 

entitled to res judicata effect. 

As for Patient #3, the ALJ likewise 

made no findings under factors two and 

four. Instead, she noted (under factor 

five) only that Respondent ‘‘received 

information about possibly forged 

prescriptions, made inquiries, 

questioned the patient, was deceived, 

and ultimately stopped prescribing.’’ 

ALJ at 25–26. 

The findings of the 1995 Agency 

Order regarding Patient #3 were, 

however, considerably more extensive 

than, and materially different from, 


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12 In fact, the 1995 Order makes clear that Patient 

#3 forged multiple prescriptions. 

13 I have also considered the other factors. With 

respect to factor one—the recommendation of the 

state medical board—while the MBC suspended his 

license for only six months and Respondent now 

holds a California medical license, the MBC has 

made no recommendation in this matter. Thus, 

while Respondent now meets a threshold 

requirement for obtaining a DEA registration, see 21 

U.S.C. 823(f), DEA has long held that a 

practitioner’s possession of state authority to handle 

controlled substances is not dispositive of the 

public interest inquiry. See Patrick Stodola, 74 FR 

20727, 20730 (2009); Leslie, 68 FR at 15230. 

As for factor three, ‘‘while 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.’’ Dewey 

C. Mackay, M.D., 75 FR 49956, 49973 (2010) (citing 

Jayam Krishna-Iyer, 74 FR 459, 461 (2009), and 

Edmund Chein, 72 FR 6580, 6593 n.22 (2007)). 

Accordingly, that Respondent has not been 

convicted of an offense within the purview of factor 

three ‘‘is not dispositive of whether * * * his 

registration [would be] consistent with the public 

interest.’’ Id. 

14Having explained above that the evidence does 

not support a finding of changed circumstances 

with respect to Respondent’s prescribing practices 

so as to deny the application of res judicata to the 

findings of the earlier proceedings, I conclude that 

it is unnecessary to repeat that discussion here. 

what the ALJ related. More specifically, 

the Order found that Respondent was 

notified that Patient #3 was forging 

prescriptions on three separate 

occasions, including one that occurred 

more than two years before the Patient 

forged seven additional prescriptions. 

The 1995 Order also found that Patient 

#3 had told Respondent of his past 

addiction problems, that Respondent 

had talked to Patient #3 about the 

latter’s forging of prescriptions, that 

Patient #3 had denied doing so but that 

Respondent did not believe his denial, 

and that Respondent nonetheless 

continued to prescribe narcotics to him. 

See 60 FR at 55049. Moreover, the DA 

found it concerning that Respondent 

continued to prescribe controlled 

substances to a known drug abuser and 

that he did so even though he knew of 

Patient #3’s criminal behavior. 

Once again, Respondent attempted to 

relitigate the findings of the 1995 

proceeding, Tr. 128–32, essentially 

contending that there was confusion, 

that the prescription was not forged but 

rather had actually been photocopied, 

and that he told the pharmacy to fill it 

because he had in fact issued Patient #3 

such a prescription.12 Here again, 

Respondent could have, and should 

have, presented this evidence in the first 

proceeding. I therefore conclude that the 

1995 Order’s findings and conclusions 

of law with respect to Patient #3 are res 

judicata. 

I further reject the ALJ’s 

characterization of Patient #3’s 

prescriptions as ‘‘possibly forged’’ and 

her assertion that Respondent 

‘‘questioned the Patient [and] was 

deceived.’’ ALJ at 25–26. The findings of 

the 1995 Agency Order make clear that 

Respondent knew that Patient #3 had 

forged prescriptions and was abusing 

drugs, and yet Respondent continued to 

prescribe controlled substances to him. 

Here again, the ALJ erred in failing to 

give res judicata effect to the findings of 

the 1995 Order. 

I therefore hold that the findings of 

the 1995 Agency Order, as well as the 

findings of the 1997 MBC Order, 

establish not only that Respondent 

committed numerous recordkeeping 

violations, but also that he violated both 

California law and the CSA by 

prescribing controlled substances 

without performing a good faith medical 

examination and without medical 

indication. See Cal.Bus.& Prof.Code 

§ 2242; see also 21 CFR 1306.04(a) (‘‘A 

prescription for a controlled substance 

to be effective must be issued for a 

legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice.’’). I also find that Respondent 

violated California law by prescribing 

excessive quantities of controlled 

substances, Cal. Health & Safety Code 

§ 11153; that he violated 21 CFR 

1306.22(a) by prescribing excessive 

refills of both Vicodin and Darvocet-N; 

and that he prescribed Lortab to a 

known drug abuser and prescription 

forgerer. I thus conclude that 

Respondent’s experience in dispensing 

controlled substances and record of 

compliance with Federal and State laws 

related to the dispensing of controlled 

substances establishes a prima facie 

showing that Respondent’s registration 

would be ‘‘inconsistent with the public 

interest.’’ 13 21 U.S.C. 823(f). 

Sanction 

As explained above, Agency 

precedent establishes that ‘‘the critical 

issue in this proceeding is whether the 

circumstances, which existed at the 

time of the prior proceeding, have 

changed sufficiently to support [the] 

conclusion that’’ granting the 

application would be consistent with 

the public interest. See Azen, 61 FR at 

57893–94. While the ALJ initially 

acknowledged this precedent, see ALJ at 

17, 19–20, she then cited to a different 

line of cases, explaining that ‘‘[w]hen 

assessing the appropriate remedy in a 

particular case, the DA should consider 

all facts and circumstances at hand.’’ Id. 

at 20 (citing Martha Hernandez, M.D., 

62 FR 61145, 61147 (1997)). The ALJ 

did not recognize the tension between 

these two precedents and proceeded to 

evaluate ‘‘the totality of the 

circumstances’’ rather than apply the 

Azen rule. She thus considered various 

circumstances which are no different 

today than they were at the time of the 

original proceeding such as his ‘‘overall 

track record’’ and the degree of 

Respondent’s culpability.14 Id. at 22–24. 

Hernandez did not, however, involve 

a matter in which the Agency had 

previously issued a final order of 

revocation to an applicant; indeed, the 

decision did not even acknowledge the 

then-recent decisions in Azen and Turk. 

Moreover, subsequent to the issuance of 

the decision in Hernandez, this Agency 

continued to apply the Azen rule. See 

Robert Golden, 65 FR at 5663, 5664 

(2000); Leslie, 64 FR at 25908. Thus, it 

is clear that the Hernandez decision did 

not overrule Azen. Moreover, 

Respondent had a meaningful 

opportunity to litigate such issues as the 

degree of his culpability and his ‘‘overall 

track record’’ in prescribing controlled 

substances in the first proceeding. Due 

Process does not require that he be 

given a second bite of the apple as to 

these issues. Rather, as explained above, 

to rebut the Government’s prima facie 

case and demonstrate that his 

registration would be consistent with 

the public interest, Respondent must 

establish that he accepts responsibility 

for the full range of his misconduct and 

demonstrate that he will not engage in 

similar misconduct in the future. 

Medicine Shoppe, 73 FR at 387; Leslie, 

60 FR at 14005. 

The ALJ acknowledged that 

‘‘Respondent failed to express remorse 

for the entirety of his prescribing 

practices.’’ ALJ at 28. Indeed, what is 

clear is that Respondent does not 

acknowledge wrongdoing for anything 

other than his inadequate recordkeeping 

as he continues to dispute both the 

findings of this Agency and the MBC 

with respect to Patient #1, maintaining 

that this patient was not an addict 

(notwithstanding the MBC’s finding that 

he was), that he provided this patient 

with ‘‘textbook treatment’’ and treatment 

in accordance with nationally accepted 

standards (again, notwithstanding the 

MBC’s findings that Respondent’s 

dispensings to him violated numerous 

provisions of State and Federal law), 

and that he properly monitored this 

patient (notwithstanding the MBC’s 

finding that there was ‘‘overwhelming’’ 

evidence that the patient was abusing 

prescription medication, that ‘‘his abuse 

was manifest,’’ and that ‘‘Respondent 

could not have been ignorant of this.’’). 


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15Speculating as to ‘‘why it is hard for the 

Respondent to ‘admit errors in judgment,’ ’’ the ALJ 

observed that the MBC had ‘‘noted that the 

Respondent was vilified in the media by Agent 

Babcock of the California Bureau of Narcotic 

Enforcement, [and] that her statements hurt her 

credibility.’’ ALJ at 27. The ALJ then noted that 

‘‘[d]espite this poor treatment on the part of Agent 

Babcock, the Respondent has taken full 

responsibility for his record-keeping violations.’’ Id. 

The ALJ did not explain why Respondent’s 

having been vilified by Agent Babcock would 

prevent him from taking responsibility for his 

prescribing violations but not his recordkeeping 

ones. In any event, it strains credulity to suggest 

that fifteen years later, Respondent’s inability to 

accept responsibility for the full scope of his 

misconduct is because he was vilified in the media. 

16 In Krishna-Iyer, I noted that a study of the 

National Center on Addiction and Substances 

Abuse (CASA) had found that ‘‘[t]he number of 

people who admit abusing controlled prescription 

drugs increased from 7.8 million in 1992 to 15.1 

million in 2003.’’ National Center on Addiction and 

Substance Abuse, Under the Counter: The Diversion 

and Abuse of Controlled Prescription Drugs in the 

U.S. 3 (2005) (quoted at 74 FR at 463). Moreover, 

‘‘[a]pproximately six percent of the U.S. population 

(15.1 million people) admitted abusing controlled 

prescription drugs in 2003, 23 percent more than 

the combined number abusing cocaine (5.9 million), 

hallucinogens (4.0 million), inhalants (2.1 million) 

and heroin (328,000).’’ Id. The study further found 

that ‘‘[b]etween 1992 and 2003, there has been a 

* * * 140.5 percent increase in the self-reported 

abuse of prescription opioids,’’ and in the same 

period, the ‘‘abuse of controlled prescription drugs 

has been growing at a rate twice that of marijuana 

abuse, five times greater than cocaine abuse and 60 

times greater than heroin abuse.’’ Id. at 4. 

17The ALJ further reasoned that ‘‘the majority of 

[Respondent’s] issues emanated from his treatment 

of Patient #1 and only when Patient #1 was living 

in Respondent’s home.’’ ALJ at 23. She then asserted 

that ‘‘this Agency has considered the effect a 

relative’s medical issues can have on a practitioner 

and recognized that when those stresses are taken 

out of the picture, it is less likely that the 

circumstances would ever be repeated.’’ Id. (citing 

Cecil M. Oakes, M.D., 63 FR 11907 (1998)). 

While it is true that the Agency’s factual findings 

in Oakes noted that the respondent had testified 

that at the time he altered his DEA registration, he 

was dealing ‘‘with the financial and emotional 

burdens that accompanied his son’s having been 

diagnosed as having Attention Deficit Disorder,’’ 63 

FR at 11908, he further testified that he was ‘‘in no 

Nor, given the latter finding, am I 

persuaded that Respondent’s violations 

with respect to Patient #1 are solely 

attributable to his inadequate 

recordkeeping. 

Moreover, as the MBC found, 

Respondent ‘‘fails to acknowledge any 

responsibility for any of his actions. He 

blames others or completely excuses his 

actions.’’ While Respondent now 

acknowledges that he failed to maintain 

proper records, it is disturbing that he 

continues to deny any wrongdoing with 

respect to his dispensing of controlled 

substances not only to Patient #1, but 

also to Patients #2 and 3. 

While the ALJ acknowledged that 

‘‘Respondent must demonstrate remorse 

to the full extent of his documented 

misconduct,’’ ALJ at 24 (citing Prince 

George Daniels, 60 FR 62884, 62887 

(1995)), and that Respondent had ‘‘failed 

to express remorse for the entirety of his 

prescribing practices,’’ id. at 28, she 

nonetheless recommended that 

Respondent be granted a restricted 

registration to ‘‘afford[ him] an 

opportunity to demonstrate that he can 

responsibly handle controlled 

substances.’’ Id. Noting that fifteen years 

had passed since the first Agency 

decision, the ALJ rejected the 

Government’s contention that ‘‘the 

passage of time is not dispositive, 

especially when coupled with a 

respondent’s refusal to accept 

responsibility for [his] misconduct.’’ ALJ 

at 20 (citing Gov. Br. 6). She further 

maintained that one of the cases cited in 

the Government’s Brief, John Porter 

Richards, D.O., 61 FR 13878 (1996), 

actually supported granting 

Respondent’s application, stating that in 

that case, the ‘‘applicant ‘continued to 

maintain that he had not committed the 

crimes for which he had been 

convicted.’’’ ALJ at 21 (quoting 61 FR at 

13879); see also ALJ at 27. The ALJ then 

asserted that in Richards, ‘‘the DA 

approved the applicant’s application 

without restrictions despite the fact that, 

at the hearing, the applicant accepted 

his conviction but did not completely 

admit to the crimes for which he was 

convicted.’’ Id. at 21 (quoting 61 FR at 

13879–80) (emphasis in ALJ’s decision). 

It is clear, however, that the ALJ took 

the quoted language out of context, 

ignoring that the language was merely a 

paraphrase of a question asked of the 

applicant by the Government’s counsel. 

See 61 FR at 13879 (‘‘When asked on 

cross-examination whether, consistent 

with his not guilty plea, he continued to 

maintain that he had not committed the 

crimes for which he had been convicted, 

the Respondent testified, ‘I accept my 

conviction,’ and when asked to what 

extent he did so, he replied, ‘In its 

completeness.’ ’’). Notably, the Agency 

did not find in Richards that the 

respondent ‘‘continued to maintain that 

he had not committed the crimes’’ of 

which he had been convicted. While in 

Richards, the applicant’s answer to the 

Government’s question may not have 

been entirely responsive, there is no 

indication in the decision that the 

Government followed up by asking him 

whether he denied having committed 

the crimes and the findings of the 

decision do not establish what 

testimony the applicant offered on his 

direct examination. Beyond this, most 

reasonable fact finders would, in the 

absence of testimony denying that one 

had committed the crime (thus 

demonstrating that one was talking out 

of both sides of his mouth), find that the 

statements referred to above established 

acceptance of responsibility. 

By contrast, Respondent has 

continued to deny wrongdoing with 

respect to his dispensing practices. 

While it has been fifteen years since the 

first Agency order (which also found 

that he lacked remorse for both his 

unlawful recordkeeping and refill 

practices), and thirteen years since the 

MBC Order (which also found that he 

did not accept responsibility), 

Respondent continues to deny 

wrongdoing with respect to a significant 

portion of the misconduct which was 

found proved in the respective 

proceedings.15

The ALJ also cited Paul J. Caragine, 

M.D., 63 FR 51592, 51601 (1998), noting 

that the Agency had granted the 

respondent in that case a restricted 

registration, notwithstanding that he 

‘‘had not adequately demonstrated 

remorse for his mis-prescribing * * * to 

allow [him] to demonstrate that he can 

responsibly handle controlled 

substances in his medical practice.’’ ALJ 

at 27. However, more than a year before 

the hearing in this case, I made clear 

that: 

[w]hile some isolated decisions of this 

Agency may suggest that a practitioner who 

[has] committed only a few acts of diversion 

was entitled to regain his registration even 

without having to accept responsibility for 

his misconduct, * * * the great weight of the 

Agency’s decisions are to the contrary. In any 

event, the increase in the abuse of 

prescription controlled substances calls for a 

clarification of this Agency’s policy. Because 

of the grave and increasing harm to public 

health and safety caused by the diversion of 

prescription controlled substances, even 

where the Agency’s proof establishes that a 

practitioner has committed only a few acts of 

diversion, this Agency will not grant or 

continue the practitioner’s registration unless 

he accepts responsibility for his misconduct. 

Jayam Krishna-Iyer, M.D., 74 FR 459, 

464 (2009) (citation omitted). I further 

explained that to the extent any 

‘‘decision of this Agency suggests 

otherwise, it is overruled.’’ 16 Id. at n.9. 

It is perplexing that the ALJ did not 

even acknowledge the holding of 

Krishna-Iyer. However, it is the law of 

this Agency. Moreover, the requirement 

that a practitioner accept responsibility 

for his misconduct applies regardless of 

whether the acts of diversion were done 

intentionally, recklessly or negligently. 

See Dewey C. Mackay, 75 FR at 49978 

n.39 (noting disagreement with 

Caragine). This is so because the harm 

to the public is not dependent on the 

practitioner’s mental state in 

committing the act of diversion, and 

recognizing one’s misconduct is the first 

and an essential step in demonstrating 

that it will not happen again.17 To make 


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Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 16835 

way * * * using (his son’s problems) as an excuse 

for bad behavior or to try to rationalize it away 

* * * as being justified.’’ Id. Moreover, in 

discussing the public interest factors and whether 

the respondent had rebutted the Government’s 

prima facie case, the decision made no reference to 

the medical issues of his son. See 63 FR at 11909– 

10. It is thus inaccurate to say that the Agency 

‘‘considered the effect a relative’s medical issues 

can have on a practitioner and recognized that 

when those stresses are taken out of the picture, it 

is less likely that the circumstances will ever be 

repeated.’’ ALJ at 23. 

Most significantly, the Agency’s decision in 

Oakes noted in at least three different places that 

the respondent had expressed remorse and accepted 

responsibility for his misconduct. See 63 FR at 

11909 (noting that ‘‘the evidence in favor of denial 

of Respondent’s application is overcome by * * * 

his expressions of remorse and acceptance of 

responsibility for his actions’’); id. at 11910 (noting 

that while the respondent’s misrepresentation on a 

state application ‘‘is troublesome, it does not 

warrant the denial of Respondent’s application in 

light of his expressions of remorse and acceptance 

of responsibility for his actions’’). 

Thus, contrary to the ALJ’s reasoning, Oakes 

provides no comfort to Respondent. Moreover, even 

giving weight to Respondent’s testimony that he is 

not likely to again invite a patient to live with him, 

his testimony does not address his misconduct with 

respect to Patients #2 and 3. 

18The ALJ also noted that since the revocation of 

his registration, ‘‘Respondent has had no further 

problems related to his practice of medicine.’’ ALJ 

at 20. Given that DEA does not regulate the practice 

of medicine, it is an open question whether such 

evidence is even relevant in assessing whether an 

applicant’s registration would be consistent with 

the public interest. See Edmund Chein, 72 FR 6580, 

6590 (2007) (declining to decide ‘‘whether a 

registrant’s unwillingness to comply with State 

rules that are unrelated to controlled substances can 

be considered [in a revocation proceeding] when 

the registrant maintains a valid State license’’). 

What is noteworthy, however, are the State ALJ’s 

extensive findings regarding Respondent’s 

dispensing of controlled substances to Patient #1, 

not only during the period following the issuance 

of the first Order to Show Cause on July 29, 1993, 

but also after the DEA ALJ’s issuance of his 

recommended decision on January 12, 1995. While 

the DEA ALJ’s decision was not a final decision of 

the Agency, it found that Respondent dispensed 

controlled substances to Patient #1 ‘‘on demand,’’ 

‘‘virtually upon request,’’ with ‘‘virtually no 

scrutiny,’’ that his ‘‘prescribing and dispensing to 

[Patient #1] was outside of the context of the 

Respondent’s usual professional practice’’ and thus 

violated 21 CFR 1306.04(a), and that the 

Government had ‘‘established a prima facie case 

under factor (2).’’ GX 6, at 20. Yet thereafter, 

Respondent continued to engage in what the State 

ALJ ‘‘characterized as irrational polypharmacy’’; the 

State ALJ further noted that ‘‘[t]otally absent from 

his care and treatment of [Patient #1] was control, 

monitoring and periodic assessment’’ and that 

‘‘[f]rom 1990 to 1996, almost all of respondent’s 

prescribing to [Patient #1] took place in the absence 

of a legitimate physical examination.’’ GX 8, at 15– 

16. 

clear, Respondent is not entitled to ‘‘an 

opportunity to demonstrate that he can 

responsibly handle controlled 

substances’’ through the issuance of 

even a restricted registration unless and 

until he accepts responsibility for his 

misconduct.18

It is acknowledged that fifteen years 

have passed since the first Agency 

Order. See ALJ at 20–21, 28. However, 

DEA has long held that ‘‘[t]he paramount 

issue is not how much time has elapsed 

since [his] unlawful conduct, but rather, 

whether during that time. * * * 

Respondent has learned from past 

mistakes and has demonstrated that he 

would handle controlled substances 

properly if entrusted with a new 

registration. Leonardo v. Lopez, 54 FR 

36915 (1989); see also Leslie, 68 FR at 

15227 (revoking registration issued 

through administrative error on ground 

that practitioner still refused to 

acknowledge misconduct which he 

committed seventeen years earlier 

notwithstanding that there was no 

evidence that he had mishandled 

controlled substances under the 

erroneously issued registration). 

Moreover, it should be noted that 

neither the 1995 Order, nor any Agency 

rule, barred Respondent from reapplying at an earlier date. What does 

bar his obtaining of a new registration 

is his failure to fully acknowledge his 

misconduct. Absent Respondent’s 

acknowledgment of the full scope of his 

misconduct, I am compelled to 

conclude that issuing him a new 

registration would be ‘‘inconsistent with 

the public interest.’’ 21 U.S.C. 823(f). 

Accordingly, I reject the ALJ’s 

recommended ruling and will deny 

Respondent’s application. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823(f), as well as 28 CFR 

0.100(b) and 0.104, I order that the 

pending application of Robert L. 

Dougherty, M.D., for a DEA Certificate 

of Registration as a practitioner, be, and 

it hereby is, denied. This Order is 

effective immediately. 

Dated: March 11, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–7014 Filed 3–24–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Erwin E. Feldman, D.O.; Revocation of 

Registration 

On May 29, 2009, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Erwin E. Feldman, D.O. 

(Respondent), of Madison Heights, 

Michigan. The Show Cause Order 

proposed the revocation of 

Respondent’s DEA Certificate of 

Registration, AF9086415, which 

authorizes him to dispense controlled 

substances as a practitioner, and the 

denial of any pending applications to 

renew his registration, on the ground 

that his ‘‘continued registration is 

inconsistent with the public interest.’’ 

Show Cause Order at 1 (citing 21 U.S.C. 

823(f) and 824(a)). 

More specifically, the Show Cause 

Order alleged that on January 18, 2005, 

DEA issued an Order to Show Cause to 

Respondent, which alleged, inter alia, 

that between December 2001 and July 

2004, he had prescribed controlled 

substances on ten occasions to 

undercover agents without performing a 

medical examination, and that he had 

issued prescriptions for Suboxone ‘‘to 

treat opiate addiction without having 

obtained’’ certification from the 

Michigan Center for Substance Abuse 

Treatment and a separate DEA 

registration to prescribe controlled 

substances for ‘‘maintenance and 

detoxification treatment of opiate 

addiction as required by 21 U.S.C. 

823(g).’’ Id. at 1–2. 

Next, the Show Cause Order alleged 

that on April 4, 2007, Respondent 

entered into a Memorandum of 

Agreement (MOA) with the Agency to 

resolve the allegations of the 2005 Show 

Cause Order, which was to remain in 

force through May 2010. Id. at 2. The 

Show Cause Order then alleged that 

under the MOA, Respondent agreed that 

he would prescribe controlled 

substances for only a thirty-day supply 

with one refill; that he would not 

prescribe controlled substances to 

persons who were not residents of the 

State of Michigan; that he would not 

prescribe controlled substances to 

family members; that he would 

maintain a log of all controlled 

substance prescriptions he issued; that 

he would maintain in patient charts, 

reports from the Michigan Automated 

Prescriptions System (MAPS) for all 

patients who received controlled 

substances from him for ‘‘in excess of six 

months’’; and that he would notify DEA 

‘‘in writing, within twenty days of the 

initiation of any proceedings which 

impacted [his] ability to handle 

controlled substances, including the 

initiation of any action by a state entity 

to restrict, deny, rescind, suspend, 

revoke or otherwise limit [his] authority 

to handle controlled substances.’’ Id. 

Finally, the Show Cause Order alleged 

that Respondent had violated the MOA. 

Id. The Order specifically alleged that 

‘‘on several occasions,’’ Respondent had 

issued controlled substance 

prescriptions ‘‘with as many as seven 

refills’’; that he had prescribed 

controlled substances to residents of 

Florida and Colorado; that he had 

prescribed Phenobarbital, a schedule IV 


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