[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16823-16835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7014]


-----------------------------------------------------------------------

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 record-keeping,'' and that the 
``DA's summarized findings focused on record-keeping,'' the ALJ 
concluded that

[[Page 16824]]

Respondent had generally accepted responsibility.\2\ Id.
---------------------------------------------------------------------------

    \1\ As 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.
    \2\ The 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.
---------------------------------------------------------------------------

    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 mid-December 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 Sec.  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

[[Page 16825]]

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 Sec. Sec.  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.
---------------------------------------------------------------------------

    \3\ The DA found that during the execution of a search warrant, 
various controlled substances were found in both Respondent's office 
and home and that he did not have required inventories, receipts, 
and dispensing records. 60 FR at 55050. Moreover, Respondent 
conceded that he did not keep receipts for controlled-substance 
samples including those of Xanax, Valium and Halcion, which he had 
received gratis from sales representatives. 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 
Sec. Sec.  725, 4211). The Accusation also charged Respondent with 
violating state record-keeping requirements for schedule II controlled 
substances, id. (citing Cal. Health & Safety Code Sec.  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

[[Page 16826]]

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.
---------------------------------------------------------------------------

    \4\ The 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.
---------------------------------------------------------------------------

    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.'').
---------------------------------------------------------------------------

    \5\ The 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.
---------------------------------------------------------------------------

    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 Sec.  2242, Cal. Health & Safety 
Code Sec.  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).
---------------------------------------------------------------------------

    \6\ The State ALJ also found that Respondent had committed 
unprofessional conduct under several provisions of California law. 
GX 8, at 26-27.
---------------------------------------------------------------------------

    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?''

[[Page 16827]]

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 re-litigate 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 
re-litigate 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

[[Page 16828]]

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 anti-inflammatories such as Aleve 
and Naproxen with Patient 1 to no avail, and that he had 
referred him to ``a so-called 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

[[Page 16829]]

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

[[Page 16830]]

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 Shoppe-Jonesborough, 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 
Sec.  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, Sec.  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).
---------------------------------------------------------------------------

    \7\ There is no dispute that neither the 1995 DEA Order, nor the 
1997 MBC Order, was vacated by a court.
---------------------------------------------------------------------------

    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 then-Deputy 
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\
---------------------------------------------------------------------------

    \8\ See 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'').
---------------------------------------------------------------------------

    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

[[Page 16831]]

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 Sec.  2242, and that ``he excessively prescribed controlled 
substances,'' in violation of Cal. Health & Safety Code Sec.  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

[[Page 16832]]

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.''
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 Sec.  
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 Bristol-Myers 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\
---------------------------------------------------------------------------

    \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 Sec.  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.'')).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \11\ The 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.
---------------------------------------------------------------------------

    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,

[[Page 16833]]

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.
---------------------------------------------------------------------------

    \12\ In fact, the 1995 Order makes clear that Patient 3 
forged multiple prescriptions.
---------------------------------------------------------------------------

    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 Sec.  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 Sec.  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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \14\ Having 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.
---------------------------------------------------------------------------

    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.'').

[[Page 16834]]

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\
---------------------------------------------------------------------------

    \15\ Speculating 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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

[[Page 16835]]

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\
---------------------------------------------------------------------------

    \17\ The 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 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.
    \18\ The 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.
---------------------------------------------------------------------------

    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 re-applying 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