Robert L. Dougherty, M.D.; Denial of Application, 16823-16835 [2011-7014]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16823-16835]
From the Federal Register Online via the Government Printing 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 onl