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