[Federal Register Volume 61, Number 115 (Thursday, June 13, 1996)]
[Notices]
[Pages 30099-30102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14953]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 94-26]
Nestor A. Garcia, M.D.; Grant of Restricted Registration
On February 18, 1994, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Nestor A. Garcia, M.D., (Respondent) of North
Miami, Florida, notifying him of an opportunity to show cause as to why
DEA should not deny his application for registration as a practitioner
under 21 U.S.C. 823(f), as being inconsistent with the public interest.
Specifically, the Order to Show Cause alleged in substance that: (1)
Between April and August of 1990, the Respondent entered three separate
addiction programs for treatment of his abuse of Demerol, a Schedule II
controlled substance. (2) On February 13, 1991, the Florida Department
of Professional Regulation (DPR) issued an emergency order suspending
his state medical license, but on July 27, 1992, ordered the
reinstatement of his state license subject to certain limitations.
However, there were three actions pending against his license. (3) On
February 28, 1991, after the suspension, the Respondent submitted DEA
Form 222 to a pharmacy to order meperidine, a Schedule II controlled
substance. (4) On November 5, 1991, the Respondent surrendered his DEA
Certificate of Registration, AG2355370.
On March 22, 1994, the Respondent, through counsel, filed a timely
request for a hearing, and following prehearing procedures, a hearing
was held in Miami, Florida, on March 29, 1995, before Administrative
Law Judge Mary Ellen Bittner. At the hearing, both parties called
witnesses to testify, and the Government introduced documentary
evidence. After the hearing, counsel for both sides submitted proposed
findings of fact, conclusions of law and argument. On December 5, 1995,
Judge Bittner issued her Opinion and Recommended Ruling, recommending
that the Respondent's application for registration be granted only as
to controlled substances in Schedules IV and V, with specifically
enumerated restrictions. Neither party filed exceptions to her
decision, and on January 16, 1996, Judge Bittner transmitted the record
of these proceedings to the Deputy Administrator.
The Deputy Administrator has considered the record, and pursuant to
21 CFR 1316.67, hereby issues his final order based upon findings of
fact and conclusions of law as hereinafter set forth. The Deputy
Administrator adopts, in full, the Opinion and Recommended Ruling of
the Administrative Law Judge, and his adoption is in no manner
diminished by any recitation of facts, issues and conclusions herein,
or of any failure to mention a matter of fact or law.
Specifically, the Deputy Administrator finds that the parties have
stipulated that Demerol is a Schedule II controlled substance pursuant
to 21 CFR 1308.12. the Deputy Administrator also finds that Valium is
the brand name for diazepam, a Schedule IV controlled substance
pursuant to 21 CFR 1308.14.
The Respondent is a physician who specializes in psychiatry. On
January 26, 1993, he completed an Application for Registration under
the Controlled Substances Act, requesting DEA register him as a
practitioner and authorize him to handle Schedule II nonnarcotic
substances, both narcotic and nonnarcotic Schedule III substances,
Schedule IV substances, and Schedule V substances. The Respondent also
disclosed on the form that his medical license had been suspended on or
about February 25, 1990, but had been reinstated on December 8, 1992.
A detective from the Broward County, Florida, Sheriff's Department
(Detective) testified at the hearing before Judge Bittner, stating that
in late 1988, the Respondent was arrested and charged with sexual
activity, while in custodial and familial authority, with a sixteen-
year-old girl, LW. The Detective testified that LW told him that in
November of 1988, while she was a patient at South Florida State
Hospital, she had developed a relationship with the Respondent, her
treating psychiatrist. She told the Detective that she had been
transferred to the psychiatric unit of Hollywood Memorial Hospital, had
escaped from that hospital, and had lived with the Respondent in a
motel room across the street from the hospital where he worked. LW told
the Detective that she had maintained a sexual relationship with the
Respondent. The Detective testified that he was able to verify some of
the information provided by LW, specifically that the Respondent had
rented the motel room. However, the charges were eventually dropped.
The Respondent did not testify before Judge Bittner. However, Dr.
Goetz, the director of the Physicians' Recovery Network (PRN)
testified, stating that he had visited the Respondent on April 5, 1990,
and on that same day the Respondent was admitted to the Chemical
Dependency Unit of the Mt. Sinai Medical Center in Miami. There, a
urine sample tested positive for
[[Page 30100]]
meperidine and benzodiazepine, and the Respondent was diagnosed as
having advanced chemical dependency to intravenous and intramuscular
Demerol. The Respondent admitted that he had self-prescribed and self-
injected Demerol and Valium.
During the course of the Respondent's treatment, he was transferred
to the Talbott Recovery Center in Atlanta, Georgia, then to the
Parkside Recovery Center in Illinois, but he did not complete the
treatment program at either location. After his discharge from
Parkside, the Respondent returned to Talbott for reassessment, and on
August 27, 1990, the medical directors of Talbott and Parkside
recommended to the PRN that the Respondent refrain from practicing
medicine for one year, allowing him time to focus on his recovery.
In October of 1990, Dr. Goetz wrote to the Florida Department of
Professional Regulation (DPR), recommending that the Respondent's
license be suspended because he had not progressed satisfactorily in
his recovery program, and because he was still exhibiting drug-seeking
behavior. On December 13, 1990, the DPR ordered the Respondent to
submit to mental and physical examinations, and the physician who
conducted the mental examination concluded that the Respondent's
chemical dependency and sociopathic personality traits ``could impair
his ability to practice medicine with reasonable skill and safety.''
As a result, on February 13, 1991, the DPR issued an emergency
suspension order, suspending the Respondent's state medical license on
the grounds that he had violated Florida Statute section 458.331(1)(s)
by ``being unable to practice medicine with reasonable skill and safety
to patients by reason of illness or use of alcohol, drugs, narcotics,
chemicals, or any other type of materials or as a result of any mental
or physical condition,'' and based upon a finding that the Respondent's
continued practice of medicine ``constitutes an immediate and serious
danger to the health, safety and welfare of the public.'' Yet on
February 25, 1991, the Respondent used a DEA Form 222 to order
meperidine.
After a formal hearing,on September 23, 1991, the DPR's Board of
Medicine (Medical Board) issued a final order suspending the
Respondent's medical license for one year, ``or until he appears before
the Board and exhibits his ability to practice with skill and safety.''
The Medical Board found that the Respondent was impaired as a
consequence of drug dependency, that the dependency rendered him unable
to practice medicine with reasonable skill and safety to his patients,
that his dependency was a chronic condition that tends to relapse, and
that he had failed to establish that he had recovered from his impaired
condition. On November 5, 1991, the Respondent voluntarily surrendered
his DEA Certificate of Registration. Subsequently, on July 27, 1992,
the Medical Board granted the Respondent's petition for reinstatement,
``contingent on his appearance before the Probation Committee with a
current psychiatric evaluation by a psychiatrist approved by the Board
and a very stringent proposed practice plan.''
Dr. Goetz further testified before Judge Bittner that, when he
first met the Respondent in April of 1990, the Respondent was addicted
to Demerol. He opined that addicts commonly engage in the type of
behavior displayed by the Respondent, for drug addiction changes the
addict's ``emotional responses,'' affects sexual behavior, and distorts
the addict's perceptions of reality and his value system. However, he
also testified that once an individual had been out of treatment, drug-
free, and in recovery for a few years, he typically is able to return
to work. Dr. Goetz stated that ``[a]ll of our records indicate that
[the Respondent] is in compliance, that he's been able to function well
since he's been relicensed by the Board of Medicine, and I think it's
fair to say that he is in early recovery.''
Dr. Goetz also recalled that he had previously testified before the
Medical Board, stating that the Respondent was in a state of recovery
and no longer posed a threat to the public interest. He also opined
before Judge Bittner that the Medical Board's decision to reinstate the
Respondent's license represented a finding that the Respondent was fit
to practice medicine. He concluded that the public interest would be
served if the Respondent were to receive a DEA registration.
However, Judge Bittner noted in her opinion that Dr. Goetz did not
testify as to any firsthand knowledge of the Respondent's condition or
state of recovery, ``but rather about addiction in general and about
what he had learned of Respondent's recovery from examining the PRN's
records.'' Also, on cross-examination, Dr. Goetz agreed that an addict
can have relapses even after years of sobriety, that a psychiatrist can
practice without a Schedule II registration, and that physicians with
self-abuse problems are particularly hard to treat because they can so
easily obtain controlled substances. He also stated that, as of the
date of the hearing before Judge Bittner, the Respondent was still on
probation with the Medical Board. However, since September of 1991, the
Respondent had complied with the PRN requirements, including submitting
to random urine tests.
Dr. Jules Trop, a specialist in addictionology, also testified
before Judge Bittner, stating that he had treated approximately 10,000
addicts and alcoholics in his practice, and that, since August of 1991,
he had been the Respondent's ``monitoring physician'', the physician
who maintains contact with the Respondent on behalf of the PRN and
reports to the PRN about his progress. However, Dr. Trop testified
that, beginning in approximately June of 1994, he had ceased directly
observing the Respondent, who had been assigned to a small group for
treatment. Yet Dr. Trop stated that he received reports from the
Respondent's therapist, and that ``all reports are that [the
Respondent's] attendance has been regular. His cooperation has
continued. His recovery is ongoing. His urines have been negative.
That's essentially it.''
Dr. Trop also testified that an addict typically loses his or her
moral and ethical standards, and that recovery is dependent upon
regaining those standards and behaviors. He observed that he had seen
change in the Respondent and believed that he is now in ``progressive
recovery.'' On cross-examination, Dr. Trop acknowledged that the term
``progressive recovery'' implies that recovery is never complete, and
that it is always possible that an addict will relapse. Like Dr. Goetz,
Dr. Trop also testified that physicians were particularly susceptible
to addiction because their work was high-stress, and because physicians
had money and access to controlled substances. However, Dr. Trop also
opined that a physician who was being monitored by the PRN was less
likely to relapse, with the monitoring serving as a deterrent. Dr. Trop
also agreed with Dr. Goetz, stating that it would not be against the
public interest to grant the Respondent's DEA application.
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an
application for registration as a practitioner, if he determines that
granting the registration would be inconsistent with the public
interest. Section 823(f) requires 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, or conducting
research with respect to controlled substances.
[[Page 30101]]
(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 or
safety.
These factors are to be considered in the disjunctive; the Deputy
Administrator may rely on any one or a combination of factors and may
give each factor the weight he deems appropriate in determining whether
a registration should be revoked or an application for registration
denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-42, 54 FR 16422
(1989).
Noting the absence of any conviction record, the Deputy
Administrator finds factors one, two, four, and five relevant in
determining whether the Respondent's registration would be inconsistent
with the public interest. As to factor one, ``recommendation of the
appropriate State licensing board,'' the Florida DPR suspended the
Respondent's medical license in 1991, and reinstated the license in
July of 1992, under probationary conditions that remain in effect
through September of 1996. The Deputy Administrator concurs with Judge
Bittner's analysis of the State licensing board's actions. By
reinstating the Respondent's medical license, the DPR indicated that it
viewed the Respondent's condition as less threatening to the public's
interest than in 1991. However, by levying probationary conditions upon
his practice of medicine, the DPR asserted that the Respondent's
conduct continued to require scrutiny for the protection of the public.
Although the Government placed into the record two outstanding
administrative complaints, pending before the DPR since 1992, the
Deputy Administrator agrees with Judge Bittner's evaluation of these
complaints. She wrote:
I conclude that it would be inappropriate to rely on the
unresolved administrative complaints in deciding the issues before
me, for they are merely allegations, analogous to complaints in
indictments, and do not prove the violations alleged therein by a
preponderance of the evidence. Cf. Alra Lab., Inc., No. 92-42, 59
Fed. Reg. 50620, 50620 (DEA 1994) (allegations contained in an
indictment should not be considered because there was nothing on the
record tending to prove or disprove them).
As to factor two, the Respondent's ``experience in dispensing * * *
controlled substances,'' and factor four, the Respondent's
``[c]ompliance with applicable State, Federal, or local laws relating
to controlled substances,'' the Deputy Administrator finds significant
the Respondent's history of self-prescribing and self-injecting of
Demerol and Valium, leading to his self-professed addiction to Demerol.
As Judge Bittner wrote, ``[the] Respondent's self-prescribing of
Demerol to maintain his addiction was not for a legitimate medical
purpose and was therefore not a lawful prescription within the meaning
of 21 CFR 1306.04.''
Further, in February of 1991, after his medical license had been
suspended, the Respondent used a DEA Form 222 to order meperidine, when
he no longer was authorized to so act. The Deputy Administrator agrees
with Judge Bittner's finding that such unauthorized ordering of Demerol
violated applicable state and federal law.
As to factor five, ``[s]uch other conduct which may threaten the
public health or safety,'' the Respondent's actions documented in the
record pertaining to LW in 1988 cause the Deputy Administrator concern.
Specifically, the Detective's testimony concerning the Respondent's
actions with a sixteen-year-old patient who had escaped from a
custodial psychiatric treatment setting remains unrebutted in the
record. The Respondent's defense, that such actions were a result of
his drug addiction, does little to alleviate the concern raised by his
unprofessional conduct, especially given the Respondent's failure in
the drug rehabilitation treatment programs at Talbott and Parkside. The
Deputy Administrator also finds it significant that both Dr. Goetz and
Dr. Trop agreed that physicians were particularly susceptible to
addiction because of their access to controlled substances.
However, as to the Government's offer of proof concerning more
recent acts involving the Respondent and LW, the Deputy Administrator
concurs with Judge Bittner's ruling concerning the offered evidence.
The Deputy Administrator finds that, under the circumstances, due
process requires that he not consider the offered evidence in reaching
a determination in this matter, and, accordingly, he has not considered
the Detective's testimony concerning the Respondent's conduct with LW
in 1990.
The Deputy Administrator also finds that the Respondent provided
mitigating evidence through the testimony of Dr. Goetz and Dr. Trop.
Specifically, both doctors noted that the Respondent remained in
compliance with the conditions of his probation. Further, the Medical
Board has found the Respondent fit to practice medicine, although also
finding it necessary to reinstate his license on probationary terms.
The Respondent has continued to successfully participate in a drug
rehabilitation program of counselling and urinalysis testing as
monitored by the PRN. Although both Dr. Goetz and Dr. Trop testified
that the Respondent was in ``early recovery,'' or that his recovery was
``ongoing,'' the Deputy Administrator concurs with Judge Bittner's
conclusion that ``the evidence that [the] Respondent remained drug-free
for three-and-one-half-years prior to the hearing weighs in favor of
granting his application.''
Therefore, after reviewing the record, the Deputy Administrator
agrees with Judge Bittner's recommendation and finds that the public
interest is best served by granting the Respondent a restricted
registration. Specifically, that portion of the Respondent's
application to handle controlled substances in Schedule II,
nonnarcotic, and Schedule III, is denied. However, the portion of his
application to handle controlled substances in Schedules IV and V is
granted, with the following restrictions and conditions: (1) The
Respondent's controlled substances-handling authority is limited to the
writing of prescriptions only. He shall not be authorized to dispense,
possess, or store any controlled substances, except that he may
administer controlled substances in a hospoital setting, and he may
possess controlled substances that are medically necessary for his own
use and have been obtained pursuant to a valid prescription issued by
another practitioner. (2) The Respondent is not authorized to prescribe
any controlled substances for his own use. (3) For two years from the
effective date of this order, the Respondent shall, every calendar
quarter, submit a log to the Special Agent in charge of the nearest DEA
office or his designee. The log shall contain a list of all
prescriptions for controlled substances the Respondent has written
during the previous quarter, to include the date of each prescription,
the patient's name, the name and amount of the controlled substance(s)
prescribed, and the pathology for which the prescription was written.
Accordingly, the Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in him by 21 U.S.C.
823, and 28 CFR 0.100(b) and 0.104, hereby orders that the pending
application of Nestor A. Garcia, M.D., for a DEA Certificate of
Registration for a practitioner be, and it hereby is, denied in part
and granted in part, subject to the limitations enumerated above. This
order is effective July 15, 1996.
[[Page 30102]]
Dated: June 7, 1996.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 96-14953 Filed 6-12-96; 8:45 am]
BILLING CODE 4410-09-M
