[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