[Federal Register Volume 59, Number 171 (Tuesday, September 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21829]


[[Page Unknown]]

[Federal Register: September 6, 1994]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[Docket No. 92-90]

 

John W. Copeland, M.D.; Revocation of Registration

    On September 9, 1992, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to John W. Copeland, M.D. (Respondent), of Antioch, 
California, proposing to revoke Respondent's DEA Certificate of 
Registration, AC8638085, and to deny any pending applications for 
registration as a practitioner under 21 U.S.C. 823(f) and 824(a). The 
Order to Show Cause alleged that Respondent's continued registration is 
inconsistent with the public interest, as that term is used in 21 
U.S.C. 823(f) and 824(a)(4) and that Respondent was convicted of a 
felony under State law relating to controlled substances, as set forth 
in 21 U.S.C. 824(a)(2). Specifically, the Order to Show Cause alleged 
that between December 1987 and October 1989, Respondent dispensed 
Ritalin, a Schedule II controlled substance, to ten individuals for 
other than legitimate medical purposes and outside the scope of his 
professional practice; between January 1988 and October 1989, 
Respondent dispensed anabolic steroids, Schedule III controlled 
substances under applicable state law, to fifteen individuals for other 
than legitimate medical purposes and outside the scope of his 
professional practice; and on May 30, 1991, Respondent was convicted in 
the State of California of six felony counts of prescribing controlled 
substances to addicts or habitual users of controlled substances and 
such prescriptions were not issued as part of an authorized methadone 
program.
    Respondent, through counsel, timely filed a request for a hearing 
on the issues raised in the Order to Show Cause and the matter was 
docketed before Administrative Law Judge Mary Ellen Bittner. Following 
prehearing procedures, a hearing was held, beginning on June 29, 1993, 
in San Francisco, California.
    On April 21, 1994, Judge Bittner issued her opinion and recommended 
ruling, findings of fact, conclusions of law and decision, recommending 
that Respondent's DEA Certificate of Registration be revoked. 
Respondent filed exceptions to the administrative law judge's decision 
pursuant to 21 CFR 1316.66, and attached a Stipulation, Decision and 
Order of the Medical Board of California (MBC), dated March 30, 1994, 
which allowed Respondent to retain all controlled substance privileges 
except that Respondent was prohibited from handling anabolic steroids 
and was allowed to use Schedule II controlled substances only in a 
hospital setting. The MBC order also placed Respondent's medical 
license on probation for five years with various other conditions. The 
Government filed a response to Respondent's exceptions.
    On May 23, 1994, Judge Bittner transmitted the record of the 
proceedings, including the Respondent's exceptions and the Government's 
response thereto, to the Deputy Administrator. The Deputy Administrator 
has carefully considered the record and adopts the opinion and 
recommended decision of the administrative law judge in its entirety. 
Pursuant to 21 CFR 1316.67, the Deputy Administrator hereby issues his 
final order in this matter.
    The Deputy Administrator finds that Respondent has had a solo 
practice in family and emergency medicine since 1967. For a short time 
in 1969 to 1971, he volunteered as a treating physician in a drug 
addiction clinic. Sometime after this clinic closed in 1971, Respondent 
continued to treat some of the former patients of this clinic in the 
course of his general practice. At no time did Respondent ever posses a 
DEA registration to operate a narcotic treatment program as required by 
21 U.S.C. 823(g).
    Respondent's treatment of drug addiction was not the subject of any 
law enforcement investigation until 1988, when one of his patients was 
arrested and found with prescription vials for Tylenol with codeine, a 
Schedule III controlled substance, and Valium, a Schedule IV controlled 
substance. The prescribing physician was Respondent. When asked about 
these prescriptions, Respondent stated that they were issued to treat 
the patient for heroin addiction. As a result, the California Bureau of 
Narcotic Enforcement (BNE) commenced an investigation of Respondent's 
medical practice.
    In April 1988, a BNE undercover operative made her first visit to 
Respondent's office and informed him that she was addicted to Ritalin 
and that she also abused methamphetamine, a Schedule II controlled 
substance. Respondent issued her a prescription for 60 dosage units of 
Ritalin. She returned to Respondent's office three weeks later, seeking 
a refill before her first Ritalin prescription should have expired. 
Respondent complied by issuing her another prescription for 60 dosage 
units of Ritalin. She made two more visits to Respondent's office 
(about a month apart) and each time Respondent issued her another 
Ritalin prescription, one for 50 dosage units and the other for 60 
dosage units. She did not return to Respondent's office until May of 
1989, at which time she saw Respondent's associate physician who 
prescribed her only 8 dosage units of Ritalin to hold her until she 
could see Respondent. Three days later, when she saw Respondent, he 
decided not to reissue her a Ritalin prescription. Respondent, however, 
suggested that she ``quit speed'' and use marijuana, a Schedule I 
controlled substance, instead.
    A patient who had been treated by Respondent with controlled 
substances for drug addiction since 1974 agreed to act as an undercover 
operative along with a police detective who posed as her boyfriend. 
During their visit in April 1989, Respondent admonished the female 
undercover operative for missing a prior appointment by stating, 
``Where are you going to find a doctor doing what I am doing?'' 
Respondent did not issue her a Valium prescription as she requested, 
but issued her a prescription for 40 dosage units of Restoril, a 
Schedule IV controlled substance. Her medical bill indicated that the 
prescription was issued for drug withdrawal.
    Although the undercover detective was not seeking treatment, 
Respondent asked him if he had any problems. When the detective 
answered that he liked methamphetamine but that his drug problem was 
not as bad as his girlfriend's addiction, Respondent wrote the 
detective a prescription for 60 dosage units of Restoril. The detective 
returned to Respondent's office less than a month later and again 
stated that he was abusing methamphetamine. Respondent issued him 
another prescription for 60 dosage units of Restoril and then asked the 
detective if he shared the drugs with his girlfriend. When the 
detective responded in the affirmative Respondent increased the 
Restoril prescription to 80 dosage units. In addition, Respondent 
dispensed 30 dosage units of Fastin, a Schedule IV controlled substance 
used for diet control, to the detective. Respondent explained that he 
wanted the detective to stop taking methamphetamine and instead use 
``legal'' drugs.
    Several of Respondent's patients were arrested in 1989. One was 
arrested for driving under the influence of drugs. The day before her 
arrest, Respondent had issued her a prescription for 100 dosage units 
of Valium, a Schedule IV controlled substance, a prescription for 100 
dosage units of Darvocet, a Schedule IV controlled substance, and a 
prescription for 60 dosage units of Restoril. At the time of the arrest 
only 50 dosage units of Valium and 73 dosage units of Darvocet remained 
in the vials. Following the arrest, it was determined that the 
individual was a drug addict whom Respondent was treating.
    One of Respondent's employees stated that many of Respondent's 
patients were drug addicts. This statement was confirmed when many of 
Respondent's patient files were seized during a state criminal search 
warrant executed at Respondent's office on October 17, 1989. The files 
revealed that 150 patients who were addicts were being treated with 
controlled substances; another 16 patients who were addicts were no 
longer being treated by Respondent. Many of these patients continually 
received controlled substances for a number of years. For example, one 
patient received 4,005 dosage units of Tylenol with codeine #4, 2,330 
dosage units of Valium 10 mg., and 900 dosage units of phenobarbital, a 
Schedule IV controlled substance, between January 22, 1987, and October 
12, 1989.
    Respondent was interviewed about his treatment of drug addicts 
during the execution of the October 1989 search warrant. Respondent 
stated that patients were required to pay cash and that he determined 
that certain individuals were drug addicts based upon physical 
indications and discussions with his nurse, a former drug addict. He 
admitted, however, that he did not perform blood or urine tests because 
they were too expensive and did not keep any recovery logs for these 
patients, to memorialize the quantity and length of time that drugs are 
prescribed and what recovery programs the addict attends. Respondent 
also disclosed that after he learned that some of his drug addict 
patients were selling the drugs he prescribed, he raised his treatment 
prices, so that his patients would have less financial incentive to 
sell their drugs.
    Two physician expert reports found that Respondent was not acting 
in the course of professional medical practice by prescribing the 
dosages of controlled substances that he did, especially when he was 
aware that the patients were drug addicts.
    The BNE investigation also focused on Respondent's prescribing and 
dispensing of anabolic steroids. In June 1987, an investigator from the 
then-California Board of Medical Quality Assurance (now MBC) had a 
discussion with Respondent about allegations that Respondent dispensed 
anabolic steroids to high school students. Respondent denied such 
allegations and maintained that he lectured high school students on the 
health hazards of using such substances. On April 3, 1989, a BNE 
investigator also discussed the use of anabolic steroids with 
Respondent. When Respondent opined that such substances could be 
dispensed to enhance a person's physical appearance under close medical 
supervision, the investigator informed him of the California statute 
that classified anabolic steroids as controlled substances which became 
effective in 1986. Respondent also stated that he was discontinuing the 
dispensing and prescribing of anabolic steroids because he had heard 
rumors that the police were planning to make an undercover purchase of 
these substances from him.
    The BNE investigation also revealed that Respondent was one of the 
two highest purchasers of Anavar, an anabolic steroid, from a 
particular supplier between 1985 and 1988. Some of Respondent's 
employees divulged that Respondent prescribed, dispensed and 
administered anabolic steroids out of his office to young adult males 
for the purpose of body enhancement. These employees also disclosed 
that Respondent required cash payments and that Respondent seldom 
conducted blood tests on these individuals.
    A police detective admitted that he had received steroids from 
Respondent in 1988. Another officer, who also admitted to obtaining 
anabolic steroids from Respondent for purposes of body enhancement, 
indicated he used steroids based upon Respondent's recommendation. 
While a BNE investigator was executing the search warrant at 
Respondent's office on October 17, 1989, she encountered a patient who 
was there to obtain anabolic steroids for body enhancement. The 
individual explained to her that when he initially obtained steroids 
from Respondent he was not warned about any dangers that accompanied 
the use of such substances. He was only given one initial blood test by 
Respondent.
    Patient files recovered from Respondent's office revealed that many 
had received steroids from Respondent since 1987. Few, if any, blood 
tests were conducted on these patients. Another patient obtained 
anabolic steroids from Respondent after the patient revealed that he 
had taken these substances in the past, was depressed and attempted 
suicide ten months earlier. There were ten patients who obtained 
anabolic steroids from Respondent after April 3, 1989, the date when 
Respondent was informed by a BNE investigator that anabolic steroids 
were controlled substance under California law; one patient received 
nine injections in May and June of 1989. The patient files revealed 
that 97 patients received anabolic steroids from Respondent during the 
three years preceding the execution of the search warrant and that 
another 103 patients had previously received anabolic steroids from 
Respondent.
    A number of medical journal articles concerning the dangers of 
continual anabolic steroid use were introduced into evidence. These 
articles revealed that use of such substances was associated with 
certain psychological problems such as irritability, violent 
aggression, forgetfulness, confusion, abrupt mood swings and 
depression. Such use also was correlated with physiological problems 
such as decreased libido, insomnia, anorexia and metabolic 
disturbances. Many of these problems were reversible if the patient 
discontinued the use of these substances.
    An expert physician reviewed Respondent's patient records and 
concluded that 24 patients obtained anabolic steroids from Respondent 
not for legitimate medical purposes. He opined that it was improper to 
use anabolic steroids in conjunction with other controlled substances 
prescribed by Respondent and that the steroids were particularly 
contraindicated in light of some of the patients' medical illnesses. 
The expert found that it was ``medically dangerous'' to give anabolic 
steroids to a patient who had experienced prior depression.
    Another expert physician testified on behalf of Respondent that the 
doses of anabolic steroids that Respondent gave to his patients would 
be considered therapeutic and modest compared to reported doses used by 
athletes without a physician's authorization. This expert acknowledged, 
however, that although it is ethical to monitor the use of anabolic 
steroid use, it is not ethical for physicians to use such substances 
for the purpose that Respondent used them and that he would try to 
dissuade a patient from using anabolic steroids because ``* * * these 
things are cheating in the world of sport * * *.'' Moreover, there 
would be no way to determine if Respondent's patients were obtaining 
additional steroids or other illicit drugs on the street. The expert 
noted that if a physician is providing anabolic steroids, the physician 
should weigh the individual and take his blood pressure on every visit. 
In addition, the patient's lipid levels, cholesterol and triglycerides 
should be measured on the first visit to establish a baseline. 
Respondent's files demonstrated that, for the most part, this protocol 
was not followed.
    During execution of the search warrant, Respondent confirmed that 
he dispensed anabolic steroids to his patients for purposes of body 
enhancement. He explained that his services were necessary because if 
he did not provide that patients with anabolic steroids they would 
obtain the substances from the illicit market.
    On May 30, 1991, in the Contra Costa County Court, State of 
California, Respondent pled nolo contendere to and was convicted of six 
felony counts of issuing controlled substance prescriptions without a 
legitimate medical purpose. Respondent was placed on probation and 
fined.
    During execution of the search warrant, samples of various Schedule 
II through V controlled substances were discovered in various locations 
throughout Respondent's office, including Respondent's desk. There were 
no records of receipts or dispensing for any of the controlled 
substance samples as required by Federal law. There was only one 
completed DEA 222 order form for fentanyl although Respondent also 
possessed Demerol, another Schedule II controlled substance.
    In evaluating whether Respondent's continued registration by the 
Drug Enforcement Administration would be inconsistent with the public 
interest, as that term is used in 21 U.S.C. 824(a)(4), the Deputy 
Administrator considers the factors enumerated in 21 U.S.C. 823(f). 
They are as follows:
    (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.
    (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.
    In determining whether a registrant's continued registration is 
inconsistent with the public interest, the Deputy Administrator is not 
required to make findings with respect to each of the factors listed 
above. Instead, the Deputy Administrator has the discretion to give 
each factor the weight he deems appropriate, depending upon the facts 
and circumstances of each case. See David E. Trawick, D.D.S., Docket 
No. 88-69, 53 FR 5326 (1988).
    The Deputy Administrator concurs with the opinion and recommended 
ruling of the administrative law judge and finds that the second, 
third, fourth and fifth factors apply. Respondent clearly provided 
controlled substances to addicts to maintain their customary use. This 
conclusion is not only supported by Respondent's patient files and the 
information provided by Respondent and his employees, it is supported 
by Respondent's conviction of six felony offenses in the State of 
California.
    Although Respondent acknowledged his treatment of addicts, he 
argued that he had no knowledge that he was operating unlawfully and, 
in any event, his treatment was effective. The administrative law judge 
found that it is Respondent's duty to be aware of all applicable laws 
and regulations. Walter S. Gresham, Docket No. 91-39, 57 FR 44213 
(1992).
    In addition, while there was some testimony from several of 
Respondent's patients that his drug treatment helped them, the record, 
for the most part, belies this contention. Respondent prescribed and 
dispensed controlled substances without establishing any medical need 
other than that the patient was an addict. Even if Respondent were 
registered to operate a narcotic treatment program as required by 21 
U.S.C. 823(g), the prescribing of narcotics would have been unlawful 
pursuant to 21 CFR 1306.07(a).
    Moreover, Respondent had little basis initially to verify that his 
patients were drug addicts other than their word. He did nothing to 
ensure that his patients abstained from controlled substances other 
than those he prescribed and he took no steps to prevent diversion of 
the controlled substances he supplied other than raising his price to 
prevent diversion for economic gain. Although Respondent contended that 
he was operating a detoxification program, many patients had been 
obtaining controlled substances from Respondent for several years. One 
patient was arrested for driving while under the influence of drugs 
after apparently consuming large amounts of controlled substances 
prescribed by Respondent on the previous day. The undercover visits 
further reinforce the conclusion that Respondent did nothing to treat 
his patients' addictions other than supply them with substitute 
controlled substances. Respondent volunteered to prescribe controlled 
substances for the undercover detective without seeking any information 
about the detective's alleged drug use or past treatment. Respondent 
did not offer the undercover detective any counseling and treatment and 
the amount of the Restoril prescription was increased on the 
detective's verbal assurances that he shared the Restoril with his 
``girlfriend'' even though she was not present for this visit.
    Respondent dispensed anabolic steroids in violation of applicable 
state law. Again, Respondent did not deny dispensing the drugs but 
maintained that he was unaware that it was illegal and that he 
dispensed these substances in order to prevent his patients from 
obtaining illicit steroids on the street. Respondent's discussion with 
various state regulatory and law enforcement officers in 1987 and 1989 
contradict this assertion. As was the case with Respondent's use of 
controlled substances for drug addicts, he had a duty to know that his 
conduct regarding steroids was unlawful. In addition to the above 
violations, Respondent failed to keep any records of dispensing or 
receipt of controlled substances located in his office with the sole 
exception of one DEA 222 order form.
    These violations represent a significant part of Respondent's 
practice There is nothing in the record to indicate that Respondent 
understood the grave consequences of his actions, other than 
acknowledging that his conduct violated the law. Rather, Respondent 
made great efforts to justify much of his unlawful conduct. Indeed, 
Respondent did not cease his illegal conduct completely even after the 
search warrant was served. The MBC Consent Decree in no way detracts 
from these findings and conclusions. The Deputy Administrator has 
considered Respondent's arguments submitted in his exceptions and finds 
that the administrative law judge's findings of fact and conclusions of 
law are amply supported by the record. Under these circumstances, 
revocation of Respondent's DEA registration is the appropriate remedy 
at this time.
    Accordingly, the Deputy Administrator of the Drug Enforcement 
Administration, pursuant to the authority vested in him by 21 U.S.C. 
823 and 824 and 28 CFR 0.100(b) and 0.104 (59 FR 23637), hereby orders 
that DEA Certificate of Registration, AC8638085, previously issued to 
John W. Copeland, be, and it hereby is, revoked, and any pending 
applications for the renewal of such registration, be, and they hereby 
are, denied. This order is effective October 6, 1994.

    Dated: August 30, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-21829 Filed 9-2-94; 8:45 am]
BILLING CODE 4410-09-M