[Federal Register Volume 61, Number 33 (Friday, February 16, 1996)]
[Notices]
[Pages 6262-6264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3508]



=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[Docket No. 94-62]


James W. Shore, M.D., Denial of Application

    On July 6, 1994, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to James W. Shore, M.D., (Respondent) of Martin, 
Tennessee, notifying him of an opportunity to show cause as to why DEA 
should not deny his pending 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, among 
other things, that (1) in May of 1991, the Respondent's medical license 
was placed on probation for two years, and his authority to handle 
Schedule II and III controlled substances was suspended for one year, 
as a result of his prescribing Schedule II controlled substances and 
anabolic steroids in a manner which violated State law; and (2) on 
October 25, 1991, the Respondent entered a guilty plea in the U.S. 
District Court for the Western District of Tennessee, to three felony 
counts of unlawfully prescribing a controlled substance, and he was 
sentenced to eighteen months probation and ordered to surrender his 
controlled substances registration.
    On July 21, 1994, the Respondent, through counsel, filed a timely 
request for a hearing, and following prehearing procedures, a hearing 
was held in Memphis, Tennessee, on January 11, 1995, before 
Administrative Law Judge Mary Ellen Bittner. At the hearing both 
parties called witnesses to testify and introduced documentary 
evidence, and after the hearing, counsel for both sides submitted 
proposed findings of fact, conclusions of law and argument. On July 10, 
1995, Judge Bittner issued her Opinion and Recommended Ruling, 
recommending that the Respondent's application for DEA registration be 
denied. Neither party filed exceptions to her decision, and on August 
28, 1995, Judge Bittner transmitted the record of these proceedings to 
the Deputy Administrator.
    The Deputy Administrator has considered the record in its entirety, 
and pursuant to 21 CFR 1316.67, hereby issues his final order based 
uppon findings of fact and conclusions of law as hereinafter set forth. 
The Deputy Administrator adopts, in full, the Opinion and Recommended 
Ruling, Findings of Fact, Conclusions of Law and Decision 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.
    The Deputy Administrator finds that on June 16, 1993, the 
Respondent signed a DEA Application for Registration as a practitioner, 
seeking registration to handle Schedules II through V controlled 
substances. On that application, the Respondent disclosed that he had 
had restrictions placed upon his practice of medicine and his 
prescribing of controlled substances. The parties do not contest the 
facts concerning the Respondent's past misconduct in prescribing 
controlled substances. Also, the parties have stipulated that (1) 
Biphetamine is a brand name for a product containing amphetamine, a 
Schedule II controlled substance pursuant to 21 CFR 1308.12(d); (2) 
Percodan and Percocet are brand names for products containing 
oxycodone, a Schedule II narcotic controlled substance pursuant to 21 
CFR 1308.12(b); (3) Fastin is a brand name for a product containing 
phentermine hydrochloride, a Schedule IV controlled substance pursuant 
to 21 CFR 1308.14(e); (4) Tylox is a brand name for a product 
containing oxycodone, a Schedule II narcotic controlled substance 
pursuant to 21 CFR 1308.12(b); and (5) anabolic steroids are Schedule 
III controlled substances pursuant to 21 CFR 1308.13(f).
    The Deputy Administrator specifically finds that on May 8, 1986, an 
undercover agent for the Tennessee Bureau of Investigation (TBI), 
received two prescriptions for Biphetamine from the Respondent for no 
legitimate medical purpose and not in the usual course of his 
professional practice, for the Respondent had failed to take a medical 
history, to conduct a physical examination of the agent and to diagnose 
a condition requiring such medication. On July 10, 1986, a second TBI 
agent received two prescriptions for Biphetamine from the Respondent 
for no legitimate medical purpose and not in the usual course of his 
professional practice, for again the Respondent had failed to conduct a 
physical examination or any other clinical tests, and he had failed to 
identify a medical condition requiring such a prescription. In the same 
manner, on June 16, 1986, an undercover police officer acquired from 
the Respondent two prescriptions for the controlled substance Fastin 
for no legitimate medical purpose and not in the usual course of 
professional practice. Tape recordings were made of the conversations 
between these law enforcement officials and the Respondent, and 
transcripts of these tape recordings were made a part of the record.
    As part of its investigation of the Respondent's conduct, the 
Tennessee Board of Pharmacy conducted a prescription audit of 
prescriptions issued by the Respondent in Weakley County, Tennessee, 
from February of 1984 through February of 1987. This prescription audit 
was sent to Dr. Harbison, a research scientist, pharmacist, and teacher 
at the University of Arkansas, for his review and comment. Dr. Harbison 
wrote that the Respondent had prescribed controlled substances not in 
the usual course of medical practice to more than a dozen patients, 
concluding that ``it is my opinion that after reviewing the 
prescription records, [the Respondent] did not prescribe [] 
Biphetamine, Tylox, Percocet, Percodan [,] and Mepergan Fortis in a 
manner consistent with the usual course of medical practice.''

[[Page 6263]]

    In May of 1991, as a result of this conduct, the Respondent entered 
an agreed order with the State of Tennessee State Board of Medical 
Examiners (Medical Board), resulting in his medical license being 
placed on probation for two years, and his Schedule II and III 
controlled substances privileges being suspended for one year. The 
Medical Board found that the Respondent had prescribed Schedule II 
drugs ``on a routine, chronic, long term basis with little or no 
documented medical reasoning for such continued prescribing,'' and that 
the Respondent had engaged in conduct which violated State law, to 
include State laws governing prescribing of controlled substances. 
Also, on October 25, 1991, the Respondent entered a guilty plea in the 
U.S. District Court for the Western District of Tennessee for three 
felony counts of unlawfully prescribing a controlled substance. As part 
of his plea agreement, the Respondent agreed to surrender his DEA 
registration in Schedules II through IV, which he did on November 26, 
1991. He was also sentenced to eighteen months of supervised probation, 
which was successfully completed by the Respondent on April 9, 1993. In 
May of 1993, the Medical Board terminated the probation of the 
Respondent's medical license, renewing it without restrictions.
    During the hearing before Judge Bittner, one of the Respondent's 
current employers, the business manager of the Martin Medical Center in 
Martin, Tennessee, testified that he was familiar with the criminal and 
administrative proceedings involving the Respondent. He opined that the 
Respondent would not engage in similar misconduct in the future, and 
that he was aware that the Respondent had received remedial training at 
the Vanderbilt University School of Medicine. He also testified about 
the professional limitations caused by the Respondent's lack of a DEA 
Certificate of Registration, including his suspension from practicing 
in a preferred provider organization, and his difficulties in 
participating in TennCare, Tennessee's Medicaid program. Also, the 
Respondent's patients had problems getting mail order prescription drug 
suppliers to fill the Respondent's prescriptions.
    The Respondent testified that he had attended a two-day course at 
Vanderbilt University primarily for ``impaired physicians.'' 
Specifically, the course focused on the philosophy of prescribing, 
giving the Respondent the ability to recognize drug-seeking behavior. 
The Respondent testified that the course ``also made me look in my soul 
and my heart and try to identify my feelings toward why these people 
were able to manipulate me like they did.'' However, the course did not 
provide training in pharmacology or the therapeutics of pharmacology 
with regard to specific substances, and when questioned by the 
Government's counsel, the Respondent had difficulty discussing such 
concepts as ``benzodiazepam loading'', and in identifying the dangers 
of chronic use of sedative hypnotics. Finally, the Respondent testified 
about his need for a DEA Certificate of Registration in his current 
medical practice.
    Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an 
application for a DEA Certificate of Registration 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.
    (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).
    In this case, factors one through four are relevant in determining 
whether granting the Respondent's application would be inconsistent 
with the public interest. As to factor one, ``recommendation of the 
appropriate State licensing board,'' the Medical Board found that the 
Respondent had prescribed Schedule II controlled substances in a manner 
which violated State law. Accordingly, that Board took disciplinary 
action against the Respondent.
    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,'' it is undisputed that the Respondent 
prescribed controlled substances without a legitimate medical purpose 
and outside the usual course of medical practice in violation of both 
State and Federal law. Specifically, his conduct of prescribing 
controlled substances without taking a medical history, conducting a 
medical examination or clinical tests, or identifying a medical 
condition warranting the medications, violated the legal requirements 
for prescribing controlled substances.
    As to factor three, the Respondent's conviction record under 
Federal laws, the Respondent was convicted in Federal court of three 
felony counts of unlawfully prescribing a controlled substance as a 
result of the previously described unlawful conduct.
    Further, the Deputy Administrator notes that the Respondent has 
taken some responsibility for his misconduct, as evidenced by his 
entering an agreed order with the Medical Board, and his entry of a 
guilty plea in Federal court. Further, he has successfully completed 
his probation and a course at the Vanderbilt University on prescribing 
practices. He has also stated remorse for his past misconduct.
    However, the remedial course taken by the Respondent did not 
provide training in pharmacology or the therapeutics of pharmacology, 
and the Respondent's testimony before Judge Bittner disclosed the 
Respondent's deficiencies in this area. Further, the Deputy 
Administrator finds compelling Judge Bittner's observations:

    [The] Respondent's only explanation for his prescribing 
practices was that he was manipulated by his patients * * * 
Respondent did not, however, explain how he would avoid being 
manipulated in the future or why he prescribed controlled substances 
upon request in the first place. In any event, purported 
manipulation cannot justify prescribing thousands of dosage units of 
controlled substances over a period of several years.
    In addition, the transcripts of Respondent's conversations with 
the under cover officers show that Respondent initiated the 
discussion of stimulants * * *. Neither of these `patients' 
manipulated [the] Respondent into issuing him prescriptions, and 
[the] Respondent does not contend otherwise * * *. In addition, 
[the] Respondent told the Medical Board that he believed that the 
Schedule II drugs he prescribed did no harm and presented only 
minimal risks to the patients, comments evidencing an extremely 
cavalier attitude toward controlled substances.

    Therefore, the Deputy Administrator finds that the public interest 
is best served by denying the Respondent's application at this time. 
The Deputy Administrator realizes that the Respondent's misconduct 
occurred 

[[Page 6264]]
almost ten years ago, but evidence of the Respondent's ``cavalier 
attitude'' occurred in 1991 before the Medical Board, and in 1994 in 
the hearing before Judge Bittner. As Judge Bittner noted, the DEA has 
previously determined that ``[t]he paramount issue is not how much time 
has elapsed since [the Respondent's] unlawful conduct, but rather, 
whether during that time [the] Respondent has learned from past 
mistakes and has demonstrated that he would handle controlled 
substances properly if entrusted with a DEA registration.'' Leonardo V. 
Lopez, M.D., 54 FR 36915 (1989). Here, the Deputy Administrator is 
currently not convinced that the Respondent would properly handle 
controlled substances if his registration is granted.
    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 DEA 
Certificate of Registration application of James W. Shore, M.D., be, 
and it hereby is, denied. This order is effective March 18, 1996.

    Dated: February 12, 1996.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 96-3508 Filed 2-15-96; 8:45 am]
BILLING CODE 4410-09-M