[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