[Federal Register Volume 60, Number 86 (Thursday, May 4, 1995)]
[Notices]
[Pages 22076-22078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10927]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
[Docket No. 93-56]
Michael G. Sargent, M.D.; Revocation of Registration
On June 2, 1993, the Deputy Assistant Administrator (then
Director), Office of [[Page 22077]] Diversion Control, Drug Enforcement
Administration (DEA), issued an Order to Show Cause to Michael G.
Sargent, M.D. of Katy, Texas (Respondent), proposing to revoke his DEA
Certificate of Registration, AS2512374, as a practitioner and deny any
pending application for registration as a practitioner. The statutory
basis for the Order to Show Cause was that Respondent's continued
registration as a practitioner would be inconsistent with the public
interest as that term is used in 21 U.S.C. 823(f) and 824(a)(4).
Respondent, through counsel, requested 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 on January 5 and 6, 1994, in Houston,
Texas. On August 25, 1994, the administrative law judge issued her
opinion and recommended ruling, findings of fact, conclusions of law
and decision recommending that Respondent's registration be revoked.
Respondent filed exceptions to the opinion on September 19, 1994.
On October 13, 1994, the administrative law judge transmitted the
record of the proceeding to the Deputy Administrator. After a careful
consideration of the record in its entirety, the Deputy Administrator
enters his final order in this matter, in accordance with 21 CFR
1316.67, based on findings of fact and conclusions of law as set forth
herein.
The administrative law judge found that, in July 1991, DEA
investigators in Houston, Texas, received an anonymous complaint that
Respondent was prescribing controlled substances to individuals without
a legitimate medical purpose. As a result, DEA investigators conducted
prescription surveys of pharmacies located near Respondent's office.
These surveys established that Respondent was prescribing Tylenol #3
with codeine, a Schedule III controlled substance, in conjunction with
Valium, a Schedule IV controlled substance.
Judge Bittner further found that, on five separate occasions from
August 16, 1991 through April 16, 1992, Respondent prescribed
combinations of Tylenol #3 with codeine and Valium to two undercover
agents without a legitimate medical purpose and not in the usual course
of professional medical practice. Respondent failed to conduct and
record an appropriate patient history and failed to conduct a physical
examination of either agent prior to prescribing this combination of
controlled substances.
The administrative law judge considered testimony from the
Government's expert medical witness who concluded that Respondent was
not acting within the normal course of his professional practice when
these prescriptions were issued. Conversely, Respondent's expert
medical witness concluded that Respondent issued the prescription at
issue for a legitimate medical need and in the normal course of
professional practice, and, at worse may have exercised poor judgment
with respect to prescribing Tylenol with codeine.
Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy
Administrator may revoke a DEA Certificate of Registration and deny any
application for such registration, if he determines that continued
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 [registrant's] experience in dispensing or conducting
research with respect to controlled substances.
(3) The [registrant'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.''
The Deputy Administrator may properly rely on any one or a
combination of these factors, and give each factor the weight he deems
appropriate in determining whether a registration should be revoked or
an application for registration denied. Henry J. Schwartz, Jr., M.D. 54
FR 16422 (1989). In the present case, the administrative law judge
found that factors two, four and five were relevant in determining
whether Respondent's registration should be revoked.
Judge Bittner found that Respondent's prescribing of controlled
substances to the undercover agents was not for a legitimate medical
purpose. Further, Respondent did not conduct comprehensive physical
examinations of the two agents and failed to maintain proper records
regarding his prescribing of controlled substances.
The administrative law judge concluded that the record does not
support Respondent's contentions that the controlled substances he
prescribed were warranted by, and appropriate for, the medical ailments
that the investigators presented to him. She further found that the
record demonstrates Respondent neither conducted anything resembling
comprehensive physical examinations nor asked probing questions of the
agents as to their symptoms, the possible causes of these symptoms, or
alternative treatments for their complaints. See James H. Brown, M.D.,
59 FR 37778 (1994). Respondent additionally was remiss in his
responsibilities as a DEA registrant by failing to keep appropriate
patient files on the agents.
Judge Bittner additionally found that a negative inference is
warranted where, as in the present case, Respondent did not testify.
See Raymond A. Carlson, M.D., 53 FR 7425 (1988). The administrative law
judge concluded that Respondent has not discharged his responsibilities
as a DEA registrant in the past and there is no indication that he is
more likely to do so in the future. Judge Bittner recommended that
Respondents DEA Certificate of Registration be revoked and any pending
applications for registration as a practitioner be denied.
Respondent took exception to Judge Bittner's opinion and
recommendation arguing that there was not sufficient, reliable,
probative, and substantial evidence to support such recommendation of
revocation. Respondent further contended that Judge Bitter, in finding
that 21 U.S.C. 823(f) (2), (4) and (5) were relevant, failed to discuss
Respondent's threat to the public interest under these factors.
Respondent additionally argued that the record, as a whole, does not
support a conclusion that his behavior was egregious, that Judge
Bittner failed to address the requirements of 21 CFR 1306.04 concerning
valid prescriptions, that Respondent did not have inadequate
recordkeeping practices, and that a negative inference was not
warranted from Respondent's decision not to testify. Respondent further
objected to the characterization that he did not perform any diagnostic
tests, and to the administrative law judge's description of the agents'
visit to Respondent's office on March 23, 1992. Respondent also took
exception to the use of the testimony given by the Government's expert
medical witness.
The Deputy Administrator adopts the opinion and recommended
decision of the administrative law judge in its entirety. The Deputy
Administrator concurs with the administrative law judge's finding that
the Government had met its burden of proof with respect to establishing
the factors set forth under 21 U.S.C. 823(f) (2), (4) and (5). The
Deputy Administrator finds that Respondent prescribed controlled
[[Page 22078]] substances to the undercover agents without legitimate
medical purpose and not in the usual course of professional medical
practice. Further, Respondent's recordkeeping practices, medical
examinations and patient history procedures were extremely deficient.
Finally, the Deputy Administrator concurs with the administrative law
judge's finding that a negative inference was warranted from
Respondent's decision not to testify.
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, hereby orders that DEA
Certificate of Registration, AS2512374, previously issued to Michael G.
Sargent, M.D, be, and it hereby is, revoked, and any pending
applications for such registration be, and hereby are, denied. This
order is effective June 5, 1995.
Dated: April 28, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-10927 Filed 5-3-95; 8:45 am]
BILLING CODE 4410-09-M