[Federal Register Volume 59, Number 132 (Tuesday, July 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16738]
[[Page Unknown]]
[Federal Register: July 12, 1994]
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DEPARTMENT OF JUSTICE
[Docket No. 93-9]
Steven E. Warren, M.D.; Revocation of Registration
On October 5, 1992, the Administrator of the Drug Enforcement
Administration (DEA), issued an Order to Show Cause to Steven E.
Warren, M.D. (Respondent), of Salt Lake City, Utah, proposing to revoke
his DEA Certificate of Registration, AW1662609, and to deny any pending
applications for registration as a practitioner. The Order to Show
Cause alleged that Respondent's continued registration would be
inconsistent with the public interest as that term is used in 21 U.S.C.
823(f) and 824(a)(4), in that the Respondent was personally abusing
narcotic controlled substances and obscured this use from others; that
Respondent misused his registration privilege to obtain Schedule II
controlled substances for other than legitimate medical purposes; that
Respondent failed to maintain complete and accurate controlled
substance records; that Respondent failed to account for 40 to 50
multi-dose vials of Demerol; that Respondent added saline solution to a
commercial vial of Demerol in an effort to mislead investigators; and
that Respondent distributed controlled substance samples without a
legitimate medical purpose.
Additionally, citing his preliminary finding that Respondent's
continued registration posed an imminent danger to the public health
and safety, the Administrator ordered the immediate suspension of DEA
Certificate of Registration, AW1662609, during the pendency of these
proceedings. 21 U.S.C. 824(d).
The Respondent, by counsel, responded to the Order to Show Cause
and requested a hearing. The matter was docketed before Administrative
Law Judge Paul A. Tenney. A hearing was held in Salt Lake City, Utah on
July 28, 1993.
On October 6, 1993, the administrative law judge issued his
findings of fact, conclusions of law, and recommended ruling in which
he recommended, iner alia, that the Respondent's DEA registration be
revoked and that any pending applications be denied. The administrative
law judge also recommended that the Administrator grant the Respondent
alternative relief in the form of a waiver of DEA regulations to permit
the San Juan County Hospital to employ Respondent and permit him to
order controlled substances for hospital patients. The Government filed
exceptions to this recommendation, and the Respondent filed a response
to the Government's exceptions. The administrative law judge
transmitted the record to the Acting Administrator on November 8, 1993.
The Deputy Administrator has considered the record in its entirety and,
pursuant to 21 CFR 1316.67, enters his final order in this matter,
based on findings of fact and conclusions of law as hereinafter set
forth.
The administrative law judge found that the Respondent graduated
from medical school with the assistance of a National Service Corps
scholarship, and was subsequently assigned to a remote county in Utah
to complete his four year obligation to the Federal Government. After
completion of his obligation, Respondent continued to practice in the
area. For a period of approximately two years, Respondent was the only
physician in the county.
In 1991 and 1992, Utah State licensing authorities initiated an
investigation into the Respondent's prescribing practices by conducting
audits of two local pharmacies. No violations were found. However, in
June 1992, after anonymous complaints that the Respondent was receiving
injections during his medical practice, the state initiated a new
investigation and determined that the Respondent was unable to account
for quantities of Demerol, a Schedule II narcotic controlled substance.
Additionally, investigators determined that improper transfers of
Demerol from the local hospital to the Respondent's medical office had
been made.
At the DEA administrative hearing, Respondent testified that he had
started self-administering Demerol for shoulder pain and migraine
headaches after a fall off the roof of his home. Subsequently, the
Respondent was exposed to a contaminated needle in the course of his
practice, became ill, and was admitted to a hospital for several days.
There, he discussed his addiction with physicians, who arranged his
admission to a five-week rehabilitative program. The Respondent
surrendered his state controlled substance license in October 1992.
The administrative law judge found that the Respondent used
Demerol, without a legitimate medical purpose, and became addicted
during the summer of 1992. To obscure his use of the drug from hospital
and clinic personnel, the Respondent used Demerol from the hospital
inventory, wrote false prescriptions, and, at least once, injected
saline solution into a Demerol vial. Additionally, the Respondent
failed to keep complete and accurate records of his acquisition,
disposition, and inventory of controlled substances. The administrative
law judge found that the Respondent's demanding work schedule, his
spouse's health problems, and a shoulder injury predisposed the
Respondent to Demerol addiction.
The Respondent was charged, under Utah State law, with possessing
and distributing a counterfeit substance, possession of a controlled
substance without a valid prescription, possession of a false
prescription and failure to make a record for prescribing and
administering controlled substances. On May 3, 1993, before the Seventh
Judicial District Court for San Juan County, Utah, the Respondent pled
guilty to five felony counts. The Respondent's sentence included a
fine, imprisonment not to exceed five years, and a one-year suspension
of his medical license. The Court's Judgment and Order stayed the
sentence for a period of five years and the Respondent was placed on
probation with conditions, which included a two year prohibition from
reapplying for a state controlled substance license. On May 5, 1993,
the State of Utah Division of Occupational and Professional Licensing
issued a Stipulation and Order with terms similar to that of the
Judgment and Order, including a provision that the Respondent complete
a rehabilitation program.
The administrative law judge found that the Respondent participated
in an aftercare recovery program, attending Alcoholics Anonymous
meetings; agreed to random drug screening all of which were negative;
and was complying with or working on the conditions imposed in his
probation agreement and in his licensing board stipulations. The
administrative law judge concluded that the Respondent had made
substantial efforts at rehabilitation, is presently in recovery, and
that his prognosis for a full recovery is good.
Under 21 U.S.C. 824(a), the Deputy Administrator of the Drug
Enforcement Administration may revoke the registration of a
practitioner ``* * *upon a finding that the registrant--
(1) has materially falsified any application filed pursuant to or
required by this subchapter or subchapter II of this chapter;
(2) has been convicted of a felony under this subchapter or
subchapter II of this chapter or any other law of the United States, or
of any State, relating to any substance defined in this subchapter as a
controlled substance;
(3) has had his State license or registration suspended, revoked,
or denied by competent State authority and is no longer authorized by
State law to engage in the manufacturing, distribution, or dispensing
of controlled substances or has had the suspension, revocation, or
denial of his registration recommended by competent State authority;
(4) has committed such acts as would render his registration under
Section 823 of this title inconsistent with the public interest as
determined under such section; or
(5) has been excluded (or directed to be excluded) from
participation in a program pursuant to section 1320a-7(a) of Title
42.''
The administrative law judge determined that subsections (2), (3),
and (4) provide a basis for revocation based on Respondent's conviction
of five felony counts relating to controlled substances, his surrender
of his state controlled substance license, and the public interest
factors.
Under 21 U.S.C. 824(a)(4), and pursuant to 21 U.S.C. 823(f), ``[i]n
determining the public interest, the following factors shall 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 and
safety.''
It is well established that these factors are to be considered in
the disjunctive, i.e., the Deputy Administrator may properly rely on
any one or a combination of factors, and give each factor the weight he
deems appropriate. Henry J. Schwarz, Jr., M.D., 54 FR 16422 (1989).
The administrative law judge found that all of the factors listed
in 21 U.S.C. 823(f) are relevant. Respondent surrendered his state
controlled substance license and the State of Utah has recommended that
he not apply for reinstatement for a period of time. Respondent
admitted to wrongfully obtaining Demerol for his own use, and he pled
guilty to five felony counts relating to controlled substances. As to
factor (5), the administrative law judge found that the public health
and safety are not at risk, since the Respondent has made progress in
his rehabilitation and both the criminal plea agreement and medical
board agreement require that the Respondent comply with numerous
conditions to ensure that he will not suffer a relapse in his recovery.
The DEA has consistently held that it does not have statutory
authority under the Controlled Substances Act to register a
practitioner unless that practitioner is authorized by the state to
dispense controlled substances. DEA has consistently held that
termination of a registrant's state authority to handle controlled
substances requires that DEA revoke the registrant's DEA Certificate of
Registration. Bobby Watts, M.D., 53 FR 11919 (1987). Based on the
foregoing, the Deputy Administrator concludes that the Respondent's
registration must be revoked. 21 U.S.C. 824(a) (2), (3) and (4).
As an additional issue, the administrative law judge found that the
Respondent presented evidence that the local community has suffered by
the lack of Respondent's ability to practice in the hospital emergency
room. The Respondent and the San Juan County Hospital entered into a
protocol in which the Respondent would be able to write hospital
patient prescriptions for controlled substances under the hospital's
DEA number. This agreement is contingent on the successful application
to the Deputy Administrator of the DEA by the hospital for a waiver of
the provisions of 21 CFR 1301.76(a), which precludes the hospital from
employing an individual with access to controlled substances if that
individual has been convicted of a controlled substance related felony.
The San Juan County Hospital requested that the Deputy Administrator
grant a waiver to allow the employment of the Respondent. The
administrative law judge recommended that such a waiver be granted by
the Deputy Administrator pursuant to his authority under 21 CFR
1307.03.
The Government filed an exception to the recommendation of the
administrative law judge that a waiver of 21 CFR 1301.76(a) be granted
contending that since the Respondent has no underlying state controlled
substance license nor a DEA registration, he should not be permitted to
handle controlled substances under any circumstance. The Respondent, in
response to the Government exception, presented a letter from the Utah
Attorney General's office permitting the Respondent, with the
appropriate DEA exemption, to order controlled substances for hospital
patients, until such time as the Utah State Division of Occupational
and Professional Licensing arrived at a formal opinion on this issue.
The Deputy Administrator disagrees with the administrative law
judge's recommendation with regard to a waiver or exemption from
regulations and agrees with the Government's contention that such a
waiver should not be granted. In fact, on December 7, 1993, DEA
previously denied the request of San Juan Hospital that it be granted
an exemption from the regulations to allow the Respondent's employment
with access to controlled substances.
The Deputy Administrator adopts the findings of fact, conclusions
of law, and recommended ruling of Administrative Law Judge Tenney,
except as otherwise noted herein. 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,
AW1662609, previously issued to Steven E. Warren, M.D., be, and it
hereby is, revoked, and that any pending applications for registration,
be, and they hereby are, denied. This order is effective July 12, 1994.
Dated: July 5, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-16738 Filed 7-11-94; 8:45 am]
BILLING CODE 4410-09-M
