[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