[Federal Register Volume 59, Number 28 (Thursday, February 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3028]


[[Page Unknown]]

[Federal Register: February 10, 1994]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE
[Docket No. 93-13]

 

James Henry Holmes, M.D.; Partial Revocation of Registration

    On October 23, 1992, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), directed an 
Order to Show Cause to James Henry Holmes, M.D. (Respondent), proposing 
to revoke his DEA Certificate of Registration, BH0285331, as a 
practitioner under 21 U.S.C. 824(a)(4), and to deny any pending 
applications under 21 U.S.C. 823(f). The Order to Show Cause alleged 
that the continued registration of the Respondent would be inconsistent 
with the public interest.
    The Respondent requested a hearing on the issues raised in the 
Order to Show Cause. The matter was docketed before Administrative Law 
Judge Paul A. Tenney. Following prehearing procedures a hearing was 
held in Sacramento, California on April 20, 1993.
    On July 1, 1993, Judge Tenney issued his findings of fact, 
conclusions of law, and recommended ruling in which he recommended that 
the Respondent's registration be continued and that he be given a 
formal reprimand. The Government filed exceptions to this opinion, and 
on August 13, 1993, the administrative law judge transmitted the record 
of the proceedings to the Administrator.
    The Acting 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 received a 
degree in physical therapy from Loma Linda University in 1960, and 
worked as a physical therapist until he entered medical school in 1971. 
Respondent received his medical degree in 1974, and entered private 
practice in Stockton, California in 1976, where he continued as a sole 
practitioner for seventeen years.
    In 1989, the California Department of Health Services noted that 
the Respondent frequently appeared as a prescribing physician for 
patients who were under investigation for Medi-Cal fraud. In 1990, the 
State Attorney General initiated an investigation of the Respondent. On 
October 2, 1990, a State investigator, operating in an undercover 
capacity, made a visit to the Respondent's office. The investigator, 
who gave no indication of immediate pain, asked for a prescription for 
Tylenol with codeine. The Respondent provided the undercover 
investigator with a prescription for the substance, ostensibly on the 
belief that the patient's job as a construction worker might require 
occasional treatment for pain.
    The undercover investigator returned to Respondent's office on four 
more occasions between November 1990 and April 1991, and on each 
occasion, Respondent issued the undercover investigator a prescription 
for Tylenol with codeine. The undercover investigator did not give any 
indication of pain during these visits. Respondent testified that he 
issued these prescriptions because he assumed that since he had issued 
the undercover investigator a prescription in the past, there was a 
valid medical need for the drug prescribed.
    On February 25, 1991, another undercover investigator, posing as 
the first investigator's friend, went to Respondent's office and 
requested and received a prescription for Tylenol with codeine, based 
upon the Respondent's stated belief that the individual would 
experience discomfort similar to that of the first undercover 
investigator. On several occasions, the Respondent refused to issue 
undercover investigators prescriptions for Tylenol with codeine.
    On May 28, 1991, an undercover investigator who had initially been 
refused a prescription by Respondent, telephoned Respondent and asked 
for a prescription for Tylenol with codeine. When Respondent asked if 
the undercover investigator was having any problems, the investigator 
stated, ``[o]h yeah, that's right. I have to have a problem. My elbow 
hurts.'' Respondent then telephoned in a prescription for Tylenol with 
codeine for the undercover investigator.
    On June 11, 1991, the initial undercover investigator telephoned 
Respondent and warned him that investigators were asking about 
Respondent's prescriptions. Subsequently, Respondent added the notation 
``back pain'' to the undercover investigator's medical records. On July 
31, 1991, the undercover investigator returned to Respondent's Office 
and was again issued a prescription for Tylenol with codeine for no 
apparent medical need.
    Judge Tenney found that the Respondent, on eight occasions during 
the period October 1990 to May 1991, prescribed the Schedule III 
controlled substance Tylenol #3 with codeine to undercover operatives, 
without a legitimate medical purpose, but under strong mitigating 
circumstances; and that on four occasions in March through May 1991, 
Respondent refused to so prescribe the same substance.
    In November 1991, the State of California filed an eight count 
misdemeanor complaint alleging that Respondent had improperly 
prescribed Tylenol with codeine. On January 6, 1992, the Respondent 
pled guilty to a single misdemeanor count of a violation of the 
California Health and Safety Code, for prescribing a controlled 
substance without a legitimate medical purpose. Subsequently, the State 
of California suspended the Respondent for an indefinite period from 
participation as a provider in the California Medical Assistance 
Program (Medi-Cal). The Respondent has been excluded by the U.S. 
Department of Heath and Human Services from participation in the 
Medicare and Medicaid programs for period of three years. However, 
since this was a permissive exclusion it is not considered as a 
separate ground for revocation under 21 U.S.C. 824 (a)(5).
    The administrative law judge found that the Respondent indicated 
remorse for his conduct, and testified that he had instituted new 
office procedures before approving any prescriptions for controlled 
substances. The administrative law judge further found that the 
Respondent is an active highly respected member of the Stockton 
community and is one of the few area physicians who will accept Medi-
Cal patients. The Respondent provides free medical assistance for the 
homeless, and a number of his patients wrote letters on his behalf and 
attested to his fine character.
    Under 21 U.S.C. 824(a)(4), the Administrator of the Drug 
Enforcement Administration may revoke the registration of a 
practitioner if he determines that such registration would be 
inconsistent with the public interest as determined under 21 U.S.C. 
823.
    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 
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 Administrator may properly rely on any one 
or a combination of factors, and give each factor the weight he deems 
appropriate. Henry J. Schwartz, Jr., M.D., 54 FR 16422 (1989).
    Of the stated factors, the administrative law judge found that the 
Government established a prima facie case for revocation under 21 
U.S.C. 823(f) (2) through (5). Judge Tenney found that the evidence 
supported a finding that the Respondent's experience with regard to 
dispensing controlled substances and compliance with applicable laws 
included eight occasions where he prescribed controlled substances 
absent a legitimate medical purpose and while not acting in the usual 
course of medical practice; that the Respondent was convicted under 
State law of unlawfully prescribing a controlled substance; and that 
the Respondent's conduct in falsifying patient records posed a threat 
to the public health and safety.
    The administrative law judge concluded that the mitigating 
circumstances outweigh the prima facie violations. Judge Tenney found 
that Respondent trusted the representations of the undercover 
investigator. In addition, on four occasions, Respondent refused to 
prescribe Tylenol with codeine to the undercover investigators. 
Respondent is respected in the community and has changed his 
prescribing practices.
    As a result the administrative law judge concluded that even though 
Respondent prescribed controlled substances for no legitimate medical 
purpose, Respondent should be permitted to continue his registration. 
Accordingly the administrative law judge recommended that Respondent be 
given a formal reprimand for his prescribing practices and that he be 
given another chance.
    The Government filed an exception to the conclusion of the 
administrative law judge that the violations of law occurred under 
strong mitigating circumstances. The Government contended that the 
Respondent had been identified as a high prescriber of controlled 
substances by a California State agency and had prescribed controlled 
substances without a legitimate medical purpose notwithstanding the 
quality of his interaction with his patients. The Government also 
opposed the administrative law judge's recommendation that the 
Respondent's registration be continued, and recommended revocation. The 
Government also recommended, in the alternative, that if a lesser 
sanction is warranted, then the Respondent's registration should be 
continued in Schedules IV and V only, subject to restrictions that he 
maintain a separate journal of controlled substances prescribed, 
administered, or dispensed, and that all such records be made available 
to DEA on demand.
    The Acting Administrator adopts the findings of fact, conclusions 
of law, and recommended ruling of Administrative Law Judge Tenney 
except as otherwise noted herein. The Acting Administrator specifically 
declines to adopt the finding of the administrative law judge that the 
mitigating circumstances of this case outweigh the prima facie 
violations. There is no doubt in the record that the Respondent's 
conduct in prescribing controlled substances to the undercover 
operatives was unlawful, that he attempted to conceal this unlawful 
conduct, and that he continued this conduct even when he became aware 
that his practices were in question.
    Based on the foregoing, the Acting Administrator concludes that the 
Respondent's continued registration as a practitioner in Schedules II 
and III is inconsistent with the public interest. However, the 
mitigating circumstances indicate that the Respondent would not pose a 
risk to the public interest if he were to continue as a practitioner 
under the following conditions and restrictions. Respondent will 
maintain a separate journal of all controlled substances prescribed, 
administered, or dispensed for a period of one year, and the Respondent 
will agree to make all such records available for DEA inspection, 
during normal business hours, without the requirement of a notice of 
inspection or an administrative inspection warrant.
    Accordingly, the Acting 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), hereby orders that DEA Certificate of 
Registration, BH0285331, issued to James Henry Holmes, M.D., be and it 
hereby is, revoked, in Schedules II and III; and orders that it be 
continued in Schedules IV and V, under the terms and conditions noted 
herein. This order is effective March 14, 1994.

    Dated: February 4, 1994.
Stephen H. Greene,
Acting Administrator of Drug Enforcement.
[FR Doc. 94-3028 Filed 2-9-94; 8:45 am]
BILLING CODE 4410-09-M