[Federal Register Volume 61, Number 19 (Monday, January 29, 1996)]
[Notices]
[Pages 2840-2841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1560]



=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Earl A. Humphreys, M.D.; Revocation of Registration

    On April 12, 1995, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Earl A. Humphreys, M.D., (Respondent) of 
Pittsburgh, Pennsylvania, notifying him of an opportunity to show cause 
as to why DEA should not revoke his DEA Certificate of Registration, 
AH1675252, under 21 U.S.C. 824(a)(4), and deny any pending application 
under 21 U.S.C. 823(f), as being inconsistent with the public interest. 
Specifically, the Order to Show Cause alleged that ``from the early 
1980s to mid-1993, [the Respondent] prescribed controlled substances to 
at least four individuals without a legitimate medical need and with 
knowledge that these individuals were not the ultimate recipients of 
the controlled substances.''
    On May 1, 1995, the Respondent, through counsel, filed a reply to 
the show cause order (Reply), waiving his hearing right and providing a 
factual response to the allegations in the show cause order. 
Accordingly, the Deputy Administrator now enters his final order in 
this matter pursuant to 21 C.F.R. 1301.54(e), 1301.57, without a 
hearing and based on the investigative file and the written Reply 
submitted by the Respondent.
    The Deputy Administrator finds that the Respondent is licensed to 
practice medicine and surgery in the Commonwealth of Pennsylvania, 
specializing in gastroenterology and internal medicine. He is 
registered as a practitioner with the DEA, AH1675252, to handle 
Schedules II through V controlled substances. In his Reply, the 
Respondent wrote that he had been in practice for thirty-five years, 
and ``I have not had a mark against my record.''
    The Respondent was the personal physician and friend of Justice 
Rolf Larsen of the Pennsylvania Supreme Court. Justice Larsen was 
charged with 27 state felony counts for obtaining controlled substances 
by fraud, deceit, and subterfuge. At a pre-trial hearing, the 
Respondent had testified that beginning in 1981 and continuing until 
1993, he had issued prescriptions for Schedule IV controlled substances 
intended for Justice Larsen's use, but he had issued the prescriptions 
in the name of third-parties. Specifically, during this time he wrote 
approximately 34 prescriptions for Valium, diazepam, Ativan, and Serax 
in the names of two of Justice Larsen's secretaries and one law clerk. 
The Respondent had never met these individuals, and they were not his 
patients. The three named individuals testified at the pre-trial 
hearing that in each instance they had picked up the filled 
prescription at a local pharmacy, had delivered the medication to 
Justice Larsen, and in no case had they taken the prescribed 
medications themselves. The Respondent was not paid for issuing these 
prescriptions.
    During this time, Justice Larsen was being treated by either a 
psychologist or a psychiatrist, but the Respondent was his family 
physician. The Respondent testified that he examined Justice Larsen 
about every six months, but not necessarily prior to issuing each of 
the prescriptions. Rather, Justice Larsen would telephone the 
Respondent and tell him what substances he wanted and in whose name to 
issue the prescription. The Respondent would then comply with his 
patient's request. The Respondent also testified that he was aware of 
Justice Larsen's diagnosed condition, to include clinical depression 
and anxiety, and that it was the Respondent's belief that every 
medication he prescribed for Justice Larsen was for a legitimate 
medical purpose. The Respondent testified that he had prescribed the 
substances in legitimate medical dosage amounts and at appropriate time 
intervals. He stated that he prescribed these controlled substances in 
this manner in order to preserve his patient's privacy, for ``[t]he 
public doesn't have to know what medications he's taking. That's my job 
to provide privacy for him.'' However, the Respondent was not aware of 
any prescriptions issued to Justice Larsen by his treating psychiatrist 
or psychologist, and he had not coordinated his prescribing with any of 
his patient's other care providers.
    In the Reply, the Respondent's attorney wrote that ``[t]he facts 
developed during [Justice Larsen's] trial showed that for a period of 
many years a local newspaper * * * had carried stories relating not 
just to Justice Larsen's judicial conduct, but to his family and 
personal matters * * * So that, it was not simply the normal need for 
privacy that all psychiatric patients have, but the enlarged need 
caused by the political nature of these facts. Testimony at trial 
showed that psychiatric patients suffer a stigma in society, and that 
public figures bear [an] even greater burden.'' The Respondent also 
wrote that during the trial, Justice Larsen's psychiatrist and 
neurologist had testifed that ``they probably would have done the same 
thing * * * [that] it is common practice, especially in psychiatric 
patients, to do this. There have been dire consequences where this 
privacy has been broken.'' However, the trial transcript from Justice 
Larsen's trial was not a part of the investigative record, and the 
Respondent did not attach a copy of the referenced sections to his 
Reply.
    On September 14, 1995, the Pennsylvania Bureau of Professional and 
Occupational Affairs (Bureau) filed formal disciplinary charges and a 
show cause order against the Respondent. The Bureau's charges focused 
upon the Respondent's prescribing practices to Justice Larsen between 
March 1981 and March 1993, noting that he had prescribed controlled 
substances to four named individuals who were not his patients and had 
not received treatment from him. Further, the Bureau alleged that the 
Respondent had failed to conduct physical examinations and re-
evaluations concurrent with the issuing of prescriptions to Justice 
Larsen, and that the records the Respondent maintained pertaining to 
Justice Larsen were incomplete and inaccurate. The order also asserts 
that the Respondent's actions were ``unprofessional'' and departed from 
or failed to conform to ``an ethical or quality standard of the 
profession.'' The order also states that if found, these violations of 
Pennsylvania law and regulations would result in civil penalties to 
include fines and the revocation of his medical license. However, the 
results of this proposed State action are not reflected in the 
investigative file or in the Respondent's Reply.
    Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy 
Administrator may revoke the Respondent's DEA Certificate of 
Registration and deny any pending applications, if he determines that 
the 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 applicant's experience in dispensing, or conducting 
research with respect to controlled substances. 

[[Page 2841]]

    (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. Schwartz, Jr., M.D., Docket No. 88-42, 54 FR 
16,422 (1989).
    In this case, factors one, two, four, and five are relevant in 
determining whether the Respondent's continued registration would be 
inconsistent with the public interest. As to factor one, 
``recommendation of the appropriate State licensing board,'' the 
Pennsylvania Bureau has issued an extensive and comprehensive show 
cause order alleging that the Respondent has engaged in a twelve year 
pattern of prescribing controlled substances to individuals who were 
not his patients. The Bureau asserted that such conduct, if found, 
would violate state law and regulations, potentially justifying 
revocation of his medical license and imposition of a fine for each 
instance of such behavior. However, the result of this show cause order 
is not contained in the record reviewed at this time by the Deputy 
Administrator. Therefore, although relevant that the Bureau, after 
investigating the Respondent's conduct, initiated disciplinary action, 
the Deputy Administrator has weighed the State's actions accordingly, 
remaining aware that the Bureau has merely asserted allegations, and 
that the outcome of the State's actions remains unknown.
    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,'' the investigative file clearly alleges, and 
the Respondent has not denied, that he engaged in a course of conduct 
over a twelve year period which clearly violated federal regulations 
promulgated pursuant to the Controlled Substances Act. Specifically, to 
be effective, a prescription for a controlled substance ``must be 
issued for a legitimate medical purpose by an individual practitioner 
acting in the usual course of his professional practice.'' 21 C.F.R. 
1306.04(a); see also Harlan J. Borcherding, D.O, 60 FR 28,796, 28,798 
(1995). The Respondent's issuing prescriptions for controlled 
substances to individuals unknown to him and not under his medical care 
would not meet this criteria. Further, the Respondent's prescribing of 
controlled substances to Justice Larsen merely upon his request, 
without seeing him, examining him, or otherwise making a medical 
evaluation prior to issuing the prescription, demonstrated behavior 
such that the patient's demands seemed to replace the physician's 
judgment. The Deputy Administrator has previously found that 
prescriptions issued under such circumstances were not a legitimate 
medical purpose: for example, when an undercover officer dictated the 
controlled substance to be given, ``rather than Respondent, as a 
practitioner, determining the medication appropriate for the medical 
condition presented by the officer.'' Ibid. Such uncontroverted actions 
on the part of the Respondent are preponderating evidence that he has 
dispensed controlled substances in violation of federal law.
    As to factor five, ``[s]uch other conduct which may threaten the 
public health or safety,'' the Deputy Administrator finds significant 
that the Respondent, in issuing controlled substance prescriptions for 
the use of Justice Larsen, failed to coordinate these prescriptions 
with his patient's other care providers. Although, in the normal course 
of prescribing, safeguards may exist at pharmacies to prevent over-
prescribing of controlled substances to a single patient, in this case, 
since the prescriptions were not issued in the patient's name, such 
safeguards would fail to identify this patient as a recipient of 
multiple, controlled substances prescriptions.
    Further, the public was at risk from the potential for diversion of 
controlled substances by both the patient who could have received, 
undetected, multiple prescriptions for controlled substances, and the 
named individuals who were prescribed controlled substances without a 
legitimate medical need. The very safeguards established to prevent 
such dangers were circumvented by the Respondent's practice. Although 
evidence exists to show that diversion, in this case, did not occur, 
the potential remained over a twelve year period for such abuse, and 
this potential created a threat to the public interest, as well as to 
the safety of this individual patient. Therefore, the Deputy 
Administrator finds that the public interest is best served by revoking 
the Respondent's DEA Certificate of Registration at this time. The 
Respondent is certainly free to reapply for a Certificate of 
Registration and to provide information which would assure the Deputy 
Administrator that the Respondent's future prescribing practices would 
not pose a threat to the public interest.
    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, AH1675252, issued to Earl A. Humphreys, 
M.D. be, and it hereby is, revoked, and any pending applications for 
renewal of said registration are denied. This order is effective 
February 28, 1996.

    Dated: January 23, 1996.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 96-1560 Filed 1-26-96; 8:45 am]
BILLING CODE 4410-09-M