[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]
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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
