[Federal Register Volume 60, Number 195 (Tuesday, October 10, 1995)]
[Notices]
[Pages 52705-52707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24949]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 94-2]
Herman E. Walker, Jr., M.D.; Revocation of Registration
On September 16, 1993, the Deputy Assistant Administrator, Office
of Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Herman E. Walker, Jr., M.D., (Respondent) of
Houma, Louisiana, notifying him of his opportunity to show cause as to
why DEA should not revoke his DEA Certificate of Registration,
AW3369697, and should not deny any pending application for renewal of
his registration, under 21 U.S.C. 823(f) and 824(a)(4), as being
inconsistent with the public interest. Specifically, the Order to Show
Cause alleged that: (1) On two occasions in the fall of 1986, the
Respondent prescribed Schedule II controlled substances to an
undercover police officer for no legitimate medical reason; (2) between
October 1986 and September 1988, the Respondent maintained 52 patients
on prolonged and continuous regimens of Schedule III controlled
substances (``anorectics''); (3) on or about January 19, 1989, an
Administrative Complaint was filed against the Respondent by the
Louisiana State Board of Medical Examiners (Board) charging him with
prescribing, dispensing or administering legally controlled substances
or any dependency-inducing medication without legitimate medical
justification; (4) on September 27, 1989, the Board suspended his
license to practice medicine for five years, and he was ordered by the
Board to surrender his Schedule II controlled substance privileges
permanently. On November 21, 1989, Louisiana's Fourth Circuit Court of
Appeals stayed the Board's decision suspending his license, but upheld
its decision regarding the surrender of his Schedule II controlled
substances privileges. The Order to Show Cause noted that the
Respondent was, therefore, without state authorization to handle
controlled substances in Schedule II, citing 21 U.S.C. 824(a)(3).
By letter dated October 14, 1993, the Respondent, through counsel,
timely filed a request for a hearing on the issues raised by the Order
to Show Cause, and the matter was docketed before Administrative Law
Judge Mary Ellen Bittner. Following prehearing procedures, a hearing
was held in New Orleans, Louisiana, on April 13, 1994, where both
parties called witnesses to testify and introduced documentary
evidence. On September 19, 1994, the Respondent filed Proposed Findings
of Fact and Conclusions of Law and Argument, and on September 20, 1994,
the Government filed its Proposed Finding of Fact, Conclusions of Law
and Argument.
On November 30, 1994, Judge Bittner issued her Opinion and
Recommended Ruling, Finding of Fact, Conclusions of Law and Decision of
the Administrative Law Judge, recommending that Respondent's DEA
registration be revoked, and that any pending applications be denied.
The Respondent filed exceptions to Judge Bittner's decision on January
5, 1995. On January 12, 1995, Judge Bittner transmitted the record of
these proceedings, including the Respondent's exceptions, to the Deputy
Administrator.
The Deputy Administrator has considered the record in its entirety,
to include the Respondent's exceptions, and pursuant to 21 C.F.R.
1316.67, hereby issues his final order based upon findings of fact and
conclusions of law as hereinafter set forth. The Deputy Administrator
adopts, in full, the Opinion and Recommended Ruling, Findings of Fact,
Conclusions of Law and Decision of the Administrative Law Judge, and
his adoption is in no manner diminished by any recitation of facts,
issues and conclusions herein, or of any failure to mention a matter of
fact or law.
The Deputy Administrator finds that in 1986, as a result of an
anonymous complaint against the Respondent, the Louisiana State Police
Department initiated an investigation of Respondent. As part of this
investigation, on October 30, 1986, a State Police Officer, posing as a
patient, visited the Respondent complaining that he worked long hours,
was not sleeping at night, and that he wanted something ``to perk him
up.'' He did not complain of any other medical or mental condition or
problem. The Officer received a prescription from the Respondent for 30
dosage units of Ritalin. Ritalan is the brand name of a product
containing methylphenidate, a Schedule II controlled substance. On
November 24, 1986, the State Police Officer returned to the
Respondent's office, did not complain of any medical or mental
condition requiring treatment, and told Respondent that he had lost or
[[Page 52706]]
misplaced his Ritalin prescription. The Officer received another
prescription from the Respondent for, inter alia, 15 dosage units of
Ritalin. Although the same State Police Officer returned to the
Respondent's office on January 14, 1987, the Respondent did not
prescribe any controlled substances at that time.
On May 14, 1987, a second State Police Officer visited the
Respondent and told him that he had to drive all night and sought a
stimulant to help him stay awake. In response to the Respondent's
questions, the Officer told him that he slept very well and getting to
sleep was not his problem. The Respondent refused to give the Officer a
prescription for amphetamines, but the Respondent gave the Officer a
prescription for XANAX, to help him sleep. XANAX is a product
containing alprazolam, a Schedule IV controlled substance.
On January 19, 1989, the Board's Investigating Officer filed an
Administrative Complaint against the Respondent, primarily alleging
that on approximately fifty occasions between September 1987 and
September 1988, the Respondent concurrently prescribed multiple or
excessive amounts of controlled substances to approximately fifty-two
patients. After conducting a hearing, the Board issued its decision on
September 27, 1989, concluding that the Respondent had substituted--
Prolonged medication regimes and polypharmacology for sound
medical treatment, repeatedly and consistently prescribed legally
controlled, dependency-inducing substances without legitimate
medical justification therefor . . . [and that] such practices
clearly and convincingly demonstrate medical incompetency on the
physician's part and continuing and recurring medical practice which
fails to satisfy the prevailing and usually accepted standards of
medical practice in this state.
The board, inter alia, ordered Respondent to permanently refrain
from handling Schedule II controlled substances and to surrender his
registration as to that schedule. However, when contacted by a DEA
Diversion Investigator, the Respondent refused to surrender his DEA
registration with respect to Schedule II. The district court affirmed
the Board's order, and the appellate court affirmed the district
court's decision. The record contains notice from the Respondent of his
intent to file an appeal to the Louisiana Supreme Court, but it does
not contain anything further concerning the status of that appeal.
During the hearing before Judge Bittner, Mr. Hingle, a registered
pharmacist and consultant to the Board, testified that he had also
served as the acting chief of the State Narcotics Program in the health
Department. He testified that the Respondent had prescribed
amphetamine-type substances, also called anorectics, and that the State
Board of Medical Examiners had issued a policy statement (Statement) in
1984, advising physicians that if a prescription for anorectics was
issued without medical justification, the physician's medical license
was subject to suspension or revocation. The Statement also established
standards, which if violated, would be considered per se evidence of
prescribing controlled substances without legitimate medical
justification. These standards included restricting the period of time
anorectics could be prescribed to a single patient to 12 consecutive
weeks, restricting the quantity of dosages per patient to insure the
patient did not ingest more than one maximum therapeutic dosage unit
per day, and restricting the issuance of anorectic prescriptions to
persons who were not drug dependent and who demonstrated weight loss
during the course of treatment. The Statement was part of the record,
and Mr. Hingle testified that the Statement was given to physicians
when they applied for their annual relicensure and was also published
in a newsletter issued by the Board to all state licensed physicians.
Because of complaints and subsequent investigation results, a DEA
Assistant Special Agent issued subpoenas to five pharmacies, and a DEA
Diversion Investigator obtained prescriptions written for specified
patients by the Respondent between January 1992 and September 1993. At
the hearing before Judge Bittner, the Investigator testified that
patient profiles were prepared by using those prescriptions. Mr. Hingle
then testified, after referring to the patient profiles, that in
numerous instances the Respondent had issued to individual patients
concurrent prescriptions for multiple substances, and that he would not
have filled these concurrent prescriptions because of the potential for
abuse of the substances if taken in conjunction with one another. He
also testified about the quantity of controlled substances contained in
numerous prescriptions and opined that in specified instances the
quantities prescribed or the period of time the substance was to be
consumed was excessive and could result in physical dependency. For
example, in a single month, one specific patient was prescribed
quantities of Valium and Vicodin which would allow the patient to take
approximately 11 doses a day. Vicodin was described as a phenanthrene
opioid, and Valium as the brand name of a product containing diazepam,
a Schedule IV controlled substance.
Also, Mr. Hingle noted a specific instance in which a prescription,
dated November 22, 1993, was issued for two substances containing
hydrocodone as a principal product ingredient. He testified that if the
patient had filled and consumed these substances together, the effect
would have been of taking a duplicate dosage of a depressant to the
central nervous system, and that such effect could have been dangerous
to the patient. He also testified that the Respondent had issued on
January 7, 1993, five prescriptions for central nervous system
depressants to one patient, that such a prescription practice was
unusual, and that he could not recall ever having seen five
prescriptions for controlled substances or central nervous system
depressants issued on the same day to a single patient for concurrent
use.
The Respondent testified during the hearing before Judge Bittner,
stating that he was a physician in general practice and had been
practicing medicine in Houma, Louisiana, since 1966. He stated that he
was aware that Ritalin was mostly prescribed to children for attention
deficit disorder, and that he had prescribed Ritalin to the State
Police Officer knowing that he did not have that condition. He also
testified that he knew XANAX was often used as a sleeping pill.
Further, the Respondent testified about his usual treatment and
prescribing practices, especially of patients participating in his
weight-control practice. During his testimony, the Respondent denied
knowledge prior to the Board's action against him of the ``12-week
rule'' pertaining to the prescription of anorectics. He testified that,
after he became aware of the rule, he had continued prescribing
anorectics in compliance with the rule, but that he had not prescribed
any anorectics since the end of 1990.
In response to Mr. Hingle's testimony, the Respondent testified
about his diagnosis, treatment, and issuance of prescriptions relative
to specifically addressed patients. However, he did not offer into
evidence any patient treatment records documenting his practices. Also,
the Respondent did not acknowledge committing any wrongdoing in his
prescription practices, despite the 1989 findings of the Board and the
patient profile evidence of his multiple prescriptions to single
patients in 1992 and 1993 presented during the hearing before
[[Page 52707]]
Judge Bittner. He also did not present any evidence of remedial actions
taken or proposed, except his testimony that he had stopped prescribing
anorectics in 1990.
Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy
Administrator may revoke a DEA Certificate of Registration and deny any
application for such registration, if he determines that the continued
registration would be inconsistent with the public interest. Section
823(f) provides that the following factors be considered ``in
determining the public interest:''
(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.
These factors are to be considered in the disjunctive. That is, 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. Schwarz, Jr., M.D., Docket No. 88-42,
54 FR. 16422 (1989).
Here, the Deputy Administrator finds that factors one, two, four
and five are relevant in determining whether the Respondent's continued
DEA registration would be inconsistent with the public interest.
Evidence of record bearing on factor one includes the action of the
Louisiana Board of Medical Examiners, as upheld by the Louisiana Fourth
Circuit Court of Appeals, in ordering the Respondent to surrender his
Schedule II controlled substance privileges permanently. Such action
clearly reflects that Board's recommendation as to this Respondent's
access to Schedule II substances.
The Respondent's testimony demonstrated his knowledge of the
medical purposes for which Ritalin and XANAX would be prescribed. Yet
his actions of prescribing Ritalin, which contains a Schedule II
substance, and XANAX, which contains a Schedule IV substance, to State
Police Officers for no legitimate medical reason is not in compliance
with applicable laws relating to the dispensing of controlled
substances. Such actions are relevant to factors two and four of
Section 823(f).
Further, the record also established that in 1987 and 1988 the
Respondent prescribed anorectics in a manner which directly violated
the Louisiana Medical Board's disseminated 1984 Statement concerning
the limitations placed upon issuing prescriptions for that substance.
Although the Respondent denied knowledge of that Statement,
significantly of record is the Board's reply to the same contention
raised by the Respondent before it:
Our findings and conclusions here, however, do not depend on
whether or not Respondent did in fact have prior notice of the
Statement, and we make no finding in that regard. The substance of
the Statement is accepted medical fact of which any competent
physician who undertakes to prescribe anorectic medications is, or
should be, aware. Thus, as a physician who testified on [the
Respondent's] behalf observed with respect to overprescribing
anorectics, without recalling whether he himself had seen the
Board's Statement, all physicians have been ``cautioned about it.
I've been cautioned about amphetamines, all of us have, that you
don't use them over a prolonged period of time, excessive long
period of time.''
Finally, the Board's findings as to the Respondent's medical
treatment and prescription practices, and the testimony of Mr. Hingle,
establish instances in the record of the Respondent's prescribing
excessive amounts of substances to individuals in combinations commonly
seen in cases of suspected substance abuse. Despite the Respondent's
testimony explaining his prescribing practices, the Deputy
Administrator finds that the preponderance of the evidence warrants a
conclusion that the Respondent's prescribing practices are not
consistent with the prevailing and usually accepted standards of
medical practice in the State of Louisiana, and ``may threaten the
public health or safety.'' 21 U.S.C. 832(f)(5).
In his filed exceptions, the Respondent asserts that Judge Bittner
erred in admitting hearsay evidence during the administrative hearing.
However, since the Respondent's hearing was conducted in accordance
with applicable statutes and regulations, the Deputy Administrator
declines to adopt the Respondent's exceptions based upon his challenged
evidentiary rulings. See, e.g., Klinestiver v. Drug Enforcement
Administration, 606 F.2d 1128, 1129-30 (D.C. Cir. 1979); Gary E.
Stanford, M.D., Docket No. 91-30, 58 FR 14430 (1993).
Next, the Respondent has requested that any restrictions placed
upon his DEA registration be limited to Schedule II substances as
recommended by the Board. He wrote that he had been practicing medicine
for the past five years under these restrictions without any violation
or charges. However, the record demonstrates through the patient
profiles and Mr. Hingle's testimony that the Respondent, in 1992 and
1993, had prescribed excessive quantities of controlled substances, to
include substances from Schedule IV, to individual patients. Thus, the
Respondent's requested restriction is inadequate; revocation is the
appropriate remedy.
Accordingly, the Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in him by 21 U.S.C.
823 and 824, 28 C.F.R. 0.100(b) and 0.104, hereby orders that DEA
Certificate of Registration, AW3369697, previously issued to Herman E.
Walker, Jr., M.D., be, and it hereby is, revoked. It is further ordered
that any pending applications for renewal of said registration be, and
hereby are, denied.
This order is effective November 9, 1995.
Dated: October 3, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-24949 Filed 10-6-95; 8:45 am]
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