[Federal Register Volume 64, Number 119 (Tuesday, June 22, 1999)]
[Notices]
[Pages 33319-33321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15750]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 98-15]
Saihb S. Halil, M.D.; Revocation of Registration; Denial of
Request for Modification
On November 6, 1996, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA) issued an
Order to Snow Cause to Saihb S. Halil, M.D. (Respondent) of California,
notifying him of an opportunity to show cause as to why DEA should not
revoke his DEA Certificate of Registration AH1993749, and deny any
pending applications for renewal of such registration pursuant to 21
U.S.C. 823(f) and 824(a)(3), for reason that his California medical
license was revoked effective May 3, 1995, and he is therefore not
currently authorized to handle controlled substances in that state.
Following subsequent communication between Respondent and DEA,
Respondent submitted a letter to DEA dated January 29, 1998, requesting
that his DEA Certificate of Registration be modified to reflect a
Puerto Rico address. On February 20, 1998, DEA issued an Amended Order
to Show Cause to Respondent proposing to revoke his DEA Certificate of
Registration pursuant to 21 U.S.C. 824(a)(1) and (a)(3), and to deny
his request to modify his registration and to deny any pending
applications for renewal of such registration under 21 U.S.C. 823(f)
for reason that his continued registration would be inconsistent with
the public interest.
By letter dated March 2, 1998, Respondent timely filed a request
for a hearing, and following prehearing procedures, a hearing was held
in San Francisco, California on July 1, 1998, before Administrative Law
Judge Gail A. Randall. At the hearing, both parties called a witness to
testify and introduced documentary evidence. After the hearing, both
parties filed proposed findings of fact, conclusions of law and
argument. On November 19, 1998, Judge Randall issued her Opinion and
Recommended Ruling, recommending that Respondent's DEA registration be
revoked and that his request for modification and any pending
applications for renewal be denied. Neither party filed exceptions to
the Opinion and Recommended Ruling of the Administrative Law Judge, and
on January 6, 1999, Judge Randall transmitted the record of these
proceedings to the Deputy Administrator.
The Deputy Administrator has considered the record in its entirety,
and pursuant to 21 CFR 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 findings of fact and
conclusions of law of the Administrative Law Judge, and adopts Judge
Randall's recommended ruling with one exception. 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 Respondent was issued DEA
Certificate of Registration AH1993749 on March 18, 1983.
Effective July 10, 1995, the Medical Board of California (Board)
revoked Respondent's license to practice medicine based upon his
patient care in 1987 and 1988. The Board concluded that Respondent's
license should be revoked (1) ``For gross negligence in his treatment
of [3 named patients];'' (2) ``for repeated acts of negligence in his
treatment of [3 named patients];'' (3) ``for acts and omissions which
constitute incompetence in his treatment of [2 named patients];'' (4)
``for dishonest and corrupt acts in his dealings with [1 named
patient];'' and (5) ``for sexual misconduct with [1 named patient].''
Further the Board adopted the state administrative Law judge's finding
that Respondent had been ``untruthful in his depositions in 1990, and
he [had been] untruthful at trial in 1994.''
In October 1995, Respondent submitted a renewal application for his
DEA Certificate of Registration listing a California address. On this
application, Respondent listed the license number for his revoked
California medical license in response to the question regarding the
status of his state licensure. Further, Respondent answered ``No'' in
response to the question on the application (hereinafter referred to as
the liability question'') which asks in relevant part: ``Has the
applicant ever * * * had a State professional license or controlled
substance registration revoked, suspended denied, restricted or placed
on probation, or is any such action pending against the applicant?'' At
the hearing in this matter, Respondent testified that he had not
personally completed this renewal application nor had he signed it.
On November 6, 1996, DEA issued the first Order to Show Cause to
Respondent. By letter dated November 22, 1996, Respondent informed DEA
that he currently was practicing medicine in Puerto Rico, and requested
information concerning what other action he should take in response to
the Order to Show Cause. DEA did not reply to Respondent's letter until
December 30, 1997. DEA informed Respondent that he needed to request a
modification of his DEA registration to reflect his Puerto Rico
address. By letter dated January 29, 1998, Respondent requested
modification of his DEA Certificate of Registration to reflect a Puerto
Rico address.
At the hearing in this matter, Respondent admitted that he lacked
in-depth knowledge of the applicable DEA regulations. He further
testified that although he has pursued extensive medical training while
in Puerto Rico, the training did not include classes concerning the
handling of controlled substances.
The Government contends that Respondent's DEA Certificate of
Registration must be revoked since he is no longer authorized to
practice medicine or handle controlled substances in California, and
state authorization is a necessary prerequisite to DEA registration.
Further the Government contends that Respondent's request for
modification of his DEA registration to reflect a Puerto Rico address
should be denied based upon Respondent's material falsification of his
October 1995 renewal application.
Respondent asserts that his request for modification of his DEA
Certificate of Registration should be granted because he did not
materially falsify his renewal application; the Government failed to
prove that modification of his registration would be inconsistent with
the public interest; and the Government is estopped from taking adverse
action based upon its failure to process his application in a timely
manner. Respondent further asserts that if his request for modification
is granted to reflect a Puerto Rico address, then the Government no
longer has a basis for revoking his DEA registration.
As to Respondent's estoppel argument, the Deputy Administrator
agrees with Judge Randall that ``[t]he chronology of agency action in
this case
[[Page 33320]]
is troubling * * *''. Respondent submitted a timely reply to the
initial Order to Show Cause requesting further guidance; however the
Government did not respond for 13 months.
But, DEA has previously held that:
[P]rinciples of equitable estoppel cannot be applied to deprive the
public of the protection of a statute because of the mistaken
action, or lack of action, on the part of public officials * * *.
Generally, a governmental unit is not estopped when functioning in a
governmental capacity.
James Dell Potter, M.D., 49 FR 9970 (1994) (alteration and omission in
original).
The Deputy Administrator agrees with Judge Randall's conclusion
that ``[a]lthough worthy of consideration and concern, such lack of
timeliness does not overcome the public interest in this case.
Equitable estoppel does not operate under these circumstances to
preclude the DEA from protecting the public health and safety.''
Therefore, the Deputy Administrator must determine whether Respondent's
registration should be revoked and his request for modification denied
in light of the facts of this case and the relevant law.
Initially, the Deputy Administrator notes that DEA does not have
the statutory authority under the Controlled Substances Act to register
a practitioner unless that practitioner is authorized to handle
controlled substances by the state in which he or she practices. See
802(21), 823(f), and 824(a)(3). DEA has consistently held that a
practitioner may not maintain a DEA registration when the practitioner
lacks authority to handle controlled substances in the state in which
he or she practices. See, e.g., Charles Milton Waller, D.D.S., 62 FR
34,310 (1997); Suzanne Kirkwood King, M.D., 62 FR 33,680 (1997); Anne
Lazar Thorn, M.D., 62 FR 12,847 (1997).
The Deputy Administrator finds that it is undisputed that
Respondent is not currently authorized to practice medicine in the
State of California, where he is registered with DEA. Therefore, it is
reasonable to infer that he is also not authorized to handle controlled
substances in that state. As a result, Respondent is not entitled to
maintain a DEA registration in that state.
However, Respondent has sought to modify his DEA registration to an
address in Puerto Rico where he is authorized to handle controlled
substances. Pursuant to 21 CFR 1301.51, requests for modification
``shall be handled in the same manner as an application for
registration.''
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an
application for a DEA Certificate of Registration, if he determines
that the registration would be inconsistent with the public interest.
Section 823(f) requires 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; 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., 54 FR 16,422
(1989).
The Deputy Administrator agrees with Judge Randall that factors one
and five are relevant in this case in determining the public interest.
As to factor one, it is undisputed that Respondent's California medical
license was revoked in July 1995. However, Respondent is currently
licensed to practice medicine and handle controlled substances in the
Commonwealth of Puerto Rico.
The Government argues that Respondent's material falsification of
his DEA renewal application should be considered under factor five in
determining whether Respondent's continued registration is inconsistent
with the public interest. Answers to liability questions are considered
material, because DEA relies upon such answers to determine whether an
investigation is needed prior to granting the application. See Ezzat E.
Majd Pour, M.D., 55 FR 47,547 (1990). DEA has consistently held that
the test for determining whether an applicant has materially falsified
an application for registration is whether the applicant knew or should
have known that the information he provided on the application was
false. See Herbert J. Robinson, M.D., 59 FR 6304 (1994); Bobby Watts,
M.D. 58 FR 46,995 (1993).
Respondent's California medical license was revoked in July 1995,
yet he indicated in his October 1995 renewal application that no action
had been taken against his state license. Respondent knew or should
have known, at the time that his renewal application was submitted,
that his answer to the liability question was false.
As Judge Randall noted, ``[a]though the Respondent testified that
he had not personally completed the renewal application, such an
assertion does not relieve him of the responsibility of assuring the
truthfulness of information submitted to the DEA on his behalf.'' The
Deputy Administrator agrees with Judge Randall that the Government has
presented a prima facie case of material falsification.
The Deputy Administrator also agrees with Judge Randall that
Respondent's admission of a lack of in-depth knowledge of controlled
substance regulations is relevant under factor five. Registrants must
be familiar with the regulations relating to controlled substances to
ensure that controlled substances are properly handled and not diverted
for illicit purposes.
Judge Randall concluded that Respondent's registration should be
revoked based upon his lack of state authorization to handle controlled
substances, and that his request for modification of his registration
should be denied based upon his material falsification of his renewal
application and his admitted lack of knowledge of controlled substance
regulations. But Judge Randall further stated that:
given the extraordinary lapse of time since the Respondent's
unacceptable medical practices in 1987 and 1988, should the
Respondent (1) Apply for a new registration with a truthful
application, disclosing his complete license history, and (2) submit
evidence of recent training in the handling of controlled
substances, then I would recommend that the Deputy Administrator
consider granting such an application.
The Deputy Administrator agrees that Respondent's request for
modification of his DEA registration to reflect a Puerto Rico address
should be denied as inconsistent with the public interest. Respondent
was responsible for the material falsification of his renewal
application. In addition, his admitted lack of knowledge concerning the
proper handling of controlled substances is troubling to the Deputy
Administrator. As a result, the Deputy Administrator is not convinced
that Respondent can be trusted to responsibly handle controlled
substances.
The Deputy Administrator further concludes that since Respondent's
request for modification is denied, Respondent is left with his DEA
registration in California. Respondent cannot maintain his DEA
registration in California based upon his lack of authorization to
handle controlled
[[Page 33321]]
substances in that state. As a result, his DEA Certificate of
Registration must be revoked.
Therefore, the Deputy Administrator agrees with Judge Randall that
Respondent's registration must be revoked and his request for
modification denied. But, the Deputy Administrator declines to indicate
under what circumstances DEA would consider granting any future
applications. Any such applications will be considered in light of the
facts and circumstances that exist at that time.
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 AH1993749, issued to Saihb S. Halil, M.D.,
be, and it hereby is, revoked. The Deputy Administrator further orders
that Dr. Halil's request to modify his registration, and any pending
applications for renewal of his registration, be, and they hereby are,
denied. This order is effective July 22, 1999.
Dated: June 14, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-15750 Filed 6-21-99; 8:45 am]
BILLING CODE 4410-09-M
