[Federal Register Volume 63, Number 47 (Wednesday, March 11, 1998)]
[Notices]
[Pages 11907-11910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6158]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 97-15]
Cecil E. Oakes, Jr., M.D.; Grant of Restricted Registration
On February 25, 1997, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Cecil E. Oakes, Jr., M.D., (Respondent) of Fort
Benning, Georgia and Fairfield, California, notifying him of an
opportunity to show cause as to why DEA should not deny his
applications for registration as a practitioner under 21 U.S.C. 823(f),
for reason that such registration would be inconsistent with the public
interest.
By letter dated April 1, 1997, Respondent, proceeding pro se, filed
a request for a hearing and following prehearing procedures, a hearing
was held in San Francisco, California on August 20, 1997, before
Administrative Law Judge Gail A. Randall. At the hearing, the
Government called witnesses to testify and introduced documentary
evidence. Respondent testified on his own behalf. After the hearing,
both sides submitted proposed findings of fact, conclusions of law and
argument. On December 15, 1997, Judge Randall issued her Recommended
Rulings, Findings of Fact, Conclusions of Law, and Decision,
recommending
[[Page 11908]]
that Respondent be granted a DEA Certificate of Registration subject to
several conditions. On January 2, 1998, Government counsel filed
Exceptions to the Conclusion and Recommended Decision of the
Administrative Law Judge, and on January 20, 1998, Judge Randall
transmitted the record of these proceedings to the Acting Deputy
Administrator.
The Acting 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 Acting Deputy Administrator adopts, except as specifically
noted below, the Recommended Rulings, Findings of Fact, Conclusions of
Law, and Decision of the Administrative Law Judge. 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 Acting Deputy Administrator finds that according to Respondent,
he first obtained a DEA Certificate of Registration in the late 1960's.
At some point, he became licensed to practice medicine in the state of
Ohio and on December 29, 1987, was issued DEA Certificate of
Registration AO9640168, for a Columbus, Ohio address bearing an
expiration date of December 31, 1990. Respondent was not subsequently
issued any other Certificates of Registration by DEA.
Sometime in 1994, DEA was contacted by a credentials coordinator
with the Department of the Army, regarding the status of Respondent's
DEA Certificate of Registration. The credentials coordinator forwarded
a copy of Respondent's credentials file to DEA. Upon reviewing the
file, it became apparent that on three separate occasions, Respondent
altered the last DEA Certificate of Registration issued to him. First,
Respondent changed the date of issuance to December 29, 1988, with an
expiration date of December 31, 1991. Then Respondent altered the
issuance date to read December 29, 1990, and the expiration date to
read December 31, 1993. Finally, Respondent altered the date of
issuance to December 29, 1993, with an expiration date of December 31,
1996. On this last altered certificate, Respondent also changed the
address to a location in Tulsa, Oklahoma.
Further investigation revealed that at various times between 1991
and 1994, Respondent worked at two different army hospitals in Georgia.
Documents supplied by the hospitals show that between January 1993 and
January 1994, Respondent prescribed controlled substances to patients
at one of the hospitals, and between June 16, 1994 and August 15, 1994,
Respondent dispensed controlled substances to patients at the other
hospital. Respondent did not possess a valid DEA Certificate of
Registration during these time periods.
During the course of the investigation, DEA discovered that
Respondent worked for an employment agency for doctors that perform
locum tenens work. DEA advised the agency that Respondent was not
registered with DEA to handle controlled substances. Subsequently, on
August 12, 1994, the employment agency sent a letter to Respondent
asking for ``a statement attesting to the fact that you currently
possess a current DEA registration and the current expiration date.''
Respondent replied, ``I have a current DEA registration. The expiration
date is 1996.''
Respondent then contacted DEA to arrange a meeting. When confronted
with the altered Certificates of Registration, Respondent admitted that
he knew that they were altered. Respondent was advised that he was not
registered with DEA and therefore not authorized to handle controlled
substances. Respondent was provided with an application for a new
registration.
DEA was advised by officials at Respondent's then-employer at Fort
Benning that Respondent was a competent physician; that he was good at
his job; and that they would continue employing Respondent. As a
result, the DEA Atlanta office decided to register Respondent pursuant
to a Memorandum of Agreement that would place certain restrictions on
his DEA registration, including that he would abide by all laws and
regulations relating to controlled substances; that he would admit that
he handled controlled substances knowing that he did not have a current
DEA registration; and that he would be restricted to the institutional
use of his DEA registration at the hospital at Fort Benning. The terms
of the agreement were to remain in effect for three years.
Respondent signed the Memorandum of Agreement on November 4, 1995.
The agreement was forwarded to the DEA Atlanta office by letter dated
November 4, 1995, in which Respondent also requested that he be allowed
to transfer his restricted registration from Fort Benning, Georgia to
California. There is no evidence in the record regarding DEA's response
to this request, however the DEA Atlanta Diversion Group Supervisor
signed the agreement on behalf of DEA on November 15, 1995.
In the midst of the Memorandum of Agreement being negotiated and
executed, Respondent applied for a California medical license on August
17, 1995. Thereafter, Respondent was issued a California medical
license, however Respondent was subsequently cited and fined by the
Medical Board of California for falsely representing his date of birth
in both his application materials and to a medical board investigator.
On June 14, 1996, Respondent submitted an application for a DEA
Certificate of Registration at an address in California. Regarding this
application, Respondent was not offered the opportunity to become
registered subject to a Memorandum of Agreement, similar to the one
executed by the DEA Atlanta office in 1995.
Respondent testified at the hearing in this matter that at the time
he altered his DEA Certificate of Registration, he was contending with
the financial and emotional burdens that accompanied his son's
diagnosis with Attention Deficit Disorder (ADD). His son attempted
suicide on three occasions, he was in the process of divorcing his
wife, and he had to file for bankruptcy. Respondent testified that,
``in no way am I using (his son's problems) as an excuse for bad
behavior or to try to rationalize it away unduly as being justified.
But I also know within myself at least that this would never have
happened if there hadn't been accumulating, seemingly never-ending
pressures, stresses and all the impact that it had on me during those
years.''
Respondent asserted that his son's problems are now under control,
and he ``can't think of any circumstance in which those actions would
ever be repeated.'' Respondent testified that he had received
counseling himself. Respondent recognized that there is no way that he
can ever prove totally that his actions will not be repeated without
having the opportunity to demonstrate that he can be trusted.
Respondent is currently employed at a clinic in California that
only treats patients with ADD. Respondent testified that there are only
five specific controlled substances prescribed in the treatment of ADD
at the clinic where he works, and no drugs are dispensed. Respondent
further testified that he intends to only practice at this clinic.
During the course of the hearing, Respondent indicated that he no
longer wishes to be registered at the Georgia location listed on his
September 1, 1994 application.
The Founder and President of the Haight Ashbury Free Clinics, Inc.
submitted a letter on Respondent's
[[Page 11909]]
behalf indicating that he had known and worked with Respondent for 25
years. He stated that Respondent ``has high medical standards and a
strong code of ethics. He has never abused drugs personally or over-
prescribed controlled substances with his patients * * *. I give him
the highest recommendation.''
As a preliminary matter, Judge Randall concluded that Respondent
has indicated that he no longer wishes to be registered with DEA in
Georgia. Accordingly, she recommended that Respondent be granted
permission to withdraw his September 1, 1994 application pursuant to 21
CFR 1301.16. The Acting Deputy Administrator agrees with Judge Randall
that Respondent should be allowed to withdraw his application. However,
Respondent still wishes to be registered with DEA to handle controlled
substances in California.
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
such registration would be inconsistent with the public interest. In
determining the public interest, the following factors are 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.
(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 be
denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-42, 54 FR 16-422
(1989).
Regarding factor one, it is undisputed that the Medical Board of
California cited and fined Respondent for falsely representing his date
of birth both in his application materials for a California medical
license and to a Medical Board investigator. However, there is no
evidence in the record that Respondent's ability to practice medicine
and handle controlled substances has been restricted in any way by the
Medical Board.
Factors two and four, Respondent's experience in dispensing
controlled substances and his compliance with laws relating to
controlled substances, are both relevant in determining whether
Respondent's registration would be inconsistent with the public
interest. The Acting Deputy Administrator finds that there is no
question that Respondent has not been registered with DEA to handle
controlled substances since December 31, 1990, yet he continued to use
his expired DEA registration to prescribe and dispense those substances
in violation of 21 U.S.C. 841(a)(1) and 843(a)(2).
As to factor three, there is no evidence that Respondent has any
convictions relating to the handling of controlled substances.
Regarding factor five, Respondent's alteration of his DEA
Certificate of Registration on three separate occasions and the
misrepresentation of his date of birth on his application for a
California medical license raise serious concerns regarding
Respondent's trustworthiness. As Judge Randall found, ``these acts
would justify denial of the Respondent's application for registration,
for it calls into question the Respondent's truth and veracity, two
traits the DEA must rely upon in its relationship with registrants.''
Judge Randall concluded that the Government has presented a prima
facie case for the denial of Respondent's application based upon the
falsification of his DEA Certificate of Registration, his handling of
controlled substances without proper authorization and his
misrepresentations of his date of birth to the Medical Board of
California. However, Judge Randall found it significant that even after
knowing about Respondent's alterations of his DEA Certificate of
Registration, DEA entered into a Memorandum of Agreement with
Respondent concerning his application for registration in Georgia.
Judge Randall further found ``it inconsistent that the DEA has since
refused to offer a similar Memorandum for the Respondent's California
practice,'' particularly since Respondent's handling of controlled
substances in his practice in California would be more limited than
what was proposed in Georgia. Judge Randall also found significant
Respondent's expressions of remorse and his acceptance of
responsibility for his serious mistakes, as well as, the letter from
the Founder and President of the Haight Ashbury Free Clinics, Inc. who
attested to Respondent's high medical and ethical standards.
Judge Randall concluded that while Respondent's acts during 1991 to
1994 warrant concern, the ``totality of the circumstances would justify
a remedy less severe than total denial of the Respondent's
application.'' Therefore, Judge Randall recommended that the
``[g]ranting of a restricted registration, similar to the registration
offered the Respondent in the 1995 Memorandum, would still protect the
public interest.'' Judge Randall recommended that the following
conditions be placed on Respondent's registration:
1. For a period of three years from the effective date of the
Deputy Administrator's final order, the Respondent provide the DEA
San Francisco Field Division, information of the Respondent's change
of employment, if any, thirty days prior to the effective date of
the actual change of employment.
2. For a period of three years from the effective date of the
Deputy Administrator's final order, the Respondent file annually
with the DEA San Francisco Field Division, evidence of his current
California medical license.
3. That the Respondent abide by all Federal, state and local
laws and regulations relating to the registration to handle and the
actual handling of controlled substances.
The Government filed exceptions to Judge Randall's recommended
decision. First, the Government seems to suggest that it is
inconsistent for the Administrative Law Judge to find that the
Government has presented a prima facie case for the denial of the
application, yet recommend that Respondent be granted a restricted
registration. The Acting Deputy Administrator finds that by definition,
prima facie case means ``such as will prevail until contradicted and
overcome by other evidence.'' Black's Law Dictionary (6th ed. 1990).
Here, the Government has established that grounds exist to deny
Respondent's application for registration given his alterations of his
Certificate of Registration, his handling of controlled substances
without proper authorization, and his misrepresentations to the Medical
Board of California. However, the Acting Deputy Administrator concludes
that the evidence in favor of denial of Respondent's application is
overcome by the fact that he was not offered a Memorandum of Agreement
similar to that offered in 1995, his expressions of remorse and
acceptance of responsibility for his actions, and the letter of support
submitted on his behalf. Therefore, the Acting Deputy Administrator
does not find that Judge Randall's finding and recommendation are
inconsistent.
Second, the Government argues that Judge Randall's recommended
action is a departure from prior agency practice and policy. The
Government cites several cases where the applicant/
[[Page 11910]]
registrant ``engaged in conduct which was untruthful and lacking in
trustworthiness and integrity,'' and DEA ``found that revocation was
the appropriate sanction.'' However, the Acting Deputy Administrator
finds that those cases can be distinguished from the facts and
circumstances of this case. In those cases the registrant/applicant
either continued to deny any wrongdoing or presented no evidence in
mitigation. See Maxicare Pharmacy, 61 FR 27368; Stanley Karpo, D.P.M.,
61 FR 13,876 (1996); Albert L. Pulliam, M.D. 60 FR 54,513 (1995);
Richard D. Close, M.D., 53 FR 43,947 (1988). The Government also cited
Alra Laboratories, Inc. v. DEA, 54 F.3d 450 (7th Cir. 1995), for the
proposition that ``past performance is the best predictor of future
performance.'' The Acting Deputy Administrator finds that this case can
also be distinguished from the present case, since the registration of
a distributor was revoked based upon a long history of non-compliance
with controlled substance laws and regulations.
Next, the Government asserts that the 1995 Memorandum of Agreement
entered into by the DEA Atlanta office was limited to a very
restrictive set of circumstances and has no effect on the DEA
Sacramento office's decision to seek an order proposing denial of
Respondent's application for registration in California. The Government
contends that the Atlanta Memorandum of Agreement limited Respondent to
practice at a certain army hospital and did not extend to any other
employment by Respondent. Additionally, Government counsel argues that
it ``is aware of no policy or regulation which would require any DEA
Field Division to accept or offer the same terms of registration as
might have been offered from another DEA office * * *.''
The Acting Deputy Administrator disagrees with the Government's
suggestion that Respondent's access to controlled substances in Atlanta
would have been more restricted than his access at his current place of
employment in California. In Atlanta, he would have been working at
only one army hospital, but he would have been working in the emergency
room with access to a wide variety of controlled substances. In
addition, his handling of controlled substances would not have been
limited to prescribing only. At his present employment in California,
Respondent has testified that he will only prescribe five specific
controlled substances in his treatment of ADD patients.
The Acting Deputy Administrator also disagrees with the
Government's suggestion that it was improper for Judge Randall to find
that it was inconsistent for the DEA Sacramento office not to offer
Respondent the same restricted registration as was offered by the DEA
Atlanta office in 1995. The Acting Deputy Administrator finds that the
only difference in the facts surrounding Atlanta's decision to give
Respondent a restricted registration and Sacramento's proposed denial
of his application is that Respondent misrepresented his date of birth
to the Medical Board of California. While this misrepresentation is
troublesome, it does not warrant the denial of Respondent's application
in light of his expressions of remorse and acceptance of responsibility
for his actions. Therefore, the Acting Deputy Administrator finds it
reasonable to register Respondent in California subject to certain
terms and conditions.
Finally, the Government argues in its exceptions that the
conditions to be placed on Respondent's registration proposed by Judge
Randall are of no benefit, since they are either already provided for
in the regulations relating to the handling of controlled substances or
they would merely provide DEA with advance notice of something that it
would ultimately learn from the state. However, the Government did not
offer any alternative restrictions.
The Acting Deputy Administrator agrees with the Government that the
proposed conditions recommended by Judge Randall are of limited
benefit. Serious questions remain regarding Respondent's
trustworthiness. But as Respondent testified, he will never be able to
totally assure DEA that he can be trusted to responsibly handle
controlled substances unless he is given an opportunity to prove
himself with a restricted registration. Therefore, the Acting Deputy
Administrator agrees with Judge Randall's recommendation to grant
Respondent a restricted registration. Such a resolution will provide
Respondent with the opportunity to demonstrate that he can responsibly
handle controlled substances, while at the same time protect the public
health and safety, by providing a mechanism for rapid detection of any
improper activity. See Michael J. Septer, D.O., 61 FR 53762 (1996);
Steven M. Gardner, M.D. 51 FR 12576 (1986). However, the Acting Deputy
Administrator concludes that the terms and conditions of Respondent's
registration recommended by Judge Randall must be modified as follows:
1. By the effective date of this final order, Respondent shall
notify the Resident Agent in Charge of the DEA Sacramento Resident
Office, or his designee, of his place of employment at that time.
Thereafter, for three years from the date of issuance of the DEA
Certificate of Registration, Respondent shall immediately notify the
Resident Agent in Charge of the DEA Sacramento Resident Office, or
his designee, of any changes in his employment.
2. For three years from the date of issuance of the DEA
Certificate of Registration, Respondent's controlled substance
handling authority shall be limited to the writing of prescriptions
only for the five specific drugs identified by Respondent to be
needed in his treatment of Attention Deficit Disorder patients:
Ritalin, Dexedrine, Adderall, Desoxyn, all of which are Schedule II
controlled substances, and Cylert, a Schedule IV controlled
substance.
3. For three years from the date of issuance of the DEA
Certificate of Registration, Respondent shall maintain a log of all
prescriptions that he issues. At a minimum, the log shall indicate
the date that the prescription was written, the name of the patient
for whom it was written, and the name and dosage of the controlled
substance prescribed. Upon request of the Resident Agent in Charge
of the Sacramento Resident Office, or his designee, Respondent shall
submit or otherwise make available his prescription log for
inspection.
4. For three years from the date of issuance of the DEA
Certificate of Registration, Respondent shall consent to periodic
inspections by DEA personnel based on a Notice of Inspection rather
than an Administrative Inspection Warrant.
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in him by
21 U.S.C. 823 and 824 and 29 CFR 0.100(b) and 0.104, hereby orders that
the application dated September 1, 1994, submitted by Cecil E. Oakes,
Jr., M.D., be, and it hereby is, withdrawn. The Acting Deputy
Administrator further orders that the application dated June 14, 1996,
submitted by Cecil E. Oakes, Jr., M.D., be, and it hereby is, granted
in Schedules II nonnarcotic and IV subject to the above described
restrictions. This order is effective April 10, 1998.
Dated: March 4, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-6158 Filed 3-10-98; 8:45 am]
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