[Federal Register Volume 75, Number 206 (Tuesday, October 26, 2010)]
[Notices]
[Pages 65663-65667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27028]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Gilbert Eugene Johnson, M.D.; Revocation of Registration
On November 20, 2008, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Gilbert Eugene Johnson, M.D. (Respondent), of Idabel,
Oklahoma. The Show Cause Order proposed the revocation of Respondent's
DEA Certificate of Registration, AJ6783535, as a practitioner, and the
denial of any pending applications to renew or modify his registration,
on the ground that Respondent's ``continued registration is
inconsistent with the public interest, as that term is used in 21
U.S.C. 823(f).'' Show Cause Order at 1.
The Show Cause Order alleged that the Oklahoma State Board of
Medical Licensure had found that: (1) Respondent ``prescribed or
administered a drug (i.e., meperidine, a schedule II controlled
substance, and hydrocodone, a schedule III controlled substance) or
treatment without sufficient examination or the establishment of a
valid physician patient relationship''; (2) Respondent ``engaged in
indiscriminate or excessive prescribing, dispensing or administering of
controlled or narcotic drugs''; and (3) Respondent ``prescribed,
dispensed or administered controlled substances or narcotic drugs in
excess of the amount considered good medical practice or prescribed,
dispensed or administered controlled substances or narcotic drugs
without medical need.'' Id. at 1-2.
Next, the Show Cause Order alleged that on June 23, 2008, based on
the Oklahoma Board's action, the Medical Board of California ``ordered
the revocation of [Respondent's] license to practice medicine in that
state, effective July 23, 2008.'' Id. at 2. Finally, the Order alleged
that on July 7, 2008, Respondent ``falsified'' his application for
renewal of his DEA registration ``by answering `no' to the question
concerning whether [Respondent] had ever had a state professional
license revoked or placed on probation or whether any such action was
pending.'' Id.
On December 16, 2008, the Show Cause Order was served on Respondent
by certified mail to him at the address which he had recently given the
Agency as his new registered location on his application to modify his
registration. On January 29, 2009, Respondent's counsel filed a request
for a hearing and the matter was placed on the docket of the Agency's
Administrative Law Judges (ALJs).
Thereafter, the ALJ requested that the parties address whether
Respondent had timely requested a hearing. See Corrected Order
Cancelling Hearing and Terminating Proceedings, at 1. Following receipt
of the parties' submissions, the ALJ found that Respondent's request
was not timely because it was not filed within 30 days of service of
the Show Cause Order as required by 21 CFR 1301.43(a). Id. at 2.
Because Respondent had not ``provide[d] a basis upon which to find good
cause,'' the ALJ held that his failure to file a timely request
constituted a waiver of his right to a hearing. Id. (citing 21 CFR
1301.43(d) and Brinton D. Glisson, 72 FR 54296 (2007)). Accordingly,
the ALJ canceled the scheduled hearing, terminated the proceedings, and
directed that the
[[Page 65664]]
matter be forwarded to me for final agency action pursuant to 21 CFR
1301.43(d) and 1301.46.
Thereafter, the Government forwarded the investigative record to me
for final agency action. Having considered the record, I agree with the
ALJ's finding that Respondent has waived his right to a hearing because
he failed to timely file his request and has not offered good cause for
his failure to do so. I further find that Respondent materially
falsified his July 2008 application and that he has committed acts
which render his registration inconsistent with the public interest. 21
U.S.C. 823(f) & 824(a)(1) & (4). Accordingly, Respondent's registration
will be revoked and his pending application to modify his registration
will be denied. I make the following findings.
Findings
Respondent previously held DEA registration, AJ6783535. While this
registration expired on December 31, 2007, on July 9, 2008, Respondent
submitted a renewal application and the registration was reinstated
with an expiration date of December 31, 2010. Moreover, on December 11,
2008, Respondent requested to change the address of his registered
location. I therefore find that Respondent has a registration and that
his application to modify his registration is pending before the
Agency.
On March 22, 2007, Respondent and the Oklahoma Board of State
Medical Licensure and Supervision (Oklahoma Board) entered into an
Order Accepting Voluntary Submittal to Jurisdiction (hereinafter,
Order). Therein, Respondent pled guilty to the allegations in a
Complaint and Citation which the Oklahoma Board had filed on January
27, 2007.
In the Order, the Oklahoma Board found that Respondent treated
another physician, DWW, from around January 2004 through July 2006.
During this period, Respondent issued ``two (2) prescriptions for
Meperidine, a Schedule II controlled dangerous substance * * * six (6)
prescriptions for Testosterone and Hydrocodone, both Schedule III
controlled dangerous substances * * * and twelve (12) prescriptions for
Alprazolam, Soma, and But/Apap/Caf, Schedule IV controlled dangerous
substances.'' \1\ Order at 2, Oklahoma ex rel. Bd. of Medical Licensure
& Supervision v. Johnson (Okla. Bd. of Med. Lic. & Super. Mar. 22,
2007). Respondent issued these prescriptions without ``perform[ing] any
physical examination on DWW'' and without establishing either ``a valid
physician patient relationship'' or ``a legitimate medical need for the
medical treatment.'' Id. In addition, he ``failed to maintain complete
and accurate records of all controlled dangerous drugs prescribed.''
Id. When questioned by an Oklahoma Board investigator, Respondent
admitted that he did not keep a patient record on DWW. Id.
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\1\ Neither Soma (carisoprodol) nor But/Apap/Caf is a controlled
substance under Federal law. However, the other drugs noted in the
Board's order are controlled under Federal law.
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The Oklahoma Board also found that Respondent treated JWW, DWW's
wife, from around November 2004 through February 2005. Id. at 3.
Respondent issued to JWW, ``one (1) prescription for Demerol, a
Schedule II controlled dangerous substance[,] * * * one (1)
prescription for Histinex HC, a Schedule III controlled dangerous
substance, and six (6) prescriptions for Alprazolam and But/Apap/Caf,
Schedule IV controlled dangerous substances.'' Id. As in the case of
DWW, Respondent issued these prescriptions to JWW without
``perform[ing] any physical examination'' and without establishing ``a
valid physician patient relationship'' or ``a legitimate medical need
for the medical treatment.'' Id. Again, Respondent failed to ``maintain
complete and accurate records of all controlled dangerous substances
prescribed'' and admitted to an Oklahoma Board investigator that he did
not see JWW ``as a patient.'' Id.
The Oklahoma Board further found that on two occasions, Respondent
issued prescriptions to JOW, one of his employees, for ``Diazepam, a
Schedule IV controlled dangerous substance''; the Board also found that
on another occasion, he issued prescriptions for ``Fiorinal w/Codeine
and Coughtuss, Schedule III controlled dangerous substances.'' Id. at
3. As to these prescriptions, the Board found that ``he failed to
perform any physical examination on JOW prior to prescribing the
controlled dangerous drugs in her name, that he did not establish a
valid physician patient relationship prior to prescribing the
medications, that he did not establish a legitimate medical need for
the medical treatment, and that he failed to maintain complete and
accurate records of all controlled dangerous drugs prescribed.'' Id.
Furthermore, the Board found that Respondent instructed JOW to fill the
diazepam prescriptions at City Drug and then return them to him for
``office use.'' Id.
The Oklahoma Board then found Respondent guilty of ``unprofessional
conduct'' based on his violations of numerous provisions of state law
and regulations. Id. at 4. The Board found, inter alia, that he: (1)
``[p]rescribed or administered a drug or treatment without sufficient
examination and the establishment of a valid physician patient
relationship,'' in violation of 59 Okla. Stat. Sec. 509(12); (2)
``[e]ngaged in indiscriminate or excessive prescribing * * * of
controlled or narcotic drugs,'' in violation of Okla. Admin. Code
435:10-7-4(1); (3) ``[v]iolated * * * state or federal law or
regulation relating to controlled substances,'' in violation of Okla.
Admin. Code 435:10-7-4(27); (4) ``[p]rescribed * * * controlled
substances or narcotic drugs in excess of the amount considered good
medical practice or prescribed * * * controlled substances or narcotic
drugs without medical need in accordance with published standards,'' in
violation of 59 Okla. Stat. Sec. 509(16) and Okla. Admin. Code 435:10-
7-4(2); 5) ``[w]rote a false or fictitious prescription for any drugs
or narcotics declared by the laws of [Oklahoma] to be controlled or
narcotic drugs,'' in violation of 59 Okla. Stat. Sec. 509(11); and 6)
``[p]urchased or prescribed any regulated substance in Schedule I
through V, as defined by the Uniform Controlled Dangerous Substances
Act, for the physician's personal use,'' in violation of Okla. Admin.
Code 435:10-7-4(5). Id. at 4-5.
Based on its findings, the Oklahoma Board reprimanded Respondent.
The Board also placed Respondent's medical license on probation for one
year, beginning March 22, 2007, subject to certain conditions including
that he could not call in any controlled-substance prescriptions, that
he complete board-approved courses in controlled substance prescribing
and recordkeeping, and that he maintain duplicate, serially-numbered
prescriptions of controlled substances, which are readily retrievable
and which must be provided on request to the Board's investigators. Id.
at 7.
On June 23, 2008, the Medical Board of California (California
Board) adopted a Default Decision and Order in a proceeding against
Respondent's California license. See Decision at 1, In re Gilbert E.
Johnson, M.D. (Med. Bd. Cal. 2008). In the Default decision, the Board
found that Respondent had been served with the accusation on September
25, 2007, and that his attorney had filed a response. Default Decision
and Order at 1. The Board also noted that Respondent and his attorney
had been served with a Notice of Hearing, which informed him of the
scheduled date of the hearing, but that neither Respondent, nor his
attorney, had appeared. Id.
[[Page 65665]]
Based on the findings of the Oklahoma Board, the California Board
concluded that Respondent had committed unprofessional conduct by,
inter alia, prescribing controlled substances ``to several individuals
without a prior physical examination, without a valid physician-patient
relationship, without establishing a medical need for the treatment,
and without maintaining complete and accurate records.'' Id. at 2-3.
The California Board further found that Respondent had committed
unprofessional conduct when he issued the controlled substance
prescriptions in the name of his employee, ``without a prior physical
examination or medical indications, and without maintaining an adequate
medical record, and directed the employee to fill the prescriptions and
then return the drugs to respondent.'' Id. at 3. The Board then revoked
Respondent's California medical license, effective July 23, 2008.
Decision at 1.
On July 7, 2008, Respondent completed and signed his renewal
application for his DEA registration.\2\ In section 4 of the
application, Respondent was required to answer four ``liability''
questions. The third of these asked: ``Has the applicant ever
surrendered (for cause) or had a state professional license or
controlled substance registration revoked, suspended, denied,
restricted, or placed on probation, or is any such action pending?''
(emphasis added). Respondent answered ``No.''
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\2\ The form is stamped with the filing date of July 9, 2008.
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Discussion
Section 304(a)(1) of the Controlled Substances Act (CSA) provides
that a registration ``may be suspended or revoked by the Attorney
General upon a finding that the registrant * * * has materially
falsified any application pursuant to or required by this subchapter.''
21 U.S.C. 824(a)(1). Section 304(a)(4) also provides that a
registration to ``dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). With respect to a practitioner, the CSA requires that the
following factors be considered in making the public interest
determination:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The [registrant's] experience in dispensing * * * controlled
substances.
(3) The [registrant'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.21 U.S.C. 823(f).
``[T]hese factors * * * are considered in the disjunctive.'' Robert
A. Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a
combination of factors and give each factor the weight I deem
appropriate in determining whether to revoke an existing registration
or to deny an application to modify a registration. Id. Moreover, I am
``not required to make findings as to all of the factors.'' Morall v.
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005); see also Volkman v. DEA,
567 F.3d 215, 222 (6th Cir. 2009).
Having considered the evidence, I conclude that the record provides
two independent grounds to evoke Respondent's registration and to deny
his pending application to modify his registration. First, Respondent
materially falsified his July 2008 application when he answered ``no''
to the question whether he had ever had a state licensed sanctioned or
if any such action was pending. Second, based on the Oklahoma Board's
findings regarding his prescribing of controlled substances, I conclude
that Respondent has committed acts which render his registration
inconsistent with the public interest.
The Material Falsification Allegation
As found above, on his July 7, 2008 application, Respondent
provided a ``no'' answer to the question: ``Has the applicant ever
surrendered (for cause) or had a state professional license or
controlled substance registration revoked, suspended, denied,
restricted, or placed on probation, or is any such action pending?''
Respondent's answer was false for two reasons: (1) The Oklahoma Board
had previously placed him on probation, and (2) the California Board
had initiated a proceeding against him and had adopted the Default
Decision, although the revocation of his license was not yet
``effective.''
Respondent knew that his statement was false with respect to both
proceedings. As to his failure to disclose the Oklahoma proceeding,
Respondent appeared in person before the Board and signed the Order
Accepting Voluntary Submittal to Jurisdiction which he had entered into
with the Board. He thus knew that the Oklahoma Board had placed him on
probation.
As for his failure to disclose the California proceeding, while at
the time he submitted his application, the revocation of his state
license had yet to go into effect, the Default Decision specifically
noted that Respondent had been served with the accusation, that his
attorney had filed a response to it, and that the State had received
signed certified mail receipts establishing that both he and his
attorney had received the Notice of Hearing. Thus, Respondent clearly
knew that the Medical Board of California had brought an action against
him which was then ``pending.''
It is likewise clear that Respondent's failure to disclose both
proceedings was a materially false statement under the CSA. A false
statement is material if it ``has a natural tendency to influence, or
was capable of influencing, the decision of the decisionmaking body to
which it was addressed.'' Kungys v. United States, 485 U.S. 759, 770
(1988) (int. quotation and other citations omitted). While the evidence
must be ``clear, unequivocal, and convincing,'' the ``ultimate finding
of materiality turns on a substantive interpretation of the law.'' Id.
at 772 (int. quotations and citations omitted). See also Craig H.
Bammer, 73 FR 34327, 34328 (2008). However, ``[i]t makes no difference
that a specific falsification did not exert influence so long as it had
the capacity to do so.'' United States v. Alemany Rivera, 781 F.2d 229,
234 (1st Cir. 1985).
Respondent's false statement was material because, under the public
interest standard, the Agency is required to consider, inter alia, an
applicant's experience in dispensing controlled substances and his
compliance with applicable state and federal laws related to controlled
substances. See 21 U.S.C. 823(f)(2) & (4). As found above, both Boards'
actions were based on Respondent's prescribing of various controlled
substances including meperidine (a schedule II controlled substance),
testosterone and hydrocodone (schedule III controlled substances), and
diazepam and alprazolam (schedule IV controlled substances) without
establishing a valid physician-patient relationship and without a
legitimate medical purpose. In addition, Respondent issued fraudulent
diazepam prescriptions in the name of his employee in order to obtain
the drugs for his own use (whether he personally used them or sold them
is legally irrelevant). Not only did these prescribings violate
Oklahoma law (and provide grounds for discipline under California law),
as explained more fully below, they also violated the
[[Page 65666]]
prescription requirement of Federal law. See 21 CFR 1306.04(a) (``A
prescription for a controlled substance to be effective must be issued
for a legitimate medical purpose by an individual practitioner acting
in the usual course of his professional practice.''). See also 21
U.S.C. 841(a)(1) (prohibiting knowing or intentional distribution/
dispensing of a controlled substance ``[e]xcept as authorized by'' the
CSA); 21 U.S.C. 843(a)(3) (``It shall be unlawful for any person
knowingly or intentionally * * * to acquire or obtain possession of a
controlled substance by misrepresentation, fraud, forgery, deception,
or subterfuge[.]'').
Because both the Oklahoma and California Board proceedings were
based on his unlawful prescribing of controlled substances, his failure
to disclose the proceedings on his application clearly had the capacity
to influence (and did influence) the Agency's decision to grant his
July 2008 application. I therefore hold that Respondent's failure to
disclose the Oklahoma and California proceedings was a material
falsification of his application; this conclusion provides reason alone
to revoke his registration and to deny his application to modify his
registration. See 21 U.S.C. 824(a)(1).
The Public Interest Allegations
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Compliance With State and Federal Laws Related to
Controlled Substances
As noted above, the Oklahoma Board found that, on multiple
occasions, Respondent prescribed various controlled substances in
schedules II through IV including Demerol (meperidine), hydrocodone
(including both Histinex and Coughtuss), testosterone, Fiorinal with
codeine, and alprazolam, to persons he had not physically examined
prior to issuing the prescriptions. The Board further found that
Respondent did not establish a valid physician-patient relationship
with these persons, that he did not establish that these persons had a
legitimate medical need for the controlled substances, and that he
failed to maintain complete and accurate records of the controlled
substances he prescribed. The Board also found that Respondent had
issued diazepam prescriptions in the name of his employee (again
without establishing a valid doctor-patient relationship and a
legitimate medical need for the prescription) and directed the employee
to fill the prescription and bring it back to the office.
The Oklahoma Board further found that in issuing these
prescriptions Respondent violated various provisions of state law
including, inter alia, prohibitions against prescribing ``without
sufficient examination and the establishment of a valid physician
patient relationship,'' 59 Okla. Stat. Sec. 509(12); ``[e]ngag[ing] in
indiscriminate or excessive prescribing * * * of controlled
substances,'' Okla. Admin Code 435:10-7-4(1); prescribing a controlled
substance ``without medical need in accordance with published
standards,'' 59 Okla. Stat. Sec. 509(16); writing false prescriptions
for controlled substances, id. Sec. 509(11); and prescribing
controlled substances for his ``personal use.'' Okla. Admin. Code
435:10-7-4(5).
Both the Oklahoma Board's factual findings and its legal
conclusions that Respondent violated state law are entitled to
preclusive effect in this proceeding. See University of Tennessee v.
Elliot, 478 U.S. 788, 797-98 (1986) (``When an administrative agency is
acting in a judicial capacity and resolves disputed issues of fact
properly before it which the parties have had an adequate opportunity
to litigate, the courts have not hesitated to apply res judicata'')
(int. quotations and citations omitted). I therefore adopt the Board's
findings that Respondent violated Oklahoma law and regulations with
respect to his prescribing to DWW, JWW, and JOW, of those drugs which
are controlled under Federal law.
I further hold that Respondent repeatedly violated Federal law when
he prescribed controlled substances to these individuals. As noted
above, under a longstanding Federal regulation, ``[a] prescription for
a controlled substance to be effective must be issued for a legitimate
medical purpose by an individual practitioner acting in the usual
course of his professional practice.'' 21 CFR 1306.04(a).
As the Supreme Court recently explained, ``the prescription
requirement * * * ensures patients use controlled substances under the
supervision of a doctor so as to prevent addiction and recreational
abuse. As a corollary, [it] also bars doctors from peddling to patients
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon,
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122,
135, 143 (1975)).
Under the CSA, ``it is fundamental that a practitioner must
establish a bona fide doctor-patient relationship in order to act `in
the usual course of * * * professional practice' and to issue a
prescription for a `legitimate medical purpose,' '' as required by 21
CFR 1306.04(a). Patrick W. Stodola, 74 FR 20727, 20731 (2009) (citing
Moore, 423 U.S. at 141-43. The CSA generally looks to state law to
determine ``whether a doctor and patient have established a bona fide
patient relationship.'' Id.; see also Kamir Garces-Mejias, 72 FR 54931,
54935 (2007); United Prescription Services, Inc., 72 FR 50397, 50407
(2007).
The Oklahoma Board found that Respondent did not establish a
``valid physician patient relationship'' with JWW, DWW and JOW, and
that he did not establish that these individuals had a legitimate
medical need for the prescriptions. Accordingly, I hold that in
prescribing to these persons, Respondent acted outside of the usual
course of professional practice and lacked a legitimate medical purpose
and therefore violated Federal law as well. See 21 U.S.C. 841(a)(1); 21
CFR 1306.04(a). I further hold that Respondent violated Federal law
when he acquired diazepam by issuing fraudulent prescriptions to JOW
and directed the latter to fill the prescriptions and bring them back
to the office. See 21 U.S.C. Sec. 843(a)(3).
As the forgoing demonstrates, Respondent's experience in dispensing
controlled substance and his record of compliance with applicable laws
is characterized by his numerous violations of both State and Federal
drug laws.\3\ I therefore hold that Respondent has committed acts which
render his registration ``inconsistent with the public interest.'' Id.
Sec. 824(a)(4). This conclusion provides an independent ground (apart
from his material falsification) to revoke his registration and to deny
his application to modify his registration.
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\3\ While the Oklahoma Board placed Respondent on probation, it
made no recommendation in this matter (factor one). Moreover, even
were I to deem the Board's decision to continue Respondent's medical
license as a recommendation, the Board's decision is not
dispositive. While holding authority under state law is a necessary
prerequisite to obtaining a DEA registration, see 21 U.S.C. 823(f),
DEA has long held that ``the Controlled Substances Act requires that
the Administrator * * * make an independent determination as to
whether the granting of controlled substances privileges would be in
the public interest.'' Mortimer Levin, 57 FR 8680 (1992). Of course,
the California Board revoked Respondent's California license based
on the same conduct.
It is also acknowledged that Respondent has not been convicted
of either a State or Federal offense related to the distribution or
dispensing of controlled substances (factor three). However, the
absence of a criminal conviction is not dispositive of the public
interest inquiry. See, e.g., Jayam Krishna-Iyer, 74 FR 459, 461
(2009); Edmund Chein, 72 FR 6580, 6593 n.22 (2007).
In light of the extensive evidence under factors two and four, I
conclude that there is no need to make findings under factor five.
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[[Page 65667]]
Conclusion
The investigative record shows that Respondent materially falsified
his July 2008 application and that he repeatedly prescribed controlled
substances in violation of both Oklahoma and Federal law. The record
thus establishes two independent and adequate grounds for revoking
Respondent's registration and denying his application to modify his
registration. Accordingly, Respondent's registration will be revoked
and his application will be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b) & 0.104, I order that DEA
Certificate of Registration, AJ6783535, issued to Gilbert Eugene
Johnson, M.D., be, and it hereby is, revoked. I further order that the
pending application of Gilbert Eugene Johnson, M.D., to modify his
registration, be, and it hereby is, denied. This Order is effective
November 26, 2010.
Dated: October 14, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-27028 Filed 10-25-10; 8:45 am]
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