Registrant Actions - 2013
[Federal Register Volume 78, Number 60 (Thursday, March 28, 2013)]
[Notices]
[Pages 19009-19012]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07194]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 13-7]
Gary Alfred Shearer, M.D.; Decision And Order
On February 4, 2013, Administrative Law Judge (ALJ) Christopher B.
McNeil issued the attached recommended decision. Neither party filed
exceptions to the decision.
Having reviewed the record in its entirety, including the ALJ's
recommended decision, I have decided to adopt the ALJ's rulings,
findings of fact, conclusions of law,\1\ and
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\1\ In opposing the Government's Motion for Summary Disposition,
Respondent argues that the Kentucky Board of Medical Licensure's
Order is based upon information provided by law enforcement which
"is seriously flawed, misconstrued, unverified, unsupported, or
simply, untrue." Resp. Reply to Govt's Mot. for Summ. Disp., at 2.
Respondent raises a plethora of contentions, including that the
conduct of the investigators "was highly prejudicial and, frankly,
inept," id.; that the Board "cherry-picked" the charts its
consultant reviewed and that the consultant's conclusion that
Respondent "violated the standard of care was wrong--because there
was no standard of care in Kentucky regarding what a physician
should do in the face of inconsistent [urine drug screens] at the
time these patients were being treated," id. at 4; and that the
Board ignored the consultant's recommendations that his prescribing
issues could be addressed by educating [him] about proper follow
up." Id. at 8. He then concludes by arguing that "DEA created the
case against [him] that led to his suspension[,]" that "[t]he
agency now wants to bootstrap the suspension it caused as a reason
to revoke [his] license to write controls" [sic], and that the
Board "most likely would never have suspended [his] medical license
without the DEA's biased, unfairly prejudicial input." Id. at 26-
27. As relief, Respondent seeks a hearing and a stay of the matter
until after the Board's hearing.
The fact remains that the Board's Order of Emergency Suspension
remains in effect, and "DEA has held repeatedly that a registrant
cannot collaterally attack the result of a state criminal or
administrative proceeding in a proceeding under section 304, 21
U.S.C. 824, of the CSA." Zhiwei Lin, 77 FR 18862, 18864 (2012)
(citing cases). As I held in Lin, "Respondent's various challenges
to the validity of the [Board's] Suspension Order must be litigated
in the forums provided by the State," and his "contentions
regarding the validity of the [Board's] Suspension Order are
therefore not material to this Agency's resolution of whether he is
entitled to maintain his DEA registration in" Kentucky. Id. As
explained by the ALJ, because Respondent no longer meets the CSA's
threshold requirement for holding a practitioner's registration, see
U.S.C. 802(21) and 823(f), he is not entitled to maintain his
registration and I decline his request to stay the matter until the
State concludes its proceeding.
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[[Page 19010]]
recommended Order.\2\
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\2\ While the ALJ "order[ed] that this case be forwarded to the
Deputy Assistant Administrator for final disposition," Order
Granting Govt's Motion for Summ. Disp., at 9; under Department of
Justice regulations, that official has not been delegated the
authority to issue "final orders in connection with [the]
suspension, denial or revocation of [a] registration." 28 CFR
0.104, Appendix to Subpart R of Part 0, Sec. 7.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration AS6213172, issued to Gary Alfred Shearer, M.D., be, and it
hereby is, revoked. I further order that any pending application of
Gary Alfred Shearer, M.D., to renew or modify his registration, be, and
it hereby is, denied. This Order is effective immediately.\3\
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\3\ Based on the findings set forth by the Kentucky Board of
Medical Licensure in the Emergency Order of Suspension, I conclude
that the public interest necessitates that this Order be effective
immediately. See 21 CFR 1316.67.
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Dated: March 21, 2013.
Michele M. Leonhart,
Administrator.
Anthony Yim, Esq., for the Government
Robert T. Core, Esq., for the Respondent
Recommended Ruling, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
Procedural History
Christopher B. McNeil, Administrative Law Judge. On November 28,
2012, the Deputy Administrator of the Drug Enforcement Administration,
Office of Diversion Control, filed an Order to Show Cause proposing to
revoke the DEA Certificate of Registration, Number AS6213172, issued to
Gary Alfred Shearer, M.D. ("Respondent"), pursuant to 21 U.S.C.
824(a)(3),(4) and 21 U.S.C. 823(f). As grounds for revocation, the
Government alleges that Respondent is "without authority to handle
controlled substances in the State of Kentucky." \1\
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\1\ Order to Show Cause Nov. 28, 2012 at 1.
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On December 26, 2012, Respondent, through counsel, filed a timely
request for hearing. Respondent does not dispute that his state license
was suspended by the Kentucky Board of Medical Licensure. He argues,
however, that the suspension was imposed "without any due process
hearing" and "is temporary in nature and is not permanent." \2\
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\2\ Request for Hearing Dec. 26, 2012 at 1.
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On January 2, 2013, the Government was ordered to provide evidence
to support the allegation that Respondent lacks state authority to
handle controlled substances. Its Motion for Summary Disposition was
received on January 8, 2013, with proof of service upon the Respondent.
Accompanying the Motion was an affidavit by Stephanie Burkhart, dated
January 3, 2013, and a photocopy of a document entitled "Emergency
Order of Suspension," appearing to be filed on September 24, 2012,
with the Commonwealth of Kentucky Board of Medical Licensure. This
Order states that the Board suspended the medical license it issued to
the Respondent, Gary A. Shearer, M.D., effective upon the Respondent's
receipt of the Order.
In my Order dated January 2, 2013, I provided to Respondent the
opportunity to respond to the Government's Motion for Summary
Disposition. I received that response on January 22, 2013. In his Reply
to the Government's Motion for Summary Disposition, Respondent, through
counsel, requests that I overrule the Government's motion, that a
hearing be held prior to the disposition of this administrative charge,
that these proceedings be held in abeyance until at least May 7, 2013,
at which time Respondent anticipates presenting evidence to the
Kentucky Medical Board, and that he be given an opportunity "to prove
that he has violated no law and adhered to the standards of care of his
profession." \3\
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\3\ Reply to the Government's Motion for Summary Disposition
Jan. 22, 2013 at 1.
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Accompanying the Respondent's Reply was a compact disk, the
contents of which were described within the Reply. Summarized, the
contents include records that Respondent avers are relevant to his
assertion that he has violated no law and has adhered to the standards
of care of his profession. I have not read all of the pages contained
on the disk. I have, however, examined portions of the 7,000 or so
pages contained therein. Coupled with the factual and legal premises
Respondent's counsel presented in his Reply, I believe I have a
sufficient understanding of the contents of the disk to proceed. (For
reasons set forth below, the disk has not been admitted as an exhibit,
nor are its contents evidence in this proceeding. The disk remains in
the record strictly as a proffer.)
Contained on the disk are medical records reflecting treatment
provided by Respondent and other medical professionals. The records
provide information about the treatment of patients whose circumstances
were examined by the Kentucky Medical Board. In his Reply brief,
Respondent states that the Motion for Summary Disposition now before me
is based on the judgment of the Kentucky Medical Board, but that the
Board's judgment was not predicated on evidence gathered during a Board
hearing, and that in fact Respondent has not yet been permitted to
present evidence to that Board. He stated he expects to make such a
presentation during a due process hearing currently scheduled to take
place before the Kentucky Medical Board on May 7, 8, and 9, 2013.\4\
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\4\ Id.
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Issue
The substantial issue raised by Respondent concerns this set of
circumstances. Respondent correctly contends that the Government's
Motion for Summary Disposition is based on the determination by the
Kentucky Medical Board that his license to practice medicine in the
Commonwealth should be suspended. He states that he currently is not
practicing medicine and is not prescribing any controlled substances.
He states that because of the temporary suspension of his license, his
medical practice is now idled.\5\
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\5\ Id. at 1-2.
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Beyond his contention that the Medical Board's action has been
taken without the opportunity to present evidence or respond to the
same, Respondent makes a pointed claim regarding the role of the United
States Department of Justice and the Drug Enforcement Administration.
Respondent contends that the Medical Board's action is predicated
wholly on action by investigators of the Drug Enforcement
Administration, averring that "the suspension was imposed by the Board
because of information furnished to it by Diversion and Task Force
Investigators of the DEA." \6\ He then asserts that DEA Diversion
personnel "approached the [Medical Board] and loaded the [B]oard up
with misinformation []." \7\ He contends that "much of the alleged
information the DEA Diversion Investigators provided the [Medical
Board] is seriously flawed, misconstrued, unverified, unsupported, or,
simply, untrue." \8\ According to Respondent, the evidence presented
to the Medical Board "was highly prejudicial and, frankly, inept."
\9\ The
[[Page 19011]]
sum and substance of this feature of Respondent's Reply is that the
Diversion investigators "ought not be permitted to engineer a state
licensure suspension, then bootstrap that questionable conduct into a
DEA summary revocation." \10\
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\6\ Id. at 2.
\7\ Id.
\8\ Id.
\9\ Id.
\10\ Id.
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The Respondent's Contentions
There are thus two legal bases upon which Respondent relies in his
argument against summary disposition. First, he challenges the
propriety of the Kentucky Medical Board's decision to summarily suspend
his medical license without first giving him the opportunity to
confront evidence against him and introduce evidence in support of his
own cause. Second, he challenges the propriety (and the fairness) of
conditions that permit the DEA to force the revocation of his DEA
Certificate without ever having the opportunity to present evidence in
his own behalf and without the chance to challenge evidence that has
been presented against him.
Missing from the otherwise thorough iteration of his premises is
any reference to authority, legal or otherwise, that would permit me to
enter into the weighing of the evidence Respondent has presented in
this Reply. The scope and focus of the proceedings now before me are
relatively concrete and highly circumscribed. They also are accurately
set forth by the Government in its Motion for Summary Disposition, an
analysis I am endorsing here.
Scope of Authority
The case before me is presented under a grant of authority to
either suspend or revoke a registration "upon a finding" that a
registrant "has had his State license or registration suspended,
revoked, or denied by competent State authority and is no longer
authorized by State law to engage in the * * * dispensing of controlled
substances." \11\ My authority in this case arises because the DEA has
jurisdiction over, and can register, "practitioners." Federal
statutory authority describes a "practitioner" as "a physician * * *
or other person licensed, registered, or otherwise permitted, by the
United States or the jurisdiction in which he practices * * * to
distribute, dispense, * * * [or] administer * * * a controlled
substance in the course of professional practice * * *." \12\ In
addition, Congress provided that the Attorney General, through the
DEA's Administrator, "shall register practitioners * * * if the
applicant is authorized to dispense * * * controlled substances under
the laws of the State in which he practices." \13\ These two
provisions are internally consistent and are unambiguous. They also
support the core premise set forth in the Government's Motion: that
upon suspension or revocation of his medical license in Kentucky,
Respondent no longer meets the statutory definition of a
"practitioner," which is a mandatory condition to continuing as a
Registrant.\14\ This construction of statutory authority has been
endorsed and applied by the Administration and by courts on appeal.\15\
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\11\ 21 U.S.C. 824(a)(3).
\12\ 21 U.S.C. 802(21).
\13\ 21 U.S.C. 823(f).
\14\ Government's Motion for Summary Disposition Jan. 8, 2013 at
4.
\15\ See Id.
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Facts
Given this body of law, the material fact here, indeed the sole
fact of consequence, is whether the Kentucky Medical Board has
suspended Respondent's medical license. Where, as here, no material
fact is in dispute, there is no need for an evidentiary hearing and
summary disposition is appropriate.\16\ The sole question of fact
before me can be addressed, and has been addressed, by stipulation. Our
record includes a declaration under penalty of perjury \17\ by
Stephanie Burkhart.\18\ Ms. Burkhart is the Lead Diversion Investigator
associated with this case. In her declaration, Ms. Burkhart avers that
the Kentucky Medical Board suspended Respondent's medical license on
September 24, 2012.\19\ She further states that this license is
currently suspended, and that Respondent is not authorized to prescribe
or dispense controlled substances in the Commonwealth.\20\ (Although I
note that, while the Government attributes Board action to that of the
Florida Department of Health,\21\ its citation to Appendix B
establishes that such action was by the Board in Kentucky, not
Florida.)
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\16\ See Michael G. Dolin, M.D., 65 FR 5661 (2000); see also
Philip E. Kirk, M.D., 48 FR 32887 (1983), aff'd sub nom. Kirk v.
Mullen, 749 F.2d 297 (6th Cir. 1984).
\17\ See 28 U.S.C. 1746.
\18\ Government's Motion for Summary Disposition Jan. 8, 2013 at
Appendix A.
\19\ Id. at 1.
\20\ Id.
\21\ Id. at 2.
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Also accompanying the Government's Motion is a photocopy of the
Commonwealth's Emergency Order of Suspension issued by Board of Medical
Licensure.\22\ This document appears to confirm the factual contentions
presented in D.I. Burkhart's Declaration, in that it declares it to be
an Emergency Order and orders the suspension of Respondent's medical
license, effective "upon receipt by the licensee." \23\ There is a
certificate of service accompanying the Board's Order, indicating that
a copy was sent by certified mail on September 24, 2012.
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\22\ Id. at Appendix B.
\23\ Id. at 13-14.
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In order to establish the factual predicate necessary to determine
this issue, I issued a procedural order dated January 23, 2013,
directing the Respondent to indicate whether the following four facts
are in dispute:
1. Respondent is registered with the Drug Enforcement
Administration as a practitioner in Schedules II through V pursuant
to DEA registration AS6213172, with a registered location of 7210
Turfway Road, Suite B, Florence, Kentucky 41042. This registration
expires by its terms on February 28, 2015.
2. On September 24, 2012, the Kentucky Board of Medical
Licensure, in case number 1433, issued an Emergency Order of
Suspension, suspending the Respondent's license to practice medicine
and prescribe controlled substances in Kentucky.
3. The Order of Suspension described above is admitted as ALJ
Exhibit 1.
4. The Order of Suspension is currently in effect, and has been
in effect continuously since the date Dr. Shearer received a copy of
that Order.
On January 31, 2013, I received Respondent's Response to this
procedural order, in which he stipulated to these four statements as
being true. Also noted in the procedural order was the fact that the
record did not establish when the Kentucky Board's Emergency Order of
Suspension was received by Respondent. The evidence otherwise
establishes that, indeed, Respondent has received the Board's Order,
and receipt is deemed to have been effective as of September 28, 2012.
Analysis
In determining whether to grant the Government's motion for summary
disposition, I am required to apply the principle of law that holds
such a motion may be granted in an administrative proceeding if no
material question of fact exists:
It is settled law that when no fact question is involved or the
facts are agreed, a plenary, adversary administrative proceeding
involving evidence, cross-examination of witnesses, etc., is not
obligatory--even though a pertinent statute prescribes a hearing. In
such situations, the rationale is that Congress does not intend
administrative agencies to perform meaningless tasks (citations
omitted).\24\
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\24\ NLRB v. International Assoc. of Bridge, 549 F.2d 634, 638
(9th Cir. 1977) (quoting United States v. Consolidated Mines &
Smelting Co., Ltd., 455 F.2d 432, 453 (9th Cir. 1971)).
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[[Page 19012]]
In this context, I am further guided by prior decisions before the
DEA involving certificate holders whose state medical licenses have
been revoked or suspended. On the issue of whether an evidentiary
hearing is required, "it is well settled that when there is no
question of material fact involved, there is no need for a plenary,
administrative hearing." \25\ Under this guidance, the Government's
motion must be sustained unless a material fact question has been
presented.
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\25\ See Michael G. Dolin, M.D., 65 FR 5661 (2000); Jesus R.
Juarez, M.D., 62 FR 14945 (1997); see also Philip E. Kirk, M.D., 48
FR 32887 (1983), aff'd sub nom. Kirk v. Mullen, 749 F.2d 297 (6th
Cir. 1984).
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The Government argues that the sole determinative fact now before
me is that Respondent's medical license has been suspended by the
Kentucky Medical Board. I agree. In order for a medical doctor to be
authorized to administer controlled substances, he or she must meet the
definition of "practitioner" as found in the Controlled Substances
Act.\26\ Such a person must be "licensed, registered, or otherwise
permitted by * * * the jurisdiction in which he practices * * * to
distribute, dispense, [or] administer * * * a controlled substance in
the course of professional practice." \27\ Delegating to the Attorney
General the authority to determine who may or may not be registered to
perform these duties, Congress permitted such registration only "if
the applicant is authorized to dispense * * * controlled substances
under the laws of the state in which he practices." \28\
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\26\ 21 U.S.C. 802(21).
\27\ Id.
\28\ 21 U.S.C. 823(f).
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These two sources of authority complement the provision that is
triggered when a registrant loses his or her state license to practice:
where, as here, a registrant "has had his State license or
registration suspended, revoked, or denied by competent State authority
and is no longer authorized by State law to engage in the * * *
dispensing of controlled substances," \29\ the registrant is no longer
entitled to registration by the DEA. As cited by the Government in its
Motion for Summary Disposition, there is substantial authority both
through agency precedent and through decisions of courts in review of
that precedent, holding that a petitioner's DEA registration is
dependent upon his or her license to practice medicine.\30\ Under the
doctrine before me, the Government meets its burden of establishing
grounds to revoke a registration upon sufficient proof establishing the
registrant's medical license has been suspended or revoked. That proof
is in the record before me, and it warrants the summary revocation of
Respondent's DEA certificate.
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\29\ 21 U.S.C. 824(a)(3).
\30\ Government's Motion for Summary Disposition Jan. 8, 2013 at
4, and cases cited therein.
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I am mindful of the arguments raised by Respondent in his Reply to
the Government's Motion for Summary Disposition. At the outset,
Respondent noted that he has not yet had an opportunity to present
evidence to the Kentucky Medical Board, and urges that action by the
DEA to revoke his registration wait until that process has run its
course.\31\ Emphasizing the temporary nature of the Medical Board's
emergency order, Respondent asserts that the Board acted on the basis
of evidence which, according to Respondent, is of questionable
weight.\32\ Beyond the concerns raised about not having been permitted
to challenge this evidence and about the accuracy or sufficiency of the
evidence, Respondent criticizes the DEA investigation and complains
about its undue influence on the Medical Board, all occurring without
benefit of a hearing.\33\
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\31\ Reply to the Government's Motion for Summary Disposition
Jan. 22, 2013 at 1.
\32\ Id. at 2.
\33\ Id.
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Some care should be taken to assure the parties that the actions
taken in this administrative proceeding conform to constitutional
requirements. Although he cites no authority in support of his claim, I
have examined the parties' contentions with an eye towards ensuring all
tenets of due process have been adhered to. There is, however, no
authority for me to evaluate the facts that underlie Respondent's
contentions. Those contentions are summarized in his Reply to the
Government's Motion for Summary Disposition. These generally describe
his meritorious service as a physician and the extenuating
circumstances that may have led to adverse outcomes for some of his
patients.\34\ While the details of these circumstances may well be of
interest to the Kentucky Medical Board, the facts or allegations
presented in his Reply are not material in the administrative
proceedings now before the DEA. In the proceedings now before me, the
only material question is answered by the stipulation that establishes
the suspension of Respondent's license. Further, and as is sufficiently
set forth in the Government's Motion for Summary Disposition,
revocation of the DEA certificate is warranted "even where a
practitioner's state authority has been summarily suspended and the
State has yet to provide the practitioner with a hearing to challenge
the State's action at which he may ultimately prevail." \35\
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\34\ Id. at 3-9 and 10-17.
\35\ Government's Motion for Summary Disposition Jan. 8, 2013 at
4 (quoting Kamal Tiwari, M.D., 76 FR 71604, 71606 (2011)).
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Conclusion, Order, and Recommendation
I find there is no genuine dispute regarding the action taken by
the Kentucky Medical Board, and that because of that action the
Respondent's medical license in Kentucky has been and remains
suspended. I find no other material facts at issue, for the reasons set
forth in the Government's Motion for Summary Disposition. Accordingly,
I grant the Government's Motion for Summary Disposition.
Upon this finding, I order that this case be forwarded to the
Deputy Assistant Administrator for final disposition. I recommend the
Respondent's DEA Certificate of Registration, Number AS6213172, be
revoked.
Dated: February 4, 2013.
Christopher B. Mcneil,
Administrative Law Judge.
[FR Doc. 2013-07194 Filed 3-27-13; 8:45 am]
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