Registrant Actions - 2013
[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Notices]
[Pages 7813-7815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02232]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 12-57]
Sanjay Trivedi, M.D.; Decision and Order
On September 25, 2012, Administrative Law Judge (ALJ) Gail A.
Randall issued the attached recommended decision. Neither party filed
exceptions to the decision. Having reviewed the entire record, I have
decided to adopt the ALJ's rulings, findings of fact, conclusions of
law, and recommended Order.
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 FT0896754, issued to Sanjay Trivedi, M.D., be, and it
hereby is, revoked. I further order that any pending application of
Sanjay Trivedi, M.D., to renew or modify his registration, be, and it
hereby is, denied. This Order is effective immediately.\1\
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\1\ For the same reason I ordered that Respondent's registration
be immediately suspended, I conclude that the public interest
necessitates that this Order be effective immediately. See 21 CFR
1316.67.
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Dated: January 25, 2013.
Michele M. Leonhart,
Administrator.
Michelle F. Gillice, Esq., for the Government.
Matthew R. Kachergus, Esq., for the Respondent.
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
I. Facts
Gail A. Randall, Administrative Law Judge. The Administrator, Drug
Enforcement Administration ("DEA" or "Government"), issued an Order
to Show Cause and Immediate Suspension of Registration ("Order")
dated June 25, 2012, proposing to revoke the DEA Certificate of
Registration, No. FT0896754, of Sanjay Trivedi, M.D. ("Respondent"),
as a practitioner, pursuant to 21 U.S.C. 824(a)(4) (2006), and deny any
pending applications for renewal or modification of such registration
pursuant to 21 U.S.C. 823(f) (2006), because the continued registration
of the Respondent would be inconsistent with the public interest, as
that term is used in 21 U.S.C. 823(f). The Respondent's registration
will expire by its own terms on November 30, 2013.
Specifically, the Order alleged that the Respondent dispensed at
least
[[Page 7814]]
226,752 dosage units of controlled substance prescriptions between
April 24, 2011, and April 25, 2012. [Order at 2]. The Order alleged
that the controlled substances most frequently prescribed during the
year time period were: oxycodone 30mg; hydrocodone/apap 10-500mg; and
oxycodone/apap 10-325mg. [Id.]. The Order further alleged that the
Respondent prescribed controlled substances to undercover law
enforcement officers between October and November 2011 in violation of
Federal, State, and local law because the prescriptions were not for a
legitimate medical purpose. [Id. 2-3]. Additionally, the Order alleged
that the Respondent prescribed excessive and unnecessary doses of
controlled substances to the undercover law enforcement officers
without a clinical basis to do so, without conducting adequate physical
examinations, without providing legitimate referrals for evaluations,
and without giving proper attention to the possibility of misuse or
diversion of controlled substances. [Id. at 3]. Lastly, the Order
alleged that the Respondent is involved in a conspiracy in which
controlled substances are prescribed to patients throughout the state
of Florida without a legitimate medical purpose. [Id. at 4].
On July 27, 2012, the Respondent, through counsel, filed a letter
with the Court requesting an extension of time ("Respondent's
Request") to respond to the Order to Show Cause. [Respondent's Request
at 1]. Specifically, the Respondent requested that in order to properly
respond to the Order to Show Cause, the Respondent needed to obtain the
patient records at issue and these records had been seized by law
enforcement in conjunction with the criminal prosecution. [Id.].
On July 30, 2012, the Court issued an Order Granting Respondent's
Request for Extension of Time ("Court's Order"). Therein, the Court
found that the Respondent had demonstrated good cause to justify
granting a thirty-day extension of time to respond to the Order to Show
Cause. [Court's Order at 1].
On August 31, 2012, the Respondent, through counsel, filed a letter
with the Court requesting an extension of time ("Respondent's Second
Request") to respond to the Order to Show Cause. [Respondent's Second
Request at 1]. Specifically, the Respondent explained that he needed
additional time to respond to the Order to Show Cause because the
requested patient files at issue in the above-captioned matter had not
yet been received since law enforcement had seized the records in
conjunction with the criminal prosecution. [Id.]. That same day, the
Court issued an Order Granting Respondent's Request for Extension of
Time ("Court's Second Order"). Therein, the Court found that
Respondent had demonstrated good cause to justify granting a second
brief extension of time. [Court's Second Order at 2]. The Court ordered
that the Respondent must clearly indicate his desire for a hearing on
or before September 7, 2012. [Id.].
On September 7, 2012, the Respondent, through counsel, timely filed
a Request for Hearing in the above-captioned matter.
On September 10, 2012, the Government filed a Motion for Summary
Disposition and Motion to Stay Proceedings ("Government's Motion").
Therein, the Government requested that the Court summarily revoke
Respondent's DEA registration because the Respondent's Florida state
medical license is under an emergency suspension order. [Government's
Motion at 1]. The Government stated that the Respondent was no longer
authorized to handle controlled substances in Florida, the state where
the Respondent is registered with the DEA. [Id. at 1-2]. The Government
attached to its motion, a State of Florida Department of Health Order
of Emergency Suspension of License ("Emergency Suspension"), filed
June 27, 2012, in which the State of Florida Department of Health
ordered the emergency suspension of the Respondent's license.
[Government's Motion at Exhibit A]. The Government argues, therefore,
that in accordance with Agency precedent, the DEA is barred by statute
from continuing the Respondent's registration because his state medical
license was suspended. [Id. at 1-2].
On September 11, 2012, the Court issued an Order for Prehearing
Statements and an Order for Respondent's Response to Government's
Motion for Summary Disposition and to Stay Proceedings.
On September 19, 2012, the Respondent, through counsel, filed
Respondent's Response to Motion for Summary Disposition and Motion to
Stay Proceedings and Request for Extension of Time for Further Response
("Respondent's Response"). Therein, the Respondent argues that the
Court should grant him a thirty-day extension to respond to the
Government's Motion because the Respondent is currently involved in
settlement negotiations with the Florida Department of Health in which
his Florida medical state license will be restored. [Respondent's
Response at 1-3].
On September 19, 2012, the Government filed Government's Reply to
Respondent's Response to Motion for Summary Disposition and Motion to
Stay Proceedings and Request for Extension of Time for Further Response
("Government's Reply"). Therein, the Government argues that the only
due process that need be afforded to the Respondent is an "opportunity
to oppose a motion for summary disposition by showing that his state
authority has not been suspended or revoked." [Government's Reply at
1]. The Government further argues that because there has not been a
showing that Respondent's state license is valid, the Respondent
currently lacks state authority to handle controlled substances and
thus, the Respondent cannot remain registered by the DEA. [Id. at 2].
For the reasons set forth below, I will grant the Government's
Motion and recommend that the Administrator revoke the Respondent's DEA
Certificate of Registration. But, I note that, pursuant to 21 CFR
1301.13(a) (2012), the Respondent may apply for a new DEA Certificate
of Registration at any time.
II. Discussion
A. Respondent Currently Lacks Authority To Handle Controlled Substances
In Florida
The DEA will not maintain a controlled substances registration if
the registrant is without state authority to handle controlled
substances in the state in which the registrant practices. The
Controlled Substances Act ("CSA") provides that obtaining a DEA
registration is conditional on holding a state license to handle
controlled substances. See 21 U.S.C. 802(21) (2006) (defining
"practitioner" as "a physician * * * 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"); 21 U.S.C. 823(f)
(2006) ("the Attorney General shall register practitioners * * * if
the applicant is authorized to dispense * * * controlled substances
under the laws of the State in which he practices"). The DEA,
therefore, has consistently held that the CSA requires the DEA to
revoke the registration of a practitioner who no longer possesses a
state license to handle controlled substances. See 21 U.S.C. 824(a)(3)
(2006) (stating "a registration may be suspended or revoked by the
Attorney General upon a finding that the registrant has had his State
license or
[[Page 7815]]
registration suspended, revoked or denied by competent State
authority"); Beverley P. Edwards, M.D., 75 FR 49,991 (DEA 2010);
Joseph Baumstarck, M.D., 74 FR 17,525 (DEA 2009).
In this case, the Respondent does not dispute that he currently
lacks state authority to handle controlled substances. However, the
Respondent argues that his current state medical license suspension is
temporary, as he and the Florida Department of Health are currently
involved in settlement negotiations in which he anticipates that he
will regain his Florida medical license. [Respondent's Response at 1-
3]. Respondent argues that his DEA registration should not be revoked
because he will soon likely regain his state medical license in the
state of Florida. [Id. at 2-3]. However, the Emergency Suspension from
the Florida Department of Health effectively suspends the Respondent's
license to practice medicine in the state of Florida. Regardless of
whether the Respondent and the Florida Department of Health eventually
decide upon a settlement agreement in which the Respondent's state
license is reinstated, the Respondent currently lacks the necessary
state authority to practice medicine and handle controlled substances
in Florida. Consequently, his DEA registration must be revoked. See
Joseph Baumstarck, M.D., 74 FR 17,525, 17,527 (DEA 2009) (stating that
"a practitioner may not maintain his DEA registration if he lacks
state authority to handle controlled substances under the laws of the
state in which he practices"); Treasure Coast Specialty Pharmacy, 76
FR 66,965 (DEA 2011); Roy Chi Lung, M.D., 74 FR 20,346 (DEA 2009);
Gabriel Sagun Orzame, M.D., 69 FR 58,959 (DEA 2004).
While the Respondent argues that his state license may be
reinstated in the future, this possibility is immaterial in light of
the Respondent's current lack of state registration. Indeed, the CSA
and Agency precedent make clear that as a prerequisite to registration
the Respondent must have state authority to handle controlled
substances, and that without such authority all other issues before
this forum are moot. See 21 U.S.C. 802(21); 21 U.S.C. 823(f); Joseph
Baumstarck, M.D., 74 FR at 17,527 (DEA 2009). Thus, because there is no
dispute that the Respondent lacks state authority to handle controlled
substances, the Respondent's registration must be revoked.
B. Respondent Is Entitled To Reapply for Registration With the DEA
Any person who is required to register with the DEA may apply for
registration at any time. 21 CFR 1301.13(a) (2012) ("Any person who is
required and who is not registered may apply for registration at any
time. No person required to be registered shall engage in any activity
for which registration is required until the application for
registration is granted and a Certificate of Registration is issued by
the Administrator to such person").
The Respondent is permitted to reapply for a Certificate of
Registration with the DEA at any time in the future. 21 CFR 1301.13(a).
However, the Respondent will not be permitted to engage in activity for
which a registration is required until his application is granted by
the DEA. Id.
III. Conclusion, Order, and Recommendation
Consequently, there is no genuine dispute of material fact
regarding the Respondent's lack of state authority to handle controlled
substances. Thus, summary disposition for the Government is
appropriate. It is well settled that when there is no question of
material fact involved, there is no need for a plenary, administrative
hearing. See Michael G. Dolin, M.D., 65 FR 5,661 (DEA 2000). Here,
there is no genuine dispute that the Respondent currently lacks state
authority to practice medicine and to handle controlled substances in
Florida.
Accordingly, I hereby
grant the Government's Motion for Summary Disposition.
I also forward this case to the Administrator for final
disposition. I recommend that the Respondent's DEA Certificate of
Registration, Number FT0896754, be revoked.\2\
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\2\ The sole basis of my recommendation is the loss of
Respondent's state licensure. I make no findings or conclusions
concerning the other allegations asserted in the Order to Show
Cause.
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Dated: September 25, 2012.
Gail A. Randall,
Administrative Law Judge.
[FR Doc. 2013-02232 Filed 2-1-13; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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