Registrant Actions - 2012
[Federal Register Volume 77, Number 219 (Tuesday, November 13, 2012)]
[Notices]
[Pages 67673-67675]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27554]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 12-56]
Fernando Valle, M.D.; Decision and Order
On August 10, 2012, Chief Administrative Law Judge John J.
Mulrooney, Jr., issued the attached Recommended Decision. Neither party
filed exceptions to the Recommended Decision.
Having reviewed the entire record, I have decided to adopt the
ALJ's findings of fact, conclusions of law, and recommended order.
Accordingly, I will order that Respondent's DEA Certificates of
Registration be revoked and that any pending applications to renew or
modify his registrations be denied.
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 Numbers FV1935595, FV2000711, and FV2000735, issued to
Fernando Valle, M.D., be, and they hereby are, revoked. I further order
that any pending applications of Fernando Valle, M.D., to renew or
modify his registrations, be, and they hereby are, denied. This Order
is effective immediately.\1\
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\1\ Based on the findings of the Florida Department of Health's
Order of Emergency Suspension of License, I conclude that the public
interest requires this Order be effective immediately. 21 CFR
1316.67.
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Dated: October 26, 2012.
Michele M. Leonhart,
Administrator.
Michelle Gillice, Esq., for the Government.
Dale Sisco, Esq., for the Respondent.
Order Granting the Government's Motion for Summary Disposition and
Recommended Decision
Chief Administrative Law Judge John J. Mulrooney, II. On June 25,
2012, the Administrator of the Drug Enforcement Administration (DEA),
issued an Order to Show Cause and Immediate Suspension of Registration
(OSC/ISO) immediately suspending and proposing to revoke the DEA
Certificate of Registration (COR), Number FV1935595, of the Respondent
pursuant to 21 U.S.C. 824(a), and to deny any pending applications for
registration, renewal or modification pursuant to 21 U.S.C. 823(f) and
824(a) because the Respondent's continued registration would "be
inconsistent with the public interest, as that term is defined in 21
U.S.C. 823(f)." As grounds for these proposed actions, the OSC/ISO
alleges that the Respondent "prescribed * * * controlled substances to
* * * undercover law enforcement officers not for a legitimate medical
purpose in the usual course of professional practice in violation of
applicable Federal, State and local law." OSCI/ISO, at 1. The OSC/ISO
was served on the Respondent on June 27, 2012. Gov't Not. of Service.
On July 26, 2012, the Respondent, through counsel, filed a timely
request for hearing.
On July 27, 2012, the Government filed a Motion for Summary
Disposition and Motion to Stay Proceedings ("MSD"), in which it
represented that "[o]n June 26, 2012, the State of Florida [the state
in which Respondent holds his COR] Department of Health executed an
emergency order suspending Respondent's medical license M41752,
effective immediately." \1\ MSD, at 1. Based on the foregoing, the
Government sought the following relief: (1) Summary disposition; (2) a
recommendation that the "Respondent's DEA registration be revoked and
any pending application for renewal or modification of such
registration be denied;" (3) the transmission of the instant matter to
the Administrator for Final Agency Action; and (4) a stay of these
administrative proceedings pending the results of the Government's
motion for summary disposition. MSD, at 3.
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\1\ The order of suspension ("Emergency Order") is attached to
the MSD as "Exhibit A." The emergency suspension appears to be
based on the same allegations set forth in the OSC/ISO.
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By a July 27, 2012, Order, this tribunal granted the Government's
motion to stay, and directed the Respondent to file a response to the
Government's motion for summary disposition on or before August 6,
2012. Order Regarding Government's Motion for Summary Disposition, at
2.
On August 3, 2012, the Respondent filed his response to the MSD.
Respondent's Response to Government's Motion for Summary Disposition
("Response"). In the Response, the Respondent contends that
revocation based on the Emergency Order "will effectively result in a
denial of Due Process to Respondent without notice or opportunity for
hearing and based only on the minimal standards of probable cause."
Response, at 2-3. The Respondent further submits that:
Summary Disposition is inappropriate prior to resolution of the
numerous questions of material fact, as well as procedural issues,
associated with the emergency suspension of his Florida Medical
License and immediate suspension of his DEA registrations. With
regard to his DEA registrations, these include, but are not limited
to, whether the immediate suspension of the Respondent's
registration was based on a valid inspection and investigation;
whether the continued registration of the Respondent constitutes an
imminent danger to the public health and safety; and whether other
grounds exist for the Government to limit the suspension of the
Respondent's registration.
Response, at 3.
On August 6, 2012, the Government filed a Reply to Respondent's
Response
[[Page 67674]]
to Motion for Summary Disposition and Motion to Stay Proceedings
("Reply"). In its reply, the Government contends that the
"Respondent does not dispute that his medical license is suspended and
that he lacks authority to handle controlled substances in the State of
Florida, the jurisdiction where he is licensed to practice medicine.
Absent authority by the State of Florida, Respondent simply is not
authorized to possess a DEA registration in that state." Reply, at 1.
In its MSD and its Reply, the Government correctly contends that
state authority is a necessary condition precedent for the acquisition
or maintenance of a DEA registration, and the suspension of the
Respondent's state practitioner's license precludes the continued
maintenance of his DEA COR, thus requiring revocation. MSD at 1-2;
Reply at 1-2. The Controlled Substances Act (CSA) requires that, in
order to maintain a DEA registration, a practitioner must be authorized
to handle controlled substances in "the jurisdiction in which he
practices." See 21 U.S.C. Sec. 802(21) ("[t]he term 'practitioner'
means 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"); see also id. Sec. 823(f) ("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."). DEA has long held that possession
of authority under state law to dispense controlled substances is an
essential condition for obtaining and maintaining a DEA registration.
Serenity Caf[eacute], 77 FR 35027, 35028 (2012); David W. Wang, 72 FR
54297, 54298 (2007); Sheran Arden Yeates, 71 FR 39130, 39131 (2006);
Dominick A. Ricci, M.D., 58 FR 51104 (1993); Bobby Watts, M.D., 53 FR
11919 (1988). Notwithstanding the foregoing, the Respondent contends
that the Emergency Order may not form the basis of revocation insofar
as the order was issued prior to a hearing. Response, at 3.
Because "possessing authority under state law to handle controlled
substances is an essential condition for holding a DEA registration,"
this Agency has consistently held that "the CSA requires the
revocation of a registration issued to a practitioner who lacks [such
authority]." Roy Chi Lung, 74 FR 20346, 20347 (2009); see also Scott
Sandarg, D.M.D., 74 FR 17528, 174529 (2009); John B. Freitas, D.O., 74
FR 17524, 17525 (2009); Roger A. Rodriguez, M.D., 70 FR 33206, 33207
(2005); Stephen J. Graham, M.D., 69 FR 11661 (2004); Abraham A.
Chaplan, M.D., 57 FR 55280 (1992); see also Harrell E. Robinson, 74 FR
61370, 61375 (2009). Notably, "revocation 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." Kamal Tiwari,
M.D., 76 FR 71604, 71606 (2011) (emphasis added); see also Bourne
Pharmacy, Inc., 72 FR 18273, 18274 (2007); Anne Lazar Thorn, 62 FR
12847 (1997).
The Respondent's assertions that the State of Florida and DEA acted
in temporally close fashion has no bearing on the correct resolution of
the issue raised by the Government's MSD. Neither does it matter that
the Respondent intends to contest the emergency order at a state
administrative hearing. Tiwari, M.D., 76 FR at 71606. It is uncontested
that the Respondent does not presently enjoy the privileges of handling
controlled substances in the State of Florida, the state where his COR
is registered. In Anne Lazar Thorn, M.D., 62 FR 12847 (1997), the
Agency affirmed the Administrative Law Judge's summary disposition
recommended decision and specifically rejected the view that a COR
could coexist in the face of an absence of state authority to handle
controlled substances. In that case, the Agency held that:
the controlling question is not whether a practitioner's license
to practice medicine in the state is suspended or revoked; rather,
it is whether the Respondent is currently authorized to handle
controlled substances in the state. In the instant case, it is
undisputed that Respondent is not currently authorized to handle
controlled substances in the [state where his COR has its listed
address]. Therefore * * * Respondent is not currently entitled to a
DEA [COR].
Id. at 12848 (emphasis supplied). Similarly, in Calvin Ramsey, M.D., 76
FR 20034, 20036 (2011), the Agency stated its position with such
unambiguous precision that little room is realistically left for debate
on the matter:
DEA has repeatedly held that the CSA requires the revocation of
a registration issued to a practitioner whose state license has been
suspended or revoked. David W. Wang, 72 [FR] 54297, 54298 (2007);
Sheran Arden Yeates, 71 [FR] 39130, 39131 (2006); Dominck A. Ricci,
58 [FR] 51104, 51105 (1993); Bobby Watts, 53 [FR] 11919, 11920
(1988). This is so even where a state board has suspended (as
opposed to revoked) a practitioner's authority with the possibility
that the authority may be restored at some point in the future.
[Roger A. Rodriguez, 70 FR 33206, 33207 (2005)].
Although the Respondent avers his intention to vigorously contest the
grounds for Florida's emergency order,\2\ that intention does not
affect the correct resolution of the present question. The Agency has
held that even without evaluating the specific bases for state
administrative action against a medical license, a "[s]tate's action
in suspending [a registrant's] medical license is by itself, an
independent ground to revoke [a] registration." James L. Hooper, M.D.,
76 FR 71371, 71372 (2011).
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\2\ Response at 3.
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The seminal issue presented by the MSD, whether a hearing is
appropriate under the uncontroverted circumstances present here, must
be answered in the negative. Congress does not intend for
administrative agencies to perform meaningless tasks. See Philip E.
Kirk, M.D., 48 FR 32887 (1983), aff'd sub nom. Kirk v. Mullen, 749 F.2d
297 (6th Cir. 1984); see also Puerto Rico Aqueduct & Sewer Auth. v.
EPA, 35 F.3d 600, 605 (1st Cir. 1994); NLRB v. Int'l Assoc. of Bridge,
Structural & Ornamental Ironworkers, AFL-CIO, 549 F.2d 634 (9th Cir.
1977); United States v. Consol. Mines & Smelting Co., 455 F.2d 432, 453
(9th Cir. 1971). Thus, it is well-settled that, where no genuine
question of fact is involved, or when the material facts are agreed
upon, a plenary, adversarial administrative proceeding is not required.
See Jesus R. Juarez, M.D., 62 FR 14945 (1997); Dominick A. Ricci, M.D.,
58 FR 51104 (1993).
At this juncture, no genuine dispute exists over the fact that the
Respondent lacks state authority to handle controlled substances in the
State of Florida. Because the Respondent lacks such state authority,
both the plain language of applicable federal statutory provisions and
Agency interpretive precedent dictate that the Respondent is not
entitled to maintain his DEA registration. Simply put, there is no
contested factual matter adducible at a hearing that would provide DEA
with the authority to allow the Respondent to continue to hold his COR.
I therefore conclude that further delay in ruling on the Government's
motion for summary disposition is not warranted.\3\ See Veg-
[[Page 67675]]
Mix, Inc., 832 F.2d 601, 607 (D.C. Cir. 1987) ("an agency may
ordinarily dispense with a hearing when no genuine dispute exists");
see also Gregory F. Saric, M.D., 76 FR 16821 (2011) (stay denied in the
face of Respondent's petition based on pending state administrative
action wherein he was seeking reinstatement of state privileges).
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\3\ Even assuming arguendo the possibility that the Respondent's
state controlled substances privileges could be reinstated, summary
disposition would still be warranted because "revocation is also
appropriate when a state license has been suspended, but with the
possibility of future reinstatement," Rodriguez, 70 FR at 33207
(citations omitted), and even where there is a judicial challenge to
the state medical board action actively pending in the state courts.
Michael G. Dolin, M.D., 65 FR 5661, 5662 (2000).
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Accordingly, I hereby grant the Government's Motion for Summary
Disposition; and recommend that the Respondent's DEA registration be
revoked forthwith and any pending applications for renewal be denied.
Dated: August 10, 2012.
/s/ JOHN J. MULROONEY, II,
Chief Administrative Law Judge.
[FR Doc. 2012-27554 Filed 11-9-12; 8:45 am]
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