Registrant Actions - 2012
[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Notices]
[Pages 18862-18865]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7421]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-54]
Zhiwei Lin, M.D.; Decision and Order
On September 19, 2011, Administrative Law Judge (ALJ) Timothy D.
Wing issued the attached recommended decision (also ALJ). Therein, the
ALJ found that Respondent is currently without authority to dispense
controlled substances in California, the State in which he practices
medicine and holds his DEA Registration and therefore recommended that
his registration be revoked. Thereafter, Respondent filed two motions
\1\ and the Government filed a response to the motions. Having reviewed
the record in its entirety including the ALJ's recommended decision and
the various pleadings, I have decided to adopt the ALJ's rulings,
findings of fact, conclusions of law, and
[[Page 18863]]
recommended order, except as noted below.
---------------------------------------------------------------------------
\1\ The motions were titled "Motion for Reconsideration--
Opposition for Summary Disposition'' and "Amended Motion for
Reconsideration--Exceptions to Order of Summary Disposition.''
---------------------------------------------------------------------------
Following the receipt of Respondent's request for a hearing, the
ALJ commenced pre-hearing procedures and issued an Order for Prehearing
Statements. The Order clearly stated "that in the case of a motion,
the non-moving party shall have until 4 p.m. EDT three business days
after the date of service of any motion to file a responsive pleading''
and that "[i]n the absence of good cause failure to file a written
response * * * will be deemed a waiver of objection.'' ALJ at 2-3 \2\
(citing Order for Prehearing Statements, at 3).
---------------------------------------------------------------------------
\2\ All citations to the ALJ's decision are to the slip opinion.
---------------------------------------------------------------------------
On September 12, 2011, the Government filed a Motion for Summary
Disposition, asserting that on July 28, 2011, the Medical Board of
California (MBC) had issued an Interim Suspension Order against
Respondent's medical license, and that consequently, Respondent no
longer has authority to handle controlled substances in California, the
jurisdiction in which he maintains his DEA registration. Mot. for Summ.
Disp., at 1. The Government served the motion by both first class mail
and facsimile. See id. at 3. When, by September 19, 2011, Respondent
had not filed a response to the Government's motion, the ALJ issued his
recommended decision finding that because Respondent was currently
without authority under California law, he was not entitled to hold his
DEA registration. ALJ at 4. The ALJ thus recommended that I revoke
Respondent's registration. Id. at 5.
On September 20, 2011 Respondent filed a pleading titled Motion for
Reconsider[sic]--Opposition for Motion for Summary Disposition
(hereinafter, Motion for Reconsideration). On the same day, he also
filed a document entitled Amended Motion for Reconsideration--
Exceptions to Order of Summary Disposition--Opposition to Motion for
Summary Disposition (Amended Motion).
In both motions, Respondent asserted that he had good cause for
having failed to timely file a response to the Government's Motion for
Summary Disposition within the time for filing a response. More
specifically, Respondent's attorney stated that he did not see the
faxed copy sent by the Government to his office on September 12, 2011
because he was in trial at the time and was receiving voluminous items
of evidence by fax during that time. Motion for Reconsideration, at 1-
2. See also Amended Motion at 1-2. Respondent's attorney further stated
that the mailed copy of the Government's Motion for Summary Disposition
was not received in his office until September 16, 2011, and that
because of his trial obligations he did not actually see the
Government's Motion until September 19, 2011, by which date the time
for filing his opposition to the motion had expired. Id. at 1-2.
Respondent's Amended Motion also asserted good cause to set aside
the Order for Summary Disposition, stating that the finality of the
MBC's Suspension Order should be questioned. Id. at 3-4. In the motion,
Respondent argued that the Order to Show Cause and the MBC's Interim
Suspension Order "are based largely on an assertion that Respondent
began prescribing Vicodin to [a] DEA Special Agent [who acted in an
undercover capacity (UC)] without an adequate examination.'' Id. at 2.
Respondent asserted that the audio recording evidence of the initial
appointment between the UC and Respondent was incomplete and contained
a number of serious abnormalities that preclude authentication. Id. at
3. Respondent contended that the audio evidence may have been
"intentionally erased, which would in turn impune (sic) Agent['s]
credibility both for the purposes of the Medical Board hearing and the
DEA OSC hearing.'' Id. at 3.
Respondent further argued that the instant case is factually
distinguishable from the DEA decisions cited in Government's Motion for
Summary Disposition because "in none of those cases was there credible
evidence suggesting that the Department's agents had destroyed crucial
evidence leading to the State Medical Board License Revocation
Proceeding as well as the DEA Order to Show Cause.'' Id. Respondent
contended that "[t]he DEA Administrative process has unique powers to
compel the production of the [original recording and recording device]
evidence that Respondent's counsel needs to inspect.'' Id. Finally,
Respondent argued that "it is in the interest of justice for the
[Agency] proceeding to determine whether * * * agents submitted
falsified evidence to the [MBC], which * * *would lead to a ruling that
would give cause for the Medical Board to set aside its suspension as
well as for the Department to keep Respondent's DEA certificate in
force.'' Id.
On September 21, the Government filed a Response to Respondent's
Amended Motion for Reconsideration, arguing that Respondent's assertion
of good cause for his late submission of his opposition to its summary
disposition motion was unpersuasive. Government Response to Motion for
Reconsideration, at 1. The Government also argued that the evidentiary
issues raised by Respondent are inapposite to the assertion that
Respondent currently lacks authority to handle controlled substances in
California, a fact which Respondent does not deny, and that therefore,
he is not authorized to possess a DEA registration in that State.
Government Response at 2 (citations omitted).
On September 22, 2011, the ALJ denied Respondent's motions. Ruling
on Respondent's Amended Motion for Reconsideration-Exceptions to Order
of Summary Disposition-Opposition To Motion For Summary Disposition, at
4. While the ALJ found that Respondent had demonstrated good cause for
the late filing of his motions (due to "an inadvertent office
management error'' by his counsel), the ALJ found that his "request to
set aside [the] previous ruling is without legal authority.'' Id. at 3.
The ALJ further explained that "[a]lthough Respondent's arguments
regarding the audio recording may be relevant at hearing, Respondent is
not entitled to a hearing because he has failed to demonstrate that he
has state authority to handle controlled substances.'' Id.
I need not decide whether Respondent established good cause \3\ for
his failure to timely file an opposition to the Government's summary
disposition motion because under the Administrative Procedure Act and
DEA regulations, Respondent is entitled to file exceptions to the
Administrative Law Judge's decision, which is only a recommendation. 5
U.S.C. 557(c); 21 CFR 1316.66. Under the Agency's rule, exceptions must
be filed within twenty days after the date on which the recommended
decision is served and there is no dispute that Respondent's pleading,
which he also titled as exceptions, was timely filed. 21 CFR
1316.66(a). Thus, I will consider Respondent's post-ruling motions as
timely filed exceptions to the ALJ's recommended decision.
---------------------------------------------------------------------------
\3\ But see Kamir Garces Mejias, 72 FR 54931, 54932 (2007)
(quoting De la Torre v. Continental Ins. Co., 15 F.3d 12, 15 (1st
Cir. 1994) ("Respondent's claim 'that [her] attorney was
preoccupied with other matters * * * has been tried before and
regularly has been found wanting.' * * * 'Most attorneys are busy
most of the time and they must organize their work so as to be able
to meet the time requirements of matters they are handling or suffer
the consequences.''') (quoting Pinero Schroeder v. FNMA, 5874 F.2d
1117, 1118 (1st Cir. 1978) (other citation omitted))).
---------------------------------------------------------------------------
As noted above, in his Exceptions, Respondent argues that the MBC's
[[Page 18864]]
Interim Suspension Order (Suspension Order) and this Agency's
subsequent Order to Show Cause is based on the allegation that he
prescribed Vicodin to a DEA Special Agent "without an adequate
examination.'' Exceptions at 2. Respondent maintains that "the crucial
events of [the Agent's] conversations with Respondent are somehow
'missing' from the audio recording'' of the Agent's visit and that a
copy of an audio recording of the visit "contains a number of serious
abnormalities that preclude [its] authentication.'' Id. at 3.
Respondent thus raises the specter of Government misconduct arguing
that there is "credible evidence suggesting that the Department's
agents ha[ve] destroyed crucial evidence leading to the State Medical
Board License Revocation Proceeding.'' Id. Respondent then contends
that "[i]f indeed government Agents were actively involved in the
destruction of evidence * * * leading to the license revocation action
which forms the basis for the Motion for Summary Disposition, it is in
the interest of justice for [the DEA] proceeding to determine whether
the Department's agents submitted falsified evidence to the [MBC]
which, if further explored through the discovery process, would lead to
a ruling that would give cause for the [MBC] to set aside its
suspension as well as for the [Agency] to keep Respondent's DEA
certificate in force.'' Id.
This fishing expedition cannot leave the dock, however, for two
reasons. First, Respondent's license remains subject to the interim
order of the MBC which suspended his California Physician and Surgeon's
Certificate. As explained in the ALJ's decision, this action, which is
undisputed, rendered Respondent without authority to dispense
controlled substances in the State in which he practices medicine and
holds his DEA registration, and thus he no longer meets an essential
condition for holding a registration. See 21 U.S.C. 824(a)(3)
(authorizing revocation of registration based "upon a finding that the
registrant * * * has had his State license * * * suspended [or] revoked
* * * by competent State authority and is no longer authorized by State
law to engage in the * * * dispensing of controlled substances''); see
also id. Sec. 802(21) (defining "the term 'practitioner' [to] mean[]
a * * * physician * * * or other person 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''); 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.'').
Second, Respondent's contention is a collateral attack on the
validity of the MBC's Suspension Order. However, 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. Calvin Ramsey, 76 FR 20034,
20036 (2011) (other citations omitted); Brenton D. Glisson, 72 FR
54296, 54297 n.2 (2007); Shahid Musud Siddiqui, 61 FR 14818, 14818-19
(1996). Rather, Respondent's various challenges to the validity of the
MBC's Suspension Order must be litigated in the forums provided by the
State of California. Thus, Respondent's contentions regarding the
validity of the MBC's Suspension Order are therefore not material to
this Agency's resolution of whether he is entitled to maintain his DEA
registration in California.
Because it is undisputed that Respondent currently lacks authority
to dispense controlled substances in California, the State in which he
holds his DEA registration, Respondent is not entitled to maintain his
registration. Accordingly, I adopt the ALJ's recommended decision and
will order that Respondent's registration be revoked and that any
pending application 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 BL7325079, issued to Zhiwei Lin, M.D., be, and it hereby
is, revoked. I further order that any pending application of Zhiwei
Lin, M.D., to renew or modify his registration, be, and it hereby is,
denied. This Order is effective immediately.\4\
---------------------------------------------------------------------------
\4\ For the same reasons that the State imposed its emergency
suspension of Respondent's medical license, I conclude that the
public interest requires that this Order be effective immediately.
21 CFR 1316.67.
---------------------------------------------------------------------------
Dated: March 20, 2012.
Michele M. Leonhart,
Administrator.
Christine Menendez, Esq., for the Government
Alan I. Kaplan, Esq., for the Respondent
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge
Timothy D. Wing, Administrative Law Judge. This proceeding is an
adjudication governed by the Administrative Procedure Act, 5 U.S.C.
Sec. 551 et seq., to determine whether a practitioner's Certificate of
Registration (COR) with the Drug Enforcement Administration (DEA,
Government or Agency) should be revoked and any pending applications
for renewal or modification of that registration denied. Without this
registration, Zhiwei Lin, M.D. (Respondent), would be unable to
lawfully possess, prescribe, dispense or otherwise handle controlled
substances.
I. Procedural Posture
On August 8, 2011, the Deputy Assistant Administrator, DEA, issued
an Order to Show Cause (OSC) of DEA COR BL7325079. The OCS provided
notice to Respondent of an opportunity to show cause as to why the DEA
should not revoke Respondent's DEA COR BL7325079, pursuant to 21 U.S.C.
Sec. 824(a)(4), and deny any pending applications for renewal or
modification, on the grounds that Respondent's continued registration
would be inconsistent with the public interest under 21 U.S.C. Sec.
823(f). On September 2, 2011, Respondent, through counsel, in a letter
dated August 31, 2011, timely requested a hearing with the DEA Office
of Administrative Law Judges.
I issued an Order for Prehearing Statements on September 6, 2011.
On September 12, 2011, the Government filed a Motion for Summary
Disposition, with a copy served on Respondent via U.S. mail. (Mot. at
3.) Pursuant to the September 6, 2011 Order for Prehearing Statements,
Respondent had "until 4 p.m. EDT three business days after the date of
service of any motion to file a responsive pleading* * * . In the
absence of good cause, failure to file a written response to the moving
party's motion after three business days will be deemed a waiver of
objection.'' (Order for Prehearing Statements at 3.)
As of September 19, 2011, five business days after service of the
Government's Motion for Summary Disposition, Respondent had not yet
filed a response. While not dispositive, Respondent is deemed to have
waived any objection to the Government's motion.
II. The Parties' Contentions
A. The Government
In support of its Motion for Summary Disposition, the Government
asserts that on July 28, 2011, the Medical Board of California issued
an Interim Suspension Order suspending Respondent's medical license,
and that Respondent consequently lacks authority to handle
[[Page 18865]]
controlled substances in California, the jurisdiction in which he
maintains his DEA registration. (Mot. at 1.) The Government contends
that such state authority is a necessary condition for maintaining a
DEA COR and therefore asks that I summarily recommend to the
Administrator that Respondent's COR be revoked and any pending
applications for renewal or modification be denied. (Mot. at 1-2.) In
support of its motion, the Government cites Agency precedent and
attaches the Interim Suspension Order issued by the Medical Board of
California, marked for identification as Exhibit B.
B. Respondent
As noted above, Respondent did not respond to the Government's
Motion for Summary Disposition, or seek an extension within the
deadline for response, and is therefore deemed to waive objection.
III. Discussion
At issue is whether Respondent may maintain his DEA COR given that
California has suspended Respondent from the practice of medicine or
surgery.
Under 21 U.S.C. Sec. 824(a)(3), a practitioner's loss of state
authority to engage in the practice of medicine and to handle
controlled substances is grounds to revoke a practitioner's
registration. Accordingly, this Agency has consistently held that a
person may not hold a DEA registration if he is without appropriate
authority under the laws of the state in which he does business. See
Scott Sandarg, D.M.D., 74 Fed. Reg. 17,528 (DEA 2009); David W. Wang,
M.D., 72 Fed. Reg. 54,297 (DEA 2007); Sheran Arden Yeates, M.D., 71
Fed. Reg. 39,130 (DEA 2006); Dominick A. Ricci, M.D., 58 Fed. Reg.
51,104 (DEA 1993); Bobby Watts M.D., 53 Fed. Reg. 11,919 (DEA 1988).
Summary disposition in a DEA suspension case is warranted even if
the period of suspension of a respondent's state medical license is
temporary, or even if there is the potential for reinstatement of state
authority because "revocation is also appropriate when a state license
had been suspended, but with the possibility of future reinstatement.''
Stuart A. Bergman, M.D., 70 Fed. Reg. 33,193 (DEA 2005); Roger A.
Rodriguez, M.D., 70 Fed. Reg. 33,206 (DEA 2005).
It is well-settled that when no question of fact is involved, or
when the material facts are agreed upon, a plenary, adversarial
administrative proceeding is not required, under the rationale that
Congress does not intend administrative agencies to perform meaningless
tasks. See Layfe Robert Anthony, M.D., 67 Fed. Reg. 35,582 (DEA 2002);
Michael G. Dolin, M.D., 65 Fed. Reg. 5661 (DEA 2000); see also Philip
E. Kirk, M.D., 48 Fed. Reg. 32,887 (DEA 1983), aff'd sub nom. Kirk v.
Mullen, 749 F.2d 297 (6th Cir. 1984). Accord Puerto Rico Aqueduct &
Sewer Auth. v. EPA, 35 F.3d 600, 605 (1st Cir. 1994).
In the instant case, the Government asserts, and Respondent does
not contest, that Respondent's California license to practice medicine
and surgery is presently suspended. This allegation is confirmed by
Government Exhibit B. I therefore find there is no genuine dispute as
to any material fact, and that substantial evidence shows that
Respondent is presently without state authority to handle controlled
substances in California. Because "DEA does not have statutory
authority under the Controlled Substances Act to maintain a
registration if the registrant is without state authority to handle
controlled substances in the state in which he practices,'' Sheran
Arden Yeates, M.D., 71 Fed. Reg. 39,130, 39,131 (DEA 2006), I conclude
that summary disposition is appropriate. It is therefore
ORDERED that the hearing in this case, scheduled to commence on
November 15, 2011, is hereby CANCELLED; and it is further
ORDERED that all proceedings before the undersigned are STAYED
pending the Agency's issuance of a final order.
Recommended Decision
I grant the Government's Motion for Summary Disposition and
recommend that Respondent's DEA COR BL7325079 be revoked and any
pending applications denied.
September 19, 2011.
s/Timothy D. Wing,
Administrative Law Judge.
[FR Doc. 2012-7421 Filed 3-27-12; 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).
|
