[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Notices]
[Pages 18862-18865]
From the Federal Register Online via the Government Publishing 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