FR Doc E9-17714[Federal Register: July 24, 2009 (Volume 74,
Number 141)] [Notices] [Page 36758-36760] From the Federal
Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jy09-135]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 08-59]
Roy E. Berkowitz, M.D.; Revocation of Registration
On August 26, 2008, the Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration,
issued an Order to Show Cause to Roy E. Berkowitz, M.D.
(Respondent), of Slidell, Louisiana. The Show Cause Order
proposed the revocation of Respondent's DEA Certificate of
Registration, BB0492912, as a practitioner, and the denial of
any pending applications to renew or modify his registration, on
the grounds that Respondent does "not have authority to
prescribe controlled substances in the State of Louisiana,'' and
that his "continued registration is inconsistent with the
public interest.'' Show Cause Order at 1.
More specifically, the Show Cause Order alleged that as a
result of prescriptions for controlled substances which
Respondent issued in 2006 and 2007 that were inconsistent with
State rules and regulations, Respondent entered into a Consent
Order with the Louisiana State Board of Medical Examiners, which
"strips [Respondent] of authority to handle controlled
substances in the State of Louisiana, the state in which [he is]
registered with DEA.'' Id.
Respondent requested a hearing on the allegations, and the
matter was assigned to an Administrative Law Judge (ALJ), who
commenced pre- hearing procedures. Thereafter, the Government
moved for summary disposition on the ground that Respondent
"currently lacks authority to handle controlled substances
in the State of Louisiana--his state of registration.'' Gov.
Mot. at 1.
In support of its motion, the Government attached a
declaration of a DEA Diversion Investigator (DI). Therein, the
DI stated that on October 15, 2008, she had queried the
Louisiana State Board of Pharmacy's Web site to determine
Respondent's license status, and found that "the Controlled
Dangerous Substance license 33853 of Roy E. Berkowitz, M.D. was
delinquent, having expired on September 25, 2008.'' Id. at
Appendix I.
The ALJ allowed the Respondent to file a response to the
motion through October 30, 2008. Moreover, on October 29, 2008,
the ALJ granted Respondent an extension of the due date until
November 6, 2008, on which date Respondent filed his response.
Therein, Respondent noted that while the Show Cause Order had
relied on the State Board's Consent Order, the motion for
summary disposition relied on a "declaration * * *
asserting that a license issued by the Louisiana Board of
Pharmacy to [Respondent] expired on September 25, 2008.'' Resp.
at 1. Respondent maintained that the Government was improperly
changing its theory of the case, and argued that "[t]he DEA
without leave to amend the Order to Show Cause has sought to
change the underlying basis of the case.'' \1\ Id. at 2-3.
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\1\ Respondent also invoked the "mend the hold
doctrine,'' an obscure common law rule which prohibits a party
to a contract from changing its position on the contract's
meaning during the course of litigation over it. Id. at 3
(citing Utica Mut. Ins. Co. v. Vigo Coal Co., Inc., 393 F.3d
707, 716 (7th Cir. 2004)). Specifically, Respondent contended
that the Government's reliance on the expiration of
Respondent's lack of a state controlled substance license was
"analogous to an attempt to mend the hold,'' presumably
because the Show Cause Order had cited the consent agreement
rather than the expiration. Id. at 3 (citation omitted).
Respondent did not renew this argument in his exceptions, and
in any event, the analogy is misplaced.
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Next, Respondent argued that the Agency lacks authority to
revoke his registration because in his view, 21
U.S.C. 824(a)(3) requires both a suspension, denial or
revocation of the state license or registration, and that the
practitioner no longer be authorized by state law to handle
controlled substances. Id. at 3-4. In support of his contention,
Respondent attached his declaration in which he stated that he
submitted his application for renewal of his Louisiana
Controlled Dangerous Substance License in July 2008, and that he
was "advised by the Louisiana Board of Pharmacy that this
agency was unable to process'' his application. Id., Ex. A at 1.
The declaration further asserted that the Louisiana Board of
Pharmacy "did not enter an order'' denying, suspending or
revoking Respondent's application. Id. at 1-2. Thus, Respondent
argued that the Government's motion should be denied "[b]ased
upon a failure to establish the elements required under 21 U.S.C.
824(a)(3) and 21 U.S.C. 824(a)(4).'' Resp. at 5.
On January 27, 2009, the ALJ issued her Opinion and
Recommended
[[Page 36759]]
Decision. Therein, the ALJ granted the Government's motion
for summary disposition and recommended that I revoke
Respondent's registration and deny any pending applications. The
ALJ rejected Respondent's argument that his due process rights
were violated by the Government's reliance on the expiration of
his state's dangerous substances license, as Respondent was
"advised * * * of the grounds on which the Government
relied in seeking to revoke his registration and * * * addressed
those grounds in his response.'' ALJ at 4.
The ALJ also rejected Respondent's argument that the
Government had failed to show that his continued registration
was inconsistent with the public interest, reasoning that the
"subsections of 21
U.S.C. 824(a) are to be considered in the disjunctive.'' Id.
Framing the issue as "whether Respondent is currently
authorized to handle controlled substances in Louisiana,'' the
ALJ noted Respondent's contention that he had applied for a new
state controlled substance registration, but that the State
Board of Pharmacy had advised him that it could not act on his
application. Id. at 5. The ALJ then rejected Respondent's
argument, reasoning that Respondent did not dispute that his
state registration "is expired, and although he asserts
that there should be a hearing on whether his filing of a
renewal application extends his authority to handle controlled
substances in Louisiana, he makes no showing that he has applied
for and been granted the requisite authority.'' Id.
The ALJ thus concluded that there was no dispute over the
material fact "that Respondent is currently not authorized
to handle controlled substances in Louisiana, the State in which
he is registered with the DEA.'' Id. Applying the Agency's
settled rule that "[b]ecause Respondent lacks this state
authority * * * he is not currently entitled to a DEA
registration in Louisiana,'' the ALJ granted the Government's
motion and recommended that Respondent's registration be revoked
and that any pending application be denied. Id.
Thereafter, on February 13, 2008, Respondent submitted his
Exceptions to the ALJ's decision, and on March 9, 2009, the ALJ
forwarded the record to me for final agency action. Having
considered the entire record including Respondent's exceptions,
I adopt the ALJ's finding that Respondent currently lacks
authority to handle controlled substances in Louisiana, and
therefore, is not entitled to maintain his DEA registration. I
also adopt the ALJ's recommendation that Respondent's
registration be revoked and that any pending application be
denied.
I find that Respondent currently holds DEA Certificate of
Registration, BB0492912, which authorizes him to dispense
controlled substances in Schedules II through V, as a
practitioner, at the registered location of 1632 Marina Drive,
Slidell, Louisiana. Respondent's Registration does not expire
until July 31, 2009. I further find that Respondent Louisiana
Controlled Dangerous Substance (CDS) License expired on
September 25, 2008.
I also find that while Respondent has applied for a new State
CDS license, he has provided no evidence that Board of Pharmacy
has issued one to him. Moreover, Respondent cites to no
authority establishing that under Louisiana law, his filing of
the application extended his CDS license past its expiration
date. Cf. 5 U.S.C. Sec. 558(c). I thus adopt the ALJ's
conclusion that Respondent does not possess authority to
dispense controlled substances under Louisiana law, and
therefore does not meet an essential prerequisite for holding a
registration under Federal law. ALJ at 5.
Respondent nonetheless excepts to the ALJ's decision on
various grounds. First, Respondent contends that the ALJ erred
in granting the Government's motion for summary disposition
because it relied on an issue (the expiration of his State CDS
license) which was not raised in the Show Cause Order. In
Respondent's view, a motion for summary disposition in an
administrative proceeding should be treated analogously to a
motion for summary judgment, and that the "[p]leadings may
not be disregarded in ruling on a motion for summary judgment in
Federal court.'' Exc. at 2. According to Respondent, "if
the pleadings, depositions, answers to interrogatories, and
admissions on file, together with the affidavits, if any, show
that there is no genuine issue as to any material fact and that
the moving party is entitled to judgment as a matter of law,''
then the motion should be granted. Exc. at 2-3 (emphasis in
original). By emphasizing, "pleadings,'' Respondent
apparently wished to emphasize his position that the Show Cause
Order should have contained all the grounds on which the
revocation was ultimately based.
This Agency's proceedings are not, however, governed by the
Federal Rules of Civil Procedure. And while those rules (and the
judicial decisions interpreting them) may be a useful guide,
they are not binding on the Agency. Instead, what is binding on
the Agency is the Due Process Clause, the Administrative
Procedure Act, and the Agency's regulations.
Contrary to Respondent's understanding, to decide this matter
on the grounds asserted in the Government's motion does not
violate his right to due process. As the Federal Courts have
recognized, "`[p]leadings in administrative proceedings are
not judged by the standards applied to an indictment at common
law.''' Citizens State Bank of Marshfield v. FDIC, 751 F.2d 209,
213 (8th Cir. 1984) (quoting Aloha Airlines, Inc., v. CAB, 598
F.2d 250, 262 (DC Cir. 1979)). An agency is not required
"to give every [Respondent] a complete bill of particulars
as to every allegation that [he] will confront.'' Boston
Carrier, Inc. v. ICC, 746 F.2d 1555, 1560 (DC Cir. 1984); see
also Paul H. Volkman, 73 FR 30630, 30641 n.35 (2008). Indeed,
the Federal Courts routinely uphold agency adjudications which
are based on matters which were not initially raised in a
charging document but which were nonetheless litigated in a
proceeding. See, e.g., Pergament United Sales, Inc., v. NLRB,
920 F.2d 130, 137 (2d Cir.1990) (no due process violation where
NLRB did not cite in complaint specific provision of NLRA which
Board ultimately relied on in its order because the employer
"was not kept in the dark [and] was aware of and actively
litigated'' the relevant issue); Facet Enters., Inc., v. NLRB,
907 F.2d 963, 972 (10th Cir. 1990) ("A material issue which
has been fairly tried by the parties * * * may be decided by the
Board regardless of whether it has been specifically
pleaded.''); Citizens State Bank, 751 F.2d at 213; Kuhn v. CAB,
183 F.2d 839, 842 (DC Cir. 1950)(("If it is clear that the
parties understand exactly what the issues are when the
proceedings are had, they cannot thereafter claim surprise or
lack of due process because of alleged deficiencies in the
language of the particular pleadings.'').
Notably, in the Show Cause Order, the Agency notified
Respondent that it was seeking the revocation because he "do[es]
not have authority to prescribe controlled substances in the
State of Louisiana,'' and that as a consequence, "DEA must
revoke your DEA registration based upon your lack of authority
to handle controlled substances in the State of Louisiana.''
Show Cause Order at 1. The Government thus provided Respondent
with notice as to the legal basis for the proceeding.
Moreover, even though the Government relied on the expiration
of Respondent's State CDS license rather
[[Page 36760]]
than the Consent Order to support its motion, Respondent had
an ample and meaningful opportunity to present evidence refuting
the Government's evidence and creating a triable issue and/or to
make argument (were there any viable ones to be made), regarding
the legal effect of his filing of the State renewal application.
While Respondent further argues that if the Agency "was
going to place in issue allegations that were not named in the
Order to Show Cause, the proper course of action would have been
to move to amend the Order to Show Cause,'' he does not identify
how he has been prejudiced by the Government's failure to amend
the Order. Exc. at 4; cf. Facet Enterprises, 907 F.2d at 972
("In determining whether a respondent can be held liable
for an unfair labor practice not charged in the complaint, the
central inquiry is fairness: considering the circumstances of
the case, did the respondent know what conduct was being alleged
and have `a fair opportunity to present [its] defense?''')
(quoting Soule Glass & Glazing Co. v. NLRB, 652 F.2d 1055,
1074 (1st Cir. 1985)).\2\
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\2\ Likewise, the Administrative Procedure Act requires
only that "[p]ersons entitled to notice of an agency
hearing shall be timely informed of * * * the matters of fact
and law asserted.'' 5 U.S.C. 554(b). He was.
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The rules governing DEA hearings do not require the formality
of amending a show cause order to comply with the evidence. The
Government's failure to file an amended Show Cause Order
alleging that Respondent's state CDS license had expired does
not render the proceeding fundamentally unfair.
Respondent also argues that the ALJ's ruling on the summary
disposition motion "should have been stayed pending
disclosure of evidence.'' Exc. at 5. Respondent analogizes the
prehearing statements to civil discovery and argues that
"the usual prehearing procedures for exchanging information
was [sic] not completed.'' Id. There is, however, no general
right to discovery under either the APA or DEA regulations, but
rather only a limited right to receive in advance of the hearing
the documentary evidence and summaries of the testimony which
the Government intends to rely upon. Nicholas A. Sychak, d/b/a
Medicap Pharmacy, 65 FR 75959, 75961 (2000) (citing McClelland
v. Andrus, 606 F.2d 1278, 1285 (DC Cir. 1979)); see also 21
CFR 1316.54(e) & 1316.57.
Nor, given the narrowness of the issue upon which the motion for
summary disposition was based--whether Respondent has authority
under state law to dispense a controlled substance--has
Respondent shown what material evidence he might have obtained
from the Government which he could not have obtained from
another source such as the State itself. The contention is
therefore without merit.
Respondent also argues that the ALJ unlawfully shifted the
burden of proof to him. According to Respondent, "[t]here
is an issue of disputed fact as to whether there has been [a]
suspension[,] revocation[,] or denial of [his] state authority
to prescribe controlled substances or merely [a] delay in
processing his renewal application.'' Exc. at 6. Respondent
further claims that the ALJ did not require the DEA to show that
the license was "pending,'' and placed on him the burden of
"show[ing] that he had been granted the requisite
authority.'' Id. at 7. Relatedly, Respondent maintains that the
Government cannot revoke his registration under 21
U.S.C. 824(a)(3) because it has not shown that his
registration has been suspended, revoked, or denied by competent
authority. Id.
Respondent ignores, however, that Congress has made the
possession of state authority a prerequisite for obtaining a DEA
registration. See id. Section
823(f) ("The Attorney General shall register
practitioners * * * to dispense * * * controlled substances * *
* if the applicant is authorized to dispense * * * controlled
substances under the laws of the State in which he
practices.''). In addition, the CSA defines the term
"practitioner'' to "mean[] a physician * * * or other
person licensed, registered, or otherwise permitted, by * * *
the jurisdiction in which he practices * * * to dispense [or]
administer * * * a controlled substance in the course of
professional practice.'' 21
U.S.C. 802(21). A physician who no longer holds authority
under State law to dispense a controlled substance is therefore
not a practitioner within the meaning of the CSA and cannot
lawfully dispense. DEA has therefore consistently held that a
practitioner may not maintain his registration if he lacks state
authority to dispense controlled substances. This rule has been
applied to revoke the registration of a practitioner even when
the practitioner's loss of state authority was based on the
expiration of a state license rather than a formal disciplinary
action of a state board. See William D. Levitt, 64 FR 49822,
49823 (1999); see also id. at 49822 (collecting cases). As the
Agency explained in Levitt, because
state authorization was clearly intended to be a prerequisite
to DEA registration, Congress could not have intended for DEA to
maintain a registration if a registrant is no longer authorized
by the state in which he practices to handle controlled
substances due to the expiration of his state license.
Therefore, it is reasonable for DEA to interpret that 21
U.S.C. Sec. 824(a)(3) would allow for the revocation of a
DEA * * * Registration where, as here, a registrant's state
authorization has expired.
Id. at 49823. See also Chevron, Inc., v. NRDC, Inc., 467 U.S.
837, 843 (1984) (where Congress is silent on a question, courts
defer to an agency's reasonable interpretation of the statute it
administers). Accordingly, in relying on the undisputed fact
that Respondent's State CDS license had expired, the ALJ did not
erroneously shift the burden of proof from the Government to
him. Rather, she correctly applied the Agency's settled
precedent that because Respondent clearly lacks authority to
dispense controlled substances in the State in which he holds
his DEA registration and practices medicine, he is not entitled
to maintain his registration. Respondent's registration will
therefore be revoked.
Order
Pursuant to the authority vested in me by 21
U.S.C. 823(f) & 824(a),
as well as by 28 CFR 0.100(b) & 0.104, I hereby order that
DEA Certificate of Registration, BB0492912, issued to Roy E.
Berkowitz, M.D., be, and it hereby is, revoked. I further order
that any pending application of Roy E. Berkowitz, M.D., for
renewal or modification of his registration be, and it hereby
is, denied. This order is effective immediately.\3\
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\3\ Because of the importance of the legal issues raised by
Respondent, I conclude that the public interest necessitates
that this Order be made effective immediately.
Dated: July 17, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-17714 Filed 7-23-09; 8:45 am]
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