Roy E. Berkowitz, M.D.; Revocation of Registration, 36758-36760 [E9-17714]
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36758
Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Notices
the following: (1) The date that a controlled
substance was administered, or dispensed
(whether by prescription or actual delivery of
the drug); (2) the name of the patient to
whom a controlled substance was
administered or dispensed (whether by
prescription or actual delivery); (3) the
patient’s dental complaint; (4) the name,
dosage, and quantity of the substance
prescribed, dispensed or administered; and
(5) the date that the medication was
previously prescribed, dispensed or
administered to that patient if the medication
was prescribed, dispensed or administered in
the last year, as well as the amount last
provided to that patient. If no controlled
substances are prescribed, administered, or
dispensed during a given quarter,
Respondent shall submit a letter to the DEA
office indicating that there was no activity to
report during the quarter.
(B) Within 15 days of the event,
Respondent shall inform the local DEA office
of any proceeding initiated against him by a
State licensing board, whether the board
regulates his professional practice or his
authority to prescribe controlled substances.
In addition, within 15 days of the event,
Respondent shall inform the local DEA office
of any interim or final order of a State
licensing board which imposes a sanction,
whether the sanction be a reprimand, a fine,
a civil penalty, a probationary period, a
rejection of a petition for termination of
probation, an imposition of a condition, a
suspension, or a revocation of any State
professional license or authority to prescribe
a controlled substance.
(C) In the event that Respondent changes
employment during this three-year period, he
shall immediately notify the local DEA office
that is monitoring his drug activity logs.
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To ensure that there is no confusion
as to the duration of these conditions,
all three conditions shall remain in
effect for a period of three years from
the date of this Order’s publication in
the Federal Register.
Moreover, because Respondent has
not previously appreciated the
seriousness of these proceedings and his
obligation to comply with the CSA, the
Agency’s rules, and the conditions
imposed pursuant to the 2002 Order, I
further conclude that a period of
outright suspension of his registration is
warranted. Accordingly, while I grant
Respondent a new registration, said
registration will be suspended outright
for a period of three months.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823 and 824, as well as 28
CFR 0.100(b) and 0.104, I hereby order
that the application of Gregory D.
Owens, D.D.S., to renew his DEA
Certificate of Registration, be, and it
hereby is, granted subject to the
conditions set forth above. I further
order that the DEA Certificate of
Registration issued to Gregory D.
Owens, be, and it hereby is, suspended
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18:55 Jul 23, 2009
Jkt 217001
for a period of three months from the
effective date of this Order. This Order
is effective August 24, 2009.
Dated: July 16, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–17681 Filed 7–23–09; 8:45 am]
BILLING CODE 4410–09–P
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 prehearing 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
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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.
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
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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Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Notices
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
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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.
§ 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
PO 00000
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36759
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
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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
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
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.
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
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18:55 Jul 23, 2009
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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.
§ 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
Dated: July 17, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–17714 Filed 7–23–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Office of the Secretary
Submission for OMB Review:
Comment Request
July 20, 2009.
The Department of Labor (DOL)
hereby announces the submission of the
following public information collection
request (ICR) to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. chapter 35).
A copy of this ICR, with applicable
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.
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Agencies
[Federal Register Volume 74, Number 141 (Friday, July 24, 2009)]
[Notices]
[Pages 36758-36760]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17714]
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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.
---------------------------------------------------------------------------
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]
BILLING CODE 4410-09-P