Registrant Actions - 2011
[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78695-78697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32393]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11-49]
Barry M. Schultz, M.D.; Decision and Order
On June 17, 2011, Administrative Law Judge (ALJ) Gail A. Randall
issued the attached recommended decision. Neither party filed
exceptions to the ALJ's decision.
Having reviewed the record in its entirety, I have decided to adopt
the ALJ's rulings, findings of fact, conclusions of law, and
recommended order.
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 BS1314210, issued to Barry M. Schultz, M.D., be, and it
hereby is, revoked. I further order that any pending application of
Barry M. Shultz, M.D., to renew or modify his registration, be, and it
hereby is, denied. This Order is effective immediately.\1\
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\1\ For the same reasons that led me to order the Immediate
Suspension of Respondent's registration, I conclude that the public
interest requires that this order be effective immediately. See 21
CFR 1316.67.
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Dated: December 8, 2011.
Michele M. Leonhart,
Administrator.
Dedra S. Curteman, Esq., for the Government.
Michael R. Lowe, Esq., for the Respondent.
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
I. Facts
Gail A. Randall, Administrative Law Judge. On April 19, 2011, the
Administrator, Drug Enforcement Administration ("DEA" or
"Government"), issued an Order to Show Cause and an Immediate
Suspension of Registration ("Order to Show Cause" or "Order"),
immediately suspending the DEA Certificate of Registration, Number
BS1314210, of Barry M. Schultz, M.D. ("Respondent"), as a
practitioner, pursuant to 21 U.S.C. 824(d) (2006), because the
Respondent's continued registration constitutes an imminent danger to
the public health and safety. The Order also proposed to revoke the
Respondent's registration, pursuant to 21 U.S.C. 824(a)(4), and deny
any pending applications for renewal or modification of such
registration, pursuant to 21 U.S.C. 823(f), because the Respondent's
continued registration is inconsistent with the public interest, as
that term is defined in 21 U.S.C. 823(f). Specifically, the Order
alleged that between May of 2009 and August of 2010, the Respondent
issued prescriptions for an inordinate amount of controlled substances
to ten patients for illegitimate medical purposes. [Order at 1]. The
Government set out the various circumstances of those prescriptions
including that during one month, the Respondent prescribed "over 5,000
thirty milligram oxycodone tablets to R.L.," and "on one occasion
[the Respondent] prescribed 1,980 thirty milligram oxycodone tablets
per day that equates to an individual ingesting 66 thirty milligram
oxycodone per day." [Id. at 2].
The Order also alleged that from March 2009 through December 2009,
the Respondent ordered approximately 281,000 dosage units of oxycodone
to be delivered to his pain management clinic in Del Ray Beach,
Florida. [Id. at 3]. The Order similarly alleged that from January 2010
through August 2010, the Respondent ordered approximately 378,000
dosage units of oxycodone. [Id. at 3].
Further, the Government alleged that on March 24, 2011, the
Respondent was arrested and charged with trafficking in oxycodone and
writing illegal prescriptions. [Id. at 3].
Last, the Order alleged that on April 14, 2011, the Florida
Department of Health suspended the Respondent's authority to practice
medicine in Florida. [Id. at 3].
On May 19, 2011, the Respondent, through counsel, timely filed a
request for a hearing in the above-captioned matter.
On May 20, 2011, the Government filed its Motion for Summary
Disposition and Motion to Stay Proceedings ("Government's Motion").
Therein, the Government requested that I grant its Motion for Summary
Disposition, terminate the hearing in this matter, and forward the
matter to the Deputy Administrator for a Final Order with a
recommendation that the Respondent's registration be revoked and
pending applications be denied. [Government's Motion ("Govt") at 2].
The Government argues that summary disposition is appropriate where
the Respondent lacks state authority to handle controlled substances as
the DEA is barred by statute from continuing the Respondent's
registration. [Id. at 1 (citing 21 U.S.C. 801(21), 823(f), 824(a)(3);
Layfe Robert Anthony, M.D., 67 FR 20,346 (2009)]. Hence, the Government
argues, the DEA has consistently revoked such registrations. [Govt. at
1 (citing Roy Chi Lung, M.D., 74 FR 20,346 (2009); Michael Chait, M.D.,
73 FR 40,382 (2008); Shahid Musud Siddiqui, 61 FR 14,818 (1996);
Michael D. Lawton, 59 FR 17,792 (1994); Abraham A. Chaplan, M.D., 57 FR
55,280 (1992)].
In addition, the Government argues that summary revocation is
appropriate even where the suspension of the state license is temporary
and, thus, may be reinstated. [Govt. at 2 (citing Stuart A. Bergman,
M.D., 70 FR 33,193 (2005); Roger A. Rodriguez, M.D., 70 FR 33,206
(2005)].
Consequently, the Government argues that summary revocation of the
Respondent's registration in this case is appropriate as he currently
lacks state authority to handle controlled substances. [Govt. at 1-2].
The Government attached to its motion an order for the emergency
suspension of the Respondent's medical license ("ESO"), issued by the
State of Florida Department of Health on April 13, 2011. [Govt. Exhibit
("Exh.") A].
[[Page 78696]]
On May 24, 2011, I ordered the Respondent to respond to the
Government's Motion, if at all, on or before June 1, 2011. On June 6,
2011, the Respondent, through counsel, filed Respondent's Motion For
Extension Of Time For Respondent To File His Response To The DEA's
Motions For Summary Disposition And To Stay Proceedings ("Respondent's
Motion"). On June 3, 2011, I granted the Respondent's Motion and
ordered him to file his response on or before June 13, 2011.
On June 13, 2011, the Respondent filed Respondent's Response To
DEA's Motion For Summary Disposition And To Stay Proceedings
("Respondent's Response"). Therein, the Respondent did not dispute
that his Florida medical license is currently suspended. [Respondent's
Response ("Response") at 1]. However, the Respondent requests that
the proceedings be held in abeyance pending the outcome of his appeal
of the ESO before the 1st District Tribunal of Appeals, State of
Florida. [Id. at 1]. In the alternative, the Respondent requests to be
heard as to why the Attorney General should order a "narrowly tailored
suspension, allowing Respondent to continue practicing in the areas of
geriatric, internal and primary care." [Id. at 5].
In support of his request, the Respondent first argues that summary
disposition is inappropriate because the state's ESO, "which forms the
basis of the Government's integrity behind requesting Summary
Disposition, is currently under review and challenge" due to its non-
compliance with statutory standards. [Id. at 2-3]. Specifically, the
Respondent avers that that order is invalid because of its lack of
particularized allegations and failure to be narrowly tailored. [Id. at
2].
Next, the Respondent contends that several questions of material
fact as well as procedural issues remain, and that summary disposition
is inappropriate absent their resolution. [Id. at 3]. Some of those
factual and procedural issues include: whether the immediate suspension
of the Respondent's registration was based on a valid inspection and
investigation; whether the continued registration of the Respondent
constitutes an imminent danger to the public health and safety; and
whether other grounds exist for the United States Attorney General to
limit the suspension of the Respondent's registration. [Id. at 3-4]. In
furtherance of this argument, the Respondent states that he "calls
into question the validity of the DEA's inspection and the manner in
which the investigation was carried out." [Id. at 4].
Further, the Respondent argues that the DEA's reliance on Layfe
Robert Anthony, M.D., 67 FR 35,582 (DEA 2002), is inappropriate on the
basis that that case "involved a suspension resulting from a closed
door hearing at which Dr. Anthony argued he was unable to question
witnesses or present evidence." [Id.]. Here, the Respondent
distinguishes, his appeal of the ESO is pending in state court on
grounds that it fails to comply with state law. [Id.]
Last, the Respondent highlights the Attorney General's authority to
issue a limited suspension or revocation of the Respondent's
registration, and asks that he be afforded the opportunity to plead
certain facts that would merit such a finding. Specifically, the
Respondent seeks to inform this tribunal that the ESO is based on
roughly 1% of the Respondent's medical practice, 6-8 patients total,
and that a full suspension of his license "is not so narrowly tailored
as to adhere to Florida Law and to protect his due process rights."
[Id. at 4-5]. The Respondent concludes that granting him a hearing
before this Court will afford him due process "by allowing him to
petition this Tribunal for either an abeyance of the Administration's
proceedings or the recommendation to the Attorney General that a
narrowly tailored suspension be entered allowing Respondent to practice
medicine in the areas of geriatric, internal and primary care." [Id.
at 5].
For the reasons set forth below, I will grant the Government's
Motion and recommend that the Deputy Administrator revoke the
Respondent's DEA Certificate of Registration and deny any currently
pending applications to renew this registration.
II. Discussion
The DEA will not maintain a controlled substances registration if
the registrant is without state authority to handle controlled
substances in the state in which the registrant practices. The
Controlled Substances Act ("CSA") provides that obtaining a DEA
registration is conditional on holding a state license to handle
controlled substances. [See 21 U.S.C. 802(21) (2006) (defining
"practitioner" as "a physician * * * licensed, registered, or
otherwise permitted, by * * * the jurisdiction in which he practices *
* * to distribute, dispense, [or] administer * * * a controlled
substance in the course of professional practice"); 21 U.S.C. 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"). See also Sec.
824(a)(3) (stating "a registration may be suspended or revoked by the
Attorney General upon a finding that the registrant has had his State
license or registration suspended, revoked or denied by competent State
authority")]. The DEA, therefore, has consistently held that the CSA
requires the DEA to revoke the registration of a practitioner who no
longer possesses a state license to handle controlled substances. [See
e.g. Joseph Baumstarck, 74 FR 17, 525, 17, 527 (DEA 2009) (stating the
"ALJ applied the Agency's long-settled ruled [sic] that a practitioner
may not maintain his DEA registration if he lacks authority to handle
controlled substances under the laws of the state in which he
practices"); Roy Chi Lung, M.D., 74 FR 20,346 (DEA 2009); Gabriel
Sagun Orzame, M.D., 69 FR 58,959 (DEA 2004); Alton E. Ingram, Jr.,
M.D., 69 FR 22,562 (DEA 2004); Graham Travers Schuler, M.D., 65 FR
50,570 (DEA 2000); Dominick A. Ricci, M.D., 58 FR 51,104 (DEA 1993)].
Here, the Respondent does not dispute that he currently lacks state
authority to handle controlled substances. Regardless, the Respondent
requests that this tribunal grant him a hearing before the DEA to
afford him his due process rights. However, I find that the Respondent
will be afforded due process in the state proceedings. Furthermore, I
find the Respondent's other arguments unpersuasive for granting his
request.
A. Right to a Hearing and Due Process
First, while the Respondent correctly asserts that the due process
clause applies, I find that the Respondent's hearing in state court
satisfies that right.
The Respondent has a constitutionally protected property interest
in his DEA registration. [See Lujan v. G & G Fire Sprinklers, Inc., 532
U.S. 189, 196 (2001) (finding that a claimant has a right to due
process where "the claimant was denied a right by virtue of which he
was presently entitled either to exercise ownership dominion over real
or personal property, or to pursue a gainful occupation"). See also
Wedgewood Village Pharmacy v. Ashcroft, 293 F. Supp. 2d 462, 469-70 (D.
N.J. 2003) (finding that "[d]epriving [a company] of its rights to
dispense and receive controlled drugs without notice and a hearing
would violate * * * due process")].
In the event of an immediate suspension of his DEA registration,
the Respondent must, therefore, be provided with notice and a
meaningful post-deprivation hearing. [See Edwards v. Dunn, No. 3:10-CV-
0145-O-BH,
[[Page 78697]]
2010 WL 1644134, at *3 (N.D. Tex. March 31, 2010) (stating "[w]hen a
temporary license suspension 'falls within the public health and safety
class of due process cases * * * the Due Process Clause requires no
more than adequate post deprivation process' and finding that post-
deprivation due process applies to the immediate suspension of
respondent's DEA license") (quoting Camuglia v. City of Albuquerque,
375 F. Supp. 2d 1299, 1306 (D. N.M. 2005))].
Further, where the state has revoked or suspended a registrant's
license to handle controlled substances, summary revocation of the
registrant's DEA registration is only appropriate if the registrant
will be afforded a state hearing on the merits of the state revocation
or suspension. [See Roger A. Rodriguez, M.D., 70 FR 33,206, 33,207 (DEA
2005) (finding summary disposition appropriate where a hearing was
scheduled before the state board regarding the temporary suspension of
the Respondent's state license); Hichman K. Riba, D.D.S., 73 FR 75,773,
75,774 (DEA 2008) (finding summary disposition appropriate where the
respondent was seeking judicial review of state proceedings); Bourne
Pharmacy, Inc., 72 FR 18,273, 18,274 (DEA 2007) (summary disposition
appropriate where the state revocation was "pending a final decision
on the merits"); Odette Louise Campbell, M.D., Docket No. 09-62 (April
16, 2010) (unpublished) (finding summary disposition inappropriate
where "granting the Government's request will deny her any opportunity
to litigate the allegations upon which both the Federal and State
suspension orders are based")].
Here, the Respondent will be afforded such a hearing. Pursuant to
Florida law, the Respondent is entitled to judicial review of the ESO,
and the Respondent has pursued such review. [Fla. Stat. Sec. Sec.
120.6, 120.68 (2007); Response at 1]. Therefore, I find that the
Respondent will be afforded due process via the state hearing, and
accordingly, under the facts of this case, has no constitutional right
to a hearing before this agency.
B. Respondent's Other Arguments
I similarly find the Respondent's other arguments unpersuasive as
to why this Court should not grant the Government's Motion in this
proceeding.
First, while the Respondent may have raised genuine disputes of
fact, those disputes are immaterial in light of the Respondent's lack
of state registration. Indeed, the Controlled Substances Act and DEA
case law make clear that as a pre-requisite to registration the
Respondent must have state authority and that without such authority
all other issues before this Court are moot. [21 U.S.C. 802(21)
(defining "practitioner" as "a physician * * * licensed, registered,
or otherwise permitted, by * * * the jurisdiction in which he practices
* * * to distribute, dispense, [or] administer * * * a controlled
substance in the course of professional practice") Sec. 823(f)
(requiring the agency to register "practitioners"); Baumstarck, 74 FR
at 17, 527 (interpreting that language to require state licensure)].
Thus, where there is no dispute of material fact, the Respondent's lack
of state authority to handle controlled substances, there is no need
for a plenary, administrative hearing. [See Michael G. Dolin, M.D., 65
FR 5,661 (DEA 2000); Jesus R. Juarez, M.D., 62 FR 14,945 (DEA 1997);
see also Philip E. Kirk, M.D., 48 FR 32,887 (DEA 1983), aff'd sub nom
Kirk v. Mullen, 749 F.2d 297 (6th Cir. 1984)].
Furthermore, to the extent that the Respondent believes that the
agency's immediate suspension of the Respondent's registration was
inappropriate, either substantively or procedurally, that matter is not
reviewable by this tribunal, and must be pursued in federal District
Court or directly to the Administrator. [See Sec. 824(d) (stating that
an immediate suspension order remains in effect "until either
withdrawn by the Administrator or dissolved by a court of competent
jurisdiction"); 21 CFR 1301.36 (2010) (identical language)].
In addition, to the extent that the state's ESO is invalid due to
its non-compliance with Florida law, that issue is certainly not before
this agency, and should be litigated in the Respondent's state hearing.
Next, while the Respondent may have factually distinguished between
the present case and Layfe Robert Anthony, that distinction is without
a difference, as that case is relied on by the Government not for its
factual similarities to the present one but for the principle that
without state authority the Respondent may not maintain a federal
controlled substances registration. [Govt. Brief at 1-2]. As the agency
has reiterated that principle in several of its other decisions, I am
not persuaded that any distinction between this case and Anthony is a
meaningful one. [See e.g. Riba, 73 FR at 75,774; Bourne Pharmacy, Inc.,
72 FR at 18,274].
Last, the Respondent's argument that due process affords him the
right to "petition this Tribunal for * * * the recommendation to the
Attorney General that a narrowly tailored suspension be entered
allowing Respondent to continue practicing in the areas of geriatric,
internal and primary care" mischaracterizes the scope of this agency's
regulatory authority.\1\ The DEA is charged with regulating the
handling of controlled substances and list I chemicals, and not the
practice of medicine generally. [See Dispensing Controlled Substances
for the Treatment of Pain, 76 FR 52,715, 52717 (2006) (stating
"although DEA is the agency responsible for administering the CSA, DEA
does not act as the Federal equivalent of a State medical board
overseeing the general practice of medicine. State laws and State
licensing bodies (such as medical licensing boards) collectively
regulate the practice of medicine")]. Therefore, nothing in the DEA's
Order generally precludes the Respondent from continuing to practice in
those areas. Rather, the DEA's Order affects the Respondent's ability
to handle controlled substances.
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\1\ In addition, the Respondent overlooks that the Attorney
General's authority under the Controlled Substances Act has been
delegated to the Deputy Administrator of the DEA. [See 21 U.S.C.
871(a); 28 CFR 0.100].
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III. Conclusion, Order, and Recommendation
Consequently, there is no genuine dispute of material fact as there
is no dispute that the Respondent currently lacks state authority to
handle controlled substances and that he is entitled to a hearing on
the merits of the state's ESO in state court. Therefore, summary
disposition for the Government is appropriate.\2\
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\2\ This opinion does not reach the other factual issues made in
the Order to Show Cause. Rather, this opinion solely addresses the
Respondent's loss of his ability to practice medicine in the State
of Florida, and, thus, his ability to handle controlled substances.
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Accordingly, I hereby grant the Government's Motion for Summary
Disposition.
I also forward this case to the Deputy Administrator for final
disposition. I recommend that the Respondent's DEA Certificate of
Registration, Number BS1314210, be revoked and any pending renewal
applications for this registration be denied.
Date: June 17, 2011.
Gail A. Randall,
Administrative Law Judge.
[FR Doc. 2011-32393 Filed 12-16-11; 8:45 am]
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