[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78695-78697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-32393]


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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.

    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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