David A. Ruben, M.D.; Decision and Order, 12027-12029 [2018-05471]
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Federal Register / Vol. 83, No. 53 / Monday, March 19, 2018 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17–38]
sradovich on DSK3GMQ082PROD with NOTICES
David A. Ruben, M.D.; Decision and
Order
On June 12, 2017, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause to David A. Ruben, M.D.
(Respondent), of Tucson, Arizona. The
Show Cause Order proposed the
revocation of Respondent’s DEA
Certificate of Registration No.
AR9258434 on the ground that he
‘‘do[es] not have authority to handle
controlled substances in the State of
Arizona, the [S]tate in which [he is]
registered with the DEA.’’ Order to
Show Cause, at 1 (citing 21 U.S.C. 823(f)
and 824(a)(3)).
With respect to the Agency’s
jurisdiction, the Show Cause Order
alleged that Respondent is the holder of
Certificate of Registration No.
AR9258434 ‘‘as a data-waived DW/30
practitioner in schedules II through V,’’
at the registered address of 2016 South
4th Avenue, Tucson, Arizona. Id. The
Order also alleged that this registration
does not expire until April 30, 2020. Id.
Regarding the substantive grounds for
the proceeding, the Show Cause Order
alleged that on April 6, 2017,
Respondent’s ‘‘authority to prescribe
and administer controlled substances in
the State of Arizona was suspended,’’
and that Arizona is ‘‘the [S]tate in which
[he is] registered with the DEA.’’ Id.
Based on his ‘‘lack of authority to
[dispense] controlled substances in . . .
Arizona,’’ the Order asserted that ‘‘DEA
must revoke’’ his registration. Id. (citing
21 U.S.C. 823(f)(1) and 824(a)(3)).
The Show Cause Order notified
Respondent of (1) his right to request a
hearing on the allegations or to submit
a written statement in lieu of a hearing
‘‘[w]ithin 30 days after the date of
receipt of this Order to Show Cause,’’ (2)
the procedure for electing either option,
and (3) the consequence for failing to
elect either option. Id. at 2 (citing 21
CFR 1301.43). The Show Cause Order
also notified Respondent of his right to
submit a corrective action plan
(hereinafter, CAP) to the Assistant
Administrator, Diversion Control
Division, and the procedure for doing
so. Id. at 2–3.
On July 18, 2017, Respondent
submitted his CAP by letter from his
counsel (dated July 12, 2017) to the
Agency. In his CAP, Respondent
explained:
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Dr. Ruben intends to continue to pursue
and to prevail on the appeal of the
underlying order issued by [t]he Arizona
Medical [B]oard . . . . Alleged violation of
that order is the basis of the Arizona Medical
Board suspension dated April 6, 2017. The
underlying matter is on appeal in Maricopa
County Arizona Superior Court . . .
At least part of that Order being appealed
stems from an Arizona license restriction of
Dr. Ruben as to Schedule [II] drugs which
was imposed partly as punishment for an
earlier Certificate [of] Suspension by the
DEA,1 which itself was based upon the
earlier same Arizona suspension dating from
2009 and 2010. The entire matter is
ludicrous, and will result in the lifting of the
suspension of concern here, as this is the
fourth iteration of punishment by the
Arizona Medical Board and the DEA
cannibalizing one another’s actions in order
to inflict multiple punishments for the same
acts from 2009 and 2010.
All remaining bases of the Arizona
suspension will also be overturned as
unsupported by the evidence. The DEA
[Show Cause Order] is premature and
unnecessary and any hearing should be
continued pending the outcome of the
remaining state matters on appeal.
CAP, at 1. On December 4, 2017, the
Acting Assistant Administrator rejected
Respondent’s CAP and further
‘‘determined there is no potential
modification of your []CAP that could or
would alter my decision in this regard.’’
See Letter from Acting Assistant
Administrator Demetra Ashley to
Respondent (dated December 4, 2017)
(hereinafter CAP Rejection Ltr or CAP
Rejection Letter), at 1.2
1 On June 18, 2013, the Agency suspended
Respondent’s DEA Certificate of Registration for one
year and imposed four conditions on his
registration for two years. David A. Ruben, M.D., 78
FR 38363, 38387–88 (2013). The Ninth Circuit
Court of Appeals denied his petition for review of
the Agency’s decision. 617 Fed. Appx. 837 (9th Cir.
2015) (unpublished).
2 Respondent’s CAP was attached as Exhibit 1 to
Respondent’s counsel’s letter requesting a hearing.
CAP, at 1 (attached as ‘‘EXHIBIT 1 TO REQUEST
FOR HEARING’’ to Letter from Respondent’s
Counsel to Hearing Clerk (dated July 12, 2017). The
letter setting forth Respondent’s request for a
hearing (hereinafter, Hearing Request) was
addressed to the Office of Administrative Law
Judges (OALJ) as well as to the Assistant
Administrator, Diversion Control Division, Louis
Milione. Hearing Request, at 1. As discussed more
fully infra, the record reflects that the OALJ
received this letter on July 18, 2018. See id. In
addition, the Acting Assistant Administrator’s CAP
Rejection Letter attached a copy of Respondent’s
Hearing Request (and a copy of the CAP) datestamped ‘‘Jul 18, 2017’’ and a handwritten notation
above it stating ‘‘DC received.’’ The CAP Rejection
Letter stated that her office did not receive the CAP
until September 29, 2017. CAP Rejection Ltr, at 1.
The record does not reflect facts explaining why the
CAP Rejection Letter states that the CAP was not
received by DEA’s Diversion Control Division until
September 29, 2017.
In the CAP Rejection Letter, the Acting Assistant
Administrator states that she was responding to
Respondent’s CAP ‘‘in connection with an Order to
Show Cause . . . issued by the Assistant
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On July 18, 2017, Respondent also
filed a letter with the Office of
Administrative Law Judges (OALJ)
pursuant to which he requested a
hearing on the allegation of the Show
Cause Order. Letter from Respondent’s
Counsel to Hearing Clerk (dated July 12,
2017) (hereinafter, Hearing Request).
The matter was placed on the OALJ’s
docket and assigned to Administrative
Law Judge Charles Wm. Dorman
(hereinafter, ALJ). On July 21, 2017, the
ALJ issued an order entitled ‘‘Briefing
Schedule for Lack of State Authority
Allegations’’ in which the ALJ found,
inter alia, that ‘‘[t]he Respondent filed a
timely Request for Hearing.’’ Briefing
Schedule for Lack of State Authority
Allegations (hereinafter, Briefing Order),
at 1.3
Pursuant to 21 CFR 1301.43(a), ‘‘any
person entitled to a hearing . . . and
desiring a hearing shall, within 30 days
after the date of receipt of the order to
show cause, . . . file with the
Administrator a written request for a
hearing.’’ Accord Show Cause Order, at
2. The ALJ did not indicate in his
Briefing Order or in his Recommended
Decision—and the rest of the
administrative record does not
indicate—when Respondent received
the Show Cause Order. Without any
evidence in the record establishing
when Respondent received the Show
Cause Order, the only way in which I
could find that Respondent’s Hearing
Request was timely is if it had been filed
with the Administrator within 30 days
of the June 12, 2017 date of the Show
Cause Order. However, the OALJ did
not receive Respondent’s Hearing
Request until July 18, 2017.4 Hearing
Request, at 1. Accordingly, I find that
Respondent’s Hearing Request was not
Administrator on June 29, 2017.’’ Id. As already
noted, however, the Show Cause Order was issued
on June 12, 2017. Show Cause Order, at 1. The CAP
Rejection Letter does attach, inter alia, a copy of
Respondent’s Hearing Request and CAP in
connection with the June 12, 2017 Show Cause
Order. See Attachment to CAP Rejection Ltr at 2–
4. Thus, I find that the CAP Rejection Letter’s
reference to a June 29, 2017 Show Cause Order was
merely a scrivener’s error and that the Acting
Assistant Administrator intended to refer to the
June 12, 2017 Show Cause Order.
3 Although the date next to the ALJ’s signature
states ‘‘June 21, 2017,’’ id. at 2, the ALJ’s Docket
Sheet indicates that this order was signed on ‘‘July
21, 2017.’’ I find that the date in the Briefing Order
was a scrivener’s error and that in fact the ALJ
signed the order on July 21, 2017 as reflected in the
ALJ’s Docket Sheet.
4 Although the front of Respondent’s Hearing
Request is stamped ‘‘Received’’ by the Office of
Administrative Law Judges on July 18, 2017, the
photocopy of the envelope that purportedly
contained Respondent’s Hearing Request reveals a
‘‘Received/Date’’ of ‘‘July 17, 2017.’’ Compare
Hearing Request, at 1, with id. at 4. In any event,
neither date is within 30 days of the June 12, 2017
date of the Show Cause Order.
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Federal Register / Vol. 83, No. 53 / Monday, March 19, 2018 / Notices
timely filed pursuant to 21 CFR
1301.43(a), and as a result, Respondent
waived his right to a hearing.
In the absence of a timely hearing
request, I also find that the ALJ
consequently lacked jurisdiction to hear
the case. See Brown’s Discount
Apothecary BC, Inc., and Bolling
Apothecary, Inc., 80 FR 57393, 57394
(2015) (‘‘in the absence of a hearing
request, the ALJ had no authority to rule
on the issue of whether its registration
should be revoked’’). I therefore cancel
the hearing nunc pro tunc held by the
ALJ by summary disposition. See 21
CFR 1301.43(e). Accordingly, I will treat
this case as a Request for Final Agency
Action and issue this Decision and
Order based on the relevant evidence
forwarded to my office by the ALJ on
September 18, 2017.5 See id. I make the
following findings.
sradovich on DSK3GMQ082PROD with NOTICES
Findings of Fact
Respondent is a holder of DEA
Certificate of Registration No.
AR9258434, as well as DATA-Waiver
identification number XR9258434.
Government Exhibit (GX) 1 to Govt.
Mot. Pursuant to his registration,
Respondent is authorized to dispense
controlled substances in schedules III 6
through V as a practitioner, and he is
authorized to dispense or prescribe
schedule III–V narcotic controlled
substances which ‘‘have been approved
5 In his Briefing Order, the ALJ ordered the
Government to file evidence to support its
allegation that Respondent lacks state authority to
handle controlled substances, and any motion for
summary disposition on these grounds, on August
3, 2017. Briefing Order at 1. The ALJ also directed
Respondent to file his response to any summary
disposition motion on August 10, 2017. Id. On
August 3, 2017, the Government filed its Motion for
Summary Disposition, and the Respondent filed his
response on August 10, 2017. See Government’s
Motion for Summary Disposition (hereinafter Govt.
Mot.); Response to Motion for Summary Disposition
(hereinafter Resp. Br.). On August 15, 2017, the ALJ
issued his Order granting summary disposition and
Recommended Decision. Order Granting Summary
Disposition and Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision (hereinafter,
Recommended Decision or R.D.). Neither party filed
exceptions to the ALJ’s Recommended Decision.
Although the ALJ’s Recommended Decision did not
establish that the ALJ had jurisdiction in this case,
I will nonetheless consider the administrative
record that he submitted to me in its entirety.
6 Although the Show Cause Order alleges that
Respondent’s registration authorizes him to
dispense controlled substances ‘‘in Schedules II
through V,’’ see Show Cause Order, at 1, the record
establishes that Respondent is not authorized to
dispense any schedule II controlled substances. GX
1. In addition, to the extent that the Show Cause
Order’s statement that Respondent’s status ‘‘as a
data-waived DW/30 practitioner in Schedules II–V’’
suggests that this status authorized Respondent to
dispense schedule II controlled substances, that
suggestion is incorrect as a matter of law. 21 U.S.C.
823(g)(2)(a) (limiting authority to dispense to
‘‘narcotic drugs in schedule III, IV, or V’’); 21 CFR
1301.28(a) (same).
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by the Food and Drug Administration
. . . specifically for use in maintenance
or detoxification treatment’’ for up to
100 patients. 21 CFR 1301.28(a) &
(b)(1)(iii); see GX 1. Respondent’s
registered address is 2016 South 4th
Avenue, Tucson, Arizona. GX 1.
Respondent’s registration and DATAWaiver authority do not expire until
April 30, 2020. Id.
On April 6, 2017, the Arizona Medical
Board issued an Order stating the
Respondent’s ‘‘license to practice
allopathic medicine in the State of
Arizona . . . is summarily suspended.’’
GX 2, at 7. The Board also prohibited
Respondent ‘‘from practicing medicine
in the State of Arizona’’ and ‘‘from
prescribing any form of treatment
including prescription medications or
injections of any kind.’’ Id. Finally, the
Board stated that ‘‘Respondent is
entitled to a formal hearing to defend
these charges within 60 days after the
issuance of this order.’’ Id. Based on the
above, I find that Respondent does not
currently have authority under the laws
of Arizona to dispense controlled
substances.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of the CSA, ‘‘upon a
finding that the registrant . . . has had
his State license . . . suspended [or]
revoked . . . by competent State
authority and is no longer authorized by
State law to engage in the . . .
dispensing of controlled substances.’’
Also, DEA has long held that the
possession of authority to dispense
controlled substances under the laws of
the State in which a practitioner engages
in professional practice is a
fundamental condition for obtaining
and maintaining a practitioner’s
registration. See, e.g., James L. Hooper,
76 FR 71371 (2011), pet. for rev. denied,
481 Fed. Appx. 826 (4th Cir. 2012); see
also Frederick Marsh Blanton, 43 FR
27616 (1978) (‘‘State authorization to
dispense or otherwise handle controlled
substances is a prerequisite to the
issuance and maintenance of a Federal
controlled substances registration.’’).
This rule derives from the text of two
provisions of the CSA. First, Congress
defined ‘‘the term ‘practitioner’ [to]
mean[ ] a . . . physician . . . or other
person licensed, registered or otherwise
permitted, by . . . the jurisdiction in
which he practices . . . to distribute,
dispense, [or] administer . . . a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). Second, in setting the
requirements for obtaining a
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practitioner’s registration, Congress
directed that ‘‘[t]he Attorney General
shall register practitioners . . . if the
applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which he practices.’’ 21
U.S.C. 823(f). Because Congress has
clearly mandated that a practitioner
possess state authority in order to be
deemed a practitioner under the CSA,
DEA has held repeatedly that revocation
of a practitioner’s registration is the
appropriate sanction whenever he is no
longer authorized to dispense controlled
substances under the laws of the State
in which he engages in professional
practice. See, e.g., Calvin Ramsey, 76 FR
20034, 20036 (2011); Sheran Arden
Yeates, M.D., 71 FR 39130, 39131
(2006); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR
11919, 11920 (1988); Blanton, 43 FR at
27616.
Moreover, because ‘‘the controlling
question’’ in a proceeding brought
under 21 U.S.C. 824(a)(3) is whether the
holder of a practitioner’s registration ‘‘is
currently authorized to handle
controlled substances in the [S]tate,’’
Hooper, 76 FR at 71371 (quoting Anne
Lazar Thorn, 62 FR 12847, 12848
(1997)), the Agency has also long held
that revocation is warranted even where
a practitioner has lost his state authority
by virtue of the State’s use of summary
process and the State has yet to provide
a hearing to challenge the suspension.
Bourne Pharmacy, 72 FR 18273, 18274
(2007); Wingfield Drugs, 52 FR 27070,
27071 (1987). Thus, it is of no
consequence that the Arizona Medical
Board summarily suspended
Respondent’s state medical license.
What is consequential is the undisputed
fact that Respondent is no longer
currently authorized to dispense
controlled substances in Arizona, the
State in which he is registered.
As for Respondent’s CAP, I conclude
that there were adequate grounds for
denying it. Specifically, Respondent’s
position in his CAP is that his DEA
registration should not be revoked until
the conclusion of his appeal of the
Arizona Medical Board’s decision. As
already noted, however, revocation is
warranted even where a practitioner has
lost his state authority and the State has
yet to provide a hearing to challenge the
suspension. See Bourne Pharmacy, 72
FR at 18274; Wingfield Drugs, 52 FR at
27071. Thus, I agree with the Agency’s
denial of Respondent’s CAP.
I will therefore reject Respondent’s
CAP and order that his registration (and
DATA-Waiver number) be revoked.7
7 The ALJ received and considered the
Government’s Motion for Summary Disposition and
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Federal Register / Vol. 83, No. 53 / Monday, March 19, 2018 / Notices
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 No.
AR9258434 and DATA-Waiver
Identification Number XR9258434,
issued to David A. Ruben, M.D., be, and
they hereby are, revoked. I further order
that any pending application of David
A. Ruben to renew or modify the above
registration, or any pending application
of David A. Ruben for any other
registration, be, and it hereby is, denied.
This Order is effective immediately.8
Dated: March 7, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018–05471 Filed 3–16–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Executive Office for Immigration
Review
[OMB Number 1125–NEW]
Agency Information Collection
Activities; Proposed eCollection;
Comments Requested; New
Executive Office for
Immigration Review, Department of
Justice.
ACTION: Notice.
AGENCY:
The Department of Justice,
Executive Office for Immigration
Review, is submitting the following
information collection request to the
Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995.
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SUMMARY:
the ‘‘Response to Motion for Summary Disposition’’
filed by Respondent. In his responsive brief,
Respondent argued that ‘‘[u]nder the terms of that
[Arizona Medical] Board Order, the suspension was
for 60 days beginning on April 6, 2017 until the
matter was set for a formal hearing’’ before the
Board. Resp. Br. at 1. However, as already noted
above, the Arizona Medical Board’s Order
‘‘summarily suspended’’ Respondent ‘‘from
prescribing any form of treatment including
prescription medications or injections of any kind.’’
GX 2, at 7. Thus, I agree with the ALJ that the fact
that the Board gave Respondent the right to a formal
hearing within 60 days of its April 6, 2017 Order
‘‘does not obviate the fact that the Respondent
currently does not possess state authority to handle
controlled substances in Arizona,’’ the State in
which he is registered. R.D. at 5. Accordingly, if the
ALJ had the authority to issue his conclusion
rejecting Respondent’s argument, I would have
adopted it, and I would have done so for the same
reason.
8 For the same reasons which led the Arizona
Medical Board to revoke Respondent’s medical
license, I conclude that the public interest
necessitates that this Order be effective
immediately. 21 CFR 1316.67.
VerDate Sep<11>2014
The Department of Justice
encourages public comment and will
accept input until May 18, 2018.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments
especially on the estimated public
burden or associated response time,
suggestions, or need a copy of the
proposed information collection
instrument with instructions or
additional information, please contact
Jean King, General Counsel, Office of
the General Counsel, 5107 Leesburg
Pike, Suite 2600, Falls Church, VA
22041, telephone: (703) 305–0470.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
address one or more of the following
four points:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the Executive Office for
Immigration Review, including
whether the information will have
practical utility;
—Evaluate the accuracy of the agency’s
estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
—Evaluate whether and if so how the
quality, utility, and clarity of the
information to be collected can be
enhanced; and
—Minimize the burden of the collection
of information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms
of information technology, e.g.,
permitting electronic submission of
responses.
DATES:
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Jkt 244001
Overview of This Information
Collection
1. Type of Information Collection:
New Voluntary Collection.
2. The Title of the Form/Collection:
Office of the Chief Administrative
Hearing Officer E-Filing Portal.
3. The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
There is no agency form number for this
collection. The applicable component
within the Department of Justice is the
Office of the Chief Administrative
Hearing Officer (OCAHO).
4. Affected public who will be asked
or required to respond, as well as a brief
abstract: Individuals, Business or other
for-profit, and not-for-profit institutions.
5. An estimate of the total number of
respondents and the amount of time
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estimated for an average respondent to
respond: 51, 50 minutes per response,
2,550 annual hours.
6. An estimate of the total public
burden (in hours) associated with the
collection: $5,220.53.
If additional information is required
contact: Melody Braswell, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE, 3E.405A,
Washington, DC 20530.
Dated: March 14, 2018.
Melody Braswell,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2018–05532 Filed 3–16–18; 8:45 am]
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DEPARTMENT OF JUSTICE
Notice of Proposed Administrative
Settlement Agreement Under the Clean
Comprehensive Environmental
Response, Compensation, and Liability
Act
On March, 12, 2018, the Department
of Justice formally proposed to enter a
Settlement Agreement and Order on
Consent for Response Action
(‘‘Settlement Agreement’’) with the
Bunker Hill Mining Corp. (‘‘BHMC’’), in
connection with BHMC’s purchase of
property located at the Bunker Hill
Mine, south of Kellogg, in the Silver
Valley of Shoshone County, Idaho (the
‘‘Mine’’), which is located in and part of
the ‘‘Non-Populated Areas Operable
Unit of the Bunker Hill Superfund Site.’’
As described in the Settlement
Agreement, BHMC agrees to perform
response actions at or in connection
with the Mine and to make payments
for, and in satisfaction of the liability of
Placer Mining Corp. and the Estate of
Robert Hopper, Sr., under the
Comprehensive Environmental
Response, Compensation, and Liability
Act, 42 U.S.C. 9601–9675 (‘‘CERCLA’’).
Under the proposed Settlement
Agreement, BHMC has agreed, as part of
the consideration BHMC is paying to
purchase the Mine and in satisfaction of
the liability of Placer Mining Co. and
Robert Hopper, Jr., the current owners of
the Mine, to reimburse the United States
over 80 percent of its costs incurred in
connection with the Bunker Hill Mine
property and have agreed to pay for
treatment of acid water discharged from
the Mine and to otherwise manage Mine
water as requested by the
Environmental Protection Agency.
The publication of this notice opens
a period for public comment on the
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[Federal Register Volume 83, Number 53 (Monday, March 19, 2018)]
[Notices]
[Pages 12027-12029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05471]
[[Page 12027]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17-38]
David A. Ruben, M.D.; Decision and Order
On June 12, 2017, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (DEA), issued an Order to
Show Cause to David A. Ruben, M.D. (Respondent), of Tucson, Arizona.
The Show Cause Order proposed the revocation of Respondent's DEA
Certificate of Registration No. AR9258434 on the ground that he
``do[es] not have authority to handle controlled substances in the
State of Arizona, the [S]tate in which [he is] registered with the
DEA.'' Order to Show Cause, at 1 (citing 21 U.S.C. 823(f) and
824(a)(3)).
With respect to the Agency's jurisdiction, the Show Cause Order
alleged that Respondent is the holder of Certificate of Registration
No. AR9258434 ``as a data-waived DW/30 practitioner in schedules II
through V,'' at the registered address of 2016 South 4th Avenue,
Tucson, Arizona. Id. The Order also alleged that this registration does
not expire until April 30, 2020. Id.
Regarding the substantive grounds for the proceeding, the Show
Cause Order alleged that on April 6, 2017, Respondent's ``authority to
prescribe and administer controlled substances in the State of Arizona
was suspended,'' and that Arizona is ``the [S]tate in which [he is]
registered with the DEA.'' Id. Based on his ``lack of authority to
[dispense] controlled substances in . . . Arizona,'' the Order asserted
that ``DEA must revoke'' his registration. Id. (citing 21 U.S.C.
823(f)(1) and 824(a)(3)).
The Show Cause Order notified Respondent of (1) his right to
request a hearing on the allegations or to submit a written statement
in lieu of a hearing ``[w]ithin 30 days after the date of receipt of
this Order to Show Cause,'' (2) the procedure for electing either
option, and (3) the consequence for failing to elect either option. Id.
at 2 (citing 21 CFR 1301.43). The Show Cause Order also notified
Respondent of his right to submit a corrective action plan
(hereinafter, CAP) to the Assistant Administrator, Diversion Control
Division, and the procedure for doing so. Id. at 2-3.
On July 18, 2017, Respondent submitted his CAP by letter from his
counsel (dated July 12, 2017) to the Agency. In his CAP, Respondent
explained:
Dr. Ruben intends to continue to pursue and to prevail on the
appeal of the underlying order issued by [t]he Arizona Medical
[B]oard . . . . Alleged violation of that order is the basis of the
Arizona Medical Board suspension dated April 6, 2017. The underlying
matter is on appeal in Maricopa County Arizona Superior Court . . .
At least part of that Order being appealed stems from an Arizona
license restriction of Dr. Ruben as to Schedule [II] drugs which was
imposed partly as punishment for an earlier Certificate [of]
Suspension by the DEA,\1\ which itself was based upon the earlier
same Arizona suspension dating from 2009 and 2010. The entire matter
is ludicrous, and will result in the lifting of the suspension of
concern here, as this is the fourth iteration of punishment by the
Arizona Medical Board and the DEA cannibalizing one another's
actions in order to inflict multiple punishments for the same acts
from 2009 and 2010.
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\1\ On June 18, 2013, the Agency suspended Respondent's DEA
Certificate of Registration for one year and imposed four conditions
on his registration for two years. David A. Ruben, M.D., 78 FR
38363, 38387-88 (2013). The Ninth Circuit Court of Appeals denied
his petition for review of the Agency's decision. 617 Fed. Appx. 837
(9th Cir. 2015) (unpublished).
---------------------------------------------------------------------------
All remaining bases of the Arizona suspension will also be
overturned as unsupported by the evidence. The DEA [Show Cause
Order] is premature and unnecessary and any hearing should be
continued pending the outcome of the remaining state matters on
appeal.
CAP, at 1. On December 4, 2017, the Acting Assistant Administrator
rejected Respondent's CAP and further ``determined there is no
potential modification of your []CAP that could or would alter my
decision in this regard.'' See Letter from Acting Assistant
Administrator Demetra Ashley to Respondent (dated December 4, 2017)
(hereinafter CAP Rejection Ltr or CAP Rejection Letter), at 1.\2\
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\2\ Respondent's CAP was attached as Exhibit 1 to Respondent's
counsel's letter requesting a hearing. CAP, at 1 (attached as
``EXHIBIT 1 TO REQUEST FOR HEARING'' to Letter from Respondent's
Counsel to Hearing Clerk (dated July 12, 2017). The letter setting
forth Respondent's request for a hearing (hereinafter, Hearing
Request) was addressed to the Office of Administrative Law Judges
(OALJ) as well as to the Assistant Administrator, Diversion Control
Division, Louis Milione. Hearing Request, at 1. As discussed more
fully infra, the record reflects that the OALJ received this letter
on July 18, 2018. See id. In addition, the Acting Assistant
Administrator's CAP Rejection Letter attached a copy of Respondent's
Hearing Request (and a copy of the CAP) date-stamped ``Jul 18,
2017'' and a handwritten notation above it stating ``DC received.''
The CAP Rejection Letter stated that her office did not receive the
CAP until September 29, 2017. CAP Rejection Ltr, at 1. The record
does not reflect facts explaining why the CAP Rejection Letter
states that the CAP was not received by DEA's Diversion Control
Division until September 29, 2017.
In the CAP Rejection Letter, the Acting Assistant Administrator
states that she was responding to Respondent's CAP ``in connection
with an Order to Show Cause . . . issued by the Assistant
Administrator on June 29, 2017.'' Id. As already noted, however, the
Show Cause Order was issued on June 12, 2017. Show Cause Order, at
1. The CAP Rejection Letter does attach, inter alia, a copy of
Respondent's Hearing Request and CAP in connection with the June 12,
2017 Show Cause Order. See Attachment to CAP Rejection Ltr at 2-4.
Thus, I find that the CAP Rejection Letter's reference to a June 29,
2017 Show Cause Order was merely a scrivener's error and that the
Acting Assistant Administrator intended to refer to the June 12,
2017 Show Cause Order.
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On July 18, 2017, Respondent also filed a letter with the Office of
Administrative Law Judges (OALJ) pursuant to which he requested a
hearing on the allegation of the Show Cause Order. Letter from
Respondent's Counsel to Hearing Clerk (dated July 12, 2017)
(hereinafter, Hearing Request). The matter was placed on the OALJ's
docket and assigned to Administrative Law Judge Charles Wm. Dorman
(hereinafter, ALJ). On July 21, 2017, the ALJ issued an order entitled
``Briefing Schedule for Lack of State Authority Allegations'' in which
the ALJ found, inter alia, that ``[t]he Respondent filed a timely
Request for Hearing.'' Briefing Schedule for Lack of State Authority
Allegations (hereinafter, Briefing Order), at 1.\3\
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\3\ Although the date next to the ALJ's signature states ``June
21, 2017,'' id. at 2, the ALJ's Docket Sheet indicates that this
order was signed on ``July 21, 2017.'' I find that the date in the
Briefing Order was a scrivener's error and that in fact the ALJ
signed the order on July 21, 2017 as reflected in the ALJ's Docket
Sheet.
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Pursuant to 21 CFR 1301.43(a), ``any person entitled to a hearing .
. . and desiring a hearing shall, within 30 days after the date of
receipt of the order to show cause, . . . file with the Administrator a
written request for a hearing.'' Accord Show Cause Order, at 2. The ALJ
did not indicate in his Briefing Order or in his Recommended Decision--
and the rest of the administrative record does not indicate--when
Respondent received the Show Cause Order. Without any evidence in the
record establishing when Respondent received the Show Cause Order, the
only way in which I could find that Respondent's Hearing Request was
timely is if it had been filed with the Administrator within 30 days of
the June 12, 2017 date of the Show Cause Order. However, the OALJ did
not receive Respondent's Hearing Request until July 18, 2017.\4\
Hearing Request, at 1. Accordingly, I find that Respondent's Hearing
Request was not
[[Page 12028]]
timely filed pursuant to 21 CFR 1301.43(a), and as a result, Respondent
waived his right to a hearing.
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\4\ Although the front of Respondent's Hearing Request is
stamped ``Received'' by the Office of Administrative Law Judges on
July 18, 2017, the photocopy of the envelope that purportedly
contained Respondent's Hearing Request reveals a ``Received/Date''
of ``July 17, 2017.'' Compare Hearing Request, at 1, with id. at 4.
In any event, neither date is within 30 days of the June 12, 2017
date of the Show Cause Order.
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In the absence of a timely hearing request, I also find that the
ALJ consequently lacked jurisdiction to hear the case. See Brown's
Discount Apothecary BC, Inc., and Bolling Apothecary, Inc., 80 FR
57393, 57394 (2015) (``in the absence of a hearing request, the ALJ had
no authority to rule on the issue of whether its registration should be
revoked''). I therefore cancel the hearing nunc pro tunc held by the
ALJ by summary disposition. See 21 CFR 1301.43(e). Accordingly, I will
treat this case as a Request for Final Agency Action and issue this
Decision and Order based on the relevant evidence forwarded to my
office by the ALJ on September 18, 2017.\5\ See id. I make the
following findings.
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\5\ In his Briefing Order, the ALJ ordered the Government to
file evidence to support its allegation that Respondent lacks state
authority to handle controlled substances, and any motion for
summary disposition on these grounds, on August 3, 2017. Briefing
Order at 1. The ALJ also directed Respondent to file his response to
any summary disposition motion on August 10, 2017. Id. On August 3,
2017, the Government filed its Motion for Summary Disposition, and
the Respondent filed his response on August 10, 2017. See
Government's Motion for Summary Disposition (hereinafter Govt.
Mot.); Response to Motion for Summary Disposition (hereinafter Resp.
Br.). On August 15, 2017, the ALJ issued his Order granting summary
disposition and Recommended Decision. Order Granting Summary
Disposition and Recommended Rulings, Findings of Fact, Conclusions
of Law, and Decision (hereinafter, Recommended Decision or R.D.).
Neither party filed exceptions to the ALJ's Recommended Decision.
Although the ALJ's Recommended Decision did not establish that the
ALJ had jurisdiction in this case, I will nonetheless consider the
administrative record that he submitted to me in its entirety.
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Findings of Fact
Respondent is a holder of DEA Certificate of Registration No.
AR9258434, as well as DATA-Waiver identification number XR9258434.
Government Exhibit (GX) 1 to Govt. Mot. Pursuant to his registration,
Respondent is authorized to dispense controlled substances in schedules
III \6\ through V as a practitioner, and he is authorized to dispense
or prescribe schedule III-V narcotic controlled substances which ``have
been approved by the Food and Drug Administration . . . specifically
for use in maintenance or detoxification treatment'' for up to 100
patients. 21 CFR 1301.28(a) & (b)(1)(iii); see GX 1. Respondent's
registered address is 2016 South 4th Avenue, Tucson, Arizona. GX 1.
Respondent's registration and DATA-Waiver authority do not expire until
April 30, 2020. Id.
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\6\ Although the Show Cause Order alleges that Respondent's
registration authorizes him to dispense controlled substances ``in
Schedules II through V,'' see Show Cause Order, at 1, the record
establishes that Respondent is not authorized to dispense any
schedule II controlled substances. GX 1. In addition, to the extent
that the Show Cause Order's statement that Respondent's status ``as
a data-waived DW/30 practitioner in Schedules II-V'' suggests that
this status authorized Respondent to dispense schedule II controlled
substances, that suggestion is incorrect as a matter of law. 21
U.S.C. 823(g)(2)(a) (limiting authority to dispense to ``narcotic
drugs in schedule III, IV, or V''); 21 CFR 1301.28(a) (same).
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On April 6, 2017, the Arizona Medical Board issued an Order stating
the Respondent's ``license to practice allopathic medicine in the State
of Arizona . . . is summarily suspended.'' GX 2, at 7. The Board also
prohibited Respondent ``from practicing medicine in the State of
Arizona'' and ``from prescribing any form of treatment including
prescription medications or injections of any kind.'' Id. Finally, the
Board stated that ``Respondent is entitled to a formal hearing to
defend these charges within 60 days after the issuance of this order.''
Id. Based on the above, I find that Respondent does not currently have
authority under the laws of Arizona to dispense controlled substances.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the
CSA, ``upon a finding that the registrant . . . has had his State
license . . . suspended [or] revoked . . . by competent State authority
and is no longer authorized by State law to engage in the . . .
dispensing of controlled substances.'' Also, DEA has long held that the
possession of authority to dispense controlled substances under the
laws of the State in which a practitioner engages in professional
practice is a fundamental condition for obtaining and maintaining a
practitioner's registration. See, e.g., James L. Hooper, 76 FR 71371
(2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); see
also Frederick Marsh Blanton, 43 FR 27616 (1978) (``State authorization
to dispense or otherwise handle controlled substances is a prerequisite
to the issuance and maintenance of a Federal controlled substances
registration.'').
This rule derives from the text of two provisions of the CSA.
First, Congress defined ``the term `practitioner' [to] mean[ ] a . . .
physician . . . or other person licensed, registered or otherwise
permitted, by . . . the jurisdiction in which he practices . . . to
distribute, dispense, [or] administer . . . a controlled substance in
the course of professional practice.'' 21 U.S.C. 802(21). Second, in
setting the requirements for obtaining a practitioner's registration,
Congress directed that ``[t]he Attorney General shall register
practitioners . . . if the applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated
that a practitioner possess state authority in order to be deemed a
practitioner under the CSA, DEA has held repeatedly that revocation of
a practitioner's registration is the appropriate sanction whenever he
is no longer authorized to dispense controlled substances under the
laws of the State in which he engages in professional practice. See,
e.g., Calvin Ramsey, 76 FR 20034, 20036 (2011); Sheran Arden Yeates,
M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105
(1993); Bobby Watts, 53 FR 11919, 11920 (1988); Blanton, 43 FR at
27616.
Moreover, because ``the controlling question'' in a proceeding
brought under 21 U.S.C. 824(a)(3) is whether the holder of a
practitioner's registration ``is currently authorized to handle
controlled substances in the [S]tate,'' Hooper, 76 FR at 71371 (quoting
Anne Lazar Thorn, 62 FR 12847, 12848 (1997)), the Agency has also long
held that revocation is warranted even where a practitioner has lost
his state authority by virtue of the State's use of summary process and
the State has yet to provide a hearing to challenge the suspension.
Bourne Pharmacy, 72 FR 18273, 18274 (2007); Wingfield Drugs, 52 FR
27070, 27071 (1987). Thus, it is of no consequence that the Arizona
Medical Board summarily suspended Respondent's state medical license.
What is consequential is the undisputed fact that Respondent is no
longer currently authorized to dispense controlled substances in
Arizona, the State in which he is registered.
As for Respondent's CAP, I conclude that there were adequate
grounds for denying it. Specifically, Respondent's position in his CAP
is that his DEA registration should not be revoked until the conclusion
of his appeal of the Arizona Medical Board's decision. As already
noted, however, revocation is warranted even where a practitioner has
lost his state authority and the State has yet to provide a hearing to
challenge the suspension. See Bourne Pharmacy, 72 FR at 18274;
Wingfield Drugs, 52 FR at 27071. Thus, I agree with the Agency's denial
of Respondent's CAP.
I will therefore reject Respondent's CAP and order that his
registration (and DATA-Waiver number) be revoked.\7\
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\7\ The ALJ received and considered the Government's Motion for
Summary Disposition and the ``Response to Motion for Summary
Disposition'' filed by Respondent. In his responsive brief,
Respondent argued that ``[u]nder the terms of that [Arizona Medical]
Board Order, the suspension was for 60 days beginning on April 6,
2017 until the matter was set for a formal hearing'' before the
Board. Resp. Br. at 1. However, as already noted above, the Arizona
Medical Board's Order ``summarily suspended'' Respondent ``from
prescribing any form of treatment including prescription medications
or injections of any kind.'' GX 2, at 7. Thus, I agree with the ALJ
that the fact that the Board gave Respondent the right to a formal
hearing within 60 days of its April 6, 2017 Order ``does not obviate
the fact that the Respondent currently does not possess state
authority to handle controlled substances in Arizona,'' the State in
which he is registered. R.D. at 5. Accordingly, if the ALJ had the
authority to issue his conclusion rejecting Respondent's argument, I
would have adopted it, and I would have done so for the same reason.
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[[Page 12029]]
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 No. AR9258434 and DATA-Waiver Identification Number
XR9258434, issued to David A. Ruben, M.D., be, and they hereby are,
revoked. I further order that any pending application of David A. Ruben
to renew or modify the above registration, or any pending application
of David A. Ruben for any other registration, be, and it hereby is,
denied. This Order is effective immediately.\8\
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\8\ For the same reasons which led the Arizona Medical Board to
revoke Respondent's medical license, I conclude that the public
interest necessitates that this Order be effective immediately. 21
CFR 1316.67.
Dated: March 7, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-05471 Filed 3-16-18; 8:45 am]
BILLING CODE 4410-09-P