[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).
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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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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]
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