[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]



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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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[[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]
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