[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60041-60044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27186]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Michel P. Toret, M.D.; Decision and Order

    On July 13, 2017, the Acting Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause to Michel P. Toret, M.D. 
(hereinafter, Applicant) of Jeannette, Pennsylvania. GX 5. The Show 
Cause Order proposed the denial of Applicant's application for a DEA 
Certificate of Registration on the ground that Applicant's 
``registration is inconsistent with the public interest.'' GX 5, at 1 
(citing 21 U.S.C. 823(f)).
    As to the Agency's jurisdiction, the Show Cause Order alleged that, 
on February 14, 2017, Applicant applied for DEA Certificate of 
Registration. GX 5, at 2. See also GX 4 (DEA Form 224 submitted by 
Applicant).
    As the substantive grounds for the proceeding, the Show Cause Order 
alleged that Applicant was registered with the DEA as a practitioner in 
schedules II through V pursuant to Certificate of Registration No. 
AT9432460, and that Applicant surrendered that registration for cause 
on November 29, 2016. GX 5, at 1. The Show Cause Order further alleged 
that Applicant ``continued to issue prescriptions for controlled 
substances'' after he surrendered that DEA registration. GX 5, at 2. 
According to the Show Cause Order, ``DEA's investigation of . . . 
[Applicant's] medical practice reveals that . . . [Applicant] issued 
approximately 17 prescriptions for controlled substances after November 
29, 2016 in violation of Federal law.'' Id. (citing 21 U.S.C. 841(a) 
and 843(a)(2)).
    The Show Cause Order further alleged that Applicant materially 
falsified his application for a Certificate of Registration. GX 5, at 
2. Specifically, the Show Cause Order alleged that Applicant's material 
falsification was his having ``answered `no' when asked, `[h]as the 
applicant ever surrendered (for cause) or had a federal controlled 
substance(s) registration revoked, suspended, restricted, or denied, or 
is any such answer pending.' '' GX 5, at 2. According to the Show Cause 
Order, ``this answer represents a material falsification on an 
application for a DEA Registration and, as such, is sufficient for 
denial of the pending application.'' GX 5, at 2 (citing 21 U.S.C. 
843(a)(4) and 824(a)(1)).
    The Show Cause Order notified Applicant of his right to request a 
hearing on the allegations or to submit a written statement while 
waiving his right to a hearing, the procedures for electing each 
option, and the consequences for failing to elect either option. GX 5, 
at 2 (citing 21 CFR 1301.43). The Show Cause Order also notified 
Applicant of the opportunity to submit a corrective action plan. GX 5, 
at 3 (citing 21 U.S.C. 824(c)(2)(C)).

Adequacy of Service

    By Declaration dated August 23, 2017, a Diversion Investigator 
(hereinafter, DI), who described herself as the lead DI assigned to the 
regulatory matter involving Applicant, stated that, on July 21, 2017, 
she ``personally served Registrant with a copy of the Order to Show 
Cause why Registrant's application for a new DEA COR should not be 
denied.'' GX 6, at 2 (hereinafter, DI Declaration). Based on the 
Government's sworn statement, I find that the Government's service of 
the Show Cause Order on Applicant was legally sufficient.
    In its Request for Final Agency Action dated August 25, 2017, the 
Government represented that ``more than thirty days have passed since 
the Order to Show Cause was served on . . . [Applicant] and no request 
for hearing or other correspondence has been received by DEA.'' Request 
for Final Agency Action (hereinafter, RFAA), at 1. The Government 
requested that Applicant's application for a DEA Certificate of 
Registration be denied based on Applicant's ``issuing prescriptions 
without a DEA COR and then committing a material falsification on his 
subsequent application for a new DEA COR.'' RFAA, at 5.
    Based on the Government's sworn statement and written 
representations, and based on my review of the record, I find that more 
than 30 days have now passed since the date on which Applicant was 
served with the Show Cause Order. Further, based on the Government's 
written representations, I find that neither Applicant, nor anyone 
purporting to represent him, has requested a hearing, submitted a 
written statement while waiving Applicant's right to a hearing, or 
submitted a corrective action plan. Accordingly, I find that Applicant 
has waived his right to a hearing and his right to submit a written 
statement and corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 
824(c)(2)(C). I, therefore, issue this Decision and Order based on the 
record submitted by the Government. 21 CFR 1301.43(e).

Findings of Fact

Jurisdictional Facts

    On or about February 13, 2017, Applicant submitted an application 
for a DEA registration under the Controlled Substances Act. GX 4. On 
that application, Applicant certified to the truth and correctness of 
the information he furnished on the application, including that he 
never ``surrendered (for cause) or had a federal controlled substance 
registration revoked, suspended, restricted or denied.'' Id. at 1. 
Based on the evidence in the record, I find that this certification was 
false.

[[Page 60042]]

Applicant's Voluntary Surrender of His Registration

    Applicant, a medical doctor, previously held DEA Certificate of 
Registration AT9432460, pursuant to which he was authorized to dispense 
controlled substances in schedules II-V, at the address of Colony 
Building, 8962 Hill Drive, North Huntingdon, PA 15642. GX 1. On 
November 29, 2016, Applicant signed a ``Voluntary Surrender of 
Controlled Substances Privileges,'' Form DEA-104 (hereinafter, 
Voluntary Surrender Form). GX 2. According to the Voluntary Surrender 
Form he signed, Applicant ``freely and under no duress, implied or 
express, execute[d] . . . [the] document and . . . [chose] to take the 
actions . . . [i]n view of . . . [his] alleged failure to comply with 
the Federal requirements pertaining to controlled substances, and as an 
indication of . . . [his] good faith in desiring to remedy any 
incorrect or unlawful practices.'' Id. Applicant's signed Voluntary 
Surrender Form stated that Applicant voluntarily surrendered his DEA 
registration certificate, unused order forms, and all controlled 
substances. Id. It also stated that, ``I understand that, beginning on 
the date that I sign below, I am not authorized to order, manufacture, 
distribute, possess, dispense, administer, prescribe, or engage in any 
other controlled substance activities whatsoever.'' Id.
    The only evidence the Government submitted with its RFAA concerning 
Applicant's voluntary surrender of his registration was the Voluntary 
Surrender Form. In other words, the Government did not submit any 
evidence concerning the events leading up to Applicant's voluntary 
surrender of his registration, the facts constituting Applicant's 
``alleged failure to comply with the Federal requirements pertaining to 
controlled substances,'' the specific Federal requirements that 
Applicant was alleged to have violated, or the resolution, if any, of 
the allegations against Applicant referenced in the Voluntary Surrender 
Form.

Applicant's Issuance of Controlled Substance Prescriptions After He 
Voluntarily Surrendered His Registration

    According to the Government, after Applicant voluntarily 
surrendered his DEA registration, Applicant issued 17 prescriptions for 
controlled substances. GX 5, at 2; GX 3. See also GX 6, at 2 (DI 
Declaration). According to the DI Declaration, GX 3 consisted of copies 
of the prescriptions Applicant issued after November 29, 2016. GX 6, at 
2.
    I reviewed each page of GX 3. Based on my review of GX 3, 15 of the 
pages reflect prescriptions clearly written after November 29, 2016, 
the date Applicant voluntarily surrendered his DEA registration. GX 3, 
at 1-8, 10-12, 14-17. Of those 15, 14 clearly concerned at least one 
controlled substance. Id. at 1-3, 5-8, 10-12, 14-17. Based on my review 
of GX 3, the prescriptions Applicant issued after November 29, 2016 
included Suboxone and Subutex, controlled substances in schedule III; 
Ambien, Tramadol, Lunesta, and Xanax, controlled substances in schedule 
IV; and Lyrica, a controlled substance in schedule V. Id. at 1, 5, 7-8; 
id. at 2, 3, 6, 10, 11, 14-17; and id. at 12, respectively.
    Thirteen of the pages in GX 3 were written on Applicant's 
prescription pad and included the number of the registration that 
Applicant voluntarily surrendered on November 29, 2016. GX 3, at 1, 3-
11, 13, 14, 17. Two of the pages in GX 3 were written on Applicant's 
prescription pad but did not show a DEA registration number on the line 
after ``DEA #.'' GX 3, at 2, 12. See 21 CFR 1306.05(a) (``All 
prescriptions for controlled substances shall be dated as of, and 
signed on, the day when issued and shall bear the . . . registration 
number of the practitioner.''). Two of the pages in GX 3 consisted of 
``365 Hospice LLC'' ``Medication Profile'' for patient PS and 
indicated, in their top right corner, that Applicant issued two ``new'' 
schedule IV prescriptions for patient PS on December 2nd and 19th, 
2016. GX 3, at 15-16.
    Based on my review of the Government's evidence, I find that 
Applicant issued at least 14 controlled substance prescriptions after 
he voluntarily surrendered his registration on November 29, 2016.

Discussion

    Pursuant to section 303(f) of the Controlled Substances Act, 
hereinafter CSA, ``[t]he Attorney General shall register practitioners 
. . . to dispense . . . controlled substances . . . 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). Section 303(f) 
further provides that an application for a practitioner's registration 
may be denied upon a determination that ``the issuance of such 
registration . . . would be inconsistent with the public interest.'' 
Id. In making the public interest determination, the CSA requires 
consideration of the following factors:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

    Id.
    These factors are . . . considered in the disjunctive.'' Robert A. 
Leslie, M.D., 68 FR 15,227, 15,230 (2003). I ``may rely on any one or a 
combination of factors and may give each factor the weight [I] deem[ ] 
appropriate in determining whether . . . an application for 
registration [should be] denied.'' Id. Moreover, while I am required to 
consider each of the factors, I ``need not make explicit findings as to 
each one,'' and I ``can `give each factor the weight . . . [I] 
determine[ ] is appropriate.' '' MacKay v. Drug Enforcement Admin., 664 
F.3d 808, 816 (10th Cir. 2011) (quoting Volkman v. Drug Enforcement 
Admin., 567 F.3d 215, 222 (6th Cir. 2009) quoting Hoxie v. Drug 
Enforcement Admin., 419 F.3d 477, 482 (6th Cir. 2005)). In other words, 
the public interest determination ``is not a contest in which score is 
kept; the Agency is not required to mechanically count up the factors 
and determine how many favor the Government and how many favor the 
registrant. Rather, it is an inquiry which focuses on protecting the 
public interest; what matters is the seriousness of the registrant's 
misconduct.'' Jayam Krishna-Iyer, 74 FR 459, 462 (2009).
    Pursuant to section 304(a)(1), the Attorney General is also 
authorized to suspend or revoke a registration ``upon a finding that 
the registrant . . . has materially falsified any application filed 
pursuant to or required by this subchapter.'' 21 U.S.C. 824(a)(1). It 
is well established that the various grounds for revocation or 
suspension of an existing registration that Congress enumerated in this 
section are also properly considered in deciding whether to grant or 
deny an application under section 303. See Richard J. Settles, D.O., 81 
FR 64,940, 64,945 (2016); Arthur H. Bell, D.O., 80 FR 50,035, 50,037 
(2015); The Lawsons, Inc., 72 FR 74,334, 74,338 (2007); Samuel S. 
Jackson, D.D.S., 72 FR 23,848, 23,852 (2007); Alan R. Schankman, M.D., 
63 FR 45,260, 45,260 (1998); Kuen H. Chen, M.D., 58 FR 65,401, 65,402 
(1993). Thus, the allegation that Applicant materially

[[Page 60043]]

falsified his application is properly considered in this proceeding. 
Richard J. Settles, supra, 81 FR at 64,945; Arthur H. Bell, supra, 80 
FR at 50,037; Samuel S. Jackson, supra, 72 FR at 23,852. Moreover, just 
as materially falsifying an application provides a basis for revoking 
an existing registration without proof of any other misconduct, see 21 
U.S.C. 824(a)(1), it also provides an independent and adequate ground 
for denying an application. Richard J. Settles, supra, 81 FR at 64,945; 
Arthur H. Bell, supra, 80 FR at 50,037; The Lawsons, Inc., supra, 72 FR 
at 74,338; Bobby Watts, M.D., 58 FR 46,995, 46,995 (1993); Shannon L. 
Gallentine, D.P.M., 76 FR 45,864, 45,865 (2011).
    The Government has the burden of proving that the requirements for 
a registration are not satisfied. 21 CFR 1301.44(d).
    Having considered all of the public interest factors, as well as 
the separate allegation that Applicant materially falsified his 
application for a DEA registration, I conclude that the Government has 
established that the granting of Applicant's application would not be 
in the public interest because Applicant issued controlled substance 
prescriptions after he voluntarily surrendered his DEA registration. 
Accordingly, even though the Government did not submit sufficient 
evidence to prove that Applicant's false application was ``materially 
false,'' I will order that Applicant's application be denied.

Acts Inconsistent With the Public Interest Factors

    In its Show Cause Order, the Government alleged that Applicant's 
registration would be inconsistent with the public interest as that 
term is defined in 21 U.S.C. 823(f). As to this allegation, I reviewed 
the evidence the Government submitted and determined that Applicant 
issued at least 14 controlled substance prescriptions after he 
voluntarily surrendered his registration on November 29, 2016. This 
evidence is properly considered in the public interest determination. 
21 U.S.C. 823(f)(2) and (4).

Factors Two and Four--The Registrant's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances

The Dispensing Allegations
    With limited exceptions not applicable here, ``[e]very person who 
dispenses . . . any controlled substance . . . shall obtain from the 
Attorney General a registration.'' 21 U.S.C. 822(a)(2). See also 21 
U.S.C. 822(b) (authorizing registered persons to prescribe a controlled 
substance). Further, according to the CSA, it is unlawful for any 
person knowingly or intentionally to dispense a controlled substance 
except as authorized by the CSA. 21 U.S.C. 841(a)(1). See also 21 
U.S.C. 843(a)(2); 21 CFR 1306.03(a)(2).
    Factor Two is Applicant's experience in dispensing controlled 
substances. According to my review of the Government's evidence, 
Applicant issued at least 14 controlled substance prescriptions after 
he voluntarily surrendered his registration on November 29, 2016. 
Applicant's issuance of these controlled substance prescriptions after 
he voluntarily surrendered his registration was contrary to legal 
requirements.
    Factor Four is Applicant's compliance with applicable State, 
Federal, or local laws relating to controlled substances. The 
Government's evidence showed that Applicant issued at least 14 
controlled substance prescriptions when Applicant was not registered 
with the Agency and, thus, in violation of Federal law relating to 
controlled substances. 21 U.S.C. 841(a)(1); 21 U.S.C. 822(a)(2).
    I therefore find that the evidence with respect to Factors Two and 
Four supports the conclusion that issuing a registration to Applicant 
``would be inconsistent with the public interest.'' 21 U.S.C. 823(f).
The Material Falsification Allegation
    When Applicant submitted his application for a registration on or 
about February 13, 2017, he answered ``no'' to whether he had ``ever 
surrendered (for cause) or had a federal controlled substance 
registration revoked, suspended, restricted or denied.'' GX 4, at 1. As 
found above, this certification was false. The Government alleged that 
this false certification was ``materially false,'' but the Government 
did not provide sufficient evidence for a finding of material 
falsification.
    The Supreme Court has held that the ``most common formulation'' of 
the concept of materiality is that ``a concealment or misrepresentation 
is material if it `has a natural tendency to influence, or was capable 
of influencing, the decision of' the decisionmaking body to which it 
was addressed.'' Kungys v. United States, 485 U.S. 759, 770 (1988) 
(quoting Weinstock v. United States, 231 F.2d 699, 701 (DC Cir. 1956) 
(other citation omitted)). The Court explicitly addressed what has 
``never been the test of materiality[,] that the misrepresentation or 
concealment would more likely than not have produced an erroneous 
decision, or even that it would more likely than not have triggered an 
investigation.'' Kungys, supra, 485 U.S. at 771. Instead, the Court 
articulated the specific test as ``whether the misrepresentation or 
concealment was predictably capable of affecting, i.e., had a natural 
tendency to affect, the official decision.'' Id.
    The Government's only evidence concerning the material 
falsification allegation was the Voluntary Surrender Form Applicant 
executed on November 29, 2016. On that Form, Applicant checked the box 
indicating that he ``freely and under no duress, implied or express, 
execute[d] . . . [the] document and . . . [chose] to take the actions . 
. . [i]n view of . . . [his] alleged failure to comply with the Federal 
requirements pertaining to controlled substances, and as an indication 
of . . . [his] good faith in desiring to remedy any incorrect or 
unlawful practices.'' GX 2.
    This evidence, alone, is an insufficient basis for a finding of 
``material falsification.'' The Voluntary Surrender Form indicated 
nothing about Applicant's failure to comply with any requirement 
concerning controlled substances. The Government did not submit any 
evidence explaining why Government investigators had sought the 
surrender of Applicant's registration. Applicant's admitting to an 
``alleged failure'' to ``comply with Federal requirements pertaining to 
controlled substances'' indicated nothing about the nature of his 
``alleged failure,'' let alone how that ``alleged failure'' was 
relevant to any of the public interest factors or to any other ground 
which would support the denial of his application. Thus, Applicant's 
admission, standing alone, is insufficient for a determination that a 
``misrepresentation or concealment was predictably capable of 
affecting, i.e., had a natural tendency to affect, the official 
decision.'' Kungys, supra, 485 U.S. at 771.
    Accordingly, I find that the Government did not meet its burden of 
showing that Applicant's false certification constituted a ``material 
falsification.''

Order

    Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 
823(f), as well as 28 CFR 0.100(b), I order that Applicant's 
application for DEA Certificate of Registration be denied. This order 
is effective January 17, 2018.


[[Page 60044]]


    Dated: December 1, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-27186 Filed 12-15-17; 8:45 am]
 BILLING CODE 4410-09-P