Mikhayl Soliman, M.D.: Decision and Order, 47826-47829 [2016-17394]
Download as PDF
47826
Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
2017 aggregate production quota for
controlled substances in schedules I and
II and establishing an assessment of
annual needs for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine, 21 CFR
1303.11(c) and 1315.11(f).
Dated: July 14, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–17370 Filed 7–21–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ehiers on DSK5VPTVN1PROD with NOTICES
Mikhayl Soliman, M.D.: Decision and
Order
On March 27, 2015, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Mikhayl Soliman, M.D.
(hereinafter, Applicant), of both Wayne,
Michigan and Los Angeles, California.
The Show Cause Order proposed the
denial of Applicant’s applications for
DEA Certificates of Registration in the
States of Michigan and California on
multiple grounds. GX 7, at 1.
First, the Show Cause Order alleged
that Applicant had previously been
registered to handle controlled
substances in only Schedule III and IIIN,
at the registered address of 3152 South
Wayne Road, Wayne, Michigan. Id. The
Show Cause Order alleged that on
September 14, 2012, Applicant was
issued an Order to Show Cause and
Immediate Suspension of Registration
and that he subsequently voluntarily
surrendered his registration.
The Show Cause Order alleged that on
September 24, 2012, Applicant applied
for a new DEA practitioner’s registration
at his previous registered location in
Wayne, Michigan, and that on October
2, 2012, he applied for a new
practitioner’s registration at a proposed
location in Los Angeles, California. Id.
The Order then alleged that on both
applications, Applicant had failed to
disclose that he had voluntarily
surrendered his registration and had
materially falsified both applications.
Id. at 1–2 (citing 21 U.S.C. 843(a)(4)(A)).
Second, the Show Cause Order
alleged that as a result of actions taken
by the medical boards of California and
Michigan, Applicant is ‘‘without
authority to practice in the States . . .
in which [he] applied for’’ DEA
registrations. Id. at 2. Specifically, the
Show Cause Order alleged that on
January 15, 2014, the Michigan Board of
Medicine issued a Consent Order which
VerDate Sep<11>2014
15:19 Jul 21, 2016
Jkt 238001
found that he ‘‘had prescribed
controlled substances . . . in a manner
which demonstrated negligence,
incompetence, and a lack of good moral
character’’ and that he ‘‘prescribed, gave
away or administered drugs for other
than lawful diagnostic or therapeutic
purposes.’’ Id. The Order also alleged
that the Michigan Board had suspended
his medical license for six months and
one day and required that he petition
the Board for reinstatement; the Order
then alleged that Applicant’s Michigan
medical license remains suspended. Id.
The Order further alleged that based on
the Michigan Board’s findings, the
Medical Board of California revoked his
California license effective October 10,
2014. Id.
Finally, the Show Cause Order alleged
that on May 16, 2012, DEA Investigators
had seized 323 patient files which
Applicant had discarded in the trash at
his residence, and that the files showed
that Applicant had prescribed both
hydrocodone (then a Schedule III
controlled substance) and alprazolam (a
Schedule IV drug) ‘‘to the majority of
these patients.’’ Id. The Order then
alleged that DEA Investigators obtained
information from the Michigan
Automated Prescriptions System which
showed that ‘‘between January 1, 2007
and August 20, 1012, [Applicant]
prescribed at least 19,409 dosage units
of [s]chedule II [drugs], 725,760 dosage
units of [s]chedule IV [drugs], and
246,397 dosage units of [s]chedule V
[drugs], without the registered authority
to do so.’’ Id.1
Thereafter, the Government attempted
to serve the Show Cause Order by FedEx
delivered to the proposed business
address Applicant used when he
applied for a registration in Los Angeles.
GX 9, at 1. The Government did not,
however, require a signature. Id. at 1–2.
Moreover, the Government does not
point to any precedent of either the
courts or this Agency which allows for
the use of FedEx to serve a charging
document or complaint (as opposed to
post-service filings) on a person.2 Thus,
this attempt was deemed inadequate to
accomplish service.
The Government also noted that it
emailed a lawyer who was representing
Applicant ‘‘in a pending criminal
matter’’ and asked him if he could
1 The Show Cause Order also notified Applicant
of his right to either request a hearing on the
allegations of the Order to Show Cause or to submit
a written statement while waiving his right to a
hearing, the procedure for electing either option,
and the consequence of failing to elect either
option. GX 7, at 3.
2 Nor am I aware of any rules of procedure which
allow for a charging document or complaint to be
served in this manner.
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
confirm Applicant’s current address or
accept service on Applicant’s behalf. GX
10. The lawyer, however, did not
respond. Request for Final Agency
Action, at 3. Moreover, according to the
Government, a Supervisory Diversion
Investigator phoned the attorney and
asked for Applicant’s address in order to
serve the Show Cause Order. Id.
According to the Government, while the
attorney stated that he would contact
the Government’s counsel, he did not.3
Id.
The Government then mailed the
Show Cause Order by certified mail,
return receipt requested, addressed to
Applicant at his proposed business
address in Wayne, Michigan. GX 11, 12,
and 13. Several weeks later the mailing
was returned unclaimed, with the Post
Office indicating that it was ‘‘unable to
forward’’ the mailing. GX 13. The
Government did not, however, send the
Show Cause Order to Applicant by First
Class Mail. See Jones v. Flowers, 547
U.S. 220 (2006).
Subsequently, the Government
submitted a Request for Final Agency
Action along with the Investigative File.
Upon review of the record, I found that
service was inadequate and directed
that the Request for Final Agency
Action be returned.
On November 9, 2015, the
Government again mailed the Show
Cause Order by certified mail, return
receipt requested, addressed to
Applicant at his proposed registered
location. Here again, several weeks later
the mailing was returned by the Post
Office as undeliverable. GX 18.
Also on November 9, 2015, the same
day the Government had re-mailed the
Show Cause Order, it emailed the Order
to Applicant at the email address he had
provided to the Agency on his
applications. According to an affidavit
submitted by the Government, it ‘‘did
not receive any bounce-back email or
other indication that the email . . . was
undeliverable or otherwise not
received.’’ GX 19.
Upon re-submission of its Request for
Final Agency Action, the Government
advised that on September 24, 2015,
Applicant was found guilty in the
United States District Court for the
Eastern District of Michigan on multiple
counts of health care fraud and aiding
and abetting the unlawful distribution
of controlled substances. Request for
Final Agency Action, at 4; see also GX
15, at 5). The Government further
advised that on October 5, 2015,
3 Given that Applicant had been criminally
charged and released on bond, the Pre-Trial
Services Office would likely have been a more
fruitful source for obtaining his residence address.
E:\FR\FM\22JYN1.SGM
22JYN1
ehiers on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
Applicant failed to appear for a bond
hearing leading the District Court to
issue a bench warrant for his arrest.
Based on the above, I find that the
Government has satisfied its obligation
under the Due Process Clause ‘‘to
provide ‘notice reasonably calculated,
under all the circumstances, to apprise
interested parties of the pendency of the
action and afford them an opportunity
to present their objections.’ ’’ Jones, 547
U.S. at 226 (quoting Mullane v. Central
Hanover Bank & Trust Co., 339 U.S.
306, 314 (1950)). Due process does not,
however, require actual notice, Jones,
547 U.S. at 226 (quoting Dusenbery v.
United States, 534 U.S. 161, 170 (2002)),
but rather, only ‘‘ ‘notice reasonably
calculated, under all the circumstances,
to apprise interested parties of the
pendency of the action and afford them
an opportunity to present their
objections.’ ’’ Id. (quoting Mullane, 339
U.S. at 314). Moreover, the Government
is not required to undertake ‘‘heroic
efforts’’ to find an applicant. Dusenbery,
534 U.S. at 170 (2002).
Here, I conclude that Applicant’s
secreting himself rendered the
Government’s use of the traditional
means of service futile, and that
therefore, the Government was entitled
to attempt to serve the Show Cause
Order by emailing it to him at the email
address he had previously provided to
the Agency. See Rio Properties, Inc. v.
Rio Int’l Interlink, 284 F.3d 1007, 1017–
18 (9th Cir. 2002); see also Snyder, et al.
v. Alternate Energy Inc., 857 N.Y.S. 2d
442, 447–449 (N.Y. Civ. Ct. 2008); In re
International Telemedia Associates,
Inc., 245 B.R. 713, 721–22 (Bankr. N.D.
Ga. 2000).
To be sure, courts have recognized
that the use of email to serve process
has ‘‘its limitations,’’ including that
‘‘[i]n most instances, there is no way to
confirm receipt of an email message.’’
Rio Properties, 284 F.3d at 1018. Here,
however, I conclude that the use of
email to serve Applicant satisfied due
process because service was made to an
email address he had previously
provided to the Agency and the
Government did not receive back either
an error or undeliverable message. See
Richard C. Quigley, D.O., 79 FR 50945
(2014); Emilio Luna, M.D., 77 FR 4829
(2012), see also Robert Leigh Kale, 76 FR
48898, 48899–900 (2011). Thus, I am
satisfied that the Government has
provided Applicant with notice
‘‘reasonably calculated . . . to apprise
[him] of the pendency of the action’’
and to present his objections.4 Jones, 547
4 Because
Applicant is a fugitive, I need not
decide whether the Government could have
satisfied its constitutional obligation by simply re-
VerDate Sep<11>2014
15:19 Jul 21, 2016
Jkt 238001
U.S. at 226 (quoting Mullane, 339 U.S.
at 314).
Having found that the service of the
Show Cause Order was constitutionally
adequate, I turn to whether Applicant
has waived his right to a hearing or to
submit a written statement in lieu of a
hearing. According to the Government,
since the re-service of the Show Cause
Order, neither Applicant, nor anyone
purporting to represent him, has
requested a hearing or submitted a
written statement of position.
Accordingly, as more than 30 days have
now passed since the date of service, I
find that Applicant has waived his right
to a hearing or to submit a written
statement. 21 CFR 1301.43(d). I
therefore issue this Decision and Final
Order based on relevant evidence
contained in the Investigative Record
submitted by the Government. Id.
1301.43(d) & (e). I make the following
additional findings of fact.
Findings of Fact
Applicant previously held DEA
Certificate of Registration BS9471309,
pursuant to which he was authorized to
dispense controlled substances in
Schedules III and IIIN, at the registered
address of Soliman Medical Center,
3152 South Wayne Road, Wayne,
Michigan. GX 2, at 1. However, on
September 14, 2012, the former
Administrator issued an Order to Show
Cause and Immediate Suspension of
Registration to Applicant, based on
allegations that he was prescribing
controlled substances in Schedules II,
IV, and V, for which he lacked
authority, and that he also issued
prescriptions for drug cocktails of
hydrocodone (then Schedule III) and
alprazolam (Schedule IV) which lacked
a legitimate medical purpose. GX 3, at
1–2. The former Administrator also
noted that of the 323 patient files DEA
Investigators found in his trash, 143 of
the patients had ‘‘criminal histories
involving controlled substance
violations.’’ Id. at 2. The same day,
Applicant voluntarily surrendered his
registration ‘‘in view of [his] alleged
failure to comply with the Federal
requirements pertaining to controlled
substances.’’ GX 4, at 1.
Four days later, on September 21,
2012, Applicant submitted an
application for a new registration as a
practitioner in Schedules IIN, III, IIIN
and IV at the registered address of 3152
South Wayne Road, Wayne, Michigan.
The DEA Chief of Registration certified
mailing the Show Cause Order to him by regular
first class mail as the Supreme Court’s decision in
Jones v. Flowers suggests. Jones, 547 U.S. at 234–
35.
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
47827
that on his application, Applicant
answered ‘‘No’’ to question 3, which
asks: ‘‘[h]as the applicant ever
surrendered (for cause) or had a federal
controlled substance registration
revoked, suspended, restricted or
denied, or is any such action pending?’’
GX 1, at 1, 3. This application remains
pending before the Agency. Id. at 1.
On October 1, 2012, Applicant
submitted a second application for
registration as a practitioner in
Schedules III, IIIN, IV, and V, at the
registered address of 3844 Wasatch Ave
#4, Los Angeles, California. GX 8. The
DEA Chief of Registration certified that
on his application, Applicant answered
‘‘No’’ to the question, ‘‘Has the
applicant ever surrendered (for cause) or
had a federal controlled substance
registration revoked, suspended,
restricted or denied, or is any such
action pending?’’ GX 8, at 2, 4.
On February 25, 2013, the Michigan
Board of Medicine’s Disciplinary
Subcommittee filed an Administrative
Complaint against Applicant. GX 5, at
13. Based on a review of 20 patient
charts, the Board alleged that his
charting was lacking:
(1) ‘‘information pertaining to past medical
history or current treating clinicians’’;
(2) ‘‘any findings pertaining to pain
assessment, level of dysfunction from pain,
treatment plan, or diagnostic testing’’;
(3) ‘‘any documentation pertaining to
patient informed consents, prescribing
agreements, pain assessments, clinical
documentation, drug analysis screens, lab
test results, patient risk assessments, copies
of previous medical records, or the
implementation of a pain management
program’’; and
(4) ‘‘any documentation that [he]
monitored the patients’ use of the controlled
substances for drug dependency or diversion,
or that he verified the efficacy of the long
term use of the controlled substances in
treating the diagnoses of the patients.’’
Id. at 10–11. The Board also alleged
that the charts ‘‘lack[ed] documentation
that [he] counselled the patients about
the risk associated with being
prescribed a combination of
hydrocodone and alprazolam, or the
long term effects of continued
consumption of acetaminophen.’’ Id.
Based on its findings, the Board alleged
that Applicant had violated various
provisions of Michigan law, and had
engaged in ‘‘selling, prescribing, giving
away, or administering drugs for other
than lawful diagnostic or therapeutic
purposes.’’ Id. at 12 (quoting Mich.
Comp. Laws section 162221(c)(iv)).
On January 15, 2014, Applicant
stipulated with the Board to the entry of
a Consent Order, pursuant to which his
medical license was suspended for six
months and one day, effective February
E:\FR\FM\22JYN1.SGM
22JYN1
ehiers on DSK5VPTVN1PROD with NOTICES
47828
Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
15, 2014.5 GX 5, at 1–3. However, the
Consent Order also provided that the
reinstatement of Applicant’s medical
license ‘‘is not automatic and that he
will have to petition for reinstatement’’
and show that he is of ‘‘good moral
character,’’ that he has ‘‘the ability to
practice . . . with reasonable skill and
safety,’’ that he has satisfied ‘‘the
guidelines on reinstatement,’’ and that
the reinstatement of his license ‘‘is in
the public interest.’’ Id. at 2. See also
M.C.L.A. 333.16221.
To date, Applicant has not been
reinstated. I therefore find that
Applicant is currently without authority
to dispense controlled substances in
Michigan, one of the States in which he
seeks registration.
Applicant also formerly held a
Physician’s and Surgeon’s Certificate
issued by the Medical Board of
California. However, on October 10,
2014, the Medical Board revoked his
Physician’s and Surgeon’s Certificate
based on the Michigan Board of
Medicine’s suspension of his Michigan
medical license.
In its Request for Final Agency
Action, the Government notes that the
Order to Show Cause also sought to
deny Applicant’s application for a DEA
registration in California on the basis
that the California Medical Board had
revoked his medical license. Request for
Final Agency Action, at 2 n.1. The
Government, however, now advises that
‘‘subsequent to the issuance of the
[Show Cause Order], the undersigned
counsel learned that the . . . Los
Angeles Field Division . . . withdrew
[Applicant]’s application pursuant to 21
CFR 1301.16(b), which provides that
‘failure of the applicant to respond to
official correspondence regarding the
application, when sent by registered or
certified mail, return receipt requested,
shall be deemed to be a withdrawal of
the application.’ ’’ Id. (quoting 21 CFR
1301.16(b)). The Government further
explains that in December 2014, the Los
Angeles Field Division ‘‘attempted to
reach [Applicant] via certified mail at
his application addresses in California
and Michigan, [but] the certified letters
were returned as unclaimed and
undeliverable, and consequently, [his]
application for a DEA Registration in
California was ‘deemed’ a withdrawal
and terminated in the registration
database.’’ Id. at 2–3.
The Agency’s registration records (of
which I take official notice, see 5 U.S.C.
556(e)), show that on December 5, 2014,
Applicant was sent a letter requesting
that he provide a valid California
5 Applicant was not required to admit that the
allegations were true. GX 5, at 3.
VerDate Sep<11>2014
15:19 Jul 21, 2016
Jkt 238001
Medical Board license number in order
to process his pending application for
registration. According to the affidavit
of the then-chief of the Agency’s
registration unit, on February 27, 2015,
Applicant’s October 1, 2012, application
for his proposed Los Angeles, California
address was deemed ‘‘withdrawn and
retired from the DEA computer system.’’
GX 8, at 1.
Discussion
Pursuant to section 303(f) of the
Controlled Substances Act, ‘‘[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 the
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 15227, 15230 (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.’’
MacKay v. DEA, 664 F.3d 808, 816 (10th
Cir. 2011) (quoting Volkman, 567 F.3d
215, 222 (6th Cir. 2009) (quoting Hoxie,
419 F.3d 477, 482 (6th Cir. 2005))).6
In this case, I conclude that the record
supports two independent grounds for
6 ‘‘In short, this 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
[applicant]. Rather, it is an inquiry which focuses
on protecting the public interest; what matters is
the seriousness of the [applicant’s] misconduct.’’
Jayam Krishna-Iyer, 74 FR 459, 462 (2009).
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
denying Applicant’s application for a
DEA registration. First, Applicant does
not possess authority under the laws of
Michigan, the State in which he seeks
registration with the Agency. Second,
Applicant materially falsified his
application for a DEA registration.
Applicant’s Lack of State Authority
Under the Controlled Substances Act
(CSA), a practitioner must be currently
authorized to handle controlled
substances in ‘‘the jurisdiction in which
he practices’’ in order to obtain a DEA
registration. See 21 U.S.C. 823(f) (‘‘The
Attorney General shall register
practitioners . . . if the applicant is
authorized to dispense . . . controlled
substances under the laws of the State
in which he practices.’’). See also 21
U.S.C. 802(21) (‘‘[t]he term ‘practitioner’
means a physician . . . licensed,
registered, or otherwise permitted, by
. . . the jurisdiction in which he
practices . . . to distribute, dispense,
[or] administer . . . a controlled
substance in the course of professional
practice’’). Moreover, the CSA
authorizes the revocation of a
registration ‘‘upon a finding that the
registrant . . . has had his State license
or registration suspended [or] revoked
. . . and is no longer authorized by
State law to engage in the . . .
distribution [or] dispensing of
controlled substances.’’ Id. section
824(a)(3). As the Supreme Court has
explained, ‘‘[i]n the case of a physician,
this scheme contemplates that he is
authorized by the State to practice
medicine and to dispense drugs in
connection with his professional
practice.’’ United States v. Moore, 423
U.S. 122, 140–41 (1975).
Based on these provisions, DEA has
long and repeatedly held that the
possession of state authority is a
prerequisite for obtaining and
maintaining a practitioner’s registration.
See Frederick Marsh Blanton, M.D., 43
FR 27616, 27617 (1978) (‘‘State
authorization to dispense or otherwise
handle controlled substances is a
prerequisite to the issuance and
maintenance of a Federal controlled
substances registration.’’). See also
Sheran Arden Yeates, 71 FR 39130,
39131 (2006); Dominick A. Ricci, 58 FR
51104, 51105 (1993); Bobby Watts, 53
FR 11919, 11920 (1988).
Here, the investigative file establishes
that the Michigan Board suspended
applicant’s medical license on February
15, 2014. Moreover, as found above,
Applicant’s Michigan medical license
remains suspended as of the date of this
Decision and Order. I therefore find that
Applicant is without authority to
dispense controlled substances in
E:\FR\FM\22JYN1.SGM
22JYN1
Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
ehiers on DSK5VPTVN1PROD with NOTICES
Michigan, the State in which he seeks
registration. Because he does not meet
this prerequisite for obtaining a DEA
registration, I will deny his application
on this basis.
Material Falsification
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 section 304(a), 21 U.S.C.
824(a), are also properly considered in
deciding whether to grant or deny an
application under section 303. See The
Lawsons, Inc., 72 FR 74334, 74337
(2007); Anthony D. Funches, 64 FR
14267, 14268 (1999); Alan R.
Schankman, 63 FR 45260 (1998); Kuen
H. Chen, 58 FR 65401, 65402 (1993).
Thus, the allegation that Applicant
materially falsified his application is
properly considered in this proceeding.
See Samuel S. Jackson, 72 FR 23848,
23852 (2007). 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. The Lawsons, 72 FR 74338;
cf. Bobby Watts, M.D., 58 FR 46995
(1993).
Here, the Government’s evidence
shows that upon being served with an
Order to Show Cause and Immediate
Suspension of Registration which
alleged that he had prescribed
controlled substances in violation of the
CSA, Applicant surrendered his
registration. GXs 3 & 4. Moreover, on the
Voluntary Surrender form, Applicant
acknowledged that he was doing so
‘‘[i]n view of my alleged failure to
comply with the Federal requirements
pertaining to controlled substances.’’ GX
4. Yet days later, Applicant applied for
a new registration and provided a ‘‘no’’
answer to the question: ‘‘[h]as the
applicant ever surrendered (for cause) or
had a federal controlled substance
registration revoked, suspended,
restricted or denied, or is any such
action pending?’’ GX 1, at 1, 3.
Applicant’s answer was false as he
had clearly surrendered his registration
for cause. His false answer was also
material as ‘‘it ‘ha[d] 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,
VerDate Sep<11>2014
15:19 Jul 21, 2016
Jkt 238001
485 U.S. 759, 770 (1988) (quoting
Weinstock v. United States, 231 F.2d
699, 701 (D.C. Cir. 1956)) (other citation
omitted); see also United States v. Wells,
519 U.S. 482, 489 (1997) (quoting
Kungys, 485 U.S. at 770). As the
Supreme Court has further explained,
‘‘it 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, but
rather, whether the misrepresentation or
concealment was predictably capable of
affecting, i.e., had a natural tendency to
affect, the official decision.’’ Kungys,
485 U.S. at 771. While the evidence
must be ‘‘clear, unequivocal, and
convincing,’’ the ‘‘ultimate finding of
materiality turns on an interpretation of
the substantive law.’’ Id. at 772 (int.
quotations and citations omitted).
Applicant’s false answer to the
question of whether he had ever
surrendered his federal registration was
clearly ‘‘capable of affecting’’ the
decision of whether to grant his
application. As the evidence shows,
Applicant surrendered his registration
in response to allegations that he
violated the CSA and DEA regulations
by prescribing controlled substances
that were in schedules for which he
lacked authorization, as well as
allegations that he issued prescriptions
that lacked a legitimate medical
purpose. GX 3, at 2 (Sept. 24, 2012
Immediate Suspension Order) (citing 21
U.S.C. 822(b) and 841(a)(1); 21 CFR
1301.12(a) and 1306.04(a)). Notably,
under the public interest standard, the
Agency is required to consider both the
Applicant’s ‘‘experience in dispensing
. . . controlled substances’’ and his
‘‘[c]ompliance with applicable State,
Federal, or local laws relating to
controlled substances.’’ 21 U.S.C.
823(f)(2) & (4). See also Shannon L.
Gallentine, D.P.M., 76 FR 45864, 45866
(2011).
Thus, notwithstanding that the
Agency did not grant his application,
his false answer was still material as it
was capable of influencing the decision
as to whether to grant his application.
See United States v. Alemany Rivera,
781 F.2d 229, 234 (1st Cir. 1985) (‘‘It
makes no difference that a specific
falsification did not exert influence so
long as it had the capacity to do so.’’);
United States v. Norris, 749 F.2d 1116,
1121 (4th Cir. 1984) (‘‘There is no
requirement that the false statement
influence or effect the decision making
process of a department of the United
States Government.’’). Accordingly, I
conclude that Applicant materially
falsified his September 2012 application
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
47829
for registration. This provides a further
reason to deny his pending application.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 28 CFR 0.100(b),
I order that the application of Mikhayl
Soliman, M.D., for a DEA Certificate of
Registration as a practitioner, be, and it
hereby is, denied. This Order is effective
immediately.
Dated: July 15, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–17394 Filed 7–21–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–420P]
Proposed Adjustments to the
Aggregate Production Quotas for
Schedule I and II Controlled
Substances and Assessment of
Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2016
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice with request for
comments.
AGENCY:
The Drug Enforcement
Administration (DEA) proposes to
adjust the 2016 aggregate production
quotas for several controlled substances
in schedules I and II of the Controlled
Substances Act and assessment of
annual needs for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine.
SUMMARY:
Interested persons may file
written comments on this notice in
accordance with 21 CFR 1303.13(c) and
1315.13(d). Electronic comments must
be submitted, and written comments
must be postmarked, on or before
August 22, 2016. Commenters should be
aware that the electronic Federal Docket
Management System will not accept
comments after 11:59 p.m. Eastern Time
on the last day of the comment period.
Based on comments received in
response to this notice, the
Administrator may hold a public
hearing on one or more issues raised. In
the event the Administrator decides in
his sole discretion to hold such a
hearing, the Administrator will publish
a notice of any such hearing in the
Federal Register. After consideration of
any comments or objections, or after a
hearing, if one is held, the
Administrator will publish in the
DATES:
E:\FR\FM\22JYN1.SGM
22JYN1
Agencies
[Federal Register Volume 81, Number 141 (Friday, July 22, 2016)]
[Notices]
[Pages 47826-47829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17394]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Mikhayl Soliman, M.D.: Decision and Order
On March 27, 2015, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Mikhayl Soliman, M.D. (hereinafter, Applicant), of both
Wayne, Michigan and Los Angeles, California. The Show Cause Order
proposed the denial of Applicant's applications for DEA Certificates of
Registration in the States of Michigan and California on multiple
grounds. GX 7, at 1.
First, the Show Cause Order alleged that Applicant had previously
been registered to handle controlled substances in only Schedule III
and IIIN, at the registered address of 3152 South Wayne Road, Wayne,
Michigan. Id. The Show Cause Order alleged that on September 14, 2012,
Applicant was issued an Order to Show Cause and Immediate Suspension of
Registration and that he subsequently voluntarily surrendered his
registration.
The Show Cause Order alleged that on September 24, 2012, Applicant
applied for a new DEA practitioner's registration at his previous
registered location in Wayne, Michigan, and that on October 2, 2012, he
applied for a new practitioner's registration at a proposed location in
Los Angeles, California. Id. The Order then alleged that on both
applications, Applicant had failed to disclose that he had voluntarily
surrendered his registration and had materially falsified both
applications. Id. at 1-2 (citing 21 U.S.C. 843(a)(4)(A)).
Second, the Show Cause Order alleged that as a result of actions
taken by the medical boards of California and Michigan, Applicant is
``without authority to practice in the States . . . in which [he]
applied for'' DEA registrations. Id. at 2. Specifically, the Show Cause
Order alleged that on January 15, 2014, the Michigan Board of Medicine
issued a Consent Order which found that he ``had prescribed controlled
substances . . . in a manner which demonstrated negligence,
incompetence, and a lack of good moral character'' and that he
``prescribed, gave away or administered drugs for other than lawful
diagnostic or therapeutic purposes.'' Id. The Order also alleged that
the Michigan Board had suspended his medical license for six months and
one day and required that he petition the Board for reinstatement; the
Order then alleged that Applicant's Michigan medical license remains
suspended. Id. The Order further alleged that based on the Michigan
Board's findings, the Medical Board of California revoked his
California license effective October 10, 2014. Id.
Finally, the Show Cause Order alleged that on May 16, 2012, DEA
Investigators had seized 323 patient files which Applicant had
discarded in the trash at his residence, and that the files showed that
Applicant had prescribed both hydrocodone (then a Schedule III
controlled substance) and alprazolam (a Schedule IV drug) ``to the
majority of these patients.'' Id. The Order then alleged that DEA
Investigators obtained information from the Michigan Automated
Prescriptions System which showed that ``between January 1, 2007 and
August 20, 1012, [Applicant] prescribed at least 19,409 dosage units of
[s]chedule II [drugs], 725,760 dosage units of [s]chedule IV [drugs],
and 246,397 dosage units of [s]chedule V [drugs], without the
registered authority to do so.'' Id.\1\
---------------------------------------------------------------------------
\1\ The Show Cause Order also notified Applicant of his right to
either request a hearing on the allegations of the Order to Show
Cause or to submit a written statement while waiving his right to a
hearing, the procedure for electing either option, and the
consequence of failing to elect either option. GX 7, at 3.
---------------------------------------------------------------------------
Thereafter, the Government attempted to serve the Show Cause Order
by FedEx delivered to the proposed business address Applicant used when
he applied for a registration in Los Angeles. GX 9, at 1. The
Government did not, however, require a signature. Id. at 1-2. Moreover,
the Government does not point to any precedent of either the courts or
this Agency which allows for the use of FedEx to serve a charging
document or complaint (as opposed to post-service filings) on a
person.\2\ Thus, this attempt was deemed inadequate to accomplish
service.
---------------------------------------------------------------------------
\2\ Nor am I aware of any rules of procedure which allow for a
charging document or complaint to be served in this manner.
---------------------------------------------------------------------------
The Government also noted that it emailed a lawyer who was
representing Applicant ``in a pending criminal matter'' and asked him
if he could confirm Applicant's current address or accept service on
Applicant's behalf. GX 10. The lawyer, however, did not respond.
Request for Final Agency Action, at 3. Moreover, according to the
Government, a Supervisory Diversion Investigator phoned the attorney
and asked for Applicant's address in order to serve the Show Cause
Order. Id. According to the Government, while the attorney stated that
he would contact the Government's counsel, he did not.\3\ Id.
---------------------------------------------------------------------------
\3\ Given that Applicant had been criminally charged and
released on bond, the Pre-Trial Services Office would likely have
been a more fruitful source for obtaining his residence address.
---------------------------------------------------------------------------
The Government then mailed the Show Cause Order by certified mail,
return receipt requested, addressed to Applicant at his proposed
business address in Wayne, Michigan. GX 11, 12, and 13. Several weeks
later the mailing was returned unclaimed, with the Post Office
indicating that it was ``unable to forward'' the mailing. GX 13. The
Government did not, however, send the Show Cause Order to Applicant by
First Class Mail. See Jones v. Flowers, 547 U.S. 220 (2006).
Subsequently, the Government submitted a Request for Final Agency
Action along with the Investigative File. Upon review of the record, I
found that service was inadequate and directed that the Request for
Final Agency Action be returned.
On November 9, 2015, the Government again mailed the Show Cause
Order by certified mail, return receipt requested, addressed to
Applicant at his proposed registered location. Here again, several
weeks later the mailing was returned by the Post Office as
undeliverable. GX 18.
Also on November 9, 2015, the same day the Government had re-mailed
the Show Cause Order, it emailed the Order to Applicant at the email
address he had provided to the Agency on his applications. According to
an affidavit submitted by the Government, it ``did not receive any
bounce-back email or other indication that the email . . . was
undeliverable or otherwise not received.'' GX 19.
Upon re-submission of its Request for Final Agency Action, the
Government advised that on September 24, 2015, Applicant was found
guilty in the United States District Court for the Eastern District of
Michigan on multiple counts of health care fraud and aiding and
abetting the unlawful distribution of controlled substances. Request
for Final Agency Action, at 4; see also GX 15, at 5). The Government
further advised that on October 5, 2015,
[[Page 47827]]
Applicant failed to appear for a bond hearing leading the District
Court to issue a bench warrant for his arrest.
Based on the above, I find that the Government has satisfied its
obligation under the Due Process Clause ``to provide `notice reasonably
calculated, under all the circumstances, to apprise interested parties
of the pendency of the action and afford them an opportunity to present
their objections.' '' Jones, 547 U.S. at 226 (quoting Mullane v.
Central Hanover Bank & Trust Co., 339 U.S. 306, 314 (1950)). Due
process does not, however, require actual notice, Jones, 547 U.S. at
226 (quoting Dusenbery v. United States, 534 U.S. 161, 170 (2002)), but
rather, only `` `notice reasonably calculated, under all the
circumstances, to apprise interested parties of the pendency of the
action and afford them an opportunity to present their objections.' ''
Id. (quoting Mullane, 339 U.S. at 314). Moreover, the Government is not
required to undertake ``heroic efforts'' to find an applicant.
Dusenbery, 534 U.S. at 170 (2002).
Here, I conclude that Applicant's secreting himself rendered the
Government's use of the traditional means of service futile, and that
therefore, the Government was entitled to attempt to serve the Show
Cause Order by emailing it to him at the email address he had
previously provided to the Agency. See Rio Properties, Inc. v. Rio
Int'l Interlink, 284 F.3d 1007, 1017-18 (9th Cir. 2002); see also
Snyder, et al. v. Alternate Energy Inc., 857 N.Y.S. 2d 442, 447-449
(N.Y. Civ. Ct. 2008); In re International Telemedia Associates, Inc.,
245 B.R. 713, 721-22 (Bankr. N.D. Ga. 2000).
To be sure, courts have recognized that the use of email to serve
process has ``its limitations,'' including that ``[i]n most instances,
there is no way to confirm receipt of an email message.'' Rio
Properties, 284 F.3d at 1018. Here, however, I conclude that the use of
email to serve Applicant satisfied due process because service was made
to an email address he had previously provided to the Agency and the
Government did not receive back either an error or undeliverable
message. See Richard C. Quigley, D.O., 79 FR 50945 (2014); Emilio Luna,
M.D., 77 FR 4829 (2012), see also Robert Leigh Kale, 76 FR 48898,
48899-900 (2011). Thus, I am satisfied that the Government has provided
Applicant with notice ``reasonably calculated . . . to apprise [him] of
the pendency of the action'' and to present his objections.\4\ Jones,
547 U.S. at 226 (quoting Mullane, 339 U.S. at 314).
---------------------------------------------------------------------------
\4\ Because Applicant is a fugitive, I need not decide whether
the Government could have satisfied its constitutional obligation by
simply re-mailing the Show Cause Order to him by regular first class
mail as the Supreme Court's decision in Jones v. Flowers suggests.
Jones, 547 U.S. at 234-35.
---------------------------------------------------------------------------
Having found that the service of the Show Cause Order was
constitutionally adequate, I turn to whether Applicant has waived his
right to a hearing or to submit a written statement in lieu of a
hearing. According to the Government, since the re-service of the Show
Cause Order, neither Applicant, nor anyone purporting to represent him,
has requested a hearing or submitted a written statement of position.
Accordingly, as more than 30 days have now passed since the date of
service, I find that Applicant has waived his right to a hearing or to
submit a written statement. 21 CFR 1301.43(d). I therefore issue this
Decision and Final Order based on relevant evidence contained in the
Investigative Record submitted by the Government. Id. 1301.43(d) & (e).
I make the following additional findings of fact.
Findings of Fact
Applicant previously held DEA Certificate of Registration
BS9471309, pursuant to which he was authorized to dispense controlled
substances in Schedules III and IIIN, at the registered address of
Soliman Medical Center, 3152 South Wayne Road, Wayne, Michigan. GX 2,
at 1. However, on September 14, 2012, the former Administrator issued
an Order to Show Cause and Immediate Suspension of Registration to
Applicant, based on allegations that he was prescribing controlled
substances in Schedules II, IV, and V, for which he lacked authority,
and that he also issued prescriptions for drug cocktails of hydrocodone
(then Schedule III) and alprazolam (Schedule IV) which lacked a
legitimate medical purpose. GX 3, at 1-2. The former Administrator also
noted that of the 323 patient files DEA Investigators found in his
trash, 143 of the patients had ``criminal histories involving
controlled substance violations.'' Id. at 2. The same day, Applicant
voluntarily surrendered his registration ``in view of [his] alleged
failure to comply with the Federal requirements pertaining to
controlled substances.'' GX 4, at 1.
Four days later, on September 21, 2012, Applicant submitted an
application for a new registration as a practitioner in Schedules IIN,
III, IIIN and IV at the registered address of 3152 South Wayne Road,
Wayne, Michigan. The DEA Chief of Registration certified that on his
application, Applicant answered ``No'' to question 3, which asks:
``[h]as the applicant ever surrendered (for cause) or had a federal
controlled substance registration revoked, suspended, restricted or
denied, or is any such action pending?'' GX 1, at 1, 3. This
application remains pending before the Agency. Id. at 1.
On October 1, 2012, Applicant submitted a second application for
registration as a practitioner in Schedules III, IIIN, IV, and V, at
the registered address of 3844 Wasatch Ave #4, Los Angeles, California.
GX 8. The DEA Chief of Registration certified that on his application,
Applicant answered ``No'' to the question, ``Has the applicant ever
surrendered (for cause) or had a federal controlled substance
registration revoked, suspended, restricted or denied, or is any such
action pending?'' GX 8, at 2, 4.
On February 25, 2013, the Michigan Board of Medicine's Disciplinary
Subcommittee filed an Administrative Complaint against Applicant. GX 5,
at 13. Based on a review of 20 patient charts, the Board alleged that
his charting was lacking:
(1) ``information pertaining to past medical history or current
treating clinicians'';
(2) ``any findings pertaining to pain assessment, level of
dysfunction from pain, treatment plan, or diagnostic testing'';
(3) ``any documentation pertaining to patient informed consents,
prescribing agreements, pain assessments, clinical documentation,
drug analysis screens, lab test results, patient risk assessments,
copies of previous medical records, or the implementation of a pain
management program''; and
(4) ``any documentation that [he] monitored the patients' use of
the controlled substances for drug dependency or diversion, or that
he verified the efficacy of the long term use of the controlled
substances in treating the diagnoses of the patients.''
Id. at 10-11. The Board also alleged that the charts ``lack[ed]
documentation that [he] counselled the patients about the risk
associated with being prescribed a combination of hydrocodone and
alprazolam, or the long term effects of continued consumption of
acetaminophen.'' Id. Based on its findings, the Board alleged that
Applicant had violated various provisions of Michigan law, and had
engaged in ``selling, prescribing, giving away, or administering drugs
for other than lawful diagnostic or therapeutic purposes.'' Id. at 12
(quoting Mich. Comp. Laws section 162221(c)(iv)).
On January 15, 2014, Applicant stipulated with the Board to the
entry of a Consent Order, pursuant to which his medical license was
suspended for six months and one day, effective February
[[Page 47828]]
15, 2014.\5\ GX 5, at 1-3. However, the Consent Order also provided
that the reinstatement of Applicant's medical license ``is not
automatic and that he will have to petition for reinstatement'' and
show that he is of ``good moral character,'' that he has ``the ability
to practice . . . with reasonable skill and safety,'' that he has
satisfied ``the guidelines on reinstatement,'' and that the
reinstatement of his license ``is in the public interest.'' Id. at 2.
See also M.C.L.A. 333.16221.
---------------------------------------------------------------------------
\5\ Applicant was not required to admit that the allegations
were true. GX 5, at 3.
---------------------------------------------------------------------------
To date, Applicant has not been reinstated. I therefore find that
Applicant is currently without authority to dispense controlled
substances in Michigan, one of the States in which he seeks
registration.
Applicant also formerly held a Physician's and Surgeon's
Certificate issued by the Medical Board of California. However, on
October 10, 2014, the Medical Board revoked his Physician's and
Surgeon's Certificate based on the Michigan Board of Medicine's
suspension of his Michigan medical license.
In its Request for Final Agency Action, the Government notes that
the Order to Show Cause also sought to deny Applicant's application for
a DEA registration in California on the basis that the California
Medical Board had revoked his medical license. Request for Final Agency
Action, at 2 n.1. The Government, however, now advises that
``subsequent to the issuance of the [Show Cause Order], the undersigned
counsel learned that the . . . Los Angeles Field Division . . .
withdrew [Applicant]'s application pursuant to 21 CFR 1301.16(b), which
provides that `failure of the applicant to respond to official
correspondence regarding the application, when sent by registered or
certified mail, return receipt requested, shall be deemed to be a
withdrawal of the application.' '' Id. (quoting 21 CFR 1301.16(b)). The
Government further explains that in December 2014, the Los Angeles
Field Division ``attempted to reach [Applicant] via certified mail at
his application addresses in California and Michigan, [but] the
certified letters were returned as unclaimed and undeliverable, and
consequently, [his] application for a DEA Registration in California
was `deemed' a withdrawal and terminated in the registration
database.'' Id. at 2-3.
The Agency's registration records (of which I take official notice,
see 5 U.S.C. 556(e)), show that on December 5, 2014, Applicant was sent
a letter requesting that he provide a valid California Medical Board
license number in order to process his pending application for
registration. According to the affidavit of the then-chief of the
Agency's registration unit, on February 27, 2015, Applicant's October
1, 2012, application for his proposed Los Angeles, California address
was deemed ``withdrawn and retired from the DEA computer system.'' GX
8, at 1.
Discussion
Pursuant to section 303(f) of the Controlled Substances Act,
``[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 the 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 15227, 15230 (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.'' MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011) (quoting
Volkman, 567 F.3d 215, 222 (6th Cir. 2009) (quoting Hoxie, 419 F.3d
477, 482 (6th Cir. 2005))).\6\
---------------------------------------------------------------------------
\6\ ``In short, this 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
[applicant]. Rather, it is an inquiry which focuses on protecting
the public interest; what matters is the seriousness of the
[applicant's] misconduct.'' Jayam Krishna-Iyer, 74 FR 459, 462
(2009).
---------------------------------------------------------------------------
In this case, I conclude that the record supports two independent
grounds for denying Applicant's application for a DEA registration.
First, Applicant does not possess authority under the laws of Michigan,
the State in which he seeks registration with the Agency. Second,
Applicant materially falsified his application for a DEA registration.
Applicant's Lack of State Authority
Under the Controlled Substances Act (CSA), a practitioner must be
currently authorized to handle controlled substances in ``the
jurisdiction in which he practices'' in order to obtain a DEA
registration. See 21 U.S.C. 823(f) (``The Attorney General shall
register practitioners . . . if the applicant is authorized to dispense
. . . controlled substances under the laws of the State in which he
practices.''). See also 21 U.S.C. 802(21) (``[t]he term `practitioner'
means a physician . . . licensed, registered, or otherwise permitted,
by . . . the jurisdiction in which he practices . . . to distribute,
dispense, [or] administer . . . a controlled substance in the course of
professional practice''). Moreover, the CSA authorizes the revocation
of a registration ``upon a finding that the registrant . . . has had
his State license or registration suspended [or] revoked . . . and is
no longer authorized by State law to engage in the . . . distribution
[or] dispensing of controlled substances.'' Id. section 824(a)(3). As
the Supreme Court has explained, ``[i]n the case of a physician, this
scheme contemplates that he is authorized by the State to practice
medicine and to dispense drugs in connection with his professional
practice.'' United States v. Moore, 423 U.S. 122, 140-41 (1975).
Based on these provisions, DEA has long and repeatedly held that
the possession of state authority is a prerequisite for obtaining and
maintaining a practitioner's registration. See Frederick Marsh Blanton,
M.D., 43 FR 27616, 27617 (1978) (``State authorization to dispense or
otherwise handle controlled substances is a prerequisite to the
issuance and maintenance of a Federal controlled substances
registration.''). See also Sheran Arden Yeates, 71 FR 39130, 39131
(2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53
FR 11919, 11920 (1988).
Here, the investigative file establishes that the Michigan Board
suspended applicant's medical license on February 15, 2014. Moreover,
as found above, Applicant's Michigan medical license remains suspended
as of the date of this Decision and Order. I therefore find that
Applicant is without authority to dispense controlled substances in
[[Page 47829]]
Michigan, the State in which he seeks registration. Because he does not
meet this prerequisite for obtaining a DEA registration, I will deny
his application on this basis.
Material Falsification
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
section 304(a), 21 U.S.C. 824(a), are also properly considered in
deciding whether to grant or deny an application under section 303. See
The Lawsons, Inc., 72 FR 74334, 74337 (2007); Anthony D. Funches, 64 FR
14267, 14268 (1999); Alan R. Schankman, 63 FR 45260 (1998); Kuen H.
Chen, 58 FR 65401, 65402 (1993).
Thus, the allegation that Applicant materially falsified his
application is properly considered in this proceeding. See Samuel S.
Jackson, 72 FR 23848, 23852 (2007). 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. The Lawsons, 72 FR 74338; cf. Bobby Watts,
M.D., 58 FR 46995 (1993).
Here, the Government's evidence shows that upon being served with
an Order to Show Cause and Immediate Suspension of Registration which
alleged that he had prescribed controlled substances in violation of
the CSA, Applicant surrendered his registration. GXs 3 & 4. Moreover,
on the Voluntary Surrender form, Applicant acknowledged that he was
doing so ``[i]n view of my alleged failure to comply with the Federal
requirements pertaining to controlled substances.'' GX 4. Yet days
later, Applicant applied for a new registration and provided a ``no''
answer to the question: ``[h]as the applicant ever surrendered (for
cause) or had a federal controlled substance registration revoked,
suspended, restricted or denied, or is any such action pending?'' GX 1,
at 1, 3.
Applicant's answer was false as he had clearly surrendered his
registration for cause. His false answer was also material as ``it
`ha[d] 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 (D.C. Cir. 1956)) (other citation
omitted); see also United States v. Wells, 519 U.S. 482, 489 (1997)
(quoting Kungys, 485 U.S. at 770). As the Supreme Court has further
explained, ``it 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, but rather, whether the
misrepresentation or concealment was predictably capable of affecting,
i.e., had a natural tendency to affect, the official decision.''
Kungys, 485 U.S. at 771. While the evidence must be ``clear,
unequivocal, and convincing,'' the ``ultimate finding of materiality
turns on an interpretation of the substantive law.'' Id. at 772 (int.
quotations and citations omitted).
Applicant's false answer to the question of whether he had ever
surrendered his federal registration was clearly ``capable of
affecting'' the decision of whether to grant his application. As the
evidence shows, Applicant surrendered his registration in response to
allegations that he violated the CSA and DEA regulations by prescribing
controlled substances that were in schedules for which he lacked
authorization, as well as allegations that he issued prescriptions that
lacked a legitimate medical purpose. GX 3, at 2 (Sept. 24, 2012
Immediate Suspension Order) (citing 21 U.S.C. 822(b) and 841(a)(1); 21
CFR 1301.12(a) and 1306.04(a)). Notably, under the public interest
standard, the Agency is required to consider both the Applicant's
``experience in dispensing . . . controlled substances'' and his
``[c]ompliance with applicable State, Federal, or local laws relating
to controlled substances.'' 21 U.S.C. 823(f)(2) & (4). See also Shannon
L. Gallentine, D.P.M., 76 FR 45864, 45866 (2011).
Thus, notwithstanding that the Agency did not grant his
application, his false answer was still material as it was capable of
influencing the decision as to whether to grant his application. See
United States v. Alemany Rivera, 781 F.2d 229, 234 (1st Cir. 1985)
(``It makes no difference that a specific falsification did not exert
influence so long as it had the capacity to do so.''); United States v.
Norris, 749 F.2d 1116, 1121 (4th Cir. 1984) (``There is no requirement
that the false statement influence or effect the decision making
process of a department of the United States Government.'').
Accordingly, I conclude that Applicant materially falsified his
September 2012 application for registration. This provides a further
reason to deny his pending application.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28
CFR 0.100(b), I order that the application of Mikhayl Soliman, M.D.,
for a DEA Certificate of Registration as a practitioner, be, and it
hereby is, denied. This Order is effective immediately.
Dated: July 15, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-17394 Filed 7-21-16; 8:45 am]
BILLING CODE 4410-09-P