Ajay S. Ahuja, M.D.; Decision and Order, 5479-5498 [2019-02865]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of the
listed registrants to import the
applicable basic classes of schedule I or
II controlled substances is consistent
with the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated each of the company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule I or schedule II controlled
substances to the above listed
companies.
Dated: January 29, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–02866 Filed 2–20–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17–01]
Ajay S. Ahuja, M.D.; Decision and
Order
amozie on DSK3GDR082PROD with NOTICES1
On May 25, 2017, Administrative Law
Judge (ALJ) Charles Wm. Dorman issued
the attached Recommended Decision
(R.D.).1 Neither party filed exceptions to
the ALJ’s Recommended Decision.
Having reviewed the entire record, I
have decided to adopt the ALJ’s findings
of fact as modified,2 conclusions of law,
and recommended sanction except as
explained below.
Respondent’s Registration Status
Respondent is the holder of DEA
Certificate of Registration AA3029293,
pursuant to which he is authorized to
dispense controlled substances in
schedules II through V as a practitioner,
at the registered address of 825 High
Ridge Road, Stamford, Connecticut.
Government Exhibit (GX) 1, at 1.
Although not alleged in the Order to
Show Cause, see Administrative Law
1 All citations to the Recommended Decision are
to the slip opinion issued by the ALJ.
2 I have modified the Recommended Decision by
replacing the full name of DEA and state law
enforcement officials with their initials. I have
indicated where I have made these modifications in
the Recommended Decision with brackets.
VerDate Sep<11>2014
17:08 Feb 20, 2019
Jkt 247001
Judge Exhibit (ALJ Ex.) 1, I also find that
the administrative record in this case
and this Agency’s registration records,
of which I take official notice,3 show
that Respondent is the holder of DATAWaiver Identification Number
XA3029293. See GX 1, at 1.
Respondent’s DATA-Waiver authority
authorized him 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
275 patients. 21 CFR 1301.28(a) &
(b)(1)(iii).
Respondent’s registration was due to
expire on June 30, 2017. GX 1, at 1.
Although the ALJ correctly indicated
that the record before him did ‘‘not
contain evidence that the Respondent
filed an application of renewal,’’ R.D., at
2 n.1, the Agency’s registration records
do indicate, and I take official notice,4
that Respondent submitted a renewal
application on May 9, 2017. Because
Respondent has submitted a timely
renewal application, I find that
Respondent’s registration has remained
in effect pending the issuance of this
Decision and Final Order. See 5 U.S.C.
558(c); 21 CFR 1301.36(i). Moreover,
because Respondent’s DATA-Waiver
authority is contingent on Respondent
being a practitioner with a valid DEA
registration, see 21 U.S.C. 823(g)(2)(A);
21 CFR 1301.28(a), I find that
Respondent’s DATA-Waiver authority
also remained in effect pending
issuance of this Decision and Final
Order. Thus, this case remains a live
controversy, and I have jurisdiction to
decide this matter.
Respondent’s Corrective Action Plan
After submitting a timely request for
a hearing on October 6, 2016, see ALJ
Ex. 2, Respondent submitted a
Corrective Action Plan (CAP) pursuant
to 21 U.S.C. 824(c)(2)(C) on October 25,
2016 to the Deputy Assistant
Administrator of DEA’s Office of
Diversion Control. ALJ Ex. 9. As part of
his CAP, Respondent promised that he:
3 Under the Administrative Procedure Act (APA),
an agency ‘‘may take official notice of facts at any
stage in a proceeding—even in the final decision.’’
U.S. Dept. of Justice, Attorney General’s Manual on
the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance
with the APA and DEA’s regulations, Respondent
is ‘‘entitled on timely request to an opportunity to
show to the contrary.’’ 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). To allow Respondent the
opportunity to refute the facts of which I take
official notice, Respondent may file a motion for
reconsideration within 15 calendar days of service
of this order which shall commence on the date this
order is mailed.
4 I take official notice of this fact pursuant to the
same authority set forth supra in footnote 3.
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
5479
(1) ‘‘will not order or dispense
controlled substances;’’ (2) ‘‘will no
longer prescribe controlled substances
to his family members;’’ (3) ‘‘will retain
an independent monitor to review and
evaluate his practice;’’ (4) ‘‘will
continue to educate himself on issues
related to drug diversion and enroll in
related continuing medical education;’’
(5) ‘‘will cooperate with DEA in a
candid and truthful manner in future
communications with DEA;’’ and (6)
‘‘will authorize DEA to access all his
prescribing records for controlled
substances in the Connecticut
Prescription Monitoring and Reporting
System (‘CPMRS’).’’ Id. at 2–3.
On November 4, 2016, the Assistant
Administrator of DEA’s Diversion
Control Division 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 Exhibit A (Letter from
then-Assistant Administrator Louis J.
Millione to Respondent (dated
November 4, 2016)) to ALJ Ex. 11, at 1.
I conclude that the facts set forth in the
adopted Recommended Decision
demonstrate that the Agency had
adequate grounds to deny Respondent’s
CAP. Thus, I agree with the Agency’s
denial of Respondent’s CAP, and I too
reject it.
Pre-Hearing Identification of
Documents Used To Impeach a Witness
on Cross-Examination
In his Recommended Decision, the
ALJ criticized the Government’s use of
the Respondent’s earlier deposition
testimony 5 to impeach Respondent
during cross-examination because, inter
alia, ‘‘the Government had not
identified the deposition transcript as a
document it intended to use prior to the
hearing.’’ R.D., at 10. I do not adopt the
ALJ’s suggestion that a party is
precluded from using information or a
document to impeach a witness during
cross-examination unless it is identified
prior to the administrative hearing. The
APA states that ‘‘[a] party is entitled
. . . to conduct such cross-examination
as may be required for a full and true
disclosure of the facts.’’ 5 U.S.C. 556(d).
Likewise, Agency precedent has applied
this APA standard to hold that ALJs lack
the authority to preclude a party from
using relevant information to impeach a
witness during cross-examination. See
Trinity II, 83 FR 7304, 7322 n.43 (2018)
5 The deposition of Respondent apparently
occurred in connection with a civil case brought by
the United States Attorney’s Office for the District
of Connecticut against Respondent. See Transcript
61–62, 64, 109–10, 291; United States v. Ahuja, No.
3:14–CV–1558, 2017 WL 1807561 (D. Conn. May 5,
2017), aff’d, 736 F. App’x 20 (2d Cir. 2018).
E:\FR\FM\21FEN1.SGM
21FEN1
5480
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
(‘‘the CALJ lacks the authority to
preclude a respondent from using
relevant information to impeach a
witness during cross-examination’’)
(citing 5 U.S.C. 556(d)); Farmacia Yani,
80 FR 29053, 29063 n.25 (2015) (finding
that it was prejudicial error to preclude
a respondent from using a document to
impeach a witness on crossexamination, even where respondent
had failed to present the document to
the Government in advance of the
hearing). Thus, all parties have the right
to use any relevant information to
impeach a witness, regardless of
whether the party disclosed that
information prior to the administrative
hearing.
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.
AA3029293 and DATA-Waiver
Identification Number XA3029293,
issued to Ajay S. Ahuja, M.D., be, and
they hereby are, revoked. I further order
that any pending application of Ajay S.
Ahuja to renew or modify the above
registration, or any pending application
of Ajay S. Ahuja for any other
registration, be, and it hereby is, denied.
This Order is effective immediately.
Dated: February 10, 2019.
Uttam Dhillon,
Acting Administrator.
Paul A. Dean, Esq., for the Government
Ronald W. Chapman II, Esq., and Robert
J. Andertz, Esq., for the Respondent
RECOMMENDED RULINGS, FINDINGS
OF FACT, CONCLUSIONS OF LAW,
AND DECISION OF THE
ADMINISTRATIVE LAW JUDGE
amozie on DSK3GDR082PROD with NOTICES1
Charles Wm. Dorman, Administrative
Law Judge.
The Drug Enforcement
Administration (‘‘DEA’’ or
‘‘Government’’) served Ajay S. Ahuja,
M.D., (‘‘Respondent’’) with an Order to
Show Cause (‘‘OSC’’), seeking to revoke
his DEA Certificate of Registration
(‘‘COR’’), Number AA3029293.
Administrative Law Judge Exhibit
(‘‘ALJ-’’) 1. In response to the OSC, the
Respondent timely requested a hearing
before an Administrative Law Judge.
ALJ-2. The hearing in this matter was
held in Hartford, Connecticut on March
13, 2017.
The issue before the Administrator is
whether the record as a whole
establishes that the Respondent’s COR
should be revoked and any pending
VerDate Sep<11>2014
17:08 Feb 20, 2019
Jkt 247001
applications 6 be denied because the
Respondent’s registration would be
inconsistent with the public interest
under 21 U.S.C. §§ 824(a)(4) and 823(f).
This Recommended Decision is based
on my consideration of the entire
administrative record, including all of
the testimony, admitted exhibits, and
the oral and written arguments of
counsel.
ALLEGATIONS
I. Improper Recordkeeping
1. Between February 2012 and
February 2014, the Respondent failed to
maintain accurate dispensing records
for the following controlled substances,
in violation of 21 U.S.C. § 827(a)(3), 21
C.F.R. § 1304.21(a), and Conn. Agencies
Regs. § 21a-326-1(d)(2), (6) 7:
Alprazolam 1 mg tablets (Schedule IV),
Hydrocodone Bitartrate with
Acetaminophen 10/650 mg tablets
(Schedule III), Guaifenesin with
Codeine Phosphate 10 mg syrup
(Schedule V), Testosterone Cypionate
200 mg/mL injectable (Schedule III),
and Zolpidem Tartrate ER 12.5 mg
tablets (Schedule IV). ALJ-1, at 2-3.
2. Between February 2012 and
February 2014, the Respondent was
unable to account for the following
controlled substances, in violation of 21
U.S.C. § 827(a)(3), 21 C.F.R.
§ 1304.21(a), and Conn. Agencies Regs.
§ 21a-326-1(d)(2), (6): 59 bottles
(approximately 5310 tablets) of
Alprazolam 1 mg tablets (nearly 10% of
total supply), 21 bottles (approximately
630 tablets) of Hydrocodone 10/650 mg
tablets (approximately 17.5% of total
supply), 58 bottles of Guaifenesin with
Codeine Phosphate 10 mg syrup
(approximately 27.36% of total supply),
2 vials of Testosterone Cypionate 200
mg/mL injectable (entire supply), and 3
bottles (90 tablets) of Zolpidem Tartrate
6 The Respondent’s COR will expire by its terms
on June 30, 2017. ALJ-1, at 1. The record does not
contain any evidence that the Respondent filed an
application for renewal. See 21 C.F.R. § 1301.36(i);
Richard J. Settles, D.O., 81 FR 64940, 64940-42,
(2016).
7 In the OSC and Government’s Prehearing
Statement, many of the Government’s citations to
the Connecticut statutes and regulations were
incorrect. See ALJ-1; ALJ-13, at 12. This issue was
addressed during the December 5, 2016 Prehearing
Conference, and in my Prehearing Order, issued the
same day, and the Government was ordered to
prepare copies of the Connecticut statutes and
regulations it intended to rely upon. ALJ-20, at 2.
In its Supplemental Prehearing Statement, the
Government provided an updated list and copies of
the correct Connecticut statutes and regulations.
ALJ-30, at 12, attach. A. Accordingly, the
Respondent was put on notice of the Connecticut
statutes and regulations that the Government
alleged the Respondent violated. I refer to these
updated statutes and regulations in this
Recommended Decision.
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
ER 12.5 mg tablets (entire supply). ALJ1, at 2-3.
3. Between December 2011 and
February 2014, the Respondent failed to
maintain a dispensing log in accordance
with federal law for the following
controlled substances: Alprazolam 1 mg
tablets, Hydrocodone 10/650 mg tablets,
and Guaifenesin with Codeine
Phosphate 10 mg syrup. ALJ-1, at 2-3.
Specifically, the Respondent’s
dispensing records did not include the
typewritten or written initials of the
dispensing physician and/or the address
of the person to whom the medication
was dispensed, in violation of 21 U.S.C.
§ 827(a)(3), 21 C.F.R. §§ 1304.22(c),
Conn. Gen. Stat. § 21a-254(f), and Conn.
Agencies Regs. § 21a-326-1(d)(2), (6).
ALJ-1, at 2-3.
4. Between February 2012 and
January 2014, the Respondent failed to
maintain controlled substance receipts
for the following orders of controlled
substances, in violation of 21 U.S.C.
§ 842(a)(5), 21 C.F.R. §§ 1304.04(a) and
1304.21(a), Conn. Gen. Stat. § 21a254(c), and Conn. Agencies Regs. § 21a326-1(d)(2), (6): 17 shipments of
Alprazolam 1 mg tablets, 8 shipments of
Hydrocodone Bitartrate with
Acetaminophen 10/650 mg tablets, 7
shipments of Guaifenesin with Codeine
Phosphate 10 mg syrup, a shipment of
Testosterone Cypionate 200 mg/mL
injectable, and a shipment of Zolpidem
Tartrate ER 12.5 mg tablets from A&S
Medical Solutions, and 10 shipments of
Lyrica 75 mg tablets, and 8 shipments
of Lyrica 50 mg tablets from J. Knipper
& Company, Inc. ALJ-1, at 3-4.
5. Between December 2011 and
February 2014, the Respondent failed to
separate his Schedule III-V controlled
substance records from his noncontrolled substance records, in
violation of 21 C.F.R. § 1304.04(f)(2),
Conn. Gen. Stat. § 21a-254(f), and Conn.
Agencies Regs. § 21a-326-1(d)(2), (6).
ALJ-1, at 4.
6. The Respondent failed to perform
and maintain a biennial inventory of
controlled substances, in violation of 21
U.S.C. § 827(a)(1), 21 CFR § 1304.11(c),
Conn. Gen. Stat. § 21a-254(h), and Conn.
Agencies Regs. § 21a-326-1(d)(2), (6).
ALJ-1, at 4.
7. The Respondent failed to report to
the Connecticut State Commissioner of
Consumer Protection that he was
engaging in dispensing drugs, and failed
to biennially notify the Commissioner of
his intent to continue to dispense drugs,
in violation of Conn. Gen. Stat. §§ 20-14f
and 21a-317 and 21 C.F.R.
§ 1306.03(a)(1). ALJ-1, at 5.
E:\FR\FM\21FEN1.SGM
21FEN1
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
II. Improper Prescribing to Himself &
Family Members
8. Between 2012 and 2014, the
Respondent issued controlled substance
prescriptions to himself and his family
members for other than a legitimate
medical purpose and outside the course
of professional practice, in violation of
Conn. Gen. Stat. §§ 20-14e(b), 21a322(3), (8), (10), 21a-252(a), Conn.
Agencies Regs. § 21a-326-1(c), (d), and
21 C.F.R. § 1306.04(a). ALJ-1, at 5-6.
III. Improper Prescribing to Patients
amozie on DSK3GDR082PROD with NOTICES1
9. The Respondent issued controlled
substance prescriptions to patients for
other than a legitimate medical purpose
and outside the course of professional
practice, in violation of Conn. Gen. Stat.
§§ 20-14e(b), 21a-322(3), (8), (10), 21a252(a), Conn. Agencies Regs. § 21a-3261(c), (d), and 21 C.F.R. § 1306.04(a). ALJ1, at 6-10.
a. Specifically, on at least 20
occasions between May 2012 and
November 2014, the Respondent issued
multiple overlapping prescriptions for
controlled substances to his patients,
which made it possible for these
patients to receive early refills of
controlled substances and facilitated
potential diversion of those controlled
substances. ALJ-1, at 6-7.
b. On at least 35 occasions involving
at least eight of the Respondent’s
patients between July 2010 and
November 2014, the Respondent issued
prescriptions to those patients without
any documentation of those
prescriptions, or any bases for the
prescriptions, in the patient’s record, in
violation of Conn. Gen. Stat. §§ 2014e(b), 21a-322(3), (8), (10), 21a-252(a),
Conn. Agencies Regs. § 21a-326-1(c), (d),
and 21 C.F.R. § 1306.04(a). ALJ-1, at 78.
c. On at least 9 occasions involving at
least three of the Respondent’s patients
between April 2011 8 and March 2014,
the Respondent dispensed controlled
substances to those patients from his
office supply without any
documentation of those dispenses, or
any bases for those dispenses, in the
patient’s records, in violation of Conn.
Gen. Stat. §§ 20-14e(b), 21a-322(3), (8),
(10), 21a-252(a), Conn. Agencies Regs.
§§ 21a-326-1(c), (d), and 21 C.F.R.
§ 1306.04(a). ALJ-1, at 8.
8 Paragraph 9(c) of the OSC lists the inclusive
dates as February 2012 and March 2014. ALJ-1 at
8. Subparagraph 9(c)(ii) of the OSC, however, lists
the dates as April 2011 and March 2014. ALJ-1, at
8. Further, the Respondent stipulated to the dates
of April 2011 and March 2014. ALJ-32, at 6, para.
42. Thus, the Respondent was on notice that the
inclusive dates for this allegation were April 2011
and March 2014.
VerDate Sep<11>2014
17:08 Feb 20, 2019
Jkt 247001
d. On at least 26 occasions involving
at least seven of the Respondent’s
patients between April 2011 and
October 2014 the Respondent issued
prescriptions to those patients without
sufficient documentation of those
prescriptions, or any bases for the
prescriptions, in the patient’s records, in
violation of Conn. Gen. Stat. §§ 2014e(b), 21a-322(3), (8), (10), 21a-252(a),
Conn. Agencies Regs. § 21a-326-1(c)(d),
and 21 C.F.R. § 1306.04(a). ALJ-1, at 9.
e. On at least 45 occasions involving
at least seven patients between May
2010 and March 2014, the Respondent
dispensed controlled substance
prescriptions from his office supply
without sufficient documentation of
those dispenses, or sufficient
documentation of the bases for them, in
the patient’s records, in violation of
Conn. Gen. Stat. § 20-14e(b), 21a-322(3),
(8), (10), 21a-252(a), Conn. Agencies
Regs. § 21a-326-1(c)(d), and 21 C.F.R.
§ 1306.04(a). ALJ-1, at 10.
IV. Failure to Maintain Adequate
Security
10. The Respondent failed to maintain
adequate security for the controlled
substances in his possession, in
violation of 21 C.F.R. § 1301.75(b) and
Conn. Agencies Regs. §§ 21a-262-6(a)(c), 21a-326-1(d). ALJ-1, at 11.
V. Other Conduct Threatening the
Public Health and Safety (Factor Five)
11. Additionally, the Respondent
engaged in conduct which may threaten
the public health and safety, in violation
of 21 U.S.C. C.F.R. § 823(f)(5). ALJ-1, at
11.
WITNESSES
I. The Government’s Witnesses
The Government presented its case
through the testimony of five witnesses.
First, the Government presented the
testimony of [R.M.], Director of the Drug
Control Division of the State of
Connecticut. Tr. 15-32. [R.M.] has held
his current position for under a year,
and he was previously a Connecticut
Drug Control Agent. Tr. 15-16. [R.M.]
testified concerning his background,
training, and previous experience. Tr.
16. Along with DEA Diversion
Investigator [N.C.], [R.M.] was involved
in the removal of controlled substances
from the Respondent’s clinic. Tr. 18.
Additionally, [R.M.] testified about the
nature and workings of Connecticut’s
Prescription Monitoring Program
(‘‘PMP’’) and that physicians who
dispense controlled substances are
required to report that dispensing to the
Connecticut PMP. Tr. 17-18. I find
[R.M.]’s testimony to be thorough,
detailed, and internally consistent.
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
5481
Therefore, I merit it as credible in this
Recommended Decision.
Second, the Government presented
the testimony of DEA Diversion
Investigator [N.C.]. Tr. 33-48. [N.C.] has
been stationed at the DEA Camden
Resident Office in Maple Shade, New
Jersey since November 28, 2016, but was
previously stationed at the DEA
Hartford Resident Office in Rocky Hill,
Connecticut. Tr. 33-34. [N.C.] testified
concerning his background, training,
and experience as a diversion
investigator for the DEA. Tr. 34. [N.C.]
testified that his Group Supervisor,
[L.L.], directed him to assist the State of
Connecticut in retrieving controlled
substances from the Respondent’s
clinic. Tr. 35. [N.C.] testified that he
went with [R.M.] to the Respondent’s
clinic to pick-up the Respondent’s
expired controlled substances. Tr. 3637. I find [N.C.]’s testimony to be
thorough and internally consistent.
Therefore, I merit [N.C.]’s testimony as
credible in this Recommended Decision.
Third, the Government presented the
testimony of [P.L.], who was a Drug
Control Agent with the Connecticut
Department of Consumer Protection. Tr.
49-78. [P.L.] is currently a pharmacist
with the Food and Drug Administration,
a position she has held since January
2017. Tr. 49. [P.L.] worked with the
State of Connecticut Drug Division
during the course of the investigation
into the Respondent. Tr. 49. [P.L.]
testified as to how the investigation into
the Respondent began and about how
she contacted Diversion Investigator
[M.J.] to assist with the investigation. Tr.
51-52. In January 2014, [P.L.] went with
[M.J.] to the Respondent’s clinic to ask
the Respondent some questions. Tr. 55.
[P.L.] testified about her interactions
with the Respondent during this visit,
specifically, statements the Respondent
made concerning why the investigators
were asking the Respondent about
alprazolam, as he did not believe that it
was a diverted or abused substance. Tr.
55. [P.L.] and [M.J.] went back to the
Respondent’s clinic in February 2014 to
execute an Administrative Inspection
Warrant (‘‘AIW’’). Tr. 59. Additionally,
[P.L.] testified about the security
measures in place for controlled
substances at the Respondent’s clinic
during both of her visits, and how these
measures violated Connecticut state
regulations. Tr. 64-65. Finally, [P.L.]
testified concerning an e-mail
correspondence that she had with the
Respondent, in which he requested
assistance with his expired controlled
substances. Tr. 63. I find [P.L.]’s
testimony to be thorough, detailed, and
internally consistent. Therefore, I merit
E:\FR\FM\21FEN1.SGM
21FEN1
5482
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
amozie on DSK3GDR082PROD with NOTICES1
it as credible in this Recommended
Decision.
Fourth, the Government presented the
testimony of DEA Diversion Investigator
[M.J.]. Tr. 79-140. [M.J.] testified that
she has held her position for six years,
and discussed her background and
thirteen-week training at the DEA
Training Academy at Quantico. Tr. 80.
[M.J.] initially became involved in the
investigation into the Respondent when
she was requested to assist the
Connecticut Drug Control Division in
their investigation of the Respondent.
Tr. 80-81. [M.J.] testified about how she
and [P.L.] pulled PMP records for the
Respondent. Tr. 81-82.
[M.J.] also testified about her meeting
with the Respondent in January 2014
and some of the advisements that she
and [P.L.] provided the Respondent
with regards to the Respondent’s
recordkeeping and security practices.
Tr. 84-86. Additionally, [M.J.] testified
about statements the Respondent made
questioning why she and [P.L.] were
investigating the Respondent’s
benzodiazepine prescriptions because
he did not believe they were being
diverted or abused. Tr. 87. [M.J.] also
testified about the events that took place
on February 21, 2014, when she, along
with [P.L.], another diversion
investigator, and two Connecticut police
officers, served the Respondent with an
AIW. Tr. 94. I find [M.J.]’s testimony to
be thorough, detailed, and internally
consistent. Therefore, I merit it as
credible in this Recommended
Decision.9
Finally, the Government presented
the testimony of Adam Perrin, M.D.
(‘‘Dr. Perrin’’). Tr. 141-209. Dr. Perrin
was accepted as an expert, without
objection, in the field of clinical
medicine in the State of Connecticut
with respect to prescribing controlled
substances. Tr. 149, 153. Dr. Perrin is
currently employed by the University of
Connecticut School of Medicine and
specializes in family medicine and
primary care sports medicine. Tr. 141,
143. He also maintains a medical license
in the State of Connecticut, a Certificate
of Added Qualification in Primary Care
Sports Medicine, a Certificate from the
American College of Medical Quality,
and is Board Certified in Family
Medicine. Tr. 143-44. Additionally, Dr.
9 I found [M.J.]’s testimony to be disingenuous
concerning her knowledge of the DEA policy
concerning the use of DEA Form 82, and whether
the form included an advisement to a practitioner
of the right to counsel at the time of an inspection.
Given her experience and the ‘‘hundreds’’ of times
she has used DEA Form 82, that portion of her
testimony was not credible. Nevertheless, that
testimony concerned only a peripheral issue in this
case, and it does not detract from the credibility of
the remainder of her testimony. Tr. 112-14, 137-38.
VerDate Sep<11>2014
17:08 Feb 20, 2019
Jkt 247001
Perrin does team physician work for
Wesleyan University, and consulting
work for the Livanta Organization,
where he conducts peer reviews of cases
and determines the appropriateness of a
patient’s discharge and whether the
patient was at the necessary level of
care. Tr. 142.
Dr. Perrin testified that he has taken
continuing medical education courses
in the areas of controlled substances and
pain management, most recently
through the Connecticut State Medical
Society. Tr. 144. He also testified that he
has experience treating patients with
controlled substances, specifically
opiates, dealt with addictive issues of
patients, and is familiar with the risks
of prescribing controlled substances. Tr.
146-47. He testified that he is familiar
with the standards of care in the State
of Connecticut and is ‘‘familiar with
how doctors should conduct themselves
in Connecticut while prescribing
controlled substances for a legitimate
medical purpose.’’ Tr. 148. This body of
knowledge is based on Dr. Perrin’s
experience as a physician and as a
teacher of physicians. Tr. 147.
Dr. Perrin testified about Suboxone,
what it is and what it is used for. Tr.
153-55. Dr. Perrin reviewed the Ahuja
family patient file, Government Exhibit
11, as well as prescriptions written by
Dr. Ahuja to his family members to
determine whether the records revealed
any therapeutic duplication of
controlled substances. Tr. 157-59.
Additionally, Dr. Perrin reviewed copies
of prescriptions written by the
Respondent and was asked to compare
those prescriptions to the patient files
for members of the Respondent’s family
to determine if the prescriptions were
documented in those patient files. Tr.
159-63.
Dr. Perrin reviewed the Stipulations
of Fact, ALJ-32, and was asked his
opinion with respect to the standard of
care. Tr. 164-82. Specifically, Dr. Perrin
discussed the potential harm of
overlapping prescriptions, Tr. 165, 178,
and why having inadequate or no
documentation in a patient’s file would
fall below the standard of care in
Connecticut. Tr. 166, 202-04.
I find Dr. Perrin’s testimony to be
thorough, detailed, and internally
consistent. Therefore, I merit is as
credible in this Recommended
Decision.10
10 I note that Dr. Perrin mistakenly testified that
Suboxone is a Schedule II controlled substances,
when it is actually Schedule III. Tr. 154. I also
found Dr. Perrin’s testimony concerning the reason
that he would not write prescriptions for himself or
for family members to be less than convincing.
Specifically, he testified that there is no law or
regulation in Connecticut that prevents a doctor
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
II. The Respondent’s Witness
The Respondent presented his case
through his own testimony. Tr. 210-303.
The Respondent testified concerning his
background, medical education and
training. Tr. 211-14. The Respondent
also testified as to how he began treating
Suboxone patients and the nature of his
treatment of these patients. Tr. 216-24.
He testified that currently about 80% of
his medical practice is devoted to
treatment of Suboxone patients. Tr. 217.
The Respondent also testified about his
treatment of patient D.M., and about a
prescription he wrote to this patient for
Percocet. Tr. 225-26. Additionally, the
Respondent testified about the security
measures present in his clinic,
including an alarm system, and where
he stored his controlled substances. Tr.
227-34. The Respondent also testified as
to his interactions with [M.J.] and [P.L.]
during their investigation in 2014. Tr.
238, 254-56.
Throughout his testimony on direct
examination, the Respondent testified
about his changing opinions with
regards to what controlled substances
are being abused and diverted, Tr. 23839, and various patient behaviors that
present red flags. Tr. 240-42. His
opinions changed after he took medical
education courses which changed the
way he practiced medicine and
prescribed controlled substances. Tr.
239-51. The Respondent also testified
that during a course he took in January
2017 he learned the importance of
documenting the treatment he provided
to his patients. Tr. 246.
While the Respondent testified with
confidence and clarity during direct
examination, his testimony on cross
examination was somewhat combative,
confusing, and evasive. For example,
when the Respondent was asked to
compare the content of the OSC with
the facts he had stipulated to, he was
unable to do so. Tr. 259-63. When the
Respondent was asked if his testimony
on several issues was different at the
hearing than at an earlier deposition,
and when showed the transcript of the
deposition, the Respondent was unable
to recall. Tr. 279-92. When asked twice
from writing a prescription for himself or for family
members, but, based on guidance from the
American Medical Association (‘‘AMA’’), it would
be considered an ethical violation to do so. Tr. 194.
He further testified that few physicians are aware
of the AMA guidelines. Tr. 196-97. He then testified
that he would not write such prescriptions because
he would be worried about his own license and
what his peers might think. Tr. 196, 205. Dr. Perrin
finally testified he would not write such
prescriptions as a matter of personal philosophy.
Tr. 205-06. These two minor areas of Dr. Perrin’s
testimony, do not undermine my assessment that,
overall, his testimony is credible and merits
significant weight.
E:\FR\FM\21FEN1.SGM
21FEN1
amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
when his office associate, Dr. Jacobson,
left the Respondent’s medical practice,
the Respondent gave rambling answers,
but he did not answer the question of
when Dr. Jacobson left. In addition,
when badgered as to the number of
Suboxone patients that he treats, the
Respondent eventually did not even
give an approximate number. Tr. 27579.
While combativeness, confusion and
evasiveness tend to undermine the
credibility of a witness, here the
combativeness, confusion and
evasiveness concerned issues of little
significance. For example, having the
Respondent agree that the factual
allegations contained in the OSC
matched many of the facts to which the
Respondent had already stipulated was
meaningless. The two documents speak
for themselves. Further, the
Government’s use of the Respondent’s
earlier deposition testimony was a
meaningless exercise for several
reasons. First, the Government had not
identified the deposition transcript as a
document it intended to use prior to the
hearing. Second, the issues the
Government questioned the Respondent
about, based upon his deposition
testimony, do not relate to the
allegations contained in the OSC, except
for the disposition of some cough syrup,
where the Respondent admitted he took
some home. Tr. 291, 298. Third, it had
minimal impeachment value. Finally, as
the Respondent noted, the exact number
of Suboxone patients the Respondent
treats, so long as it is less than the
number he is allowed to treat, is of no
consequence to this decision.
Accordingly, when accessing the
Respondent’s credibility, I find that the
clear and confident manner in which
the Respondent testified on direct
examination outweighs the manner in
which he testified on cross examination.
Further, when comparing his testimony
to that of other witnesses, I find that it
was generally consistent with that of the
Government’s witnesses. Thus, I find
the Respondent’s testimony credible on
all relevant factual issues. I, however,
find it less credible than that of other
witnesses in one area.
The Respondent testified that he did
not recall telling [M.J.] and [P.L.] that
benzodiazepines are not commonly
diverted or abused. Tr. 282. [P.L.]
testified that the Respondent did not
understand why she was concerned
about alprazolam, which is a
benzodiazepine, because he did not
think it was diverted or abused. Tr. 55.
[M.J.] also testified that she heard the
Respondent make a similar statement.
Tr. 87. The Respondent testified that he
told [M.J.] and [P.L.] that oxycodone
VerDate Sep<11>2014
17:08 Feb 20, 2019
Jkt 247001
was more addictive than a
benzodiazepine. Tr. 253, 282. Given the
Respondent’s acknowledgement of
discussing the topic and his inability to
recall if he made the statement reported
by both [M.J.] and [P.L.], I credit their
testimonies on this issue.
The parties stipulated to the
authenticity of all of the Government’s
exhibits, accordingly, all of the
Government’s exhibits were admitted
into evidence. Tr. 8. Additionally, the
parties stipulated to the authenticity of
Respondent Exhibits A, C-J, accordingly,
these exhibits were also entered into
evidence. Tr. 9.
The factual findings below are based
on a preponderance of the evidence,
including the detailed, credible, and
competent testimony of the
aforementioned witnesses, the exhibits
entered into evidence, and the record
before me.
STIPULATIONS OF FACT 11
The Government and the Respondent
stipulated the following facts (‘‘Stip. of
Fact’’):
1. Respondent is registered with the
DEA as a practitioner to handle
Controlled Substances in Schedules II–
V under DEA COR AA3029293 at 825
High Ridge Road, Stamford, Connecticut
06905-1904.
2. Respondent is presently licensed in
Connecticut as a medical doctor (M.D.)
with medical license 25539.
3. On February 21, 2014, DEA
executed an Administrative Inspection
Warrant at Respondent’s medical
practice. During the execution of the
warrant, DEA and state drug control
agents reviewed documentation of
Respondent’s recordkeeping practices
related to his obligations under the
Controlled Substances Act (CSA), its
regulations, and state law.
Recordkeeping Violations
4. Between February 2012 and
February 2014, Respondent failed to
maintain accurate dispensing records
for his dispensation of Alprazolam 1 mg
tablets, a Schedule IV controlled
substance, and was unable to account
for 59 bottles (approximately 5310
tablets) of Alprazolam 1 mg tablets
received from his supplier.
5. Between February 2012 and
February 2014, Respondent failed to
maintain a dispensing log for
Alprazolam 1 mg tablets in accordance
with federal law. In particular,
Respondent’s dispensing records did
not include the typewritten or written
11 These stipulations of fact are numbered the
same manner as those found in ALJ-32, and also
correspond to the references made to a specific
stipulation mentioned in the transcript.
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
5483
initials of the dispensing physician and/
or the address of the person to whom
the medication was dispensed.
6. Between February 2012 and
February 2014, Respondent failed to
maintain accurate dispensing records
for his dispensation of Hydrocodone
Bitartrate with Acetaminophen 10/650
mg (Hydrocodone 10/650 mg) tablets, a
Schedule III controlled substance, and
was unable to account for 21 bottles
(approximately 630 tablets) of
Hydrocodone 10/650 mg tablets
received from his supplier.
7. Between January 2012 and
February 2014, Respondent failed to
maintain a dispensing log for
Hydrocodone 10/650 mg tablets in
accordance with federal law. In
particular, Respondent’s dispensing
records did not include the typewritten
or written initials of the dispensing
physician and/or the address of the
person to whom the medication was
dispensed.
8. Between February 2012 and
February 2014, Respondent failed to
maintain accurate dispensing records
for his dispensation of Guaifenesin with
Codeine Phosphate 10 mg syrup, a
Schedule V controlled substance, and
was unable to account for 58 bottles of
Guaifenesin with Codeine Phosphate 10
mg syrup received from his supplier.
9. Between December 2011 and
February 2014, Respondent failed to
maintain a dispensing log for
Guafenesin with Codeine Phosphate 10
mg syrup in accordance with federal
law. In particular, Respondent’s
dispensing records did not include the
typewritten or written initials of the
dispensing physician and/or the address
of the person to whom the medication
was dispensed.
10. Between May 2012 and February
2014, Respondent failed to maintain
accurate dispensing records for his
dispensation of Testosterone Cypionate
200 mg/mL injectable, a Schedule III
Controlled Substance and was unable to
account for 2 vials of Testosterone
Cypionate 200 mg/mL injectable
received from his supplier.
11. Between August 2013 and
February 2014, Respondent failed to
maintain accurate dispensing records
for his dispensation of Zolpidem
Tartrate ER 12.5 mg tablets, a Schedule
IV controlled substance, and was unable
to account for 3 bottles (90 tablets) of
Zolpidem Tartrate ER 12.5 mg tablets
received from his supplier.
12. Between February 2012 and
November 2013, Respondent ordered 17
shipments of Alprazolam 1 mg tablets
from A&S Medical Solutions.
Respondent failed to maintain
E:\FR\FM\21FEN1.SGM
21FEN1
amozie on DSK3GDR082PROD with NOTICES1
5484
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
controlled substance receipt records for
any of these shipments.
13. Between February 2012 and
November 2013, Respondent ordered 8
shipments of Hydrocodone Bitartrate
with Acetaminophen 10/650 mg tablets
from A&S Medical Solutions.
Respondent failed to maintain
controlled substance receipt records for
any of these shipments.
14. Between February 2012 and
November 2013, Respondent ordered 7
shipments of Guaifenesin with Codeine
Phosphate 10 mg syrup from A&S
Medical Solutions. Respondent failed to
maintain controlled substance receipt
records for any of these shipments.
15. Between February 2012 and
January 2014, Respondent ordered a
shipment of Testosterone Cypionate 200
mg/mL injectable from A&S Medical
Solutions. Respondent failed to
maintain controlled substance receipt
records for this shipment.
16. Between February 2012 and
January 2014, Respondent ordered a
shipment of Zolpidem Tartrate ER 12.5
mg tablets from A&S Medical Solutions.
Respondent failed to maintain
controlled substance receipt records for
this shipment.
17. Between February 2012 and
January 2014, Respondent ordered 10
shipments of Lyrica 75 mg tablets, a
Schedule V controlled substance, from J.
Knipper & Company, Inc. Respondent
failed to maintain controlled substance
receipt records for these shipments.
18. Between February 2012 and
January 2014, Respondent ordered 8
shipments of Lyrica 50 mg tablets, a
Schedule V controlled substance, from J.
Knipper & Company, Inc. Respondent
failed to maintain controlled substance
receipt records for these shipments.
19. Between December 2011 and
February 2014, Respondent failed to
separate Schedule III–V controlled
substance records from his noncontrolled substance records.
Specifically, Respondent’s Schedule III–
V dispensing logs included dispensing
logs for Azithromycin, which is not a
controlled substance.
20. Respondent failed to perform and
maintain a biennial inventory of
controlled substances.
21. Respondent failed to report to the
State Commissioner of Consumer
Protection that he was engaged in
dispensing drugs, and Respondent
failed to biennially notify the
Commissioner of his intent to continue
to dispense drugs.
Improper Prescribing to Family
Members
22. After the execution of the
administrative warrant, DEA issued
VerDate Sep<11>2014
17:08 Feb 20, 2019
Jkt 247001
Respondent two successive
administrative subpoenas for copies of
patient records for several individuals to
whom Respondent had issued
controlled substances prescriptions,
including Respondent and several
family members.
23. On December 18, 2014, pursuant
to an administrative subpoena,
Respondent provided DEA with a copy
of, among others, patient records for
himself and certain family members,
including N.A., U.A., and G.A.
24. On at least two occasions between
December 2012 and December 2014,
Respondent either issued, or dispensed,
overlapping prescriptions of controlled
substances constituting early fills for
himself (alprazolam 1 mg, Schedule IV)
and a family member, N.A., (zolpidem
tartrate 10 mg).
25. On at least seven additional
occasions, between February and
September 2014, Respondent either
issued a controlled substance
prescription to himself (lorazepam,
Schedule IV) or dispensed controlled
substances to himself (guaifenesin with
codeine, Schedule V; alprazolam 1 mg,
Schedule IV) with inadequate
documentation in the medical record.
26. On at least five additional
occasions, between February and
October 2014, Respondent issued his
family member, N.A., prescriptions for a
variety of controlled substances
(including Lunesta 3 mg, Schedule IV;
zolpidem tartrate 10 mg, Schedule IV;
alprazolam 1 mg, Schedule IV) with
inadequate documentation in the
medical record.
27. On at least one additional
occasion, between April and December
2014, Respondent issued a controlled
substance prescription (hydrocodone 10
mg/acetaminophen 650 mg (Lorcet),
formerly Schedule III) to family
member, G.A., and inadequately
documented that prescription and the
basis for it in G.A.’s medical record.
Improper Prescribing to Patients
28. On December 18, 2014 and July
31, 2015, pursuant to DEA
administrative subpoenas, Respondent
provided DEA with a copy of patient
records for certain patients, including
J.C., J.Cu., W.L., L.M., R.P., M.R., A.S.,
J.T., and J.V.
29. On ten occasions between May
and November 2012, Respondent issued
multiple overlapping prescriptions for
alprazolam 1 mg (Schedule IV) to his
patient, J.Cu., within days of issuing
previous prescriptions to J.Cu. for the
same controlled substance. For example,
in the course of 199 days in which, by
Respondent’s instructions, J.Cu. should
not have consumed more than 597
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
dosage units of Alprazolam 1 mg,
Respondent prescribed J.Cu. 1870
dosage units of Alprazolam 1 mg.
30. On five occasions between
October and November 2014,
Respondent issued multiple overlapping
prescriptions for controlled substances
(Tramadol 50 mg (Schedule IV),
Methylphenidate 20 mg (Schedule II),
and dextroamphetamine/amphetamine
20 mg (Schedule II)) to his patient, J.T.,
within days of issuing previous
prescriptions to J.T. for the same
controlled substances. In the course of
28 days in which, by Respondent’s
limited instructions, J.T. should not
have consumed more than 84 dosage
units of Tramadol 50 mg, Respondent
prescribed or dispensed to J.T. 540
dosage units of Tramadol. Likewise,
Respondent issued J.T. a prescription
for 90 tablets of Methylphenidate 20 mg
for a thirty day supply. Six days later
Respondent issued J.T. two additional
prescriptions for a total of 90 additional
tablets of Methylphenidate. On
November 15, 2014, Respondent issued
J.T. a prescription for 30 tablets of
Dextroamphetamine/Amphetamine 20
mg, a 15 day supply. Three days later,
Respondent issued J.T. another
prescription for 45 additional tablets of
the same controlled substance.
31. On four occasions between June
and October 2012, Respondent issued
multiple overlapping prescriptions for
alprazolam 1 mg to his patient, A.S.,
within days of issuing a previous
prescription to A.S. for the same
controlled substance. In the course of
133 days in which, by Respondent’s
limited instructions, A.S. should not
have consumed more than 399 dosage
units of Alprazolam 1 mg, Respondent
prescribed or dispensed to A.S. at least
780 dosage units of Alprazolam 1 mg.
32. On one occasion in October 2012,
Respondent issued an overlapping
prescription for alprazolam 1 mg
(Schedule IV) to his patient, M.R.,
within days of issuing a previous
prescription to M.R. for the same
controlled substance. In the course of 28
days in which, by Respondent’s
instructions, M.R. should have
consumed 42 dosage units of
Alprazolam 1 mg, Respondent
prescribed M.R. 150 dosage units of
Alprazolam 1 mg during that time
frame.
33. On eight occasions between
October and November 2014,
Respondent issued controlled substance
prescriptions (including Tramadol 50
mg (Schedule IV), methylphenidate 20
mg (Schedule II), and
dextroamphetamine/amphetamine 20
mg (Schedule II)) to his patient J.T.
without any documentation of those
E:\FR\FM\21FEN1.SGM
21FEN1
amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
prescriptions, or the bases for them, in
the patient’s medical record.
34. On seven occasions between July
2010 and July 2014, Respondent issued
controlled substance prescriptions
(Diazepam 5 and 10 mg (Schedule IV))
to his patient L.M. without any
documentation of those prescriptions, or
the bases for them, in the patient’s
medical record.
35. On six occasions between May
2012 and March 2013, Respondent
issued controlled substance
prescriptions (including
dextroamphetamine/amphetamine 20
mg and alprazolam 1 mg) to his patient
W.L. without any documentation of
those prescriptions, or the bases for
them, in the patient’s medical record.
36. On four occasions between May
2012 and February 2013, Respondent
issued controlled substance
prescriptions (including alprazolam 1
mg and phenobarbital 60 mg—both
Schedule IV) to his patient J.Cu. without
any documentation of those
prescriptions, or the bases for them, in
the patient’s medical record.
37. On four occasions between May
2011 and November 2013, Respondent
issued controlled substance
prescriptions (Hydrocodone 7.5 mg/
Ibuprofen 200 mg (Schedule III)) to his
patient R.P. without any documentation
of those prescriptions, or the bases for
them, in the patient’s medical record.
38. On four occasions between
November 2011 and March 2014,
Respondent issued controlled substance
prescriptions (alprazolam 1 mg
(Schedule IV) and Oxycodone 10 mg/
Acetaminophen 325 mg (Schedule III))
to his patient M.R. without any
documentation of those prescriptions, or
the bases for them, in the patient’s
medical record.
39. On at least one occasion in
December 2013, Respondent issued a
prescription for alprazolam 1 mg
(Schedule IV) to his patient J.C. without
any documentation of that prescription,
or the basis for it, in the patient’s
medical record.
40. On at least one occasion in
October 2012, Respondent issued a
prescription for alprazolam 1 mg
(Schedule IV) to his patient A.S.
without any documentation of that
prescription, or the basis for it, in the
patient’s medical record.
41. On five occasions between June
2012 and April 2013, Respondent
dispensed controlled substances
(alprazolam 1 mg (Schedule IV) and
hydrocodone 10 mg/acetaminophen 650
mg (Schedule III)) from his office supply
to his patient A.S. without any
documentation of those dispenses, or
VerDate Sep<11>2014
17:08 Feb 20, 2019
Jkt 247001
their bases, in the patient’s medical
record.
42. On two occasions between April
2011 and March 2014, Respondent
dispensed controlled substances
(alprazolam 1 mg (Schedule IV) and
hydrocodone 10 mg/acetaminophen 650
mg (Schedule III)) from his office supply
to his patient W.L. without any
documentation of those dispenses, or
their bases, in the patient’s medical
record.
43. On two occasions between
February 2012 and October 2012,
Respondent dispensed controlled
substances (hydrocodone 10 mg/
acetaminophen 650 mg (Schedule III))
from his office supply to his patient J.V.
without any documentation of those
dispenses, or their bases, in the patient’s
medical record.
44. On ten occasions between
September 2013 and March 2014,
Respondent issued controlled substance
prescriptions (dextroamphetamine/
amphetamine 20 mg and 30 mg
(Schedule II) and alprazolam 1 mg
(Schedule IV)) to his patient J.C. with
insufficient documentation of those
prescriptions, or the bases for them, in
the patient’s medical record.
45. On six occasions between April
2011 and March 2014, Respondent
issued controlled substance
prescriptions (dextroamphetamine/
amphetamine 20 mg) to his patient W.L.
with insufficient documentation of
those prescriptions, or the bases for
them, in the patient’s medical record.
46. On at least two occasions between
May 2012 and February 2013,
Respondent issued controlled substance
prescriptions (phenobarbital 60 mg
(Schedule IV) and alprazolam 1 mg
(Schedule IV)) to his patient J.Cu. with
insufficient documentation of those
prescriptions, or the bases for them, in
the patient’s medical record.
47. On at least two occasions between
February 2013 and July 2013,
Respondent issued controlled substance
prescriptions (diazepam 10 mg
(Schedule IV)) to his patient L.M. with
insufficient documentation of those
prescriptions, or the bases for them, in
the patient’s medical record.
48. On at least two occasions between
April 2012 and October 2012,
Respondent issued controlled substance
prescriptions (hydrocodone 10 mg/
acetaminophen 325 mg (Schedule III)
and on at least two occasions between
April 2012 and October 2012,
Respondent issued controlled substance
prescriptions (hydrocodone 7.5 mg/
ibuprofen 200 mg (Schedule III) and
hydrocodone 10 mg/acetaminophen 650
mg (Schedule III)) to his patient R.P.
with insufficient documentation of
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
5485
those prescriptions, or the bases for
them, in the patient’s medical record.
49. On at least two occasions between
May 2012 and October 2012,
Respondent issued controlled substance
prescriptions (oxycodone 7.5 mg/
ibuprofen 200 mg (Schedule III) and
alprazolam 1 mg (Schedule IV)) to his
patient M.R. with insufficient
documentation of those prescriptions, or
the bases for them, in the patient’s
medical record.
50. On two occasions in October 2014,
Respondent issued controlled substance
prescriptions (methylphenidate 20 mg
(Schedule II) and dextroamphetamine/
amphetamine 20 mg (Schedule II)) to his
patient J.T. with insufficient
documentation of those prescriptions, or
the bases for them, in the patient’s
medical record.
51. On 12 occasions between May and
November 2012, Respondent dispensed
controlled substances (hydrocodone 10
mg/acetaminophen 650 mg (Schedule
III) and alprazolam 1 mg (Schedule IV))
from his office supply to his patient
J.Cu. with insufficient documentation of
those dispenses, or the bases for them,
in the patient’s medical record.
52. On 12 occasions between May
2010 and July 2013, Respondent
dispensed a controlled substance
(hydrocodone 10 mg/acetaminophen
650 mg (Schedule III)) from his office
supply to his patient J.V. with
insufficient documentation of those
dispenses, or the bases for them, in the
patient’s record.
53. On nine occasions between May
2011 and November 2013, Respondent
dispensed controlled substances
(hydrocodone 7.5 mg/ibuprofen 200 mg
(Schedule III), hydrocodone 7.5 mg/
acetaminophen 650 mg, and guaifenesin
with codeine (Schedule V)) from his
office supply to his patient R.P. with
insufficient documentation of those
dispenses, or the bases for them, in the
patient’s medical record.
54. On seven occasions between April
2011 and July 2013, Respondent
dispensed controlled substances
(hydrocodone 10 mg/acetaminophen
650 mg and alprazolam 1 mg) from his
office supply to his patient W.L. with
insufficient documentation of those
dispenses, or the bases for them, in the
patient’s medical record.
55. On two occasions between June
2013 and March 2014, Respondent
dispensed a controlled substance
(alprazolam 1 mg (Schedule IV)) from
his office supply to his patient M.R.
with insufficient documentation of
those dispenses, or the bases for them,
in the patient’s medical record.
56. On at least two occasions between
October 2012 and April 2013,
E:\FR\FM\21FEN1.SGM
21FEN1
5486
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
Respondent dispensed a controlled
substance (alprazolam 1 mg) from his
office supply to his patient A.S. with
insufficient documentation of those
dispenses, or the bases for them, in the
patient’s medical record.
57. On at least one occasion between
September 2013 and March 2014,
Respondent dispensed a controlled
substance (alprazolam 1 mg (Schedule
IV)) from his office supply to his patient
J.C. with insufficient documentation of
those dispenses, or the bases for them,
in the patient’s medical record.
Accordingly, the Respondent
stipulated to a majority of the facts
alleged by the Government in the OSC.
However, the Respondent did not
stipulate to the factual allegations:
concerning prescribing to himself and
his family members; concerning his
failure to maintain adequate security;
and concerning his other conduct which
may have threatened the public health
and safety.
FINDINGS OF FACT 12
amozie on DSK3GDR082PROD with NOTICES1
I. Respondent’s Background
1. The Respondent was born and
raised in New Delhi, India. Tr. 211. As
a child, the Respondent spoke Hindi,
Punjabi, and a little English at home
with his family. Tr. 211.
2. The Respondent earned his college
degree in 1971 from the College of
Sciences in New Delhi. Tr. 211.
Subsequently, the Respondent went to
medical school at the Maulana Azad
Medical College in New Delhi, and
graduated in 1977. Tr. 211-12.
3. In April of 1979, the Respondent
came to the United States. Tr. 212.
4. Once in the United States, the
Respondent took a three-month course
to prepare to take the Educational
Commission for Foreign Medical
Graduates exam, to have his medical
degree recognized in the United Sates.
Tr. 212. The Respondent passed this
exam in July of 1979. Tr. 213.
5. In July 1980, the Respondent began
an internship at LaGuardia Hospital in
Forest Hills, New York. Tr. 213.
6. After his internship, the
Respondent finished his residency at
Andover Hospital in 1984. Tr. 213. The
Respondent specialized in internal
medicine. Tr. 213.
7. The Respondent was licensed to
practice medicine in the State of
Connecticut in January 1985. Tr. 214.
12 The extensive and detailed stipulations of fact
essentially establish the factual bases for most of the
allegations contained in the OSC. It is, therefore,
unnecessary to make additional findings of fact
based upon my independent review of documentary
evidence and my evaluation of the credible
testimony, where those findings would essentially
duplicate the stipulations of fact.
VerDate Sep<11>2014
17:08 Feb 20, 2019
Jkt 247001
8. After being licensed, the
Respondent worked at a ‘‘walk-in’’
medical clinic in Danbury, Connecticut.
Tr. 214.
9. In 1988, the Respondent opened the
Immediate Medical Care Center, which
he still owns and where he maintains
his medical practice. Tr. 215.
II. The 2014 Investigation
10. [P.L.] began investigating the
Respondent after she received
information from a probation officer
who had concerns about the
Respondent’s prescribing habits. Tr. 51.
[P.L.] ran a report using Connecticut’s
prescription monitoring and reporting
system (‘‘PMP’’) to review the
Respondent’s prescribing habits and she
identified prescriptions suggestive of
‘‘early refills or duplicate therapy.’’ Tr.
51. [P.L.] also contacted the DEA, [M.J.],
because of the controlled substances
involved. Tr. 52, 81. At this point, it was
a joint investigation between the DEA
and the State of Connecticut. Tr. 52-53.
11. Pharmacies in Connecticut are
required to submit information into the
PMP when they fill a prescription. Tr.
73. In addition, when a doctor dispenses
a controlled substance, the doctor is
required to report that event to the PMP
within 24 hours. Tr. 18, 30-31. When
[P.L.] ran the Respondent’s PMP, it
should have shown ‘‘all prescriptions
that have been filled by pharmacies
uploaded into the PMP under [the
Respondent] as the prescriber,’’ as well
as any controlled substances the
Respondent had dispensed and
reported. Tr. 73-74. Administering a
controlled substance directly to the
patient would not show up on the PMP,
but dispensing the substance to the
patient to take home would show up on
the PMP—if properly reported. Tr. 7576.
12. [P.L.] and [M.J.] went through the
Respondent’s PMP report and then
collected copies of prescriptions the
Respondent had written from the
pharmacies that filled the prescriptions.
Tr. 51, 54, 62-63.
13. [M.J.] also pulled data from the
Automation of Reports and
Consolidated Orders System
(‘‘ARCOS’’). Tr. 83. ARCOS is a DEA
system where manufacturers and
distributors report purchases of specific
controlled substances by a registrant. Tr.
83-84.
14. Although the ARCOS records
indicated that the Respondent had
obtained controlled substances, the PMP
report did not indicate that he had
dispensed any. Tr. 81, 139.
15. On the morning of January 31,
2014, [M.J.] and [P.L.] arrived,
unannounced, at the Respondent’s
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
clinic to speak with him. Tr. 55-56, 83,
117. When they arrived, the only other
employee at the Respondent’s clinic was
his secretary. Tr. 77. Because the
Respondent was busy with patients, he
asked [M.J.] and [P.L.] if they could talk
later that day when another physician
would be in the office to see patients.
Tr. 55, 117, 254-55. When [M.J.] and
[P.L.] came back later in the day on
January 31, 2014, another physician was
present. Tr. 78.
16. When [P.L.] and [M.J.] returned to
the Respondent’s office on January 31,
2014, they asked the Respondent if he
prescribed to his family members. Tr.
55, 86. The Respondent indicated he
mostly did not, ‘‘because he did not
want to take the responsibility if
something went wrong.’’ Tr. 55-56; see
also Tr. 70, 87. When [P.L.] showed the
Respondent the prescriptions written for
family members, the Respondent
verified that he wrote the prescriptions.
Tr. 56. When [M.J.] and [P.L.] asked the
Respondent if he had copies of patient
files for his family members the
Respondent said he did not. Tr. 56, 87.
17. On January 31, 2014, [M.J.] and
[P.L.] advised the Respondent of the
requirement to conduct a biennial
inventory and about the security of
controlled substances. Tr. 84-85, 118.
18. On January 31, 2014, [M.J.] and
[P.L.] asked the Respondent to sign an
agreement stating that he would no
longer treat his family members, but he
refused to do so. Tr. 56.
19. The Respondent refused to allow
[M.J.] and [P.L.] to conduct an audit of
the controlled substances he had in his
clinic on January 31, 2014, and he
denied their request to conduct an
inspection. Tr. 56, 87, 93-94, 117.
20. On January 31, 2014, the
Respondent told [M.J.] and [P.L.] that he
was not aware that alprazolam, a
benzodiazepine, was being abused or
diverted. Tr. 55, 87; see also Tr. 238,
253, 268-69.
21. On February 21, 2014, [M.J.],
[P.L.], DI [J.H.], and two Stanford police
officers, arrived at the Respondent’s
clinic to execute an Administrative
Investigation Warrant (‘‘AIW’’) in order
to collect records and to perform a count
of the Respondent’s controlled
substances. Tr. 59-60, 94.
22. [M.J.] served the Respondent with
the warrant on February 21, 2014, and
he was not cooperative initially. Tr. 60,
94-95. [J.H.], one of the police officers,
and the Respondent’s secretary,
encouraged the Respondent to comply
with the warrant. Tr. 60, 94-95.
23. On February 21, 2014, [M.J.]
attempted to conduct an audit of the
Respondent’s controlled substances, but
was unable to do so because there was
E:\FR\FM\21FEN1.SGM
21FEN1
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
no biennial inventory. Tr. 96. Instead,
[M.J.] performed a closing count and the
investigators collected what records
they were able to from the Respondent,
including some dispensing logs and
what the Respondent called his
medication log. Tr. 96-97.
III. Recordkeeping & PMP
Requirements
24. There were recordkeeping issues
in the Respondent’s practice prior to
February 2014. Tr. 224.
25. After reviewing the documents
that [M.J.] and [P.L.] were able to obtain
during the execution of the AIW on
February 21, 2014, they were able to
identify some problem patients, review
their data, and request their records. Tr.
102-03.
26. Prior to April 2014, the
Respondent had never logged onto the
PMP system. Tr. 102. Although there is
nothing in the Code of Federal
Regulations (‘‘CFR’’) that specifically
requires a physician to check the PMP
records, Tr. 103, federal law requires a
practitioner to comply with state law.13
Tr. 103.
27. In Connecticut, a practitioner is
required to notify the state of his intent
to dispense controlled substances.
Conn. Gen. Stat. § 20-14f; Tr. 19.
28. After the Respondent stopped
dispensing controlled substances, he no
longer had an obligation to report that
he intended to dispense controlled
substances. Tr. 25.
29. Respondent Exhibit D is a ‘‘Record
of Surrender or Disposal’’ issued by the
State of Connecticut—Department of
Consumer Protection, Drug Control
Division. RE-D. The record is signed by
the Respondent, [R.M.], and [N.C.], and
it documents the controlled substances
that were received from the
Respondent’s clinic on March 4, 2016.
Tr. 21, 40; RE-D.
30. Even if the Respondent is no
longer dispensing controlled substances,
it would still be considered a state
violation in 2017 if the Respondent
failed to report dispensing controlled
substance to the state that occurred in
2014. Tr. 29.
IV. Security
amozie on DSK3GDR082PROD with NOTICES1
31. The purpose of requiring that a
storage cabinet be substantially secure is
13 In determining whether the continued
registration is in the public interest, federal law
requires the consideration of the respondent’s
compliance with applicable state, federal, or local
laws related to controlled substances. 21 U.S.C.
§ 823(f)(4) (‘‘Factor Four’’). The DEA has found that
a respondent’s failure to report various dispensings
to the state’s PMP, in violation of that state’s law,
was a violation under Factor Four. See Keith Ky Ly,
D.O., 80 Fed. Reg. 29025, 29035 (2015).
VerDate Sep<11>2014
17:08 Feb 20, 2019
Jkt 247001
to prevent the theft or diversion of
controlled substances. Tr. 123.
32. The Respondent stored all of his
controlled and non-controlled
substances in the same location.14 Tr.
57.
33. Prior to [M.J.] and [P.L.]’s arrival
at the Respondent’s office on January
31, 2014, the Respondent kept his
controlled substances in an unlocked
closet, with a louvered door, located in
a locked unused patient care room. Tr.
57-58, 65-66, 85-86, 229, 232, 301-03.
34. The Respondent stored unused
medical equipment, valued at
approximately $150,000, in the unused
locked examination room, where he also
stored his controlled substances. Tr.
229-30.
35. On February 21, 2014, the
controlled substances were in the same
unlocked closet as they were when
[M.J.] and [P.L.] visited the Respondent
on January 31, 2014. Tr. 60-61, 95, 232.
36. The Respondent did not order any
additional controlled substances after
the investigators came to visit him. Tr.
231.
37. The Respondent ‘‘set up a lock in
the closet’’ because the investigators
asked him to do so. Tr. 231-32; see also
Tr. 36, 40.
38. When [R.M.] came to the
Respondent’s clinic on March 4, 2016,
he does not remember if the
Respondent’s controlled substances
were locked in a cabinet. Tr. 22.
39. When [R.M.] and [N.C.] arrived at
the Respondent’s clinic on March 4,
2016, to retrieve the Respondent’s
expired controlled substances, the closet
where the controlled substances were
stored was not locked. Tr. 36-37, 41.
The door to the unused examination
room was closed, but [N.C.] does not
recall if it was locked. Tr. 42, 46-47.
40. The Respondent denies that he
failed to maintain adequate security of
the controlled substances in his
possession. Tr. 268; 301.
V. Prescribing to Self and Family
41. Concerning the allegation of
therapeutic duplication, the Respondent
knew that the patient would not take the
two medications at the same time
because the patient was his own son,
N.A. Tr. 266-67. N.A. came to the
Respondent and told him that the
medication he was currently taking was
not working and asked the Respondent
14 At the hearing, [P.L.] testified that storing
controlled and non-controlled substances in the
same location was a separate violation of
regulations. Tr. 57. This allegation, however, was
never raised in the OSC or in any of the
Government’s prehearing or post-hearing filings.
See ALJ-1; ALJ-13; ALJ-30. Therefore, I give no
weight to this testimony.
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
5487
if he could prescribe something else. Tr.
267. N.A. lived with the Respondent. Tr.
267.
42. The Respondent wrote
prescriptions for controlled substances
to either himself or to family members,
N.A. or U.A., at least 14 times between
June 2012 and December 2014 without
any documentation of those
prescriptions or any bases for those
prescriptions in any medical records.
Tr. 56, 87, 161-63, 267-68; GE-11, GE13-23, GE-25-31.
43. Government Exhibit 8 is a
prescription for Percocet written by the
Respondent to patient D.M. on
November 23, 2013. Tr. 92, 225; GE-8.
D.M. is the Respondent’s patient. Tr.
225. When the pharmacy filled this
prescription, it was issued to the
Respondent, rather than to D.M. Tr. 92;
GE-8.
44. D.M.’s patient file does not
contain an entry on November 23, 2013.
Tr. 93.
45. The prescription written to D.M.
is for Percocet, which contains
oxycodone. Tr. 226; GE-8. The
Respondent cannot take oxycodone. Tr.
226-27.
VI. Dr. Perrin’s Testimony
46. Physicians who write
prescriptions and dispense controlled
substances in Connecticut are subject to
regulatory review. Tr. 153.
47. Dr. Perrin’s testimony regarding
inadequate documentation was based on
his review of the patient files of the
Respondent’s patients, to include those
of the Respondent’s family. Tr. 156, 20102.
48. Suboxone is a synthetic opioidbased medication that is primarily used
to treat patients who are addicted to
opioids. Tr. 154, 198.15
49. Alprazolam is a Schedule IV
controlled substance and is classified as
a benzodiazepine. Tr. 154.
50. According to Centers for Disease
Control and Prevention guidance,
prescribing opioids and
benzodiazepines in conjunction with
each other ‘‘should be avoided because
the combination can be potentially very
dangerous in terms of overdose and
addictive potential.’’ Tr. 155. The
rationale being that ‘‘[w]hen you
combine those two substances, they can
be significantly over-sedating’’ and put
the patient at a ‘‘higher risk for
overdose.’’ Tr. 199.
51. Government Exhibit 18 is a
prescription for Lunesta, indicating five
refills, issued by the Respondent to N.A.
15 Although Dr. Perrin testified that Suboxone is
a Schedule II substance, Tr. 154, it is in fact listed
in Schedule III. 21 C.F.R. § 1308.13(e)(2)(i).
E:\FR\FM\21FEN1.SGM
21FEN1
amozie on DSK3GDR082PROD with NOTICES1
5488
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
on February 24, 2014. GE-18; Tr. 157.
Lunesta is a sedative hypnotic agent that
is used to treat insomnia. Tr. 156-57.
52. Government Exhibit 19 is a
prescription for Ambien, with five
refills, issued by the Respondent to N.A.
on March 5, 2014. GE-19; Tr. 157.
Ambien is also a sedative hypnotic used
to treat insomnia. Tr. 156-57.
53. Government Exhibit 19 is an
overlapping prescription with
Government Exhibit 18. Tr. 157.
54. The combination of prescriptions
Lunesta and Ambien constitutes
therapeutic duplication. Tr. 157.
55. In the Respondent’s patient file for
N.A., there is a notation, dated March 5,
2014, that ‘‘Luntesta doesn’t help
changed to Ambien 10 mg #30.’’ GE-11,
at 7. In Dr. Perrin’s opinion, this
notation is not sufficient to justify the
therapeutic duplication. Tr. 158-59.
Therapeutic duplication can be
dangerous if one prescription is not
discontinued in favor of the other. Tr.
159. Dr. Perrin explained that ‘‘[i]t has
to be carefully explained not to mix’’
and that ‘‘[i]deally we like to dispose of
the prior prescription’’ and have that
noted in the patient file. Tr. 159.
56. The Respondent’s practice of
issuing overlapping prescriptions of
controlled substances for himself, a
family member, and other patients fell
below the standard of care in
Connecticut. Tr. 164-65, 169-73, 203-04;
Stip. of Fact 24, 29-32. Issuing
‘‘overlapping prescriptions . . . could
pose potential harm if taken
simultaneously for . . . those who don’t
know to take it properly.’’ Tr. 165.
Additionally, ‘‘it’s a cumulative effect of
too much of a potentially sedating
medication that also has addictive
potential.’’ Tr. 165.
57. Overlapping prescriptions
increase the potential for diversion
because of the additional controlled
substances floating around. Tr. 207.
58. Issuing early refills is not a
legitimate medical practice in the State
of Connecticut. Tr. 165.
59. There is no law or regulation in
the State of Connecticut that prohibits a
doctor from self-proscribing. Tr. 194,
206. According to the American Medical
Association (‘‘AMA’’), however, it is
considered an ‘‘ethical violation’’ to
self-prescribe controlled substances. Tr.
166, 194. The AMA ethical rules do not
automatically set the standard of care.
Tr. 194. Additionally, there are
exceptions in the AMA rule to selfprescribing, including short-term
treatment or minor problems. Tr. 195.
60. The Respondent’s practice of
issuing a controlled substance
prescription to himself or his family
members, or dispensing a controlled
VerDate Sep<11>2014
17:08 Feb 20, 2019
Jkt 247001
substance to himself or his family
members, however, without adequate
documentation in the medical record is
below the standard of care in the State
of Connecticut. Stip. of Fact 25-27; Tr.
166. With any prescription of a
controlled substance, it is ‘‘important to
provide adequate documentation as to
the precise reason for why [the]
particular substance is indicated.’’ Tr.
166. There needs to be ‘‘an appropriate
diagnosis that underlies the prescribing
of said substance, and [there] has to be
documentation that’s beyond cursory to
substantiate the choice of prescribing
said substance.’’ Tr. 166.
61. Where a patient’s medical record
does not contain adequate
documentation to explain the reason for
prescribing a highly addictive
controlled substance there is no
legitimate medical purpose for the
prescription.16 Tr. 202. Thus, the
Respondent’s practice of issuing
controlled substance prescriptions or
dispensing controlled substances from
his office supply, to patients without
adequate documentation, or bases for
the prescription or dispensing in the
patient’s medical record fell below the
standard of care in the State of
Connecticut and were not issued or
dispensed for a legitimate medical
purpose. Tr. 167-69, 173, 179-81; Stip.
of Fact 25-27, 33-57.
VII. Acceptance of Responsibility
62. The Respondent admitted to most
of the factual allegations contained in
the COR, but he refused to answer the
questions regarding whether his actions
were either below the standard of care
or outside the course of professional
practice. Tr. 264-66; see also Stip. of
Fact 4-57.
63. The Respondent denied that he
had issued overlapping prescriptions to
N.A. in a manner that constituted
therapeutic duplication. Tr. 267.
64. The Respondent denied that he
failed to maintain adequate security of
his controlled substances, as alleged in
paragraph 10 of the OSC. Tr. 268. The
Respondent admitted to most of factual
allegations contained in paragraph 10 of
the OSC, but he denies that the room
where the controlled substances were
kept in an unlocked closet was
unlocked. Tr. 302-03.
65. The Respondent denies that he
made any statement suggesting that his
‘‘dispensing of ‘benzos’ was not worthy
of DEA investigation, particularly given
how other doctors in [his] community
16 While Dr. Perrin’s testimony on this issue
focused on Stip. of Fact 30, I find the reasoning
applicable to situations where there is inadequate
documentation of the need to prescribe a controlled
substance.
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
were distributing Schedule II controlled
substances,’’ as alleged in paragraph
11(a) of the OCS. ALJ-1, at 11; Tr. 26869.
66. The Respondent denies the
allegations contained in paragraph 11(b)
of the OSC, alleging that he attempted
to mislead the DEA during its
investigation. Tr. 269.
Additional facts required to resolve
the issues in this case are included in
the Analysis section of this
Recommended Decision.
ANALYSIS
To revoke a respondent’s registration,
the Government must prove, by a
preponderance of the evidence, that the
regulatory requirements for revocation
are satisfied. Steadman v. SEC, 450 U.S.
91, 100-02 (1981); 21 C.F.R.
§ 1301.44(e). Under 21 U.S.C.
§ 824(a)(4), the DEA may revoke a
registrant’s COR if the registrant acted in
a way that renders continued
registration ‘‘inconsistent with the
public interest.’’ The DEA considers the
following five factors to determine
whether continued registration is in the
public interest:
(1) The recommendation of the
appropriate State licensing board or
professional disciplinary authority.
(2) The [registrant’s] experience in
dispensing, or conducting research with
respect to controlled substances.
(3) The [registrant’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. 21
U.S.C. § 823(f) (2012).
These public interest factors are
considered separately. See Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003).
Each factor is weighed on a case-by-case
basis. Morall v. DEA, 412 F.3d 165, 17374 (D.C. Cir. 2005). Any one factor, or
combination of factors, may be decisive.
David H. Gillis, M.D., 58 FR 37507,
37508 (1993). Thus, there is no need to
enter findings on each of the factors.
Hoxie v. DEA, 419 F.3d 477, 482 (6th
Cir. 2005). Further, there is no
requirement to consider a factor in any
given level of detail. Trawick v. DEA,
861 F.2d 72, 76-77 (4th Cir. 1988). When
deciding whether registration is in the
public interest, the totality of the
circumstances must be considered. See
generally Joseph Gaudio, M.D., 74 FR
10083 (2009).
The Government bears the initial
burden of proof, and must justify
revocation by a preponderance of the
E:\FR\FM\21FEN1.SGM
21FEN1
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
amozie on DSK3GDR082PROD with NOTICES1
evidence. Steadman, 450 U.S. at 100-03.
If the Government presents a prima
facie case for revocation, the burden of
proof shifts to the registrant to show that
revocation would be inappropriate.
Med. Shoppe-Jonesborough, 73 FR 364,
387 (2008). A registrant may prevail by
successfully attacking the veracity of the
Government’s allegations or evidence.
Alternatively, a registrant may rebut the
Government’s prima facie case for
revocation by accepting responsibility
for wrongful behavior and by taking
remedial measures to ‘‘prevent the reoccurrence of similar acts.’’ Jeri
Hassman, M.D., 75 FR 8194, 8236
(2010). In addition, when assessing the
appropriateness and extent of
sanctioning, the DEA considers the
egregiousness of the offenses and the
DEA’s interest in specific and general
deterrence. David A. Ruben, M.D., 78 FR
38363, 38385 (2013).
I. The Government’s Position
Here, the Government seeks to revoke
the Respondent’s COR based on Factors
Two, Four, and Five. Post-Hearing Brief
on Behalf of the Government (‘‘Gov’t
Brief’’).17 ALJ-37 at 19-22. With regard
to Factors Two and Four, the
Government argues that the
Respondent’s ‘‘repeated failure to
comply with Federal and State laws
relating to the prescribing, dispensing,
and recordkeeping of controlled
substances strongly militate in favor of
revocation . . . .’’ Id. at 19. The
Government notes that the Respondent:
dispensed overlapping prescriptions at
least 22 times; issued prescriptions to
family members at least 27 times
without adequate medical
documentation in their medical records;
issued 35 prescriptions for controlled
substances to non-family members
without any medical documentation;
dispensed controlled substances at least
9 times to non-family members without
any medical documentation, and an
additional 71 times without adequate
documentation. Id. at 20-21. The
Government contends that these
prescriptions and the dispensing of
controlled substances were not for
legitimate medical purposes, and were
outside the usual course of professional
treatment. Id. at 19.
The Government also points to the
numerous recordkeeping violations that
the Respondent committed. Those
violations resulted in the Respondent
being unable to account for thousands of
dosages of controlled substances. Id. at
21. The Government notes that ‘‘careless
recordkeeping is sufficient grounds unto
17 The Post-Hearing Brief on Behalf of the
Government has been marked as ALJ-37.
VerDate Sep<11>2014
18:03 Feb 20, 2019
Jkt 247001
itself for the Administrator to revoke
Respondent’s COR.’’ Id.
With respect to Factor Five, the
Government argues that the
Respondent’s lack of candor supports
revocation. Id. at 22. Specifically, the
Government argues that the
Respondent’s initial denial of having
any family medical files, and then his
later producing them, suggests that the
Respondent created the files ‘‘to thwart
DEA’s investigation.’’ Id. The
Government also argues that the
Respondent was less than candid during
his testimony on cross-examination,
when he ‘‘was forced to admit that he
had previously testified differently.’’ Id.
at 23.
The Government also contends that
the Respondent has not accepted
responsibility for his conduct, and
therefore any remediation he has taken
is irrelevant. Id. at 23-26. In addition,
the Government seeks an adverse
inference that the Respondent did not
accept responsibility for his actions
based upon the Respondent’s refusal to
answer questions of whether his actions
fell below the standard of care or were
outside the course of professional
practice. Id. at 26-27. Finally, the
Government also argues that even if the
Respondent had accepted responsibility
his actions were so egregious that
revocation of his COR would be
appropriate in this case. Id. at 27-28.18
II. The Respondent’s Position
In the Respondent’s Proposed
Findings of Fact and Conclusions of
Law 19 (‘‘Resp’t Brief’’), the Respondent
argues that the public interest factors,
when viewed in their totality, weigh in
favor of his continued registration. ALJ38, at 17. Initially, the Respondent
argues that the Government’s failure to
present any evidence of action by the
State of Connecticut against his medical
license or evidence of any conviction of
the Respondent weigh in favor of his
continued registration. Id. at 17-18.
Further, while the Respondent
acknowledges past dispensing issues, he
notes that he no longer dispenses
controlled substances and he
voluntarily surrendered all of his
18 The
Government did not address two
significant issues in its Post Hearing Brief. First, the
Government provided no analysis to support its
allegation that the Respondent had failed to
maintain adequate security of his controlled
substances. Second, the Government’s brief is silent
concerning its allegation, under Factor Five, that
the Respondent’s statement to DEA investigators
that he did not understand why they were
concerned about ‘‘benzos’’ constitutes conduct
which may threaten the public health and safety.
19 The Respondent’s Proposed Findings of Fact
and Conclusions of Law have been marked as ALJ38.
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
5489
controlled substances. Id. at 18. He
argues that such action ‘‘supports a
finding that his continued registration is
consistent with the public interest at
this time.’’ Id. at 18.
The Respondent also contends that
the Government failed to meet its
burden of proof with respect to:
paragraph 7(b) of the OSC concerning
his issuance of overlapping
prescriptions to a family member in a
manner that constituted therapeutic
duplication; paragraph 7(c) of the OCS,
concerning writing a prescription for
oxycodone to himself; 20 and paragraph
10 of the OSC concerning whether he
maintained adequate security of his
controlled substances. ALJ-38, at 19-22.
With respect to Factor Five, the
Respondent contends that he did not
engage in other misconduct that may
threaten the public health and safety. Id.
at 22-25. Specifically, he contends that
the statements he made to [M.J.] and
[P.L.] comparing the relative dangers of
schedule II controlled substances when
compared to schedule IV controlled
substances does not ‘‘rise to the level of
creating even a possible threat to public
health and safety.’’ Id. at 23. The
Respondent also denies the allegations
contained in paragraph 11(b) of the
OSC, because the testimony does not
support a conclusion that the
Respondent told the investigators that
he did not write prescriptions to family
members.21
The Respondent asserts that through
his testimony, and by entering into 57
stipulations of fact, he has accepted
responsibility for his actions. ALJ-38, at
25-27. The Respondent also asserts that
his refusal to answer questions about
whether his actions fell below the level
of care or were outside the usual course
of professional practice does not negate
his acceptance of responsibility. Id. at
26. He argues that the few questions he
declined to answer called for legal
conclusions, but that he unequivocally
accepted responsibility for his actions.
Id. Finally, the Respondent notes that he
has taken the following remedial
measures: the Respondent has taken
numerous continuing medical education
20 Paragraph 7(c) of the OSC does not mention
any specific controlled substance; rather it alleges
that the Respondent issued prescriptions for
controlled substances to himself and family
members without any documentation of those
prescriptions being placed in his medical record or
the records of family members. Of note, at the
hearing, the Respondent testified that the facts
alleged in paragraph 7(c) of the OSC are true. Tr.
267-68.
21 The Resp’t Brief does not address the
allegation, also contained in paragraph 11(b), that
the Respondent told the investigators that he did
not have any patient files for his family members,
but then later provided those records. ALJ-1, at 11.
E:\FR\FM\21FEN1.SGM
21FEN1
5490
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
amozie on DSK3GDR082PROD with NOTICES1
courses; the Respondent has
incorporated what he learned in the
courses into his current daily medical
practice; the Respondent has
discontinued dispensing controlled
substances; and the Respondent no
longer prescribes or dispenses
controlled substances to himself or
family members. Id. at 27–30.
Accordingly, the Respondent argues
that, due to his acceptance of
responsibility and the remedial actions
he has taken, revocation of his COR is
not appropriate at this time. Id. at 31.
Factors One & Three: The
Recommendation of the Appropriate
State Licensing Board or Professional
Disciplinary Authority, and Conviction
Record Under Federal or State Laws
Relating to the Manufacture,
Distribution, or Dispensing of
Controlled Substances
In this case, it is undisputed that the
Respondent holds a valid and current
state license to practice medicine in
Connecticut. The record contains no
evidence of a recommendation
regarding the Respondent’s medical
privileges by a relevant state licensing
board or professional disciplinary
authority. However, possession of a
state license does not entitle a holder of
that license to a DEA registration. Mark
De La Lama, P.A., 76 FR 20011, 20018
(2011). Rather, a state medical board’s
decision to allow a doctor to practice
medicine is not dispositive as to
whether the doctor’s DEA registration is
consistent with the public interest.
Patrick W. Stodola, M.D., 74 FR 20727,
20730 n.16 (2009).
The Respondent argues that the lack
of state board action weighs against
revocation. ALJ-38, at 17-18. Agency
precedent, however, establishes that
where the record contains no evidence
of a recommendation by a state
licensing board that absence does not
weigh for or against revocation. See
Roni Dreszer, M.D., 76 FR 19434, 19444
(2011) (‘‘The fact that the record
contains no evidence of a
recommendation by a state licensing
board does not weigh for or against a
determination as to whether
continuation of the Respondent’s DEA
certification is consistent with the
public interest.’’) Accordingly, Factor
One does not weigh for or against
revocation in this matter.
As to Factor Three, there is no
evidence that Respondent has been
convicted of an offense under either
federal or Connecticut law ‘‘relating to
the manufacture, distribution, or
dispensing of controlled substances.’’ 21
U.S.C. 823(f)(3). However, there are a
number of reasons why even a person
VerDate Sep<11>2014
19:03 Feb 20, 2019
Jkt 247001
records and logs, see 21 CFR 1304.21(a)
and 1304.22(c); (2) maintain receipt
records for all controlled substances
received, see 21 CFR 1304.04(a) and
1304.21(a); (3) maintain records of
controlled substances listed in
Schedules III–V, separate from other
records, see 21 CFR 1304.04(f)(2); and
(4) perform and maintain a biennial
inventory, see 21 CFR 1304.11(c). Such
recordkeeping is one of the central
features of the Controlled Substances
Act (‘‘CSA’’) because ‘‘a registrant’s
accurate and diligent adherence to this
obligation is absolutely essential to
Factors Two and Four: The
protect against the diversion of
Respondent’s Experience in Dispensing
controlled substances.’’ Superior
Controlled Substances and Compliance
Pharmacy I & Superior Pharmacy II, 81
With Applicable State, Federal, or
FR 31310, 31337 (2016) (quoting
Local Laws Relating to Controlled
Volkman, 73 FR at 30644). The Supreme
Substances
Court has noted that ‘‘[t]he CSA and its
Factors Two and Four are often
implementing regulations set forth strict
analyzed together. See, e.g., Fred
requirements regarding . . .
Samimi, M.D., 79 FR 18698, 18709
recordkeeping.’’ Gonzales v. Raich, 545
(2014); John V. Scalera, M.D., 78 FR
U.S. 1, 14 (2005). However, the DEA has
12092, 12098 (2013). Under Factor Two, also held that, where non-egregious
the DEA analyzes a registrant’s
recordkeeping errors are acknowledged
‘‘experience in dispensing . . .
and remedied promptly, revocation may
controlled substances.’’ 21 U.S.C.
not always be required. See Terese, Inc.,
823(f)(2). Factor Two analysis focuses
D/B/A Peach Orchard Drugs, 76 FR
on an applicant’s acts that are
46843, 46848 (2011).
inconsistent with the public interest,
First, the Government alleged that the
rather than on an applicant’s neutral or
Respondent failed to maintain accurate
positive acts and experience. Randall L. dispensing records and logs, in violation
Wolff, M.D., 77 FR 5106, 5121 n.25
of 21 U.S.C. 827(a)(3), 21 CFR
(2012) (explaining that ‘‘every registrant 1304.21(a) and 1304.22(c), and Conn.
can undoubtedly point to an extensive
Agencies Regs. § 21a–326–1(d)(2), (6).
body of legitimate prescribing over the
ALJ-1, at 2–3. The Respondent,
course of [the registrant’s] professional
however, stipulated to numerous facts
career’’) (quoting Jayam Krishna-Iyer,
that establish by a preponderance of the
M.D., 74 FR 459, 463 (2009)). Similarly,
evidence that he repeatedly failed to
under Factor Four, the DEA analyzes an maintain accurate dispensing records
applicant’s compliance with federal and and logs. Stip. of Fact 4-11.
state controlled substance laws. 21
Accordingly, the Government’s
U.S.C. 823(f)(4). Factor Four analysis
allegations that the Respondent failed to
focuses on violations of state and federal maintain accurate dispensing records
and logs, as alleged in paragraphs 4(b),
laws and regulations. Volkman v. DEA,
4(d), and 4(f) of the OSC, are
567 F.3d 215, 223-24 (6th Cir. 2009)
SUSTAINED and weigh in favor of
(citing Gonzales v. Oregon, 546 U.S.
revocation of the Respondent’s DEA
243, 272, 274 (2006)); see Joseph
registration.
Gaudio, M.D., 74 FR 10083, 10090-91
Second, the Government alleged that
(2009).
the Respondent failed to maintain
Here, the Government alleges that
controlled substance receipts for orders
revocation of the Respondent’s COR is
of controlled substances, in violation of
appropriate under Factors Two and
21 U.S.C. 842(a)(5), 21 CFR 1304.04(a)
Four for four reasons: (1) improper
recordkeeping; (2) improper prescribing and 1304.21(a), Conn. Gen. Stat. § 21a254(c), and Conn. Agencies Regs. § 21ato himself and family members; (3)
improper prescribing to patients; and (4) 326-1(d)(2), (6). ALJ-1, at 3-4. Here, too,
the Respondent stipulated to numerous
failure to maintain adequate security.
facts that established by a
ALJ-1, 13, 30, 37.
preponderance of the evidence that he
I. Improper Recordkeeping
repeatedly failed to maintain controlled
Registrants are required to keep
substance receipts for orders of
certain records and inventories of their
controlled substances that he received
controlled substances. Paul H. Volkman, in his office. Stip. of Fact 12–18.
Accordingly, the Government’s
M.D., 73 FR 30630, 30644 (2008).
allegations that the Respondent failed to
Among those requirements, registrants
are to: (1) maintain adequate dispensing maintain controlled substance receipts
who has engaged in criminal
misconduct may never have been
convicted of an offense or even
prosecuted for one. Dewey C. MacKay,
M.D., 75 Fed. Reg 49956, 49973 (2010),
pet. for rev. denied, MacKay v. DEA, 664
F.3d 808, 822 (10th Cir. 2011). The
Agency has, therefore, held that ‘‘the
absence of such a conviction is of
considerably less consequence in the
public interest inquiry’’ and is therefore
not dispositive. Id. Accordingly, Factor
Three neither weighs for or against
revocation in this case.
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
E:\FR\FM\21FEN1.SGM
21FEN1
amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
for orders of controlled substances, as
alleged in paragraphs 4(i)–4(o) of the
OSC, are SUSTAINED and weigh in
favor of revocation of the Respondent’s
DEA registration.
Third, the Government alleged that
the Respondent failed to maintain
records of controlled substances listed
in Schedules III–V, separate from other
records, in violation of 21 CFR
1304.04(f)(2), Conn. Gen. Stat. § 21a254(f), and Conn. Agencies Regs. § 21a326-1(d)(2), (6). ALJ-1, at 4. With respect
to this allegation, the Respondent
stipulated that he had failed to keep his
records of his Schedules III–V
controlled substances separate from his
records of other controlled substances.
Stip. of Fact 19. This factual stipulation
establishes by a preponderance of the
evidence that the Respondent failed to
maintain records of controlled
substances, listed in Schedules III–V,
separate from other records.
Accordingly, that allegation, as set forth
in paragraph 4(p) of the OSC, is
SUSTAINED and weighs in favor of
revocation of the Respondent’s DEA
registration.
Fourth, the Government alleged that
the Respondent failed to perform and
maintain a biennial inventory of his
controlled substances, in violation of 21
U.S.C. 827(a)(1), 21 CFR 1304.11(c),
Conn. Gen. Stat. § 21a-254(h), and Conn.
Agencies Regs. § 21a-326-1(d)(2), (6).
ALJ-1, at 4. The Respondent stipulated
to the fact that he failed to perform and
maintain a biennial inventory of his
controlled substances. Stip. of Fact 20.
This stipulation satisfies the
preponderance of evidence standard to
prove that the Respondent did not
perform or maintain a biennial
inventory as he was required to do.
Accordingly, the Government’s
allegation that the Respondent failed to
perform and maintain a biennial of his
controlled substances, as alleged in
paragraph 4(q) of the OSC, is
SUSTAINED and weighs in favor of
revocation of the Respondent’s DEA
registration
Fifth, the Government alleged that as
a result of the Respondent’s poor record
keeping he was unable to account for
significant quantities of several different
controlled substances he received from
his supplier, in violation of 21 U.S.C.
827(a)(3), 21 CFR 1304.21(a), and Conn.
Agencies Regs. § 21a-326-1(d)(2), (6).
ALJ-1, at 2-3. The Respondent conceded
that these allegations were true. Stip. of
Fact 4, 6, 8, 10, 11. These stipulations
satisfy the preponderance of evidence
standard to prove that the Respondent
was unable to account for significant
quantities of his controlled substances.
Accordingly, the Government’s
VerDate Sep<11>2014
19:03 Feb 20, 2019
Jkt 247001
allegations that the Respondent was
unable to account for quantities of
controlled substances he received from
his supplier, as alleged in paragraphs
4(a), 4(c), 4(e), 4(g), and 4(h) of the OSC,
are SUSTAINED and weigh in favor of
revocation of the Respondent’s DEA
registration.
Finally, the last recordkeeping
violation the Government alleged was
that the Respondent failed to report to
the Connecticut State Commissioner of
Consumer Protection that he was
dispensing drugs, and that the
Respondent failed to biennially notify
the Commissioner of his intent to
continue to dispense drugs, in violation
of Conn. Gen. Stat. §§ 20-14f and 21a317, and 21 CFR 1306.03(a)(1). ALJ-1, at
5. The Respondent stipulated to these
facts. Stip. of Fact 21. This stipulation
meets the evidentiary standard of
preponderance of the evidence.
Accordingly, the Government’s
allegation that the Respondent failed to
report to the Commissioner that he was
dispensing drugs and intended to
continue to do so, as alleged in
paragraphs 4(r) of the OSC, is
SUSTAINED and weighs in favor of
revocation of the Respondent’s DEA
registration.
II. Improper Prescribing to Himself &
Family Members
Under federal regulations, ‘‘[a]
prescription for a controlled substance
. . . must be issued for a legitimate
medical purpose by an individual
practitioner acting in the usual course of
his professional practice.’’ 21 CFR
1306.04(a). The prescription
requirement prevents ‘‘doctors from
peddling to patients who crave the
drugs for . . . prohibited uses.’’ George
C. Aycock, M.D., 74 FR 17529, 17541
(2009) (citing Gonzales v. Oregon, 546
U.S. 243, 274 (2006)). Accordingly,
‘‘[a]n order purporting to be a
prescription issued not in the usual
course of professional treatment . . . is
not a prescription[,] . . . and the person
knowingly . . . issuing it, shall be
subject to the penalties provided for
violations of the provisions of law
relating to controlled substances.’’ 21
CFR 1306.04(a).
Under the CSA, it is fundamental that
a practitioner must establish and
maintain a legitimate doctor-patient
relationship in order to act in the usual
course of professional practice and to
issue a prescription for a legitimate
medical purpose. Fiaz Afzal, M.D., 79
FR 61651, 61653 (2014); see also
Samuel Mintlow, M.D., 80 FR 3630,
3648 (2015) (citing United States v.
Moore, 423 U.S. 122, 142–43 (1975)).
The CSA ‘‘generally looks to State law
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
5491
and standards of medical practice to
determine whether a doctor and patient
have established (and are maintaining) a
bona fide doctor-patient relationship.’’
Dewey C. MacKay, M.D., 75 FR 49956,
49973 (2010).
Here, the Government alleged that the
Respondent repeatedly issued
controlled substance prescriptions to
himself and his family members for
other than legitimate medical purposes
and outside the course of professional
practice, in violation of Conn. Gen. Stat.
§§ 20-14e(b), 21a-322(3), (8), (10), 21a252(a), Conn. Agencies Regs. § 21a-3261(c), (d), and 21 CFR 1306.04(a). ALJ-1,
at 5-6. Specifically, the Government
alleged in the OSC: [7(a)] that the
Respondent either issued or dispensed
overlapping prescriptions of controlled
substances to himself and a family
member, N.A., constituting early refills;
[7(b)] that the Respondent issued to
N.A. overlapping prescriptions for
controlled substances that are similar or
have similar effects on the body,
constituting therapeutic duplication;
[7(c)] that the Respondent issued to
himself, and his family members N.A.
and U.A., prescriptions for controlled
substances without any documentation
of those prescriptions or the bases for
them in the medical records; [7(d)] that
the Respondent either issued a
prescription or dispended controlled
substances to himself without adequate
documentation in the medical record;
[7(e)] that the Respondent issued
prescriptions to N.A. for a variety of
controlled substances without adequate
documentation in the medical record;
and [7(f)] that the Respondent issued a
controlled substance prescription to a
family member G.A. and inadequately
documented that prescription or the
basis for it in G.A.’s medical record.
ALJ-1, at 5–6.
Regarding the allegations in paragraph
7(a) of the OSC, the Respondent
stipulated to the factual allegations that
he issued overlapping prescriptions of
controlled substances to himself and a
family member, N.A., constituting early
refills. Stip. of Fact 24. Similarly,
regarding the allegations in paragraphs
7(d), 7(e), and 7(f), the Respondent
stipulated to the factual allegations that
he issued a prescription or dispensed
controlled substances to himself, or to
family members, N.A. and G.A., without
adequate documentation in the medical
record. Stip. of Fact 25-27.
There are, however, two allegations
that the Respondent disputes.
Specifically, the Respondent contests
the allegations contained in paragraph
7(b) of the OSC. That paragraph alleges
that the Respondent issued overlapping
prescriptions for controlled substances
E:\FR\FM\21FEN1.SGM
21FEN1
amozie on DSK3GDR082PROD with NOTICES1
5492
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
to a family member, N.A. It further
alleges that those prescriptions have
similar effects on the body, constituting
therapeutic duplication. The
Respondent also contests paragraph 7(c)
of the OSC. ALJ-38, at 21. That
paragraph alleges that the Respondent
issued prescriptions for controlled
substances to himself and family
members N.A. and U.A. without any
documentation or bases for the
prescriptions in the patients’ medical
records. ALJ-1, at 5.
With regards to the allegation in
paragraph 7(b) of the OSC, the
Respondent argues that ‘‘the
Government has failed to meet its
burden of proof that the prescription
constituted therapeutic duplication.’’
ALJ-38, at 21. The Respondent points to
a notation in the Respondent’s patient
file for N.A., dated March 5, 2014,
which indicates ‘‘Luntesta doesn’t help
changed to Ambien 10 mg #30.’’ GE-11,
at 7; ALJ-38, at 21. Additionally, the
Respondent argues that Dr. Perrin
testified that he did not know whether
patient N.A. was taking the medication
in an overlapping fashion. Tr. 189; ALJ38, at 21. Furthermore, the Respondent
argues that he knew patient N.A. would
not take the two medications at the
same time because patient N.A. is his
son, who lived with the Respondent.
ALJ-38, at 21; Finding of Fact (‘‘FF’’) 41.
N.A. came to the Respondent and told
him that the medication he was
currently taking was not working and
asked the Respondent if he could
prescribe something else. FF 41.
With regards to the allegation
contained in paragraph 7(c) of the OSC,
the Respondent argues that ‘‘[t]he
Government has failed to prove by a
preponderance of the evidence that
Respondent prescribed oxycodone to
himself as alleged in Paragraph 7c’’ of
the OSC. ALJ-38, at 21. However, as
previously discussed, 7(c) alleges that
the Respondent issued prescriptions for
controlled substances to himself and his
family members, N.A. and U.A., without
any documentation or bases of those
prescriptions in the patients’ medical
records. ALJ-1, at 5. It does not mention
oxycodone at all. Furthermore, the
Respondent admitted at the hearing to
the factual allegations contained in 7(c).
Tr. 267-68; FF 42.22
In order to establish the standard of
care for the State of Connecticut, the
Government presented the expert
opinion of Dr. Perrin. Dr. Perrin testified
22 When inquiring about paragraph 7(c),
Government counsel states, ‘‘My question on this
was whether you admit that this occurred. It’s a
factual question.’’ Tr. 268. To which the
Respondent replied, ‘‘Yeah, it’s a factual question.
This occurred, yes, it occurred.’’ Tr. 268.
VerDate Sep<11>2014
19:03 Feb 20, 2019
Jkt 247001
that the Respondent’s practice of issuing
overlapping prescriptions of controlled
substances to himself and to his family
members fell below the standard of care
in the State of Connecticut. FF 56; Stip.
of Fact 24. The concern with issuing
overlapping prescriptions is that if the
medications are taken simultaneously
there is a potential for harm to the
patient. FF 56. Furthermore, there is ‘‘a
cumulative effect of too much
potentially sedating medication that
also has addictive potential.’’ Tr. 165;
FF 56.
Additionally, according to Dr. Perrin,
the Respondent’s practice of issuing a
prescription or dispensing controlled
substances to himself or his family
members, without adequate
documentation in the medical record, is
below the standard of care in the State
of Connecticut. FF 60; Stip. of Fact 2527. Dr. Perrin reasoned that with any
prescription of a controlled substance, it
is ‘‘important to provide adequate
documentation as to the precise reason
for why [the] particular substance is
indicated.’’ Tr. 166; FF 60. Moreover,
there needs to be ‘‘an appropriate
diagnosis that underlies the prescribing
of said substance, and [there] has to be
documentation that’s beyond cursory to
substantiate the choice of prescribing
said substance.’’ Tr. 166; FF 61. Where
a patient’s medical record does not
contain adequate documentation to
explain the reason for prescribing a
highly addictive controlled substance,
there is no legitimate medical purpose
for that prescription. FF 61.
Significantly, Dr. Perrin also opined
that where a doctor’s prescriptions are
outside the standard of care, the doctor
is also prescribing outside the usual
course of professional practice. Tr. 183.
Accordingly, Dr. Perrin’s credible and
persuasive testimony, coupled with the
Respondent’s admissions, are sufficient
to establish that the Respondent’s
actions of issuing overlapping
prescriptions for controlled substances
and issuing prescriptions for controlled
substances without adequate
documentation in the patients’ medical
records fell below the standard of care
in the State of Connecticut and that
these prescriptions were not issued for
a legitimate medical purpose in the
usual course of professional practice.
Dr. Perrin identified two sets of
overlapping prescriptions issued by the
Respondent to his son, N.A. First, Dr.
Perrin identified Government Exhibit 13
as a prescription for Lunesta (with five
refills) issued by the Respondent to his
son, N.A., on December 6, 2012. Tr. 15657. Lunesta is a sedative hypnotic agent
that is used to treat insomnia. Tr. 15657. Dr. Perrin identified Government
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
Exhibit 14 as a prescription for Ambien
(with five refills) issued by the
Respondent to N.A. on March 23, 2013.
Tr. 156-57. Like Lunesta, Ambien is a
sedative hypnotic used to treat
insomnia. Tr. 156. In Dr. Perrin’s
opinion, the refills indicated on
Government Exhibit 13 overlap with the
date on the prescription on Government
Exhibit 14, and the combination of these
two prescriptions constitutes
therapeutic duplication. Tr. 157.
Second, Dr. Perrin identified
Government Exhibit 18 as a prescription
for Lunesta (with five refills) issued by
the Respondent to N.A. on February 24,
2014. FF 51. Dr. Perrin also identified
Government Exhibit 19 as a prescription
for Ambien (with 5 refills) issued by the
Respondent to N.A. on March 5, 2014.
FF 52. In Dr. Perrin’s opinion,
Government Exhibits 18 and 19 are
overlapping prescriptions.23 FF 53.
In Dr. Perrin’s opinion, the notation in
the Respondent’s patient file for why he
changed N.A.’s prescription to Ambien
is not sufficient to justify the
therapeutic duplication. FF 55.
However, it was also Dr. Perrin’s
opinion that prescribing overlapping
prescriptions could be legitimate if there
was an explanation as to why one
substance was being withdrawn in favor
of another; for example, due to an
adverse reaction, intolerance, or truly
ineffective after a fair trial. Tr. 170-71.
As the Respondent argues, he knew that
his son was not taking both medications
at the same time, noting that his son
lived with him. He also testified that he
noted in his son’s patient file that
Lunesta was not working based on what
his son had told him, so he changed his
son’s prescription to Ambien. GE-11, at
7; ALJ-38, at 21. I find that the note in
N.A.’s patient file clearly indicates why
the Respondent changed his son’s
prescription from Lunesta to Ambien.
Further, based on the evidence before
me, it is apparent that the Respondent
was intimately involved in his son’s
welfare. See Belinda R. Mori, N.P., 78
FR 36582, 36587 (2013).
Accordingly, the Government’s
allegations that the Respondent
repeatedly issued controlled substance
prescriptions to himself and his family
23 Paragraph 7(b) of the OSC alleges that the
Respondent issued overlapping prescriptions to his
son in 2014. The Government’s evidence would
support a finding that the Respondent issued only
one overlapping prescription to his son in 2014, the
one issued on March 5, 2014. See GE–19. The
Respondent was never placed on notice that the
Government would be introducing prescriptions
from 2012 and 2013, GE–13–14, to support this
allegation. See ALJ-37, at 6, para. 25. Accordingly,
when making my Recommended Decision in this
case, I place no weight on the evidence of an
overlapping prescription that occurred in 2013.
E:\FR\FM\21FEN1.SGM
21FEN1
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
amozie on DSK3GDR082PROD with NOTICES1
members for other than legitimate
medical purposes and outside the
course of professional practice, as
alleged in paragraphs 7(a) and 7(c)-7(f)
of the OSC, are SUSTAINED and weigh
in favor of revocation of the
Respondent’s DEA registration.
However, as discussed above, I find that
the Government has not established, by
a preponderance of the evidence, the
allegation contained in paragraph 7(b) of
the OSC. Therefore, the allegation
contained in paragraph 7(b) of the OSC
is NOT SUSTAINED.24
III. Improper Prescribing to Patients
The Government alleged that the
Respondent repeatedly issued
controlled substance prescriptions to
patients for other than a legitimate
medical purpose and outside the course
of professional practice, in violation of
Conn. Gen. Stat. §§ 20-14e(b), 21a322(3), (8), (10), 21a-252(a), Conn.
Agencies Regs. § 21a-326-1(c), (d), and
21 CFR 1306.04(a). ALJ-1, at 6-10.
Specifically, the Government alleged
that the Respondent issued multiple
overlapping prescriptions for controlled
substances to his patients, issued
prescriptions to his patients without
any, or sufficient, documentation or
bases for the prescriptions in the
patients’ records, and dispensed
controlled substances to patients from
his office supply without any, or
sufficient, documentation of dispensing
those controlled substances, or the bases
for them in the patients’ medical
records. ALJ-1, at 6-10.
The Respondent stipulated to all of
the factual allegations regarding
improper prescribing to patients. Stip.
of Fact 28-57. Specifically, the
Respondent admitted that on at least 20
occasions between 2012 and 2014, he
issued multiple overlapping
prescriptions for controlled substances
to at least four separate patients. Stip. of
Fact 29-32. The Respondent admitted
that on at least 35 occasions between
2010 and 2014, he issued prescriptions
to at least eight separate patients
without any documentation or bases for
the prescriptions in their medical
records. Stip. of Fact 33-40. The
Respondent admitted that on at least
nine occasions between 2012 and 2014,
he dispensed controlled substances to at
least three of his patients from his office
supply without any documentation or
bases for dispensing those controlled
substances in their medical records.
24 There was lengthy discussion during the
hearing concerning the issue of whether it is below
the standard of care in the State of Connecticut for
a physician to self-prescribe. That issue is not
squarely before me, however, because the OSC does
not contain that allegation.
VerDate Sep<11>2014
19:03 Feb 20, 2019
Jkt 247001
Stip. of Fact 41-43. The Respondent
admitted that on at least 26 occasions
between 2011 and 2014, he issued
prescriptions to at least seven patients
without sufficient documentation or
bases for the prescriptions in their
medical records. Stip. of Fact 44-50.
Finally, the Respondent admitted that
on at least 45 occasions between 2010
and 2014, he dispensed controlled
substances to at least seven patients
from his office supply without sufficient
documentation or bases for them in
their medical records. Stip. of Fact 5157.
The Government again offered the
testimony of Dr. Perrin to establish the
standard of care in the State of
Connecticut regarding the allegations of
the Respondent’s improper proscribing
to patients. Dr. Perrin testified that the
Respondent’s practice of issuing
multiple overlapping prescriptions for
controlled substances fell below the
standard of care in the State of
Connecticut. FF 56. Dr. Perrin further
explained that the concern with issuing
overlapping prescriptions is the
potential for diversion with additional
controlled substances floating around.
Tr. 207; FF 57. Additionally, Dr. Perrin
noted that where a patient’s medical
record does not contain adequate
documentation to explain the reason for
prescribing a highly addictive
controlled substance, there is no
legitimate medical purpose for the
prescription. Tr. 202; FF 61. Therefore,
the Respondent’s practice of issuing
controlled substance prescriptions or
dispensing controlled substances from
his office supply to patients without
adequate documentation or bases for the
prescription or dispensing in the
patient’s medical record fell below the
standard of care in the State of
Connecticut, and was also outside the
usual course of professional practice. Tr.
183; FF 61.
Dr. Perrin’s testimony, coupled with
the Respondent’s admissions, is
sufficient to establish that the
Respondent issued controlled
substances for other than a legitimate
medical purpose and outside the course
of professional practice. Accordingly,
the Government’s allegations contained
in paragraph 9 of the OSC are
SUSTAINED and weigh in favor of
revocation of the Respondent’s DEA
registration.
IV. Failure to Maintain Security of
Controlled Substance.
The Government alleged that the
Respondent failed to maintain adequate
security of his controlled substances.
Specifically, the Government alleged
that the Respondent’s ‘‘controlled
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
5493
substances were stored in an unlocked
cabinet in an unlocked room . . . in the
front-desk reception area . . . , ’’ in
violation of 21 CFR 1301.75(b) and
Conn. Agencies Regs. §§ 21a-262-6(a)(c), 21a-326-1(d). ALJ-1, at 11. Clearly, a
registrant must maintain the physical
security of his controlled substances to
prevent unlawful diversion. Jerry Neil
Rand, M.D., 61 FR 28895, 28897 (1996).
Further, registrants are required to store
controlled substances in ‘‘a securely
locked, substantially constructed
cabinet.’’ 21 CFR 1301.75(b). When a
registrant leaves controlled substances
unattended, the controlled substances
must be placed in a proper storage
cabinet. Jeffery J. Becker, D.D.S., 77 FR
72387, 72405 (2012) (citing to D-Tek
Enter., 56 FR 28926 (1991), and the
Merriam-Webster Dictionary).
The Government bears the burden of
proof concerning this allegation. 5
U.S.C. 556(d); 21 CFR 1301.44(e); Jack
A. Danton, M.D., 76 FR 60900, 60920
(2011). To prove this allegation, the
Government presented the testimonies
of [R.M.], [N.C.], [P.L.], and [M.J.]. In
addition, the Respondent also testified
on this issue. Initially, no witness
testified that the Respondent stored his
controlled substances in the ‘‘front-desk
reception area’’ of his office. Second, it
is also clear that prior to February 21,
2014, the Respondent stored his
controlled substances in a louvered
closet that did not have a lock on it. FF
33, 34, 35, 36, 38. Third, the closet
where the Respondent’s controlled
substances were stored was located in a
room (‘‘examination room’’), which
contained a patient examination table
and expensive unused medical
equipment. FF 32, 33, 34, 35.
The question of whether the
examination room where the controlled
substances were stored, in an unlocked
closet, was locked, is not readily clear.
Neither [R.M.] nor [N.C.] could recall if
the examination room was locked on
March 4, 2016. Tr. 21-22, 42. [P.L.]
testified that the door to the
examination room was not locked when
she was at the Respondent’s office in
January 2014, but she did not know if
the door was locked when she was there
in February 2014. Tr. 58, 61. [M.J.]’s
testimony concerning whether the door
to the examination room was locked
during her visits to the Respondent’s
office in January 2014 and again in
February 2014, is not particularly
precise. Concerning the January visit
she testified that the Respondent ‘‘told
us that [the controlled substances] were
stored in an unlocked examination room
in an unlocked closet, which we also
later visually observed.’’ Tr. 85. It is not
clear just what was ‘‘observed.’’ When
E:\FR\FM\21FEN1.SGM
21FEN1
amozie on DSK3GDR082PROD with NOTICES1
5494
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
asked if the examination room was
locked in February 2014, [M.J.] testified,
‘‘Not to my recollection.’’ Tr. 95. She
noted, however, that she was not the
first one in the room; rather, she was
right behind another investigator who
‘‘opened it right up.’’ Id. Further
confusing the matter, she could not
recall, however, if the Respondent had
led them into the examination room. Id.
Thus, the Government presented four
witnesses who had a total of eight
opportunities 25 to observe whether the
door to the examination room was
locked prior to their entrance into the
room. Only [P.L.] testified that the room
was unlocked on her first visit to the
Respondent’s office on January 31, 2014,
but she provided no explanation of how
or why she recalled that fact.
The Respondent testified that he kept
the examination room locked because
he had kept expensive medical
equipment in the room since about
2009. Tr. 229-30, 301-03. The
Respondent also testified: that the
outside door to his clinic was kept
locked except during normal business
hours, Tr. 228-29; that his office had a
‘‘key pad’’ security alarm and an alarm
would sound if someone entered the
clinic without disabling the alarm
system, Tr. 228; and that he had security
cameras installed in his clinic. Tr. 228.
Comparing the testimony of the
Government’s witness with that of the
Respondent, and considering the
Respondent’s stated reason for keeping
the door to the examination room
locked, I find that the preponderance of
the evidence does not support the
conclusion that Respondent stored his
controlled substances in an unlocked
room. Rather, the evidence supports the
conclusion that the door to the
examination room was kept locked.
Here the Government charged that the
Respondent’s security measures violated
21 CFR 1301.75(b), which requires that
Schedule II–V controlled substances ‘‘be
stored in a securely locked,
substantially constructed cabinet.’’
While the regulations do not define the
term ‘‘cabinet,’’ the New College Edition
of the American Heritage Dictionary of
the English Language (1976) includes
the following definition of ‘‘cabinet’’: ‘‘a
small or private room set aside for some
specific activity.’’ Further the Danton
decision suggests that that the term
‘‘cabinet’’ has a broader meaning than
the Government seeks to impose.
25 [M.J.] and [P.L.] each had three opportunities
to observe the door. They went to the Respondent’s
office twice on January 31, 2014, and once on
February 21, 2014. FF 38-39. [R.M.] and [N.C.] were
both at the Respondent’s office on March 4, 2016.
FF 15, 21.
VerDate Sep<11>2014
19:03 Feb 20, 2019
Jkt 247001
In Danton, DEA investigators found
oxycodone in a closet in Danton’s office.
76 FR at 60907-08, 60920. The closet
was in the dispensing area of the clinic.
Id. at 60920. The closet also contained
security monitoring equipment. Id. The
investigators, however, did not know if
the closet was locked or even if it could
be locked. Id. The DEA alleged that
Danton had violated 21 CFR 1301.75
because the oxycodone was in a closet
that ‘‘was not a securely locked,
substantially constructed cabinet
suitable for the storage of control
substances.’’ Id. Because the
Government failed to demonstrate how
the closet failed to meet the
requirements of the regulation, the
Administrator found that the
Government failed to prove that Danton
had violated 21 CFR 1301.75(b). Id.
In this case the Government’s focus in
charging the Respondent with failing to
maintain adequate security of his
controlled substances was whether
those substances were in a locked
cabinet. See ALJ-1, at 11; Tr. 22-23, 39,
43, 67, 95, 134. That is understandable
due to the language in 21 CFR
1301.75(b) that controlled substances
are to ‘‘be stored in a securely locked,
substantially constructed cabinet.’’
There are no further regulations,
however, that define those terms. See
Tr. 67-68. Further when questioned on
DEA guidance related to a substantial
cabinet, [M.J.] testified, ‘‘It needs to be
substantially secure. The intent of the
storage is to have it be secure so as to
prevent from theft or diversion.’’ Tr.
123. Further, 21 CFR 1301.71(b) states
that the Administrator can consider any
of 15 different security related factors in
deciding whether a registrant was in
‘‘substantial compliance’’ with 21 CFR
1301.75(b). Thus the answer to the
question of whether the Respondent
failed to maintain adequate security of
his controlled substances is not solely
dependent on the answer to the
question of whether the container in
which the controlled substances were
located was itself locked. If that were
the case, the 15 factors and the language
of ‘‘substantial compliance’’ contained
in 21 CFR 1301.71(b) would be
meaningless.
In this case the Respondent kept his
controlled substances in a locked room
where he stored high value medical
equipment. Second, the Respondent’s
office was protected by a security
system and by cameras. Third, there
were only a total of three individuals
who worked in the Respondent’s office.
Fourth, there is no evidence that the
Respondent’s office was located in a
high crime area or that there was an
absence of local police protection.
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
Finally, there is no evidence that the
examination room was being used for
any purpose other than to store high
valued medical equipment and the
Respondent’s controlled substances.
Given the nature of the evidence
contained in the administrative record,
it is not necessary to find that the
‘‘examination room’’ met the
requirements of 21 CFR 1301.75(b).
Rather, in light of the absence of
evidence as to why the ‘‘examination
room’’ failed to satisfy the requirements
of 21 CFR 1301.75(b), and considering
the five points detailed in the paragraph
above, as well as the guidance contained
in Danton,26 I find that the Government
failed to prove that the Respondent
violated 21 CFR 1301.75(b) when he
stored his medication in the locked
‘‘examination room.’’ Further,
considering [M.J.]’s testimony that the
‘‘intent of the storage is to have it be
secure so as to prevent from theft or
diversion,’’ Tr. 123, the record
established that the Respondent clearly
met that intent.
In light of the discussion above, and
giving due consideration to the factors
contained in 21 CFR 1301.71(b), the
Government’s allegation that the
Respondent violated 21 CFR 1301.75(b)
is NOT SUSTAINED. Furthermore, the
Government’s allegations that the
Respondent violated the cited
provisions of Connecticut Regulations,
Conn. Agencies Regs. §§ 21a-262-6(a)(c), 21a-32601(d), with respect to his
storage of his controlled substances are
not sustained.27
Factor Five: Other Conduct Which May
Threaten the Public Health and Safety
Under Factor Five, the DEA is
authorized to consider ‘‘other conduct
which may threaten the public health
and safety.’’ 21 U.S.C. 823(f)(5). This
factor encompasses ‘‘conduct which
creates a probable or possible threat
(and not only an actual [threat]) to
public health and safety.’’ Jacobo
Dreszer, M.D., 76 FR 19386, 19386 n.3
(2011). Under Factor Five, the
Government has alleged two bases upon
which it seeks to revoke the
Respondent’s COR. First, citing Dreszer,
the Government alleges that a statement
that the Respondent made to DEA and
Connecticut investigators that ‘‘ ‘benzos’
[were] not worthy of DEA investigation,
particularly given how other doctors in
[his] community were distributing
Schedule II controlled substances,’’ is
conduct that may threaten the public
26 I also considered the Administrator’s analysis
in Howard N. Robinson, M.D., 79 FR 19356, 19372
(2014).
27 The Government made no argument in its posthearing brief concerning paragraph 10 of the OSC.
E:\FR\FM\21FEN1.SGM
21FEN1
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
amozie on DSK3GDR082PROD with NOTICES1
health and safety. ALJ-1, at 11, para.
11(a). Next the Government alleges that
the Respondent attempted to mislead
DEA and Connecticut investigators by
denying that he had issued
prescriptions to family members and by
denying that he had any medical
records concerning his treatment of
family members. Id. at para. 11(b). The
Government further alleged that several
days after the Respondent denied
having such records, he produced a file
concerning his treatment of family
members and that the delay in
producing the records ‘‘strongly
suggest[s] that the file was created after
the fact in response to the DEA’s
investigation.’’ Id. The Government
alleges that such conduct is evidence of
a lack of candor, which is ‘‘an important
factor when assessing whether a
physician’s registration is consistent
with the public interest.’’ Id. at 11-12
(citing Hoxie v. DEA, 419 F.3d 477, 483
(6th Cir. 2005)). In its Post-Hearing Brief
the Government argues that the
Respondent was also less than candid
during his testimony on crossexamination, when he ‘‘was forced to
admit that he had previously testified
differently.’’ ALJ-37, at 22-23.
I. The ‘‘Benzos’’ Statement
Paragraph 11(a) of the OSC alleges
that the Respondent’s purported
statement that ‘‘‘benzos’ [were] not
worthy of DEA investigation,
particularly given how other doctors in
[his] community were distributing
Schedule II controlled substances,’’ ALJ1, at 11, is conduct that should be
considered under Factor Five. The only
authority the Government cites for its
position is the Dreszer decision. In its
Post-Hearing Brief, the Government
does not even address this issue. ALJ37.
Based upon my review of the
testimony, I concluded that the
Respondent made a statement to [M.J.]
and [P.L.] that closely matches the
language cited in the paragraph 11(a) of
the OSC. But my review of the Dreszer
decision does not convince me that such
a statement would be a basis for
revocation under Factor Five. As the
Respondent appropriately argues,
‘‘nothing in Dreszer stands for the
proposition that Respondent’s simple
statements . . . rise to the level of
creating even a possible threat to public
health or safety.’’ ALJ-38, at 23. While
I need not decide if language by itself,
wherein the individual simply states an
opinion, would ever give rise to
actionable conduct, the Government
has come nowhere near meeting its
burden of proof concerning the language
quoted above. Accordingly, the
VerDate Sep<11>2014
19:03 Feb 20, 2019
Jkt 247001
allegations contained in paragraph 11(a)
of the OSC are NOT SUSTAINED.
II. Attempt to Mislead
In paragraph 11(b) of the OSC, the
Government alleged that the
Respondent engaged in acts wherein he
attempted to mislead the DEA during its
investigation concerning him. First, the
Government alleges that the Respondent
told the investigators that he did not
issue prescriptions to members of his
family. Second, the Government alleges
that the Respondent told the
investigators that he did not have any
records concerning the medical
treatment he provided to family
members, and then ‘‘several days’’ later
the Respondent produced a file of those
records. The Government further alleges
that the manner in which the
Respondent produced the records
‘‘strongly suggests that the file was
created after the fact . . . .’’ ALJ-1 at 11.
A. Statements Concerning Prescribing
to Family Members
The evidence of whether the
Respondent told the investigators that
he did not prescribe to family members
is a bit convoluted. [P.L.] testified that
the Respondent initially told the
investigators that he did not prescribe to
family members because he did not
want to take responsibility of something
going wrong. Tr. 55-56. [P.L.] then
showed him some prescriptions he had
written for family members and the
Respondent verified he had written the
prescriptions. Tr. 56. On crossexamination, however, [P.L.] testified
that she did not recall the exact
language the Respondent had used, and
that it was possible that he had
answered ‘‘mostly not,’’ when he was
asked if he wrote prescriptions to family
members. Tr. 70. [M.J.], who sat through
[P.L.]’s testimony, testified that the
Respondent initially denied writing
prescriptions to family, but she, too,
indicated that his answer was ‘‘mostly
not.’’ Tr. 86-87. The Respondent
testified that he acknowledged writing
prescriptions to family members, but his
position was ‘‘mostly no.’’ Tr. 255.
Keeping in mind that the Government
has the burden of proof concerning each
of its allegations, I find that the
testimony does not support the
conclusion that Respondent denied that
he had written prescriptions to members
of his family. Both of the Government
witness on this issue, as well as the
Respondent, used the terms ‘‘mostly
not.’’ Further, even if the Respondent
initially denied writing to family
members, he quickly corrected the
record. Under these facts, I find no
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
5495
‘‘attempt to mislead.’’ 28 Accordingly,
the Government’s allegation, contained
in Paragraph 11(b) of the OSC, that the
Respondent told the investigators that
he did not issue prescriptions to
members of his family in an attempt to
mislead them is NOT SUSTAINED.
B. Fabrication of Family Medical
Records
With respect to the family medical
records, which the Respondent
produced, the Government alleged that
after the Respondent denied having the
records he produced them a few days
later. The Government further suggests
that the Respondent used the time to
create the file ‘‘after the fact in response
to the DEA’s investigation . . . .’’ ALJ1, at 11. The Government has not
alleged, nor has it argued, that the
Respondent lied to the investigators
when he told them he did not have
family medical records. Rather, the
Government’s allegation in paragraph
11(b) of the OSC and in its argument in
its Post Hearing Brief is that the
Respondent falsified the medical
records ‘‘to thwart DEA’s investigation.’’
ALJ-37, at 22. In support of this
allegation the Government cited the
same two cases in both the OSC and its
post-hearing brief: Jerry Neil Rand,
M.D., 61 Fed. Reg. 28895 (1996), and
Nelson A. Smith, D.D.S, 58 Fed. Reg.
65403 (1993).
The testimony supporting the
allegation that the Respondent told
[M.J.] and [P.L.] that he did not have
family medical records is not
contradicted. [P.L.] testified that the
Respondent was asked if the
investigators could see the medical
records concerning his treatment of
family members and ‘‘[h]e did not have
any.’’ Tr. 56. [M.J.] also testified that the
Respondent denied having any patient
charts for his family members. Tr. 87.
The Respondent did not provide direct
testimony on this issue, but he did
testify that he did not intentionally
mislead the investigators. Tr. 256.
The evidence is also clear that the
Respondent did not produce the file
containing the patient charts for himself
and members of his family ‘‘several
days’’ after he told the investigators that
he did not have such files. [M.J.] and
[P.L.] met with the Respondent on
January 31, 2014. FF 15. It was on that
date that the Respondent told [M.J.] and
[P.L.] he did not have treatment files for
family members. FF 16. [M.J.] and [P.L.]
found out about the patient charts from
28 I also note that the Respondent has some
difficulty hearing, which certainly could have
contributed to miscommunication. Tr. 254; see also
Tr. 210.
E:\FR\FM\21FEN1.SGM
21FEN1
5496
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
amozie on DSK3GDR082PROD with NOTICES1
a doctor who worked with the
Respondent. Tr. 88. The Respondent
also mentioned the patient files before
they were produced. Tr. 88. Then, about
18 months after the January 31, 2014
meeting with the Respondent, [M.J.]
‘‘submitted an administrative subpoena
. . . in July of 2015 for the family
records . . . and [the Respondent]
returned them to [her] . . . within a
week or so.’’ Tr. 88. Thus the OSC does
not paint an accurate picture of what
actually happened.29
While the facts underlying the
allegation contained in paragraph 11(b)
of the OSC are relatively clear from the
record, the allegation is one of specific
intent—that the Respondent attempted
to mislead by first denying that he had
family medical files and then producing
them a few days later after he had
created them. As with any allegation,
the Government bears the burden of
proof regarding its claim that the
Responded attempted to mislead DEA
investigators during their investigation.
See ALJ-1, at 11. Concerning this
allegation, however the Government’s
case rests primarily upon conjecture.
Further, ‘‘under the substantial evidence
test, the evidence must ‘do more than
create a suspicion of the existence of the
fact to be established.’ ’’ Alvin Darby,
M.D., 75 Fed. Reg. 26993, 26999 n.31
(2010) (citing NLRB v. Columbian
Enameling & Stamping Co., 306 U.S.
292, 300 (1939)). In my view, suspicion
is all the Government has presented on
the issue of whether the Respondent
created the family medical files after he
was asked about them on January 31,
2014.
I, therefore, reject the Government’s
allegation that the Respondent
fabricated Government Exhibit 11 in an
attempt to mislead the DEA during its
investigation. First, unlike the two cases
the Government relies upon, Rand and
Smith, the Government presented no
direct evidence that the Respondent
either altered patient files or falsified
those files. Second, the Respondent did
not quickly produce the files after he
first denied having them; rather he
produced them 18 months later, and in
response to a subpoena. Third, a review
of Government Exhibit 11, and
comparing it to prescriptions written to
29 The Government has provided no explanation
of why it alleged that the Respondent produced the
family records ‘‘several days’’ after having told
investigators that he did not have any, when in fact
they were produced about 18 months later after the
documents were subpoenaed. A fair reading of the
OSC suggests that something sinister was afoot by
denying the existence of the documents but them
producing them only several days later. The OSC
suggests a linkage between the denial and quick
turn-around time. The record does not support that
conjecture.
VerDate Sep<11>2014
19:03 Feb 20, 2019
Jkt 247001
family members, reveals nothing
suggestive of fabrication, and the
Government has not identified or
presented evidence of any specific
examples of fabrication. Finally, the
Respondent is a well-educated medical
doctor, who immigrated to the United
States and passed the Foreign Medical
Graduates exam only three months after
he arrived here. He appears to be an
intelligent and well-spoken individual.
Certainly if the Respondent created
Government Exhibit 11 to mislead the
DEA he could have done a far better job
in fabricating medical records for
himself and for family members. In fact,
it is the poor quality of those medical
records that the Government relied
upon as the bases of other allegations
the DEA successfully brought against
the Respondent in the OSC. See ALJ-1,
at 5-6, para. 7(c)-(f). Accordingly, the
Government’s allegation, in Paragraph
11(b) of the OSC, that the Respondent
told the investigators that he did not
have any records with respect to his
family members and then several days
later produced those records in an
attempt to mislead the DEA is NOT
SUSTAINED.
III. Lack of Candor
In its Post-Hearing Brief, the
Government argues that the Respondent
demonstrated a lack of candor during
his testimony at the hearing on March
13, 2017. ALJ-37, at 22-23. In addition,
the Government proposed 12 facts that
it contends support its argument that
the Respondent’s testimony
demonstrated a lack of candor. ALJ-37,
at 11-12.
The DEA has consistently held that
‘‘[c]andor during DEA investigations,
regardless of the severity of the
violations alleged, is considered by the
DEA to be an important factor when
assessing whether . . . registration is
consistent with the public interest.’’ Jeri
Hassman, M.D., 75 Fed. Reg. 8194, 8236
(2010) (citing Hoxie v. DEA, 419 F.3d
477, 483 (6th Cir. 2005)). For example,
the DEA held that a respondent’s lack of
candor weighed against his registration
under Factor Five when he lied to DEA
investigators ‘‘when first confronted’’
about his wrongful conduct. John V.
Scalera, M.D., 78 Fed. Reg. 12092,
12100 (2013). The DEA ‘‘places great
weight on a registrant’s candor, both
during an investigation and in [a]
subsequent proceeding.’’ Robert F.
Hunt, D.O., 75 Fed. Reg. 49995, 50004
(2010) (citing The Lawsons, Inc., t/a The
Medicine Shoppe Pharmacy, 72 Fed.
Reg. 74334, 74338 (2007)). Thus, the
DEA may consider a respondent’s lack
of candor to be a threat to public health
PO 00000
Frm 00093
Fmt 4703
Sfmt 4703
and safety. Annicol Marrocco, M.D., 80
Fed. Reg. 28695, 28705 (2015).
The Government contends that the
Respondent was less than candid when
testifying about: the number of
Suboxone patients the Respondent
currently treats; whether he had ever
provided a prescription in exchange for
service; whether he had told
investigators that benzodiazepines were
not commonly diverted or abused;
whether he would prescribe controlled
substances to someone who said they
were giving the controlled substances to
someone else; and whether he had ever
taken drugs home to give to a family
member. ALJ-37, at 11-12. Many of these
issues were raised in context of
testimony the Respondent apparently
gave in prior hearings or depositions.
The Government, however, did not offer
the transcripts of those prior
testimonies. Furthermore, even the
transcripts of prior testimony, which
may differ from testimony the
Respondent presented in his testimony
before me, would neither prove nor
disprove that the Respondent lacked
candor when he testified on March 13,
2017.30
Many of the items of testimony are
not as clear cut as the Government
suggests. For example, there is no
evidence in the record concerning the
number of Suboxone patients the
Respondent treats. When asked multiple
times, the Respondent consistently
testified that he treats between 90–100
patients. Tr. 216, 275-78. While
Government counsel made the
statement, ‘‘I don’t believe that’s
actually the case. I believe you’re
treating less than that,’’ Tr. 278, the
Government presented no evidence as to
the number of Suboxone patients the
Respondent is treating. This issue raised
by the Government does not
demonstrate any lack of candor, and the
number is totally irrelevant to these
proceedings. In fact when Government
counsel was given the opportunity to
proffer the relevance of this information,
all he said was, ‘‘I was just going to
credibility of the witness . . . .’’ Tr. 279.
With respect to the issue of whether
the Respondent ever bartered his
medical services, my understanding of
the testimony was that he had done that
in the past, but he would not do it again
because it is considered unethical. Tr.
250. Furthermore, whether he did or did
30 For example, it is possible that the Respondent
was lacking in candor during his prior testimony,
rather than during the March 13, 2017 hearing. He
also could have just been confused. Further, there
is no evidence in this Administrative Record that
the Respondent’s March 15, 2016 deposition, Tr.
280, was taken in any sort of DEA proceeding or
court proceedings that involved the DEA.
E:\FR\FM\21FEN1.SGM
21FEN1
amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
not barter in the past is not relevant to
the issues before me. There is no lack
of candor concerning this irrelevant
issue.
The Government has made much of
the Respondent’s exact wording when
he discussed benzodiazepines with
[M.J.] and [P.L.]. Nevertheless, the
Respondent admitted during the hearing
that he had made a comparison between
benzodiazepine and oxycodone, stating
that oxycodone was more addictive. Tr.
253. He also testified that at the time he
met with [M.J.] and [P.L.] he was of the
impression that ‘‘benzodiazepines were
not being abused and diverted.’’ Tr. 238.
During the Government’s crossexamination of the Respondent on this
subject, I did not find any lack of candor
regarding this issue.
The Government incorrectly
characterizes the Respondent’s
testimony about whether the
Respondent would prescribe controlled
substances to a patient who told the
Respondent that he was giving some of
the controlled substances to another
individual. My review of the record
leads me to the conclusion that the
Respondent testified that he would not
do that now, not what he may have
done in the past. The record is not clear
what question may have been asked at
an earlier deposition concerning this
peripheral issue. Tr. 285-88. I find no
lack of candor.
Finally, the Government suggests that
the Respondent lacked candor when he
testified concerning whether he had
ever taken ‘‘drugs’’ home to give to
family members. In context, I find no
relevance to any answers to this line
questioning, particularly concerning the
issues before me. First, the Respondent
was not on notice of this issue and the
question did not deal with controlled
substances; rather, the Respondent was
asked about ‘‘drugs’’. Second, I do not
find a lack of candor because the
Respondent essentially testified that he
did not remember if he had taken drugs
home to give to a family member, and
then acknowledged that an earlier
deposition indicated that he ‘‘may have
taken drugs home.’’ Tr. 290-91
(emphasis added).
Earlier in this decision I assessed the
Respondent’s credibility at length. Upon
further review, specifically considering
the Government’s allegation that the
Respondent lacked candor during his
testimony, I reemphasize my earlier
finding. When accessing the
Respondent’s credibility, I find that the
clear and confident manner in which
the Respondent testified on direct
examination outweighs the manner in
which he testified on cross examination.
Further, when comparing his testimony
VerDate Sep<11>2014
19:03 Feb 20, 2019
Jkt 247001
to that of other witnesses, I find that it
was generally consistent with that of the
Government’s witnesses. Thus, I find
that the Respondent’s testimony to be
generally credible. Accordingly, the
Government’s allegation, raised in its
Post Hearing Brief, that the
Respondent’s testimony at the hearing
demonstrated a lack of candor is NOT
SUSTAINED.
DISCUSSION
Factors One and Three neither weigh
for or against revocation in this case. As
discussed, the Government did not
present sufficient evidence of any other
conduct the Respondent may have
engaged in that may threaten the public
health and safety. Accordingly, Factor
Five does not weigh in favor of
revocation. However, Factors Two and
Four strongly weigh in favor of revoking
the Respondent’s COR because of his
improper recordkeeping, and improper
prescribing to himself, his family
members, and his patients. Considering
the public interest factors in their
totality, I find that the Government has
made a prima facie case showing that
the Respondent’s registration would be
inconsistent with the public interest.
After the Government presents a
prima facie case for revocation, the
Respondent has the burden of
production to present ‘‘sufficient
mitigating evidence’’ to show why he
can be entrusted with a DEA
registration. See Medicine Shoppe—
Jonesborough, 73 Fed. Reg. 364, 387
(2008) (quoting Samuel S. Jackson,
D.D.S., 72 Fed. Reg. 23848, 23853
(2007)). To rebut the Government’s
prima facie case, the Respondent must
both accept responsibility for his actions
and demonstrate that he will not engage
in future misconduct. Patrick W.
Stodola, M.D., 74 Fed. Reg. 20727,
20734–35 (2009).
The Respondent may accept
responsibility by providing evidence of
his remorse, his efforts at rehabilitation,
and his recognition of the severity of his
misconduct. See Robert A. Leslie, M.D.,
68 Fed. Reg. 15227, 15228 (2003). To
accept responsibility, a respondent must
show ‘‘true remorse’’ for wrongful
conduct. Michael S. Moore, M.D., 76
Fed. Reg. 45867, 45877 (2011). An
expression of remorse includes
acknowledgment of wrongdoing. See
Wesley G. Harline, M.D., 65 Fed. Reg.
5665, 5671 (2000). A respondent must
express remorse for all acts of
documented misconduct, Jeffrey Patrick
Gunderson, M.D., 61 Fed. Reg. 26208,
26211 (1996), and may be required to
acknowledge the scope of his
misconduct, Arvinder Singh, M.D., 81
Fed. Reg. 8247, 8250–51 (2016).
PO 00000
Frm 00094
Fmt 4703
Sfmt 4703
5497
Acceptance of responsibility and
remedial measures are assessed in the
context of the ‘‘egregiousness of the
violations and the [DEA’s] interest in
deterring similar misconduct by [the]
Respondent in the future as well as on
the part of others.’’ David A. Ruben,
M.D., 78 Fed. Reg. 38363, 38364 (2013).
Here, the Government accurately
argued in its Post-Hearing Brief that
‘‘[t]he record contains no evidence that
Respondent has actually accepted
responsibility for the misconduct at
issue in these proceedings and this is
fatal to his cause.’’ ALJ-37, at 23. While
the Respondent admitted to many of the
facts that support the allegations against
him, he failed to fully accept
responsibility for the most egregious
aspects of his actions. Specifically, the
Respondent failed to acknowledge that
his prescribing and dispensing practices
fell below the standard of care in the
State of Connecticut. FF 62.
Furthermore, the Respondent refused to
admit that the prescriptions that he
issued or dispensed to himself, his
family, and his patients were issued or
dispensed for other than legitimate
medical purposes and outside the
course of professional practice, despite
being provided the opportunity to do
so.31 Tr. 264-66. I find, however, that by
31 Additionally, the Government requests that I
draw an adverse inference against the Respondent,
with respect to his admission of responsibility,
because the Respondent invoked his Fifth
Amendment rights when asked by Government
counsel if his actions were outside the course of
professional practice. ALJ-37, at 26. It is well settled
that at a DEA administrative hearing, it is
permissible to draw an adverse inference from a
respondent’s failure ‘‘to testify in response to
probative evidence offered against’’ him. Darryl J.
Mohr, M.D., 77 Fed. Reg. 34998, 35001 (2012)
(citing Baxter v. Palmigiano, 425 U.S. 308, 316
(1976)). The Respondent argues that I should not
draw a negative inference here because, unlike
cases cited to by the Government, the Respondent
did not refuse to testify, but just refused to answer
questions that the Respondent argues called for a
legal conclusion. ALJ-38, at 26. However, in Mohr,
the registrant, offered testimony at hearing only in
regards to his prescribing to K.R., an undercover
patient. Mohr, 77 Fed. Reg. at 35000. Dr. Mohr
offered no testimony as to why he prescribed to
K.R. and also offered no testimony addressing his
medical justification for prescribing a controlled
substance to B.K., another undercover patient. Id.
at 35001. Based on Dr. Mohr’s failure to address
why he prescribed to both patients, the
Administrator found it ‘‘appropriate to draw the
adverse inference that [Dr. Mohr] knowingly
prescribed controlled substances to both B.K. and
K.R. without a legitimate medical purpose.’’ Id.
Accordingly, based on the Respondent’s
unwillingness to acknowledge that his prescribing
of controlled substances was outside the course of
professional conduct, it is appropriate to draw the
adverse inference that the Respondent did not
accept responsibility for the allegations set for in
paragraphs 7 and 9 of the OSC and which are
supported by a preponderance of the evidence. See
MacKay v. DEA, 664 F.3d 808, 820 (10th Cir. 2011)
(holding that it was not ‘‘improper for the Deputy
E:\FR\FM\21FEN1.SGM
Continued
21FEN1
5498
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
amozie on DSK3GDR082PROD with NOTICES1
entering into Stip. of Fact 4-21 the
Respondent accepted responsibility for
his recordkeeping violations that
occurred in his practice prior to
February 2014, as alleged in paragraph
4 of the OSC. FF 24. This limited
acceptance of responsibility is
outweighed by his numerous
prescribing and dispensing
transgressions, for which he has not
accepted responsibility.32 See Hatem M.
Ataya, M.D., 81 Fed. Reg. 8221, 8244
(2016) (‘‘[T]here are cases in which,
notwithstanding a finding that a
registrant has credibly accepted
responsibility, the misconduct is so
egregious and extensive that the
protection of the public interest
nonetheless warrants the revocation of a
registration or the denial of an
application.’’).
When considering whether the
Respondent’s continued registration is
consistent with the public interest, the
ALJ must consider both the
egregiousness of the registrant’s
violations and the DEA’s interest in
deterring future misconduct by both the
registrant as well as other registrants.
David A. Ruben, M.D., 78 Fed. Reg.
38363, 38364 (2013); see also Richard J.
Settles, D.O., 81 Fed. Reg. 64940, 64945
n.17 (2016) (‘‘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 registrant. Rather, it is
an inquiry which focuses on protecting
the public interest; what matters is the
seriousness of the registrant’s
misconduct.’’ (quoting Jayam KrishnaIyer, M.D., 74 Fed. Reg. 459, 462 (2009)).
While I do not believe that the
Respondent’s transgressions rise to the
level of intentional or knowing
diversion, I do find his multiple and
repeated recordkeeping and prescribing
violations to be sufficiently egregious to
warrant revocation.33 See Dewey C.
Administrator to draw an adverse inference from
[the Respondent’s] failure to testify’’). I note,
however, that even absent the adverse inference,
there is sufficient evidence to support the
conclusion that the Respondent has not accepted
responsibility for his improper prescribing and
dispensing of controlled substances.
32 Although the Respondent also stipulated to
many of the facts underlying the allegations contain
in paragraphs 7 and 9 of the OSC, those stipulations
do not admit to any misconduct. They just admit
to facts. The essence of the allegations contained in
paragraphs 7 and 9 of the OSC is that the
Respondent’s actions involving controlled
substances were outside the course of professional
practice and furthered no legitimate medical
purposes.
33 I acknowledge that the Respondent has taken
some remedial steps to reduce the likelihood that
his actions would result in future violations of the
CSA and/or its implementing regulations.
Nevertheless, a registrant does not accept
VerDate Sep<11>2014
19:03 Feb 20, 2019
Jkt 247001
MacKay, M.D., 75 Fed. Reg. 49956,
49974 n.35 (2010) (‘‘[U]nder the public
interest standard, DEA has authority to
consider those prescribing practices of a
physician, which, while not rising to the
level of intentional or knowing
misconduct, nonetheless create a
substantial risk of diversion.’’).
RECOMMENDATION
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Navinta LLC
ACTION:
The Government established that the
Respondent’s continued registration is
inconsistent with the public interest
because of his improper recordkeeping
and improper prescribing, and/or
dispensing, of controlled substances to
himself, his family, and his patients.
While the Respondent admitted to many
of the Government’s factual allegations,
he failed to fully accept responsibility
and acknowledge that his egregious
actions fell below the standard of care
in the State of Connecticut, and/or
lacked any legitimate medical purpose.
Accordingly, I RECOMMEND that the
Respondent’s DEA COR be REVOKED
and that any application for renewal of
his registration be DENIED.
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before April 22, 2019.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
Dated: May 25, 2017
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
s/Charles Wm. Dorman
respect to the promulgation and
U.S. Administrative Law Judge
implementation of 21 CFR part 1301,
incident to the registration of
CERTIFICATE OF SERVICE
manufacturers, distributors, dispensers,
This is to certify that the undersigned, importers, and exporters of controlled
on May 25, 2017, caused a copy of the
substances (other than final orders in
foregoing to be transmitted via facsimile connection with suspension, denial, or
and placed in interoffice mail addressed revocation of registration) has been
to Paul A. Dean, Esq., Office of Chief
delegated to the Assistant Administrator
Counsel, Drug Enforcement
of the DEA Diversion Control Division
Administration, 8701 Morrissette Drive, (‘‘Assistant Administrator’’) pursuant to
section 7 of 28 CFR part 0, appendix to
Springfield, VA 22152; facsimile (202)
subpart R.
307–4946, and a copy to be transmitted
via facsimile and mailed, postage
In accordance with 21 CFR
prepaid, to counsel for the Respondent,
1301.33(a), this is notice that on
Ronald W. Chapman, II, Esq. and Robert September 13, 2018, Navinta, LLC.,
J. Andretz, Esq., 1441 West Long Lake
1499 Lower Ferry Road, Ewing, New
Road, Suite 310, Troy, Michigan 48098;
Jersey 08618–1414 applied to be
facsimile (248) 644–6324.
registered as a bulk manufacturer of the
lllllllllllllllllll following basic classes of controlled
substances:
Rhonda L. Gore
Secretary to Judge Charles Wm. Dorman
Office of Administrative Law Judges
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug
code
Schedule
[FR Doc. 2019–02865 Filed 2–20–19; 8:45 am]
BILLING CODE 4410–09–P
responsibility for its actions simply by taking
remedial measures. Holiday CVS, L.L.C., d/b/a CVS/
Pharmacy Nos. 219 & 5195, 77 Fed. Reg. 62316,
62346 (2012). Further, where a registrant has not
accepted responsibility it is not necessary to
consider evidence of the registrant’s remedial
measures. Jones Total Health Care Pharmacy, L.L.C.
& SND Health Care, L.L.C., 81 Fed. Reg. 79188,
79202–03 (2016).
PO 00000
Frm 00095
Fmt 4703
Sfmt 4703
Pentobarbital ............
4-Anilino-Nphenethyl-4-piperidine (ANPP).
Levorphanol ..............
Remifentanil ..............
Fentanyl ....................
2270
8333
II
II
9220
9739
9801
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers.
E:\FR\FM\21FEN1.SGM
21FEN1
]]>Agencies
[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5479-5498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02865]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17-01]
Ajay S. Ahuja, M.D.; Decision and Order
On May 25, 2017, Administrative Law Judge (ALJ) Charles Wm. Dorman
issued the attached Recommended Decision (R.D.).\1\ Neither party filed
exceptions to the ALJ's Recommended Decision. Having reviewed the
entire record, I have decided to adopt the ALJ's findings of fact as
modified,\2\ conclusions of law, and recommended sanction except as
explained below.
---------------------------------------------------------------------------
\1\ All citations to the Recommended Decision are to the slip
opinion issued by the ALJ.
\2\ I have modified the Recommended Decision by replacing the
full name of DEA and state law enforcement officials with their
initials. I have indicated where I have made these modifications in
the Recommended Decision with brackets.
---------------------------------------------------------------------------
Respondent's Registration Status
Respondent is the holder of DEA Certificate of Registration
AA3029293, pursuant to which he is authorized to dispense controlled
substances in schedules II through V as a practitioner, at the
registered address of 825 High Ridge Road, Stamford, Connecticut.
Government Exhibit (GX) 1, at 1. Although not alleged in the Order to
Show Cause, see Administrative Law Judge Exhibit (ALJ Ex.) 1, I also
find that the administrative record in this case and this Agency's
registration records, of which I take official notice,\3\ show that
Respondent is the holder of DATA-Waiver Identification Number
XA3029293. See GX 1, at 1. Respondent's DATA-Waiver authority
authorized him 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 275 patients. 21 CFR 1301.28(a) &
(b)(1)(iii).
---------------------------------------------------------------------------
\3\ Under the Administrative Procedure Act (APA), an agency
``may take official notice of facts at any stage in a proceeding--
even in the final decision.'' U.S. Dept. of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and
DEA's regulations, Respondent is ``entitled on timely request to an
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). To allow Respondent the opportunity to refute the
facts of which I take official notice, Respondent may file a motion
for reconsideration within 15 calendar days of service of this order
which shall commence on the date this order is mailed.
---------------------------------------------------------------------------
Respondent's registration was due to expire on June 30, 2017. GX 1,
at 1. Although the ALJ correctly indicated that the record before him
did ``not contain evidence that the Respondent filed an application of
renewal,'' R.D., at 2 n.1, the Agency's registration records do
indicate, and I take official notice,\4\ that Respondent submitted a
renewal application on May 9, 2017. Because Respondent has submitted a
timely renewal application, I find that Respondent's registration has
remained in effect pending the issuance of this Decision and Final
Order. See 5 U.S.C. 558(c); 21 CFR 1301.36(i). Moreover, because
Respondent's DATA-Waiver authority is contingent on Respondent being a
practitioner with a valid DEA registration, see 21 U.S.C. 823(g)(2)(A);
21 CFR 1301.28(a), I find that Respondent's DATA-Waiver authority also
remained in effect pending issuance of this Decision and Final Order.
Thus, this case remains a live controversy, and I have jurisdiction to
decide this matter.
---------------------------------------------------------------------------
\4\ I take official notice of this fact pursuant to the same
authority set forth supra in footnote 3.
---------------------------------------------------------------------------
Respondent's Corrective Action Plan
After submitting a timely request for a hearing on October 6, 2016,
see ALJ Ex. 2, Respondent submitted a Corrective Action Plan (CAP)
pursuant to 21 U.S.C. 824(c)(2)(C) on October 25, 2016 to the Deputy
Assistant Administrator of DEA's Office of Diversion Control. ALJ Ex.
9. As part of his CAP, Respondent promised that he: (1) ``will not
order or dispense controlled substances;'' (2) ``will no longer
prescribe controlled substances to his family members;'' (3) ``will
retain an independent monitor to review and evaluate his practice;''
(4) ``will continue to educate himself on issues related to drug
diversion and enroll in related continuing medical education;'' (5)
``will cooperate with DEA in a candid and truthful manner in future
communications with DEA;'' and (6) ``will authorize DEA to access all
his prescribing records for controlled substances in the Connecticut
Prescription Monitoring and Reporting System (`CPMRS').'' Id. at 2-3.
On November 4, 2016, the Assistant Administrator of DEA's Diversion
Control Division 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 Exhibit A (Letter from then-
Assistant Administrator Louis J. Millione to Respondent (dated November
4, 2016)) to ALJ Ex. 11, at 1. I conclude that the facts set forth in
the adopted Recommended Decision demonstrate that the Agency had
adequate grounds to deny Respondent's CAP. Thus, I agree with the
Agency's denial of Respondent's CAP, and I too reject it.
Pre-Hearing Identification of Documents Used To Impeach a Witness on
Cross-Examination
In his Recommended Decision, the ALJ criticized the Government's
use of the Respondent's earlier deposition testimony \5\ to impeach
Respondent during cross-examination because, inter alia, ``the
Government had not identified the deposition transcript as a document
it intended to use prior to the hearing.'' R.D., at 10. I do not adopt
the ALJ's suggestion that a party is precluded from using information
or a document to impeach a witness during cross-examination unless it
is identified prior to the administrative hearing. The APA states that
``[a] party is entitled . . . to conduct such cross-examination as may
be required for a full and true disclosure of the facts.'' 5 U.S.C.
556(d). Likewise, Agency precedent has applied this APA standard to
hold that ALJs lack the authority to preclude a party from using
relevant information to impeach a witness during cross-examination. See
Trinity II, 83 FR 7304, 7322 n.43 (2018)
[[Page 5480]]
(``the CALJ lacks the authority to preclude a respondent from using
relevant information to impeach a witness during cross-examination'')
(citing 5 U.S.C. 556(d)); Farmacia Yani, 80 FR 29053, 29063 n.25 (2015)
(finding that it was prejudicial error to preclude a respondent from
using a document to impeach a witness on cross-examination, even where
respondent had failed to present the document to the Government in
advance of the hearing). Thus, all parties have the right to use any
relevant information to impeach a witness, regardless of whether the
party disclosed that information prior to the administrative hearing.
---------------------------------------------------------------------------
\5\ The deposition of Respondent apparently occurred in
connection with a civil case brought by the United States Attorney's
Office for the District of Connecticut against Respondent. See
Transcript 61-62, 64, 109-10, 291; United States v. Ahuja, No. 3:14-
CV-1558, 2017 WL 1807561 (D. Conn. May 5, 2017), aff'd, 736 F. App'x
20 (2d Cir. 2018).
---------------------------------------------------------------------------
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. AA3029293 and DATA-Waiver Identification Number
XA3029293, issued to Ajay S. Ahuja, M.D., be, and they hereby are,
revoked. I further order that any pending application of Ajay S. Ahuja
to renew or modify the above registration, or any pending application
of Ajay S. Ahuja for any other registration, be, and it hereby is,
denied. This Order is effective immediately.
Dated: February 10, 2019.
Uttam Dhillon,
Acting Administrator.
Paul A. Dean, Esq., for the Government
Ronald W. Chapman II, Esq., and Robert J. Andertz, Esq., for the
Respondent
RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION
OF THE ADMINISTRATIVE LAW JUDGE
Charles Wm. Dorman, Administrative Law Judge.
The Drug Enforcement Administration (``DEA'' or ``Government'')
served Ajay S. Ahuja, M.D., (``Respondent'') with an Order to Show
Cause (``OSC''), seeking to revoke his DEA Certificate of Registration
(``COR''), Number AA3029293. Administrative Law Judge Exhibit (``ALJ-
'') 1. In response to the OSC, the Respondent timely requested a
hearing before an Administrative Law Judge. ALJ-2. The hearing in this
matter was held in Hartford, Connecticut on March 13, 2017.
The issue before the Administrator is whether the record as a whole
establishes that the Respondent's COR should be revoked and any pending
applications \6\ be denied because the Respondent's registration would
be inconsistent with the public interest under 21 U.S.C. Sec. Sec.
824(a)(4) and 823(f).
---------------------------------------------------------------------------
\6\ The Respondent's COR will expire by its terms on June 30,
2017. ALJ-1, at 1. The record does not contain any evidence that the
Respondent filed an application for renewal. See 21 C.F.R. Sec.
1301.36(i); Richard J. Settles, D.O., 81 FR 64940, 64940-42, (2016).
---------------------------------------------------------------------------
This Recommended Decision is based on my consideration of the
entire administrative record, including all of the testimony, admitted
exhibits, and the oral and written arguments of counsel.
ALLEGATIONS
I. Improper Recordkeeping
1. Between February 2012 and February 2014, the Respondent failed
to maintain accurate dispensing records for the following controlled
substances, in violation of 21 U.S.C. Sec. 827(a)(3), 21 C.F.R. Sec.
1304.21(a), and Conn. Agencies Regs. Sec. 21a-326-1(d)(2), (6) \7\:
Alprazolam 1 mg tablets (Schedule IV), Hydrocodone Bitartrate with
Acetaminophen 10/650 mg tablets (Schedule III), Guaifenesin with
Codeine Phosphate 10 mg syrup (Schedule V), Testosterone Cypionate 200
mg/mL injectable (Schedule III), and Zolpidem Tartrate ER 12.5 mg
tablets (Schedule IV). ALJ-1, at 2-3.
---------------------------------------------------------------------------
\7\ In the OSC and Government's Prehearing Statement, many of
the Government's citations to the Connecticut statutes and
regulations were incorrect. See ALJ-1; ALJ-13, at 12. This issue was
addressed during the December 5, 2016 Prehearing Conference, and in
my Prehearing Order, issued the same day, and the Government was
ordered to prepare copies of the Connecticut statutes and
regulations it intended to rely upon. ALJ-20, at 2. In its
Supplemental Prehearing Statement, the Government provided an
updated list and copies of the correct Connecticut statutes and
regulations. ALJ-30, at 12, attach. A. Accordingly, the Respondent
was put on notice of the Connecticut statutes and regulations that
the Government alleged the Respondent violated. I refer to these
updated statutes and regulations in this Recommended Decision.
---------------------------------------------------------------------------
2. Between February 2012 and February 2014, the Respondent was
unable to account for the following controlled substances, in violation
of 21 U.S.C. Sec. 827(a)(3), 21 C.F.R. Sec. 1304.21(a), and Conn.
Agencies Regs. Sec. 21a-326-1(d)(2), (6): 59 bottles (approximately
5310 tablets) of Alprazolam 1 mg tablets (nearly 10% of total supply),
21 bottles (approximately 630 tablets) of Hydrocodone 10/650 mg tablets
(approximately 17.5% of total supply), 58 bottles of Guaifenesin with
Codeine Phosphate 10 mg syrup (approximately 27.36% of total supply), 2
vials of Testosterone Cypionate 200 mg/mL injectable (entire supply),
and 3 bottles (90 tablets) of Zolpidem Tartrate ER 12.5 mg tablets
(entire supply). ALJ-1, at 2-3.
3. Between December 2011 and February 2014, the Respondent failed
to maintain a dispensing log in accordance with federal law for the
following controlled substances: Alprazolam 1 mg tablets, Hydrocodone
10/650 mg tablets, and Guaifenesin with Codeine Phosphate 10 mg syrup.
ALJ-1, at 2-3. Specifically, the Respondent's dispensing records did
not include the typewritten or written initials of the dispensing
physician and/or the address of the person to whom the medication was
dispensed, in violation of 21 U.S.C. Sec. 827(a)(3), 21 C.F.R.
Sec. Sec. 1304.22(c), Conn. Gen. Stat. Sec. 21a-254(f), and Conn.
Agencies Regs. Sec. 21a-326-1(d)(2), (6). ALJ-1, at 2-3.
4. Between February 2012 and January 2014, the Respondent failed to
maintain controlled substance receipts for the following orders of
controlled substances, in violation of 21 U.S.C. Sec. 842(a)(5), 21
C.F.R. Sec. Sec. 1304.04(a) and 1304.21(a), Conn. Gen. Stat. Sec.
21a-254(c), and Conn. Agencies Regs. Sec. 21a-326-1(d)(2), (6): 17
shipments of Alprazolam 1 mg tablets, 8 shipments of Hydrocodone
Bitartrate with Acetaminophen 10/650 mg tablets, 7 shipments of
Guaifenesin with Codeine Phosphate 10 mg syrup, a shipment of
Testosterone Cypionate 200 mg/mL injectable, and a shipment of Zolpidem
Tartrate ER 12.5 mg tablets from A&S Medical Solutions, and 10
shipments of Lyrica 75 mg tablets, and 8 shipments of Lyrica 50 mg
tablets from J. Knipper & Company, Inc. ALJ-1, at 3-4.
5. Between December 2011 and February 2014, the Respondent failed
to separate his Schedule III-V controlled substance records from his
non-controlled substance records, in violation of 21 C.F.R. Sec.
1304.04(f)(2), Conn. Gen. Stat. Sec. 21a-254(f), and Conn. Agencies
Regs. Sec. 21a-326-1(d)(2), (6). ALJ-1, at 4.
6. The Respondent failed to perform and maintain a biennial
inventory of controlled substances, in violation of 21 U.S.C. Sec.
827(a)(1), 21 CFR Sec. 1304.11(c), Conn. Gen. Stat. Sec. 21a-254(h),
and Conn. Agencies Regs. Sec. 21a-326-1(d)(2), (6). ALJ-1, at 4.
7. The Respondent failed to report to the Connecticut State
Commissioner of Consumer Protection that he was engaging in dispensing
drugs, and failed to biennially notify the Commissioner of his intent
to continue to dispense drugs, in violation of Conn. Gen. Stat.
Sec. Sec. 20-14f and 21a-317 and 21 C.F.R. Sec. 1306.03(a)(1). ALJ-1,
at 5.
[[Page 5481]]
II. Improper Prescribing to Himself & Family Members
8. Between 2012 and 2014, the Respondent issued controlled
substance prescriptions to himself and his family members for other
than a legitimate medical purpose and outside the course of
professional practice, in violation of Conn. Gen. Stat. Sec. Sec. 20-
14e(b), 21a-322(3), (8), (10), 21a-252(a), Conn. Agencies Regs. Sec.
21a-326-1(c), (d), and 21 C.F.R. Sec. 1306.04(a). ALJ-1, at 5-6.
III. Improper Prescribing to Patients
9. The Respondent issued controlled substance prescriptions to
patients for other than a legitimate medical purpose and outside the
course of professional practice, in violation of Conn. Gen. Stat.
Sec. Sec. 20-14e(b), 21a-322(3), (8), (10), 21a-252(a), Conn. Agencies
Regs. Sec. 21a-326-1(c), (d), and 21 C.F.R. Sec. 1306.04(a). ALJ-1,
at 6-10.
a. Specifically, on at least 20 occasions between May 2012 and
November 2014, the Respondent issued multiple overlapping prescriptions
for controlled substances to his patients, which made it possible for
these patients to receive early refills of controlled substances and
facilitated potential diversion of those controlled substances. ALJ-1,
at 6-7.
b. On at least 35 occasions involving at least eight of the
Respondent's patients between July 2010 and November 2014, the
Respondent issued prescriptions to those patients without any
documentation of those prescriptions, or any bases for the
prescriptions, in the patient's record, in violation of Conn. Gen.
Stat. Sec. Sec. 20-14e(b), 21a-322(3), (8), (10), 21a-252(a), Conn.
Agencies Regs. Sec. 21a-326-1(c), (d), and 21 C.F.R. Sec. 1306.04(a).
ALJ-1, at 7-8.
c. On at least 9 occasions involving at least three of the
Respondent's patients between April 2011 \8\ and March 2014, the
Respondent dispensed controlled substances to those patients from his
office supply without any documentation of those dispenses, or any
bases for those dispenses, in the patient's records, in violation of
Conn. Gen. Stat. Sec. Sec. 20-14e(b), 21a-322(3), (8), (10), 21a-
252(a), Conn. Agencies Regs. Sec. Sec. 21a-326-1(c), (d), and 21
C.F.R. Sec. 1306.04(a). ALJ-1, at 8.
---------------------------------------------------------------------------
\8\ Paragraph 9(c) of the OSC lists the inclusive dates as
February 2012 and March 2014. ALJ-1 at 8. Subparagraph 9(c)(ii) of
the OSC, however, lists the dates as April 2011 and March 2014. ALJ-
1, at 8. Further, the Respondent stipulated to the dates of April
2011 and March 2014. ALJ-32, at 6, para. 42. Thus, the Respondent
was on notice that the inclusive dates for this allegation were
April 2011 and March 2014.
---------------------------------------------------------------------------
d. On at least 26 occasions involving at least seven of the
Respondent's patients between April 2011 and October 2014 the
Respondent issued prescriptions to those patients without sufficient
documentation of those prescriptions, or any bases for the
prescriptions, in the patient's records, in violation of Conn. Gen.
Stat. Sec. Sec. 20-14e(b), 21a-322(3), (8), (10), 21a-252(a), Conn.
Agencies Regs. Sec. 21a-326-1(c)(d), and 21 C.F.R. Sec. 1306.04(a).
ALJ-1, at 9.
e. On at least 45 occasions involving at least seven patients
between May 2010 and March 2014, the Respondent dispensed controlled
substance prescriptions from his office supply without sufficient
documentation of those dispenses, or sufficient documentation of the
bases for them, in the patient's records, in violation of Conn. Gen.
Stat. Sec. 20-14e(b), 21a-322(3), (8), (10), 21a-252(a), Conn.
Agencies Regs. Sec. 21a-326-1(c)(d), and 21 C.F.R. Sec. 1306.04(a).
ALJ-1, at 10.
IV. Failure to Maintain Adequate Security
10. The Respondent failed to maintain adequate security for the
controlled substances in his possession, in violation of 21 C.F.R.
Sec. 1301.75(b) and Conn. Agencies Regs. Sec. Sec. 21a-262-6(a)-(c),
21a-326-1(d). ALJ-1, at 11.
V. Other Conduct Threatening the Public Health and Safety (Factor Five)
11. Additionally, the Respondent engaged in conduct which may
threaten the public health and safety, in violation of 21 U.S.C. C.F.R.
Sec. 823(f)(5). ALJ-1, at 11.
WITNESSES
I. The Government's Witnesses
The Government presented its case through the testimony of five
witnesses. First, the Government presented the testimony of [R.M.],
Director of the Drug Control Division of the State of Connecticut. Tr.
15-32. [R.M.] has held his current position for under a year, and he
was previously a Connecticut Drug Control Agent. Tr. 15-16. [R.M.]
testified concerning his background, training, and previous experience.
Tr. 16. Along with DEA Diversion Investigator [N.C.], [R.M.] was
involved in the removal of controlled substances from the Respondent's
clinic. Tr. 18. Additionally, [R.M.] testified about the nature and
workings of Connecticut's Prescription Monitoring Program (``PMP'') and
that physicians who dispense controlled substances are required to
report that dispensing to the Connecticut PMP. Tr. 17-18. I find
[R.M.]'s testimony to be thorough, detailed, and internally consistent.
Therefore, I merit it as credible in this Recommended Decision.
Second, the Government presented the testimony of DEA Diversion
Investigator [N.C.]. Tr. 33-48. [N.C.] has been stationed at the DEA
Camden Resident Office in Maple Shade, New Jersey since November 28,
2016, but was previously stationed at the DEA Hartford Resident Office
in Rocky Hill, Connecticut. Tr. 33-34. [N.C.] testified concerning his
background, training, and experience as a diversion investigator for
the DEA. Tr. 34. [N.C.] testified that his Group Supervisor, [L.L.],
directed him to assist the State of Connecticut in retrieving
controlled substances from the Respondent's clinic. Tr. 35. [N.C.]
testified that he went with [R.M.] to the Respondent's clinic to pick-
up the Respondent's expired controlled substances. Tr. 36-37. I find
[N.C.]'s testimony to be thorough and internally consistent. Therefore,
I merit [N.C.]'s testimony as credible in this Recommended Decision.
Third, the Government presented the testimony of [P.L.], who was a
Drug Control Agent with the Connecticut Department of Consumer
Protection. Tr. 49-78. [P.L.] is currently a pharmacist with the Food
and Drug Administration, a position she has held since January 2017.
Tr. 49. [P.L.] worked with the State of Connecticut Drug Division
during the course of the investigation into the Respondent. Tr. 49.
[P.L.] testified as to how the investigation into the Respondent began
and about how she contacted Diversion Investigator [M.J.] to assist
with the investigation. Tr. 51-52. In January 2014, [P.L.] went with
[M.J.] to the Respondent's clinic to ask the Respondent some questions.
Tr. 55. [P.L.] testified about her interactions with the Respondent
during this visit, specifically, statements the Respondent made
concerning why the investigators were asking the Respondent about
alprazolam, as he did not believe that it was a diverted or abused
substance. Tr. 55. [P.L.] and [M.J.] went back to the Respondent's
clinic in February 2014 to execute an Administrative Inspection Warrant
(``AIW''). Tr. 59. Additionally, [P.L.] testified about the security
measures in place for controlled substances at the Respondent's clinic
during both of her visits, and how these measures violated Connecticut
state regulations. Tr. 64-65. Finally, [P.L.] testified concerning an
e-mail correspondence that she had with the Respondent, in which he
requested assistance with his expired controlled substances. Tr. 63. I
find [P.L.]'s testimony to be thorough, detailed, and internally
consistent. Therefore, I merit
[[Page 5482]]
it as credible in this Recommended Decision.
Fourth, the Government presented the testimony of DEA Diversion
Investigator [M.J.]. Tr. 79-140. [M.J.] testified that she has held her
position for six years, and discussed her background and thirteen-week
training at the DEA Training Academy at Quantico. Tr. 80. [M.J.]
initially became involved in the investigation into the Respondent when
she was requested to assist the Connecticut Drug Control Division in
their investigation of the Respondent. Tr. 80-81. [M.J.] testified
about how she and [P.L.] pulled PMP records for the Respondent. Tr. 81-
82.
[M.J.] also testified about her meeting with the Respondent in
January 2014 and some of the advisements that she and [P.L.] provided
the Respondent with regards to the Respondent's recordkeeping and
security practices. Tr. 84-86. Additionally, [M.J.] testified about
statements the Respondent made questioning why she and [P.L.] were
investigating the Respondent's benzodiazepine prescriptions because he
did not believe they were being diverted or abused. Tr. 87. [M.J.] also
testified about the events that took place on February 21, 2014, when
she, along with [P.L.], another diversion investigator, and two
Connecticut police officers, served the Respondent with an AIW. Tr. 94.
I find [M.J.]'s testimony to be thorough, detailed, and internally
consistent. Therefore, I merit it as credible in this Recommended
Decision.\9\
---------------------------------------------------------------------------
\9\ I found [M.J.]'s testimony to be disingenuous concerning her
knowledge of the DEA policy concerning the use of DEA Form 82, and
whether the form included an advisement to a practitioner of the
right to counsel at the time of an inspection. Given her experience
and the ``hundreds'' of times she has used DEA Form 82, that portion
of her testimony was not credible. Nevertheless, that testimony
concerned only a peripheral issue in this case, and it does not
detract from the credibility of the remainder of her testimony. Tr.
112-14, 137-38.
---------------------------------------------------------------------------
Finally, the Government presented the testimony of Adam Perrin,
M.D. (``Dr. Perrin''). Tr. 141-209. Dr. Perrin was accepted as an
expert, without objection, in the field of clinical medicine in the
State of Connecticut with respect to prescribing controlled substances.
Tr. 149, 153. Dr. Perrin is currently employed by the University of
Connecticut School of Medicine and specializes in family medicine and
primary care sports medicine. Tr. 141, 143. He also maintains a medical
license in the State of Connecticut, a Certificate of Added
Qualification in Primary Care Sports Medicine, a Certificate from the
American College of Medical Quality, and is Board Certified in Family
Medicine. Tr. 143-44. Additionally, Dr. Perrin does team physician work
for Wesleyan University, and consulting work for the Livanta
Organization, where he conducts peer reviews of cases and determines
the appropriateness of a patient's discharge and whether the patient
was at the necessary level of care. Tr. 142.
Dr. Perrin testified that he has taken continuing medical education
courses in the areas of controlled substances and pain management, most
recently through the Connecticut State Medical Society. Tr. 144. He
also testified that he has experience treating patients with controlled
substances, specifically opiates, dealt with addictive issues of
patients, and is familiar with the risks of prescribing controlled
substances. Tr. 146-47. He testified that he is familiar with the
standards of care in the State of Connecticut and is ``familiar with
how doctors should conduct themselves in Connecticut while prescribing
controlled substances for a legitimate medical purpose.'' Tr. 148. This
body of knowledge is based on Dr. Perrin's experience as a physician
and as a teacher of physicians. Tr. 147.
Dr. Perrin testified about Suboxone, what it is and what it is used
for. Tr. 153-55. Dr. Perrin reviewed the Ahuja family patient file,
Government Exhibit 11, as well as prescriptions written by Dr. Ahuja to
his family members to determine whether the records revealed any
therapeutic duplication of controlled substances. Tr. 157-59.
Additionally, Dr. Perrin reviewed copies of prescriptions written by
the Respondent and was asked to compare those prescriptions to the
patient files for members of the Respondent's family to determine if
the prescriptions were documented in those patient files. Tr. 159-63.
Dr. Perrin reviewed the Stipulations of Fact, ALJ-32, and was asked
his opinion with respect to the standard of care. Tr. 164-82.
Specifically, Dr. Perrin discussed the potential harm of overlapping
prescriptions, Tr. 165, 178, and why having inadequate or no
documentation in a patient's file would fall below the standard of care
in Connecticut. Tr. 166, 202-04.
I find Dr. Perrin's testimony to be thorough, detailed, and
internally consistent. Therefore, I merit is as credible in this
Recommended Decision.\10\
---------------------------------------------------------------------------
\10\ I note that Dr. Perrin mistakenly testified that Suboxone
is a Schedule II controlled substances, when it is actually Schedule
III. Tr. 154. I also found Dr. Perrin's testimony concerning the
reason that he would not write prescriptions for himself or for
family members to be less than convincing. Specifically, he
testified that there is no law or regulation in Connecticut that
prevents a doctor from writing a prescription for himself or for
family members, but, based on guidance from the American Medical
Association (``AMA''), it would be considered an ethical violation
to do so. Tr. 194. He further testified that few physicians are
aware of the AMA guidelines. Tr. 196-97. He then testified that he
would not write such prescriptions because he would be worried about
his own license and what his peers might think. Tr. 196, 205. Dr.
Perrin finally testified he would not write such prescriptions as a
matter of personal philosophy. Tr. 205-06. These two minor areas of
Dr. Perrin's testimony, do not undermine my assessment that,
overall, his testimony is credible and merits significant weight.
---------------------------------------------------------------------------
II. The Respondent's Witness
The Respondent presented his case through his own testimony. Tr.
210-303. The Respondent testified concerning his background, medical
education and training. Tr. 211-14. The Respondent also testified as to
how he began treating Suboxone patients and the nature of his treatment
of these patients. Tr. 216-24. He testified that currently about 80% of
his medical practice is devoted to treatment of Suboxone patients. Tr.
217. The Respondent also testified about his treatment of patient D.M.,
and about a prescription he wrote to this patient for Percocet. Tr.
225-26. Additionally, the Respondent testified about the security
measures present in his clinic, including an alarm system, and where he
stored his controlled substances. Tr. 227-34. The Respondent also
testified as to his interactions with [M.J.] and [P.L.] during their
investigation in 2014. Tr. 238, 254-56.
Throughout his testimony on direct examination, the Respondent
testified about his changing opinions with regards to what controlled
substances are being abused and diverted, Tr. 238-39, and various
patient behaviors that present red flags. Tr. 240-42. His opinions
changed after he took medical education courses which changed the way
he practiced medicine and prescribed controlled substances. Tr. 239-51.
The Respondent also testified that during a course he took in January
2017 he learned the importance of documenting the treatment he provided
to his patients. Tr. 246.
While the Respondent testified with confidence and clarity during
direct examination, his testimony on cross examination was somewhat
combative, confusing, and evasive. For example, when the Respondent was
asked to compare the content of the OSC with the facts he had
stipulated to, he was unable to do so. Tr. 259-63. When the Respondent
was asked if his testimony on several issues was different at the
hearing than at an earlier deposition, and when showed the transcript
of the deposition, the Respondent was unable to recall. Tr. 279-92.
When asked twice
[[Page 5483]]
when his office associate, Dr. Jacobson, left the Respondent's medical
practice, the Respondent gave rambling answers, but he did not answer
the question of when Dr. Jacobson left. In addition, when badgered as
to the number of Suboxone patients that he treats, the Respondent
eventually did not even give an approximate number. Tr. 275-79.
While combativeness, confusion and evasiveness tend to undermine
the credibility of a witness, here the combativeness, confusion and
evasiveness concerned issues of little significance. For example,
having the Respondent agree that the factual allegations contained in
the OSC matched many of the facts to which the Respondent had already
stipulated was meaningless. The two documents speak for themselves.
Further, the Government's use of the Respondent's earlier deposition
testimony was a meaningless exercise for several reasons. First, the
Government had not identified the deposition transcript as a document
it intended to use prior to the hearing. Second, the issues the
Government questioned the Respondent about, based upon his deposition
testimony, do not relate to the allegations contained in the OSC,
except for the disposition of some cough syrup, where the Respondent
admitted he took some home. Tr. 291, 298. Third, it had minimal
impeachment value. Finally, as the Respondent noted, the exact number
of Suboxone patients the Respondent treats, so long as it is less than
the number he is allowed to treat, is of no consequence to this
decision. Accordingly, when accessing the Respondent's credibility, I
find that the clear and confident manner in which the Respondent
testified on direct examination outweighs the manner in which he
testified on cross examination. Further, when comparing his testimony
to that of other witnesses, I find that it was generally consistent
with that of the Government's witnesses. Thus, I find the Respondent's
testimony credible on all relevant factual issues. I, however, find it
less credible than that of other witnesses in one area.
The Respondent testified that he did not recall telling [M.J.] and
[P.L.] that benzodiazepines are not commonly diverted or abused. Tr.
282. [P.L.] testified that the Respondent did not understand why she
was concerned about alprazolam, which is a benzodiazepine, because he
did not think it was diverted or abused. Tr. 55. [M.J.] also testified
that she heard the Respondent make a similar statement. Tr. 87. The
Respondent testified that he told [M.J.] and [P.L.] that oxycodone was
more addictive than a benzodiazepine. Tr. 253, 282. Given the
Respondent's acknowledgement of discussing the topic and his inability
to recall if he made the statement reported by both [M.J.] and [P.L.],
I credit their testimonies on this issue.
The parties stipulated to the authenticity of all of the
Government's exhibits, accordingly, all of the Government's exhibits
were admitted into evidence. Tr. 8. Additionally, the parties
stipulated to the authenticity of Respondent Exhibits A, C-J,
accordingly, these exhibits were also entered into evidence. Tr. 9.
The factual findings below are based on a preponderance of the
evidence, including the detailed, credible, and competent testimony of
the aforementioned witnesses, the exhibits entered into evidence, and
the record before me.
STIPULATIONS OF FACT \11\
---------------------------------------------------------------------------
\11\ These stipulations of fact are numbered the same manner as
those found in ALJ-32, and also correspond to the references made to
a specific stipulation mentioned in the transcript.
---------------------------------------------------------------------------
The Government and the Respondent stipulated the following facts
(``Stip. of Fact''):
1. Respondent is registered with the DEA as a practitioner to
handle Controlled Substances in Schedules II-V under DEA COR AA3029293
at 825 High Ridge Road, Stamford, Connecticut 06905-1904.
2. Respondent is presently licensed in Connecticut as a medical
doctor (M.D.) with medical license 25539.
3. On February 21, 2014, DEA executed an Administrative Inspection
Warrant at Respondent's medical practice. During the execution of the
warrant, DEA and state drug control agents reviewed documentation of
Respondent's recordkeeping practices related to his obligations under
the Controlled Substances Act (CSA), its regulations, and state law.
Recordkeeping Violations
4. Between February 2012 and February 2014, Respondent failed to
maintain accurate dispensing records for his dispensation of Alprazolam
1 mg tablets, a Schedule IV controlled substance, and was unable to
account for 59 bottles (approximately 5310 tablets) of Alprazolam 1 mg
tablets received from his supplier.
5. Between February 2012 and February 2014, Respondent failed to
maintain a dispensing log for Alprazolam 1 mg tablets in accordance
with federal law. In particular, Respondent's dispensing records did
not include the typewritten or written initials of the dispensing
physician and/or the address of the person to whom the medication was
dispensed.
6. Between February 2012 and February 2014, Respondent failed to
maintain accurate dispensing records for his dispensation of
Hydrocodone Bitartrate with Acetaminophen 10/650 mg (Hydrocodone 10/650
mg) tablets, a Schedule III controlled substance, and was unable to
account for 21 bottles (approximately 630 tablets) of Hydrocodone 10/
650 mg tablets received from his supplier.
7. Between January 2012 and February 2014, Respondent failed to
maintain a dispensing log for Hydrocodone 10/650 mg tablets in
accordance with federal law. In particular, Respondent's dispensing
records did not include the typewritten or written initials of the
dispensing physician and/or the address of the person to whom the
medication was dispensed.
8. Between February 2012 and February 2014, Respondent failed to
maintain accurate dispensing records for his dispensation of
Guaifenesin with Codeine Phosphate 10 mg syrup, a Schedule V controlled
substance, and was unable to account for 58 bottles of Guaifenesin with
Codeine Phosphate 10 mg syrup received from his supplier.
9. Between December 2011 and February 2014, Respondent failed to
maintain a dispensing log for Guafenesin with Codeine Phosphate 10 mg
syrup in accordance with federal law. In particular, Respondent's
dispensing records did not include the typewritten or written initials
of the dispensing physician and/or the address of the person to whom
the medication was dispensed.
10. Between May 2012 and February 2014, Respondent failed to
maintain accurate dispensing records for his dispensation of
Testosterone Cypionate 200 mg/mL injectable, a Schedule III Controlled
Substance and was unable to account for 2 vials of Testosterone
Cypionate 200 mg/mL injectable received from his supplier.
11. Between August 2013 and February 2014, Respondent failed to
maintain accurate dispensing records for his dispensation of Zolpidem
Tartrate ER 12.5 mg tablets, a Schedule IV controlled substance, and
was unable to account for 3 bottles (90 tablets) of Zolpidem Tartrate
ER 12.5 mg tablets received from his supplier.
12. Between February 2012 and November 2013, Respondent ordered 17
shipments of Alprazolam 1 mg tablets from A&S Medical Solutions.
Respondent failed to maintain
[[Page 5484]]
controlled substance receipt records for any of these shipments.
13. Between February 2012 and November 2013, Respondent ordered 8
shipments of Hydrocodone Bitartrate with Acetaminophen 10/650 mg
tablets from A&S Medical Solutions. Respondent failed to maintain
controlled substance receipt records for any of these shipments.
14. Between February 2012 and November 2013, Respondent ordered 7
shipments of Guaifenesin with Codeine Phosphate 10 mg syrup from A&S
Medical Solutions. Respondent failed to maintain controlled substance
receipt records for any of these shipments.
15. Between February 2012 and January 2014, Respondent ordered a
shipment of Testosterone Cypionate 200 mg/mL injectable from A&S
Medical Solutions. Respondent failed to maintain controlled substance
receipt records for this shipment.
16. Between February 2012 and January 2014, Respondent ordered a
shipment of Zolpidem Tartrate ER 12.5 mg tablets from A&S Medical
Solutions. Respondent failed to maintain controlled substance receipt
records for this shipment.
17. Between February 2012 and January 2014, Respondent ordered 10
shipments of Lyrica 75 mg tablets, a Schedule V controlled substance,
from J. Knipper & Company, Inc. Respondent failed to maintain
controlled substance receipt records for these shipments.
18. Between February 2012 and January 2014, Respondent ordered 8
shipments of Lyrica 50 mg tablets, a Schedule V controlled substance,
from J. Knipper & Company, Inc. Respondent failed to maintain
controlled substance receipt records for these shipments.
19. Between December 2011 and February 2014, Respondent failed to
separate Schedule III-V controlled substance records from his non-
controlled substance records. Specifically, Respondent's Schedule III-V
dispensing logs included dispensing logs for Azithromycin, which is not
a controlled substance.
20. Respondent failed to perform and maintain a biennial inventory
of controlled substances.
21. Respondent failed to report to the State Commissioner of
Consumer Protection that he was engaged in dispensing drugs, and
Respondent failed to biennially notify the Commissioner of his intent
to continue to dispense drugs.
Improper Prescribing to Family Members
22. After the execution of the administrative warrant, DEA issued
Respondent two successive administrative subpoenas for copies of
patient records for several individuals to whom Respondent had issued
controlled substances prescriptions, including Respondent and several
family members.
23. On December 18, 2014, pursuant to an administrative subpoena,
Respondent provided DEA with a copy of, among others, patient records
for himself and certain family members, including N.A., U.A., and G.A.
24. On at least two occasions between December 2012 and December
2014, Respondent either issued, or dispensed, overlapping prescriptions
of controlled substances constituting early fills for himself
(alprazolam 1 mg, Schedule IV) and a family member, N.A., (zolpidem
tartrate 10 mg).
25. On at least seven additional occasions, between February and
September 2014, Respondent either issued a controlled substance
prescription to himself (lorazepam, Schedule IV) or dispensed
controlled substances to himself (guaifenesin with codeine, Schedule V;
alprazolam 1 mg, Schedule IV) with inadequate documentation in the
medical record.
26. On at least five additional occasions, between February and
October 2014, Respondent issued his family member, N.A., prescriptions
for a variety of controlled substances (including Lunesta 3 mg,
Schedule IV; zolpidem tartrate 10 mg, Schedule IV; alprazolam 1 mg,
Schedule IV) with inadequate documentation in the medical record.
27. On at least one additional occasion, between April and December
2014, Respondent issued a controlled substance prescription
(hydrocodone 10 mg/acetaminophen 650 mg (Lorcet), formerly Schedule
III) to family member, G.A., and inadequately documented that
prescription and the basis for it in G.A.'s medical record.
Improper Prescribing to Patients
28. On December 18, 2014 and July 31, 2015, pursuant to DEA
administrative subpoenas, Respondent provided DEA with a copy of
patient records for certain patients, including J.C., J.Cu., W.L.,
L.M., R.P., M.R., A.S., J.T., and J.V.
29. On ten occasions between May and November 2012, Respondent
issued multiple overlapping prescriptions for alprazolam 1 mg (Schedule
IV) to his patient, J.Cu., within days of issuing previous
prescriptions to J.Cu. for the same controlled substance. For example,
in the course of 199 days in which, by Respondent's instructions, J.Cu.
should not have consumed more than 597 dosage units of Alprazolam 1 mg,
Respondent prescribed J.Cu. 1870 dosage units of Alprazolam 1 mg.
30. On five occasions between October and November 2014, Respondent
issued multiple overlapping prescriptions for controlled substances
(Tramadol 50 mg (Schedule IV), Methylphenidate 20 mg (Schedule II), and
dextroamphetamine/amphetamine 20 mg (Schedule II)) to his patient,
J.T., within days of issuing previous prescriptions to J.T. for the
same controlled substances. In the course of 28 days in which, by
Respondent's limited instructions, J.T. should not have consumed more
than 84 dosage units of Tramadol 50 mg, Respondent prescribed or
dispensed to J.T. 540 dosage units of Tramadol. Likewise, Respondent
issued J.T. a prescription for 90 tablets of Methylphenidate 20 mg for
a thirty day supply. Six days later Respondent issued J.T. two
additional prescriptions for a total of 90 additional tablets of
Methylphenidate. On November 15, 2014, Respondent issued J.T. a
prescription for 30 tablets of Dextroamphetamine/Amphetamine 20 mg, a
15 day supply. Three days later, Respondent issued J.T. another
prescription for 45 additional tablets of the same controlled
substance.
31. On four occasions between June and October 2012, Respondent
issued multiple overlapping prescriptions for alprazolam 1 mg to his
patient, A.S., within days of issuing a previous prescription to A.S.
for the same controlled substance. In the course of 133 days in which,
by Respondent's limited instructions, A.S. should not have consumed
more than 399 dosage units of Alprazolam 1 mg, Respondent prescribed or
dispensed to A.S. at least 780 dosage units of Alprazolam 1 mg.
32. On one occasion in October 2012, Respondent issued an
overlapping prescription for alprazolam 1 mg (Schedule IV) to his
patient, M.R., within days of issuing a previous prescription to M.R.
for the same controlled substance. In the course of 28 days in which,
by Respondent's instructions, M.R. should have consumed 42 dosage units
of Alprazolam 1 mg, Respondent prescribed M.R. 150 dosage units of
Alprazolam 1 mg during that time frame.
33. On eight occasions between October and November 2014,
Respondent issued controlled substance prescriptions (including
Tramadol 50 mg (Schedule IV), methylphenidate 20 mg (Schedule II), and
dextroamphetamine/amphetamine 20 mg (Schedule II)) to his patient J.T.
without any documentation of those
[[Page 5485]]
prescriptions, or the bases for them, in the patient's medical record.
34. On seven occasions between July 2010 and July 2014, Respondent
issued controlled substance prescriptions (Diazepam 5 and 10 mg
(Schedule IV)) to his patient L.M. without any documentation of those
prescriptions, or the bases for them, in the patient's medical record.
35. On six occasions between May 2012 and March 2013, Respondent
issued controlled substance prescriptions (including dextroamphetamine/
amphetamine 20 mg and alprazolam 1 mg) to his patient W.L. without any
documentation of those prescriptions, or the bases for them, in the
patient's medical record.
36. On four occasions between May 2012 and February 2013,
Respondent issued controlled substance prescriptions (including
alprazolam 1 mg and phenobarbital 60 mg--both Schedule IV) to his
patient J.Cu. without any documentation of those prescriptions, or the
bases for them, in the patient's medical record.
37. On four occasions between May 2011 and November 2013,
Respondent issued controlled substance prescriptions (Hydrocodone 7.5
mg/Ibuprofen 200 mg (Schedule III)) to his patient R.P. without any
documentation of those prescriptions, or the bases for them, in the
patient's medical record.
38. On four occasions between November 2011 and March 2014,
Respondent issued controlled substance prescriptions (alprazolam 1 mg
(Schedule IV) and Oxycodone 10 mg/Acetaminophen 325 mg (Schedule III))
to his patient M.R. without any documentation of those prescriptions,
or the bases for them, in the patient's medical record.
39. On at least one occasion in December 2013, Respondent issued a
prescription for alprazolam 1 mg (Schedule IV) to his patient J.C.
without any documentation of that prescription, or the basis for it, in
the patient's medical record.
40. On at least one occasion in October 2012, Respondent issued a
prescription for alprazolam 1 mg (Schedule IV) to his patient A.S.
without any documentation of that prescription, or the basis for it, in
the patient's medical record.
41. On five occasions between June 2012 and April 2013, Respondent
dispensed controlled substances (alprazolam 1 mg (Schedule IV) and
hydrocodone 10 mg/acetaminophen 650 mg (Schedule III)) from his office
supply to his patient A.S. without any documentation of those
dispenses, or their bases, in the patient's medical record.
42. On two occasions between April 2011 and March 2014, Respondent
dispensed controlled substances (alprazolam 1 mg (Schedule IV) and
hydrocodone 10 mg/acetaminophen 650 mg (Schedule III)) from his office
supply to his patient W.L. without any documentation of those
dispenses, or their bases, in the patient's medical record.
43. On two occasions between February 2012 and October 2012,
Respondent dispensed controlled substances (hydrocodone 10 mg/
acetaminophen 650 mg (Schedule III)) from his office supply to his
patient J.V. without any documentation of those dispenses, or their
bases, in the patient's medical record.
44. On ten occasions between September 2013 and March 2014,
Respondent issued controlled substance prescriptions
(dextroamphetamine/amphetamine 20 mg and 30 mg (Schedule II) and
alprazolam 1 mg (Schedule IV)) to his patient J.C. with insufficient
documentation of those prescriptions, or the bases for them, in the
patient's medical record.
45. On six occasions between April 2011 and March 2014, Respondent
issued controlled substance prescriptions (dextroamphetamine/
amphetamine 20 mg) to his patient W.L. with insufficient documentation
of those prescriptions, or the bases for them, in the patient's medical
record.
46. On at least two occasions between May 2012 and February 2013,
Respondent issued controlled substance prescriptions (phenobarbital 60
mg (Schedule IV) and alprazolam 1 mg (Schedule IV)) to his patient
J.Cu. with insufficient documentation of those prescriptions, or the
bases for them, in the patient's medical record.
47. On at least two occasions between February 2013 and July 2013,
Respondent issued controlled substance prescriptions (diazepam 10 mg
(Schedule IV)) to his patient L.M. with insufficient documentation of
those prescriptions, or the bases for them, in the patient's medical
record.
48. On at least two occasions between April 2012 and October 2012,
Respondent issued controlled substance prescriptions (hydrocodone 10
mg/acetaminophen 325 mg (Schedule III) and on at least two occasions
between April 2012 and October 2012, Respondent issued controlled
substance prescriptions (hydrocodone 7.5 mg/ibuprofen 200 mg (Schedule
III) and hydrocodone 10 mg/acetaminophen 650 mg (Schedule III)) to his
patient R.P. with insufficient documentation of those prescriptions, or
the bases for them, in the patient's medical record.
49. On at least two occasions between May 2012 and October 2012,
Respondent issued controlled substance prescriptions (oxycodone 7.5 mg/
ibuprofen 200 mg (Schedule III) and alprazolam 1 mg (Schedule IV)) to
his patient M.R. with insufficient documentation of those
prescriptions, or the bases for them, in the patient's medical record.
50. On two occasions in October 2014, Respondent issued controlled
substance prescriptions (methylphenidate 20 mg (Schedule II) and
dextroamphetamine/amphetamine 20 mg (Schedule II)) to his patient J.T.
with insufficient documentation of those prescriptions, or the bases
for them, in the patient's medical record.
51. On 12 occasions between May and November 2012, Respondent
dispensed controlled substances (hydrocodone 10 mg/acetaminophen 650 mg
(Schedule III) and alprazolam 1 mg (Schedule IV)) from his office
supply to his patient J.Cu. with insufficient documentation of those
dispenses, or the bases for them, in the patient's medical record.
52. On 12 occasions between May 2010 and July 2013, Respondent
dispensed a controlled substance (hydrocodone 10 mg/acetaminophen 650
mg (Schedule III)) from his office supply to his patient J.V. with
insufficient documentation of those dispenses, or the bases for them,
in the patient's record.
53. On nine occasions between May 2011 and November 2013,
Respondent dispensed controlled substances (hydrocodone 7.5 mg/
ibuprofen 200 mg (Schedule III), hydrocodone 7.5 mg/acetaminophen 650
mg, and guaifenesin with codeine (Schedule V)) from his office supply
to his patient R.P. with insufficient documentation of those dispenses,
or the bases for them, in the patient's medical record.
54. On seven occasions between April 2011 and July 2013, Respondent
dispensed controlled substances (hydrocodone 10 mg/acetaminophen 650 mg
and alprazolam 1 mg) from his office supply to his patient W.L. with
insufficient documentation of those dispenses, or the bases for them,
in the patient's medical record.
55. On two occasions between June 2013 and March 2014, Respondent
dispensed a controlled substance (alprazolam 1 mg (Schedule IV)) from
his office supply to his patient M.R. with insufficient documentation
of those dispenses, or the bases for them, in the patient's medical
record.
56. On at least two occasions between October 2012 and April 2013,
[[Page 5486]]
Respondent dispensed a controlled substance (alprazolam 1 mg) from his
office supply to his patient A.S. with insufficient documentation of
those dispenses, or the bases for them, in the patient's medical
record.
57. On at least one occasion between September 2013 and March 2014,
Respondent dispensed a controlled substance (alprazolam 1 mg (Schedule
IV)) from his office supply to his patient J.C. with insufficient
documentation of those dispenses, or the bases for them, in the
patient's medical record.
Accordingly, the Respondent stipulated to a majority of the facts
alleged by the Government in the OSC. However, the Respondent did not
stipulate to the factual allegations: concerning prescribing to himself
and his family members; concerning his failure to maintain adequate
security; and concerning his other conduct which may have threatened
the public health and safety.
FINDINGS OF FACT \12\
---------------------------------------------------------------------------
\12\ The extensive and detailed stipulations of fact essentially
establish the factual bases for most of the allegations contained in
the OSC. It is, therefore, unnecessary to make additional findings
of fact based upon my independent review of documentary evidence and
my evaluation of the credible testimony, where those findings would
essentially duplicate the stipulations of fact.
---------------------------------------------------------------------------
I. Respondent's Background
1. The Respondent was born and raised in New Delhi, India. Tr. 211.
As a child, the Respondent spoke Hindi, Punjabi, and a little English
at home with his family. Tr. 211.
2. The Respondent earned his college degree in 1971 from the
College of Sciences in New Delhi. Tr. 211. Subsequently, the Respondent
went to medical school at the Maulana Azad Medical College in New
Delhi, and graduated in 1977. Tr. 211-12.
3. In April of 1979, the Respondent came to the United States. Tr.
212.
4. Once in the United States, the Respondent took a three-month
course to prepare to take the Educational Commission for Foreign
Medical Graduates exam, to have his medical degree recognized in the
United Sates. Tr. 212. The Respondent passed this exam in July of 1979.
Tr. 213.
5. In July 1980, the Respondent began an internship at LaGuardia
Hospital in Forest Hills, New York. Tr. 213.
6. After his internship, the Respondent finished his residency at
Andover Hospital in 1984. Tr. 213. The Respondent specialized in
internal medicine. Tr. 213.
7. The Respondent was licensed to practice medicine in the State of
Connecticut in January 1985. Tr. 214.
8. After being licensed, the Respondent worked at a ``walk-in''
medical clinic in Danbury, Connecticut. Tr. 214.
9. In 1988, the Respondent opened the Immediate Medical Care
Center, which he still owns and where he maintains his medical
practice. Tr. 215.
II. The 2014 Investigation
10. [P.L.] began investigating the Respondent after she received
information from a probation officer who had concerns about the
Respondent's prescribing habits. Tr. 51. [P.L.] ran a report using
Connecticut's prescription monitoring and reporting system (``PMP'') to
review the Respondent's prescribing habits and she identified
prescriptions suggestive of ``early refills or duplicate therapy.'' Tr.
51. [P.L.] also contacted the DEA, [M.J.], because of the controlled
substances involved. Tr. 52, 81. At this point, it was a joint
investigation between the DEA and the State of Connecticut. Tr. 52-53.
11. Pharmacies in Connecticut are required to submit information
into the PMP when they fill a prescription. Tr. 73. In addition, when a
doctor dispenses a controlled substance, the doctor is required to
report that event to the PMP within 24 hours. Tr. 18, 30-31. When
[P.L.] ran the Respondent's PMP, it should have shown ``all
prescriptions that have been filled by pharmacies uploaded into the PMP
under [the Respondent] as the prescriber,'' as well as any controlled
substances the Respondent had dispensed and reported. Tr. 73-74.
Administering a controlled substance directly to the patient would not
show up on the PMP, but dispensing the substance to the patient to take
home would show up on the PMP--if properly reported. Tr. 75-76.
12. [P.L.] and [M.J.] went through the Respondent's PMP report and
then collected copies of prescriptions the Respondent had written from
the pharmacies that filled the prescriptions. Tr. 51, 54, 62-63.
13. [M.J.] also pulled data from the Automation of Reports and
Consolidated Orders System (``ARCOS''). Tr. 83. ARCOS is a DEA system
where manufacturers and distributors report purchases of specific
controlled substances by a registrant. Tr. 83-84.
14. Although the ARCOS records indicated that the Respondent had
obtained controlled substances, the PMP report did not indicate that he
had dispensed any. Tr. 81, 139.
15. On the morning of January 31, 2014, [M.J.] and [P.L.] arrived,
unannounced, at the Respondent's clinic to speak with him. Tr. 55-56,
83, 117. When they arrived, the only other employee at the Respondent's
clinic was his secretary. Tr. 77. Because the Respondent was busy with
patients, he asked [M.J.] and [P.L.] if they could talk later that day
when another physician would be in the office to see patients. Tr. 55,
117, 254-55. When [M.J.] and [P.L.] came back later in the day on
January 31, 2014, another physician was present. Tr. 78.
16. When [P.L.] and [M.J.] returned to the Respondent's office on
January 31, 2014, they asked the Respondent if he prescribed to his
family members. Tr. 55, 86. The Respondent indicated he mostly did not,
``because he did not want to take the responsibility if something went
wrong.'' Tr. 55-56; see also Tr. 70, 87. When [P.L.] showed the
Respondent the prescriptions written for family members, the Respondent
verified that he wrote the prescriptions. Tr. 56. When [M.J.] and
[P.L.] asked the Respondent if he had copies of patient files for his
family members the Respondent said he did not. Tr. 56, 87.
17. On January 31, 2014, [M.J.] and [P.L.] advised the Respondent
of the requirement to conduct a biennial inventory and about the
security of controlled substances. Tr. 84-85, 118.
18. On January 31, 2014, [M.J.] and [P.L.] asked the Respondent to
sign an agreement stating that he would no longer treat his family
members, but he refused to do so. Tr. 56.
19. The Respondent refused to allow [M.J.] and [P.L.] to conduct an
audit of the controlled substances he had in his clinic on January 31,
2014, and he denied their request to conduct an inspection. Tr. 56, 87,
93-94, 117.
20. On January 31, 2014, the Respondent told [M.J.] and [P.L.] that
he was not aware that alprazolam, a benzodiazepine, was being abused or
diverted. Tr. 55, 87; see also Tr. 238, 253, 268-69.
21. On February 21, 2014, [M.J.], [P.L.], DI [J.H.], and two
Stanford police officers, arrived at the Respondent's clinic to execute
an Administrative Investigation Warrant (``AIW'') in order to collect
records and to perform a count of the Respondent's controlled
substances. Tr. 59-60, 94.
22. [M.J.] served the Respondent with the warrant on February 21,
2014, and he was not cooperative initially. Tr. 60, 94-95. [J.H.], one
of the police officers, and the Respondent's secretary, encouraged the
Respondent to comply with the warrant. Tr. 60, 94-95.
23. On February 21, 2014, [M.J.] attempted to conduct an audit of
the Respondent's controlled substances, but was unable to do so because
there was
[[Page 5487]]
no biennial inventory. Tr. 96. Instead, [M.J.] performed a closing
count and the investigators collected what records they were able to
from the Respondent, including some dispensing logs and what the
Respondent called his medication log. Tr. 96-97.
III. Recordkeeping & PMP Requirements
24. There were recordkeeping issues in the Respondent's practice
prior to February 2014. Tr. 224.
25. After reviewing the documents that [M.J.] and [P.L.] were able
to obtain during the execution of the AIW on February 21, 2014, they
were able to identify some problem patients, review their data, and
request their records. Tr. 102-03.
26. Prior to April 2014, the Respondent had never logged onto the
PMP system. Tr. 102. Although there is nothing in the Code of Federal
Regulations (``CFR'') that specifically requires a physician to check
the PMP records, Tr. 103, federal law requires a practitioner to comply
with state law.\13\ Tr. 103.
---------------------------------------------------------------------------
\13\ In determining whether the continued registration is in the
public interest, federal law requires the consideration of the
respondent's compliance with applicable state, federal, or local
laws related to controlled substances. 21 U.S.C. Sec. 823(f)(4)
(``Factor Four''). The DEA has found that a respondent's failure to
report various dispensings to the state's PMP, in violation of that
state's law, was a violation under Factor Four. See Keith Ky Ly,
D.O., 80 Fed. Reg. 29025, 29035 (2015).
---------------------------------------------------------------------------
27. In Connecticut, a practitioner is required to notify the state
of his intent to dispense controlled substances. Conn. Gen. Stat. Sec.
20-14f; Tr. 19.
28. After the Respondent stopped dispensing controlled substances,
he no longer had an obligation to report that he intended to dispense
controlled substances. Tr. 25.
29. Respondent Exhibit D is a ``Record of Surrender or Disposal''
issued by the State of Connecticut--Department of Consumer Protection,
Drug Control Division. RE-D. The record is signed by the Respondent,
[R.M.], and [N.C.], and it documents the controlled substances that
were received from the Respondent's clinic on March 4, 2016. Tr. 21,
40; RE-D.
30. Even if the Respondent is no longer dispensing controlled
substances, it would still be considered a state violation in 2017 if
the Respondent failed to report dispensing controlled substance to the
state that occurred in 2014. Tr. 29.
IV. Security
31. The purpose of requiring that a storage cabinet be
substantially secure is to prevent the theft or diversion of controlled
substances. Tr. 123.
32. The Respondent stored all of his controlled and non-controlled
substances in the same location.\14\ Tr. 57.
---------------------------------------------------------------------------
\14\ At the hearing, [P.L.] testified that storing controlled
and non-controlled substances in the same location was a separate
violation of regulations. Tr. 57. This allegation, however, was
never raised in the OSC or in any of the Government's prehearing or
post-hearing filings. See ALJ-1; ALJ-13; ALJ-30. Therefore, I give
no weight to this testimony.
---------------------------------------------------------------------------
33. Prior to [M.J.] and [P.L.]'s arrival at the Respondent's office
on January 31, 2014, the Respondent kept his controlled substances in
an unlocked closet, with a louvered door, located in a locked unused
patient care room. Tr. 57-58, 65-66, 85-86, 229, 232, 301-03.
34. The Respondent stored unused medical equipment, valued at
approximately $150,000, in the unused locked examination room, where he
also stored his controlled substances. Tr. 229-30.
35. On February 21, 2014, the controlled substances were in the
same unlocked closet as they were when [M.J.] and [P.L.] vi
