[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]
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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.
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\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.
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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).
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\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.
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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.
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\4\ I take official notice of this fact pursuant to the same
authority set forth supra in footnote 3.
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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.
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\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).
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration No. 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).
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\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).
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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.
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\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.
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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.
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\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.
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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\
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\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.
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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\
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\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.
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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.
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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 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, GE-13-23, 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, 201-02.
48. Suboxone is a synthetic opioid-based medication that is
primarily used to treat patients who are addicted to opioids. Tr. 154,
198.\15\
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\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. Sec. 1308.13(e)(2)(i).
---------------------------------------------------------------------------
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.
[[Page 5488]]
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
self-prescribing, 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 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 were
distributing Schedule II controlled substances,'' as alleged in
paragraph 11(a) of the OCS. ALJ-1, at 11; Tr. 268-69.
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. Sec. 1301.44(e). Under 21 U.S.C. Sec. 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. Sec. 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, 173-74 (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
[[Page 5489]]
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 re-occurrence
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.
---------------------------------------------------------------------------
\17\ The Post-Hearing Brief on Behalf of the Government has been
marked as ALJ-37.
---------------------------------------------------------------------------
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 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\
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\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.
---------------------------------------------------------------------------
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. ALJ-38, 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 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.
---------------------------------------------------------------------------
\19\ The Respondent's Proposed Findings of Fact and Conclusions
of Law have been marked as ALJ-38.
---------------------------------------------------------------------------
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\
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\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.
---------------------------------------------------------------------------
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
[[Page 5490]]
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 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.
Factors Two and Four: The Respondent's Experience in Dispensing
Controlled Substances and Compliance With Applicable State, Federal, or
Local Laws Relating to Controlled Substances
Factors Two and Four are often analyzed together. See, e.g., Fred
Samimi, M.D., 79 FR 18698, 18709 (2014); John V. Scalera, M.D., 78 FR
12092, 12098 (2013). Under Factor Two, the DEA analyzes a registrant's
``experience in dispensing . . . controlled substances.'' 21 U.S.C.
823(f)(2). Factor Two analysis focuses on an applicant's acts that are
inconsistent with the public interest, rather than on an applicant's
neutral or positive acts and experience. Randall L. Wolff, M.D., 77 FR
5106, 5121 n.25 (2012) (explaining that ``every registrant can
undoubtedly point to an extensive body of legitimate prescribing over
the course of [the registrant's] professional career'') (quoting Jayam
Krishna-Iyer, M.D., 74 FR 459, 463 (2009)). Similarly, under Factor
Four, the DEA analyzes an applicant's compliance with federal and state
controlled substance laws. 21 U.S.C. 823(f)(4). Factor Four analysis
focuses on violations of state and federal laws and regulations.
Volkman v. DEA, 567 F.3d 215, 223-24 (6th Cir. 2009) (citing Gonzales
v. Oregon, 546 U.S. 243, 272, 274 (2006)); see Joseph Gaudio, M.D., 74
FR 10083, 10090-91 (2009).
Here, the Government alleges that revocation of the Respondent's
COR is appropriate under Factors Two and Four for four reasons: (1)
improper recordkeeping; (2) improper prescribing to himself and family
members; (3) improper prescribing to patients; and (4) failure to
maintain adequate security. ALJ-1, 13, 30, 37.
I. Improper Recordkeeping
Registrants are required to keep certain records and inventories of
their controlled substances. Paul H. Volkman, M.D., 73 FR 30630, 30644
(2008). Among those requirements, registrants are to: (1) maintain
adequate dispensing 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 protect against the diversion of controlled
substances.'' Superior Pharmacy I & Superior Pharmacy II, 81 FR 31310,
31337 (2016) (quoting Volkman, 73 FR at 30644). The Supreme Court has
noted that ``[t]he CSA and its implementing regulations set forth
strict requirements regarding . . . recordkeeping.'' Gonzales v. Raich,
545 U.S. 1, 14 (2005). However, the DEA has also held that, where non-
egregious recordkeeping errors are acknowledged and remedied promptly,
revocation may not always be required. See Terese, Inc., D/B/A Peach
Orchard Drugs, 76 FR 46843, 46848 (2011).
First, the Government alleged that the Respondent failed to
maintain accurate dispensing records and logs, in violation of 21
U.S.C. 827(a)(3), 21 CFR 1304.21(a) and 1304.22(c), and Conn. Agencies
Regs. Sec. 21a-326-1(d)(2), (6). ALJ-1, at 2-3. The Respondent,
however, stipulated to numerous facts that establish by a preponderance
of the evidence that he repeatedly failed to maintain accurate
dispensing records and logs. Stip. of Fact 4-11. Accordingly, the
Government's allegations that the Respondent failed to maintain
accurate dispensing records and logs, as alleged in paragraphs 4(b),
4(d), and 4(f) of the OSC, are SUSTAINED and weigh in favor of
revocation of the Respondent's DEA registration.
Second, the Government alleged that the Respondent failed to
maintain controlled substance receipts for orders of controlled
substances, in violation of 21 U.S.C. 842(a)(5), 21 CFR 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). ALJ-1, at 3-4. Here, too, the Respondent
stipulated to numerous facts that established by a preponderance of the
evidence that he repeatedly failed to maintain controlled substance
receipts for orders of controlled substances that he received in his
office. Stip. of Fact 12-18. Accordingly, the Government's allegations
that the Respondent failed to maintain controlled substance receipts
[[Page 5491]]
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. Sec. 21a-254(f), and Conn. Agencies Regs. Sec. 21a-
326-1(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. Sec. 21a-254(h), and Conn. Agencies Regs. Sec. 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. Sec. 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 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.
Sec. Sec. 20-14f and 21a-317, 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 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. Sec. Sec. 20-
14e(b), 21a-322(3), (8), (10), 21a-252(a), Conn. Agencies Regs. Sec.
21a-326-1(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
[[Page 5492]]
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; ALJ-38, 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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 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 25-27. 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.
156-57. Lunesta is a sedative hypnotic agent that is used to treat
insomnia. Tr. 156-57. Dr. Perrin identified Government 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
[[Page 5493]]
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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. Sec. Sec. 20-14e(b), 21a-
322(3), (8), (10), 21a-252(a), Conn. Agencies Regs. Sec. 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. 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 51-57.
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 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. Sec. Sec. 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
[[Page 5494]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
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. 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.
---------------------------------------------------------------------------
\26\ I also considered the Administrator's analysis in Howard N.
Robinson, M.D., 79 FR 19356, 19372 (2014).
---------------------------------------------------------------------------
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.
Sec. Sec. 21a-262-6(a)-(c), 21a-32601(d), with respect to his storage
of his controlled substances are not sustained.\27\
---------------------------------------------------------------------------
\27\ The Government made no argument in its post-hearing brief
concerning paragraph 10 of the OSC.
---------------------------------------------------------------------------
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
[[Page 5495]]
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 cross-
examination, 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,'' ALJ-1, 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.
ALJ-37.
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 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 cross-
examination, 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 ``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.
---------------------------------------------------------------------------
\28\ I also note that the Respondent has some difficulty
hearing, which certainly could have contributed to miscommunication.
Tr. 254; see also Tr. 210.
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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 . . . .'' ALJ-
1, 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
[[Page 5496]]
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\
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\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.
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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
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 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\
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\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.
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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
[[Page 5497]]
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
cross-examination 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 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). 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
[[Page 5498]]
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.'').
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\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 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.
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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 Krishna-Iyer, 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. 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.'').
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\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 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).
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RECOMMENDATION
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.
Dated: May 25, 2017
s/Charles Wm. Dorman
U.S. Administrative Law Judge
CERTIFICATE OF SERVICE
This is to certify that the undersigned, on May 25, 2017, caused a
copy of the foregoing to be transmitted via facsimile and placed in
interoffice mail addressed to Paul A. Dean, Esq., Office of Chief
Counsel, Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, VA 22152; facsimile (202) 307-4946, and a copy to be
transmitted via facsimile and mailed, postage prepaid, to counsel for
the Respondent, Ronald W. Chapman, II, Esq. and Robert J. Andretz,
Esq., 1441 West Long Lake Road, Suite 310, Troy, Michigan 48098;
facsimile (248) 644-6324.
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Rhonda L. Gore
Secretary to Judge Charles Wm. Dorman
Office of Administrative Law Judges
[FR Doc. 2019-02865 Filed 2-20-19; 8:45 am]
BILLING CODE 4410-09-P