[Federal Register Volume 79, Number 67 (Tuesday, April 8, 2014)]
[Notices]
[Pages 19356-19374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07806]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 12-2]
Howard N. Robinson, M.D.; Decision and Order
On March 1, 2012, Chief Administrative Law Judge (ALJ) John J.
Mulrooney, II, issued the attached Recommended Decision.\1\ The
Government filed Exceptions to the ALJ's Decision. Thereafter,
Respondent moved to file a Response to the Exceptions, and upon the
ALJ's granting of his motion, filed a Response.
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\1\ For purposes of citation, the ALJ's Recommended Decision is
abbreviated as R.D. All citations to the ALJ's Recommended Decision
are to the slip opinion as issued by him.
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Having considered the entire record, including the Government's
Exceptions and Respondent's Response to them, I have decided to adopt
the ALJ's findings of fact and conclusions of law with the exception of
his conclusion that Respondent violated 21 CFR 1307.21(a)(1). See
Jeffery J. Becker, D.D.S., 77 FR 72387, 72387-88 (2012); see also R.D.
at 36, 41. Moreover, while I agree with the ALJ's conclusion that
Respondent ``has successfully shown cause why his [registration] should
not be revoked,'' R.D. at 44, and reject the Government's contention
that Respondent has not put forward sufficient evidence to establish
that he can be entrusted with a registration, I conclude that
additional requirements should be imposed on his registration to
protect the public interest. A discussion of the Government's
Exceptions follows.
Exception One--Respondent Has Not Provided ``Sufficient Mitigating
Evidence'' To Demonstrate That He Can Be Entrusted With a Registration
The Government contends that Respondent has not provided sufficient
evidence of the remedial measures he has undertaken to prevent the
recurrence of some of the violations he committed and ``to prevent
future diversion.'' Exceptions at 3. With respect to the former, the
Government points to Respondent's failure to complete the order forms
for schedule II controlled substances (DEA Form 222s) by noting the
number of commercial or bulk containers received and the date of
receipt. Exceptions at 2-3; see also 21 CFR 1305.13(d). In the
Government's view, while Respondent produced evidence that he is now
keeping the forms in a separate folder and apart from other records,
``[t]he record evidence does not support that [he] is properly
completing'' them. Id. at 3. The Government also contends that
``Respondent has not demonstrated that he has a system in place to
prevent future diversion of controlled substances'' because he
acknowledged that he is not in the office every day and controlled
substances deliveries may occur on day when he is not present. Id. at
4. Finally, the Government contends that the ALJ misapplied Agency
precedent when he concluded that the record as a whole does not support
revocation. Id. at 6-8.
With regard to the completion of the Form 222s, the Government
completely ignores the testimony and report of Respondent's Expert, who
reviewed his recordkeeping and procedures. As the Expert testified,
while Respondent ``was not aware of his obligations and requirements .
. . once he was informed, he took every action possible to correct them
[the violations] and [did so] as quickly as possible.'' Tr. 397.
Respondent's Expert further testified that with the exception of one
suggestion, on which Respondent immediately took action, he ``found
total compliance at the clinic'' and that ``everything else was in
complete compliance.'' Id.
Moreover, in his second report, Respondent's Expert found that
Respondent ``now properly completes the check in procedures by listing
the amount received and the date received on both the filled 222 forms
and the perpetual narcotic inventory log book.'' RX 18, at 2. See also
RX 17 (expert's report) (noting that while Respondent ``may not have
fully complied with certain record keep[ing] obligations prior to the
DEA investigation, . . . [w]hen the oversights were identified, he took
immediate action to correct all problematic issues pointed out to him,
in a timely fashion''); id. (``My review of the current procedures and
operations of the clinic confirm that all corrective action has taken
place and all regulations are being followed.'') (emphasis added).
While the ALJ was not impressed by the Expert's various attempts to
excuse Respondent's
[[Page 19357]]
failings,\2\ he nonetheless found that his testimony ``was sufficiently
detailed, authoritative and candid to be credited.'' R.D. at 20.
Accordingly, the Expert's testimony and report provide substantial
evidence, that in the absence of refutation by the Government,
establishes that Respondent is in compliance with the requirements of
21 CFR 1305.13(d).
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\2\ For example, the Expert noted that Respondent ``was not a
full time practitioner'' at the clinic, RX 18, at 2, and that ``much
of the problem stems from his good faith reliance on the
professionalism of other co-workers and employees at the clinic, the
licensed Consultant Pharmacist, and other regulatory agencies to do
their jobs correctly.'' Id. at 3.
The Government also notes the Expert's ``testimony that it is
legal to destroy all narcotics by flushing [them] down the toilet,
that he had followed this practice for 30 years, and that in the
past, he had not contacted the Special Agent in Charge regarding the
destruction of controlled substances.'' Exceptions at 6. The
Government contends that the Expert's ``testimony exhibits a
disregard of federal law and therefore, should not constitute
sufficient mitigating evidence to assure the Administrator that he
can be entrusted with [the] responsibility of carrying such a
registration.'' Id. (citations omitted).
As an initial matter, whether the Expert can be entrusted with a
registration is not at issue in this proceeding. Moreover, even
assuming that the Government meant that the Expert's testimony
should not be credited because of his putative disregard for federal
law, as recently explained, the Agency's disposal regulation is not
a model of clarity and the Expert is hardly alone in his views. See
Jeffery J. Becker, 77 FR at 72388 n.3 (noting testimony of dentist-
anesthesiologist and professor emeritus at Ohio State University
regarding standard practice of Ohio dentists, who perform sedation,
as to the disposal of excess drug). Finally, I am satisfied that in
finding the Expert's testimony credible, the ALJ properly considered
both that which supported, and that which detracted from, crediting
his testimony.
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As noted above, the Government also contends that Respondent lacks
effective controls against diversion based on his testimony that he is
not at the clinic every day of the week and may not be present when
controlled substances are delivered. Exceptions at 3-5. The Government
takes issue with the adequacy of Respondent's controls, because he is
now the only person at the clinic who has access to the controlled-
substances cabinet and has directed the clinic staff not to open any
shipments if he is not present.
Neither the CSA nor DEA regulations require, however, that a
registrant be present at his registered location whenever controlled
substances are delivered to it. And while the controlled substances
must be ``stored in a securely locked, substantially constructed
cabinet,'' 21 CFR 1301.75(b), nothing in the CSA or DEA regulations
prohibits a registrant from designating a properly-screened and
trustworthy employee (or appointing an agent from the clinic's
properly-screened employees if he is not the owner) to accept the
delivery and place the controlled substances in the controlled-
substances cabinet.
Indeed, it is undoubtedly the case that numerous clinics throughout
the country receive deliveries of controlled substances when their
registrants are not present and place them in the controlled-substances
cabinet, and yet the Government points to no evidence that such
practices create a substantial risk of diversion. While diversion
clearly occurred here, the evidence establishes that this was the
result of the actions of a rogue employee, who happened to be a
convicted drug smuggler and who was subsequently terminated. See RX 21.
To be sure, adherence to DEA regulations, in particular 21 CFR
1301.76(a),\3\ would likely have entirely prevented this (as would have
a periodic review of the narcotic log book). That being said, there is
no basis to conclude that a registrant's practice of authorizing a non-
registrant to accept deliveries and place the drugs in the controlled-
substances cabinet, establishes that the registrant lacks an adequate
system for monitoring the receipt of controlled substances, 21 CFR
1301.71(b)(14), or lacks effective controls against diversion. Id.
Sec. 1301.71(a).
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\3\ This regulation provides, in relevant part, that a
``registrant shall not employ as an agent or employee who has access
to controlled substances, any person who has been convicted of a
felony offense relating to controlled substances.'' 21 CFR
1301.76(a). While Respondent did not hire the employee, he is still
responsible for ensuring compliance with agency regulations at his
registered location.
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Finally, the Government contends that the ALJ misapplied two recent
Agency cases, when he explained that they stand for the proposition
that `` `when considering recordkeeping violations, the Agency has
coupled consideration of the degree of severity with an analysis of
whether the registrant has both acknowledged culpability and
demonstrated credible efforts aimed at correction.' '' Exceptions at 7
(quoting R.D. at 34) (discussing Ideal Pharmacy Care, Inc., d/b/a
Esplanade Pharmacy Care, Inc., 76 FR 51415, 51416 (2011), and Terese,
Inc., d/b/a Peach Orchard Drugs, 76 FR 46843, 46848 (2011)). The
Government contends that the ALJ's conclusion that revocation is not
supported by the record is misplaced, because the evidence shows that
``the recordkeeping violations include more than non-egregious
recordkeeping violations, such as the failure to account for
significant deviations of controlled substances and the failure of
Respondent to correct all violations.'' Id. Later, relying on Ideal
Pharmacy, a case in which I revoked a pharmacy's registration based on
large shortages of controlled substances, the Government argues that
its audit of Respondent's handling of controlled substance activities
showed percentage deviations comparable to those found in Ideal, and
``represent significant amounts of controlled substances for which
Respondent could not account and thus, on this basis alone, warrant
revocation.'' Exceptions at 8.
While the shortages and overages found in the Government's audit
are sufficiently significant to support a revocation order, see Paul
Weir Battershell, 76 FR 44359, 44368 (2011), the audit results here
must be considered along with the evidence as to their underlying
cause,\4\ and in any event, to adopt the Government's position would
require overruling thirty years of agency precedent. See, e.g., Leo R.
Miller, 53 FR 21931, 21932 (1988); David E. Trawick, 53 FR 5326, 5327
(1988). Whether there may be a case in which a registrant's misconduct
is so egregious, that the protection of the public interest would
require revocation even if the registrant accepted responsibility and
undertook remedial measures, I need not decide.\5\ Here, Respondent's
misconduct cannot be characterized as anything more than negligence,
and as the ALJ found, Respondent has fully accepted responsibility and
demonstrated that he is not likely to commit similar omissions in the
future. R.D. at 43-44.
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\4\ In Ideal Pharmacy, the audit results found shortages of
nearly 150,000 dosage units of hydrocodone drugs, more than 83,000
dosage units of alprazolam, and more than 1.6 million milliliters of
promethazine with codeine. 76 FR at 51416. While the registrant
waived its right to a hearing, it is doubtful that it could have put
on any evidence to rebut the conclusion that its principals were
engaged in a scheme to intentionally divert drugs.
\5\ See Robert Raymond Reppy, 76 FR 61154 (2011); Paul H.
Volkman, 73 FR 30630 (2008).
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Accordingly, I reject the Government's contention that revocation
is warranted. However, because I find that Respondent's misconduct is
serious, and led to the diversion of controlled substances, I conclude
that additional sanctions are necessary to protect the public interest.
Consistent with the sanctions I have ordered in other cases, see
Battershell, 76 FR at 44369, I conclude that a suspension of
Respondent's registration is warranted.
Accordingly, I will order that Respondent's registration be
suspended for a period of six months. However, in light of Respondent's
acceptance of responsibility and the unrefuted evidence that upon being
informed of
[[Page 19358]]
the violations, he immediately undertook remedial measures, I will stay
the suspension and place Respondent on probation for a period of three
years to begin on the date of this Order. Said suspension shall be
vacated upon Respondent's successful completion of the probationary
period.
In addition, I will adopt, but modify, the second and third
conditions proposed by the ALJ.\6\ With respect to the ALJ's
recommendation that Respondent submit reports, at sixty-day intervals,
regarding monthly regulatory compliance inspections, I conclude that
such inspections need only be conducted on a quarterly basis ending on
March 31st, June 30th, September 30th, and December 31st. Said
inspections must be conducted by an independent and state-licensed
consultant pharmacist and must include an audit of Respondent's
controlled-substance handling, which must be verified for accuracy and
signed by Respondent. The consultant pharmacist's report, which must
identify any violations of controlled-substance regulations, along with
a copy of the quarterly audit, must be submitted to the local DEA field
office no later than fifteen (15) days after the close of each quarter.
In the event Respondent materially fails to comply with this provision,
his registration shall be subject to an order of Immediate Suspension.
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\6\ In its Exceptions, the Government takes issue with the ALJ's
criticism of its invocation of the law enforcement privilege when
its lead DI was questioned as to whether she knew the identity of a
person who had called her and alleged that the clinic's owner (and
not Respondent) was a drug abuser and diverter. Notably, while the
Government initially argued that the issue is moot, see ALJ Ex. 25,
at 2; in its Exceptions, the Government now argues that it is not.
See Exceptions at 8 (citing Norman v. Reed, 502 U.S. 279, 287-88
(1992) (issue not moot if capable of repetition yet evading
review)).
Upon review, I conclude that the Government's initial view is
correct because the DI ultimately answered the question, and
testified that she did not know the caller's identity. As for
whether the issue is capable of repetition yet evading review, many
of the points made in the ALJ's Addendum are well taken and it is
expected that they will be carefully studied by Government counsel.
Thus, I conclude that it is speculative to conclude that Government
counsel will, in the future, attempt to invoke the privilege in a
factually similar circumstance, i.e., where it has elicited
testimony regarding allegations of misconduct from a putatively
anonymous source without first determining whether its witness knows
the identity of the person and obtaining the requisite approval to
invoke the privilege if necessary.
Finally, as the ALJ acknowledged, ``the Respondent's case was
not prejudiced in any cognizable manner.'' R.D. at 49. Accordingly,
I decline to publish the Addendum.
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In addition, within fifteen days of the date of issuance of this
Order, Respondent shall execute a document manifesting his consent to
inspections by DEA personnel and waiving his right to require that DEA
personnel obtain an administrative inspection warrant prior to
conducting any inspection. In the event Respondent fails to execute
said document, his registration will be revoked.
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 hereby order that the DEA
Certificate of Registration issued to Howard N. Robinson, M.D., be, and
it hereby is, continued, subject to the conditions set forth above.
This order is effective immediately.
Dated: March 27, 2014.
Michele M. Leonhart,
Administrator.
Robert C. Gleason, Esq., and Dedra Curteman, Esq., for the
Government Jason M. Wandner, Esq., for the Respondent
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
Chief Administrative Law Judge John J. Mulrooney, II. On September
7, 2011, the Deputy Assistant Administrator of the Drug Enforcement
Administration (DEA or Government), issued an Order to Show Cause (OSC)
proposing to revoke the DEA Certificate of Registration (COR), Number
AR8666109 \7\ of Howard Robinson, M.D., (Respondent), pursuant to 21
U.S.C. Sec. 824(a)(4), and deny any pending applications for renewal
or modification. On October 6, 2011, the Respondent, through counsel,
timely filed a request for hearing with the DEA Office of
Administrative Law Judges (OALJ). The requested hearing was conducted
in Miami, Florida on November 29-30, 2011.
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\7\ A copy of Respondent's COR and a certification of
Respondent's registration history have been admitted into the record
as Government Exhibits 1 and 2, respectively. Respondent previously
possessed COR Number BR9176238. Gov't Ex. 13. However, on January 4,
2011, Respondent voluntarily surrendered the BR9176238 registration
as surplusage. Gov't Ex. 13, at 2; Tr. at 67-69.
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The issue ultimately to be adjudicated by the Administrator, with
the assistance of this recommended decision, is whether the record as a
whole establishes, by substantial evidence, that the Respondent's COR
should be revoked as inconsistent with the public interest, as that
term is used in 21 U.S.C. Sec. Sec. 823(f) and 824(a).
After carefully considering the testimony elicited at the hearing,
the admitted exhibits, the arguments of counsel, and the record as a
whole, I have set forth my recommended findings of fact and conclusions
of law below.
The Allegations
The OSC issued by the Government contends that revocation of the
Respondent's COR is appropriate because: (1) An audit of the
Respondent's records revealed a number of unexplained recordkeeping
abnormalities with regard to stocks of controlled substances, in
violation of 21 U.S.C. Sec. Sec. 827(a)(3), 842(a)(5) and 21 CFR
Sec. Sec. 1304.03-04, 1304.21; (2) the Respondent ``failed to maintain
inventories and records of Schedule I and II controlled substances
separately from all other records,'' in violation of 21 CFR
1304.04(f)(1); (3) the Respondent ``failed to properly record on a DEA
Form 222, the number of Schedule II commercial or bulk containers and
the dates on which the containers were received in violation of 21 CFR
1305.13(e);'' (4) the Respondent ``failed to properly dispose of
controlled substances in violation of 21 CFR Sec. 1307.21(a)(1);'' (5)
the Respondent ``failed to record nine shipments of Schedule II
controlled substances that were transferred from [his] registered
address in violation of 21 CFR Sec. 1305.03;'' (6) the Respondent
``failed to maintain a biennial inventory of the controlled substances
on the premises of [his] registered location and failed to properly
maintain records for the controlled substances in violation of 21 CFR
Sec. Sec. 1304.11(c) and 1304.21a(a);'' (7) the Respondent allowed a
nurse anesthetist on his staff to place orders for controlled
substances under the authority of his COR without having first executed
a power of attorney as required by the regulations; and (8) the
Respondent did not have access to the controlled substances in his
office, and thus ``failed to provide an adequate system for monitoring
the receipt, distribution and disposition of controlled substances,''
in violation of 21 CFR Sec. 1301.71.
The Stipulations of Fact
The Government and the Respondent, through counsel, have entered
into stipulations regarding the following matters:
(1) The Respondent is an employee of Premiere Center for Cosmetic
Surgery (PCCS), which is owned by VM.\8\
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\8\ See Addendum.
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(2) The Respondent has not been charged or convicted with any
criminal offense in relation to the underlying cause.
(3) The Respondent has not been disciplined by the State of Florida
[[Page 19359]]
Department of Health for the allegations in the underlying cause.
(4) The Respondent has not materially falsified any application.
(5) The Respondent has not been excluded from participation in any
program.
The Evidence
The Government's case-in-chief rested on the testimony of a single
witness, Diversion Investigator (DI) Victoria McRae. DI McRae testified
that she has been a Diversion Investigator with the DEA since 1988 and
that she has been stationed in the DEA's Miami Field Division since
November of 1989. Tr. 35-37. DI McRae testified that she has a college
degree and has completed numerous DEA training evolutions. Tr. 37-38.
Regarding the merits of the case, DI McRae testified that, on
September 20, 2010, she received a telephone call from a ``person who
wished to remain anonymous,'' who informed DI McRae that ``there was a
nurse anesthetist at a medical office that appeared to be abusing
controlled substances and was self-administering.'' Tr. 38-39. The
caller identified the alleged drug abuser as VM, the owner of PCCS in
Coconut Grove, Florida. Tr. 39. In this regard, the caller informed DI
McRae that: (1) There were ``bloody gauze strips left in a bathroom;''
(2) ``there was drug paraphernalia in the trash cans;'' (3) ``everyone
at the office was aware of behavior by [VM] that looked like drug
activity;'' and (4) the Chief Operating Officer of the PCCS clinics, an
ex-boyfriend of VM, ``had the employees at both of the locations sign a
form stating that they were not going to spread any rumors about any
activities by [VM].'' \9\ Tr. 40. The caller told DI McRae that
``patients were not given enough medication while they were on the
operating table [a]nd that some of the patients were squirming because
they hadn't had enough.'' Tr. 61-62. Finally, the caller stated that
controlled substances were purportedly transferred from the PCCS
facility in Coconut Grove to a PCCS facility in Tampa, but ``that the
drugs were probably being used by [VM] and not actually arriving at the
Tampa office.'' Tr. 64.
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\9\ The non-disclosure document was not found during the
investigation. Tr. 237. However, DI McRae testified that the
document would not have been within the scope of the administrative
inspection warrant. Id.
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After the phone call ended, DI McRae accessed the RICS \10\
database and looked up the names of the physicians mentioned during the
call. Tr. 41. DI McRae also accessed the Florida Division of
Corporations database \11\ and confirmed that PCCS had locations in
Coconut Grove and Tampa, Florida. Tr. 42-44. DI McRae found that VM was
listed as the registered agent, president, vice president, secretary
and treasurer of PCCS.\12\ Tr. 42-44.
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\10\ DI McRae explained that ``RICS is a database that we have
at DEA that contains all of the DEA registrants.'' Tr. 42.
\11\ DI McCrae testified that the database, found at Sunbiz.org,
is an open source database available to the general public on the
Internet. Tr. 43.
\12\ DI McRae testified that the Florida Department of Health is
``still working in [its] part of the investigation.'' Tr. 163.
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On January 4, 2011, based on her anonymous lead, DI McRae issued a
notice of inspection to the Respondent for the Coconut Grove PCCS
location. Tr. 45-46. At the time of her inspection visit, DI McRae was
accompanied by three employees of the Florida Department of Health.\13\
Tr. 60-61. Upon her arrival at the office, McRae presented the
Respondent with the notice of inspection, which he signed.\14\ Tr. 47;
Gov't Ex. 3. DI McRae then ``advised [the Respondent] that [she] would
be looking at his controlled substance records, and that [she] would
also be counting the controlled substances that he had on hand in order
to do a closing inventory.'' Tr. 47. DI McRae ``asked for copies of all
controlled substance records for the past two years [and] was provided
with copies of order forms [and] invoices from the wholesaler, Prime
Medical.'' Tr. 83. DI McRae also asked for, and was provided with, a
copy of the Respondent's narcotics log. Tr. 83. It was McRae's
recollection that the requested documents were handed over by an
employee at the practice named ``Priscilla.'' Tr. 169.
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\13\ DI McRae contacted the Florida Department of Health because
of the allegations concerning patient care. Tr. 62.
\14\ Tr. 47.
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After the execution of the notice of inspection, VM offered to take
DI McRae to the office's controlled substances safe, but stated that
``at that time the office only had Versed \15\ in stock because the
other medications were on backorder.'' Tr. 47-48. VM also stated that,
because the controlled substances were kept in a sterile area, DI McRae
would have to change into a gown and a wear a facemask and hair net.
Tr. 48.
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\15\ Versed is the brand name of a drug containing midazolam. 6-
V Attorneys' Dictionary of Medicine V-123111. Midazolam is a
Schedule IV controlled substance. 21 CFR Sec. 1308.14(c)(35).
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VM led DI McRae to a room where the former asked the latter to
change into a set of green scrubs. Tr. 48. As McRae was donning the top
of the scrubs, a capped hypodermic needle fell out of the left breast
pocket of the scrubs she had been given. Tr. 48. DI McRae testified
that when she picked up the needle she observed that it had some
``redness in it,'' which she believed to be blood. Tr. 48, 52-53. DI
McRae inquired why a capped hypodermic needle would come tumbling out
of the scrubs she was offered, and VM responded that the needle was not
hers, that ``[i]t couldn't have been one of the staff members, because
all of the staff wear black scrubs [but] it could have been a patient's
because the patients wear green scrubs.'' \16\ Tr. 50. After this
exchange, DI McRae picked up the hypodermic needle and gave it to VM,
who put it in a sharps container and led DI McRae into an operating
room.\17\ Tr. 50.
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\16\ DI McRae later testified that the patients she observed
that day ``had on a gown, not scrubs.'' Tr. 55.
\17\ Later, DI McRae asked the Respondent about the loose
needle. Tr. 55-56. The Respondent speculated that an employee could
have ``simply capped the needle, placed it in the pocket . . .
continued on with their paperwork, and . . . forgotten to place the
needle in a sharps container.'' Tr. 56.
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In the operating room, VM ``unlocked [a] box on the wall where the
drugs were contained.'' Tr. 50. VM and DI McRae counted five sealed
vials of midazolam, plus ``one vial which [VM and DI McRae estimated]
to contain three milliliters of liquid in it.'' Tr. 53-54, 75; Gov't
Ex. 4. Based on this count, DI McRae wrote out a closing inventory form
reflecting the 53 milliliters of midazolam on hand, which VM signed at
DI McRae's direction. Id.
In addition to the closing inventory, DI McRae conducted an
inspection of the Respondent's records. Tr. 76. Of relevance to this
case, DI McRae looked at a binder that was styled ``peer review
pharmacy book,'' which contained ``order forms . . . among other
documents.'' \18\ Tr. 76. Mixed with these documents was a November 23,
2010, prescription for fifty vials of Demerol \19\ written by the
Respondent for VM. Tr. 76; Gov't Ex. 11. When asked about this
prescription (which was written to the owner of the clinic and tucked
into a book that was clearly not a patient file) the Respondent
explained that he wrote this prescription for VM during a time when
``all of our drugs were on back order, [and the practice] needed some
medication for office supply. So I wrote
[[Page 19360]]
the prescription for [VM], and she had it filled at a pharmacy.'' Tr.
81. DI McRae then informed the Respondent that the writing of
prescriptions for office use is a violation of DEA regulations. Tr. 81.
On cross-examination, DI McRae agreed that Respondent's records
reflected the addition of fifty vials of Demerol on November 23, 2010.
Tr. 177. Thus, DI McRae testified that, although the medication was
procured by prescription through a method not authorized under the
regulations, the available paperwork (such as it was) did reflect the
addition of the medication to the practice's stock of controlled
substances. Tr. 177-78.
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\18\ DI McRae testified that ``there were order forms [and]
other forms that had to do with the office. There was a contract in
there between the medical office and the consultant pharmacist that
was there at the time.'' Tr. 80.
\19\ Demerol is the brand name for tablets containing meperdine
hydrochloride. 2-D Attorneys' Dictionary of Medicine D-32709.
Meperdine is a Schedule II controlled substance pursuant to 21 CFR
Sec. 1308.12(c)(18).
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DI McRae also found an order form dated December 28, 2010, but was
told by VM that the order had not been received because ``everything
was on backorder.'' Tr. 116. Later, DI McRae received a shipping
invoice for the December 28, 2010, order directly from the supplier.
Tr. 116-18. The invoice corroborates VM's account to the extent that it
shows that, while both fentanyl \20\ and Demerol were ordered, only
fentanyl was shipped because the Demerol was on backorder. Tr. 116. DI
McRae's investigation revealed that the fentanyl was shipped on
December 28, 2010. Tr. 118. However, the Respondent's practice had no
records of receipt of this shipment. Tr. 118.
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\20\ Fentanyl is a Schedule II controlled substance pursuant to
21 CFR Sec. 1308.12(c)(9) (2011).
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When the closing inventory and inspection of the records were
completed, DI McRae had a conversation with the Respondent wherein she
inquired about office procedures related to the ordering of controlled
substances. Tr. 57-58. The Respondent told DI McRae that drugs were
ordered by VM, one of the nurse anesthetists, or by the
anesthesiologist at the practice. Tr. 58. The Respondent told DI McRae
that he believed drugs were ordered from a supplier called
McKesson,\21\ and that once shipped, the drugs were received at PCCS
either by VM or by DM, a female employee. Tr. 59-60. McRae's assessment
of what she learned was that VM ``would complete the order form as to
what particular drugs the office needed and then [the Respondent] would
look at it and he would sign it.'' \22\ Tr. 184. DI McRae spoke to the
supplier and was told ``that usually someone named Priscilla [is]
responsible for receiving medication.'' \23\ Tr. 189.
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\21\ Subsequent investigation revealed that McKesson was not a
supplier for the Respondent's practice. Tr. 62.
\22\ DI McRae testified that in her opinion this practice was
compliant with the relevant regulations. Tr. 184. Thus, according to
McRae (and contrary to the allegation in the Government's OSC), no
power of attorney would be required under this protocol.
\23\ Though DI McRae did not know whether the Priscilla
described by the supplier was the Priscilla at the front desk, she
did not know of any other Priscilla's employed by the Respondent.
Tr. 189.
---------------------------------------------------------------------------
During the same meeting, DI McRae asked the Respondent who had
access to controlled substances. Tr. 63. The Respondent answered that
only VM and DM had access to the controlled substances. Tr. 63. At this
point, DI McRae told the Respondent that ``because these drugs are
ordered under your DEA number, you're ultimately responsible for them,
so you should know what's been coming in. You should know what's on
hand at all times.'' Tr. 63-64.
When asked about the alleged transfers between the PCCS facilities
at Coconut Grove and Tampa, the Respondent initially indicated that he
did not believe that controlled substances were transferred to Tampa,
but on further reflection, told McRae that such transfers may have
taken place under the direction of either VM, or Dr. Gloria Thomas--a
doctor at the Tampa location. Tr. 64-65. The Respondent told DI McRae
that there was no paperwork documenting such transfers.\24\ Tr. 64-65.
Upon learning that the transfers of controlled substances had been made
without paperwork, DI McRae informed the Respondent of the regulatory
documentation requirements relative to transfers between practices. Tr.
65-66. A subsequent inspection of the narcotics logbook at the Tampa
location found that, while ``[t]here were notations in the log . . .
there were no DEA order forms on site to . . . document that
transfer.'' Tr. 147; see also id. at 239-40.
---------------------------------------------------------------------------
\24\ DI McRae does not attribute any malfeasance to the
Respondent's initial denial of transfers. Tr. 185. Indeed, DI McRae
testified that Respondent was cooperative during the investigation.
Tr. 66.
---------------------------------------------------------------------------
McRae also learned from the Respondent that biennial inventories
\25\ were not kept, and that needles containing controlled substances
were emptied into a waste container, practices which DI McRae informed
the Respondent were against DEA regulations. Tr. 60, 87. DI McRae asked
the Respondent whether there had been any thefts or losses at the
clinic, and Respondent stated that he was not aware of any. Tr. 63.\26\
Finally, DI McRae informed the Respondent that she would be conducting
an audit based upon the copies of the records that she had obtained,
and that she would let him know the results of the audit at a later
date. Tr. 57. DI McRae estimated that her discussion with the
Respondent that day spanned approximately one half hour and that, in
her view, the Respondent was cooperative throughout. Tr. 58, 66.
---------------------------------------------------------------------------
\25\ See 21 CFR Sec. 1304.11(c).
\26\ At the hearing, the Government introduced a March 24, 2005,
theft report from the Coconut Grove location. Tr. 109; Gov't Ex. 8.
The form was filled out by Jon F. Harrell, D.O., of the same address
as PCCS (3370 Mary Street, Coconut Grove, Florida). Id. When
questioned on the relevance of the document, Government counsel
proffered that ``this document is relevant to the extent that the
Registrant . . . was unaware or untruthful.'' Tr. 110. Although the
document was received into evidence without objection, id., it
referred to a different registrant during a period that was outside
the parameters of the audit. The regulations provide for the
admission of evidence that is ``competent, relevant, material, and
not unduly repetitious.'' 21 CFR Sec. 1316.59(a). ``Relevant
evidence means evidence having any tendency to make the existence of
any fact that is of consequence to the determination of the action
more probable or less probable than it would be without the
evidence.'' Fed. R. Evid. 401 (internal quotation marks omitted).
This document made no fact of consequence more or less probable.
Thus, this document has played no part in this recommended decision.
---------------------------------------------------------------------------
After the inspection,\27\ DI McRae reviewed the material and
information obtained during her inspection and conducted two audits
incorporating data from January 5, 2010, through January 4, 2011. Tr.
85. One audit was based on the purchase records of the Respondent, and
another was based on shipment records obtained from the Respondent's
supplier reflecting shipments to the Respondent's practice. Tr. 120-21.
McRae testified that she put the results of each of the comparative
audits into separate computation charts. Gov't Ex. 10. Both audits
reflected significant discrepancies between what was on hand at the
time of the closing inventory and what should have been on hand based
on the purchase records and the shipment records.\28\ McRae testified
that, based on her experience in the preparation of over a hundred
audit charts throughout her career, the records that she reviewed were
in violation of multiple recordkeeping requirements outlined in 21 CFR
Sec. 1304.21. Tr. 124, 144.\29\ Also after the January inspection, DI
McRae informed the Respondent that, ``for some unknown reason,'' he
[[Page 19361]]
had two active DEA CORs at the Coconut Grove location and that he only
needed to have one.\30\ Tr. 67-68, 70. At DI McRae's suggestion, the
Respondent filed a DEA Form 104, voluntarily relinquishing one of the
CORs as unnecessary. Tr. 67-68.
---------------------------------------------------------------------------
\27\ Tr. 83-84.
\28\ The audit based on the Respondent's records showed: (1)
shortages of 50 mg/ml Demerol and 50 mcg/ml fentanyl; and (2)
overages of 100 mcg/ml fentanyl, 10 mg/10 ml Midazolam and 2 mg/ml
Versed. Gov't Ex. 10, at 1. The audit based on the supplier's
records showed: (1) shortages of 50 mg/ml Demerol, 50 mcg/ml
fentanyl and 1 mg/ml Midazolam (10 ml vials); and (2) overages of
100 mcg/ml fentanyl, 2 mg/ml Versed and 1 mg/ml Midazolam (2 ml
vials). Gov't Ex. 10, at 2.
\29\ The Respondent acknowledges that there were deficiencies
regarding the controlled substance recordkeeping during the period
of DI McRae's audit. Tr. 622-23; Resp't Posthearing Brief, at ]] 27-
28.
\30\ DEA COR Number BR9176238 and DEA COR Number AR8666109.
---------------------------------------------------------------------------
In addition to the results of the audit,\31\ DI McRae also
testified that she found fifteen ``discrepancies'' in the narcotics
log. Tr. 94. Specifically, DI McRae testified that the narcotics log
kept a type of ``perpetual inventory'' whereby a remaining balance for
a controlled substance was written after each entry. Tr. 95. DI McRae
observed a number of instances where the perpetual inventory for a
given day was updated inaccurately. Tr. 96. That is, the remaining
balance was either greater or less than the difference (or sum) of the
previous balance and the amount used or added (as reflected in the
entry). During her testimony, McRae highlighted several examples of
this phenomenon and provided the following hypothetical: ``The office
may have ended the day with . . . 10 milliliters of a particular drug.
The next time that drug is used, there should be 10 milliliters . . .
available [but] the next day that drug was used the[y] would start with
an inventory of maybe, seven [milliliters].'' Tr. 95-96.\32\ Under
these circumstances, three milliliters would be ``unaccounted for.''
Tr. 96. Counting up the fifteen of these ``discrepancies,'' DI McRae
found the following total amount of ``unaccounted for'' drugs: (1) 213
milliliters of fentanyl; (2) 120 milliliters of Demerol; and (3) 49
milliliters of midazolam. Tr. 97-98. DI McRae testified that fourteen
of the fifteen ``discrepancies'' were ``signed off'' by VM. Tr.
196.\33\
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\31\ On cross-examination the Respondent's counsel raised the
possibility of an internal diverter. Tr. 195. While DI McRae allowed
that internal diversion was possible, she noted that ``[t]he audit
numbers would still be the same because [in her audit she was]
looking at the numbers that are reflected in the records. [T]hat's
what I use for the audit.'' Tr. 195; see also Tr. 246-47.
\32\ As an example of the foregoing, DI McRae pointed to the
narcotics log entry for February 5, 2010, which showed a final
balance of twelve milliliters of fentanyl. The next entry showed an
addition of 160 milliliters of fentanyl, yielding a final balance of
160 milliliters. Under this scenario, twelve milliliters would be
unaccounted for. Tr. 99.
\33\ DI McRae agreed that there were ``alterations''--physical
changes--in the log not counted in her list of fifteen dates where
controlled substances were unaccounted for. Tr. 198; see also Tr.
94. There did not appear to be a correlation between the dates of
alterations and which staff member verified the entries.
---------------------------------------------------------------------------
DI McRae also testified to a number of violations she found in the
DEA Form 222s she collected from the Respondent's pharmacy book.\34\
Tr. 101-03. Specifically, DI McRae testified that the Respondent had
not completed the Form 222s by filling in the number of packages
received from each order, and the dates such packages were received.
Tr. 103. DI McRae also explained that the way the Form 222s were kept
in the peer review pharmacy book was itself a violation of DEA
regulations insofar as the regulations require that records of Schedule
II controlled substances be maintained separately from other records.
Tr. 105-06.
---------------------------------------------------------------------------
\34\ The relevant Form 222s were admitted into evidence as
Government Exhibit 6.
---------------------------------------------------------------------------
On May 16, 2011, DI McRae had a follow-up meeting with the
Respondent to discuss the results of the audit. Tr. 143. During the
meeting, the Respondent acknowledged to the investigator that he had
been ``fairly casual about the procedures that had gone on at the
office,'' but that he had taken a number of steps to remedy the
problems. Tr. 143-44. In particular, the Respondent claimed that, as of
that date, he was the only one with access to the controlled substances
at the office. Tr. 143. The Respondent also stated that ``inventories
were taken . . . before and right after procedures [and] that the
records were being kept separate from the other records.'' Tr. 143.
However, the Respondent also admitted that, since the January
inspection, he had disposed of approximately ten vials of Demerol
without documenting the destruction, a practice that McRae explained to
him as being improper. Tr. 142, 206.
In summary, DI McRae persuasively testified to the following
violations uncovered at the Respondent's practice: (1) ``the Schedule
II controlled substances were maintained with other records [in]
violation of Section 1304 in the [CFR];'' (2) ``there was no biennial
inventory on hand at the facility . . . in violation of Section 1304;''
(3) ``records were not complete and accurate because there was a
discrepancy between what the doctor said he received and what the
distributor said he distributed to the doctor,'' and because the
narcotics logbook contained discrepancies; (4) ``there were no [DEA]
order forms that were completed for the transfer of medications between
the Miami and the Tampa offices;'' (5) ``the [DEA] order forms . . .
were not properly completed by [the Respondent];'' and (6) the
Respondent destroyed controlled substances without filling out a DEA
Form 41, as required by DEA regulations.\35\ Tr. 140-42, 144-45. DI
McRae presented testimony that was consistent, detailed, and plausible,
and her testimony is fully credited in this recommended decision.
---------------------------------------------------------------------------
\35\ DI McRae testified that a practitioner seeking to dispose
of controlled substances should contact a reverse distributor. Tr.
204. However, if the practitioner intends to dispose of controlled
substances himself, he must send the ``DEA a letter advising of
[how] he proposes to destroy the controlled substances.'' Tr. 204.
It is unclear whether Respondent has followed this procedure since
May of 2011. Tr. 205.
---------------------------------------------------------------------------
The Respondent testified on his own behalf, and presented the
expert testimony and reports of Robert S. Litman, a consultant
pharmacist.\36\ Litman holds degrees in Zoology and Pharmacy from the
University of Florida, is a licensed pharmacist and is Board certified
in Pharmaceutical Geriatrics.\37\ He also serves as Clinical Assistant
Professor of Pharmacy Practice (Geriatrics and Advanced Geriatrics) at
the Ohio State University College of Pharmacy and the Nova Southeastern
University, College of Pharmacy.\38\ Tr. 262; Resp't Exs. 1, 20. Over
the Government's objection,\39\ he was accepted as an expert in the
standards applicable to the documentation, record keeping and disposal
requirements of controlled substances, as those requirements pertain to
medical professionals. Tr. 266, 279.
---------------------------------------------------------------------------
\36\ Mr. Litman testified that the designation as a consultant
pharmacist requires course work, continuing education and a special
license. Tr. 262.
\37\ The Government interposed an objection to a compilation of
Mr. Litman's qualifications from a consultant Web site on the unique
basis that the document was not a CV. Tr. 256, 259-61. Although this
objection was overruled, and the document was received into evidence
(Resp't Ex. 1), Litman's CV was subsequently provided and also
admitted into the record. Resp't Ex. 25; Tr. 543-44.
\38\ Mr. Litman testified that, while ``there's always further
certifications you may get . . . in long term care, Board
certification in geriatrics is the ultimate goal for most
clinicians.'' Tr. 262-63.
\39\ Tr. 275-76. Although the Government interposed an objection
to receiving Mr. Litman as an expert, the nature of the objection
was framed entirely as an argument as to weight and raised no
appreciable issue regarding the qualifications of the witness to
present expert testimony. See Fed. R. Evid. 702. The Government's
objections, namely that the witness focused primarily on the
stricter of state versus federal requirements, and that much of his
consulting work is focused on long-term care facilities (Tr. 276),
did not shed any insight upon the salient concerns of whether: (1)
``the expert's scientific, technical, or other specialized knowledge
[would] help the trier of fact to understand the evidence or to
determine a fact in issue;'' (2) the testimony is based on
sufficient facts or data; (3) the testimony is the product of
reliable principles and methods; and (4) the expert reliably applied
the principles and methods to the facts of the case. See Fed.R.Evid.
702. This objection was without merit and was overruled.
---------------------------------------------------------------------------
Mr. Litman explained that consultant pharmacists are employed in
different venues, such as long-term care facilities, diagnostic centers
and surgical centers,
[[Page 19362]]
and that they monitor ``for proper record keeping, acquiring of
pharmaceuticals and . . . disposition of pharmaceuticals.'' Tr. 254. If
a pharmaceutical consultant uncovers a violation in the course of his
duties, it is his job ``to document it, to point it out and to further
the correction.'' Tr. 256. Mr. Litman estimated that, since becoming a
pharmacy consultant in 1984, about eighty-percent of his time has been
devoted to consulting, while twenty-percent of his time has been
devoted to actual pharmacy work.\40\ Tr. 268. Mr. Litman also conceded
that much of his consulting business relates to compliance with state
law, Tr. 274-75, and that, at present, his consulting business is
confined to long term care facilities. Tr. 411.
---------------------------------------------------------------------------
\40\ Mr. Litman works about 5-10 hours per week as a pharmacist.
Tr. 268-269.
---------------------------------------------------------------------------
Mr. Litman testified that he was retained in this case ``to do an
audit, to review records, to see if there was any diversion or any poor
record keeping [or] if there were any compliance issues as far as
storage of medications.'' Tr. 280-81. In this vein, Mr. Litman ``went
through the [Respondent's] clinic . . . . looked at storage areas . . .
. looked at narcotics aids . . . . evaluated the narcotic log book
register, went through 222 forms [and] any other documentation . . .
.that was available to look at.'' Tr. 281. The contracted rate for his
involvement is $300 per hour. Tr. 404-05.\41\
---------------------------------------------------------------------------
\41\ Mr. Litman estimated that he expected to earn approximately
$5,500 for his involvement in this case. Tr. 404-05.
---------------------------------------------------------------------------
Based on his inquiries, Mr. Litman concluded that ``[t]here was
sloppy record keeping. It was very problematic. It was inconsistent.
There was no consistency in the log[ins] meaning that some people would
log things in by vials, others by cc[]s.'' \42\ Tr. 281. Mr. Litman
found instances where controlled substances were added to the narcotics
log without a corresponding 222 order form,\43\ and where errors were
made in the perpetual balance tally.\44\ Tr. 321. Mr. Litman testified
that Respondent failed to maintain the proper documentation for
transfers and that the narcotics log contained ``write overs and
changes in numbers [and] also white out.'' \45\ Tr. 337, 426-27. Litman
characterized the recordkeeping as ``lax.'' Tr. 419.
---------------------------------------------------------------------------
\42\ Notwithstanding how critical Mr. Litman's testimony was of
the Respondent's recordkeeping, and that it was generally consistent
with the Government's position that the Respondent had committed
numerous recordkeeping violations, the Government interposed an
objection to Mr. Litman's testimony and expert reports based upon
the Respondent's failure to provide underlying data related to Mr.
Litman's audit results and opinions. Tr. 285. Agency precedent
directs that expert opinions may be excluded where a timely request
for underlying data has been registered. See C.B.S. Wholesale
Distributors, 74 FR 36746, 36749 (2009) (failure on the part of the
Government to disclose underlying documentation utilized by its
expert that was ``necessary to support [a] critical component of
[that expert's] testimony'' held to ``deny the Respondent a
meaningful opportunity to challenge the expert's conclusion'' and,
thus held to preclude[] a finding that the expert's conclusions are
supported by substantial and reliable evidence''). However, here
there was no timely request for the underlying data made by the
Government in advance of the hearing. Without reaching the issue
here, suffice it to say that had the Government sought this data in
advance of the hearing and its request was refused, the result of
its objection could well have been different and the expert opinions
derived from the withheld underlying data could have been properly
excluded from playing any role in a finding supported by substantial
evidence.
\43\ As an example of this type of discrepancy, Mr. Litman
pointed to the date of February 9, 2010, where 100 ccs of fentanyl
were added without a 222 form. Tr. 321. However, he allowed that
this type of ``discrepancy'' may not have been the type of issue a
pharmacy consultant would have looked for. Tr. 332-33. Entries
reflecting additions of controlled substances from Tampa were not
included in this category. Tr. 346.
\44\ Mr. Litman pointed to the date of November 14, 2010, where
there was an opening balance of sixty ccs, six ampuls were
administered, and 48 ccs remained. Tr. 333.
\45\ He explained that ``you should never use white out on
anything.'' Tr. 337.
---------------------------------------------------------------------------
Despite the observed discrepancies, Mr. Litman testified that he
compared patient records to the dispensing records in the narcotics log
and that ``they all jibed . . . . Everything that Dr. Robinson had
listed [in the log] for the patients was listed on the surgery
reports.'' \46\ Tr. 335. Stated differently, the entries reflecting
medications dispensed from the narcotics log matched the amounts
indicated in the surgical records from the patient charts. Further,
Litman's review of the charts told him that, although the practice was
ordering more controlled substances, the Respondent's dosage levels
during surgical procedures remained constant. Tr. 430.
---------------------------------------------------------------------------
\46\ On cross-examination Mr. Litman testified that he looked at
approximately 20% of patient records. Tr. 409. These were a ``random
sampling of charts from 2010 in various months.'' Tr. 431.
---------------------------------------------------------------------------
Additionally, Mr. Litman found eleven ``major discrepancies'' in
the narcotics log where the amount of controlled substances ordered on
a particular date varied drastically from the amount of controlled
substances checked into the log.\47\ Tr. 282. These ``major
discrepancies'' accounted for ``a little under 95 percent of the drugs
that were missing.'' Tr. 355. Mr. Litman testified that these
discrepancies could not be explained by sloppy record keeping and were,
in his opinion, caused by diversion ``at the point of entry of
reception of the drugs.'' Tr. 281-82; see also, id. at 55. In addition
to these major discrepancies, Mr. Litman identified forty instances of
what he characterized as ``smaller theft.'' Tr. 355.
---------------------------------------------------------------------------
\47\ As an example of such a discrepancy, Mr. Litman pointed to
the date of October 21, 2010, on which an order for Demerol was sent
to the supplier, but was never logged in by PCCS. Tr. 298.
---------------------------------------------------------------------------
Upon investigation, Mr. Litman learned that an employee named
Priscilla Arciniega received the Respondent's drug shipments. Tr. 355-
56. In short, Ms. Arciniega was the functionary manning ``the point of
entry'' for PCCS. Based on this information, Mr. Litman conducted a
review of Ms. Arciniega's employment records. Tr. 358. The employment
records showed that Ms. Arciniega was hired in November of 2009,\48\
one month before Mr. Litman began to see inconsistencies in the
narcotics log. Tr. 496. Mr. Litman also found that during a single week
in early March 2011, a week where Ms. Arciniega was absent from PCCS,
``there was no missing narcotics,'' and that when she returned to work
``there was diversion again.'' \49\ Tr. 362-63. Further, Litman noted
that the controlled substance losses/thefts stopped after Ms. Arciniega
was terminated from PCCS in March of 2011. Tr. 358.
---------------------------------------------------------------------------
\48\ Resp't Ex. 15.
\49\ The Respondent, through the testimony of counsel retained
by PCCS, introduced a printout from the Public Access to Court
Electronic Records (PACER) system reflecting the docket from a
criminal matter in the Eastern District of New York, U.S. v.
Arciniega, et al, 1:03-cr-00759-CBA, which shows that, in 2003, Ms.
Arcieniega pled guilty to one count of conspiring to import heroin
into the United States. Resp't Ex. 21, at 1.
---------------------------------------------------------------------------
With regard to the November 23, 2010, prescription, Mr. Litman
concluded that, while the prescription was obtained improperly, it was
``intended to be used for a medically necessary purpose.'' Tr. 338; see
also Tr. 413. Mr. Litman based this conclusion on the fact that the
prescription was kept in the peer review pharmacy book, explaining that
``[i]f they were really trying to divert that, they wouldn't have kept
a copy of it.'' Tr. 339. Thus, although obtained through the improper
vehicle of a prescription to a non-patient, the Demerol was entered and
tracked for use on patients at the clinic. Mr. Litman further explained
that drug shortages are ``becoming a big problem in our community'' and
that facilities and practitioners have been forced to obtain necessary
controlled substances by writing prescriptions for, in essence, office
use.\50\ Tr. 340-42. Litman stated
[[Page 19363]]
that drug shortages are currently so profound that hospitals and
nursing homes will sometimes borrow medications from retail or hospital
pharmacies. Tr. 340. According to Mr. Litman, ``it's not legal to do
that[,] it's not proper to do it, but it's done quite frequently.'' Id.
Mr. Litman also shared his experience that it is not uncommon for
practitioners to (improperly) write prescriptions for office use once
they have exhausted authorized channels. Tr. 342.
---------------------------------------------------------------------------
\50\ Mr. Litman testified that if a client of his was having
difficulty locating necessary controlled substances, he ``would
advise them to call different pharmacies. Call several hospital
pharmacies to see if they had it.'' Tr. 342. He said that he would
``never'' suggest that a practitioner obtain controlled substances
by writing a prescription for an employee. Tr. 343.
---------------------------------------------------------------------------
Also related to the November 23, 2010, prescription, Mr. Litman
testified that the fifty vials of Demerol obtained by filling the
prescription were added to the logbook, but that ``all the entries
[that day] were altered and changed.'' Tr. 346-47. Mr. Litman testified
that he became suspicious as to the accuracy of the November 23, 2010,
records when he saw that all fifty vials of Demerol were used on three
procedures,\51\ despite that the fact that he thought that ``they may
have used four to five vials'' throughout the day for such
procedures.\52\ Tr. 346-47. Accordingly, Mr. Litman asked to see the
records for the patients who were seen on November 23, 2010, and was
told by an unnamed PCCS staff member that two of the three relevant
charts were missing. Tr. 347, 351. Furthermore, the lone chart that was
produced to Litman by PCCS contained a significant internal
inconsistency. Tr. 352-53; Resp't Ex. 19. Specifically, that portion of
the chart, which reflects the quantity of Demerol administered during
the patient's procedure, shows eight contemporaneous administrations of
Demerol totaling three-hundred milligrams. However, the ``total''
column of Demerol administered reflects that only fifty milligrams of
Demerol had been administered to the patient during the procedure. Tr.
352-53. In short, the contemporaneous entries had been obviously
altered to show an increased amount of medication administered per
dose, but the individual who altered the document lacked the presence
of mind to alter the ultimate total figure entered, which remained
fifty milligrams.
---------------------------------------------------------------------------
\51\ Litman testified that ``at the end of the day, all 50 vials
were gone.'' Tr. 346.
\52\ Mr. Litman based this assumption on a number of apparent
alterations on the narcotics log. Tr. 349.
---------------------------------------------------------------------------
On the issue of disposal of controlled substances, Mr. Litman
testified that disposal of controlled substances is ``a tricky issue''
and that it has been his experience that ``[t]he problem is when you do
call the agency and many times for small amounts, they don't want to be
bothered by it.'' Tr. 371. Litman testified that he has called DEA in
the past to report minor thefts and destruction of controlled
substances and the employee on the other end of the phone would say
``don't bother with it, call the police.'' Tr. 372. Mr. Litman further
explained that if a client asked what to do with controlled substances
leftover from a procedure, he would ``say you flush it with a
witness.'' \53\ Tr. 377. Somewhat troublingly, Mr. Litman initially
insisted that he is licensed by the state to destroy controlled
substances without notifying the DEA, but later retreated from this
position when shown 21 CFR Sec. 1307.21. Tr. 372-73, 377-79. Despite
his testimonial epiphany on the subject of disposal authority, Litman
testified that he has been disposing of controlled substances without
notifying the DEA \54\ for approximately thirty years.\55\ Tr. 379.
---------------------------------------------------------------------------
\53\ Mr. Litman presented his (legally unfounded) opinion that
DEA regulations related to disposal may not apply to small
quantities of controlled substances. Tr. 382.
\54\ Litman stated that in his opinion, storing residual
controlled substance in a practice presents a greater risk of
diversion than destroying it outright because it could be taken and
diverted while waiting to be transported to a reverse distributor.
Tr. 376-77.
\55\ Mr. Litman pointed to section 64B16-28.303 of the Florida
Administrative Code as authority for his disposal methods. Tr. 541.
---------------------------------------------------------------------------
Mr. Litman testified regarding an October 12, 2011, letter to the
Respondent from the Florida Department of Health stating that it had
received a letter from PCCS correcting deficiencies found during a
September 12, 2011, inspection. Tr. 301. Mr. Litman explained that the
letter would have followed an inspection and that, ``if [PCCS] were not
in compliance, they would never receive this letter.'' Tr. 302.
Similarly, Mr. Litman testified regarding a certificate of
accreditation for PCCS from AAAA--the American Association for
Accreditation of Ambulatory Surgical Facilities (``Quad A'')--for the
time period from March 3, 2010, through March 31, 2011. Tr. 307; Resp't
Ex. 14. Mr. Litman explained that a Quad A certification inspection
would have included ``an investigation of record keeping and medication
and narcotics usage and documentation and disposal'' and that a
certification would be given at the conclusion of a successful
inspection. Tr. 307. Mr. Litman testified that successful inspections
by accrediting agencies would give a practitioner a ``false sense of
security.'' Tr. 311.
Mr. Litman also testified that, in his inspection of the
Respondent's records, he discovered that PCCS had retained a pharmacy
consultant named Joe Koptowsky. Tr. 312-13; Resp't Ex. 7. Of relevance
here, the agreement between PCCS and Mr. Koptowsky called for Mr.
Koptowsky ``[t]o review the pharmacy section of patient records . . . .
for conformance with State and Federal laws regarding dispensing,
labeling, storage and administration of drugs; To review the drug
distribution system, including ordering and administration or disposal
(wastage) of medications[;] To review the labeling and storage of
drugs[; and] To review the controlled substances documentation and
audit records.'' Resp't Ex. 7. By reviewing inspection records prepared
by Mr. Koptowsky, Mr. Litman discovered that Mr. Koptowsky performed
inspections of PCCS Coconut Grove approximately once every six months
from May of 2006 until May of 2009, and once every year from May of
2009, through November of 2010. Tr. 315-16, 321; Resp't Ex. 8.
Remarkably, a November 9, 2010, Koptowsky inspection found no
irregularities at the Coconut Grove facility, although that date fell
two months prior to the DEA audit that revealed the deficient
recordkeeping, and squarely within a period of time when controlled
substance losses at PCCS were at an apex. Tr. 321-24; Resp't Ex. 8, at
10.
Mr. Litman testified that, if Mr. Koptowsky had found
irregularities, it would have been incumbent upon him, as a pharmacy
consultant, to bring the irregularities to the attention of PCCS.\56\
Tr. 324. Though Mr. Litman acknowledged that the duty to maintain
accurate records was the Respondent's ultimate responsibility, he
testified, in essence, that it was not unreasonable for a practitioner
to rely on a consultant pharmacist, and that the act of hiring a
pharmacy consultant showed a desire on the part of the Respondent to
comply with the applicable regulations. Tr. 407, 533-34. According to
Litman, a pharmacy consultant who was acting responsibly would have
identified the issues raised by DEA regarding the recordkeeping and
shortage issues at PCCS and taken steps to bring the client into
compliance. Tr. 525. However, Litman also freely conceded that as a
registrant, the Respondent is ultimately responsible for actions taken
under his registration regarding controlled substances, and that he is
aware of no legal authority that would allow a practitioner to escape
responsibility for
[[Page 19364]]
his actions by virtue of his reliance upon a pharmacy consultant. Tr.
408.
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\56\ Mr. Litman has worked with Mr. Koptowsky in the past, and
regards him as a ``poor quality pharmacist.'' Tr. 327.
---------------------------------------------------------------------------
Mr. Litman testified regarding the Government's audit. Tr. 385. He
explained that, while the Government's audit, which relied on the
narcotic logbook, reflected that the Respondent's practice had
distributed fentanyl in 100 mcg/ml concentrations, no 100 mcg/ml
concentration existed.\57\ Tr. 385-87. Rather, the practice received
and distributed the medication in only the 50 mcg/ml strength, not one
hundred.\58\ Tr. 387-88. When viewed in this light, Mr. Litman asserted
that the fentanyl discrepancies found by DI McRae--the large overage of
100 mcg/ml fentanyl and the large shortage of 50 mcg/ml fentanyl--are
``almost a wash.'' Tr. 388.
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\57\ Mr. Litman believed this error was caused by the fact that
the fentanyl came in different vial sizes. Tr. 387.
\58\ Litman testified that the corrected data demonstrates
approximately 400 missing vials, not 600 or 790, as reflected in the
Government's audits. Tr. 388.
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Mr. Litman also set forth the results of an audit he conducted
based upon the Respondent's records of fentanyl and Demerol from
January 5, 2010, through March 2, 2011.\59\ Tr. 391, 418; Gov't Ex. 14.
When conducting the audit, Mr. Litman derived the starting and closing
inventories from the logbook. Tr. 496, 500. Mr. Litman explained that
he conducted an ``ongoing perpetual inventory'' based on the narcotics
log, the 222 forms and the invoices.\60\ Tr. 508. Under this process,
he noted when controlled substances were used, transferred \61\ or
received, and would tally the drugs as they went missing. Tr. 508.
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\59\ Mr. Litman chose to end the audit once he found that the
records ``showed no discrepancies.'' Tr. 492. Litman explained that
he extended the length of the audit he conducted by two months over
the audit period utilized by the Government so that he could capture
the employment time of Ms. Arciniega, which was also the end (in his
view) of the controlled substance discrepancies issues. Tr. 491-92,
497. Litman also noted that inconsistencies in the controlled
substance records at PCCS began to appear around December 2009, and
that before that, the records seemed ``very consistent.'' Tr. 496.
\60\ During the course of his testimony, Litman opined that the
numbers expressed in the Government audit, although placed into a
chart, were ``pretty arbitrary'' and that, in his view his audit
``is more accurate because [his] is done on a daily basis [and] can
actually pinpoint the days the drugs were missing,'' contrary to the
Government audit, which ``just tells you what was ordered and
received.'' Tr. 512.
\61\ Mr. Litman assumed that additions without documentation
were transfers from the Tampa office. Tr. 509.
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In his audit, Mr. Litman found shortages of Demerol and fentanyl in
the approximate \62\ amounts of 681 vials and 401 vials, respectively.
Tr. 391-92. Converting these amounts to milliliters, the unit of
measurement used by DI McRae in her audits, Mr. Litman found a shortage
of fentanyl of approximately 802 milliliters, and a shortage of Demerol
of approximately 681 milliliters.\63\
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\62\ According to Mr. Litman, ``when you have somebody who's
stealing narcotics, generally a seasoned addict will be able to
manipulate data, change records.'' Tr. 494. Accordingly, it is
difficult to ascertain the exact shortage of drugs. Tr. 494.
\63\ The Respondent received shipments of Demerol containing 1
ml vials, and shipments of fentanyl containing 2 ml ampuls. Gov't
Ex. 9.
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Mr. Litman further testified that when he was retained by the
Respondent in October of 2011, ``I found everything corrected.'' Tr.
364. In particular, Mr. Litman testified that the Respondent: (1)
``instated new narcotic lock boxes [and] lock keys;'' \64\ (2) had
assumed sole access to the combination of the lock box; (3) separated
Schedule II controlled substance records from other records; (4)
instituted a procedure of conducting a twice a day inventory whenever
surgical procedures are performed; (5) conducted perpetual and biennial
inventories; and (6) separated DEA Form 222s from other records. Tr.
365-68. Additionally since Mr. Litman was retained, the Respondent has
replaced Mr. Koptowsky.\65\ Tr. 365. Mr. Litman explained that ``I've
seen this kind of scenario before where employees will often steal . .
. drugs and blame other employees. Basically I feel [the Respondent]
was kind of a patsy in this case [and that] his greatest . . . deficit,
failure would be that he didn't monitor it properly and he trusted the
other people to inform him of problems that they never told him
about.'' Tr. 527. Mr. Litman testified that once the Respondent gained
an appreciation of the situation, he ``made every effort to put the
facility in compliance with all regulations.'' Tr. 371; see also, id.
at 523-24.
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\64\ The Government objected to the photographs of the lock
boxes the Mr. Litman examined essentially because, although he
recognized the boxes in the photos, he did not actually operate the
camera that took the pictures. This objection was overruled.
\65\ Mr. Litman explained that approximately a week before the
hearing, the Respondent ``retained'' a new consultant. Tr. 413-14.
On cross examination Mr. Litman said that a contract had not been
signed, ``but we will do it this week.'' Tr. 515. Subsequent to the
hearing, the Respondent and Mr. Litman entered into a pharmacy
consultant agreement. Resp't Ex. 22.
---------------------------------------------------------------------------
Two reports authored by Mr. Litman were received into the record.
Litman's initial report (Litman Report I), dated October 28, 2011,
contained a brief summary of his qualifications and a somewhat less
brief summary of the Respondent's contentions and factual assertions
for which Mr. Litman had no first-hand knowledge.\66\ Resp't Ex. 17.
Additionally (and more helpfully), the Litman Report I sets forth
selective analyses of various aspects of the Respondent's records and
recordkeeping practices. Included in his review was his written
evaluation of Respondent's illegal controlled-substance-stock
replenishment evolution. Id. at 2. Consistent with his testimony,
Litman characterized this evolution as ``evidence of some lax attention
to a record keeping regulation . . . .'' Id. Overall, Litman opined
that his examination of the Respondent's practice demonstrated to him
that:
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\66\ A non-exhaustive list of the areas that the Litman Report I
expounds upon on, without apparent basis for doing so, includes: (1)
Whether VM, the owner of PCCS, is addicted to controlled substances;
(2) the details of a conversation between VM and DI McRae where Mr.
Litman was not present; (3) an analysis of the regulatory
requirements for a power of attorney; (4) a signature analysis on an
entry in the PCCS narcotic logbook; and (5) whether a wholesaler
utilized by PCCS had a delay in providing Demerol. Resp't Ex. 17.
Naturally, these matters, and any others for which Mr. Litman had no
apparent factual basis for the opinions included in the Litman
Report I have been afforded no weight in this recommended decision.
[T]here was a substandard job performed in the maintenance of
the narcotic records as well as insufficient logging in of newly
received orders as the narcotic counts were not accurate. [The
Respondent] did review all narcotic orders prior to them being
ordered, but did not sign in the amounts and dates arrived properly
[sic], nor did he properly fill out forms for the transfer of
medications from one clinic to another. There was inconsistency in
the amounts of drugs received as there was no uniform system in
place for this accounting. One nurse may have logged medications as
---------------------------------------------------------------------------
``cc'' or ``ml'' leading to difficult and improper accounting.
Id., at 2. In his report, as in his testimony, Litman provides his
view that ``much of the problems stems [sic] from [the Respondent's]
good faith reliance on the professionalism of other employees at the
clinic, and [a] Consultant Pharmacist.'' Id., at 3.
Curiously, the Litman Report I contains the observation that
``[w]hen discussing these issues with [the Respondent] he was sullen
and remorseful about his poor oversight into the accounting.'' Id.
There was also some account of Litman's recollection of some self-
serving representations made by the Respondent to him concerning what
he would have done had he known about his (own) lax oversight, as well
as purported corrections he had and intended to make in the future, as
well as Litman's peculiar estimation that (despite unreliable and
inaccurate recordkeeping) the Respondent never created a risk of
diversion or to public safety. Id.
Although Mr. Litman's second report (Litman Report II),\67\ dated
November 8, 2011, unquestionably suffers from many
[[Page 19365]]
of the same variety of unsupported overreaching and extrapolation that
plagued its predecessor, the second version does a better job at
describing the data and elements of the Respondent's recordkeeping that
Litman analyzed in reaching his opinions. Specifically, the Litman
Report II indicates that its author reviewed 36 randomly-selected
charts from a total of 170 procedures conducted at PCCS in 2010
(approximately 21 percent of the procedures conducted at that
facility), and found no discrepancies between entries in the patient
charts compared to the narcotics logs. Resp't Ex. 18.
---------------------------------------------------------------------------
\67\ Resp't Ex. 18.
---------------------------------------------------------------------------
Litman's discovery of a 2010 spike in the Respondent's per-
procedure use of Demerol and fentanyl compared to the years 2009 and
2011 is presented in his report without any suggestion as to the
significance that data played in the balance of his opinions.\68\ Id.
However, during his testimony, Mr. Litman clarified the importance of
this data, explaining that, in his opinion, ``[t]hey were still using
the same amount for each procedure,\69\ but then there was an extra
amount . . . that was being stolen.'' Tr. 428-29.
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\68\ Mr. Litman's report states that the Demerol calculations
were ``based on 222 form drug orders, not actual procedures.''
Resp't Ex 18, at 1. Litman's testimony explained that he garnered
surgical procedure information from the Respondent's surgical
records.
\69\ Mr. Litman concluded that they were using the same amount
per procedure after going through the records, and after being told
by the Respondent that he was ``using consistent the same as . . .
always.'' Tr. 429-30.
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The Litman Report II also presents the results of what he
characterizes as ``an in-depth review of all [PCCS] narcotic usage,
primarily focusing [sic] on the drugs [f]entanyl and Demerol from
January 2010 thru April 2011.'' Resp't Ex 18 at 1. In what he
subsequently refers to as an ``audit,'' \70\ Litman catalogues ``major
discrepancies in drug counts,'' tallying about 40 in a 15-month time
frame. Id. (emphasis supplied). The Litman Report II documents a 681-
vial shortage of Demerol and a 401-vial shortage of fentanyl.\71\ Id.
Litman also notes eight instances where controlled substances were
shipped to the ``Tampa area clinic'' without filling out ``the proper
DEA forms as per regulation.'' Id. Further, the Litman Report II
contains his observation that ``[t]here appeared to be shrinkage
(theft) occurring randomly on a weekly-monthly basis (~ 1 box stolen
every 12 days) since January 2010 and ending immediately after March 2,
2011 . . . . [a time frame that coincides] with the employment dates of
[an] employee who had access to these missing narcotics'' that Litman
characterizes as ``questionable.'' \72\ Id., at 2. The Litman Report II
also volunteers that ``[t]here were no missing drugs during a specific
week this employee did not come to work and shrinkage resumed the week
she returned to work,'' and that ``[t]here were also white-outs noted,
combined with changed entries on the Narcotic Log Book, coincidently,
on the last day of her employment.'' Id.
---------------------------------------------------------------------------
\70\ Id.
\71\ In contrast to the audit conducted by DEA, Litman found
only shortages, and no overages. Resp't Ex. 18, at 1; Gov't Ex. 10.
\72\ It is clear from Mr. Litman's testimony that he was
referring to Ms. Arciniega.
---------------------------------------------------------------------------
Much as is true in the initial report and the witness's testimony,
the Litman Report II essays to excuse any assignment of responsibility
to the Respondent under the (legally-unsupportable) theory that all
noted discrepancies were understandably overlooked by the Respondent
because he ``was not a full time practitioner at PCCS during the year
2010[,] was not properly up to date as to proper record-keeping,
transfers of medications, logging in of new orders, and ongoing
inventory control [and really] stems from [Respondent's] good[-]faith
reliance on the professionalism of other co-workers and employees at
the clinic, the licensed Consultant Pharmacist, and other regulatory
agencies to do their jobs correctly'' Id., at 2, 4.
The Litman Report II also notes some security enhancements the
Respondent put into effect after the DEA audit, and once again
reiterates Litman's odd assurance that the Respondent's wholly
substandard recordkeeping has resulted in neither a public threat nor a
risk of drug diversion. Id. at 2.
During his testimony, Mr. Litman did not shy away from those areas
where he concluded that the Respondent fell below the standard of due
care in his recordkeeping obligations, and in many respects, his audit
assessments painted an even bleaker picture of the Respondent's
recordkeeping than the Government's version. While his view that the
Respondent should somehow be absolved of his obligations as a
registrant by virtue of his reliance upon a pharmacy consultant is
wholly unpersuasive, it did not undermine the value of his expert
opinions in this case. In short, Mr. Litman's presented testimony that
was sufficiently detailed, authoritative and candid to be credited in
this decision.
The Respondent testified that he was born in St. Louis, Missouri,
in 1946 and that he graduated from St. Louis University and the St.
Louis University School of Medicine. Tr. 549. After graduating from
medical school, the Respondent completed a two-year residency in basic
surgery at the University of Florida.\73\ Tr. 549. The Respondent
volunteered that he has published scholarly articles in his field of
practice, and that as a medical student, he discovered the cause of
burn anemia and presented his findings at a meeting of the Saint Louis
Surgical Society, where he was awarded a prize in recognition of his
achievement. Tr. 550. Once done with his residency, the Respondent
performed general surgery for two years in St. Louis, and then
completed a one-year fellowship in burns.\74\ Tr. 549. After the burns
fellowship, the Respondent finished a two-year residency in plastic
surgery at the University of Illinois in Chicago. Tr. 549, 562. During
this time, the Respondent taught a course in burn management to
pediatricians at the University of Illinois-Chicago, lectured in
pediatric burn care, and was appointed as Instructor in Surgery. Tr.
562. The Respondent moved to Broward County in 1979 to open a practice
in plastic surgery. Tr. 549. The Respondent stated that he has remained
in southern Florida since 1979. Tr. 549.
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\73\ The Respondent's CV was received into evidence without
objection. Resp't Ex. 2.
\74\ The Respondent has published several articles in the fields
of burns. However, he tested that he was ``unfortunate [in] that in
south Florida, they were unwilling to need somebody who had my
expertise.'' Tr. 550.
---------------------------------------------------------------------------
Though the Respondent maintained a general plastic surgery practice
in Pembroke Pines, Florida, he explained that for years he also covered
emergency rooms and focused his practice on ``reconstructive surgery,
primarily facial skin cancers, post-mastectomy breast reconstruction,
and . . . difficult wounds.'' Tr. 551. According to the Respondent,
``[u]ltimately, like most plastic surgeons, as [he] got older, [his]
practice gravitated to primarily cosmetic surgery,'' but allowed that
he still performs some reconstructive work. Tr. 551-52. In 1999 the
Respondent ``began doing some work'' \75\ at a PCCS office in Weston,
Florida.\76\ Tr. 550. The Respondent testified that, while he initially
worked at PCCS ``one day a week or every other Saturday . . . . as the
other physicians came and went, I seemed to get more . . . time
there.'' Tr. 550-51. Although other physicians
[[Page 19366]]
seemed to come for periods of time and move on, he testified that he
stayed with PCCS. Tr. 558-59. The Respondent explained that over the
years several physicians were appointed by PCCS as the primary doctor.
---------------------------------------------------------------------------
Tr. 559. According to the Respondent:
\75\ At this time, the Respondent was an ``independent
contractor'' at PCCS and was paid a percentage of the amount PCCS
charged for a surgery he performed. Tr. 554. The Respondent also
testified that PCCS maintained the state required certifications for
conscious and general sedation. Tr. 555-56.
\76\ Weston is in ``western Broward County west of Ft.
Lauderdale.'' Tr. 553.
I would occasionally become the primary doctor because someone
left, moved on, got fired. But I was really never the primary doctor
until maybe 2008. And even then, they would occasionally bring
someone in to either do some work or even to the majority of the
work. It disappointed me a little bit but since I had my private
office at the time, and I wasn't willing to give it up, I didn't
feel there was much I could say about that because I was not
---------------------------------------------------------------------------
devoting all my time to PCCS.
Id.
In or around 2005, the surgeon working at the Coconut Grove PCCS
location moved to Weston, so PCCS asked the Respondent to ``go down to
Coconut Grove and take his place.'' Tr. 552. Because Respondent's home
at the time was equidistant from Weston and Coconut Grove, he accepted
the proposed move. Tr. 553. It was in 2005, when he assumed the duties
at PCCS Coconut Grove,\77\ that his COR was utilized to handle
controlled substances in the clinic.\78\ Tr. 559-60. The Respondent
testified that ``when the supply of drugs got low, they would tell
[him] that they needed for [him] to fill out a form. Sometimes they
would write in the amounts, sometimes they'd tell [him] and [he] would
just write it in and sign it and they'd send it off and order the
drugs.'' Tr. 560. The Respondent indicated that he became ``the primary
doctor'' at PCCS sometime around 2008. Tr. 559.
---------------------------------------------------------------------------
\77\ The Respondent clarified that this was not ``a compensation
position.'' Tr. 561.
\78\ The Respondent indicated that he could not recall whether
he signed a document specifically authorizing the use of his DEA
COR. Tr. 561. However, he testified that he thought the document
appointing him medical director ``calls . . . for them to use my
narcotic registration.'' Tr. 561.
---------------------------------------------------------------------------
According to the Respondent, just over a year ago he began
``slowing down'' his private practice, a process which he explained as
``limiting [his] procedures, not taking on any more complicated cases
or cases that would require multiple procedures or a long time[, a]nd
basically telling the patients that [he] was going to be leaving in
some period of time.'' Tr. 571-73. On April 18, 2011, the Respondent
closed his private practice to focus on his work at PCCS.\79\ Tr. 571-
73, 665. In this regard, the Respondent explained that ``about 99
percent'' of his practice involves controlled substances and that a
limitation on his ability to use narcotics ``would be like cutting off
my hands.'' Tr. 575.
---------------------------------------------------------------------------
\79\ The Respondent testified that his decision to focus on PCCS
was motivated by his desire to ``not have any overhead to worry
about, not have to worry about payrolls and all the other things
that you have to concern yourself with and then . . . [he] could
pretty much walk away from there because [he] didn't have the same
responsibilities [he] had in a private practice.'' Tr. 573.
---------------------------------------------------------------------------
Turning to the allegations underlying this case, the Respondent
testified that ``when I first discovered that I had done something
wrong . . . I was pretty devastated. I couldn't believe it. The center
seemed to run so well for a number of years.'' \80\ Tr. 566.
---------------------------------------------------------------------------
\80\ The Respondent testified that there were ``very minor''
problems regarding entries in the narcotics log, where ``one person
was using cc[]s and the other person was using vials.'' Tr. 567-68.
---------------------------------------------------------------------------
As a partial explanation for his surprise, the Respondent offered
PCCS' employment of Mr. Koptowsky as a pharmacy consultant. Tr. 567. In
this regard, the Respondent testified that he met Mr. Koptowsky once,
during his November 9, 2010, inspection, and that, while he had never
seen the actual inspection forms, he ``was aware that they existed and
that there wasn't anything that applied, there wasn't any correction or
problem that was listed that . . . I needed to do something about.''
Tr. 630, 639. 41; Resp't Ex. 9.
Relatedly, the Respondent also testified that the Board of Medicine
requires that a facility be accredited by one of three organizations--
Quad A, AAA, or the State--``in order to be able to perform procedures
which require general anesthesia or conscious sedation.'' \81\ Tr. 580.
To obtain certification through either the State or the Quad A, a
facility must undergo an inspection conducted by a medical doctor. Tr.
587-88. The Respondent presented his understanding that the physician
conducting such an inspection examines many facets of the practice,
including procedure manuals, a random sampling of charts, and the
operating room. Tr. 588, 590.
---------------------------------------------------------------------------
\81\ The Respondent never sought certification for his private
practice because he was able to perform surgeries at a local
ambulatory surgical facility. Tr. 557.
---------------------------------------------------------------------------
On March 31, 2010, the PCCS facility in Coconut Grove passed a Quad
A inspection, and was granted a certification to March 31, 2011. Resp't
Ex. 14. Sometime after the Quad A inspection, PCCS opted to obtain a
certification through the State. Tr. 590-91. However, due to a backlog,
the State inspection did not occur until September of 2011. Tr. 590-91.
When the State inspection took place, the inspector found some
violations, which the Respondent explained as ``mostly small things,''
such as ``some of the more recent charts [not having] their operating
notes.'' Tr. 592-93. After the inspection, PCCS sent a letter to the
State stating that the uncovered deficiencies had been corrected. Tr.
592-93; Resp't Ex. 4. On October 12, 2011, the State sent a letter to
PCCS acknowledging the receipt of the correction letter.\82\ The
Respondent explained that the October 12, 2011, letter was ``final.''
Tr. 593.
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\82\ According to the Respondent, in a State inspection,
deficiencies are outlined in a letter directing correction and that
when the issues are minor, no post-correction re-inspection
customarily occurs. Tr. 589.
---------------------------------------------------------------------------
The Respondent testified that when the allegations regarding VM's
drug abuse surfaced, ``she wanted to be drug tested because she totally
denied the allegations.'' Tr. 577. Accordingly, the Respondent
authorized a drug test for VM. Tr. 577. On April 19, 2011, a hair
sample from VM was collected. Gov't Ex. 3. Three days later, on April
22, 2011, the sample tested negative for all controlled substances.
Gov't Ex. 3.\83\
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\83\ Respondent Exhibit 3, which was admitted into evidence,
also contains two negative drug tests from September of 2011. The
Respondent testified ``I don't think I wrote the one in September.''
Tr. 663.
---------------------------------------------------------------------------
With regard to the November 23, 2010, prescription to VM, the
Respondent explained that, on the relevant date, he had three surgeries
planned, but there were no narcotics on hand at the practice. Tr. 593-
94. To address this problem, the Respondent issued a prescription in
VM's name ``so that at least we'd have some for future surgeries if we
needed them [a]nd that was obviously a mistake.'' Tr. 595-96.\84\
Later, when reviewing the patient charts for the three patients seen on
November 23, 2010, the Respondent discovered that two of the three
anesthesia records from the November 23, 2010, operations were missing.
Tr. 599-600. Furthermore, the remaining anesthesia record that was
found reflected indicia of alterations. Tr. 599-602.
---------------------------------------------------------------------------
\84\ The Respondent further testified (incorrectly) that ``I
should have written a prescription to each, for each patient for the
amount of narcotic I thought we were going to use. And that way,
probably would be all proper. I'm not sure . . . .'' Tr. 595. See 21
CFR Sec. 1305.03.
---------------------------------------------------------------------------
The Respondent explained that, when he performs a surgery requiring
anesthesia, the nurse anesthetist or the anesthesiologist will keep the
anesthesia record by ``writ[ing] in each of the drugs that are being
administered and . . . what dosage is administered [a]nd then at the
end, they usually put some sort of a total.'' Tr. 599. However, the
anesthesia record from November 23, 2010, reflected ``way too many
drugs . . . listed across the contemporaneous portion.'' Tr. 601.
Specifically, the
[[Page 19367]]
Respondent testified that the particular procedure reflected on the
chart would have taken about an hour, but that he saw what ``looked
like seven ampules had been administered [a]nd that's . . . just not
going to be done for a procedure that takes less than an hour.'' Tr.
601-02.\85\ The Respondent allowed that if the high doses reflected on
the chart reflected the reality, the patient's respiratory muscles
would have been paralyzed, which the Respondent testified did not
occur. Tr. 609-10. It is the Respondent's opinion that the logs were
altered. Tr. 611. When questioned about who would have access to the
logs, the Respondent testified that ``the three people that would
always be present in the operating room were the anesthetist . . .
[DN], who was the scrub nurse; and myself.'' Tr. 611. However,
Priscilla Arciniega, the receptionist at the office, would ``often''
help clean up. Tr. 611-13. Furthermore, it ``was part of Ms.
Arciniega's responsibility to at least . . . ha[ve] access to all the
medical records.'' \86\ Tr. 614.
---------------------------------------------------------------------------
\85\ The patient chart was admitted as Respondent's Exhibit 19.
The chart shows eight contemporaneous administrations of Demerol
totaling 300 milligrams. However, the ``total'' column reflects that
only 50 mgs of Demerol had been administered to the patient. Though
acknowledging that he is ``not a handwriting expert,'' the
Respondent testified that the handwriting for the higher dosages
appeared different than other entries on the chart. Tr. 607.
However, he could not remember the name of the anesthesiologist. Tr.
672-73.
\86\ The Respondent testified that it is standard for office
staff to have access to patient medical records. Tr. 614-15. When
asked whether he could limit staff access to medical records the
Respondent replied that ``it's not efficient and it's not
required.'' Tr. 616-17.
---------------------------------------------------------------------------
The Respondent testified that Ms. Arciniega was ``hired as kind of
a jack of all trades. [I]t turned out that another plastic surgeon
whose office [VM] used to provide anesthesia for was retiring or
closing his office and . . . had worked with [Arciniega] . . . before.
And since we needed a person [VM] gave [Arciniega] a job.'' Tr. 612.
The Respondent testified that although he was not present when
Arciniega left the practice, it was his understanding that she was
terminated for cause when she was unable to supply a physician's note
as requested by VM to excuse a work absence. Tr. 658-59. The Respondent
testified that the allegedly unexcused absence occurred sometime at the
end of February of 2011. Tr. 655. However, a timecard admitted into
evidence shows that from February 23 through March 9, 2011, Ms.
Arciniega worked 34.5 hours. Resp't Ex. 15, at 5. The Respondent also
testified that, during the preparation for his testimony with his
counsel, he learned that Ms. Arciniega had ``been arrested in New York
for distribution of narcotics.'' \87\ Tr. 660.
---------------------------------------------------------------------------
\87\ The Respondent testified that, if he had known that Ms.
Arciniega had been arrested for drug trafficking, ``I don't think
she would have ever been hired . . . and if she were hired, she
would have been terminated immediately.'' Tr. 660.
---------------------------------------------------------------------------
The Respondent testified that he took numerous steps to address the
compliance issues that had been related to him by DI McRae during her
January visit. Tr. 569. Specifically, the Respondent testified that he:
(1) ``Assumed immediate control of the key [to the controlled
substances safe];'' (2) ``took control of the record keeping and
[checks] the addition and subtraction after every single case and at
the end of the operating day;'' and (3) implemented a new policy
wherein he personally oversees the opening of all controlled substance
shipments to the office.\88\ Tr. 569-71. The Respondent explained that
``if there [is] any medication that's sitting on the anesthesia cart,
we put it back in the box after our inventory has been done. I lock the
box and take the key, put it back in the lock box and close it.'' Tr.
620. The Respondent also fixed a broken lock on the controlled
substance safe and created separate folders for DEA Form 222s and
biennial inventories. Tr. 624-27. During the hearing he expressed an
intention to begin performing background checks on new hires. Tr. 661.
When asked about his current level of attention to his responsibilities
as a registrant, the Respondent declared that his current practice is
``[a] 180 from what was going on before. I have taken complete control
and I have now accepted my responsibility, which I obviously had
neglected before.'' Tr. 623.
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\88\ The Respondent indicated his intention to seek Agency
advice on the issue of how to better implement this control in light
of the limited number of days he works in the PCCS office. Tr. 569-
71, 621, 674-77, 688.
---------------------------------------------------------------------------
The Respondent presented testimony that was sufficiently detailed,
internally consistent, and plausible to be fully credited in this
recommended decision. When asked about his missteps as a registrant,
the Respondent unequivocally offered: ``Obviously I made some terrible
mistakes but I felt there wasn't anything there that I couldn't
correct, that I didn't want to correct.'' Tr. 569. At another point in
his testimony, the Respondent declared that he ``absolutely
recognize[s]'' that he has not complied with his obligations as a
registrant, and flatly acknowledged that, notwithstanding the fact that
his practice prior to 2005 involved others handling controlled
substances during his procedures, that he ``was ultimately
responsible.'' Tr. 575. His demeanor presented all the indicia
generally associated with candor, including unfaltering
acknowledgements of weaknesses in his past performance as a registrant
and mistakes he has made founded in lack of the oversight required by
his position. He presented the fact that a (derelict) consultant had
been retained by PCCS in a manner that made it clear that he was not
shrinking from his own culpability regarding the condition of his
recordkeeping and other issues.
The Government presented the testimony of DI McRae in a purported
rebuttal to Mr. Litman's testimony. Tr. 607. In truth, while some
nuances of Littman's audit and some elements (such as time span
covered) of that audit that distinguished it from the Government's
audit were elicited, there was little of consequence that was actually
rebutted. The Respondent's recordkeeping, as he has conceded from the
outset, was problematic.
Other facts required for a disposition of this matter are set forth
in the balance of this recommended decision.
The Analysis
Pursuant to 21 U.S.C. 824(a)(4) (2006), the Administrator \89\ is
permitted to revoke a COR if persuaded that the registrant ``has
committed such acts as would render . . . registration under section
823 . . . inconsistent with the public interest . . . .'' The following
factors have been provided by Congress in determining ``the public
interest'':
---------------------------------------------------------------------------
\89\ This authority has been delegated pursuant to 28 CFR
Sec. Sec. 0.100(b) and 0.104 (2010).
(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) (2006 & Supp. III 2010).
``[T]hese factors are considered in the disjunctive.'' Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003). Any one or a combination of
factors may be relied upon, and when exercising authority as an
impartial adjudicator, the Administrator may properly give each factor
whatever weight she deems appropriate in determining whether a
registration should be rejected. Morall v.
[[Page 19368]]
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005); JLB, Inc., d/b/a Boyd
Drugs, 53 Fed. Reg. 43945, 43947 (1988); David E. Trawick, D.D.S., 53
Fed. Reg. 5326, 5327 (1988); see also Joy's Ideas, 70 Fed. Reg. 33195,
33197 (2005); David H. Gillis, M.D., 58 Fed. Reg. 37507, 37508 (1993);
Henry J. Schwarz, Jr., M.D., 54 Fed. Reg. 16422, 16424 (1989).
Moreover, the Administrator is ``not required to make findings as to
all of the factors . . . .'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir.
2005); see also Morall, 412 F.3d at 173-74. The Administrator is not
required to discuss consideration of each factor in equal detail, or
even every factor in any given level of detail. Trawick v. DEA, 861
F.2d 72, 76 (4th Cir. 1988) (the Administrator's obligation to explain
the decision rationale may be satisfied even if only minimal
consideration is given to the relevant factors and remand is required
only when it is unclear whether the relevant factors were considered at
all). The balancing of the public interest factors ``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 . . . .'' Jayam Krishna-Iyer, M.D.,
74 Fed. Reg. 459, 462 (2009).
In an action to revoke a registrant's COR, the DEA has the burden
of proving that the requirements for revocation are satisfied. 21 CFR
Sec. 1301.44(e) (2011). The Government may sustain its burden by
showing that the Respondent has committed acts inconsistent with the
public interest. Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8235-36 (2010).
Once DEA has made its prima facie case for revocation of the
registrant's COR, the burden of production then shifts to the
Respondent to present sufficient mitigating evidence to assure the
Administrator that he or she can be entrusted with the responsibility
commensurate with such a registration. Steven M. Abbadessa, D.O., 74
Fed. Reg. 10077, 10078, 10081 (2009); Medicine Shoppe-Jonesborough, 73
Fed. Reg. 364, 387 (2008); Samuel S. Jackson, D.D.S., 72 Fed. Reg.
23848, 23853 (2007);. Morall, 412 F.3d at 174; Humphreys v. DEA, 96
F.3d 658, 661 (3d Cir. 1996); Shatz v. U.S. Dept. of Justice, 873 F.2d
1089, 1091 (8th Cir. 1989); Thomas E. Johnston, 45 Fed. Reg. 72311,
72312 (1980). ``[T]o rebut the Government's prima facie case, [the
Respondent] is required not only to accept responsibility for [the
established] misconduct, but also to demonstrate what corrective
measures [have been] undertaken to prevent the reoccurrence of similar
acts.'' Jeri Hassman, M.D., 75 Fed. Reg. at 8236. Normal hardships to
the practitioner and even to the surrounding community that are
attendant upon the lack of registration are not relevant
considerations. Abbadessa, 74 Fed. Reg. at 10078; see also Gregory D.
Owens, D.D.S., 74 Fed. Reg. 36751, 36757 (2009).
The Agency's conclusion that past performance is the best predictor
of future performance has been sustained on review in the courts, Alra
Labs. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as has the Agency's
consistent policy of strongly weighing whether a registrant who has
committed acts inconsistent with the public interest has accepted
responsibility and demonstrated that he or she will not engage in
future misconduct. Hoxie, 419 F.3d at 483; Ronald Lynch, M.D., 75 Fed.
Reg. 78745, 78749 (2010) (Respondent's attempts to minimize misconduct
held to undermine acceptance of responsibility); George Mathew, M.D.,
75 Fed. Reg. 66138, 66140, 66145, 66148 (2010); East Main Street
Pharmacy, 75 Fed. Reg. 66149, 66165 (2010); George C. Aycock, M.D., 74
Fed. Reg. 17529, 17543 (2009); Abbadessa, 74 Fed. Reg. at 10078;
Krishna-Iyer, 74 Fed. Reg. at 463; Medicine Shoppe, 73 Fed. Reg. at
387.
While the burden of proof at this administrative level is a
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S.
91, 100-01 (1981), the Administrator's factual findings will be
sustained on review so long as they are supported by ``substantial
evidence.'' Hoxie, 419 F.3d at 481. Thus, ``the possibility of drawing
two inconsistent conclusions from the evidence'' does not limit the
Administrator's ability to find facts on either side of the contested
issues in the case. Shatz, 873 F.2d at 1092; Trawick, 861 F.2d at 77.
However, in rendering a decision, the Administrator must consider all
``important aspect[s] of the problem,'' such as a Respondent's defense
or explanation that runs counter to the Government's evidence.
Wedgewood Vill. Pharmacy v. DEA, 509 F.3d 541, 549 (D.C. Cir. 2007);
Humphreys, 96 F.3d at 663. The ultimate disposition of the case must be
in accordance with the weight of the evidence, not simply supported by
enough evidence to justify, if the trial were to a jury, a refusal to
direct a verdict when the conclusion sought to be drawn from it is one
of fact for the jury. Steadman, 450 U.S. at 99 (internal quotation
marks omitted).
Regarding the exercise of discretionary authority, the courts have
recognized that gross deviations from past agency precedent must be
adequately supported. Morall, 412 F.3d at 183. Mere unevenness in
application standing alone does not, however, render a particular
discretionary action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (D.C.
Cir. 2008) (citing Butz v. Glover Livestock Comm. Co., 411 U.S. 182,
188 (1973)), cert. denied, U.S., 129 S. Ct. 1033, 1033 (2009). It is
well-settled that since the Administrative Law Judge has had the
opportunity to observe the demeanor and conduct of hearing witnesses,
the factual findings set forth in a recommended decision are entitled
to significant deference. Universal Camera Corp. v. NLRB, 340 U.S. 474,
496 (1951). Thus, a recommended decision constitutes an important part
of the record that must be considered in the Administrator's decision.
Morall, 412 F.3d at 179. However, any recommendations set forth herein
regarding the exercise of discretion are not binding on the
Administrator and do not limit the exercise of that discretion. 5
U.S.C. Sec. 557(b) (2006); River Forest Pharmacy, Inc. v. DEA, 501
F.2d 1202, 1206 (7th Cir. 1974); Attorney General's Manual on the
Administrative Procedure Act 8 (1947).
Factors 1 and 3: The Recommendation of the Appropriate State Licensing
Board or Professional Disciplinary Authority; and Any 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 Florida. The record
contains no evidence of a recommendation regarding the Respondent's
medical privileges by any cognizant state licensing board or
professional disciplinary authority. However, that a state has not
acted against a registrant's medical license is not dispositive in this
administrative determination as to whether continuation of a
registration is consistent with the public interest. Patrick W.
Stodola, M.D., 74 Fed. Reg. 20727, 20730 (2009); Jayam Krishna-Iyer, 74
Fed. Reg. at 461. It is well-established Agency precedent that a
``state license is a necessary, but not a sufficient condition for
registration.'' Leslie, 68 Fed. Reg. at 15230; John H. Kennedy, M.D.,
71 Fed. Reg. 35705, 35708 (2006). Even the reinstatement of a state
medical license does not affect the DEA's independent responsibility to
determine whether a registration is in the public interest. Mortimer B.
Levin, D.O., 55 Fed. Reg. 9209, 8210 (1990).
[[Page 19369]]
The ultimate responsibility to determine whether a registration is
consistent with the public interest has been delegated exclusively to
the DEA, not to entities within state government. Edmund Chein, M.D.,
72 Fed. Reg. 6580, 6590 (2007), aff'd, Chein v. DEA, 533 F.3d 828 (D.C.
Cir. 2008), cert. denied, U.S., 129 S. Ct. 1033 (2009). Congress vested
authority to enforce the CSA in the Attorney General, not state
officials. Stodola, 74 Fed. Reg. at 20375. Here, there is no evidence
of record that the state licensing board has even considered the issue
of a formal action against the Respondent's licensure. Thus, on these
facts, the absence 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. See Roni Dreszer, M.D., 76 Fed. Reg. 19434, 19444 (2011)
(``[T]he 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.'').
Regarding the third factor (convictions relating to the
manufacture, distribution, or dispensing of controlled substances), the
record in this case does not contain evidence that the Respondent has
been convicted of (or charged with) a crime related to the manufacture,
distribution, or dispensing of controlled substances. DEA
administrative proceedings are non-punitive and ``a remedial measure,
based upon the public interest and the necessity to protect the public
from those individuals who have misused controlled substances or their
DEA COR, and who have not presented sufficient mitigating evidence to
assure the [Administrator] that they can be trusted with the
responsibility carried by such a registration.'' Jackson, 72 Fed. Reg.
at 23853; Leo R. Miller, M.D., 53 Fed. Reg. 21931, 21932 (1988). Where
evidence in a particular case reflects that the Respondent has acquired
convictions relating to the manufacture, distribution, or dispensing of
controlled substances, those convictions must be carefully examined and
weighed in the adjudication of whether the issuance of a registration
is in the public interest. 21 U.S.C. Sec. 823(f).
Although the standard of proof in a criminal case is more stringent
than the standard required at an administrative proceeding, and the
elements of both federal and state crimes relating to controlled
substances are not always co-extensive with conduct that is relevant to
a determination of whether registration is within the public interest,
evidence that a registrant has been convicted of crimes related to
controlled substances is a factor to be evaluated in reaching a
determination as to whether he or she should be entrusted with a DEA
certificate. The probative value of an absence of any evidence of
criminal prosecution is somewhat diminished by the myriad of
considerations that are factored into a decision to initiate, pursue,
and dispose of criminal proceedings by federal, state, and local
prosecution authorities. See Robert L. Dougherty, M.D., 76 Fed. Reg.
16823, 16833 n.13 (2011); Dewey C. Mackay, M.D., 75 Fed. Reg. 49956,
49973 (2010) (``[W]hile a history of criminal convictions for offenses
involving the distribution or dispensing of controlled substances is a
highly relevant consideration, there are any number of reasons why a
registrant may not have been convicted of such an offense, and thus,
the absence of such a conviction is of considerably less consequence in
the public interest inquiry''), aff'd, Mackay v. DEA, 664 F.3d 808
(10th Cir. 2011); Ladapo O. Shyngle, M.D., 74 Fed. Reg. 6056, 6057 n.2
(2009).
Accordingly, consideration of the evidence of record under the
first and third factors neither supports the Government's argument for
revocation nor militates against it.
Factors 2 and 4: Experience in Dispensing Controlled Substances and
Compliance With Applicable State, Federal, or Local Laws Relating to
Controlled Substances
In this case, the gravamen of the Government's case seeking
revocation relates to its allegations that the Respondent failed to
adhere to the CSA's recordkeeping and security requirements and was
unable to account for both shortages and overages of controlled
substances. Factors Two and Four are relevant to the analysis.
Regarding Factor Two, in requiring an examination of a registrant's
experience in dispensing controlled substances, Congress manifested an
acknowledgement that the qualitative manner and the quantitative volume
in which a registrant has engaged in the dispensing of controlled
substances, and how long he or she has been in the business of doing
so, are significant factors to be evaluated in reaching a determination
as to whether he or she should be entrusted with a DEA COR. In some
cases, viewing a registrant's actions against a backdrop of how she has
performed activity within the scope of the certificate can provide a
contextual lens to assist in a fair adjudication of whether continued
registration is in the public interest.
Evidence that a practitioner may have conducted a significant level
of sustained activity within the scope of the registration for a
sustained period is a relevant and correct consideration, which must be
accorded due weight. The registrant's knowledge and experience
regarding the rules and regulations applicable to practitioners also
may be considered. See Volusia Wholesale, 69 Fed. Reg. 69409, 69410
(2004) (List I case).\90\ However, the Agency has taken the reasonable
position that this factor can be outweighed by acts held to be
inconsistent with the public interest. Jayam Krishna-Iyer, 74 Fed. Reg.
at 463; see also Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8235 (2010)
(acknowledging Agency precedential rejection of the concept that
conduct which is inconsistent with the public interest is rendered less
so by comparing it with a respondent's legitimate activities which
occurred in substantially higher numbers); Paul J. Cargine, Jr., 63
Fed. Reg. 51592, 51560 (1998) (``[E]ven though the patients at issue
are only a small portion of Respondent's patient population, his
prescribing of controlled substances to these individuals raises
serious concerns regarding [his] ability to responsibly handle
controlled substances in the future.''). The Agency's approach in this
regard has been sustained by on review. Mackay, 664 F.3d at 819.
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\90\ In Cynthia M. Cadet, M.D., 76 Fed. Reg. 19450, 19450 n.1
(2011), the Agency reasonably ruled that the Volusia Wholesale List
I analysis of Factor Two experience would not be applied to
practitioner cases where intentional diversion allegations were
sustained. However, insofar as the CSA requires consideration of
``experience'' in both the List I and practitioner contexts, it is
reasonable (and not inconsistent with existing Agency precedent) to
apply this measure in practitioner cases where intentional diversion
has not been established. Compare 21 U.S.C. 823(h) (List I section
mandating consideration of ``any past experience of the applicant in
the manufacture and distribution of chemicals,'') (emphasis added)
with 21 U.S.C. 823(f) (practitioner section mandating consideration
of ``[t]he applicant's experience in dispensing, or conducting
research with respect to controlled substances.); see U.S. v.
Tinklenberg, 131 S.Ct. 2007, 2019-20 (2011) (``Identical words used
in different parts of a statute are presumed to have the same
meaning absent indication to the contrary.''). In reaching this
conclusion, the word ``past'' in 823(h) is treated in surplusage for
the simple reason that all experience is past. See Merriam-Webster's
Collegiate Dictionary 440 (11th ed. 2007); c.f. TMW Enterprises,
Inc. v. Federal Ins. Co., 619 F.3d 574, 580 (6th Cir. 2010)
(``[A]pplying the rule against surplusage is often overrated.'').
---------------------------------------------------------------------------
Experience which occurred prior or subsequent to proven allegations
of malfeasance may be relevant. Evidence that precedes proven
misconduct may add support to the contention that, even
[[Page 19370]]
acknowledging the gravity of a registrant's transgressions, they are
sufficiently isolated and/or attenuated that adverse action against his
registration may not be compelled by public interest concerns.
Likewise, evidence presented by the Government that the proven
allegations are congruous with a consistent past pattern of poor
behavior can enhance the Government's case.
In a similar vein, conduct which occurs after proven allegations
can shed light on whether a registrant has taken steps to reform and/or
conform his conduct to appropriate standards. Contrariwise, a
registrant who has persisted in incorrect behavior, or made attempts to
circumvent Agency directives, even after being put on notice, can
diminish the strength of his case. Novelty, Inc., 73 Fed. Reg. 52689,
52703 (2008), aff'd, 571 F.3d 1176 (D.C. Cir. 2009); Southwood Pharm.,
Inc., 72 Fed. Reg. 36487, 36503 (2007); John J. Fotinopoulous, 72 Fed.
Reg. 24602, 24606 (2007).
In Jayam Krishna-Iyer, 74 Fed. Reg. at 463, DEA acknowledged the
reality that even a significant and sustained history of uneventful
practice under a DEA certificate can be offset by proof that a
registrant has committed acts inconsistent with the public interest.
Id. The Agency, in its administrative precedent, has further curtailed
the scope of Factor Two. The Agency's current view regarding Factor Two
is that, while evidence of a registrant's experience handling
controlled substances may be entitled to some weight in assessing
whether errant practices have been reformed, where the evidence of
record raises intentional or reckless actions on the part of the
registrant, such evidence is entitled to no weight where a practitioner
fails to acknowledge wrongdoing in the matters before the Agency.
Cynthia M. Cadet, M.D., 76 Fed. Reg. at 19450 n.3; Roni Dreszer, M.D.,
76 Fed. Reg. 19434 n.3 (2011); Michael J. Aruta, M.D., 76 Fed. Reg.
19420 n.3 (2011); Jacobo Dreszer, M.D., 76 Fed. Reg. 19386-87 n.3
(2011). Even, ``evidence that a practitioner has treated thousands of
patients does not negate a prima facie showing that the practitioner
has committed acts inconsistent with the public interest.'' Jayam
Krishna-Iyer, M.D., 74 Fed. Reg. at 463.This evolution is rooted in the
sensible logic that conduct that is never acknowledged as improper
cannot reasonably be argued as aberrant. This is so because the actor
in such a scenario has not isolated his past actions to be in any way
wrong and worthy of avoidance in the future. This feature of the
Agency's interpretation of its statutory mandate has also been
sustained on review. Mackay, 664 F.3d at 822.
As discussed more fully, infra, the Government's evidence that the
Respondent improperly prescribed Demerol to replenish office stocks, as
well as the actions he took upon being apprised of his deficiencies as
a registrant reflect negatively and positively, respectively under
Factor Two.
Regarding Factor Four (compliance with laws related to controlled
substances), to effectuate the dual goals of conquering drug abuse and
controlling both legitimate and illegitimate traffic in controlled
substances, ``Congress devised a closed regulatory system making it
unlawful to manufacture, distribute, dispense, or possess any
controlled substance except in a manner authorized by the CSA.''
Gonzales v. Raich, 545 U.S. 1, 13 (2005). ``Recordkeeping is one of the
central features of the CSA's closed system of distribution. . . . . A
registrant's accurate and diligent adherence to this obligation is
absolutely essential to protect against the diversion of controlled
substances.'' Satinder Dang, M.D., 76 Fed. Reg. 51424, 51429 (2011)
(internal punctuation and citations omitted). There is no question that
the maintenance of accurate records by registrant's is key to the DEA's
ability to fulfill its obligations to regulate controlled substances.
As previously held by the Agency, ``[r]ecordkeeping is one of the CSA's
central features; a registrant's accurate and diligent adherence to
this obligation is absolutely essential to protect against the
diversion of controlled substances.'' Paul H. Volkman, 73 Fed. Reg.
30630, 30633 (2008), aff'd, Volkman, 567 F.3d at 224 (DEA
Administrator's reliance on recordkeeping violations in denying COR
application specifically upheld). Thus, recordkeeping deficiencies may
``provide[] reason alone to conclude (with respect to factors two and
four) that [a registrant's] continued registration is inconsistent with
the public interest.'' Id. (internal punctuation omitted). However, the
Agency has also held that where non-egregious recordkeeping errors are
acknowledged and remedied promptly, revocation may not always be
required. Terese, Inc., d/b/a/Peach Orchard Drugs, 76 Fed. Reg. 46843,
46848 (2011).
In Terese, substantial evidence established that the registrant had
failed to conduct an initial inventory as required under 21 CFR Sec.
1304.11(b), failed to execute a power of attorney form as required by
21 CFR Sec. 1305.05(a), and failed to include dates on DEA Forms 222,
as required by 21 CFR Sec. 1305.13(e). In declining to revoke Terese's
registration, the Agency, emphasizing that the registrant had accepted
responsibility for its violations and had instituted corrective
actions, determined that, under the circumstances, the three
recordkeeping violations did not render its continued registration
inconsistent with the public interest. Id. at 46848. In Ideal Pharmacy
Care, Inc. d/b/a/Esplande Pharmacy, 76 Fed. Reg. 51415, 51416 (2011),
an audit of the registrant's records showed a shortage of 150,000
dosage units of hydrocodone, 83,000 dosage units of alprazolam, and 1.6
million milliliters of promethazine with codeine. However, in contrast
to Terese, the Agency found \91\ that Ideal Pharmacy's failure to
maintain accurate records constituted an act which rendered its
continued registration inconsistent with the public interest. Id. Taken
together, Ideal and Terese indicate that, when considering
recordkeeping violations, the Agency has coupled consideration of the
degree of severity with an analysis of whether the registrant has both
acknowledged culpability and demonstrated credible efforts aimed at
correction. The current state of the Agency's precedent thus provides a
logical framework upon which the current evidence can be evaluated.
---------------------------------------------------------------------------
\91\ The registrant in Ideal waived its right to hearing and
presented no evidence to the Agency on its behalf. Id.
---------------------------------------------------------------------------
DEA regulations provide that ``[e]very registrant required to keep
records pursuant to Sec. 1304.03 \92\ shall maintain on a current
basis a complete and accurate record of each substance . . . imported,
received, sold, delivered, exported, or otherwise disposed of by him/
her, except that no registrant shall be required to maintain a
perpetual inventory.'' 21 CFR Sec. 1304.21(a). Additionally, Florida
law requires that all persons dispensing or distributing controlled
substances must, ``on a current basis, [maintain] a complete and
accurate record of each substance, manufactured, received, sold,
delivered, or otherwise disposed of by him or her.'' Fla. Stat. Sec.
893.07(1)(b).
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\92\ Section 1304.03 provides that ``[e]each registrant shall
maintain the records and inventories and shall file the reports
required by this part, except as exempted by this section.''
Respondent does not contend that any of the Sec. 1304.03 exemptions
apply in this case.
---------------------------------------------------------------------------
In this case, factual issues related to compliance with applicable
laws do not reflect well on the Respondent's suitability as a
registrant. DI McRae's audit revealed shortages of Demerol and 50 mcg/
ml fentanyl accounting for approximately 75% and 100% of the
Respondent's inventory, respectively.
[[Page 19371]]
Furthermore, the audit revealed overages of: (1) 2,371.6% of the
Respondent's inventory of 100 mcg/ml fentanyl; (2) 100% of the
Respondent's inventory of 10 mg/10ml Midazolam; and (3) 290.2% of
Respondent's inventory of 2 mg/2 ml Versed. Gov't Ex. 10. The audit
conducted by Respondent's expert likewise found significant shortages
of Diazepam and fentanyl, but no overages.\93\ Resp't Ex. 18. While the
dates and results of the audits conflict, it is unnecessary to resolve
the differences because, regardless of the audit considered, it is
clear that the Respondent's records were disturbingly inaccurate, that
the discrepant amounts were significant, and that substantial evidence
supports the conclusion that the Respondent violated federal law by
failing to maintain a complete and accurate record of each substance.
See Bill Lloyd Drug, 64 Fed. Reg. 1823, 1824 (1999) (``The shortages
and overages revealed by the accountability audit show that Respondent
does not keep complete and accurate records of its controlled substance
handling as required by 21 U.S.C. 827 and 21 CFR 1304.21.''); see also
Alexander Drug Company, Inc., 66 Fed. Reg. 18299, 18303 (2001)
(Shortages or overages constitute violations of 21 CFR Sec. 1304.21
and 21 U.S.C. Sec. 827.); Ellis Turk, M.D., 62 Fed. Reg. 19603, 19605
(1997) (same). Furthermore, insofar as it is clear that the Respondent
failed to maintain accurate records of the controlled substances
received at his office, substantial evidence supports a conclusion that
he violated Fla. Stat. Sec. 893.07(1)(b). These are conclusions that
the Respondent does not resist.
---------------------------------------------------------------------------
\93\ As explained above, the Mr. Litman's audit did not consider
the Respondent's supplies of Midazolam.
---------------------------------------------------------------------------
DEA regulations also require that ``[i]nventories and records of
controlled substances listed in Schedules I and II shall be maintained
separately from all of the records of the registrant.'' 21 CFR Sec.
1304.04(f)(1). Florida law has also adopted the separate record
requirement for inventories and records of Schedule I or Schedule II
controlled substances. Fla. Stat. Sec. 893.07(4)(A). In the present
matter, substantial evidence supports the conclusion that the
Respondent violated the foregoing federal and state separate records
requirements by maintaining his Schedule II records with other records
in the peer review pharmacy book. Tr. 105-06.
DEA regulations require that each registrant ``take a new inventory
of all stocks of controlled substances on hand at least every two
years.'' 21 CFR Sec. 1304.11(c). Florida law has also adopted this
biennial record requirement. See Flat. Stat. Sec. 893.07(1)(a). The
Government's evidence establishes that the Respondent did not conduct
the biennial inventory as required by these federal and state
regulations. Tr. 87.
DEA regulations also contain a requirement that a purchaser
desiring to obtain a supply of Schedule I or Schedule II controlled
substances must execute three copies of a DEA Form 222. See 21 CFR
Sec. Sec. 1304.03, 1304.13. Upon completion, two copies must be sent
to the supplier, while one copy must be retained by the purchaser. 21
CFR Sec. 1301. These federal regulations require that the purchaser
retain its copy of the form in its files, and that the supplier retain
its copies of the form in its files. Id. ``The purchaser must record on
[its copy] of the DEA Form 222 the number of commercial or bulk
containers furnished on each item and the dates on which the containers
are received by the purchaser.'' 21 CFR Sec. 1305.13(e). It is a
violation of the regulations to file an incomplete, illegible,
improperly prepared, improperly executed, or improperly endorsed Form
222. 21 CFR Sec. 1305.15(a)(1). Similarly, 21 CFR Sec. 1305.03,
requires that (subject to specified exceptions not applicable here) ``a
DEA Form 222 or its electronic equivalent . . . is required for each
distribution of a Schedule I or II controlled substance.'' In the
present case, the Respondent transferred Schedule II controlled
substances from his registered address, in Miami, Florida, to a Tampa,
Florida, PCCS office, without complying with the federal recordkeeping
requirements of section 1305.03. Tr. 64-65, 426-27. Furthermore, it is
undisputed that the Respondent failed to fill out at least fourteen
Form 222s properly, insofar as he did not record the quantity of
controlled substance shipments received, or the dates that the
shipments arrived. Gov't Ex. 6.
Beyond the recordkeeping violations at issue here, the Government
has also alleged that the Respondent ``failed to properly dispose of
controlled substances in violation of 21 CFR Sec. 1307.21(a)(1).''
Section 1307.21(a)(1) provides that, a person desiring to dispose of a
controlled substance may contact the cognizant DEA Special Agent in
Charge in order to gain authority to dispose of the substance.
Necessarily, this language implies that a person who does not request
assistance to dispose of a controlled substance does not have authority
to dispose of such substance. This is a classic example of permissive
language which ``plainly carr[ies] a restrictive meaning.'' See Forest
Grove School Dist. v. T.A., 129 S.Ct. 2484, 2499 n. 1 (2009) (citing
Carlisle v. U.S., 517 U.S. 416-431-32 (1996) (collecting cases)). Under
a plain reading of the regulation, a registrant is not required to
dispose of controlled substances, but once he or she elects to do so,
such disposal may not be made without authorization from the specified
DEA official. To obtain the necessary authorization, a registrant
``shall list the controlled substance or substances which he . . .
desires to dispose of on DEA Form 41, and submit three copies of that
form to the Special Agent in Charge in his . . . area.'' 21 CFR Sec.
1307.21(a)(1). Here, substantial evidence supports the conclusion that,
on numerous occasions, the Respondent disposed of controlled substances
without notifying the DEA. Tr. 60, 142.
In its charging document, the Government also alleged that the
Respondent failed to execute a power of attorney to authorize VM to
order controlled substances on his behalf, as required by 21 CFR Sec.
1305.05(a). ALJ Ex. 1 at 2. Section 1305.05 provides, in relevant part,
that ``[a] registrant may authorize one or more individuals . . . to
issue orders for Schedule I and II controlled substances on the
registrant's behalf by executing a power of attorney for each such
individual . . . .'' As with the disposal provisions discussed above,
the language of section 1305.05 clearly is intended to create a
restrictive meaning whereby a registrant may not authorize another
person to issue orders for Schedule I or Schedule II controlled
substances absent an authorized power of attorney. See Forest Grove
School Dist., 129 S.Ct. at 2499 n. 1. During the hearing, DI McRae
testified that the Respondent's practice of having a staff member fill
out the DEA Form 222s was not a violation of the relevant regulation
because the Respondent signed the DEA Form 222s. Tr. 184. Thus, this
allegation stands unsupported by the evidence of record.
The Government contends that the Respondent ``failed to provide an
adequate system for monitoring the receipt, distribution, and
disposition of controlled substances, in violation of 21 CFR Sec. Sec.
1305.05(a) and 1301.71.'' Gov't Posthearing Brief, at 20; see also ALJ
Ex. 1, at 2. As an initial matter, as discussed immediately above, DI
McRae testified that the Respondent's ordering process was not a
violation of the power of attorney requirements of section 1305.05. Tr.
184. As to the allegation of a security violation, 21 CFR Sec. 1301.71
provides, in relevant part, that ``[a]ll applicants and registrants
shall provide effective controls and procedures to
[[Page 19372]]
guard against theft and diversion of controlled substances. In order to
determine whether a registrant has provided effective controls against
diversion, the Administrator shall use the security requirements set
forth in Sec. Sec. 1301.72-1301.76 as standards for the physical
security controls and operating procedures necessary to prevent
diversion.'' However, 21 CFR Sec. 1301.71(b) sets forth fifteen
factors which may be used to determine whether there is a ``need for
strict compliance with [the] security requirements.'' Of relevance
here, one of the section (b) factors is ``[t]he adequacy of the
registrant's . . . system for monitoring the receipt, manufacture,
distribution, and disposition of controlled substances in its
operations.'' 21 CFR Sec. 1301.71(b)(14).
While the ``security requirements'' set forth in sections 1301.72
through 1301.76 are used as standards to determine compliance with
section 1301.71(a), the language of each of these sections is phrased
in mandatory terms. See e.g., 21 CFR Sec. 1301.75(a) (``Controlled
substances listed in Schedule I shall be stored in a securely, locked,
substantially constructed cabinet.'') (emphasis added); 21 CFR
1301.76(a) (``The registrant shall not . . . .'') (emphasis added).
Thus, while compliance with the security provisions is a consideration
under 21 CFR Sec. 1301.71(a)'s inquiry into the adequacy of a
registrant's security system, violation of any such provision will be
an independent consideration under Factor Four. In contrast, insofar as
the factors set forth in subsection (b) are to be used only to
determine the ``need for strict compliance with [the] security
requirements,'' it follows that non-compliance with any of the factors
in subsection (b) is not a per se violation of the security
requirements. Accordingly, the Government's contention that the
Respondent's alleged violation of section 1301.71(b)(14) may be used to
sustain a violation of section 1301.71(a)'s security requirements is a
facially defective allegation ab initio.
Finally, DEA regulations provide explicitly that ``[a] prescription
may not be issued in order for an individual practitioner to obtain
controlled substances for supplying the individual practitioner for the
purpose of general dispensing to patients.'' 21 CFR Sec. 1306.04(b).
Similarly, Florida law provides as grounds for a disciplinary action
the act of ``[p]rescribing any medicinal drug appearing on Schedule II
\94\ in chapter 893 by the physician for office use.'' Fla. Stat. Sec.
458.331(1)(bb). Here, the Government's evidence establishes that on a
single occasion, the Respondent procured Demerol through a prescription
written in the name of an individual who was never intended as its
recipient, in violation of federal and state law.\95\
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\94\ Meperidine, the generic form of Demerol, is listed as a
Schedule II drug under Chapter 893 of the Florida code. See Fla.
Stat. Sec. 893.03(2).
\95\ As discussed elsewhere in this recommended decision, the
evidence of record presented by the Government simply did not
support its espoused theory that VM was addicted to and abusing
Demerol which was supplied by the Respondent. Agency precedent is
clear that ``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 FR 26993, 26999, n.31 (2010)
(citing NLRB v. Columbian Enameling & Stamping Co., 306 U.S. 292,
300 (1939)).
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In light of the foregoing, substantial evidence of record supports
a finding that: (1) The Respondent violated 21 CFR Sec. 1304.21(a) and
Fla. Stat. Sec. 893.07(1)(b) by failing to keep accurate records of
controlled substances; (2) the Respondent violated 21 CFR Sec.
1304.04(f)(1) and Fla. Stat. Sec. 893.07(4)(A) by failing to maintain
inventories and records of Schedule I and Schedule II controlled
substances separately from other inventories and records; (3) the
Respondent transferred Schedule II controlled substances from his
registered address without complying with the recordkeeping
requirements of section 1305.03; (4) the Respondent disposed of
controlled substances without completing a DEA Form 41, as required by
21 CFR Sec. 1307.21(a)(1); and (5) the Respondent violated 21 CFR
Sec. 1306.04(b) and Fla. Stat. Sec. 458.331(1)(bb) by prescribing
Demerol for office use, which also reflected negatively on the
Respondent's experience in dispensing controlled substances under
Factor Two.
Insofar as the preceding statutes and regulations relate to
controlled substances, this litany of violations weighs substantially
in favor of revocation under Factor Four. See Ideal Pharmacy, 76 Fed.
Reg. at 51416 (Severe recordkeeping violations sufficient to meet
Government's prima facie burden). Regarding the Respondent's experience
in dispensing controlled substances under Factor Two, the record
establishes that, prior to the events underlying this case, the
Respondent practiced uneventfully for more than thirty years--at least
to the extent that his conduct did not arouse the attention of DEA or
other regulatory authorities. Tr. 549-62. As discussed, supra, in view
of the Respondent's election to take responsibility for his
wrongdoings, and because there has been no intentional diversion proven
in this case, such experience may be considered in a positive light
under Factor Two. See supra note 98 and accompanying text. However, the
positive value of such experience is tempered by the Respondent's
admitted uncertainty regarding certain requirements of DEA regulations.
See Tr. 595, 680-81 (Where the Respondent expressed uncertainty
regarding DEA requirements); see also Volusia Wholesale, 69 Fed. Reg.
at 69410 (Factor Two requires consideration of the Respondent's
knowledge of DEA regulations and requirements). Furthermore, the
evidence or record which unequivocally establishes that he issued a
Demerol prescription to improperly replenish his office stocks reflects
that the Respondent is an individual who simply did not make any
serious effort to understand his important responsibilities as a
registrant.\96\ Under these circumstances, the experience component of
Factor Two, even assuming, arguendo, that the Respondent's many years
of prior practice were compliant with the applicable regulations,
weighs in favor of revocation.
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\96\ The act of prescribing is a form of ``dispensing'' under
the CSA. 21 U.S.C. Sec. 802(10).
---------------------------------------------------------------------------
Factor Five: Such Other Conduct Which May Threaten the Public Health
and Safety
The fifth statutory public interest factor directs consideration of
``[s]uch other conduct which may threaten the public health and
safety.'' 21 U.S.C. 823(f)(5) (emphasis supplied). Existing Agency
precedent has long held that this factor encompasses ``conduct which
creates a probable or possible threat (and not only an actual [threat])
to public health and safety.'' Dreszer, 76 FR at 19434 n.3; Aruta, 76
FR at 19420 n.3; Boshers, 76 Fed. Reg. 19403 n.4; Dreszer, 76 FR at
19386-87 n.3. Agency precedent has generally embraced the principle
that any conduct that is properly the subject of Factor Five must have
a nexus to controlled substances and the underlying purposes of the
CSA. Terese, 76 FR 46848; Tony T. Bui, M.D., 75 FR 49979, 49989 (2010)
(prescribing practices related to a non-controlled substance such as
human growth hormone may not provide an independent basis for
concluding that a registrant has engaged in conduct which may threaten
public health and safety); cf., Paul Weir Battershell, N.P., 76 FR
44359, 44368 n.27 (2011) (although
[[Page 19373]]
a registrant's non-compliance with the Food, Drug, and Cosmetic Act is
not relevant under Factor Five, consideration of such conduct may
properly be considered on the narrow issue of assessing a respondent's
future compliance with the CSA).
Similar ``catch all'' language is employed by Congress in the CSA
related to the Agency's authorization to regulate controlled substance
manufacturing and List I chemical distribution, but the language is by
no means identical. 21 U.S.C. 823(d)(6), (h)(5). Under the language
utilized by Congress in those provisions, the Agency may consider
``such other factors as are relevant to and consistent with the public
health and safety.'' Id. (emphasis supplied). In Holloway Distributors,
72 FR 42118, 42126 (2007), the Agency held this catch all language to
be broader than the language directed at practitioners under ``other
conduct which may threaten the public health and safety'' utilized in
21 U.S.C. 823(f)(5). In Holloway, the Administrator stated that
regarding the List I catch all:
[T]he Government is not required to prove that the
[r]espondent's conduct poses a threat to public health and safety to
obtain an adverse finding under factor five. See T. Young, 71 [Fed.
Reg.] at 60572 n.13. Rather, the statutory text directs the
consideration of ``such other factors as are relevant to and
consistent with the public health and safety.'' 21 U.S.C. Sec.
823(h)(5). This standard thus grants the Attorney General broader
discretion than that which applies in the case of other registrants
such as practitioners. See id. Sec. 823(f)(5) (directing
consideration of ``[s]uch other conduct which may threaten the
public health and safety'').
72 FR at 42126.\97\ Thus, the Agency has recognized that, while the
fifth factor applicable to List I chemical distributors--21 U.S.C.
823(h)(5)--encompasses all ``factors,'' the Factor Five applied to
practitioners--21 U.S.C. Sec. 823(f)(5)--considers only ``conduct.''
However, because section 823(f)(5) only implicates ``such other
conduct,'' it necessarily follows that conduct considered in Factors
One through Four may not be considered at Factor Five.
---------------------------------------------------------------------------
\97\ In Bui, the Agency clarified that ``an adverse finding
under [Factor Five did not require a] showing that the relevant
conduct actually constituted a threat to public safety.'' 75 Fed.
Reg. 49888 n.12.
---------------------------------------------------------------------------
In this case, the Government has not alleged any conduct which may
be properly considered under Factor Five.\98\ Accordingly, Factor Five
does not weigh for or against revocation.
---------------------------------------------------------------------------
\98\ In the section of its brief dealing with Factor Five, the
Government alleges that the ``Respondent was unaware of his
obligations [as a registrant]'' (2) the Respondent ``exhibited
ongoing violations of Federal law;'' and (3) the Respondent
``admitted that he does not have a system in place to prevent the
future of diversion [sic] of controlled substances.'' Gov't
Posthearing Brief, at 22-23. These issues are more properly
considered under the discussion of the Respondent's rebuttal case,
infra. See Hassman, 75 Fed. Reg. at 8236 (``to rebut the
Government's prima facie case, [the Respondent] is required not only
to accept responsibility for [the established] misconduct, but also
to demonstrate what corrective measures [have been] undertaken to
prevent the reoccurrence of similar acts.'' ).
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Recommendation
Based on the foregoing, the Government has certainly established
that the Respondent has committed acts that are inconsistent with the
public interest. Consideration of the record evidence under the Fourth
and Second Factors weighs in favor of revocation. On this record, the
recordkeeping violations are alone are sufficient to establish a prima
facie case that the Respondent has committed acts which render his
continued registration inconsistent with the public interest. See Ideal
Pharmacy, 76 Fed. Reg. at 51416 (Severe recordkeeping violations
sufficient to meet Government's prima facie burden). However, this is
not a case of only recordkeeping violations. Indeed, the record also
establishes violations of the disposal and dispensing provisions of the
CSA. Accordingly, a balancing of the statutory public interest factors
as presented by the Government in its case-in-chief is sufficient to
sustain a revocation of the Respondent's COR. Id.
Because the Government has sustained its burden of showing that
Respondent committed acts inconsistent with the public interest, the
burden shifts to the Respondent to show that he can be entrusted with a
DEA registration. As discussed above, ``to rebut the Government's prima
facie case, [the Respondent] is required not only to accept
responsibility for [the established] misconduct, but also to
demonstrate what corrective measures [have been] undertaken to prevent
the reoccurrence of similar acts.'' Jeri Hassman, M.D., 75 Fed. Reg. at
8236; Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005); Ronald Lynch,
M.D., 75 Fed. Reg. 78745, 78749 (Respondent's attempts to minimize
misconduct held to undermine acceptance of responsibility); George
Mathew, M.D., 75 Fed. Reg. 66138, 66140, 66145, 66148 (2010); George C.
Aycock, M.D., 74 Fed. Reg. 17529, 17543 (2009); Steven M. Abbadessa,
D.O., 74 Fed. Reg. 10077, 10078 (2009); Jayam Krishna-Iyer, M.D., 74
Fed. Reg. 459, 463 (2009); Medicine Shoppe-Jonesborough, 73 Fed. Reg.
364, 387 (2008). This feature of the Agency's interpretation of its
statutory mandate has been sustained on review. Mackay, 664 F.3d at
822. Evidence that the Respondent has persisted in wrongful activity
after being informed of a violation will weigh against a finding that
he may be entrusted with continued registration. See Paul Weir
Battershell, N.P., 76 Fed. Reg. 44359, 44368 (2011) (finding that
continued violations ``raises a serious question as to whether
Respondent can be trusted to responsibly discharge his obligations as a
registrant.''). In contrast, prompt corrective action weighs in a
respondent's favor. Terese, 76 Fed. Reg. at 46848.
In this case, the preponderant credible evidence establishes that,
after learning that his Form 222s were not completed at the time of
receipt and were stored improperly, the Respondent assumed control of
the receipt of drugs and created a separate folder for the Form 222s.
Tr. 569-71, 624-27. Upon his (albeit late) estimation that controlled
substances may have been diverted at the time of receipt at PCCS, the
Respondent prohibited the opening of controlled substance shipments
without his supervision. Tr. 569-71. As a further safeguard against
diversion, the Respondent assumed exclusive control of the controlled
substances safe and has installed procedures requiring the keeping of
an accurate perpetual inventory. Tr. 365-68; 569-71. Violations
regarding the creation and maintenance of biennial inventories have
been corrected as well. Tr. 365-68. Finally, to ensure future
compliance, the Respondent has retained a new pharmacy consultant. Tr.
365. While it is unquestionably fair to observe that these steps amount
to no more than a prudent registrant would be required to undertake
without the Government enduring the expense of an administrative
enforcement action, these proceedings are not punitive, and current
Agency precedent places high value on acknowledgement of wrongdoing and
establishment of measures to preclude future transgressions.
The Government argues that, despite taking these steps, the
Respondent has failed to rebut the Government's case because: (1) The
``Respondent was unaware of his obligations [as a registrant]'' (2) the
Respondent ``exhibited ongoing violations of Federal law;'' and (3) the
Respondent ``admitted that he does not have a system in place to
prevent the future of diversion [sic] of controlled substances.'' Gov't
Posthearing Brief, at 22-23.
Addressing the purported lack of controls against diversion, the
Government contends that the
[[Page 19374]]
``Respondent specifically testified that he is not at his registered
address when controlled substances arrive and that controlled
substances are left unguarded at the registered location and can be
left unsecured for up to two days due to his absence from the clinic.''
Gov't Posthearing Brief, at 24. Without entering a specific finding on
the issue, it would be difficult to characterize this argument as
anything other than a clear misstatement of the Respondent's testimony.
The Respondent testified that, because he has prohibited employees at
PCCS from opening shipments of controlled substances, and because he is
not in the practice every day, it is possible that a future shipment of
controlled substances could be left unsecured, but that he is in the
process of divining a solution to the issue and intends to contact DI
McRae to seek her counsel on the matter. Tr. 569-71, 675-77. The
Respondent also testified that he felt that he could place an order for
controlled substances so as to avoid a shipment from being delivered on
a day that he is absent. Tr. 689. Given this testimony, and the
specified remedial steps outlined above, the Government's contention
that the Respondent replied at this hearing that he ``does not have a
system in place to prevent . . . future diversion'' \99\ is simply not
what the man said.\100\
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\99\ Gov't Posth'g Brf. at 23.
\100\ C.f., Berger v. United States, 295 U.S. 78, 88 (1935) (a
prosecutor ``may strike hard blows [but is not] at liberty to strike
foul ones'').
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Turning to the alleged post-inspection violations, the record
establishes that the Respondent disposed of approximately ten vials of
Demerol in May of 2011 and that, despite learning of thefts of
controlled substances which occurred as late as February or March of
2011, the Respondent failed to notify the Miami Field Division Office
of such thefts and to file a DEA Form 106 reporting the thefts, in
violation of 21 C.F.R. Sec. 1301.76(b).\101\ Under the circumstances
presented here, where the Respondent first became aware of the
recordkeeping deficiencies in the course of an audit that was conducted
by DI McRae, that the Respondent did not submit a report of theft to
DEA during active enforcement proceedings, based on the litigation
theory of his counsel that a former employee may have perpetrated
diversion, is not evidence that persuasively militates in favor of
revocation. While post-inspection violations can raise ``a serious
question as to whether [the] Respondent can be trusted to responsibly
discharge his obligations as a registrant,'' they do not compel
revocation on their own, Battershell, N.P., 76 Fed. Reg. at 44368-69
(declining to revoke registration despite post-inspection violations),
and clearly do not do so in this case.
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\101\ 21 C.F.R. Sec. 1301.76(b) provides, in relevant part:
``The registrant shall notify the Field Division Office of the
Administration in his area, in writing, of the theft or significant
loss of any controlled substances within one business day of
discovery of such loss or theft. The registrant shall also complete,
and submit to the Field Division Office in his area, DEA Form 106
regarding the loss or theft.''
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In whole, the Respondent has expressed contrition for his
negligence and has corrected every violation represented to him, but
for the unlicensed disposal, which was brought to the attention of the
DEA by the Respondent himself, and the failure to report thefts, which
were brought to the Government's attention during this proceeding as a
potential defense investigated and tendered by Respondent through
counsel. While the post-inspection violations are relevant
considerations, on this record, they are not dispositive to the public
interest inquiry. Battershell, N.P., 76 Fed. Reg. at 44368-69. Rather,
the record has a whole shows that the Respondent has transgressed
profoundly in his failure to understand and execute his obligations as
a registrant, acknowledged his failings without discernible
reservation, made a committed and sustained effort to come into
compliance with the requirements of the CSA, DEA, and state law, and
has outlined a reasonable approach to maintaining that compliance.
Thus, the Respondent has successfully demonstrated, that he can be
entrusted with continued registration. Jeri Hassman, M.D., 75 Fed. Reg.
at 8236. These proceedings are non-punitive,\102\ and current Agency
precedent requires no more to lodge successful rebuttal to the
Government's prima facie case.
---------------------------------------------------------------------------
\102\ See Jackson, 72 Fed. Reg. at 23853; Leo R. Miller, M.D.,
53 Fed. Reg. 21931, 21932 (1988).
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Accordingly, the Respondent, consistent with the direction set
forth in the OSC issued in this matter, has successfully shown cause
why his Certificate of Registration should not be revoked, and thus,
the Government's petition to revoke the Respondent's Registration
should be DENIED. However, the record in this matter justifies the
IMPOSITION OF SPECIFIED CONDITIONS ON THE RESPONDENT'S REGISTRATION, to
wit: (1) the Respondent must comply with all regulatory obligations
relative to the prescribing, dispensing, storage, and handling of
controlled substances under his COR; (2) the Respondent, at his own
expense, shall submit regular reports at sixty-day intervals (or such
other interval as directed by DEA) to a designated DEA official, from
an independent pharmacy contractor, pre-approved by a designated DEA
official, reflecting monthly regulatory compliance inspections; and (3)
within thirty days of the issuance a final Agency order in this case,
the Respondent will execute a document memorializing an irrevocable
consent for any and all agents of DEA to inspect any and all records
related to the handling and prescribing of controlled substances for a
period of one year. The Respondent is placed on notice that the failure
on his part to timely and correctly submit all documentation required
by these conditions, and to comply scrupulously with all requirements
set forth in these enumerated conditions, will constitute an
independent basis for administrative enforcement proceedings.
Dated: March 1, 2012.
John J. Mulrooney, II,
Chief Administrative Law Judge.
[FR Doc. 2014-07806 Filed 4-7-14; 8:45 am]
BILLING CODE 4410-09-P