[Federal Register Volume 79, Number 191 (Thursday, October 2, 2014)]
[Notices]
[Pages 59504-59517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23473]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 14-01]
The Medicine Shoppe; Decision and Order
On March 24, 2014, Administrative Law Judge Gail A. Randall issued
the attached Recommended Decision. Respondent filed Exceptions to the
Recommended Decision.
Having reviewed the entire record including Respondent's
Exceptions, I have decided to adopt the ALJ's findings of fact,
conclusions of law, and recommended order. A discussion of Respondent's
Exceptions follows.
Respondent's Exceptions
Respondent raises twelve different exceptions to the ALJ's decision
in no logical order. His contentions can be summarized as follows:
(1) That the ALJ failed to consider less punitive sanctions than
revocation;
[[Page 59505]]
(2) that the ALJ improperly rejected his evidence of remedial
measures by requiring him to produce corroborating evidence because she
failed to rule on the Government's motion in limine and never granted
him permission to introduce such evidence;
(3) that the ALJ ``imposed an undefined and vague standard of
proof'' on the issue of his remedial measures because she rejected his
testimony in the absence of corroborating evidence;
(4) that the ALJ improperly relied on the testimony of the
Government's Expert for various reasons and thus made multiple findings
which are unsupported by substantial evidence (exceptions 4-6, 8);
(5) that the ALJ's application of the public interest factors is
unsupported by substantial evidence and is arbitrary and capricious;
(5) that the ALJ's findings of fact and conclusions of law
regarding Respondent's employment of a convicted drug felon are
unsupported by substantial evidence;
(6) that the ALJ's findings of fact and conclusions of law
regarding Respondent's recordkeeping deficiencies are unsupported by
substantial evidence;
(7) that the ALJ's findings of fact and conclusions of law
regarding Respondent's audit and inventory deficiencies are unsupported
by substantial evidence; and
(8) that his acceptance of responsibility and evidence of remedial
measures renders his continued registration consistent with the public
interest.
Resp. Exceptions, at 5-26. Notwithstanding the order in which
Respondent presents his exceptions, I first address his challenges that
the ALJ's findings of various violations are unsupported by substantial
evidence.
Challenges to the Substantiality of the Evidence
At the hearing, the Government alleged that Respondent (through its
pharmacists) violated its corresponding responsibility under the
Controlled Substances Act (CSA) by dispensing prescriptions that lacked
a legitimate medical purpose, see 21 CFR 1306.04(a), as well as
prescriptions that did not comply with 21 CFR 1306.05(a) because they
were missing required information such as addresses and/or were not
signed by the prescribing practitioner. As support for the allegations,
the Government introduced several hundred controlled substance
prescriptions, and elicited the testimony of an Expert witness in
pharmacy practice.
Respondent asserts that the Government's Expert was not competent
to testify as an Expert because, while she teaches a class in pharmacy
law, ``on cross-examination . . . she could [not] name the federal and
state statutes that govern the standards she applied when rendering her
expert opinion.'' Exceptions, at 13. Respondent contends that ``[t]hese
are of course the Federal Controlled Substances Act and the Texas
Controlled Substances Act found in the Texas Health & Safety Code'' and
that ``[i]t defies logic how [she] could be legitimately regarded as an
expert in the field of pharmacy law and retail pharmacy.'' Id.
It is true that the Expert stated that ``I can't answer that'' when
asked what the federal and state statutes were called. However, she
then testified that ``It's just federal law and Texas law that we use
to apply. For the exact statute or standard number and heading, I
cannot recall.'' Tr. 71. And on further questioning, the Expert
explained that ``we don't teach the numbers. If you ask most
pharmacists, I don't think that they would be able to tell you the
statute or the standard number, but they would be able to recite the
law to you and how it is applied to pharmacy practice.'' Id. Thus, read
in its entirety, the transcript shows that the Expert interpreted the
question as asking for the specific section numbers of the relevant
provisions of the CSA and State law, and not for the name of the
respective statutes.
Moreover, Respondent does not identify any testimony on the part of
the Expert which is inconsistent with the decisional law of either the
courts or this Agency. I thus reject Respondent's Exception (Number
Five) that the Government's Expert was not qualified to testify as an
Expert in pharmacy law and practice.\1\
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\1\ Respondent also contends that the ALJ overlooked the
Expert's testimony that: she ``is only a fill-in part-time pharmacy
at Walgreens and rarely works at the VA so she has no real
applicable experience to assist the ALJ in understanding whether or
not Respondent's errors were to such a degree as to support the
decision that its continued registration is inconsistent with the
public interest and should therefore be revoked.''
Exceptions, at 13. Respondent does not, however, cite to where
in the transcript the quoted testimony occurred, and while the
Expert acknowledged that she works as a relief pharmacist, at no
point did she testify that ``she has no real applicable experience
to assist the ALJ in understanding whether . . . Respondent errors
were to such a degree as to support'' the ALJ's ultimate conclusion
of law. I thus reject this contention.
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Respondent also takes exception to the ALJ's reliance on the
Expert's testimony when she found that Respondent violated its
corresponding responsibility when it failed to verify the validity of
154 prescriptions it dispensed which presented red flags. Exceptions,
at 11-12. According to Respondent, the ALJ should have rejected the
Expert's testimony because during cross-examination, it was established
that she was provided with ``photocopies of one side of the
prescriptions, instead of both sides which included the data she
claimed was missing.'' Exceptions, at 12. Moreover, Respondent contends
that included in the exhibits was a spreadsheet which listed ``the
prescriptions and a description of what finding its expert was to make
regarding each prescription.'' Id. Respondent then argues that the
Expert ``testified she never asked for any other information about the
prescriptions and simply endorsed the findings provided to her by the
Government'' while its owner ``testified to the resolution of those
`red flags' but his testimony was INEXPLICABLY rejected in favor of
[that of] the Government's expert.'' Id.
No citations to the record are provided to support Respondent's
assertions that the Expert was provided with only one side of the
prescriptions. Indeed, the prescriptions submitted for the record
include a photocopy of the front of the prescription and the back on
which the dispensing labels were placed. See Tr. 72-73 (Expert's
testimony that the second page of the prescription ``was provided with
all of the prescriptions.''). Thus, Respondent's assertion is a blatant
mischaracterization of the record.
Nor is there any evidence to support the contention that the Expert
``simply endorsed the findings provided to her by the Government'' on a
spreadsheet. Here again, there is no reference to this in the
transcript, and even assuming that there was such a spreadsheet, the
Expert fully explained the basis for her conclusions as to why the
prescriptions she was asked about raised various red flags. These
included that: (1) The patient's address was missing on some 169
prescriptions; (2) 98 prescriptions contained a stamped signature
rather than the prescriber's actual signature; (3) the prescribers' DEA
numbers were missing or incorrect on 33 prescriptions; (4) the name of
the physician on the label was different from the name of the actual
prescriber on 157 of the prescriptions; (5) several doctors were
prescribing drug cocktails of narcotic and benzodiazepines; (6) a
patient was prescribed a narcotic cough syrup in an amount that far
exceeded the quantity ordinarily prescribed in the course of legitimate
medical treatment; (7) some patients filled prescriptions for
duplicative narcotics such as
[[Page 59506]]
hydrocodone tablets and hydrocodone cough syrup; (8) some patients only
filled narcotic prescriptions and not their prescriptions for non-
controlled drugs; (9) at least 22 times, Respondent returned the
original prescription to a patient notwithstanding that it had filled
the controlled substances and typically made no marking as to what it
had filled on the returned prescription; (10) Respondent disregard
physician's instructions to either fill all the prescriptions or none
of them; (11) Respondent filled prescriptions in which the number of
refills was left blank; and (12) and in five instances, the
prescriptions had not been signed by the prescriber. R.D. at 10-12.
The Government's Expert further testified that it is the usual
custom in pharmacy practice for a pharmacist to document his/her
attempts to resolve red flags on the face of the prescription. Tr. 33.
However, the Expert found no evidence that this occurred with respect
to any of these prescriptions. Id.
In his sixth exception, Respondent contends that the ALJ's
recommended sanction of revocation is arbitrary and capricious because
it is ``unsupported by substantial evidence of egregious and
intentional diversion.'' Resp. Exceptions, at 13-14. Putting aside for
the moment whether this is so, Respondent correctly notes that this
Agency considers the egregiousness and degree of culpability of a
Registrant's misconduct in making the public interest determination.
However, this Agency has long held that ``[j]ust because misconduct is
unintentional, innocent, or devoid of improper motivation, [this] does
not preclude revocation or denial. Careless or negligent handling of
controlled substances creates the opportunity for diversion and [can]
justify revocation or denial.'' Paul J. Caragine, Jr., 63 FR 51592,
51601 (1998).
In any event, there is ample evidence of egregious misconduct
including evidence that supports the inference that Respondent engaged
in the intentional or knowing diversion of controlled substances. Here,
the evidence shows that the Government conducted an audit of
Respondent's handling of controlled substances which revealed massive
shortages of multiple controlled substances. More specifically, the
Government's audit, which covered slightly more than a one-year period,
showed that Respondent had a shortage of 27,334 milliliters (929
ounces) of promethazine with codeine cough syrup (a schedule V drug); a
shortage of 3,445 hydrocodone 10mg tablets (a schedule III drug), and
shortages of 43,359 alprazolam 1mg and 7,769 alprazolam 2mg tablets
(schedule IV).\2\ Tr. 138-40; GX 13.
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\2\ The Government's evidence also showed that Respondent had
overages of 445 tablets of methadone 10mg; 1,508 tablets of
hydrocodone 5mg; and 18,721 of hydrocodone 7.5mg. Tr. 138-40; GX 13.
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These shortages are extraordinary and support a finding of massive
and egregious recordkeeping failures on Respondent's part. This alone
supports a finding that Respondent violated the Controlled Substances
Act, which requires the maintenance of ``complete and accurate''
inventories, as well as a ``complete and accurate record of each
substance . . . received, sold, delivered or otherwise disposed of.''
21 U.S.C. 827(a). And while later in his Exceptions, Respondent takes
issue with the ALJ's findings regarding the audit, arguing that ``[t]he
ALJ presumes these audit results are the correct and final tallies,''
Exceptions, at 24; notably, Respondent put forward no evidence that
calls into question the validity of the audit's findings.
Moreover, the quantities involved support the inference that
Respondent was engaged in the intentional diversion of controlled
substances, given that it has put forward no evidence to provide a
plausible explanation for the shortages.\3\ And even if the Government
proved no other violations, ``the audit results alone are sufficient to
satisfy the Government's prima facie burden of establishing that
Respondent's registration would be `inconsistent with the public
interest.''' Fred Samimi, 79 FR 18698, 18712 (2014) (quoting 21 U.S.C.
823(f)); see also Medicine Shoppe-Jonesborough, 73 FR 364, 386 (2008).
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\3\ Indeed, Respondent notes that the pharmacy has no ``history
of break-ins or burglaries.'' Exceptions, at 15 (citing Tr. 157-58).
Thus, theft is not a plausible explanation for the massive
shortages.
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Nor is this the only evidence that supports a finding that
Respondent engaged in intentional diversion. Rather, the Government
showed that Respondent filled drug cocktails of narcotics such as
hydrocodone, benzodiazepines such as alprazolam (Xanax), and Soma
(carisoprodol).\4\ Indeed, the Government's evidence showed that with
respect to patient B.B., Respondent filled prescriptions she presented
on a single day for 90 Norco (hydrocodone/apap) 10/325, 90 Xanax 1mg,
90 Soma 350mg, and four ounces of promethazine with codeine cough
syrup.\5\ GX 3, at 19-20. Moreover, the prescription B.B. presented did
not include her address, a violation of 21 CFR 1306.05(a).\6\ Id. at
19. B.B. was allowed to take the original prescription, notwithstanding
that DEA's regulations require that the prescription be filed and
maintained by the pharmacy. 21 CFR 1306.24(d). Finally, the evidence
suggests that notwithstanding that B.B. had filled four of the five
prescriptions on the form, no marking was made on the returned
prescription to indicate that Respondent had dispensed the Norco,
Xanax, Soma and promethazine with codeine prescriptions. See Tr. 53-54
(Expert's testimony that where Respondent returned the original
prescription after dispensing controlled substances and did not mark
through the drug or note the dispensing on the prescription, this
``allows the patient to refill the same two medications again at
another pharmacy'').
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\4\ In decisions published before Respondent dispensed the
prescriptions at issue here, DEA had discussed the abuse of drug
cocktails which included hydrocodone, alprazolam, and carisoprodol.
See East Main Street Pharmacy, 75 FR 66149, 66158 (2010) (testimony
of expert in pharmacy that ``[i]t is well known in the pharmacy
profession [that] the combination of a benzodiazepine, narcotic pain
killer, and Soma [is] being used by patient abusing prescription
drugs''); Paul Volkman, 73 FR 30630, 30637 (2008) (testimony of
medical expert that ``prescrib[ing] drug cocktails . . . often
including an opioid, . . . a benzodiazepine and Soma . . . greatly
increased the chance for drug abuse, diversion, [and]/or
addiction''). See also George C. Aycock, 74 FR 17529, 17531 n.4
(2009); Your Druggist Pharmacy, 73 FR 75774, 75775 n.1 (2008).
\5\ The prescriptions were written on a single form, and also
included a prescription for Lyrica which B.B. did not fill. GX 3, at
19-20.
\6\ The labels for the dispensed prescriptions list B.B.'s
address as being in Austin, Texas, which is some distance from San
Antonio. GX 3, at 20.
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There were also multiple other instances in which patients
presented prescriptions for a similar drug cocktail of hydrocodone,
alprazolam, and carisoprodol, and Respondent filled at least some of
the prescriptions. See GX 3, at 43 (Rx for J.F., with no patient
address, for 240 Norco 10mg, 60 Xanax 1mg, 120 Soma 350mg); id. at 47
(Rx to J.G., with no patient address, for 60 Vicodin Extra Strength, 60
Xanax 1mg, and 60 Soma); id. at 66-67 (Rx to K.J., with no patient
address, for 90 Norco 10mg, 90 Xanax 1mg; 30 Soma; and 4 ounces of
Tussionex (hydrocodone) cough syrup).; id. at 76 (Rx to S.J., with no
patient address, for 240 Norco 10mg, 90 Xanax 1mg; 120 Soma 350mg, and
120 ml of phenergan with codeine); id. at 78 (Rx to B.M., with no
patient address, for 60 hydrocodone 10/325mg, 60 alprazolam 1mg, 60
Soma 350mg, and 4 ounces of promethazine with codeine); id. at 90 (Rx
to D.R., with no patient address, for 90 Vicodin 10/500, 60 Xanax 2mg,
60 Soma 350mg, and 4 ounces of Tussionex).
There were also other prescriptions which Respondent filled,
[[Page 59507]]
notwithstanding that they provided for duplicative therapy of both
hydrocodone tablets and narcotic cough syrups, such as Tussionex, which
contains hydrocodone; Promethazine with codeine; and Cheratussin AC, a
cough medicine which also contains codeine. Here again, the Expert
noted that these prescriptions presented red flags which should have
been resolved before dispensing the drugs because they contain ``the
same ingredient or drug.'' Tr. 44-45. However, there was no evidence
that Respondent's pharmacist even attempted to resolve the red flag.
Id. at 45.\7\ See also GX 3, at 13 (Tussionex and hydrocodone/apap 10/
500); id. at 55 (Tussionex and Vicodin 10/500 along with Xanax); id. at
57 (Tussionex, Norco 10/325, and Xanax); id. at 60-65 (promethazine
with codeine, Norco 10/325, and Xanax 2mg); id. at 70 (Tussionex, Norco
10/325, and Xanax); id. at 97 (Vicodin 10/500, Tussionex, and Xanax);
id. at 104 (Norco 10/325, Promethazine with codeine, and Xanax 2mg);
id. at 107 (Norco 10/325, Promethazine w/codeine, and Xanax).
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\7\ The Expert also explained that ``hydrocodone is a codeine
derivative.'' Tr. 44.
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As it did with B.B., in several instances Respondent returned the
original prescriptions to the patient and did so without making any
markings or notes indicating that it had dispensed some of the
controlled substances. See Tr. at 53-54. For example, M.F. presented
prescriptions (all on the same form) which authorized the dispensing of
both 90 alprazolam 1mg and 60 Xanax 1mg (these being the same drug) but
with different dosing instructions, as well as 240 Norco 10mg. GX 3, at
41. While Respondent returned the original prescription to M.F., there
is no indication on the copy it retained that it had noted on the
original that it had dispensed the 90 tablets of alprazolam. Id. at 41-
42. See also id. at 13 (no marking on Rx indicating dispensing of
hydrocodone and alprazolam); id. at 43 (no marking on Rx indicating
dispensing of alprazolam); id. at 70 (no marking on RX indicating
dispensing of Tussionex); id. at 90 (no marking on Rx indicating
dispensing of Xanax); id. at 104 (no marking on Rx indicating
dispensing of alprazolam and promethazine w/codeine).\8\
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\8\ In another instance in which Respondent return the hard copy
of a prescription to B.M., there are check marks next to
hydrocodone, alprazolam, and promethazine, each of which was
dispensed on the date the prescription was issued. GX 3, at 78. As
the original prescription is not in the record, it is unknown
whether these checkmarks were placed on it. However, none of the
three drugs were lined out and there is no other notation advising
any subsequent pharmacist to whom B.M. might present the
prescription that the drugs had been dispensed by Respondent. Id.
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In still another other instance, Respondent dispensed a
prescription for a 30-day supply of promethazine with codeine cough
syrup. GX 4, at 218-19. According to the Expert, cough syrups are
typically dispensed in 10-14 day quantities ``for the length of the
cough.'' Tr. 47. Moreover, here again, the prescription did not contain
the patient's address and was facially invalid. Id. at 47; GX 4, at
218. Yet there was no evidence that Respondent resolved the red flags
raised by the prescription. Tr. 47; GX 4, at 218-19.\9\
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\9\ The prescription also authorized one refill. While there is
no evidence that Respondent refilled the prescription (as there is
no label corresponding to a refill on the back of the copy of the
prescription), as noted above, Respondent had a shortage of more
than 27,000 milliliters of promethazine with codeine.
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Accordingly, I reject Respondent's assertion that it's ``misconduct
cannot be characterized as anything more than negligence.'' Exceptions,
at 15. Between the shortages of tens of thousands of dosage units of
controlled substances and the numerous dispensing violations, many of
which establish that Respondent's pharmacists were engaged in knowing
or intentional diversion, the Government has more than met is burden in
showing why Respondent's misconduct is egregiousness enough to warrant
revocation.\10\
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\10\ So too, I reject Respondent's eighth exception, in which it
argues that most of the suspicious prescriptions raised resolvable
red flags and ``unresolvable red flags were not the type that
predominated with the Respondent.'' Exceptions, at 18. Notably, as
the Government's Expert testified, while some of the red flags were
resolvable, there was no evidence that Respondent's pharmacists ever
attempted to do so. See generally Tr. 30-69, 75, 82-83, 85. As for
its contention that prescriptions which raised ``unresolvable red
flags'' did not ``predominate[]'' at Respondent, suffice it to say
that there were more than enough of them to conclude that Respondent
knowingly diverted controlled substances.
In this exception, Respondent also contends that even the
Government's Expert acknowledged that sometimes patients may have
been given drug samples and thus may not need to fill all of their
prescriptions at that time, as well as that some lower income
``patients do not have the funds to get both non-controlled and
controlled substances filled at the same time.'' Exceptions, at 18.
Putting aside that most of the controlled substances at issue here
are available as generic drugs, the fact that a patient may not have
sufficient funds to fill all of his/her prescriptions does not
excuse Respondent's practice of returning the original prescription
form to the patient and then failing to mark on the form what drugs
have been dispensed, thus allowing the patient to present the
prescription to another pharmacy for filling.
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Respondent further argues that because it was not subject to an
immediate suspension of its registration and has been permitted to
continue to operate since the execution of the Administrative
Inspection Warrant in October 2011, ``[t]hese factors militate against
revocation.'' Id. They don't. The decision as to whether to commence a
proceeding by simply issuing an Order to Show Cause or by issuing an
Immediate Suspension Order is fully within the Government's
prosecutorial discretion, subject of course, to the requirement
applicable to the latter that a finding be made that a registrant's
continued registration poses ``an imminent danger to the public health
or safety.'' 21 U.S.C. 824(d). Indeed, as the Supreme Court has made
clear, ``except for [in] extraordinary situations where some valid
governmental interest is at stake that justified postponing the hearing
until after the'' initial deprivation, the Due Process Clause requires
pre-deprivation process when the Government seeks to terminate a
property interest. Boddie v. Connecticut, 401 U.S. 371, 379 (1971).
Beyond this, in an ordinary Show Cause Proceeding, the Government is
not required to prove that a registrant poses ``an imminent danger to
the public health or safety,'' but rather, only whether the registrant
``has committed such acts as would render [its] registration . . .
inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). This
standard has clearly been met here.\11\
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\11\ In his seventh exception, Respondent contends that the
ALJ's analysis was arbitrary and capricious because she failed to
consider factor one--the recommendation of the state licensing
board--and factor three--the registrant's conviction record of
controlled substances offense. Exceptions, at 16. It is true that
the ALJ made no findings with respect to either factor. See R.D. at
21-31.
For purposes of this review, I have assumed that Respondent
holds an unrestricted state license. There is, however, no
recommendation from the Texas State Board of Pharmacy in the record.
Moreover, even assuming that Respondent retains its state license
(and that its license is not subject to any restrictions on its
controlled substance dispensing authority), DEA has repeatedly held
that while a practitioner's possession of state authority
constitutes an essential condition for maintaining a registration,
see 21 U.S.C. 802(21) & 823(f), it ```is not dispositive of the
public interest inquiry.''' George Mathew, 75 FR 66138, 66145
(2010), pet. for rev. denied Mathew v. DEA, 472 Fed. Appx. 453, 455
(9th Cir. 2012); see also Patrick W. Stodola, 74 FR 20727, 20730
n.16 (2009); Robert A. Leslie, 68 FR 15227, 15230 (2003). As the
Agency has long held, ``the Controlled Substances Act requires that
the Administrator . . . make an independent determination [from that
made by state officials] as to whether the granting of controlled
substance privileges would be in the public interest.'' Mortimer
Levin, 57 FR 8680, 8681 (1992). Thus, while Respondent satisfies the
CSA's requirement that it be currently authorized to dispense
controlled substances under the laws of the State in which it
practices pharmacy, this factor is not dispositive either for, or
against, the continuation of Respondent's registration. Paul Weir
Battershell, 76 FR 44359, 44366 (2011) (citing Edmund Chein, 72 FR
6580, 6590 (2007), pet. for rev. denied Chein v. DEA, 533 F.3d 828
(D.C. Cir. 2008)).
As for factor three, I find that there is no evidence that
either Respondent, or its principal, has been convicted of an
offense related to the manufacture, distribution or dispensing of
controlled substances. There are, however, a number of reasons why a
person (whether a corporate entity or natural person) may never be
convicted of an offense falling under this factor, let alone be
prosecuted for one. Thus, ``the absence of such a conviction is of
considerably less consequence in the public interest inquiry'' and
is not dispositive. Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet.
for rev. denied MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011).
I therefore reject Respondent's exception.
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[[Page 59508]]
Exceptions Two and Three--The ALJ's Failure To Rule on the Government's
Motion in Limine and Rejection of Respondent's Testimony Regarding
Remedial Measures
According to Respondent, in its Prehearing Statement and
Supplemental Prehearing Statement, it provided notice of its intent to
introduce evidence of its remedial measures. Exceptions, at 5-6. In
response, the Government filed a Motion in Limine to bar the evidence
on the ground that because Respondent had provided no notice of its
intent to accept responsibility for its misconduct, this evidence was
irrelevant. Id. at 6. Thereafter, Respondent filed a ``Motion for Leave
to File Second Supplemental Prehearing Statement,'' which included a
section in which Respondent provided notice to the Government
``admit[ting] that the Government . . . has met its burden and shown by
a preponderance of evidence that Respondent has committed acts
inconsistent with the public interest.'' Response to Gov. Motion in
Limine and Motion for Leave to File Resp.'s Second Supp. Pre-hearing
Statement, at 2.\12\
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\12\ In this pleading, Respondent provided notice that it
intended to withdraw two witnesses it had previously identified as
J.A.C. and L.D.A. Resp. to Gov. Mot. in Limine and Motion for Leave
to File Resp.'s Second Supp. Prehearing Statement, at 5. However,
Respondent reiterated its earlier notice that it intended to call
Respondent's owner and pharmacist-in-charge, a second pharmacist-
employee, and a pharmacy technicians, maintaining that ``their
testimony is relevant and material to show the Respondent will not
engage in future misconduct.'' Id.
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According to Respondent, ``the ALJ never ruled on the Government's
Motion in Limine and never gave [it, i.e., Respondent] permission to
include in its Prehearing Exhibits any evidence related to the remedial
measures it had taken since being served with the'' Administrative
Inspection Warrant. Exceptions, at 6. Respondent maintains that had
such permission been granted, it would have put forward such evidence
as its policies and procedures, continuing education certificates,
evidence of criminal background checks conducted on its employees, and
its operations manual which includes training of its pharmacists and
pharmacy technicians in identifying and resolving red flags. Id. at 6-
7. However, it then asserts that because the ALJ ``had not granted [it]
permission to supplement its [p]rehearing [e]xhibits . . . it was
consigned to discussing these remedial measure through the sworn
testimony of'' its owner. Id. Continuing, Respondent asserts that
because the ALJ ultimately gave little weight to its owner's testimony,
the ALJ ``put Respondent in an unwinnable situation.'' Id. at 9.
While it is true that the ALJ did not rule on either the
Government's motion in limine or Respondent's motion to file a second
supplemental pre-hearing statement prior to the hearing, I find
Respondent's argument entirely unpersuasive for several reasons. First,
Respondent ignores that prior to the ALJ's ruling, it filed a Response
to the Government's Motion in Limine in which it expressly stated that
it ``does not intend to introduce any other documentary evidence other
than that made a part of his'' Supplemental Pre-Hearing Statement.
Response to Gov't Mot. in Limine, at 5. However, in its Supplemental
Pre-Hearing Statement, Respondent had proposed to introduce only three
exhibits: (1) A criminal background check of its employee A.G. from
2008; (2) a copy of the Texas Board of Pharmacy rule establishing
disciplinary sanctions on licensees and registrants for various
criminal offenses (22 Tex. Admin. Code Sec. 281.64); and 3)
prescription copies (front and back) for nine patients. Resp.
Supplemental Pre-Hrng. Statement, at 23. While Respondent did introduce
both the criminal background check on A.G. and the Board of Pharmacy
rule, neither of these was probative of the issue of whether Respondent
has undertaken sufficient remedial measures to rebut the Government's
prima facie case.
Second, while the ALJ did not rule on either motion prior to the
hearing, her Order made clear that she would ``decide on the
admissibility of each piece of evidence as it is offered.'' Order
Deferring Judgment on Govt. Mot. in Limine and Resp.'s Mot. to File
Second Supp. Prehearing Statement, at 2. However, at the hearing,
Respondent did not seek to introduce any documentary evidence other
than the two exhibits identified above.
Third, notwithstanding that in its Pre-Hearing Statement,
Respondent identified two witnesses (A.C., a pharmacist, and R.G., a
pharmacy tech) in addition to its owner/pharmacist-in-charge, and
proffered that these witnesses would testify as to various procedures
being employed by the pharmacy to ensure compliance with federal law,
see Resp. Pre-Hrng. Statement at 19-21, Respondent did not call either
person to testify. Notably, in its Response to the Government's Motion
in Limine, Respondent continued to identify these two witnesses (in
addition to its owner) as offering ``testimony [that] is relevant and
material to show the Respondent will not engage in future misconduct.''
Resp. to Govt's Motion in Limine, at 5. Thus, even if the ALJ's
deferral of her ruling created some uncertainty as to whether the
testimony of these witnesses would be admissible, Respondent's failure
to call these witnesses constitutes a waiver of the issue.
Nor do I find merit in Respondent's contention that the ALJ imposed
on it an undefined and vague standard of proof when she rejected its
owner's testimony as to several assertions regarding remedial measures
it had undertaken in the absence of corroborating evidence. Indeed,
even were I to find some merit to this contention, it would not change
my ultimate decision, because Respondent ignores that the ALJ also
questioned the credibility of its owner's testimony regarding his
acceptance of responsibility. Moreover, my own review of the record
finds that Respondent's testimony as to his acceptance of
responsibility is properly described as double talk, because while he
initially testified that he accepted responsibility for his misconduct,
on further questioning he denied having ever diverted drugs. So too,
while the Government put forward Expert testimony that there were
numerous prescriptions which raised red flags and which should not have
been filled, either because Respondent never attempted to resolve the
red flag (if it was resolvable) or the red flags were not resolvable,
Mr. Lewka nonetheless maintained that there were no prescriptions which
Respondent should not have filled.
While the ALJ noted that on direct examination, Mr. Lewka took full
responsibility for its misconduct, she further found that on cross-
examination, ``he presented testimony inconsistent with other testimony
in the record.'' R.D. at 29. As support, the ALJ specifically noted Mr.
Lewka's testimony regarding the hiring of A.G. to work as a driver
delivering prescriptions, including controlled substance prescriptions.
Id.; see also Tr. 127. As explained above, this was a violation of DEA
regulations. See 21 CFR 1301.76(a). According to A.G., he told Mr.
Lewka that he had a felony conviction for distributing controlled
substances before he started working for Respondent. Tr. 16. Mr. Lewka
denied
[[Page 59509]]
this, id. at 200-01, even though the evidence showed that Lewka told
A.G. to obtain his criminal history and A.G. obtained a letter from the
San Antonio, Texas Police Department, which while showing that he had
not been arrested by San Antonio police, explicitly stated that the
``background check does not include [the] Bexar county Sheriff['s]
Office, other cities, counties or states.'' RX 1.\13\
---------------------------------------------------------------------------
\13\ In his ninth exception, Respondent challenges the ALJ's
finding that it violated DEA regulations because it employed a
person with a felony drug conviction as its delivery driver.
Exceptions, at 19-23. While Respondent does not dispute that this
was a violation of a DEA regulation, it argues that the ALJ acted
arbitrarily and capriciously because she ``placed great emphasis''
on the violation, which it maintains was unintentional. Id. at 19-
20. It further maintains that the former employee ``lied during his
testimony and stated that he informed [Respondent's owner] at the
time he was hired as a delivery driver in 2008 that he had a felony
conviction for a drug offense.'' Id. at 20.
To the extent the ALJ found credible the former employee's
testimony that he had told Respondent's owner about his felony drug
conviction at the time of his employment interview, see R.D. at 29,
I adopt her finding. Indeed, the evidence showed that following the
interview, Respondent directed the employee to obtain his criminal
history. Thus, there was obviously some discussion between the
employee and Respondent's owner as to the former's criminal history.
Most significantly, the report which was provided by the San
Antonio Police Department clearly indicated that it was limited to
the Police Department's records and did not include the records of
the ``Bexar County Sheriff,'' as well as others cities, counties or
states. RX 1. Given this disclaimer, Respondent cannot credibly
claim that he was duped when the report came back negative for any
criminal history. See Exceptions at 21 (asserting that Respondent's
owner ``was duped and did not know that the Bexar County Sheriff's
Department criminal records check would not contain all of A.G.'s
criminal history''). Moreover, as the employer, Respondent's owner
was the person responsible for conducting a proper background check.
Thus, even if his failure to perform a proper background check does
not rise to the level of an intentional violation of the regulation,
it was still properly considered by the ALJ as evidence of his
compliance with applicable laws related to controlled substances.
See 21 U.S.C. Sec. 823(f)(4). Notably, the ALJ did not state that
this violation alone was sufficient to warrant the revocation of
Respondent's registration. Nor do I. I thus reject this exception.
---------------------------------------------------------------------------
Moreover, a DEA Investigator credibly testified that she had told
Mr. Lewka that A.G. had a felony conviction in July of 2013. R.D. at 14
(citing Tr. 132). Mr. Lewka continued to employ A.G. until September
2013, Tr. 14, maintaining that DEA did not tell him that A.G. was a
convicted felon until September 2013. Id. at 204; see also R.D. at 29.
As another example of his inconsistent testimony regarding his
acceptance of responsibility, the ALJ relied on Mr. Lewka's testimony
regarding Respondent's handling of various prescriptions, which
contained prescriptions for both controlled and non-controlled drugs
and which were stamped by the physician's instruction to the pharmacy
to fill ``all or none'' of the prescriptions. The Government produced
evidence showing that in several instances, Respondent had dispensed
only the controlled substances and/or disregarded the physician's
instruction to fill ``all or none.'' See GX 3, at 15, 17, 55, and 96.
As for Mr. Lewka's testimony regarding this conduct, the ALJ found
that he ``seemed to deny that there was any misconduct when the
prescription contained both controlled substances and non-controlled
substances,'' or included the physician's instruction to fill ``all or
none'' of the prescriptions'' and ``was filled by only distributing the
controlled substances.'' R.D. at 29. As the record shows, the
Government specifically asked Mr. Lewka regarding a prescription for
three drugs, including promethazine with codeine cough syrup, issued to
patient L.B. which was stamped in two places with the instruction ``ALL
OR NONE.'' Tr. 206; GX 3, at 15. The evidence further showed that
Respondent dispensed only the promethazine with codeine. See GX 3, at
16.
When asked if he had disobeyed the prescribing physician's
instructions, Mr. Lewka asserted: ``[t]hat's not true'' because he had
personally called the physician. Tr. 206. When then asked why there was
no such note on the prescription,\14\ Mr. Lewka asserted that the note
was ``on the computer'' and that one of the Agency's Investigators
``was supposed to access what we have in the computer that attached to
most of these prescriptions.'' Id. at 207. However, when the Government
pointed out that the Show Cause Order had specifically alleged that
Respondent's dispensing of this prescription was unlawful, Mr. Lewka
asserted that he didn't know that he would have to bring his computer
notes. Id. at 207-08.
---------------------------------------------------------------------------
\14\ The Government's Expert testified that a red flag is raised
when a customer presents a prescription for both controlled and non-
controlled drugs but requests that the pharmacy fill only the
controlled substances. Tr. 32-33. She further testified that the
resolution of the red flag would be documented ``directly on the
hard copy prescription and possibly in the patient's profile.'' Id.
at 33.
---------------------------------------------------------------------------
When the Government again asked Mr. Lewka whether he was accepting
responsibility, he asserted that he was ``accepting responsibility, but
. . . was explaining what I did on the process.'' Id. at 210. However,
when the Government again asked whether he had disobeyed the doctor's
``all or none'' instruction, Mr. Lewka again asserted that he had
talked to L.B.'s doctor. As for what L.B.'s doctor told him, Mr. Lewka
replied:
Well, he said one of the problems he having [sic] is he put them
in to see if they'll get them, but if they don't have insurance,
than they should get what they want. I told him personally, I said,
[q]uit having your employee stamp the prescriptions; it's affecting
the customers. He said, [t]hat's the procedure we do here, and
they're supposed to fill the prescriptions at that doctor's
pharmacy, and I don't know why they brought them out. That's what he
told me. And he make me have some of them come back with the
prescriptions.
Tr. 210.
Noting that Respondent failed to produce any evidence to support
Mr. Lewka's claim that he had called the physician who approved his
filling only the promethazine, the ALJ concluded that ``[t]his
inconsistent testimony certainly calls into question [his] genuine
remorse for the misconduct proved by the Government.'' R.D. at 29.
Indeed, on this issue, Mr. Lewka testified out of both sides of his
mouth, and as ultimate factfinder, see 5 U.S.C. Sec. 557(b), I do not
believe his testimony that a physician who had previously instructed
the pharmacist to fill ``all or none'' of a prescription, would then
tell the pharmacist that the patient ``should get what they want.''
Moreover, while Mr. Lewka offered a generalized acceptance of
responsibility to the allegations, other portions of his testimony
demonstrate that he is not sincerely remorseful. When asked by his
counsel to explain his professed understanding of ``the importance of
avoiding diversion'' and why this Agency is concerned with diversion,
Mr. Lewka testified:
Well, that the cocktail medication that you fill in the pharmacy
has to be for good legitimate reasons, and diversion is costing the
country and everybody a lot of problems. There's a lot of drug
addicts out there, but I never do diversion at Medicine Shoppe. I
never knew that some of the things they said on the paper was
diversion. I looked at it. It's not diversion at that point, because
I've already talked to the doctor. I know the patient, and I also do
what they want us to do now, making sure that you are also liable
for what the patient is doing.
But diversion is when multiple patients . . . bring cocktail
medication, like controlled substances, Xanax, Soma, hydrocodone,
all in one prescription, scripts, with the intent to--like in this
case, if Dr. [L] give me a prescription with all the same patients
have the same prescriptions, and they brought it to the pharmacy,
and we were filling it, we made a lot of calls to him, especially
those that work for him, all they say, That's what the doctor wants,
and that's how the doctor write his prescriptions.
Tr. 197 (emphasis added). Unexplained by Mr. Lewka is why, if he never
does
[[Page 59510]]
diversion, he even offered his token acceptance of responsibility. So
too, in Mr. Lewka's view, only when drug cocktails of Xanax, Soma
(carisoprodol) and hydrocodone are prescribed to multiple patients are
the prescriptions being diverted; thus, if a single patient presents
these prescriptions, it is not diversion and is appropriate to fill the
prescriptions. And as long as the doctor's staff says that a cocktail
of these three drugs is ``what the doctor wants, and that's how the
doctor write his prescriptions,'' it is appropriate to fill the
prescriptions.
This view, however, has been squarely rejected by both the federal
courts and this Agency. See United States v. Hayes, 595 F.2d 258, 261
(5th Cir. 1979) (``Verification by the issuing practitioner on request
of the pharmacist is evidence that the pharmacist lacks knowledge that
the prescription was issued outside the scope of professional practice.
But it is not an insurance policy against a fact finder's concluding
that the pharmacist had the requisite knowledge despite a purported but
false verification.''); United States v. Seelig, 622 F.2d 207, 213 (6th
Cir. 1980) (upholding jury instruction that knowledge may be inferred
from evidence that pharmacists ``deliberately close their eyes to what
would otherwise be obvious to them''); Holiday CVS, L.L.C., d/b/a CVS
Pharmacy Nos. 219 and 5195, 77 FR 62315, 62322 n.26 (2012) (noting that
``for more than thirty years (if not longer), it has been settled law
that a pharmacist can be held liable for violating 21 CFR 1306.04(a)
even if he calls the prescriber and verifies the prescriptions'');
Ralph J. Bertolino, 55 FR 4730 (1990).
Moreover, when asked whether there were ``any specific
prescriptions'' which the Government's Expert opined should not have
been filled, which he ``agree[d] should not have been filled,'' Tr.
219, Respondent again offered testimony inconsistent with his earlier
statement that he accepted responsibility. He testified that:
There's no prescription that she said that I shouldn't have
filled that I looked at it from her point of view. But most of the
things she said was factual. But not filling the prescriptions--I
know the prescription; I know the doctors; I know the patients more
than she does, so she was looking at it from somebody who do relief.
I don't relieve. I'm a regular pharmacist on this station, so I know
most of my customers.
Tr. 219-20 (emphasis added).
However, as explained above, the Expert identified twelve different
issues with the prescriptions Respondent filled. These include, inter
alia, that various prescriptions were missing the patient's address;
some prescriptions bore a stamped signature rather than the
prescriber's actual signature; some prescriptions were entirely missing
the prescriber's signature; some prescriptions were missing the
prescriber's DEA number; some labels bore a different prescriber name
than that of the actual prescriber; some doctors were prescribing drug
cocktails of narcotics, benzodiazepines, and carisoprodol; some
patients were filling prescriptions for duplicative narcotics such as
hydrocodone tablets and hydrocodone cough syrups; and a prescription
for a narcotic cough syrup authorized the dispensing of a quantity of
the drug that far exceeded the quantity ordinarily prescribed in the
course of legitimate medical treatment. Finally, Respondent filled
controlled substance prescriptions for multiple patients and then
returned the original prescriptions to the patients without making any
marking on the original prescriptions that a controlled substance had
been dispensed, thus allowing the patients to obtain the same drug at a
second pharmacy.\15\
---------------------------------------------------------------------------
\15\ In his tenth exception, Respondent maintains that his
recordkeeping deficiencies ``were situational and the result of the
turbulent and catastrophic demise and ultimate death of Mr. Lewka's
wife.'' Exceptions, at 23. The record is, however, devoid of any
evidence to support this contention.
Respondent also argues that his recordkeeping errors are not
sufficiently egregious to warrant revocation. Id. (citing Terese,
Inc., d/b/a Peach Orchard Drugs, 76 FR 46483, 46848 (2011)).
Respondent also cites Howard N. Robinson, 79 FR 19356 (2014) (in his
eleventh exception), apparently arguing that the audit results
should be considered along with the evidence as to their underlying
cause.
As for the first contention, in Terese, the Government put
forward no evidence that it had done an audit and found that the
pharmacy could not account for the controlled substances it handled,
and the three recordkeeping violations that were proved were
comparatively minor and corrected as soon as they were brought to
the attention of the pharmacist. See 76 FR at 46848. So too, while
in Robinson, the Administrator rejected the Government's contention
that the audit results warranted the revocation of his registration,
she noted that the ALJ had found that the physician had put forward
credible evidence that the shortages were the result of diversion
which was committed by ``a rogue employee, who happened to be a
convicted drug smuggler,'' who was hired by the physician's employer
and not the physician, and had since been terminated. 79 FR at
19357. Moreover, the Administrator noted that the physician's
misconduct was merely negligent, that he ``fully accepted
responsibility and demonstrated that he [wa]s not likely to commit
similar omissions in the future.'' Id. By contrast, in this matter,
Respondent has failed to offer any explanation as to the likely
cause of the massive shortages found during the audit, and while
Respondent contends that the ALJ ignored evidence that Mr. Lewka had
hired an independent company to conduct an inventory, Exceptions, at
24; an inventory and audit are not the same, and in any event, there
is no evidence in the record establishing that Respondent hired an
independent firm to conduct either inventories or audits.
---------------------------------------------------------------------------
Yet Respondent asserted that none of these dispensings was
improper. Moreover, as the ALJ found, Respondent entirely failed to
address the shortages found during the DEA audit.
I thus conclude that Respondent has not accepted responsibility for
its misconduct. As such there is no need to address whether the
remedial measures he claims to have instituted are adequate to protect
the public interest. Medicine Shoppe--Jonesborough, 73 FR 363, 387
(2008). Indeed, in light of Mr. Lewka's testimony to the effect that it
is appropriate to fill prescriptions for drug cocktails as long as the
doctor's staff tells him that is how the doctor writes his
prescriptions, I would still conclude--even were I to give weight to
all of Mr. Lewka's testimony as to his remedial measures--that his
understanding of his obligations as a dispenser of controlled
substances is so lacking as to preclude a finding that Respondent's
registration is consistent with the public interest. See 21 U.S.C.
823(f) and 824(a)(4).
Finally, in its twelfth exception, Respondent contends that the
ALJ's recommended order of revocation is arbitrary and capricious
because:
[c]urrent DEA precedent sets up a no win scenario for any
registrant that has in its history one or two violations of DEA
Regulations. That is, DEA precedent holds that unless the Respondent
accepted responsibility for its ``misconduct.'' Even if there is no
intentional diversion by the Respondent. Consequently, the
Respondent's due process rights have been denied since there is no
meaningful and fair due process proceeding available.
Exceptions, at 25-26.
As found above, Respondent is in no position to argue that it has
been placed in a ``no win'' scenario either because it has committed
only one or two violations of DEA regulations or has not intentionally
diverted controlled substances. Rather, the record is replete with
various violations of the CSA, including violations which support a
finding that it intentionally diverted drugs. So too, the record
establishes that it cannot account for tens of thousands of dosage
units. Thus, to the extent Respondent is in a ``no win scenario,'' this
is entirely of its own making.
As for its opaque suggestion that it has been denied a fair hearing
because the Agency's precedent required it to acknowledge its
misconduct, this is an argument which, while not framed in
constitutional terms, has previously been tried and rejected. As the
Tenth
[[Page 59511]]
Circuit held in rejecting a challenge to the Agency's rule:
The DEA may properly consider whether a physician admits fault
in determining if the physician's registration should be revoked.
When faced with evidence that a doctor has a history of distributing
controlled substances unlawfully, it is reasonable for the Deputy
Administrator to consider whether that doctor will change his or her
behavior in the future. And that consideration is vital to whether
continued registration is in the public interest.
MacKay v. DEA, 664 F.3d 808, 820 (10th Cir. 2011) (citing Hoxie v. DEA,
419 F.3d 477, 483 (6th Cir. 2005)); see also Hoxie, 419 F.3d at 483
(``The DEA properly considers the candor of the physician . . . and
admitting fault [to be] important factors in determining whether the
physician's registration should be revoked.''). I therefore also reject
this exception.
Conclusion
Finding no merit in any of Respondent's Exceptions, I reject its
contention that I should either reopen the hearing or impose a lesser
sanction such as probation with monitoring. Because I find that
substantial evidence supports the conclusion that Respondent's
registration is ``inconsistent with the public interest,'' 21 U.S.C.
824(a)(4), I adopt the ALJ's recommendation that I revoke its
registration.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a)(4), as well as 28 CFR 0.100(b) and 0.104, I order that DEA
Certificate of Registration BT8599891, issued to The Medicine Shoppe,
be, and it hereby is, revoked. I further order that any pending
application of The Medicine Shoppe to renew or modify its registration
be, and it hereby is, denied. This Order is effective November 3, 2014.
Dated: September 18, 2014.
Thomas M. Harrigan,
Deputy Administrator.
Frank Mann, Esq., for the Government.
Jeffrey C. Grass, Esq., for the Respondent.
RECOMMENDED FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE
ADMINISTRATIVE LAW JUDGE
I. INTRODUCTION
Gail A. Randall, Administrative Law Judge. This proceeding is an
adjudication governed by the Administrative Procedure Act, 5 U.S.C.
Sec. Sec. 551 et. seq., to determine whether a pharmacy's
registration with the Drug Enforcement Administration (``DEA'')
should be revoked and any pending applications for renewal of such
registration be denied under the Controlled Substances Act, 21
U.S.C. Sec. Sec. 823(f) and 824(a).
I. PROCEDURAL BACKGROUND
On October 7, 2013, the Deputy Assistant Administrator, Office
of Diversion Control, Drug Enforcement Administration (DEA), issued
an Order to Show Cause, proposing to revoke DEA Certificate of
Registration, Number BT8599891, of the Medicine Shoppe,
(``Respondent''), as a retail pharmacy, pursuant to 21 U.S.C. Sec.
824(a), and deny any pending applications for renewal or
modification of such registration, pursuant to 21 U.S.C.Sec.
823(f). [Administrative Law Judge Exhibit (``ALJ Exh.'') 1]. On
October 18, 2013, The Medicine Shoppe, through counsel, filed a
written request for a hearing. [ALJ Exh. 2].
A hearing was held in San Antonio, Texas, on January 7, 2014.
[ALJ Exh. 4]. On February 18, 2014, the Government filed its
Proposed Findings of Fact and Conclusions of Law (``Government's
Brief''). Also on February 18, 2014, the Respondent filed its
Proposed Findings of Fact and Conclusions of Law (``Respondent's
Brief'').
II. ISSUE
The issue in this proceeding is whether or not the record as a
whole establishes by a preponderance of the evidence that the Drug
Enforcement Administration should revoke the DEA Certificate of
Registration, Number BT8599891, of The Medicine Shoppe, as a retail
pharmacy pursuant to 21 USC Sec. 824(a), and deny any pending
applications for renewal or modification of such registration,
pursuant to 21 U.S.C. Sec. 823(f), because its continued
registration would be inconsistent with the public interest, as that
term is defined in 21 U.S.C. Sec. 823(f). [ALJ Exh. 3; Transcript
``Tr.'' at 5].
III. FINDINGS OF FACT
I find, by a preponderance of the evidence, the following facts:
A. Stipulated Facts
The parties have stipulated to the following fact: Respondent is
registered with DEA as a retail pharmacy authorized to handle
controlled substances in Schedules II-V under DEA COR (Certificate
of Registration) number BT8599891 at 2004 East Houston Street, San
Antonio, Texas. DEA Certificate of Registration BT8599891 will
expire by its terms on November 30, 2015. [ALJ Exh. 3; Tr. at 7-8].
At the hearing, the parties also stipulated to the following
fact: Respondent, The Medicine Shoppe, employed and paid wages to
A.G. during the years 2011, 2012, and 2013. [Tr. at 8].
B. The Investigation
Diversion Investigator (``DI'') Ramirez has been a Diversion
Investigator for DEA for approximately four-and-one-half years. [Tr.
102]. She began her investigation of the Respondent after she
learned that patients of a specific doctor accused of issuing
illegitimate prescriptions were filling those prescriptions at the
Respondent pharmacy. [Tr. 103]. The investigation was not started in
response to any complaints about the Respondent's dispensing
practices. [Tr. 157].
On November 9, 2011, an administrative inspection warrant was
executed at the Respondent's location. [Tr. 159]. DEA inspected and
copied Respondent's records, to include original prescriptions,
copies of prescriptions, records showing the receipt of controlled
substances, and computer data \16\. [Tr. 108]. From that date until
the present, the pharmacy continued to operate. [Tr. 161]. The
record shows that Mr. Lekwa, owner and pharmacist in charge, was
cooperative with the DEA. [Tr. 164].
---------------------------------------------------------------------------
\16\ DEA had difficulties downloading data from the Respondent's
computer. DI Ramirez testified that this was why information from
the computer was not utilized or made part of the record in this
proceeding. [Tr. 166].
---------------------------------------------------------------------------
The record contains no evidence that the Respondent pharmacy,
any pharmacist or pharmacy technician who has worked for the
Respondent has ever been charged with any crime by a state or
federal law enforcement agency.\17\ [Tr. 183]. Further, the
Respondent has not had any suspicious reports regarding break-ins or
burglaries. [Tr. 157-58].
---------------------------------------------------------------------------
\17\ However, the Respondent hired and fired a delivery driver
with a felony conviction related to the handling of controlled
substances. This will be discussed infra.
---------------------------------------------------------------------------
C. Red Flags
Dr. Amy Poore Witte works at the University of the Incarnate
Word, San Antonio, Texas. Since July of 2006, Dr. Witte has served
as an associate professor with tenured status in the Department of
Pharmacy Practice. [Tr. 26-27]. In May of 2004, Dr. Witte was
awarded her doctorate of pharmacy degree. [Tr. 27-28]. Dr. Witte
worked as a licensed pharmacist for Walgreens from 2004 to 2010, and
she currently has a clinical pharmacist position at the VA Hospital
in San Antonio, Texas. [Tr. 28]. As a licensed pharmacist, Dr. Witte
has experience in dispensing controlled substances. [Tr. 29;
Government Exhibit (``Gov't Exh.'') 2].
As a professor, Dr. Witte taught a class in pharmacy law, and
she is familiar with the requirements for dispensing controlled
substances under both Texas and federal law. [Tr. 29-30]. Dr. Witte
was the Government's witness and was recognized as an expert witness
in the field of retail pharmacy. [Tr. 35].
Dr. Witte explained the method a pharmacist would use to
dispense a controlled substance. First, the pharmacist would look at
the prescription to determine if it is facially valid. Specifically,
the pharmacist would ensure the prescription contains the patient's
name and address. Next, she would look at the bottom of the
prescription to verify that a physician has manually signed the
prescription, and has entered the date of the prescription and a DEA
number. Lastly, she would look at the body of the prescription for
the drug name, the strength or dose of the drug, the quantity to
dispense, and the directions for use. [Tr. 30].
Dr. Witte confirmed that a pharmacist has a corresponding
responsibility to ensure that a prescription for a controlled
substance is issued for a legitimate medical purpose. [Tr. 31]. To
determine this purpose, the
[[Page 59512]]
pharmacist talks to the patient and reviews the patient's
prescription profile. [Tr. 31]. The pharmacist looks to determine if
the patient has used the controlled substance in the past, whether
the patient is obtaining the drug from multiple physicians, and
whether the prescription is tailored to the patient's needs. [Tr.
31-32].
The pharmacist may encounter ``red flags'' when presented with
the prescription. Dr. Witte defined a ``red flag'' as something
``brought to your attention when looking at the prescription which
could lead you to think there may be signs of drug diversion.'' [Tr.
32]. Examples of ``red flags'' would be a prescription for an
unusually large quantity of the controlled substance, irregular
dosing instructions, and a patient opting to fill only controlled
substances on a prescription that also contains a noncontrolled
substance. [Tr. 32-33]. It is accepted practice for a pharmacist to
investigate the ``red flag'' and to note on the hard copy of the
prescription the results of that investigation. [Tr. 33]. Such
investigation takes place before the drug is dispensed. [Tr. 33].
Dr. Witte reviewed several hundred prescriptions dispensed at
the Respondent. [Tr. 36; Govt Exhs. 3, 4, 8, 9]. These prescriptions
were for both controlled and noncontrolled substances. [Tr. 36]. In
general, Dr. Witte noticed that there were issues with the
prescriptions, to include 1) missing patients' addresses, 2) missing
DEA numbers, 3) the wrong physician's name on the dispensing label,
4) stamped signatures instead of manual signatures, and 5)
prescribing patterns by specific physicians. [Tr. 37]. It is not
acceptable pharmacy practice to dispense a prescription without an
address, with a stamped signature, or with a missing DEA number.
[Tr. 37-38].
Dr. Witte also explained that a ``drug cocktail'' is usually two
or more controlled substances on a prescription that are usually
highly abused drugs sought by drug-seeking individuals. [Tr. 39]. A
prescription containing a ``drug cocktail'' would be a potential
``red flag'' for diversion. [Tr. 39]. In one instance, customer C.H.
received a ``drug cocktail'' of Tussionex, hydrocodone, and
alprazolam. The prescription also contained non-controlled
substances, which the customer declined to get filled. The non-
controlled substances were ``maintenance meds'' which are ``used to
treat chronic health conditions'' and would be needed ``right
away.'' [Tr. 60; Gov't Exh. 3 at 57-58]. Dr. Witte noted that the
resolution of this ``red flag'' was not annotated on the
prescription, and accordingly, these prescriptions should not have
been filled.
``Pattern prescribing'' occurs when a physician prescribes the
same drug and the same dosage to every patient the physician sees.
This is another ``red flag,'' for the prescription should be
tailored to each patient's individual needs based on their chronic
conditions. [Tr. 39-40]. In reviewing prescriptions from the
Respondent, Dr. Witte recalled seeing prescriptions that were
indicative of pattern prescribing by a Dr. Edwards. [Tr. 40]. Prior
to September of 2011, Dr. Edwards prescribed Xanax and hydrocodone
to all of his patients \18\. [Tr. 40]. Dr. Witte reviewed a specific
prescription of Dr. Edwards' that fit this pattern. [Tr. 41; Gov't
Exh. 9 at 66]. She also noted that the prescription contained a
stamped signature. [Tr. 41; Gov't Exh. 9 at 66]. The dosing
instructions were also unusual. All of these examples would be ``red
flags'' for potential diversion. [Tr. 42; see also Gov't Exh. 9 at
68]. The prescription contains no evidence that these ``red flags''
were investigated prior to the dispensing of these drugs. [Tr. 42].
In Dr. Witte's opinion, these drugs should not have been dispensed
without resolving these ``red flags.'' [Tr. 42].
---------------------------------------------------------------------------
\18\ Such prescriptions would be for a ``drug cocktail.'' [Tr.
40-41; Gov't Exh. 9 at 66].
---------------------------------------------------------------------------
Another of Dr. Edwards' prescriptions contained two drugs that
were codeine based. [Gov't Exh. 8 at 7]. Dr. Witte explained that
such prescribing would be a ``red flag'' and she would not have
dispensed this prescription without first talking to the physician
to suggest he change one of the codeine derivative drugs. [Tr. 44-
45]. The prescription did not contain any evidence that this ``red
flag'' was resolved prior to dispensing the drugs. [Tr. 45].
Dr. Edwards also prescribed two medications to patient D.K.,
hydrocodone, a Schedule III controlled substance, and Skelaxin, a
non-controlled drug. Both of these drugs are designed to treat the
same condition in the same manner. [Tr. 45-46; Gov't Exh. 8 at 16].
Dr. Witte found that this would be a ``red flag,'' and the
prescription fails to contain an annotation of the actions taken to
resolve this ``red flag'' prior to dispensing the drugs. [Tr. 46].
Reviewing another prescription, Dr. Witte noticed that a cough
syrup containing codeine, promethazine with codeine, was dispensed
in a thirty-day amount. [Tr. 47; Gov't Exh. 4 at 218]. Dr. Witte
explained that cough syrup is usually not dispensed in such an
amount. Rather, a cough syrup is dispensed for the length of the
illness, usually ten to fourteen days. [Tr. 47]. Also, the address
is missing on this prescription. [Tr. 47; Gov't Exh. 4 at 218].
These would be two ``red flags'' for this prescription. The
prescription contains no evidence that these ``red flags'' were
resolved prior to dispensing the medication. [Tr. 47-48].
Reviewing another prescription, Dr. Witte noted that a
prescription was presented with the refill portion of the
prescription left blank. [Tr. 48; Gov't Exh. 4 at 98]. That would be
a ``red flag,'' for the prescription was for a controlled substance,
and anyone could have filled in the refill number prior to
presenting the prescription for dispensing. [Tr. 48]. The second
prescription on the page was for a controlled substance and also had
a blank refill portion of the prescription. Both prescriptions
lacked a patient address. [Tr. 48-49; Gov't Exh. 4 at 98]. There was
no evidence that these ``red flags'' were resolved prior to
dispensing the drug. [Tr. 49]. Dr. Witte opined that these two
prescriptions should not have been dispensed, given the unresolved
``red flags.'' [Tr. 49].
In her review of prescriptions, Dr. Witte noted that on several
occasions a controlled substance was dispensed, and the patient was
given back the hard copy of the prescription. [Tr. 51-55, 165; Gov't
Exh. 3 at 13-14, 19-20]. Such a practice is not acceptable in the
field of pharmacy and creates a risk of diversion \19\. [Tr. 52, 54-
55].\20\
---------------------------------------------------------------------------
\19\ However, on cross-examination, DI Ramirez credibly
testified that she had not investigated whether or not these
prescriptions resulted in duplicate filling of controlled
substances. [Tr. 165].
\20\ Dr. Witte also credibly testified that on one prescription
an annotation stating ``Pt took hard copy back'' meant that the
patient took back the hard copy of the prescription. [Gov't Exh. 3
at 70]. However, since the comment was not initialed, Dr. Witte did
not know who had written the comment. [Tr. 99-100]. I find that it
is a reasonable assumption, based on the totality of the
prescriptions presented and the lack of any challenge from the
Respondent concerning this notation, that the annotation was made by
an employee of the Respondent. [Tr. 109-111].
---------------------------------------------------------------------------
On a prescription dated December 2, 2010, the physician had
stamped ``All or None.'' The prescription was for three drugs, and
the only drug dispensed was the controlled substance. [Tr. 56-57;
Gov't Exh. 3 at 15-16]. Also, the physician's DEA number was missing
on the prescription, and the patient's address was missing. [Tr.
56]. Such a prescription would have been a ``red flag'' which should
have been resolved prior to dispensing the medication. Per Dr.
Witte, no resolution was annotated on the prescription. [Tr. 57].
She opined that this prescription should not have been dispensed in
the manner utilized by the Respondent's pharmacist. [Tr. 57; see
also Gov't Exh. 3 at 17-18 and Tr. 57-59].
Dr. Witte reviewed another prescription dated December 15, 2010,
which contained a total of five drugs. The patient only requested
that the controlled substances be dispensed. [Tr. 59-60; Gov't Exh.
3 at 57-58]. Such conduct would be a ``red flag'' and should have
been resolved prior to dispensing the medication. Dr. Witte saw no
evidence that the problems were resolved prior to dispensing the
medication, and she opined that these controlled substances should
not have been dispensed prior to resolving these ``red flags.'' [Tr.
60]. Likewise, two patients sharing the same address presented
prescriptions with multiple medications, and the pharmacist only
filled the controlled substance. [Tr. 61-63; Gov't Exh. 4 at 235-
36]. Again, such conduct would be a ``red flag,'' and the
prescription fails to indicate any action taken to resolve the ``red
flag'' prior to dispensing the controlled substance. [Tr. 62].
Dr. Witte also reviewed two prescriptions written for the same
patient. One was dated November 23, 2010, and the second
prescription was dated December 9, 2010, and both prescriptions
contained controlled substances. [Tr. 65; Gov't Exh. 3 at 70, 76].
The prescriptions were written by different practitioners. After
filling the controlled substance on the November 23, 2010
prescription, the pharmacist handed back the prescription to the
patient. Such conduct would allow the patient to fill the November
23 prescription at another pharmacy, and then fill the December 9
prescription at yet another pharmacy. Although the controlled
substance was dispensed from the November
[[Page 59513]]
23 prescription, the prescription did not contain a notation of the
dispensing that would alert any other pharmacist that that drug had
already been dispensed. [Tr. 65-66]. Such prescriptions, as handled
by the Respondent's pharmacist, presented ``red flags,'' and the
prescriptions had no notations demonstrating that the ``red flags''
were resolved prior to the dispensing of the controlled substances.
[Tr. 67]. The prescription on December 9, 2010, should not have been
dispensed. [Tr. 67].
Lastly, Dr. Witte reviewed three prescriptions containing
controlled substances written for the same patient, who was also an
employee of the Respondent. The patient had a prior conviction for
drug distribution, and such prescriptions would raise ``red flags.''
[Tr. 67-68; Gov't Exh. 4 at 84-89, Gov't Exh. 10]. The fact that the
prescriptions contained multiple medications, and that the patient
only filled some of the controlled substances, Dr. Witte found these
``red flags'' should have been resolved prior to dispensing the
controlled substances. The patient's criminal conviction for drug
distribution would add another ``red flag'' for these prescriptions.
[Tr. 68]. The prescriptions did not contain any annotation that the
pharmacist resolved the ``red flags'' prior to dispensing the
controlled substances. In Dr. Witte's view, these controlled
substances should not have been dispensed in this manner. [Tr. 68-
69].
Overall, Dr. Witte opined that the Respondent did not exercise
its corresponding responsibility to ensure that prescriptions for
controlled substances were issued for a legitimate medical purpose.
[Tr. 69].
D. Prescription Issues
After reviewing the prescriptions found in Government Exhibit 3,
DI Ramirez credibly testified that she found six instances when the
controlled substances were filled and the non-controlled substances
were not filled. [Tr. 111]. Mr. Lekwa stated that for one of those
prescriptions, he had called the doctor concerning the prescription.
He had placed his notes from the call in the computer, not on the
back of the prescription. [Tr. 205-08; Gov't Exh. 3 at 16].
Further, DI Ramirez found five examples in Government Exhibit 3
of prescriptions that did not contain a signature from the
prescribing practitioner. [Tr. 114]. DI Ramirez also found
approximately 44 prescriptions in Government Exhibit 3 that failed
to contain a patient address. [Tr. 115-16]. She also found
approximately 11 prescriptions in Government Exhibit 3 that had a
missing or incorrect DEA number. [Tr. 116]. DI Ramirez also found 4
prescriptions where the name on the front of the prescription for
controlled substances did not match the name on the dispensing
label. [Tr. 117-19; see also Tr. 121-22, Gov't Exh. 4 at 192-93].
After reviewing Government Exhibit 4, DI Ramirez found
approximately 125 prescriptions for controlled substances without a
patient address. [Tr. 124]. This exhibit also contained
approximately 157 prescription labels for controlled substances that
identified the wrong prescribing practitioner. [Tr. 116-17, 124-25;
Gov't Exhs. 3, 4]. There were also 22 prescriptions for controlled
substances that either had a missing or incorrect prescriber DEA
number. [Tr. 125].
DI Ramirez also credibly testified that 98 prescriptions
purportedly from a Dr. Leo Edwards had a signature stamp rather than
a manual signature. [Tr. 141-44; Gov't Exh. 8, 9]. When asked by DI
Ramirez, Dr. Edwards confirmed that he had used a signature stamp on
his prescriptions. [Tr. 144; Gov't Exh. 8, 9].
On at least 22 occasions, the Respondent's personnel filled
controlled substance prescriptions and then returned the original
paper prescriptions to the customer. [Tr. 109-10; Gov't Exh. 3 at 5,
11, 13, 19, 28, 35, 37, 39, 41, 43, 45, 47, 53, 70, 75, 76, 78, 82,
84, 90, 92, and 104].
DI Ramirez found several instances in which controlled
substances were provided to customers without any valid prescription
whatsoever for that individual. For example, Respondent's personnel
distributed alprazolam to customer T.J., but the only record
attached to the prescription label was a prescription for
hydrocodone issued to customer R.S. [Tr. 117; Gov't Exh. 3 at 99-
100; see also Tr. 118-19, 121-22; Gov't Exh. 3 at 103, 111; Tr. 121-
22; Gov't Exh. 4 at 192-93].
DI Ramirez did not discover any evidence of any outright forged
or fraudulent prescriptions. [Tr. 168]. She also did not identify
any clientele that were coming from out of state. [Tr. 168].
E. The Audit
On the date that the Administrative Inspection Warrant was
served, November 9, 2011, DI Ramirez conducted an audit of different
dosages of controlled substances. [Tr. 136, 159; Gov't Exh. 13]. The
starting point for the audit was the Respondent's inventory of
October 30, 2010 \21\, and the ending date of the audit was November
8, 2011. [Gov't Exh. 13]. DI Ramirez took a count of seven different
strengths of controlled substances that were on-hand at the pharmacy
on the date of the audit. She also added the receipts of each dosage
for the audit timeframe to get a ``total accounted for'' amount.
[Tr. 137; Gov't Exh. 13]. Next, DI Ramirez obtained sales and
distribution records for the dosages of controlled substances sold
and added that figure to the total on-hand on the day of the audit
to show what the pharmacy could account for in their records. As a
result of this audit, the Respondent had an overage of 445 Methodone
10 mg. tablets, a shortage of 27,344 ml. of Promethazone with
codeine (or 929 ounces), an overage of 1,508 Hydrocodone 5 mg.
tablets, an overage of 18,721 Hydrocodone 7.5 mg. tablets, a
shortage of 3,445 Hydrocodone 10 mg. tablets, a shortage of 43,359
Alprazalam 1 mg. tablets, and a shortage of 7,769 Alprazalam 2 mg.
tablets. [Tr. 138-140; Gov't Exh. 13]. DI Ramirez did not discuss
these results with Mr. Lekwa, Respondent's owner. [Tr. 139]. At the
hearing, Mr. Lekwa gave no explanation for these discrepancies.
---------------------------------------------------------------------------
\21\ DI Ramirez confirmed that an annual inventory was conducted
at the Respondent pharmacy. When DI Ramirez executed the
Administrative Inspection Warrant, Mr. Lekwa, owner of the
Respondent, was in the process of conducting his annual inventory.
[Tr. 161].
---------------------------------------------------------------------------
F. Recordkeeping Deficiencies
When DI Ramirez reviewed the Respondent's receiving invoices,
she noted that the dates of the receipt of the controlled substances
and verification of the quantities received were missing. [Tr. 146;
Gov't Exh. 5]. Of these eight invoices, there were 19 entries for
controlled substances, and the required annotations were lacking.
[Tr. 146; Gov't Exh. 5]. This pattern was repeated for other
invoices. [Tr. 148-51; Gov't Exh. 6, 7]. Also, in looking at the DEA
222 forms, which are used to record the receipt of Schedules I and
II controlled substances, DI Ramirez also noted that the forms lack
what was received, the quantity received, and the date that the
controlled substances were received by the pharmacy. [Tr. 152; Gov't
Exh. 12].
G. Hiring of a Prior Felon
A.G. worked for the Respondent from 2008 to September of 2013.
[Tr. 14; Gov't Exh. 11, 14]. He worked as a delivery driver, and he
delivered controlled substances as part of his work
responsibilities. [Tr. 15, 127-28].
In 1989, A.G. was convicted of distribution of crack cocaine.
[Tr. 15-16]. This was a felony conviction. [Tr. 16, 1321-33; Gov't
Exh. 10].
Mr. Lekwa asked A.G. to retrieve a document showing his criminal
conviction, and A.G. went to the Texas Department of Public Safety
and obtained a document that he subsequently provided to Mr. Lekwa.
[Tr. 16, 20; Resp't Exh. 1]. The document related that ``The
criminal history record file of the San Antonio Police Department
did not reveal at this time any arrest information on the above-
named individual.'' [Resp't Exh. 1]. However, A.G.'s conviction
occurred in Waco, Texas. [Tr. 24].
At the hearing, Mr. Lekwa admitted that he had not contacted the
City of San Antonio Police Department or any county in the state of
Texas to get a criminal background check on A.G. [Tr. 202].
In July of 2013, DI Ramirez told Mr. Lekwa about A.G.'s
conviction, but Mr. Lekwa continued to employ A.G. until September
of 2013. [Tr. 132].
H. Mr. Lekwa
Mr. Lekwa, the pharmacist in charge and the owner of the
Respondent, graduated from Texas Southern University in 1993. [Tr.
181]. English is a second language for him. [Resp't Br. at 18]. He
is licensed in Texas as a pharmacist. [Tr. 182]. He worked for
Walgreens for ten years, first as a pharmacist and then as a
pharmacy manager. [Tr. 181]. He opened the Respondent in 2003. [Tr.
186]. The Respondent is a franchise, and the franchise agreement
provided that the company would do the site layout, would provide
financing at a low interest rate, would assist in marketing the
Respondent, and would provide training. The company also has
consultants for the Respondent to consult. [Tr. 187-88].
Mr. Lekwa hired a permanent pharmacist, rather than using relief
pharmacists like in the past. [Tr. 189]. He also trains the pharmacy
technicians to ensure they follow
[[Page 59514]]
the DEA requirements. [Tr. 189]. Specifically, he requires the
technicians to put the address and phone number on the front of a
prescription prior to filling it. [Tr. 190]. As for prescriptions
for ``drug cocktails,'' Mr. Lekwa stated that his new procedure is
to confirm the prescription with the prescribing practitioner, to
annotate that confirmation on the prescription, and to ask the
practitioner to fax the diagnosis to the pharmacy. [Tr. 190-91].
Mr. Lekwa also trained his personnel who sign for the receipt of
controlled substances to fill out the paperwork completely at the
time the controlled substances are actually received, rather than to
wait until the end of the month to reconcile the receipts. [Tr.
190].
Mr. Lekwa has served many of his customers for the past ten-plus
years. [Tr. 193]. Most of Mr. Lekwa's clients are elderly and use
Medicaid or Medicare for their prescriptions. [Tr. 192]. Some of his
customers do not have insurance. [Tr. 192]. Because of money
constraints, some of his customers request to fill part of their
prescription on one day and to return another day to purchase the
rest of the medication. [Tr. 192]. Now Mr. Lekwa advises such
customers that the patient has to have the means to purchase all of
their prescribed medication at one time. [Tr. 192].
Also, Mr. Lekwa acknowledged that he returned the original
prescriptions in some cases to the customer. [Tr. 193-94]. He
credibly testified that he was not doing this practice now. [Tr.
194-95].
Mr. Lekwa has never been the subject of an investigation or
disciplinary action by any state board. [Tr. 182].
Mr. Lekwa acknowledged that mistakes were made at the Respondent
pharmacy. [Tr. 184, 220, 223]. Specifically, after he understood the
true nature of A.G.'s criminal record, he fired him. [Tr. 185-86].
He also instructed his personnel to make sure the patient's address
and phone number are on the front of the prescription. [Tr. 220].
Mr. Lekwa also testified that he did not send DEA any kind of
correspondence indicating that he accepted responsibility for any
kind of misconduct. [Tr. 200]. Mr. Lekwa testified that he
instituted new policies and procedures. Specifically he reviews the
Medicine Shoppe manual with each of his employees. He also keeps the
manual updated.\22\ [Tr. 214-15].
---------------------------------------------------------------------------
\22\ The Government made the point that Mr. Lekwa did not bring
the manual to the hearing or place it into the record. [Tr. 216].
---------------------------------------------------------------------------
IV. CONCLUSIONS OF LAW AND DISCUSSION
A. Position of the Parties
1. The Government's Position
The Government seeks revocation of the Respondent's Certificate
of Registration because to continue its registration would be
against the public interest. [Gov't Br. at 30]. Specifically, the
Government argues that DEA is bound by agency precedent to revoke
Respondent's DEA registration. Citing to DEA final orders, the
Government asserts that the Respondent violated state and Federal
law by failing to exercise its corresponding responsibility to
ensure that prescriptions for controlled substances are issued for a
legitimate medical purpose, as required by the Controlled Substances
Act and the implemented regulations. [Gov't Br. at 13]. The
Government further argued that the Respondent repeatedly filled
facially invalid prescriptions, failed to maintain adequate records,
and failed to keep an accurate inventory of the controlled
substances it purchased. [Gov't Br. at 13-14]. Lastly, the
Respondent violated Federal law by employing a convicted drug felon
in a position where the felon had access to controlled substances.
[Gov't Br. at 14].
Next, the Government asserts that the Respondent dispensed
controlled substances despite the unresolved red flags. [Gov't Br.
at 14]. Specifically, the Government argues that the Respondent's
personnel distributed controlled substances pursuant to
prescriptions that contained one or more unresolved ``red flags.''
Dr. Witte's testimony establishes this fact. [Gov't Br. at 14-16].
Additionally, the Government argues that the Respondent's
failure to keep accurate records violated Federal statutory and
regulatory provisions that require an accurate inventory of
controlled substances. [Gov't Br. at 16]. The inadequacy of the
Respondent's system is evidenced by the audit conducted by the DEA
resulting in large shortages and overages. [Gov't Br. at 17]. The
Respondent's records were also deficient because Mr. Lekwa failed
correctly to record complete invoices of controlled substances
received. [Gov't Br. at 17-18]. Lastly, the Respondent, by
permitting customers to retain their original prescriptions,
violated Federal regulations that require the Respondent to maintain
the paper prescription for Schedules III, IV, and V controlled
substances at the registered location. [Gov't Br. at 18].
The Government also argues that the Respondent violated DEA
regulations by hiring A.G., a felon convicted of a drug-related
crime, and by failing to do a proper and thorough background check.
[Gov't Br. at 19]. Also, the Respondent failed to prove that it
accepted responsibility for its actions or to demonstrate that it
will not engage in future misconduct. Further, a Respondent's lack
of candor and inconsistent explanations may serve as a basis for
denial of a registration. [Gov't Br. at 20-24].
The Government asserts that the Respondent's practices
significantly increased the risk of diversion. [Gov't Br. at 24].
Further, the Respondent has provided insufficient evidence of facts
that demonstrate mitigating circumstances. [Gov't Br. at 25].
Lastly, the Government argues that Mr. Lekwa's testimony was not
credible and should be given no weight. [Gov't Br. at 28]. The
Government states that ``[n]otwithstanding the confusing and
contradictory nature of his testimony, Mr. Lekwa's wholesale failure
to produce a single written document to support his position
militates in favor of finding him to be an incredible witness. . . .
Mr. Lekwa has also testified in a manner that was non-responsive,
evasive, and internally inconsistent.'' [Gov't Br. at 29].
In light of all of the above, the Government requests that I
recommend that the Respondent's Certificate of Registration should
be revoked. [Gov't Br. at 30].
2. The Respondent's Position
The Respondent asserts that its Certificate of Registration
should not be revoked and any pending applications for renewal
should be granted. [Resp't Br. at 23]. First, Respondent asserts
that it holds a valid license in the State of Texas, and the State
has not made a recommendation in this matter. Thus, factor one of
the statutory provision is not an impediment to the Respondent's
keeping his registration. [Resp't Br. at 6].
As for factor three, the Respondent states that the record does
not contain evidence that the Respondent, its owner, or any
pharmacist or key employee of the pharmacy has been convicted of a
crime related to the manufacture, distribution, or dispensing of
controlled substances. [Resp't Br. at 7].
As for factor two, the Respondent asserts that neither the
Respondent, Mr. Lekwa nor any other pharmacist or pharmacy
technician employed by Respondent has ever been investigated,
disciplined or charged with any violation of state or federal
administrative, regulatory, or criminal law. [Resp't Br. at 7].
As for factor four, the Respondent admitted that the Government
has met its burden of proof and has shown by a preponderance of the
evidence that the Respondent has committed acts inconsistent with
the public interest. [Resp't Br. at 8]. Mr. Lekwa testified that the
Respondent accepted responsibility for its misconduct. Then he
asserted that a qualitative assessment of the Respondent's current
practices should occur to determine whether or not sufficient
corrective action has been taken to prevent similar occurrences of
future misconduct. [Resp't Br. at 8-9].
The Respondent then analyzes the difference between resolvable
and unresolvable red flags. As for resolvable red flags, the
Respondent asserts that such indicators may be resolved through
discussions with patients and prescribers, as well as through the
pharmacist's own knowledge of the patient's past history as a
customer. [Resp't Br. at 10]. Unresolvable red flags are situations
in which ``no amount of information gathered or verification made by
the pharmacist could foresee any explanation that would satisfy a
Pharmacist's corresponding responsibility under federal law not to
fill the scripts.'' [Resp't Br. at 10]. He concludes that
``[r]esolvable red flags, if resolved, are lawful prescriptions.
Unresolvable red flags are illegal and substantial evidence of drug
diversion.'' [Resp't Br. at 11]. The ``type of red flags that
support a finding that Respondent's pharmacists repeatedly and
intentionally dispensed prescriptions are those where they had
reason to know that the prescriptions lacked a legitimate medical
purpose and were issued outside of the usual course of professional
practice.'' [Resp't Br. at 12].
The Respondent asserts that now there are policies and
procedures in place at Respondent to correct missing or incomplete
data on prescriptions. [Resp't Br. at 12]. For example, the
Respondent has hired another
[[Page 59515]]
pharmacist to supervise employees in Mr. Lekwa's absence, and has
obtained an independent audit of all records relating to the
inventory, to include purchasing, storing, dispensing and
recordkeeping practices of the Respondent. [Resp't Br. at 14]. Mr.
Lekwa has instituted additional training regimen, has conducted FBI
criminal background checks on all of his employees, and has
implemented a policy whereby all of the prescribed drugs or none of
the prescribed drugs will be dispensed per prescription. [Resp't Br.
at 14].
Yet, Mr. Lekwa admits that he dispensed drugs for prescriptions
that were suspicious and not resolvable. The Respondent affirms that
calling the physician does not immunize the Respondent from its duty
to ensure the prescriptions are for a legitimate medical purpose.
[Resp't Br. at 13].
The Respondent cites DEA precedent for the proposition that the
DEA ``has declined to revoke a registration where non-egregious
recordkeeping errors were acknowledged by the pharmacy PIC and
remedied promptly.'' Terese, Inc., d/b/a Peach Orchard Drugs, 76
Fed. Reg. 46,843, 46,848 (DEA 2011).\23\ He then asserted that the
flaws in the biannual inventory were non-egregious flaws. Further,
the error of receipts and invoices lacking necessary date,
acknowledged by the Respondent, was non-egregious. [Resp't Br. at
17].
---------------------------------------------------------------------------
\23\ The Respondent asserts that Mr. Lekwa has hired a private
company to conduct an annual inventory. This fact, however, is not
part of the record and the Respondent did not cite any record source
for this fact.
---------------------------------------------------------------------------
Next, the Respondent argues that its ``acceptance of
responsibility was . . . significant and deserving of great weight
and consideration since it occurred before the hearing and
presentation of the evidence.'' [Resp't Br. at 17]. It has presented
sufficient mitigating evidence to assure the Administrator that it
can be entrusted with the responsibility of a continued
registration, the Respondent asserts. [Resp't Br. at 17-18].
According to Respondent, ``[t]he evidence shows that the
Respondent's continued registration would not threaten the public
safety.'' [Resp't Br. at 20].\24\ In conclusion, the Respondent
asserts that although the Government has met its burden of proof,
``the evidence further shows that Respondent will not commit future
acts of misconduct making its continued registration consistent with
the public interest.'' [Resp't Br. at 23].
---------------------------------------------------------------------------
\24\ The Respondent rebuts the Government's expert witness by
asserting that her professional opinion was based upon incomplete
information. [Resp't Br. at 20].
---------------------------------------------------------------------------
B. Statement of Law and Discussion
Pursuant to 21 U.S.C. Sec. 824(a)(4), the Deputy Administrator
\25\ may revoke a registration, and deny a pending application for
renewal or modification, if he determines that the continuation or
issuance of such registration would be ``inconsistent with the
public interest'' as determined pursuant to 21 U.S.C. Sec. 823(f).
Section 823(f) requires that the following factors be considered:
---------------------------------------------------------------------------
\25\ The Deputy Administrator has the authority to make such
determinations pursuant to 28 C.F.R. Sec. Sec. 0.100(b) and 0.104
(2009).
---------------------------------------------------------------------------
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. Sec. 823(f); see also Alexander Drug Co., 66 Fed. Reg.
18,302 (DEA 2001); Nicholas A. Sychak, d/b/a Medicap Pharmacy, 65
Fed. Reg. 75,959, 75,967 (DEA 2000). These factors may be considered
in the disjunctive: The Deputy Administrator may properly rely on
any one or a combination of these factors, and may give each factor
the weight he deems appropriate, in determining whether a
registration should be revoked or an application for registration
denied. Liddy's Pharmacy, L.L.C., 76 Fed. Reg.48,887, 48,893 (DEA
2011) (citing Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005);
Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005)); Robert A.
Leslie, M.D., 68 Fed. Reg. 15,227, 15,230 (DEA 2003).
Factors two and four are relevant.
Further, in an action to revoke a registrant's certificate, the
DEA has the burden of proving that the requirements for revocation
are satisfied. 21 C.F.R. Sec. 1301.44(e). The burden of proof then
shifts to the Respondent once the Government has made its prima
facie case. Arthur Sklar, R.Ph., d/b/a King Pharmacy, 54 Fed. Reg.
34,623, 34,627 (DEA 1989). Specifically, after the Government ``has
proved that a registrant has committed acts inconsistent with the
public interest, a registrant must `present sufficient mitigating
evidence to assure the Administrator that [the Respondent] can be
entrusted with the responsibility carried by such a registration.'''
Medicine Shoppe, 73 Fed. Reg. at 387 (quoting Samuel S. Jackson, 72
Fed. Reg. 23,848, 23,853 (DEA 2007) (quoting Leo R. Miller, 53 Fed.
Reg. 21,931, 21,932 (DEA 1988)). ``Moreover, because `past
performance is the best predictor of future performance,' ALRA Labs,
Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), [DEA] has repeatedly
held that where a registrant has committed acts inconsistent with
the public interest, the registrant must accept responsibility for
[its] actions and demonstrate that [it] will not engage in future
misconduct.'' Medicine Shoppe, 73 Fed. Reg. at 387; see also
Jackson, 72 Fed. Reg. at 23,853; John H. Kennedy, 71 Fed. Reg.
35,705, 35,709 (DEA 2006); Prince George Daniels, 60 Fed. Reg.
62,884, 62,887 (DEA 1995); See also Hoxie v. DEA, 419 F.3d 477, 483
(6th Cir. 2005) (``admitting fault'' is ``properly consider[ed]'' by
DEA to be an ``important factor'' in the public interest
determination)].
1. Prescriptions
Pursuant to the Controlled Substances Act and its implementing
regulations, a pharmacy, a prescription-dispensing registrant, has a
corresponding responsibility, along with the physician, a
prescription-issuing registrant, to ensure the prescription is
valid. 21 C.F.R. Sec. 1306.04(a). When considering whether a
pharmacy has violated its corresponding responsibility, the Agency
considers whether the entity, not the pharmacist, can be charged
with the requisite knowledge. Holiday CVS, L.L.C., d/b/a CVS
Pharmacy Nos. 219 and 5195, 77 Fed. Reg. 62316 (DEA 2012)
[hereinafter CVS]; see also United Prescription Services, 72 Fed.
Reg. at 50,407; Pharmboy Ventures Unlimited, Inc., 77 Fed. Reg.
33,770, 33,772 n.2 (DEA 2012) (``DEA has long held that it can look
behind a pharmacy's ownership structure `to determine who makes
decisions concerning the controlled substance business of a
pharmacy.'''); S&S Pharmacy, Inc., 46 Fed. Reg. 13051, 13052 (DEA
1981) (``the corporate pharmacy acts through the agency of its
pharmacist in charge''). Knowledge obtained by the pharmacists and
other employees acting within the scope of their employment may be
imputed to the pharmacy itself. See U.S. v. One Parcel of Land, 965
F.2d 311, 316 (7th Cir. 1992) (``Only knowledge obtained by
corporate employees acting within the scope of their employment is
imputed to the corporation.'').
The applicable regulations state that the test for the proper
prescribing and dispensing of controlled substances is as follows:
A prescription for a controlled substance to be effective must
be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional
practice. The responsibility for the proper prescribing and
dispensing of controlled substances is upon the prescribing
practitioner, but a corresponding responsibility rests with the
pharmacist who fills the prescription.
21 C.F.R. Sec. 1306.04(a). Thus, for a prescription to be lawful,
it needs to be written for a legitimate medical purpose in the
practitioner's usual course of professional practice. Id. The
pharmacist has a corresponding responsibility to verify the validity
of a prescription, and if a prescription seems suspect, the
pharmacist has a duty to investigate the prescription to determine
its legitimacy. See CVS, 77 Fed. Reg. at 62,340-41. The
corresponding responsibility to ensure the dispensing of valid
prescriptions extends to the pharmacy itself. Medicine Shoppe-
Jonesborough, 73 Fed. Reg. at 384 (finding that a respondent
pharmacy was properly charged with violating corresponding
responsibility); United Prescription Services, Inc., 72 Fed. Reg.
50397, 50407-08 (2007) (same). EZRX, LLC, 69 Fed. Reg. 63,178,
63,181 (DEA 2004) (``DEA has issued orders to show cause and
subsequently revoked the DEA registrations of pharmacies which
failed to fulfill their corresponding responsibility in Internet
prescribing operations . . . .'')
DEA has consistently interpreted the prescription provision as
prohibiting a pharmacist from filling a prescription for a
controlled substance when he either ``knows or has reason to know
that the prescription was not written for a legitimate medical
purpose.'' Medic-Aid Pharmacy, 55 Fed. Reg.
[[Page 59516]]
30,043, 30,044 (DEA 1990). See also Frank's Corner Pharmacy, 60 Fed.
Reg. 17,574, 17,576 (DEA 1995); Ralph J. Bertolino, d/b/a Ralph J.
Bertolino Pharmacy, 55 Fed. Reg. 4,729, 4,730 (DEA 1990)
[hereinafter Bertolino]; United States v. Seelig, 622 F.2d 207, 213
(6th Cir. 1980). This Agency has further held that ``[w]hen
prescriptions are clearly not issued for legitimate medical
purposes, a pharmacist may not intentionally close his eyes and
thereby avoid [actual] knowledge of the real purpose of the
prescription.'' Bertolino, 55 Fed. Reg. at 4,730 (citations
omitted); see also Sun & Lake Pharmacy, Inc., 76 Fed. Reg. 24,523,
24,530 (DEA 2011); Liddy's Pharmacy, L.L.C., 76 Fed. Reg. at 48,893;
East Main Street Pharmacy, 75 Fed. Reg. 66,149, 66,163 (DEA 2010);
Lincoln Pharmacy, 75 Fed. Reg. 65,667, 65,668 (DEA 2010); Bob's
Pharmacy, 74 Fed. Reg. 19,599, 19,601 (DEA 2009). However, the DEA
does not require omniscience. Carlos Gonzalez, 76 Fed. Reg. 63,118,
63,142 (DEA 2011) (citing Holloway Distrib., 72 Fed. Reg. 42,118,
42,124 (DEA 2007)).
Yet, when an attempted transaction would give rise to suspicion
in a ``reasonable professional,'' there is a duty to ``question the
prescription[].''Bertolino, 55 Fed. Reg. at 4730. The ``reasonable
professional'' has been further developed into the ``reasonable
pharmacist'' standard. East Main Street Pharmacy, 75 Fed.Reg. at
66165; see also Winn's Pharmacy, 56 Fed.Reg. 52559, 52561 (DEA
1991). Accordingly, a pharmacist or pharmacy may not dispense a
prescription in the face of a red flag (i.e., a circumstance that
does or should raise a reasonable suspicion as to the validity of a
prescription) unless he or it takes steps to resolve the red flag
and ensure that the prescription is valid. East Main Street
Pharmacy, 75 Fed. Reg. at 66,165. Because Agency precedent limits
the corresponding responsibility to circumstances which are known or
should have been known, Sun & Lake Pharmacy, Inc., 76 Fed. Reg. at
24,530, it follows that, to show a violation of a corresponding
responsibility, the Government must establish that: ``(1) The
Respondent dispensed a controlled substance; (2) a red flag was or
should have been recognized at or before the time the controlled
substance was dispensed; and (3) the question created by the red
flag was not resolved conclusively prior to the dispensing of the
controlled substance.'' CVS, 77 Fed. Reg. at 62316; see also Sun &
Lake Pharmacy, 76 Fed. Reg. at 24,532 (finding that pharmacy
violated corresponding responsibility when it took no steps to
resolve red flags prior to dispensing controlled substances.). The
steps necessary to resolve the red flag conclusively is dependent
upon the nature of the specific red flag. CVS, 77 Fed. Reg. at
62,341.
In support of its allegation that the Respondent has violated
its corresponding responsibilities, the Government has introduced
evidence that the Respondent pharmacy: (1) dispensed controlled
substances without a prescription; (2) dispensed controlled
substances when the prescription was ``signed'' using a signature
stamp; (3) allowed customers to retain the original controlled
substances prescriptions; (4) dispensed controlled substances when
the prescription contained irregular dosing instructions; (5)
dispensed controlled substances when the prescriptions revealed
``pattern prescribing'' by the physician; (6) dispensed controlled
substances when the prescription lacked a patient's address and the
physician's DEA registration number; (7) placed a prescription label
on the back of the prescription with a physician's name that is not
consistent with the name on the front of the prescription; (8)
accepted prescriptions where the refill line was blank; and (9)
allowed patients with prescriptions containing both controlled and
non-controlled substances to fill only the controlled substances'
portion of the prescription.
Further, the Respondent also violated state law, which prohibits
dispensing controlled substances pursuant to prescriptions that lack
a correct DEA registration number, patient address, or prescriber's
signature. See Tex. Health & Safety Code Ann. Sec. 481.074; Tex.
Admin. Code Sec. 13.75.\26\
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\26\ These statutory and regulatory requirements provide in
relevant part that a prescription for a controlled substance must
show the quantity of the substance prescribed, the date of the
issue, the name, address, and date of birth or age of the patient,
the name and strength of the controlled substance prescribed, the
directions for use, the name, address, DEA number, and telephone
number of the practitioner at the practitioner's usual place of
business, and, if the prescription is handwritten, the signature of
the prescribing practitioner. Tex. Health & Safety Code Ann. Sec.
481.074.
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The record contains no evidence that these ``red flags'' were
resolved prior to the dispensing of the controlled substances. A
preponderance of the evidence proves that the Respondent violated
its corresponding responsibility in the way it dispensed controlled
substances pursuant to these defective prescriptions.
2. Recordkeeping Deficiencies
Further, ``[r]ecordkeeping is one of the CSA's central
features,'' and ``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.
30,630, 30,644 (DEA 2008), aff'd 567 F.3d 215, 224 (6th Cir. 2009).
The statute provides that ``it shall be unlawful . . . to refuse or
negligently fail to make, keep, or furnish any record, notification,
declaration, order or order form, statement, invoice or information
required.'' 21 U.S.C. 842(a)(5). The implementing regulations
require that a dispensing registrant must maintain accurate records
that include ``the number of units or volume of such finished form
dispensed, including the name and address of the person to whom it
was dispensed, the date of dispensing, the number of units or volume
dispensed, and the written or typewritten name or initials of the
individual who dispensed'' the controlled substance. 21 C.F.R. Sec.
1304.22(c).
Here, the Respondent's recordkeeping was deficient. The
Government presented evidence that the Respondent's invoices were
incomplete, and the DEA 222 forms lacked a notation of what was
received, the quantity of the controlled substance received, and the
date the controlled substance was received by the pharmacy. 21
C.F.R. Sec. 1305.13.\27\ Without such records, the pharmacy would
be unable to produce an accurate inventory or audit.
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\27\ This regulation provides in relevant part that the
pharmacy, as the purchaser, must record on the DEA Form 222 the
number of commercial containers furnished on each item, and the
dates on which the containers were received.
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DEA, however, attempted to conduct an audit of the Respondent.
The results were telling, for the Respondent was unable to
accurately account for 27,344 ml. of Promethazone with codeine (or
929 ounces), 1,508 Hydrocodone 5 mg. tablets, 18,721 Hydrocodone 7.5
mg. tablets, 3,445 Hydrocodone 10 mg. tablets, 43,359 Alprazalam 1
mg. tablets, and 7,769 Alprazalam 2 mg. tablets. This inability to
account for this significant number of dosage units creates a grave
risk of diversion. Medicine Shoppe, 73 Fed. Reg. at 367 (finding any
amount over 50 dosage units a significant amount); see also Paul H.
Volkman, 73 Fed. Reg. 30630, 30644 (DEA 2008), pet. for rev. denied
567 F.3d 215, 224 (6th Cir. 2009) (finding that ``a registrant's
accurate and diligent adherence to this obligation is absolutely
essential to protect against the diversion of controlled
substances''). The DEA has also held that it need not find that
diversion was the cause of the unaccounted dosage units, to conclude
that the Respondent does not maintain effective controls against
diversion. Jack A. Danton, D.O., 76 Fed. Reg. 60,900, 60,919 (DEA
2011) (citations omitted). Because the records provided to the DEA
failed to correctly record what was accurately received and
dispensed, such recordkeeping errors contributed ``to the inability
of the Respondent and subsequently the DEA to conduct an
accountability audit with accurate results,'' and, thus, violated
Federal law. Jack A. Danton 76 Fed. Reg. at 60,919.
3. Hiring of a Convicted Felon
DEA regulations provide 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 C.F.R. Sec. 1301.76(a). Further, the
Respondent had a duty to conduct an inquiry concerning any
convictions its employees may have on their record. 21 C.F.R. Sec.
1301.90.
Here, the Respondent hired an individual who had a felony
conviction for distributing crack cocaine to deliver prescribed
drugs, to include controlled substances. Prior to employing this
individual, Mr. Lekwa told him to obtain documentation of his
criminal record, and A.G. opted to get a criminal background report
from the City of San Antonio. This was an insufficient background
check, for the applicant had a felony conviction in Waco, Texas, not
San Antonio.\28\ Indeed, the report itself states that
[[Page 59517]]
it does not include A.G.'s criminal history in any other
jurisdiction. [Resp't Exh. 1]. Again, the Government has proved by a
preponderance of the evidence that the Respondent violated DEA
regulations.
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\28\ There was testimony challenging whether the applicant told
Mr. Lekwa about his conviction prior to his being hired. I find this
irrelevant. The legal point is that Mr. Lekwa did not perform an
adequate background check prior to hiring this individual.
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Thus, the burden of production now shifts to the Respondent to
demonstrate that it takes full responsibility for its unlawful
conduct and that it has put in place remedial measures so that such
violations will not happen in the future. Medicine Shoppe, 73 Fed.
Reg. at 387 (quoting Samuel S. Jackson, 72 FR 23,848, 23,853 (DEA
2007)) (holding that a registrant must ``present sufficient
mitigating evidence to assure the Administrator that [it] can be
entrusted with the responsibility carried by such a registration'');
Leo R. Miller, 53 Fed. Reg. 21,931, 21,932 (DEA 1988).
On direct examination, Mr. Lekwa took full responsibility for
any misconduct attributable to the Respondent. However, on cross
examination, Mr. Lekwa presented testimony inconsistent with other
testimony in the record. First, he denied that A.G., at the time of
his employment interview, told him about his felony conviction for
distribution of crack cocaine. A.G. testified to the contrary.
Further, DI Ramirez testified that, in July of 2013, she had told
Mr. Lekwa about A.G.'s felony conviction, yet Mr. Lekwa denied
having this conversation with DI Ramirez. Rather, Mr. Lekwa
testified that he had a conversation in September 2013 with DI
Ramirez's supervisor. That was when he first learned of the felony
conviction, he asserted.
Next, Mr. Lekwa seemed to deny that there was any misconduct
when the prescription containing both controlled substance and non-
controlled substance entries, as well as a notation of ``all or
none,'' was filled by only distributing the controlled substance.
Rather, Mr. Lekwa testified that he had contacted the doctor and
received permission to fill the prescription in that manner. Yet the
record contains no evidence of this verification action. This
inconsistent testimony certainly calls into question Mr. Lekwa's
genuine remorse for the misconduct proved by the Government.
As for remedial measures, the record contains unrefuted evidence
that Mr. Lekwa fired A.G. in September of 2013. Also, Mr. Lekwa
testified that he now trains each employee on the procedures to
follow in filling a controlled substance prescription. He announced
that there was a training manual to help with this training.
However, on cross examination Mr. Lekwa stated that the manual was
the one the franchise company provided. Although he kept the manual
current, there is no evidence that he altered procedures to come
into compliance with legal requirements. Rather, Mr. Lekwa testified
that the manual was not deficient, but the implementation of the
manual provisions was lacking prior to the Order to Show Cause being
served. Arguably, this new training would be a meaningful remedial
measure. But the record contains no excerpts from the manual to
bolster the adequacy of this training.
Next, Mr. Lekwa testified that when he receives a prescription
containing a ``drug cocktail,'' he now requires the physician to fax
to him confirmation of the diagnosis that resulted in this kind of
prescribing. Unfortunately, the record contains no evidence that
this procedure has been successfully implemented.
V. CONCLUSION AND RECOMMENDATION
Given the extent of the misconduct and the unreliability of the
testimony concerning the acceptance of responsibility, I conclude
that the Respondent's registration should be revoked. Accordingly,
that is my recommendation based on this record.
Dated: March 24, 2014
Gail A. Randall
Administrative Law Judge
[FR Doc. 2014-23473 Filed 10-1-14; 8:45 am]
BILLING CODE 4410-09-P