Registrant Actions - 2012
[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 44069-44105]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17973]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 08-19]
Grider Drug 1 & Grider Drug 2; Decision and
Order
On October 30, 2007, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Grider Drug 1, the holder of DEA Certificate of
Registration No. AG3498347, and Grider Drug 2, the holder of
DEA Certificate of Registration No. AG9715751, (hereinafter, Respondent
or Respondents), of Russell Springs, Kentucky.\1\ ALJ Ex. 1, at 1. The
Show Cause Order proposed the revocation of each Respondent's retail
pharmacy registration, as well as the denial of any pending
applications to renew or modify each registration, on the ground that
the Respondents' "continued registrations are inconsistent with the
public interest." Id. (citing 21 U.S.C. 823(f); 824(a)). The Show
Cause Order alleged that each Respondent had committed numerous
violations of federal regulations, as well as that Leon Grider, the
owner of Respondents, had been indicted on state law charges of
trafficking in controlled substances and bribing a witness.\2\ Id. at
4.
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\1\ The Order also sought the revocation of the registration
issued to a third pharmacy, Grider Drug Key Village. ALJ Ex. 1, at
1. However, this store discontinued selling pharmaceuticals in
November 2008 and the proceeding was subsequently terminated with
respect to it. ALJ Ex. 5.
\2\ The specifics of the various allegations are discussed
below.
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Subsequently, on June 22, 2010, the Government raised additional
allegations that Respondents were dispensing prescriptions to six
persons engaged in doctor-shopping and that "Respondents knew or
should have known that the above dispensed controlled substances were
likely to be diverted or used for other than legitimate medical
purposes" and that they "failed to fulfill their corresponding
responsibility for the proper dispensing of controlled substances." GX
21, at 1-3. Based on the allegations that this conduct had continued
through early May 2010, I concluded that there was a "substantial
likelihood" that it would continue. Id. at 3. Accordingly, I concluded
that Respondents' continued registration during the pendency of the
proceedings "would constitute an imminent danger to the public health
and safety" and authorized the immediate suspension of each
Respondent's registration.\3\ Id. at 3-4.
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\3\ Apparently, the Government raised additional allegations in
its pre-hearing statements.
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Following service of the initial Show Cause Order, Respondents
requested a hearing on the allegations and the matter was placed on the
docket of the Agency's Office of Administrative Law Judges (ALJ) and
assigned to an ALJ, who proceeded to conduct pre-hearing procedures. On
June 6, 2008, the ALJ granted Respondents' motion to stay the
proceedings pending the conclusion of a state-court criminal case
against their owner Leon Grider, which was scheduled to conclude on
October 10, 2008, noting that "the parties believe that the
presentation of evidence in the above-captioned matter will be
facilitated." Order Granting Stay of Proceedings, at 1. However, nine
months later, after further delays in the state proceeding, the ALJ
terminated the stay, and finally, in August 2009, the ALJ commenced the
hearing.\4\
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\4\ The ALJ also granted three continuances because of the
medical condition of Respondent's counsel. Tr. 3005.
The proceeding also included an interlocutory appeal to this
Office by Respondents of the ALJ's denial of their motion to stay
the proceeding while they sought the return of numerous documents
which were seized by the Kentucky Bureau of Investigation and the
Medicaid Fraud Unit of the Kentucky's Attorney General's Office
pursuant to a state criminal search warrant. See ALJ Ex. 10. I
denied the interlocutory appeal. See ALJ Ex. 11.
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Giving new force to Justice Douglas's dissenting opinion in Sierra
Club v. Morton,\5\ the parties proceeded to take twenty-seven days of
testimony over the ensuing twenty months and create a record comprised
of more than 6200 pages of transcript as well as several thousand pages
more of various exhibits, with much of the record devoted to litigating
issues which are plainly irrelevant. Primary responsibility for the
state of the record lies with the ALJ, who failed to exercise anything
more than minimal control over the parties' respective presentations.
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\5\ See 405 U.S. 727, 741 (1972) (citing Stone, 45 S. Cal. L.
Rev. 450 (1972)).
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After the hearing, both parties submitted briefs containing their
proposed findings of fact, legal conclusions and argument.\6\
Thereafter, on September 23, 2011, the ALJ issued her recommended
decision.
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\6\ These submissions will be cited as Gov. Post-Hearing Br. and
Resp. Post-Hearing Br., respectively.
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With respect to factors two (Respondents' experience in dispensing
controlled substances) and four (Respondents' compliance with
applicable laws related to controlled substances), the ALJ found, inter
alia, that Respondents' owner, Leon Grider, had, on various occasions,
distributed controlled substances to several persons without a
prescription. ALJ at 85-85. Based on audits which Respondents paid an
accounting firm to conduct on themselves, the ALJ further found that
Respondents could not "account for a substantial number of dosage
units of controlled substances" including hydrocodone and methadone.
Id. at 85-86. In addition, the ALJ found that Respondents did not
report various thefts of controlled substances and failed to reduce to
writing and maintain called-in prescriptions. Id. at 87.
The ALJ further found that Respondents had violated their
corresponding responsibility under 21 CFR 1306.04(a) by dispensing to
the six persons (as alleged in the Immediate Suspension Order)
controlled-substance prescriptions which lacked a legitimate medical
purpose and that Respondents' pharmacists ignored various red flags
indicative that the patients were engaged in drug abuse or diversion.
Id. at 89-90.
Next, the ALJ rejected various allegations of violations that were
based on data from the State of Kentucky's Prescription Monitoring
Program (KASPER) on the ground that the Government had not obtained a
court order as required by state law to render these reports and the
underlying data contained in them admissible in this proceeding. ALJ at
91. However, the ALJ found that Respondents had violated federal
regulations by dispensing schedule II controlled substances without
retaining the hard copy of the prescription, as well as by dispensing
prescriptions "that were never called-in or authorized by the
prescribing physicians." Id. at 92.
As for factor five--such other conduct which may threaten public
health and safety--the ALJ found that Respondents' pharmacists had
improperly billed Medicaid for medications (including controlled
substances) by billing for one medication while actually dispensing
another and that this conduct circumvented "the prescription check and
balance such Medicaid reporting creates." ALJ at 94. In addition, the
ALJ found that Leon Grider had "inaccurately" labeled prescription
bottles as well as placed false prescription labels on bottles he
provided to a confidential informant. Id.
Based on her findings under factors two, four, and five, the ALJ
thus concluded that the Government had satisfied its prima facie case
by showing that Respondent had committed acts inconsistent with the
public interest. Id. at 95. The ALJ then held that
[[Page 44071]]
Respondents had failed to rebut the Government's prima facie showing,
noting that Respondents' owner did not testify and thus had not shown
"any remorse for the past failings of the Respondents or [that] he
ha[s] implemented any procedures that would ensure such failings do not
occur in the future." Id. In addition, the ALJ noted that Eric Grider
(Respondents' owner's son and the pharmacist in charge at Grider
2) testified that "Respondents had not implemented any
operational or policy changes in response to this proceeding," and
that even after the service of the first Show Cause Order, Respondents
had continued to violate 21 CFR 1306.04(a) by failing to fulfill their
corresponding responsibility to not dispense unlawful prescriptions.
Id. at 95-96. Finally, the ALJ rejected Respondents' contentions that
the violations proved by the Government were "so minor and
understandable in pharmacies doing extensive filling of controlled
substances that those violations are insufficient * * * to justify
suspension, revocation and/or denial of" their registrations. Id. at
96. The ALJ thus recommended the revocation of Respondents'
registrations and the denial of their pending applications. Id.
Respondents filed exceptions to the ALJ's decision.\7\ Thereafter,
the ALJ forwarded the record to me for final agency action.
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\7\ Respondent's Exceptions have been thoroughly considered and
are discussed throughout this decision.
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Having considered the entire record, I adopt the ALJ's conclusions
of law with respect to factors two and four, as well as her ultimate
conclusion that Respondents have committed acts which render their
registrations inconsistent with the public interest.\8\ I also adopt
the ALJ's legal conclusion that Respondents have not rebutted the
Government's prima facie case. I therefore also adopt her recommended
order. I make the following findings.
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\8\ The ALJ's factual findings comprise 270 paragraphs, many of
which contain multiple findings. As explained below, I adopt some of
the findings and reject others for a variety of reasons. For
example, the ALJ made extensive findings based on KASPER data and
reports only to ultimately conclude that the KASPER data and reports
were not admissible. Compare ALJ at 49-54, with id. at 91-92.
However, because I conclude that the ALJ correctly held that the
KASPER data were not admissible, and cannot be disclosed other than
in accordance with the KASPER statute, she should not have made
these findings. The ALJ also made extensive findings as to the
result of a Government audit of Respondents' handling of controlled
substances which was performed by a new Diversion Investigator. Id.
at 59-63. However, the Government did not rely on this audit, and
its lead witness candidly acknowledged that the audit was flawed.
Because these findings are not probative of any issue in the case,
they should not have been made. Other findings of the ALJ are
discussed throughout this opinion.
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Findings of Fact
Respondents' Registration and License Status
Respondent Grider Drug 1 is the holder of DEA Certificate
of Registration AG3498347, under which it was authorized to handle
controlled substances at the registered location of 539 Main St.,
Russell Springs, Kentucky. GX 1. While this registration was due to
expire on September 30, 2005, on August 23, 2005, Respondent filed a
renewal application. GX 2. According to an affidavit of an official in
charge of the DEA Registration Unit, upon filing this application,
Respondent was authorized to continue dispensing controlled substances
until the issuance of the immediate suspension order on June 22, 2010.
Id. I therefore find that Grider Drug 1 has both a
registration and an application currently pending before the Agency.
Respondent Grider Drug 2 formerly held DEA Certificate of
Registration AG9715751, which authorized it to handle controlled
substances at the registered location of 124 Dowell Rd., Russell
Springs, Kentucky. GX 3. The expiration date of this registration was
September 30, 2008, and Respondent did not file a renewal application
until September 25, 2008. GX 4. According to an affidavit of the
official in charge of the DEA Registration Unit, upon filing this
application, Respondent was authorized to continue dispensing
controlled substances until the issuance of the immediate suspension
order on June 22, 2010. However, while the official's affidavit states
that this was timely renewal application, id., it was not because on
October 30, 2007, the instant Order to Show Cause was issued to Grider
2, and under the Agency's regulation, when an Order to Show
Cause has been issued to a registrant, the registrant must submit its
renewal application "at least 45 days before the date on which the
existing registration is due to expire" in order for its registration
to be continued pending the issuance of the final order. 21 CFR
1301.36(i). Accordingly, I find that Respondent Grider Drug
2's registration expired on September 30, 2008. However,
Respondent's Grider Drug 2's application is pending before the
Agency. See Paul H. Volkman, 73 FR 30630, 30641 (2008), pet. for rev.
denied 567 F.3d 215 (6th Cir. 2009).
The record contains evidence that Leon Grider, who is the
pharmacist-in-charge at Grider Drug 1, owns both pharmacies.
However, there is also some evidence that other Grider family members
own shares in the pharmacies.
The Substantive Allegations
In the initial Show Cause Order, the Government raised a plethora
of allegations. ALJ Ex. 1. These allegations included, inter alia,
that:
(1) Grider 1 and 2 had refilled schedule II
controlled substances seventeen and eight times respectively, in
violation of 21 CFR 1306.12;
(2) Grider 1 and 2 had refilled prescriptions
for schedule III-V controlled substances without the prescribing
physician's authorization fifty-seven and seventeen times respectively,
in violation of 21 CFR 1306.21(a);
(3) Grider 1 and 2 filled prescriptions bearing
invalid or expired DEA registration numbers 186 and 161 times
respectively, in violation of 21 CFR 1306.05;
(4) Grider 1 refilled prescriptions for schedule III and
IV controlled substances more than six months after the date of the
original prescription, in violation of 21 CFR 1306.22(a);
(5) Grider 1 and Grider 2 engaged in the
unauthorized transfer of prescriptions and prescription refills from
Grider Drug Key Village 289 and 40 times respectively, in violation of
21 CFR 1306.25(a); \9\
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\9\ The Show Cause Order also alleged that Grider Drug Key
Village engaged in 139 unauthorized transfers of controlled
substance prescriptions and refills from Grider Drug 1 to
Grider Drug Key Village and 150 unauthorized transfers of
prescriptions and refills from Grider 2 to Grider Drug Key
Village. ALJ Ex. 1, at 3-4.
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(6) data from the Kentucky All-Schedule Prescriptions Electronic
Reporting System (hereinafter, KASPER) show that Grider 1 had
filled schedule III-V prescriptions for which it could not produce the
actual prescription in nine instances, in violation of 21 CFR
1306.21(a);
(7) Grider 1 and 2 failed to take and maintain a
biennial inventory, as required by 21 CFR 1304.11(c);
(8) "[a]n accountability audit of 50 controlled substances
covering [the] period of May 31, 2003 to August 19, 2004, revealed a
shortage of 22,219 dosage units of controlled substances" at Grider
1 and 105,913 dosage units at Grider 2;
(9) Grider Drug 1 "filled four controlled-substance
prescriptions which incorrectly listed Grider Drug 2 as the
'issuing physician' and that Grider 2 filled several schedule
II controlled-substance prescriptions which listed itself as the
physician, in violation of 21 CFR 1306.05(a); and
(10) Grider Drug 1 and Grider Drug 2 engaged in
133 unauthorized
[[Page 44072]]
transfers of prescriptions and prescription refills between themselves,
in violation of 21 CFR 1306.25(a).
Id. The Government raised additional allegations in its Pre-Hearing
Statements, as well as in the Immediate Suspension Order. ALJ 21.
The Admissibility of KASPER Data
With respect to most of these allegations, a principal component of
the Government's proof was reports and/or data contained in reports
which were obtained by law enforcement personnel from the State of
Kentucky's KASPER system. Notwithstanding Respondents' repeated
objection to the use of this data on various grounds, the ALJ relied on
it to make numerous findings regarding the allegations that Respondents
had filled prescriptions under expired, invalid, or surrendered DEA
numbers, that Respondents listed themselves as the prescribing
physician in numerous instances, that Respondents refilled schedule II
controlled substance prescriptions, that Respondent dispensed
prescriptions without retaining a hard copy of them, and that
Respondents dispensed refills of prescriptions for schedule III-V drugs
which were not authorized. ALJ at 49-54. However, in her conclusions of
law, the ALJ noted that Respondents also challenged the admissibility
of the KASPER reports, and held that under Kentucky law, a court order
is required for the reports and the data contained therein to be
admissible in this proceeding. ALJ at 91 & n.46 (citing Ky. Rev. Stat.
Sec. 218A.202(8); Sangster v. Kentucky Bd. of Med. Lic., 2010 WL
4294213 (Ky. Ct. App. 2010)).\10\
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\10\ Given the ALJ's conclusion that this evidence was not
admissible, it is perplexing that the ALJ made numerous factual
findings relying on this evidence.
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In its post-hearing brief, the Government argued that in several
previous proceedings, the Agency's final orders had relied on KASPER
data in making various findings. Gov. Br., at 101. See Paul Volkman, 73
FR 30630, 30633 (2008). However, as the ALJ recognized, the
admissibility of KASPER reports and data has not been previously
challenged in a DEA proceeding.
Under Kentucky law, KASPER data may only be disclosed "to persons
and entities authorized to receive that data under this section.
Disclosure to any other person or entity, including disclosure in the
context of a civil action where the disclosure is sought either for the
purpose of discovery or for evidence, is prohibited unless specifically
authorized by this section." Ky. Rev. Stat. Sec. 218A.202(6). The
statute authorizes disclosure of KASPER data to eight categories of
persons or entities, including: (1) "[a] designated representative of
a board responsible for the licensure, regulation, or discipline of
practitioners, pharmacists, or other person authorized to prescribe,
administer, or dispense controlled substances and who is involved in a
bona fide specific investigation involving a designated person"; and
(2) a certified peace officer of a State, "or a federal peace officer
whose duty is to enforce the laws of this Commonwealth, of another
state, or of the United States relating to drugs and who is engaged in
a bona fide specific investigation involving a designated person." Id.
However, "[a]uthorized users must apply for an account" and
provide appropriate proof of their identity and credentials. RX 42, at
20. Most significantly, applicants must also execute an account use
agreement pursuant to which they agree that access to KASPER "is
granted only with the authority and rights allowed under KRS
218A.202," as well as "to use the reports only in manners set forth
under KRS 218A.202." RX 52, at 1. See also Tr. 179 (testimony of
supervisory DI: "We have an account with KASPER and in order to get
that account we had to apply to KASPER and get all our information
notarized and then approved by the Cabinet for Health Services.").
The KASPER statute further provides that "[a] person who receives
data or any report of the system from the cabinet shall not provide it
to any other person or entity except by order of a court of competent
jurisdiction and only to a person or entity authorized to receive the
data or the report under this section, except" when done pursuant to
three exceptions, none of which apply here. KRS Sec. 218A.202(8).
While one of these exceptions provides that "[t]he Department for
Medicaid Services may submit the data as evidence in an administrative
hearing held in accordance with KRS Chapter 13B," an Opinion of the
Kentucky Attorney General explains that:
The fact that the General Assembly deemed it necessary to make a
special exception for Medicaid hearings indicates that
administrative hearings, in general, were not contemplated as a
permissible forum for disclosure of KASPER data. We must therefore
conclude that data from the KASPER system cannot, without a court
order, be used as either documentary or testimonial evidence in an
administrative hearing before the Board of Medical Licensure. Any
drug transactions at issue in the hearing must be proved from other
sources.
5 Op. Ky. Att'y Gen. 7, at 6 (2005). However, as the Kentucky Attorney
General further explained, "there is no 'fruit of the poisonous tree'
doctrine associated with KRS 218A.202, which would make the use of the
KASPER information as a starting point for seeking confirming evidence
into the equivalent of a 'disclosure.' " Id. at 7.
More recently, the Supreme Court of Kentucky has held that the
KASPER statute creates an evidentiary privilege, which fosters
important objectives, even if it is not absolute. Commonwealth Cabinet
for Health and Family Services v. Chauvin, 316 SW.3d 279, 288 (Ky.
2010). In Chauvin, the Kentucky Supreme Court further explained that
the statute's exceptions which permit disclosure "are rather limited
and do not undermine the general prohibition on disclosure." Id.\11\
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\11\ Under 21 U.S.C. 876(a), the Attorney General is authorized
to "require the production of any records * * * which the Attorney
General finds relevant or material to" an investigation under the
CSA. This case does not, however, present any question as to whether
the CSA preempts the KASPER statute's prohibition against disclosure
in a proceeding under 21 U.S.C. 824(a).
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Here, while there is no argument that DEA Investigators were
authorized to obtain KASPER data to pursue their investigation, they
agreed, as a condition of obtaining this data, to use the reports only
in the manners permitted under Kentucky law. However, as explained
above, with the exception of a state Medicaid proceeding, Kentucky law
does not authorize disclosure of this information in an administrative
proceeding without a court order. Because DEA Investigators did not
obtain a court order authorizing the use of the KASPER data in this
proceeding and agreed to use the reports and data only as authorized by
Kentucky law, the reports and data contained therein were not
admissible.
Accordingly, the ALJ should not have made any findings based on
them. However, where DEA Investigators merely used the KASPER reports
and data as an investigative tool to facilitate the search for other
evidence which establishes violations on the part of Respondents, that
other evidence is admissible. Accordingly, I turn to whether the
various allegations set forth above are supported by substantial
evidence.\12\
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\12\ The Government also introduced data from the DEA ARCOS
system to show Respondents' purchases of oxycodone and hydrocodone
in various years and compare them with the average purchases of
pharmacies in the local area, the State of Kentucky, and United
States. However, while some of the figures show that Respondents
were purchasing greater quantities than the average of the
pharmacies in these categories, some of the data shows the opposite.
And while the hydrocodone data generally shows that Respondents
purchased more than the average pharmacy in each of the three
categories, no further evidence was offered to explain the
statistical significance of Respondents' purchases. Moreover, in its
brief, the Government offered no further explanation as to what this
evidence proved.
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[[Page 44073]]
Allegation One--Refilling Schedule II Controlled Substances
The Controlled Substances Act explicitly prohibits the refilling of
a schedule II controlled substance. See 21 U.S.C. 829(a).\13\ With
respect to Grider 1, the Government produced copies of fifteen
schedule II prescriptions which it alleged were refilled. GX 13.
However, with respect to many of these prescriptions, the DI testified
(and/or the copies of the prescriptions include a handwritten notation)
that his finding was based on his review of the KASPER report. Tr. 357-
371; GX 13, at 3, 7, 9, 15, 17, 19. In another instance, the DI
identified two prescriptions for OxyContin issued to a patient on
December 20, 2002 (with a fill date of 1/30/03) and February 13, 2003.
GX 13, at 5-6; Tr. 361. However, when questioned regarding these
prescriptions, the DI testified that "I made no annotations. I don't
think I saw anything really wrong with these two." Tr. 361. And with
respect to other prescriptions in this exhibit (See GX 13, at 11-14),
the DI offered no explanation at all as to why they were included. Tr.
364-65.
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\13\ However, under a DEA regulation promulgated several years
after the prescriptions at issue here, a practitioner "may issue
multiple prescriptions authorizing the patient to receive a total of
up to a 90-day supply of a schedule II controlled substances
provided" that several "conditions are met," including that the
"practitioner provides written instruction on each prescription * *
* indicating the earliest date on which a pharmacy may fill each
prescription." 21 CFR 1306.12(a).
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The Government's Exhibit with respect to Grider 2's
refilling of schedule II drugs contained thirteen prescriptions (two of
which were actually for Lortab, a schedule III drug, and Xanax, a
schedule IV drug). See GX 15. Here again, the Government's contention
that Grider 2 refilled the schedule II prescriptions was based
on inadmissible KASPER data. Tr. 418-35 (DI's testimony at Tr. 427:
"[a]ll the prescriptions and the annotations [in GX 15] were done in
comparing and contrasting with KASPER."). In addition, with respect to
the first prescription contained in this exhibit (which was for a
schedule II drug), the DI acknowledged that the prescription had not
been refilled. Id. at 420. Instead, the DI's concern was prompted by
the fact that the KASPER report indicated that it had been filled on a
Sunday, when the pharmacy was closed. Id. Even if this fact was adduced
by admissible evidence, by itself, it would not constitute substantial
evidence of any violation of the CSA.
However, another document in this exhibit is a copy of a label for
a hydrocodone prescription. GX 15, at 4. Consistent with the annotation
on this document, the DI testified that during a 2004 search of
Respondents, Investigators did not find either a hard copy (i.e., a
prescription signed by the prescriber) or a called-in prescription. Tr.
422. Rather, the only document found by the Investigators was the
label. Id. See also Tr. 468-74 and GX 39, at 4 (dispensings for
Duragesic (fentanyl) and Roxicet filled on April 8, 2003 to patient
LC). As explained more fully below, this evidence does constitute
substantial evidence of a violation of the CSA, which prohibits the
dispensing of controlled substances by a pharmacist without a
prescription. See 21 U.S.C. 829(a) (schedule II) & (b) (schedules III &
IV).
The DI also testified to a split distribution of a prescription for
15 Duragesic patches, noting that ten of the patches had been dispensed
initially and the remaining five had been dispensed eight days later
and that this was "an instance where it seems the pharmacy didn't have
enough in stock." Tr. 426. However, once again, this allegation was
based on inadmissible KASPER data and no other evidence establishes
that the prescription was dispensed in this manner.
Allegation Two--Refilling Schedule III Through V Prescriptions Without
Authorization of the Prescriber
As noted above, the Government alleged that both Respondents
dispensed numerous unauthorized refills of schedule III through V
controlled substances. However, the documentary evidence with respect
to Grider 1 included only four prescriptions (two for
hydrocodone combination drugs, and two for Ambien (zolpidem)); with
respect to Grider 2, the evidence included only six
prescriptions (three for Xanax, one for diazepam, and two for Lorcet
(hydrocodone)). See GXs 14 & 16. In addition, the Government offered
the testimony of its lead DI and Dr. CS and two exhibits regarding
Grider 1's dispensing of multiple refills for Dr. CS's patient
BW. See GXs 30 & 31.
As for the prescriptions contained in GX 14 (Grider 1),
once again the DI relied on the KASPER data in concluding that Grider
1 had dispensed unauthorized refills. GX 14, at 1-2. As for
the Grider 2 prescriptions, the first prescription found in GX
16 (a Xanax prescription to BP, which authorized no refills) was the
subject of the DI's concern because while both the prescription and the
label were dated June 5, 2003, KASPER data indicated that it was filled
eighteen days later. GX 16, at 1-2. However, there is no contention
that the KASPER data shows that the prescription was filled on both
dates, and thus, even if this data was admissible, it would not
establish that this was an unauthorized refill as there is otherwise no
indication that this prescription was filled more than once.
The DI further asserted that per KASPER records, a June 18, 2003
prescription for Xanax issued to JB, which authorized no refills, was
filled on both June 18 and June 19, 2003. Id. at 3. Once again, the
Government produced no other evidence to prove its allegation.\14\
However, the Government did produce a copy of a label for a Xanax
prescription which was dispensed on March 12, 2003 to JB. Id. at 6.
According to the DI's testimony (and a notation on the copy),
Investigators could not find either the original signed prescription or
a called-in prescription for this dispensing. Id.; Tr. 442.
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\14\ This page of GX 16 also includes a March 26, 2003
prescription for Xanax with no refills issued by the same physician
to JB and a copy of the prescription label which bears the date
"03/26/03." GX 16, at 3-4. No contention was made that this
prescription was improperly refilled. In addition, the exhibit
contains an August 14, 2003 prescription for diazepam issued by a
Dr. JE with two refills, and a label for the dispensing which is
dated "09/16/03." Id. at 5-6. Here again, no contention was raised
that this prescription was improperly refilled.
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Also included in this exhibit were two prescriptions for 30 Lorcet
(TID, a 10-day supply), with no refills, which were dated December 24,
2002, and January 3, 2003, as well as labels indicating that the
prescriptions were filled on December 31, 2002 and January 6, 2003. GX
16, at 7-8. Next to the signed prescription which is dated January 3,
2003, is the handwritten notation: "Script filled 1-6-2003, just one
(1) day after refilling script above!" Id. at 7. However, the
Government elicited no testimony from the DI explaining the basis for
this statement. Tr. 441-44. Here again, this does not constitute
substantial evidence of the allegation.
However, the evidence also shows that on June 6, 2007, Dr. CS
issued a prescription for 91 Lortab 7.5/500 to BW, with no refills,
with instructions to take a decreasing dose of the medicine at two-week
intervals and then stop. GX 30, at 1. The evidence further shows
[[Page 44074]]
that the prescription was dispensed on the date of issuance. Id.
Dr. CS testified that in 2006, she instituted a policy that her
staff was not authorized to call in refills because she had received
two phone calls from pharmacies that patients were "masquerading as
[her] office staff, trying to obtain * * * Lortab." Tr. 3031-32. Dr.
CS further testified that on June 6, 2007, BW had wanted to get off of
Lortab and that the prescription she wrote was to taper BW off of the
drug. Tr. 3050-52, 3056.
According to the evidence, another doctor had run a KASPER on BW
and upon noticing that she was getting Lortab refills, contacted Dr. CS
regarding the refills. GX 30, at 2. On November 9, 2007, Dr. CS's
Office Manager (LBB) then called Grider 1 and spoke with Leon
Grider regarding the refills and documented this conversation in BW's
medical record. Tr. 3040, 3054-55. According to the note:
He [Leon Grider] stated that the DEA has the original
prescription and he would contact them to fax it to us. He also
stated that Richard Potters filled the original prescription and it
showed 0 refills. He said someone from our office must have called
in refills. The last one filled was on 10/18/07. I informed him that
we do not call in controlled's-which is stated in our policy. We
also discussed that controlled's prescribed from our office are not
to be refilled earlier than one day.--lbb
GX 70.\15\ Dr. CS further testified that no one from her office had
called in refills for BW. Tr. 3055-56. Dr. CS subsequently filed a
complaint with the State Attorney General regarding the refills.\16\
Id. at 3056.
---------------------------------------------------------------------------
\15\ Dr. CS testified that GX 70 "are notes that I made from my
chart records concerning the patient who had brought complaints to
me about discrepancies or discrepancies that we found during their
visits, and also [a] note about one patient who actually had
unauthorized refills." Tr. 3040.
\16\ Respondent's star witness was James Faller, a federally
convicted swindler and money launderer, see GXs 79 (judgment of
conviction) & 80 (opinion of the Eleventh Circuit denying appeal),
who was allowed to sit in on the entire proceeding as a
representative of Respondents and then testify regarding the various
allegations. Faller asserted that Dr. CS "was in some kind of
trouble" and "was under some kind of investigation" because her
prescription pads had been stolen and that these were used to obtain
controlled substances which were used by employees of the call
center Faller ran. Tr. 5508. He then maintained that he had evidence
to contradict Dr. CS's testimony, stating "we have the records of
what actually took place, not only the state's records, and her
records and the pharmacy records. And they contradict that." Id. at
5509. As was typically the case throughout his testimony, Faller's
bark was stronger than his bite, as notwithstanding his statement,
Respondents produced no such records.
While Faller's felony conviction does not render him incompetent
to testify, there is ample reason to reject nearly all (if not all)
of his testimony as incredible. According to Faller, his legal
troubles which led to the federal convictions began back in 1993,
when he had "blown the whistle" on his boss, who was purportedly
stealing from various people to fund the PKK, a terrorist
organization, and that his boss was doing this "on behalf of the
United States Government." Id. at 5519. Faller claimed that
following this, threats were made on the lives of his attorneys;
that he was falsely incarcerated; that shortly before he was
indicted on the money laundering and fraud charges, an FBI agent had
"contacted my attorneys and I [sic] * * * and said [that] if I
wouldn't shut up and go away, if I wouldn't pay him money he would
destroy my life." Id. at 5521. According to Faller, following this,
the FBI "had [his] car stolen in Europe"; caused his daughter to
be "sexually assaulted," by tampering with a custody dispute he
had with his ex-wife, id. at 5523 & 5540; "threatened to rape and
murder my wife and cut the baby out of her stomach," id. at 5523;
then "were going to try to shoot" him; and tried to kill his
attorney and her husband by running them off the road. Id. at 5526-
27.
Faller also alleged that upon moving to Russell Springs in April
2001 to run a call center, he developed new legal troubles because
both the Police Chief and the Commonwealth Attorney "wanted me out
because we were knocking down * * * drug problems" by "start[ing]
mandatory drug testing for all the employees." Id. at 5011. Faller
then claimed that the Police Chief and Commonwealth Attorney had
interfered with his efforts to address Russell Spring's drug problem
because the Police Chief was "a part of it." Id. at 5569. As for
why the Commonwealth Attorney also "wanted [him] out," Faller
stated this was because he had "raised so much cane all across the
board" with the Commonwealth Attorney, id., even though he had only
recently moved to Russell Springs.
Faller further testified he had filed a lawsuit alleging public
corruption against the Police Chief, the State Police Detective who
investigated the Respondents, and other officials of Russell
Springs, and "got the grand jury fired up," but that the grand
jury "actually had convicted drug dealers on" it and that "[i]t
was incredible what they did to tamper with" it. Id. at 5570. He
then claimed that "there would have been indictments," but that
the State of Kentucky moved to stop them by bringing in a KBI
[Kentucky Bureau of Investigation] Agent (Agent Dudinsky), who had
assisted in executing the 2007 state search warrants at Respondents;
he also claimed that "[t]hey immediately removed the foreperson of
the grand jury" and replaced him/her with DB, who he alleged was a
drug dealer associated with the Police Chief. Faller asserted that
the Police Chief and the KBI agent "were using a cell phone to
eavesdrop on the grand jury," id. at 5574, and that he was going to
be held in contempt by the state judge, R. Cletus Maricle, who was
supervising the grand jury, because he found this out, but that the
FBI arrested Judge Maricle and charged the Judge with various crimes
of which he was eventually convicted. Id.
However, a report issued by the Grand Jury states that it
believed that the KBI Agent "ha[d] very efficiently carried out our
instructions in investigating the matter we have asked him to
investigate," that he had provided "able assistance," and that he
"ha[d] been unfairly vilified for simply doing his job." GX 85, at
2-3. The Grand Jury further stated that the original foreperson
"was excused due to illness." Id. Moreover, the Grand Jury report
was signed by its foreperson, whose name was not DB. Id. at 3.
Apparently the Grand Jury did not return any indictments as, in
Faller's words, "[i]t was another one of these whitewashing grand
juries." Tr. 5104. Faller further claimed that he had been asked by
the FBI and U.S. Attorney to prepare "an aid in sentencing Judge
Maricle, which [he] did," (which seems rather strange given his
past history with the FBI) and that he said "in the sentencing
memorandum" that Judge Maricle "was involved in the same exact
conduct in Russell County to protect Chief Irvin" as the conduct
which led to his conviction. Tr. 5577.
Faller asserted the existence of still other conspiratorial acts
on the part of various governmental entities. These included the
Kentucky Attorney General, who "somehow managed to get the
Department of Defense * * * to ask Express Scripts to cut off Grider
Drug and all insurance carriers," Tr. 5456; that during the 2007
search, KBI Agent Dudinsky had planted drugs in Leon Grider's
office, which Faller purportedly based on a videotape he viewed but
which was not presented at the hearing, id. at 5448-53; and then the
IRS, which had recently searched Faller's home (for reasons unclear
on the record), and which, following the search, "accidentally
turned over" files that Faller had been working on for the Griders
which Faller alleged had been stolen during a break-in of his home
"years ago." Id. at 5436-38.
It is further noted that much of Faller's testimony, which went
on for nearly three days, was plainly irrelevant, and even when he
testified regarding one of the Government's allegations, it was
typically clear that he lacked personal knowledge of the allegation.
See Tr. 5018 (Faller's testimony that he was first contacted by Leon
Grider in April 2006). The ALJ ultimately ignored nearly all (but
not all) of Faller's testimony, which was typically provided in a
rambling narrative even when questioned by Respondents' counsel
(notwithstanding the Government's objections and the ALJ's
instructions), and did not even address whether she found it
credible. It is perplexing that the ALJ did not exercise more
control over Faller's typically irrelevant and ludicrous testimony.
---------------------------------------------------------------------------
While the note recorded by Dr. CS's Office Manager is hearsay, I
conclude that it is sufficiently reliable to constitute substantial
evidence. Leon Grider's statements establish that he did in fact refill
Dr. CS's prescription and constitute an admission. While that statement
was made to Dr. CS's Office Manager, it was recorded in the patient's
medical record, a source of evidence which the Supreme Court has long
recognized as inherently reliable. See Richardson v. Perales, 402 U.S.
389 (1971). Moreover, Leon Grider did not testify and refute this
evidence. Thus, this allegation is proved without resort to the KASPER
data.\17\
---------------------------------------------------------------------------
\17\ In his affidavit, the supervisory DI also stated that a
review of the prescriptions (which was completed by November 1,
2004) issued at Grider Drug 2 and seized during the August
2004 search showed "sixteen (16) instances of refilling a schedule
III-V controlled substances [sic] prescription without authorization
in violation of 21 U.S.C. 829(b) and 21 CFR 1306.21 and 1306.22."
GX 9, at 16. These provisions require that any controlled substance,
which is a prescription drug, may only be dispensed pursuant to a
prescription and that "[s]uch prescriptions may not be filled or
refilled more than six months after the date thereof or be refilled
more than five times after the date of the prescription unless
renewed by the practitioner." See 21 U.S.C. 829(b).
Noting the above statement, Government Counsel then asked the
supervisory DI: "With regard to this particular paragraph, during
the course of your investigation did you come across a physician by
the name of Robert Shipp." Tr. 436. The DI answered "[y]es," and
then explained that "[i]n July of 2004, Dr. Shipp surrendered his
DEA registration to us as a result of an investigation that we
conducted of his medical clinic in Columbia, Kentucky, which is
about a 30 minute drive from Russell Springs." Id. at 437.
According to the DI, "[t]he case was well publicized" and that
"Dr. Shipp is very well known, or was very well known in the
area." Id. The DI then explained that in July 2008, he had obtained
a further KASPER report on the Respondents for the period of January
1, 2005 through July 7, 2008, and found that several prescriptions
had been dispensed by Grider 2 under the registration
number of Dr. Shipp after he had surrendered his registration. GX
18.
When the Government moved for the admission of the KASPER report
(GX 18), the Respondent objected to the admission of this exhibit
both because it was a KASPER report and on grounds of relevancy. Tr.
440. However, the ALJ admitted the exhibit. Even if this evidence
was relevant to prove the allegation (which does not appear to have
been made in either the Show Cause Order or the Government's various
pre-hearing statements), here again, the Government's proof of the
dispensings was based solely on an inadmissible KASPER report. The
allegation is therefore not supported by substantial evidence.
---------------------------------------------------------------------------
[[Page 44075]]
Allegation Three--Respondents Filled Prescriptions Bearing Invalid or
Expired DEA Numbers
Next, the Government alleged that Respondent filled numerous
prescriptions that bore invalid or expired DEA numbers. While the
Government submitted copies of various prescriptions which Respondent
filled, see GXs 23 & 26; it produced no evidence that any of the DEA
numbers on the prescriptions themselves were either expired or invalid.
Rather, the Government's proof was based on KASPER reports submitted by
Respondents which listed DEA numbers which differed from those on the
actual prescriptions. See id; see also GX 9; Tr. 316, 321. Here again,
the Government relied on inadmissible evidence to prove the violations.
Accordingly, the allegation is not supported by substantial evidence.
There is, however, evidence that Respondents violated DEA
regulations because, in some instances, the labels they affixed to
prescriptions contained the wrong physician's name. See GX 26, at 1-2;
7-8; 9-10.
Allegation Four--Grider 1 Refilled Prescriptions More Than Six
Months After the Date of the Original Prescription
In support of this allegation, the DI asserted that on four
occasions between January 2003 and August 2004, Grider filled schedule
III and IV controlled substance prescriptions that had been issued more
than six months earlier. GX 9, at 14. With respect to Grider
1, the Government's proof was limited to the bare assertion by
the DI that he had "reviewed prescriptions seized from Grider
1, and compared and contrasted these prescriptions with
prescription logs, transfer records, and KASPER reports." \18\ Id. No
further evidence was offered specifically identifying the
prescriptions, their date of issuance, and the date on which they were
refilled. Moreover, here again, it appears that this allegation was
based on KASPER data.
---------------------------------------------------------------------------
\18\ This statement was made in support of six different
allegations which the DI raised in his affidavit. See GX 9, at 14.
---------------------------------------------------------------------------
The Government did submit an exhibit which purports to show that
Grider Key Village engaged in the same practice. GX 24. Although this
allegation is properly considered given the common ownership of the
three pharmacies, the documentary evidence, which includes four
prescriptions and four labels for refills, does not support the
allegation as the dates of the refills are all well within six months
of the date of the original prescriptions. See id. And while the
exhibit contains various handwritten comments asserting that refills
occurred more than six months after the original prescription was
issued (two were allegedly refilled one day late), when asked by the
ALJ what was the source of the information as to the refill dates, the
DI testified that it came from the KASPER report. Tr. 308. Here again,
the Government's reliance on inadmissible KASPER data precludes a
finding that the allegation is supported by substantial evidence.
Allegations Five and Ten--Grider 1 and Grider 2
Engaged In the Unauthorized Transfer of Prescriptions and Refills To
and From Grider Key Village, as Well as To and From Each Other
In his affidavit, the supervisory DI stated that his review of
Grider 1's "prescription logs, transfer records, and KASPER
reports" showed that there were 289 "instances of unauthorized
transfer of controlled substances [sic] prescriptions and/or
prescription refills from Grider Drug-Key Village to Grider Drug
1," and 453 "instances of unauthorized transfer of
controlled substances [sic] prescriptions and/or prescription refills
from Grider Drug 2 to Grider Drug 1." GX 9, at 14.
The supervisory DI further testified that during the August 2004 search
of the pharmacies, one of his investigators relayed information to him
regarding the existence of logbooks listing prescriptions which were
transferred between the pharmacies. Tr. 695-96. The supervisory DI
testified that "[t]here were two logs," which were provided to DEA by
either Mr. Grider or another employee, and which bore on their cover,
the titles of either "Grider-Key Village transfers or Grider Drug
2 transfers." Id. at 696-97.
The DI further testified that the logs contained "the date and the
prescription that was being or had been courtesy filled." Id. at 697.
Explaining the term "courtesy fill," the DI gave the example of where
"the prescription was originally brought * * * to Grider 2,
but for some reason or other it was * * * actually filled at Grider
1, but the records and the distribution of that filling, when
you look at the KASPER and you get the actual prescriptions, is at
Grider Drug 2." Id. The DI subsequently testified that the
only information in the log was "the date and the prescription
number," and acknowledged that he determined that the prescriptions
had been filled at the other pharmacy by looking at KASPER data. Id. at
699. However, the DI then explained that pharmacy's employees had told
the Investigators that the log was used to list prescriptions that were
actually filled by other pharmacies. Id.
The DI then added that this was not permitted under the law because
while "you can transfer a prescription from one pharmacy to the other
* * * once you transfer that prescription, you can't transfer that
prescription back." Id. at 701. Continuing, the DI explained that this
"is a violation" of regulations requiring the pharmacy "to maintain
complete and accurate records of receipt and distribution" and that
this is "what causes the skewage" in "the audit figures" with one
pharmacy being short of a drug and the other pharmacy having an
overage.\19\ Id. at 701-02.
---------------------------------------------------------------------------
\19\ This allegation might well have been proved without
introducing KASPER data (given the testimony that pharmacy employees
had stated what the logs documented). However, the Government did
not introduce the logbooks into the record and thus there is a lack
of evidence to substantiate the number of instances in which the
prescriptions were transferred.
---------------------------------------------------------------------------
Allegation Six--KASPER Data Shows That Grider 1 Filled Nine
Schedule III--V Prescriptions for Which It Could Not Produce the Actual
Prescriptions
On its face, proof of this allegation requires KASPER data for
which the Government did not obtain the required court order.
Accordingly, the allegation is not supported by substantial evidence.
Allegation Seven--Grider 1 and Grider 2 Failed to
Take and Maintain a Biennial Inventory, as Required by 21 CFR
1304.11(c)
As evidence of this violation, the Government submitted the DI's
affidavit. GX 9. Therein, the DI stated that he "developed further
information
[[Page 44076]]
during the execution of the * * * search warrants [on August 19, 2004]
that each of the three Grider Drug locations failed to take and
complete a biennial inventory as required by 21 U.S.C. 827(a) and 21
CFR 1301.11(c)." \20\ Id. at 13.
---------------------------------------------------------------------------
\20\ The Show Cause Order had also alleged that Grider Drug--Key
Village did not take and maintain a biennial inventory. ALJ Ex. 1,
at 4.
---------------------------------------------------------------------------
However, less than a month after executing his affidavit, the DI
testified that he had done an audit of the three pharmacies' handling
of certain drugs. Tr. 606-13. Contradicting the statement in his
affidavit, the DI testified that in performing the audit, he had used
Grider 1's and Grider 2's biennial inventories of May
31, 2003 as the initial inventories, and that there was no biennial
inventory for Grider Drug--Key Village, "because it wasn't required
for them at that time." Tr. 609. Given the DI's testimony at the
hearing, this allegation is not supported by substantial evidence.
Allegation Eight--The Accountability Audits
The Government further alleged that it had performed an audit of 50
controlled substances for the period May 31, 2003 through August 19,
2004 and that the audit "revealed a shortage of 22,219 dosage units of
controlled substances" at Grider Drug 1 and "105,913 dosage
units of controlled substances" at Grider Drug 2. ALJ Ex. 1,
at 2-3. The evidence shows that this audit was done by a DI \21\ who
was a recent graduate of the Basic Diversion Investigators Course, and
who told her supervisor that she "did not have the experience" and
"really was unsure [of] what [she] would be doing." Tr. 2863.
According to the supervisory DI, the DI's audit was flawed because it
included both invoices for Respondents' purchases and some
distributions which occurred outside of the audit period. Id. at 607-
08.
---------------------------------------------------------------------------
\21\ To make clear, this DI did not take the closing
inventories; these were done by inspectors from Kentucky Drug
Control and Kentucky Board of Pharmacy. Tr. 608.
---------------------------------------------------------------------------
The Government did not, however, introduce this audit into
evidence. Rather, it relied on a separate audit of three drugs (Xanax,
alprazolam (the generic for Xanax), and methadone) which was done by
the supervisory DI. GX 11. According to the DI, this audit found
numerous shortages and overages, some of which would be significant if
the audit was accurate. See, e.g., id. (finding shortages of 5,842 and
5,225 dosage units of alprazolam .5mg and 1mg respectively at Grider
Drug 1 and 3,271 and 8,900 dosage units of same drugs at
Grider 2, and a shortage of 3,562 and 2,786 dosage units of
methadone 5 and 10mg respectively at Grider 2). However, in
doing his audit, the DI used KASPER information to determine the
distributions by each Respondent. Tr. 617-19. The DI did not verify the
totals provided by KASPER against the individual patient information he
had also obtained from KASPER. Id. at 619. Most significantly, in
determining the quantity of the drugs that Respondents distributed, the
DI did not use the pharmacies' dispensing records, even though they
were required to maintain these records under the CSA and DEA
regulations. See 21 U.S.C. 827(a)(3); 21 CFR 1304.22(c). Moreover, on
cross-examination, the DI acknowledged that he had "no idea how
accurate" the KASPER data was. Tr. 622.
Respondents put on extensive evidence challenging the DEA audits.
More specifically, the evidence shows that shortly after DEA executed
the August 19, 2004 search warrant, Respondents hired an entity
(McDonald Group) to conduct inventories at each store on August 28,
2004. Tr. 1987-88. Respondents also hired Stivers and Associates, an
accounting firm, to review the DEA audit results. Tr. 1980. David W.
Hicks, CPA, who has been Stiver's Auditing Director for the past twelve
years and has nearly twenty years of professional auditing experience,
RX 101, at 1-2, conducted what he termed a "consultation examination"
of Respondents. Id. at 3; Tr. 2009. According to Mr. Hicks, "[a]n
audit differs from our consultation examination in that our
consultation examination focuses directly in one specific area and
tests at 100% with available information, whereas an audit provides
only reasonable assurance and sample tests available information to
provide an opinion on the reliability of the information." RX 101, at
3; Tr. 2010.
In its report, Stivers detailed the procedures it used in
conducting its examination. Id. at 62. For the beginning or initial
inventory, Stivers used the same May 31, 2003 inventories taken by
Grider 1 and 2 as DEA did in doing its audits. To
determine Respondents' purchases of controlled substances, Stivers
received reports directly from Respondents' suppliers and compiled a
schedule for each store which tabulated the quantity purchased by drug
name and strength. Id. at 62. In obtaining this information, Stivers
also obtained credit memos for Respondents' returns of drugs to their
suppliers. Id. Stivers then added the purchases and subtracted the
returns to the initial inventory figures to determine the total amount
for which Respondents were accountable (Total Accountable For). Id.
To determine the amount of drugs Respondents could account for
(Total Accounted For), Stivers used the inventories conducted on August
28, 2004 by the McDonald Group. Id. at 63. With respect to outdated/
expired drugs, Stivers explained that they were set aside in a separate
bin apart from the pharmacies' stock until they could be disposed of,
and that on September 2, 2006, Stivers inventoried the drugs that had
expired prior to August 28, 2004, when the McDonald Group performed its
inventory. Id. Mr. Hicks maintained that these drugs "would have been
removed from [the] current inventory prior to the McDonald Group's
inventory" and were thus not included in the August 28, 2004 counts.
Id. Stivers counted a total of 2,414 dosage units of expired drugs. Tr.
2043.
As for Respondents' dispensings, Stivers tabulated the quantities
for each drug "for each location from the PC V computer software
system Narcotic and Controlled Substance Drug Sales Report," obtaining
monthly reports for the audit period for each of the fifty drugs that
were initially audited by DEA. RX 101, at 63. Stivers totaled the
monthly quantities for each drug to determine the total number of
dosage units sold during the audit period. Id. Stivers then added the
August 28, 2004 inventories, the outdated drugs, and Respondents' sales
to determine the "Total Accounted For" for each drug. Id.
While Stivers' results demonstrate that both DEA audits were flawed
(largely because the DIs used KASPER data to determine the amounts of
the dispensings), they provide little comfort to Respondent because
they point to massive accountability problems at each of the
pharmacies. For example, at Grider 1, Stivers found that the
pharmacy had the following shortages (by number of dosage units): (1)
Alprazolam, 2,316; (2) Ambien, 170; (3) diazepam, 6,372; (4) Duragesic,
462; (5) Endocet, 214; (6) hydrocodone, 28,097; (7) lorazepam, 2,191;
(8) Lorcet, 500; (9) Lortab, 375; (10) Valium, 40; and (11) Vicodin,
200. Id. at 14. Stivers also found that Grider 1 had overages
in the following drugs: (1) Clonazepam, 7,568; (2) methadone, 3,025;
(3) oxycodone, 1,335; (4) OxyContin, 262; (5) phentermine, 1,751; and
(6) Stagesic, 514. Id.
At Grider 2, Stivers found that the pharmacy had the
following shortages: (1) Ambien, 428; (2) Duragesic, 290; (3)
hydrocodone, 8,135; (4) lorazepam, 1,253; (5) methadone, 3,207; (6)
oxycodone, 1,240; (7) OxyContin,
[[Page 44077]]
17,875; (8) phentermine, 3,203; and (9) Stagesic, 2,013. Id. In
addition, Stivers found that Grider 2 had the following
overages: (1) Clonazepam, 3,979; (2) diazepam, 2,787; (3) Endocet, 425;
(4) Lorcet, 619; (5) Lortab, 342; (6) Valium, 662; and (7) Vicodin,
109. Id.
Moreover, even after Stivers took the figures for all three
pharmacies (including Grider Key Village) to determine the combined
shortages and overages, there were still substantial shortages and
overages of various drugs (all figures in d.u.). The combined shortages
included: (1) Alprazolam, 1,496; (2) diazepam, 7,329; (3) Duragesic,
605; (4) hydrocodone, 35,418; (5) lorazepam, 4,928; (6) OxyContin,
16,998; (7) phentermine, 2,791; and (8) Stagesic, 717. Id. The combined
overages included: (1) Clonazepam, 31,951; (2) Endocet, 871; (3)
Lorcet, 1,051; (4) Lortab, 889; (5) methadone, 15,747; (6) oxycodone,
900; and (7) Valium, 872. Id.
Regarding the results of his examination, Mr. Hicks testified that
when all the drugs for the three stores were added up, Respondents only
failed to account for an overage of 644 pills. Id.; Tr. 2035. He then
asserted that this result is "so minute, it's just totally
immaterial." Tr. 2035.
This conclusion is properly characterized as "fuzzy math," as
contrary to Mr. Hicks' understanding, the various controlled substances
which a DEA registrant handles are not fungible. Rather, pursuant to
the CSA and DEA regulations, a registrant which dispenses is required
to maintain "a complete and accurate record of each such substance * *
* received, sold, delivered, or otherwise disposed of by" it. 21
U.S.C. 827(a)(3) (emphasis added); 21 CFR 1304.21(a). This means that
each drug (including a generic (alprazolam) v. a legend drug (Xanax)),
must be separately accounted for. Moreover, "[s]eparate records shall
be maintained by a registrant for each registered location." 21 CFR
1304.21(a). As Mr. Hicks' examination demonstrated, both Grider
1 and Grider 2 had numerous material shortages and
overages of the controlled substances they handled.\22\
---------------------------------------------------------------------------
\22\ For reasons explained in my discussion of the public
interest factors, I reject Respondents' exception that the Stivers'
audit was not accurate and reliable as to the overages and
shortages. While I conclude that the DEA audits were inaccurate, I
am not required to ignore other reliable evidence in the record.
---------------------------------------------------------------------------
Allegation Nine--Grider Drug 1 Filled Four Controlled
Substance Prescriptions Which Listed Grider Drug 2 as the
Issuing Physician and Grider Drug 2 Listed Itself as Issuing
Physician On Several Schedule II Controlled Substance Prescriptions
In support of this allegation, the Government offered the testimony
and affidavit of the supervisory DI. See GX 9, at 3-11. The Government
did not enter into evidence any of the prescriptions which the DI
asserted listed Respondents as the prescribing physician, and the DI's
affidavit makes clear that the evidentiary basis for this allegation is
the data contained in KASPER reports the DI obtained on Respondents.
See id. Because the Government produced no evidence other than the
inadmissible KASPER data to prove the allegation, it is not supported
by substantial evidence.
Allegation Eleven--Respondent[s] Filled Prescriptions Issued by a
Tennessee Mid-Level Practitioner in Violation of Kentucky Law
In support of this allegation (which was raised in the Government's
pre-hearing statement), the supervisory DI stated in his affidavit that
the Louisville District Office "Diversion Unit completed a * * *
review of prescriptions seized on August 18, 2004 from Grider Drug
2," and that "the review of these prescriptions revealed * *
* [t]welve (12) instances of filling prescriptions issued by a Mid-
Level Practitioner licensed in Tennessee, who is not authorized to
prescribe controlled substances in Kentucky in violation of 21 U.S.C.
829(b) and 21 U.S.C. 842(a)(1) and [KRS Sec. ] 314.011(8) and [Sec. ]
314.042." GX 9, at 16. Yet, when asked at the hearing to "elaborate
further" on this assertion, the supervisory DI testified that "[i]n
conducting my review of the KASPER reports and of course running the
DEA numbers through our system and trying to identify the prescribers,
I came upon the fact that--I identified 12 prescriptions that were
being filled for a nurse practitioner out of Tennessee." Tr. 200-01;
see also GX 9, at 7-11 (listing KASPER data for Grider 2
including prescriptions issued by a "TN MLP"). The DI then explained
that at the time the prescriptions were filled, nurse practitioners
were not authorized to prescribe drugs in Kentucky and thus the
pharmacy should not have filled the prescriptions. Tr. 201.
The Government offered no further evidence establishing the
identity of the prescriber and his/her licensing status. Nor,
notwithstanding the DI's statement in his affidavit that he had
reviewed the prescriptions, did the Government introduce into evidence
the prescriptions, the pharmacy's dispensing log, or copies of the
labels for the dispensed prescriptions. Indeed, given the DI's
testimony at the hearing, it is unclear whether the DI based this
allegation on anything other than the KASPER data. I therefore conclude
that this allegation is not supported by substantial evidence.
Allegation Twelve--Respondents Failed to Report All Thefts of
Controlled Substances to DEA
The Government put forward evidence that numerous break-ins and
thefts had occurred at the Respondents and that several of them were
not reported to DEA as required by federal regulations. According to
the supervisory DI, he received information from Narcotics Detective
with the Kentucky State Police (Scott Hammond) and the Police Chief of
Russell Springs (Joe Michael Irvin), who alleged that Leon Grider was
trading controlled substances for sex and "hiding * * * the
distribution[s] by reporting theft and losses for the pharmacy." Tr.
160. In addition to the theft and loss reports which he obtained from
the Police Chief and the State Pharmacy Board, the DI also obtained
from the Russell Springs Police Department a chronology of the various
break-ins which had occurred at Respondents.\23\ Id. at 162-63; see
also GX 32.
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\23\ It does not appear that the Government provided adequate
notice of its intent to litigate this allegation in either the Show
Cause Order or the Pre-Hearing Statements. However, Respondents did
not object that the allegation was beyond the scope of the
proceeding and that they were denied adequate notice of it.
Moreover, Respondent fully litigated the issue. As judicial
decisions make clear, even where the Government fails to provide
notice of an allegation in the Show Cause Order or Pre-Hearing
Statements, the parties, in the absence of objection, can be deemed
to have litigated the allegation by consent where the parties fully
litigate the issue. See Citizens State Bank v. FDIC, 751 F.2d 209,
213 (8th Cir. 1984) (citing Kuhn v. Civil Aeronautics Bd., 183 F.2d
839, 841-42 (D.C. Cir. 1950)); Yellow Freight System, Inc., v.
Martin, 954 F.2d 353, 358 (6th Cir. 1992).
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The Government introduced into evidence an exhibit which contains
sixteen police reports \24\ documenting the various incidents; also
included in this exhibit were a number of DEA Form 106s, a form which a
registrant is required to submit to report the theft of controlled
substances. See 21 CFR
[[Page 44078]]
1301.76. However, there was not an accompanying DEA Form 106 for each
incident for which the police filed a report and the DI testified that
on comparing the theft and loss reports which DEA had received from
Respondents with the police reports, he determined that Respondents had
not filed reports with DEA for some of the incidents. Tr. 169. More
specifically, there were four instances in which a theft of controlled
substances occurred at one of the Respondent's locations which was not
also reported to DEA. See GX 33, at Tab E (Feb. 22, 2002 theft from
Grider 2); id. at Tab L (Oct. 28, 2003 theft from Grider
1); id. at Tab M (November 2, 2003 theft from Grider
2); id. at Tab N (November 3, 2003 theft from Grider
2).\25\
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\24\ While the cover of GX 33--Tab E states that it includes a
report for a February 22, 2002 break-in at Grider Drug 2,
the tab actually includes reports for both this break-in and a
second incident, which occurred later that morning at Grider
1; however, the report for Grider 1 stated that
while the store's window had been broken with a large rock, no entry
was made. GX 33, Tab E, at 5.
\25\ Not proved by credible evidence was Respondents' far-
fetched contentions that: (1) The Russell Springs Police Chief was
actually behind the break-ins because he sold alarm systems on the
side and Leon Grider refused to buy one from him, and/or (2) that
the Russell Springs Police Chief was behind the break-ins because he
was dealing the drugs that were stolen.
With respect to the latter contention, James Faller testified
that he had been called by one Bobby Bunch, who "said that he had
burglarized Grider drugs" and that when he was caught by the
police, he had "a whole lot more [pills] than what were turned into
evidence," Tr. 5086, and that Bunch " had agreed to testify about
what had happened to him," but was murdered and no one has been
charged with the crime because "[i]t was another one of these
whitewashing grand juries." Id. at 5103. No further evidence was
offered to corroborate Faller's testimony regarding Bunch's
purported statements regarding the disposition of the drugs the
police seized from him, or even that Bunch had, in fact, been
murdered.
Another of Faller's incoherent tales was that Leon Grider had
received a call from a prisoner Brian Lawless (which Grider
purportedly had on tape, but which was not produced at the hearing),
who, according to Faller, had written a letter to the Commonwealth
Attorney stating "that Leon had left money for him that was paying
him to break into these stores," and that this letter was used to
get Leon Grider indicted. Tr. 5085-86. According to Faller, Lawless
had stated that he wrote the letter because the Chief "told [him]
he was going to kill [his] little brother if I didn't write them."
Id. While Respondents introduced a transcript of a sworn statement
given by Kevin Lawless, Brian's brother, which Faller obtained in
his pursuit of his public corruption claims, the only persons
present were Mr. Lawless, Faller, and Grider. RX 13. Moreover,
nothing in Kevin Lawless's statement corroborates Faller's
contention that Brian Lawless made up his story. Id. Contrary to
Faller's assertion that Brian Lawless's letter was used to procure
Leon Grider's indictment, the record seems clear enough that the
only indictments brought against Leon Grider were based on his
having unlawfully trafficked in controlled substances to LW and PG
and not on conduct related to the break-ins. GXs 44, 45.
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Allegation Thirteen--Respondents' Owner, Leon Grider, Unlawfully
Distributed Controlled Substances
In the initial Order to Show Cause, the Government alleged that in
August 2005, Leon Grider had been indicted in both the Russell County
and Adair County Circuit Courts on state felony charges of trafficking
in controlled substances. ALJ Ex. 1, at 4. The Show Cause Order further
alleged that Leon Grider had also been indicted in Russell County on
charges of bribing a witness. Id. In its initial pre-hearing statement,
the Government provided further notice that it intended to elicit
testimony from Scott Hammond, a narcotics detective with the Kentucky
State Police, regarding "illicit distributions of controlled
substances from" the Respondent and various "undercover operations."
Gov. Pre-Hearing Statement, at 7.
As part of its case-in-chief, the Government called Detective
Hammond who testified regarding the decision to initiate undercover
operations and the undertaking of the operations in the investigation
of Respondents. The ALJ found Detective Hammond's testimony
credible.\26\ ALJ 56 at nn.22 & 23. In addition, as part of its
rebuttal case, the Government called LW, who had acted as a
confidential informant and who obtained controlled substances from Leon
Grider on various occasions without a prescription. Notwithstanding the
determined efforts of Respondents' counsel to destroy the credibility
of the Detective and LW, the ALJ found their testimony credible as do
I. ALJ at 56 n.52.
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\26\ The Detective acknowledged that his mother had formerly
worked as a cashier at Grider 2, and that she was either
fired or quit on her own after the August 2004 DEA search in which
the Detective assisted. Tr. 1389, 1540, 1617-18. In addition, the
Detective testified that his wife's sister was married to Greg
Grider, Leon Grider's oldest son. Tr. 1388.
In an attempt to impeach Detective Hammond's credibility, Mr.
Faller asserted that Hammond had threatened to have LW's children
murdered, that he had gotten her thrown out of her apartment, that
PG (LW's former boyfriend) had told him that he had things he wanted
to share but "was afraid for his life," and that Hammond had
"start[ed] harassing me [Faller] and running witnesses off the
road." Tr. 5098.
LW testified, however, that Detective Hammond had never
threatened her. Tr. 5935. Moreover, while LW testified that
Detective Hammond had moved her to a safe house, he had done so at
her request. Id. at 6131.
Respondents introduced into evidence a transcription of an
unsworn interview Faller conducted of PG, during which Faller made
numerous suggestive statements to PG regarding the conduct of
Hammond and Irvin. See RX 25, at 22 (p. 51,"my guess is, what
happened is, they created a crime against you, too. That's my
belief."); id. ("I think they've threatened you ruthlessly. I
think they're telling you you're going to come up with the testimony
they want you to come up with. I think that they've . . . used the
kids and the threat of the kids and everything else to try to force
you to go along with this stuff. * * * And I think, quite frankly,
you're scared to death. * * * In fact, the * * * scared to death
part I'm sure of it, because I can see it. This isn't a guess * * *
you know, it's nothing against you. It's clear to me you're scared
to death."). Subsequently, PG related a conversation during which
Hammond and Irvin were attempting to recruit him and LW to work as
informants PG said:
Leon's got enough money. If we done something like this to him,
it wouldn't be no problem for him to have us took care of. And the
statement was made to me not to worry about Leon, that we'd be more
or less--I think their words were, they could help us or they could
hurt us, make our life easier or make our life hell, and, more or
less to watch what's I'm doing. And their exact words were, that
they could take us out and nobody would ever find us was their exact
words.
RX 25, at 32. Faller then asked, "In other words, they'd kill
you," to which PG said, "uh-huh." Id. Faller then asked: That's
the way you took it?" Id. PG replied: "That was their exact words,
without saying, I'm going to kill you, but just, I'll take you out
and nobody will ever find you. You don't have to worry about Leon."
Id. Another participant in the interview then asked PG: "They
didn't use the words, I'll kill you, though?" Id. PG responded:
"No. They said you don't have to worry about Leon killing you. We
can take you out, nobody will ever find you. And he would, too."
Id. Later, PG asserted that "they did threaten us with Federal
charges and to hurt the kids." Id.
Putting aside the ambiguity of PG's statement as to whether his
life was threatened by either Hammond or Irvin, because both
Detective Hammond and LW were placed under oath and were subject to
cross-examination and the ALJ found them to be credible, I reject
the unsworn hearsay statement of PG as inherently unreliable.
It is further noted that Respondents did not take exception to
the ALJ's finding that Detective Hammond's testimony was credible.
See generally Respondents Exceptions.
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According to the Detective, sometime in May or June 2003, SD, a
female in her early to mid-twenties,\27\ was arrested by the Russell
Springs Police Department on a DUI charge; at the time of the arrest,
PC was her passenger.\28\ Tr. 1404. A day or so after their arrests,
the Detective interviewed them and asked them where they got their
drugs. Id. at 1404-5. While they were initially "uncooperative," they
told the Detective that they were getting drugs from Leon Grider
without a prescription. Id. SD agreed to cooperate and told the
Detective she would see Leon Grider after the pharmacy's closing, knock
on the door, go in if the door was open, ask him for controlled
substances, and that most of the time he gave them to her. Id. at 1406.
When asked what she provided in return, SD denied paying for the drugs
or providing stolen property to Leon Grider. Id. at 1407. However, when
then asked if she had sex with him, SD would neither confirm nor deny
doing so. Id. SD also admitted that she was addicted to drugs and had
previously been arrested for possession of some unidentified drug. Id.
at 1408.
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\27\ The Detective described SD as having blond hair, brown
eyes, and being "probably five-four or five-five," and "115 or
120 pounds." Tr. 1407.
\28\ According to the Detective, he had first received
information about SD and PC from an Investigator with the State
Pharmacy Board and had discussed them with Chief Irvin of the
Russell Springs Police Department. Tr. 1403.
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SD agreed to attempt a controlled drug buy which both the Detective
and
[[Page 44079]]
the Police Chief (Joe Michael Irvin) observed; however, upon SD's going
to Grider 1, the door was locked and she was unable to get in.
Id. at 1409-10. After debriefing SD, who said that Grider would answer
the door, the Detective went to SD's apartment complex to do
surveillance (which was "right down the road" from Grider 1)
and the Police Chief watched the back of Grider 1. Id. at
1410. Shortly after he arrived at SD's apartment complex, the Detective
was called by the Chief and told that Grider had left the store and was
carrying something. Id. The Detective returned to Grider 1,
picked up the Chief, and the two observed Leon Grider go to his house,
stay a few minutes and then leave. Id. at 1411-12. The Detective and
Chief then watched Grider drive to a "community called Salem," where
he met up with a red Jeep that was behind a church. Id. at 1412. A
woman got out of the Jeep and entered Grider's car. Id. at 1415. After
fifteen minutes, Grider and the Jeep departed; the Detective and Chief
followed the Jeep to a "community called Eli" and obtained its
license plate number, which was traced to a female, PL. Id. at 1412.
Either the next day or the day after, the Detective and the Chief
went to PL's residence and asked to speak with her. Id. at 1413. PL did
not want to do so at her residence, but agreed to meet the officers at
the Russell Springs Police Department, where she was interviewed. Id.
During her interview, PL admitted that Leon Grider had brought her
both Xanax and hydrocodone, for which she did not have a prescription.
Id. at 1414-15. When asked what she was doing in Grider's car, PL
admitted to "just messing around," but when asked to define what she
meant, she stated "let's just leave it at that. We were just messing
around." Id. at 1415. While PL said that she also received methadone
prescriptions from a physician, id.at 1418-19, she further stated that
she had gotten controlled substances from Leon Grider both with and
without a prescription, id. at 1416, and that when she had a
prescription, she would ask for some extra. Id. at 1418.
PL agreed to act as a cooperating witness, and was approved by the
Detective's supervisors; her background check did not reveal any
felonies. Id. at 1416. On October 21, 2003, PL obtained a methadone
prescription and met with the Detective on the outskirts of town, where
she was searched, interviewed, had a transmitting/recording device
placed on her, and was driven to Grider 1. Id. at 1419-20. PL
entered the pharmacy, spoke with Leon Grider, and asked him to come out
from behind the counter and into an aisle, where she gave him her
methadone prescription and said that she "need[ed] some Zs," street
slang for Xanax. Id. at 1420-21.
Leon Grider did not say anything and went back behind the counter
and filled PL's methadone prescription. Id. at 1420. PL left the
pharmacy and had a smoke, while standing around its back entrance. Id.
PL then re-entered the pharmacy and came back out with a white bag; PL
was then picked up by the Detective, and after being searched, gave him
the bag. Id. at 1420-21. Upon opening the bag, the Detective found a
pill bottle containing methadone, as well as "thirty orange, oval-
shaped pills that were loose in the bottom of the bag." Id. at 1421.
The Detective gave PL the methadone and placed the other pills in
evidence bags, which he turned in to the Kentucky State Police; the
orange pills were subsequently tested by the lab and determined to be
Xanax. Id. at 1421-22. PL was debriefed and confirmed what the
Detective heard through the transmitter; she was then allowed to leave.
Id. Detective Hammond further testified that PL did not have a
prescription for the Xanax. Id. at 1422. PL was used to obtain drugs
only this one time. Id.
In either late November or early December 2003, the Detective
received a phone call from SD, who stated that she had been at "the
Manor," a Government housing project in Russell Springs and had seen
Leon Grider there. Id. at 1423. SD also stated that LW was receiving
hydrocodone from Leon Grider. Id.
Upon receiving this information, the Detective interviewed LW, who
initially denied that she received controlled substances from Leon
Grider. Id. at 1424. However, LW then admitted "that she was getting
controlled substances from" Grider. Id. During the interview, LW
admitted that she had obtained hydrocodone, Xanax, and alprazolam from
Leon Grider, both with and without a prescription; she also told the
Detective that she believed she could get more drugs from him without a
prescription. Id. LW, who was then in her early twenties,\29\ denied
trading either money or sex for the drugs. Id. at 1426.
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\29\ The Detective described LW as being "five-two, blond hair,
blue eyes, [and] 115 pounds the last time I saw her." Tr. 1426.
---------------------------------------------------------------------------
While during the interview, LW agreed to perform undercover
transactions for the Detective, sometime in December 2003, she then
told Leon Grider about her having been contacted by the Detective, that
the police knew what was going on, and that she was "scared to
death." Id. at 1427, 1435. Grider told her she "needed to leave the
county for a little while just to let them cool off of" her.\30\ Id.
at 6019. LW then left town and would not "answer her cell phone." Id.
at 1426. However, eventually, the Detective regained contact with LW,
who told him that she had gone to Leon Grider and told Grider that the
state police knew what was going on. Id. at 1427, 1435. LW told the
Detective that Grider "gave her some money" and "an undetermined
amount of hydrocodone and told her to leave." Id. at 1435. LW told the
Detective that she had gone to Bowling Green and Somerset, Kentucky
with PG, her boyfriend. Id.
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\30\ According to LW, Leon Grider never told her not to become a
CI. Tr. 6020.
---------------------------------------------------------------------------
The Detective developed additional information showing that on six
occasions beginning on December 19, 2003 and ending on January 14,
2004, Leon Grider wired a total of $2800 to PG through Western Union
offices in Bowling Green and Somerset, Kentucky. See GX 46; Tr. 1490.
In a second interview he conducted with LW in January 2004, she stated
that Leon Grider "told her to leave town and stay from us." Id. at
1489.
On some date not specified in the record, LW agreed again to work
as a cooperating witness and was signed up to do so.\31\ Tr. 1495. LW
contacted Leon Grider and said she needed to see him; Grider told her
to come to Grider 1 before it opened on February 24, 2004. Id.
Before LW went to the store, she was searched, a recorder was placed on
her, and she was given instructions. Id. The Detective followed LW and
PG to the store; upon their arrival, LW, accompanied by PG, went inside
and told Leon Grider that they were going to court and were "short on
their pills" and were concerned that they would be subjected to a pill
count.\32\ Id. at 1495-96. Grider gave them 40 hydrocodone tablets and
40 alprazolam tablets in two pill bottles, which LW brought to the
Detective. Id. at 1496. LW did not have a prescription for the drugs.
Id. at 1497.
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\31\ At one point, LW testified that she was in Bowling Green
for six months. Tr. 6066-67. However, other evidence suggests that
she was in Bowling Green for a considerably shorter period of time.
Tr. 1496; GX 46.
\32\ According to the Detective, PG accompanied LW on the
undercover transaction. Tr. 1498-99.
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On June 4, 2004, LW performed undercover transactions in both the
morning and either the afternoon or evening. Id. at 1499; 1513-14. In
the morning, the Detective drove LW, who was wearing a recorder, to
Grider 1. Tr. 1515. LW went into the store and obtained Lortab
and alprazolam, which
[[Page 44080]]
Leon Grider placed loose in a brown bag; she then got back in the
Detective's car and they left the scene. Id.; see also id. at 6033
(testimony of LW that "I just went in and asked him [Leon] for some
pills, and he gave them to me."); id. (testimony of LW that she
received Lortab and Xanax at first transaction); GX 48. Notably, the
pills were not placed in a prescription bottle. Tr. 6033.
As for the second set of transactions, LW and PG lived together in
a trailer in Adair County, the county next to Russell County. Id. at
1500. LW called Leon Grider and asked him to bring some methadone to
her. Id. During a phone call, Leon Grider explained that he needed to
go to Grider 2; in a subsequent phone call, Grider told LW
that he would bring some methadone to her at her residence. Id. Another
officer followed Leon Grider to within a short distance of LW's
residence, with the detective being "just around the corner" from
LW's residence. Id.
Upon his arrival, Leon Grider gave LW 60 alprazolam in an envelope
and 100 dosage units of methadone, which were in a sealed
"distributor's bottle." Id. at 1501. After Grider left, the Detective
entered the residence and obtained the controlled substances. Id. LW
did not have a prescription for either drug. Id.
On April 24, 2005, a further undercover transaction occurred. On
some date not clear on the record, LW and PG contacted the Detective
and indicated that they could still obtain controlled substances from
Leon Grider. Tr. 1507. The Detective (along with the Police Chief) met
with LW and PG, who offered to call Leon Grider and seek more drugs
from him; LW and PG stated that they believed that he would give them
Duragesic (fentanyl) patches. Id.
On the date of the transaction, LW and PG were searched and
recorders were placed on them. Id. At 3:49 p.m., LW called Leon Grider
and left a voicemail message in which she asked to meet with him; a
short while later, Leon Grider returned the call. GX 27. Because Leon
was going to see his mother, he agreed to meet LW (and PG) at a church
graveyard on the Adair and Russell County line; the Detective and Chief
observed Leon Grider arrive at the graveyard and watched the
transaction from the back side of the graveyard. Id. at 1507-08.
The Detective used a scanner to listen to the conversation between
Leon Grider, LW, and PG, during which LW asked if she could get
Duragesic patches from Leon Grider. Id. at 1508; GX 27. Leon Grider
explained what strength the patches were and that he had to go back to
town to get the patches, after which he would meet LW and PG at
Houchens Supermarket in Key Village. GX 27, at 3-4. However, while
driving back to town, Leon Grider observed the Detective and Police
Chief and called LW and PG to tell them that they were being watched;
however, he still told LW and PG to go to Houchens but that he was
going stay at Grider 1 for fifteen to twenty minutes. Id. at
4. LW passed this information on to the Detective. Id. Grider then told
LW and PG to go to the parking lot of Houchens. Id.
Leon Grider returned to Grider 1. Id. In the meantime, the
Detective also told LW to call Leon and tell him that he and the Chief
were no longer around; LW did so. Id. The Detective and Chief switched
vehicles, drove to Key Village, and parked across the parking lot from
Houchens. Id.
Upon arriving, Leon Grider entered the store and PG went in and met
him. Id. at 1508-09. Following a conversation, Leon Grider gave PG
twenty Duragesic patches and 88 alprazolam; PG did not have a
prescription for either drug Id. at 1509; GX 27. After PG left the
store, he (and LW) met the Detective and Chief who searched them and
their car; the Detective also took possession of twenty Duragesic
patches and 88 Xanax pills.\33\ GX 27, at 2, 4. The CIs did not have
prescriptions for the drugs. Id. at 2.
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\33\ It is acknowledged that there is a conflict in the evidence
as to the number of patches. I conclude that the conflict is not
material to the resolution of this matter.
---------------------------------------------------------------------------
LW testified that while she initially had legitimate prescriptions
for both Lortab and Xanax, she had heard from acquaintances that Leon
Grider would provide extra pills and that she noticed that she would
get extra pills in her prescriptions Tr. 5911, 5915. Eventually, LW
started asking Leon Grider "if there was any way possible" he could
"double" her prescriptions; Grider did so. Id. at 5916-17. LW
testified that about a year to a year and a half later, she started
getting 500-1000 Lortab 10mg a week in commercial-size containers,\34\
and that this continued for a period of "about two years." Id. at
5917, 5925. LW took 50 to 60 pills a day and also sold some of them.
Id. at 5918. According to LW, Leon Grider expressed his attraction to
her and asked if he could stay at her house; however, LW denied
engaging in sexual activities with him. Id. at 5920. LW also stated
that Leon Grider had given her his cell phone number so that she could
reach him without calling the store. Id. at 5921.
---------------------------------------------------------------------------
\34\ LW also testified that her physician eventually stopped
prescribing to her. Tr. 5928.
---------------------------------------------------------------------------
Leon Grider also told LW that some of the commercial bottles that
were labeled for hydrocodone actually had pinto beans in them and were
marked with either a red line or a red X. Id. According to LW, Leon
Grider did this in the event he was robbed. Id. at 5921-22. LW
testified that Leon Grider never gave her a hydrocodone bottle which
actually contained pinto beans rather than hydrocodone. Id. at 5922,
6039. LW also testified that Leon Grider had told her "not to come in
the store when [his wife, Anna Mae] was around" and that Leon Grider
would leave drugs for her outside of the store in the gutter of Grider
1.\35\ Id. at 5923, 5926-27.
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\35\ According to LW, the gutter was at her "head-level," and
standing "flat-footed," she could reach into it with her hand. Tr.
6042.
---------------------------------------------------------------------------
LW testified that sometime probably in 2004,\36\ she asked Leon
Grider for some pills and Grider told her to meet him at Grider Key
Village. Id. at 5930-31. LW parked in front of the store, knocked on
the door and was let in by Leon. Id. at 5931. Grider gave LW a bottle
with 500 pills; however, before LW could leave, Anna Mae Grider pulled
up in the front and entered the store. Leon told LW to leave out the
back, but the rear door was locked; LW sat in a storage room but Anna
Mae came to the room, found LW, and took the pills from her. Id. at
5931-32. LW then left the store. Id. at 5932.
---------------------------------------------------------------------------
\36\ However, LW later testified that this incident occurred
before she agreed to work as a confidential informant. Tr. 6037.
---------------------------------------------------------------------------
The next day, LW called Leon and told him that she was "starting
to detox really bad" and asked "if there was any way possible [she]
could get that bottle back." Id. Leon told LW to meet him later, and
upon meeting at Grider 1, gave her two 500-count bottles. Id.
at 5932-33.
Anna Mae Grider also testified regarding this incident. At the
hearing, Mrs. Grider asserted that the bottle contained pinto beans,
Tr. 4802, and that Leon had given it to LW, who "was in there begging
for pills," id. at 4803, "[p]robably to get her off his neck." Id.
at 4804. However, in a deposition she had previously given in a civil
action, Mrs. Grider testified that the bottle contained hydrocodone,
that the bottle was a white bottle and not a prescription vial, and
that she did not give the bottle back to LW. GX 68, at 212-15. Given
the inconsistency between Mrs. Grider's testimony at the hearing and at
her earlier deposition as to the contents of the bottle, I find that
her deposition testimony is more credible than her testimony at the
hearing. I further find that Mrs. Grider's deposition testimony
corroborates LW's
[[Page 44081]]
testimony regarding the Key Village incident.
LW further testified that neither Detective Hammond nor Chief Irvin
threatened her or threatened to take her children away from her. Tr.
5935. She also testified that neither Detective Hammond nor Chief Irvin
had ever engaged in inappropriate conduct towards her. Id. at 5953. She
further testified that neither Detective Hammond nor Chief Irvin
threatened PG. Id. at 5936.
LW also acknowledged that she had become addicted to drugs and that
she was paid $150 to $300 for each undercover transaction. Id. at 6046.
In addition, LW "guessed" that her addiction had caused "a little
bit of damage" to her brain and had caused, in the words of
Respondent's counsel, "little problems with [her] recall sometimes."
Id. at 6099-6100. She further noted that it had been six or seven years
since the events to which she testified. Id. However, LW later
testified that her past drug use had no effect on her recollection of
her interactions with Leon Grider. Id. at 6124. As noted above, the ALJ
generally found LW's testimony credible as do I.\37\ See also ALJ at
84-85.
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\37\ Respondents took exception to the ALJ's finding that LW was
credible, noting her testimony as to her drug addiction and its
effect on her memory, her having admitted to selling controlled
substances, as well as the incentives she had to lie about her work
(such as the money she was paid for her work as a confidential
informant and that she was still at risk for criminal prosecution
because under Kentucky law, there is no statute of limitations for
felonies). Resp. Exceptions at 11-12.
However, LW's testimony was corroborated in large part by
Detective Hammond and her testimony was internally consistent.
Moreover, having personally observed LW's testimony, the ALJ's
finding is entitled to deference. See Universal Camera Corp. v.
NLRB, 340 U.S. 474, 496 (1951).
---------------------------------------------------------------------------
Regarding her decision to leave Russell County upon being
approached by Detective Hammond and Chief Irvin, LW testified that Leon
Grider gave her $1000 and three 500-count bottles of hydrocodone and
told her that she "needed to leave town" and "to let them slack off
of me for a while." Id. at 5939; see also id. at 5941-42. She also
testified that when she and PG were staying in Bowling Green, Leon
wired the money in PG's name because "it would look better." Id. at
5942-43.
LW testified that in 2004, she had asked for and received a bottle
of 100 methadone from Leon Grider without having a prescription. Id. at
5939-40. LW also testified that after she had stopped talking to Leon
Grider "as much" and was coming off of methadone, she obtained four
Suboxones from him to help her "from detoxing." Id. at 5946. LW
testified that she eventually had a seizure and woke up in an ambulance
on her way to the hospital. Id. at 5946-47. LW further testified that
she had received about twenty-five morphine \38\ patches worth about
$2,500 to $3,500, as well as 98 OxyContin tablets, from Leon Grider.
Id. at 5948, 6096. Regarding her obtaining of the morphine patches, LW
testified that she told Leon Grider that she needed money and was going
to sell them. Id. at 6092.
---------------------------------------------------------------------------
\38\ LW testified that the patches were turned over to Detective
Hammond and Chief Irvin. Thus, I find that this is actually the
incident in which Leon Grider provided the Duragesic patches to LW.
Duragesic patches actually contain fentanyl, a drug which is
considerably more powerful than morphine. However, both drugs are
schedule II narcotic controlled substances. See 21 CFR 1308.12(b) &
(c).
---------------------------------------------------------------------------
As for the 98 OxyContin tablets, LW testified that she obtained
this drug from Leon Grider before she agreed to work as a confidential
informant and that she needed the drug for her addiction because she
was concerned about the number of Lortab tablets she was taking and the
effect of the Tylenol (acetaminophen, which is combined with
hydrocodone in Lortab) on her liver. Id. at 6095-96. LW testified that
she consumed the OxyContin in five days but did not ask Leon Grider for
more because she did not think that he would provide the drug to her
again. Id. at 6097. LW also testified that after she "didn't have a
prescription anymore," Leon Grider created false prescription labels
so she would not "get caught" with the drugs if she was stopped by
the police.\39\ Id. at 6126.
---------------------------------------------------------------------------
\39\ In his testimony, Faller alleged that various recordings
that were made of the undercover transactions had been tampered
with. Tr. 5045-64. However, Faller's testimony was (as was typical)
confused and incoherent.
It is further acknowledged that Respondents submitted several
affidavits of an individual who maintained that he is a Forensic
Audio and Video Examiner, which were prepared for other litigation
between Leon Grider and the Commonwealth and Chief Irvin. Therein,
the affiant asserts that various tapes were either copies, have
erasures, or were edited. RX 28. While in an affidavit (dated
October 2, 2007), Respondent's Expert made reference to tapes which
appear to be of the various undercover transactions engaged in by
LW, even here, the affidavits fall short of establishing that any of
the original tapes were altered. See id. at 9 ("Q-4 is a 'copy' of
a video tape (not the original) of a scene behind a commercial
location where an alleged transaction took place."); ("Q-5 has
been identified as a 'copy' (not the original) of a video tape with
a portion of the tape as a tape over edit. I will need the original
tape and proper recorder to properly determine the extent and
content of the edits. (This video tape is of some sort of
surveillance at a cemetery.)"). Notwithstanding that the record in
this proceeding did not close for another three years, Respondents
produced no credible evidence that the original recordings of these
transactions had been tampered with.
Most significantly, the Government did not introduce the tapes
into evidence. Nor was the Government required to as the testimony
of Detective Hammond and LW, which the ALJ found to be credible, is
substantial evidence that Leon Grider distributed controlled
substances to LW, even though she did not have a prescription for
the drugs. I thus reject Respondent's suggestion that because
Detective Hammond did not actually view Leon Grider distribute the
drugs to LW, the Government was required to produce the tapes. See
Resp. Exceptions at 12-13.
I further reject the ALJ's finding that "[t]he record casts
serious doubts as to the reliability of any audio or video tapes
made related to this proceeding," ALJ at 56 n.22, as unsupported by
substantial evidence. Given that neither party introduced the tapes
into evidence and the ALJ observed both Detective Hammond and LW
testify and found them to be credible, this finding is both
incorrect and unnecessary.
---------------------------------------------------------------------------
In addition to the incidents involving PL and LW, the record
contains substantial evidence that Leon Grider distributed controlled
substances to BL without a prescription. More specifically, JD, who is
BL's daughter, testified that her mother sold Suboxone (buprenorphine
and naxalone) and Klonopin (clonazepam), which she obtained through
prescriptions, the majority of which she filled at Grider 1.
Id. at 3139. JD admitted that she participated in the transactions,
which took place at her mother's house, by handing the drugs over to
the buyer and obtaining the money. Id. at 3139-40. JD further testified
that her mother had obtained Lortab 7.5 and Klonopin from Leon Grider
without a prescription, and that while her mother initially had a
prescription for the Klonopin, she had run out and yet Grider had gone
to BL's house and given her more of the drug using "the same label of
the original prescription." Id. at 3142. Moreover, while JD was not
present at her mother's house when Leon Grider delivered the drugs, she
"saw the medication that [her mother] didn't have a prescription
for." Id. at 3173.
JD also testified that on March 15, 2006, she had spoken with Chief
Irvin regarding her mother's "slurring speech, stumbling, drunken
behavior, [and] drug behavior." Id. at 3144. JD further testified that
she "had found two bottles with the same date and [that] there was
another bottle of Klonopin that had been duplicated" and that she
reported this to Chief Irvin. Id. According to Irvin, he then met with
JD who told him that Leon Grider had provided her mother with "pills
that she wasn't supposed to be getting" when she was hospitalized. Id.
at 3201. JD also told Irvin "this was being done * * * with multiple
pill bottles with duplicat[e] labels." Id. Irvin then told JD, who
"claimed to have" the bottles, that if she gave them to him, he would
see what he could do. Id. Later that day, JD called Irvin and asked to
meet again; Irvin agreed and during the meeting, JD gave him the pill
bottles. Id.
[[Page 44082]]
at 3202. The Government subsequently introduced into evidence
photographs of two pill bottles; the bottles bear prescriptions labels
for 28 Suboxone tablets under the prescription number 4439582, and list
BL as the patient and a Dr. WLS as the prescriber. GX 71.
On March 18, BL called the dispatch center and the call was patched
through to Chief Irvin, who was then at home. Tr. 3203. The call was
recorded and played into the record; in addition, a copy of the
recording was submitted into evidence. Id. at 3204; 3215.
During the call, BL complained that her daughter had seen Irvin
"the other day about Leon." Id. at 3215. BL further stated that her
daughter had attempted to fill an outdated prescription but that Leon
Grider had refused to so and that JD had told her that because Grider
wouldn't fill her prescriptions, she was going to "get him." Id. at
3216. BL accused her daughter of making up the allegations she raised
with Irvin. Id. at 3216-17.
When BL maintained that Grider had not been giving out pills, Irvin
responded: "Well, can you explain to me why that there are bottles
with your name on them, with your name on them, that are exactly
duplicated, that's a violation of the law?" Id. at 3217. BL replied:
"no, no, no, no, no, no, no, no," and in response to Irvin's follow-
up question, stated: "he has not done that." Id. After stating that
he had a different view of Grider's conduct and he knew that the
allegation was true, BL explained that "[t]he only time he ever
fronted me--and that was when I was in the hospital, because I missed
my doctor's appointment, and he g[a]ve me a couple but he took it right
back out when I came in and went to the doctor's." Id. at 3218. Asked
by Irvin to explain her answer, BL then stated: "What I mean by that
is he went to the hospital. He knew I needed that medication. He knew
that I was going to the doctor. And he took that back out of my
prescriptions. * * * I don't see anything wrong with that." Id. BL
then asserted that "as soon as [she] got out of the hospital, [she]
went to the doctor," and that upon filling the prescription, Grider
took out "what he had given me" and that she did not "see anything
wrong with that." Id. When asked why she needed a pharmacist to give
her medication when she was in the hospital, BL stated that she "was
getting ready to leave and * * * didn't know how quickly I could get in
to my doctor." Id. at 3219. BL further asserted that Grider "was
doing this to help me out. He knew I needed the medication" and that
"I was going to get them and that I would pay him right back." Id. at
3221.
Respondents introduced into evidence an affidavit of BL (dated
April 17, 2006) which she provided in a civil action brought by Leon
Grider and others against Irvin and others. RX 106. Therein, BL stated
that she "had a valid prescription for [c]lonazepam which [she] had
filed [sic] at Grider Drug" and that she had "asked the pharmacist to
provide [her with] two (2) bottles so that [she] could legally carry
and possess this medication" when she was not home as she "did not
want to carry an entire, full bottle" on her person. Id. at 1. In the
affidavit, BL further stated that "Leon Grider has never provided me
any prescription medications without a Doctor prescribing them." Id.
at 2.
Respondents also introduced into evidence various pharmacy records
including a Narcotic and Controlled Drug Sales Report (compiled from
the Grider 1 pc V Pharmacy System software) listing BL's
prescriptions from December 2005 through July 1, 2010, as well as
copies of her prescriptions. See RX 121. While the sales report lists
prescription number 4439582, with a date of "01/30/06" for Suboxone
and lists Dr. WLS as the prescriber, see id. at 1, the exhibit does not
contain a copy of the prescription. Moreover, while the sales report
also lists a January 3, 2006 Suboxone prescription issued by Dr. WLS,
the report indicates that no refills were authorized by it. See id.
Having reviewed the relevant evidence (including having listened to
the recording of BL's phone conversation with Chief Irvin), I find that
BL's statement in her affidavit was false. I further conclude that
substantial evidence supports a finding that Leon Grider distributed
Suboxone to BL on or about January 30, 2006, at which time she did not
have a prescription for the drug.\40\
---------------------------------------------------------------------------
\40\ I have considered the various issues raised by Respondents
to impeach both JD's and Chief Irvin's credibility. With respect to
JD's credibility, I note that the ALJ repeatedly found her testimony
credible notwithstanding that at the time of her testimony, she was
under indictment for drug trafficking charges. ALJ at 47-48. It is
further noted that BL's statement during her phone call to Chief
Irvin corroborated JD's testimony with respect to Leon Grider's
having distributed Suboxone to BL when she was in the hospital.
Respondents also waged an extensive assault on Chief Irvin's
credibility. In her opinion, however, the ALJ cited Chief Irvin's
testimony as support for her finding that BL obtained controlled
substance from Leon Grider without a prescription. See ALJ at 48
(FoF 187 (citing Tr. 3204-05)). I also find Chief Irvin's testimony
credible.
The ALJ nonetheless made several findings regarding Irvin which
can only be described as gratuitous. For example, she found that
"Anna Mae Grider provided uncontested testimony concerning" a
traffic stop that Irvin made of a Grider employee (ML), which Grider
alleged was done to harass ML. ALJ at 58 (FoF 227). Anna Mae Grider,
however, had no firsthand knowledge of this incident and the only
other evidence supporting it is an unsworn letter by ML. Thus, even
if this finding would tend to show bias on the part of Chief Irvin,
it is not supported by substantial evidence.
Next, the ALJ also found that "[t]he record contains evidence
of other complaints being made against Irvin" and "Mrs. Grider
believes Det. Hammond and Chief Irvin 'have it out' for the
Griders." Id. at 59 (FoFs 229 and 232).
This proceeding is neither an internal affairs review board nor
an investigating grand jury such as the one which Mr. Faller got
"fired up." Rather, the ALJ's sole function is to make findings
that are relevant and material to the allegations raised by the
Government. The ALJ's findings numbers 229 and 232 are not probative
of any material issue in the case.
The ALJ made a further finding based on Anna Mae Grider's
testimony that following a burglary at one of the Respondents, Chief
Irvin retrieved a surveillance tape at the store and that "faces
were seen on the tape," but that Irvin took the tape and when Mrs.
Grider went to the police station to view the tape, it had been
erased. Id. (FoF 231). However, Mrs. Grider was not present when the
tape was initially viewed. Tr. 4758. Moreover, while Greg Grider
(another son of Anna Mae and Leon) testified that a face was visible
on the tape, the ALJ did not cite this testimony as a basis for her
finding and did not make any finding as to whether his testimony was
credible. Thus, as ultimate factfinder, I reject this finding.
---------------------------------------------------------------------------
Allegation Fourteen--Respondents Violated Their Corresponding
Responsibility by Distributing Controlled Substance Prescription to
Patients Engaged in Doctor-Shopping
As explained above, during the course of the proceeding, the
Government issued a second Show Cause Order which also immediately
suspended Respondents' registrations. ALJ Ex. 21. The Order raised
additional allegations that Respondents were filling controlled
substance prescriptions for six patients (TA, RB, JB, JR, SR, CR), who
were obtaining the prescriptions from multiple doctors, and that in
doing so, Respondents were violating their corresponding responsibility
because they "knew or should have known that the * * * dispensed
controlled substances were likely to be diverted or used for other than
legitimate medical purposes." Id. at 2-3.
As proof of the allegation, the Government submitted exhibits
showing Respondents' dispensings of controlled substances to each of
these patients, which were prepared by Detective Hammond. See GXs 52-
57. While Detective Hammond reviewed KASPER reports and developed
information regarding the patients, he also subpoenaed each patient's
profiles from the pharmacies, as well as his/her medical records from
their doctors. Tr. 3299-301. Finally, Detective Hammond interviewed
many of the prescribing physicians and/or dentists and prepared
[[Page 44083]]
spreadsheets for each patient listing their prescriptions, the date
issued, the quantity dispensed and the number of days of supply it
provided, the prescriber, and the dispensing pharmacy. Id.
The Government also elicited the testimony of Donald Sullivan,
Ph.D.,\41\ a registered pharmacist who is also a Professor of Pharmacy
Practice and the Department Chair of Pharmacy Practice at Ohio Northern
University. Dr. Sullivan was qualified as an expert and testified as to
the standards of pharmacy practice with respect to the dispensing of
controlled substances; Dr. Sullivan also prepared a report based on his
review of the prescriptions issued to each of the six patients and
testified as to whether Respondents dispensings violated the Controlled
Substances Act. GXs 65-66, Tr. 3405, 3414-26.
---------------------------------------------------------------------------
\41\ Dr. Sullivan obtained his Ph.D. in Pharmaceutical
Administration; he also holds an M.S. in this area and a B.S. in
Pharmacy; he obtained all three degrees from The Ohio State
University. GX 65. Dr. Sullivan has published dozens of articles on
pharmacy practice in peer-reviewed journals, as well as several
books. Id. In addition, he has made numerous presentations on
pharmacy-related topics including state and federal pharmacy laws.
Id.
---------------------------------------------------------------------------
To refute the Government's contentions, Respondents called Eric
Grider, the son of Leon Grider and pharmacist in charge of Grider
2, as well as Tonya Moses, a pharmacist and employee of
Respondents who worked at each of the stores. In addition, Respondents
called each of the six patients who were accused of doctor-shopping to
testify, as well as several of the practitioners who prescribed to
them. Additionally, Respondents introduced various documents.
The Expert's Testimony and Report
The ALJ found that Dr. Sullivan credibly testified as an expert
witness in the areas of the standards of pharmacy practice and the
standards for dispensing controlled substances. ALJ at 25; see also Tr.
3402. In preparing his report, Dr. Sullivan reviewed prescriptions, a
report prepared by Detective Hammond, patient profiles from the
Respondents, Kentucky pharmacy regulations, and KASPER reports. Tr.
3393, 3427-28, 3429-33, 3442-43, 3497-98. However, because Dr. Sullivan
clearly reviewed the prescriptions and patient profiles, the Government
has established that his testimony was based on sources other than the
KASPER data.
Dr. Sullivan testified that the concept of "corresponding
responsibility" means that the pharmacist and the physician "have a
shared responsibility to make sure that each prescription is for a
legitimate medical purpose." Tr. 3403, 3418. According to Dr.
Sullivan, pharmacists are taught to question prescriptions that they
may find are unlawful or suspicious. Dr. Sullivan identified the
following examples of "red flags" which should lead a pharmacist to
question the legitimacy of a prescription: (1) When a patient is
obtaining controlled substances from multiple doctors, (2) when
patients are being prescribed duplicate controlled substances that
treat the same indications, (3) when patients seek early refills, (4)
when patients obtain prescriptions for large quantities and large
doses, and (5) when patients travel long distances from where they live
to either the prescriber or the pharmacy. Id. at 3404; see also GX 66,
at 3.
Dr. Sullivan further testified as to the obligation of a pharmacist
under Kentucky law to review a patient's profile and conduct a drug
utilization review (DUR) prior to dispensing a prescription. Tr. 3410.
As he explained in his report:
Kentucky and federal law states that, prior to dispensing every
prescription, the pharmacist shall review the patient profile
(prospective drug utilization review or DUR) for the following:
(a) Over-utilization or under-utilization,
(b) Therapeutic duplication,
(c) Drug-disease state contraindications,
(d) Drug-drug interactions,
(e) Incorrect drug dose or duration of treatment,
(f) Drug-allergy interaction,
(g) Abuse/misuse,
(h) Inappropriate duration of treatment,
(i) Documented food/nutritional supplements-drug interactions.
GX 66, at 2. Dr. Sullivan further explained that over-utilization could
involve "a couple of different things," including "using more than
one prescription drug for the same indication" and patients seeking
refills "too early." Tr. 3411. As an example of incorrect/
inappropriate dosing and/or duration of treatment, Dr. Sullivan
explained that "some narcotic cough syrups * * * should only be used
for a limited period of time, based on the diagnosis." Id. at 3412.
And as examples of abuse or misuse, Dr. Sullivan testified "[t]hat's
where you would look for patterns of patients getting things filled too
early, going to multiple doctors, traveling long distances, therapeutic
duplication, just a pattern of there's something not quite right going
on with how this patient is using this therapy." Id.
Regarding the statement in his report that it was "clear that the
pharmacists at the Grider Drugs did not do prospective DUR," GX 66, at
2; Dr. Sullivan explained that this is a legal requirement, which is
"very easy" to comply with, as it can be done "[j]ust by pulling up
the patient profile and looking at it." Tr. 3413. Dr. Sullivan also
testified that even though a pharmacist does not have access to a
patient's medical file, the pharmacist should not simply defer to the
prescribing physician and fill the prescription because the
corresponding responsibility requires that the prescription be issued
for a legitimate medical purpose. Id. at 3417-18.
Dr. Sullivan testified that when confronted with these "red
flags," a pharmacist can take a number of steps in response, including
having an extensive conversation with the patient, calling the
physician, or refusing to fill the prescription. Id. at 3448-49. While
in some instances, a pharmacist fulfills his obligation by calling the
prescriber, Dr. Sullivan testified that "there's nothing in the law
that says [pharmacists] have to fill anything," especially if they
feel that a prescription has not been issued for a legitimate medical
purpose. Id. at 3474-75, 3477-84. Dr. Sullivan also testified that it
is a pharmacist's primary responsibility to ensure patient safety. Id.
at 3407-08; Govt. Exh. 66, at 1.
With respect to his review of patient profiles for the six patients
identified in the Suspension Order, Dr. Sullivan opined that "these
patients all exhibited multiple instances of" several of the red flags
he identified. Govt. Exh. 66, at 3. Dr. Sullivan further opined that
any "reasonable and prudent pharmacist would have caught this behavior
and refused to dispense controlled substances to these patients. These
are all textbook examples of drug abuse and/or drug diversion. Any
reasonable and prudent pharmacist would quickly recognize this based on
their education, training, and experience." Id. at 8. And in his
testimony, Dr. Sullivan opined that the manner in which controlled
substances were dispensed by the Respondents was not in compliance with
the accepted standards of practice observed by pharmacies and
pharmacists in the Commonwealth of Kentucky. Tr. 3426. A discussion of
the patient-specific evidence follows.\42\
---------------------------------------------------------------------------
\42\ Noting the ALJ's ruling on the admissibility of the KASPER
data, Respondents also contend that Dr. Sullivan's opinions "were
based almost exclusively on the prescriptions information he was
provided based on KASPER report data provided him." Resp.
Exceptions at 15. Dr. Sullivan made clear, however, that he had also
reviewed copies of the prescriptions. Tr. 3430-31.
---------------------------------------------------------------------------
[[Page 44084]]
TA
TA (GX 52) is a woman in her early to mid-thirties. Between June
19, 2009 and April 29, 2010, TA obtained thirty-four prescriptions for
federally-controlled substances such as Duragesic (fentanyl, a schedule
II drug); Endocet (oxycodone, a schedule II drug); hydrocodone with
acetaminophen (schedule III); alprazolam and clorazepate (both schedule
IV drugs); as well as eight prescriptions for carisoprodol, which at
the time was scheduled only under Kentucky law but which has since been
placed in schedule IV of the Controlled Substances Act. GX 52, Tab C;
see also 21 CFR 1308.12 (listing schedule II drugs), 1308.13 (schedule
III), 1308.14 (schedule IV); ALJ at 5-6 (stipulated facts); 76 FR 77330
(2011) (scheduling of carisoprodol).\43\ All but three of the thirty-
four prescriptions were filled by either Grider 1 or Grider
2, with all but three of the prescriptions being filled by
Grider 1. GX 52, Tab B, at 3 & Tab C; Tr. 3298, 3857-3859.
---------------------------------------------------------------------------
\43\ The Final Order scheduling carisoprodol discussed the
extensive evidence of the abuse of carisoprodol, especially when
taken in conjunction with other drugs such as narcotics and
benzodiazepines. See 76 FR 77330.
---------------------------------------------------------------------------
TA's prescriptions were written by twelve different prescribers. GX
52, at Tab C. The prescribers included two pain clinic doctors (Dr. H
and Dr. P); three dentists practicing at a clinic named Associates in
Dentistry (Dr. C, Dr. S, and Dr. M); another dentist (Dr. G); two oral
surgeons who did not practice together (Dr. A and Dr. H); a
psychiatrist (Dr. M); and his nurse practitioner (NP W). Tr. 3844-47,
4435.
While the prescriptions written by the various dentists who treated
TA were typically only for a few days' supply of hydrocodone,
throughout this period TA was also receiving prescriptions from pain
management doctors for thirty-day supplies of both schedule II and III
drugs such as Duragesic (fentanyl), Endocet (oxycodone), and
hydrocodone/apap. GX 52, at Tab C. For example, on June 19, 2009, TA
received prescriptions from Dr. H for 10 Duragesic patches and 90
tablets of hydrocodone 10/500, both being a thirty-day supply. Id. Yet
on June 24, 2009, TA received an additional twelve hydrocodone/apap
from Dr. C, a dentist. Id. Similarly, on August 15, 2009, TA received
another 100 hydrocodone 10/500 (this being a twenty-five day supply)
from Dr. H, and on August 24, she received another sixteen tablets of
hydrocodone from Dr. G. Id.
On September 4, TA obtained another prescription for 100
hydrocodone 10mg, a twenty-five day supply from Dr. H (her pain
doctor), followed by a prescription on September 16 for twenty
hydrocodone 10mg from Dr. H (the oral surgeon), which she refilled on
September 18; followed by a September 24 prescription for 120 Endocet,
a thirty-day supply, from Dr. P, her new pain doctor. \44\ Id.; see
also Tr. 3882. On October 22, Dr. P issued TA a second prescription for
120 Endocet (also a thirty-day supply), and yet TA received twenty
hydrocodone from Dr. S on October 31, twenty-four hydrocodone from Dr.
A on November 4, and sixteen hydrocodone from Dr. C on November 16. GX
52, at Tab C.
---------------------------------------------------------------------------
\44\ In addition to Endocet, Dr. P prescribed thirty-day
supplies of carisoprodol to TA numerous times. GX 52, at Tab C.
---------------------------------------------------------------------------
On November 18, Dr. P issued TA another prescription for 120
(thirty-day supply) Endocet; TA then obtained ten hydrocodone from Dr.
G on November 30, twelve hydrocodone from Dr. M on December 3, and
twenty hydrocodone from Dr. A on December 10. Id. Continuing this
pattern, on December 17, Dr. P issued TA another prescription for 120
(thirty-days) of Endocet; TA then obtained twelve hydrocodone from Dr.
C on December 28, twelve hydrocodone on January 2, 2010 from Dr. M,
twelve hydrocodone from Dr. S on January 4, and twelve more hydrocodone
on January 6 also from Dr. M. Id. In addition to the various narcotics
she received (and the carisoprodol), beginning on December 31, 2009, TA
obtained prescriptions for thirty-day supplies of benzodiazepines
including clorazepate and alprazolam from NP W, and Dr. M.
Over the course of time, TA had all of her teeth extracted; she
also testified that she was never told that any of the extractions were
unnecessary. Tr. 3912, 3926, 3969. Dr. G, one of the dentists who
treated TA on various occasions in 2006 (when he extracted two of her
teeth) and 2009, testified at the hearing that he had reviewed her
chart and that she had "bad teeth. They weren't in great shape and she
needed extractions." Id. at 4446. Dr. G also testified that at one of
TA's visits, which probably occurred in 2009, she complained that an
extraction, which had recently been done by another dentist, was
causing lots of pain. Id. at 4447. Dr. G testified that it was "hard
to tell exactly what [was] going" and because TA claimed she had
"lots of pain," he referred her to an oral surgeon. Id. at 4448. Dr.
G testified that he wrote TA a prescription for "a few days of pain
pills to give her time to get into the oral surgeon." Id. at 4449.
While Dr. G testified that TA's pain complaint seemed reasonable, he
further explained that when a patient comes in after having seen
another doctor, he would start checking up on the patient. Id. at 4449-
50.
Following this incident, Dr. G saw TA several more times. At the
first of these visits, TA wanted another tooth extracted; however,
because Dr. G "thought that it would be a difficult extraction," he
referred her to an oral surgeon. Id. at 4457. At the second visit, Dr.
G told TA that she needed to have a "full mouth extraction" and would
need to have this done by an oral surgeon. Id. After referring TA to an
oral surgeon, Dr. G made a chart entry on TA's chart indicating that
she was not to be prescribed any more pain medications. Id. at 4490-91.
In his report, Detective Hammond noted that TA engaged in a pattern
of going to a dentist to have a procedure performed and then going to
another dentist or oral surgeon to complain about the procedure that
was done and to seek hydrocodone. GX 52, at Tab B, at 3. During his
interview with Dr. A, one of the oral surgeons who treated TA, Dr. A
noted that during her last visit (January 26, 2010), TA had complained
about a procedure performed by another practice, Dental Associates, and
had asked him to look at it. Id. However, Dr. A referred her back to
Dental Associates and noted in TA's chart that "she was seeking pain
medications." Id. Detective Hammond further noted that the dental
providers TA saw "ranged from Somerset, KY to Campbellsville, KY which
are about 75 miles apart." Id.
Dr. G acknowledged that it would be the "norm" for a patient
whose teeth have deteriorated to the point of requiring a total
extraction to have pain. Tr. 4459. However, when questioned as to
whether he would have prescribed hydrocodone 5/500 to TA (as he did on
August 24, 2009) if he had known that she had received 100 hydrocodone
10/500 from Dr. H (her first pain doctor) on August 15th, Dr. G stated
that "he wouldn't have prescribed that with knowledge of the previous
prescription" because the earlier prescription was "twice as strong
as what [he] prescribes for four days." Id. at 4467. Upon being asked
by Respondents' counsel whether he "would prescribe this limited
amount as a booster on top of what she was already prescribed," Dr. G
stated that he "would not prescribe" it even for a limited
period.\45\ Id. Moreover, on
[[Page 44085]]
cross-examination, Dr. G was asked whether he would have issued his
November 30 prescription for ten hydrocodone 5/500 if he had known that
TA had obtained a prescription for Endocet twelve days earlier. Id. at
4479-80. Dr. G answered "no" and explained that he "wouldn't have
prescribed something that's not near as strong just because the
stronger medication should normally take care of the pain." Id. at
4480. And later in his testimony, Dr. G explained that while he did not
"know what's considered a lot of medication in the world of pain
clinics * * * I just know that there is no reason for me to prescribe
it, and there are different doctors." Id. at 4520.
---------------------------------------------------------------------------
\45\ Dr. G did testify that on occasion he has had chronic pain
patients, who would require extra medication for four days after a
procedure, because otherwise they would run out of the medication
they take for chronic pain. Tr. 4451-52. However, Dr. G explained
that in this situation he would "have to get with the pharmacist *
* * or have to call [the patient's] physician." Id. at 4451.
However, on both Respondents' direct examination and the
Government's cross-examination, Dr. G was adamant that he would not
have prescribed to TA if he had known about her prescription for 120
hydrocodone 10/500. Id. at 4478.
---------------------------------------------------------------------------
Dr. G reiterated that he did not receive a phone call from Grider
1 regarding any of the prescriptions that TA was receiving
from other practitioners. Id. at 4511. Indeed, he testified that he was
never contacted by either Grider 1 or Grider 2
regarding any of his patients. Id. at 4479. Moreover, upon reviewing
the spreadsheet (Tab C) and examining the names of the various
prescribers, Dr. G testified that "[t]he only prescriber [he]
recognize[d] are a few of the dentists and oral surgeons. All of the
physicians, I assume they are physicians, I don't recognize any of
their names. I don't even know what county they are in." Id. at 4468.
In her testimony, TA denied ever having sold prescriptions. Tr.
3901. However, on May 11, 2010, Detective Hammond went to Dr. P's
clinic and interviewed him regarding TA; he also reviewed the medical
record which Dr. P maintained on her and observed that Dr. P had
performed several urine drug screens on her. GX 52, at Tab B, at 2-3.
While the report for TA's March 10, 2010 urinalysis noted that she had
listed that she was taking Percocet, hydrocodone, Soma, and Xanax, the
results came back negative for benzodiazepines, opiates, and oxycodone.
Id. TA, however, had received a prescription for 60 tablets (a thirty-
day supply) of alprazolam on February 18, as well as a prescription for
120 tablets (also a thirty-day supply) of oxycodone on February 11.\46\
GX 52, Tab B, at 3.
---------------------------------------------------------------------------
\46\ While TA's urine drug screen was negative for opiates, and
Detective Hammond noted that she had listed hydrocodone as a drug
she was taking, TA's last hydrocodone prescriptions provided only a
two-day supply and had been issued approximately two weeks earlier.
---------------------------------------------------------------------------
TA testified that she was unsure whether the dentists knew about
the controlled substance prescriptions from Dr. H or Dr. P. Id. at
3915, 3941. However, she testified that she believed that she did not
inform her dentists of those prescriptions. Id. at 3915-3916. TA
believed the pain management doctor was the one who had to know about
all of the controlled substances that were being prescribed to her. Id.
at 3942.
Tonya Moses, a pharmacist and former employee of Respondents, also
testified for Respondent. Ms. Moses acknowledged that Grider 1
had filled prescriptions for TA for a lesser strength of hydrocodone
from a dentist (Lortab 5) which overlapped with prescriptions for
Lortab 10 from a pain management doctor. Id. at 4203. The ALJ found
credible Ms. Moses' testimony that the second, lesser strength
prescription would not be justified, because "[i]f the 10 mg is not
controlling the pain, the five isn't. So, she had no reason to get
that." Id. Ms. Moses acknowledged that this was an example of
therapeutic duplication. Id. Ms. Moses further testified that it was
"incumbent upon a pharmacist to verify with the doctor if he sees
multiple physicians prescribing, basically, the same medication." Tr.
4214.
Respondents also called Dr. M, a family practitioner with thirty
years of medical practice, whose wife's sister is married to Eric
Grider, and who is a partner with Leon Grider in the medical office
building where he maintains his office and Grider 2 is
located. Id. at 5266-67. Dr. M acknowledged the existence of doctor-
shopping and the prevalence of prescription drug abuse in Eastern
Kentucky. Id. at 5962-63. Dr. M did not treat TA. Id. at 5357, 5361.
However, upon being shown the spreadsheet listing TA's prescriptions,
Dr. M acknowledged that TA's pattern of obtaining prescriptions and
"taking about four [hydrocodone] a day on a regular basis," as well
as other drugs, and seeing different doctors, "would be a matter of
major concern" and "probably [wa]s a potential" doctor-shopping
situation. Id. at 5364-65.
Dr. Sullivan noted the multiple instances in which Grider Drug
1 filled hydrocodone and/or oxycodone prescriptions issued by
different doctors days before the date on which an earlier prescription
for either of these drugs would have been totally consumed. Tr. 3416-
17; Govt. Exh. 66, at 3-4. As Dr. Sullivan wrote in his report:
"[t]his pattern of filling hydrocodone and oxycodone prescriptions
early when the patient still had medication left from a previous
prescription occurred a total [of] 11 times during a ten-month
period." Id. at 4. Dr. Sullivan also noted that "[i]n addition to the
hydrocodone and Endocet prescriptions, the patient was also receiving
alprazolam and carisoprodol, which are known to be heavily abused. This
provides further evidence that the patient was engaged in the abuse
and/or diversion of controlled substances." Id. Finally, Dr. Sullivan
opined that "[a]ny reasonable and prudent pharmacist would have
determined that the patient was either abusing and/or diverting these
controlled substances." Id.
Notably, Leon Grider, who was the pharmacist at Grider 1,
did not testify in the proceeding.
RB
RB (GX 53) is forty-year old female. Between December 2007 and
April 2010, RB filled approximately 200 prescriptions which were
written by two doctors (Dr. L & Dr. P) for such controlled substances
as hydrocodone/apap tablets, alprazolam, and various narcotic cough
syrups including Polytussin, Vicotuss, Z Hist, Tussionex, and Z
Tuss.\47\ GX53, at Tab C. At least 172 of these prescriptions were
filled at Respondents, with all but seven filled at Grider 2.
Id. Moreover, approximately 100 of the prescriptions were for the
narcotic cough syrups. Id. However, according to Dr. Sullivan, narcotic
cough suppressants are intended for the short-term relief of cough due
to upper respiratory conditions, and in 2006, the clinical guidelines
were changed to "strongly discourage the use of any type of cough
suppressant in treating any type of cough." Tr. 3419. Yet for the
entirety of the twenty-eight months covered by the spreadsheet, RB
received prescriptions from both Drs. P and L for narcotic cough
suppressants which authorized the dispensing of 15,000 milliliters of
these drugs. Id. at 3419-21; GX 66, at 4; GX 53, at Tab C.
---------------------------------------------------------------------------
\47\ This figure excludes the 52 prescriptions for Ultram
(tramadol) which were listed on the spreadsheet. However, this drug
is not currently controlled under federal law.
---------------------------------------------------------------------------
RB also repeatedly obtained hydrocodone tablets throughout this
period while she was receiving the narcotic cough suppressants. See GX
53, Tab C, at 1. For example, on December 7, 2007, RB filled at Grider
2 a prescription from Dr. L for 60 tablets (a thirty-day
supply) of Lorcet 7.5/650mg; however, on December 12, 17, 20, as
[[Page 44086]]
well as January 2 and 4, 2008, she also filled at Grider 2
four prescriptions for Polytussin and one for Codiclear. Id. Notably,
while Dr. P wrote the Polytussin prescriptions, Dr. L wrote the
Codiclear prescription. Id.
Likewise, on January 7, 2008, RB filled at Grider 2 a
prescription from Dr. L for another 60 tablets (again a thirty-day
supply) of Lorcet. Id. However, RB filled at Grider 2 two
prescriptions issued by Dr. P for Polytussin on January 11 and 16, a
prescription for Codiclear issued by Dr. L on January 22, and
prescriptions for Z Hist issued by Dr. P on January 30 and February 4,
2008. Id.
As another example, on March 18, 2009, RB filled at Grider
2 a prescription issued by Dr. L for thirty tablets (a thirty-
day supply) of Lorcet. Id. at 3. RB then filled prescriptions issued by
Dr. P for Z Hist on March 20 and 30, as well as April 13, and a
prescription issued by Dr. L for Tussionex on March 26. Each of these
prescriptions was filled at Grider 2, and while the Z Hist
prescriptions were for either four or six-day supplies, the Tussionex
prescription was for a twelve-day supply. Id. In addition,
notwithstanding that RB had obtained a thirty-day supply of Lorcet on
March 18, on both March 30 and April 6, RB also filled at Grider
2 prescriptions issued by Dr. P for twenty additional tablets
of Lorcet. Id.
In addition, even putting aside that RB was obtaining prescriptions
from both doctors, the evidence shows that on multiple occasions, RB
obtained early fills (or refills) of her prescriptions. For example, on
July 21, 2008, RB filled at Grider 2 a prescription issued by
Dr. L for a twelve-day supply of Tussionex, yet only four days later,
she again obtained at Grider 2, an additional twelve-day
supply of Tussionex. Id. at 2.
Moreover, on both April 28 and May 22, 2009, RB filled at Grider
2 prescriptions issued by Dr. L, each being for thirty tablets
of Lorcet (a thirty-day supply).\48\ Id. at 3. The latter prescription
was thus filled six days early. Moreover, on June 16, RB filled a
prescription (also written by Dr. L) for another thirty tablets of
Lorcet at Grider 1, this also being a thirty-day supply; this
dispensing was thus five days early.\49\ Id.
---------------------------------------------------------------------------
\48\ Also, on both May 13 and June 18, Grider 2 filled
a prescription for twenty tablets of Lorcet issued by Dr. P. GX 53,
Tab C, at 3-4.
\49\ While the spreadsheet does not list what pharmacy this
prescription was filled at, a listing of RB's Medical Expenses
establishes that she filled the prescription at Grider 1.
GX 53, at Tab D.
---------------------------------------------------------------------------
Also, on July 15, 2009, RB filled at Grider 2 a
prescription for 60 tablets of Lorcet (this also being a thirty-day
supply). Id. at 4. Yet on August 5, 2009, RB filled at Grider
2 a prescription for 60 tablets of Lorcet; thus, this
dispensing was nine days early. Id.
As for the Xanax (alprazolam), on July 23, 2009, RB filled at
Grider 2 a thirty-day supply. Id. Yet on August 12, 2009, RB
obtained another thirty-day supply; thus, this dispensing was ten days
early. Id. Moreover, on November 6, 2009, RB filled at Grider
2 another thirty-day supply. Id. at 5. However, on November
27, RB obtained at Grider 2 another thirty-day supply, this
dispensing being nine days early. Id. Finally, RB obtained at Grider
2 a thirty-day supply on January 28, February 15, and March
8, 2010. Id. The February 15 dispensing was thus twelve days early, and
the March 8 dispensing was nine days early.\50\ Id.
---------------------------------------------------------------------------
\50\ There is also evidence showing that RB also filled
prescriptions for hydrocodone and alprazolam at other pharmacies,
during the same period in which she was obtaining these drugs at
Respondents. See GX 53, Tab C.
---------------------------------------------------------------------------
On April 7, 2010, Detective Hammond interviewed Dr. L. GX 53, Tab
B. Dr. L stated that he did not know that RB was also seeing Dr. P
during the same period she was seeing him. Id. at 1. When Detective
Hammond asked Dr. L whether he would have prescribed any controlled
substances to RB if he had known that she was also obtaining the same
or similar drugs from Dr. P, Dr. L answered "absolutley [sic] not."
Id.
On April 9, 2010, Detective Hammond interviewed Dr. P, who likewise
stated that he was unaware that RB was also seeing Dr. L at the same
time she was seeing him. Id. at 2. Dr. P also stated that he would not
have prescribed controlled substances to RB if he had known that she
was also receiving the same or similar drugs from Dr. L.\51\ Id.
---------------------------------------------------------------------------
\51\ Respondent introduced a statement from Dr. P. stating that
RB "has a legitimate reason to take pain medicine" because of
various displaced discs. RX 127. However, Dr. P further stated that
he "did not know until April 2010 she was seeing other
physicians," thus corroborating in part the statement in Detective
Hammond's written report. Id.
However, even if RB has a legitimate reason to take pain
medicine for her back, Dr. P's statement does not explain why she
was obtaining narcotics from Dr. L as well. Nor does Dr. P's
statement establish that RB had a medical condition which warranted
the prescribing of narcotic cough syrups, or the alprazolam. Thus,
this letter does not refute the Government contention that RB was
engaged in doctor-shopping and that Respondents violated their
corresponding responsibility under federal law in filling her
prescriptions.
---------------------------------------------------------------------------
Upon reviewing the spreadsheet of RB's prescriptions, Eric Grider
testified that he did not find RB's controlled substance prescriptions
unusual, given the limited number of days' supply provided by each
prescription. Tr. 3607-08. Regarding RB's numerous prescriptions for
narcotic cough medicines, Grider asserted that these drugs could be
used on both a short and long term basis, and gave as an example of the
latter, COPD or chronic coronary disease with a cough. Id. at 3673.
However, Grider admitted that he did not know if RB had either
condition and that he never asked her doctors whether she had one of
these conditions. Id. Moreover, RB testified that she never talked to a
pharmacist at Grider Drugs about her medications, id. 4676, and that no
one at Grider Drugs ever questioned her about her prescriptions. Id. at
4688-89.
Eric Grider further testified that, notwithstanding that RB was
being prescribed narcotic cough syrups by two different doctors, he did
not see any potential for abuse or misuse of the medications. Id. at
3678. However, in retrospect, Grider conceded that he should have
contacted RB's doctors to ensure they were aware that the other was
prescribing to her. Id.
As for RB's having filled the prescriptions at several different
pharmacies, Eric Grider acknowledged that this was "sometimes"
indicative of doctor-shopping. Id. at 3680. However, Grider testified
that because his store was not signed up to obtain KASPER reports and
RB did not have insurance and was "a cash-paying patient," there was
"no way to know" that she was getting prescriptions filled at other
(non-Grider) pharmacies. Id. at 3602.
Dr. Sullivan concluded that RB's behavior "clearly indicates this
patient was abusing and or diverting this medication." GX 66, at 4.
Dr. Sullivan opined that this abuse and or diversion "should
definitely have been caught by the pharmacist." Id. Also, at the same
time RB was taking this narcotic cough suppressant containing
hydrocodone, RB was also taking hydrocodone-containing pain killers.
Such drug overlap indicates a duplicate therapy was being used. Tr.
3421. Dr. Sullivan also noted a pattern of early refills of Xanax
prescriptions. He concluded that "[n]o reasonable and prudent
pharmacist would fill Xanax prescriptions this early on so many
occasions." GX 66, at 5.
JB
JB is a female in her mid-fifties. GX 54, Tab A. Between September
2, 2009 and May 4, 2010, JB filled fifty-seven controlled substance
prescriptions; fifty of the prescriptions were filled at Grider
2, with the remaining seven being filled at the Russell
Springs Pharmacy. Id. at Tab C. The prescriptions, which were issued by
three different doctors,
[[Page 44087]]
were for Lyrica (pregabalin), Propoxyphene N/Apap, Tussionex (a
schedule III drug containing hydrocodone indicated for cough and
allergy), hydrocodone/apap, alprazolam and Valium (diazepam). Id.
The evidence shows that Grider 2 repeatedly filled
prescriptions presented by JB for alprazolam and Valium which were
issued by two different doctors. Specifically, on September 17, 2009,
Grider 2 filled a prescription issued by Dr. B for 90
alprazolam .5mg (a thirty-day supply), and yet on September 24, Grider
2 filled a prescription issued by Dr. E for 60 Valium 10mg (a
twenty-day supply). Id. On October 13, Grider 2 filled a
prescription issued by Dr. E for another 60 diazepam (also a twenty-day
supply), and three days later, it filled a prescription issued by Dr. B
for 90 alprazolam (thirty-day supply). Id. Respondent filled additional
prescriptions issued by Dr. E for 60 diazepam (twenty-day supply) on
October 31, December 7, 2009, and January 28, February 17, March 9,
April 9, and April 30, 2010; it also filled additional prescriptions
issued by Dr. B for 90 alprazolam (thirty-day supply) on November 19,
December 18, 2009, and January 21, February 17, March 18, and April 21,
2010. Id. In total, Grider 2 dispensed eight alprazolam
prescriptions, each providing a thirty-day supply, for a total of 240-
days' supply of this drug, and nine diazepam prescriptions, each
providing a twenty-day supply, for a total of 180-days' supply of this
drug; these prescriptions thus provided 420-days' supply of medication
for a period which was only eight-months in duration.
With respect to these prescriptions, Dr. Sullivan explained that
alprazolam and diazepam are controlled substances in the same
therapeutic class of benzodiazepines. Continuing, Dr. Sullivan
explained that:
[t]he two drugs, diazepam 10mg and alprazolam 0.5mg are used for
the same indication. I cannot think of any clinical reason why a
patient would be using these two drugs at the same time for a period
of seven months. Any reasonable and prudent pharmacist would not
have filled prescriptions for these two medications to be taken at
the same time. This is an obvious sign of either prescription drug
abuse and/or diversion.
GX 66, at 5. Dr. Sullivan also observed that on February 17, 2010,
Grider 2 had filled prescriptions for both diazepam and
alprazolam presented by JB. Id.
With respect to JB, the evidence also shows that throughout most of
the period in question, she was simultaneously receiving prescriptions
for hydrocodone from both Dr. E and Dr. J. GX 54, at Tab C. However,
while JB filled Dr. E's prescriptions at Grider 2, she filled
Dr. J's prescriptions at the Russell Springs Pharmacy. Id.
Respondents called JB to testify. Tr. 5072. However, after some
preliminary questions, JB informed the tribunal that she was under
indictment for prescription fraud and that she was invoking her Fifth
Amendment privilege. Id. at 5073. JB was excused, and although she was
subject to recall, id. at 5077, Respondents did not recall her.
Eric Grider, pharmacist at Grider Drug 2, also testified
regarding JB's prescriptions. Grider, who offered the remarkable
testimony that he did know of any doctor-shopping having occurred in
Russell County, id. at 3639, testified that JB's prescriptions did not
raise a red flag with him even though she was simultaneously obtaining
them from three doctors.\52\ Id. at 3613. Regarding the hydrocodone
prescriptions which JB was simultaneously filling at both Grider
2 and the Russell Springs Pharmacy, Eric Grider testified that
Russell Springs Pharmacy was not connected with Grider Drugs. Id. at
3611. Mr. Grider then suggested that the only way he would have known
about the prescriptions filled at Russell Springs Pharmacy was if it
had billed Medicaid because JB had Medicaid, but if Russell Springs
Pharmacy did not "bill her Medicaid, [he] wouldn't [have] know[n]"
about those prescriptions. Id. However, in his testimony, Mr. Grider
admitted that Respondents did not subscribe to KASPER and thus did not
check to see whether their patients were obtaining drugs from multiple
doctors or pharmacies. Id. at 3539-40, 3551.
---------------------------------------------------------------------------
\52\ According to Eric Grider, Dr. J is a family physician, Dr.
E is an ear, nose and throat specialist, and Dr. B is a
psychiatrist. Tr. 3612-13.
---------------------------------------------------------------------------
As for the prescriptions that Grider 2 filled, Mr. Grider
maintained that he had talked with the patient and that "the rest of
them [we]re legitimate prescriptions for her symptoms." Id. at 3613.
He also asserted that the prescriptions were not a large number given
the number of days' supply they provided. Id. at 3615; RX 120F; GX 54,
Tab C. However, Grider offered no further explanation as to why it was
appropriate to fill JB's prescriptions for alprazolam and diazepam, and
as found above, the prescriptions for these two drugs provided 420
days' supply for period of eight months' duration.
JR
JR is a male in his late fifties. GX 55, Tab A. Between November 2,
2009 and April 29, 2010, JR filled thirty-four prescriptions for
narcotics including hydrocodone, OxyContin, and Tussionex, which were
issued by five different doctors; all but one of the prescriptions were
filled at Grider 1. Id. at Tab C. However, JR testified that
he was diagnosed with colon cancer in September or October 2009, and
that he was terminally ill at the time of his testimony in December
2010.\53\ Tr. 4235. JR further testified that Dr. W was his family
doctor and that Dr. M worked with Dr. W, that Dr. N was his oncologist,
that Dr. K was a surgeon who had performed various procedures on him,
and Dr. B was a pain management specialist. Id. at 4238-39. In
addition, a Dr. JB performed a surgical procedure on JR. RX 120B, at 9,
34.
---------------------------------------------------------------------------
\53\ The ALJ did not, however, make a finding as to whether she
found this testimony credible. See ALJ at 37-39.
---------------------------------------------------------------------------
JR testified that he had several bulging or ruptured disks in his
back and that he had been on disability for a long time and been
receiving painkillers for fifteen years. Id. at 4243. According to JR,
Dr. W issued the November 2 prescription for 90 hydrocodone 7.5/500 (a
thirty-day supply) for his back pain; Dr. K issued the November 23
prescription for 20 hydrocodone 10/500 (for a three-day supply) for
post-surgery pain, likely following a biopsy. Id. at 4244. On December
1, JR received an additional 60 hydrocodone 7.5/500 (this also being a
thirty-day) supply, and two days later, Dr. JB wrote him an additional
prescription for twenty hydrocodone 10/500 (also a three-day supply),
for pain following the installation of a chemotherapy port.\54\ GX 55,
at Tab C; RX 120B, at 34; Tr. 4246. Dr. W wrote additional
prescriptions for 60 hydrocodone 10/500 (these being fifteen-day
supplies) on December 31, as well as on January 14 and 28, and February
10, 2010. GX 55, at Tab C. However, on January 21, JR also filled a
prescription for another 30 hydrocodone issued by Dr. N, his
oncologist. Id.
---------------------------------------------------------------------------
\54\ While the actual prescription was written by Dr. JB, the
label for the prescription that was dispensed listed Dr. K as the
prescriber. RX 120B, at 34. On December 18 and 23, as well as
January 8, 2010, Dr. K wrote additional short term prescriptions for
hydrocodone10/500. The record does not, however, establish why.
---------------------------------------------------------------------------
On February 19, 2010, Grider 1 dispensed to JR 60 tablets
of OxyContin 20mg (a thirty-day supply) based on a prescription issued
by Dr. K. Id. Yet one week later (Feb. 26), Grider 1 filled
for JR a prescription for 60 hydrocodone 7.5/500 (also a thirty-day
supply) issued by Dr. W, and five days later (March 3), Respondent
dispensed to JR 120
[[Page 44088]]
hydrocodone 10/500 (a thirty-day supply), based on a prescription
issued by Dr. B. Id.
Moreover, on March 8 (just five days later), Grider 1
dispensed to JR another 60 tablets of OxyContin 20mg (a thirty-day
supply) which was prescribed by Dr. B, and on March 19, it dispensed to
JR 60 tablets of OxyContin 30mg (a thirty-day supply), as well as 30
tablets of hydrocodone 10/500, both of which were prescribed by Dr. K.
Id. Only one week later (on March 26), Grider 1 dispensed to
JR another 60 OxyContin 20mg (thirty-day supply) and another 30
hydrocodone 10/500; both prescriptions being issued by Dr. K. Id. On
April 2, JR filled at Grider 1 a prescription for 120
hydrocodone 10/500 (thirty-day supply) issued by Dr. B; he also filled,
albeit at a different pharmacy, a prescription for 60 OxyContin 20mg,
which was also issued by Dr. B.\55\
---------------------------------------------------------------------------
\55\ In addition, on ten occasions throughout this period, Dr. W
prescribed a ten-day supply of Tussionex, a hydrocodone based cough
syrup, to JR. GX 55, at Tab C.
---------------------------------------------------------------------------
Ms. Moses filled several of JR's prescriptions at Grider
1; she also reviewed Grider 1's records and prepared
notes regarding several of the dispensings. On November 23, 2009, she
had filled a prescription for twenty tablets of hydrocodone 10mg which
was issued by Dr. K. Ms. Moses documented on the prescription that JR
had filled a prescription for Lortab 7.5mg on November 2, to be taken
one tablet, twice a day. Dr. K's prescription was for one tablet every
six hours. Ms. Moses justified filling the hydrocodone 10mg
prescription because JR had seen a surgeon, the strength of the drug
was higher, and the dosing interval had increased. Tr. 4164-65.
Ms. Moses became aware of the Lortab 7.5mg prescription from the
pharmacy technician who had run the Lortab 10mg prescription through
the computer. Ms. Moses did not call either physician. Id. at 4165-66.
She asked JR if he had had surgery done, and JR told her that Dr. K had
put in a port for his chemotherapy. Id. at 4166; but see id. at 4244
(JR's testimony that he may have had a biopsy done on this date). Ms.
Moses testified that she collected this information on November 23,
before she filled the prescription. Id.
According to Ms. Moses, a similar scenario arose with the
prescription of December 3, 2009, because she knew JR was a cancer
patient and had undergone a colon re-section. Id. at 4167-68. Moreover,
the December 3rd prescription (issued by Dr. JB) was limited to a
three-day supply of hydrocodone 10mg to help JR control his pain. Id.
While Ms. Moses was aware that JR had also obtained hydrocodone 7.5mg
from his primary care physician, she testified that she used her
professional judgment in deciding to fill the hydrocodone 10mg
prescription because she knew that hydrocodone 7.5mg twice a day would
not control his post-surgical pain. Tr. 4167-68; RX 120B. Ms. Moses
knew that after the 3-day supply was exhausted, JR would return to the
hydrocodone 7.5mg medication for pain control. Tr. 4168.
Ms. Moses also testified regarding a January 21, 2010 prescription
issued to JR by his oncologist Dr. N. Id. According to Ms. Moses, JR
presented a prescription for the same strength (hydrocodone 10/500) and
dosing interval (four tablets per day) as provided in a prescription
Grider 1 had filled one week earlier which was issued by JR's
primary care doctor. Id. at 4168. Ms. Moses testified that she called
JR's oncologist to get his approval to fill the prescription and was
told by a nurse that it was "okay to fill," which she annotated on
the hard copy of the prescription. Id. The evidence corroborates this.
See RX 120B, at 46-47.
Ms. Moses offered a similar explanation as to why Grider 1
filled a March 8, 2010 prescription for OxyContin 20mg. Tr. 4169. Ms.
Moses testified that she recognized that JR had received an earlier
prescription for OxyContin 20mg on February 19, and that she told JR
that she could not fill the prescription until March 17. Id. JR then
told Ms. Moses that "he was completely out of his medicine, because *
* * the dosing * * * wasn't controlling his pain." Id. Ms. Moses
testified that she agreed to call the "the surgeon's office" and that
the nurse said "that they were aware that [JR] was out of his
medicine, and gave me the okay to fill that." Id; see also RX 120B, at
65. Ms. Moses further stated that it was within professional standards
to fill this prescription. Id.
Respondents' counsel also asked Ms. Moses about the March 26, 2010
OxyContin prescription for a thirty-day supply which was filled by Leon
Grider. Id. This prescription was at issue because the previous
OxyContin prescription, which was also for a thirty-day supply, had
been filled only one week earlier. As Ms. Moses testified, the March 26
prescription bore the notation: "ok early per MD--last RX stolen pt
had police report." RX 120B, at 71. As noted above, both the March 19
and 26 prescriptions were issued by Dr. K. GX 54, at Tab C. Ms. Moses
testified that filling this prescription was within professional
standards. Tr. 4170.
Next, Respondents' counsel asked Ms. Moses about the May 5, 2010
refill request it received from Dr. W, JR's primary physician. This
form, which was faxed into Grider 1, stated "needs all meds
called in (including cough syrup)" and listed numerous medications;
however, various controlled drugs including Lortab and OxyContin were
crossed out and the document also bore the notation "No controlled
drugs except Ativan." RX 120B, at 80.
According to Ms. Moses, a staff member at Dr. W's office "wrote
down all of [JR's] medications, including OxyContin 20mg, which Dr. W
does not prescribe for him. Therefore, Dr. W was aware of JR's taking
this for pain control from another physician." Id.; see also Tr. 4170-
71. However, even if this evidence establishes that Dr. W was aware
that JR was receiving OxyContin from another doctor (and it does not
establish whether Dr. W was aware that JR was still obtaining
prescriptions from another doctor on the various dates when he
prescribed a thirty-day supply of hydrocodone to JR), it does not
address whether Drs. K and B, who were prescribing OxyContin and
hydrocodone to JR during the same time period, were aware that they
were also simultaneously prescribing these drugs.
JR testified that he told Dr. K and Dr. N about the prescriptions
he was receiving from Dr. W for his chronic back pain. Tr. 4246, 4256.
However, during an interview Detective Hammond conducted with Dr. K on
May 4, 2010, Dr. K stated that "he had given him [JR] multiple
prescriptions while treating him but had he known he was getting
controlled substances from other doctors he would not have prescribed
him anything other than right after surgery and he wouldn't have
prescribed him as much." GX 55, Tab B, at 1. Dr. K further told the
Detective that JR "did not tell him what he was getting from other
doctors" and that while "[h]e assumed Dr. W, his family physician,
had given him something for pain * * * he did not know it was an
ongoing situation. Also, he did not know [JR] was going to a pain
clinic." Id.
On the same date, Detective Hammond interviewed Dr. W, JR's primary
care physician who had referred him to Dr. K. Id. at 2. Dr. W stated
that he knew JR "would get something from Dr. K after his surgery but
did not know [JR] would be continually getting medications * * * from
Dr. K." Id. Dr. W further stated that he would not have prescribed the
hydrocodone and Tussionex if he had
[[Page 44089]]
known [that JR] was getting the same and/or similar medication from Dr.
K because [JR] was getting 'too much' with both of them prescribing."
Id. Dr. W also stated that JR "did not tell him that Dr. K was also
giving him pain medications on a regular basis." Id.\56\
---------------------------------------------------------------------------
\56\ In their Exceptions, Respondents contend that "[t]he fact
that a patient's surgeon over this period was prescribing small
quantities of the same controlled substance, although in varying
degrees of strength, that the patient's primary care physician was
prescribing would not trigger the need to question either of these
doctors' prescriptions." Resp. Exceptions at 19. Respondents do not
cite any evidence to support this contention, and the statements of
Drs. K and W indicate that had they known that JR was obtaining
prescriptions they would have taken steps to reduce the quantities
that were being prescribed.
---------------------------------------------------------------------------
Detective Hammond also interviewed Dr. B, who runs a pain
management clinic at a hospital in Danville, Kentucky. Id. at 3. Dr. B.
stated that "he did not know [JR] was getting OxyContin from Dr. K or
controlled substances from Dr. W." Id. Dr. B also stated that
"patients at his clinic * * * are locked into a pain management
contract in which they are the only ones that will be treating their
pain," and that if he had known that JR was getting controlled
substances from other doctors, he would not have treated him.\57\ Id.
---------------------------------------------------------------------------
\57\ With respect to Dr. K's authorization of a new prescription
(which was filled on March 26, 2010) based on the theft of JR's
OxyContin, Detective Hammond noted that the theft had occurred at
the Russell County Hospital and that the incident was captured by a
video camera. Id. at 2. Detective Hammond interviewed the police
officer who responded to this incident and noted that upon reviewing
the video tape, JR's "car was not locked and the person who broke
into the vehicle appeared to know exactly where the pills were
located" as she "was in the vehicle only a short amount of time
and did not appear to be searching in the vehicle." Id. The
responding officer also stated that JR "was very persistent * * *
about the pills being stolen and that she [the officer] may have to
talk to the doctor so he could get his pain pills. [JR] was also
very knowledgeable about the fact that the break in should be caught
on video as he was within range of a security camera, [and] in fact
he informed [the officer] of this." Id.
In his report, Detective Hammond also noted various notations in
the patient filed maintained by Dr. W. These included a report that
on October 29, 2009, JR called and requested a refill of Lortab,
which Dr. W apparently rejected as he noted in the chart: "Hell no!
not due." Id. Moreover, on November 19, 2009, a person called Dr.
W's office to report that JR was "selling his pain pills and
Xanax" to her daughter. Id. Also, a chart note dated November 20,
2009 stated: "Patient needs to bring in pill bottles next week for
pill counts and UDS-any day next week." According to the chart, on
November 23, JR "brought in his Xanax bottle with 2\1/2\ pills
left" and did not have a bottle for the Lortab. Id. at 3. The chart
further noted: "Patient stated no Lortab left, no bottle, his
yorkies get the lids off." Id. Notably, Detective Hammond's
statements regarding both the November 19 phone call and JR's
November 23 visit are corroborated by other evidence in the record.
See GXs 75 and 76.
In his report, Detective Hammond then noted that while he was at
Dr. B's clinic, he was approached by a nurse (JB), who told him that
"she had received a call from a Russell Co. phone number, in which
the caller said [JR] was diverting his pain pills to her grandson in
exchange for him mowing his yard" and that "her grandson is
addicted to pain pills." Id. Also, in his testimony, JR admitted
that he had "loaned" controlled substances to friends on occasion.
Tr. 4317-18, 4320-21.
Accordingly, I find that while JR had a serious medical
condition which warranted the prescribing of controlled substances,
there is also substantial evidence that he engaged in the diversion
of controlled substances.
---------------------------------------------------------------------------
With respect to JR's OxyContin and hydrocodone prescriptions, Dr.
Sullivan noted that that while "on rare occasions, cancer patients
will use a second narcotic like hydrocodone for break-through pain on
an 'as needed basis' for a short-term period[,] [t]he same doctor would
write prescriptions for both." GX 66, at 6. However, Dr. Sullivan then
noted that JR "was receiving prescriptions from both Dr. [K] and Dr.
[B] for both drugs at the same time. He also received Tussionex
(hydrocodone) prescriptions from Dr. [W] as well during this period."
Id. Dr. Sullivan then explained that "[t]his is a major red flag that
the patient was receiving hydrocodone prescriptions from three
different doctors and OxyContin from two different doctors at the same
time. Any reasonable and prudent pharmacist would have caught this and
not filled these prescriptions." Id.
Dr. Sullivan further noted "[o]f the thirty three controlled
substance prescriptions filled" by Grider 1, "at least
eleven times the pharmacy filled the medication too early." Id. Dr.
Sullivan opined that "[t]his is clearly a sign of the pharmacy not
conducting prospective DUR for abuse/misuse[,]" and that "[n]o
reasonable or prudent pharmacist would have filled this many narcotic
prescriptions this early." Id. Finally, Dr. Sullivan noted that the
"duplicate therapy with both hydrocodone and oxycodone (OxyContin)
from more than one prescriber is a clear indication of drug abuse and/
or diversion and any reasonable and prudent pharmacist would have
detected this." Id.
CR
CR is a male in his late fifties. CR testified that in July of
1996, he was involved in an incident in which another person beat his
back with a two-by-four and broke two of his ribs; CR was treated in
the emergency room and prescribed Lorcet. Tr. 4030-31. Thereafter, Dr.
P, CR's family doctor, treated his back injury, and prescribed
controlled substances to him. Id. at 4033. CR also testified that
sometime in 2007, he again injured his back while he was visiting a
hospital; however, CR told two different versions of this incident, as
he initially testified that as he was leaving a bathroom, boxes fell
off a cart and knocked him back against the wall, but then testified
that he was run over by a cart that weighed 1200 pounds. Compare id. at
3985 with id. at 4044. However, CR testified that he was not on pain
medication at the time of this incident. Id. at 4044.
CR testified that Dr. P referred him to Dr. C for potential surgery
and pain management. Id. at 4033-34, 4042-43. CR decided not to have
the surgery until he changed his mind in January 2010. Id. at 4035. CR
filled his controlled substance prescriptions at the Respondents. Id.
at 4040.
The Government submitted a spreadsheet showing CR's controlled
substance prescriptions between November 16, 2007 and April 2, 2010. GX
56, Tab C. The spreadsheet shows that during this period, CR filled
approximately 170 controlled substance prescriptions,\58\ and of these,
all but seven were filled at either Grider 1 or Grider
2. See id. The prescriptions were for such drugs as alprazolam
(schedule IV), hydrocodone combined with acetaminophen (schedule III),
Demerol (schedule II), and various narcotic cough medicines including
Pneumotussin, Z Hist, and Z Tuss Acc.\59\ See id.
---------------------------------------------------------------------------
\58\ This figure excludes some twenty-six tramadol
prescriptions.
\59\ CR filled approximately twenty prescriptions for narcotic
cough syrups throughout the nearly thirty-month period covered by
the spreadsheet. See GX 56, Tab C.
---------------------------------------------------------------------------
Moreover, CR was simultaneously obtaining prescriptions for
narcotics from both Drs. P and C. Typically, CR would receive a
prescription for 120 tablets of Vicodin 5 (hydrocodone 5/500mg) for a
thirty-day supply from Dr. C, each of which he filled at Grider
1.\60\See id. While by themselves these prescriptions would
not appear to be suspicious given the quantity and dates of issuance,
throughout the period, CR also obtained and filled 49 additional
prescriptions for twenty tablets of hydrocodone 7.5/650mg which were
issued by Dr. P. See id. While the prescriptions issued by Dr. P were
generally for only a three or five-day supply, notably, CR filled all
but two of these prescriptions at Grider 2.\61\See id. Also,
CR obtained seven prescriptions
[[Page 44090]]
from Dr. P for Demerol, which he also filled at Grider 2. See
id.
---------------------------------------------------------------------------
\60\ In total, CR received thirty such prescriptions from Dr. C;
however, the last two prescriptions, which were also for a thirty-
day supply, were for only 90 tablets. GX 56, Tab C, at 7.
\61\ On December 26, 2007, CR also obtained a prescription for
twenty-eight hydrocodone/apap from NP CR, which he filled at Grider
2.
---------------------------------------------------------------------------
Notably, while CR testified that Dr. P knew he was also seeing Dr.
C, CR testified that he did not tell Dr. P that he was also getting
controlled substances from Dr. C and Dr. P did not ask him if he was.
Tr. 4028-29. Moreover, on April 9, 2010, the Detective, who had
reviewed the medical record maintained by Dr. P on CR, interviewed Dr.
P and asked him whether he would have prescribed controlled substances
to CR if he had known that CR was getting the same or similar drugs
from Dr. P. GX 56, Tab B, at 2. Dr. P answered "no." Id.
The Detective also interviewed Dr. C, who said that he had asked CR
if he was obtaining controlled substances from any other doctors and
that CR said "he was not." GX 56, Tab B, at 1.\62\ The Detective then
asked Dr. C if he would have prescribed controlled substances to CR if
he had known that CR was obtaining the same or similar drugs from other
doctors. Id. Dr. C answered "absolutely not." Id.
---------------------------------------------------------------------------
\62\ CR testified that he did not recall that the patient
history forms he completed for Dr. C had asked about what drugs he
was taking. Tr. 4047. However, CR admitted that he never told Dr. C
that he was also receiving controlled substances from Dr. P, stating
that:
I never had any reason to. I didn't know if he knew or--I mean I
just figured everybody knowed [sic]. I thought they could pull these
KASPERS I think they call it and find out anything so I didn't think
there was anything wrong. I thought you could go from little drug to
just a tiny bit stronger. Because Lortab 75's ain't enough to--
nothing to even touch what pain I have most days.
Id. at 4039.
---------------------------------------------------------------------------
Respondents did not call either Dr. P or Dr. C to testify. Instead,
they called a Nurse Practitioner C-R,\63\ who worked in an emergency
room and treated CR after an accident in which he represented that he
had hurt his elbow. Tr. 4051-52. NP C-R prescribed twenty-eight tablets
of hydrocodone/apap 7.5/650mg, which CR filled at Grider 2.
However, six days earlier, CR had filled at Grider 1 a
prescription issued by Dr. C for 120 tablets of hydrocodone/apap 5/
500mg. Id. at 4006-07, 4052; GX 56, Tab C, at 1.
---------------------------------------------------------------------------
\63\ NP C-R testified concerning her current practices in
prescribing controlled substances and reviewing KASPER reports. Tr.
4340-4434.
---------------------------------------------------------------------------
NP C-R did not remember CR or any facts surrounding her treatment
and prescribing to him. Tr. 4360-63, 4367. However, upon being shown
the evidence that CR had filled the prescription for 120 tablets only
six days earlier, NP C-R testified that given the close proximity of
the two prescriptions, she would have expected the pharmacist to call
her to verify the authenticity of the second prescription. Id. at 4429.
Ms. Tanya Moses, Respondent's witness, also testified regarding
these two prescriptions. Similar to the testimony of NP C-R, Ms. Moses
testified that if NP C-R's prescription had been presented to her, she
would have called the physician to let him/her know of the overlapping
prescription. Id. at 4220-21.
Dr. Sullivan further noted that on multiple occasions, Respondents
had filled prescriptions for both hydrocodone tablets and narcotic
cough suppressants, which contain hydrocodone. GX 66, at 7. Most
significantly, in his report, Dr. Sullivan opined that "[a] reasonable
and prudent pharmacist would have not allowed a patient to take these
medications at the same time and noticed this as a potential indication
of prescription drug abuse and/or drug diversion." Id.
In addition to the narcotic prescriptions, the evidence shows that
CR received 64 alprazolam prescriptions and refills that were
authorized by Dr. P, each of which was for a thirty-day supply, for a
total of 1,920 days' supply of the drug during a period of thirty
months. See 56, Tab C. Of these prescriptions, all but seven of them
were filled at Respondents, and of the seven which were not filled by
Respondents, CR did not start filling these at another pharmacy until
late April 2009. See id. Thus, for approximately seventeen months, CR
filled all of the alprazolam prescriptions at either Grider 1
or Grider 2. Indeed, the frequency at which CR presented the
alprazolam prescriptions and sought refills of them provides compelling
evidence that CR was engaged in self-abuse and/or diversion.
For example, on November 23, 2007, Grider 2 filled a
thirty-day supply; it also refilled the prescription on December 18 and
on January 31, 2008. See id. at 1. Yet on December 29, 2007, Grider
1 also filled a thirty-day supply based on a different
prescription; it refilled the prescription on January 26, February 23,
and March 21, 2008. See id. Moreover, notwithstanding that it had
dispensed a refill the previous day, on February 1, 2008, Grider
2 filled a new prescription for thirty-day supply, which it
refilled on February 29 and March 27, 2008. See id. Moreover, on March
31, 2008, Grider 1 dispensed a new prescription, even though
it had refilled the previous prescription only ten days earlier and
that Grider 2 had refilled a prescription only four days
earlier. Id.
The evidence shows numerous other instances in which Respondents
filled or refilled the alprazolam prescriptions within days of having
filled or refilled an earlier prescription. For example, on April 24,
2008, Grider 2 dispensed a refill, and yet, just six days
later on April 30, it dispensed a new prescription. Id. at 2. Moreover,
on April 28, Grider 1 dispensed a refill. Id.
Likewise, on May 24, 2008, Grider 1 dispensed a further
refill, and yet, on May 27, Grider 2 also dispensed a refill.
Id. Moreover, on June 20, Grider 1 dispensed another refill,
and on June 23, Grider 2 dispensed another refill. Id. Grider
2 also dispensed a new prescription on July 3, refilled a
previous prescription on July 21 (which was first filled on April 30),
and then on July 31, it refilled the July 3rd prescription. Id.
As other examples, Grider 1 filled or refilled thirty-day
alprazolam prescriptions on December 29, 2008, as well as on January 16
and 27, February 14 and 23, and March 12, 2009. Id. at 3-4. Grider
2 also filled or refilled thirty-day prescriptions on January
5, February 27, and and March 27, 2009.\64\ Id.
---------------------------------------------------------------------------
\64\ As noted above, CR apparently decided to become somewhat
less brazen as beginning in late April 2009, he started filling some
of the alprazolam prescriptions at a Rite Aid. However, even then
there were numerous instances in which he filled or refilled
alprazolam prescriptions at Respondents within days of each other.
For example, on August 21, 2009, Grider 1 filled a new
prescription, and yet, on August 25, Grider 2 refilled a
prescription. See GX 56, Tab C, at 5. Also, on October 15, 2009,
Grider 1 refilled a prescription, and yet on October 22,
Grider 2, filled a new prescription. Id.
---------------------------------------------------------------------------
Regarding the alprazolam prescriptions, CR offered two
explanations, neither of which is credible. First, when questioned
about the alprazolam prescriptions he filled on January 31, as well as
on February 1, 2008, CR claimed that he got the extra alprazolam
because he "was going out of town for a couple or three weeks." Tr.
4013. Yet earlier in his testimony, CR stated that the earliest he ever
got a refill was three to four days early; he also testified that he
did not regularly go out of town. Id. at 3995-96. Moreover, CR had just
obtained a refill on January 26. Thus, even if CR actually was going
out of town, he had no need for either the January 31 or February 1,
2008 refills and I find that this testimony is patently disingenuous.
Next, when asked about the alprazolam prescriptions he filled on
March 21, 27, and 31, 2008, CR testified that Dr. P had written him
another prescription because "I was going through some bad things,"
and that while he was "not sure," Dr. P did so instead of writing a
prescription for two
[[Page 44091]]
tablets a day or 60 tablets. Id. CR then stated that it was his belief
that this "is the way it is done." Id.
Yet the alprazolam prescriptions (including those in which Dr. P
purportedly doubled his dosing) all gave the same dosing instruction of
"one tab at bedtime." RX 120, Tab C. Moreover, one would expect that
if a doctor was actually doubling a patient's frequency of dosing, the
prescription would reflect this as is required by federal regulations.
See 21 CFR 1306.05(a) (requiring that a prescription list, inter alia,
a drug's "strength * * * [the] quantity prescribed, [and the doctor's]
directions for use"). Thus, if it had been the case that Dr. P had
determined that CR had a legitimate medical need to double his dose of
alprazolam, Dr. P should have simply increased the dosing instructions
on the prescription. And even if CR's condition required that his dose
be doubled, that still would not explain why he filled or refilled the
prescription three times within a ten-day period (March 21-31, 2008),
or did so an additional three times within a six-day period the
following month (April 24-30, 2008). Here again, CR's testimony was
patently ludicrous and disingenuous.\65\
---------------------------------------------------------------------------
\65\ As another example of CR's frequently disingenuous
testimony, on cross-examination, CR initially denied seeing any
physician (other then when he went to an emergency-room) in Florida,
where, at the time of the hearing, he was renting a house in
Palmetto, Florida with others. Tr. 4103-04, 4109, 4025. However,
upon being confronted with a prescription he had obtained (on
November 29, 2010) for oxycodone 30mg from a doctor at the Pain
Center of Broward, a pain clinic located in Fort Lauderdale, see GX
73, CR then changed his testimony claiming that he had "got to
hurting so bad" because he had "been cut off" by his Kentucky
doctors in April 2010 (seven months before he got the oxycodone in
Florida), apparently after they were interviewed by Detective
Hammond. Tr. 4107. Subsequently, CR claimed that the day before he
obtain the oxycodone he had hurt his back moving furniture and that
his pain level following this incident was an "[e]leven" on a
scale of "one to ten." Id. at 4125.
When asked how he had found out about the Pain Center of
Broward, CR claimed that he had woken up at about four in the
morning because he "couldn't breathe" and had his roommates take
him to the emergency room, where he asked the doctor where he could
get "a family doctor" because he "was having trouble with [his]
back." Id. at 4131-32. CR then made the absurd assertion that
Broward is "kind of a suburb[] of Tampa." Id. Pursuant to 5 U.S.C.
556(e) and 21 CFR 1316.59, I take official notice of the map of the
State of Florida contained in the 1994 Rand McNally Business
Traveler's Road Atlas, at 22-23. As this shows, Palmetto and Fort
Lauderdale are located on opposite coasts of the State of Florida
and are more than 200 miles apart. This begs the further question of
why, if CR's pain level was so high, he would travel more than 200
miles to get drugs instead of seeking treatment closer to where he
lived.
At another point in his testimony, CR was asked by the
Government if he "ever g[a]ve his pills away to anybody else?" Id.
at 4098. CR replied: "I'd rather not say. Is that okay? I mean can
I get by with that or do I have to answer that?" Id. CR then added:
"I've never sold a pill, I'll put it like that." Id. at 4099.
In short, much of CR's testimony was transparently disingenuous.
---------------------------------------------------------------------------
Eric Grider, the pharmacist in charge at Grider 2,
recalled that CR was seeing Dr. P for some back problems, but did not
recall the nature of those back problems. Tr. 3744-45. Moreover, Eric
Grider admitted that he did not talk to Dr. P about CR, id. at 3786,
even though Dr. P's office is in the same building as Grider
2. Id. at 3989-90.
Eric Grider further asserted that Grider 2 would not have
known about the controlled-substance prescriptions CR filled at other
pharmacies (including at Grider 1) because CR was "a cash-
paying patient." Id. at 3619. In addition, Grider stated that he would
be unaware of the prescriptions CR filled at Grider 1 "unless
[he] looked in [the patient's] files," and then offered the
unconvincing explanation that he "had no reason to" do so. Id. Grider
then testified that he did not recall inquiring with Grider Drug
1 about CR's filling of prescriptions at that location, or
that Grider 1 had asked Grider 2 about the latter's
filling of CR's prescriptions. Id. at 3689, 3694. Also, as found above,
Grider testified that he was not signed up to obtain KASPER reports on
the pharmacy's patients. Id. at 3621.
In addition, on direct examination, Eric Grider asserted that the
prescriptions which CR filled at Grider 2 would not, by
themselves, raise a red flag or lead him to conclude that CR was a
problem patient. Id. at 3621-22. He also denied being aware of any
unauthorized refills which occurred at Grider 2. Id. at 3623.
Yet when asked on cross-examination about Grider 2's filling
of alprazolam prescriptions (on February 1, 2008, notwithstanding
having dispensed a refill of an earlier prescription the day before)
and refilling (on April 24 and then April 30, 2008), Grider maintained
that "the only way" he would have done so was if he checked with the
doctor (Dr. P) to ensure it was okay to do so. Id. at 3690-3. However,
the ALJ found that Grider could not specifically recall if he did so in
regards to these prescriptions and I find that he did not. ALJ at 43-44
(citing Tr. 3692-93).
Eric Grider then conceded that CR appeared to be a doctor-shopper
who engaged in conduct that fit Grider's definition of a problem
patient. Id. at 3694, 3696. Moreover, contrary to Grider's claim that
he had no reason to check the patient profile maintained on CR by
Grider 1, I find that given the numerous early alprazolam
prescriptions CR presented, Eric Grider had reason to know that CR was
engaged in either drug abuse or diversion and thus, Grider had ample
reason to check with Grider 1 to determine whether CR was also
filling prescriptions there.\66\
---------------------------------------------------------------------------
\66\ There was also evidence that CR saw a Dr. C, who surgically
treated him for a hernia, Tr. 4008-09, as well as other doctors
because he believed that Dr. P was planning on retiring. These
included a Dr. L (who he saw twice), a Dr. W (who he saw three or
four times), and a Dr. B (who he saw two to three times). Id. at
4010-11, 4056-57, 4065, 4068-69. There was also testimony that CR
obtained hydrocodone and Valium from Dr. W and both a cough syrup
containing a controlled substance and several hydrocodone
prescriptions from Dr. B. Id. at 4056-57, 4061, 4068-69, 4071. While
the ALJ found that these prescriptions were filled at Respondent and
that Dr. B's prescriptions overlapped with those of Dr. P (ALJ at
41, FoF s 162-63), with the exception of the prescriptions
issued by Dr. C, no further evidence was put forward establishing
the dates on which these other prescriptions were filled. I thus do
not adopt the ALJ's findings on the prescriptions.
---------------------------------------------------------------------------
Dr. Sullivan noted that there were "multiple instances where" CR
filled the alprazolam prescriptions "early at both pharmacies." GX
66, at 7. Indeed, after listing four instances of dispensings made by
Respondent which ranged from fifteen to "twenty-nine days too early,"
Dr. Sullivan observed that "[t]his pattern of filling alprazolam too
early for this patient occurred on at least ten other occasions." Id.
Dr. Sullivan then explained that a "reasonable and prudent pharmacist
would never have filled these alprazolam prescriptions as early as the
Grider pharmacies did. This shows a pattern of either abuse and/or drug
diversion." Id. I agree with Dr. Sullivan's conclusion.\67\
---------------------------------------------------------------------------
\67\ As noted above, Leon Grider, the pharmacist in charge at
Grider 1, did not testify in the proceeding.
---------------------------------------------------------------------------
SR
SR is a woman in her mid-fifties. GX 57, at Tab A. SR testified
that she has Type 2 diabetes, that she had neuropathy in her feet, bad
arthritis in her shoulders, hands, back, and knees, and anxiety; she
also testified that she had to have a tooth extracted and developed a
dry socket following this procedure. Tr. 4694-95.
According to the spreadsheet of her prescriptions, between October
3, 2009 and April 23, 2010, SR filled twenty-four controlled substance
prescriptions at Grider 2. GX 57, at Tab C. The prescriptions
included sixteen for hydrocodone/apap, one for Endocet (oxycodone), and
seven for clonazepam.\68\ Id. While all of the
[[Page 44092]]
clonazepam prescriptions were issued by Dr. Z, SR received five of the
hydrocodone prescriptions and the Endocet prescription from Dr. H; of
the hydrocodone prescriptions, eight were issued by Dr. S, and one
prescription each was issued by Dr. M, Dr. W, and Nurse Practitioner H.
Id.
---------------------------------------------------------------------------
\68\ The spreadsheet also lists a prescription for Fioricet, but
it is unclear whether this formulation is controlled.
---------------------------------------------------------------------------
SR denied that she was a doctor shopper, stating that Dr. Z was her
psychiatrist and treating her for anxiety. Tr. 4697, 4711. She also
stated that Dr. H was an orthopedic surgeon who had performed surgery
on her shoulder in March 2010, id. at 4697, 4720; that Dr. S and NP H
were in the same practice and that Dr. W had replaced Dr. S and was her
family practitioner who was treating her for arthritis; \69\ that Dr.
JS was her foot doctor; and that Dr. M was a dentist who was in an
office which had several dentists. Id. at 47087, 4711.
---------------------------------------------------------------------------
\69\ SR also referred to Dr. W by her married name of Dr. D. Tr.
4708.
---------------------------------------------------------------------------
The evidence shows that on October 5, 2009, SR received 42
hydrocodone 5/500, a fourteen-day supply, from Dr. S (her then family
practitioner); that on October 13, 2009, SR received twelve hydrocodone
7.5/650 (this being a three-day supply), from Dr. M, a dentist;\70\ and
that on October 21, 2009, SR received 42 hydrocodone 5/500 from NP H.
All three prescriptions were filled at Grider 2. Tr. 3592-94,
3710, 3714-15, 4710-11; GX 57, Tab C & Tab D, at 2.
---------------------------------------------------------------------------
\70\ SR's dental record contains a chart note which indicates
that her tooth was extracted on October 8, 2009 and that she was
prescribed the twelve hydrocodone on that date. GX 77, at 2.
---------------------------------------------------------------------------
However, SR's dental records include a list of medications she was
taking as of October 8, 2009, the date on which she had a tooth
extracted; this list is also repeated on the first page of the chart
which is an undated form which includes the type of information which a
patient would typically complete on the initial visit (such as
Identifying Information, Dental Insurance, Medical History,
Acknowledgement of Receipt of Notice of Privacy Practices, and
Consent). See GX 77. Notably, hydrocodone is not on either list even
though SR had been prescribed this drug just three days earlier. See
id. at 1, 3; GX 57, at Tab C & Tab D, at 2.
RS initially testified that she had just forgotten to list
hydrocodone because she has "trouble with [her] memory." Tr. 4716.
However, she later denied having written the list of drugs which
appears on the first page of the form, id. at 4727, and did not recall
when she had written out the list on page 3 of the form which is dated
"10/8/09." Id. at 4726.
In addition, the evidence shows that on March 8, 2010, Dr. S (her
family doctor) prescribed 90 tablets of hydrocodone 5/500 (a thirty-day
supply) and that after this, Dr. H (her orthopedic surgeon) prescribed
her thirty tablets of hydrocodone 7.5/500 on March 10, 18, 24, and
April 1; most of the prescriptions had dosing instructions of one
tablet every six hours, thus providing a week's supply. GX 57, Tab C.
In addition, on April 8, Dr. W (who replaced Dr. S as her family doctor
but was in the same office) prescribed her 90 more hydrocodone 5/500
(also a thirty-day supply) and on April 23, Dr. H issued her a
prescription for another 30 tablets of hydrocodone 7.5/500. Id. In
total, between October 5, 2009 and April 23, 2010, SR received sixteen
prescriptions for hydrocodone representing a 247-day supply. RX
120A.\71\
---------------------------------------------------------------------------
\71\ RX 120A is a computation chart showing these sixteen
prescriptions and the Respondent's computation of the number of days
each prescription should last if the medication is taken as
prescribed.
---------------------------------------------------------------------------
On May 7, 2010, Detective Hammond interviewed Dr. H, who
acknowledged that he was treating SR for a shoulder injury. GX 57, Tab
B, at 1. Dr. H stated that he may have given SR the Endocet
prescription "after surgery or told her to double up on the
hydrocodone if he had known she was still receiving them from Dr. S."
Id. at Tab C, at 1. However, Dr. H stated that "he would not have
prescribed * * * hydrocodone [to SR] if he was aware [that] she was
receiving it from Dr. S." Id. Thereafter, Detective Hammond reviewed
Dr. H's chart on SR and noted that he "was aware that she was taking
hydrocodone." Id. Detective Hammond conducted a further interview in
which he asked Dr. H about this; Dr. H stated that "the medication
list shown in her records is generated automatically by computer from
SR's past visits and that she had been a patient since 2003." Id. Dr.
H further stated "that at the time in question he did not know [SR]
was receiving hydrocodone from Dr. S or he would not have given it to"
her. Id. Dr. H also stated that "he would have contacted Dr. S and
they would have decided who would be treating [SR] for pain to avoid an
overlap in [her] prescriptions." Id.
Detective Hammond also interviewed Dr. M, who had performed the
extraction. Id. at 2. Dr. M stated that if SR had "disclosed [that]
she was receiving hydrocodone from another doctor he would not have
prescribed it to her." Id.
Detective Hammond interviewed Dr. S, her former family physician.
Dr. S stated that SR had entered into a contract under which she was
not permitted to receive controlled substances from another physician
without his prior authorization. Id. Dr. S also stated that "[h]e did
not know that that [SR] was receiving pain medication from other
doctors," and that if he had known, "he would not have prescribed her
anything." Id. While Dr. S was aware that SR "was going to have
surgery and would potentially receive a controlled substance right
after surgery[,] * * * he was not aware that she was receiving
controlled substances from the surgeon beyond the initial surgery."
Id.
Finally, on May 19, 2010, Detective Hammond met with Dr. W. Id. Dr.
W, who had seen SR on April 8, 2010 and had prescribed 90 tablets of
hydrocodone to her, stated that she was unaware that SR was receiving
controlled substances from Dr. H; she also stated that SR was subject
to a controlled-substances contract pursuant to which she could not
obtain controlled substances from "other doctors without notifying"
her practice. Id. Dr. W further stated that she would not have
prescribed hydrocodone if she had known that SR was getting the drug
from "somewhere else." Id.
As noted above, all of SR's prescriptions were filled at Grider
2, where Eric Grider was the pharmacist charge. In her
decision, the ALJ made the following finding: "Mr. Eric Grider
believes, for it is his practice, that he would have told SR not to
take the hydrocodone prescribed to her by Dr. S while she takes the
stronger hydrocodone prescribed to her by Dr. M. However, he could not
specifically recall doing so in this instance, and he does not make
notes regarding such counseling because he usually does not have
time." ALJ at 44 (citing Tr. 3717-18, 3734-38). However, SR testified
that no one at Grider Drugs counseled her about her prescriptions. Tr.
4701-02, 4719. SR also testified that she was never questioned by a
pharmacist at Grider Drug 2 about the prescriptions she
received from Drs. S, M, or any other practitioners. Id. at 4719. She
was also unaware of anyone from that pharmacy contacting her
prescribers. Id. at 4724.
Eric Grider acknowledged that he had an obligation to counsel the
patient, given the therapeutic duplication noted in these
prescriptions. Id. at 3724. He also stated that he possibly would call
the prescribing practitioners, but he could not recall whether he
called Dr. H, and that he did not call Dr. M.\72\ Id.
[[Page 44093]]
at 3725-26. Likewise, he did not recall whether Dr. W had been
contacted regarding the therapeutic duplication involved in SR's
prescriptions. Id. at 3729. Grider denied that he had an obligation to
contact the prescribing practitioner, explaining that he views such
contact as a courtesy. Id. at 3727-28. Grider also testified that he
did not believe he had an obligation to call these physicians if he had
counseled the patient concerning the appropriate manner in which to
consume these duplicative drugs. Tr. 3730.
---------------------------------------------------------------------------
\72\ Eric Grider testified that he was aware that SR was seeing
Dr. H for a shoulder injury, and he believed SR had told him that
information. Tr. 3708. However, he did not contact Dr. H regarding
this surgery. Tr. 3789.
---------------------------------------------------------------------------
Grider also testified that he did not find the quantity of
hydrocodone he dispensed to SR to be unusual, given the limited number
of days' dosage represented by each prescription. Id. at 3597-98, 3716.
However, as found above, SR received 247 days of hydrocodone during a
period of a little more than six and one-half months' duration.
Dr. Sullivan observed that sixteen of SR's prescriptions were for
hydrocodone, and ten of these were filled too early because the patient
should still have had medication left from a previous prescription. GX
66, at 7.
Summary of Dr. Sullivan's Testimony
With respect to the six patients discussed above, Dr. Sullivan
concluded that "the evidence presented * * * is overwhelming and shows
a pattern of dispensing controlled substances significantly early to
patients who [were] either abusing controlled substances themselves or
[were] diverting prescription drugs for illegal purposes. There are
dozens of instances of this occurring in these six patients." GX 66,
at 8. The pharmacist should have caught this during the process of
conducting prospective [drug utilization reviews] before filling these
prescriptions." Id. at 2. Dr. Sullivan explained that it was
"extremely obvious" that these patients were "either abusing
controlled substances, obtaining them for the purpose of diversion, or
a combination of the two." Id. at 3. In addition, Dr. Sullivan noted
that while a pharmacist may "on an extremely rare occasion fill a
prescription for a controlled substances early," he then observed that
"[t]here are dozens of instances" of Respondents providing early
refills to these patients. Id. at 8.
Dr. Sullivan thus concluded that any "reasonable and prudent
pharmacist would have * * * refused to dispense controlled substances
to all six of these individuals." Id. Noting that these persons were
"textbook examples" of persons engaged in "drug abuse and/or drug
diversion," Dr. Sullivan explained that "[a]ny reasonable and prudent
pharmacist would quickly recognize this based on their education,
training, and experience." Id. Dr. Sullivan concluded that the
Respondents' dispensings to these patients violated the accepted
standards of practice observed by pharmacies and pharmacists in the
Commonwealth of Kentucky.\73\ Tr. 3426. I agree with Dr. Sullivan's
conclusions.
---------------------------------------------------------------------------
\73\ It is acknowledged that Dr. Sullivan is licensed in Ohio
but not Kentucky. Because of this, the ALJ explained that she did
not recognize Dr. Sullivan as an expert in the obligations of a
pharmacy specifically under Kentucky law, Tr. 3401-02, and that she
gave less weight to his testimony only as it relates to the unique
standards imposed by the Commonwealth of Kentucky. ALJ at 47 n.15.
The ALJ did not provide any further explanation as to what testimony
of Dr. Sullivan she gave less weight to.
In any event, even after Gonzalez v. Oregon, 546 U.S. 243
(2006), several courts of appeals "have applied a general-practice
standard when determining whether the practitioner acted in the
'usual course of professional practice.' " See United States v.
Smith, 573 F.3d 639, 647-48 (8th Cir. 2009); see also id. at 648
(discussing Moore; "Thus informed by the Supreme Court and other
controlling and persuasive precedent, we believe that it was not
improper to measure the 'usual course of professional practice'
under Sec. 841(a)(1) and [21 CFR] 1306.04 with reference to
generally recognized and accepted medical practices * * *."); see
also United States v. Merrill, 513 F.3d 1293, 1306 (11th Cir. 2008)
(quoting Moore, 423 U.S. at 139) ("The appropriate focus is not on
the subjective intent of the doctor, but rather it rests upon
whether the physician prescribes medicine 'in accordance with a
standard of medical practice generally recognized and accepted in
the United States.' "); United States v. Feingold, 454 F.3d 1001,
1009 (9th Cir. 2006) ("[B]oth the Supreme Court and this Circuit
have previously approved jury instructions that refer to a national
standard of care.").
Nor is Volkman v. DEA, 567 F.3d 215 (6th Cir. 2009), to the
contrary. As the Sixth Circuit observed, in Gonzales, the Supreme
Court invalidated the Attorney General's interpretive rule that
"[a]ssisting suicide is not a 'legitimate medical purpose' within
the meaning of 21 CFR 1306.04" and a violation of the CSA which
would subject a practitioner's registration to revocation under 21
U.S.C. 824(a)(4), without regard to whether state law authorized a
physician to engage in such conduct. Id. at 222 (other citation
omitted). The Sixth Circuit further explained that the Supreme Court
held in Gonzales that "the Controlled Substances Act does not give
the Attorney General the authority to 'define general standards of
medical practice.' " Id. at 223. Thus, the Supreme Court
invalidated the interpretive rule "because it was not based on the
'public interest' factors described in 21 U.S.C. Sec. 823(f) but
was instead the Attorney General's own judgment on a controversial
practice without regard to state law." Id. However, as the Sixth
Circuit further recognized, the Supreme Court affirmed that the CSA
"'regulates medical practice insofar as it bars doctors from using
their prescription-writing powers as a means to engage in illicit
drug-dealing and trafficking.' " Id. Thus, in Volkman, the Sixth
Circuit rejected a physician's challenge to the denial of his
application based on Gonzales, noting that the Agency's "assessment
of Volkman's prescribing and record-keeping practices was tethered
securely to state law," and that the Agency's action was consistent
with the CSA's "'recognition of state regulation of the medical
profession.' " Id. (quoting 546 U.S. at 272).
It is further noted that although Dr. Sullivan's testimony and
report were largely based on generally accepted standards of
pharmacy practice, he did review the Kentucky Board of Pharmacy's
rule on Drug Utilization Review. Tr. 3410-14; GX 66, at 2. With the
possible exception of the issue of whether under Kentucky law, a
pharmacy technician (rather than a licensed pharmacist or pharmacy
intern) can lawfully contact a prescribing physician to question the
legitimacy of a prescription, regarding which Dr. Sullivan testified
that "[t]echnicians should not be making those phone calls,
judgment or discussions with physicians, even if it's not that way
in Kentucky law," Tr. 3463-64, no other evidence was put forward
showing that the duties of a pharmacist to which he testified would
prohibit conduct permitted under state law. Thus, I find that his
testimony regarding a pharmacist's obligations to be generally
reliable and probative of whether Respondents (and their
pharmacists) violated their corresponding responsibility under
federal law.
---------------------------------------------------------------------------
Allegation Fifteen--Respondents Violated Kentucky Law by Failing To
Provide Complete and Accurate Information to KASPER
The Government also alleged that Respondents violated Kentucky law
by failing to file KASPER reports. Gov. Post-Hrng Br. at 12, 88. In
support of this allegation, the Government introduced into evidence a
letter (dated May 13, 2005) from Dave Sallengs, a Registered Pharmacist
and Pharmacist Investigator who is the manager of the Drug Enforcement
Professional Practices Branch of the Kentucky Cabinet for Health and
Family Services Office of the Inspector General, to Grider 2.
GX 28; Tr. 2302-03. Therein, Mr. Sallengs noted that the KASPER records
show that Grider 2 had not reported any prescriptions for the
periods of February 18 through 27, 2003; July 4 through August 4, 2003;
and February 1, 2005 to the date of the letter. GX 28. In addition, the
Government noted that the KASPER data reported by Respondents contained
numerous inaccuracies (such as the double reporting of prescriptions)
or the misreporting (or non-reporting) of various prescriber's DEA
registration numbers.
Mr. Sallengs, who was called as a witness by Respondents,
equivocated as to whether this letter established a serious breach of
state law by Grider 2. Tr. 2394-95. More specifically, Mr.
Sallengs testified that while "it's serious from the standpoint that
state law says you have to report, and it has to be within certain
days, but in our dealings with it, we understand that a lot of times *
* * the pharmacy might not even be aware of this until they get this
letter." Id. at 2394. Mr. Sallengs then explained that if his office
did not get a response from a pharmacy to such a letter (which they
send out to approximately fifteen to twenty pharmacies a week), it
would send out a follow-up letter and copy the letter to
[[Page 44094]]
the state pharmacy board, which would determine whether to cite the
pharmacy for a violation. Id. at 2395. Mr. Sallengs further explained
that the letter would not cause him to believe that a pharmacy was
being improperly operated because usually a pharmacy's failure to
report is due to either changing a computer system or a maintenance
problem with a computer system. Id. at 2396-97. With respect to the
letter sent to Grider 2, Mr. Sallengs did not know if his
office had sent out a second letter to it. Id. at 2398.
Moreover, Mr. Sallengs expressed the view that where multiple
entries under the same prescription number were reported within a few
days of each other, it was likely a result "of a glitch or a technical
error, [an] insurance billing issue, or something like that." Id. at
2391. Indeed, Mr. Sallengs testified that some pharmacy software
systems would report under a single prescription number, both when a
patient presented a prescription to a pharmacy but could not pay for it
that day, as well as the subsequent dispensing of the prescription. Id.
at 2338. Mr. Sallengs further noted that there were several innocent
explanations for the misreporting of various prescribers' DEA
registration numbers, including errors in using the database provided
by pharmacy software (which typically use a dropdown menu listing all
prescribers in the country and which may include both a practitioner's
current and expired registration numbers). Id. at 2323-25. Mr. Sallengs
also explained that from the inception of KASPER until two months
before his testimony, once a pharmacy reported information to the
database, it was not able to correct any errors in the data. Id. at
2446.
On cross-examination, Mr. Sallengs acknowledged that the May 13
letter set forth violations of state law which are a Class A
misdemeanor under Kentucky law. Id. at 2418. However, Mr. Sallengs
further testified that Kentucky law proscribed only the knowing or
intentional failure to transmit the information. Id. at 2485. Moreover,
Mr. Sallengs testified that while he would "love for everything to be
exactly right" in the KASPER reports, his office does not consider
every error to constitute a violation of the statute.
Allegation Sixteen--Respondents Committed Medicaid Fraud
While not alleged in the Order to Show Cause, the Government
provided notice in its initial and supplemental pre-hearing statements
that it intended to elicit the testimony of an Agent of the Medicaid
Fraud Division of the Kentucky Attorney General's Office. More
specifically, the Government provided notice that the Agent "will
speak of the recent indictment of Eric Grider, the son of Leon Grider,
on six counts related to devising schemes to defraud the Kentucky
Medical Assistance Program (KMAP)." Gov. Supplemental Pre-Hearing
Statement at 5-6.
At the hearing, there ensued nearly three days of testimony by the
Agent regarding her investigation of Respondents' billing practices,
the execution of a search warrant and the seizure of Respondents'
records by state officials, and the subsequent indictment of Eric
Grider on six state counts of having submitted fraudulent claims to the
KMAP "for prescriptions not dispensed as billed," GX 43. See Tr. 842-
1372. Regarding the alleged fraud, the Agent testified that "the
patient got what was prescribed" but that "Medicaid was billed for
something different" Tr. 1092, if the drug was not in the Medicaid
formulary. Id. at 1108; see also id. at 860 (Agent's testimony that
"if a patient came in with a prescription, that patient would receive
what the doctor ordered."). Throughout the Agent's testimony, there
was but a single vague comment relating the allegations of misconduct
to Respondents' handling of controlled substances, which occurred when
the Agent was asked by Respondent's counsel whether the types of drugs
being billed for and the types of drugs being dispensed were controlled
or non-controlled drugs, and answered: "They were across-the-board."
Id. at 1116. Ultimately, the indictment against Eric Grider was
dismissed by the state court, after it declared a mistrial. RX 128. No
further evidence has been offered establishing that the indictment was
reinstated and that Eric Grider (or Respondent) has been convicted of
an offense which subjects Respondents to mandatory exclusion from
participation in federal health care programs under 42 U.S.C. 1320a-
7(a).\74\
---------------------------------------------------------------------------
\74\ Of course, once the Government was allowed to pursue this
allegation, understandably, Respondents did not simply rely on their
counsel's cross-examination of the Agent but also put on the
testimony of their own witnesses regarding the allegations.
---------------------------------------------------------------------------
Discussion
Section 304(a) of the Controlled Substances Act provides that "[a]
registration * * * to * * * dispense a controlled substance * * * may
be suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render [its]
registration under section 823 of this title inconsistent with the
public interest as determined under such section." 21 U.S.C.
824(a)(4).\75\ In the case of a practitioner, which includes a
pharmacy,\76\ the CSA requires that the Agency consider the following
factors in making the public interest determination:
---------------------------------------------------------------------------
\75\ DEA is also authorized to suspend or revoke a registration
upon a finding that a registrant "has been excluded (or directed to
be excluded) from participation in a program pursuant to section
1320a-7(a) of Title 42." 21 U.S.C. 824(a)(5). However, the
Government did not cite this provision as a basis for the
proceeding.
\76\ See 21 U.S.C. 802(21).
---------------------------------------------------------------------------
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id. Sec. 823(f).
"[T]hese factors are * * * considered in the disjunctive." Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I may rely on any one or a
combination of factors, and may give each factor the weight I deem
appropriate in determining whether a registrant has committed acts
which render its registration inconsistent with the public interest.
Id. Moreover, although I "must consider each of these factors," I am
not required to make "explicit findings as to each" factor. MacKay v.
DEA, 664 F.3d 808, 816 (10th Cir. 2011); see also Volkman v. DEA, 567
F.3d 215, 222 (6th Cir. 2009) (quoting Hoxie v. DEA, 419 F.3d 477, 482
(6th Cir. 2005)); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C
Cir. 2005).
The Government has the burden of proving by a preponderance of the
evidence that a Respondent has committed acts which render its
registration inconsistent with the public interest. 21 CFR 1301.44(d) &
(e). However, where the Government has made out a prima facie case, the
burden shifts to the Respondent to either refute the Government's case
or to "'present [] sufficient mitigating evidence' " to show why,
notwithstanding that it has committed acts which render its
registration inconsistent with the public interest, it can be entrusted
with a new registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387
(2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting
Leo R.
[[Page 44095]]
Miller, 53 FR 21931, 21932 (1988))), pet. for rev. denied, Medicine
Shoppe-Jonesborough v. DEA, 300 Fed. Appdx. 409 (6th Cir. 2008). See
also MacKay, 664 F.3d at 817.
"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 FR at 387; see
also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709
(2006); Cuong Trong Tran, 63 FR 64280, 64283 (1998); Prince George
Daniels, 60 FR 62884, 62887 (1995).
Having considered all of the factors, I conclude that the evidence
pertinent to factors two and four makes out a prima facie showing that
each Respondent "has committed such acts as would render [its]
registration * * * inconsistent with the public interest." \77\ 21
U.S.C. 824(a)(4). I further conclude that Respondents have not rebutted
the Government's prima facie case.
---------------------------------------------------------------------------
\77\ As to factor one, the Kentucky Board of Pharmacy has not
made a recommendation in this matter. See 21 U.S.C. 823(f)(1).
Moreover, while there is no evidence that the State Board has
revoked either Respondent's pharmacy license or the pharmacist's
license of either Leon or Eric Grider, DEA has held repeatedly that
a registrant's possession of a valid state license is not
dispositive of the public interest inquiry. See Patrick W. Stodola,
74 FR 20727, 20730 n.16 (2009); Robert A. Leslie, 68 FR at 15230. As
DEA has long held, "the Controlled Substances Act requires that the
Administrator * * * make an independent determination as to whether
the granting of controlled substances privileges would be in the
public interest." Mortimer Levin, 57 FR 8680, 8681 (1992).
It is likewise noted that there is no evidence in the record
that either Leon or Eric Grider (or either of the Respondents) has
been convicted of any offenses under Federal or state laws related
to the distribution or dispensing of controlled substances. 21
U.S.C. 823(f)(3). However, there are multiple reasons why even
serious misconduct may not be the subject of a criminal prosecution
and thus, "the absence of such a conviction is of considerably less
consequence in the public interest inquiry." MacKay, 664 F.3d at
818. DEA has therefore recognized that the lack of any criminal
convictions related to controlled substances is not dispositive. See
Edmund Chein, 72 FR 6580, 6593 n.22 (2007).
Accordingly, that both Respondents may still hold Kentucky
pharmacy licenses and Leon and Eric Grider may still hold their
pharmacist licenses is not dispositive. So too, that neither the
Respondents, nor either Leon or Eric Grider, have been convicted of
an offense related to controlled substances, is not dispositive.
---------------------------------------------------------------------------
Factors Two and Four--Respondents' Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Laws Related to
Controlled Substances
While many of the allegations are not proved by substantial
evidence because the Government relied on inadmissible KASPER reports
and data (or failed to put forward anything other than conclusory
evidence), the record nonetheless establishes numerous violations on
the part of each Respondent. More specifically, substantial evidence
supports a finding that Leon Grider violated the CSA by distributing
controlled substances to several persons who did not have prescriptions
for the drugs and that both Respondents (and their pharmacists)
violated their corresponding responsibility under 21 CFR 1306.04(a) by
dispensing controlled substances to several individuals who were
clearly engaged in drug-seeking behavior. In addition, the record shows
that Respondents could not account for massive quantities of various
controlled substances they handled and thus violated their obligations
under 21 U.S.C. 827(a) to maintain complete and accurate records of the
controlled substances they purchased, distributed, or dispensed.
Finally, there is also substantial evidence establishing that
Respondents dispensed controlled substances but could not produce
either the original prescription or documentation that a prescription
was called in, that it filled (or refilled) prescriptions which were
not authorized by the prescriber, and that it failed to report several
theft incidents to DEA.
Leon Grider's Distributions to PL, LW, and BL
Under the CSA, "[p]ersons registered by the Attorney General * * *
to manufacture, distribute or dispense controlled substances * * * are
authorized to possess, manufacture, distribute, or dispense such
substances * * * to the extent authorized by their registration and in
conformity with the other provisions of this subchapter." 21 U.S.C.
822(b) (emphasis added). Under 21 U.S.C. 823(f), a pharmacy
registration authorizes its holder to dispense controlled substances,
i.e., "to deliver a controlled substance to an ultimate user * * * by,
or pursuant to the lawful order of, a practitioner." Id. Sec.
802(10).
The CSA further provides that "[e]xcept when dispensed directly by
a practitioner, other than a pharmacist, to an ultimate user, no
controlled substance in schedule III or IV, which is a prescription
drug as determined under the Federal Food, Drug, and Cosmetic Act, may
be dispensed without a written or oral prescription in conformity with
* * * 21 U.S.C. 353(b)." 21 U.S.C. 829(b); see also 21 CFR 1306.21 ("A pharmacist may dispense directly a controlled substance listed in
schedule III, IV, or V which is a prescription drug * * * only pursuant
to either a written prescription signed by a practitioner or a
facsimile of a written, signed prescription transmitted by the
practitioner or [her] agent to the pharmacy or pursuant to an oral
prescription made by an individual practitioner and promptly reduced to
writing by the pharmacist.").\78\ The CSA thus makes it "unlawful for
any person * * * who is subject to the requirements of part C [the
registration provisions] to distribute or dispense a controlled
substance in violation of section 829." 21 U.S.C. 842(a)(1). See also
21 U.S.C. 841(a)(1).
---------------------------------------------------------------------------
\78\ See also 21 CFR 1306.11(d) (except in emergency, "[a]
pharmacist may dispense directly a controlled substance listed in
schedule II, which is a prescription drug * * * only pursuant to a
written prescription signed by the practitioner").
---------------------------------------------------------------------------
As found above, on October 21, 2003, PL, who was cooperating with
law enforcement, went to Grider 1 and presented a methadone
prescription to Leon Grider; PL also told Grider that she needed some
Zs, a street term for Xanax. Tr. 1420-21. However, PL did not have a
prescription for Xanax. Id. at 1422. After leaving the pharmacy to have
a smoke, PL re-entered the pharmacy and then emerged with a white bag,
which she turned over to Detective Hammond. Id. at 1421. Upon
inspecting the bag, Hammond found a pill bottle holding methadone, as
well as thirty orange oval-shape pills, which were loose in the bottom
of the bag. Id. Hammond took custody of the orange pills and submitted
them for testing; the pills tested as Xanax. Id. at 1421-22.
Substantial evidence thus supports the conclusion that Leon Grider
violated the CSA in distributing Xanax to PL. 21 U.S.C. 829, 841(a)(1)
& 842(a)(1).
The evidence further shows that Leon Grider unlawfully distributed
controlled substances to LW on multiple occasions. On February 24,
2004, Leon Grider gave LW forty tablets of both hydrocodone and
alprazolam when LW, accompanied by her boyfriend, went to Grider
1 and told Leon Grider that they were going to court but were
short on their pills and were concerned that they would be subjected to
a pill count. Tr. 1495-96. LW did not have a prescription for the
drugs. Id. at 1497. Substantial evidence thus supports the conclusion
that Leon Grider violated the CSA in distributing
[[Page 44096]]
both hydrocodone and alprazolam to LW. 21 U.S.C. 829, 841(a)(1) &
842(a)(1).
On June 4, 2004, LW obtained drugs from Leon Grider without a
prescription on two occasions. First, in the morning, LW went to Grider
1 and obtained both Lortab (hydrocodone) and Xanax. As LW
testified, she just went in and asked Leon Grider for some pills which
he gave her loose in a brown bag. Tr. 6033. Given that placing loose
pills in a bag is not how a prescription is dispensed in the usual
course of professional pharmacy practice, see 21 CFR 1306.24, and that
Leon Grider did not testify in the proceeding, I conclude that he
distributed Lortab and Xanax to LW without a prescription.
Later that day, LW called Leon Grider asked him to bring her some
methadone. Tr. 1500. Grider agreed to do so and delivered both
methadone, which was in a sealed distributor's bottle and another 60
alprazolam (Xanax), which were in an envelope, to LW at her residence.
Id. at 1500-01. LW did not have a prescription for either drug. Id.
Substantial evidence thus supports the conclusion that on June 4, 2004,
Leon Grider unlawfully distributed Lortab, methadone, and alprazolam to
LW. See 21 U.S.C. Sec. Sec. 829, 841(a)(1), 842(a)(1).
On April 24, 2005, LW participated in a further undercover
operation. On this occasion, LW (accompanied by PG) met with Leon
Grider at a graveyard and asked him for some Duragesic patches. Tr.
1507-08; GX 27. Leon Grider agreed, and later that day, he met PG at a
local supermarket, where he gave PG nineteen or twenty Duragesic
patches and 88 Xanax pills. Id. at 1508-09; GX 27. Neither LW nor PG
had a prescription for the drugs. GX 27, at 2. Moreover, LW testified
that she told Leon Grider that she was going to sell the patches
because she needed money. Tr. 6092. Once again, substantial evidence
supports the conclusion that on April 24, 2005, Leon Grider violated
the CSA by unlawfully distributing Duragesic (fentanyl, a schedule II
drug) and alprazolam, to LW and PG. See 21 U.S.C. Sec. Sec. 829,
841(a)(1) & 842(a)(1).
In addition to the three undercover operations in which she
participated, LW credibly testified regarding other instances in which
she obtained controlled substances from Leon Grider. More specifically,
LW testified that when she was initially confronted by Detective
Hammond, Leon Grider gave her $1,000 and three 500-count bottles of
hydrocodone and told her that she "needed to leave town" to let the
authorities "slack off of [her] for a while." Tr. 5396, 5941-42. It
does not matter whether this conduct constituted bribing a witness
under Kentucky law. Rather, what matters is that this is another
example of Leon Grider's distributing controlled substances to LW when
she did not have a prescription authorizing the dispensing. Thus,
substantial evidence supports the conclusion that Leon Grider
unlawfully distributed 1,500 hydrocodone tablets to LW. See 21 U.S.C.
Sec. Sec. 829, 841(a)(1) & 842(a)(1).
LW also testified regarding an incident in which Leon Grider had
given her a 500-count bottle at the Key Village store only to have his
wife (Anna Mae) walk in on the deal. Tr. 5930-32. While Anna Mae
testified in the hearing that she took the bottle from LW and that the
pills were actually pinto beans, id. at 4803, as found above, in a
deposition she had previously given, Mrs. Grider testified that the
bottle (which was a white bottle and not a prescription vial) contained
hydrocodone. GX 68, at 212-15. Moreover, LW testified that the next
day, she called Leon Grider, who agreed to meet her at Grider
1, and that upon meeting, Grider gave her two 500-count
bottles. Tr. 5932-33. Once again, substantial evidence supports the
conclusion that on this occasion, Leon Grider unlawfully distributed
1,000 hydrocodone tablets to LW. See 21 U.S.C.
Sec. Sec. 829, 841(a)(1) & 842(a)(1).
LW further testified that she had also received 98 OxyContin
tablets as well some Suboxone, also without a prescription, and that
Leon Grider would create false prescription labels to provide cover for
LW if she was caught by the police. Tr. 5946, 6095-96, 6125. Thus,
substantial evidence supports the conclusion that Leon Grider
distributed both OxyContin and Suboxone to LW in violation of the CSA.
See 21 U.S.C.
Sec. Sec. 829, 841(a)(1) & 842(a)(1).
In addition, substantial evidence supports the conclusion that Leon
Grider unlawfully distributed Suboxone to BL when she did not have a
prescription for the drug. With respect to this allegation, the
evidence included a contemporaneous recording of a phone conversation
between BL and Chief Irvin in which BL acknowledged that Leon Grider
had given her the Suboxone when she was in the hospital and did not
have a prescription for the drug, photos of the vials (and their
labels) which Leon Grider used to distribute the drug that was
delivered, and the testimony of BL's daughter. In addition, while
Respondent produced a copy of a sales report listing BL's
prescriptions, and this report shows drugs that had previously been
prescribed to her, no refills were authorized under the previous
prescription and Respondents did not produce a copy of any prescription
corresponding to the prescription listed on the vials. I therefore hold
that substantial evidence supports the conclusion that Leon Grider
distributed Suboxone to BL in violation of the CSA. See 21 U.S.C.
Sec. Sec. 829, 841(a)(1) & 842(a)(1).
I further hold that Leon Grider's conduct in unlawfully
distributing controlled substances to PL, LW, and BL, is egregious, and
is sufficient, by itself, to support the conclusion that Respondents
have committed acts which render their registrations "inconsistent
with the public interest." 21 U.S.C. 824(a)(4). Thus, this conduct
provides reason alone to revoke each Respondent's registration and to
deny their applications to renew their registrations.
Respondents' Violations of 21 CFR 1306.04(a)
Under a longstanding DEA regulation, a prescription for a
controlled substance is unlawful unless it has been "issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice." 21 CFR 1306.04(a). This
regulation further provides that while "[t]he responsibility for the
proper prescribing and dispensing of controlled substances is upon the
prescribing practitioner, * * * a corresponding responsibility rests
with the pharmacist who fills the prescription." Id. (emphasis added).
Continuing, the regulation states that "the person knowingly filling
such a purported prescription, as well as the person issuing it, [is]
subject to the penalties provided for violations of the provisions of
law relating to controlled substances." \79\ Id.
---------------------------------------------------------------------------
\79\ As the Supreme Court has explained, "the prescription
requirement * * * ensures patients use controlled substances under
the supervision of a doctor so as to prevent addiction and
recreational abuse. As a corollary, [it] also bars doctors from
peddling to patients who crave the drugs for those prohibited
uses." Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United
States v. Moore, 423 U.S. 122, 135 (1975)).
---------------------------------------------------------------------------
DEA has consistently interpreted this 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.' " East Main St. Pharmacy,
75 FR 66149, 66163 (2010) (quoting Medicine Shoppe-Jonesborough, 73 FR
at 381 (quoting Medic-Aid Pharmacy, 55 FR 30043, 30044 (1990))); see
also Frank's Corner Pharmacy, 60 FR 17574, 17576 (1995); Ralph J.
Bertolino, 55 FR 4729, 4730
[[Page 44097]]
(1990); 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 FR at 4730
(citations omitted).
As the Government's Expert explained, pharmacists are required
under Kentucky law to perform a prospective drug utilization review
(DUR) prior to dispensing every prescription. See 201 Ky. Admin. Regs.
2:210; Sec. 4. The Kentucky regulation requires that the DUR "shall
include an assessment of a patient's drug therapy and the prescription
order." Id. In addition, the DUR "shall include a review by the
pharmacist of the" following:
(a) Known allergies;
(b) Rationale for use;
(c) Proper dose, route of administration, and directions;
(d) Synergism with currently employed modalities;
(e) Interaction or adverse reaction with applicable:
1. Drugs;
2. Foods; or
3. Known disease states
(f) Proper utilization for optimum therapeutic outcomes; and
(g) Clinical misuse or abuse.
Id.
The Government's Expert further identified various "red flags"
that pharmacists are trained to be aware of to identify suspicious and
unlawful prescriptions. These include: (1) When a patient is obtaining
controlled substances from multiple doctors, (2) when patients are
being prescribed duplicate controlled substance medications that treat
the same indications, (3) when patients seek early refills, (4) when
patients are obtaining prescriptions for large quantities and large
doses, and (5) when patients travel long distances from where they live
to either the prescriber or the pharmacy. Id. at 3404.
While Dr. Sullivan explained that when confronted with a red flag,
there are several steps a pharmacist can take including talking to the
patient, calling the physician, or refusing to fill the prescription,
he further opined that each of the six patients whose prescription
profiles were entered into the record were "textbook examples" of
persons engaged in "drug abuse and/or drug diversion." GX 66, at 8.
According to Dr. Sullivan, each patient "exhibited multiple instances
of" such red flags as obtaining controlled substances from multiple
doctors, obtaining duplicate controlled substances to treat the same
indication, and seeking early refills, i.e., filling a prescription or
seeking a refill when the patient should still have medication left
from a prior dispensing. Id. at 3. Dr. Sullivan thus concluded that
"any reasonable and prudent pharmacist would have caught this behavior
and refused to dispense controlled substances to" the six patients.
Id.
For example, TA, who filled all but three of her prescriptions at
either Grider 1 or Grider 2, obtained prescriptions
from twelve different prescribers including dentists, oral surgeons,
pain clinic doctors, a psychiatrist, and a nurse practitioner. The
record is replete with instances in which even though TA had recently
received controlled substances (and more specifically schedule II
(fentanyl and Endocet) and III narcotics (hydrocodone), which provided
lengthy supplies (25 to 30 day supplies), TA obtained more
prescriptions for the same or a similar drug which Respondents filled
notwithstanding that she should have had ample medication left from her
previous prescription. This pattern occurred over and over. See GX 66,
at 4 (Expert noting that it occurred eleven times in a ten-month
period). Moreover, even if TA had legitimate dental problems which
caused pain, Dr. G, a dentist who treated TA (who was called by
Respondent), testified that he would not have prescribed hydrocodone
even on a short-term basis if he had known that TA had recently
obtained narcotics from pain doctors. Tr. 4467, 4478-80, 4520. Dr. G
also testified that he was never called by Grider 1 regarding
any of the prescriptions TA was receiving from other practitioners.\80\
Id. at 4520.
---------------------------------------------------------------------------
\80\ TA herself admitted she did not tell the various dentists
she saw about the controlled substance prescriptions she was
obtaining from her pain management doctor. Tr. 3915-16.
---------------------------------------------------------------------------
Tonya Moses, a pharmacist and former employee of Respondents who
also testified on their behalf, acknowledged that Grider 1 had
filled hydrocodone prescriptions from a dentist which overlapped with
even stronger hydrocodone prescriptions TA received from a pain
management doctor. Ms. Moses further admitted that these prescriptions
were not justified and involved therapeutic duplication and that it was
"incumbent upon a pharmacist to verify with the doctor if he sees
multiple physicians prescribing, basically, the same medication." Id.
at 4214. And upon being shown TA's prescription profile, Dr. M, another
of Respondents' witnesses, acknowledged that TA's pattern of drug use
and seeing different doctors "would be a matter of major concern" and
"probably" was "a doctor-shopping situation." Id. at 5364-65. Yet
Grider 1's pharmacists did not even call the prescribers.
Dr. Sullivan further noted that in addition to such narcotics as
hydrocodone and Endocet, TA was also obtaining alprazolam and
carisoprodol, "which are known to be heavily abused." GX 66, at 4.
Accordingly, I agree with Dr. Sullivan's conclusion that "any
reasonable and prudent pharmacist would have determined that [TA] was
either abusing and/or diverting these controlled substances." Id. I
further conclude that substantial evidence supports a finding that
Respondents violated their corresponding responsibility in dispensing
controlled substances to TA.\81\ 21 CFR 1306.04(a).
---------------------------------------------------------------------------
\81\ Respondents took exception to the ALJ's conclusion that any
evidence as to TA's medical conditions is "irrelevant" because
there is no evidence that any pharmacist at Grider 1 was
aware of her conditions at the time the prescriptions were filled.
Resp. Exceptions, at 10 and 22 (citing ALJ at 31 n.12). However,
even if Leon Grider was aware of TA's medical condition, there is
unrefuted evidence that even where a patient may have a medical
condition warranting the prescription of controlled substances, a
pharmacist has a duty to determine whether filling a prescription
will result in therapeutic duplication and to take appropriate
action. Notably, Respondent's witness Ms. Moses testified that she
had reviewed the prescriptions of the various patients whose
prescriptions were the subject of the Immediate Suspension Order,
and while Ms. Moses offered testimony as to why various
prescriptions were filled for some of the patients, she offered no
testimony regarding any notations on TA's prescriptions establishing
that Leon Grider (or other any other pharmacist) notified the
prescribing physician that TA was receiving controlled substances
from other prescribers. In addition, while Respondents entered into
evidence TA's prescriptions, none of them contain a notation that
the pharmacist (whether Leon Grider or someone else) had called TA's
prescriber. See RX 120D. Moreover, Ms. Moses admitted that Grider
1 had filled prescriptions for TA that were unjustified.
Tr. 4202-03. I therefore reject this exception.
---------------------------------------------------------------------------
With respect to RB, the evidence shows that in a twenty-eight month
period, she filled 172 controlled substance prescriptions at
Respondents, with all but seven being filled at Grider 1. RB's
prescriptions were written by two doctors, and were for hydrocodone
tablets, alprazolam, and various narcotic cough syrups.
Regarding the latter medications, the Government's Expert gave
unrefuted testimony that these drugs are intended for short-term relief
of cough and that clinical guidelines were changed in 2006 (before any
of the prescriptions at issue were dispensed) to "strongly discourage
the use of any type of cough
[[Page 44098]]
suppressant in treating any type of cough." Tr. 3419. Yet RB filled
approximately 100 such prescriptions (for a total of 15,000 ml of the
drugs) at Respondents during the period and was obtaining the
prescriptions from two doctors. Tr. 3419-21; GX 66, at 4; GX 53, at Tab
C. Moreover, in addition to receiving the narcotic cough syrups, RB
also filled at Respondents prescriptions for hydrocodone tablets, which
she also was obtaining from the two doctors.
In other instances, Respondent filled prescriptions for hydrocodone
tablets issued by one doctor, even though RB should still have had a
large amount of hydrocodone tablets from a thirty-day prescription she
had recently filled which was issued by another doctor. Finally, the
evidence also shows that RB obtained early fills or refills of
prescriptions for hydrocodone tablets, narcotic cough syrups, and
alprazolam, even when the prescriptions had been written (or authorized
pursuant to an earlier prescription issued) by a single doctor. Indeed,
many of the dispensings were more than five days early, and some were
as much as nine to twelve days early.
RB testified that no one at Grider Drugs had ever talked to her
about her medications or questioned her about her prescriptions. Tr.
4676, 4688-89. Moreover, while Eric Grider, the pharmacist in charge at
Grider 2, where RB filled most of her prescriptions, testified
that narcotic cough syrups could be prescribed on a long-term basis for
COPD or chronic coronary disease with a cough, he subsequently admitted
that he did not know whether RB had either condition and had never
asked her doctors if she had either condition. Id. at 3673. As for Eric
Grider's self-serving testimony that even though RB was obtaining
medications from two doctors, he did not see any potential for abuse or
misuse of them by her;2 Grider eventually conceded that he should have
contacted her doctors to ensure that each was aware that the other was
also prescribing to her.\82\
---------------------------------------------------------------------------
\82\ Grider also asserted that he had no way of knowing whether
RB was a doctor shopper because Respondents did not have an account
with KASPER. I note that Dr. Sullivan offered no testimony as to
whether the standards of pharmacy practice in either Kentucky (or
nationally) require that a pharmacist use an available prescription
monitoring database where one is available. Thus, I place no weight
on Leon or Eric Grider's failure to run KASPER reports on any of the
six patients.
While Grider also asserted that because RB did not have
insurance, he had no way of knowing whether she was filling
prescriptions at other non-Grider stores, Tr. 3602, I note that
Grider did not even check to see what prescriptions RB filled at the
other Grider stores.
---------------------------------------------------------------------------
Dr. Sullivan concluded that RB's behavior clearly indicated that
she was either abusing and/or diverting controlled substances and that
this "should definitely have been caught by the pharmacist." GX 66,
at 4. He further noted that RB was obtaining duplicate therapy \83\ (in
that she was obtaining both narcotic cough suppressants and hydrocodone
tablets), and with respect to the Xanax, he concluded that "[n]o
reasonable and prudent pharmacist would fill Xanax prescriptions this
early on so many occasions." Id. at 5. I agree with Dr. Sullivan's
conclusions and I further conclude that substantial evidence supports a
finding that Respondents violated their corresponding responsibility in
dispensing controlled substances to RB. 21 CFR 1306.04(a).
---------------------------------------------------------------------------
\83\ As explained in footnote 52, while Dr. P provided an
unsworn statement that RB had "a legitimate reason to take pain
medicine," he offered no explanation as to why she needed to obtain
narcotics from another doctor. Nor did he explain what condition RB
had that warranted the long-term prescribing of narcotic cough
syrups or alprazolam. Indeed, Dr. P corroborated Detective Hammond's
statement that he did not know RB was seeing another physician until
April 2010.
---------------------------------------------------------------------------
As to JB, the evidence shows that during an eight-month period,
Grider 2 repeatedly filled prescriptions for alprazolam and
diazepam, which are both benzodiazepines, which she obtained from two
doctors. The evidence further shows that Grider 2 frequently
did this within days of having filled a previous prescription, and that
it even filled (or refilled) prescriptions JB presented for both drugs
on the same day. Moreover, during the eight-month period covered by
JB's prescription profile, Grider 2 dispensed eight alprazolam
prescriptions, each for a thirty-day supply, as well as nine diazepam
prescriptions, each being for a twenty-day supply, and thus provided
420-days' supply of these drugs during the period.
Regarding JB, Eric Grider offered the self-serving testimony that
JB's prescriptions did not raise a red flag and that they were not a
large number given the number of days' supply they provided. Tr. 3613,
3615. However, Grider offered no further explanation as to why it was
appropriate to dispense 420-days' worth of alprazolam and diazepam
during the eight-month period when these drugs are prescribed for the
same indication.
Moreover, Dr. Sullivan observed he could not "think of any
clinical reason why a patient would be using these two drugs at the
same time for a period of seven months" and that "[a]ny reasonable
and prudent pharmacy would not have filled prescriptions for these two
medications to be taken at the same time." GX 66, at 5. Dr. Sullivan
further explained that "[t]his is an obvious sign of either
prescription drug abuse and/or diversion." Id. I agree with Dr.
Sullivan's conclusions and hold that substantial evidence supports a
finding that Respondents violated their corresponding responsibility in
dispensing controlled substances to JB. 21 CFR 1306.04(a).
As for JR, it is undisputed that JR had been taking painkillers for
a back injury for a lengthy period of time and that he had been
recently diagnosed with colon cancer and had undergone various
procedures, including a colon re-section, and was undergoing
chemotherapy. However, while these were undoubtedly serious medical
conditions which could cause pain and warrant the prescribing of
controlled substances, Respondent Grider 1 filled
prescriptions JR was simultaneously obtaining from multiple doctors for
narcotics including OxyContin and hydrocodone.
It is acknowledged that Ms. Moses offered credible evidence
explaining why several of the short-term prescriptions were filled, as
well as why two of the OxyContin prescriptions had been filled early.
Moreover, even assuming (as Ms. Moses testified) that the refill
request form which Dr. W's office faxed into Grider 1
establishes that Dr. W was aware that JR was taking OxyContin for pain
control, it does not explain why Respondents also filled prescriptions
for both OxyContin and hydrocodone which JR was obtaining from Drs. K
(his surgeon) and B (a pain management specialist) at the same time he
was also obtaining hydrocodone from Dr. W.
With respect to JR's OxyContin and hydrocodone prescriptions, Dr.
Sullivan noted that while "on rare occasions, cancer patients will use
a second narcotic like hydrocodone for break-through pain on an 'as
needed basis' for a short-term period[,] [t]he same doctor would write
prescriptions for both." GX 66, at 6. As Dr. Sullivan then explained,
"[t]his is a major red flag that the patient was receiving hydrocodone
prescriptions from three different doctors and OxyContin from two
different doctors at the same time. Any reasonable and prudent
pharmacist would have caught this and not filled these prescriptions."
Id. In addition, Dr. Sullivan noted that "[o]f the thirty-three
controlled substance prescriptions filled" by Grider 1, "at
least eleven times the pharmacy filled the medication too early." Id.
[[Page 44099]]
Dr. Sullivan thus concluded that the "duplicate therapy with both
hydrocodone and oxycodone (OxyContin) from more than one prescriber is
a clear indication of drug abuse and/or diversion and any reasonable
and prudent pharmacist would have detected this." \84\ Id.
Accordingly, while JR had a serious medical condition for which the
prescribing of controlled substances was warranted, I conclude that
substantial evidence supports a finding that Grider 1 violated
its corresponding responsibility in dispensing multiple prescriptions
for these drugs to him. 21 CFR 1306.04(a).
---------------------------------------------------------------------------
\84\ As Detective Hammond found in reviewing JR's patient file,
there is other reliable evidence establishing that JR engaged in
drug abuse and/or diversion. See supra n.60. Moreover, as found
above, JR admitted to sharing his medications with others. While a
pharmacist would not have this information, Respondent did have
evidence that JR was obtaining prescriptions for the same drugs from
multiple doctors and yet chose to fill the prescriptions anyway.
---------------------------------------------------------------------------
The evidence with respect to CR shows that between November 2007
and early April 2010, he filled at Respondents approximately 163
prescriptions for such drugs as Demerol, hydrocodone/apap tablets,
various narcotic cough syrups, and alprazolam. While CR asserted that
he had a back injury, the evidence shows, throughout the period, that
while he received prescriptions from Dr. C for 120 tablets of Vicodin
5/500mg (a thirty-day supply), which he filled at Grider 1, he
also filled an additional 49 prescriptions for twenty tablets of
hydrocodone 7.5/650, which he obtained from Dr. P. Notably, CR filled
all but two of Dr. P's hydrocodone prescriptions at Grider 2.
In addition, on multiple occasions, CR filled prescriptions for both
hydrocodone tablets and narcotic cough suppressants.
In addition, CR obtained 64 alprazolam prescriptions and refills,
each being authorized by Dr. P and providing a thirty-day supply. All
but seven of these were filled at Respondents, and while CR eventually
started filling some of the alprazolam prescriptions at another
pharmacy, he did not do so until late April 2009. The evidence further
shows that on numerous occasions, Respondents filled or refilled an
alprazolam prescription within days of having filled or refilled a
prescription for the drug. As found above, CR obtained a total of 1,920
days' supply of alprazolam in a period lasting approximately 900 days.
CR admitted that he did not tell Dr. P that he was also getting
controlled substances from Dr. C, and claimed that Dr. P did not ask
him. Tr. 4029. Moreover, CR admitted that he never told Dr. C that he
was also receiving controlled substances from Dr. P. Id. at 4039.
Eric Grider admitted that he did not talk to Dr. P about CR.
Moreover, he then offered the self-serving testimony that because CR
was a cash-paying patient, he was unaware that CR was filling
prescriptions at other pharmacies; indeed, Grider raised the ostrich
defense, claiming that he "had no reason to" even check to see if CR
was filling prescriptions at Grider 1. Id. at 3619.
Most remarkably, Grider offered the patently disingenuous testimony
that he was unaware of unauthorized refills which occurred at Grider
2, notwithstanding that on February 1, 2008, it filled a new
alprazolam prescription even though it had refilled a prescription for
the drug the day before. GX 56, Tab C, at 2. Moreover, on April 30,
2008, Grider 2 dispensed a new alprazolam prescription even
though it had dispensed a refill of a previous alprazolam prescription
six days earlier, and on April 28, Grider 1 also filled an
alprazolam prescription for CR. Id. Thus, early on in the period
covered by the spreadsheet, Eric Grider had reason to know that CR was
engaged in either drug abuse or diversion. Yet Eric Grider failed to
question CR's doctors to determine if they knew that other doctors were
also prescribing to him and could not even be bothered to check to see
whether CR was filling prescriptions at Grider 1.
As Dr. Sullivan noted, "in multiple instances," CR filled
alprazolam prescriptions "early at both pharmacies," and did so
approximately fourteen times, with some of the refills occurring as
much as "twenty-nine days too early." GX 66, at 7. As Dr. Sullivan
further explained, "a reasonable and prudent pharmacist would never
have filled these alprazolam prescriptions as early as the Grider
pharmacies did. This shows a pattern of either abuse and/or drug
diversion." Id. I agree with Dr. Sullivan's conclusions and hold that
substantial evidence supports a finding that Respondents violated their
corresponding responsibility in dispensing controlled substances to
CR.\85\ 21 CFR 1306.04(a).
---------------------------------------------------------------------------
\85\ Upon being shown the evidence that CR had filled a
prescription for twenty-eight tablets of hydrocodone only six days
after filling a prescription for 120 hydrocodone tablets, Ms. Moses,
who testified on behalf of Respondent, stated that she would have
called the physician to let her know of the overlapping
prescription. Tr. 4429.
---------------------------------------------------------------------------
With respect to SR, the evidence shows that during a period of less
than seven months, she filled twenty-four controlled substance
prescriptions at Grider 2 for hydrocodone, oxycodone, and
clonazepam. Five of the hydrocodone prescriptions and one oxycodone
prescription were issued by Dr. H, an orthopedic surgeon; eight were
issued by Dr. S, a family practitioner; one by NP H, who was in the
same practice as Dr. S, and one by Dr. M, who was a dentist. More
specifically, on October 5, SR filled a prescription issued by Dr. S
for 42 hydrocodone 5/500, this being a fourteen-day supply; on October
13, she filled a prescription from Dr. M for twelve hydrocodone 7.5/
650, this being a three-day supply; and on October 21, she filled a
prescription issued by NP H for another 42 hydrocodone, also a
fourteen-day supply.
Other evidence shows that on October 8, 2009, SR had a tooth
extracted and that she was prescribed the hydrocodone for post-
operative pain. However, SR's dental records contained no indication
that she had reported her use of hydrocodone to Dr. M.
SR's prescriptions in March and April 2010 provide more convincing
evidence that she was engaged in doctor-shopping. Specifically, on
March 8, 2010, Dr. S (her family doctor) prescribed 90 tablets of
hydrocodone 5/500, a thirty-day supply, and on April 8, Dr. W (who
replaced Dr. S as her family doctor but was in the same office)
prescribed her another 90 tablets. Moreover, on March 10, 18, and 27,
as well as April 1 and 23, SR filled prescriptions issued by Dr. H,
each being for thirty tablets of hydrocodone 7.5/500.
Detective Hammond interviewed Drs. H, M, S, and W, each of whom
told Hammond that they would not have prescribed controlled substances
to SR if he/she had been aware that SR was obtaining controlled
substances from another physician. Drs. S and W further told Hammond
that SR was subject to a pain management contract pursuant to which SR
could not obtain controlled substances from another physician without
prior authorization. In addition, Dr. H stated that if he had known
that SR was receiving controlled substances from Dr. S, he would have
contacted Dr. S to ensure that they were not issuing overlapping
prescriptions.
By contrast, SR, who testified that she had undergone surgeries on
both her elbow and shoulder, testified that she told the admitting
nurse prior to a surgery performed by Dr. H that she was taking
hydrocodone fives, thus suggesting that Dr. H knew that she was
obtaining controlled substances from
[[Page 44100]]
her family doctor.\86\ Tr. 4721. However, in her decision, the ALJ did
not address whether she found SR's testimony, which was vague as to the
date of the incident, credible.
---------------------------------------------------------------------------
\86\ SR also testified that she did not tell her family
practitioner about the prescription she had obtained from her
dentist "because it was in between visits when I got the ones
from" the dentist. Tr. 4722. The Government also asked SR whether
she told Dr. W that she was receiving controlled substances from Dr.
S; SR, who was apparently confused by the question, testified that
she told Dr. W that she had gotten pain medicine after her surgery.
Id. at 4723. However, as noted above, Drs. S and W were both family
practitioners who worked at the same office.
---------------------------------------------------------------------------
In any event, I conclude that it is not necessary to resolve this
dispute because Eric Grider acknowledged that SR's prescriptions
involved therapeutic duplication and he did not recall having called
either Dr. H or Dr. W. Indeed, Grider denied having any obligation to
call SR's prescribers, asserting that such contact was "a courtesy"
and that he fulfilled his obligation if he counseled a patient as to
the appropriate manner in which to take the drugs. However, SR
testified that she was neither questioned by anyone at Grider
2 about her prescriptions nor counseled as to how to take the
medications.
As Dr. Sullivan testified, when confronted with evidence of red
flags, there are several things a pharmacist can do, including having
an extensive conversation with the patient, calling the physician, or
refusing to fill the prescription. Id. at 3448-49. However, with
respect to SR, Eric Grider did none of the above. Indeed, as Dr.
Sullivan testified, it is clear that Respondents did not do prospective
DUR with respect to any of the six patients even though this is
required by the Kentucky Board of Pharmacy's rules. Id. at 3453-54. I
therefore conclude that substantial evidence supports a finding that
Grider 2 dispensed controlled substances to SR in violation of
21 CFR 1306.04(a).
I further hold that Respondents' dispensing violations are
egregious and provide further support for the conclusion that each has
committed acts which render its registration "inconsistent with the
public interest" and thus support the revocation of its
registration.\87\ 21 U.S.C. 824(a)(4).
---------------------------------------------------------------------------
\87\ Respondents further contend that the Government was "only
able to identify these six instances of what [it] alleges to be
'doctor shopping.' " Respondent Exceptions, at 21. Suffice it to
say that the Government's evidence is more than enough to sustain
the allegations, given that several of the patients demonstrated a
sustained pattern of obtaining prescriptions for similar drugs
issued by different prescribers or presenting numerous early
refills.
Respondents also contend that because Dr. Sullivan based his
conclusions "by looking only at the prescription patterns" of the
patients and testified that he was generally unaware of their
medical conditions, this does not constitute substantial evidence of
doctor-shopping. Id. at 21-22 & n.3. However, with respect to
several of the patients, several of Respondent's witnesses
acknowledged that the prescription patterns were indicative of
doctor-shopping. Indeed, even Eric Grider conceded (albeit,
grudgingly) that CR was a doctor shopper; he also acknowledged that
he should have called RB's and SR's prescribers.
---------------------------------------------------------------------------
The Audits
As found above, DEA Investigators performed two audits of
Respondents' handling of controlled substances. However, the Government
conceded that the first audit was flawed because it included both
purchases and distributions which occurred outside of the audit period.
While the supervisory DI performed a second audit on a limited number
of controlled substances, this audit was also flawed because it relied
on KASPER data (notwithstanding that Kentucky does not guarantee the
accuracy of the data, Tr. 2335, and KASPER reports contain this caveat,
id. at 2337), rather than the dispensing records which Respondents are
legally required to maintain under the CSA and DEA regulations to
determine the quantities of drugs which they dispensed.
Recordkeeping is one of the CSA's principal tools for preventing
the diversion of controlled substances. Paul H. Volkman, 73 FR 30630,
30644 (2008). Under the Act, "every registrant * * * dispensing a
controlled substance or substances shall maintain, on a current basis,
a complete and accurate record of each such substance * * * received,
sold, delivered, or otherwise disposed of by him." 21 U.S.C. 827(a)
(emphasis added). I have further explained that "a registrant's
accurate and diligent adherence to [its recordkeeping] obligations is
absolutely essential to protect against the diversion of controlled
substances." Volkman, 73 FR at 30644.
One of the purposes of performing an audit is to assess a
registrant's level of compliance with the CSA's recordkeeping
requirements. Thus, using data from a non-CSA required record rather
than CSA required records, cannot, by definition, provide an accurate
picture as to the adequacy of a registrant's compliance with section
827.\88\ That error is compounded where, as here, the source of the
data expressly disclaims any guarantee that its data is accurate and it
is unclear to what degree the reports are accurate. Indeed, the DI
acknowledged that he had "no idea how accurate" the KASPER data was.
Tr. 622. Thus, this audit was also flawed.
---------------------------------------------------------------------------
\88\ This is not to say that using other data sources would be
inappropriate in all cases. For example, if sizeable portions of a
registrant's dispensing records are missing, use of data or records
from a non-CSA source would be justified to determine whether
diversion is occurring. Of course, in such a case, it would already
be clear that the registrant had failed to comply with its
recordkeeping obligations. However, in this case, there is no
evidence that either of the Respondents was missing any dispensing
records.
---------------------------------------------------------------------------
Nonetheless, I agree with the ALJ's conclusion that the results of
the "consultation examination" performed by Stivers and Associates
provide substantial evidence that Respondents cannot account for
significant quantities of various controlled substances and thus have
violated section 827. ALJ at 85-87. Indeed, the shortages and overages
that Stivers found at each of the Grider stores are stunning and
establish that Respondents have committed egregious recordkeeping
violations and likely diverted thousands of dosage units (d.u.) of
controlled substances.
As found above, Grider 1 had shortages of the following
benzodiazepines: 2,316 d.u. of alprazolam, 6,372 diazepam, and 2,191
lorazepam. With respect to the narcotics it handled, Grider 1
had shortages of 28,097 d.u. of hydrocodone, 462 Duragesic (fentanyl)
patches, 500 Lorcet, 375 Lortab, 214 Endocet, and 200 Vicodin. Grider
1 also had overages of 7,568 clonazepam, 3,025 methadone,
1,751 phentermine, 1,335 oxycodone, 514 Stagesic, and 262 OxyContin.
Grider 2 had shortages of 17,875 d.u. of OxyContin, 8,135
hydrocodone, 3,207 methadone, 3,203 phentermine, 2,013 Stagesic, 1,253
lorazepam, 428 Ambien, and 290 Duragesic. It also had overages of 8,615
clonazepam, 2,787 diazepam, 662 Valium, 619 Lorcet, 425 Endocet, 342
Lortab, and 109 Vicodin.
Moreover, even after combining the shortages and overages for all
three stores, Respondents had shortages of 1,496 alprazolam, 7,329
diazepam, 4,928 lorazepam, 605 Duragesic (fentanyl) patches, 35,418
hydrocodone, 16,998 OxyContin, and 2,791 phentermine. Respondents also
had overages of 31,951 clonazepam, 15,747 methadone, 1,051 Lorcet, 900
oxycodone, 889 Lortab, 871 Endocet, and 872 Valium.\89\ As explained in
my findings of fact, under the CSA, Respondents are required to
maintain accurate and complete records for each registered location and
for each finished form of a drug.
---------------------------------------------------------------------------
\89\ To make clear, under section 827, each registrant is
required to maintain complete and accurate records. While I discuss
the combined figures for all three stores, as found above, each of
the Grider stores could not account for massive quantities of
controlled substances.
---------------------------------------------------------------------------
In their Exceptions, Respondents contend that its audit "was not
presented as a final and accurate audit
[[Page 44101]]
of the period in question" but "was presented to demonstrate that the
DEA audit was not reliable." Exceptions at 5. Mr. Hicks, however,
testified at length as to the procedures his firm employed in
performing its examination and it is clear that those procedures
provided an accurate result. For example, while Respondents argue that
Mr. Hicks "did not review some prescriptions when he performed the
audit," his report stated that he tabulated the quantities of the
dispensings from the Respondents' pc V computer software system
Narcotic and Controlled Substances Drug Sales Report, a record which
constitutes a dispensing record for purposes of the CSA. See RX 101, at
63.
Because Registrants are required to maintain the dispensing records
under federal law and Agency regulations, and those records are
required to be "complete and accurate," 21 U.S.C. Sec. 827, an audit
is not rendered invalid because the hard copy prescriptions were not
reviewed. Indeed, in performing audits, DEA personnel typically review
only the dispensing log to determine the respective quantities of the
various controlled substances which have been distributed.
Equally unpersuasive is Respondents' claim that the Stivers'
results were skewed by "an inaccurate beginning inventory."
Exceptions, at 5. As Mr. Hicks explained in his report, his firm "used
the same beginning inventory [May 31, 2003] as the DEA did." RX 101,
at 62. However, the evidence shows that the beginning inventories which
DEA used were actually inventories which Respondents had themselves
performed. Thus, if the beginning inventories used by Mr. Hicks's firm
were inaccurate, it is because Respondents themselves did not take
accurate inventories. Moreover, Mr. Hicks was adamant that the ending
inventories were reliable, Tr. 2095, and that he had relied on "source
documentation," i.e., records provided by the companies that sold
controlled substances to Respondents to determine their purchases. Id.
at 2102.
Thus, it is patently disingenuous for Respondents to now assert
that their own audit is not reliable. And as explained above, each DEA
registrant is required to maintain complete and accurate records for
each controlled substance it handles. Thus, the testimony of Mr. Hicks
that when all the controlled substances are added up across all three
stores, the audit shows an overage of 644 pills, which in his view is
immaterial, is utter nonsense. Rather, the audit reflects an abject
failure on Respondents' part to comply with the CSA's record keeping
requirements and gives substantial credence to the Government's
contention that Respondents were engaged in massive diversion. This
provides further reason to conclude that Respondents have committed
acts which render their registrations "inconsistent with the public
interest." 21 U.S.C. 824(a)(4).
Other Violations
As explained above, a principal component of the Government's
evidence in support of many of the remaining allegations was data or
reports obtained from KASPER. However, because the Government did not
obtain a court order, it cannot rely on that evidence in this
proceeding. Nonetheless, a few of the allegations were proved by
substantial evidence.
For example, in several instances, the Government produced copies
of labels for various prescriptions which were dispensed and yet they
could not find either the original signed prescriptions or a called-in
prescription which authorized the dispensing. These included
prescriptions for hydrocodone (see GX 15, at 4; Tr. 422) and Xanax (GX
16, at 6; Tr. 442). As explained previously, under 21 U.S.C Sec. 829 and 21 CFR 1306.21(a), a pharmacist may dispense controlled substances
(in schedules III through V) "only pursuant to either a written
prescription signed by a practitioner or a facsimile of a written,
signed prescription transmitted by the practitioner or the
practitioner's agent to the pharmacy or pursuant to an oral
prescription made by an individual practitioner and promptly reduced to
writing by the pharmacist." 21 CFR 1306.21(a). Moreover, a pharmacy is
required to maintain the prescription for a period of two years.\90\ 21
U.S.C. 827(b); 21 CFR 1304.04 (a) & (h).
---------------------------------------------------------------------------
\90\ Respondents also take exception to the ALJ's finding that
they dispensed controlled substances without retaining a hard copy
of the prescriptions "because the only basis for the alleged
violations are[sic] the failure of Agent Otero to find the hard
copies of the prescriptions in the records he seized" on August 19,
2004. Resp. Exceptions at 24. Respondents further noted that on
November 21, 2005, the State Pharmacy Board seized its prescriptions
pursuant to three administrative subpoenas, and that they have been
unable to obtain copies of the documents seized by the Pharmacy
Board. Id.
Respondents thus argue that "the substantial evidence that the
Respondents did not have hard copies of some prescriptions for
schedule II drugs was Otero's inability to find those hard copies in
the record the DEA seized. There was no evidence presented by the
Government that Otero had searched the records seized by the
Kentucky Pharmacy Board to determine whether the missing hard copies
of the prescriptions in question were there." Id. at 25.
DI Otero testified, however, that during the search, the
Investigators could not find some of the prescriptions, even though
under Federal law, Respondents were required to maintain them at the
respective registered location. Tr. 213; 671-72. This testimony is
more than enough to provide substantial evidence that Respondent
could not provide hard copies of various prescriptions. Contrary to
Respondents' understanding, the Investigators were not required to
conduct a subsequent search to establish this violation, let alone a
review of the records seized by another agency more than a year
later.
Respondents also contend that because of the ongoing state
criminal proceedings against both Leon and Eric Grider, the ALJ
"should not [have] allow[ed] the inability of the Respondents to
rebut these alleged violations by providing the requisite hard
copies of the prescriptions and call-in scripts carry the day * * *
when it is a matter of record that the Respondents have been
deprived of their records throughout these proceedings." Resp.
Exceptions, at 26.
To make clear, DEA did not deprive Respondents of any of their
records, but rather allowed them to make copies of the records
seized by the Agency. Tr. 214-16. Beyond this, the argument is to no
avail because under Federal law and DEA regulations, Respondents
were required to have the prescriptions at issue on hand and
available on the date of the DEA search. See 21 U.S.C. 827(b)
("Every inventory or other record required under this section * * *
shall be kept and be available, for at least two years, for
inspection and copying by officers or employees of the United States
authorized by the Attorney General."); see also 21 CFR 1304.04(a).
---------------------------------------------------------------------------
In addition, the record contains substantial evidence (apart from
KASPER data) that Leon Grider provided an unauthorized refill of a
Lortab (hydrocodone) prescription to BW. See GX 30; GX 70; Tr. 3040,
3050-52, 3054-55. Dr. CS, BW's physician, testified that BW wanted to
get off of Lortab and that she was tapering BW off of the drug and had
authorized no refills. Nonetheless, Leon Grider provided refills to BW,
thus interfering with the clinical judgment of Dr. CS. It is manifest
that Grider's action is outrageous and threatened the safety of BW.
The Government further established that a number of the
prescription labels Respondent prepared contained the name of a
physician other than the one who had actually prescribed the drug. See
GX 26, at 1-2; 7-8; 9-10. This is a violation of 21 CFR 1306.24(a)
("The pharmacist filling a prescription for a controlled substance
listed in schedule III, IV, or V shall affix to the package a label
showing the pharmacy name and address, the serial number and date of
initial filling, the name of the patient, [and] the name of the
practitioner issuing the prescription * * *.") (emphasis added). In
addition, other evidence shows that Respondent put false prescription
labels on bottles. See Tr. 5946, 6095-96, 6126 (testimony by LW) and
Tr. 3201, GX 71 (Chief Irvin's testimony and evidence of duplicate pill
bottles for BL).
Finally, the Government also established that on several occasions,
[[Page 44102]]
Respondents failed to report thefts of controlled substances to DEA.
This is a violation of 21 CFR 1301.76(b), which requires that a
registrant "notify the Field Division Office of the Administration in
his area, in writing, of the theft and significant loss of any
controlled substances within one business day of the discovery of such
loss or theft" and to complete and submit a written report of the
incident on DEA Form 106. However, these violations are relatively
minor when compared to the other misconduct proved in this matter.
The Government also contends that Respondents violated Kentucky law
by failing to provide complete and accurate information to KASPER. See
Gov. Post-Hearing Br., at 100-101. However, under Kentucky law, only
the knowing or intentional failure to transmit such information is a
violation and there is no evidence that the State has undertaken
enforcement action against Respondents, let alone held them to be in
violation. Indeed, much to the Government's dismay, Mr. Sallengs, the
director of KASPER, did not seem particularly troubled by Respondents'
various reporting errors and omissions. In light of this, I dismiss
this allegation.
Factor Five
In its post-hearing brief, the Government also contends that the
findings of an investigation of the Kentucky Medicaid Fraud Division
establish that Grider 2 engaged in the billing fraud when it
billed Medicaid for drugs that were not actually dispensed including
controlled substances. Gov. Post-Hrng. Br., at 92. However, in support
of its contention, the Government offered nothing more that the
conclusory assertion that "[f]actor five is also relevant to findings
of the investigation of the Kentucky Medicaid Fraud Division that * * *
Grider Drug 2 unlawfully billed Medicaid (including
transactions involving prescriptions for controlled substances) where
prior authorization was not provided." Id. The Government did not cite
any authority for its position.
The ALJ agreed with the Government, reasoning that this conduct
constitutes "[s]uch other conduct which may threaten public health and
safety" because "[w]hen a registrant clearly engages in conduct
involving controlled substances that is untruthful, that registrant
creates yet another risk of diversion." ALJ at 93-94 (citing Alexander
Drug Company, Inc., 66 FR 18299, 18304 (2001); Nicholas A. Sychak, d/b/
a Medicap Pharmacy, 65 FR 75959,75968 (2000); Arthur Sklar, d/b/a King
Pharmacy, 54 FR 34623, 34627 (1989)). Based on her finding that Eric
Grider and another pharmacist "reported to Medicaid one medication
when they actually dispensed another" and that "[t]hese medications
included controlled substances," the ALJ further explained that "the
prescription check and balance such Medicaid reporting creates was
circumvented by this false method of reporting" and that "[w]ithout
such trust and truthfulness, the system of monitoring the transit of
controlled substances falls apart." Id. at 94.
However, while two of the three cases cited by the ALJ arguably
support the proposition that billing fraud constitutes conduct which is
actionable under factor five, in both cases the creation of a
fraudulent record was clearly part of a scheme to divert controlled
substances. For example, in Alexander Drug, a pharmacist had dispensed
lorazepam to himself "without a prescription issued by a practitioner
in the usual course of professional practice" and then created a false
prescription in his wife's name because her insurance did not require a
co-payment. 66 FR at 18301. Likewise, in Sychak, there were findings
which support the conclusion that the billing fraud was engaged in as
part of a scheme to divert drugs. Id. at 75965 (noting interview of
pharmacy employee that when she reviewed her prescription profile, she
"discovered numerous prescriptions listed as billed to her insurance
carrier that were allegedly issued to her by various physicians she had
never seen for drugs she had never received" and that when the
employee confronted the pharmacist, he replied: "How do you think I
pay for your health insurance?").\91\
---------------------------------------------------------------------------
\91\ As for Sklar, that case contains no discussion of billing
fraud and whether it is actionable conduct under factor five.
---------------------------------------------------------------------------
Most significantly, more than seven weeks before the ALJ issued her
decision in this matter, I issued my Decision in Terese, Inc., D/B/A
Peach Orchard Drugs, 76 FR 46843 (2011). Yet the ALJ failed to even
acknowledge Terese, let alone explain why it is not controlling.
In Terese, the Agency sought, pursuant to its public interest
authority, to revoke a pharmacy registration issued to the spouse of a
pharmacist, who had opened up a new pharmacy, after her spouse and his
pharmacy had been convicted of health care billing fraud. Id. Therein,
the Government alleged four reasons for doing so: (1) The pharmacy
owner's spouse had been convicted of health care fraud and mandatorily
excluded from participation in federal health care programs pursuant to
42 U.S.C. 1320a-7(a); (2) that the pharmacy had materially falsified
its state Medicaid application; (3) that the pharmacy had failed to
provided information that was requested by the state Medicaid program;
and (4) that the convicted pharmacist had unlawfully dispensed Medicaid
controlled substance prescriptions. Id. There was, however, no evidence
substantiating the allegation that the convicted pharmacist (and his
pharmacy) had committed violations of the CSA. Id. at 46846.
In rejecting the Government's contentions, I noted that the CSA, as
originally enacted, authorized the revocation of a registration only on
the following three grounds: (1) Where a registrant has materially
falsified an application for registration; (2) where a registrant has
been convicted of a felony related to controlled substances; and (3)
where a registrant is no longer authorized by state law to handle
controlled substances. See 21 U.S.C. 824(a)(1)-(3). I further noted
that it was not until 1984 that Congress, having concluded that the
existing grounds had proved "'overly limited"' and had "'a severe
adverse impact on Federal anti-diversion efforts,"' amended the CSA to
add the public interest authority. 76 FR at 46847-48 (quoting H.R. Rep.
No. 98-1030, at 266 (1984)).\92\ However, in Terese, I also noted that
Congress did not amend section 824 to grant the Agency authority to
revoke the registration of an individual or entity subject to mandatory
exclusion by the Secretary of HHS from Medicare or Medicaid until three
years after it enacted public interest provisions. Id. at 46848
(discussing history of 21 U.S.C. 824(a)(5)).
---------------------------------------------------------------------------
\92\ The House Report was reprinted in 1984 U.S.C.C.A.N. 3182,
3448.
---------------------------------------------------------------------------
Moreover, as I explained in Terese, under 42 U.S.C. 1320a-7(a), the
Secretary's mandatory exclusion is triggered only when an individual or
entity has been convicted of one of four categories of offenses such as
for "program-related crimes," which includes, in part, "a criminal
offense related to the delivery of an item or service under * * * 42
U.S.C. Sec. Sec. 1395 et seq. * * * or under any State health care
program," or "a conviction 'under Federal or State law, in connection
with the delivery of a health care item or service or with respect to
any act or omission in a health program * * * operated by or financed
by any Federal, State, or local government agency, of a criminal
offense consisting of a felony relating to fraud, theft, embezzlement
[[Page 44103]]
* * * or other financial misconduct."' 42 U.S.C. 1320a-7(a) (emphasis
added). Accordingly, a person or entity's DEA registration is not
subject to revocation under section 824(a)(5) unless he/it has been
convicted of an offense falling within one of the four enumerated
categories. Notably, section 824(a)(5) does not give the Agency
authority to revoke the registration of a person or entity which is
subject only to the Secretary's permissive exclusion authority, even
though the Medicare/Medicaid exclusion statute contains some sixteen
separate grounds for permissive exclusion, many of which involve acts
of misconduct which reflect adversely on the truthfulness of the person
subject to the exclusion. See 42 U.S.C. 1320A-7(b).
In Terese, I further explained that under the Government's
interpretation of the scope of its authority under the CSA's public
interest provisions, there was no need for Congress to enact section
824(a)(5) and that its interpretation would render this provision, and
the limitation it imposes, meaningless. 76 FR at 46848. However, as I
noted, statutes "are not to be construed in a manner that renders
their texts superfluous." Id. (citing Bloate v. United States, 130
S.Ct. 1345 1355 (2010) (quoting Duncan v. Walker, 533 U.S. 167, 174
(2001) ("[A] statute ought, upon, the whole, to be so construed that,
if it can be prevented, no clause, sentence or word shall be
superfluous, void, or insignificant."))). In short, were an allegation
that a Registrant has committed Medicaid fraud actionable under factor
five of the public interest standard as "such other conduct which may
threaten public health and safety," then Congress did not need to
amend section 824 by adding subsection (a)(5). Yet not only did
Congress amend the statute, it then limited the Agency's revocation
authority to those instances in which a registrant has been convicted
of a felony enumerated in 42 U.S.C. 1320A-7(a).
In Terese, I also explained that where an allegation both
implicates a public interest factor (or another of the Agency'
revocation authorities), as well as falls within the Secretary's
permissive exclusion authority, DEA retains authority to revoke under
the applicable authority of section 824. However, as Terese makes
clear, the Agency cannot disregard clear statutory text and the CSA's
history. Thus, even though it is indisputable that committing billing
fraud is egregious misconduct, simply overcharging the Government
without more does not necessarily threaten "threaten public health and
safety." 21 U.S.C. 824(a)(5).
As explained above, the ALJ concluded that Respondent's alleged
Medicaid billing falls within factor five because "the prescription
check and balance such Medicaid reporting creates was circumvented by
this false method of reporting" and that "[w]ithout such trust and
truthfulness, the system of monitoring of controlled substances falls
apart." ALJ at 94.
However, there is no evidence in this proceeding that Medicaid
billing records are used to monitor the disposition of controlled
substances and whether they are being diverted, and as explained above,
the CSA creates its own scheme of recordkeeping to monitor the
disposition of controlled substances. Second, to the extent the
Government's evidence even constitutes substantial evidence of billing
fraud--an issue which need not be decided--there is no evidence that
Grider 2's pharmacists engaged in the fraud as part of a
scheme to divert controlled substances.
As the KBI agent testified, the fraud involved billing for a drug
in the Medicaid formulary when a patient brought in a prescription for
a drug which was not covered by the formulary and would require pre-
authorization. However, the KBI Agent testified that the patient
received the drug that the doctor prescribed. Indeed, while in response
to the question of whether the drugs involved controlled or non-
controlled substances, the KBI Agent testified that "[t]hey were
across-the-board," Tr. 1116, neither the Agent in her testimony, nor
any of the Interview Summaries of Respondents' employees, provide any
basis for concluding that Respondents engaged in the scheme to
facilitate the diversion of controlled substances.
In short, the Government's evidence simply establishes run-of-the-
mill billing fraud, without any further proof as to how the fraud
threatened public health or safety as required under factor five.
Moreover, no evidence was offered that either Eric Grider or Grider
2 has been convicted of health care fraud and is subject to
mandatory exclusion from participation in federal health care programs
pursuant to 42 U.S.C. 1320a7(a).
This is not to deny the ALJ's well-placed concern that the
commission of health care fraud raises a serious question as to the
trustworthiness of a registrant. However, with respect to allegations
that a registrant has engaged in health care fraud, because the CSA
limits the Agency's revocation authority to those instances in which a
registrant has been convicted of an offense which subjects it to
mandatory exclusion, absent evidence that the fraud was engaged in as
part of scheme to divert controlled substances, the CSA clearly
contemplates that these allegations are to be litigated in the first
instance in federal and state criminal courts, and not in DEA
registration proceedings.\93\ The allegation is thus not properly
considered in this proceeding.
---------------------------------------------------------------------------
\93\ Even where there is evidence that billing fraud was engaged
in as a part of a scheme to divert controlled substances, the fraud
is, at most, secondary to the diversion and adds little to the
Government's case. In this matter, the Government's decision to
litigate the issue resulted in at least five days of additional
testimony (if not more) and prompted an interlocutory appeal, thus
further delaying the resolution of the serious charges raised in
this matter. Notwithstanding the importance of the issue to its case
(at least as presented at the hearing), the Government's discussion
of the allegation produced but a single sentence in its brief.
---------------------------------------------------------------------------
Summary of the Government's Case
As found above, under factors two and four, the Government has
proved with substantial evidence numerous violations of the CSA. These
include: (1) Leon Grider's distribution of controlled substances either
without a prescription or by providing refills which were not
authorized by the prescribing physician; (2) Respondents' repeated
dispensing of controlled substances to persons who were obviously
either engaged in drug abuse or diversion; (3) Respondents' clear
inability to account for substantial amounts of the controlled
substances they handle; (4) their inability to provide prescriptions
for various dispensings; and (5) the creation of false prescription
labels. In sum, Respondents (and their principals, Leon and Eric
Grider) have committed egregious misconduct which supports the further
finding that they have "committed such acts as would render [their]
registration[s] * * * inconsistent with the public interest" and which
supports the revocation of their registrations. 21 U.S.C. 824(a)(4). I
further conclude that the allegations underlying the Immediate
Suspension Order have been proved by substantial evidence.
Sanction
Where, as here, the Government has made out a prima facie case, the
burden shifts to the Respondents to " 'present[ ] sufficient
mitigating evidence' " to show why, notwithstanding that it has
committed acts which render its registration inconsistent with the
public interest, it can be entrusted with a new registration. Medicine
Shoppe-Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S Jackson,
72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932
(1988))), pet.
[[Page 44104]]
for rev. denied, Medicine Shoppe-Jonesborough v. DEA, 300 Fed. Appdx.
409 (6th Cir. 2008). See also MacKay, 664 F.3d at 817.
"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 FR at 387; see
also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709
(2006); Cuong Trong Tran, 63 FR 64280, 64283 (1998); Prince George
Daniels, 60 FR 62884, 62887 (1995).
Respondents have utterly failed to rebut the Government's prima
facie case. With respect to Grider 1, as the ALJ noted, Leon
Grider, the pharmacist in charge at Grider 1, and the
principal owner of both pharmacies, did not testify in the
proceeding.\94\ Moreover, Grider 1 produced no evidence as to
corrective measures it has undertaken to prevent a re-occurrence of the
misconduct it has committed. Thus, Respondent has produced no evidence
that it (as well as its owner and pharmacist in charge) accept
responsibility for their misconduct and that they will not engage in
future misconduct.\95\ Cf. Baxter v. Palmigiano, 425 U.S 308, 319
(1976) ("[T]he Fifth Amendment does not forbid adverse inferences
against parties to civil actions when they refuse to testify in
response to probative evidence offered against them.").
---------------------------------------------------------------------------
\94\ The Government did not call Leon Grider to testify; nor did
he testify on Respondents' behalf.
\95\ Other evidence, while not essential to reach this
conclusion, supports this finding. Specifically, the evidence shows
that even though Leon Grider was aware that he was under
investigation, he continued to unlawfully distribute controlled
substances to persons such as LW and BL.
---------------------------------------------------------------------------
While Eric Grider testified regarding the violations committed by
Grider 2, he acknowledged that only one of the patients (CR)
to whom Grider 2 had unlawfully dispensed controlled
substances was engaged in doctor-shopping, and even then, did so
grudgingly. Moreover, when taken as a whole, Eric Grider's testimony
manifests that he neither accepts responsibility for his misconduct nor
has implemented corrective measures to prevent diversion in the future.
For example, when confronted with evidence of a patient obtaining
prescriptions from multiple doctors, Grider testified that he
nonetheless considers calling the prescriber to be a courtesy. As a
further example, Grider testified that he would not even check to see
if a patient was obtaining controlled substances from his father's
store. Finally, Grider offered no evidence as to any remedial measures
which have been undertaken at Grider 2. Thus, I conclude that
Eric Grider remains utterly indifferent as to the scope of his and
Grider 2's obligations under both Kentucky and Federal law to
prevent the abuse and diversion of controlled substances. Accordingly,
I conclude that Respondents have failed to rebut the Government's case.
Respondents nonetheless argue that I should reject the ALJ's
conclusions that because Leon Grider did not testify, there is no
evidence that he is remorseful or has implemented any corrective
measures. Resp. Exceptions at 6. Noting that they made "repeated
efforts to stay this proceeding," Respondents argue that because Leon
Grider was under two state court indictments at the time of this
hearing, the ALJ should have stayed this proceeding until the
conclusion of the two state criminal cases so as not to " 'undermine
the party's Fifth Amendment privilege against self-incrimination.' "
Id. at 8-9 (quoting SEC v. Dresser Industries, Inc., 628 F.2d1368,
1375-76 (D.C Cir. 1980)).\96\
---------------------------------------------------------------------------
\96\ On June 4, 2008, Respondent filed a motion "to stay the
proceedings until after October 10, 2008, the date Leon Grider's
Kentucky State Court Trial is presently scheduled to conclude."
Therein, Respondents "stipulated and agreed that any continuance of
the Russell Circuit Court trial beyond October 10, 2008 will not be
a basis to extend the stay of proceedings, should the Administrative
Judge grant this motion and order the requested stay of
proceedings." Motion for Stay, at 3. Having made this
representation, Respondents cannot now complain that the ALJ
eventually lifted the stay.
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Respondents acknowledge that " 'as a general matter, due process
is not infringed merely because an accused person is subjected, without
his consent, to an administrative hearing concerning matters involved
in a pending criminal proceedings.' " Id. at 9 (quoting 628 F.2d at
1376 n.21). However, Respondents point to Dresser Industries' further
dictum that "an administrative proceeding can in some circumstances
prejudice the rights of a citizen or the government," and that "
'[i]n such cases the agencies and courts may have a duty to take
appropriate correction action.' " Id. Thus, they argue that Leon
Grider's decision "not to testify in this proceeding should not be
used against the Respondents in any way in these proceedings," and
that "having declined to continue these proceedings despite Leon
Grider facing two pending state criminal indictments, this tribunal
cannot in turn penalize Leon Grider for declining to testify in this
hearing." Id.
Respondents' argument gives no reason to reject the ALJ's
conclusions.\97\ The Fifth Amendment protects a witness only from being
compelled to testify against himself. Notably, the Government did not
call Leon Grider as a witness, and in any event, the Fifth Amendment
privilege is not "a sword whereby a claimant asserting the privilege
[is] freed from adducing proof in support of a burden which would
otherwise have been his." United States v. Rylander, 460 U.S 752, 758
(1983). See also MacKay, 664 F.3d at 820 (quoting Keating v. Office of
Thrift Supervision, 45 F.3d 322, 326 (9th Cir. 1995)).
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\97\ As Dresser Industries notes, "[t]he civil and regulatory
laws of the United States frequently overlap with the criminal laws
creating the possibility of parallel [administrative] and criminal
proceedings, either successive or simultaneous" and that "[i]n the
absence of substantial prejudice to the rights of the parties
involved, such parallel proceedings are unobjectionable." 628 F.2d
at 1374. As the D.C. Circuit observed: "[t]he Constitution * * *
does not ordinarily require a stay of civil proceedings pending the
outcome of criminal proceedings." Id. at 1375.
While the D.C. Circuit further explained that "the strongest
case for deferring civil proceedings is where a party under
indictment for a serious offense is required to defend a civil or
administrative action involving the same matter," the potential
harm to a party's Fifth Amendment privilege is just one of four
reasons which may justify staying the noncriminal proceeding. Id. at
1375-76. Continuing, the court explained that "[i]f delay of the
noncriminal proceedings would not seriously injure the public
interest, a court may be justified in deferring it." Id. (emphasis
added).
It is, of course, commonplace that matters involving DEA
registrants will lead to both a revocation proceeding and a criminal
investigation and subsequent charges at either the federal or state
level. Moreover, the very purpose of a proceeding brought under 21
U.S.C. 823(f) and 824(a)(4) is to protect the public interest.
Here, it is noted that the ALJ did stay the proceeding for
approximately nine months (between June 2008 and March 2009).
Moreover, even after the stay was lifted, the actual hearing did not
commence until August 11, 2009, five months later, and Respondents
did not start putting on their case until December 2009. At that
point, the two criminal cases against Leon Grider had been pending
since August 2005, and thus for more than four years.
It is further noted that during the period of the stay,
Respondents continued diverting controlled substances. Thus, the
delay of this proceeding did cause serious injury to the public
interest. As this case demonstrates, under Dresser, a stay of a DEA
revocation proceeding brought under section 824(a)(4) is unlikely to
ever be justified.
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As explained above, it is settled that where the Government has
established a prima facie case, "the burden shifts to the [registrant]
to show why [its] continued registration would be consistent with the
public interest." MacKay, 664 F.3d 817 (citing cases). Because
Respondents have failed to rebut the Government's prima facie case, I
will revoke the existing
[[Page 44105]]
registration of Grider Drug 1 and deny the pending application
of both Grider Drug 1 and Grider Drug 2.\98\
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\98\ Respondents further contend that an email from the
supervisory DI to the DI he initially assigned to conduct the
investigation, evidences "bad faith or malicious government
tactics" and that the tribunal therefore has "a duty to take
appropriate corrective actions" to ensure that Leon Grider's
decision not to testify, because of the two state criminal cases, is
not used against Respondents "in any way." Resp. Exceptions at 10
(citing RX 103) (emphasis added).
In support of their contention, Respondents quote the following
paragraph from an email the supervisory DI wrote to his subordinate,
who had expressed concern as to whether she could handle the matter:
All we need to do with [Leon Grider] is document how many
scripts are bad for possible criminal sanctions, how many civil
violations he has for nonconformance and a fine, and what we intend
to do when we have the full picture (revocation/suspension/etc.). It
will just take a while, that's all. He got off the hook before. We
will not give him the opportunity this time. We cannot cut corners
with him. We will drown him in violations. The more concrete the
violation, the better.
Id. (quoting RX 103).
This email does not even remotely establish bad faith or
malicious intent on the part of the supervisory DI. Indeed, in a
subsequent portion of the email, the supervisory DI told his
subordinate to "look[] for bogus scripts, unauthorized refills, and
failure to comply with prescriptions requirements, such as refilling
schedule II's," each of which constitutes a violation of the CSA.
RX 103. He then instructed her "to be methodical. Pick a doctor
with lots of scripts and question them. Record the bad ones and
write a report. Look at whether any of these were filled early per
KASPER, per early refill book, that would confirm fraudulent
reporting." Id.
Notably, nowhere did the supervisory DI instruct his
subordinate to find violations even in the absence of probable cause
or to violate Leon Grider's constitutional rights. And ultimately,
Respondents were allowed to test the Government's evidence with
respect to every violation of the CSA which it alleged. Likewise,
each of the two state criminal proceedings was initiated by
indictment, which requires a finding of probable cause.
I therefore reject Respondent's contention that it was improper
for the ALJ to rely on Leon Grider's silence in concluding that
Respondents had not rebutted the Government's prima facie case.
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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), I order that DEA Certificate of
Registration AG3498347, issued to Grider Drug 1, be, and it
hereby is revoked. I further order that any pending applications of
Grider Drug 1 and Grider Drug 2, be, and they hereby
are, denied. This Order is effective immediately.\99\
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\99\ Based on the extensive and egregious acts of diversion
proved on this record, I concluded that the public interest
necessitates that this Order be effective immediately. See 21 CFR
1316.67.
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Dated: July 13, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-17973 Filed 7-25-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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