[Federal Register Volume 75, Number 207 (Wednesday, October 27, 2010)]
[Notices]
[Pages 66149-66165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27096]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09-48]
East Main Street Pharmacy; Affirmance of Suspension Order
On April 23, 2009, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to East Main Street Pharmacy (``Respondent''), of Columbus,
Ohio. The Show Cause Order proposed the revocation of Respondent's DEA
Certificate of Registration, BE5902615, as a retail pharmacy, as well
as the denial of any pending applications to renew or modify its
registration, ``for reason that [Respondent's] continued registration
is inconsistent with the public interest, as that term is used in 21
U.S.C. 823(f) and 824(a)(4).'' ALJ Ex. 1, at 1. More specifically, the
Order alleged that Respondent had violated its corresponding
responsibility under Federal regulations to not fill unlawful
prescriptions. Id. at 2 (citing 21 CFR 1306.04(a)).
The Show Cause Order alleged that Respondent was owned by Eugene H.
Fletcher, Respondent's sole pharmacist, and that from ``September 2005
through February 2006'' it ``filled 6,619 controlled substance
prescriptions'' including 4,979 prescriptions issued by Dr. Paul
Volkman of Portsmouth, Ohio. Id. at 1. The Show Cause Order further
alleged that on February 10, 2006, DEA had immediately suspended
Volkman's registration and that the Agency subsequently found that he
had ```repeatedly violated Federal law by prescribing controlled
substances without a legitimate medical purpose and outside the course
of professional practice.''' Id. (citing Paul H. Volkman, 73 FR 30630,
30642 (2008)). The Order also alleged that ``Dr. Volkman directed his
patients to have their prescriptions filled at'' Respondent, who
``filled them mostly in exchange for cash,'' and that ``[n]inety-eight
percent of Dr. Volkman's patients that filled their prescriptions at
[Respondent] did not reside in the Columbus area.'' Id. Relatedly, the
Order alleged that some of Volkman's patients travelled from Portsmouth
and Chillicothe, Ohio to Respondent, a distance of 92 and 45 miles,
respectively; that one of Volkman's patients had travelled from South
Central Kentucky to Respondent to obtain his prescriptions, that many
of Volkman's patients were obtaining prescriptions from other
physicians, and that several of these persons died of overdoses. Id. at
2.
The Show Cause Order further alleged that Respondent ``filled
prescriptions for combinations of controlled substances and the non-
controlled, but highly addictive drug carisoprodal [sic] (Soma), under
circumstances indicating that the prescriptions were issued outside the
usual course of professional practice.'' Id. at 2. More specifically,
the Order alleged that Respondent filled for numerous patients of
Volkman, ``large quantity prescriptions'' for a benzodiazepine, two
narcotic pain medications, and Soma, and that ``[t]hese drug
combinations are generally known in the medical and pharmacy profession
as being favored by drug-seeking individuals.'' Id. The Order also
alleged that Respondent ``filled several of the above combination
prescriptions when the patients should have had two to three weeks'
supply of medication from a previous prescription'' and it either ``did
not recognize, or ignored these indicators of drug diversion and
abuse.'' Id.
Finally, the Order alleged that, with regard to Dr. Volkman's
prescriptions, Mr. Fletcher had told a DEA Investigator ``that it was
`not [his] job to question a physician.' '' Id. Based on the above, the
Order alleged that Respondent ``knew, or should have known that [the]
controlled substance prescriptions it filled for patients of Dr.
Volkman were for no legitimate medical purpose.'' Id.
By letter of May 20, 2009, counsel for Respondent timely requested
a hearing.\1\ ALJ Ex. 2, at 1. The matter was then placed on the docket
of the Agency's Administrative Law Judges (ALJs), and an ALJ proceeded
to conduct pre-hearing procedures.
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\1\ Therein, Respondent denied the allegations maintaining that
``Mr. Fletcher, based on his experience, training, and expertise,
reasonably believed that all prescriptions filled were for a
legitimate medical purpose'' and that he ``frequently exercised
independent judgment to determine if the prescriptions were for
legitimate medical purposes, and often refused to fill prescriptions
written by licensed medical doctors, including Dr. Volkman.'' ALJ
Ex. 2, at 2.
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On May 26, 2009, the ALJ issued an Order for Pre-Hearing
Statements. ALJ Ex. 14. The ALJ's order directed the parties to prepare
a written statement, to be filed with the Hearing Clerk and served on
opposing counsel, disclosing the ``names and addresses of all witnesses
whose testimony is to be presented.'' Id. at 2. The ALJ further ordered
the parties to provide a:
[b]rief summary of the testimony of each witness, with the
Government to indicate clearly each and every act, omission or
occurrence upon which it relies in seeking to revoke Respondent's
DEA Certificate of Registration, and the Respondent to indicate
clearly each and every matter as to which it intends to introduce
evidence in opposition thereto. The summaries are to state what the
testimony will be, rather than merely listing the areas to be
covered. The parties are reminded that testimony not disclosed in
the prehearing statements or pursuant to subsequent filing is likely
to be excluded at the hearing.
Id.
On July 31, 2009, the ALJ conducted a pre-hearing conference call
with the parties and also issued a Prehearing Ruling. See ALJ Ex. 3. In
her Prehearing Ruling, the ALJ ordered that ``[i]f either party chooses
to amend its witness list, it must file a supplement to its Prehearing
Statement, noting any changes. The names of additional witnesses must
be listed, along with a summary of the proposed testimony.'' Id. at 2.
The ALJ further ``reminded'' the parties ``that testimony not
summarized in prehearing statements or
[[Page 66150]]
supplements thereto may be excluded at the hearing.'' Id.
Pursuant to my authority under 21 U.S.C. 824(d), on November 10,
2009, I further ordered that Respondent's registration be suspended
immediately because its ``continued registration * * * constitutes an
imminent danger to the public health and safety.'' ALJ Ex. 8, at 1. The
Immediate Suspension Order incorporated by reference the allegations of
the Order to Show Cause and cited the additional allegations that
Respondent had recently filled more prescriptions for controlled
substances for two persons who were travelling substantial distances to
obtain the drugs. Id. at 1-2.
More specifically, the Immediate Suspension Order alleged that on
October 2, 2009, L.D.C., a resident of Portsmouth, Ohio obtained from a
physician practicing in Wheelersburg, Ohio, prescriptions for 90
tablets of oxycodone 30 mg. and 60 tablets of carisoprodol (a non-
controlled but highly abused drug which metabolizes into meprobamate, a
Schedule IV depressant), and that she then travelled ``approximately
100 miles from Wheelersburg to Columbus'' and filled the prescriptions
at Respondent. Id. at 2. The Order alleged that the next morning,
L.D.C. ``was found dead at her residence * * * with a prescription vial
identifying [Respondent] as the dispensing pharmacy and several
scattered oxycodone tablets * * * next to her body,'' and that the
Coroner's Office had preliminarily determined that she ``died from the
* * * `probable toxic effects of drugs (oxycodone, carisoprodol and
others).' '' Id.
The Immediate Suspension Order also alleged that on various dates
including July 3, September 1, and October 1, 2009, Respondent had
filled various prescriptions for oxycodone issued to S.J.P., of
Waverly, Ohio. Id. The Order alleged that Waverly, Ohio is
``approximately 64 miles from Columbus'' and that the prescriptions
were issued by physicians who practiced ``in Lees [sic] Summit,
Missouri,'' as well as in Dayton and Portsmouth, Ohio, which are 78 and
92 miles, respectively, from Respondent. Id.
The Order thus alleged that Respondent ``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
``[b]y dispensing such prescriptions, [Respondent] failed to fulfill
its corresponding responsibility for the proper dispensing of
controlled substances.'' Id. at 3. Based on the above, I concluded that
there was a ``substantial likelihood that [Respondent] will continue to
violate its corresponding responsibility to properly dispense
controlled substances'' and that Respondent's continued registration
during the pendency of the proceeding ``would constitute an imminent
danger to the public health and safety.'' Id. I, therefore, ordered
that Respondent's registration be suspended.
On November 18-19, 2009, as well as on March 23-25, 2010, the ALJ
conducted a hearing in Columbus, Ohio.\2\ At the hearing, both parties
elicited testimony from witnesses and submitted documentary evidence
into the record. Following the hearing, both parties filed briefs
containing their proposed findings of fact, conclusions of law, and
argument.
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\2\ On February 4, 2010, the Government filed a motion in limine
to exclude the testimony of various witnesses for Respondent on the
ground that their names and an adequate summary of their testimony
had not been previously disclosed as required by the ALJ's Order for
Pre-Hearing Statements. ALJ Ex. 20. At the hearing on March 23, the
Government renewed its motion. The ALJ found that Respondent's
Counsel had violated her Order because ``the Summary of Witnesses
[sic] testimonies was not provided by the deadlines, and the summary
that was provided is topical in nature, and not specific'' and did
not provide ``full disclosure of proposed witness testimony.'' Tr.
786-87. While deeming ``such conduct abhorrent'' and acknowledging
that the Government's Motion ``in all [of] parameters should be
granted,'' she nonetheless allowed Respondent to call all of its
witnesses even though the Government was ``being prejudiced'' by the
inadequacy of the disclosure. Id. at 786-88. This was because the
ALJ understood that she has ``a responsibility to develop a
record.'' Id. at 787.
The ALJ's comments reflect a clear misunderstanding of her
role. Proceedings under sections 303 and 304 of the Controlled
Substances Act are adversarial and not inquisitorial in nature. As
such, it is not the ALJ's role but rather that of the parties to
develop the record; the ALJ's role is to ensure that the parties do
so in accordance with the Agency's rules of procedure and the
Administrative Procedure Act and that the proceeding is conducted
with due regard for the Respondent's rights under the Due Process
Clause.
Equally troubling is the ALJ's failure to resolve the issues
raised by the Government's motion prior to the second phase of the
hearing, which did not reconvene until March 23, 2010. Notably,
Respondent filed its response to the Government's motion and its
second supplemental pre-hearing statement on February 12, 2010;
surely, at some point during this nearly six-week-long period and
prior to the hearing, the ALJ could have ruled on the motion and
issued an appropriate order.
However, while I find the ALJ's delay in handling the motion and
her ruling disturbing, much (if not most) of the evidence presented
in this matter (including that presented by the Government) is not
probative of the issue of whether Respondent violated 21 CFR
1306.04(a). Moreover, many of Respondent's witnesses testified as to
the character/reputation of its owner; while disclosure regarding
these witnesses should have been more detailed, the prejudice to the
Government was minimal.
As to the remaining witnesses, only three of them (Mark Aalyson,
Catherine Smith, and Carisa Cole) offered any testimony that is
arguably relevant to, and probative of, the central issue. Notably,
in its post-hearing brief, the Government does not contend that it
was prejudiced by inadequate disclosure of the testimony of these
witnesses. I therefore conclude that Government has not preserved
its objection.
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On May 18, 2010, the ALJ issued her Recommended Decision. Applying
the public interest factors, see 21 U.S.C. 823(f), the ALJ concluded
that the ``record demonstrates that it is against the public interest
for the Respondent to retain its controlled substances registration''
and recommended that ``Respondent's registration be revoked and any
pending applications for renewal be denied.'' ALJ at 54.
Under the first factor--the recommendation of the appropriate State
licensing board or professional disciplinary authority--the ALJ found
that ``the Ohio Board of Pharmacy has not made a recommendation in this
proceeding.'' Id. at 45. The ALJ further found, however, that on March
5, 2009, the Board had fined Mr. Fletcher and placed his license on
probation because he ``did not ensure, on three separate occasions,
that a qualified person was at * * * Respondent to receive deliveries
of controlled substances,'' which ``were left at unsecure locations
pending his arrival at the Respondent. '' Id. The ALJ concluded that
this ``security violation weighs in favor of revocation'' of
Respondent's registration. Id.
As to the second factor--Respondent's experience in dispensing
controlled substances--the ALJ found that ``Respondent ignored numerous
`red flags' when dispensing controlled substances to Dr. Volkman's
patients.'' Id. at 46. In particular, the ALJ relied on the testimony
and report of the Government's Expert that various patients of Volkman:
(1) were driving long distances to have their prescriptions filled,
(2) were receiving large volumes of controlled substances in the
highest strength in each prescription, (3) were not receiving
individualized therapy, for 75% of these patients received the same
four drug `cocktail,' (4) were paying large amounts of cash for
their prescriptions, and (5) were receiving multiple narcotic pain
killers on the same day.
Id.
Noting Agency precedent 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 prescriptions,' '' id. at 47 (quoting Ralph J.
Bertolino, 55 FR 4729, 4730 (1990)), the ALJ concluded that Respondent
``clos[ed] a blind eye to these obvious red flags,'' and accordingly,
``was not taking seriously its corresponding responsibility for these
prescriptions'' to
[[Page 66151]]
these patients. Id. (citing 21 CFR 1306.04(a)).
The ALJ also noted that ``[m]any of Dr. Volkman's patients had told
[Respondent's owner] that other pharmacies would not fill Dr. Volkman's
prescriptions'' and yet Respondent's owner did not call these other
pharmacies to ask why. Id. She also noted that Respondent had an
``unconventional'' relationship with Volkman in that Volkman referred
his patients to Respondent, that Mr. Fletcher and Volkman's office
would coordinate keeping Respondent ``open late in the evenings'' so
that Volkman's patients could fill their controlled substance
prescriptions, and that it ``kept large quantities of controlled
substances on hand to fill these large prescriptions.'' Id. at 48.
Relatedly, the ALJ found that one of Volkman's patients credibly
testified that she had filled prescriptions at Respondent ``while
exhibiting `high' behavior such as slurred speech, stumbling walk, and
probably `drooling.' '' Id. at 49.
The ALJ further found that ``a number of Dr. Volkman's patients
died from drug overdoses after having prescriptions filled at the
Respondent'' and that while ``these patients were often drug addicts
who did not take the prescription drugs in the manner prescribed,'' the
quantities Respondent dispensed ``provided these patients with the
means to ingest such quantities as to cause an overdose death.'' Id. at
47. The ALJ also found that the quantities Respondent dispensed were
large enough not only to support various Volkman patients' ``own
addiction, but to also sell the extra controlled substances to provide
the income needed for the next prescriptions, or to sponsor someone
else in their quest for the drugs needed to feed their addiction.'' Id.
at 48.
While noting that Respondent's owner had called Dr. Volkman ``to
verify his legitimacy,'' as well as ``a local attorney to inquire about
Dr. Volkman's reputation in the community,'' that he had called other
prescribing physicians to verify prescriptions, and that he required
customers to show identification prior to dispensing controlled
substances and had no security issues beyond those for which he was
cited by the Ohio Board, the ALJ concluded that ``Respondent's failure
to react to the `red flags' raised by the conduct of Dr. Volkman's
patients and the dispensing patterns the Respondent used for these
patients weigh in favor of revocation.'' Id. at 49-50.
As to the third factor--Respondent's conviction record under
Federal or State laws relating to the manufacture, distribution, or
dispensing of controlled substances--the ALJ found that the record
``contains no evidence of a conviction of * * * Respondent or Mr.
Fletcher related to the dispensing of controlled substances.'' ALJ at
50.
As to the fourth factor--Respondent's compliance with applicable
State, Federal, or local laws relating to controlled substances--the
ALJ found that ``Respondent violated recordkeeping requirements by
failing to have readily retrievable biennial inventories'' and thus
violated 21 U.S.C. 827(a)(1) and 21 CFR 1304.11(c). Id. The ALJ also
found that ``Mr. Fletcher failed to do drug utilization reviews prior
to dispensing controlled substances.'' Id. at 51.
Next, the ALJ found that ``in 2008 and 2009, [Mr. Fletcher]
conducted searches on the OARRS \3\ database'' for ``individuals who
had predeceased the search'' and thus ``violat[ed] the requirement that
he only search this database for current customers.'' Id. She also
found that ``Respondent's banking conduct related to its dispensing
business violated bank structuring laws and regulations'' because ``Mr.
Fletcher made deposits just short of $10,000, thus avoiding the
reporting requirement of the Bank Secrecy Act.'' Id.
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\3\ Ohio Automated Rx Reporting System. The law allowing the
Ohio Board of Pharmacy (BOP) to develop its prescription monitoring
program (OARRS) became effective May 18, 2005; the rules
implementing the law went into effect on January 1, 2006. GX 18, at
2 (Ohio Automated Rx Reporting System Handbook). These rules require
every pharmacy (including out-of-State pharmacies) that ``services
outpatients and dispenses to an Ohio residence any controlled
substance or any product containing tramadol or carisoprodol'' ``to
submit the dispensing information to the BOP.'' Id.
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Finally, the ALJ reiterated her previous findings that Respondent
had ignored the ``red flags'' indicating that Dr. Volkman's
prescriptions were illegal. Id. Noting ``the lack of individual
therapy, the quantities and strength of the medications, and the other
behavior patterns demonstrated by'' the Volkman patients, the ALJ
concluded that Respondent had ``adequate evidence to determine that the
prescriptions were not written for a legitimate medical purpose,'' and
that its violation of its ``corresponding responsibility weights
greatly in favor of revocation in this matter.'' Id. at 51-52.
As for the fifth factor--such other conduct which may threaten the
public health and safety--the ALJ noted that Mr. Fletcher did not
testify in the proceeding. Id. at 52. While she acknowledged the
settled case law that notwithstanding the Fifth Amendment privilege, an
adverse inference may be drawn in a civil matter based on a party's
failure to testify, the ALJ nevertheless declined to ``draw an adverse
inference'' even though she found Mr. Fletcher's ``inconsistent
handling of controlled substances'' to be ``most troubling.'' Id.
(citing, inter alia, Baxter v. Palmigiano, 425 U.S. 308, 318 (1976)).
More specifically, the ALJ observed that Mr. Fletcher ``clearly knew
the questions to ask when dispensing controlled substances to a
customer'' but that ``in six months he filled over 4,900 prescriptions
without seeming to consistently engage in such conversations with Dr.
Volkman's patients'' and that, even ``when they demonstrated their
addictive behavior before him, he filled [their] prescriptions
anyway.'' Id. The ALJ concluded that this conduct was ``adverse to the
public health'' and supported revocation. Id. at 53. The ALJ further
noted that Mr. Fletcher had failed to provide assurances that he will
not engage in future misconduct. Id. (citing numerous Agency cases).\4\
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\4\ Based on the testimony of Respondent's character witnesses
(which included some of his customers), the ALJ concluded that this
``evidence demonstrates that the Respondent acts responsively in
many of his dealings with others.'' ALJ at 54. The ALJ concluded,
however, this evidence does ``not negate the fact that at least
between September 2005 and February of 2006, Mr. Fletcher chose to
turn a blind eye to the conduct of Dr. Volkman's patients and to
dispense controlled substances irresponsibly.'' Id.
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The ALJ thus concluded that the Government had ``met its burden of
proof'' and demonstrated that Respondent's continued registration is
inconsistent with ``the public interest.'' Id. at 54. She therefore
recommended that ``Respondent's registration be revoked and [that] any
pending applications for renewal be denied.'' Id.
On June 17, 2010, Respondent timely filed Exceptions to the ALJ's
Decision; its Exceptions have been considered in my review of this
matter. Having reviewed the record in its entirety, I agree with the
ALJ's ultimate finding that Respondent's continued registration is
inconsistent with the public interest. However, because Respondent's
registration has expired and it has not filed a renewal application,
there is neither a registration to revoke nor a renewal application to
deny.
As noted above, Respondent's registration was suspended prior to
the hearing pursuant to my authority under 21 U.S.C. 824(d). I,
therefore, conclude that this case is not moot and uphold the
suspension order. As the ultimate finder of fact, I make the following
findings.
[[Page 66152]]
Findings
Respondent previously held DEA Certificate of Registration,
BE5902615, under which it was authorized to dispense controlled
substance in Schedules II through V at the registered location of 1336
East Main Street, Columbus, Ohio 43205. GXs 1 & 2. Respondent last
renewed its registration on August 27, 2007; its registration expired
on August 31, 2010. Id. According to the records of the Agency, of
which I take official notice, Respondent has not filed a renewal
application.\5\
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\5\ An agency ``may take official notice of facts at any stage
in a proceeding-even in the final decision.'' U.S. Dept. of Justice,
Attorney General's Manual on the Administrative Procedure Act 80
(1947). In accordance with the Administrative Procedure Act and
DEA's regulation, Respondent is ``entitled on timely request to an
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). Accordingly, Respondent may file a motion for
reconsideration of this fact within fifteen days of service of this
Order which shall commence with the mailing of the Order.
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Respondent is owned by Eugene H. Fletcher, who is also its sole
pharmacist.\6\ ALJ Ex. 3, at 2. Respondent sells only prescription
pharmaceuticals. Tr. 863.
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\6\ Mr. Fletcher additionally owns and operates a dumpster
business and owns and manages both commercial and residential rental
properties. Id. at 866, 1598.
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In 2003, Dr. Paul Volkman, a physician who was unable to obtain
malpractice insurance because of several large malpractice settlements
and judgments, commenced working at a Portsmouth, Ohio pain clinic
owned by one Denise Huffman. GX 6, at 2. As previously found by the
Agency (and as upheld by the United States Court of Appeals for the
Sixth Circuit), Volkman frequently prescribed large quantities of
multiple controlled substances including narcotics containing oxycodone
\7\ and hydrocodone,\8\ benzodiazepines such as Xanax (alprazolam) and
Valium (diazepam),\9\ as well as the currently non-controlled drug Soma
(carisoprodol) which is nonetheless popular with drug abusers, without
a legitimate medical purpose and outside of the usual course of
professional practice. GX 6, at 2-3; Paul H. Volkman, 73 FR 30630,
30633-34, 30639 (2008), pet. for rev. denied, Volkman v. DEA, 567 F.3d
1215 (6th Cir. 2009). In plain English, the record in the Agency
proceeding involving Dr. Volkman conclusively established that he was a
drug dealer.
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\7\ Oxycodone is a schedule II controlled substance. 21 CFR
1308.12(b)(1)(xiii).
\8\ Hydrocodone, when combined with another non-narcotic
therapeutic ingredient such as acetaminophen, is a schedule III
controlled substance. 21 CFR 1308.13(e)(1).
\9\ Alprazolam and diazepam are benzodiazepines and are schedule
IV depressants. 21 CFR 1308.14(c).
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On September 9, 2005 (several months after DEA executed a search
warrant at Huffman's clinic), Volkman left the clinic; three days
later, he started seeing patients out of his residence at 1310 Center
St. in Portsmouth.\10\ GX 6, at 4; 73 FR at 30635. However, Volkman's
patients encountered problems filling his prescriptions. GX 39, at 1.
D.S., one of Volkman's patients, helped Volkman by going on the
Internet to search for pharmacies that would fill his prescriptions;
according to D.S., she would call and ask the pharmacists if they
``would fill prescriptions for oxycodone 30 mg., hydrocodone 10 mg.,
Xanax 2mg., [and] Soma 350 mg., and if they had the drugs on hand.''
\11\ Id. While the pharmacists at other pharmacies ``either said they
did not have the medications in stock or would not fill prescriptions
for Dr. Volkman,'' Mr. Fletcher said that he had the ``drugs in stock''
and that ``he would fill the prescriptions.'' Id. at 2.
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\10\ According to a Diversion Investigator (DI), Volkman started
writing prescriptions out of his residence on September 12, 2005. GX
9, at 9.
\11\ It is acknowledged that D.S.'s affidavit stated that in
September 2005, she had started taking people to Respondent to fill
prescriptions. GX 39, at 3. D.S. further stated that she had taken
her friend C.R. to Respondent to fill prescriptions and that C.R.
overdosed and died the same day as her first trip to Respondent. Id.
at 5. Subsequently, the Government acknowledged that C.R. had died
on March 9, 2004. Letter of Government Counsel to ALJ, at 1. (May
10, 2010).
Notwithstanding D.S.'s misrepresentation, there is substantial
circumstantial evidence establishing the relationship between
Respondent and Volkman. I therefor find credible D.S.'s statement
regarding how she found Respondent.
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Thereafter, D.S. posted a notice on a bulletin board in Volkman's
office which provided Respondent's name, address, and phone number.
Id.; see also GX 15. Directions were also provided from Volkman's
residence to Respondent.\12\ See GX 15, at 1, 2, 4, 5. Moreover, when,
in October 2005, Volkman moved to Chillicothe, Ohio, he posted similar
notices with directions to Respondent. The distance from Volkman's
Portsmouth residence to Respondent was approximately 94 miles, see GX
15, at 2; the distance from his Chillicothe office to Respondent was 56
miles. GX 9, at 23.
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\12\ In October 2005, the Portsmouth Police executed a search
warrant at Volkman's residence. GX 6, at 4. While no charges were
filed, Volkman was issued a condemnation notice. Id. Shortly
thereafter, Volkman moved to Chillicothe, Ohio. Id.
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According to Dr. Volkman's former security guard, ``Volkman
instructed his employees to send all his patients to [Respondent] to
have their prescriptions filled.'' GX 22, at 2; see also GX 23, at 1.
Moreover, ``just about every day, a call was made from [Volkman's]
clinic to [Respondent] or from the [Respondent] to the clinic'' during
which Mr. Fletcher was told when Volkman's ``last patient had been
seen'' so that he would know how late to keep the pharmacy open to fill
the prescriptions Volkman issued. GX 22, at 2. At times, patients would
show up at Respondent and fill their prescriptions as late as midnight.
GX 24, at 3; see also GX 23, at 2 (L.W. relating that she filled
prescriptions at Respondent as late as 9 or 10 p.m.). Volkman's ex-
security guard stated that the patients ``did not appear to be in
pain'' and that he believed that ``about 60% of [them] were pill
patients and not pain patients.'' GX 22, at 3. See also GX 24, at 6
(affidavit of A.S.; ``[t]here were some legitimate patients, but most
of Dr. Volkman's patients were not legitimate. They were going to Dr.
Volkman and [Respondent] for drugs to abuse and to sell.''); GX 9, at
11 (photographs of patients waiting to see Volkman taken on date
Portsmouth P.D. executed search warrant at his practice).
As part of the investigation, DEA Diversion Investigators (DIs)
obtained data from the Agency's ARCOS system showing Respondent's
purchases of oxycodone and hydrocodone combination drugs; these drugs
are Schedule II and III narcotics, respectively. Tr. 533-34. The
oxycodone data showed that in 2004, Respondent had purchased 96,000
dosage units. GX 9, at 33. However, during 2005, Respondent purchased
495,000 dosage units; of this amount, approximately 400,000 dosage
units were purchased between September and December. Id. Likewise, in
2004, Respondent purchased 88,000 dosage units of hydrocodone. Id. at
34. In 2005, Respondent purchased 328,000 dosage units; of this amount,
more than 200,000 were purchased between September and December.\13\
Id. While in 2004, Respondent was only the 300th largest pharmacy
purchaser of oxycodone in Ohio; in 2005, it was the eleventh largest
purchaser, and in 2006, it was the seventh largest. Id.
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\13\ The data also showed that in 2006, Respondent purchased
820,000 dosage units of oxycodone and 224,000 dosage units of
hydrocodone. GX 9, at 33-34.
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On February 10, 2006, a search warrant was executed at Respondent
and its dispensing records were seized.\14\ Tr. 523. The records showed
that between September 1, 2005 and February 10, 2006, Respondent
dispensed a total of 6,619 controlled-
[[Page 66153]]
substance prescriptions; 4,979 of the prescriptions (75%) had been
issued by Dr. Volkman.\15\ GX 9, at 62. Corresponding with Mr.
Fletcher's agreeing to fill Volkman's prescriptions, Respondent
experienced multi-fold increases in the amounts of prescriptions it
filled for oxycodone, hydrocodone, diazepam and alprazolam. Tr. 526; GX
9, at 29.
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\14\ On the same day, a search warrant was also executed at Dr.
Volkman's Chillicothe office and his registration was suspended. GX
9, at 13.
\15\ During this period, Respondent filled a total of 5,206
prescriptions issued by Volkman. GX 9, at 24, 28.
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Nearly ninety-nine percent of the persons who obtained controlled-
substance prescriptions from Volkman and filled them at Respondent did
not live in Columbus, Ohio. GX 9, at 24; Tr. 522. Approximately half of
the patients were from Kentucky, with some of the patients driving
three to four hours to obtain the drugs; \16\ many other patients were
from the Portsmouth, Ohio area.\17\ See GX 14; Tr. 571-72. From
Portsmouth to Respondent there were 40 other pharmacies along the
route. GX 34, at 2. Moreover, the dispensing records showed that 87
percent of Respondent's customers paid cash for their prescriptions; by
contrast, according to the Government's Expert, ``the national average
of cash paying customers for prescriptions [was] 11.4% in 2005 and 10%
in 2006.'' \18\ GX 20, at 2; Tr. 534-35. Only five percent of the
customers paid with insurance, and eight percent paid with a
combination of insurance and cash. Tr. 534-35; GX 9, at 41.
---------------------------------------------------------------------------
\16\ Several persons drove to Respondent from Paintsville,
Kentucky, a distance of 182 miles; according to a DI, there were 96
pharmacies enroute. GX 34, at 3.
\17\ According to the testimony of Lisa Roberts, R.N., who works
for the Portsmouth Health Department and who is a member of the Ohio
Department of Health Poison Action Group, Tr. 26, Scioto County
(where Portsmouth is located) ``showed a 360 percent increase in
unintentional prescription drug overdoses'' from 1999 to 2009. Id.
at 32. In a Community Health Assessment she prepared for the City of
Portsmouth, Ms. Roberts wrote that ``Scioto County has long been the
target of lucrative `Pill Mills' [which] prescribe powerful
prescription drugs to individuals without proof of chronic pain.''
GX 8, at 6. Continuing, Ms. Roberts noted that ``[m]any people have
become addicted as a result of these establishments'' and that
``much of the pills distributed there end up being illegally
diverted to the public, including [to] high school students.'' Id.
She also noted that ``[p]eople come from other states as well to
patronize these establishments.'' Id. Ms. Roberts testified that she
``knew people that went to [Dr. Volkman] to get drugs to sell,'' as
well as about the practice of sponsoring, by which an abuser or drug
dealer recruits another person and fronts the person the money
needed to pay for a doctor visit and to fill the prescriptions; the
sponsor then receives half the pills back which can then be sold.
Tr. 43, 62-63. See also Tr. 264, 266, 276, 283.
\18\ Payment information was taken from the seized
prescriptions. Tr. 570.
---------------------------------------------------------------------------
L.W., a resident of Quincy, Kentucky, and A.S., a resident of
Portsmouth, were among those persons who obtained controlled-substance
prescriptions from Volkman and filled them at Respondent. See GXs 23 &
24; Tr. 272. On October 10, 2005, L.W. filled at Respondent
prescriptions for 270 tablets of oxycodone 30 mg., 240 tablets of
hydrocodone/apap (10/500),\19\ 90 tablets of alprazolam 2 mg. (generic
for Xanax), and 180 tablets of carisoprodol 350 mg. GX 12, at 2. On
November 7, L.W. obtained from Respondent an additional 270 tablets of
oxycodone 30 mg., 240 hydrocodone 10/500, 90 alprazolam 2 mg., and 240
tablets of carisoprodol; on December 6, she obtained the same four
drugs and quantities, the sole difference being that she received only
180 oxycodone 30 mg. Id. Finally, on February 3, 2006, L.W. obtained
from Respondent 360 tablets of oxycodone 30 mg., 360 tablets of
hydrocodone 10/325, 90 tablets of alprazolam 2 mg., and 240
carisoprodol. Id.
---------------------------------------------------------------------------
\19\ Apap is the abbreviation for acetaminophen.
---------------------------------------------------------------------------
In an affidavit, L.W. stated that while she initially needed to
take pain medication following two accidents, the last of which
occurred in February 2004, at the time she was seeing Dr. Volkman and
filling the prescriptions at Respondent, she was both selling the drugs
and taking them ``to get high.'' GX 23, at 4. She stated that on those
occasions when she spoke with Mr. Fletcher at Respondent, he ``never
asked me about my medical condition but would just make small talk.''
Id.\20\ She further stated that she ``was high on drugs several times
when having prescriptions filled at [Respondent] and at times was high
when [she] spoke with'' Mr. Fletcher. Id. at 3-4. L.W. further stated
that on her last visit to Respondent, she was ``so high'' that her
``slurred speech and unsteady walk would have been very noticeable''
and that her ``head was hanging down and [she] was probably drooling.''
Id. at 4.
---------------------------------------------------------------------------
\20\ Cf. GX 22, at 3 (affidavit of Delbert Evans, Dr. Volkman's
security guard; ``Some calls by Eugene were to speak with Dr.
Volkman but the majority of the calls were to determine how late he
should stay open to fill Dr. Volkman's prescriptions.'').
---------------------------------------------------------------------------
Respondent filled A.S.'s prescriptions, which she obtained from Dr.
Volkman, for oxycodone, hydrocodone, diazepam, alprazolam, and
carisoprodol on seven occasions between September 13, 2005 and February
1, 2006. GX 12, at 1. More specifically, on September 13, Respondent
dispensed to her 240 oxycodone 30 mg., 180 hydrocodone/apap 10/650, 90
diazepam 10 mg., and 90 carisoprodol 350 mg. Id. Respondent made
additional dispensings of Volkman's prescriptions as follows: On
October 10, 330 oxycodone 30 mg., 240 hydrocodone 10/500, 90 alprazolam
2 mg., and 180 carisoprodol 350 mg.;\21\ on November 8, 165 oxycodone
30 mg., 120 hydrocodone, 45 alprazolam, and 90 carisoprodol; on
December 2, 180 oxycodone 5 mg., 240 hydrocodone, 90 alprazolam, and
180 carisoprodol; on December 20, 90 oxycodone 5 mg., 120 hydrocodone,
45 alprazolam, and 90 carisoprodol; on January 2, 2006, 240 oxycodone
15 mg., 240 hydrocodone, 90 alprazolam, and 180 carisoprodol; and on
February 1, 240 oxycodone 30 mg., 240 hydrocodone, 90 alprazolam, and
180 carisoprodol. Id.
---------------------------------------------------------------------------
\21\ After this date, each of the hydrocodone dispensings was
for the 10 mg. strength (which is the strongest formulation); the
alprazolam dispensings were for the 2 mg. strength, and the
carisoprodol was for the 350 mg. strength. See GX 12, at 1.
---------------------------------------------------------------------------
A.S. testified at the hearing. While the ALJ found portions of her
testimony not credible because ``she became vague, and contradicted
herself,'' ALJ at 23 n.6, the ALJ found credible her testimony that her
sister-in-law told her about Dr. Volkman and sponsored her by giving
her the money to pay for her office visit and to fill the prescriptions
she obtained. Id. at 22 n.5; Tr. 264. The ALJ further found credible
A.S.'s testimony that she gave her sister-in-law ``half of the pills,''
which her sister-in-law then sold to raise money to sponsor someone
else. ALJ at 22 & n.5. (citing Tr. 266, 276, 283.) A.S. testified that
her sister-in-law ``would take several people to the doctor'' and that
they would go to Respondent to fill the prescriptions. Tr. 283. A.S.'s
sister-in-law would pay for everything and receive ``half [of] the
medication.'' Id. A.S. testified that Volkman gave her combination
prescriptions and that Volkman's office told her to go to Respondent,
which was a two-hour drive (one-way) from Portsmouth. Id. at 274-75.
A.S. also admitted that she was addicted to oxycodone and had been at
the time she obtained prescriptions from Dr. Volkman and filled them at
Respondent.\22\ Id. at 253 & 336.
---------------------------------------------------------------------------
\22\ On cross-examination, A.S. admitted that she never told Mr.
Fletcher that she was addicted or that she was giving half of her
drugs to her sister-in-law. Tr. 312. However, one would hardly
expect a drug abuser or diverter to tell a pharmacist why she was
seeking the drugs. A.S. also testified on cross-examination that she
presented valid prescriptions to Mr. Fletcher. Id. at 314. However,
Respondent's counsel did not clarify what he meant by the term
``valid,'' which can mean one of several things such as that the
prescriptions were not fraudulent or forged, that they were issued
for a legitimate medical purpose, or that they were in proper form
and contained the required information.
A.S. also testified that she had been in constant pain since a
1996 car accident, that she was in pain when she testified in this
proceeding, and that she had pain at the level of an eight on the
scale of one to ten. Id. at 258-60.
---------------------------------------------------------------------------
[[Page 66154]]
S.L.J. was a confidential informant for the Portsmouth Police
Department (PPD). GX 4, at 744. On September 16, 2005, the PPD sent
S.L.J. to see Dr. Volkman and to obtain controlled- substance
prescriptions. Id. Dr. Volkman wrote her prescriptions for oxycodone 30
mg. and Percocet,\23\ which S.L.J. turned over to the police. Id. On
September 26, S.L.J., who was an addict, returned to Dr. Volkman's
office on her own initiative and without the PPD's knowledge; she
obtained prescriptions for 135 tablets of Percocet 5/325 mg. and 135
tablets of oxycodone 30 mg. Id. at 745-46. The same day, S.L.J. filled
those prescriptions at Respondent. Id. at 746. On September 29, 2005,
S.L.J. was found dead; the coroner determined that the cause of death
was ``multiple drug intoxication.'' Id. The Government did not,
however, submit the coroner's report or a police report and thus did
not establish that Respondent dispensed the drugs on which S.L.J.
overdosed.\24\
---------------------------------------------------------------------------
\23\ Percocet is a brand-name product containing oxycodone and
acetaminophen and is a schedule II controlled substance. ALJ Ex. 5,
at 1.
\24\ While I previously found in the Volkman decision that
S.L.J. had died of multiple drug intoxication and had both oxycodone
and alprazolam in her system, see 73 FR 30636 n.23, Respondent was
not a party to that proceeding. The Government was thus required to
prove this fact anew, which it failed to do because the DI testified
that he was unsure of, and did not recall the cause of S.L.J.'s
death. Accordingly, I conclude that the Government has not proved
that S.L.J.'s death was caused by the prescriptions she filled at
Respondent.
---------------------------------------------------------------------------
E.R. lived in Grayson, Kentucky and went to Dr. Volkman at his
Chillicothe, Ohio clinic on just one occasion. GX 4, at 749 & 750; Tr.
407. He had planned to obtain prescriptions for controlled substances,
fill them, and then sell the drugs on the street to get out of debt.
Tr. 405-07, 409-10. E.R., who had heard from friends that Volkman would
write large-volume controlled-substance prescriptions, drove for
several hours with a friend to see Volkman. Id. at 406, 410. E.R.
obtained from Volkman prescriptions for 240 oxycodone 30 mg., 240
hydrocodone/apap 10/500, 90 alprazolam 2 mg., and 90 Soma 350 mg. Id.
at 408; GX 4, at 750. The following day, E.R. drove with his wife to
Respondent and filled the prescriptions. Id. at 409-12.
Immediately after he obtained the drugs, E.R. entered his car and
proceeded to crush and snort two oxycodone tablets. Id. at 412. On the
return trip, ``he also took a couple of Xanax.'' Id. Following a stop
at the local WalMart, E.R. and wife went to see a friend who sold
controlled substances and E.R. offered to sell him some of the
hydrocodone. Id. at 413. However, the drug dealer was having a domestic
dispute so E.R. and his wife returned to their home. Id.
Later that evening, the drug dealer came to E.R.'s house and
``partied with'' E.R. for several hours. Id. The following morning,
E.R. was found dead. Id. at 413-14. However, once again, the Government
did not introduce into evidence the coroner's report or a police report
and thus has not established in this case that E.R. overdosed on the
drugs he obtained at Respondent.
The evidence also showed that in October 2005, and shortly after
Respondent started dispensing the Volkman prescriptions, Mr. Fletcher
phoned Robin Padolik, who was then employed as an Automated Clearing
House Coordinator for the Commerce National Bank (CNB), where he held
various accounts. GX 25, at 1, 3. According to Ms. Padolik, beginning
around September 2005, CNB personnel began noticing an increase in the
amounts of Mr. Fletcher's cash deposits and placed him on CNB's ``Watch
List.'' Id. The same month, Mr. Fletcher's transfers to his outside
accounts became more frequent, and in mid-October, Mr. Fletched called
and asked Ms. Padolik ``at what point the bank would be required to
file a form when he made a cash deposit; how a deposit would [be]
process[ed]''; and, if making deposits into two ``separate accounts
[would] prevent a form submission.'' Id. at 3. Ms. Padolik specifically
related that on October 13, 2005, Mr. Fletcher called and asked whether
``if he deposited $6,000 in one account and $4,000 in another
account,'' the bank would be required ``to submit `that report.' '' Id.
Based on Mr. Fletcher's question, Ms. Padolik, who had been trained in
the Bank Secrecy Act and the recognition of money-laundering, concluded
that Mr. Fletcher ``apparently knew [that] the threshold for reporting
was any amount over $10,000, but did not know the name of the form the
bank was required to file.'' Id. Ms. Padolik ducked Mr. Fletcher's
question. Id.
On October 18, Mr. Fletcher called Ms. Padolik and asked if
``account deposit amounts were associated with the Taxpayer
Identification Number (TIN).'' Id. at 4. He also asked ``how he could
change his TIN'' for the accounts he maintained for Respondent and for
his other business ventures. Id. Ms. Padolik again ducked Mr.
Fletcher's questions and reported him to Andrew Reardon, CNB's
Compliance Manager. Id.
As Ms. Padolik testified, ``it was really a big red flag when he
started asking questions about dollar amounts * * * so it looked like
he was really fishing for information on how he can [sic] get around
BSA reporting.'' Tr. 167. Ms. Padolik explained that ``[d]eposit
structuring * * * is a break-up of cash deposits that are turned into
other financial transactions * * * it's cash that is taken from its
criminal origin and passed through the system with many transactions *
* * Structuring is a way to take cash from an illegal source and make
it look more legal by passing it through the financial system.'' Tr.
157-58.
Ms. Padolik specifically identified six transactions by Mr.
Fletcher which raised her suspicion that he was engaged in structuring
to avoid the bank's filing of a Currency Transaction Report (CTR). GX
25, at 4; see also Tr. 166; 31 CFR 103.11. These included deposits of
$9,900 on October 11, a check for $41,000 issued to an investment
company on October 15, a deposit of $9,980 on October 17, a deposit of
$8,380 on October 18, a deposit of $9,950 on October 19, and a deposit
of $9,900 on October 20, 2005. GX 25, at 4. Following a review of his
transactions by the CNB's High Risk Committee, the Bank concluded that
Mr. Fletcher had engaged in structuring in violation of Federal banking
regulations and closed his accounts. Tr. 207-08; GX 28.\25\ A DI
further found that Mr. Fletcher's ``net profit from dispensing for Dr.
Volkman [was] almost $500,000.'' Tr. 620.
---------------------------------------------------------------------------
\25\ To refute this evidence, Respondent put on the testimony of
his accountant, who maintained that Mr. Fletcher ``more than
likely'' was of ``low sophistication'' in regards to banking
regulations. Tr. 1602. However, I find credible Ms. Padolik's
testimony (both at the hearing and in her affidavit) regarding the
questions Mr. Fletcher asked regarding the bank's reporting
obligations and conclude that he clearly knew what he was doing and
was engaged in structuring.
---------------------------------------------------------------------------
DEA Investigators interviewed Mr. Fletcher regarding the Volkman
prescriptions on two occasions, February 10, 2006 and November 27,
2007. Tr. 600. According to the DI who conducted the latter interview,
Mr. Fletcher said that ``he had questions about'' Dr. Volkman. Id. at
606. Mr. Fletcher maintained that he had called Dr. Volkman, who told
him that ``he did an MRI, and blood tests.'' \26\ Id. Mr. Fletcher also
maintained that Volkman's prescriptions were valid because ``the
physician was licensed in Ohio and [the prescription] was written to
the person
[[Page 66155]]
presenting'' it. Id. He stated the prescriptions were not forged. Id.
---------------------------------------------------------------------------
\26\ There was also testimony that Volkman's patients complained
to Respondent's employees of having to pay extra for drug tests. Tr.
1265-67; 1713-14.
---------------------------------------------------------------------------
However, twice in the interview, Mr. Fletcher admitted that his
customers had told him that ```other pharmacists would not fill Dr.
Volkman's prescriptions.''' Id. at 622 & 624. The DI then asked Mr.
Fletcher if he had ``call[ed] the other pharmacists and asked them why
they were not filling Dr. Volkman's scripts.'' Id. at 622. Mr. Fletcher
answered: ``I don't communicate with other pharmacists.'' Id.
The DI also asked Mr. Fletcher if he ever felt that Dr. Volkman's
patients were addicted to drugs; Mr. Fletcher answered that it was
```hard to say.' '' Id. at 606. Mr. Fletcher told the DI that sometimes
Dr. Volkman's patients would ask him to sell them extra pills; Mr.
Fletcher stated that he had refused to do so. Id. He also stated that
he did ``not get into'' the ``personal life'' of his customers to
determine their medical conditions. GX 9, at 69.
When the DI asked Mr. Fletcher about his ``corresponding
responsibility,'' he acknowledged that a physician must prescribe ``for
a legitimate ailment, and [that] the dose must be correct.'' GX 9, at
68. However, Mr. Fletcher maintained that ``what to prescribe and the
quantities'' was for the physician to decide and that it was ``not his
job to question a physician.'' Id. He further asserted that he did not
find it suspicious that the customers were traveling long distances,
paying cash, obtaining combinations of controlled substances, and that
other pharmacies had refused to fill the prescriptions. Id. at 69.
The Government introduced evidence showing that Respondent's
purchases and dispensings of controlled substances were substantially
greater than that of a single CVS pharmacy which was located 1.6 miles
from it. GX 9, at 30-39. It also introduced evidence comparing the
prices Respondent and four other independent pharmacies (two of which
were located in Columbus, two of which were located in Portsmouth) paid
their suppliers for various controlled substances as well as what they
charged their customers; the Government asserts that this evidence
shows that these four pharmacies sold controlled substances at an
average price 37% cheaper than that charged by Respondent. GX 9, at 55-
56.
It is obvious, however, that neither strand of evidence rises to
the level of substantial evidence because neither is based on a
statistically valid sample. Indeed, to compare Respondent's controlled-
substance dispensings to that of a single CVS located 1.6 miles away
ignores that the two stores may serve communities with substantially
different demographics such as the age of the residents and the
presence of competitors. So too, comparing Respondent's prices with
those charged by four other pharmacies (out of likely thousands of
pharmacies in the State of Ohio including hundreds of independents) and
which do not even appear to have been selected at random, is manifestly
inadequate to prove that Respondent charged more because it was selling
to an illicit market.
The Government also put on extensive evidence to the effect that
Respondent was located in a bad/high-crime neighborhood and that Mr.
Fletcher carried a gun while at his business. As for the character of
Respondent's neighborhood, the principal issue in this case was whether
Respondent was dispensing controlled-substance prescriptions which it
either knew or had reason to know lacked a legitimate medical purpose
and were issued outside of the usual course of professional practice.
See ALJ Ex. 1, at 1-2 (citing 21 CFR 1306.04(a)). Whether Respondent is
located in a bad neighborhood is of no relevance in determining whether
Mr. Fletcher violated his corresponding responsibility under the CSA.
While there is evidence (discussed below) that Respondent and Mr.
Fletcher were found by the Ohio Board of Pharmacy to have violated
State law because he was not present on three occasions when controlled
substances were delivered and the drugs were not properly stored, GX
16, at 2, presumably, this would have been a violation even if
Respondent had been located in the safest neighborhood in the State of
Ohio. So too, the evidence that Mr. Fletcher carried a gun is entirely
irrelevant.\27\
---------------------------------------------------------------------------
\27\ The Government also introduced evidence showing that Mr.
Fletcher had violated the Ohio Board of Pharmacy's Acceptable Use
Policy for the OARRS, because he obtained prescription information
on two persons who had died. Tr. 930-31, 1803, 1808; GX 42, at 1.
According to the Government's Expert, this violated the Board's
policy because a pharmacy can only obtain information on a current
customer. Tr. at 930-31. Notably, the Government's Expert did not
testify that this conduct violated any State law or regulation.
While this may be an improper use of the database and a
violation of the Board's policy, the matter is best left to the
Board to resolve.
---------------------------------------------------------------------------
Evidence Regarding Respondent's Practices After February 10, 2006
The Government also obtained data from OARRS, the Ohio prescription
monitoring program, showing controlled-substance prescriptions that
were issued by Florida-based physicians and filled by Respondent. Tr.
476; GXs 10 & 11. The Government submitted a spreadsheet showing more
than fifty prescriptions for drugs such as oxycodone in 15 mg. and 30
mg. strength and alprazolam, which Respondent filled between September
4, 2007 and September 2, 2008. See GX 10. At least seventeen of the
persons listed as having filled prescriptions at Respondent were
residents of Kentucky; several individuals filled multiple
prescriptions for oxycodone on the same day. See id. For example, on
April 25, 2008, A.B., a resident of Denton, Kentucky (143 miles from
Respondent), filled prescriptions for 180 oxycodone 30 mg., 120
oxycodone 15 mg., and 90 alprazolam 2 mg.; on July 23, 2008, C.W., a
resident of Ashland, Kentucky (123 miles from Respondent), filled
prescriptions for 240 oxycodone 30 mg., 60 oxycodone 15 mg., and also
60 alprazolam 2 mg.; and on August 11, 2008, N.W., a resident of
Flatwoods, Kentucky (118 miles from Respondent), filled prescriptions
for 240 oxycodone 30 mg., 90 oxycodone 15 mg., and also 60 alprazolam 2
mg. GX 10, at 1-2. Moreover, on August 25, 2008, C.L. filled
prescriptions for 90 diazepam 10 mg. and 60 alprazolam 2 mg.\28\ Id. at
1.
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\28\ On March 20, 2009, the Ohio Board of Pharmacy sent a notice
to pharmacists explaining that it had observed ``a significant
volume of prescriptions from physicians in Florida'' who were
prescribing oxycodone, Xanax, Percocet and Soma for residents of
Ohio and Kentucky who were ``generally 20-55 years old and usually
pay cash.'' GX 17. The Board further explained that ``[i]n many of
these cases, we are wondering how the term `legitimate medical
purpose' applies when a patient who is supposedly in severe pain can
ride to Florida and back to receive treatment when we have excellent
facilities in Ohio.'' Id. The Board requested pharmacists who had
``already filled such prescriptions'' to contact one of its Agents
because the Board believed that ``this may be a coordinated effort
to obtain drugs and we are trying to develop a list of the people
involved.'' Id.
There was also evidence that because of the effectiveness of the
State of Kentucky's prescription monitoring program, drug dealers
were sponsoring people to go to South Florida to obtain controlled-
substance prescriptions and that some of these individuals would
fill the prescriptions in Ohio. Tr. 429-34.
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Additional Evidence Regarding Patient Deaths
The Government also introduced evidence regarding two additional
persons, L.D.C. and B.A., who obtained controlled substances from
Respondent and died the following day. Both deaths occurred in the fall
of 2009.
L.D.C., who was 34 years old at the time of her death, lived in
West Portsmouth, Ohio. GX 29. On October 2, 2009, L.D.C. obtained
prescriptions from Dr. Georgescu of Wheelersburg, Ohio for 90 tablets
of oxycodone 30 mg. (90 dosage units) and 60 tablets of
[[Page 66156]]
carisoprodol which she then filled at Respondent. GX 32, at 1, 4; GX
29, at 2; Tr. 629. These were the first and last prescriptions she
filled at Respondent. GX 32, at 1.
According to the report filed by the Scioto Sheriff's Office, on
October 3, L.D.C.'s boyfriend found her lying on the floor of the
master bedroom near the footboard of their bed with blood coming from
her nose and mouth. Id. On arriving at the scene, a Deputy Sheriff
observed ``38 white pills laying beside her and a pill bottle labeled
oxycodone 30 mg. [which] was prescribed on October 2, 2009 and filled
at'' Respondent. GX 29, at 2. The officer also found that ``on a
dresser next to her [were] 10 oblong pills scored GG/2/4/9 and a pill
bottle labeled Soma 350 mg. with 48 pills in it.'' Id. He also ``saw a
silver spoon with white residue on it and a needle with no cap on it.''
Id. at 4. A second officer made the same observations and reported that
the pills labeled GG/2/4/9 were ``believed to be Xanax.'' Id. at 5.
Thereafter, an autopsy was performed on L.D.C. On November 30,
2009, the Coroner issued her Opinion that the cause of L.D.C.'s death
was the ``[t]oxic effects of drugs'' including ``oxycodone, oxymorphone
and others.'' GX 37, at 1. According to the toxicology report,
oxycodone, oxymorphone, carisoprodol, and meprobamate were found in her
blood. Id. at 2; GX 31.
On November 4, 2009, B.A., ``a recovering drug addict'' and
resident of Morehead, Kentucky, ``went to a doctor in Portsmouth[,]
Ohio'' and obtained four controlled-substance prescriptions, which he
then filled at Respondent the same day. GX 38, at 1 & 7. The
prescriptions were for 60 tablets of Roxicodone 30 mg. (oxycodone), 120
tablets of oxycodone 15 mg., 180 tablets of Roxicodone 30 mg.
(oxycodone), and 30 alprazolam 1 mg. Id. at 7.
B.A. ``went to bed at around 2300-2400 on Thursday November 4[,]
2009 and was high when he went to bed.'' Id. at 1. He was ``found
deceased the next morning by his room-mate.'' Id.
The next morning, a Detective went to B.A.'s trailer and
interviewed B.A.'s roommate L.R., who reported that B.A. ``appeared to
be a little high last night before he went to bed'' but because B.A.
``had not been home all day yesterday * * * he did not know exactly
what all [B.A.] had done.'' Id. at 4. L.R. further stated that B.A.
``really didn't seem right,'' that he had been in the bathroom ``for a
long time,'' that when B.A. went to bed, he was ``snoring really loud''
but that when L.R. got up to use the bathroom at about 3:30 a.m., B.A.
was no longer snoring. Id. at 5.
The Detective obtained L.R.'s consent to search the premises and
found a key on B.A.'s car key ring which fit a safe in B.A.'s bedroom.
Id. at 5. The Detective opened the safe and found six pill bottles,
including the four prescriptions which B.A. had filled the day before
at Respondent. Id. at 5-6.
With respect to these four prescriptions, the Detective found that
there were no tablets left in the bottle which had contained 60
Roxicodone 30 mg., there were only fifty-two tablets left in the bottle
which had contained 120 oxycodone 15 mg., there were only nineteen
tablets left in the bottle which had contained 180 Roxicodone 30 mg.,
and there were only eight tablets left of the thirty alprazolam. Id. at
7.
The Detective also interviewed two persons who had accompanied B.A.
on his trip to the doctor's office and to Respondent. Id. They stated
that when B.A. emerged from the doctor's office, he had a `` `mapquest'
printout'' with directions to Respondent; B.A. told them that the
doctor's staff had said to fill his prescriptions at Respondent. Id. at
8.
Following L.D.C.'s death, Investigators conducted surveillance of
Respondent during which they observed the license plates of its
customers to determine where they were coming from. Tr. 592. One of the
plates was traced to S.P., a resident of Waverly, Ohio. Tr. 593; GX 33.
The Investigators then obtained an OARRS report on S.P. and prepared a
spreadsheet listing the prescriptions she filled by date between
November 6, 2007 and October 30, 2009, the dispensing pharmacy, and the
prescriber. GX 33.
The report showed that S.P. had obtained oxycodone from Respondent
on eighteen occasions during this period using prescriptions she had
obtained from seven different doctors. See GX 33. Moreover, according
to the OARRS report, the doctors were located in Waverly, Beavercreek,
Dayton, Wheelersburg and Portsmouth; two of the Portsmouth doctors
practiced at different clinics.\29\ Id.
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\29\ However, Drs. J.C. and M.G. appeared to have practiced at
the same Portsmouth address. See GX 33, at 2; GX 38, at 7-8. There
is, however, no evidence that J.C. and M.G. were at the clinic in
the same time period.
In the Immediate Suspension Order, the Government alleged that
Dr. M.F. was in Lee's Summit, Missouri. ALJ Ex. 8, at 2. On cross-
examination, the DI conceded that the prescription issued by Dr.
M.F. had indicated that he was in Wheelersburg, Ohio. Tr. 701.
During cross-examination of the DI, Respondent's counsel also
suggested that Dr. P.C. was not practicing in Dayton but rather in
Portsmouth when he wrote the prescriptions for S.P. Id. at 629-31.
However, the DI said he did not have information that Dr. P.C. was
practicing in Portsmouth and Respondent produced no evidence
establishing this as a fact. Id. at 631.
---------------------------------------------------------------------------
The prescriptions included ones for oxycodone issued by the
following doctors: (1) On November 6 and December 4, 2007, as well as
on January 9 and February 14, 2008, by Dr. B.B. of Waverly, Ohio; (2)
on May 20, June 13 and 23, July 11, August 12, 2008 and January 6,
2009, by Dr. D.B. of Beavercreek, Ohio; (3) on September 10, October 1
and 27, and November 27, 2009, by Dr. M.G. of Portsmouth (Medical
Solutions, L.L.C.); (4) on July 3, 2009, by Dr. J.D. of a different
Portsmouth clinic (Complete Pain Management, L.L.C.); (5) on September
1, 2009, by Dr. P.C. of Dayton; (6) on October 1, 2009, by Dr. M.F. of
Wheelersburg; and (7) on October 30, 2009, by Dr. J.C. of Portsmouth.
See GX 33. The OARRS Report also contained controlled-substance
prescriptions written by additional doctors which S.P. filled at other
pharmacies. See id.
On November 6, 2009, DEA Investigators conducted an administrative
inspection of Respondent. Tr. 610, 692. Investigators requested that
Mr. Fletcher provide Respondent's biennial inventory of its controlled
substances, but Respondent was unable to do so. Id. at 693-94. The lead
DI further testified that Mr. Fletcher stated that he was unaware of
the requirement of maintaining a biennial inventory. Id. at 694.
The Government's Expert Witness
The Government called Donald Sullivan, R.Ph. and PhD, as its expert
witness. Dr. Sullivan, who holds active pharmacist licenses in Ohio and
Florida, obtained a B.S. in Pharmacy from The Ohio State University, as
well as both an M.S. and PhD in Pharmaceutical Administration, also
from The Ohio State University. GX 19, at 1; Tr. 922. Between 1997 and
2006, Dr. Sullivan was an Associate Professor of Pharmacy Practice at
Ohio Northern University. GX 19, at 1; Tr. 920. Thereafter, Dr.
Sullivan was appointed to the rank of Full Professor and has been
Chairman of the Department of Pharmacy at Ohio Northern University for
the last four years. Tr. 920.
During graduate school, Dr. Sullivan worked as a Registered
Pharmacist at both retail and mail order pharmacies. GX 19, at 2; Tr.
934. He testified that he has worked at ``several different
independents in the central Ohio area'' and that he currently works
part-time as a pharmacist for North Central Mental Health. Id. at 934-
35. Dr. Sullivan was offered and accepted as an ``expert witness * * *
on standard pharmacy
[[Page 66157]]
practice and standards for dispensing controlled substances.'' Id. at
938.
Dr. Sullivan testified that the curriculum at pharmacy college
includes courses in pharmacology and therapeutics, which cover ``the
actual pharmacology and pathophysiology of drug abuse,'' as well as in
pharmacy law, which covers the subject of prescription drug abuse and
prescription drug fraud. Id. at 925. He testified that the American
Council of Pharmaceutical Education, which accredits schools of
pharmacy, requires that these subject areas ``be taught.'' Id. at 925-
26. Dr. Sullivan has taught pharmacy law since his time as a teaching
assistant in graduate school; in addition to his teaching at Ohio
Northern University, he also teaches pharmacy law in continuing
education programs and in review classes for the NAPLEX exam. Id. at
933.
Dr. Sullivan testified that under both Ohio and Federal law, there
``is corresponding responsibility between the physician and the
pharmacist.'' Tr. 939. He further explained that ``[a] lot of
pharmacists think that just because the physician wrote it, I have to
fill it.'' Id. However, Dr. Sullivan stated that [t]here is nothing in
Ohio law that says you have to fill any prescription.'' Id. at 939-40.
He then explained that ``one of the first things we try to get the
students and pharmacist to understand is that under Ohio law, and
federal law * * * 50 percent of the responsibility falls on the
pharmacy, the pharmacist, 50 percent falls on the physician. Don't just
fill it because the doctor wrote it.'' Id.
Similarly, in his report, Dr. Sullivan, after discussing the CSA's
prescription requirement (21 CFR 1306.04(a)), explained that:
The State of Ohio has similar language in its laws and
regulations. Ohio Law states that: The pharmacist who fills any
prescription has a corresponding responsibility with the physician
to make sure that the prescription has been issued for a Legitimate
Medical Purpose. The responsibility to ensure that a prescription is
for a legitimate medical purpose in the usual course of a
prescriber's professional practice is equal for both the physician
and pharmacist. (Fifty percent of this responsibility is on the
pharmacist and 50% is on the physician). The argument that ``Just
because a physician wrote the prescription, I can legally fill it''
is no excuse.
GX 20, at 1 \30\ (emphasis in original).
---------------------------------------------------------------------------
\30\ While the Ohio courts may have interpreted State law as
described above, as explained below, Dr. Sullivan's testimony that
Federal law allocates fifty percent of the responsibility to the
physician and fifty percent to the pharmacist is not a correct
statement of the law, which has been amply explained in numerous
decisions of the Federal courts and this Agency. To make clear,
Federal law does not apportion the responsibility for dispensing
unlawful prescriptions between a prescribing practitioner and a
pharmacist. Rather, Federal law imposes separate and independent
duties on the prescriber and the pharmacist.
More specifically, the prescriber must act within the usual course
of professional practice and have a legitimate medical purpose to
lawfully issue a controlled-substance prescription. 21 CFR 1306.04(a).
As the Supreme Court and numerous Federal courts have made plain, to
lawfully prescribe a controlled substance the physician must act ``in
accordance with a standard of medical practice generally recognized and
accepted in the United States.'' United States v. Moore, 423 U.S. 122,
138-39 (1975); see also United States v. Smith, 573 F.3d 639, 647-48
(8th Cir. 2009); United States v. Merrill, 513 F.3d 1293, 1306 (11th
Cir. 2008).
By contrast, a ``pharmacist is not required to * * * practice
medicine.'' United States v. Hayes, 595 F.2d 258, 261 (5th. Cir 1979).
``What is required of [a pharmacist] is the responsibility not to fill
an order that purports to be a prescription but is not a prescription
within the meaning of the statute because he knows [or has reason to
know] that the issuing practitioner issued it outside the scope of
medical practice.'' Id. at 261. As the Fifth Circuit has further
explained, ``a pharmacist can know that prescriptions are issued for no
legitimate medical purpose without his needing to know anything about
medical science.'' Id at 261 n.6; see also United States v. Henry, 727
F.2d 1373, 1379 (5th Cir. 1984) (applying ``reason to believe''
standard to pharmacist); United States v. Seeling, 622 F.2d 207, 213
(6th Cir. 1980) (upholding use of deliberate ignorance instruction in
prosecution of pharmacist).
However, Dr. Sullivan's statements that: (1) A pharmacist is not
required to fill any prescription, and (2) it is not an excuse that
because a doctor wrote the prescription, it can be legally filled, are
consistent with Federal law.
More importantly, Dr. Sullivan testified that a pharmacist is
``[a]bsolutely'' taught to question the legality of a prescription. Tr.
940. As examples of prescriptions he had refused to fill, Dr. Sullivan
noted an instance where a physician had written for a combination of a
narcotic, a benzodiazepine, a muscle relaxant, and a sleeping pill;
there were ``similar doses for everybody, [with] no individualization
of therapy''; and ``maximum doses for everyone.'' Id. at 940-41. Dr.
Sullivan further testified that when he called the physician to
determine what was wrong with the patients, ``so we could document
whether it is for a legitimate purpose,'' the physician never provided
a ``good answer'' and he ``stopped filling prescriptions for these
patients.'' Id. at 941.
Continuing, Dr. Sullivan explained that ``[m]ore is required'' from
a pharmacist than merely verifying the prescription with the doctor and
that ``[i]t is still [a pharmacist's] professional judgment to make the
call * * * is it for a legitimate purpose or not?'' Id. at 942. Dr.
Sullivan emphasized that ``just because the physician tells [a
pharmacist] that, yes, it is for a legitimate medical purpose * * *
[the pharmacist] still ha[s] that 50 percent corresponding liability to
make [his] own judgment, is that for a legitimate medical purpose or
not.'' Id.
Dr. Sullivan testified that there are ``red flags'' which
pharmacists need to recognize and consider before they dispense a
prescription. Tr. 936. As examples, he testified that pharmacists are
``required to do drug utilization review on every prescription * * *
before it is dispensed in the pharmacy'' to determine whether ``doses *
* * are too high, duplicate therapy, potential use or misabuse [sic],
[and prescriptions are] being filled too soon.'' \31\ Id. Additional
red flags include ``[m]aximum doses being seen for every single
patient, lack of individuation of therapy, certain patterns from
physicians of potential abuse of seeing the same types of controlled
substances over, and over, and over, again.'' Id. at 937. Moreover,
other red flags involve ``drug interactions [such as] [t]wo drugs being
used for the same thing, three drugs being used for the same thing,
three drugs in different classes[ ] that can cause the same side
effects, such as respiratory [depression] where you might see a
benzodiazepine, a muscle relaxer, and a narcotic pain killer.'' Id. at
937.
---------------------------------------------------------------------------
\31\ According to Dr. Sullivan, as part of the prospective drug
utilization review, a pharmacist is required to check a patient's
profile 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[; and] (i) documented good/nutritional supplements-drug
interactions.'' GX 20, at 3-4 (emphasis in original).
---------------------------------------------------------------------------
On cross-examination, Dr. Sullivan explained that ``[t]here is no
permanent physical checklist. [A pharmacist] should look for several
different things, such as number of drugs being prescribed, quantities,
types of drugs, patient profile, what is going on with that patient's
drug therapy in the past, because you have to do prospective DUR. Where
the patient lives, where they are coming from, and even method of
payment.'' Id. at 993.
Dr. Sullivan further testified that it is ``[a]bsolutely''
important that pharmacists communicate with one another. Tr. 950-51.
Dr. Sullivan explained that a pharmacist readily ``develop[s] a pretty
quick informal network among the pharmacists * * * within a five to ten
mile radius'' of his store because of the need to transfer
prescriptions and that these informal networks also host such
discussion as whether there is suspicious prescribing going on in
various parts of the State. Id. at 951-52. Continuing, he testified
that if a pharmacist is presented with a
[[Page 66158]]
prescription which another pharmacy had refused to fill, ``there had
better be a lot of documentation, a lot of conversation with the
physician, and a very, very good explanation * * * professionally as to
why that patient needs that prescription filled'' before the pharmacist
``risk[s] [his] license and fill[s] that prescription.'' Id. at 953.
Dr. Sullivan explained that were a patient to tell him that another
pharmacy had refused to fill the prescription, he would first call that
pharmacist and ask why he refused to fill the prescription and why he
suspected that the prescription was not ``for a legitimate medical
purpose.'' Id. Dr. Sullivan also explained that it was ``[a]bsolutely''
important that a pharmacist maintain an open line of communication with
a prescribing physician. Id. at 954.
Dr. Sullivan reviewed the prescriptions issued to fifty-five
patients by Dr. Volkman which were filled by Respondent between
September 13, 2005 and February 9, 2006. Id. at 948, 991, 1011; GX
20.\32\ He subsequently prepared a report which was submitted into the
record. GX 20.
---------------------------------------------------------------------------
\32\ While the ALJ found that ``Dr. Sullivan was provided 55
prescriptions,'' ALJ at 30, his subsequent testimony made clear that
he had actually reviewed hundreds of prescriptions. Tr. 1011
(``There were 55 patients, there were hundreds of prescriptions that
I looked at.'').
Respondent's Counsel also took issue with Dr. Sullivan's
statement that he had reviewed a ``random'' sample. See Tr. 992
(``So you would agree with me that this isn't really a random
sample, wouldn't you?''). Dr. Sullivan testified that the sample
represented ten percent of the prescriptions seized from Respondent
by DEA and that the selection of that ten percent was ``based on a
statistical formula'' that he obtained from a statistics Web site
and had later validated, but he did not include the formula in his
report. Id. at 992.
However, it is immaterial whether the sample Dr. Sullivan
reviewed was randomly selected as Mr. Fletcher's obligation under 21
CFR 1306.04(a) applies to every prescription he dispensed.
---------------------------------------------------------------------------
At the outset of his report, Dr. Sullivan observed that ``all these
patients were from extreme southern Ohio and northern Kentucky'' and
were ``driving 2+ hours to Columbus to have their prescriptions
filled.'' Id. at 1. Dr. Sullivan noted that the customers ``would have
bypassed [dozens of other] pharmacies en route to Columbus.'' Id.; Tr.
960. Dr. Sullivan opined that ``[t]his would be a major red flag to any
pharmacist'' and that ``a reasonable pharmacist would seriously
question why these patients were driving such a long distance to have
their prescriptions filled.'' GX 20, at 1. At the hearing, Dr. Sullivan
further explained that according to the Shearing Report, which ``looks
at why consumers shop at certain community pharmacies,'' in ``at least
28 out of the last 30 years, the number one reason is proximity to
where they live.'' Tr. 959. Dr. Sullivan thus observed that ``[t]his
pattern of patients traveling long distances from the location of their
home and physician is extremely unusual and very suspicious.'' GX 20,
at 2.
In addition, Dr. Sullivan noted that forty of the fifty-five
patients (73%) had paid cash for their prescriptions'' and that ``the
national average of cash paying customers for prescriptions [was] 11.4%
in 2005 and 10% in 2006.'' \33\ Id. Explaining that ``profit margins on
cash prescriptions are 30% higher than insurance prescriptions for
brand-name[] drugs and 100% to 500% higher than insurance prescriptions
for generics,'' he concluded that this ``is an obvious example of a
pharmacy profiting from drugs that are most likely being abused or
diverted for sale on the street'' and that ``[a]ny reasonable
pharmacist knows that a patient that wants to pay cash for a large
quantity of controlled substances is immediately suspect.'' Id.
---------------------------------------------------------------------------
\33\ The ALJ found that Dr. Sullivan ``credibly'' testified that
``nationwide[ ] only 10% of prescriptions [are] paid for in cash.''
ALJ at 31 (citing Tr. 961). Dr. Sullivan further testified that IMS
Health, ``the number one data collection firm for basically all
prescription drug prescribing, dispensing, and pricing,'' was the
source of this data. Tr. 961.
---------------------------------------------------------------------------
In his report, Dr. Sullivan stated that in all of his ``years of
practice and teaching, I have never seen such an abuse of controlled
substances dispensing by one pharmacy, especially in schedule II
controlled substances.'' \34\ GX 20, at 1. Dr. Sullivan also found
``extremely surprising the volume of controlled substances this one
doctor [wrote], especially for schedule II drugs.'' GX 20, at 1-2.
According to Dr. Sullivan, this ``should have been a major red flag for
any reasonable pharmacist that this physician is nothing more than a
controlled substance prescription mill for patients who are diverting
and abusing narcotic drugs.'' Id. at 2.
---------------------------------------------------------------------------
\34\ In his testimony, Dr. Sullivan elaborated that he had
``almost never seen'' cases where physicians were ``abusing the
prescribing of controlled substances'' by issuing prescriptions for
schedule II drugs and that most cases typically involved schedule
III and IV drugs. Tr. 955-56. On cross-examination, Dr. Sullivan
admitted that he had probably not filled a pain medication
prescription in approximately twelve years, id. at 977, and that
this report represented his first determination that ``a pharmacy is
abusing controlled substances.'' Id. at 990. However, he had
previously filled ``probably 1,000'' prescriptions for oxycodone and
thousands of prescriptions for alprazolam. Id. at 980-981.
---------------------------------------------------------------------------
Dr. Sullivan further observed that ``75% of the [Volkman] patients
received the same four drug cocktail, which included a benzodiazepine,
two narcotic pain killers and Soma (a muscle relaxer known to be highly
abused).'' Id. at 3. According to Dr. Sullivan, ``[i]t is well known in
the pharmacy profession [that] the combination of a benzodiazepine,
narcotic pain killer, and Soma [is] being used by patients abusing
prescription drugs.'' Id. Dr. Sullivan then noted that Dr. Volkman
``took this to another level by prescribing two narcotic pain killers
at the same time.'' Id.
In his testimony, Dr. Sullivan explained that pharmacists refer to
the combination of ``the benzodiazepine, the narcotic * * * pain
killer, and the sleeping pill'' as ``[t]he triple,'' and that when Soma
(carisoprodol) is added, the combination is known as the ``homerun.''
Tr. 956. Noting that Volkman was issuing duplicate prescriptions for
schedule II narcotics, Dr. Sullivan testified that he had never seen
two schedule II narcotics prescribed together other than for treatment
of cancer or hospice patients. Id. at 956-57, 1027-28.\35\ He further
observed that ``41 of the 55 [patients] (75%) received two narcotic
pain killers on the same day,'' and that this happened ``68 different
times for these 41 patients.'' GX 20, at 3. He then reiterated that
``[t]o have two schedule II controlled substances, or two narcotics, a
schedule II, and a schedule III * * * like * * * a Vicodin * * * or a
Lortab * * * combined together * * * was something [he] had never seen
to this extent before these prescriptions.'' Id. at 957.
---------------------------------------------------------------------------
\35\ When asked on cross-examination if he knew what break-
through pain is and whether he was aware that Dr. Volkman
``practiced pain break-through type treatment,'' Dr. Sullivan
explained that there is no such separate specialty in pain
management and that this ``is when a patient is on a dose of
medication, and they are having flare-ups in pain, then another drug
is given to help on a temporary acute basis to take care of that
pain flare.'' Tr. 1027. He further stated that such treatment
regimens were sometimes seen ``in hospice patients and cancer
patients.'' Id. at 1028. Respondent did not establish that Volkman
was legitimately prescribing multiple drugs for this purpose.
---------------------------------------------------------------------------
Noting that a pharmacist's primary obligation is to take care of
the patient, Dr. Sullivan stated that if he saw two prescriptions for
two narcotic pain killers for one patient, he would worry about the
potential central nervous system (CNS) effects or ``the respiratory
depression that might occur with this patient.'' Id. at 957. Observing
that ``a lot of these drugs'' have a ``synergistic effect on
respiratory depression,'' he explained that ``[i]t is not two narcotics
equal twice the respiratory depression, it is one plus one equals three
or four times the respiratory depression.'' Id. Moreover, when a
benzodiazepine and a muscle relaxant are added ``on top of that,''
there is a concern as to whether ``the patient
[[Page 66159]]
[is] going to be able to safely take these medications together.'' Id.
He then testified that looking at the quantities, doses, and that
multiple drugs were being prescribed for a single patient, he would ask
himself ``how could this possibly be for a legitimate medical
purpose.'' Tr. 958.
In his report, Dr. Sullivan further noted that there were three
patients who ``received three narcotic pain killers on the same day''
and that ``[t]here is no logical reason why the patient would be on two
or three narcotic pain killers at the same time.'' GX 20, at 3.
Continuing, he explained that this is ``a major red flag'' which is
strongly suggestive of abuse and that ``[n]o reasonable pharmacist
would fill two or three of these prescriptions on the same day.'' Id.
See also id. at 5 (discussing M.C., who on the same day received
prescriptions for Percocet 10/325, Norco 10/325,\36\ and oxycodone 30
mg.).
---------------------------------------------------------------------------
\36\ Norco is a brand name drug containing hydrocodone
bitartrate and acetaminophen, and a schedule III controlled
substance pursuant to 21 CFR 1308.13(e)(1). ALJ Ex. 5, at 2.
---------------------------------------------------------------------------
With regard to the narcotic pain killers Respondent dispensed, Dr.
Sullivan explained that the ``normal dose of oxycodone'' is ``5 mg. to
10 mg. every four hours,'' but that ``80% of the patients in the sample
were prescribed 15 mg. to 60 mg. every two or three hours.'' GX 20, at
4. Dr. Sullivan explained that ``a reasonable pharmacist would
recognize this as a problem and a marker of drug abuse and addiction.''
Id.
As to the prescriptions for schedule III hydrocodone/apap drugs,
Dr. Sullivan noted that ``100% (89/89) were for the highest strength
available, which is 10 mg. of hydrocodone.'' Id. Observing that it was
``clinically impossible that all the patients in the sample would
always need the highest possible dose of hydrocodone with
acetaminophen,'' Dr. Sullivan thus concluded that there was ``no
individualization of dosing based on pain in these patients, which
should have been a major red flag for any pharmacist.'' Id. Moreover,
``[a]ny pharmacist would have known that this was a problem and a
strong indicator of a doctor operating a controlled substance
prescribing mill.'' Id.\37\
---------------------------------------------------------------------------
\37\ Dr. Sullivan also observed that ``[m]any of the narcotic
prescriptions had the words `severe LBP' on them,'' which ``most
likely stands for `Severe Low Back Pain.' '' GX 20, at 5. Explaining
that ``[l]ower back pain is viewed in the medical field as the
`biggest scam to obtain controlled substances' because it is the
hardest to disprove due to the lack of definitive clinical
measures,'' he reported that ``[i]t is very unusual that all these
patients had the same diagnosis and they all had to be on the
maximum doses of these controlled substances including Soma.'' Id.
---------------------------------------------------------------------------
With respect to the Xanax (alprazolam) prescriptions, ``one of the
most highly abused benzodiazepines on the market'' and a drug ``in high
demand on the street,'' Dr. Sullivan observed that all sixty
prescriptions were for the maximum strength of the drug. Id. Moreover,
ninety-three percent of the prescriptions ``exceeded the FDA approved
maximum daily dosage of 4 mg. per day'' and thirty-two percent
``exceeded the FDA approved dosing schedule of three times a day.'' Id.
At the hearing, Dr. Sullivan explained that Xanax 2 mg. is generally
only prescribed to patients with post-traumatic stress disorder. Tr.
970.
Again, Dr. Sullivan noted that there was ``no individualization of
therapy'' and that ``[e]very patient was prescribed the same strength
at extremely high doses.'' GX 20, at 4. He further opined that ``[a]ny
pharmacist would have known that this was a problem and a strong
indicator of a doctor operating a controlled substance prescribing
mill.'' Id.
With regard to the Valium (diazepam), which is also ``a highly
abused benzodiazepine in high demand on the street,'' Dr. Sullivan
noted that all of the forty-two prescriptions he reviewed were for the
highest strength available, 10 mg. GX 20, at 4. He then noted that
Patient K.D. ``was prescribed Valium 20 mg. at bedtime, twice the
maximum dose,'' and ``[a]t least 50% of the prescriptions were written
for a maximum dose of four times daily.'' Id. at 5. Dr. Sullivan again
explained that ``[a]ny pharmacist would have known that this was a
problem and a strong indicator of a doctor operating a controlled
substance prescribing mill.'' Id.
After noting that over the period of September 2005 through January
2006, Dr. Volkman ``seemed to be writ[ing] larger doses and higher
quantities as time went on'' and that this was ``definitely a sign of
drug abuse'' which ``a reasonable pharmacist \38\ would have caught,''
Dr. Sullivan discussed ``a few of the most blatant examples of abuse
and diversion.'' Id. These included instances in which Respondent
provided early refills such as for L.B., who on December 28, 2005,
received a Xanax prescription two weeks early; and S.K., who, on
September 13, 2005, received a prescription for 240 tablets of
oxycodone 15 mg., with eight tablets to be taken per day (thus being a
thirty-day supply), and who, one week later, obtained an additional 168
tablets of the same drug. Id. at 5-6. Moreover, M.P. filled two
prescriptions for Percocet 5/325 on the same day, and L.A.T. filled two
prescriptions for oxycodone on the same day. Id. at 6.
---------------------------------------------------------------------------
\38\ On cross-examination Dr. Sullivan elaborated that ``a
reasonable pharmacist'' is ``[a] pharmacist who looks out for the
best interest of their patients, takes care of their patients,
within the legal requirements of the law.'' Tr. 1025.
---------------------------------------------------------------------------
Dr. Sullivan further observed that J.C. had received a prescription
for 720 tablets of oxycodone 15 mg. with a dosing of two tablets every
two hours (or twenty-four tablets per day), as well as for twelve
tablets per day of hydrocodone/apap 10 mg./325 mg.; according to Dr.
Sullivan, ``[n]o patient could take this much narcotic in one day and
not overdose.'' Id. at 5. He also noted that M.C. had received three
different narcotics on the same day including 180 Percocet 10/325, 180
Norco 10/325, and 240 oxycodone 30 mg., and observed that ``[a]t these
doses[,] this patient [was] taking 300 mg. of oxycodone per day along
with 60 mg. of hydrocodone'' and that ``[n]o patient could take this
much narcotic in one day and not overdose.'' Id. Finally, with respect
to J.C. (a resident of Grayson, Ky.) and M.C. (a resident of Flatwoods,
Ky.), Dr. Sullivan explained that ``[a] reasonable pharmacist would
notice [the amounts being taken] as a problem'' and that the amounts
were a marker of drug abuse or diversion such that a reasonable
pharmacist would not have filled the prescriptions. Id.
Dr. Sullivan concluded his report as follows:
A pharmacist might act in the best interest of the patient and
fill an occasion[al] prescription for a high dose or large quantity.
However, the evidence presented above is overwhelming and shows a
pattern of dispensing controlled substances to patients who are
known drug abusers \39\ or are diverting prescription drugs for
illegal purposes. There are dozens of patients with the same drugs
on their profile[s] and all at maximum doses and beyond. There is no
medically sound reason why patients should be treated with two or
three drugs in the same class for the same thing as these patients
are. Any reasonable pharmacist would notice this as a problem very
quickly and easily. In addition, these drugs when combined cause CNS
(central nervous system) depression and can easily lead to overdose.
Any reasonable pharmacist would recognize this danger and would not
dispense these medications (duplicate therapy) together. These are
all textbook examples of drug abuse and/or drug diversion. Any
reasonable pharmacist would quickly recognize this based on their
education and training. In all my years of practicing and teaching,
I have never seen such an abuse of controlled substance
[[Page 66160]]
dispensing by one pharmacy, especially in schedule II controlled
substances.
---------------------------------------------------------------------------
\39\ On cross-examination, Dr. Sullivan clarified that he
described the patients as ``known drug abusers'' because ``[t]hat is
my professional opinion based on what I saw in the prescriptions.''
Tr. 1032-33.
---------------------------------------------------------------------------
Id. at 6.
On cross-examination, Dr. Sullivan conceded that he ``would not
have turn[ed] away every one of'' the customers whose prescriptions
were reviewed in his report but that after he had ``seen a pattern,''
he ``would have started to make phone calls and then started to not
fill them.'' Tr. 1009. Moreover, ``based on the large quantities'' and
``the safety of the patient,'' there were some prescriptions, including
those ``for three narcotic pain killers'' that he ``would not have
filled'' at all. Id. at 1010. Dr. Sullivan further explained that in
determining which prescriptions he would have filled, he would ``had to
have looked at the patient history, and [considered] the conversation
of the physician.'' Id. at 1011. Clarifying his testimony, Dr. Sullivan
explained that while it might have required time to detect a pattern
with respect to some of the prescriptions, others should not have been
filled at all ``just looking blatantly at the doses, the combinations,
that would have been, definitely, harmful to that patient, taking those
drugs in those doses.'' Id. at 1012-13. Dr. Sullivan then explained
that part of the reason for his equivocation with respect to whether he
would have filled some of the prescriptions is that when he reviewed
them, he did not ``know how long [Mr. Fletcher] had been treating those
patients.'' Id. at 1013.
Dr. Sullivan also acknowledged that he does not have actual
knowledge of whether the Volkman patients were abusing or diverting the
drugs. Id. at 1019. However, he reiterated his opinion that based on
the quantities and doses that Volkman was prescribing, the drugs were
either being abused or diverted because the patients would be dead if
they took the amounts that were prescribed. Id. at 1032. Notably, the
ALJ found that Dr. Sullivan ``rationally and credibly concluded that
these patients abused the drugs, diverted the drugs, or [if they had]
consumed them * * * would be dead.'' ALJ at 35 (citing Tr. 1032); Tr.
1019.
The State Board Proceeding
On March 5, 2009, the Ohio State Board of Pharmacy (Board) found
that on three occasions between August 29, 2006 and November 27, 2007,
deliveries of controlled substances were made to Respondent when a
pharmacist was not on duty and that the drugs were not properly
secured. GX 16, at 2-3 & 4; Tr. 1066. In the first instance, the
delivery was placed in a hallway closet outside of Respondent; in both
the second and third instances, the drugs were placed in a pharmacy
technician's automobile, which was parked in Respondent's parking lot.
GX 16, at 2. Based on these incidents, the Board found that Respondent
violated Ohio law. Id. at 2-3 (citing Ohio Rev. Code Sec. 4729.55).
The Board fined Respondent $1,000.00, id. at 3, and Mr. Fletcher
$1,500.00. Tr. 1073. In addition, the Board placed Mr. Fletcher's
pharmacist's license on probation for two years and suspended it for
twelve weeks, but then waived ten weeks of the suspension.\40\ Tr.
1074. According to the Board's Order in the case against Respondent, it
had the right to appeal to the State courts. GX 16, at 3.
---------------------------------------------------------------------------
\40\ Regarding the Ohio Board proceedings, the ALJ allowed
Respondent to elicit the testimony of Barton Kaderly, who had
previously been a citizen member of the Board; Mr. Kaderly testified
as to his being ``appalled'' over the decision of his fellow board
members to fine Respondent and Mr. Fletcher. Tr. 1064, 1074-75.
Beyond the fact that Mr. Kaderly's personal opinion is irrelevant
and should have been excluded, the ALJ apparently forgot that DEA
has held that a registrant cannot collaterally attack the results of
a State board proceeding in proceedings under 21 U.S.C. 823 & 824.
See Hicham K. Riba, 73 FR 75773, 75774 (2008). I therefore give no
weight to his testimony.
---------------------------------------------------------------------------
Respondent's Evidence
Respondent called fifteen witnesses, half of whom testified
regarding the Government's various excursions into such issues as the
character of the neighborhood, Mr. Fletcher's practice of carrying a
gun at work, and his prices. Having concluded that the character of the
neighborhood and Mr. Fletcher's carrying of a gun are not relevant in
assessing his compliance with 21 CFR 1306.04(a) and that the Government
has not proved with substantial evidence that Respondent charged higher
prices than similar pharmacies, it is not necessary to discuss the
testimony of those witnesses Respondent called to refute these
contentions.\41\ Accordingly, only four witnesses offered testimony
arguably relevant to the issues in this proceeding.
---------------------------------------------------------------------------
\41\ These witnesses include Ms. Adkins, Ms. Berring, Mr.
Gordon, Mr. Cates, Dr. Will, Mr. Macke, and Mr. Kimbler. I have,
however, considered the testimony of these individuals (as well as
that of Ms. Banks and Ms. Del Guzzo) to the extent they testified as
to Mr. Fletcher's reputation and character.
As previously discussed, I have considered the testimony of Mr.
Newman, Respondent's CPA, in making my findings regarding
Respondent's structuring activities as well as that of Mr. Kaderly.
---------------------------------------------------------------------------
Mark Aalyson testified that he had practiced law in Portsmouth,
Ohio, that his ``practice was devoted exclusively'' to representing
injured workers before the Industrial Commission of Ohio, and that he
knew most of the doctors who practiced in Scioto County. Tr. 1156. Mr.
Aalyson testified that in the ``early fall of 2006,'' Mr. Fletcher
called him and asked whether he ``had ever heard of a Dr. Paul
Volkman.'' \42\ Id. According to Mr. Aaylson, Mr. Fletcher told him
that he was getting patients from the Scioto County area who were
getting prescriptions for pain medication from Dr. Volkman. Id. at
1157. Mr. Aalyson testified that he told Mr. Fletcher that he did not
know who Volkman was and was ``not sure how long he has been around.''
Id. at 1158-59. Mr. Aalyson then asked Mr. Fletcher ``what is the
problem?'' Id. Mr. Fletcher answered: ``I'm getting a lot of people
coming in, and I'm beginning to wonder if the guy is legitimate.'' Id.
at 1159.
---------------------------------------------------------------------------
\42\ Respondent's counsel asked Mr. Aalyson six times when this
conversation occurred, going so far as to suggest that ``you are not
sure of the year, you don't have a telephone record, or anything, to
show what year it would have been, it could have been 2005?'' See
Tr. 1156, 1166. While Mr. Aalyson answered this last question: ``I
can't remember, I'm sorry,'' he had previously testified repeatedly
that the conversation had occurred around the time he entered into
the agreement by which he sold his law practice and that this
happened in October 2006. Tr. 1156, 1166.
.
---------------------------------------------------------------------------
Julie Fuller worked as a sales representative for AmeriSource
Bergen, a major drug distributor, from December 2003 until January
2007. Tr. 1550. She testified that during her visits to Respondent, she
saw Mr. Fletcher check for early refills and for drug interactions. Id.
at 1567-68. However, she acknowledged that the purpose of her visits
was not ``to observe him'' in the practice of pharmacy but to get his
business. Id. at 1584. Moreover, Ms. Fuller testified that she believed
that Respondent closed at 6 p.m. and that her visits occurred
``[s]omewhere between 10 and 5,'' Tr. 1582; she did not testify that
she observed Mr. Fletcher filling any of Dr. Volkman's controlled-
substance prescriptions. Her testimony is therefore of no probative
value.
Respondent also called Mr. Fletcher's cousin, Carisa Cole, who
worked at Respondent between December 2004 and October 2009. Id. at
1704-05. In her testimony, Ms. Cole maintained that she never saw
anyone who appeared under the influence of either drugs or alcohol and
that Mr. Fletcher would not serve persons who appeared under the
influence (although it is not clear how she would know that Mr.
Fletcher would not serve such persons if she never saw any one who
appeared under the influence). Id. at 1708. However, on cross-
examination, she testified that she could not recall that any of the
patients Mr. Fletcher refused to dispense to for this reason were
patients of Dr.
[[Page 66161]]
Volkman. Id. at 1741. She also stated that he turned away a person who
presented a prescription issued by a Florida-based doctor but could not
recall when this happened. Id. at 1712. Finally, she testified that he
also sometimes turned people away because they did not have a photo ID.
Id. at 1747.
Ms. Cole maintained that she was present when Dr. Volkman's
patients came to the pharmacy and that ``a lot of them complained of
having blood taken too often'' to ``make sure that they were actually
taking their medication.'' Id. at 1713. She also testified that while
Respondent's hours were ``until 5:30,'' ``[t]here were a few times''
that Mr. Fletcher would stay open later because he knew that Volkman's
patients were coming. Id. at 1716, 1720. However, Ms. Cole never talked
with either Dr. Volkman or his security guard. Id. at 1721.
On cross-examination, Ms. Cole stated that she would typically
leave Respondent at ``[a]bout 5:30,'' but that sometimes she would stay
past 5:30 two or three times per week for the Volkman patients, and had
stayed as late as 9:30 for a Volkman patient. Id. at 1733. However, she
acknowledged that she would not typically be at the pharmacy after nine
o'clock because she has ``three children'' and ``child care issues.''
Id. at 1743-44. Moreover, she did not work at Respondent on Saturdays.
Id. at 1740.
Ms. Cole acknowledged that Volkman's patients were typically not
from the Columbus area and were coming from Portsmouth and Southern
Ohio, as well as Kentucky and West Virginia. Id. at 1723. Ms. Cole also
stated that Mr. Fletcher had asked these patients why they were filling
their prescriptions at his pharmacy and that the patients had stated
that other pharmacies did not have the medication or had run out. Id.
at 1724. When then asked whether she knew if Mr. Fletcher had ever
asked the patients ``why they never filled their prescriptions at any
pharmacies in between Portsmouth and Columbus,'' she answered that she
did not know if there were any pharmacies between these cities even
though she acknowledged that it was a two hour drive. Id. at 1726-27.
Ms. Cole also maintained that Mr. Fletcher had tried calling some
of the pharmacies but then acknowledged that she was ``not real sure''
if she was present when any of these calls were made. Id. at 1725.
Moreover, as found above, during an interview with a DEA Investigator,
Mr. Fletcher stated that he did not call other pharmacies regarding the
Volkman prescriptions. Id.
Ms. Cole also acknowledged that the Volkman prescriptions would
include at least one schedule II drug, that being oxycodone, which
would be prescribed in combination with Soma and alprazolam. Id. at
1732. She further acknowledged that Volkman patients would typically
present their prescriptions at the same time and that they ``typically
had the same prescriptions.'' Id. at 1736.
Subsequently, Ms. Cole testified that ``every time we got a
prescription from Florida, or anywhere out of the State of Ohio, [or]
even within the State of Ohio [but from outside of Columbus] * * * that
we would call and verify the prescriptions,'' which Ms. Cole stated,
would be done on ``[t]he business line.'' Tr. 1747-48, 1753. Ms. Cole's
recollection is patently erroneous as shown by the evidence that
Respondent filled 4,900 controlled-substance prescriptions for
Volkman's patients and the phone records Respondent submitted, which
establish that during the five-month period in which it filled
Volkman's prescriptions, it never made more than ninety-seven long
distance phone calls in a month.\43\ See RX 19. Ms. Cole also testified
that she remembered D.S. (who had sponsored A.S.) bringing other people
to Respondent to have her prescriptions filled. Tr. 1757.
---------------------------------------------------------------------------
\43\ This also assumes that every single phone call was made to
Dr. Volkman even though Respondent's phone bills show calls to
numerous cities in Ohio where there is no evidence that Volkman
worked or lived, as well as to cities in other States.
---------------------------------------------------------------------------
Ms. Cole further testified that Mr. Fletcher questioned those
persons who obtained controlled-substance prescriptions from Florida
doctors, and that they claimed that they had recently moved to either
Kentucky or Ohio or were working in Columbus and couldn't go home. Id.
at 1749. Ms. Cole stated that she was ``skeptical'' of the people
presenting these prescriptions because of the distances involved. Id.
With the exception of her testimony as to her skepticism, the remainder
of this testimony is absurd on its face--if a person had in fact
recently moved to Kentucky or Southern Ohio, this fact would have been
verifiable by simply looking at his/her driver's license as Ms. Cole
claimed Mr. Fletcher always did. Moreover, if a person had recently
moved to these areas, one must wonder how they would find out so
quickly that only Respondent would fill their prescriptions. As for
those persons who claimed they were working in Columbus and could not
go home, it is odd that they could travel to South Florida to obtain
the prescriptions in the first place.
Respondent also called Catherine Smith, who worked as a pharmacy
technician at Respondent and who considered Mr. Fletcher to be her
``best friend.'' Id. at 1235.\44\ Ms. Smith testified that her duties
involved a variety of functions including working at the front window
and ``talk[ing] to [the] patients,'' ``look[ing] at prescriptions,''
and also ``fill[ing] prescriptions.'' Id. Ms. Smith testified that she
saw the prescriptions ``first,'' and that if one did not ``look legit''
(meaning forged), she would ``present it to Mr. Fletcher.'' Id. at
1425. Ms. Smith also testified that she was the person who ``counted
the medicine'' and ``put [it] in a bottle'' and that she ``explained it
to the patients.'' Id. at 1429-30. According to Ms. Smith, Mr. Fletcher
would enter the prescription information into the pharmacy computer and
print out the labels. Id. at 1430.
---------------------------------------------------------------------------
\44\ Ms. Smith testified that she did not work Saturdays and
that only Mr. Fletcher worked then. Tr. 1240.
---------------------------------------------------------------------------
Ms. Smith further maintained that if a patient did not seem right
to her, she would mention it to Mr. Fletcher, who would then question
the patient and not fill the script if the patient was showing symptoms
of being under the influence. Id. at 1238. She also claimed that Mr.
Fletcher would ask Respondent's customers why they were taking the pain
medicine; he would also tell the patients ``this is a large quantity of
pills you are taking here'' and ask them ``can you work without the
medicine?'' Id. at 1253-54. Ms. Smith further maintained that Mr.
Fletcher would tell the patients ``be careful of the way you take it,
take it the way you are supposed to take it, the way they prescribe
it'' and that he would ``tell them some of the cautions to take with
it.'' Id. at 1254. She maintained that Mr. Fletcher ``talked to
everybody about their prescriptions.'' Id. at 1281.
On cross-examination, however, Ms. Smith then qualified her
testimony, stating: ``I'm not saying he talks to everybody, but the
majority of them * * * that is on that kind of pain medicine.'' Id. at
1423. Moreover, when DEA Investigators interviewed numerous patients of
Dr. Volkman, most of them stated that Mr. Fletcher did not ask about
their medical conditions. GX 9, at 86; see also GX 23, at 3 (affidavit
of L.W., ``When having prescriptions filled at [Respondent], most of
the time I spoke with Eugene's assistants but I did speak with Eugene
several times also. When we spoke together, Eugene never asked me about
my medical
[[Page 66162]]
condition but would just make small talk.'').
Ms. Smith also maintained that Mr. Fletcher would call the doctors
``and make sure that the script is legit.'' Id. at 1264. However, while
Mr. Fletcher may have spoken with Dr. Volkman on some occasions,
according to Volkman's former security guard, the majority of the calls
Mr. Fletcher made to Volkman's office ``were to determine how late he
should stay open to fill Dr. Volkman's prescriptions.'' GX 22, at 1-2.
Moreover, in the calls the security guard answered, ``Eugene never
asked about the medical condition of any patients and I never recall
hearing any other staff members discuss with Eugene any patient's
medical condition or anything else other than to arrange pharmacy
hours.'' Id. at 3. And as noted above, Respondent's phone records
suggest that Respondent filled numerous prescriptions without calling
Dr. Volkman.\45\ Moreover, neither Ms. Smith nor Ms. Cole testified as
to any specific instances in which Mr. Fletcher had refused to fill
prescriptions presented by Volkman's patients on the ground that the
prescriptions lacked a legitimate medical purpose.\46\
---------------------------------------------------------------------------
\45\ Respondent also asked Ms. Smith, who formerly held a
license as a registered nurse, a series of questions about the
proper dosing of pain medications. Tr. 1279-80. Ms. Smith has not,
however, maintained her license and did not testify as to having any
expertise in the treatment of chronic pain patients. Id. at 1280.
\46\ It is acknowledged that the ALJ found that Ms. Cole
credibly testified that Mr. Fletcher refused to fill a prescription
for a patient because the ``patient may have been trying to fill a
schedule II prescription too early.'' ALJ at 20 (quoting Tr. 1737).
She did not, however, recall the name of the patient, and her
testimony suggests that this was a one-time occurrence as she did
not assert that this had happened on more than one occasion. Tr.
1737. Most significantly, she did not testify that he refused to
fill the prescription because it lacked a legitimate medical purpose
and the great weight of the evidence (including the volume of
prescriptions, the type and quantity of the drugs, and Mr.
Fletcher's statements to Investigators), supports the conclusion
that he never refused to fill a prescription issued by Volkman
because it lacked a legitimate medical purpose.
---------------------------------------------------------------------------
Finally, notwithstanding the substantial probative evidence offered
against him, Mr. Fletcher did not testify in this proceeding.
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). In determining the public interest in the case of a
practitioner, the Act directs that the following factors be considered:
(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, it is well settled that I am ``not required to make
findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482
(6th Cir. 2005); see also Morall 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 the 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. Miller, 53 FR 21931, 21932 (1988))), pet. for rev. denied,
Medicine Shoppe-Jonesborough v. DEA, 2008 WL 4899525 (6th Cir.).
``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 [his] actions and demonstrate that [he] 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, 62483 (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
Respondent ``has committed such acts as would render [its] registration
* * * inconsistent with the public interest.'' \47\ 21 U.S.C.
824(a)(4). I further conclude that Respondent has not rebutted the
Government's prima facie case. Accordingly, I affirm the order of
immediate suspension.\48\
---------------------------------------------------------------------------
\47\ As to factor one, the Ohio 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 or Mr. Fletcher's license, 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 that either
Respondent or Mr. Fletcher 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. Thus, DEA has 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 Respondent may still hold its Ohio pharmacy
license and that neither it, nor Mr. Fletcher, has been convicted of
a criminal offense is not dispositive.
\48\ While Respondent allowed his registration to expire and has
not submitted a renewal application, there is no evidence that Mr.
Fletcher has surrendered Respondent's pharmacy license and his
pharmacist's license, and neither party argues that this case is
moot. Moreover, Respondent's registration was immediately suspended
at which time its controlled substances were seized. Under the CSA,
``[a]ll right, title, and interest in'' any controlled substances
seized pursuant to a suspension order ``vest in the United States
upon a revocation order becoming final'' and ``shall be forfeited to
the United States.'' 21 U.S.C. 824(f). DEA has previously held that
``a litigant cannot defeat the effect of this provision by simply
allowing its registration to expire.'' Meetinghouse Community
Pharmacy, Inc., 784 FR 10073, 10074 n.5 (2009). Accordingly, there
are collateral consequences which preclude a finding of mootness.
See id.; Trinity Health Care Corp., 72 FR 30849, 30853-54 (2007).
---------------------------------------------------------------------------
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Relating to Controlled
Substances
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
[[Page 66163]]
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.'' \49\ Id.
---------------------------------------------------------------------------
\49\ As the Supreme Court recently 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.' '' 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 (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).
Respondent contends that ``[t]he [G]overnment can point to no
specific violation of a known rule, but merely relies upon the general
and vague allegation that Respondent did not satisfy a `corresponding
duty' to ensure that [it] dispenses controlled substances for a
legitimate medical purpose.'' Resp. Exceptions, at 1. It further
contends that it ``has been held to an unknown and ambiguous standard,
[which is] higher than any standard previously imposed on any
pharmacist.'' Id. at 6. Contrary to Respondent's contention, the
Federal courts have had little problem applying the regulation and long
ago expressly rejected the argument that the regulation is
unconstitutionally vague and does not provide fair notice of what
conduct is prohibited. See, e.g., United States v. Hayes, 595 F.2d 258,
260 (5th Cir. 1979) (``The regulation gives fair notice that certain
conduct is proscribed.'') (int. quotations and citations omitted).
Most significantly, the great weight of the evidence establishes
that Mr. Fletcher filled numerous controlled-substance prescriptions
which he had reason to know were not issued for a legitimate medical
purpose by a practitioner acting in the usual course of professional
practice. Indeed, Mr. Fletcher knew from the outset that Dr. Volkman's
prescriptions lacked a legitimate medical purpose. As found above, Mr.
Fletcher was specifically asked in a phone call by one of Dr. Volkman's
patients if he would fill prescriptions written by Volkman for multiple
drugs including oxycodone 30 mg. and hydrocodone 10 mg., which are
schedule II and III narcotics respectively, Xanax 2 mg., a schedule IV
benzodiazepine, and Soma (carisoprodol), a muscle relaxant which is
currently a non-scheduled drug but which is nonetheless popular with
drug abusers and which metabolizes into meprobamate, a schedule IV
drug.\50\
---------------------------------------------------------------------------
\50\ Because of its potential for abuse, DEA has, however,
initiated a proceeding to place carisoprodol into schedule IV of the
Controlled Substances Act. See 74 FR 59108, 59109 (2009).
---------------------------------------------------------------------------
As the Government's Expert explained, the combination of a
benzodiazepine, a narcotic and carisoprodol is ``well known in the
pharmacy profession'' as being used ``by patients abusing prescription
drugs.'' GX 20, at 3. Moreover, as the Government's Expert elaborated,
Dr. Volkman took this ``to another level'' by prescribing two narcotics
in addition to a benzodiazepine and carisoprodol, thus distributing a
schedule II narcotic, a schedule III narcotic, a schedule IV
depressant, and carisoprodol, for a total of four drugs at the same
time. Id.
The Government's Expert further explained that the combination of
these two narcotics, a benzodiazepine, and a muscle relaxant would have
a ``synergistic effect'' on a patient's central nervous system and
cause respiratory depression thus posing a substantial risk to any
patient actually taking the drugs as prescribed. Thus, from the time
Mr. Fletcher agreed to fill the prescriptions, he had reason to know
that Volkman's prescriptions lacked ``a legitimate medical purpose.''
21 CFR 1306.04(a).
Notwithstanding this, there is ample evidence showing that
Respondent repeatedly dispensed cocktail prescriptions for oxycodone,
hydrocodone, alprazolam, and carisoprodol. See GX 12 (spreadsheet of
prescriptions dispensed to A.S. and L.W.); GX 20, at 3 (Gov. Expert's
report noting that ``75% of the patients received the same four drug
cocktail which included a benzodiazepine, two narcotic pain killers and
Soma''). With respect to A.S.\51\ and L.W., many of the oxycodone
prescriptions were for 30 mg. and were for quantities which would
provide a daily dose multiple times the amount that the Government's
Expert--whose testimony was unrefuted--stated was the ``normal dose of
oxycodone'' and thus indicated that Volkman was running a pill mill.
Likewise, the prescriptions for hydrocodone and alprazolam were always
for the strongest formulations of the drug; with respect to the
alprazolam, the Government's Expert explained that ninety-three percent
of the prescriptions he reviewed exceeded the FDA-approved maximum
daily dosage and that the two-milligram strength of the drug is
generally only prescribed for a patient with post-traumatic stress
disorder.
---------------------------------------------------------------------------
\51\ While A.S. testified that she had been in pain caused by an
auto accident, she also testified that she diverted drugs. Moreover,
while A.S.'s pain may have justified the prescribing of a controlled
substance, Respondent offered no evidence refuting the Government
Expert's testimony that the four-drug cocktail of oxycodone,
hydrocodone, alprazolam, and carisoprodol, which Volkman repeatedly
prescribed to her, does not have a legitimate medical purpose.
---------------------------------------------------------------------------
Respondent also filled prescriptions issued to a single patient for
multiple schedule II drugs on the same day, as well as three narcotic
controlled substances on a single day. Moreover, in the prescriptions
he reviewed, the Government Expert observed that there was ``no
individualization of dosing based on pain in these patients'' with
respect to the hydrocodone and alprazolam prescriptions and that
``[a]ny pharmacist would have known that this was a problem and a
strong indicator of a doctor operating a controlled substance
prescribing mill.'' The Government's Expert also noted various
instances of Respondent dispensing refills that were weeks early.
In addition, the fact that Mr. Fletcher had been called by D.S.,
who lived in Southern Ohio and was seeing a doctor whose office was
nearly 100 miles away from his pharmacy, and yet, was obviously having
problems filling her prescriptions, provided further reason to know
that the prescriptions were not legitimate. While Mr. Fletcher did not
ask where D.S. and Dr. Volkman were from and thus may not have had
actual knowledge at the time of the initial phone call where Volkman
and the patients were from, see GX 39, at 2; under a DEA regulation,
each controlled-substance prescription must include the name and
address of both
[[Page 66164]]
the patient and prescriber. 21 CFR 1306.05(a).
Thus, the first time one of Volkman's patients presented a
prescription to him, Mr. Fletcher knew that Volkman was practicing in
Portsmouth, approximately 90 miles from Columbus, as well as the
location of the patient's residence; he also knew with each successive
prescription he received from a Volkman patient that they were
travelling great distances to fill their prescriptions.
As the evidence shows, only a few of Volkman's patients lived in
the Columbus area, and most of them were travelling great distances
(and sometimes with others) to get their prescriptions filled at
Respondent, with approximately half of them coming from Kentucky (more
than two hours away) and many others coming from the Portsmouth area.
Notwithstanding that many of the patients were travelling for hours to
fill their prescriptions at Respondent, Volkman's controlled-substance
prescriptions accounted for seventy-five percent of the total amount of
controlled-substance prescriptions dispensed by Respondent, and
controlled substances accounted for approximately ninety-five percent
of Volkman's prescriptions. As the Government's Expert testified, the
fact that the patients were driving so far to get their prescriptions
filled ``would be a major red flag to any pharmacist.''
Indeed, Mr. Fletcher admitted in an interview that he had been told
by Volkman's patients that no other pharmacists would fill the
prescriptions. Yet, even when presented with this fact, he did not call
any pharmacists to determine why. He also admitted in an interview that
some of Volkman's patients had asked him to sell them extra pills, a
clear indication that Volkman's patients were either abusing and/or
selling the drugs. Yet he continued to fill Volkman's prescriptions.
Moreover, in substantial contrast to the national average of cash-
paying customers which is approximately ten to eleven percent, nearly
eighty-seven percent of the Volkman patients paid cash for their
prescriptions. This, too, was a red flag as ``[a]ny reasonable
pharmacist knows that a patient that wants to pay cash for a large
quantity of controlled substances is immediately suspect.''
The evidence further shows that Respondent and Dr. Volkman's clinic
would call each other on a daily basis to discuss when Volkman had seen
his last patient so that Mr. Fletcher would know how late to stay open
and that he stayed open as late as midnight to await the arrival of
Volkman's patients and to fill their prescriptions. Relatedly, the
evidence shows that Volkman directed his patients to go to Respondent
and even provided driving directions to it. And the evidence also
showed that Volkman's patients would travel to Respondent in groups.
Moreover, in early October 2005, Volkman, following a raid by the
Portsmouth P.D., moved his ``practice'' to Chillicothe. Mr. Fletcher
knew that Volkman had moved to Chillicothe because he called Volkman at
this clinic. GX 22. This begs the question of whether Mr. Fletcher
asked Volkman why he had moved his practice, which, like all of the
other questions raised by his conduct, Mr. Fletcher has failed to
address because he did not testify.\52\ See, e.g., Baxter v.
Palmigiano, 425 U.S. 308, 316 (1976). In light of the substantial
probative evidence offered against Respondent and Mr. Fletcher, Mr.
Fletcher's failure to testify supports the drawing of an adverse
inference against Respondent and Mr. Fletcher. I therefore conclude
that Mr. Fletcher knew that Volkman's prescriptions lacked ``a
legitimate medical purpose'' and thus violated Federal law.
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\52\ The evidence also shows that in October 2005, shortly after
he had commenced filling Volkman's prescriptions, Mr. Fletcher was
aware of the $10,000 threshold which triggers a bank's obligation to
report a cash deposit under the Bank Secrecy Act and that he then
structured multiple bank deposits in an attempt to avoid his bank's
filing of Currency Transaction Reports, which would draw attention
to his activities. This evidence further supports the conclusion
that Mr. Fletcher clearly knew that by filling the Volkman
prescriptions, he was engaging in illegal activity.
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Against this evidence, Respondent elicited the testimony of his two
employees. Ms. Smith testified that Mr. Fletcher would question his
customers as to why they were taking the medicine, tell them that they
were taking a large quantity of pills, and ask them if they could work
without the drugs. She further maintained on direct examination that
Mr. Fletcher ``talked to everybody about their prescriptions'' but then
retreated from this testimony, stating that he did not talk ``to
everybody'' but only ``the majority of them.'' Moreover, earlier in her
testimony, she had stated that she explained the medications to the
patients and most of the patients interviewed by DEA Investigators
stated that Mr. Fletcher did not ask them about their medical
condition.
As for Ms. Cole, much of her testimony is of dubious credibility.
For example, Ms. Cole testified that Mr. Fletcher had tried calling
some of the pharmacies which had refused to fill Volkman's
prescriptions. Yet, when interviewed by a DEA Investigator, Mr.
Fletcher stated that he did not talk to other pharmacists. Ms. Cole
also testified that every time Mr. Fletcher received prescriptions from
outside of the Columbus area, he would call to verify the
prescriptions. However, Respondent's phone records show otherwise.
Regardless, even if Mr. Fletcher had called to verify each and
every prescription that Dr. Volkman issued, the evidence would still
support the conclusion that he repeatedly violated his corresponding
responsibility under Federal law because many of the Volkman
prescriptions patently served no legitimate medical purpose. See United
States v. Hayes, 595 F.2d at 260 (``[A] pharmacist may not fill a
written order from a practitioner, appearing on its face to be a
prescription, if he knows the practitioner issued it in other than the
usual course of medical treatment.'').
As the Fifth Circuit has explained, while ``[v]erification by the
issuing practitioner on request of the pharmacist is evidence that the
pharmacist lacks knowledge that the prescription was issued outside the
scope of professional practice[,] * * * it is not an insurance policy
against a fact finder's concluding that the pharmacist had the
requisite knowledge despite a purported but false verification.'' Id.
at 261. A pharmacist has ``the responsibility not to fill an order that
purports to be a prescription but is not a prescription within the
meaning of the [CSA] because he knows that the issuing practitioner
issued it outside the scope of medical practice.'' Id.
In an interview with a DEA Investigator, Mr. Fletcher admitted that
``he had questions about'' Dr. Volkman but that he was satisfied
because Volkman told him that he did an MRI and blood tests.\53\
However, as found above, Respondent repeatedly dispensed drug cocktails
for multiple controlled substances including oxycodone, hydrocodone,
and alprazolam, as well as carisoprodol, a combination which is widely
known in the pharmacy profession as being popular with drug abusers,
and it did so in such quantities that any reasonable pharmacist would
have asked how the prescriptions could possibly serve a legitimate
medical purpose. The Government's Expert also explained that these
cocktails would have a synergistic effect on a person's central nervous
system and could cause respiratory
[[Page 66165]]
depression. Accordingly, even if Volkman told Mr. Fletcher that he did
blood tests and MRIs, this would not make the prescriptions any more
legitimate.\54\
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\53\ Respondent's employees also testified that some of
Volkman's patients complained that he was requiring them to undergo
blood or urine tests. This sliver of evidence provides no reason to
ignore the overwhelming evidence against Respondent.
\54\ Respondent also elicited the testimony of Mr. Aalyson, a
lawyer who practiced workers compensation law in Portsmouth and who
knew most of the local doctors, that Mr. Fletcher had called and
asked him if knew whether Dr. Volkman was a legitimate doctor. Tr.
1159. Mr. Aalyson testified that the phone call occurred in October
2006, more than a year after Mr. Fletcher started filling Volkman's
prescriptions and eight months after DEA suspended Volkman's
registration and thus could no longer prescribe.
To the extent this testimony was offered to support the
contention that Mr. Fletcher tried to do due diligence, it provides
no comfort to him as the conversation occurred more than a year
after he started filling Volkman's prescriptions. Moreover, even if
the conversation had occurred shortly after Mr. Fletcher started
filling Volkman's prescriptions (the apparent point of Respondent's
repeated questioning of Mr. Aalyson regarding when the conversation
occurred), his testimony that Mr. Fletcher stated that he was
``getting a lot of people coming in, and I'm beginning to wonder if
the guy is legitimate,'' Tr. 1159, would actually support the
Government's case that Mr. Fletcher knew Volkman's prescriptions
were not legitimate.
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This alone supports the conclusion that Mr. Fletcher violated
Federal law in dispensing the Volkman prescriptions. 21 CFR 1306.04(a).
The other evidence--such as that related to the quantities of the
various drugs being prescribed, the dosing, and lack of
individualization of therapy; the distances the patients were
travelling and the typical method of payment; the fact that Mr.
Fletcher knew that other pharmacists had refused to fill Volkman's
prescriptions; the percentage and number of Volkman's prescriptions
that were for controlled substances--is simply icing on the cake.
Moreover, even after a DEA Investigator had interviewed Mr.
Fletcher and asked him if he found it suspicious that Volkman's
patients were travelling long distances to fill their prescriptions,
Mr. Fletcher proceeded to fill numerous oxycodone and alprazolam
prescriptions for residents of Kentucky who had travelled to South
Florida to obtain the prescriptions. Indeed, even one of Respondent's
employees was ``skeptical'' as to whether these were legitimate
prescriptions. While Respondent contends that Mr. Fletcher stopped
filling prescriptions issued by Florida pain-clinic physicians after he
received the Ohio Board of Pharmacy's Notice, Mr. Fletcher did not
testify in this proceeding and so has failed to offer any explanation
as to why he filled the prescriptions in the first place. Furthermore,
a responsible DEA registrant should be able to make these
determinations without the authorities having to provide the
information to him on a silver platter.
Nor was this the end of Respondent's abysmal experience in
dispensing controlled substances. On November 4, 2009, Respondent
dispensed to B.A., a recovering drug addict who lived in Morehead,
Kentucky, four controlled-substance prescriptions issued by a
Portsmouth physician, including two for Roxicodone 30 mg. (totaling 240
tablets), one for 120 oxycodone 15 mg., and one for 30 alprazolam; B.A.
had been directed by the doctor's staff to fill his prescriptions at
Respondent. Later that day, B.A. got high, and the next morning, he was
found dead; the detective who found the prescription vials noted that
there were only nineteen tablets left out of the total of 240
Roxicodone 30 mg., there were only fifty-two tablets left out of the
120 oxycodone 15 mg., and only eight tablets out of the 30 alprazolam.
The quantity of oxycodone provided by these prescriptions totaled 300
mg. per day, an amount which was five to ten times the normal daily
dose of oxycodone (5 to 10 mg. every four hours) as testified to by the
Government's Expert. Moreover, on this single day, Respondent dispensed
three prescriptions for the same schedule II narcotic. According to the
Government's Expert, both the multiple prescriptions which B.A.
presented and the large quantities prescribed were ``red flags'' which
are suggestive of abuse and ``no reasonable pharmacist would fill'' the
prescriptions. Here again, however, Mr. Fletcher failed to testify and
thus offered no explanation as to why he did so.
DEA Investigators also obtained an OARRS report which showed that
on eighteen different occasions between November 6, 2007 and October
30, 2009, Respondent had dispensed oxycodone to S.P. based on
prescriptions she obtained from seven different doctors; most of the
doctors practiced in different cities (Waverly, Beavercreek, Dayton and
Wheelersburg), and while three of the doctors practiced in Portsmouth,
two of them practiced at different clinics. Notwithstanding that its
own dispensing records should have shown that S.P. was a doctor shopper
(indeed, there was no need for Mr. Fletcher to check the OARRS to make
this determination), Respondent repeatedly dispensed this highly abused
schedule II controlled substance to her. Here again, Mr. Fletcher did
not testify and thus has failed to explain why he ignored the
information in his own records.
Respondent and Mr. Fletcher also violated the CSA and DEA
regulations because during the November 6, 2009 inspection, it could
not produce the biennial inventory of controlled substances which it is
required to maintain. See 21 U.S.C. 827(a)(1) (``every registrant * * *
shall * * * as soon * * * as such registrant first engages in the * * *
dispensing of controlled substances, and every second year thereafter,
make a complete and accurate record of all stocks thereof on hand'');
see also 21 CFR 1304.11. Moreover, Mr. Fletcher was unaware that there
is such a requirement. Finally, as found by the Ohio Board of Pharmacy,
Mr. Fletcher and Respondent violated Ohio law on three occasions
because Mr. Fletcher, as ``the responsible pharmacist[,] failed to
maintain supervision and control over the custody and possession of
dangerous drugs'' which had been delivered to the pharmacy.
I therefore conclude that the evidence relevant to Respondent's
experience in dispensing controlled substances and its record of
compliance with applicable Federal and State laws related to controlled
substances shows that it has committed acts which render its continued
registration inconsistent with the public interest and which justified
the suspension of its registration. Notably, Mr. Fletcher failed to
testify in this proceeding; Respondent therefore has not rebutted the
Government's prima facie case. While there is only the suspension order
to review (because Respondent allowed its registration to expire),
which I affirm, had Respondent filed a renewal application, I would
have denied it.
Order
Pursuant to the authority vested in me by 21 U.S.C. 824, as well as
by 28 CFR 0.100(b) and 0.104, I hereby affirm my order which
immediately suspended the now-expired DEA Certificate of Registration,
BE5902615, issued to East Main Street Pharmacy. This Order is effective
immediately.
Dated: October 15, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-27096 Filed 10-26-10; 8:45 am]
BILLING CODE 4410-09-P