East Main Street Pharmacy; Affirmance of Suspension Order, 66149-66165 [2010-27096]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 75, Number 207 (Wednesday, October 27, 2010)]
[Notices]
[Pages 66149-66165]
From the Federal Register Online via the Government Printing 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
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    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, 200