Paul H. Volkman; Denial of Application, 30630-30644 [E8-11851]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 73, Number 103 (Wednesday, May 28, 2008)]
[Notices]
[Pages 30630-30644]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11851]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[No. 06-45]


Paul H. Volkman; Denial of Application

    On February 10, 2006, I, the Deputy Administrator of the Drug 
Enforcement Administration, issued an Order to Show Cause and Immediate 
Suspension of Registration to Paul H. Volkman, M.D. (Respondent), of 
Chillicothe, Ohio. The Order immediately suspended Respondent's DEA 
Certificate of Registration, AV6952837, as a practitioner, on the 
grounds that his continued registration during the pendency of the 
proceeding ``would constitute an imminent danger to public health and 
safety because of the substantial likelihood that [he] will continue to 
divert controlled substances to persons who will abuse these 
products.'' Id. at 12.
    More specifically, the Show Cause Order alleged that in twelve 
instances, Respondent had prescribed multiple controlled substances to 
persons who, within days, died of overdoses of the drugs. Id. at 9-11. 
The Show Cause Order further alleged that Respondent had issued 
prescriptions to these persons for multiple controlled substances 
including opiates in schedule II (oxycodone) and/or schedule III 
(hydrocodone); schedule IV benzodiazepines such as diazepam and valium; 
and carisoprodol, a non-controlled drug which is nonetheless highly 
abused. Id.; see also id. at 3. Relatedly, the Order alleged that in 
July 2005, the assistant coroner for the county in which Respondent was 
practicing, had notified DEA ``that his staff [had] observed an 
increase in emergency room overdoses and believed that several recent 
drug-related deaths involving young [and] otherwise healthy individuals 
could be attributed to the consumption of large amounts of oxycodone, 
hydrocodone and alprazolam,'' which Respondent had dispensed. Id. at 8.
    The Show Cause Order also alleged that DEA had received information 
from various distributors that Respondent was ordering excessive 
quantities of controlled substances. Id. Relatedly, the Show Cause 
Order alleged that during 2004, Respondent was the largest 
practitioner-purchaser of oxycodone in the country having purchased 
438,000 dosage units, when the average amount of this drug purchased by 
other physicians ``was only 4,792 dosage units.'' Id. at 2.
    The Show Cause Order further alleged that DEA investigators 
interviewed several of Respondent's patients who informed them that 
Respondent had prescribed controlled substances without performing 
physical examinations, that the clinic charged between $160 and $200 
for an office visit, and that the clinic required that the patients pay 
cash and would not accept third-party payments from insurers, Medicare, 
Medicaid or worker's compensation. Id. at 4.
    The Show Cause Order also alleged that on various dates, 
confidential sources had visited the clinic, and that Respondent had 
issued these persons prescriptions for controlled substances without 
performing physical examinations and other medical tests. Id. at 5. The 
Show Cause Order specifically alleged that on two occasions, the 
confidential sources had told the clinic's employees that their pain 
levels were ``one or two'' and ``zero'' on a scale of one-to-ten (with 
the latter being the most severe); that upon Respondent's asking them 
how they felt, the sources had told him ``fair'' and ``pretty good''; 
and that Respondent,

[[Page 30631]]

without performing a physical exam on either person, immediately issued 
to each of them, prescriptions for 180 tablets of hydrocodone/
acetaminophen 10/650 mg., 90 tablets of diazepam 10 mg., and 60 tablets 
of carisoprodol. Id. at 5-6. Both sources then allegedly filled the 
prescriptions at Respondent's clinic for an additional charge. Id. at 
6.
    The Show Cause Order further alleged that in May 2005, DEA 
investigators received information from another confidential source who 
acknowledged his/her involvement in diverting controlled substances. 
Id. The source allegedly identified Respondent as a physician who would 
write prescriptions for Oxycontin and other controlled substances 
without performing a physical examination; the source allegedly stated 
that he and a friend had obtained from Respondent prescriptions for 
drugs which they then sold on the street. Id.
    Next, the Show Cause Order alleged that in July 2005, DEA 
investigators conducted an accountability audit of the controlled 
substances which were ordered under Respondent's registration by the 
clinic where he worked. Id. at 7. The investigators allegedly found 
that Respondent did not maintain dispensing records in violation of 
Federal regulations. Id. Moreover, Respondent allegedly ``could not 
account for more than 850,000 dosage units of controlled substances 
that were ordered and dispensed under [his] DEA registration.'' Id. The 
Order specifically alleged that Respondent was short nearly 89,000 
dosage units of alprazolam 2 mg., nearly 48,000 dosage units of 
diazepam 10 mg., 77,000 dosage units of hydrocodone/apap \1\ (10/500 
mg.), and more than 126,000 dosage units of hydrocodone/apap 10/650. 
Id. With respect to drugs containing oxycodone, the Order alleged, 
inter alia, that Respondent was short more than 49,000 dosage units of 
oxycodone 5 mg., 48,506 dosage units of oxycodone/apap (5/325 mg.), 
165,500 dosage units of Roxicodone 15 mg., and 130,000 dosage units of 
Roxicodone 30 mg. Id. at 7-8.
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    \1\ Apap is the abbreviation for acetaminophen.
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    Respondent requested a hearing on the allegations, and the matter 
was assigned to Administrative Law Judge (ALJ) Gail Randall. Following 
various extensions which both parties sought, as well as pre-hearing 
procedures,\2\ a hearing was held in Columbus, Ohio on December 5-8, 
2006, and January 9-10, 2007. At the hearing, both parties submitted 
documentary evidence and presented the testimony of witnesses.
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    \2\ While Respondent requested an expedited hearing, on March 
17, 2006, his first counsel withdrew. ALJ at 2. While on May 2, 
2006, a new counsel entered an appearance on Respondent's behalf, on 
October 10, 2006, a third counsel entered a notice of appearance. 
Id.
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    Following the hearing, the Government submitted a brief containing 
its proposed findings, conclusions of law, and recommendations. 
Respondent chose not to submit a post-hearing brief and instead filed a 
petition for review with the Sixth Circuit.
    On June 20, 2007, the ALJ issued her recommended decision 
(hereinafter cited as ALJ). In her decision, the ALJ found that ``[t]he 
record contains abundant evidence to demonstrate that the Respondent 
did not issue prescriptions 'in the usual course of his professional 
practice,''' and that he ``failed to limit his prescribing of 
controlled substances to cases where such medication would be provided 
for a legitimate medical purpose.'' ALJ at 39-40 (citation omitted). 
More specifically, the ALJ concluded that ``without adequate physical 
examinations and development of medical histories, the Respondent 
failed to adequately diagnose the patients,'' and yet ``prescribed 
controlled substances even when interacting with a patient for the 
first time.'' Id. at 40.
    The ALJ further noted that ``Respondent prescribed the same 
combinations of controlled substances to a majority of his patients, 
again without adequate examinations or ongoing diagnoses,'' and that 
``[t]his combination of drugs was common in the drug-abuse community'' 
and was known as ``a cocktail or the trifecta.'' Id. (int. quotation 
and citations omitted). Finally, the ALJ noted that ``Respondent 
treated at least sixteen patients between June of 2003 and February of 
2006 who died of drug-related causes,'' and that ``Respondent's lack of 
adequate monitoring of these patients directly contributed to [their] 
deaths.'' Id. at 41.
    The ALJ further noted that Respondent was dispensing controlled 
substances ``obtained through the use of [his] DEA registration,'' id., 
and yet failed to maintain the required inventory and dispensing 
records and ``to adequately supervise the individuals to whom he had 
delegated such dispensing responsibilities.'' Id. at 43. Moreover, 
Respondent ``was unable to account for over one million tablets of 
controlled substances.'' Id. at 42. Finally, the ALJ noted that 
Respondent had failed to accept responsibility for his conduct. Id. at 
44.
    The ALJ thus concluded that the Government had established a prima 
facie case that Respondent's continued registration would be 
inconsistent with the public interest. Id. at 45. Because Respondent 
had failed to ``justify his past conduct'' and ``to provide adequate 
assurances that his future handling of controlled substances would meet 
the standards required of a DEA registrant,'' the ALJ recommended that 
I revoke his registration and deny his pending applications to renew 
and modify his registration. Id.
    Respondent filed exceptions to the ALJ's decision raising numerous 
issues, and the Government filed a response. More specifically, 
Respondent contends that the Government failed to provide adequate 
notice and thus violated his rights under the Due Process Clause 
because it expanded its presentation beyond the allegations of the Show 
Cause Order, Exceptions at 4-10; that the proceeding violated his First 
Amendment rights because the ALJ failed to exclude an e-mail which the 
Government introduced into evidence in which Respondent portrayed the 
Agency, the ALJ, and the prosecuting attorney in a ``not flattering'' 
manner, id. at 10-11; that the Agency was unlawfully regulating the 
practice of medicine, id. at 11-12; that the ALJ failed to consider his 
evidence; and that records which he subpoenaed were not turned over to 
him.\3\
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    \3\ To the extent that Respondent's exceptions are based on the 
ALJ's weighing of the evidence or alleged failure to consider 
certain evidence, the ALJ's decision is only a recommendation. See 
21 CFR 1316.65(a). As ultimate factfinder, I have carefully 
considered the entire record including the ALJ's report and 
Respondent's exceptions.
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    Having considered the record as a whole, I reject each of 
Respondent's exceptions. While I do not adopt all of the ALJ's factual 
findings, I adopt the ALJ's conclusions of law that Respondent 
repeatedly dispensed controlled substances outside of the usual course 
of professional practice and without a legitimate medical purpose. I 
also adopt her conclusions with respect to Respondent's failure to 
maintain proper records and properly supervise clinic employees, as 
well as his inability to account for large quantities of controlled 
substances. Finally, I adopt the ALJ's conclusion that the Government 
has established its prima facie case that Respondent's registration is 
inconsistent with the public interest and that Respondent has not 
demonstrated that he can be entrusted with a registration.
    As explained below, Respondent did not file a timely renewal 
application in accordance with agency rules, and therefore, there is no 
existing registration to revoke or modify. Respondent did, however, 
apply for a registration; that application will be denied. I make the 
following findings.

[[Page 30632]]

Findings

    Respondent formerly held DEA Certificate of Registration, 
AV6952837, which authorized him to dispense controlled substances in 
schedules II through V, and which expired on May 31, 2006. GX 1. 
Between April 16, 2003, and November 18, 2003, Respondent's registered 
location was Tri-State Health Care (hereinafter, Tri-State), 1200 Gay 
Street, Portsmouth, Ohio. GX 2. Between November 19, 2003, and 
September 11, 2005, Respondent's registered location was 1219 Findlay 
St., Portsmouth, id., which apparently was Tri-State's new location. GX 
11, at 2 (inspection report of Ohio State Board of Pharmacy). 
Subsequently, Respondent left Tri-State, and on September 12, 2005, 
Respondent changed his registered location to 1310 Center St., 
Portsmouth. GX 2. On May 12, 2006, at which time his registration was 
suspended and which was less than forty-five days before the expiration 
of his registration, Respondent applied for a renewal of his 
registration and requested an address change to his home in Chicago, 
Illinois. Id., see also RX P at 1.
    Respondent holds both an M.D. and Ph.D. from the University of 
Chicago and has practiced as an emergency room physician, as well as in 
family practice and pediatrics. Id. at 3. Respondent testified that in 
the course of his practice, he had two medical malpractice cases which 
his insurers settled without his consent and his admitting liability, 
and ``two cases [that] resulted in judgments against'' him. Tr. 1400. 
According to Respondent, by 2003, the awards and settlements totaled 
``over a million-and-a-half dollars,'' and as a result, he was ``unable 
to obtain malpractice insurance.'' Id. As a consequence, Respondent 
``could no longer work in emergency medicine, and * * * couldn't work 
for another clinic * * * because virtually every clinic that required 
hospital coverage of nighttime patients requires the doctor to have 
insurance.'' Id.
    Respondent therefore needed to find a job which did not require 
malpractice insurance. Id. Searching on the internet, Respondent found 
a job posting for Tri-State Health Care in Portsmouth, Ohio. Id. at 
1400-01. During discussions with Tri-State's owner, Ms. Denise Huffman, 
Respondent was told that he did not need malpractice insurance to work 
for her clinic. Id. at 1401. Respondent accepted the position, and in 
June 2003, he obtained board certification in pain management. Id. at 
1402.
    In April 2003, Respondent began working at Ms. Huffman's clinic 
under an ``informal handshake'' agreement which paid him $5000 a week 
to start; his pay was later raised to $5500. Id. at 1404. Ms. Huffman 
was not a licensed physician and was ``not any type of a health care 
professional'' even though she was running ``a pain clinic.'' Id. 
Respondent ``did not think'' to ask to see Ms. Huffman's licenses or 
verify her credentials. Id. at 1404. Respondent further maintained that 
he ``didn't know that I should have done'' that, and that he did not 
find out that he should have made these inquiries until being advised 
of this (``two years later'') by one of his attorneys. Id. In light of 
Respondent's thirty years of experience in the medical profession and 
his educational background, I find implausible Respondent's testimony 
regarding his failure to verify whether Ms. Huffman was properly 
licensed.
    Ms. Huffman's daughter Alice was Tri-State's office manager. ALJ at 
3-4 (stipulated findings). According to the report of Agent Kevin 
Kinneer of the Ohio State Board of Pharmacy, Alice Huffman was a 
``former employee and patient of Dr. [David] Proctor,'' GX 12, at 4, a 
convicted drug dealer. Tr. 1014-15. Mr. Chad Ball, who was Alice 
Huffman's boyfriend (and subsequently became her husband), worked as a 
security guard at the clinic. Tr. 521, 530. Other employees included 
Chris Helton (who also worked as security guard) and Denise Huffman's 
nieces, Ms. Tara Bentley and Ms. Elizabeth Madden. Id. at 530. 
Respondent was the only licensed physician and DEA registrant at the 
clinic. Id. at 530-31.\4\
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    \4\ To clarify, the clinic did not hold a DEA registration.
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    During an interview with a DEA diversion investigator (DI), Ms. 
Denise Huffman stated that Tri-State ``was a full cash business'' and 
did no ``third-party billing.'' Id. at 543. The DI further testified 
that Ms. Huffman stated that ``it would not be cost effective to have 
somebody file a medical insurance claim.'' Id. at 544.\5\ Tri-State 
charged $200 for an office visit. Id. at 854-56.
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    \5\ The record does, however, contain a document entitled 
``UTILIZATION REVIEW--NOTICE OF DENIAL'' issued by Liberty Mutual 
Managed Care, Inc., which is addressed to Respondent at Tri-State's 
Findlay St. address. GX 65. This document stated that Liberty Mutual 
had performed a utilization review for the Kentucky Worker's 
Compensation program of a ``proposed treatment/service request'' for 
a patient named ``Paul Huffman,'' and determined that it did not 
meet ``nationally accepted practice protocols.'' Id. More 
specifically, the document noted that ``[t]he request for oxycodone 
425 pills per month (fourteen/day) and Valium 125 pills per month 
(four/day) is not medically necessary or appropriate. The current 
narcotic situation is not beneficial in that the claimant is taking 
narcotics around the clock.'' Id.
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    Beginning in the summer of 2003, numerous pharmacies refused to 
fill Respondent's prescriptions. Tr. 1428-29. Accordingly, Respondent 
and Denise Huffman decided that they ``should institute a dispensary 
on-site'' so that they could provide pain medicines for their patients. 
Id. Respondent agreed that his registration could be used to order 
controlled substances, id. at 1550, and Tri-State proceeded to order 
large quantities of both oxycodone, a schedule II controlled substance, 
and combination hydrocodone/apap, a schedule III controlled substance. 
GX 10. For example, between August 18, 2003, and December 30, 2003, 
Tri-State ordered nearly 136,000 dosage units of oxycodone under 
Respondent's DEA registration. Id. at 140. During 2004, Tri-State 
ordered more than 457,000 dosage units of oxycodone under his 
registration. Id. at 143. Finally, between January 1, 2005, and 
September 2, 2005 (shortly before he left Tri-State), the clinic 
ordered more than 414,000 dosage units of oxycodone under his 
registration. Id. at 145. Respondent was the largest practitioner-
purchaser of oxycodone in the nation during both 2004 and the first 
nine months of 2005. Id. at 5 & 28.
    Moreover, Respondent's purchases of oxycodone dwarfed that of other 
Ohio-based practitioners. For example, during the last six months of 
2003, Respondent purchased more than twenty-eight times the amount of 
oxycodone purchased by the second largest Ohio-based practitioner 
(4,800 dosage units); by contrast, the fourth through thirteenth 
largest purchasers bought only between 300 to 100 dosage units. Id. at 
51.
    In 2004, Respondent purchased nearly 110 times the amount of 
oxycodone purchased by the second largest Ohio-based practitioner 
(4,160 dosage units); by contrast, the third through tenth largest 
practitioners purchased between 3,228 and 400 dosage units. Id. at 29. 
Finally, in a little more than the first eight months of 2005, 
Respondent purchased approximately thirty-eight times the amount of 
oxycodone purchased by the second largest Ohio-based practitioner-
purchaser; by contrast, the sixth through tenth largest practitioner-
purchasers bought between 600 and 240 dosage units. Id. at 7.
    With respect to hydrocodone, between July 24, 2003, and the end of 
that year, Respondent purchased 222,600 dosage units. Id. at 148. In 
2004, Respondent purchased 263,500 dosage units, and in a little more 
than the first eight months of 2005, he purchased 168,500 dosage units 
of the drug. Id. at 150-52. Between 2003 and

[[Page 30633]]

2005, Respondent ranked between the eleventh to twenty-third largest 
purchaser nationwide of combination hydrocodone drugs, and was the 
largest Ohio-based practitioner-purchaser of combination hydrocodone 
drugs by a wide margin.\6\ Id. at 72-73, 95-96, 118-20.
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    \6\ In the first nine months of 2005, Respondent purchased 11 
times the amount of hydrocodone purchased by the second largest 
Ohio-based practitioner; in 2004, he purchased 11.7 times the amount 
purchased by the second largest Ohio-based practitioner; in the last 
six months of 2003, he purchased approximately 16.5 times the amount 
purchased by the second largest Ohio-based practitioner. Id. at 73-
74, 96-97, 120-21.
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    A DEA DI subsequently obtained a report of the prescriptions 
written by Respondent that were filled by Kentucky pharmacies during 
2004 from the State of Kentucky's KASPER system.\7\ Upon review of the 
data, the DI found that Respondent had prescribed three or more drugs 
per visit to 419 of his patients and that Respondent had issued three 
or more prescriptions per visit 1974 times. GX 71. The DI further found 
that 54 percent of Respondent's prescribing involved ``three or more 
prescriptions per visit,'' and that in 1065 separate instances, 
Respondent had prescribed four drugs including oxycodone, hydrocodone, 
a benzodiazepine, and carisoprodol. Id. at 2. The DI also found that 
during 2004, Kentucky pharmacies dispensed 647,440 dosage units of 
oxycodone and 537,691 dosage units of hydrocodone pursuant to 
Respondent's prescriptions. Id.
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    \7\ KASPER is the ``Kentucky All Scheduled Prescriptions 
Electronic Reporting'' program. GX 71. Under KASPER, pharmacies are 
required to periodically report to the State all scheduled-drug 
prescriptions that they dispense. Physicians are also able to access 
the database to determine whether their patients are obtaining 
controlled substances from other practitioners. GX 26, Tr. 1030.
    These figures do not, however, include prescriptions issued by 
Respondent which were filled at pharmacies in Ohio and other States; 
nor do they include the prescriptions dispensed at Tri-State.
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The Investigations of Respondent

    As found above, in April 2003, Respondent commenced his employment 
at Tri-State. On April 17, 2003, one day after Respondent obtained his 
DEA registration at Tri-State's 1200 Gay Street location, Agent Kevin 
Kinneer of the Ohio State Board of Pharmacy received two reports from 
Portsmouth pharmacists regarding Respondent's prescribing practices. GX 
12, at 1-2.
    The first pharmacist reported that Respondent was ``writing large 
quantities of narcotics and benzodiazepines,'' and that his patients 
were presenting ``prescriptions for 180 to 300 tablets of Lorcet 10/650 
mgs.,'' id., a schedule III controlled substance containing hydrocodone 
and acetaminophen. ALJ at 5. The pharmacist further reported that some 
patients had ``two types of narcotic prescriptions,'' that the 
prescriptions were for a quantity beyond the ``manufacturer's suggested 
[daily] supply of Tylenol [acetaminophen] intake,'' and that ``[t]hese 
patients also had prescriptions [for] Xanax 2 mg. and a Soma 
[carisoprodol] prescription.'' Id. The pharmacist further reported that 
``many of the patients are prior problem patients'' of a physician (Dr. 
Proctor),\8\ who had been convicted of drug trafficking and is 
currently incarcerated. Id. at 1-2; Tr. 1015. According to the 
pharmacist, these persons ``had prior drug abuse problems'' including 
arrests on drug charges. GX 12, at 1-2. The pharmacist also told Agent 
Kinneer that ``he would not fill any of'' Respondent's prescriptions. 
Id. at 2.
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    \8\ The pharmacist also stated that these individuals were 
patients of another problem physician, Dr. Williams. GX 12, at 2. 
The testimony indicates that another area physician, Dr. Fortune 
Williams, was convicted of drug trafficking, but his conviction was 
overturned on appeal. Tr. 1016. It is unclear whether the 
pharmacist's reference to Dr. Williams was to this individual.
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    The second pharmacist told Agent Kinneer that he had ``refused to 
fill prescriptions for high quantities of narcotics and Xanax 2mgs and 
Soma [that were] prescribed by'' Respondent. Id. The pharmacist further 
notified Agent Kinneer that Respondent was prescribing ``duplicate 
therapy of narcotics'' and large amounts of acetaminophen. Id.
    Approximately two months later, another Portsmouth-area pharmacist 
informed Agent Kinneer of ``trouble with [Respondent's] patients.'' Id. 
More specifically, the pharmacist reported that on or about June 11, 
2003, five persons came in a van to his pharmacy and that one of them 
``smelled of beer and dope.'' Id. These persons all presented ``the 
same type of prescriptions'' and the pharmacist refused to fill them. 
Id.; Tr. 255-56.
    One week later on June 18, 2003, Respondent telephoned Agent 
Kinneer and complained that local pharmacists were refusing to fill his 
prescriptions. Tr. 256. Respondent demanded that the Board order the 
pharmacists to fill his prescriptions. Id.; GX 12, at 3. Agent Kinneer 
told Respondent that he was not going to do so because the pharmacists 
had the right to exercise their own professional judgment in practicing 
pharmacy. GX 12, at 3; Tr. 256.
    Throughout the summer of 2003, Agent Kinneer received further 
complaints from pharmacists about Respondent's prescribing practices. 
GX 12, at 3. These included that many of the patients were from 
Kentucky, West Virginia and Tennessee; that Respondent was writing 
prescriptions for multiple narcotics, Xanax 2 mg. and carisoprodol 
``for the same patient [in] high quantities''; that the prescriptions 
were for drugs with ``a high abuse potential''; that ``[f]amily members 
within the same address [were] receiving the same type of controlled 
substance''; that ``many of the patients'' were known ``to be drug 
abusers''; and that some of the patients had ``large amounts of cash on 
their person.'' Id. Agent Kinneer also received information that 
Respondent had called pharmacists and demanded that they fill his 
prescriptions. Id. Moreover, between July and September 2003, 
pharmacists in Columbus and Cincinnati notified Agent Kinneer that 
persons were presenting prescriptions issued by Respondent. Id. at 5.
    On July 22, 2003, Agent Kinneer (and another state agent) visited 
Tri-State to conduct an inspection pursuant to Respondent's obtaining 
of a clinic license, which under Ohio law, was required ``to obtain 
controlled substances to dispense out of [the] clinic.'' Tr. 244; see 
also GX 12, at 3. During the inspection, Alice Huffman told the agents 
that a bodyguard patrolled the parking area and monitored the waiting 
room.\9\ GX 12, at 3-4. The agents observed the security arrangements, 
explained recordkeeping requirements, provided Respondent and Ms. 
Huffman with copies of the applicable federal and state laws and 
regulations, and gave Respondent the license. Id. at 4.
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    \9\ It is unclear whether there were multiple bodyguards on the 
premises. During an inspection conducted on December 30, 2003, Agent 
Kinneer noted that there were two bodyguards at the clinic.
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    On December 30, 2003, Agent Kinneer and another agent went to Tri-
State's new address at 1219 Findlay St. to conduct an inspection for a 
new license. Id. at 5. Agent Kinneer found numerous violations 
including incomplete dispensing logs for several controlled substances. 
GX 11, at 2. More specifically, the dispensing log for hydrocodone/apap 
10/650 had not been completed since August 15, 2003. Id. Respondent 
had, however, ordered thousands of dosage units of this drug after 
August 15th. See GX 10, at 147-48. As for the other controlled 
substances the clinic was dispensing, Agent Kinneer found that the last 
entries for

[[Page 30634]]

both Xanax 1 mg., and diazepam 10 mg., had been made on August 15, 
2003.\10\ GX 11, at 2. He also found that while the log for 
hydrocodone/apap 10/325 mg. had been started on August 11, 2003, the 
last entry was dated the following day. Id.
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    \10\ Both logs were started on July 30, 2003. GX 11, at 2.
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    Agent Kinneer further found that numerous DEA 222 forms, which are 
required to order schedule II controlled substances, were not properly 
completed. Id. He observed that Alice Huffman, who was not a registered 
pharmacist, was dispensing drugs without obtaining Respondent's final 
approval. Id. at 3-5. He also found ``four vials of unmarked pills with 
unknown medications [in] the dispensing area.'' Id. at 6.
    In his report, Agency Kinneer further stated that he ``found this 
clinic not to be your normal Doctor's Office.'' Id. In support of his 
conclusion, Agent Kinneer noted that there was a Glock handgun in the 
dispensing area, that there were two night sticks and a four-foot long 
club with leather straps, and that these were ``things that [he] 
normally would not see in a physician's office or a dispensing area.'' 
Tr. 259-60; GX 12, at 7. Agent Kinneer also noted that Respondent was 
treating both Denise and Alice Huffman, that he had prescribed 
narcotics for them, and that both appeared to be ``over medicated.'' GX 
12, at 6. In his testimony, Agent Kinneer also related that he had 
received reports that ``there would be 20 to 30 cars lined up outside 
of [Respondent's] practice,'' and that people would be lined up waiting 
to enter the clinic. Tr. 260-61; see also Tr. 455-56 (testimony of 
Detective John Koch, Scioto County Sheriff's Office that he observed a 
``large group of people outside the office,'' and that he had ``never 
seen that outside of a doctor's office, where groups of people would 
hang out'').
    Agent Kinneer thus concluded that Respondent was running a 
``prescription mill.'' Id. at 260. Nonetheless, on February 4, 2004, 
following receipt of a letter from Respondent which stated that Tri-
State was ``now currently in compliance with all issues'' found at the 
inspection and that ``[a]ll log books are current and up to date and 
are being kept current,'' GX 11,\11\ Agent Kinneer delivered a new 
license to Tri-State and obtained Respondent's dispensing records. GX 
12, at 6. The same day, Agent Kinneer contacted three distributors 
(Cardinal, McKesson, and Moore Medical) to obtain copies of 
Respondent's purchases from them. GX 12, at 6-7.
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    \11\ While the letter is dated January 19, 2003, it references 
the December 30, 2003 inspection report. See GX 11. I thus find that 
the letter was actually sent on January 19, 2004. As discussed 
below, during a search warrant which was executed on June 7, 2005, 
Tri-State did not have any logbooks for 2004. See Tr. 612.
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    The purchase records showed, inter alia, that between October 13, 
2003, and January 12, 2004, Respondent had purchased 277,500 tablets of 
Roxicodone 30 mg., a schedule II controlled substance. GX 12, at 7. 
Moreover, between August 18, 2003, and January 6, 2004, Respondent 
purchased 65,700 tablets of oxycodone hcl 5 mg., and 59,000 tables of 
oxycodone/apap (5/325 mg.). Id.
    The records also showed that between July 24, 2003, and October 21, 
2003, Respondent purchased more than 57,000 dosage units of combination 
hydrocodone/apap drugs in 10/325 mg., 10/500 mg., and 10/650 mg. 
strengths.\12\ Id. Furthermore, between various dates, he had purchased 
more than 32,600 dosage units of benzodiazepines including alprazolam 
in 1 mg. and .5 mg. strengths, and both diazepam and lorazepam in 10 
mg. strength.\13\ Id. at 7.
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    \12\ Respondent was also purchasing large quantities of 
combination hydrocodone/apap drugs from PD-RX Pharmaceuticals, Inc., 
during this period See GX 10, at 147-48.
    \13\ According to the testimony of a detective with the 
narcotics unit of the Scioto County Sheriff's Office, the illegal 
trafficking of prescriptions drugs is ``[t]he number one [drug] 
problem'' in the County. Tr. 444. The Detective further testified 
that oxycodone, which is the ``most abused'' drugs sells ``for 
between 30 and 40 dollars per pill'' of thirty milligram strength, 
that Xanax sells for ``between $5 and $12'' per pill depending upon 
its strength, and that combination hydrocodone drugs sell for 
``between $7 to $15'' per pill. Id. at 450.
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    In late June 2003, a Diversion Investigator (DI) with DEA's 
Columbus, Ohio office received a phone call from a pharmacist in 
Kenova, Ohio. Tr. 472, 508, GX 6. The pharmacist inquired as to whether 
Respondent had an active DEA registration; he also told the DI that he 
was ``receiving numerous prescriptions for OxyContin and Percocet,'' as 
well as Lorcet, Xanax and Soma (carisoprodol), which Respondent had 
written. Tr. 472-73, 508. The pharmacist also stated that between June 
1, 2003, and July 15, 2003, Respondent's ``prescriptions had tripled'' 
and that the prescriptions were for ``very large'' quantities. Id. at 
473. The pharmacist further told the DI that the persons who were 
presenting prescriptions from Respondent ``were lining up outside'' of 
his pharmacy to get them filled. Id. at 507-08.
    The DI further testified that she had received phone calls from 
numerous other pharmacies regarding Respondent's prescribing practices 
including pharmacies that were located in Northern Kentucky and 
Columbus, Ohio. Id. 476. The pharmacists reported that Respondent was 
prescribing ``very high quantities'' of OxyContin, Percocet, Lortab, 
Xanax, and Somas, and that the patients were paying cash for their 
drugs.\14\
---------------------------------------------------------------------------

    \14\ The DI also received information from an FBI task force 
officer. Tr. 475. The officer told the DI that an informant had 
obtained a prescription from Respondent without the latter having 
performed an evaluation on him, and that Denise Huffman had filled 
the prescription for ``approximately $200.'' Id. The DI did not, 
however, testify as to what drug was involved. See id.
---------------------------------------------------------------------------

    The DI also received a phone call from a DI in Forth Worth, Texas, 
regarding a report from McKesson, a distributor, that Respondent had 
ordered large quantities of combination hydrocodone/apap. Tr. 482. More 
specifically, McKesson had reported that on August 7, 2003, Respondent 
ordered thirty 100-count bottles of combination hydrocodone/apap, and 
on August 15, 2003, he ordered forty 100-count bottles of the drug. Id. 
Moreover, on August 22, 2003, Respondent ordered twenty 100-count 
bottles of combination hydrocodone/apap, as well as twenty 100-count 
bottles of alprazolam. Id.; see also GX 15, at 3-5. Thereafter, the DI 
obtained copies of invoices documenting Respondent's purchases of 
controlled substances from McKesson and other distributors. GX 14-16.
    In November 2003, the Columbus-based DI was contacted by another 
Portsmouth-based physician who informed her that ``there were numerous 
patients that were coming from [Respondent's] office'' who were seeking 
detoxification treatment. Tr. 483. The physician related that 
Respondent had put the patients on excessive amounts of opiates such as 
OxyContin, Percocet, and hydrocodone. Id. The physician also told the 
DI that Respondent was telling the patients to go to particular 
pharmacies to get their prescriptions filled.\15\ Id. at 484.
---------------------------------------------------------------------------

    \15\ The DI also testified that she had been informed that one 
of Respondent's ``patients'' had contacted DEA regarding her visit 
with Respondent. Id. The patient related that she had taken a friend 
with her to the clinic and had been ``scolded'' for doing so by 
Denise Huffman, the clinic owner, because ``she didn't like anybody 
coming with patients,'' id. at 486, and ``law enforcement was 
watching the building.'' Id. at 488. The patient further stated that 
Respondent had prescribed Soma and an analgesic even though he 
``only saw her for a couple of minutes'' and had little interest in 
reviewing her x-ray. Id. at 485. Because of what was going on at the 
clinic, the patient decided to see another physician. Id. at 486. 
Respondent's office repeatedly refused to send her records to her 
new physician and the patient had to retain an attorney to obtain 
them. Id. at 486-87.

---------------------------------------------------------------------------

[[Page 30635]]

    Thereafter, DEA investigators obtained records from various 
pharmacies pertaining to Respondent's prescriptions. Id. 489; see also 
GX 18-20, 22-25. A DI also obtained from the State of Kentucky the 
previously mentioned KASPER report. See GX 26. Moreover, in April-May 
2005, the Agency also obtained records pertaining to Respondent's 
purchases from four distributors (PD-RX Pharmaceuticals, Cardinal, 
McKesson, and Moore Medical). See GX 29.
    On June 7, 2005, DEA investigators executed a search warrant at the 
Tri-State facility and seized the controlled substances that were on 
the premises, patient records, invoices, DEA Form 222s, and financial 
records.\16\ Tr. 541, 696-97. One of the DIs interviewed Denise 
Huffman, Tri-State's owner. Denise Huffman told the DI that based on 
what Respondent ``told her to order,'' she would order the controlled 
substances from the distributors. Id. at 543. Ms. Huffman also stated 
that the clinic did not do third-party billing and was a ``full cash 
business.'' Id. Ms. Huffman further related that her daughter Alice and 
Respondent ``were in complete control of the dispensing center.'' Id. 
at 545.
---------------------------------------------------------------------------

    \16\ ``To accommodate'' Respondent, the investigators made 
copies of the medical records and provided them to the clinic before 
``the summer ended.'' Tr. 697.
---------------------------------------------------------------------------

    The DI also interviewed Alice Huffman, who confirmed that Tri-State 
``was a cash only business'' with ``no third-party billing.'' Id. at 
544. Alice Huffman admitted that she filled ``all the prescriptions and 
was supposed to keep the records,'' including the dispensing records, 
but did not. Id. Alice Huffman further stated that ``she wasn't sure'' 
if there were any inventories and ``didn't know if they'' would be 
accurate if there were any. Id. at 545. When asked by the DI whether 
she was aware of whether any of Tri-State's patients had overdosed, 
Huffman gave the names of two persons ``that she believed had overdosed 
on prescriptions that were written from the clinic.''\17\ Id.
---------------------------------------------------------------------------

    \17\ The circumstances surrounding the overdose of one of these 
persons ( K.R.) is discussed below.
---------------------------------------------------------------------------

    The same day, DEA investigators attempted to interview Respondent 
at his residence, but he declined. Id. at 691. Later that day, 
Respondent arrived at the clinic and he eventually agreed to an 
interview. Id. at 692. Regarding the interview, the DI testified that 
Respondent ``declined to talk'' when asked about the deaths of Tri-
State's patients. Id. at 694. Respondent further maintained that he was 
an independent contractor and serving as a ``loc[um] ten[ens]'' 
practitioner \18\ who had found his position on the internet. Id. at 
695. Respondent could not, however, ``recall what company * * * he was 
a loc[um] ten[ens] for,'' id., and, of course, had been working at Tri-
State for more than two years at that point.
---------------------------------------------------------------------------

    \18\ As commonly understood, the term ``locum tenens'' means 
``one filling an office for a time or temporarily taking the place 
of another.'' Webster's Collegiate Dictionary 684 (10th ed. 1998).
---------------------------------------------------------------------------

    Moving on to other subjects, Respondent stated that the clinic did 
not have a physical therapist on its staff and he was not sure whether 
the clinic even had a nurse. Id. at 695. Respondent also told the DI 
that he ``rarely recommend[ed] people to other physicians'' and that 
``for the most part,'' he did not associate with other area physicians. 
Id. at 695-96.
    On the same day that the warrant was executed, DEA investigators 
attempted to conduct an accountability audit. Id. at 546. The 
investigators inventoried all of the controlled substances that were 
being seized. Id. at 613-14. Consistent with Alice Huffman's testimony, 
the DIs did not find either any initial or biannual inventories as 
required by Federal regulations. Id. at 615. Nor were there any 
dispensing logs for the year 2004. Id. at 612.
    Using records subsequently obtained from various distributors, the 
DI was able to determine the amounts of the various controlled 
substances Respondent purchased during the audit period and concluded 
that there were substantial shortages of the drugs. Id. at 615. These 
records also showed that Respondent had ordered large quantities of 
alprazolam (2 mg.) and diazepam (10 mg.), hydromorphone (4 mg.), and 
both oxycodone and combination hydrocodone in various strengths. GX 30.
    I find it unnecessary to make findings regarding the actual amounts 
of the shortages.\19\ Instead, I find that Respondent authorized the 
ordering of large quantities of numerous controlled substances, and 
that the disposition of these drugs cannot be adequately accounted for 
because Respondent failed to maintain accurate records.
---------------------------------------------------------------------------

    \19\ Because Tri-State had no inventories, the DI used the 
starting figure of ``0'' for each drug. Under the heading for the 
closing inventory, the audit chart stated ``as of 12-31-04.'' GX 30. 
The DI testified, however, that the actual inventory was taken on 
June 7, 2005. Tr. 613. The record does not establish how the DI 
arrived at the inventory figures for December 31, 2004.
    There was also testimony that during the search, Denise Huffman 
stated that the dispensing logs ``were probably at her house.'' Tr. 
669. Eventually, Ms. Huffman produced logbooks for 2005; Ms. Huffman 
admitted, however, that there were no records for 2004. Id. at 670. 
The DI further testified that the logbooks were provided only after 
the Government provided copies of the patient files subsequent to 
the search. Id. at 674-75. The logbooks ``were brand new,'' and 
appeared to have been newly created based on the copies of the 
medical records. Id.
---------------------------------------------------------------------------

    On September 9, 2005, Respondent's relationship with Tri-State 
ended. Id. at 1433-34. Respondent initially saw patients at his 
apartment in Portsmouth. Id. at 1434-35. Regarding his activities at 
this location, a DEA Investigator testified that he had interviewed the 
friend (DC) of one of Respondent's deceased patients (M.R.). Tr. 761. 
DC told the investigator that he and M.R. ``knew that [Respondent] was 
writing prescriptions without any type of medical examination.'' Id. 
Accordingly, they decided to see Respondent (at his Center St., 
Portsmouth) address to obtain drugs that they could sell on the street. 
Id.
    DC related that upon his arrival at Respondent's office, he 
encountered a former girlfriend who was now working for Respondent. Id. 
at 762. After filling out various forms, the ex-girlfriend asked DC 
what he was taking. Id. DC asked her: ``what is he writing?'' Id. She 
then wrote out ``prescriptions for oxycodone, a hydrocodone product, 
and Xanax.'' Id.
    DC further related that Respondent did not physically examine him. 
Respondent signed the prescriptions and engaged in small talk with DC 
before Respondent left the exam room. Id. at 763-64.
    On October 4, 2005, the Portsmouth Police Department executed a 
warrant at Respondent's apartment and seized various items including 
patient files.\20\ Id. at 1436-37. The Chief of Police also issued a 
condemnation notice, which in Respondent's words, ordered him ``to 
immediately vacate the premises.'' Id. at 1437.
---------------------------------------------------------------------------

    \20\ Respondent testified that the seizure occurred because the 
police ``were bigger than I was, and they decided that they were 
going to come in and do that.'' Tr. 1436. He also maintained that 
the ``search warrant * * * contained a lot of frankly irrelevant 
materials.'' Id. Respondent did not, however, produce any evidence 
that a court had quashed the warrant.
---------------------------------------------------------------------------

    Approximately a week later, Respondent relocated to Chillicothe, 
Ohio. Id. at 1437-38. On February 6, 2006, DEA investigators obtained a 
warrant to search Respondent's Chillicothe office. GX 78. On February 
10, 2006, the warrant was executed and additional patient files were 
seized. GX 73.
    A DI subsequently reviewed the 1258 patient files that were seized 
during both the June 2005 search of Tri-State and the February 2006 
search of Respondent's Chillicothe office. Id. Most significantly, the 
DI determined

[[Page 30636]]

that 900 of the patient files lacked documentation that Respondent had 
performed a physical examination on the patient. Id.
    During the course of the investigation, DEA investigators received 
information from various sources including family members, friends, 
emergency room physicians, and various coroners indicating that sixteen 
persons had died of drug overdoses shortly after seeing Respondent. Tr. 
617-20; see also GXs 32-60. For example, the widow of J.R. testified 
that her husband had obtained prescriptions from Respondent for 
Oxycontin, oxycodone, hydrocodone, valium, and Soma, and was receiving 
as many as 622 pills per month. Tr. 40, 42-43. At one point J.R. 
attempted to commit suicide and was hospitalized; J.R., however, was 
released. Id. at 81-82. On November 18, 2003, J.R. visited Respondent. 
Id. at 53; GX 61.
    On the morning of November 20, 2003, J.R. was found dead in the 
bathroom. Tr. 52. According to the Deputy Coroner's report, there were 
four pill bottles on the bathroom sink: two bottles were labeled as 
containing oxycodone (Rx'd on 10/3/03 and 10/20/03) although both were 
found empty; one contained 12 tablets of diazepam out of the original 
90 count which was prescribed on 11/18/03; and one bottle contained 
three methadone tablets. See GX 60, at 4. Respondent was listed as the 
prescriber on the two oxycodone and the diazepam bottles. Id. No 
prescriber was listed on the bottle which contained methadone. Id.
    The coroner found that the immediate cause of J.R.'s death was an 
``overdose'' due to multiple drug intoxication. GX 60, at 1. See also 
GX 59. According to J.R.'s widow, her husband was addicted to drugs. 
Tr. 33, 45. She also testified that her husband was selling some of his 
drugs to pay for his visits with Respondent. Id. at 64. According to 
her testimony, her husband had told her that Respondent ``was trying to 
give him [S]omas also and to take them, and that [Respondent] said if 
he didn't take them to sell them.'' Id. at 42.
    J.R.'s step-daughter corroborated this testimony. More 
specifically, she testified that her step-father had ``said that I 
could get more if I wanted. [Respondent] offered me [S]omas, and I told 
him that I was allergic to them, and he [Respondent] said sell them, 
trade them, whatever you need to do.'' \21\ Id. at 104.
---------------------------------------------------------------------------

    \21\ While Soma (carisoprodol) is a prescription drug, it is not 
a controlled substance. It is, however, a highly abused drug which 
metabolizes into meprobamate, a schedule IV depressant. See 21 CFR 
1308.14(c); ALJ Ex. 11, at 4; Tr. 934 (testimony of Dr. Wheeler). 
Respondent's statements to J.R. to sell or trade the drug are 
nonetheless relevant to show his knowledge and intent.
---------------------------------------------------------------------------

    During the June 2005 search of Tri-State, DEA investigators ``could 
not find [J.R.'s] medical chart.'' Id. at 706; see also id. at 709. The 
investigators did, however, find a ``sign-in sheet'' which indicated 
that J.R. had visited Respondent on November 18, 2003, two days before 
his death. Id.; see also GX 61.
    DEA did, however, obtain the medical charts of six ``patients'' who 
died while under Respondent's care and provided these to L. Douglas 
Kennedy, M.D., for his review. GX 74. Dr. Kennedy holds medical 
licenses in Kentucky, Ohio, and Florida, and board certifications in 
anesthesiology and pain medicine. GX 63, at 9. He has been a fellow in 
pain medicine at the Cleveland Clinic Foundation, served as an 
assistant professor of anesthesiology and director of the chronic pain 
management program at the University of Kentucky Medical Center, and 
has approximately fifteen years experience as the medical director of a 
pain management practice. GX 63, at 1-2. Dr. Kennedy has also lectured 
on pain management at numerous symposia and conferences. Id. at 3-7. 
Dr. Kennedy was qualified as an expert witness in the standard of care 
in pain management and the prescribing of controlled substances for the 
treatment of chronic pain. Tr. at 1021-22.
    Dr. Kennedy specifically reviewed records including Respondent's 
patient files for six individuals (M.C., S.H., S.J., C.J., D.P, and 
K.R.). GX 74, at 1-5; see also Tr. 1084-89. He also ``reviewed past or 
concurrent medical records present on [Respondent's] `patient' charts 
from other physicians [and]/or medical facilities,'' police reports, as 
well as death certificates, autopsy, coroner's, and post-mortem 
toxicology reports. GX 74, at 1. In his report, Dr. Kennedy further 
stated that he had reviewed, and was ``generally familiar with, 
regulations including Ohio Administrative Code, Chapter 4731-21 on 
Intractable Pain,'' the Federation of State Medical Board's Model 
Policy for the Use of Controlled Substances for the Treatment of Pain, 
and ``other applicable standards and guidelines with respect to pain 
management and the prescription of controlled substances for same.'' 
Id. at 2.\22\
---------------------------------------------------------------------------

    \22\ While much of the cross-examination of Dr. Kennedy focused 
on his reliance on the Kentucky guidelines, in both his report and 
testimony, Dr. Kennedy made clear that he had also reviewed the Ohio 
Administrative Code. See Tr. 1198-1203. When Dr. Kennedy offered to 
explain why Respondent also violated the Ohio regulations, 
Respondent's counsel declined to pursue this line of questioning. 
Id. at 1202-03.
---------------------------------------------------------------------------

    Dr. Kennedy specifically noted that the drugs Respondent prescribed 
``were present in the Toxicology Testing post-mortem and were the 
primary (in some cases the only) cause of death.'' \23\ Id. at

[[Page 30637]]

4. He further found that Respondent ``practiced `polypharmacy[,]' 
prescribing multiple controlled substances at the same time.'' Id. at 
5. Relatedly, Dr. Kennedy observed that Respondent ``averaged 3.8 
controlled substance prescriptions for each `patient' visit,'' and that 
``[t]his increased the likelihood of sedation, respiratory depression 
and death.'' Id. He also noted that ``[d]eath occurred on average * * * 
[three] days after the last visit with [Respondent] [with] some 
[occurring] the next day.'' Id.
---------------------------------------------------------------------------

    \23\ With respect to patient M.C., the record establishes that 
she saw Respondent on January 8, 2004, and died on January 10, 2004, 
at the age of 32. GX 84, at 6-7; GX 44. During the January 8 visit, 
Respondent issued her three prescriptions: one for 300 tablets of 
Norco (hydrocodone/apap 10/325); one for 60 tablets of oxycodone 30 
mg.; and one for 120 tablets of Xanax 2 mg. GX 84, at 6-7. The 
coroner concluded that M.C. died from ``intoxication'' caused ``by 
the combined effects of oxycodone and hydrocodone.'' GX 42 & 44.
    With respect to patient S.H., the record establishes that he saw 
Respondent on April 19, 2005, and died the next morning at the age 
of 33. GX 84, at 12-14; GX 38, at 3. During the April 19 visit, 
Respondent issued him prescriptions for 360 tablets of oxycodone (15 
mg.) with an instruction to take 12 per day; 120 tablets of Valium 
(10 mg.); 30 tablets of Xanax (2 mg.), and another drug Carafate, 
which is not controlled. GX 84, at 12-13. Respondent also issued an 
RX for an MRI during this visit. The coroner concluded that S.H. 
overdosed and died of the ``acute combined effects of oxycodone, 
diazepam, and alprazolam.'' GX 38, at 1.
    With respect to S.J., the record establishes that she saw 
Respondent on both September 16 and September 29, 2005. On September 
16, Respondent prescribed to her 270 tablets of oxycodone 30 mg.; 
270 tablets of Percocet 5/325 (oxycodone/apap); 60 tables of Xanax 
(2 mg.), and 120 tablets of Soma (350) even though her pain was 
indicated as being ``2/10.'' GX 84, at 21-24. On September 26, 2005, 
Respondent prescribed to S.J. an additional 135 tablets of both 
Percocet 5/325 and oxycodone 30. Id. at 25-26. The form documenting 
the 9/26/05 visit does not contain any indication of a medical 
complaint and the entry for ``Pain: Location, Description, 
Duration'' is blank. Id. at 26. S.J. died September 30, 2005; the 
coroner concluded that the cause of death was ``[m]ultiple drug 
intoxication, with acute bronchopneumonia contributing.'' GX 55, at 
2. The coroner further noted that S.J., who was 30 years old, had 
ingested oxycodone, alprazolam, cocaine and diphenhydramine. Id. at 
2-3.
    With respect to K.R., the record establishes that on March 8, 
2004, Respondent gave her two separate prescriptions for 90 tablets 
of oxycodone 30 mg., a prescription for 180 tablets of Lorcet 10/650 
(hydrocodone/apap), and a prescription for 120 Xanax (2 mg.). GX 84, 
at 10. The progress note for the visit suggests that Respondent also 
gave her a prescription for Soma 350. Id. at 11. K.R, who was 39 
years old, died the following day of a drug overdose. GX 51, at 2. 
The toxicology report indicates that oxycodone, benzodiazepines, and 
carisoprodol /meprobamate were present. Id. at 3.
    Dr. Kennedy specifically noted that Respondent had ``essentially 
doubled'' K.R.'s medication ``the day before she died,'' and that he 
saw ``no indication for her being on the medicines in the first 
place, let alone [Respondent's] doubling them.'' Tr. 1090.
    With respect to C.J., the record establishes that on October 16, 
2003, Respondent gave him prescriptions for 120 tablets of oxycodone 
30 mg., 180 tablets of Percocet 10/650 (oxycodone/apap); 180 Xanax 2 
mg., and 90 Soma 350 mg. GX 84, at 3-5. The progress note indicated 
that C.J.'s pain level was 5-6/10, and his spasms were 0/10. Id. at 
5. C.J. died five days later; the coroner determined that the cause 
of his death was ``acute opioid (oxycodone) toxicity.''
    With respect to D.P., the record establishes that on August 11, 
2004, Respondent issued to him prescriptions for 300 tablets of 
oxycodone 30 mg., 360 tablets of hydrocodone/apap (10/325), 120 
tablets of alprazolam 2 mg., and 180 tablets of carisoprodol 350 mg. 
GX 26, at 385. D.P. filled the first two prescriptions the same day, 
and filled the latter two the next day. Id. According to the chart, 
D.P. reported that his pain level was ``O-1/10,'' and his spasms 
were ``0/10.'' GX 84, at 17. There is a notation ``See Cleve. Clinic 
Report,'' but the note does not say what the referral was for. Id. 
There is also a notation that Rx Express Pharmacy had been called 
and D.P. had not filled either the Soma or Xanax prescriptions, Id.; 
he did, however, fill them the next day. Id.
    While the record does not contain D.P.'s death certificate, the 
testimony establishes that he died on August 12, 2004. Tr. 736. 
Moreover, the toxicology report confirmed the presence of oxycodone 
in D.P.'s blood. GX 34, at 2. According to the spreadsheet compiled 
by Dr. Kennedy, there is a handwritten note on a preliminary 
toxicology sheet which states that D.P.'s death was caused by 
``acute oxycodone toxicity.'' GX 82.
---------------------------------------------------------------------------

    Dr. Kennedy further described Respondent's practices as 
``prescrib[ing] drug `cocktails' * * * often including an opioid[] 
(often 2-3 types), a benzodiazepine, and Soma.'' Id. at 3. According to 
Dr. Kennedy, Respondent's prescribing practices ``greatly increased the 
chance for drug abuse, diversion, [and]/or addiction.'' Id.
    Moreover, based upon his review of the ``patient charts'' (which is 
more fully set forth in GX 82), Dr. Kennedy found that Respondent ``did 
not establish a doctor-patient relationship on initial visits, and did 
not establish or maintain such a relationship on followup visits.'' GX 
74, at 3. Relatedly, Dr. Kennedy noted that ``[t]here was inadequate or 
no history [and] physical examination,'' that ``[t]here was seldom any 
diagnostic testing or past medical record present,'' and that ``[w]here 
there was, [Respondent] did not rely upon it for medical decision 
making.'' Id. at 4.
    Dr. Kennedy also observed ``[t]here existed no plan to diagnose or 
treat the person's problem(s),'' and that ``[t]he `plan of care' was 
essentially the same for every person: drugs (predominately controlled 
substances), for which no medical necessity was established.'' Id. 
Moreover, once Respondent began his `` `plan of care' * * * [he] 
continued [it] with no reassessment as to effect, success, or ill 
effects.'' Id. Relatedly, Dr. Kennedy found that Respondent ``did not 
regularly and consistently address pain complaints with other methods, 
for example, nonprescription drugs, non-controlled substance 
prescription drugs, physical therapy or behavioral medicine 
consultation, before resorting to controlled substance prescriptions.'' 
Id. at 3.
    Dr. Kennedy also concluded that Respondent ``ignored and failed to 
obtain necessary testing and consultations (with Behavioral Medicine, 
Psychiatry, or Addiction Medicine) that would have identified and then 
allowed treatment for abuse and addiction as well as identifying those 
persons who may have been diverting the drugs.'' Id. at 5. More 
specifically, Dr. Kennedy found that Respondent ``rarely tested, 
checked for, or heeded signs of addiction (he rarely performed in 
office urinary drug screens). When he did perform in office urinary 
drug screens, the tests were inadequate.'' \24\ Id. at 3. As Dr. 
Kennedy explained, if a test does not pick up a drug that a physician 
has prescribed, it raises the possibility that the ``person could have 
been selling those drugs.'' Tr. 1091. Dr. Kennedy further noted that 
Respondent ``prescribed and continued to prescribe controlled 
substances to persons who exhibited behavior consistent with possible 
drug abuse, addiction [and]/or diversion.'' Id. at 3.
---------------------------------------------------------------------------

    \24\ According to Dr. Kennedy's spreadsheet, Respondent did not 
perform a single urinary drug screen on M.C., even though she made 
five visits to him over a four month period. GX 82. Notably, M.C.'s 
toxicology report was positive for cannabinoids. Id. Dr. Kennedy 
thus concluded that M.C.'s use of marijuana ``most likely would have 
been picked up by [Respondent] if he had checked, triggering an 
addiction medicine [and]/or law enforcement evaluation.'' Id. 
According to Dr. Wayne Wheeler, who also testified as an expert 
witness for the Government, M.C.'s emergency room records indicate 
that on August 5, 2003, she had been in a car accident; a drug test 
done at the hospital indicated that she was positive for marijuana 
and ``the police report indicated she had taken Soma and Percocet 
and lost control of her vehicle.'' Tr. 946.
    Dr. Kennedy noted that S.J. ``had been dismissed in 2003 for 
falsifying symptoms and cancer records.'' GX 82. Respondent did not, 
however, perform a drug screen on S.J. Id. Dr. Wheeler noted that 
S.J. had made ``multiple visits to the emergency room'' for 
conditions (falls, headaches, dental pain) that are the ``hallmarks 
of * * * pill-seeking behavior'' because it is ``very hard to find 
objective evidence'' that the patient is not telling the truth. Tr. 
948.
    Dr. Kennedy also noted that Respondent did not perform a single 
drug screen on D.P., even though he had visited Respondent seventeen 
times over the course of sixteen months and had received a total of 
74 controlled-substance prescriptions from him. GX 82.
    Respondent performed only a single drug screen on S.H., even 
though he was a patient for more than two years and saw Respondent 
thirteen times. Id. He also noted that S.H. had previously been 
treated at Tri-State (albeit at a different location) and that 
records of an earlier visit indicated an abnormal drug screen in 
that S.H. indicated that he was currently taken Lortab 10/500 and 
the screen was negative. Id. Moreover, S.H. had previously been 
hospitalized for mental illness; these records indicated that S.H. 
had stated that ``he has smoked pot [and], taken Cocaine.'' Id. 
Moreover, S.H. had a Xanax bottle which had been filled ten days 
earlier but was then empty. S.H. had also stated that he was out of 
medications and that prior to his admission, he was taking Xanax, 
Oxycontin, and oxycodone. Id. The note also stated that S.H. had a 
history of ``significant alcohol abuse'' and ``[s]uicidal ideation 
with family member stating that the patient does have the potential 
for self-destructive behavior.'' Id. Moreover, the patient had 
tested positive for benzodiazepines and cocaine but negative for 
opiates. Id. As Dr. Kennedy noted in the spreadsheet, ``[t]here are 
numerous `red flags' for significant mental illness * * * with 
medication non-compliance, drug abuse & addiction (polysubstance 
abuse), and general non-compliance with treatment recommendations.'' 
Id.
    Respondent performed a single drug screen on C.J., who was his 
patient for more than six months and saw him seven times. Id. During 
the screen, only cocaine and THC were checked for. Id.
    Finally, with respect to K.R., who was a patient for nearly 
eleven months and made 14 office visits during this period, Dr. 
Kennedy noted in his spreadsheet that Respondent had obtained two 
in-office drug screens. GX 82. On cross-examination, it appeared 
that both screens were ordered by a different physician, who was 
practicing in Tri-State's South Shore, KY office, and not 
Respondent. Id.; see also Tr. 1182-83, 1186. The first of these 
occurred on December 1, 2003, nearly eight months after K.R.'s first 
visit; the second drug screen was obtained on January 23, 2004. GX 
82. Dr. Kennedy noted that the first screen did not test for 
oxycodone and that the second test did not check for specific 
opiates or benzodiazepines. Id. Dr. Wheeler noted that while 
Respondent had referred K.R. to a yoga class, she went only one time 
and decided not to go back. Tr. 949. According to Dr. Wheeler, 
allowing the patient to quit after one class does not give that 
treatment ``modality a reasonable chance to produce any positive 
results.'' Id.
---------------------------------------------------------------------------

    Dr. Kennedy thus concluded that Respondent ``did not establish'' a 
bona-fide doctor patient relationship or ``any relationship adequate 
for prescribing controlled substances on the [patient's] initial 
visit'' or ``on subsequent visits.'' Id. at 4. Most signif