[Federal Register: May 28, 2008 (Volume 73, Number 103)]
[Notices]
[Page 30630-30644]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my08-64]
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\1\ Apap is the abbreviation for acetaminophen.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\4\ To clarify, the clinic did not hold a DEA registration.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\10\ Both logs were started on July 30, 2003. GX 11, at 2.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 significantly, he
concluded that Respondent ``knowingly and intentionally distribute[d]
prescriptions for oxycodone and other controlled substances not for a
legitimate medical purpose and beyond the bounds of medical practice.''
Id. Finally, Dr. Kennedy concluded that Respondent's ``distribution of
multiple and regular controlled substances resulted in the death'' of
``all [six]'' patients whose records he examined, and that ``each one
of these [six] deaths was preventable.'' Id. at 4-5.\25\
---------------------------------------------------------------------------
\25\ The Government also called to testify Dr. Wayne Wheeler,
who is licensed in Ohio and other states, and holds board
certifications in both emergency and occupational medicine, as well
as quality assurance and utilization review. Tr. 907-08. Dr. Wheeler
also has extensive experience in emergency medicine and has served
as a deputy coroner of Scioto County, Ohio, since 1990. GX 69, at 2.
Dr. Wheeler is a member of the Ohio Medical Malpractice Commission,
a board member of the Ohio Patient Safety Institute, and Chairman of
the Ethics Committee at the Southern Ohio Medical Center of
Portsmouth. Id. Dr. Wheeler was accepted as an expert in
occupational medicine. Tr. 915.
Dr. Wheeler testified that prescription drug abuse is ``a
particular problem in Scioto County.'' Id. at 917. Dr. Wheeler
explained that in treating a chronic pain patient, a physician must
determine the patient's complaint, the history of the problem
including ``what therapies have been tried'' and ``who has been
taking care of the problem,'' and how the condition has
``developed.'' Id. at 922. Dr. Wheeler also testified that the
treating physician ``need[s] to get a past medical history, which
included other injuries, other illnesses,'' including ``psychiatric
histories'' and ``social backgrounds.'' Id. Next, the physician
should do ``a top-to-bottom physical exam.'' Id. Finally, if other
practitioners have been ``caring for [the] patient, it become * * *
fairly important that you get their records and find out what they
have done and what their impressions have been.'' Id. at 923. Dr.
Wheeler explained that patients sometimes ``don't really understand
what has been told them about their condition or they cover up
material or just intentionally leave it out.'' Id.
Dr. Wheeler further testified that in evaluating a patient, it
is ``essential'' to determine if there is ``a history of overdosing
on drugs'' or of psychiatric problems. Id. at 927. He also explained
that he would have his patients sign releases so that he could
obtain the patients' records from the other physicians who had
previously treated them, as well as emergency room and hospital
records. Id. at 928. According to Dr. Wheeler, obtaining emergency
room records is ``not a terribly laborious or complicated process.''
Id. at 951. On cross-examination, Dr. Wheeler further explained that
while it was not his experience that a hospital would fail to
provide the records to a physician, a patient is entitled to her
medical record. Id. at 988.
While Dr. Wheeler acknowledged that ``pain is very subjective,''
he added that some patients exaggerate their pain level. Id.
Moreover, he would not prescribe a narcotic unless he ``truly
believed'' the patient was ``experiencing pain somewhere in the 5 to
6 level.'' Id. Dr. Wheeler particularly noted that drug abusers
``have long track records of pain-medicine seeking behavior'' with
multiple visits to emergency rooms. Id. at 929.
---------------------------------------------------------------------------
[[Page 30638]]
On cross-examination, Dr. Kennedy acknowledged that K.R's medical
records indicated that Respondent had performed a physical exam on her
on April 17, 2003, which was the date of K.R.'s first visit to him.\26\
Tr. 1174-78. However, during his lengthy cross-examination of Dr.
Kennedy, Respondent's counsel did not establish that Respondent had
ever performed a followup physical examination or that he properly
monitored K.R.
---------------------------------------------------------------------------
\26\ Dr. Kennedy noted that Respondent's diagnosis of ``left
sciatica'' was ``odd, because the left straight leg raise had a
greater range of motion than did the right.'' Id. at 1177.
---------------------------------------------------------------------------
Moreover, Dr. Kennedy noted that during K.R.'s first visit with
Respondent, the latter proceeded to prescribe what Dr. Kennedy termed
the ``cocktail'' or ``trifecta'' of Soma, Xanax, and Lorcet 10, which
is ``one of the highest doses of hydrocodone.'' Id. at 1178.\27\ While
Respondent testified as to the general rationale for his prescribing
practices,\28\ id. at 1416-18, he did not testify regarding his
prescribing to the six deceased patients and presented no expert
testimony refuting Dr. Kennedy's opinion that there was no legitimate
medical purpose for prescribing these drugs in combination. GX 64, at
2; GX 74, at 5 (noting that prescribing this combination of drugs
``increased the likelihood of sedation, respiratory depression and
death''); Tr. 1047 (noting that the ``cocktail * * * is very popular
amongst those individuals who go to doctors' offices to take drugs to
abuse them, [and] not [use them] for legitimate medical purposes'');
see also id. at 1036-37; 1189. Moreover, Respondent did nothing to
impeach Dr. Kennedy's findings with respect to the remaining five
deceased patients (M.C., S.H., S.J., C.J. and D.P.).
---------------------------------------------------------------------------
\27\ Respondent's counsel also cross-examined Dr. Kennedy about
two referrals that K.R. was given, one for a neurosurgeon, the other
for a neurologist. Tr. at 1183-84; 1186-87. Neither document was
admitted into the record, and the testimony suggests that both
referrals were issued by a doctor who was working at a Tri-State
Clinic in South Shore, Kentucky, and not Respondent. Id. Moreover,
Respondent's counsel did not establish that K.R. ever went to either
specialist, and Respondent did not testify that he had reviewed a
report from either specialist.
\28\ In his testimony, Respondent described at length the role
of opiates in the treatment of pain; he testified that he used both
oxycodone and hydrocodone because ``it was perfectly appropriate, as
well as usually necessary, to treat chronic severe intractable pain
with two opiates, usually a stronger or long acting one [oxycodone],
as well as a shorter acting one,'' hydrocodone, which he used ``for
[his] breakthrough medicine.'' 1418. As support for his testimony,
Respondent cited various guidelines, Ohio's regulations, and a
document of frequently asked questions published by this Agency and
two other entities. Tr. 1412-15. He also justified his prescribing
of carisoprodol on the grounds that ``I learned that almost [all] of
my patients complained of severe muscle spasms * * * usually
radiating down one or both legs.'' Id. at 1415. Finally, he
justified his prescribing of either Valium (diazepam) or Xanax
(alprazolam) on the ground that ``virtually all of these patients
needed medicine to help them sleep.'' 1417-18. He also justified his
prescribing of benzodiazepines as medically necessary to relieve
muscle spasms. Id.
---------------------------------------------------------------------------
In his defense, Respondent testified that when he ``started seeing
these patients, they were all new to me, and so I had to evaluate all
of them pretty much from scratch.'' Id. at 1407. Respondent maintained
that he ``did a physical exam on all of them, and evaluated their
complaints, evaluated the medical records that were in the charts, as
far as prior treatments, prior x-rays, prior MRIs, prior lab tests,
prior consultations with other physicians.'' \29\ Id. Relatedly, he
asserted that ``[v]irtually all the patients that I found had previous
consultations with neurosurgeons or neurologists,'' and ``[m]ost of
them had surgery one or more times,'' and ``extensive injections given
by neurosurgeons, which they reported to me had done very little to
treat their pain.'' Id. at 1409.
---------------------------------------------------------------------------
\29\ Respondent maintained that he ``would always'' do a
physical exam during his first visit with a patient. Id. at 1469. He
further testified that he would not necessarily do a new physical
exam at a subsequent visit because in ``many instances,'' there was
``no new factor to evaluate.'' Id.
---------------------------------------------------------------------------
Respondent further testified that ``[m]ost of'' his patients ``had
run the gamut of treatment from specialists, and were still in severe
chronic pain,'' and ``fit the diagnosis and the category of chronic
intractable pain patients'' who ``would need medicine on a continuing
basis for the rest of their lives [as] there was no other treatment
available to them which would in any way alleviate their pain.'' Id. He
also maintained that ``I at all times attempted to verify that all the
patients were in fact genuine patients who had a legitimate need and
requirement for pain medication.'' Id. at 1407. He also testified that
if he did see a patient who would be helped by surgery, he would refer
them to the Cleveland Clinic. Id. at 1410.\30\
---------------------------------------------------------------------------
\30\ He also testified that he arranged for a yoga instructor to
come to Portsmouth, and that the instructor did so ``two days a
week'' for about ``the better part of a year,'' when Ms. ``Huffman
decided that she did not want to subsidize the * * * instructor any
longer.'' Tr. 1411-12.
---------------------------------------------------------------------------
Respondent further testified that ``each and every one of'' his
patients ``signed narcotic contracts'' which set forth that his
patients were ``to take their medicine'' as he prescribed it and how
the patients were to secure the drugs. Id. 1420. Relatedly, Respondent
testified that he directed that the Tri-State staff call in his
patients for random pill counts and that his patients were subject to
``random drug screens.'' Id. at 1421. He further asserted that he sent
his patient to two hospitals ``for more extensive blood and urine
tests,'' id. at 1424, and that he dismissed those patients who were
non-compliant and referred them to addiction treatment programs. Id. at
1444.
Respondent further testified that ``at all times,'' he documented
his diagnosis, id. at 1471, and that he ``always wrote my justification
and my thinking as to why I put patients on certain medicines, and I
believe that would be apparent in any reading of my charts.'' Id. at
1472. Moreover, he maintained that he would document the patients'
``response to the medication,'' and any ``adverse [drug] effect'' and
changes in medication. Id. at 1473. He also contended that ``[a]t all
times [he] would look for signs of diversion'' such as abnormal drug
tests and physical signs of ``intravenous drug abuse or perhaps
intranasal drug abuse.'' Id. at 1474.
Regarding the six deceased patients whose files Dr. Kennedy
reviewed, Respondent's testimony was limited to
[[Page 30639]]
a discussion of their autopsies and toxicology results, with in some
instances, Respondent disputing the findings that the patients had
taken drugs in amounts that could be definitively shown to be the cause
of their deaths. See 1475-86.; id. at 1481 (testifying that ``post
mortem values of opiates are irrelevant to any determination of cause
of death,'' because the values only show ``the patient having ingested
those compounds, but could not speak to whether they were involved in
the cause of death.''); id. at 1482-83 (testifying regarding toxic
levels of meprobamate).
However, with respect to several patients, the coroners found that
these individuals had ingested not only opiates, but opiates in
combination with benzodiazepines (S.H.), opiates in combination with a
benzodiazepine and illicit drugs (S.J.), or opiates in combination with
benzodiazepines and carisoprodol (K.R.). Moreover, even with respect to
those patients who were found to have ingested only opiates, I reject
Respondent's testimony either because there were other findings
consistent with the Coroner's finding (M.C., GX 42; noting presence of
extreme pulmonary edema, which according to Dr. Wheeler, ``typically
occurs when someone has overdosed on a narcotic drug [or] narcotic
drugs,'' Tr. 945), or because I presume that the officials performing
the autopsies are competent and reviewed other information (including
the clinical history, EMS run sheet, and emergency room report) that is
relevant in determining the cause of death. Tr. 1196-97.
The ALJ did not make a credibility finding pertaining to this
portion of Respondent's testimony. She did, however, find that she
``doubt[ed] Respondent's credibility'' with respect to his testimony
regarding his treatment practices such as whether he took medical
histories and performed physical exams, had his patients sign narcotic
contracts, called patients in for pill counts, and performed drug
screens. ALJ at 34-35. As the ALJ explained, ``[n]either Dr. Wheeler
nor Dr. Kennedy testified about finding such safeguards in the patient
charts they reviewed for this proceeding.'' Id. at 35.
I adopt the ALJ's credibility finding. While I acknowledge that
there is evidence that Respondent performed a physical exam during
K.R's initial visit, he did not introduce any evidence to corroborate
that he performed a physical exam on any of the five other patients
whose records were reviewed by Dr. Kennedy. Notably, Respondent was
provided with the patients files for these six patients and testified
that he always documented his findings. Tr. 1471. Moreover, there was
other evidence suggesting that Respondent frequently failed to perform
physical exams including testimony regarding an interview with DC, Tr.
762-64, and a DI's analysis that in 900 of the 1258 patient files she
reviewed, there was no documentation that Respondent had performed a
physical exam. GX 73.
Furthermore, Dr. Kennedy's review of the six patient files
establishes that Respondent rarely performed drug screens on those
patients. See n.22. For example, Respondent did not perform a single
drug screen on D.P., even though he issued 74 controlled-substances
prescriptions to him during some seventeen visits over a sixteen-month
period. GX 82. He performed but a single drug screen on S.H., even
though he saw S.H. thirteen times over a period of two years. Id. This
evidence, which is unrebutted by any documentary evidence, gives ample
reason to reject Respondent's testimony.\31\
---------------------------------------------------------------------------
\31\ In his exceptions, Respondent notes that he attempted to
subpoena records from a hospital that would have showed that he
``routinely and consistently ordered urine drug screens on his
patients.'' Exceptions at 13. Respondent states: ``[o]f course, such
records were simply `not available,' '' implying that there is a
conspiracy to deny him access to records that would vindicate him.
According to Respondent: ``[t]he non-production of the forgoing
documents, records, and evidence fits synergistically with the
course of conduct of the hearing before the ALJ and stands as a
poignant indictment of the legality of the process utilized by the
agency.'' Id. at 14.
The letter from King's Daughters Medical Center merely stated
that the hospital was ``unable to retrieve the information * * *
from our system without patient specific information.'' RX T. My
review of the subpoena indicates that it sought ``records of all
urine drug screens ordered by [Respondent] from April 2003, through
February 2006.'' RX O, at 5. Respondent offered no evidence that the
records could, in fact, be retrieved based solely on his name, and
there is no evidence that he subsequently provided patient names to
the hospital.
---------------------------------------------------------------------------
Moreover, none of Respondent's other evidence (including the
various exhibits he submitted on pain management and the testimony of
his witnesses) rebuts Dr. Kennedy's ultimate findings that Respondent
did not establish and maintain valid doctor-patient relationships with
the six deceased patients and that his prescribing lacked a legitimate
medical purpose and was outside of the usual course of professional
practice. Only one of Respondent's three witnesses (I.A.) testified
that she knew one of the deceased patients (D.P.), and she did not even
know that D.P. had died of a drug overdose. Tr. 1286-87. Ms. I.A., who
worked at Tri-State, and apparently did so only ``a few hours now and
then,'' id. at 1284, testified that she ``opened the doors,''
``basically answered the phones,'' ``pulled charts, and once in a while
. . . would write a few patients up if somebody was gone'' based on
what the patient told her. Id. at 1287-88. Ms. I.A. had no personal
knowledge of Respondent's treatment of any of the six patients whose
files were reviewed by Dr. Kennedy.\32\
---------------------------------------------------------------------------
\32\ While Ms. I.A. testified that Respondent had sent her to
several specialists, Tr. 1268, this testimony is not probative of
Respondent's treatment of the six deceased patients whose files were
reviewed by Dr. Kennedy. It should also be noted that I.A. was
related to Denise Huffman, id. at 1288-89, and had testified before
a grand jury on matters related to her employment at Tri-State. Id.
Ms. I.A. also testified that Respondent ordered that blood be drawn
on any patient he prescribed to, id. at 1318, yet there was no
evidence of blood tests being performed on any of the six patients
with the possible exception of a test done on S.H. at King's
Daughters Hospital on March 2, 2005 (although it is unclear whether
the test was a urine screen or blood test). GX 82. Based on the
weight of the evidence, I reject this testimony.
---------------------------------------------------------------------------
S.S. (who was I.A.'s sister) also testified. S.S. did not work at
Tri-State and started working for Respondent only after his falling out
with the Huffmans; her employment was thus limited to the time he
worked out of his Portsmouth apartment and in Chillicothe. Id. at 1328-
29. S.S. testified that she ``would set up the charts'' and obtain
information from both the patients and the hospitals to corroborate
their stories. Id. at 1331. S.S. further testified that Respondent
``usually required his patients to have at least a year of therapy.''
Id. at 1332. S.S. further maintained that ``we obtained histories. We
did physicals. We did the drug exams'' and monitored the patients'
``drug levels.'' Id. S.S. did not, however, have any knowledge
regarding Respondent's treatment of patients (other than her sister) at
Tri-State and offered no testimony regarding his treatment of the six
deceased patients.
Respondent's remaining witness (E.S.M.) likewise worked for him for
only two months at his Chillicothe office. Id. at 1363. While E.S.M.
testified that Respondent made ``a lot of referrals,'' and that ``[h]e
was very strict with'' monitoring patient compliance, id. at 1368, she
did not work under him during the period in which he treated the six
patients whose files were reviewed by Dr. Kennedy. Furthermore, at the
time she was employed by him, Respondent clearly had reason to know
that he was the subject of criminal investigations because various law
enforcement authorities had twice searched his offices. Under these
circumstances, even if true, evidence that Respondent was making
referrals, was closely monitoring his patients and attempting to
corroborate their stories,
[[Page 30640]]
and performing physical exams, is not probative of Respondent's
practices while he was employed at Tri-State.
Finally, as for his exhibits, most of them are only marginally
relevant to the issues in this case. While one of Respondent's Exhibits
(an FAQ supported by DEA, the Last Acts Partnership, and the Univ. of
Wisconsin) indicates that it may be appropriate ``on a case by case
basis'' to prescribe more than one opiate including a short-acting one
to address ``breakthrough pain,'' RX I, at 25; nothing in this document
refutes the testimony of the Government's experts regarding the medical
propriety of Respondent's prescribing of the trifecta and quadfecta
cocktails.
Moreover, this document notes the importance of ``tak[ing] a
detailed history and perform[ing] an appropriate physical
examination,'' ``[s]creen[ing] for addictive behaviors of other family
members,'' and ``[i]dentify[ing] concurrent psychiatric illness.'' Id.
at 31. The document further notes that the physician should
``[c]onsider multiple approaches to the treatment of chronic pain''
including ``[n]onpharmacological and nonopioid analgesic approaches.''
Id. The document also explains that the physician should ``[r]ecognize
that opioid therapy is as much a `therapeutic trial' as any other
treatment[,]'' and that ``[i]f the benefits are not clear, or the risks
of adverse effects are not easily managed, the therapy can be modified
or stopped.'' Id.
Relatedly, the document suggests that the physician ``[s]tructure
the treatment in a manner that maintains the safety of the patient, and
increases both the patient's ability to maintain control and the
clinician's ability to identify medication misuse.'' Id. at 37. Among
the measures which the document recommends that a physician employ are:
``the prescribing of small quantities,'' ``the use of a single drug
(typically a long-acting opioid''), ``pill counts,'' and ``regular
screening of urine toxicology (to provide evidence of therapeutic
adherence and non-use of other drugs).'' Id. As found above, the
credible evidence establishes that Respondent rarely followed these
recommendations.
Most significantly, as found above, there is abundant evidence that
Respondent did not regularly perform physical exams, rarely conducted
drug screenings, rarely used methods other than prescribing controlled
substances to treat the six deceased patients, and continued to
prescribe controlled substances to persons whose behavior was
consistent with either diversion or self-abuse. Moreover, as found
above, Respondent's testimony that he complied with these standards is
not credible. Contrary to Respondent's contention, this document does
not support Respondent.
Discussion
Respondent's Exceptions
Two of Respondent's remaining exceptions raise constitutional
claims which are not intertwined with the merits. Accordingly, they
will be discussed before addressing the application of the public
interest standard.\33\
---------------------------------------------------------------------------
\33\ Respondent's exception that DEA is engaged in the unlawful
regulation of the practice of medicine will be discussed in the
public interest analysis.
---------------------------------------------------------------------------
The first of these is Respondent's contention that the Government
was allowed to introduce over his objection an e-mail in which
``Respondent expresse[d] some opinions about the DEA, the ALJ, and the
prosecuting DEA attorney,'' which ``are not flattering.'' Exceptions at
10. Respondent notes that he ``objected based upon relevance,
prejudice, and intentional inflammation of the factfinder,'' that the
evidence was not relevant ``to the factual issues in dispute,'' and the
admission of the evidence punished him ``for merely expressing his
Constitutionally protected opinions.'' Id.
Respondent is correct that the e-mail was not relevant to any issue
in the case. The e-mail does not contain any evidence that is probative
of either the allegations that he failed to maintain proper records and
could not account for large quantities of controlled substances, or the
allegations that his prescribing of controlled substances to various
patients violated Federal law. GX 83. The Government's contention at
the hearing that the e-mail was relevant because Respondent made
``disparaging remarks'' about the proceeding, DEA counsel and the ALJ,
and that this ``raise[s] questions about judgment, and [is] therefore
relevant to the public interest consideration,'' Tr. 1506, finds no
support in the decisions of this Agency.
While a registrant's judgment may be relevant in determining the
public interest, what makes it relevant is the nexus between the
registrant's judgment and the performance of his obligations under the
CSA and DEA regulations. As one example, entrusting one's registration
to someone without doing a background check and failing to adequately
supervise that person reflects poor judgment that is relevant in the
public interest determination. See, e.g., Rose Mary Jacinta Lewis, 72
FR 4035, 4040 (2007). In contrast to his conduct, the opinions
expressed by Respondent in his e-mail do not establish whether he
committed any violations in the past or whether he is likely to do so
in the future. The e-mail should not have been admitted into evidence
and Respondent should not have been questioned about it.
That being said, the Administrative Procedure Act recognizes a rule
of prejudicial error. See 5 U.S.C. 706. The ALJ did not rely on the e-
mail in her recommended decision. Most significantly, having concluded
that it is irrelevant, as ultimate factfinder, I have not considered
it. Respondent's exception is therefore rejected.
Respondent's second constitutionally based exception is that the
Agency violated his right to Due Process because it failed to provide
him with ``fair notice'' of its ``theory of the case'' because the
Government was repeatedly allowed to introduce ``evidence which grossly
exceeded the scope of the February 2006 show cause order.'' Exceptions
at 5 (citation omitted). While acknowledging that each of the unnamed
patients listed in the Show Cause Order (most of whom were alleged to
have died shortly after obtaining prescriptions from Respondent, see
Show Cause Order at 9-11), were identified by the Government in its
March 2006 pre-hearing statement, Respondent contends that the
Government was allowed to introduce evidence ``about more than twenty-
five specific patients,'' and that this ``effectively expanded'' the
scope of the hearing ``without proper notice or any realistic chance to
defend.'' Exceptions at 6. Respondent also notes that the Government
was allowed to ask him ``about many more patients by reading names from
a spreadsheet.'' Id.
Respondent did not, however, identify who the twenty-five patients
were by citation of either the transcript or exhibits. See 21 CFR
1316.66(a) (``[t]he party shall include a statement of supporting
reasons for such exceptions together with evidence of record (including
specific and complete citations of the pages of the transcript and
exhibits)''). Respondent has therefore failed to properly preserve this
exception.\34\
---------------------------------------------------------------------------
\34\ It appears that the twenty-five patients included those
patients who were listed on the KASPER report as having obtained
controlled substances from Respondent (see GX 26, Exceptions at 8
n.6); the Government merely asked Respondent whether he recalled
each of these patients. Tr. 1521-29. Respondent has made no showing
that the Government failed to timely provide this document to him.
In any event, I do not rely on this portion of his testimony.
---------------------------------------------------------------------------
Respondent also argues that he was denied a meaningful opportunity
to
[[Page 30641]]
respond to the Government's case because it used ``patient charts to
prepare its own expert witnesses,'' but denied him ``timely access to
these charts.'' Exceptions at 7. Respondent contends that ``it was
essential to a meaningful hearing that [he] receive copies of the very
same charts the [G]overnment used in order to procure expert opinion
testimony from their own witnesses.'' Id. Respondent further argues
that he ``asked for the charts,'' but the Government would not provide
them because it had decided not to enter them into the record. Id.
Respondent acknowledges, however, that the Government provided him
with nine patient charts, including five of the charts which were
reviewed by Dr. Kennedy. Exceptions at 8 n.6. Moreover, the record
establishes that Respondent received all six of the patient files which
Dr. Kennedy reviewed in creating his report on Respondent's prescribing
to the six deceased patients. Tr. 1126-27. While Respondent contends
that he did not have enough time to review the charts and consult an
expert witness because the Government turned over the charts only four
days before the hearing convened, Exceptions at 8 n.6, Respondent
ignores that the hearing was adjourned for approximately one month and
that the ALJ allowed him to defer his cross-examination of Dr. Kennedy
until the hearing reconvened. Tr. 1094-95.
Respondent thus had a meaningful opportunity to prepare for his
cross-examination of Dr. Kennedy, as well as to retain an expert
witness to review the patient files which Dr. Kennedy reviewed.
Accordingly, there is no merit to his contention that the proceeding
violated his rights under the Due Process Clause.\35\
---------------------------------------------------------------------------
\35\ While it is true that DEA's regulations and the
Administrative Procedure Act require that an Order to Show Cause
contain ``a summary of the matters of fact and law asserted,'' 21
CFR 1301.37(c), an agency is not required ``to give every
[Respondent] a complete bill of particulars as to every allegation
that [he] will confront.'' Boston Carrier, Inc., v. ICC, 746 F.2d
1555, 1560 (DC Cir. 1984). As the ALJ explained at the hearing, the
Show Cause Order only sets forth the parameters of the proceedings.
See Medicine Shoppe-Jonesborough, 73 FR 364, 368 (2008). The actual
conduct of the proceeding is controlled by the pre-hearing
statements.
Respondent also raises an exception based on the ALJ's denial of
his request for a subpoena requiring Dr. Kennedy to produce
``[c]opies of all opinion reports evaluating medical care by
physicians written for the DEA from December 2001 through December
2006.'' RX O, at 1. The ALJ denied Respondent's ``request absent any
further justification.'' Id. at 2. Respondent did not, however,
provide any further justification. Accordingly, this exception is
without merit. See 5 U.S.C. 555(d); 21 U.S.C. 875 & 876.
At Respondent's request, the ALJ issued a subpoena which
directed DEA to provide patient release forms it had obtained from
Dr. Joseph Delzotto. Id. at 1-3. Upon receipt of the subpoena, DEA
searched its case files and found no such documents. Id. at 10.
Respondent has made no showing that this was not the case.
---------------------------------------------------------------------------
The Public Interest Analysis
Respondent's Registration Status
At the outset, the scope of this proceeding must be determined. As
found above, Respondent's registration expired on May 31, 2006, and he
did not submit a renewal application (and his request for a
modification) until May 12, 2006. While one of the Government's
exhibits states that because Respondent filed a renewal application,
his registration has ``remained in effect on a day-to-day basis pending
the resolution of administrative proceedings,'' the document cited no
authority for this statement which is contrary to Agency regulations.
GX 2.
Under the Administrative Procedure Act, ``[w]hen [a] licensee has
made timely and sufficient application for a renewal or a new license
in accordance with agency rules, a license with reference to an
activity of a continuing nature does not expire until the application
has been finally determined by the agency.'' 5 U.S.C. 558(c). When,
however, a Show Cause Order has been issued to a registrant, DEA's
regulation provides that:
[i]n the event that an applicant for reregistration (who is
doing business under a registration previously granted and not
revoked or suspended) has applied for reregistration at least 45
days before the date on which the existing registration is due to
expire, and the Administrator has issued no order on the application
on the date on which the existing registration is due to expire, the
existing registration shall automatically be extended and continue
in effect until the date on which the Administrator so issues his/
her order. The Administrator may extend any other existing
registration under the circumstances contemplated in this section
even though the registrant failed to apply for reregistration at
least 45 days before expiration of the existing registration, if the
Administrator finds that such extension is not inconsistent with
public health and safety.
21 CFR 1301.36(i) (emphasis added).
Notwithstanding that he had previously been served with a Show
Cause Order, Respondent did not file his renewal application until
nineteen days before his registration expired. Accordingly, Respondent
did not make a timely renewal application in accordance with agency
rules; his registration has not remained in effect pending the
resolution of this proceeding. See 5 U.S.C. 558(c). Moreover, in light
of the allegations of the Show Cause Order (and the facts found above),
the extension of his registration pending this Final Order would be
manifestly ``inconsistent with public health and safety.'' 21 CFR
1301.36(i). I therefore conclude that Respondent's registration has
expired.\36\
---------------------------------------------------------------------------
\36\ No footnote.
---------------------------------------------------------------------------
Respondent did, however, submit a renewal application and a request
for modification, which under Agency regulation, is ``handled in the
same manner as an application for registration.'' 21 CFR 1301.51.
Accordingly, Respondent does have an application pending before the
Agency.
The Public Interest Factors
Section 303(f) of the Controlled Substances Act (CSA) provides that
an application for a practitioner's registration may be denied upon a
determination ``that the issuance of such registration would be
inconsistent with the public interest.'' 21 U.S.C. 823(f). In making
the public interest determination, the CSA requires the consideration
of the following factors:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id.
``These factors are considered in the disjunctive.'' Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or a
combination of factors, and may give each factor the weight [I] deem[]
appropriate in determining whether * * * an application for
registration [should be] denied.'' Id. Moreover, I am ``not required to
make findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (DC
Cir. 2005).
Having considered all of the factors, I conclude that factors two,
four, and five amply demonstrate that issuing a registration to
Respondent ``would be inconsistent with the public interest.'' 21
U.S.C. 823(f). In this matter, there is abundant evidence that
Respondent repeatedly violated Federal law by prescribing controlled
substances without a legitimate medical purpose and outside of the
course of professional practice. Moreover, the evidence also
establishes that Respondent authorized Tri-State personnel to use his
registration to order huge quantities of
[[Page 30642]]
controlled substances and that he failed to ensure the accountability
of these drugs by maintaining lawfully required records. Accordingly,
Respondent's application will be denied.
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Laws
Respondent's Prescribing Practices
One of the principal issues in this case is whether the
prescriptions Respondent issued complied with Federal law. While
Respondent maintains that his prescribing practices were compliant with
the State of Ohio's regulations of the practice of medicine, the
evidence conclusively establishes that Respondent used his prescribing
authority to act as a drug pusher.
Under a longstanding DEA regulation, a prescription for a
controlled substance is not ``effective'' unless it is ``issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' 21 CFR 1306.04(a). This
regulation further provides that ``an order purporting to be a
prescription issued not in the usual course of professional treatment *
* * is not a prescription within the meaning and intent of [21 U.S.C.
829] and * * * the person issuing it, shall be subject to the penalties
provided for violations of the provisions of law related to controlled
substances.'' Id.
In Gonzalez v. Oregon, the Supreme Court explained that ``the
prescription requirement * * * ensures patients use controlled
substances under the supervision of a doctor so as to prevent addiction
and recreational abuse. As a corollary, [it] also bars doctors from
peddling to patients who crave the drugs for those prohibited uses.''
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122,
135 & 143 (1975)).
It is fundamental that a practitioner must establish and maintain a
bona-fide doctor-patient relationship in order to be acting ``in the
usual course of * * * professional practice'' and to issue a
prescription for a ``legitimate medical purpose.'' See Moore, 423 U.S.
at 142-43 (noting that the evidence established that physician
``exceeded the bounds of `professional practice,' '' when ``he gave
inadequate physical examinations or none at all,'' ``ignored the
results of the tests he did make,'' and ``took no precautions against *
* * misuse and diversion''). Moreover, as I have explained, ``the CSA
looks to state law in determining whether a physician has established
[and is maintaining] a valid doctor-patient relationship.'' United
Prescription Services, Inc., 72 FR 50397, 50407 (2007) (citing DEA,
Dispensing and Purchasing Controlled Substances over the Internet, 66
FR 21181, 21182-83 (2001)). See also Kamir Garces-Mejias, 72 FR 54931,
54935 (2007) (citing numerous state practice standards violated by
physician).
Respondent argues that under Gonzales, DEA ``cannot lawfully
determine and enforce a national medical standard of care.'' Exceptions
at 11. Respondent further contends that because ``Gonzales directs that
the states retain the power to set parameters on the practice of
medicine, [and he] produced evidence that his prescribing practices
conformed with Ohio law,'' DEA cannot act against his federal
registration. Id. Relatedly, Respondent argues that whether he ``did or
did not conform his conduct to the mandates of Ohio law is a question
for the State Medical Board of Ohio--not DEA.'' Id. at 12. Respondent's
argument that he was in compliance with the Ohio regulations is not
factually correct; his contention that the Agency is exceeding its
authority and usurping the State's role in regulating the practice of
medicine is also mistaken.
As found above, Respondent's testimony that he complied with Ohio
law was not credible. Under Ohio law, ``when utilizing any prescription
drug for the treatment of intractable pain on a protracted basis or
when managing intractable pain with prescription drugs in amounts that
may not be appropriate when treating other medical conditions, a
practitioner shall'' perform:
[a]n initial evaluation of the patient * * * and documented in
the patient's record that includes a relevant history, including
complete medical, pain, alcohol and substance abuse histories; an
assessment of the impact of pain on the patient's physical and
psychological functions; a review of previous diagnostic studies and
previously utilized therapies; an assessment of coexisting
illnesses, diseases or conditions; and an appropriate physical
examination.
Ohio Admin. Code R. 4731-21-02(A) (emphasis added).
There is ample evidence that Respondent failed to obtain adequate
histories and perform adequate physical exams including the testimony
of Dr. Kennedy and the DI's review of Respondent's patient files which
found that there was no documentation of a physical exam in 900 of the
files as required by Ohio law. This conclusion is also supported by the
testimony regarding the interview of DC, who obtained three controlled-
substance prescriptions from Respondent without the latter having
performed a physical exam.
Moreover, the Ohio regulations require that ``[t]he practitioner's
diagnosis of intractable pain shall be made after having the patient
evaluated by one or more other practitioners who specialize in the
treatment of the anatomic area, system, or organ of the body perceived
as the source of the pain.'' Ohio Admin. Code R. 4731-21-02(A)(4)(a).
Furthermore, ``[t]he practitioner shall maintain a copy of any report
made by any practitioner to whom referral for evaluation was made under
this'' provision.\37\ Id. With respect to the six deceased patients,
there is no credible evidence that Respondent had them evaluated by
specialists \38\ or relied on reports that a specialist had prepared
``within a reasonable period of time'' before diagnosing them as having
intractable pain. Id. R. 4731-21-02(4)(b).
---------------------------------------------------------------------------
\37\ The practitioner is not ``required to obtain such an
evaluation, if the practitioner obtains a copy of medical records or
a detailed written summary thereof showing that the patient has been
evaluated and treated within a reasonable period of time by a
specialist.'' Ohio Admin. Code R. 4731-21-02(A)(4)(b). The
practitioner must, however ``obtain and review all available medical
records or detailed written summaries thereof of prior treatment of
the intractable pain or the condition underlying the intractable
pain.'' Id. Moreover, under this regulation, the practitioner is
required to ``maintain a copy of any record or report * * * on which
[he] relied.'' Id.
\38\ While there is evidence in a progress note dated 8/11/04
that D.P. had been referred to the Cleveland Clinic, the note does
not indicate what the referral was for and when it occurred. At the
time, D.P. had been seeing Respondent since April 2003.
---------------------------------------------------------------------------
Respondent argues that while Dr. Kennedy ``claim[ed] to be aware of
the Ohio guidelines,'' he was ``painfully unfamiliar with the
controlling state standards.'' Exceptions at 12 (citing Tr. 1202-03).
While it is true that much of Dr. Kennedy's testimony focused on the
Kentucky guidelines, he also testified that ``there is no significant
variation between the'' Ohio standards and the Kentucky guidelines. Tr.
1203. Moreover, when Dr. Kennedy offered to display the Ohio provisions
to the court and explain how Respondent ``violated the Ohio Code,''
Respondent's counsel declined to pursue this line of questioning. See
Id. Furthermore, in his report, Dr. Kennedy made clear that he had
reviewed and was generally familiar with the Ohio standards for
treating intractable pain (as well as other professional standards such
as those issued by the Federation of State Medical Boards). GX 74, at
2; see also Tr. 1075 (expressing opinion that Respondent knew better
because of ``the guidelines that were published by the
[[Page 30643]]
State Medical Board of Ohio [and] the Kentucky Board of Medical
Licensure that were well circulated'').
Respondent further argues that I should reject Dr. Kennedy's
testimony because ``it was clear that he had not studied the chart * *
* and was unable to harmonize his criticism of [Respondent's] care with
the actual patient record then in front of him.'' Exceptions at 11.
Respondent then argues that Dr. Kennedy ``admittedly worked from
summaries, print-outs, and other documents created by the government or
himself, based on pharmacy records--without any meaningful review and
reliance on the patient record itself.'' Id.
Respondent does not, however, support these contentions with any
citations to the record. See 21 CFR 1316.66. Moreover, in both his
report and testimony, Dr. Kennedy made clear that for each of the
patients, he had ``reviewed records obtained from [Respondent's]
office'' including his ``clinical records.'' See also GX 74, at 1-2;
see also Tr. 1068. While it is true that Respondent showed that he had
performed a physical exam on K.R. at apparently her first visit (which
also coincided with when he started working for Tri-State), he made no
such showing with respect to the other five patients. Moreover, even
with respect to K.R., Respondent did not establish that he complied
with the Ohio standards and maintained a valid doctor-patient
relationship with her.
Indeed, Respondent offered no testimony specific to his treatment
of the six deceased patients and did not submit their patient files
into the record. Accordingly, I adopt Dr. Kennedy's opinion that
Respondent ``distributed prescriptions for oxycodone and other
controlled substances not for a legitimate medical purpose and beyond
the usual course of professional practice.'' GX 74, at 3.
Respondent further argues that the Agency is acting ``in direct
contravention to Gonzales'' because it ``sought to pass judgment upon
the medical care [he] rendered.'' Exceptions at 11. Relatedly,
Respondent contends that whether he complied with Ohio law ``is a
question for the State Medical Board of Ohio [and] not DEA.'' Id. at
12.
It is true that in enacting the CSA, Congress did not adopt a
federal standard for determining whether a valid doctor-patient
relationship exists. Rather, on this issue, the CSA recognizes the
traditional role of the States in regulating the practice of medicine.
See Gonzales, 546 U.S. at 270. The CSA therefore looks to state law in
determining whether there is a valid doctor-patient relationship.
United Prescription Services, 72 FR at 50407; Dispensing and Purchasing
Controlled-Substances over the Internet, 66 FR at 21182-83.
Determining whether Respondent established and maintained a valid
doctor-patient relationship with the six deceased patients under Ohio
law is thus a necessary and permissible incident of determining whether
Respondent complied with the prescription requirement of Federal law.
Cf. 21 U.S.C. 823(f)(4) (directing consideration of applicant's
``[c]ompliance with applicable State * * * or local laws relating to
controlled substances''). Whether Respondent complied with Ohio law in
prescribing controlled substances is thus not only a question for the
Ohio Medical Board, but also a question for the Attorney General, who
has been entrusted with the authority under Federal law to determine
whether the granting of a registration to dispense controlled
substances is consistent with the public interest. See Id. section
823(f); Id. Sec. 824(a) (granting Attorney General authority to revoke
a registration where a registrant has committed acts inconsistent with
the public interest). DEA's reliance on Ohio's medical practice
standards thus does not exceed this Agency's authority as set forth in
Gonzales.\39\
---------------------------------------------------------------------------
\39\ By contrast, Gonzales did not involve reliance on a State's
medical practice standards but the issuance of an interpretive rule,
unsupported by a grant of Congressional authority, which would have
barred conducted permitted by state law. See 546 U.S. at 274-75.
Moreover, as Gonzales recognized, prior to 1984, ``the Attorney
General was required to register any physician who was authorized by
his State [and] could only deregister a physician who falsified his
application, was convicted of a felony relating to controlled
substances, or had his state license or registration revoked.'' Id.
at 261. In 1984, however, the CSA was amended to grant ``the
Attorney General the authority to deny a registration to an
applicant `if he determines that the issuance of such registration
would be inconsistent with the public interest.'' 'Id. (quoting 21
U.S.C. 823(f)). Respondent's prescribing practices are therefore
properly considered in this proceeding.
---------------------------------------------------------------------------
Accordingly, Respondent's arguments are without merit. Because the
evidence establishes that Respondent lacked a ``legitimate medical
purpose'' and acted outside of ``the usual course of his professional
practice'' in distributing numerous controlled-substance prescriptions
to the six deceased patients (and others), he violated Federal law.
This conclusion provides reason alone to conclude that granting his
application ``would be inconsistent with the public interest.'' 21
U.S.C. 823(f).
The Record Keeping Violations
The record also contains extensive evidence that Respondent
violated Federal law by failing to keep proper records for the
controlled substances that were ordered and dispensed under his
registration at Tri-State. Respondent agreed that his registration
could be used to order and dispense controlled substances for Tri-
State's customers. Tr. 1550. As the record establishes, Respondent
agreed to this because numerous pharmacists were questioning his
prescriptions and refusing to fill them. Tr. 1428-29. Moreover,
Respondent told Denise Huffman what drugs to order. Id. at 543.
Respondent rapidly became the largest practitioner-purchaser in the
nation of oxycodone, a schedule II controlled substance which is highly
sought after by drug-abusers, and which commands top dollar in the
illicit market. As found above, his purchases dwarfed that of other
Ohio-based practitioners who purchased the drug. Moreover, Respondent
also became--by a wide margin--the largest Ohio-based practitioner-
purchaser of combination hydrocodone/apap drugs.\40\
---------------------------------------------------------------------------
\40\ The record further establishes that Respondent also ordered
large quantities of hydromorphone, another schedule II controlled
substance, 21 CFR 1308.12(b)(1), and several benzodiazepines, which
are schedule IV controlled substances. Id. 1308.14(c). During the
2005 search, there were also no records documenting the handling of
these drugs.
---------------------------------------------------------------------------
Respondent proceeded to order hundreds of thousands of dosage units
of these drugs (136,000 dosage units of oxycodone between 8/18/03 and
12/30/03; 222,600 dosage units of hydrocodone between 7/24/03 and 12/
30/03) \41\ which he distributed, and was required to maintain
purchasing, inventory and dispensing records. See 21 U.S.C. 827(a); 21
CFR 1304.03(b) (requiring dispenser to keep records); see also 21 CFR
1304.11 (requiring initial and biennial inventories), id. 1304.22(c)
(requiring maintenance of receiving and dispensing records). When,
however, on December 30, 2003, Agent Kinneer of the Ohio State Board of
Pharmacy inspected Tri-State, he found that the clinic had not made any
entries in several controlled-substance dispensing logs in more than
four months. See GX 11, at 2; GX 12, at 5. Respondent was thus already
repeatedly violating Federal law.
---------------------------------------------------------------------------
\41\ As found above, in 2004, Respondent ordered 457,000 dosage
units of oxycodone and 263,500 dosage units of hydrocodone/apap.
Moreover, during the little more than eight months of 2005 when he
worked at Tri-State, Respondent ordered 414,000 dosage units of
oxycodone and 168,500 dosage units of hydrocodone.
---------------------------------------------------------------------------
[[Page 30644]]
Thereafter, in January 2004, Respondent represented to the Ohio
Board that ``[a]ll log books are current and up to date and are being
kept current.'' GX 11. He also stated that ``[a]ll controlled
medication being dispensed * * * is being logged as it is filled.'' GX
11.
Notwithstanding Respondent's representations to the state board, on
June 7, 2005, DEA investigators could not find any dispensing logs for
the year 2004, and Denise Huffman admitted that there were no such
logs. Tr. 670. Under Federal regulations, however, Respondent was
required to maintain these records for a period of two years. See 21
U.S.C. 827(b). Moreover, given the circumstances in which the 2005 logs
were not at the clinic but were later provided to the Government only
after copies of the patient files were given to the clinic (following
the search), and that the logs appeared to be brand new, it is most
unlikely that these were accurate records. In any event, the various
dispensing logs were required to be maintained at the clinic. See 21
CFR 1304.04(1). Respondent thus repeatedly violated Federal law by
failing to maintain the required records and did so over a sustained
period of time. It is no defense that Respondent delegated this
responsibility to Ms. Huffman.\42\ Tr. 1511.
---------------------------------------------------------------------------
\42\ As I have previously explained, when a registrant
authorizes another person to perform acts under his registration, he
is responsible for that individual's misuse of the registration and
failure to perform required acts. See Rose Mary Jacinta Lewis, 72 FR
4035, 4040 (2007); see also Summer Grove Pharmacy, 54 FR 28522,
28523 (1989).
---------------------------------------------------------------------------
Aggravating these violations is the fact that he ordered
extraordinary quantities of various highly abused controlled substances
and that there is no way--given the wholly deficient recordkeeping--to
determine where these drugs have gone. Recordkeeping is one of the
CSA's central features; a registrant's accurate and diligent adherence
to this obligation is absolutely essential to protect against the
diversion of controlled substances. Given the extraordinary quantities
of controlled substances which Respondent ordered and his complete lack
of accountability for them, it is likely that most of these drugs were
diverted. Respondent's failure to maintain accurate records (assuming
that they were ever accurately maintained beyond August 2003,\43\ see
GX 11, at 2), provides a further reason--which is sufficient by
itself--to conclude that granting him a registration would ``be
inconsistent with the public interest.'' 21 U.S.C. 823(f).
---------------------------------------------------------------------------
\43\ While Agent Kinneer stated in his report that during his
February 2004 visit, Respondent and Alice Huffman gave him
dispensing logs, no such logs were found during the June 2005
search.
---------------------------------------------------------------------------
At the hearing, Respondent testified that ``as far as I was
concerned, as far as my knowledge of Ohio law, Federal law, standards
of care of pain management, and anything else I could find, I had done
nothing wrong, and was following absolutely prescribed procedures that
I should in every respect.'' Tr. 1439. I beg to differ. As the record
shows, Respondent is an egregious violator of the CSA's requirements
with respect to both his prescribing practices and compliance with the
Act's recordkeeping requirements.\44\ And even assuming--given the
remedial purpose of proceedings under section 303--that there could be
circumstances in which an egregious violator of the Act might
convincingly establish that he has reformed, Respondent has offered no
credible evidence to demonstrate that he can be entrusted with a new
registration. Accordingly, I conclude that granting Respondent's
application for a new registration would be ``inconsistent with the
public interest.'' \45\ 21 U.S.C. 823(f).
---------------------------------------------------------------------------
\44\ There is also evidence in the record that Respondent told a
patient (J.R.) to sell a drug (Soma) if he did not take it. Tr. 42 &
104. While Soma is not controlled under Federal law, the evidence is
nonetheless probative of Respondent's intent.
\45\ In light of the extensive evidence of Respondent's
misconduct, I conclude that it is unnecessary to make findings
regarding the remaining factors.
---------------------------------------------------------------------------
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b) & 0.104, I order that the application of Paul H.
Volkman, M.D., for a DEA Certificate of Registration as a practitioner
be, and it hereby is, denied. This order is effective June 27, 2008.
Dated: May 16, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-11851 Filed 5-27-08; 8:45 am]
BILLING CODE 4410-09-P