[Federal Register Volume 71, Number 119 (Wednesday, June 21, 2006)]
[Notices]
[Pages 35705-35710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9706]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 02-47]
John H. Kennnedy, M.D.; Denial of Application; Introduction and
Procedural History
On May 31, 2002, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to John H. Kennedy, M.D. (Respondent). The Show
Cause Order proposed to deny Respondent's pending application for a
registration as a practitioner on the grounds that Respondent had been
convicted of a drug-related felony, see 21 U.S.C. 823(f)(3) &
824(a)(2), and had committed other acts such as to render his
registration inconsistent with the public interest. See id. Sec.
824(a)(4).
The Show Cause Order specifically alleged that on September 14,
1999, Respondent was indicted in the United States District Court for
the Eastern District of Tennessee on five counts alleging the unlawful
distribution of a controlled substance, see id. Sec. 841(a)(1),\1\ and
one count alleging the unlawful possession of marijuana. See id. Sec.
844. The Order alleged that on March 6, 2000, Respondent pled guilty to
one count of the unlawful distribution of diazepam, in violation of 21
U.S.C. 841(b)(1)(D), and one count of possession of marijuana, in
violation of 21 U.S.C. 844. The Order further alleged that on June 19,
2000, the District Court accepted Respondent's guilty pleas and
sentenced him to twelve months of home detention and five years of
probation. The terms of the probation prohibited Respondent from
employment as a physician and from dispensing prescription drugs
without the permission of his probation officer.
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\1\ Three of the counts alleged the unlawful distribution of
dihyrdocodeine; two of the counts alleged the unlawful distribution
of diazepam.
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While the Federal criminal case was ongoing, Respondent was also
the subject of state administrative proceedings. On May 9, 2000,
Respondent entered into a consent order with the Tennessee Board of
Medical Examiners (Board) which revoked his state medical license. The
Board found that Respondent had committed unprofessional, dishonorable
and unethical conduct. The Board also found that Respondent had
dispensed, prescribed or otherwise distributed controlled substances in
violation of state or Federal law. On June 15, 2000, Respondent also
voluntarily surrendered his DEA Registration, No. AK7140736.
Thereafter, Respondent reapplied for his state medical license. On
July 31, 2001, the Board approved his application.
On August 16, 2001, Respondent applied for a new DEA practitioner's
registration to handle controlled substances in Schedules II through V.
Following an investigation, DEA denied the application and issued the
Show Cause Order.
Respondent requested a hearing. The matter was assigned to
Administrative Law Judge (ALJ) Mary Ellen Bittner, who conducted a
hearing in Chattanooga, Tennessee on April 1 and 2, 2003. At the
hearing, both the Government and Respondent called witnesses and
introduced documentary evidence. Both parties filed post-hearing
briefs. Respondent also filed a letter forwarding the Tennessee Board
of Medical Examiners' Order of Compliance, which restored his state
license to unencumbered status.
On April 13, 2005, the ALJ submitted her decision. The ALJ
concluded that the Government had shown by a preponderance of the
evidence that granting Respondent's application for registration would
be inconsistent with the public interest. See ALJ at 18. The ALJ thus
recommended that Respondent's application be denied. See id. Neither
party filed exceptions.
Having considered the record as a whole, I hereby issue this
decision and final order adopting the ALJ's findings of fact and
conclusions of law except as expressly noted herein. For the reasons
set forth below, I concur with the ALJ's conclusion that granting
Respondent's application for a registration would be inconsistent with
the public interest. I therefore adopt the ALJ's recommendation that
Respondent's pending application be denied.
Findings of Fact
Respondent graduated from the University of Tennessee in 1963.
Before entering the University of Louisville School of Medicine,
Respondent served in the U.S. Navy and also was a sales representative
for the Upjohn Company for a period of seven years.
In 1975, Respondent graduated from medical school and served a one-
year internship at Erlanger Hospital in Chattanooga, Tennessee.
Following his internship, Respondent entered into a family practice,
sharing office space with another physician for a period of seven
years. In 1983, Respondent moved his practice to North Park Hospital in
Chattanooga and maintained that practice as of the date of the hearing.
Sometime in 1997, the Hamilton County Sheriff's Office received
information from an informant implicating a Ms. Beth Harvey in the
unlawful sale of Valium (Diazepam), a Schedule IV controlled substance.
Mr. Jeffrey Parton, a detective with the Hamilton County Narcotics
Division, conducted several interviews of Ms. Harvey. Ms. Harvey told
Detective Parton that she had become a patient of Respondent based on
the advice of friends who had told her that he was a good doctor to see
to obtain diet drugs. Ms. Harvey also told Detective Parton that
Respondent would provide her with pain medication without conducting a
physical exam and that she could buy hydrocodone samples from him. Tr.
32-33.
Sometime between October 28 and November 10, 1997, the Narcotics
Division executed a search warrant at Harvey's residence. During the
search, the police found a 1000-count bottle of Valium. Most of the
pills were missing. Harvey returned to her residence during the search
and was questioned by the police about the Valium's source. Harvey told
the police that she had obtained the drugs from Respondent on October
28th, and that she was to sell it on the street and return a portion of
the profits to him.
Thereafter, Harvey agreed to cooperate with the police in their
investigation of Respondent. Between
[[Page 35706]]
November 10, 1997, and January 8, 1998, Harvey visited Respondent's
office on five occasions; Harvey also had a phone conversation with
Respondent on December 2, 1997. During these events, Harvey wore a wire
to record the conversations. While the wire did not work during the
November 10, 1997 visit, and the tape of the December 18, 1997 visit
was lost, the other conversations were recorded and transcribed. While
Harvey did not testify at the hearing, the transcripts were admitted
into evidence. Following each episode, the police also debriefed
Harvey.
1. Harvey's Undercover Activities
A. The November 10, 1997 Visit
According to Detective Parton, Harvey visited Respondent's office
on November 10, 1997. Harvey paid Respondent $100, which she
represented to him as his share of the profits from the Valium sales.
Harvey also paid Respondent $40 for a sample bottle of Lortab and two
sample boxes of Vicoprofen. Both of these drugs contain Hydrocodone, a
Schedule III controlled substance. Parton testified that Harvey told
him during the debriefing that Respondent did not perform a physical
examination. Moreover, Harvey's patient record, which was also admitted
into evidence, contains no indication that Respondent dispensed the
Lortab and Vicoprofen to her on this date. Gov. Exh. 17. On cross-
examination, Respondent claimed that he had given the drugs to Harvey
because of her complaints about headaches, but no such diagnosis was
recorded on the progress notes. Id.
B. The November 19, 1997 Visit
During this visit, Harvey told Respondent that she had sold 150
Valium pills and paid him an additional $ 100 as purported profits from
the sales.\2\ Harvey then told Respondent that she needed more pills
because she did not want her husband to discover that some of the
Valium was missing. Respondent, after telling Harvey that ``I don't
want to get in deeper, you know,'' Gov. Exh. 3a at 12, then agreed to
order another bottle of Valium and advised Harvey that it would take
about a week for the drugs to be delivered. Respondent also gave Harvey
42 Lortab tablets. Respondent did not perform a physical exam and there
was no therapeutic purpose for the dispensing. Furthermore, Harvey's
progress notes contain no record of the visit.
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\2\ The ALJ found that Harvey paid Respondent $150 during the
November 19, 1997 visit. See ALJ at 5. The transcript of the
conversation between Harvey and Respondent indicates that Harvey
only counted out money up to the amount of $100. See Gov. Exh. 3a at
12. While I therefore make my own finding, it is immaterial to the
disposition of this proceeding whether the amount was $100 or $150.
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C. The December 2, 1997 Phone Conversation
During this conversation, Harvey asked Respondent whether the
Valium had arrived. Respondent told her that it had not, but that she
could pick it up at his office the following Tuesday, December 9, 1997.
D. The December 9, 1997 Visit
During this visit, Respondent gave Harvey a sealed 1,000 count
bottle of diazepam, a size which manufacturers use to send the drug to
pharmacies. Harvey also paid Respondent $100, which she represented to
him as his share of the profits from the Valium sales. During the
conversation, Harvey told Respondent that she had sold one hundred
more. Respondent then asked Harvey if ``nothing else has come out'' of
her husband. Gov. Exh.3(C), at 32. Harvey answered ``No,'' but then
added that she was ``hoping [that] he ain't going to say nothing about
me digging in it.'' Id. After counting out Respondent's share of the
profits, Harvey told him that she probably had more sold, and then
asked ``do you want me to take all of these to replace'' the missing
drugs? Id. Respondent answered: ``No, no, sell them. Hell, medicine is
to sell not to take.'' Id. Respondent then instructed Harvey: ``[D]on't
let anybody know where any of this stuff is coming from.'' Id. at 33.
Harvey then asked Respondent whether he had any pain pills.
Respondent told her he had only four pain pills, but that he had 1,000
Xanax. Respondent then asked Harvey if she knew ``anybody that takes
Xanax?'' Id. at 34. While Harvey offered to sell them for Respondent,
Respondent replied that he didn't want her with ``two bottles, two
thousand'' pills. Id. He then asked Harvey to ``[l]ine me up somebody
that can do it.'' Id. at 35. Harvey agreed to do so.
E. The December 18, 1997 Visit
On this date, Harvey returned to Respondent's office and paid him
$130, which she again represented as being his share of the profits on
the Valium sales. Respondent gave Harvey twelve Zydone, a drug which
also contains hydrocodone. Harvey did not request the drug, and told
Detective Parton that Respondent did not perform a physical exam.
Respondent made no record of the visit on Harvey's progress notes.\3\
See Gov. Exh. 14.
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\3\ The progress notes do, however, contain a record of a visit
on December 22, 1997, which shows a dispensing of 30 Lortab tablets.
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F. The January 8, 1998 Visit
On this date, Harvey returned to Respondent's office. Harvey
attempted to pay Respondent $100, which she again represented as his
share of the proceeds from the Valium sales. At first, Respondent
refused the money as he had apparently received a tip about Harvey. Tr.
276. Respondent then asked Harvey whether she had recently called in a
prescription for a cough syrup containing hydrocodone to a local
pharmacy. Harvey denied doing so, asking Respondent ``why would I call
prescriptions in when I can, hell, you give me everything I want?''
Gov. Exh. 3(E) at 5. Respondent then stated: ``That's what I thought
too. But you know that through the years, you know, everything you ever
needed or wanted, I've tried to take care of you.'' Id. Respondent
eventually accepted $100 from Harvey.
2. The Searches
Shortly after Harvey's visit, Detective Parton and other officers
from the Hamilton County Sheriff's Office, executed a search warrant at
both Respondent's home and office. Mr. Pink Anderson, a DEA Diversion
Investigator (DI), assisted with the office search.
At the office, the authorities seized samples of legal controlled
substances, marijuana, two empty bottles of Quaalude 300 (a drug which
was rescheduled to Schedule I effective August 27, 1984, see 49 FR
33870 (1984)), one bottle which contained two Quaalude 300 pills, a
1000 count bottle of alprazolam (Xanax) which contained 958 pills, a
cocaine kit consisting of a mirror, razor blades and straw, two
receipts from Access Drugs (a local drug distributor), various patient
files, and $100, which was in the same denominations as the cash that
Harvey had earlier given Respondent.
At Respondent's home, the authorities seized 60 grams of marijuana,
a bottle containing marijuana seeds, one hand-rolled marijuana
cigarette, several remnants of marijuana cigarettes, and assorted
marijuana paraphernalia including a metal tray, a bong, two pipes with
residue, rolling papers, and a briefcase which held similar items. The
authorities also seized a bottle containing 21 Quaalude 300 pills, a
bottle containing 52 Quaalude 300 pills, seven empty Quaalude 300
bottles and one empty Quaalude 150 bottle. Also
[[Page 35707]]
seized were samples of Norco, a hydrocodone-based product, 13 empty
bottles of pharmaceutical-grade cocaine hydrochloride, and one empty
bottle that had contained tetrahydrocannabinol (THC). Respondent's home
was not a registered location.
According to DI Anderson, the only records discovered during the
search of Respondent's office were the two receipts from Access Drugs.
With this exception, Respondent had no records of inventories, receipts
or the distribution of controlled substances. DI Anderson testified
that although Respondent was not charged, he also violated 21 U.S.C.
843(a)(4)(a), because he failed to keep, make or maintain required
records. See Tr. 217. Respondent testified that he had not known that
he was required to keep receipts and that he had told his office staff
that they didn't need to save them.
DI Anderson also conducted the investigation of Respondent's
application for a new DEA registration. As part of the investigation,
DI Anderson interviewed Respondent regarding his guilty pleas in the
Federal criminal proceeding. Respondent told Anderson that he had pled
guilty because a government witness was going to give false testimony
against him. Tr. 231.
Respondent's Testimony
A. Respondent's Prior Use of Controlled Substances
Respondent testified at the hearing. Respondent stated that he had
smoked marijuana occasionally while attending college and medical
school and admitted to further use during his initial years as a
physician from 1976 to 1979. Respondent claimed that he ``rarely''
purchased marijuana and that most of the marijuana was donated to him.
Tr. 439. When questioned as to how patients had become aware that
Respondent would accept these ``donations,'' Respondent testified that
his patients ``bring wild parsley. They bring a dozen * * * brown eggs.
They bring apples. I have patients that will bring apple pies, pecan
pies.'' Id. at 468. Respondent denied that his patients gave him
marijuana as payment and testified that they were ``[j]ust grateful
patients in various ways.'' Id. Respondent further testified that he
had stopped using marijuana in 1979, but that he had continued to
accept marijuana donations from his patients, which he then gave to his
oldest daughter. Id. at 472-473.
Respondent also testified that he took Quaaludes from 1977 to 1979
as a prescribed treatment for insomnia. Respondent testified that he
took all of the Quaaludes that were prescribed to him and denied
sharing them with other patients. Id. at 437-38. As for the Quaaludes
seized during the search, Respondent testified that they had ``expired
by [1986 or 1987], and have been in that bag since that time. I can
assure you that I didn't know they were in there or they would have
been put to use.'' Id. at 279.
Initially, Respondent denied using cocaine during the 1976-1983
time period. Id. at 437. Later, on cross-examination, Respondent
admitted to having used cocaine ``[o]n one or two rare occasions''
during the 1976-1983 time period, and then testified to having used
cocaine a ``[h]alf a dozen'' times during the period.Id. at 475.
Respondent subsequently testified that the empty bottles of cocaine
hydrochloride that were seized in the search were provided to him by
several pharmacies and that he kept them because he collects old
medical supplies. Id. at 513. Relatedly, Respondent similarly claimed
that some of the Quaaludes ``was a relic of old-timey medicine,'' which
``was given to me by a pharmacist'' for his bottle collection. Id. at
515-18.
The Government then turned to the 1983 to 2000 time period, during
which Respondent maintained his practice at North Park Hospital. Here
again, Respondent initially denied using controlled substances. Id. at
478. Respondent, however, then admitted to marijuana use ``[o]n rare
occasions. Off duty. Out of town.'' Id. Respondent testified that he
received the marijuana from patients and friends. Id. at 481. The ALJ
further found that Respondent had smoked marijuana with his office
staff one afternoon after work. As for the marijuana seized during the
search of Respondent's office and residence, Respondent testified that
it was ``[f]or occasional personal use when very tired and needing to
relax.'' Id. at 343.
B. The Criminal Investigation and Guilty Plea
On direct examination, Respondent testified that he had never
illegally given controlled substances to any of the persons referenced
in the search warrant affidavit, which had listed Beth Harvey. Id. at
263. He further testified on direct that he only prescribed controlled
substances for legitimate medical reasons and this was reflected in
patient records. Id. at 263-64. He further asserted that Harvey had
sought treatment for ``frequent headaches and anxiety attacks,'' id. at
270, and that he had prescribed hydrocodone products to treat her
headaches.\4\ Id. at 501; 535. Respondent denied that he had sold
hydrocodone to Harvey and asserted that the money he had received from
her was payment for the services he provided in treating her. Id. at
502-03.
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\4\ The record indicates that Respondent also gave Harvey
hormone replacement shots. Tr. at 271. It is undisputed that the
shots were given for a legitimate medical reason.
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Respondent further denied that he entered into the arrangement with
Harvey to sell diazepam and receive a share of the profits. Id. at 504-
05. Instead, he asserted that the scheme was just ``Beth Harvey
talking.'' Id. at 505. While Respondent admitted that on October 28,
1997, he had given Harvey a one-thousand count Valium bottle, which
then contained ``about 250 or 300 out of date diazepam'' pills, he
maintained that he did so ``for her to use for her anxiety and
nerves.'' Id. at 530.\5\ Respondent further testified that he was
unaware that Harvey was selling the Valium until the police searched
his office on January 8, 1998. Id. at 541. When specifically asked by
the Government whether Harvey ``all along was telling you that she was
reselling the drugs,'' Respondent answered: ``No, it's not a fact. At
that point, I should have known that that was the case, but I didn't.''
Id. at 542.
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\5\ The ALJ also found that ``Respondent denied providing Lortab
to Beth Harvey, instead testifying that she `helped herself in my
drawer before I started locking it up.' '' ALJ at 11 (quoting Tr. at
506). The cited testimony, however, refers to whether Respondent
provided Lortab to one of his employees, Sherry Millard. I thus do
not accept this finding.
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With respect to his guilty plea, Respondent testified that he was
``a hundred percent guilty.'' Id. at 273. Respondent acknowledged,
however, his statement to DI Anderson that he had pled guilty because
he expected ``false testimony against me,'' and that he feared that he
could have been sent to prison. Id. at 342. Respondent then testified
that he was not attempting to deny his guilt.
Respondent further testified that following his arrest, he had not
used marijuana. Moreover, Respondent had entered into a program run by
the Tennessee Medical Foundation that helps physicians address drug and
alcohol dependency. Respondent has also been subjected to random drug
tests and passed each one. He has also attended 200 hours of continuing
medical education and a three-day course at Vanderbilt University on
the prescribing and record keeping of controlled substances.
[[Page 35708]]
Respondent's Character Evidence
At the hearing, Respondent produced four character witnesses. The
first, Stan Lanzo, was a former state prosecutor who had known
Respondent for twenty-five years. Mr. Lanzo acknowledged, however, that
Respondent was ``[n]ot a real close friend,'' id. at 366, that he
probably had ``said ten words to him in the last five years,'' id. at
373, and was not aware of Respondent's illegal conduct prior to his
guilty plea. Id. at 375-76.
Larry Young, another former state prosecutor also testified for
Respondent. Mr. Young testified that he and Respondent ``were casual
friends,'' id. at 430, and that he was unaware of the specific facts
pertaining to Respondent's illegal distribution and his self-abuse of
controlled substances. Id. at 430-31.
Walter Puckett, M.D., testified that he had known Respondent from
the time when the latter worked as a pharmaceutical sales
representative and had encouraged Respondent to go to medical school.
Dr. Puckett further testified that he had not maintained a social
relationship with Respondent and did not know the specifics of
Respondent's guilty plea.
Timothy Davis, M.D., the regional area monitoring physician for the
Tennessee Medical Foundation, also testified on Respondent's behalf.
Dr. Davis testified that Respondent had entered into a contract to
attend weekly support group meetings, that he attended eighty-five
percent of the meetings, and that Respondent informed him when he could
not make a meeting. On cross-examination, Dr. Davis testified that he
did not ``have any particular knowledge of the [criminal] offenses,''
id. at 459, and that Respondent had not brought up the subject of his
illegal distribution of controlled substances at the support group
meetings. Id. at 462.\6\
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\6\ Respondent also submitted numerous letters of support from
patients.
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Discussion
The Controlled Substances Act 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 Act 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.
``[T]hese factors are * * * considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or
combination of factors, and may give each factor the weight [I] deem[]
appropriate in determining whether * * * an application for
registration [should be] denied.'' Id. In this matter, I have carefully
considered Respondent's evidence concerning his rehabilitation. But as
explained below, having reviewed the evidence I reach the same
conclusion the ALJ did--that Respondent still does not accept
responsibility for his criminal conduct and cannot be entrusted to
properly comply with the requirements of Federal law.
Factor One--The Recommendation of the State Licensing Board
I acknowledge that the Tennessee Board of Medical Examiners has
restored Respondent's state license to unencumbered status. It is well
established, however, that a ``state license is a necessary, but not
sufficient condition for registration,'' and thus this factor is not
dispositive. Id. Indeed, in light of the evidence adduced at the
hearing, and in particular Respondent's disingenuous testimony on
several issues (which will be discussed below), I decline to give this
factor any weight at all.
Factor Two--Respondent's Experience in Handling Controlled Substances
Respondent's experience in handling controlled substances can only
be described as abysmal. Among other things, the record shows that
Respondent illegally possessed both marijuana and Quaaludes
(methaqualone), two Schedule I controlled substances. Even were I to
give Respondent the benefit of the doubt and find that he had obtained
some of the Quaaludes pursuant to a lawful prescription, the drugs had
been banned in 1984, more than thirteen years earlier. Moreover, were I
to credit Respondent's explanation that he had accepted some of the
Quaaludes for his bottle collection--an assertion about which the ALJ
made no credibility finding--Respondent still violated federal law. One
would think that at some point contemporaneous with DEA's rescheduling
of the drug--preferably no later than the date by which all stocks were
required to be surrendered, see 49 FR 33870 (1984)--Respondent would
have properly disposed of these drugs, which were then determined to
have no legitimate medical use.
The record further indicates that Respondent provided controlled
substances to Harvey for no legitimate medical purpose on multiple
occasions. Respondent distributed large amounts of diazepam, a Schedule
IV controlled substance, to Harvey on two occasions. On the first,
October 28, 1997, Respondent gave Harvey 250 to 300 diazepam pills.
While Respondent testified that this distribution was ``for her to use
for her anxiety and nerves,'' the ALJ did not make a credibility
finding regarding this testimony. Based on the fact that Respondent
made no record of the dispensing, the testimony of Detective Parton
that Harvey told him that she was to sell the drugs and return a
portion of the profits to Respondent, and Respondent's acceptance of
several cash payments from Harvey as his share of the profits, I
conclude that there was no legitimate medical reason for the dispensing
and that Respondent's testimony was a fabrication.
On the second occasion, December 9, 1997, Respondent gave Harvey a
sealed 1,000 count bottle of diazepam, with the intent that Harvey sell
the drugs and return a share of the profits to him. Respondent pled
guilty to this count of the indictment and admitted in his post-hearing
brief that there was ``no legitimate medical purpose'' for the
dispensing. Respondent's Proposed Findings, at 23.
Respondent also provided Harvey with Lortab, Vicoprofen, and
Zydone, products which contain Hydrocodone, a Schedule III controlled
substance on three separate dates (November 10, November 19, and
December 18, 1997). While Respondent testified that he did so to treat
Harvey's headaches, the progress notes again contain no indication of
either a diagnosis or dispensing on any of these dates. Indeed, the
progress notes do not even indicate that Harvey saw Respondent on these
dates. Moreover, the evidence indicates that on at least one occasion,
the November 10, 1997 visit, Harvey paid Respondent for the drug. I
thus conclude that there was no legitimate medical reason for each of
these dispensings.
Finally, I note that Respondent committed numerous other violations
of the CSA. The record establishes that Respondent failed to keep
records of the receipt and dispensing of controlled
[[Page 35709]]
substances, including invoices for the receipt of controlled
substances, a biennial inventory, and a dispensing log. See 21 CFR part
1304. Finally, Respondent kept controlled substances at his home, which
was not a registered location. Id. Sec. 1301.12.
Respondent testified that he first became aware of the record
keeping requirements on January 8, 1998, during the search of his
office. Tr. 488. At that point, Respondent had been a practicing
physician for more than twenty years. Not only is ignorance of the law
no excuse, but someone possessing the considerable intelligence
required to become a physician ought to have some inkling that
compliance with the CSA involves more than just paying a fee and
obtaining a registration. Indeed, that the CSA imposes on practitioners
a variety of recordkeeping, prescribing and security requirements
should be obvious to every applicant for a registration.
For all of the reasons set forth above, I find that factor two
provides substantial support for the conclusion that granting
Respondent's application would be inconsistent with the public
interest.
Factor Three--Respondent's Conviction Record Relating to Controlled
Substances
The record establishes that Respondent has been convicted of two
violations of the CSA. Specifically, Respondent plead guilty to the
unlawful distribution of diazepam, in violation of 21 U.S.C.
841(b)(1)(D), and the unlawful possession of marijuana, in violation of
21 U.S.C. 844. This factor thus supports a finding that granting
Respondent's application would be inconsistent with the public
interest.
Factor Four--Respondent's Compliance With Applicable State and Federal
Controlled Substances Laws
I incorporate the discussion above under factor two with respect to
Respondent's unlawful activities in distributing controlled substances,
as well as his failure to maintain required records. He also kept
controlled substances at his home, a non-registered location. Cf. 21
CFR 1301.12.
I also note that Respondent admitted to past use of both marijuana
and cocaine, and that the police found marijuana during the searches of
both Respondent's office and home. Furthermore, during the search of
Respondent's home, the police found marijuana paraphernalia including a
metal tray, a bong, two pipes with residue, and rolling papers.
Moreover, during the search of Respondent's office, the police found a
cocaine kit consisting of a mirror, razorblades, and straw.
Respondent's possession of drug-related paraphernalia at the time of
the search suggests that Respondent continued his use of these drugs
beyond the period which he admitted to. The record thus contains
substantial evidence establishing numerous instances in which
Respondent failed to comply with applicable laws. This factor thus
supports a finding that granting Respondent's application would be
inconsistent with the public interest.
Factor Five--Other Conduct That May Threaten Public Health and Safety
Under DEA precedents, an applicant's acceptance of responsibility
for his prior misconduct is a highly relevant consideration under this
factor. See Barry H. Brooks, 66 FR 18305, 18309 (2001); Prince George
Daniels, D.D.S., 60 FR 62884, 62887 (1995); Carmel Ben-Eliezer, M.D.,
58 FR 65400, 65401 (1993). As the ALJ observed, there were a number of
material inconsistencies in Respondent's testimony regarding his prior
drug abuse, specifically his use of cocaine. Respondent initially
denied using cocaine during the 1976 to 1983 period, Tr. at 437, then
admitted using it on ``one or two rare occasions,'' and then changed
his story again, acknowledging that he used it a ``half a dozen'' times
during that period. Id. at 475. While Respondent denied cocaine usage
following this period, I am perplexed as to why Respondent would have
in his possession the paraphernalia used to snort cocaine fifteen years
after he supposedly stopped using the drug, or why he would have 13
empty bottles of pharmaceutical grade cocaine at his residence. Surely
one or two empty bottles would have sufficed for his collection.
Respondent also testified that he obtained marijuana from
``grateful patients'' as ``donations.'' Id. at 468. It is strange that
some patients brought Respondent eggs, or apples or pies, while others
knew enough to bring him marijuana. Indeed, in light of the fact that
possession of marijuana is a criminal offense, it is odd that a DEA
registrant would accept such a ``donation,'' even if he did not intend
to personally use it, but instead, give it to his oldest daughter.
In concluding that Respondent refuses to accept responsibility for
his conduct, I find particularly significant his testimony regarding
the various distributions of controlled substances to Harvey during the
1997-1998 time period. While Respondent admitted that the December 9,
1997, distribution of diazepam was a criminal act, he testified that
the other distributions of diazepam and hydrocodone products were for
legitimate medical reasons.
At the outset, I note that this is not simply a matter of ``he
said, she said.'' Rather, there is substantial corroborating evidence
that demonstrates that the other distributions were not for legitimate
medical reasons. As explained above under factor two, the progress
notes contain no record of the visits during which Respondent provided
Harvey with hydrocodone products, let alone a diagnosis of Harvey's
condition or a record of the dispensing.
As for the Valium, the record shows that Respondent accepted
substantial cash payments from Harvey, which Harvey represented as
being his share of the profits from the Valium sales. These payments
occurred on three separate dates following the October 28, 1997
distribution of Valium and before Harvey left the office on December 9,
1997, with a new supply. While Harvey's wire did not work on the first
date (November 10), it did work during the second (November 19), and
third (December 9) visits.
According to the transcripts, during the November 19th visit,
Respondent told Harvey ``I don't want to get in deeper, you know,'' and
then agreed to order the second bottle of Valium. Gov. Exh. 3a at 12.
During the December 9th visit, Respondent stated: ``No, no, sell them.
Hell, medicine is to sell not to take.'' Gov. Exh. 3(C) at 33. He then
told Harvey: ``[D]on't let anybody know where any of this stuff is
coming from.'' Id. And later in the conversation, Respondent told
Harvey that he had 1,000 Xanax and asked her to ``[l]ine me up somebody
that can [sell] it.'' Id. at 35. These are not the conversations that
occur in the normal course of doctor-patient relations. Rather, they
are the words of a drug dealer.
I thus concur with the ALJ's conclusion that Respondent's
assertions that he provided the various drugs for legitimate medical
reasons are disingenuous. I also agree with the ALJ's conclusion that
Respondent refuses to accept responsibility for his misconduct. I
further find that Respondent's refusal to accept responsibility greatly
outweighs his efforts at rehabilitation. Therefore, I conclude that
factor five supports a finding that granting Respondent's application
would threaten public health and safety. See 21 U.S.C. 823(f)(5).
Having considered all of the statutory factors, I concluded that
Respondent cannot be entrusted with a DEA registration.
[[Page 35710]]
Order
Accordingly, pursuant to the authority vested in me by 21 U.S.C.
823(f) and 28 CFR 0.100(b) and 0.104(b), I hereby order that
Respondent's application for a DEA Certificate of Registration be, and
it hereby is, denied. This order is effective July 21, 2006.
Dated: June 12, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-9706 Filed 6-20-06; 8:45 am]
BILLING CODE 4410-09-P