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John H. Kennnedy, M.D.; Denial of Application; Introduction
and Procedural History
FR Doc E6-9706 [Federal Register: June 21, 2006 (Volume 71, Number
119)] [Notices] [Page 35705-35710] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr21jn06-141]
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.
\1\ Three of the counts alleged the unlawful
distribution of dihyrdocodeine; two of the counts alleged the unlawful
distribution of diazepam.
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.
\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.
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.
\3\ The progress notes do, however, contain a record
of a visit on December 22, 1997, which shows a dispensing of 30 Lortab
tablets.
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.
\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.
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.
\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.
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\
\6\ Respondent also submitted numerous
letters of support from patients.
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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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