John H. Kennnedy, M.D.; Denial of Application; Introduction and Procedural History, 35705-35710 [E6-9706]
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Federal Register / Vol. 71, No. 119 / Wednesday, June 21, 2006 / Notices
Here, it is clear that Dr. Evans’s dental
license has been revoked and the
revocation order has not been vacated.
Consequently, Dr. Evans is not licensed
to handle controlled substances in
California, the jurisdiction in which he
is registered with DEA. Therefore, he is
not entitled to maintain that
registration.
Order
The Deputy Administrator of the Drug
Enforcement Administration, pursuant
to the authority vested in her by 21
U.S.C. 823 and 824 and 28 CFR 0.100(b)
and 0.104, hereby orders that DEA
Certificate of Registration, BE3323932,
issued to Mark C. Evans, D.D.S, be, and
it hereby is, revoked. The Deputy
Administrator further orders that any
pending applications for renewal or
modification of the aforementioned
registration be, and they hereby are,
denied. This order is effective July 21,
2006.
Dated: June 12, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6–9708 Filed 6–20–06; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 02–47]
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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. § 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.
§ 841(a)(1),1 and one count alleging the
unlawful possession of marijuana. See
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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id. § 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.
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.
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35705
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
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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 crossexamination, 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.
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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
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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physical exam and there was no
therapeutic purpose for the dispensing.
Furthermore, Harvey’s progress notes
contain no record of the visit.
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
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the visit on Harvey’s progress notes.3 See
Gov. Exh. 14.
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 handrolled 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
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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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.
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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
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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 crossexamination, 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 oldtimey 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
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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.
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.
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.
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.
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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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 twentyfive 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
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.
6 Respondent also submitted numerous letters of
support from patients.
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(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
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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 posthearing 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
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Federal Register / Vol. 71, No. 119 / Wednesday, June 21, 2006 / Notices
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. § 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.
jlentini on PROD1PC65 with NOTICES
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
VerDate Aug<31>2005
18:26 Jun 20, 2006
Jkt 208001
consisting of a mirror, razorblades, and
straw. Respondent’s possession of drugrelated 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 BenEliezer, 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
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Frm 00103
Fmt 4703
Sfmt 4703
35709
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 doctorpatient 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.
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35710
Federal Register / Vol. 71, No. 119 / Wednesday, June 21, 2006 / Notices
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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
jlentini on PROD1PC65 with NOTICES
McBride Marketing; Revocation of
Registration
On October 13, 2004, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause proposing to revoke
McBride Marketing’s (Respondent) DEA
Certificate of Registration, 002748MMY,
as a distributor of List I chemicals and
to deny any pending applications for
renewal. As grounds for the action, the
Show Cause Order alleged that
Respondent’s continued registration
would be inconsistent with the public
interest. See 21 U.S.C. 824(a)(4).
Specifically, the Show Cause Order
alleged, inter alia, that Respondent did
not have adequate security to protect
List I chemical products from diversion,
that Respondent did not maintain
adequate sales records in accordance
with 21 CFR 1310.06, that Respondent
had product shortages, and that
Respondent had been acquiring and
distributing pseudoephedrine products
even though it was not registered to do
so.
The Show Cause Order was sent by
certified mail, return receipt requested,
to Respondent’s registered location and
receipt was acknowledged on October
20, 2004. Neither Respondent, its
owner, nor anyone else purporting to
represent it has responded. Because (1)
more than thirty days have passed since
the receipt of the Show Cause Order,
and (2) no request for a hearing has been
received, I conclude that Respondent
has waived its right to a hearing. See 21
CFR 1309.53(c). I therefore enter this
final order without a hearing based on
relevant material in the investigative file
and make the following findings.
Findings
Ephedrine and pseudoephedrine are
List I chemicals that while having
therapeutic uses, are easily extracted
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18:26 Jun 20, 2006
Jkt 208001
from lawful products and used in the
illicit manufacture of
methamphetamine, a schedule II
controlled substance. See 21 U.S.C.
802(34). As noted in numerous prior
DEA orders, ‘‘methamphetamine is an
extremely potent central nervous system
stimulant.’’ A–1 Distribution Wholesale,
70 FR 28573 (2005). Methamphetamine
abuse has destroyed lives and families,
ravaged communities, and created
serious environmental harms.
Methamphetamine abuse is an
especially serious problem in
Tennessee, the State in which
Respondent’s business is located. At the
time of the issuance of the Show Cause
Order, Tennessee led the Southeast in
clandestine lab seizures, accounting for
approximately 59% of these seizures
during the second quarter of 2004.
Moreover, in enacting the Meth-Free
Tennessee Act of 2005, the Tennessee
legislature found that as a result of these
seizures, ‘‘more than 700 children are
entering state custody each year.’’ 2005
Tennessee Laws Pub. Ch. 18 (Preamble).
Respondent is an unincorporated
firmed owned by Mr. Bobby McBride.
The firm, which is located at the
McBrides’ home in Parsons, Tennessee,
has held a DEA registration to distribute
ephedrine products since 1998.
Respondent has approximately 58
convenience store and gas stations
customers which purchase listed
chemical products. Although
Respondent also sells novelty items and
toys, listed chemicals account for 30%
of its business.
On February 26, 2004, two DEA
Diversion Investigators (DIs) visited
Respondent to conduct a regulatory
investigation. They met with Nancy
McBride, the owner’s wife and
Respondent’s bookkeeper, presented her
with their credentials and a notice of
inspection, and obtained Respondent’s
consent to the inspection.
During the inspection, the DIs
determined that Respondent stored
listed chemical products in two minivans. While the vans were kept locked
at all times, the vehicles did not have
alarm systems.
The DIs also conducted an inventory
and audit of Respondent’s ephedrine
products. In reviewing the records, the
DIs determined that while Respondent’s
sales records included the purchaser’s
name, product description and quantity,
the records did not contain the brand
name of the products, price, or the
customer’s address. Therefore, in
conducting the audit, the DIs were
required to group products together
based on package size. Moreover, while
Respondent’s owner claimed that he
conducted a physical inventory each
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Frm 00104
Fmt 4703
Sfmt 4703
January, the record for January 2003
could not be found. The DIs thus used
the record for the January 2004
inventory as the beginning inventory
and conducted an accountability audit
covering the period of January 1, 2004,
through February 26, 2004.
The DI’s audit found shortages in both
the sixty-count bottles and six-count
package sizes. Notwithstanding the
relatively short period of the audit, 70
sixty-count bottles and 380 six-count
packages were unaccounted for. The DIs
also found in Respondent’s inventory
several pseudoephedrine products,
including four boxes of Tylenol Allergy
Sinus (with each box containing 50
sealed packets of one caplet), three
boxes of Aleve Cold and Sinus (with
each box containing 50 sealed packets of
two gel caps), and one box of Vick’s
Nyquil Liquicaps (with the box
containing 25 packets of two caplets).
Respondent, however, was not
registered to distribute pseudoephedrine
products. The DIs confirmed that
Respondent had been selling
pseudoephedrine products based on
their review of sales records and
interviews they conducted during
customer verification visits.
Discussion
21 U.S.C. 824(a) provides that a
registration to distribute List I chemical
may be suspended or revoked ‘‘upon a
finding that the registrant * * * has
committed such acts as would render
[its] registration under section 823 of
this title inconsistent with the public
interest as determined under [that]
section.’’ In making the public interest
determination, the Controlled
Substances Act requires the
consideration of the following factors:
(1) Maintenance by the [registrant] of
effective controls against diversion of listed
chemicals into other than legitimate
channels;
(2) Compliance by the [registrant] with
applicable Federal, State, and local law;
(3) Any prior conviction record of the
[registrant] under Federal or State laws
relating to controlled substances or to
chemicals controlled under Federal or State
law;
(4) Any past experience of the applicant in
the manufacture and distribution of
chemicals; and
(5) Such other factors as are relevant to and
consistent with the public health and safety.
Id. 823(h).
‘‘[T]hese factors are considered in the
disjunctive.’’ Joy’s Ideas, 70 FR 33195,
33197 (2005). I ‘‘may rely on any one or
combination of factors, and may give
each factor the weight [I] deem[]
appropriate in determining whether a
registration should be revoked or an
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21JNN1
Agencies
[Federal Register Volume 71, Number 119 (Wednesday, June 21, 2006)]
[Notices]
[Pages 35705-35710]
From the Federal Register Online via the Government Printing 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.
---------------------------------------------------------------------------
\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.
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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.
---------------------------------------------------------------------------
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