Steven M. Abbadessa, D.O.; Grant of Restricted Registration, 10077-10083 [E9-4906]
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Amphetamine (1100) ...................................................................................................................................................................................
Methamphetamine (1105) ...........................................................................................................................................................................
Methylphenidate (1724) ...............................................................................................................................................................................
Amobarbital (2125) ......................................................................................................................................................................................
Pentobarbital (2270) ....................................................................................................................................................................................
Secobarbital (2315) .....................................................................................................................................................................................
Phencyclidine (7471) ...................................................................................................................................................................................
Phenylacetone (8501) .................................................................................................................................................................................
Cocaine (9041) ............................................................................................................................................................................................
Codeine (9050) ............................................................................................................................................................................................
Dihydrocodeine (9120) ................................................................................................................................................................................
Oxycodone (9143) .......................................................................................................................................................................................
Hydromorphone (9150) ...............................................................................................................................................................................
Benzoylecgonine (9180) ..............................................................................................................................................................................
Ethylmorphine (9190) ..................................................................................................................................................................................
Meperidine (9230) .......................................................................................................................................................................................
Methadone (9250) .......................................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) (9273) ..............................................................................................................................
Morphine (9300) ..........................................................................................................................................................................................
Oripavine (9330) ..........................................................................................................................................................................................
Thebaine (9333) ..........................................................................................................................................................................................
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Oxymorphone (9652) ...................................................................................................................................................................................
Fentanyl (9801) ...........................................................................................................................................................................................
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The company plans to import small
quantities of the listed controlled
substances for the manufacture of
analytical reference standards.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a)
and determined that the registration of
Cerilliant Corporation to import the
basic classes of controlled substances is
consistent with the public interest, and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971, at
this time. DEA has investigated
Cerilliant Corporation to ensure that the
company’s registration is consistent
with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 952(a)
and 958(a), and in accordance with 21
CFR 1301.34, the above named company
is granted registration as an importer of
the basic classes of controlled
substances listed.
Dated: March 4, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–4945 Filed 3–6–09; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 06–78]
Steven M. Abbadessa, D.O.; Grant of
Restricted Registration
On August 7, 2006, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Steven M. Abbadessa,
D.O. (Respondent), of St. Louis,
Missouri. The Show Cause Order
proposed the denial of Respondent’s
pending application for a DEA
Certificate of Registration as a
practitioner, on the ground that his
‘‘registration would be inconsistent with
the public interest.’’ Id. at 1 (citing 21
U.S.C. 823(f)).
The Show Cause Order specifically
alleged that ‘‘[o]n or about January 1981,
[Respondent] illegally possessed and
distributed * * * cocaine in violation of
21 U.S.C. 841(a)(1),’’ that Respondent
was subsequently charged and arrested,
and that he had admitted to agents that
he had been involved ‘‘in the illegal
distribution of cocaine, a schedule II
controlled substance,’’ but that ‘‘no
further prosecution was undertaken’’
because he cooperated with authorities.
Id.
The Show Cause Order next alleged
that on December 4, 2001, Respondent
was arrested by local police at a hotel
in Clayton, Missouri, where he was
found to have in his possession cocaine,
as well as two prescription controlled
substances—a combination drug
containing hydrocodone, a schedule III
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controlled substance, and alprazolam, a
schedule IV controlled substance. Id.
The Order further alleged that the
hydrocodone and the alprazolam ‘‘had
been dispensed in the name of an
acquaintance’’ of Respondent. Id.
Relatedly, the Show Cause Order
alleged that Respondent was
subsequently indicted in state court on
one felony count of possession of
cocaine, and two felony counts of
obtaining controlled substances by
fraud. Id. The Order further alleged that
on January 31, 2003, Respondent pled
guilty to all three counts, but that he
was allowed to withdraw his pleas after
he completed a ‘‘one-year drug
program.’’ 1 Id. at 1–2.
Respondent, through his counsel,
requested a hearing on the allegations.
ALJ Ex. 2. The matter was assigned to
Administrative Law Judge (ALJ) Gail
Randall, who conducted a hearing in St.
Louis, Missouri, on May 15 and 16,
2007. At the hearing, both the
Government and Respondent put on
testimony and introduced documentary
evidence into the record. Following the
hearing, both parties submitted briefs
containing their proposed findings of
fact, conclusions of law, and argument.
On February 13, 2008, the ALJ issued
her recommended decision (ALJ). In her
decision, the ALJ concluded that the
1 The Order also noted that on March 10, 2003,
Respondent had surrendered his DEA registration,
that in February 2004, the Missouri State Board for
the Healing Arts had entered into a settlement
agreement with Respondent under which his
medical license was placed on probation for seven
years, and that in April 2006, Respondent’s state
controlled substances registration had been
restored. Id. at 1–2.
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Government had established grounds for
the denial of Respondent’s application.
ALJ at 55. The ALJ held, however, that
Respondent had accepted responsibility
for his misconduct and had ‘‘provided
ample mitigating evidence and adequate
assurances that he is able to responsibly
handle [controlled substances] and is
willing to abide by restrictions and/or
requirements placed upon him.’’ Id. at
57. The ALJ thus recommended that
Respondent’s application be granted
subject to three restrictions. Id.
Thereafter, the Government filed
exceptions to the ALJ’s decision.
Having considered the entire record
in this matter, I adopt the ALJ’s
recommended decision except for her
conclusions regarding the hardship
imposed by Respondent’s lack of a
registration, which is not a relevant
consideration under the Controlled
Substances Act. I hold that while the
Government made out a prima facie
case to deny the application,
Respondent has convincingly
demonstrated that he can be entrusted
with a new registration subject to
conditions. However, I impose
additional conditions beyond those
recommended by the ALJ. I therefore
reject the Government’s exceptions and
will grant Respondent a new registration
subject to the conditions as set forth
below. I make the following findings.
Findings
Respondent is a Doctor of Osteopathy
(D.O.) and a board-certified proctologist.
Respondent holds a license as an
Osteopathic Physician and Surgeon
from the Missouri State Board of
Registration for the Healing Arts. RX 16,
at 25. Effective February 9, 2004,
Respondent’s state license was placed
on probation for a period of seven years.
Id. Respondent also held a DEA
Certificate of Registration from 1987
until he surrendered it on March 7,
2003. GX 4.
Respondent is, however, currently
authorized to practice medicine subject
to numerous conditions. These include,
inter alia: (1) That he ‘‘abstain
completely from the personal use or
possession of controlled substances
* * * unless that use of the drug has
been prescribed by a person licensed to
prescribe such drug and with whom [he]
has a bona fide physician/patient
relationship,’’ RX 16, at 26; (2) that he
participate in the Missouri State
Medical Association’s Physician Health
Program (MPHP), id. at 25–26; (3) that
he completely abstain from the use of
alcohol, id. at 27; (4) that he ‘‘submit to
biological fluid testing’’ at his own
expense and that the presence of any
drug not supported by a valid
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prescription which had been submitted
to the Board is a violation of his
discipline, id.; (5) that he ‘‘cause a letter
of evaluation from [a] chemical
dependency professional or from the
rehabilitation or aftercare program to be
submitted to the Board’’ each quarter,
id.; and (6) that he agree to
‘‘unannounced visits from the Board’s
representatives to monitor his
compliance with’’ the agreement. Id. at
28.
On November 10, 2003, Respondent
applied for a new Missouri Controlled
Substance Registration, his previous
state registration having lapsed on
March 31, 2003. GX 10, at 6. On August
24, 2004, the Missouri Bureau of
Narcotics and Dangerous Drugs (BNDD)
denied Respondent’s application and
issued an administrative complaint.2 Id.
On April 6, 2005, Respondent and the
State entered into a stipulation and
consent order under which Respondent
acknowledged that the State had
‘‘sufficient evidence’’ to support the
allegations of the denial letter and that
cause existed to deny Respondent’s
application. Id. The parties agreed,
however, that Respondent would accept
the State’s denial of his application, but
that the State would consider a new
application on or after January 1, 2006,
and would grant the application
provided that he did not commit new
violations of controlled-substance laws
and regulations and complied with his
agreements with the state medical board
and the Missouri Physicians Health
Program. Id. at 8.
On or about January 5, 2006,
Respondent submitted a new
application for a state controlled
substances registration. GX 11, at 3. On
April 3, 2006, Respondent and the State
entered into a settlement agreement
under which Respondent again agreed
that cause existed under Missouri law to
deny his application. Id. at 3–4. The
parties agreed, however, that the State
would grant him a new registration
subject to extensive probationary terms.
Id. at 4.
The terms included, inter alia: (1)
That Respondent maintain duplicate
copies of ‘‘serially numbered’’
prescriptions and that copies be
‘‘maintained separately from each
patient’s charts,’’ (2) that Respondent
‘‘not prescribe or administer controlled
substances for himself, his immediate
family or his employees except in a lifethreatening emergency,’’ (3) that
Respondent ‘‘not order, purchase, or
accept controlled substances,’’ (4) that
Respondent ‘‘not obtain’’ any controlled
2 The incident which prompted the denial (and
this proceeding) is discussed below.
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substance unless it is prescribed to him
by a practitioner with whom he ‘‘has a
legitimate practitioner-patient
relationship,’’ and that he inform any
treating practitioner ‘‘of his prior
chemical dependence before he is given
a prescription,’’ (5) that Respondent
ensure that any prescribing practitioner
notify the BNDD of any prescription that
was issued to him including the medical
purpose of the prescription, (6) that
Respondent shall remain a member of
MPHP and ensure that quarterly reports
were released to the BNDD, (7) that the
BNDD ‘‘shall have authority to obtain
biological * * * and hair samples’’ at
Respondent’s expense, and (8) that both
state and DEA investigators ‘‘shall have
access to all required controlled drug
records at any time during regular office
hours.’’ Id. at 4–6. Respondent was thus
granted a new state controlled substance
registration; the probationary terms
remain in effect until April 3, 2011. Id.
at 1.
Respondent’s Drug-Related Incidents
The 1981 Incident
In 1981, DEA Agents in Kirksville,
Missouri, were notified by an informant
that Respondent was a ‘‘large cocaine
dealer.’’ Tr. 51. Through the informant,
a meeting was arranged at which an
Agent posed as someone interested in
buying cocaine from Respondent. Id. at
52–53. Respondent told the Agent that
he could supply him with ‘‘two to three
ounces of cocaine’’ and gave him a
sample to test. Id. at 52. Respondent
wanted money upfront, but the Agent
refused to provide it. Id. Respondent
and the Agent ended the meeting by
agreeing to meet at a later date. Id. at 53.
The following day, Respondent and
the Agent had a telephone conversation
during which the former told the latter
that he could get him ‘‘all the cocaine
he wanted,’’ which he thought was
‘‘three or four ounces.’’ GX 3, at 2.
Respondent did not, however,
consummate a deal with the Agent. Id.
Respondent did not hear again from the
Agent for several weeks, when the latter
called and told Respondent that he had
some marijuana and cocaine for sale and
asked if Respondent would ‘‘take it on
consignment.’’ Id.
Respondent agreed to meet the Agent.
Id. Upon his arrival at the meeting,
Respondent was arrested and charged
with cocaine distribution. Id.
Respondent cooperated with the
authorities; as a result of his
cooperation, two other persons were
arrested. Tr. 99. Because of his
cooperation, Respondent’s case was
sealed and he was not convicted of an
offense. Id. at 98–99.
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The 1992 Incident
In 1992, Respondent was treated for
headaches by a neurologist, who
prescribed Vicodin to him. Tr. 255–56.
When Respondent continued to seek
refills of the Vicodin over a sustained
period of time, the neurologist raised
with him the subject of whether he was
addicted. Id. at 256. Respondent agreed
to contact the MPHP and underwent an
in-patient evaluation which lasted seven
to eight days. Id. Upon being
discharged, Respondent participated in
the MPHP program for approximately
six years, during which he attend
weekly Caduceus meetings and
submitted to drug testing. Id. at 259.
Respondent left the program in 1998,
thinking that he ‘‘was okay.’’ Id. at 260.
While Respondent was fine for a little
while, he eventually started drinking
again and then abusing drugs again. Id.
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The 2001 Incident
On December 4, 2001, an employee of
a Ritz-Carlton hotel located in Clayton,
Missouri contacted local police and
reported that he had observed cocaine
in the room in which Respondent was
staying. Id. at 14–15. Upon their arrival,
the police went to Respondent’s room,
knocked on the door, and were let in by
a cab driver named Rodney. Id. at 16.
Respondent walked out of the bedroom
area, observed the officers who were in
uniform, and ran back into the bedroom.
Id. at 16–17. The officers pursued
Respondent and subdued him. Id. at 17.
On a table, the officers found a bag
containing 14.38 grams of cocaine, a
black plastic container which held
seven-tenths of a gram of cocaine, and
assorted paraphernalia used to prepare
and snort the drug such as plates,
straws, a calling card and a credit card.
Id. at 18.
The officers also seized two
prescription drug vials; one contained
thirty-seven tablets of hydrocodone, the
other contained forty-one tablets of
alprazolam. Id. at 18–19. The labels on
the vials listed Rodney as the patient
and Respondent as the prescriber (and
included his DEA number); the
quantities dispensed were forty tablets
of hydrocodone and forty-two tablets of
alprazolam. Id. Respondent was
subsequently arrested and taken to the
police station for booking. Id. at 22.
Rodney told the police that he had
first met Respondent two days earlier
when he drove him from a restaurant to
his home; on that occasion, Respondent
had asked Rodney for his business card
because he was having car problems. Id.
at 20–21. Upon meeting Respondent on
December 4th, Respondent told Rodney
that he was going to call in some
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prescriptions in Rodney’s name and
asked Rodney if he could pick them up
at the pharmacy. Id. at 21. Respondent
gave him money, and Rodney picked up
the prescriptions that were found in the
hotel room. Id.
At the police station, Respondent
admitted that he had written the two
prescriptions. Id. at 23. He was also
observed as being in ‘‘an agitated state,
pacing back and forth in his cell’’ and
hitting his head against the wall. Id.
According to the arresting officer, who
had extensive experience in narcotics
investigations, Respondent showed
signs of impairment. Id. at 24.
Respondent was subsequently
charged with three felony offenses
under state law: One count of
possession of a controlled substance,
and two counts of fraudulently
attempting to obtain a controlled
substance. GX 5. On January 31, 2003,
Respondent pled guilty to the charges
and was allowed to enter into the St.
Louis County Drug Court Program. GXs
5 & 7. Under the program, Respondent
was required to, inter alia, undergo
treatment, submit to urine and breath
tests, not possess or use either
controlled substances (unless prescribed
by his doctor) or alcoholic beverages,
and attend weekly court sessions for a
minimum period of one year. GX 7.
Respondent successfully completed the
program and was allowed to withdraw
his guilty pleas. GX 8.
Respondent’s Evidence Regarding His
Rehabilitation
Following his December 2001 arrest,
and before even entering the Drug Court
Program, Respondent sought treatment
from the MPHP program. Tr. 140–42. On
December 17, 2001, Respondent entered
the Talbott Recovery Campus to be
treated for chemical dependency. RX 6,
at 1. Respondent was treated at Talbott
for approximately four months and was
discharged on April 6, 2002. Id.
According to the discharge summary,
Respondent had ‘‘progressed well
though his treatment process and * * *
was able to develop healthier and more
positive ways of coping with life
without engaging in self destructive
behaviors.’’ Id. at 5.
On February 7, 2003, Respondent’s
attending physician at Talbott wrote a
letter to Respondent’s counsel. RX 5.
The attending physician noted that
Respondent ‘‘has complied with all the
recommendations of our treatment team
in aftercare. He has been active in
recovery groups and attends our Return
Visits. His urine drug screens have
remained negative.’’ Id.
The physician further wrote that
Respondent ‘‘is doing well in recovery.
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He impresses us as willing to comply
with all recommendations and
continued participation in recovery
activities.’’ Id. Finally, the physician
stated his belief that Respondent ‘‘is
competent to practice medicine. He
appears committed to his patients and
his profession. We would support any
administrative decision to allow him to
continue to practice medicine.’’ Id.
As further evidence of his
rehabilitation, Respondent introduced
an affidavit (dated March 15, 2007) of
Ms. Tina Steinman, Executive Director
of the Missouri State Board of
Registration for the Healing Arts. RX 4,
at 1–2. According to Ms. Steinman, ‘‘[a]s
of the date of [the] affidavit,’’
Respondent ‘‘is in compliance with the
Settlement Agreement that he signed
with the [state board] that was effective
February 9, 2004.’’ Id. at 1.
Respondent also called several
witnesses to testify regarding his
rehabilitation, including Robert
Bondurant, the coordinator of the
MPHP. Tr. 111. In his testimony, Mr.
Bondurant explained that if a physician
failed a drug test or had ‘‘some other
adverse activity,’’ he would not support
the physician before the licensing
authority. Id. at 118. Mr. Bondurant
further explained that MPHP used
several monitoring mechanisms
including random testing for both street
drugs and prescription drugs; contacting
the physician’s family members,
employers and colleagues; and
monitoring the physician’s attendance
and participation in support groups and
Caduceus meetings. Id. at 122 & 138.
With respect to Respondent, Mr.
Bondurant explained that he joined the
MPHP shortly after being treated at
Talbott and had signed a new agreement
in 2004 after the State Board placed him
on probation. Id. at 143. Mr. Bondurant
further testified that Respondent had
done everything that Talbott had
recommended for his aftercare, and that
he had joined MPHP two years before he
was ordered to do so by the State Board.
Id. at 144–45. Moreover, at the time of
the hearing, Respondent, who was then
five years into the process of his
rehabilitation, was continuing to go to
AA and Caduceus meetings. Id. at 146.
Mr. Bondurant also testified that
Respondent had been subjected to
numerous drug tests as part of both the
Drug Court Program and MPHP, and
that every test was negative. Id. at 152–
53. Mr. Bondurant testified that MPHP
will randomly call Respondent for a
drug test and that he had never refused
to undergo a test. Id. at 153–54.
Respondent is also required to call the
State Board every morning to determine
whether he has been selected for testing.
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Id. at 154. The State Board has never
reported to Mr. Bondurant that
Respondent has tested positive for a
controlled substance.3 Id. Nor has Mr.
Bondurant received any other adverse
information from the Board regarding
Respondent. Id. at 156.
Mr. Bondurant further testified that he
had no information that would indicate
that Respondent was currently using or
abusing controlled substances that had
not been prescribed to him. Id. at 161.
He also opined that Respondent is ‘‘in
a very solid recovery,’’ but that his
addiction is ‘‘going to be a lifetime issue
for him.’’ Id. at 162. Finally, Mr.
Bondurant testified that he believed that
Respondent could safely handle and
prescribe controlled substances, and
that he had ‘‘no reason to believe that
he’’ poses a threat to public safety. Id.
at 166.
Respondent also elicited the
testimony of R.S., a dentist who, at the
time of hearing, had know him for six
years from his participation in the St.
Louis Caduceus group Id. at 201–02,
210. R.S. testified that Respondent’s
‘‘level of commitment to his recovery is
outstanding,’’ that Respondent had
operated on him, and that he would not
have let Respondent do so if he did not
‘‘have his head in the right place.’’ Id.
at 212. R.S. also stated that he had
referred his wife and several friends to
Respondent and that he could not think
of any reason as to why he would not
safely prescribe controlled substances.
Id. at 212 & 214.
Respondent further called Ralph
Orlovick, Ph.D., a clinical psychologist,
who specializes in the treatment of
chemical dependency and who has run
the MPHP’s aftercare program
(Caduceus Group) since 1995. Id. at 270;
RX 15. Dr. Orlovick explained that
Respondent ‘‘accept[s] responsibility for
his own behavior,’’ Tr. 295–96, and ‘‘has
an extremely deep acceptance of the fact
that he is an addict in recovery and has
established a lifestyle that maintains
and protects that * * * recovery.’’ Id. at
287. He also testified that Respondent
was ‘‘a different person * * * than he
was’’ when he first entered the program,
id. at 289–90; that he had ‘‘no fears or
concerns about’’ Respondent’s regaining
a registration, id. at 294; and that ‘‘the
length of [his] recovery and the ways he
has been managing his life [were]
excellent indices reflecting his readiness
to get a [registration] in a responsible
way.’’ Id. at 295. Dr. Orlovick further
testified that he did not know of any
reason why the Agency should not grant
3 The record establishes that the testing screens
for prescriptions opiates including hydrocodone
and oxycodone.
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Respondent’s application, and that he
had the tools necessary to continue his
recovery. Id.
Respondent testified that while he
was allowed to withdraw his guilty
pleas to the three charges which arose
out of his December 2001 arrest, the acts
‘‘absolutely happened and I take full
responsibility.’’ 4 Id. at 352. Respondent
further testified that he was never
sanctioned for non-compliance during
his participation in the drug-court
program, and that he did all of the
things he was required to do as part of
the program. Id. at 354–56.
Respondent also testified regarding
the settlement agreement he had entered
into with the Missouri Board. In this
testimony, Respondent acknowledged
that he was chemically dependent. Id. at
358–60. He also testified regarding the
various terms of the agreement,
including that he must call every
morning to determine whether he has
been selected to provide either a urine
or hair sample. Id. at 360.
Respondent also testified regarding
his obtaining a new state controlled
substances registration and indicated
that while he had not yet had to
institute the terms and conditions
imposed by the Missouri BNDD because
he is still unable to legally prescribe a
controlled substance, he was
‘‘absolutely’’ willing to do so, and that
it would be ‘‘no’’ problem for him to do
so. Id. at 369–70. Respondent testified
that his probation with the BNDD would
last for ‘‘five years.’’ Id. at 372. He also
testified that he considered holding a
DEA registration to be ‘‘an absolute
privilege,’’ id. at 373; that he had
attended a three-day continuing medical
education course on the prescribing of
controlled substances, id. at 375; and
that he ‘‘would do anything required’’ to
regain his registration, including
agreeing to warrantless searches,
submitting to drug testing, and
maintaining a prescription log. Id. at
385.
Finally, Respondent testified that he
had not harmed any patient during the
period in which he was abusing drugs
and there is no evidence to the contrary.
Id. at 388. Nor is there any evidence that
Respondent has ever used his
prescribing authority to deal drugs to
others.
The Government put on no rebuttal
case.5
4 On cross-examination, Respondent was asked if
he ‘‘attribute[d] this whole [1981] incident to like
youthful indiscretion or how do you characterize
this?’’ Tr. 391. Respondent answered: ‘‘Yes.’’ Id.
5 In applying for a new registration, Respondent
submitted extensive documentation regarding the
2001 incident, the criminal charges and their
disposition, the voluntary surrender of his DEA
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Discussion
Section 303(f) of the Controlled
Substances Act (CSA) provides that
‘‘[t]he Attorney General may deny an
application for [a practitioner’s]
registration if he determines 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 a combination of factors, and
may give each factor the weight I deem
appropriate in determining whether an
application for a registration should be
denied. Id. Moreover, I am ‘‘not required
registration, and the actions taken by both the
Missouri Board and BNDD. See RX 16. He also
included various letters of support. These included
the letter from his attending physician at Talbott;
a letter from the MPHP supporting his application
to the state BNDD which indicated that he was ‘‘in
complete compliance’’ with the program, and that
both the program’s Medical Director and
Coordinator (Mr. Bondurant) supported his request
for a state registration; and finally, a letter from Dr.
Orlovick which discussed Respondent’s
participation in the Caduceus Group and concluded
that ‘‘[h]e is now fully ready, and deserving, of
receiving his BNDD and DEA number.’’ RX 16, at
8, 47, & 49.
At the hearing, a Diversion Group Supervisor
(GS) who oversaw the pre-registration investigation
acknowledged that these materials had been
submitted as part of the application. Tr. 84. The GS
testified, however, that while he reviewed the
application, he had not reviewed all of the
attachments and had not talked about Respondent’s
application with any person other than the DI who
was assigned the investigation. Id. at 105.
The GS also testified that the DI who performed
the investigation obtained no evidence that any of
the information provided by Respondent was
inaccurate or that Respondent was again abusing
controlled substances. Id. at 86. Finally, the DI
testified that in light of all of the information
contained in Respondent’s application, he could
not explain why it would now be inconsistent with
the public interest to grant his application. Id. at
101. When asked ‘‘what more’’ Respondent had to
do to establish that his registration would be
consistent with the public interest?, the GS
answered: ‘‘My personal opinion, I believe he’s had
two or three chances to abide by the regulations
* * * to handle controlled substances and I believe
he failed at that.’’ Id. at 108–09.
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to make findings as to all of the factors.’’
Hoxie v. DEA, 419 F.3d 477, 482 (6th
Cir. 2005); see also Morall v. DEA, 412
F.3d 165, 173–74 (D.C. Cir. 2005).
In this case, it is not disputed that
Respondent violated Federal law both in
1981, when he was charged with
cocaine distribution, and most
significantly, in December 2001, when
he possessed cocaine and obtained for
his own use, two prescription controlled
substances, hydrocodone and
alprazolam, by writing fraudulent
prescriptions which were issued in the
name of a cab driver. The Government
has therefore made out a prima facie
case to deny his application.
This Agency has repeatedly held,
however, that a proceeding under
section 303 ‘‘ ‘is a remedial measure,
based upon the public interest and the
necessity to protect the public from
those individuals who have misused
* * * their DEA Certificate of
Registration, and who have not
presented sufficient mitigating evidence
to assure the Administrator that they
can be entrusted with the responsibility
carried by such a registration.’ ’’ Samuel
S. Jackson, 72 FR 23848, 23853 (2007)
(quoting Leo R. Miller, 53 FR 21931,
21932 (1988)). Therefore, where, as
here, ‘‘the Government has proved that
a registrant has committed acts
inconsistent with the public interest, a
registrant must ‘present sufficient
mitigating evidence to assure the
Administrator that [he] can be entrusted
with the responsibility carried by such
a registration.’ ’’ Medicine ShoppeJonesborough, 73 FR 364, 387 (2008)
(quoting Jackson, 72 FR at 23853 (2007)
(quoting Leo R. Miller, 53 FR 21931,
21932 (1988))), aff’d, Medicine ShoppeJonesborough v. DEA, slip. op. at 9–10
(6th Cir. Nov. 13, 2008). ‘‘Moreover,
because ‘past performance is the best
predictor of future performance,’ ALRA
Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th
Cir. 1995), [DEA] has repeatedly held
that where a registrant has committed
acts inconsistent with the public
interest, the registrant must accept
responsibility for [his] actions and
demonstrate that [he] will not engage in
future misconduct.’’ Medicine Shoppe,
73 FR at 387; accord Jackson, 72 FR at
23853; John H. Kennedy, 71 FR 35705,
35709 (2006); Prince George Daniels, 60
FR 62884, 62887 (1995). See also Hoxie
v. DEA, 419 F.3d at 483 (‘‘admitting
fault’’ is ‘‘properly consider[ed]’’ by
DEA to be an ‘‘important factor[]’’ in the
public interest determination).
The Government raises two arguments
in support of its contention that
Respondent’s application should be
denied. In its proposed findings, the
Government contends that ‘‘[a]lthough
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Respondent presented substantial expert
and peer testimony in support of his
rehabilitation, he does not appear to
have taken full responsibility for his
past forays into addiction and drug
abuse.’’ Gov. Proposed Findings at 6. In
its Exceptions, however, the
Government argues that ‘‘[t]he evidence
that the applicant presented at the
hearing as to his rehabilitation was
sparse and less than convincing.’’ Gov.
Exceptions at 2.
As for the contention that Respondent
has not taken ‘‘full responsibility for’’
what it describes as his ‘‘past forays,’’
apparently the Government relies on
Respondent’s testimony regarding the
1981 episode, as well as the reasons he
gave for the problems he had in 1991
and 2001. The Government’s contention
is wholly unpersuasive.
As for the 1981 arrest for cocaine
distribution, twenty-seven years have
elapsed since this event and there is no
evidence that Respondent ever
subsequently engaged in the unlawful
distribution of either illicit (street) or
prescription controlled substances to
others. Furthermore, Respondent did
not deny that he had committed the
acts.
The Government apparently also finds
fault with Respondent’s testimony
regarding what led to his becoming
addicted in 1991. See Prop. Findings at
4 (‘‘He attributed his 1991–1992 drug
use to chronic headaches.’’). The
Government, however, offered no
evidence to refute Respondent’s
testimony that he was prescribed
controlled substances as treatment for a
legitimate medical condition, and that
he became addicted over the course of
that treatment. Nor is Respondent the
first person to become addicted to a
drug prescribed in the course of
legitimate medical treatment. Related to
this incident, the Government also
ignores that Respondent voluntarily
entered treatment and underwent
treatment and aftercare for
approximately six years. Moreover, in
discussing this period of his life,
Respondent did not deny that he was
chemically dependent.
Finally, the Government contends
that Respondent ‘‘attributed his 2001
conviction to personal stress’’ 6 and that
he ‘‘failed recovery after several years of
rehabilitation.’’ Id. The Government,
however, offered no evidence showing
that Respondent’s testimony was false,
and in any event, it is not clear why his
explanation—‘‘a number of things,
6 The Government’s own exhibit establishes that
Respondent was not convicted of any offense
related to the 2001 incident, which was nolprossed. See GX 8.
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10081
personal things, stress,’’ Tr. 393—
regarding the cause of his relapse,
establishes that he has failed to accept
responsibility.
In any event, the great weight of the
evidence refutes the contention.
Notably, Respondent fully
acknowledged his misconduct in
writing the prescriptions to the cab
driver. Moreover, with respect to his
addiction, Respondent produced ample
evidence demonstrating that he
acknowledges that he is chemically
dependent. This includes both
Respondent’s testimony and written
admission regarding his addiction. See
GX 9, at 3 (settlement agreement with
state board; ‘‘Respondent has admitted
he is chemically dependent’’); Tr. 261
(‘‘I went [to treatment] because
something had to change * * * I
couldn’t keep doing what I was doing’’);
id. at 358–59 (acknowledging his
admission in the state board settlement
agreement); see also GX 1, at 4 (answer
to DEA application’s liability questions;
‘‘I am committed to a lifelong recovery
program and will follow all continuing
recommendations of MPHP and the
[state] Board.’’).
Moreover, both Dr. Orlovick, the
psychologist who runs MPHP’s aftercare
program, and Mr. Bondurant, the MPHP
Program Coordinator, testified that
Respondent acknowledges his
addiction. See id. at 287 (testimony of
Dr. Orlovick; Respondent ‘‘has an
extremely deep acceptance of the fact
that he is an addict in recovery and has
established a lifestyle that maintains
and protects that * * * recovery’’); id.
at 295 (testimony of Dr. Orlovick;
Respondent ‘‘accept[s] responsibility for
his own behavior’’). Id. at 164
(testimony of Mr. Bondurant; ‘‘over the
intervening years [Respondent] has
learned that he does have limitations
and that the addiction issue is a lifelong process and he is not stronger than
the addiction’’). It is thus clear that
Respondent has accepted responsibility
for both his misconduct and addiction.
As for the contention that Respondent
has not sufficiently established his
rehabilitation, in its proposed findings,
the Government acknowledged that
‘‘Respondent presented substantial
expert and peer testimony in support of
his rehabilitation,’’ Id. at 6. In its
Exceptions, however, the Government
does an about-face and now argues that
‘‘[t]he evidence that the applicant
presented at the hearing as to his
rehabilitation was sparse and less than
convincing.’’ Gov. Exc. at 2. Even
ignoring the inconsistency between its
initial and subsequent positions, I
conclude that Respondent put forward
compelling evidence of his
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rehabilitation.7 Specifically, in addition
to his own testimony, Respondent
introduced the affidavit of the Missouri
Board’s Executive Director that he was
‘‘in compliance with the Settlement
Agreement,’’ RX 4, at 1; a letter from the
physician who treated him at Talbott,
RX 5; and again, the testimony (and
letters) of Mr. Bondurant, Dr. Orlovick,
and R.S., a dentist who was also a
member of Respondent’s aftercare
group.
More specifically, Respondent’s
treating physician at Talbott wrote that
his drug screens were negative, that he
was ‘‘doing well in recovery,’’ that he
was ‘‘willing to comply with all
recommendations and continued
participation in recovery activities,’’ and
that he ‘‘is competent to practice
medicine.’’ RX 5. Mr. Bondurant
testified as to Respondent’s compliance
with the conditions of the MPHP; that
he had never failed or refused to
undergo a drug test (whether the test
was ordered by the Drug Court, MPHP,
or the Board); that he had not received
any adverse information regarding
Respondent, who is ‘‘in a very solid
recovery’’; and that he had ‘‘no reason
to believe that [Respondent] would’’
pose a threat to public safety. Tr. 153–
54, 156, 161–62, 166.
To similar effect, Dr. Orlovick
testified that Respondent ‘‘has
established a lifestyle that maintains
and protects [his] recovery,’’ and that he
had ‘‘no fears or concerns about’’
Respondent’s regaining a registration.
Id. at 287 & 294. Dr. Orlovick also
testified that ‘‘the length of
[Respondent’s] recovery and the ways
he has been managing his life [are]
excellent indices reflecting his readiness
to’’ responsibly hold a registration. Id. at
295. Dr. Orlovick further stated that he
did know of any reason why
Respondent’s application should not be
granted and that he had the tools
necessary to maintain his recovery. Id.
Finally, R.S., who has known
Respondent for six years from their
participation in Caduceus meetings,
testified that Respondent’s
‘‘commitment to his recovery is
outstanding.’’ Id. at 212. He also stated
that he could not think of any reason
why Respondent would not responsibly
prescribe controlled substances. Id. at
214.
In response to this evidence, much of
which was available at the time
Respondent applied for a new
registration, the Government offered
7 Notwithstanding the suggestion in the
Government’s proposed findings, there is no
evidence that Respondent has relapsed following
the treatment he received in 2002.
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nothing. I hold, however, that
Respondent’s evidence as to his
rehabilitation is convincing and reject
the Government’s contention to the
contrary. Indeed, as the Supervisory DI
testified, he could not explain why it
would be inconsistent with the public
interest for Respondent to hold a
registration. I therefore conclude that
Respondent has established that
granting his application would be
consistent with the public interest. 21
U.S.C. 823(f).
Sanction
As Respondent himself recognizes,
the record nonetheless supports
imposing conditions on his registration.
Resp. Proposed Findings at 21–22.
Under the Settlement Agreement with
the State Board, Respondent is required
to maintain duplicate serially numbered
prescriptions separately from patient
charts for each controlled substance
prescription he writes. GX 11, at 4.
Respondent has agreed to provide or
make available these records to this
Agency and has also agreed to consent
to inspections of these records without
the Government having to obtain an
administrative warrant. Resp. Prop.
Findings at 22. These requirements are
therefore imposed as conditions of
Respondent’s registration.
Relatedly, the record also supports the
ALJ’s recommendation that Respondent
must maintain and submit on a
quarterly basis, a log listing in
chronological order, all controlled
substance prescriptions he issues. The
log shall include the prescription
number, patient name and address,
name, amount and strength of the drug
prescribed, and number of refills
authorized. The log shall also include
any prescriptions and refills authorized
by Respondent by telephone.
According to the terms of his
agreement with the State BNDD,
Respondent is not authorized to ‘‘order,
purchase or accept’’ any controlled
substances. GX 11, at 5. The BNDD
Order further provides that Respondent
‘‘shall not dispense any controlled
substances other than by administering
or prescribing.’’ Id.
It is unclear whether Respondent
seeks authority to administer controlled
substances at his clinic (as opposed to
in a hospital setting), whether the BNDD
agreement authorizes him to do so, and
if he is permitted to do so, how he can
legally obtain them.8 Moreover, the
8 The
record establishes that another doctor, who
was alternatively characterized as Respondent’s
associate or partner, administers controlled
substances at his clinic. Tr. 244. According to
Respondent, while his associate/partner holds a
DEA and state registration, the latter is not
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extent to which Respondent performs
procedures in his clinic which require
the administration of a controlled
substance is also not fully established
on this record.
In the event Respondent seeks
authority to administer controlled
substances at the clinic, he must first
provide evidence from the Missouri
BNDD clearly stating that he is
authorized to do so. Respondent must
also explain how any controlled
substances will be lawfully obtained
(notwithstanding his agreement with the
BNDD prohibiting his ordering and
purchasing them), how they will be
stored, and how they will be accounted
for. Respondent shall not administer
controlled substances at his clinic until
he complies with this condition and
receives written approval from this
Agency. Respondent can, however,
administer a controlled substance in a
hospital setting.
Respondent shall not prescribe any
controlled substance to himself or any
family member. Respondent shall not
obtain a controlled substance for his
own use unless it has been prescribed
by another practitioner in accordance
with the prescription requirement of
federal law. See 21 CFR 1306.04 (‘‘A
prescription for a controlled substance
to be effective must be issued for a
legitimate medical purpose by an
individual practitioner acting in the
usual course of his professional
practice.’’).
Respondent shall also ensure that the
MPHP quarterly status reports are
submitted to the Agency. All reports
and logs are to be submitted to the
Special Agent in Charge (or his
designee), St. Louis Field Division, no
later than fifteen days following the end
of the quarter. Respondent shall also
promptly notify the Special Agent in
Charge (or his designee) of any action
taken by either the State Board or BNDD
against his license or state registration.
Failure to comply with any of the
conditions specified above shall be
grounds for the suspension or
revocation of Respondent’s registration.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as 28 CFR
0.100(b) & 0.104, I hereby order that the
application of Steven M. Abbadessa,
D.O., for a DEA Certificate of
Registration as a practitioner be, and it
authorized under agreements with the state
authorities to stock controlled substances and no
controlled substances are currently being stocked at
the clinic. The record does not establish how
Respondent’s partner/associate obtains and
maintains the controlled substances which are used
at his clinic.
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hereby is, granted, subject to the
conditions set forth above. This Order is
effective immediately.
Dated: February 26, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–4906 Filed 3–6–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 06–28]
dwashington3 on PROD1PC60 with NOTICES
Joseph Gaudio, M.D.; Suspension of
Registration
On September 16, 2005, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Joseph Gaudio, M.D.
(Respondent) of Alpine, New Jersey.
The Show Cause Order sought the
revocation of Respondent’s DEA
Certificate of Registration, which
authorizes him to handle controlled
substances as a practitioner, and the
denial of any pending applications to
renew or modify his registration, on the
ground that he had committed acts
which rendered his continued
registration ‘‘inconsistent with the
public interest.’’ Show Cause Order at 1
(citing 21 U.S.C. 823(f) & 824(a)(4)).
The Show Cause Order alleged that
Respondent had issued prescriptions for
controlled substances which lacked a
legitimate medical purpose, and that in
doing so, he had acted outside of the
usual course of professional practice. Id.
at 1 & 6. The Show Cause Order
specifically alleged that Respondent had
‘‘prescrib[ed] controlled substances to
Internet customers despite never
establishing a genuine doctor-patient
relationship with the Internet
customer.’’ Id. at 5. Relatedly, the Show
Cause Order alleged that Respondent
‘‘did not see customers, had no prior
doctor-patient relationships with the
Internet customers, did not conduct
physical exams, * * * did [not] create
or maintain patient records,’’ and that
‘‘[t]he only information usually
reviewed prior to issuing drug orders
was the customer’s online
questionnaire.’’ Id. at 6.
The Show Cause Order also alleged
that ‘‘[a] review of prescriptions filled
by [Carrington Healthcare System/
Infiniti Services Group] revealed that
[Respondent] ha[d] issued drug orders
for controlled substances to Internet
customers throughout the United States,
including Georgia, Texas, Pennsylvania,
Alabama, Louisiana, and Kentucky.’’ Id.
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The Show Cause Order further alleged
that ‘‘[a] review of prescriptions filled
by [Carrington/Infiniti] for the period
October 13, 2004 to January 21, 2005,
revealed that [Respondent] ha[d] issued
16 drug orders to Internet customers in
at least nine different states.’’ Id.
On October 21, 2005, Respondent,
through his counsel, requested a hearing
on the allegations. The matter was
assigned to Administrative Law Judge
(ALJ) Gail Randall, who conducted a
hearing on May 2–5, 2006, in New York,
NY. At the hearing, both parties put on
testimony and introduced documentary
evidence. Thereafter, both parties
submitted briefs containing their
proposed findings of fact, conclusions of
law, and arguments.
On November 2, 2007, the ALJ issued
her recommended decision. In her
decision, the ALJ concluded that ‘‘[t]he
Government has clearly demonstrated
that the Respondent’s Internet practice
and his resulting issuance of controlled
substance prescriptions * * * violated
the Controlled Substances Act.’’ ALJ at
43. Applying the totality of the
circumstances test, the ALJ concluded,
however, that the revocation of
Respondent’s registration was not
warranted. Id. at 43–44.
The ALJ specifically noted that
‘‘Respondent’s conduct encompassed a
one year period,’’ that Respondent had
‘‘voluntarily cease[d]’’ his conduct, but
that he had not done so until three
months after he was served with the
Show Cause Order. Id. at 43. While the
ALJ deemed Respondent’s cessation of
his conduct as ‘‘commendable because
of its voluntary nature,’’ she further
explained that he ‘‘demonstrated a lack
of sound judgment’’ in ‘‘continuing to’’
prescribe after being served with the
Show Cause Order. Id. at 44. The ALJ
also found of concern ‘‘Respondent’s
failure to be totally truthful during his
testimony.’’ Id.
The ALJ reasoned, however, that
Respondent was ‘‘a very educated,
dedicated and talented physician
practicing in a sometimes difficult
specialty, pain management,’’ and that
the revocation of his registration would
render him ‘‘being unable to handle
controlled substances’’ in his specialty.
Id. Because the record demonstrated
that Respondent had practiced medicine
for eleven years, and that ‘‘the only
instances of [his] improper handling of
controlled substances were related to
his’’ Internet prescribing, the ALJ
recommended that Respondent’s
registration be continued subject to the
condition that he ‘‘not engage in any
activity involving prescribing controlled
substances and the Internet.’’ Id.
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10083
Having considered the entire record
in this matter, I hereby issued this
Decision and Final Order. I adopt the
ALJ’s conclusions that Respondent
violated both the Controlled Substances
Act (CSA) and various state standards of
medical practice in issuing
prescriptions to persons who ordered
drugs through an Internet site. For
reasons explained below, I reject the
ALJ’s recommended sanction as
inconsistent with agency precedent and
will order the suspension of
Respondent’s registration for a period of
one year. I make the following findings.
Findings
Respondent is a medical doctor who
is board certified in both anesthesiology
and pain management and is licensed to
practice medicine in the States of New
York and New Jersey. Tr. 488.
Respondent is also the holder of a DEA
Certificate of Registration, which
authorizes him to dispense controlled
substances in schedules II through V as
a practitioner. GX 1, at 2. While the
expiration date of Respondent’s
registration was September 30, 2006,
Respondent submitted a renewal
application on August 4, 2006. See
Reply to Respondent’s Status Report, at
1. I therefore find that Respondent’s
prior registration has remained in effect
pending the issuance of this Final Order
and that Respondent also has an
application pending before the Agency.
See 5 U.S.C. 558(c).
Respondent attended medical school
at The Autonomous University of
Guadalajara, and the New York Medical
College. RX 1, at 2. Subsequently,
Respondent did his residency in
anesthesiology at St. Luke’s/Roosevelt
Hospital, an institution which is
affiliated with the Columbia University
College of Physicians and Surgeons,
where he received an award given to the
Outstanding Graduate Resident in
Anesthesiology. Id. Respondent also did
a fellowship in Pain Management at the
Memorial Sloan Kettering Cancer
Center, where he was elected Chief
Fellow. Id. at 1.
Upon completion of his fellowship,
Respondent joined New Jersey
Anesthesia Associates (NJAA), a group
of physicians which provides anesthesia
services at St. Barnabas Medical Center.
Tr. 345–47. Respondent is a partner in
NJAA. Id. at 347. In addition to
providing anesthesia, Respondent also
treats both acute and chronic pain
patients. Id. at 555–56. Respondent is
also an attending physician and clinical
professor at St. Barnabas, where he
trains residents in anesthesia. Id. at 360.
Respondent came to the attention of
the Agency during its investigation of a
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[Federal Register Volume 74, Number 44 (Monday, March 9, 2009)]
[Notices]
[Pages 10077-10083]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4906]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 06-78]
Steven M. Abbadessa, D.O.; Grant of Restricted Registration
On August 7, 2006, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Steven M. Abbadessa, D.O. (Respondent), of St. Louis,
Missouri. The Show Cause Order proposed the denial of Respondent's
pending application for a DEA Certificate of Registration as a
practitioner, on the ground that his ``registration would be
inconsistent with the public interest.'' Id. at 1 (citing 21 U.S.C.
823(f)).
The Show Cause Order specifically alleged that ``[o]n or about
January 1981, [Respondent] illegally possessed and distributed * * *
cocaine in violation of 21 U.S.C. 841(a)(1),'' that Respondent was
subsequently charged and arrested, and that he had admitted to agents
that he had been involved ``in the illegal distribution of cocaine, a
schedule II controlled substance,'' but that ``no further prosecution
was undertaken'' because he cooperated with authorities. Id.
The Show Cause Order next alleged that on December 4, 2001,
Respondent was arrested by local police at a hotel in Clayton,
Missouri, where he was found to have in his possession cocaine, as well
as two prescription controlled substances--a combination drug
containing hydrocodone, a schedule III controlled substance, and
alprazolam, a schedule IV controlled substance. Id. The Order further
alleged that the hydrocodone and the alprazolam ``had been dispensed in
the name of an acquaintance'' of Respondent. Id.
Relatedly, the Show Cause Order alleged that Respondent was
subsequently indicted in state court on one felony count of possession
of cocaine, and two felony counts of obtaining controlled substances by
fraud. Id. The Order further alleged that on January 31, 2003,
Respondent pled guilty to all three counts, but that he was allowed to
withdraw his pleas after he completed a ``one-year drug program.'' \1\
Id. at 1-2.
---------------------------------------------------------------------------
\1\ The Order also noted that on March 10, 2003, Respondent had
surrendered his DEA registration, that in February 2004, the
Missouri State Board for the Healing Arts had entered into a
settlement agreement with Respondent under which his medical license
was placed on probation for seven years, and that in April 2006,
Respondent's state controlled substances registration had been
restored. Id. at 1-2.
---------------------------------------------------------------------------
Respondent, through his counsel, requested a hearing on the
allegations. ALJ Ex. 2. The matter was assigned to Administrative Law
Judge (ALJ) Gail Randall, who conducted a hearing in St. Louis,
Missouri, on May 15 and 16, 2007. At the hearing, both the Government
and Respondent put on testimony and introduced documentary evidence
into the record. Following the hearing, both parties submitted briefs
containing their proposed findings of fact, conclusions of law, and
argument.
On February 13, 2008, the ALJ issued her recommended decision
(ALJ). In her decision, the ALJ concluded that the
[[Page 10078]]
Government had established grounds for the denial of Respondent's
application. ALJ at 55. The ALJ held, however, that Respondent had
accepted responsibility for his misconduct and had ``provided ample
mitigating evidence and adequate assurances that he is able to
responsibly handle [controlled substances] and is willing to abide by
restrictions and/or requirements placed upon him.'' Id. at 57. The ALJ
thus recommended that Respondent's application be granted subject to
three restrictions. Id. Thereafter, the Government filed exceptions to
the ALJ's decision.
Having considered the entire record in this matter, I adopt the
ALJ's recommended decision except for her conclusions regarding the
hardship imposed by Respondent's lack of a registration, which is not a
relevant consideration under the Controlled Substances Act. I hold that
while the Government made out a prima facie case to deny the
application, Respondent has convincingly demonstrated that he can be
entrusted with a new registration subject to conditions. However, I
impose additional conditions beyond those recommended by the ALJ. I
therefore reject the Government's exceptions and will grant Respondent
a new registration subject to the conditions as set forth below. I make
the following findings.
Findings
Respondent is a Doctor of Osteopathy (D.O.) and a board-certified
proctologist. Respondent holds a license as an Osteopathic Physician
and Surgeon from the Missouri State Board of Registration for the
Healing Arts. RX 16, at 25. Effective February 9, 2004, Respondent's
state license was placed on probation for a period of seven years. Id.
Respondent also held a DEA Certificate of Registration from 1987 until
he surrendered it on March 7, 2003. GX 4.
Respondent is, however, currently authorized to practice medicine
subject to numerous conditions. These include, inter alia: (1) That he
``abstain completely from the personal use or possession of controlled
substances * * * unless that use of the drug has been prescribed by a
person licensed to prescribe such drug and with whom [he] has a bona
fide physician/patient relationship,'' RX 16, at 26; (2) that he
participate in the Missouri State Medical Association's Physician
Health Program (MPHP), id. at 25-26; (3) that he completely abstain
from the use of alcohol, id. at 27; (4) that he ``submit to biological
fluid testing'' at his own expense and that the presence of any drug
not supported by a valid prescription which had been submitted to the
Board is a violation of his discipline, id.; (5) that he ``cause a
letter of evaluation from [a] chemical dependency professional or from
the rehabilitation or aftercare program to be submitted to the Board''
each quarter, id.; and (6) that he agree to ``unannounced visits from
the Board's representatives to monitor his compliance with'' the
agreement. Id. at 28.
On November 10, 2003, Respondent applied for a new Missouri
Controlled Substance Registration, his previous state registration
having lapsed on March 31, 2003. GX 10, at 6. On August 24, 2004, the
Missouri Bureau of Narcotics and Dangerous Drugs (BNDD) denied
Respondent's application and issued an administrative complaint.\2\ Id.
On April 6, 2005, Respondent and the State entered into a stipulation
and consent order under which Respondent acknowledged that the State
had ``sufficient evidence'' to support the allegations of the denial
letter and that cause existed to deny Respondent's application. Id. The
parties agreed, however, that Respondent would accept the State's
denial of his application, but that the State would consider a new
application on or after January 1, 2006, and would grant the
application provided that he did not commit new violations of
controlled-substance laws and regulations and complied with his
agreements with the state medical board and the Missouri Physicians
Health Program. Id. at 8.
---------------------------------------------------------------------------
\2\ The incident which prompted the denial (and this proceeding)
is discussed below.
---------------------------------------------------------------------------
On or about January 5, 2006, Respondent submitted a new application
for a state controlled substances registration. GX 11, at 3. On April
3, 2006, Respondent and the State entered into a settlement agreement
under which Respondent again agreed that cause existed under Missouri
law to deny his application. Id. at 3-4. The parties agreed, however,
that the State would grant him a new registration subject to extensive
probationary terms. Id. at 4.
The terms included, inter alia: (1) That Respondent maintain
duplicate copies of ``serially numbered'' prescriptions and that copies
be ``maintained separately from each patient's charts,'' (2) that
Respondent ``not prescribe or administer controlled substances for
himself, his immediate family or his employees except in a life-
threatening emergency,'' (3) that Respondent ``not order, purchase, or
accept controlled substances,'' (4) that Respondent ``not obtain'' any
controlled substance unless it is prescribed to him by a practitioner
with whom he ``has a legitimate practitioner-patient relationship,''
and that he inform any treating practitioner ``of his prior chemical
dependence before he is given a prescription,'' (5) that Respondent
ensure that any prescribing practitioner notify the BNDD of any
prescription that was issued to him including the medical purpose of
the prescription, (6) that Respondent shall remain a member of MPHP and
ensure that quarterly reports were released to the BNDD, (7) that the
BNDD ``shall have authority to obtain biological * * * and hair
samples'' at Respondent's expense, and (8) that both state and DEA
investigators ``shall have access to all required controlled drug
records at any time during regular office hours.'' Id. at 4-6.
Respondent was thus granted a new state controlled substance
registration; the probationary terms remain in effect until April 3,
2011. Id. at 1.
Respondent's Drug-Related Incidents
The 1981 Incident
In 1981, DEA Agents in Kirksville, Missouri, were notified by an
informant that Respondent was a ``large cocaine dealer.'' Tr. 51.
Through the informant, a meeting was arranged at which an Agent posed
as someone interested in buying cocaine from Respondent. Id. at 52-53.
Respondent told the Agent that he could supply him with ``two to three
ounces of cocaine'' and gave him a sample to test. Id. at 52.
Respondent wanted money upfront, but the Agent refused to provide it.
Id. Respondent and the Agent ended the meeting by agreeing to meet at a
later date. Id. at 53.
The following day, Respondent and the Agent had a telephone
conversation during which the former told the latter that he could get
him ``all the cocaine he wanted,'' which he thought was ``three or four
ounces.'' GX 3, at 2. Respondent did not, however, consummate a deal
with the Agent. Id. Respondent did not hear again from the Agent for
several weeks, when the latter called and told Respondent that he had
some marijuana and cocaine for sale and asked if Respondent would
``take it on consignment.'' Id.
Respondent agreed to meet the Agent. Id. Upon his arrival at the
meeting, Respondent was arrested and charged with cocaine distribution.
Id. Respondent cooperated with the authorities; as a result of his
cooperation, two other persons were arrested. Tr. 99. Because of his
cooperation, Respondent's case was sealed and he was not convicted of
an offense. Id. at 98-99.
[[Page 10079]]
The 1992 Incident
In 1992, Respondent was treated for headaches by a neurologist, who
prescribed Vicodin to him. Tr. 255-56. When Respondent continued to
seek refills of the Vicodin over a sustained period of time, the
neurologist raised with him the subject of whether he was addicted. Id.
at 256. Respondent agreed to contact the MPHP and underwent an in-
patient evaluation which lasted seven to eight days. Id. Upon being
discharged, Respondent participated in the MPHP program for
approximately six years, during which he attend weekly Caduceus
meetings and submitted to drug testing. Id. at 259. Respondent left the
program in 1998, thinking that he ``was okay.'' Id. at 260. While
Respondent was fine for a little while, he eventually started drinking
again and then abusing drugs again. Id.
The 2001 Incident
On December 4, 2001, an employee of a Ritz-Carlton hotel located in
Clayton, Missouri contacted local police and reported that he had
observed cocaine in the room in which Respondent was staying. Id. at
14-15. Upon their arrival, the police went to Respondent's room,
knocked on the door, and were let in by a cab driver named Rodney. Id.
at 16. Respondent walked out of the bedroom area, observed the officers
who were in uniform, and ran back into the bedroom. Id. at 16-17. The
officers pursued Respondent and subdued him. Id. at 17. On a table, the
officers found a bag containing 14.38 grams of cocaine, a black plastic
container which held seven-tenths of a gram of cocaine, and assorted
paraphernalia used to prepare and snort the drug such as plates,
straws, a calling card and a credit card. Id. at 18.
The officers also seized two prescription drug vials; one contained
thirty-seven tablets of hydrocodone, the other contained forty-one
tablets of alprazolam. Id. at 18-19. The labels on the vials listed
Rodney as the patient and Respondent as the prescriber (and included
his DEA number); the quantities dispensed were forty tablets of
hydrocodone and forty-two tablets of alprazolam. Id. Respondent was
subsequently arrested and taken to the police station for booking. Id.
at 22.
Rodney told the police that he had first met Respondent two days
earlier when he drove him from a restaurant to his home; on that
occasion, Respondent had asked Rodney for his business card because he
was having car problems. Id. at 20-21. Upon meeting Respondent on
December 4th, Respondent told Rodney that he was going to call in some
prescriptions in Rodney's name and asked Rodney if he could pick them
up at the pharmacy. Id. at 21. Respondent gave him money, and Rodney
picked up the prescriptions that were found in the hotel room. Id.
At the police station, Respondent admitted that he had written the
two prescriptions. Id. at 23. He was also observed as being in ``an
agitated state, pacing back and forth in his cell'' and hitting his
head against the wall. Id. According to the arresting officer, who had
extensive experience in narcotics investigations, Respondent showed
signs of impairment. Id. at 24.
Respondent was subsequently charged with three felony offenses
under state law: One count of possession of a controlled substance, and
two counts of fraudulently attempting to obtain a controlled substance.
GX 5. On January 31, 2003, Respondent pled guilty to the charges and
was allowed to enter into the St. Louis County Drug Court Program. GXs
5 & 7. Under the program, Respondent was required to, inter alia,
undergo treatment, submit to urine and breath tests, not possess or use
either controlled substances (unless prescribed by his doctor) or
alcoholic beverages, and attend weekly court sessions for a minimum
period of one year. GX 7. Respondent successfully completed the program
and was allowed to withdraw his guilty pleas. GX 8.
Respondent's Evidence Regarding His Rehabilitation
Following his December 2001 arrest, and before even entering the
Drug Court Program, Respondent sought treatment from the MPHP program.
Tr. 140-42. On December 17, 2001, Respondent entered the Talbott
Recovery Campus to be treated for chemical dependency. RX 6, at 1.
Respondent was treated at Talbott for approximately four months and was
discharged on April 6, 2002. Id. According to the discharge summary,
Respondent had ``progressed well though his treatment process and * * *
was able to develop healthier and more positive ways of coping with
life without engaging in self destructive behaviors.'' Id. at 5.
On February 7, 2003, Respondent's attending physician at Talbott
wrote a letter to Respondent's counsel. RX 5. The attending physician
noted that Respondent ``has complied with all the recommendations of
our treatment team in aftercare. He has been active in recovery groups
and attends our Return Visits. His urine drug screens have remained
negative.'' Id.
The physician further wrote that Respondent ``is doing well in
recovery. He impresses us as willing to comply with all recommendations
and continued participation in recovery activities.'' Id. Finally, the
physician stated his belief that Respondent ``is competent to practice
medicine. He appears committed to his patients and his profession. We
would support any administrative decision to allow him to continue to
practice medicine.'' Id.
As further evidence of his rehabilitation, Respondent introduced an
affidavit (dated March 15, 2007) of Ms. Tina Steinman, Executive
Director of the Missouri State Board of Registration for the Healing
Arts. RX 4, at 1-2. According to Ms. Steinman, ``[a]s of the date of
[the] affidavit,'' Respondent ``is in compliance with the Settlement
Agreement that he signed with the [state board] that was effective
February 9, 2004.'' Id. at 1.
Respondent also called several witnesses to testify regarding his
rehabilitation, including Robert Bondurant, the coordinator of the
MPHP. Tr. 111. In his testimony, Mr. Bondurant explained that if a
physician failed a drug test or had ``some other adverse activity,'' he
would not support the physician before the licensing authority. Id. at
118. Mr. Bondurant further explained that MPHP used several monitoring
mechanisms including random testing for both street drugs and
prescription drugs; contacting the physician's family members,
employers and colleagues; and monitoring the physician's attendance and
participation in support groups and Caduceus meetings. Id. at 122 &
138.
With respect to Respondent, Mr. Bondurant explained that he joined
the MPHP shortly after being treated at Talbott and had signed a new
agreement in 2004 after the State Board placed him on probation. Id. at
143. Mr. Bondurant further testified that Respondent had done
everything that Talbott had recommended for his aftercare, and that he
had joined MPHP two years before he was ordered to do so by the State
Board. Id. at 144-45. Moreover, at the time of the hearing, Respondent,
who was then five years into the process of his rehabilitation, was
continuing to go to AA and Caduceus meetings. Id. at 146.
Mr. Bondurant also testified that Respondent had been subjected to
numerous drug tests as part of both the Drug Court Program and MPHP,
and that every test was negative. Id. at 152-53. Mr. Bondurant
testified that MPHP will randomly call Respondent for a drug test and
that he had never refused to undergo a test. Id. at 153-54. Respondent
is also required to call the State Board every morning to determine
whether he has been selected for testing.
[[Page 10080]]
Id. at 154. The State Board has never reported to Mr. Bondurant that
Respondent has tested positive for a controlled substance.\3\ Id. Nor
has Mr. Bondurant received any other adverse information from the Board
regarding Respondent. Id. at 156.
---------------------------------------------------------------------------
\3\ The record establishes that the testing screens for
prescriptions opiates including hydrocodone and oxycodone.
---------------------------------------------------------------------------
Mr. Bondurant further testified that he had no information that
would indicate that Respondent was currently using or abusing
controlled substances that had not been prescribed to him. Id. at 161.
He also opined that Respondent is ``in a very solid recovery,'' but
that his addiction is ``going to be a lifetime issue for him.'' Id. at
162. Finally, Mr. Bondurant testified that he believed that Respondent
could safely handle and prescribe controlled substances, and that he
had ``no reason to believe that he'' poses a threat to public safety.
Id. at 166.
Respondent also elicited the testimony of R.S., a dentist who, at
the time of hearing, had know him for six years from his participation
in the St. Louis Caduceus group Id. at 201-02, 210. R.S. testified that
Respondent's ``level of commitment to his recovery is outstanding,''
that Respondent had operated on him, and that he would not have let
Respondent do so if he did not ``have his head in the right place.''
Id. at 212. R.S. also stated that he had referred his wife and several
friends to Respondent and that he could not think of any reason as to
why he would not safely prescribe controlled substances. Id. at 212 &
214.
Respondent further called Ralph Orlovick, Ph.D., a clinical
psychologist, who specializes in the treatment of chemical dependency
and who has run the MPHP's aftercare program (Caduceus Group) since
1995. Id. at 270; RX 15. Dr. Orlovick explained that Respondent
``accept[s] responsibility for his own behavior,'' Tr. 295-96, and
``has an extremely deep acceptance of the fact that he is an addict in
recovery and has established a lifestyle that maintains and protects
that * * * recovery.'' Id. at 287. He also testified that Respondent
was ``a different person * * * than he was'' when he first entered the
program, id. at 289-90; that he had ``no fears or concerns about''
Respondent's regaining a registration, id. at 294; and that ``the
length of [his] recovery and the ways he has been managing his life
[were] excellent indices reflecting his readiness to get a
[registration] in a responsible way.'' Id. at 295. Dr. Orlovick further
testified that he did not know of any reason why the Agency should not
grant Respondent's application, and that he had the tools necessary to
continue his recovery. Id.
Respondent testified that while he was allowed to withdraw his
guilty pleas to the three charges which arose out of his December 2001
arrest, the acts ``absolutely happened and I take full
responsibility.'' \4\ Id. at 352. Respondent further testified that he
was never sanctioned for non-compliance during his participation in the
drug-court program, and that he did all of the things he was required
to do as part of the program. Id. at 354-56.
---------------------------------------------------------------------------
\4\ On cross-examination, Respondent was asked if he
``attribute[d] this whole [1981] incident to like youthful
indiscretion or how do you characterize this?'' Tr. 391. Respondent
answered: ``Yes.'' Id.
---------------------------------------------------------------------------
Respondent also testified regarding the settlement agreement he had
entered into with the Missouri Board. In this testimony, Respondent
acknowledged that he was chemically dependent. Id. at 358-60. He also
testified regarding the various terms of the agreement, including that
he must call every morning to determine whether he has been selected to
provide either a urine or hair sample. Id. at 360.
Respondent also testified regarding his obtaining a new state
controlled substances registration and indicated that while he had not
yet had to institute the terms and conditions imposed by the Missouri
BNDD because he is still unable to legally prescribe a controlled
substance, he was ``absolutely'' willing to do so, and that it would be
``no'' problem for him to do so. Id. at 369-70. Respondent testified
that his probation with the BNDD would last for ``five years.'' Id. at
372. He also testified that he considered holding a DEA registration to
be ``an absolute privilege,'' id. at 373; that he had attended a three-
day continuing medical education course on the prescribing of
controlled substances, id. at 375; and that he ``would do anything
required'' to regain his registration, including agreeing to
warrantless searches, submitting to drug testing, and maintaining a
prescription log. Id. at 385.
Finally, Respondent testified that he had not harmed any patient
during the period in which he was abusing drugs and there is no
evidence to the contrary. Id. at 388. Nor is there any evidence that
Respondent has ever used his prescribing authority to deal drugs to
others.
The Government put on no rebuttal case.\5\
---------------------------------------------------------------------------
\5\ In applying for a new registration, Respondent submitted
extensive documentation regarding the 2001 incident, the criminal
charges and their disposition, the voluntary surrender of his DEA
registration, and the actions taken by both the Missouri Board and
BNDD. See RX 16. He also included various letters of support. These
included the letter from his attending physician at Talbott; a
letter from the MPHP supporting his application to the state BNDD
which indicated that he was ``in complete compliance'' with the
program, and that both the program's Medical Director and
Coordinator (Mr. Bondurant) supported his request for a state
registration; and finally, a letter from Dr. Orlovick which
discussed Respondent's participation in the Caduceus Group and
concluded that ``[h]e is now fully ready, and deserving, of
receiving his BNDD and DEA number.'' RX 16, at 8, 47, & 49.
At the hearing, a Diversion Group Supervisor (GS) who oversaw
the pre-registration investigation acknowledged that these materials
had been submitted as part of the application. Tr. 84. The GS
testified, however, that while he reviewed the application, he had
not reviewed all of the attachments and had not talked about
Respondent's application with any person other than the DI who was
assigned the investigation. Id. at 105.
The GS also testified that the DI who performed the
investigation obtained no evidence that any of the information
provided by Respondent was inaccurate or that Respondent was again
abusing controlled substances. Id. at 86. Finally, the DI testified
that in light of all of the information contained in Respondent's
application, he could not explain why it would now be inconsistent
with the public interest to grant his application. Id. at 101. When
asked ``what more'' Respondent had to do to establish that his
registration would be consistent with the public interest?, the GS
answered: ``My personal opinion, I believe he's had two or three
chances to abide by the regulations * * * to handle controlled
substances and I believe he failed at that.'' Id. at 108-09.
---------------------------------------------------------------------------
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
``[t]he Attorney General may deny an application for [a practitioner's]
registration if he determines 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 a
combination of factors, and may give each factor the weight I deem
appropriate in determining whether an application for a registration
should be denied. Id. Moreover, I am ``not required
[[Page 10081]]
to make findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d
477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74
(D.C. Cir. 2005).
In this case, it is not disputed that Respondent violated Federal
law both in 1981, when he was charged with cocaine distribution, and
most significantly, in December 2001, when he possessed cocaine and
obtained for his own use, two prescription controlled substances,
hydrocodone and alprazolam, by writing fraudulent prescriptions which
were issued in the name of a cab driver. The Government has therefore
made out a prima facie case to deny his application.
This Agency has repeatedly held, however, that a proceeding under
section 303 `` `is a remedial measure, based upon the public interest
and the necessity to protect the public from those individuals who have
misused * * * their DEA Certificate of Registration, and who have not
presented sufficient mitigating evidence to assure the Administrator
that they can be entrusted with the responsibility carried by such a
registration.' '' Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting
Leo R. Miller, 53 FR 21931, 21932 (1988)). Therefore, where, as here,
``the Government has proved that a registrant has committed acts
inconsistent with the public interest, a registrant must `present
sufficient mitigating evidence to assure the Administrator that [he]
can be entrusted with the responsibility carried by such a
registration.' '' Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008)
(quoting Jackson, 72 FR at 23853 (2007) (quoting Leo R. Miller, 53 FR
21931, 21932 (1988))), aff'd, Medicine Shoppe-Jonesborough v. DEA,
slip. op. at 9-10 (6th Cir. Nov. 13, 2008). ``Moreover, because `past
performance is the best predictor of future performance,' ALRA Labs,
Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), [DEA] has repeatedly
held that where a registrant has committed acts inconsistent with the
public interest, the registrant must accept responsibility for [his]
actions and demonstrate that [he] will not engage in future
misconduct.'' Medicine Shoppe, 73 FR at 387; accord Jackson, 72 FR at
23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Prince George
Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419 F.3d at
483 (``admitting fault'' is ``properly consider[ed]'' by DEA to be an
``important factor[]'' in the public interest determination).
The Government raises two arguments in support of its contention
that Respondent's application should be denied. In its proposed
findings, the Government contends that ``[a]lthough Respondent
presented substantial expert and peer testimony in support of his
rehabilitation, he does not appear to have taken full responsibility
for his past forays into addiction and drug abuse.'' Gov. Proposed
Findings at 6. In its Exceptions, however, the Government argues that
``[t]he evidence that the applicant presented at the hearing as to his
rehabilitation was sparse and less than convincing.'' Gov. Exceptions
at 2.
As for the contention that Respondent has not taken ``full
responsibility for'' what it describes as his ``past forays,''
apparently the Government relies on Respondent's testimony regarding
the 1981 episode, as well as the reasons he gave for the problems he
had in 1991 and 2001. The Government's contention is wholly
unpersuasive.
As for the 1981 arrest for cocaine distribution, twenty-seven years
have elapsed since this event and there is no evidence that Respondent
ever subsequently engaged in the unlawful distribution of either
illicit (street) or prescription controlled substances to others.
Furthermore, Respondent did not deny that he had committed the acts.
The Government apparently also finds fault with Respondent's
testimony regarding what led to his becoming addicted in 1991. See
Prop. Findings at 4 (``He attributed his 1991-1992 drug use to chronic
headaches.''). The Government, however, offered no evidence to refute
Respondent's testimony that he was prescribed controlled substances as
treatment for a legitimate medical condition, and that he became
addicted over the course of that treatment. Nor is Respondent the first
person to become addicted to a drug prescribed in the course of
legitimate medical treatment. Related to this incident, the Government
also ignores that Respondent voluntarily entered treatment and
underwent treatment and aftercare for approximately six years.
Moreover, in discussing this period of his life, Respondent did not
deny that he was chemically dependent.
Finally, the Government contends that Respondent ``attributed his
2001 conviction to personal stress'' \6\ and that he ``failed recovery
after several years of rehabilitation.'' Id. The Government, however,
offered no evidence showing that Respondent's testimony was false, and
in any event, it is not clear why his explanation--``a number of
things, personal things, stress,'' Tr. 393--regarding the cause of his
relapse, establishes that he has failed to accept responsibility.
---------------------------------------------------------------------------
\6\ The Government's own exhibit establishes that Respondent was
not convicted of any offense related to the 2001 incident, which was
nol-prossed. See GX 8.
---------------------------------------------------------------------------
In any event, the great weight of the evidence refutes the
contention. Notably, Respondent fully acknowledged his misconduct in
writing the prescriptions to the cab driver. Moreover, with respect to
his addiction, Respondent produced ample evidence demonstrating that he
acknowledges that he is chemically dependent. This includes both
Respondent's testimony and written admission regarding his addiction.
See GX 9, at 3 (settlement agreement with state board; ``Respondent has
admitted he is chemically dependent''); Tr. 261 (``I went [to
treatment] because something had to change * * * I couldn't keep doing
what I was doing''); id. at 358-59 (acknowledging his admission in the
state board settlement agreement); see also GX 1, at 4 (answer to DEA
application's liability questions; ``I am committed to a lifelong
recovery program and will follow all continuing recommendations of MPHP
and the [state] Board.'').
Moreover, both Dr. Orlovick, the psychologist who runs MPHP's
aftercare program, and Mr. Bondurant, the MPHP Program Coordinator,
testified that Respondent acknowledges his addiction. See id. at 287
(testimony of Dr. Orlovick; Respondent ``has an extremely deep
acceptance of the fact that he is an addict in recovery and has
established a lifestyle that maintains and protects that * * *
recovery''); id. at 295 (testimony of Dr. Orlovick; Respondent
``accept[s] responsibility for his own behavior''). Id. at 164
(testimony of Mr. Bondurant; ``over the intervening years [Respondent]
has learned that he does have limitations and that the addiction issue
is a life-long process and he is not stronger than the addiction''). It
is thus clear that Respondent has accepted responsibility for both his
misconduct and addiction.
As for the contention that Respondent has not sufficiently
established his rehabilitation, in its proposed findings, the
Government acknowledged that ``Respondent presented substantial expert
and peer testimony in support of his rehabilitation,'' Id. at 6. In its
Exceptions, however, the Government does an about-face and now argues
that ``[t]he evidence that the applicant presented at the hearing as to
his rehabilitation was sparse and less than convincing.'' Gov. Exc. at
2. Even ignoring the inconsistency between its initial and subsequent
positions, I conclude that Respondent put forward compelling evidence
of his
[[Page 10082]]
rehabilitation.\7\ Specifically, in addition to his own testimony,
Respondent introduced the affidavit of the Missouri Board's Executive
Director that he was ``in compliance with the Settlement Agreement,''
RX 4, at 1; a letter from the physician who treated him at Talbott, RX
5; and again, the testimony (and letters) of Mr. Bondurant, Dr.
Orlovick, and R.S., a dentist who was also a member of Respondent's
aftercare group.
---------------------------------------------------------------------------
\7\ Notwithstanding the suggestion in the Government's proposed
findings, there is no evidence that Respondent has relapsed
following the treatment he received in 2002.
---------------------------------------------------------------------------
More specifically, Respondent's treating physician at Talbott wrote
that his drug screens were negative, that he was ``doing well in
recovery,'' that he was ``willing to comply with all recommendations
and continued participation in recovery activities,'' and that he ``is
competent to practice medicine.'' RX 5. Mr. Bondurant testified as to
Respondent's compliance with the conditions of the MPHP; that he had
never failed or refused to undergo a drug test (whether the test was
ordered by the Drug Court, MPHP, or the Board); that he had not
received any adverse information regarding Respondent, who is ``in a
very solid recovery''; and that he had ``no reason to believe that
[Respondent] would'' pose a threat to public safety. Tr. 153-54, 156,
161-62, 166.
To similar effect, Dr. Orlovick testified that Respondent ``has
established a lifestyle that maintains and protects [his] recovery,''
and that he had ``no fears or concerns about'' Respondent's regaining a
registration. Id. at 287 & 294. Dr. Orlovick also testified that ``the
length of [Respondent's] recovery and the ways he has been managing his
life [are] excellent indices reflecting his readiness to'' responsibly
hold a registration. Id. at 295. Dr. Orlovick further stated that he
did know of any reason why Respondent's application should not be
granted and that he had the tools necessary to maintain his recovery.
Id.
Finally, R.S., who has known Respondent for six years from their
participation in Caduceus meetings, testified that Respondent's
``commitment to his recovery is outstanding.'' Id. at 212. He also
stated that he could not think of any reason why Respondent would not
responsibly prescribe controlled substances. Id. at 214.
In response to this evidence, much of which was available at the
time Respondent applied for a new registration, the Government offered
nothing. I hold, however, that Respondent's evidence as to his
rehabilitation is convincing and reject the Government's contention to
the contrary. Indeed, as the Supervisory DI testified, he could not
explain why it would be inconsistent with the public interest for
Respondent to hold a registration. I therefore conclude that Respondent
has established that granting his application would be consistent with
the public interest. 21 U.S.C. 823(f).
Sanction
As Respondent himself recognizes, the record nonetheless supports
imposing conditions on his registration. Resp. Proposed Findings at 21-
22. Under the Settlement Agreement with the State Board, Respondent is
required to maintain duplicate serially numbered prescriptions
separately from patient charts for each controlled substance
prescription he writes. GX 11, at 4. Respondent has agreed to provide
or make available these records to this Agency and has also agreed to
consent to inspections of these records without the Government having
to obtain an administrative warrant. Resp. Prop. Findings at 22. These
requirements are therefore imposed as conditions of Respondent's
registration.
Relatedly, the record also supports the ALJ's recommendation that
Respondent must maintain and submit on a quarterly basis, a log listing
in chronological order, all controlled substance prescriptions he
issues. The log shall include the prescription number, patient name and
address, name, amount and strength of the drug prescribed, and number
of refills authorized. The log shall also include any prescriptions and
refills authorized by Respondent by telephone.
According to the terms of his agreement with the State BNDD,
Respondent is not authorized to ``order, purchase or accept'' any
controlled substances. GX 11, at 5. The BNDD Order further provides
that Respondent ``shall not dispense any controlled substances other
than by administering or prescribing.'' Id.
It is unclear whether Respondent seeks authority to administer
controlled substances at his clinic (as opposed to in a hospital
setting), whether the BNDD agreement authorizes him to do so, and if he
is permitted to do so, how he can legally obtain them.\8\ Moreover, the
extent to which Respondent performs procedures in his clinic which
require the administration of a controlled substance is also not fully
established on this record.
---------------------------------------------------------------------------
\8\ The record establishes that another doctor, who was
alternatively characterized as Respondent's associate or partner,
administers controlled substances at his clinic. Tr. 244. According
to Respondent, while his associate/partner holds a DEA and state
registration, the latter is not authorized under agreements with the
state authorities to stock controlled substances and no controlled
substances are currently being stocked at the clinic. The record
does not establish how Respondent's partner/associate obtains and
maintains the controlled substances which are used at his clinic.
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In the event Respondent seeks authority to administer controlled
substances at the clinic, he must first provide evidence from the
Missouri BNDD clearly stating that he is authorized to do so.
Respondent must also explain how any controlled substances will be
lawfully obtained (notwithstanding his agreement with the BNDD
prohibiting his ordering and purchasing them), how they will be stored,
and how they will be accounted for. Respondent shall not administer
controlled substances at his clinic until he complies with this
condition and receives written approval from this Agency. Respondent
can, however, administer a controlled substance in a hospital setting.
Respondent shall not prescribe any controlled substance to himself
or any family member. Respondent shall not obtain a controlled
substance for his own use unless it has been prescribed by another
practitioner in accordance with the prescription requirement of federal
law. See 21 CFR 1306.04 (``A prescription for a controlled substance to
be effective must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice.'').
Respondent shall also ensure that the MPHP quarterly status reports
are submitted to the Agency. All reports and logs are to be submitted
to the Special Agent in Charge (or his designee), St. Louis Field
Division, no later than fifteen days following the end of the quarter.
Respondent shall also promptly notify the Special Agent in Charge (or
his designee) of any action taken by either the State Board or BNDD
against his license or state registration. Failure to comply with any
of the conditions specified above shall be grounds for the suspension
or revocation of Respondent's registration.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b) & 0.104, I hereby order that the application of
Steven M. Abbadessa, D.O., for a DEA Certificate of Registration as a
practitioner be, and it
[[Page 10083]]
hereby is, granted, subject to the conditions set forth above. This
Order is effective immediately.
Dated: February 26, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-4906 Filed 3-6-09; 8:45 am]
BILLING CODE 4410-09-P