[Federal Register: March 9, 2009 (Volume 74, Number 44)]
[Notices]
[Page 10077-10083]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr09-80]
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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