FR Doc E9-4906[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.
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\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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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.
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\2\ The incident which prompted the denial (and this
proceeding) is discussed below.
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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.
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\3\ The record establishes that the testing screens for
prescriptions opiates including hydrocodone and oxycodone.
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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.
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\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.
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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\
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\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.
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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
[[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.
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\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.
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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.
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\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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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.
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\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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
