Registrant Actions - 2011
[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19420-19434]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8348]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-40]
Michael J. Aruta, M.D.; Decision and Order
On August 10, 2010, Administrative Law Judge (ALJ) John J.
Mulrooney, II, issued the attached recommended decision.\1\ The
Respondent did not file exceptions to the decision.
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\1\ All citations to the ALJ's Decision (ALJ) are to the slip
opinion as issued on August 10, 2010, and not to the attached
decision which has been reformatted.
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Having reviewed the record in its entirety including the ALJ's
recommended decision, I have decided to adopt the ALJ's rulings,
findings of fact,\2\ conclusions of law,\3\ and recommended Order.
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\2\ The ALJ found that there is "no evidence that the
Respondent 'prescribe[d] and dispense[d] inordinate amounts of
controlled substances." ALJ at 26. While there is no evidence as to
the amounts that Respondent directly dispensed, there is evidence,
which is unrefuted, that Respondent prescribed inordinate amounts of
controlled substances. In his report, an Expert witness explained
that the usual starting dose of Xanax is .25 to .5 mg. once to twice
per day and yet Respondent prescribed Xanax 2 mg. twice per day to
patients "who had not had Xanax before or recently," and that he
did so without documenting that he had considered any of the
possible underlying causes of his patients' complaint that they had
anxiety; moreover, Respondent did not refer the patients to a mental
health professional. GX 5, at 9-10. As the Expert explained, "[t]he
treatment was with a very high dose of the controlled substance
Xanax. This was clearly not within the boundaries of professional
practice." Id. at 10. There is also unrefuted evidence that
Respondent's prescribing of drug cocktails of oxycodone and Xanax
lacked a legitimate medical purpose. Id. at 13. In this manner,
Respondent did prescribe inordinate amounts.
\3\ I do not, however, adopt the ALJ's discussion of the
standards applied by the Agency in assessing a practitioner's
experience in dispensing controlled substances, which cites cases
involving list chemical I distributors, a different category of
registrant. See ALJ at 25-26. As the Agency has previously made
clear, DEA can revoke based on a single act of intentional diversion
and "evidence that a practitioner has treated thousands of
patients" in circumstances that do not constitute diversion "does
not negate a prima facie showing that the practitioner has committed
acts inconsistent with the public interest." Jayam Krishna-Iyer, 74
FR 459, 463 (2009). See also Dewey C. MacKay, 75 FR 49956, 49977
(2010); Medicine Shoppe-Jonesborough, 73 FR 364, 386 & n.56 (noting
that pharmacy "had 17,000 patients," but that "[n]o amount of
legitimate dispensings can render * * * flagrant violations [acts
which are] 'consistent with the public interest"'), aff'd, Medicine
Shoppe-Jonesborough v. DEA, 300 Fed. Appx. 409 (6th Cir. 2008). As I
further explained, "[w]hile such evidence may be [entitled to] some
weight in assessing whether a practitioner has credibly shown that
[he] has reformed his practices," it is entitled to no weight where
a practitioner fails to acknowledge his wrongdoing. Krishna-Iyer, 74
FR at 463.
In any event, Respondent offered no evidence on the issue of his
experience in dispensing controlled substances and the ALJ's
ultimate conclusions that Respondent violated the CSA's prescription
requirement because he dispensed controlled substance prescriptions
that were not "within 'the usual course of [his] professional
practice,' " ALJ at 39 (quoting 21 CFR 1306.04(a)), and that "the
evidence under the [experience] * * * factor[] support[s]" the
revocation of his registration, is consistent with Agency precedent.
Id.
With respect to factor five, "[s]uch other conduct which may
threaten public health and safety," 21 U.S.C. 823(f)(5), the ALJ
opined that "an adverse finding under this factor requires some
showing that the relevant conduct actually constituted a threat to
public safety." ALJ at 39 (emphasis added). Contrary to the ALJ's
reasoning, Congress, by inserting the word "may" in factor five,
clearly manifested its intent to grant the Agency authority to
consider conduct which creates a probable or possible threat (and
not only an actual) threat to public health and safety. See
Webster's Third New Int'l Dictionary 1396 (1976) (defining "may"
in relevant part as to "be in some degree likely to"); see also
The Random House Dictionary of the English Language 1189 (1987)
(defining "may" in relevant part as "used to express
possibility"). While the ALJ misstated the applicable standard, his
conclusion that Respondent repeatedly ignored "red flags"
indicative of likely diversion and thus "created a significant
potential conduit for the unchecked diversion of controlled
substances," ALJ at 39, is clearly supported by substantial
evidence and warrants an adverse finding under factor five.
The ALJ also opined that "[i]t is clear that in assessing
whether the controlled substance prescribing practices of a Florida
practitioner fall within the acceptable range of what constitutes
being within the bounds of being 'issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of
his professional practice,' resort must be had to an expert." ALJ
at 34 (quoting 21 CFR 1306.04(a)). While the ALJ properly noted the
importance of expert testimony in this case, in which the Government
primarily relied on a review of the medical charts, whether expert
testimony is needed in any case necessarily depends on the nature of
the allegations and the other evidence in the case. Where, for
example, the Government produces evidence of undercover visits
showing that a physician knowingly engaged in outright drug deals,
expert testimony adds little to the proof necessary to establish a
violation of Federal law.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 21 CFR 0.100(b) and 0.104, I order that DEA
Certificate of Registration, BA6733578, issued to Michael J. Aruta,
M.D., be, and it hereby is revoked. I further order that any pending
application of Michael J. Aruta, M.D., to renew or modify his
registration, be, and it hereby is, denied. This Order is effective
immediately.
Dated: March 31, 2011.
Michele M. Leonhart,
Administrator.
Larry P. Cote., Esq., for the Government.
Bernard M. Cassidy., Esq., for the Respondent.
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
John J. Mulrooney, II, Administrative Law Judge. On February 25,
2010, the Deputy Administrator, Drug Enforcement Administration (DEA or
Government), issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO), immediately suspending the DEA Certificate of
Registration (COR), Number BA6733578, of Michael J. Aruta, M.D.
(Respondent), as a practitioner, pursuant to 21 U.S.C. 824(d), alleging
that such registration constitutes an imminent danger to the public
health and safety. The OSC/ISO also seeks revocation of the
Respondent's registration, pursuant to 21 U.S.C. 824(a)(4), and denial
of any pending applications for renewal or modification of such
registration, pursuant to 21 U.S.C. 823(f), alleging that the
Respondent's continued registration is inconsistent with the public
interest, as that term is used in 21 U.S.C. 823(f). On March 24, 2010,
the Respondent timely requested a hearing, which was conducted in
Miami, Florida, on July 7, 2010 through July 9, 2010.\4\ The immediate
suspension of the Respondent's COR has remained in effect throughout
these proceedings.
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\4\ Pursuant to an order issued on April 15, 2010, the hearing
in this matter was consolidated with the cases of four other
registrants who were working at the same clinic as the Respondent
and who were also issued OSC/ISOs on February 25, 2010, alleging
similar and related conduct.
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The issue ultimately to be adjudicated by the Deputy Administrator,
with the assistance of this recommended decision, is whether the record
as a whole establishes by substantial evidence that Respondent's
registration with the DEA should be revoked as inconsistent with the
public interest as that term is used in 21 U.S.C. 823(f) and 824(a)(4).
The Respondent's DEA practitioner registration expires by its terms on
June 30, 2012.
After carefully considering the testimony elicited at the hearing,
the admitted exhibits, the arguments of counsel, and the record as a
whole, I have set forth my recommended findings of fact and conclusions
below.
The Evidence
The OSC/ISO issued by the Government alleges that the Respondent,
through the medical practice he had been conducting at American Pain,
LLC (American Pain), has prescribed and dispensed inordinate amounts of
controlled substances, primarily oxycodone,\5\ under circumstances
wherein he knew, or should have known, that the controlled substances
were not prescribed and/or dispensed for a legitimate medical purpose.
ALJ Ex. 1. The OSC/ISO
[[Page 19421]]
further charges that these prescriptions were issued outside the usual
course of professional practice based on a variety of circumstances \6\
surrounding the manner in which American Pain has been operated and the
manner in which its physicians, to include the Respondent, has engaged
in the practice of medicine. Id. The OSC/ISO also sets forth the
Government's allegation that Respondent's former patients have apprised
law enforcement personnel that "they were able to obtain prescriptions
for controlled substances from [the Respondent] for other than a
legitimate medical purpose and with little or no medical examination."
Id.
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\5\ A schedule II controlled substance.
\6\ The majority of which are supported by no evidence
introduced by the Government during the course of these proceedings.
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At the hearing, the Government presented the testimony of three
witnesses, DEA Miami Field Division (MFD) Group Supervisor (GS) Susan
Langston, DEA Special Agent (SA) Michael Burt, and L. Douglas Kennedy,
M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the
University of Miami, Miller School of Medicine.
GS Langston testified that the investigation of the American Pain
Clinic had its origins on November 30, 2009, during a routine
inspection that she and a subordinate diversion investigator conducted
at Appurtenance Biotechnology, LLC, a pharmacy doing business under the
name Boca Drugs (Boca Drugs), and located a few blocks away from one of
the former locations of American Pain. Tr. at 713, 717-20. According to
Langston, an examination of the prescriptions seized from Boca Drugs
revealed that the majority of those prescriptions were for oxycodone
and alprazolam authorized over the signature of physicians associated
with American Pain.\7\ Id. at 721. Under Langston's supervision, DEA
diversion investigators catalogued the prescriptions seized at Boca
Drugs (Boca Drugs Prescription Log). Govt. Ex. 118. A review of the
data relative to the Respondent on the Boca Drug Prescription Log
reveals that from November 2, 2009 through November 25, 2009, 175
controlled substance prescriptions issued over the Respondent's
signature, to eighty-nine patients, only five of whom resided in
Florida. The remainder of the patients had listed addresses in
Kentucky, Tennessee, Ohio, Georgia, Massachusetts, West Virginia, North
Carolina, Virginia, and South Carolina.
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\7\ Although GS Langston testified that DEA immediately
suspended the COR that had been issued to Boca Drugs, Tr. at 715,
and that a voluntary surrender by that registrant followed a day
later, id. at 776, no evidence has been presented that would lend
that fact any particular significance related to any issue that must
or should be found regarding the disposition of the present case.
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GS Langston also testified that, on March 3, 2010, a criminal
search warrant was executed on the American Pain Clinic simultaneously
with the OSC/ISO that initiated the present case. Tr. at 735. According
to Langston, the items seized from American Pain included a sign that
had been posted in what she believes to have served as the urinalysis
waiting room. Tr. at 735-37. The seized sign set forth the following
guidance:
ATTENTION PATIENTS
Due to increased fraudulent prescriptions, [i]t's best if you
fill your medication in Florida or your regular pharmacy. Don't go
to a pharmacy in Ohio when you live in Kentucky and had the scripts
written in Florida. The police will confiscate your scripts and hold
them while they investigate. This will take up to 6 months. So only
fill your meds in Florida or a pharmacy that you have been using for
at least 3 months or more.
Govt. Ex. 119 at 1. This sign is attached, apparently by some sort of
tape, to the top portion of two other signs, posted at the same
location, the first of which reads:
ATTENTION:
Patients
Please do NOT fill your prescriptions at any WALGREENS PHARMACY \8\
or OUTSIDE the STATE OF FLORIDA.
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\8\ GS Langston testified that she was unaware of the location
of the closest Walgreens to American Pain's offices. Tr. at 779. No
evidence was presented that would tend to establish that any
Walgreens or any other pharmacy has taken a position regarding its
willingness to fill prescriptions authorized by American Pain.
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Id. The final attachment to the composite sign bears the words "24 Hour Camera Surveillance."
Id. A photograph of the composite sign was admitted into evidence.
Langston also testified that while she was present in the American
Pain offices, she noticed that each physician's desk was equipped with
a group of stamps, each of which depicted a controlled substance
medication with a corresponding medication usage instruction (sig). Tr.
at 738-39. A photograph of one set of prescription script stamps was
admitted as an exhibit.\9\ Govt. Ex. 119 at 2.
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\9\ Although GS Langston testified that she did not actually
take the photographs taken during the search warrant execution at
American Pain, she did provide sufficient, competent evidence to
support the admission of the photographs that were ultimately
received into evidence. Tr. at 737, 739-41.
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GS Langston also testified that a great number of medical charts
were seized from the American Pain offices, and that she and her staff
selected a number of these files to be analyzed by a medical expert
procured by the Government. Tr. at 762. According to GS Langston, after
the execution of the warrant, the charts from the entire office were
placed into piles in alphabetical order, and not separated by
physician. Langston testified that she and three of her diversion
investigators reviewed the seized files with a view towards choosing
approximately fifteen files for each doctor with the aspirational
criteria that each would reflect at least three to four visits by that
doctor with a patient. Each investigator was empowered to place a chart
on the selected pile, and when the target number (or about that number)
was reached for each physician, the selection effort relative to that
physician was deemed accomplished. Id. at 765. Langston credibly
testified that there was no effort to specially select files under some
prosecution-enhancement or "cherry picking" purpose. Id. at 768.
Langston also explained DEA's Automated Record Consolidated
Ordering System (ARCOS) \10\ and testified that she generated an ARCOS
report relative to the Respondent's ordering of controlled substances
from January 2009 through February 2010.\11\ Govt. Ex. 2.
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\10\ GS Langston explained that through the ARCOS system,
"[d]rug manufacturers and distributors are required to report the
sale of certain controlled substances to DEA," and the system
"shows the history of a drug from the point of manufacture through
the distribution chain to the retail dispensing level." Tr. at 685-
86.
\11\ For reasons that were never made clear, the ARCOS report
begins with a 2006 entry. Govt. Ex. 2 at 1.
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In the same fashion, Langston explained the purposes of and
circumstances behind the generation of State prescription monitoring
reports (PMPs) relative to the Respondent maintained by West Virginia
and Kentucky. Govt. Exs. 3, 4. Review of the PMP report data reflects
that during the time period of February 1, 2006 through February 11,
2010, pharmacies filled 210 controlled substance prescriptions issued
over the Respondent's signature to fifty-five patients located in West
Virginia, and 182 similar prescriptions provided to seventy-eight
Kentucky-based patients were filled between January 1, 2009 and April
4, 2010. Id.
No evidence was introduced at the hearing that would provide any
reliable level of context regarding the raw data set forth in the
databases received into evidence at the Government's request. Other
than the observations noted above, no witness who testified at the
hearing ever explained the significance
[[Page 19422]]
of the data set forth in any of these databases to any issue that must
or should be considered in deciding the present case.
GS Langston provided evidence that was sufficiently detailed,
consistent and plausible to be deemed credible in this recommended
decision.
SA Michael Burt testified that he has been employed by DEA since
March 2004 and has been stationed with the Miami Field Division (MFD)
since September 2004. Tr. at 813-14. Burt testified that he is the lead
case agent for DEA in the investigation of American Pain Clinic and has
participated in the investigation since the latter part of 2008.
According to Burt, American Pain, which was previously known by the
name South Florida Pain, has conducted business at four different
locations, and he surveilled the Boca Raton and Lake Worth locations
both in person and by periodic live review of video captured via pole
cameras \12\ set up outside the clinic. Id. at 815-17. These pole
cameras, which were in operation during a three week period from
January to February 2010, were initially in operation on a 24 hour
basis, but Burt testified that they were later activated only between
the hours of 7 a.m. through 6 p.m. due to an observed lack of activity
at the clinic outside of that time period. Id. at 820-21. The pole
camera recordings were not offered into evidence at the hearing or made
available to opposing counsel.
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\12\ SA Burt described the pole cameras as "covert cameras that
are installed to observe the activity in the clinic." Tr. at 816.
Burt testified that he was able to use a laptop to access the live
video feed from the cameras after inputting a username and password.
The camera video was also recorded to DVR. Id. at 821.
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Based on these surveillance efforts, SA Burt testified concerning
various activities he observed occurring outside the Boca and Lake
Worth clinic locations, which were open to the public from 8 a.m. to 5
p.m. At the Boca location, Burt stated that on any given day, beginning
at 7 a.m. in the morning, automobiles could be seen pulling into the
parking lot and approximately twenty to thirty people were routinely
lined up outside of the clinic waiting to gain admittance.
Additionally, there was a steady stream of automobile and foot traffic
in and out of the clinic throughout the day. Id. at 817, 821. Burt
testified that in his estimation, approximately 80-90 percent of the
automobiles had out-of-State tags, predominantly from Kentucky, Ohio,
West Virginia and Tennessee. Id. at 817-18. Burt also observed security
personnel with "staff" written on their shirts \13\ riding around the
exterior of the building in golf carts and who, in Burt's assessment,
appeared to be directing patients into the American Pain facility. Burt
indicated his surveillance of the Lake Worth location yielded similar
observations. Id. at 818.
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\13\ Tr. at 910.
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Based on his review of some (but not all) \14\ of the audio and
video tapes made by agents and informers sent into the clinic by the
Government at various times, SA Burt also testified about his
understanding of the process by which patients obtained controlled
substance prescriptions at American Pain. According to Burt, after
entering the clinic, a patient would meet with the receptionist, who
would determine if the patient had an MRI. If not, the receptionist
would issue that individual an MRI prescription in exchange for a $50
cash payment, and the patient "would be directed to a place to obtain
an MRI." Id. at 822. Burt testified that one such MRI location was
Faye Imaging, which was a mobile MRI trailer located behind a
gentlemen's club several miles away from American Pain. Id. at 822-23.
The cost for the MRI was $250, and the patient could pay an additional
fee "to have the MRI expedited and faxed over to American Pain." Id.
at 823-24. Once the MRI was procured and faxed to American Pain, the
patient would return to the clinic and be seen by a doctor. According
to Burt, the clinic accepted what he referred to as "predominantly
cash only" \15\ for these office visits, and the six doctors at the
clinic saw "anywhere from 200 upward to 375 patients a day" \16\ in
this manner.\17\ Id. at 882-83 (emphasis supplied).
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\14\ SA Burt conceded that although he is the designated lead
case agent for DEA, he did not review all the audio and video tapes
made in the case or even review the transcripts. Tr. at 1002-05.
\15\ Later on cross-examination, SA Burt admitted that the
clinic also accepted payment via credit card. Tr. at 916.
\16\ Inasmuch as the Government provided no information from
which any specific number of patients seen by any given clinic
doctor on any day could be derived, or any expert testimony
regarding a reasonable number of pain patients that could or should
be seen per day, the value of providing the raw number of patients
walking through the door at the clinic is negligible.
\17\ Burt further testified that the doctors were paid $75.00
per patient visit, id. at 884, but because he indicated that he
could not disclose his basis of knowledge for this information, this
portion of his testimony can be afforded no weight. To proceed
otherwise would deny the Respondent the ability guaranteed by the
APA "to conduct such cross-examination as may be required for a
full and true disclosure of the facts." 5 U.S.C. 556(d); see
Richardson v. Perales, 402 U.S. 389, 402 (1971); J.A.M. Builders v.
Herman, 233 F.3d 1350, 1354 (11th Cir. 2000); Keller v. Sullivan,
928 F.2d 227, 230 (7th Cir. 1991); Calhoun v. Bailar, 626 F.2d 145,
149 (9th Cir. 1980).
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SA Burt also testified regarding his review of some \18\ of the
video and audio recordings made by an undercover agent (UC) who assumed
the name Luis Lopez capturing activity inside of American Pain.\19\ In
those recordings, Burt observed who he believed to be an American Pain
employee inside the facility standing up in a waiting room full of
patients and directing them "not to have their prescriptions filled
out of State, not to go out into the parking lot and snort their
pills," and directing the patients to have their prescriptions filled
"in house" (meaning at American Pain), at "a pharmacy they have in
Orlando, Florida," or at "a pharmacy they have down the street,"
which, in Burt's view, was a reference to Boca Drugs. Id. at 825-26.
Burt further testified that the purported employee on the recording
told the patients to "obey all the traffic laws; do not give the
police a reason to pull you over." Id. Although Burt testified as to
the contents of these recordings, the physical recordings were not
offered into evidence by the Government or made available to opposing
counsel.
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\18\ Tr. at 1002-05.
\19\ The fact that these recordings were made during the course
of seven different office visits by an undercover agent to both the
Boca Raton and Lake Worth locations was established on cross-
examination. Tr. at 900, 985.
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SA Burt also testified that he received information from Dr. Eddie
Sollie, a former physician employed during the time period American
Pain was doing business as South Florida Pain, who terminated his
employment at the Oakland Park clinic location in November or December
2008 after working there for approximately two and a half to three
months.\20\ Id. at 827, 898. During the course of an interview where
Burt was present, Dr. Sollie related various "concerns about how the
practice was being handled or managed." Id. at 827-28. These concerns
included medical records being, in his opinion, annotated inadequately
by the doctors, and what he perceived as a lack of supervision during
patient urinalysis testing, where patients would "go[] to the
bathrooms together, bringing items with them to the bathrooms that
could possibly disguise the urinalysis." According to Burt, Sollie
explained that he perceived that patients were substituting urine
produced by other persons that contained the metabolites
[[Page 19423]]
for controlled substances that the patients claimed to be legitimately
taking, with a view towards falsely providing evidence to the American
Pain doctors showing that they were actually taking prescribed
medications and not diverting them. Id. at 828-29. During cross-
examination, Burt explained that Dr. Sollie told him he had raised
these concerns with Christopher George, the owner of American Pain, and
that Burt had no evidence that the deficient practices that Sollie had
objected to continued through 2010. Id. at 900, 906. Burt also
acknowledged that he was aware Dr. Sollie had been involved in
litigation with Mr. George and that their relationship was strained.
Id. at 1009. Dr. Sollie was not called as a witness by either party.
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\20\ On cross-examination, SA Burt stated that he did not know
whether it was true that the Respondent began working at the clinic
in 2009 (a representation made by Respondent's counsel, but not in
evidence), which (at least according to the question posed) would
have been after Sollie's employment at the clinic had already ended.
Tr. at 898.
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SA Burt also provided testimony concerning three confidential
sources (only one of whom was seen by the Respondent) and their
contacts with doctors at American Pain. Relative to the Respondent,
Burt testified concerning his April 2009 debriefing of a confidential
source of information (CS2) based in Kentucky who came to Burt's
attention through his Kentucky law enforcement contacts. Id.at 866-67.
Burt assisted the source's Kentucky handlers with arranging for CS2 to
visit American Pain, at which time she was able to obtain a
prescription for oxycodone from the Respondent. Burt testified that
during the debriefing, CS2 told him the Respondent instructed her "not
to go out of the State of Florida and try to get this pain medication
[prescription] filled," and that it should instead be filled within
Florida. Id. at 869. According to Burt, CS2 also indicated that she did
not have a legitimate medical need for the controlled substances when
they were acquired from the Respondent. The Government did not submit
evidence of, or provide opposing counsel access to, a patient file
reflecting CS2's visit with the Respondent, or a copy of the
prescription allegedly issued.\21\ Burt indicated CS2's cooperation in
this investigation was as a result of "working off" criminal charges
she was subject to. Id. at 895. Burt also declined to disclose the name
of CS2 when queried on cross-examination. Id. at 893.\22\
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\21\ On cross-examination, SA Burt responded in the negative
when asked if he had "anywhere" in his possession a copy of the
prescription at issue and whether he had supplied Government counsel
with a copy of this individual's patient file. Tr. at 894.
\22\ In light of the inability to identify the name of this
source of information to opposing counsel, and the lack of detail
and corroborating evidence related to the information derived from
her, no weight can be assigned to SA Burt's testimony concerning
information provided by CS2, beyond the fact that this interaction
may have informed the course of DEA's investigation. To proceed
otherwise would deny the Respondent the ability guaranteed by the
APA "to conduct such cross-examination as may be required for a
full and true disclosure of the facts." 5 U.S.C. Sec. 556(d); see
Richardson v. Perales, 402 U.S. 389, 402 (1971); J.A.M. Builders v.
Herman, 233 F.3d 1350, 1354 (11th Cir. 2000); Keller v. Sullivan,
928 F.2d 227, 230 (7th Cir. 1991); Calhoun v. Bailar, 626 F.2d 145,
149 (9th Cir. 1980).
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SA Burt also testified regarding the drug overdose deaths of TY and
SM after obtaining controlled substances from American Pain.\23\ Burt's
record testimony indicates that DEA Task Force Officer \24\ (TFO) Barry
Adams informed him that a Kentucky resident named TY overdosed in
Kentucky from oxycodone intoxication induced by medication procured at
American Pain. Burt testified that this information was furnished
pursuant to a working law enforcement relationship between the Kentucky
State Police, Kentucky FBI, Kentucky DEA and Miami DEA aimed at
addressing "the brunt of the pill problem" centered within the State
of Kentucky relative to illegal use and resale of prescription pain
medications. Id. at 833-35. However, in his testimony, Burt was unable
to recall the name of the doctor from whom TY obtained his pills, and,
thus, no admissible evidence was presented by the Government with
respect to TY's death.\25\ Likewise, the record evidence concerning SM
did not implicate prescribing activity by the Respondent.
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\23\ Although similar testimony concerning the overdose death of
a third individual, OB, was noticed in the Government's prehearing
statement, it was not offered by the Government at the hearing. ALJ
Ex. 6 at 8.
\24\ According to SA Burt, a "task force officer" is a local
police officer or sheriff's deputy that is assigned to work on a DEA
task force, rather than a sworn DEA criminal investigator. Tr. at
1031.
\25\ See Tr. at 836-53 (addressing exclusion of Govt. Ex. 27 and
associated testimony).
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Perhaps among the more striking aspects of SA Burt's performance on
the witness stand is the anticipated testimony which he did not
provide. When viewed in its entirety, SA Burt's record testimony was
stunningly sparse when compared with his proposed testimony as noticed
in the Government's prehearing statement.\26\ That certain information
may be unavailable for reasons related to other litigation forums, or
other equally valid reasons, are of no moment with respect to the
evaluation that must be made at this administrative forum. Equally
important, such considerations do not alter the burdens imposed upon
the respective parties. Simply put, the admitted evidence must succeed
or fail on its own merits, irrespective of extraneous considerations.
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\26\ ALJ Ex. 6.
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Even apart from the marked contrast between the Burt testimony as
proffered and as realized, his testimony was marred by periodic memory
failures on significant issues and an inability to supply details to an
extent that it could arguably have diminished the weight that could be
fairly attached to those aspects of his own investigation that he did
manage to recollect. During his testimony, SA Burt acknowledged his own
marked lack of preparation and unfamiliarity with the investigation and
confessed simply that "[t]here's no excuse * * * " Id. at 1003-05.
Even acknowledging its obvious suboptimal aspects, SA Burt's
testimony had no apparent nefarious motivation or indicia of
intentional deceit. Burt came across as an earnest and believable
witness, who, regarding the aspects of the case that he did recall, was
able to impart substantial information about the investigation and
activities involving American Pain and its doctors. While frequently
lacking in detail, his testimony was not internally inconsistent or
facially implausible, and although the legal weight I have assigned to
certain portions of Burt's testimony varies given the issues described,
I find his testimony to be credible overall.
The Government presented the bulk of its case through the report
and testimony of its expert, L. Douglas Kennedy, M.D., D.A.B.P.M.,
Affiliate Clinical Assistant Professor at the University of Miami,
Miller School of Medicine.\27\ Dr. Kennedy, who testified that he is
board certified by the American Board of Pain Medicine and the American
Board of Anesthesiology,\28\ was offered and accepted as an expert in
the field of pain medicine. Tr. at 39.
---------------------------------------------------------------------------
\27\ Dr. Kennedy's CV was admitted into evidence. Govt. Ex. 117.
\28\ Tr. at 17.
---------------------------------------------------------------------------
Dr. Kennedy prepared a report in connection with the Government's
case against the Respondent, which is dated April 30, 2010, and was
admitted into evidence during his testimony. Govt. Ex. 5. The report
describes a general analysis of fifteen charts that the Respondent
maintained on as many patients, that were (selected by and) provided to
Dr. Kennedy by the Government \29\ from among an
[[Page 19424]]
unspecified number of patient files seized pursuant to a criminal
search warrant executed at the Respondent's practice on March 3, 2010
(Patient Charts Analysis).
---------------------------------------------------------------------------
\29\ Dr. Kennedy testified that he asked that the charts be
selected randomly and not be "cherry picked" or selected with a
view towards influencing his conclusions. Tr. at 214. As discussed,
above, GS Langston testified that the reviewed charts were not
selected with a view toward influencing Dr. Kennedy's opinion. Tr.
at 768.
---------------------------------------------------------------------------
In Dr. Kennedy's expert opinion, based on a documentary review of
the patient charts from the Respondent's practice that he reviewed, the
Respondent's prescribing practices fell below the standards set forth
by the Florida Medical Board. Tr. at 118. Furthermore, Dr. Kennedy
testified that after reviewing the charts, he was unable to identify
any legitimate basis for prescribing any of the controlled substance
medications prescribed to the patients named in the charts. Id.
During the course of his testimony, Dr. Kennedy explained that he
took professional issue with several aspects of the Respondent's
patient care as reflected in the charts regarding the prescribing of
controlled substances. It is apparent from his testimony that Dr.
Kennedy's analysis is restricted to those matters which can be gleaned
from an examination of the written word in that subset of the
Respondent's patient charts provided by the Government for his review,
and that limitation perforce circumscribes the breadth of his
testimony. That being said, Dr. Kennedy highlighted numerous features
in the Respondent's chart documentation that he found wanting, or at
least remarkable.
While acknowledging that some standardization and utilization of
forms is not, standing alone, improper,\30\ Dr. Kennedy took issue with
what he perceived as flaws in the forms utilized by the Respondent to
document patient care. According to Dr. Kennedy, the forms inadequately
distinguished between the history and physical examinations, and failed
to sufficiently document an adequate pain assessment. Id. at 79-80,
128-31. According to Dr. Kennedy, the charts also did not document
activities that improved or exacerbated pain symptoms, and did not
document self-described patient limits, neurological signs and
objective observations, such as gait and station. Id. at 81. Dr.
Kennedy testified that the chart entries were so defective that the
Respondent did not establish a sufficient doctor-patient relationship
to justify the prescribing of controlled substances, and that "this
was not the practice of medicine in [his] opinion. Id. at 160-61.
---------------------------------------------------------------------------
\30\ Tr. at 74.
---------------------------------------------------------------------------
Dr. Kennedy explained that there are basic elements to practicing
pain medicine. The acquisition of a thorough history and physical
examination is important. Id. at 44. He also stressed the vital
importance of obtaining past medical records to evaluate what
treatments, therapies, medications, and dosages have been utilized in
the past so that correct current treatment decisions can be made. Id.
at 47-48. Reliance upon the patient's memory of these elements without
the prior medical records, in Dr. Kennedy's view, is not reliable or
acceptable. Id. at 49-51. Although the Respondent's charts routinely
contained a form which purports to require patients to see their
primary care physicians, Dr. Kennedy testified that none of the files
contained any record of any communication with any primary care
physician from any patient. Id. at 114-16.
Kennedy also explained the importance of establishing a
differential or working diagnosis on the first visit and modifying and
reviewing that diagnosis as more information and results become
available. Id. at 52. Similarly, a diagnostic plan is a systematic
methodology of eliminating possible causes of symptoms to allow the
treating physician to accurately determine what is causing them so that
a successful treatment plan can be developed. Id. at 52-53. In other
words, the diagnostic plan allows the treating doctor to eliminate or
confirm items on the differential diagnosis. Id. at 54.
Dr. Kennedy testified that, in his expert opinion, the medical
histories taken by the Respondent in the reviewed files were
insufficiently detailed to meet the standards set by the Florida Board
of Medicine to justify the prescribing of controlled substances. Id. at
81-82. The histories and pain assessment evaluations, as documented in
the charts, were also "not adequate on the initial or ongoing basis,"
because the forms used and the manner in which they were completed did
not sufficiently catalogue key aspects, such as
[the] particular pain level, where the pain was located, what it
felt like, when was it worse, what made it better, what it made it
worse, what have you done to alleviate or past treatments, and what
can you not do with the pain? Observations on physical examination
about how the person walks, gait and station. Consistency of
neurologic and inadequacy of pathologic reflexes particularly,
presence or absence, and adequate sensory examination.
Musculoskeletal examination. And height and weight many times were
not present.
Id. at 80-81, see also id. at 128-32.
Similarly, Dr. Kennedy opined that Respondent's treatment plans, as
they were reflected in the reviewed records, were "grossly
inadequate" in that the use of controlled substances was the single
option considered and employed, "[s]o everybody got essentially the
same treatment regardless of their complaint, severity, physical
examination [and] history." Id. at 82-83. In Kennedy's view, combining
controlled substance medications that were utilized in the charts was
not "bad by itself, but it was done across the board with everybody. *
* * [with] essentially the same drugs at the same doses for all the
individuals" Id. at 98. In Dr. Kennedy's view, there were a panoply of
other treatment options that could and should have been documented and
discussed with the Respondent's pain patients. Id. 162-64.
Dr. Kennedy also made the ironic observation that although to the
"extremely rare" \31\ extent controlled substance medication
adjustments were ever effected by the Respondent, they went up, and the
forms utilized by the Respondent (and the practice in general) only
provided a checkbox for reduction, or weaning. Id. at 95-96. This is
essentially inconsistent with the normal practice of starting
controlled substance treatment at the lowest dose possible to attain
the desired result and adjusting upwards. Id. The form used by the
Respondent seems to presume that the controlled substance doses would
generally progress downward. Dr. Kennedy testified that he saw no
evidence of medication adjustment to accommodate treatment, or
"titration," in any of the charts he examined. Id. at 174.
---------------------------------------------------------------------------
\31\ Tr. at 96.
---------------------------------------------------------------------------
Although Dr. Kennedy conceded that it is the judgment of the
examining physician that is generally relied upon in determining the
necessity and appropriateness of diagnostic testing,\32\ he also
testified that the Respondent's practice of routinely ordering magnetic
resonance imaging (MRI) procedures before he met with the patients was
inappropriate because an MRI is not always required and not always
appropriate. Id. at 71-73, 153-54. In Kennedy's opinion, a physician
has an obligation to meet with the patient before including this
procedure as part of the utilized diagnostic tools. Id.
---------------------------------------------------------------------------
\32\ Tr. at 59.
---------------------------------------------------------------------------
Dr. Kennedy opined that the Respondent's prescribing of opioids
lacked a legitimate medical purpose in that he routinely prescribed
oxycodone in initial 30 milligram (mg) doses that significantly
exceeded the recommended 0.5 to 2.5 mg starting dosage.\33\ Id. at 86-
87. Kennedy
[[Page 19425]]
explained that a patient who has never had opioids, or has been off
them for two to four weeks is classified as "opioid na[iuml]ve" and
would feel the affects of the medication with smaller doses that can be
increased as needed. Id. at 83-86. The dosage levels prescribed by the
Respondent, in Dr. Kennedy's view, would always require significant
monitoring of the medication's effect on the patient, generally done in
an office or hospital, and not an outpatient setting. Id. at 86-88.
---------------------------------------------------------------------------
\33\ Dr. Kennedy testified that the recommended starting dosages
are found in the medication product insert and divined through
clinical knowledge. Tr. at 100.
---------------------------------------------------------------------------
In this regard, Dr. Kennedy highlighted the chart of patient
JR.\34\ Govt. Ex. 7. JR's patient chart reflects his disclosures that
he had not been prescribed pain medication within the twenty-eight days
preceding his first appointment with the Respondent. Id. at 20. A
notation on JR's pain contract indicates that he was not currently
taking any medications at the time of his appointment. Id. at 23.
Notwithstanding the fact that JR, at least by his representations,
presented as an opioid na[iuml]ve patient, the Respondent issued
prescription scripts for 30 mg of Roxicodone and 2 mg of Xanax. Id. at
17. Kennedy characterized prescribing these controlled substances as
"absolutely dangerous if [the patient] took that as prescribed. There
would be a significant incident of respiratory depression, drug
overdose and potentially death." Tr. at 90. When pressed on the
relative likelihood of adverse effects, Dr. Kennedy responded this way:
---------------------------------------------------------------------------
\34\ At the request of the Government, a protective order was
issued that is designed to minimize the risk of the dissemination of
identifying information related to patients and their relatives
associated with this case. Accordingly, initials have been
substituted for the names of individuals within the protection of
the protective order throughout the body of this decision. ALJ Ex.
15.
---------------------------------------------------------------------------
If the records that the patient filled out themselves [sic] are
correct, then that especially given with the Xanax, which is a
benzodiazepine like Valium[,] [i]ts generic name is alprazolam[,]
[a]nd that's a high dose of Xanax as well. [] [T]he typical starting
dose of Xanax is .25 to 0.5 [mg]. So, that's four to eight times
higher than the usual dose on that, and that's given twice daily.
Given that they work different areas in the nervous system and they
both can cause sedation and potentially respiratory depression,
there's at least an additive if not a synergistic effect between
when you mix different components of an opioid like oxycodone, a
narcotic pain reliever, with a benzodiazepine like Xanax,
alprazolam, especially at those doses in a na[iuml]ve person for both drugs, that makes it even more dangerous.
Id. at 91. Dr. Kennedy was asked to clarify whether this was an area
where reasonable medical professionals could differ and provided this
emphatic clarification:
No sir, this isn't even close. There's no room, wiggle room on
this. This is absolutely beyond the pale.
Id. at 92.
Notwithstanding his expressed concerns over the potency of some of
the controlled substances prescribed by the Respondent, Dr. Kennedy was
struck by the fact the charts of several of the Respondent's patients
reflected no indication that any acceptable measure of mental status,
cognitive ability and response time was undertaken. Id. at 102-07.
On cross-examination, Dr. Kennedy agreed that the reviewed charts
reflected objective signs that arguably supported medically
determinable impairments that could cause chronic pain conditions, and
that the controlled substance medications that were prescribed by the
Respondent were among those that could be correctly employed to treat
chronic pain. Id. at 132-33, 135-37, 140-42, 144-45, 148-51. However,
Dr. Kennedy remained steadfast in his dual views that the Respondent's
medical records simply did not contain enough information for a
physician to reach the conclusion that the prescribing was appropriate
and that the medication doses were simply too high. Id. at 123, 126-27,
166. Kennedy was also consistent in his position that MRI results,
standing alone, are not a reliable indicator of an impairment
indicating the utilization of controlled substance medications. Id. at
55-63, 130-31, 164-66.
In his Patient Charts Analysis, Dr. Kennedy focuses on a patient
chart related to GA, one of the Respondent's patients, and opines that
the flaws identified in GA's chart are common to all fifteen of the
Respondent's files that he reviewed. Specifically, the Patient Charts
Analysis states that the charts he reviewed "are essentially the same
with regard to review issues; as stated in the report of [GA]
referenced and discussed in this report in detail, [and that] there
were no significant differences that affected [his] conclusions and
summary." Govt. Ex. 5 at 2.
In Dr. Kennedy's opinion, the patient charts he reviewed that were
prepared by the Respondent reflected care that fell below the
applicable standard on multiple levels. In his report, Dr. Kennedy
noted that the treatment notes in the charts: (1) Contained no
typewritten clinical notes and were "very brief, difficult to read
(often impossible) and not within the bounds of professional practice
due to their brevity and quality"; \35\ (2) reflected prescriptions,
right from the initial patient visit, that "were almost entirely for
controlled substances, most often one or two immediate release
oxycodone pills with Xanax," and which were, in Dr. Kennedy's view,
inappropriate and more powerful than justified by the objective signs
documented in the written notes; \36\ (3) showed that "the same or
very similar 'drug cocktails' were prescribed [among all patients in
the reviewed files] in the same or very similar doses, [directions] * *
* with a 30-day supply," and were affixed to the prescription scripts
with a few prepared stamps utilized by all American Pain physicians
that reflected "drug, dose, sig (directions) and quantity dispensed";
\37\ (4) contained medication contracts that were "not always signed"
and "listed criteria that was not followed by the doctors at American
Pain; \38\ (5) failed to adequately document the efficacy of the
prescribed medication; (6) did not set forth a "diagnostic plan except
to obtain an occasional MRI, the results of which made no difference in
the 'treatment' "; \39\ (7) reflected "no therapeutic plan, except to
use controlled substances to 'treat' the subjective complaint of 'pain'
which was inadequately described; \40\ (8) reflected "inadequate
therapeutic goals * * * for improvement of quality of life (activities
of daily living, work, sleep, mood) with the prescription of
[[Page 19426]]
controlled substance 'cocktails"'; \41\ (9) did not reflect
"consultations with other physicians or specialists outside the
American Pain group [which] could have and in some cases should have
included orthopedics, neurology, neurosurgery, psychiatry, addiction
medicine and/or psychology"; \42\ (10) reflected "a gross lack of
past medical records in all charts reviewed and in some cases none at
all"; \43\ and, (11) demonstrated controlled substance patient
monitoring practices that were "not within the standard of care and
outside the boundaries of professional practice." \44\
---------------------------------------------------------------------------
\35\ Govt. Ex. 5 at 4.
\36\ Govt. Ex. 5 at 4. In Dr. Kennedy's opinion, the Respondent
"prescribed, at the first visit, very high initial doses of
controlled substance combinations despite being outside the bounds
of professional practice for histories and physical examinations and
absent past medical records." Id. at 7.
\37\ Govt. Ex. 5 at 4.
\38\ Govt. Ex. 5 at 3. As an example of the failure to adhere to
the terms of the medication contract, Dr. Kennedy cites a contract
term that provides notice that the physician may stop prescribing
opioids or change treatment if pain or activity improvement is not
demonstrated, and points out that pain and activity levels are
routinely not documented in treatment notes. Id. at 4. Similarly,
Dr. Kennedy references a medication contract warning that
termination of services may result from failure to make regular
follow-up appointments with primary care physicians, and notes that
the American Pain charts contain no notes from primary care
physicians or medical records generated by them. Id.
\39\ Govt. Ex. 5 at 7. In Dr. Kennedy's opinion, Respondent "in
effect, acted as a 'barrier' for [GA] to receive appropriate medical
evaluation and treatment. In other words, the very potent, high
doses of opioids (oxycodone) and benzodiazepine (Xanax) could mask
or cover up [GA's] underlying disease process(s), making them more
difficult to diagnose, and allowing the disease(s) to unnecessarily
worsen. Without an accurate diagnosis, all [the Respondent] was
doing was, again, masking or covering up the symptoms." Id. at 10.
\40\ Govt. Ex. 5 at 7.
\41\ Govt. Ex. 5 at 7.
\42\ Govt. Ex. 5 at 7.
\43\ Govt. Ex. 5 at 15. The only past medical record contained
in GA's chart was a report from an MRI conducted one day prior to
the patient's initial office visit at American Pain. Id. at 8.
\44\ Govt. Ex. 5 at 14.
---------------------------------------------------------------------------
Dr. Kennedy found the Respondent's controlled substance patient
monitoring to be deficient in numerous respects. From the reviewed
patient charts, Dr. Kennedy gleaned that an initial, in-office urine
drug screen was frequently executed during the patients' initial visit
to the office but repeated only occasionally. Govt. Ex. 5 at 14. It was
Dr. Kennedy's observation that even a drug screen anomaly did not alter
the seemingly inexorable continuation of controlled substance
prescribing from the Respondent. Id. Dr. Kennedy also noted that the
Respondent did not utilize out-of-office toxicology tests, or obtain
out-of-State prescription monitoring program or outside pharmacy drug
profiles, and expressed concern that the in-house urinalysis
documentation that was maintained did not provide sufficient detail
regarding the procuring and maintaining of the sample to meaningfully
gauge its reliability. Id.; Tr. at 107-111. Kennedy expressed his view
that the whole drug testing process at the Respondent's office was
inadequate. Furthermore, the charts contained only rare evidence of
contact with primary care physicians, treating physicians, pharmacists,
or other health care providers. Id.
The identified shortcomings of controlled substance patient
monitoring systems was of particular significance where Dr. Kennedy
identified specific evidence that he identified as "red flags" of
possible or likely diversion. Red flags noted by Dr. Kennedy in the
reviewed charts included the relatively young age of the Respondent's
chronic pain patients,\45\ incomplete history information provided by
the patients, periodically significant gaps between office visits,\46\
referrals from friends, relatives, or advertising, but not other
physicians,\47\ and the fact that a relatively high number of patients
were traveling significant distances to American Pain for pain
treatment, although no physician employed at that facility had any
specialized training in pain management.\48\ During his testimony, Dr.
Kennedy conceded that, standing alone, the Respondent's treating out-
of-State patients has no particular significance, and that when he was
engaged in the practice of medicine in Kentucky he had patients who
traveled to his office from Florida.\49\ Tr. at 116. Regarding the
Respondent's Kentucky patients, Dr. Kennedy observed that there were
numerous medical and osteopathic schools that were much closer to the
homes of these patients that could have provided pain management. Id.
at 116-17.
---------------------------------------------------------------------------
\45\ Govt. Ex. 5 at 15.
\46\ Govt. Ex. 5 at 13.
\47\ Govt. Ex. 5 at 7, 15.
\48\ Govt. Ex. 5 at 15; Tr. at 67-68.
\49\ Although the Government elicited testimony from Dr. Kennedy
concerning his perceived significance to a "majority" of patients
coming from out of State, Tr. at 116-17, since there was no evidence
regarding what percentage of the Respondent's patients were from
outside Florida, this inquiry and its responses have been given no
weight.
---------------------------------------------------------------------------
Although Dr. Kennedy's report and testimony appear to attach some
significance to referrals that originated in family and friends, he
later clarified that it was not unusual for a physician to treat
patients that have been referred by relatives and friends. Id. at 154.
Further, Kennedy conceded while in the course of his own medical
practice he has treated patients referred by family and friends, and
that in his report he was focusing on what he perceived as a lack of
any referrals by physicians in the files he reviewed, or what he
perceived as "trends" or "patterns." Id. at 154-55. Given Dr.
Kennedy's acknowledgement that such referrals are not unusual, coupled
with the absence of any way to measure the relative percentage of
physician referrals in the Respondent's practice based on the record
evidence, the observations regarding referral sources are of limited
value here.\50\
---------------------------------------------------------------------------
\50\ Dr. Kennedy did not testify that a referral that emanated
from a source other than a physician could or should be a basis for
a diversion red flag on a given case. His opinion was limited to
culling some manner of a trend or pattern. In view of the fact that
the record contains no development of the numbers of files with non-
physician referrals versus the total number of files, or even an
acceptable metric upon which the issue could be evaluated, there is
very little useful analysis that can come from Dr. Kennedy's
observation regarding the files he reviewed.
---------------------------------------------------------------------------
During his testimony as well as his report, Dr. Kennedy highlighted
several features of particular charts that, at least in his view, bore
the indicia of some red flags that should have signaled an increased
risk of controlled substance diversion. Kennedy detailed several
controls that should have been, but were apparently not utilized by the
Respondent to monitor diversion risks in a pain management practice.
Id. at 111. Some examples of expected diversion controls that were
available to, yet absent from the Respondent's practice included random
pill counts, communication with family members, blood tests to
supplement urinalysis drug screens, communication with patient
pharmacists and the acquisition of pharmacy readout sheets to evaluate
the prescriptions filled and sources of those prescriptions, and the
acquisition of printouts from prescription monitoring programs (PMPs)
in some of the States \51\ where his patients resided. Id. at 111-13.
---------------------------------------------------------------------------
\51\ Dr. Kennedy testified that although Florida does not have a
PMP, several of the States where some of the Respondent's patients
resided did have such programs, and that the Respondent would have
had access to obtain information about his patients in this manner.
Tr. at 113.
---------------------------------------------------------------------------
Although not touched upon by Dr. Kennedy in his testimony or
report,\52\ there were other indications of potential red flags and
related anomalies among the charts admitted into evidence. For example,
patient JR's chart contains a form indicating a positive UDS for
oxycodone and opiates from 12/30/09, yet on the same date, the
medication contract signed by JR reflects a handwritten "N/A"
notation in the section where a patient is supposed to list any
medications they are currently taking. Govt. Ex. 7 at 10, 23; see also
Govt. Ex. 19 at 10-11, 23 (similar issue). Patient MR's file, on the
other hand, indicates a positive UDS for oxycodone only, yet the
patient indicates he is currently taking Xanax (a benzodiazepine that
should have triggered a positive UDS reading) on two different
documents, a discrepancy which raises questions about the validity of
the testing procedures and/or the patient's candor. Govt. Ex. 8 at 13-
14, 28; see also Govt. Exs. 10 at 9, 22; 12 at 12, 26; 17 at 12-13
(similar discrepancies present in other patient
[[Page 19427]]
files with respect to those drugs present on UDS in comparison to
current medications listed in medication contract and other forms).
Patient BS's UDS indicates a negative test for all listed substances,
yet on two different forms she indicates she is currently taking two
strengths of Roxycodone along with Xanax. Govt. Ex. 16 at 6-7, 18. A
prescribed controlled substance that is not reflected in a drug screen
should have raised a sufficient suspicion of diversion to merit further
inquiry by the registrant reflected in the patient file. The UDS form
in patient TS's file reflects circled positive results for
benzodiazepines, opiates, and oxycodone on "2/12," yet the words
"Neg Test" is handwritten and circled in the margin. Govt. Ex. 13 at
9. Numerous patient files also reflected notations that patients
"requested" specific types and/or strengths of controlled substances.
Govt. Exs. 6 at 6; 7 at 2; 8 at 4; 17 at 2; 20 at 3; 21 at 3. At a
minimum, these observations support the conclusion there was a general
lack of vigilance on the part of the Respondent regarding his
obligations as a registrant to minimize the risk of controlled
substance diversion.
---------------------------------------------------------------------------
\52\ The Government's tactical decision to essentially unload a
pile of charts that are explained only by the representations and
generalizations in a report, with no attempt whatsoever to have its
expert witness explain the applicable aspects of most charts to this
tribunal or any future reviewing body is clearly at odds with the
directive provided by the Deputy Administrator in Gregg & Son
Distributors that "it is the Government's obligation as part of its
burden of proof and not the ALJ's responsibility to sift through the
records and highlight that information which is probative of the
issues in the proceeding." 74 FR 17517 n.1.
---------------------------------------------------------------------------
Interestingly, in his report, Dr. Kennedy also found it remarkable
that each American Pain patient file provided notice to its patients
that American Pain did not accept any form of health care insurance.
Govt. Ex. 5 at 3, 16. The report reflected Kennedy's view that this
practice was designed to "effectively keep [the physicians at American
Pain] 'off the radar' from monitoring by any private health care
insurance company as well as all State and Federal agencies (Medicaid
and Medicare respectively)." Id. at 16. Significantly, however, when
asked, Dr. Kennedy acknowledged that he conducts his own current
medical practice on a cash-only basis. Tr. at 151.
Dr. Kennedy concluded his report regarding the Respondent's
prescribing practices with the following summary:
[The Respondent] was not engaged in the practice of medicine,
rather he was engaged in an efficient, "[a]ssembly [l]ine"
business. His "patients" were revenue streams, not true patients.
This business allowed him to collect cas[h] for office visits as
well as being a "[d]ispensing [p]hysician" for controlled
substances. He prescribed controlled substances so that "patients"
would return to his office on a regular basis, allowing him to
generate further revenue. [The Respondent's] routine and excessive
prescription of multiple controlled substances (oxycodone and Xanax)
and lack of arriving at a valid medical diagnosis and treatment most
likely caused harm to the "patients" he saw. Drug diversion most
likely caused a "mushroom" effect of increased drug abuse, drug
addiction, drug overdoses, serious bodily injury and death in those
communities spread over several different states. [The Respondent's]
continued ability to prescribe controlled substances will only
perpetuate the suffering and be a threat to the public.
Govt. Ex. 5 at 16.
The Government's presentation of Dr. Kennedy's testimony at the
hearing was substantially consistent with the conclusions included in
the Patient Charts Analysis, but Dr. Kennedy's presentation was clearly
not without its blemishes. Although he testified that he was familiar
with prescribing practices in Florida, and that he utilized the medical
standards applicable to Florida practice,\53\ he was unable to identify
the documentation standard in the Florida Administrative code with any
degree of particularity, and he also acknowledged that he was not aware
of what the standard is in Florida Medical Board administrative
decisions regarding the overprescribing of medication or what
constitutes an adequate medical history. Tr. at 149-51, 233, 304.
While, overall, Kennedy presented testimony that appeared candid and
knowledgeable, there were areas in his written report that rang of
hyperbole and over-embellishment. The reasoning behind some of the
seemingly critical observations in the written report, such as the
"cash basis" of the Respondent's practice and the absence of doctor
referrals among the reviewed patient files, did not well survive the
crucible of cross examination at the hearing. However, overall, Dr.
Kennedy's testimony was sufficiently detailed, plausible, and
internally consistent to be considered credible, and, consistent with
his qualifications, he spoke persuasively and with authority on some
relevant issues within his expertise, and notwithstanding the
Respondent's objections relative to his Florida-related experience, he
is currently an assistant professor teaching at a Florida Medical
School. It may well be that the greatest and most significant aspect of
Dr. Kennedy's opinion is that on the current record, it stands
unrefuted. Thus, his opinion is the only expert opinion available for
reliance in this action.\54\ Dr. Kennedy testified that based on his
review of the selected patient charts from the Respondent's medical
practice, in his expert opinion, he "couldn't find any legitimate
basis for [the Respondent] prescribing medications to any of the
[patients] and that the Respondent's prescribing practices "were not
in compliance at all from the very first visit on" with the standards
set forth by the Florida Medical Board. Id. at 118. Accordingly, Dr.
Kennedy's expert opinion that the Respondent's controlled substance
prescribing practices, at least as evidenced through his examination of
the patient charts he reviewed, fell below the standards applicable in
Florida, and that the controlled substance prescriptions contained in
those files were not issued for a legitimate medical purpose is
unrefuted on this record and (although by no means overwhelming) is
sufficiently reliable to be accepted and relied upon in this
recommended decision.
---------------------------------------------------------------------------
\53\ Tr. at 628.
\54\ The Respondent did not testify on his own behalf.
---------------------------------------------------------------------------
The Analysis
Pursuant to 21 U.S.C. 824(a)(4), the Deputy Administrator \55\ may
revoke a registrant's DEA Certificate of Registration if persuaded that
the registrant "has committed such acts that would render * * *
registration under section 823 * * * inconsistent with the public
interest * * * ." The following factors have been provided by Congress
in determining "the public interest":
---------------------------------------------------------------------------
\55\ This authority has been delegated pursuant to 28 CFR
0.100(b) and 0.104.
---------------------------------------------------------------------------
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to 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.
21 U.S.C. 823(f).
"[T]hese factors are considered in the disjunctive." Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003). Any one or a combination of
factors may be relied upon, and when exercising authority as an
impartial adjudicator, the Deputy Administrator may properly give each
factor whatever weight she deems appropriate in determining whether an
application for a registration should be denied. JLB, Inc., d/b/a Boyd
Drugs, 53 FR 43945 (1988); England Pharmacy, 52 FR 1674 (1987); see
also David H. Gillis, M.D., 58 FR 37507, 37508 (1993); Joy's Ideas, 70
FR 33195, 33197 (2005); Henry J. Schwarz, Jr., M.D., 54 FR 16422
(1989). Moreover, the Deputy Administrator is "not required 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 (DC
Cir. 2005). The
[[Page 19428]]
Deputy Administrator is not required to discuss consideration of each
factor in equal detail, or even every factor in any given level of
detail. Trawick v. DEA, 861 F.2d 72, 76 (4th Cir. 1988) (the
Administrator's obligation to explain the decision rationale may be
satisfied even if only minimal consideration is given to the relevant
factors and remand is required only when it is unclear whether the
relevant factors were considered at all). The balancing of the public
interest factors "is not a contest in which score is kept; the Agency
is not required to mechanically count up the factors and determine how
many favor the Government and how many favor the registrant. Rather, it
is an inquiry which focuses on protecting the public interest * * * ."
Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
In an action to revoke a registrant's DEA COR, the DEA has the
burden of proving that the requirements for revocation are satisfied.
21 CFR 1301.44(e). Once DEA has made its prima facie case for
revocation of the registrant's DEA Certificate of Registration, the
burden of production then shifts to the Respondent to show that, given
the totality of the facts and circumstances in the record, revoking the
registrant's registration would not be appropriate. Morall, 412 F.3d at
174; Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v. U.S.
Dept. of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989); Thomas E.
Johnston, 45 FR 72, 311 (1980). Further, "to rebut the Government's
prima facie case, [the Respondent] is required not only to accept
responsibility for [the established] misconduct, but also to
demonstrate what corrective measures [have been] undertaken to prevent
the reoccurrence of similar acts." Jeri Hassman, M.D., 75 FR 8194,
8236 (2010).
Where the Government has sustained its burden and established that
a registrant has committed acts inconsistent with the public interest,
that registrant must present sufficient mitigating evidence to assure
the Deputy Administrator that he or she can be entrusted with the
responsibility commensurate with such a registration. Steven M.
Abbadessa, D.O., 74 FR 10077 (2009); Medicine Shoppe-Jonesborough, 73
FR 364, 387 (2008); Samuel S. Jackson, D.D.S., 72 FR 23848, 23853
(2007). Normal hardships to the practitioner, and even the surrounding
community, that are attendant upon the lack of registration are not a
relevant consideration. Abbadessa, 74 FR at 10078; see also Gregory D.
Owens, D.D.S., 74 FR 36751, 36757 (2009).
The Agency's conclusion that past performance is the best predictor
of future performance has been sustained on review in the courts, Alra
Labs. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as has the Agency's
consistent policy of strongly weighing whether a registrant who has
committed acts inconsistent with the public interest has accepted
responsibility and demonstrated that he or she will not engage in
future misconduct. Hoxie, 419 F.3d at 483; George C. Aycock, M.D., 74
FR 17529, 17543 (2009); Abbadessa, 74 FR at 10078; Krishna-Iyer, 74 FR
at 463; Medicine Shoppe, 73 FR at 387.
While the burden of proof at this administrative hearing is a
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S.
91, 100-01 (1981), the Deputy Administrator's factual findings will be
sustained on review to the extent they are supported by "substantial
evidence." Hoxie, 419 F.3d at 481. While "the possibility of drawing
two inconsistent conclusions from the evidence" does not limit the
Deputy Administrator's ability to find facts on either side of the
contested issues in the case, Shatz, 873 F.2d at 1092; Trawick, 861
F.2d at 77, all "important aspect[s] of the problem," such as a
respondent's defense or explanation that runs counter to the
Government's evidence, must be considered. Wedgewood Vill. Pharmacy v.
DEA, 509 F.3d 541, 549 (DC Cir. 2007); Humphreys, 96 F.3d at 663. The
ultimate disposition of the case must be in accordance with the weight
of the evidence, not simply supported by enough evidence to justify, if
the trial were to a jury, a refusal to direct a verdict when the
conclusion sought to be drawn from it is one of fact for the jury.
Steadman, 450 U.S. at 99 (internal quotation marks omitted).
Regarding the exercise of discretionary authority, the courts have
recognized that gross deviations from past agency precedent must be
adequately supported, Morall, 412 F.3d at 183, but mere unevenness in
application does not, standing alone, render a particular discretionary
action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (DC Cir. 2008)
(citing Butz v. Glover Livestock Comm. Co., Inc., 411 U.S. 182, 188
(1973)), cert. denied, ---- U.S. ----, 129 S.Ct. 1033 (2009). It is
well-settled that since the Administrative Law Judge has had the
opportunity to observe the demeanor and conduct of hearing witnesses,
the factual findings set forth in this recommended decision are
entitled to significant deference, Universal Camera Corp. v. NLRB, 340
U.S. 474, 496 (1951), and that this recommended decision constitutes an
important part of the record that must be considered in the Deputy
Administrator's decision, Morall, 412 F.3d at 179. However, any
recommendations set forth herein regarding the exercise of discretion
are by no means binding on the Deputy Administrator and do not limit
the exercise of that discretion. 5 U.S.C. 557(b); River Forest
Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); Attorney
General's Manual on the Administrative Procedure Act 8 (1947).
Factors 1 and 3: The Recommendation of the Appropriate State Licensing
Board or Professional Disciplinary Authority and Conviction Record
Under Federal or State Laws Relating to the Manufacture, Distribution,
or Dispensing of Controlled Substances
In this case, it is undisputed that the Respondent holds a valid
and current State license to practice medicine. The record contains no
evidence of a recommendation regarding the Respondent's medical
privileges by any cognizant State licensing board or professional
disciplinary authority. However, that a State has not acted against a
registrant's medical license is not dispositive in this administrative
determination as to whether continuation of a registration is
consistent with the public interest. Patrick W. Stodola, M.D., 74 FR
20727, 20730 (2009); Jayam Krishna-Iyer, 74 FR at 461. It is well-
established Agency precedent that a "state license is a necessary, but
not a sufficient condition for registration." Leslie, 68 FR at 15230;
John H. Kennedy, M.D., 71 FR 35705, 35708 (2006). Even the
reinstatement of a State medical license does not affect the DEA's
independent responsibility to determine whether a registration is in
the public interest. Mortimer B. Levin, D.O., 55 FR 9209, 8210 (1990).
The ultimate responsibility to determine whether a registration is
consistent with the public interest has been delegated exclusively to
the DEA, not to entities within State government. Edmund Chein, M.D.,
72 FR 6580, 6590 (2007), aff'd, Chein v. DEA, 533 F.3d 828 (DC Cir.
2008), cert. denied, ---- U.S. ----, 129 S.Ct. 1033 (2009). Congress
vested authority to enforce the CSA in the Attorney General and not
State officials. Stodola, 74 FR at 20375. Thus, on these facts, the
fact that the record contains no evidence of a recommendation by a
State licensing board does not weigh for or against a determination as
to whether continuation of the Respondent's DEA certification is
consistent with the public interest.
Similarly, regarding Factor 3, while testimony was received at the
hearing
[[Page 19429]]
that indicated that a criminal search warrant was executed regarding
the Respondent and American Pain, the record contains no evidence that
the Respondent has ever been convicted of any crime or even arrested in
connection with any open criminal investigation. Thus, consideration of
the record evidence under the first and third factors does not militate
in favor of revocation.
Factors 2, 4 and 5: The Respondent's Experience in Dispensing
Controlled Substances, Compliance With Applicable State, Federal or
Local Laws Relating to Controlled Substances, and Such Other Conduct
Which May Threaten the Public Health and Safety
In this case, the gravamen of the allegations in the OSC, as well
as the factual concentration of much of the evidence presented, share
as a principal focus the manner in which the Respondent has managed
that part of his practice relative to prescribing and dispensing
controlled substances and acts allegedly committed in connection with
his practice at American Pain. Thus, it is analytically logical to
consider public interest factors two, four and five together. That
being said, factors two, four and five involve analysis of both common
and distinct considerations.
Regarding Factor 2, the qualitative manner and the quantitative
volume in which a registrant has engaged in the dispensing of
controlled substances, and how long he has been in the business of
doing so are factors to be evaluated in reaching a determination as to
whether he should be entrusted with a DEA certificate. In some cases,
viewing a registrant's actions against a backdrop of how he has
performed activity within the scope of the certificate can provide a
contextual lens to assist in a fair adjudication of whether continued
registration is in the public interest.
There are two principal considerations embedded within a
consideration of this public interest factor. In considering a similar
factor under the List I chemical context, the Agency has recognized
that the level of experience held by those who will be charged with
recognizing and taking steps to minimize diversion factors greatly in
determining whether entrusting a COR will be in the public interest.
See Volusia Wholesale, 69 FR 69409, 69410 (2004); Xtreme Enters., Inc.,
67 FR 76195, 76197-98 (2004); Prachi Enters., 69 FR 69407, 69409
(2004); J&S Distribs., 69 FR 62089, 62090 (2004); K.V.M. Enters., 67 FR
70968, 70969 (2002). The Agency has also recognized that evidence that
a registrant may have conducted a significant level of sustained
activity within the scope of the registration for a sustained period is
a relevant and correct consideration, which must be accorded due
weight. However, this factor can be outweighed by acts held to be
inconsistent with the public interest. Experience which occurred prior
and subsequent to proven allegations of malfeasance may be relevant.
Evidence that precedes proven misconduct may add support to the
contention that, even acknowledging the gravity of a particular
registrant's transgressions, they are sufficiently isolated and/or
attenuated that adverse action against its registration is not
compelled by public interest concerns. Likewise, evidence presented by
the Government that the proven allegations are consistent with a
consistent past pattern of poor behavior can enhance the Government's
case.
In this case, the Respondent introduced no evidence regarding his
level of knowledge and experience, or even the quality or length of his
experience as a physician-registrant, but the Government has elected to
do so.
Regarding the Government's presentation, Agency precedent has long
held that in DEA administrative proceedings "the parameters of the
hearing are determined by the prehearing statements." CBS Wholesale
Distribs., 74 FR 36746, 36750 (2009) (citing Darrel Risner, D.M.D., 61
FR 728, 730 (1996); see also Roy E. Berkowitz, M.D., 74 FR 36758,
36759-60 (2009) ("pleadings in administrative proceedings are not
judged by the standards applied to an indictment at common law" and
"the rules governing DEA hearings do not require the formality of
amending a show cause order to comply with the evidence"). That being
said, however, the marked difference between the amount of evidence
that the Government noticed in its OSC/ISO and the amount that it
introduced at the hearing is striking. For example, contrary to its
allegations, there was no evidence that the Respondent "prescribe[d]
and dispense[d] inordinate amounts of controlled substances," that the
"majority" of the Respondent's patients were "from states other than
Florida," and there was no evidence that American Pain patients were
issued "pre-signed prescriptions to obtain MRI[s]," nor was there
evidence that individuals positioned outside the American Pain building
were there to "monitor the activity of patients in the parking lot to
prevent patients from selling their recently obtained controlled
substances." Likewise, no evidence was introduced at the hearing that
could support the allegations that "employees of American Pain []
frequently ma[d]e announcements to patients in the clinic advising them
on how to avoid being stopped by law enforcement upon departing the
pain clinic" and "frequently ma[d]e announcements [] advising
[patients], among other things, not to attempt to fill their
prescriptions at out-of State pharmacies and warning them against
trying to fill their prescriptions at particular local retail
pharmacies." ALJ Ex. 1 (emphasis supplied).
In like fashion, the Government's prehearing statement proffered
that SA Burt would testify to several of the items described but not
established in the OSC/ISO. Among the list of allegations that were not
supported by any evidence introduced at the hearing, were
representations that SA Burt would testify concerning the following:
Law enforcement in Florida and [other states that correspond to
license plates seen in the American Pain parking lot] frequently
arrest people for illegal possession and/or illegal distribution of
controlled substances who have obtained the controlled substances
from American Pain;
American Pain hired individuals to "roam" the parking lot of
the clinic to dissuade people from selling their recently obtained
controlled substances on the property;
[The reason American Pain placed] signs within American Pain
warning individuals not to have their prescriptions filled at
Walgreens pharmacies [is] because Walgreens refuses to dispense the
prescriptions;
Walgreens has flagged all American Pain doctors and will not
fill any of their prescriptions;
[Physical exams at American Pain are] usually no more than a
blood pressure check and some bending and stretching;
Dismissed patients would be routed to other doctors within the
clinic;
[There was] co-mingling of [American Pain] physician's drugs;
[American Pain maintained] no inventories of drugs dispensed;
[Details surrounding] the death of [American Pain] patient OB
[where] [t]he cause of death was determined to be drug
intoxication--opiate and benzodiazepine;
[Information] from a confidential source [who indicated] that
she traveled to American Pain in order to obtain controlled
substances that were later sold in Kentucky for $25 per pill[,]
[that] [the American Pain physician she encountered] did not spend
any significant time conducting a physical examination of [her] [,]
[that she would simply ask questions regarding [her] well being and
would then "stamp" a prescription for [controlled substances][,] *
* * that on one visit [during a power failure a] security guard
working for the clinic instructed everyone to be patient and that
the doctors would be with them shortly to "get your fix."
ALJ Ex. 6 at 3-9.
The Government's Prehearing Statement also represented that it
would
[[Page 19430]]
be presenting the testimony of Intelligence Analyst (IA) Janet Hines,
who would relate her encounter with a confidential source who allegedly
obtained controlled substances from the Respondent with minimal or no
physical examinations and intentionally diverted them. ALJ Ex. 6. The
Government never called IA Hines and never offered an explanation for
the differences between the expansive proffers and the less-expansive
ultimate presentation.
To be clear, it is not that the evidence was introduced and
discredited; no evidence to support these (and other) allegations was
introduced at all. To the extent the Government had this evidence, it
left it home. While the stunning disparity between the allegations
proffered and those that were supported with any evidence does not
raise due process concerns, it is worthy of noting, without deciding
the issue, that Agency precedent has acknowledged the Supreme Court's
recognition of the applicability of the res judicata doctrine in DEA
administrative proceedings. Christopher Henry Lister, P.A., 75 FR
28068, 28069 (2010) (citing University of Tennessee v. Elliot, 478 U.S.
788, 797-98 (1986) ("When an administrative agency is acting in a
judicial capacity and resolves disputed issues of fact properly before
it which the parties have had an adequate opportunity to litigate, the
courts have not hesitated to apply res judicata[.]")
The evidence the Government did present raises issues regarding not
only Factor 2 (experience dispensing \56\ controlled substances), but
also Factors 4 (compliance with Federal and State law relating to
controlled substances) and 5 (other conduct which may threaten public
health and safety). Succinctly put, the Government's evidence related
to the manner in which the Respondent practiced, and whether his
practice complied with the law and/or was a threat to the public.
---------------------------------------------------------------------------
\56\ The statutory definition of the term "dispense" includes
the prescribing and administering of controlled substances. 21
U.S.C. 802(10).
---------------------------------------------------------------------------
While true that GS Langston convincingly testified about the course
of her investigation and laid an adequate foundation for numerous
database results, the Government provided no foundational context for
any relevant uses for those database results. Without some insight into
what types of results from these databases should be expected when
compared to similarly-situated registrants engaged in acceptable
prescribing practices, the raw data is without use. In short, there was
no evidence elicited wherein the percentage of the Respondent's in-
State to out-of State patients could be assessed, and no reasonable
measuring stick based on sound principles upon which to evaluate such
data. Likewise, there was no reliable yardstick upon which to measure
the amount of controlled substances reflected in the databases compared
to what a reasonable regulator would expect to see regarding a
compliant registrant. To the extent Langston possessed this information
(and she well may have) it was not elicited from her. The same could be
said of the allegation set forth in the Government's Prehearing
Statement that alleges that from a given period the Respondent "was
the 16th largest practitioner purchaser of oxycodone in the United
States." \57\ No evidence to support that allegation (or its
relevance) was ever brought forth at the hearing. To the extent that
fact may have been true or relevant, it was never developed. What's
more, as ably pointed out by Respondent's counsel,\58\ the Florida
Administrative Code specifically eschews pain medication prescribing
analysis rooted only in evaluation of medication quantity. Fla. Admin.
Code r. 64B8-9.013(g).\59\ Lastly, there was no indication that despite
Langston's obvious qualifications to do so, that she or anyone else
ever conducted an audit of the controlled-substance-inventory-related
recordkeeping practices at American Pain.
---------------------------------------------------------------------------
\57\ ALJ Ex. 6 at 11-12.
\58\ Respt's Br. at 20.
\59\ The Respondent's brief incorrectly sites subsection (f).
---------------------------------------------------------------------------
SA Burt testified that, during a temporally limited period of time,
he observed some of the images captured by a pole camera positioned
outside American Pain, and that he observed what in his view was a high
percentage of vehicles in the parking lot with out-of-State license
tags. This testimony arguably provides some support for the
Government's contention that out-of-State patients (or at least
patients being dropped off by cars with out-of-State tags) were being
seen at the clinic, but his testimony did not provide much else in
terms of relevant information. In any event, recent Agency precedent
holds that details such as "where [a registrant's] patients were
coming from," without additional factual development, can support a
"strong suspicion that [a] respondent was not engaged in a legitimate
medical practice" but that "under the substantial evidence test, the
evidence must 'do more than create a suspicion of the existence of the
fact to be established."' Alvin Darby, M.D., 75 FR 26993, 26999, n.31
(2010) (citing NLRB v. Columbian Enameling & Stamping Co., 306 U.S.
292, 300 (1939).
Likewise, without additional details or at least some context,
Burt's testimony that individuals with "staff" written on their
shirts appeared to be directing patients into the clinic reveals
virtually nothing about the Respondent's prescribing practices. Tr.
818, 910. Furthermore, that Burt observed an individual on a videotape,
who he believed to be an American Pain employee, on a single occasion,
instruct patients not to "snort [their] pills" in the parking
lot,\60\ or advising them to comply with vehicle and traffic laws,\61\
does not shed illumination on the Respondent's prescribing practices.
There was no evidence that the Respondent knew that these isolated
incidents occurred, nor was there contextual evidence from which the
relevance to these proceedings could be gleaned. Even if this tribunal
was inclined to engage in the unsupported assignment of motives to the
actions of these employees, under these circumstances, such an exercise
could not constitute substantial evidence that could be sustained at
any level of appeal.
---------------------------------------------------------------------------
\60\ Tr. at 825.
\61\ Tr. at 826.
---------------------------------------------------------------------------
Burt's testimony regarding his conversations with Dr. Sollie, who
was formerly employed by American Pain, were also not received in a
manner that could meaningfully assist in the decision process.
According to Burt, Sollie told him that some (unnamed) physicians at
American Pain were inadequately documenting their patient charts in
some manner that was apparently never explained to Burt,\62\ and that
some patients were intentionally evading the American Pain urinalysis
process. Sollie did not work at American Pain at the same time the
Respondent did, and did not specifically name any physician as being
connected with his allegations of misconduct. Thus, this tribunal is at
something of a loss as to how the information, as presented, would tend
to establish a fact relevant to whether the continuation of the
Respondent's authorization to handle controlled substances is in the
public interest.
---------------------------------------------------------------------------
\62\ Tr. at 898.
---------------------------------------------------------------------------
The Government's evidence targeted not only the Respondent's
experience practicing under Factor 2, but also his compliance with
applicable State and Federal laws relating to controlled substances
under Factor 4. To effectuate the dual goals of conquering drug abuse
and controlling both legitimate and
[[Page 19431]]
illegitimate traffic in controlled substances, "Congress devised a
closed regulatory system making it unlawful to manufacture, distribute,
dispense, or possess any controlled substance except in a manner
authorized by the CSA." Gonzales v. Raich, 545 U.S. 1, 13 (2005).
Consistent with the maintenance of that closed regulatory system,
subject to limited exceptions not relevant here, a controlled substance
may only be dispensed upon a prescription issued by a practitioner, and
such a prescription is unlawful unless it is "issued for a legitimate
medical purpose by an individual practitioner acting in the usual
course of his professional practice." 21 U.S.C. 829; 21 CFR
1306.04(a). Furthermore, "an order purporting to be a prescription
issued not in the usual course of professional treatment * * * is not a
prescription within the meaning and intent of [21 U.S.C. 829] and the
person knowingly * * * issuing it, shall be subject to the penalties
provided for violations of the provisions of law related to controlled
substances." Id.
A registered practitioner is authorized to dispense,\63\ which the
CSA defines as "to deliver a controlled substance to an ultimate user
\64\ * * * by, or pursuant to the lawful order of a practitioner." 21
U.S.C. 802(10); see also Rose Mary Jacinta Lewis, 72 FR 4035, 4040
(2007). The prescription requirement is designed to ensure that
controlled substances are used under the supervision of a doctor, as a
bulwark against the risk of addiction and recreational abuse. Aycock,
74 FR at 17541 (citing Gonzales v. Oregon, 546 U.S. 243, 274 (2006);
United States v. Moore, 423 U.S. 122, 135, 142-43 (1975) (noting that
evidence established that a physician exceeded the bounds of
professional practice when he gave inadequate examinations or none at
all, ignored the results of the tests he did make, and took no
precautions against misuse and diversion)). The prescription
requirement likewise stands as a proscription against doctors
"peddling to patients who crave the drugs for those prohibited uses."
Id. The courts have sustained criminal convictions based on the issuing
of illegitimate prescriptions where physicians conducted no physical
examinations or sham physical examinations. United States v. Alerre,
430 F.3d 681, 690-91 (4th Cir. 2005), cert. denied, 574 U.S. 1113
(2006); United States v. Norris, 780 F.2d 1207, 1209 (5th Cir. 1986).
---------------------------------------------------------------------------
\63\ 21 U.S.C. 823(f).
\64\ "Ultimate user" is defined as "a person who has lawfully
obtained, and who possesses, a controlled substance for his own use
or for the use of a member of his household or for an animal owned
by him or by a member of his household." 21 U.S.C. 802(27).
---------------------------------------------------------------------------
While true that the CSA authorizes the "regulat[ion] of medical
practice so far as it bars doctors from using their prescription-
writing powers as a means to engage in illicit drug dealing and
trafficking as conventionally understood," Gonzales, 546 U.S. at 266-
67, an evaluation of cognizant State standards is essential. Joseph
Gaudio, M.D., 74 FR 10083, 10090 (2009); Kamir Garces-Mejias, M.D., 72
FR 54931, 54935 (2007); United Prescription Servs., Inc., 72 FR 50397,
50407 (2007). In this adjudication, the evaluation of the Respondent's
prescribing practices must be consistent with the CSA's recognition of
State regulation of the medical profession and its bar on physicians
from peddling to patients who crave drugs for prohibited uses. The
analysis must be "tethered securely" to State law and Federal
regulations in application of the public interest factors, and may not
be based on a mere disagreement between experts as to the most
efficacious way to prescribe controlled substances to treat chronic
pain sufferers. Volkman v. DEA, 567 F.3d 215, 223 (6th Cir. 2009)
(citing Gonzales, 546 U.S. at 272, 274).
Under the CSA, it is fundamental that a practitioner must establish
a bonafide doctor-patient relationship in order to act "in the usual
course of * * * professional practice" and to issue a prescription for
a legitimate medical purpose." Stodola, 74 FR at 20731; Shyngle, 74 FR
at 6057-58 (citing Moore, 423 U.S. at 141-43). The CSA looks to State
law to determine whether a bonafide doctor-patient relationship
existed. Stodola, 74 FR at 20731; Shyngle, 74 FR at 6058; Garces-
Mejias, 72 FR at 54935; United Prescription Servs., 72 FR at 50407. It
was Dr. Kennedy's uncontroverted opinion that his evaluation of chart
entries convinced him that they were so defective that the Respondent
did not establish a sufficient doctor-patient relationship to justify
the prescribing of controlled substances, and that "this was not the
practice of medicine in [his] opinion." Tr. at 160-61.
Under Florida law, grounds for disciplinary action or denial of
State licensure include "prescribing * * * any controlled substance,
other than in the course of the physician's professional practice,"
and prescribing such substances "inappropriately or in excessive or
inappropriate quantities is not in the best interest of the patient and
is not in the course of the physician's professional practice, without
regard to his or her intent." Fla. Stat. Sec. 458.331(q) (2009).
Florida law further provides that grounds for such disciplinary action
also include:
Failing to keep legible, as defined by department rule in
consultation with the board, medical records that identify the
licensed physician * * * and that justify the course of treatment of
the patient, including, but not limited to, patient histories;
examination results; test results; records of drugs prescribed,
dispensed, or administered; and reports of consultations and
hospitalizations.
Id. Sec. 458.331(m).
In exercising its rulemaking function,\65\ the Florida Board of
Medicine (Florida Board) promulgated a regulation addressing
"Standards for Adequacy of Medical Records" applicable to all
physicians. Fla. Admin. Code r. 64B8-9.003 (2009). That regulation
provides, in pertinent part:
---------------------------------------------------------------------------
\65\ Rulemaking authority regarding the practice of medicine
within the State of Florida has been delegated to the Florida Board
of Medicine (Florida Board). Fla. Stat. Sec. 458.309(1) (2009).
---------------------------------------------------------------------------
(2) A licensed physician shall maintain patient medical records
in English, in a legible manner and with sufficient detail to
clearly demonstrate why the course of treatment was undertaken.
(3) The medical record shall contain sufficient information to
identify the patient, support the diagnosis, justify the treatment
and document the course and results of treatment accurately, by
including, at a minimum, patient histories; examination results;
test results; records of drugs prescribed, dispensed or
administered; reports of consultations and hospitalizations; and
copies of records or reports or other documentation obtained from
other health care practitioners at the request of the physician and
relied upon by the physician in determining the appropriate
treatment of the patient.
(4) All entries made into the medical records shall be
accurately dated and timed. Late entries are permitted, but must be
clearly and accurately noted as late entries and dated and timed
accurately when they are entered in to the record * * * .
Fla. Admin. Code r. 64B8-9.003 (2009).
With respect to defining the parameters of what constitutes
"professional practice" in the context of pain management
prescribing, Florida State law provides:
Notwithstanding any other provision of law, a physician may
prescribe or administer any controlled substance under Schedules II-
V * * * to a person for the treatment of intractable pain,\66\
provided the physician does so in accordance with that level of
care, skill, and treatment recognized by a
[[Page 19432]]
reasonably prudent physician under similar conditions and
circumstances.
---------------------------------------------------------------------------
\66\ Florida defines "intractable pain" to mean "pain for
which, in the generally accepted course of medical practice, the
cause cannot be removed and otherwise treated." Fla. Stat. Sec.
458.326 (2009).
---------------------------------------------------------------------------
Fla. Stat. Sec. 458.326 (2009). Moreover, the Florida Board has
adopted,\67\ albeit in modified version, the Model Policy for the Use
of Controlled Substances for the Treatment of Pain (Model Policy), a
document drafted by the Federation of State Medical Boards (FSMB) to
provide professional guidelines for the treatment of pain with
controlled substances. The standards adopted by Florida share the key
tenants of the Model Policy's standards for pain management
prescribing, including the emphasis on diligent efforts by physicians
to prevent drug diversion, prescribing based on clear documentation of
unrelieved pain and thorough medical records, and compliance with
applicable Federal and State law.
---------------------------------------------------------------------------
\67\ Pursuant to authority vested in the Florida Board by the
Florida legislature to promulgate rules regarding State standards
for pain management clinical practice specifically. Fla. Stat. Sec.
458.309(5) (2009).
---------------------------------------------------------------------------
Like the Model Policy, which was promulgated "to encourage the
legitimate medical uses of controlled substances for the treatment of
pain while stressing the need to safeguard against abuse and
diversion," Florida's regulation providing "Standards for the Use of
Controlled Substances for Treatment of Pain," Fla. Admin. Code r.
64B8-9.013 (2009) (Florida Standards), recognizes that "inappropriate
prescribing of controlled substances * * * may lead to drug diversion
and abuse by individuals who seek them for other than legitimate
medical use." The language employed by the regulation under the
preamble section titled "Pain Management Principles" makes clear that
the standards "are not intended to define complete or best practice,
but rather to communicate what the [Florida Board] considers to be
within the boundaries of professional practice" (emphasis supplied),
id. at 9.013(1)(g); thus, the plain text supports an inference that the
standards provide the minimum requirements for establishing conduct
that comports with the professional practice of controlled substance-
based pain management within the State. Likewise, the level of integral
range of acceptable practice that is built into the regulation
underscores the importance of seeking an expert professional opinion in
reaching a correct adjudication of whether a registrant has met the
applicable Florida standard. It is clear that in assessing whether the
controlled substance prescribing practices of a Florida practitioner
fall within the acceptable range of what constitutes being within the
bounds of being "issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice," \68\ resort must be had to an expert.
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\68\ 21 CFR 1306.04(a).
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The Florida Standards direct that "[p]hysicians should be diligent
in preventing the diversion of drugs for illegitimate purposes," id.
at 9.013(1)(d), and provide that the prescribing of controlled
substances for pain will be considered
to be for a legitimate medical purpose if based on accepted
scientific knowledge of the treatment of pain or if based on sound
clinical grounds. All such prescribing must be based on clear
documentation of unrelieved pain and in compliance with applicable
state or Federal law.
Id. at 9.013(1)(e) (emphasis supplied).
The Florida Standards further provide that the validity of
prescribing will be judged "based on the physician's treatment of the
patient and on available documentation, rather than on the quantity and
chronicity of prescribing" (emphasis supplied). Id. at 9.013(1)(g).
Furthermore, the Standards advise that physicians should not fear
disciplinary action for "prescribing controlled substances * * * for a
legitimate medical purpose and that is supported by appropriate
documentation establishing a valid medical need and treatment plan"
(emphasis supplied), or "for failing to adhere strictly to the
provisions of these standards, if good cause is shown for such
deviation" (emphasis supplied). Id. at 9.013(1)(b),(f).
Although, as discussed above, the Florida Board instituted general
guidance applicable to all physicians regarding medical records, it
also promulgated a separate set of documentation requirements in the
Florida Standards applicable specifically to those physicians who
prescribe controlled substances in the pain-management context. The
Florida Standards, under the subheading "Medical Records," state that
"[t]he physician is required to keep accurate and complete records"
(emphasis supplied) including, though not limited to:
1. The medical history and physical examination, including
history of drug abuse or dependence, as appropriate;
2. Diagnostic, therapeutic, and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. Discussion of risks and benefits;
6. Treatments;
7. Medications (including date, type, dosage, and quantity
prescribed);
8. Instructions and agreements; and
9. Periodic reviews.
Id. at 9.013(3)(f). The same section directs that "[r]ecords must
remain current and be maintained in an acceptable manner and readily
available for review. Id.
The Florida Standards similarly emphasize the need for proper
documentation in the patient evaluation context by specifying:
A complete \69\ medical history and physical examination must be
conducted and documented in the medical record. The medical record
should document the nature and intensity of the pain, current and
past treatments for pain, underlying or coexisting diseases or
conditions, the effect of the pain on physical and psychological
function, and history of substance abuse. The medical record also
should document the presence of one or more recognized medical
indications for the use of a controlled substance.
---------------------------------------------------------------------------
\69\ The original Model Policy version of the guidelines does
not contain a reference to the need for a complete medical history,
instead only requiring a medical history generally. Thus, the
Florida Board has adopted a higher standard than the measure that
has been set in the Model Policy by the FSMB.
---------------------------------------------------------------------------
Id. at 9.013(3)(a).
Furthermore, the Florida Standards require a written treatment plan
that "should state objectives that will be used to determine treatment
success, such as pain relief and improved physical and psychosocial
function, and should indicate if any further diagnostic evaluations or
other treatments are planned." Id. at 9.013(3)(b). Subsequent to the
initiation of treatment, "the physician should adjust drug therapy to
the individual medical needs of each patient. Other treatment
modalities or a rehabilitation program may be necessary depending on
the etiology of the pain and the extent to which the pain is associated
with physical and psychosocial impairment." (emphasis supplied). Id.
Another standard adopted by the Florida Board, under the subheading
"Informed Consent and Agreement for Treatment," is the directive that
[t]he physician should discuss the risks and benefits of the use of
controlled substances with the patient, persons designated by the
patient, or with the patient's surrogate or guardian if the patient
is incompetent. The patient should receive prescriptions from one
physician and one pharmacy where possible. If the patient is
determined to be at high risk for medication abuse or have a history
of substance abuse, the physician should employ the use of a written
agreement between the physician and patient outlining patient
responsibilities, including, but not limited to:
1. Urine/serum medication levels screening when requested;
[[Page 19433]]
2. Number and frequency of all prescription refills; and
3. Reasons for which drug therapy may be discontinued (i.e.,
violation of agreement.)
Id. at 9.003(3)(c).
The Florida Standards contain a further requirement to periodically
review "the course of pain treatment and any new information about the
etiology of the pain or the patient's state of health." Id. at
9.013(3)(d). The Florida Standards explain the importance of periodic
review in the following manner:
Continuation or modification of therapy depends on the
physician's evaluation of the patient's progress. If treatment goals
are not being achieved, despite medication adjustments, the
physician should reevaluate the appropriateness of continued
treatment. The physician should monitor patient compliance in
medication usage and related treatment plans.
Id.
Under the subheading "Consultation," the Florida Board
promulgated the instruction that
[t]he physician should be willing to refer the patient as necessary
for additional evaluation and treatment in order to achieve
treatment objectives. Special attention should be given to those
pain patients who are at risk for misusing their medications and
those whose living arrangements pose a risk for medication misuse or
diversion. The management of pain in patients with a history of
substance abuse or with a comorbid psychiatric disorder requires
extra care, monitoring, and documentation, and may require
consultation with or referral to an expert in the management of such
patients.
Id. at 9.003(3)(e).
It is abundantly clear from the plain language of the Florida
Standards that the Florida Board places critical emphasis on physician
implementation of adequate safeguards in their practice to minimize
diversion and the need to document the objective signs and rationale
employed in the course of pain treatment utilizing the prescription of
controlled substances. Conscientious documentation is repeatedly
emphasized as not just a ministerial act, but a key treatment tool and
a vital indicator to evaluate whether the physician's prescribing
practices are "within the usual course of professional practice."
Here, the uncontroverted expert opinion of Dr. Kennedy, the only expert
witness to testify at these proceedings, reflects that the
documentation he reviewed in the Respondent's patient charts reflected
care that was markedly below the standard of care set by the Florida
Medical Board. Dr. Kennedy's expert assessment was consistent with the
State statutory and regulatory guidance. In Kennedy's view, the
Respondent's charts demonstrated minimalistic, incomplete, and
otherwise medically inadequate documentation of his contacts with
patients and the prescribing rationale for his issuance of controlled
substance prescriptions to those patients for alleged pain management
purposes. The boilerplate-style, "one high-dosage controlled
substances treatment plan fits all" nature of nearly all of the
patient medical records at issue, at least in the view of the
uncontroverted expert, evidences a failure on the part of the
Respondent to conduct his practice of medicine in a manner to minimize
the potential of controlled substance abuse and diversion, and supports
a conclusion that he failed to even substantially comply with the
minimum obligations for professional practice imposed under the Florida
Standards--and without "good cause [] shown for such deviation." Id.
at 9.013(1)(f).
In his Argument, Proposed Findings of Fact and Proposed Conclusions
of Law (Respondent's Brief), the Respondent's counsel has prepared and
submitted a thoughtful and detailed analysis of the counsel's
application of the relevant standards in Florida to the charts analyzed
by Dr. Kennedy. Respt's Br. at 3-17. Unfortunately, counsel's analysis
is the product of a lay evaluation of standards applicable to the
nuanced and sophisticated science that is the practice of medicine.
Where his opinion and that of the only accepted medical expert to
provide an expert opinion conflict, his opinion cannot and will not be
afforded controlling deference. Argument supplied by counsel (albeit a
diligent and persuasive counsel) that the relevant standards were
satisfactorily applied as evidenced by the protocols and procedures
documented in the patient charts cannot supplant the unrefuted view of
an accepted expert witness.
The Respondent, who was in a unique position to conclusively refute
Dr. Kennedy's views and explain the format and nuances of the reviewed
documentation, elected not to testify in this matter. At a DEA
administrative hearing, it is permissible to draw an adverse inference
from the silence of the Respondent, even in the face of a Fifth
Amendment invocation. Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005)
(citing United States v. Hale, 422 U.S. 171, 176 (1975) ("silence
gains more probative weight where it persists in the face of
accusation, since it is assumed in such circumstances that the accused
would be more likely than not to dispute an untrue accusation."));
Joseph Baumstarck, M.D., 74 FR 17525, 17528, n.3 (2009) (citing Ohio
Adult Parole Auth. v. Woodward, 523 U.S. 272, 286 (1998)). On the facts
of this case, where the allegations are of a nature that a registrant
would be more likely than not to dispute them if untrue, an adverse
inference based on the Respondent's silence is appropriate. Where, as
here, the Government, through its expert, has alleged that the
Respondent's charts do not reflect genuine analysis, but rather (at
least in its view and the opinion of its expert), a sort of sham-by-
check-box form designed specifically to present a false impression of a
compliant registrant, it is precisely the type of allegation that would
naturally all but oblige a registrant to spring to offer a
contradictory account. The Respondent's choice to remain silent in the
face of such allegations, where he could have related his version of
his practice as a registrant, adds at least some additional credence to
the factual and analytical views of the Government's expert in this
regard.
In the Social Security context, where an Administrative Law Judge
has received expert medical opinions on the issue of the claimant's
ability to work and they are not repudiated in any respect by
substantial evidence, an adverse decision should be set aside as based
on "suspicion and speculation." Miracle v. Celebrezze, 351 F.2d 361,
378 (6th Cir. 1965); see also Hall v. Celebrezze, 314 F.2d 686, 689-90
(6th Cir. 1963); cf. Harris v. Heckler, 756 F.2d 431, 436 (6th Cir.
1985) (improper to reject uncontroverted evidence supporting complaints
of pain simply because of claimant's demeanor at hearing). When an
administrative tribunal elects to disregard the uncontradicted opinion
of an expert, it runs the risk of improperly declaring itself as an
interpreter of medical knowledge. Ross v. Gardner, 365 F.2d 554 (6th
Cir. 1966). While in this case it is ironically true, much like in the
Social Security context, that the opinion of a treating physician
should be afforded greater weight than the opinion of an expert whose
opinion is limited to a review of the patient file, see Magallenes v.
Bowen, 881 F.2d 747, 751 (9th Cir. 1989), the treating-source
Respondent in this case offered no evidence, not even his own opinion,
regarding the treatment rendered. Thus, in this adjudication, the
record contains no dispute between experts to be resolved; instead,
there is but one, unrefuted, uncontroverted, credible expert opinion.
To ignore that expert opinion on this record and replace it with the
opinion of this tribunal,
[[Page 19434]]
Respondent's counsel, or any other lay source would be a dangerous
course and more importantly, a plainly erroneous one.
Accordingly, after carefully balancing the admitted evidence, the
evidence establishes, by a preponderance of the evidence, that the
prescriptions the Respondent issued in Florida were not issued within
"the usual course of [the Respondent's] professional practice." 21
CFR 1306.04(a). Consideration of the evidence under the second and
fourth factors support the COR revocation sought by the Government in
this case.
To the extent that the Respondent's prescribing practices fell
below the requisite standard in Florida, that conduct also impacts upon
the Fifth statutory factor. Under Factor 5, the Deputy Administrator is
authorized to consider "other conduct which may threaten the public
health and safety." 21 U.S.C. 823(f)(5). Although this factor
authorizes consideration of a somewhat broader range of conduct
reaching beyond those activities typically associated with a
registrant's practice, an adverse finding under this factor requires
some showing that the relevant conduct actually constituted a threat to
public safety. See Holloway Distrib., 72 FR 42118, 42126 (2007).
The evidence establishes that the Respondent engaged in a course of
practice wherein he prescribed unsafely high doses of controlled
substances to patients irrespective of the patients' need for such
medication and ignoring any and red flags that could or did indicate
likely paths of diversion. The testimony of Dr. Kennedy, the DEA
regulations, and the Florida Standards make clear that physicians
prescribing controlled substances do so under an obligation to monitor
the process to minimize the risk of diversion. The patient charts
reflect that the Respondent, contrary to his obligations as a DEA
registrant, did not follow up in the face of multiple red flags. The
Respondent's disregard of his obligations as a DEA registrant and
Federal and State laws related to controlled substances militate in
favor of revocation.
By routinely prescribing unsafely high doses of controlled
substances to opioid-na[iuml]ve patients and ignoring his
responsibilities to monitor the controlled substance prescriptions he
was authorizing to minimize diversion, and by participating in an
insufficiently documented and thoughtful process for the issuance of
potentially dangerous controlled substances, the Respondent created a
significant potential conduit for the unchecked diversion of controlled
substances. See Holloway Distrib., 72 FR at 42124 (a policy of "see no
evil, hear no evil" is fundamentally inconsistent with the obligations
of a DEA registrant). Agency precedent has long recognized that
"[l]egally, there is absolutely no difference between the sale of an
illicit drug on the street and the illicit dispensing of a licit drug
by means of a physician's prescription." EZRX, LLC, 69 FR 63178, 63181
(1988); Floyd A. Santner, M.D., 55 FR 37581 (1988).
Agency precedent has consistently held that where, as here, the
Government has met its burden to establish a prima facie case that a
registrant has committed acts demonstrating that continued registration
is inconsistent with the public interest, acceptance of responsibility
is a condition precedent to continued registration. Jeri Hassman, M.D.,
75 FR 8194, 8236 (2010); Medicine Shoppe, 73 FR at 387. The record
contains no evidence that the Respondent has either acknowledged or
accepted responsibility for the misconduct at issue in these
proceedings.
Recommendation
Based on the foregoing, the evidence supports a finding that the
Government has established that the Respondent has committed acts that
are inconsistent with the public interest. A balancing of the statutory
public interest factors supports the revocation of the Respondent's
Certificate of Registration and a denial of his application to renew.
The Respondent has not accepted responsibility for his actions,
expressed remorse for his conduct at any level, or presented evidence
that could reasonably support a finding that the Deputy Administrator
should continue to entrust him with a Certificate of Registration.
Accordingly, the Respondent's Certificate of Registration should be
revoked and any pending applications for renewal should be denied.
Dated: August 10, 2010.
John J. Mulrooney, II,
U.S. Administrative Law Judge.
[FR Doc. 2011-8348 Filed 4-6-11; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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