Registrant Actions - 2011
[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19401-19419]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8344]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-35]
Beau Boshers, M.D.; Decision and Order
On August 10, 2010, Administrative Law Judge (ALJ) John J.
Mulrooney, II, issued the attached recommended decision.\1\ Thereafter,
Respondent filed 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 had been reformatted.
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Having reviewed the record in its entirety including Respondent's
exceptions, I have decided to adopt, except as explained below, the
ALJ's
[[Page 19402]]
rulings, findings of fact, conclusions of law, and recommended Order.
Respondent raises two exceptions to the ALJ's recommended decision.
First, he argues that "he was denied the ability to present his
positive experience in dispensing controlled substances." Resp. Exc.
at 1. More specifically, he argues that he was denied "access to files
seized" by the Government which show that he discharged patients, and
that "[w]ithout access to those files," he was left "with his hands
tied behind his back and [was] unable to demonstrate his successful
treatment of patients with controlled substances." Id. at 1-2.
Respondent contends that this "effectively crippl[ed] his ability to
present any evidence of his positive, or successful, experience in
dispensing and treating patients with controlled substances." Id. at
1.
As support for his contention that he is entitled to present
evidence of his "positive experience," Respondent cites the Agency's
decision on remand in Jayam Krishna-Iyer, 74 FR 459 (2009). That
decision addressed an unpublished decision of the United States Court
of Appeals for the Eleventh Circuit, which vacated the Agency's Order
revoking a practitioner's registration on the ground that it failed to
consider the practitioner's "experience with twelve patients whose
medical charts were seized by the DEA, or with thousands of other
patients. In short, the DEA did not consider any of the Petitioner's
positive experience in dispensing controlled substances." Id. (quoting
Krishna-Iyer v. DEA, 249 Fed. Appx. 159, 160 (11th Cir. 2007)).
While this Agency complied with the Eleventh Circuit's order,
unpublished decisions are "not precedential." United States v. Shaw,
560 F.3d 1230, 1241 (11th Cir. 2009). Moreover, as I noted in Krishna-
Iyer, "[t]he Court of Appeals did not cite to any decision of either
this Agency or another court defining the term 'positive experience.'
Nor did the Court offer any guidance as to the meaning of this term,
which is not to be found in the" Controlled Substances Act. 74 FR at
460.
I thus assumed--even though there was no evidence (except for
twelve patient files) in the record regarding the legitimacy of the
practitioner's prescribing of controlled substances to the "thousands
of other patients" she had treated--that her prescribings to these
patients constituted "positive experience." Id. at 460-61. However,
the practitioner's "prescribings to thousands of other patients [did]
not * * * render her prescribings to the undercover officers any less
unlawful, or any less acts which 'are inconsistent with the public
interest."' Id. at 463 (quoting 21 U.S.C. 823(f)).\2\
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\2\ As I also explained in Krishna-Iyer, while Congress directed
the Agency to consider all of the section 823(f) factors, I am
entitled to give each factor the weight I deem appropriate and the
courts of appeals have recognized that findings under a single
factor are sufficient to support the revocation of a registration.
74 FR at 462 (citing Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir.
2005); Morall v. DEA, 412 F.3d 165, 173-174 (DC Cir. 2005). As I
further explained, "this 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; what matters is the seriousness of the registrant's
misconduct." Id. at 462.
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As Krishna-Iyer explained, because the CSA limits registration as a
practitioner "to those who have authority to dispense controlled
substances in the course of professional practice, and patients with
legitimate medical conditions routinely seek treatment from licensed
medical professionals, every registrant can undoubtedly point to an
extensive body of legitimate prescribing over the course of her
professional career." Id.; see also 21 U.S.C. 823(f) (registration
limited to a practitioner "authorized to dispense * * * controlled
substances under the laws of the State in which he practices"). I
further noted that "in past cases, [DEA] has given no more than
nominal weight to a practitioner's evidence that he has dispensed
controlled substances to thousands of patients in circumstances which
did not involve diversion." Id. (quoting Paul J. Caragine, Jr., 63 FR
51592, 51599 (1998) ("[T]he Government does not dispute that during
Respondent's 20 years in practice he has seen over 15,000 patients. At
issue in this proceeding is Respondent's controlled substance
prescribing to 18 patients."); id. at 51600 ("[E]ven though the
patients at issue are only a small portion of Respondent's patient
population, his prescribing of controlled substances to these
individuals raises serious concerns regarding [his] ability to
responsibly handle controlled substances in the future."); Medicine
Shoppe-Jonesborough, 73 FR 364, 386 & n.56 (2008) (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)).
DEA has thus revoked a practitioner's registration based on a
single act of presenting two fraudulent prescriptions to a pharmacy for
filling; see Alan H. Olefsky, 57 FR 928, 928-29 (1992), and DEA can
revoke based on a single act of diversion. Dewey C. MacKay, 75 FR
49956, 49977 (2010). See also Sokoloff v. Saxbe, 501 F.2d 571, 576 (2d
Cir. 1974) (upholding revocation of practitioner's registration based
on nolo contendre plea to three counts of unlawful distribution).
Undoubtedly, each of these practitioners could have pointed to evidence
of having treated a large number of patients in circumstances in which
he did not divert controlled substances to drug abusers or drug
dealers.
Consistent with these precedents, I held in Krishna-Iyer that
"evidence that a practitioner has treated thousands of patients in
circumstances which do not constitute diversion," and has even refused
to prescribe to certain patients,\3\ "does not negate a prima facie
showing that the practitioner has committed acts inconsistent with the
public interest." \4\ 74 FR at 463. I further held
[[Page 19403]]
that while such evidence may be entitled
to some weight in assessing "whether a practitioner has credibly shown
that she has reformed her practices, where a practitioner commits
intentional acts of diversion and insists she did nothing wrong, such
evidence is entitled to no weight." Id.
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\3\ In Krishna-Iyer, I noted that the practitioner had
discharged several patients. 74 FR at 462. However, I held that this
evidence was not probative of the practitioner's intent in
prescribing to the other patients who were focus of the proceeding.
Id. & n.6.
\4\ I do not adopt the ALJ's discussion of the standards applied
by the Agency in assessing a practitioner's experience in dispensing
controlled substances, which cites primarily to cases involving list
chemical I distributors, a different category of registrant. See ALJ
Dec. at 25-26. As one example as to why, DEA routinely issues
registrations to newly-licensed practitioners even though they
cannot point to any experience in dispensing controlled substances
(provided they have not previously violated controlled substance
laws.). Conversely, DEA has never held that a practitioner's lengthy
experience in dispensing controlled substances without diverting
precludes a finding (where supported by substantial evidence showing
that he did divert) that a practitioner has committed acts which
render his registration "inconsistent with the public interest."
21 U.S.C. 824(a)(4).
In any event, as discussed above, Respondent offered no evidence
on the issue of his experience in dispensing controlled substances
and the ALJ's ultimate conclusion that Respondent violated the CSA's
prescription requirement because he dispensed controlled substance
prescriptions that were not "within" 'usual course of [his]
professional practice," ALJ at 41 (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 actuallys constituted a threat to
public safety." ALJ at 41 (emphasis added and citation omitted.)
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" is clearly support by substantial evidence and warrants
an adverse finding under factor five. ALJ at 42.
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 37 (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 is necessarily dependent 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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Respondent's exception is neither factually nor legally well taken.
Contrary to his assertion that his hands were "tie[d] behind his
back" and that he was "effectively cripple[ed]" from "present[ing]
any evidence of" what he terms "his positive * * * experience," \5\
Respondent could have testified about his dispensing practices and
addressed those instances in which he refused to prescribe controlled
substances; his decision to not put on evidence on this issue was not a
matter "of impossibility," but of "choice." Resp. Exc. at 1.
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\5\ Nor is it clear what Respondent means by "positive
experience." Resp. Exc. at 1. While at various points Respondent
refers to files which he asserts show that he discharged patients,
he then maintains that his lack of access to the files prevent him
from presenting "any evidence of his positive, or successful,
experience in dispensing and treating patients with controlled
substances." Id. (emphasis added). He likewise contends that he was
"unable to demonstrate his successful treatment of patients with
controlled substances." Id. at 2 (emphasis added). However, it is
not DEA's role to assess whether a practitioner has successfully
treated patients, but rather, to determine whether a practitioner is
either diverting drugs or engaging in practices (whether intentional
or not) that create a substantial risk of diversion. See Caragine,
63 FR at 51601 ("Careless or negligent handling of controlled
substances creates the opportunity for diversion and [can] justify
revocation [or a registration] or denial" of an application).
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Most significantly, Respondent could have testified regarding his
prescribing practices with respect to the patients whose files were
reviewed by the Government's Expert and which formed the basis for the
latter's (and the ALJ's) conclusion that Respondent acted outside of
the usual course of professional practice and lacked a legitimate
medical purpose in prescribing controlled substances to them. See ALJ
Dec. at 41 (citing 21 CFR 1306.04(a)). Alternatively, he could have
retained his own expert to review the files and called the expert to
testify. Notably, Respondent makes no claim that the files, which were
reviewed by the Government's Expert, were not timely provided to
him.\6\
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\6\ Indeed, it appears that the patient files (which the expert
reviewed) were provided to Respondent nearly two months before the
hearing.
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Respondent also takes exception to the ALJ's finding that he was
not prejudiced by the Government's failure to turn over "the
discharged patient files," as well as evidence pertaining to a second
undercover officer to whom he refused to prescribe. Resp. Exc. at 2.
Respondent asserts that his right to Due Process was violated because
this evidence "could have exonerated" him, "or at the very least,
given him an opportunity to meaningfully defend against the
Government's allegations," and that prejudice "must [be] assume[d] *
* * because neither he nor the Court were ever given access to it."
Id.
As an initial matter, while there is evidence that Respondent
refused to prescribe to a second undercover officer, there is no
evidence establishing that there were, in fact, "discharged patient
files." Respondent neither testified, nor offered any other evidence
such as an affidavit establishing, that such files exist. Most
significantly, in his Exceptions, Respondent does not cite any
authority for the proposition that the Agency is required to provide
broad discovery in a proceeding under sections 303 and 304 of the CSA.
See generally Resp. Exc. Indeed, Respondent's contention far exceeds
what the Supreme Court has held that an agency must do to comply with
the Due Process Clause. See, e.g., Goldberg v. Kelly, 397 U.S. 254, 270
(1970).
In Goldberg, the Supreme Court held that "'where governmental
action seriously injures an individual, and the reasonableness of the
action depends on fact findings, the evidence used to prove the
Government's case must be disclosed to the individual so that he has an
opportunity to show that it is untrue.'" 397 U.S. at 270 (quoting
Greene v. McElroy, 360 U.S. 474, 496 (1959) (emphasis added)). The
Court has further explained that "[a] party is entitled * * * to know
the issues on which [the] decision will turn and to be apprised of the
factual material on which the agency relies for decision so that he may
rebut it. Indeed, the Due Process Clause forbids an agency to use
evidence in a way that forecloses an opportunity to offer a contrary
presentation." Bowman Transp., Inc., v. Arkansas-Best Freight System,
Inc., 419 U.S. 281, 288 n.4 (1974).
It is well settled, however, that neither the Due Process Clause,
nor the Administrative Procedure Act (nor DEA's rules of procedure)
require the Agency to provide a general right of discovery in
administrative proceedings. See Echostar Comm. Corp. v. FCC, 292 F.3d
749, 756 (DC Cir. 2002); Mister Discount Stockbrokers, Inc., v. SEC,
768 F.2d 875, 878 (7th Cir. 1985); Nicholas A. Sychak, d/b/a/Medicap
Pharmacy, 65 FR 75959, 75961 (2000). While "discovery must be granted
if in the particular situation a refusal to do so would so prejudice a
party as to deny him due process," McClelland v. Andrus, 606 F.2d
1278, 1285-86 (DC Cir. 1979), the party seeking discovery must rely on
more than speculation and must show that the evidence is relevant,
material, and that the denial of access to the documents is
prejudicial. See Echostar, 292 F.3d at 756; Silverman v. CFTC, 549 F.2d
28, 34 (7th Cir. 1977).
In this case, the ALJ based his conclusion that Respondent issued
numerous prescriptions outside of the usual course of professional
practice in violation of both Federal and State laws and thus had
committed acts which render his registration inconsistent with the
public interest, see ALJ Dec. at 39-42, on the Expert's testimony and
report regarding the various patients files the latter reviewed, each
of which was provided to Respondent. Accordingly, the evidence which
was the basis of the decision was disclosed to him, and contrary to his
contention, see Resp. Exc. at 2, Respondent had a meaningful
"opportunity to show that it is untrue." \7\ Goldberg, 397 U.S. at
270. Respondent offers no explanation as to why other patient files
would have "exonerated" him from the allegations that his
prescriptions to the patients, whose files were reviewed by the Expert,
were issued outside of the usual course of professional practice and
lacked a legitimate medical purpose. Nor does Respondent offer any
legal authority for his contention that prejudice--which he cannot
show--
[[Page 19404]]
must be assumed. See Mister Discount Stockbrokers, 768 F.2d at 878
(rejecting challenge to discovery procedures in administrative
proceeding noting that party failed "to demonstrate any prejudice * *
* let alone prejudice to a significant degree so as to result in a
denial of due process").
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\7\ The Government also attempted to introduce evidence that
Respondent prescribed to a member of a Boston-based drug trafficking
organization, who had been arrested with 3,000 oxycodone tablets in
his possession, and who stated that he did not have a legitimate
medical need for the drugs he obtained from Respondent. Tr. 829-32.
For the reasons stated in his decision, the ALJ properly gave this
testimony no weight. See ALJ Dec. at 10 n.23.
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There is likewise no merit to Respondent's contention that he was
prejudiced by the Government's failure to turn over the patient file of
the undercover officer to whom he refused to prescribe. A Special Agent
testified that Respondent had refused to prescribe to a second
undercover officer and the Government failed to put forward any
evidence regarding the circumstances of this visit (such as what the
officer said to Respondent). For this reason alone, it was proper for
the ALJ to draw an inference adverse to the Government and conclude
that Respondent properly complied with the rules of the Florida Board
of Medicine in evaluating the undercover officer. See ALJ at 32 (citing
UAW v. NLRB, 459 F.2d 1329, 1335-39 (D.C. Cir. 1972)).\8\ However, as
the ALJ held, that Respondent refused to prescribe controlled
substances in this single instance does not refute the Government's
prima facie showing that Respondent repeatedly violated the
prescription requirement of Federal law as established by the Expert's
review of eighteen patient files. See id. at 41 (quoting 21 CFR
1306.04(a)) ("after carefully balancing the admitted evidence, [and]
even applying an adverse inference that permits the assumption that the
Respondent was approached by an undercover agent and acted
appropriately, the evidence establishes, by a preponderance, that the
prescriptions the Respondent issued * * * were not issued within 'the
usual course of [the Respondent's] professional practice'").
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\8\ The ALJ explained that drawing an adverse inference was
"appropriate under the circumstances of this case where the
evidence of the unsuccessful US was clearly within the Government's
control and should, to maintain the integrity of the proceedings,
have been disclosed if not produced." ALJ at 32. It is unclear
whether the ALJ believed that disclosure of this evidence was
required as a matter of Due Process as the ALJ did not cite any
authority for his reasoning and numerous courts (as well as this
Agency) have held that Brady v. Maryland, 373 U.S. 83 (1963), does
not apply to administrative proceedings. See Mister Discount
Stockbrokers, 768 F.2d at 878; NLRB v. Nueva Engineering, Inc., 761
F.2d 961, 969 (4th Cir. 1985); Nicholas A. Sychak, 65 FR 75,959,
75960-61 (2000). Even if this evidence is of the type which a
refusal to disclose "would so prejudice a party as to deny him due
process," McClelland v. Andrus, 606 F.2d at 1286, the evidence was
disclosed through the testimony of the Special Agent. Respondent
thus cannot show prejudice.
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As noted above, Respondent did not testify. Nor did he offer the
testimony of an expert. Thus, Respondent did not refute the opinion
testimony of the Government's Expert that he repeatedly violated the
prescription requirement of Federal law. Because Respondent failed "to
testify in response to [the] probative evidence offered against" him,
I conclude (as did the ALJ) that it is appropriate to draw an adverse
inference against him and hold that he knowingly issued prescriptions
in violation of 21 CFR 1306.04(a). Baxter v. Palmigiano, 425 U.S. 308,
316 (1976); see also The Lawsons, Inc., 72 FR 74334, 74339 (2007).
Because Respondent failed to testify, I also conclude that he has not
accepted responsibility for his misconduct nor demonstrated that he
will not engage in future misconduct, and therefore, he has not
rebutted the Government's prima facie showing that his continued
registration is inconsistent with the public interest.\9\ See Medicine
Shoppe-Jonesborough, 73 FR at 387; Samuel S. Jackson, 72 FR 23848,
23853 (2007). I thus reject Respondent's Exceptions and adopt the ALJ's
recommended Order.
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\9\ A registrant's obligation to accept responsibility and
demonstrate that he will not engage in future misconduct applies
even where the Government's evidence does not establish that a
registrant has committed intentional acts. See Krishna-Iyer, 74 FR
at 464 n.9; Caragine, 63 FR at 51601 (granting restricted
registration where physician showed that he underwent remedial
"training to become better educated in controlled substances and
how to deal with drug-seeking patients"). Thus, even if I had
concluded that the evidence did not establish that Respondent
knowingly diverted controlled substances, I would still revoke his
registration because he failed to rebut the Government's prima facie
case.
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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, FB0254918, issued to Beau Boshers, M.D.,
be, and it hereby is revoked. I further order that any pending
application of Beau Boshers, 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
Jose M. Quinon, 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 FB02549187, of Beau
Boshers, 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 sought
revocation of the Respondent's registration, pursuant to 21 U.S.C.
824(a)(4), and denial of any pending applications for renewal \10\
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 22, 2010, the Respondent timely requested a
hearing, which, pursuant to a change of venue granted at his
request, was conducted in Miami, Florida, on July 7, 2010 through
July 9, 2010.\11\ The immediate suspension of the Respondent's COR
has remained in effect throughout these proceedings.
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\10\ Although the Respondent's COR expired on July 31, 2010, the
parties stipulated that a timely renewal application has been
submitted by the Respondent. ALJ Ex. 40.
\11\ 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).
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 participated in at
American Pain, LLC (American Pain), prescribed and dispensed
inordinate amounts of controlled substances, primarily
oxycodone,\12\ under circumstances where he knew, or should have
known, that the prescriptions were not dispensed for a legitimate
medical purpose. ALJ Ex. 1. The OSC/ISO further charges that these
prescriptions were issued outside the usual course of professional
practice based on a variety of circumstances \13\ surrounding the
manner in which American Pain is operated and the manner in which
its physicians, including the Respondent, engaged in the practice of
medicine. Id. The Respondent is also alleged, on several occasions,
to have provided undercover law enforcement personnel with
controlled substances, including, inter alia, oxycodone and
[[Page 19405]]
alprazolam,\14\ after cursory or no medical examinations, and
therefore without a legitimate medical purpose. Id. The Government's
OSC/ISO also alleges that the Respondent's former patients 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. Lastly, as an additional ground for the
OSC/ISO, the Government cites the death of one of the Respondent's
patients from an overdose of controlled substances one day after
obtaining prescriptions for some of those same controlled substances
during a visit to the Respondent at American Pain, and that the
investigation determined the deceased patient and two companions
obtained those substances "for other than a legitimate medical
purpose with the intention of selling the controlled substances in
Kentucky." Id.
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\12\ A schedule II controlled substance.
\13\ The majority of which are supported by no evidence
introduced by the Government during the course of these proceedings.
\14\ A schedule IC controlled substance.
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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.\15\
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, 166 controlled
substance prescriptions issued over the Respondent's signature, to
seventy-five patients, only six of whom resided in Florida. The
remainder of the patients had listed addresses in Kentucky,
Tennessee, Ohio, Georgia, Indiana, Alabama and West Virginia. The
data in the log further reflected that the Respondent issued three
prescriptions for non-controlled substances during that time period.
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\15\ Although GS Langston testified that DEA immediately
suspended the COR that had been issued to Boca Drugs, Tr. at 715,
and that aq 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. Id. 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
\16\ or OUTSIDE the STATE OF FLORIDA.
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\16\ 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.\17\ Govt. Ex. 119 at 2.
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\17\ Although GS Langston testified that she did not actually
take the photographs 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 an 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.\18\ Id. at 768.
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\18\ In his Discussion and Proposed Findings of Fact and
Conclusions of Law (Respondent's Brief), the Respondent argues that
the selection criteria employed by Langston deprived him of due
process and somehow created an inaccurate portrayal of his practice.
Respt's Br. at 4. However, the Respondent never explains the casual
connection between the manner in which the files were selected,
which was not based on any manner of targeting derogatory
information regarding his patient care and why any due process right
was compromised.
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Langston also explained DEA's Automated Record Consolidated
Ordering System (ARCOS) \19\ and testified that she generated an ARCOS
report relative to the Respondent's ordering of controlled substances
from January 2009 through February 2010. Govt. Ex. 23.
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\19\ 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.
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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,
Kentucky and Ohio. Govt. Exs. 24-26. Review of the PMP report data
reflects that during the time period of February 1, 2006 through
February 11, 2010, pharmacies filled 259 controlled substance
prescriptions issued over the Respondent's signature to sixty-eight
patients located in West Virginia, 173 similar prescriptions provided
to seventy-nine Kentucky-based patients were filled between January 1,
2009 and April 4, 2010, and ninety such prescriptions pertaining to
sixty-one patients located in Ohio were filled between April 1, 2008
and April 19, 2010. Id.
No evidence was introduced at the hearing that would provide any
reliable level of context regarding the raw data
[[Page 19406]]
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 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 \20\ 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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\20\ SA Burt described the pole cameras as "covert cameras that
are installed to observe the activity in the clinic." Tr. 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 recirded 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 \21\ 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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\21\ Tr. at 910.
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Based on his review of some (but not all) \22\ 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" \23\ for these office visits, and the six doctors at the
clinic saw "anywhere from 200 upward to 375 patients a day" \24\ in
this manner.\25\ Id. at 882-83 (emphasis supplied).
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\22\ 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.
\23\ Later on cross-examination, SA Burt admitted that the
clinic also accepted payment via credit card. Tr. at 916. The
parameters of what the witness meant by "predominantly" was not
the subject of further explanation.
\24\ 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.
\25\ 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. See Richardson
v. Perales, 402 U.S. 389, 402 (1971); J.A.M. Builders v. Herman, 233
F.3d 1350, 1354 (11th Cir. 2000); Kelly 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 \26\ of the
video and audio recordings made by an undercover agent (UC) who assumed
the name Luis Lopez capturing activity inside of American Pain.\27\ 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 Bart'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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\26\ Tr. at 1002-05.
\27\ 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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Although noticed in SA Burt's proposed testimony identified in the
Government's prehearing statement, testimony regarding the specifics of
the UC's visits to see the Respondent at American Pain was not elicited
by the Government during its direct examination, but was brought out on
cross-examination to meet the Government's admitted evidence consisting
of a patient file kept by the Respondent relative to the UC and the
accompanying expert report and testimony concerning that file provided
by Dr. Kennedy. Id. at 985-86; Govt. Exs. 46 (Patient File for Luis
Lopez), 131 (Supplemental Expert Report Regarding Undercover Patient
Luis Lopez). Burt testified that he did not have the UC examined by a
physician to determine his physical condition prior to going to the
clinic, he did not ask him whether he had any prior back problems, and
he did not ask him whether he had any past problems that caused a
doctor to prescribe him controlled substances; instead, Burt relied
solely on the UC's representations he was not currently in any pain
before sending him into the clinic. Tr. at 987-89. According to Burt,
the only instructions he provided to the
[[Page 19407]]
UC were to be "very vague regarding the pain," to "point to a
general area" when asked about it, and to provide a urine sample if so
requested by clinic staff. Id. at 989-90, 1001. It was further
established that an MRI was taken of the UC at Faye Imaging prior to
his seeing the Respondent. Id. at 990-91. Burt related that the UC's
first visit to the clinic was approximately an hour and fifteen
minutes, and his visit with the Respondent was ten to thirteen minutes
long. Id. at 998-99. Although these encounters between the UC and the
Respondent were recorded either via audio or video, the Government did
not offer the recordings as evidentiary exhibits at the hearing, and
opposing counsel did not have access to them.\28\
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\28\ In fact, as addressed infra, SA Burt did not review the
recordings or read the history and physical examination form
contained in the UC's patient file with an eye towards determining
if the audio corroborated the information on the forms. Furthermore,
Burt admitted these recordings were not provided to Dr. Kennedy for
his use in formulating his expert testimony and reports. Tr. at
1007.
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More troubling by far is the revelation during SA Burt's cross
examination that in addition to UC Luis Lopez, a second UC went into
American Pain during July 2009 and recorded his encounters with the
Respondent. Those encounters by the second UC did not culminate with
the Respondent prescribing controlled substances.\29\ Id. at 1027,
1029.
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\29\ As discussed in more detail anon, this development was
particularly troubling in light of the Respondent's prehearing
motion practice where he sought the disclosure of precisely this
variety of evidence.
---------------------------------------------------------------------------
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. 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 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.
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, the
first confidential source (CS1) discussed by Burt was arrested in
Washington, DC after transporting upwards of 3,000 oxycodone pills from
south Florida to Massachusetts, and at the time of his arrest, Burt
testified that an empty prescription pill bottle from American Pain
with the Respondent's name on it was found on his person. Id. at 829.
Burt relayed that at the time CS1 was searched, he had the 3,000 pills
secreted in a jock strap strapped to the inside of his leg, and they
were not in any type of bottle with the Respondent's name on it. The
individual told Burt during a July 2009 interview \30\ that he was a
member of a Boston-based drug trafficking organization that would
obtain oxycodone in southern Florida and transport it back to Boston
for resale. Id. at 831. CS1 told Burt that he did not have a legitimate
medical need for drugs when he saw the Respondent at American Pain, and
that during his office visit, the doctor did not physically touch him,
but did tell him to bend over and touch his toes. Id. at 832-33. The
Government did not submit evidence of, or provide opposing counsel
access to, a patient file reflecting CS1's visit to the Respondent, a
copy of the prescription allegedly issued, or the empty pill bottle
described.\31\ Burt's testimony divulged the fact that CS1's
cooperation with authorities was being provided in relation to his July
2009 arrest and that a record check revealed CS1 had arrests prior to
that incident, though Burt was unable to recall information of any
detail concerning the nature and disposition of those arrests. Id. at
1018-20. Burt declined to disclose the name of CS1 when queried on
cross-examination.\32\ Id. at 1017.
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\30\ Tr. at 1012.
\31\ SA Burt testified that he has never actually seen the
described pill bottle. Tr. at 830. Burt also revealed on cross-
examination that he has never reviewed a patient file relative to
CS1, and that said patient file was not reviewed by a doctor to
determine the propriety of the controlled substance prescriptions
purportedly issued by the Respondent. Id. at 1015.
\32\ 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
him, no weight can be assigned to SA Burt's testimony concerning
information provided by CS1, other than the fact that it may have
informed 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. 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).
---------------------------------------------------------------------------
SA Burt also testified regarding the drug overdose deaths of TY and
SM after obtaining controlled substances from American Pain.\33\ Burt's
record testimony indicates that DEA Task Force Officer \34\ (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.\35\ Likewise, the record evidence concerning SM
did not implicate prescribing activity by the Respondent.
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\33\ 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.
\34\ 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.
\35\ 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
[[Page 19408]]
testimony as noticed in the Government's prehearing statement.\36\ 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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\36\ ALJ Ex. 6.
---------------------------------------------------------------------------
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.\37\ Dr. Kennedy was offered by the
Government and accepted as an expert in the field of pain medicine. Id.
at 39. 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. Id. at 176-77, 365. Dr. Kennedy
stated that
---------------------------------------------------------------------------
\37\ Dr. Kennedy's CV was admitted into evidence. Govt. Ex. 117.
---------------------------------------------------------------------------
there was no true doctor/patient relationship established for the
prescription of controlled substances at the first or any visit, and []
it was grossly deficient and medically dangerous to prescribe in the fashion it was prescribed for the same reasons.
Id. Furthermore, Dr. Kennedy testified that after reviewing the charts,
he concluded that the prescribing of controlled substances by the
Respondent to the patients named in the charts was not for a legitimate
medical purpose. Id. at 182.
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 files 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, during his testimony, Dr. Kennedy acknowledged that some
level of standardization and utilization of forms is not, standing
alone, improper,\38\ Dr. Kennedy took issue with what he perceived as
flaws in the forms utilized by the Respondent to document patient care.
Dr. Kennedy even acknowledged that the Respondent's possession and use
of stamps to affix prescription descriptions and doses on scripts, was
not, standing alone, improper. Id. at 178. However, according to Dr.
Kennedy, the forms employed by the Respondent were "grossly deficient
in that [they] didn't really justify why the individual was given the
high doses of narcotics or controlled substances that they were." Id.
at 177.
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\38\ 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 41-42. 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 45-46. 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 46-47. Dr. Kennedy acknowledged that physicians
customarily accept patients at their word, but on the subject of
verifying a patient's subjective complaint and medication history, Dr.
Kennedy explained that
[s]ometimes you have to help people understand why they're suffering or
what their problems are. A person with an addiction or drug abuse
problem is no worse a human being than me. I'm not any better than
them. But it's your job as a doctor to sit down and find out what the
truth is as well as you reasonably can under the circumstances. That
wasn't done here, in my opinion.
Id. at 357.
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 49. 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 49-50. In other
words, the diagnostic plan allows the treating doctor to eliminate or
confirm items on the differential diagnosis. Id. at 50-52.
Dr. Kennedy testified that in his expert opinion, the Respondent's
histories and physical examinations were "grossly deficient in that
[the documentation] didn't really justify why the [patient] was given
the high doses of narcotics or controlled substance that they were."
Id. at 177. Kennedy stated that, in his view, the treatment plans
evident in the charts were also defective because there was no
individualized consideration apparent, that "[e]verybody got
essentially the same thing," and that the treatment plans for all
patients were invariably limited to a single option, i.e., "the
treatment plan was to give controlled substances, and that was
essentially it." \39\ Id. at 78.
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\39\ At the consolidated hearing in this matter, the Government
elicited testimony from Dr. Kennedy regarding additional aspects of
practice that he found deficient regarding the prescribing practices
of other respondents. For example, Dr. Kennedy opined that the
prescribing of 30 mg of oxycodone to an opioid na[iuml]ve patient
would, in his opinion, be dangerous and improper. Similarly, Dr.
Kennedy provided his opinion that the practice of ordering of an MRI
prior to a physician meeting with a patient would be improper.
However, regarding the charts that Dr. Kennedy reviewed relative to
this Respondent, the government adduced no testimonial evidence
regarding issues such as opioid na[iuml]vet[eacute] or the timing of
MRI scripts, and it would be unfair, improper and illogical for an
Administrative Law Judge to extrapolate the testimony elicited
relative to the patients of other physician(s) to this Respondent.
See Gregg & Son Distribs., 74 FR 17517 n.1 (2009) (data should be
provided while record is open, and "[t]o make clear, 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")
citing Southwood Pharms., Inc., 72 FR 36487, 36503 n.25 (2007). The
absence of testimonial support by Dr. Kennedy on these issues
relative to this Respondent does not adversely affect the weight to
be attached to the conclusions set forth in the reports he prepared
in connection with this Respondent which were received into
evidence. Govt. Exs. 28, 131.
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[[Page 19409]]
Although Dr. Kennedy had earlier conceded that it is the judgment
of the examining physician that is generally relied upon in determining
the necessity and appropriateness of diagnostic testing,\40\ he also
testified that, at least in his view, exclusive reliance on MRI
procedures as the sole diagnostic tool is suboptimal, because they are
not always required and not always appropriate. Id. at 75-77, 165-66.
Kennedy characterized MRIs as the Respondent's principal diagnostic
tool. Id. at 177.
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\40\ Tr. at 63.
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Dr. Kennedy prepared two reports in connection with the
Government's case against the Respondent, both of which are dated April
30, 2010, and both of which were admitted into evidence during his
testimony. Govt. Exs. 28, 131; Tr. at 174, 194. One of the reports
describes a general analysis of seventeen charts that the Respondent
maintained on as many patients, that were (selected by and) provided to
Dr. Kennedy by the Government from among patient files seized pursuant
to a criminal search warrant executed at the Respondent's practice on
March 3, 2010 (Patient Charts Analysis).\41\ Govt. Ex. 28. Although
this report purports to describe practices common to all seventeen
files reviewed by Dr. Kennedy, much of the analysis is directed toward
a chart prepared in connection with RZ,\42\ one of the Respondent's
patients. A second report (Supplemental Chart Analysis) prepared by Dr.
Kennedy focuses on the chart maintained under the name Luis Lopez,
which was the assumed name of a law enforcement officer who visited the
Respondent's practice in an undercover capacity. Govt. Ex. 131; Tr. at
188, 335.
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\41\ During the prehearing proceedings, the Respondent moved for
an order compelling production of, inter alia, all patient files
seized from his office by the Government. The request (which was
opposed by the Government) was denied in a separate order as ultra
vires. ALJ Ex. 20; see Nicholas A. Sychak, d/b/a Medicap Pharmacy,
65 FR 75959, 75961 (2000); Roy E. Berkowitz, M.D., 74 FR 3678, 36760
(2009).
\42\ 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.
17.
---------------------------------------------------------------------------
Many of the observations and conclusions contained within the two
reports are remarkably similar. Dr. Kennedy's report makes it
unambiguously clear that, at least in his opinion, all eighteen of the
Respondent's charts that he reviewed suffered from the same
shortcomings. The Patient Charts Analysis states that the Respondent's
patient charts that Dr. Kennedy reviewed "are essentially the same
with regard to review issues; as stated in the report of [RZ]
referenced and discussed in this report in detail, [and that] there
were no significant differences that affected [his] conclusions and
summary." Govt. Ex. 28 at 2. A like-worded proviso accompanies Dr.
Kennedy's analysis of the chart prepared in connection with the
undercover officer's (Luis Lopez's) interaction in the Supplemental
Chart Analysis. Govt. Ex. 131 at 1.
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 standard of care due to their
brevity and quality"; \43\ (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; \44\ (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;" \45\ (4)
contained medication contracts that were "not always signed" and
"listed criteria that was not followed by the doctors at American
Pain; \46\ (5) failed to 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"'; \47\ (7) reflected "no therapeutic plan, except to use
controlled substances to 'treat' the subjective complaint of 'pain'
which was inadequately described; \48\ (8) did not reflect "real
therapeutic goals * * * for improvement of quality of life (activities
of daily living, work, sleep, mood)"; \49\ (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 psychology"; \50\ (10) reflected "a gross lack of past
medical records in all charts reviewed and in some cases none at all";
\51\ and, (11) demonstrated controlled substance patient monitoring
practices that were "not within the standard of care and outside the
boundaries of professional practice." \52\
---------------------------------------------------------------------------
\43\ Govt. Ex. 28 at 4.
\44\ In Dr. Kennedy's opinion, the Respondent "prescribed, at
the first visit, very high initial doses of controlled substance
combinations despite not being within the standard of care for
histories, physical examinations and/or absent past medical records
[with] no apparent consideration given to patient safety with
initial or subsequent prescription of controlled substance[s]."
Govt. Ex. 28 at 7.
\45\ Govt. Ex. 28 at 4.
\46\ 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. Govt. Ex. 28 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.
\47\ Govt. Ex. 28 at 7. In Dr. Kennedy's opinion, Respondent in
effect, acted as a "barrier" for [RZ] to receive appropriate
medical evaluation and treatment. In other words, the very potent,
high doses of opioids (oxycodone) and benzodiazepine (Xanax) may
have masked or cover[ed] up [RZ'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.
\48\ Govt. Ex. 28 at 7.
\49\ Govt. Ex. 28 at 8.
\50\ Govt. Ex. 28 at 7.
\51\ Govt. Ex. 28 at 15. RZ's chart did not contain a request
for past medical records. Id. at 8.
\52\ Govt. Ex. 28 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.\53\ Govt. Ex. 28 at 14;
Tr. at
[[Page 19410]]
179-80. 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. Furthermore, the charts contained only
rare evidence of contact with primary care physicians, treating
physicians, pharmacists, or other health care providers. Id.
---------------------------------------------------------------------------
\53\ However, when pressed on the issue, Dr. Kennedy declined to
identify any specific instance regarding any of Respondent's charts
where he would have ordered an additional drug screen. Tr. at 180.
---------------------------------------------------------------------------
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. In addition to providing incomplete
information on his patient questionnaires, the undercover officer (a/k/
a Luis Lopez) admitted to the Respondent that he had previously
purchased oxycodone on the street. Govt. Exs. 46 at 9, 131 at 3. Other
red flags noted by Dr. Kennedy in the reviewed charts included the
relatively young age (in Kennedy's view) of the Respondent's chronic
pain patients,\54\ incomplete history information provided by the
patients, periodically significant gaps between office visits,\55\
referrals from friends, relatives, or advertising, but not other
physicians,\56\ 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.\57\
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\54\ Govt. Ex. 28 at 15.
\55\ Govt. Ex. 28 at 13.
\56\ Govt. Ex. 28 at 8, 15.
\57\ Govt. Ex. 28 at 16.
---------------------------------------------------------------------------
At the hearing, Dr. Kennedy testified that the entries in some of
the charts that reflected that the patients were acquiring controlled
substances "off the street," and urine drug screen results that were
inconsistent with patient disclosures, were red flags that should have
motivated a prudent physician to perform additional due-diligence
steps, that, in addition to discussing the matter with the patient,
could include reaching out to family members, previous treating
physicians and pharmacists, obtaining past medical records, and
additional testing. Tr. at 359-60, 362. Dr. Kennedy testified that his
evaluation revealed that these red flags were present in the charts and
precipitated no due-diligence actions on the Respondent's part. Id. at
360-64, 368-69.
On the issue of red flags, WA's patient file contains the
Respondent's handwritten notation indicating the patient acquired
oxycodone and Xanax "off [the] streets," yet the Respondent
authorized prescriptions for Roxicodone, Xanax, and Percocet to WA
during his initial and subsequent visits. Govt. Ex. 29 at 11, 23-33.
Like scenarios were also apparent in the charts of numerous other
patients who had informed the Respondent that they had previously
acquired such substances in this illegal manner, including the
undercover law enforcement officer (Luis Lopez). See Govt. Exs. 30 at
7; 33 at 4; 34 at 5; 37 at 1; 39 at 4; 40 at 1; 46 at 9 (notations
indicating patients acquiring controlled substances "off the
street"). Another patient file contained a similar note that the
patient had received oxycodone "from [a] friend." Govt. Ex. 44 at 13.
KA's patient file contains a form indicating a positive UDS for
opiates and oxycodone from 7/9/09, yet on the same date, the patient
comfort assessment guide and medication contract signed by KA are both
blank in the section where a patient is supposed to list any
medications he or she is currently taking. Govt. Ex. 30 at 14-15, 33;
see also Govt. Exs. 33 at 8-9, 23; 43 at 10-11, 27 (similar issues).
Patient JR's 5/27/[09] UDS indicates a negative test for all listed
substances, yet on her signed medication contract from the same date,
she indicates she is currently taking three substances which, though
misspelled, appear to refer to oxycodone, Percocet, and Xanax, a
discrepancy which raises questions about the validity of the testing
procedures and/or the patient's candor. Govt. Ex. 35 at 12, 26. Patient
AZ's \58\ UDS form, on the other hand, lists positive test results for
oxycodone and opiates only on 11/12/09, yet the patient claims on two
different documents from the same date that, in addition to two
different strengths of Roxicodone, she is also currently taking
clonazepam, a benzodiazepine that should have triggered a positive
reading for that substance on her drug screen.\59\ Govt. Ex. 45 at 9-
10, 24. 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.
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.
---------------------------------------------------------------------------
\58\ Given the testimony of SA Burt regarding the level of
activity outside American Pain parking area as observed through the
pole cam, it is remarkable that one patient actually indicated that
one of the reasons she left the previous pain clinic she frequented
was because of "people hanging outside place approaching patients
for their medications." Govt. Ex. 45 at 20.
\59\ Although a mathematically conceivable explanation for this
discrepancy could be that the patient exhausted her prescribed
clonazepam stock sufficiently in advance of the 11/12/09 testing so
as to not register a positive reading, the chart should have
reflected that the physician recognized, addressed, and documented
this red flag regarding a potential abuse or diversion issue.
---------------------------------------------------------------------------
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. 28 at 3-4, 16. Dr.
Kennedy's report set forth his opinion 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).
Govt. Ex. 28 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.
Notwithstanding the discomfiture that Dr. Kennedy expressed
regarding non-physician referrals in his report, during his testimony
at the hearing he 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 record-evidence way to measure the relative
percentage of physician referrals in the Respondent's practice based on
this limited sample of charts, the observations regarding referral
sources are of limited value here.\60\
---------------------------------------------------------------------------
\60\ 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.
---------------------------------------------------------------------------
A review of the 18 patient files that informed the analysis,
findings and
[[Page 19411]]
conclusions offered in Dr. Kennedy's written report and testimony does
reflect the presence of at least some of the red flag issues he
identified therein, but there was not the unanimity among the files
that he repeatedly urges. A review of the files reveals other treatment
modalities beyond the exclusive regimen of controlled substances
reflected in the selected patient charts urged by Kennedy in his
report.\61\ Govt. Exs. 30 at 1; 34 at 1; 35 at 1; 36 at 7; 38 at 3; 43
at 2; 44 at 2; 36 at 6, 27.
---------------------------------------------------------------------------
\61\ 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.
---------------------------------------------------------------------------
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. 28 at 16.
On cross examination at the hearing, Dr. Kennedy's attention was
directed to what would seem, at least to a lay person, to present as
including a significant level of detail set forth in the charts he
reviewed relative to the Respondent's patient documentation, including
both subjective complaints of discomfort and objective signs of medical
anomalies. Tr. at 214-27, 230, 233-38, 243-44, 246-56, 262-66, 269-70,
273-87, 289-98, 305-08, 311-18, 320-29, 332-47, 366. Even the file
prepared in connection with the undercover officer's interaction with
the Respondent reflects recorded subjective complaints coupled with a
remarkable MRI and other objective signs indicating some medical
pathology. Id. at 335-47. Undaunted, Dr. Kennedy (the sole expert to
testify at the hearing), remained committed to his position that the
manner in which the documentation was completed was fundamentally
insufficient for a physician to adequately proceed to treat the
patients with controlled substances. Id. at 226-29, 231-32, 238-41,
258, 262, 264, 267-68, 286, 290, 299-301, 309-11, 342-43, 366-67. Dr.
Kennedy, more than once, succinctly stated that "[i]t's not even
close." Id. at 268, 310.
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,\62\ 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. Id. 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.\63\ Consistent with his written report, Dr.
Kennedy testified that from what he could glean in the charts he
examined, the physical examinations were "grossly deficient in that
[the physical examination] didn't really justify why the individual was
given the high doses of narcotics or controlled substances that they
were," that MRIs were the primary diagnostic tools and they should not
have been, that the treatment plans were improperly "rubber stamped"
with few modifications, and "there was no true doctor/patient
relationship established for the prescription of controlled substances
at the first of any visit, and that it was grossly deficient and
medically dangerous to prescribe in the fashion it was prescribed for
the same reasons." Id. at 177-79. 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.
---------------------------------------------------------------------------
\62\ Tr. at 628.
\63\ The Respondent did not testify on his own behalf.
---------------------------------------------------------------------------
The Analysis
Pursuant to 21 U.S.C. 824(a)(4), the Deputy Administrator \64\ 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":
---------------------------------------------------------------------------
\64\ 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.
[[Page 19412]]
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 (D.C.
Cir. 2005). The 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 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 (D.C. 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 (D.C. 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
[[Page 19413]]
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 (D.C. 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 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, notwithstanding the Respondent's Krishna-Iyer-based
\65\ protestation in his brief that he has been somehow denied the
ability to present "positive experience in dispensing controlled
substances,"\66\ 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. The Government, on the other hand
did elect to present evidence on the subject.
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\65\ The Respondent cites the Agency's decision in Krishna-Iyer,
74 FR at 459-01 and the unpublished 11th Circuit remand related to
that case. Krishna-Iyer v. DEA, No. 06-15034 (11th Cir. 2007), Slip
Op. at 3.
\66\ Respt's Br. at 3.
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Regarding the Government's presentation, Agency precedent has long
held that in DEA administrative proceedings that "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
ultimately 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," 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;
[[Page 19414]]
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] [t]here are signs within American
Pain warning individuals not to have their prescriptions filed 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.
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 Univ. of Tenn. 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 \67\ 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.
---------------------------------------------------------------------------
\67\ 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 5th largest practitioner purchaser of oxycodone in the United
States." \68\ 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, 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). 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.
---------------------------------------------------------------------------
\68\ ALJ Ex. 6 at 11-12.
---------------------------------------------------------------------------
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,\69\ or advising them to comply with vehicle and traffic laws,\70\
does not shed illumination on the Respondent's prescribing practices.
There was neither 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.
---------------------------------------------------------------------------
\69\ Tr. at 825.
\70\ Tr. at 826.
---------------------------------------------------------------------------
Burt's testimony regarding his conversations with Dr. Sollie, who
was formerly employed by American Pain, was also not received in a
manner that could meaningfully assist in the
[[Page 19415]]
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,\71\ and that some patients were intentionally evading the
American Pain urinalysis process. Sollie 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.
---------------------------------------------------------------------------
\71\ Tr. at 898.
---------------------------------------------------------------------------
The Government evidence connected with Burt's testimony concerning
the undercover operations focused on the Respondent unfolded in a
somewhat disquieting manner when viewed in context with the prior
motion practice in this case. As a preliminary matter, it must be
acknowledged that Burt's testimony regarding the details of the Luis
Lopez evolution, because it lacked detail, was of negligible import.
Burt related that the UC told him that American Pain employees made
statements and Burt viewed some statements on videotape, but there is
no indication as to who the employees were, why Burt or the UC believed
them to be employees, or what the basis for the directions to the
patients were. For example, American Pain employees advising patients
to avoid a particular pharmacy would doubtless have more relevance to
these proceedings if the Government had presented any evidence that the
pharmacy to be avoided (Walgreens) had some aversion to filling
American Pain prescriptions. There was no such evidence. To the extent
the Government was seeking to introduce the UC interaction evidence
with a view toward reflecting on the Respondent's prescribing
practices, evidence regarding the details of the interaction between
the Respondent and the UC would seem to have been imperative.\72\ This
is particularly true here, where an MRI actually showed that the UC had
a back impairment that could be treated by the use of the controlled
substances prescribed by the Respondent. Thus, other than to provide
contextual evidence concerning one of the patient charts reviewed by
Dr. Kennedy, Burt's testimony regarding the UC interaction does not
advance the Government's case for revocation.
---------------------------------------------------------------------------
\72\ In fact, the Government actually interposed an objection
that exploration of this issue was beyond the scope of the direct
examination. Tr. at 986.
---------------------------------------------------------------------------
Of somewhat more concern is the procedural context of the UC-
related portions of the Government's case. During pre-hearing
procedures, the Respondent sought discovery in the form of, inter alia,
"[a]ll audio and video recordings pertaining to visits to American
Pain during which the undercover officer was seen by [the
Respondent]." ALJ Ex. 18 at 1. The Government correctly pointed out
that, under the Administrative Procedure Act (APA) and Agency
precedent, a discovery order is beyond the authority of this tribunal,
but went on to argue that under Agency precedent "the only formal
discovery required in DEA hearings is the exchange of documents and
summarized testimony," \73\ and that the
---------------------------------------------------------------------------
\73\ ALJ Ex. 19 at 6.
---------------------------------------------------------------------------
"Respondent in this matter will be provided the documents and
testimony to be used against him, and will be permitted to confront and
cross examine witnesses and evidence presented by the Government at hearing."
Id. at 3. In a separate order (Discovery Denial Order),\74\ the
discovery request was denied as ultra vires, and the Respondent's
attention was invited to explore other available procedural mechanisms,
such as specific subpoena requests (none were submitted), applications
to the United States District Court under Fed. R. Crim. P. 41(g), and,
if warranted, the pursuit of the application of an evidentiary adverse
inference before this tribunal. The Discovery Denial Order contained
the following language:
---------------------------------------------------------------------------
\74\ ALJ Ex. 20.
---------------------------------------------------------------------------
"While discovery beyond the regulations is not a viable option
available to the parties in this action, the position taken by the
Government, if taken to its natural analytical conclusion, would allow
it to intentionally seize exculpatory evidence, render it unavailable,
and prevail in an administrative enforcement action that requires a due
process hearing [with a footnote that added that] [t]here is no
indication that such a scenario has taken place or would take place
here. [The Order went on to state that] [w]hile the analytical
simplicity of the Government's position is facially appealing, it is
unlikely that Congress, in enacting the APA and the Controlled Substances Act, intended such a result."
ALJ Ex. 20 at 7. Ironically, the precise scenario that this tribunal
expressed confidence would not likely occur, is exactly the scenario
that unfolded at the hearing. The Government seized the Respondent's
patient charts and proceeded under a theory that the Respondent
inexorably prescribed controlled substances to essentially anyone
posing as a patient who made a request. Through an agent who was ill-
equipped to provide interaction details, the Government presented
testimony that a UC who (at least by its theory) was not a legitimate
candidate for a controlled substance prescription, received one from
the registrant. It was only through the cross-examination performed by
a co-Respondent's counsel present at the consolidated hearing that it
was revealed that another UC who attempted to procure controlled
substances from this Respondent was refused. The Respondent (and this
tribunal) have never been apprised of the details of the interaction or
been given access to the patient chart regarding the rebuffed UC.
In International Union (UAW) v. NLRB,\75\ the United States Court
of Appeals for the District of Columbia Circuit held that the National
Labor Relations Board committed reversible error by declining to apply
the "adverse inference rule" where one of the parties had "relevant
evidence within his control which he fail[ed] to produce." \76\ This
precedent was embraced by the Eleventh Circuit in Callahan v. Schultz,
783 F.2d 1543, 1545 (11th Cir. 1986). The judicious utilization of the
adverse inference rule allows an administrative tribunal to use the
tools available to it and "permits vindication of the tribunal's
authority in situations where vindication might, as a practical matter,
be impossible otherwise." Int'l Union, 459 F.2d at 1339. Such an
inference is appropriate under the circumstances of this case where the
evidence of the unsuccessful UC was clearly within the Government's
control and should, to maintain the integrity of the proceedings, have
been disclosed if not produced. Accordingly, an adverse interference
will be applied here to the extent that is will be assumed in this
recommended decision that, regarding the unsuccessful UC, his encounter
with the Respondent reflected a correct and professional interaction
memorialized by documentation that met with the standards set by the
Florida Medical Board. Thus, the evidence regarding this unsuccessful
UC, even if it had been provided to the Respondent, could have
[[Page 19416]]
logically established no greater benefit to his litigation position.
---------------------------------------------------------------------------
\75\ 459 F.2d 1329, 1336 (D.C. Cir. 1972).
\76\ The applicability of the adverse inference rule is not
dependent upon the issuance of a subpoena seeking to compel
production. Int'l Union v. NLRB, 459 F.2d at 1338.
---------------------------------------------------------------------------
Furthermore, in this case, because SA Burt's testimony regarding
the UC's interaction with the Respondent has been afforded no weight,
the non-availability of the details regarding the unsuccessful UC has
resulted in no adverse impact regarding the Respondent's case. This is
ever so much more true where an adverse inference has resulted in the
assumption that the only such credited interaction in the record was in
all ways appropriate. Put another way, the Government's attempt to show
that the Respondent's interaction with the successful UC demonstrated
his proclivity to dole out controlled substances for insufficient
reasons was not persuasive.\77\ However, if the testimonial vessel had
delivered the testimony in a more effective fashion and the testimony
regarding the successful UC had been credited, it seems that there was
at least the potential for a significant compromise to the fairness of
the adjudication. To the extent that a strained interpretation of the
APA and existing DEA regulations have empowered the Government in
espousing the position that it should rightfully be permitted to seize
all potential evidence and dole back only those portions that adversely
implicate the Respondent, that course is likely to result in precedent
on judicial review that could impose unintended appellate consequences
that could (and perhaps should) severely curtail its options in future
enforcement actions. The point raised in the Respondent's brief that
"[t]he Due Process Clause forbids an agency from using evidence in a
way that forecloses an opportunity for a party to offer a contrary
presentation," Respt's Br. at 3 (citing Volkman v. DEA, 567 F.3d 215,
220 (6th Cir. 2009), is well taken. The APA guarantees that "[a] party
is entitled to present his case or defense." 5 U.S.C. 556(d).
Irrespective of the number of assurances provided by the Government
that a respondent will be afforded all the rights to which he is
entitled, the practice of seizing all evidence from a Respondent,
presenting a selective compilation of that which tends to disparage his
case, while denying access to information from which he could
meaningfully defend against the allegations, does not have a strong
likelihood of ratification on appeal. More importantly, when brought to
its logical end, it could tend to undermine the integrity of the
adjudication in the eyes of the public. That no cognizable prejudice
was realized to this Respondent's ability to present his case here does
not enhance the wisdom of the procedural course embarked upon. That
being said, no prejudice resulted to the Respondent here.
---------------------------------------------------------------------------
\77\ As evidenced by the ultimate disposition of this
recommended decision, other evidence of record relating to the chart
analysis by Dr. Kennedy was more successful in this regard.
---------------------------------------------------------------------------
The Government's evidence at the hearing 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 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,\78\ which the
CSA defines as "to deliver a controlled substance to an ultimate user
\79\ * * * 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).
---------------------------------------------------------------------------
\78\ 21 U.S.C. 823(f).
\79\ "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, 567 F.3d at 223 (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
[[Page 19417]]
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,\80\ 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:
---------------------------------------------------------------------------
\80\ 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,\81\ provided the
physician does so in accordance with that level of care, skill, and
treatment recognized by a reasonably prudent physician under similar
conditions and circumstances.
---------------------------------------------------------------------------
\81\ 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,\82\ 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.
---------------------------------------------------------------------------
\82\ 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," \83\ resort must be had to an expert.
---------------------------------------------------------------------------
\83\ 21 CFR 306.04(a).
---------------------------------------------------------------------------
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
[[Page 19418]]
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 \84\ 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.
---------------------------------------------------------------------------
\84\ 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;
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).
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
[[Page 19419]]
(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, 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, even
applying an adverse inference that permits the assumption that the
Respondent was approached by an undercover agent and acted
appropriately, the evidence establishes, by a preponderance, 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 controlled substances to patients
irrespective of the patients' need for such medication and ignoring any
and all 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 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. 2011-8344 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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