Beau Boshers, M.D.; Decision and Order, 19401-19419 [2011-8344]
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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, 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]
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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).
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19401
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. 2011–8340 Filed 4–6–11; 8:45 am]
BILLING CODE 4410–09–P
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.
Having reviewed the record in its
entirety including Respondent’s
exceptions, I have decided to adopt,
except as explained below, the ALJ’s
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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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
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public interest.’’’ Id. at 463 (quoting 21
U.S.C. 823(f)).2
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 ShoppeJonesborough, 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 ShoppeJonesborough 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
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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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
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
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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.
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.
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
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.
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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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
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
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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19403
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—
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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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’’).
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’ ’’).
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 ShoppeJonesborough, 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.
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
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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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.
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
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.
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.
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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.
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.
GS Langston also testified that, on March
3, 2010, a criminal search warrant was
14 A
schedule IC controlled substance.
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.
15 Although
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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.
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.
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
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.
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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19405
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.
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.
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
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.
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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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.
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,
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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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.
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).
21 Tr.
at 910.
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
22 SA
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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.
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
(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).
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 crossexamination. Tr. at 900, 985.
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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
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.
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
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.
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.
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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
30 Tr.
at 1012.
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.
31 SA
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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 crossexamination.32 Id. at 1017.
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.
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
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).
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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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.
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
36 ALJ
Ex. 6.
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.
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
37 Dr.
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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.
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 naıve 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 naıvete or the timing of MRI scripts, and it
would be unfair, improper and illogical for an
Administrative Law Judge to extrapolate the
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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.
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
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.
40 Tr. at 63.
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.
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enforcement officer who visited the
Respondent’s practice in an undercover
capacity. Govt. Ex. 131; Tr. at 188, 335.
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
43 Govt.
Ex. 28 at 4.
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.
44 In
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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
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, inoffice 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
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.
53 However, when pressed on the issue, Dr.
Kennedy declined to identify any specific instance
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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 outof-office toxicology tests, or obtain outof-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.
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
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
regarding any of Respondent’s charts where he
would have ordered an additional drug screen. Tr.
at 180.
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.
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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.
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
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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.
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 nonphysician 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 recordevidence 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
A review of the 18 patient files that
informed the analysis, findings and
have reflected that the physician recognized,
addressed, and documented this red flag regarding
a potential abuse or diversion issue.
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.
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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.
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,
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.
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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 overembellishment. 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
62 Tr.
PO 00000
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.
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’’:
(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.
63 The Respondent did not testify on his own
behalf.
64 This authority has been delegated pursuant to
28 CFR 0.100(b) and 0.104.
at 628.
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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
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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
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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, l
U.S. l, 129 S.Ct. 1033 (2009). It is wellsettled 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
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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, lU.S.l, 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
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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 physicianregistrant. The Government, on the
other hand did elect to present evidence
on the subject.
Regarding the Government’s
presentation, Agency precedent has long
held that in DEA administrative
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. KrishnaIyer v. DEA, No. 06–15034 (11th Cir. 2007), Slip Op.
at 3.
66 Respt’s Br. at 3.
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19413
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;
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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
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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.
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
67 The statutory definition of the term ‘‘dispense’’
includes the prescribing and administering of
controlled substances. 21 U.S.C. 802(10).
68 ALJ Ex. 6 at 11–12.
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of the controlled-substance-inventoryrelated recordkeeping practices at
American Pain.
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 outof-state license tags. This testimony
arguably provides some support for the
Government’s contention that out-ofstate 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.
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
69 Tr.
70 Tr.
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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.
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
71 Tr.
at 898.
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.
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UC interaction does not advance the
Government’s case for revocation.
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
‘‘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:
‘‘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
73 ALJ
74 ALJ
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Ex. 20.
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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 illequipped 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
75 459
F.2d 1329, 1336 (D.C. Cir. 1972).
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.
76 The
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logically established no greater benefit
to his litigation position.
Furthermore, in this case, because SA
Burt’s testimony regarding the UC’s
interaction with the Respondent has
been afforded no weight, the nonavailability 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
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.
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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.
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
78 21
U.S.C. 823(f).
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).
79 ‘‘Ultimate
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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).
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
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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. § 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. § 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:
(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
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. § 458.309(1) (2009).
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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.
Fla. Stat. § 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.
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
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. § 458.326 (2009).
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. § 458.309(5)
(2009).
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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.
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
83 21
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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.
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
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.
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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
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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 boilerplatestyle, ‘‘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
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(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
VerDate Mar<15>2010
19:53 Apr 06, 2011
Jkt 223001
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
PO 00000
Frm 00113
Fmt 4703
Sfmt 9990
19419
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
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Agencies
[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]
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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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
[[Page 19403]]
74 FR at 463. I further held 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\6\ Indeed, it appears that the patient files (which the expert
reviewed) were provided to Respondent nearly two months before the
hearing.
---------------------------------------------------------------------------
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'').
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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' '').
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
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SA Burt also testified that he received information from Dr. Eddie
Sollie, a former physician employed during the time period American
Pain was doing business as South Florida Pain, who terminated his
employment at the Oakland Park clinic location in November or December
2008 after working there for approximately two and a half to three
months. 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).
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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.
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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