[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19386-19401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8340]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-36]
Jacobo Dreszer, M.D., Decision and Order
On August 10, 2010, Administrative Law Judge (ALJ) John J.
Mulrooney, II, issued the attached recommended decision.\1\ Thereafter,
Respondent filed exceptions to the decision.
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\1\ All citations to the ALJ's Decision (ALJ) are to the slip
opinion as issued on August 10, 2010, and not to the attached
decision which has been reformatted.
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Having reviewed the entire record including the ALJ's recommended
decision and Respondent's exceptions, I have decided to adopt the ALJ's
rulings, findings of fact,\2\ conclusions of law,\3\ and recommended
Order.
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\2\ The ALJ found that there is ``no evidence that the
Respondent `prescribe[d] and dispense[d] inordinate amounts of
controlled substances.'' ALJ at 21. While there is no evidence as to
the amounts Respondent may have dispensed directly, there is such
evidence, which is unrefuted, with respect to his prescriptions. As
explained in my discussion of Respondent's Exceptions, an Expert
witness testified as to the usual starting doses of oxycodone and
Xanax and that the prescriptions Respondent issued for both drugs,
even at the initial visit, greatly exceeded the usual starting doses
and lacked a legitimate medical purpose. 21 CFR 1306.04(a).
Moreover, there is also unrefuted evidence that Respondent's
prescribing of drug cocktails of oxycodone and Xanax lacked a
legitimate medical purpose. I thus reject the ALJ's finding to the
extent that it states that there was no evidence that Respondent
prescribed inordinate amounts.
\3\ I do not, however, adopt the ALJ's discussion of the
standards applied by the Agency in assessing a practitioner's
experience in dispensing controlled substances, which cites cases
involving list chemical I distributors, a different category of
registrant. See ALJ Dec. at 20-21. As the Agency has previously made
clear, DEA can revoke based on a single act of intentional diversion
and ``evidence that a practitioner has treated thousands of
patients'' in circumstances that do not constitute diversion ``does
not negate a prima facie showing that the practitioner has committed
acts inconsistent with the public interest.'' Jayam Krishna-Iyer, 74
FR 459, 463 (2009). See also Dewey C. MacKay, 75 FR49956, 49977
(2010); Medicine Shoppe-Jonesborough, 73 FR 364, 386 & n.56 (noting
that pharmacy ``had 17,000 patients,'' but that ``[n]o amount of
legitimate dispensings can render * * * flagrant violations [acts
which are] `consistent with the public interest' ''), aff'd,
Medicine Shoppe-Jonesborough v. DEA, 300 Fed. Appx. 409 (6th Cir.
2008). As I further explained, ``[w]hile such evidence may be
[entitled to] some weight in assessing whether a practitioner has
credibly shown that [he] has reformed his practices,'' it is
entitled to no weight where a practitioner fails to acknowledge his
wrongdoing. Krishna-Iyer, 74 FR at 463.
In any event, Respondent offered no evidence on the issue of his
experience in dispensing controlled substances and the ALJ's
ultimate conclusion that Respondent violated the CSA's prescription
requirement because he dispensed controlled substance prescriptions
that were not ``within `the usual course of [his] professional
practice,'' ALJ at 33 (quoting 21 CFR 1306.04(a)), and that ``the
evidence under the [experience] * * * factor[] support[s]'' the
revocation of his registration, is consistent with Agency precedent.
Id.
With respect to factor five, ``[s]uch other conduct which may
threaten public health and safety,'' 21 U.S.C. 823(f)(5), the ALJ
opined that ``an adverse finding under this factor requires some
showing that the relevant conduct actually constituted a threat to
public safety.'' ALJ at 34 (emphasis added). Contrary to the ALJ's
reasoning, Congress, by inserting the word ``may'' in factor five,
clearly manifested its intent to grant the Agency authority to
consider conduct which creates a probable or possible threat (and
not only an actual) threat to public health and safety. See
Webster's Third New Int'l Dictionary 1396 (1976) (defining ``may''
in relevant part as to ``be in some degree likely to''); see also
The Random House Dictionary of the English Language 1189 (1987)
(defining ``may'' in relevant part as ``used to express
possibility''). While the ALJ misstated the applicable standard, his
conclusion that Respondent repeatedly ignored ``red flags''
indicative of likely diversion and thus ``created a significant
potential conduit for the unchecked diversion of controlled
substances'' is clearly supported by substantial evidence and
warrants an adverse finding under factor five. ALJ at 34.
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 29 (quoting 21 CFR 1306.04(a)). While the ALJ properly noted the
importance of expert testimony in this case, in which the Government
primarily relied on a review of the medical charts, whether expert
testimony is needed is necessarily dependent on the nature of the
allegations and the other evidence in the case. Where, for example,
the Government produces evidence of undercover visits showing that a
physician knowingly engaged in outright drug deals, expert testimony
adds little to the proof necessary to establish a violation of
Federal law.
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[[Page 19387]]
Respondent first takes exception to the ALJ's acceptance of L.
Douglas Kennedy, M.D., as an expert on the proper prescribing of
controlled substances. Respondent contends that Dr. Kennedy should not
have been permitted to opine on his prescribing practices because he
does not hold a DEA registration in Florida, has not prescribed a
controlled substance since 2004, does not currently have either a
medical office or hospital privileges in Florida, and ``has never
practiced medicine regularly in Florida and has not practiced medicine
in Florida at all in over 10 years.'' Resp. Exc. at 1.
Respondent's contention is unavailing as Dr. Kennedy was clearly
qualified to render an expert opinion on the proper practice for
prescribing controlled substances to treat pain and whether
Respondent's controlled substance prescriptions were issued in the
usual course of professional practice and for a legitimate medical
purpose. See 21 CFR 1306.04(a). Dr. Kennedy currently holds a Florida
medical license, is a diplomate of both the American Board of Pain
Medicine and the American Board of Anesthesiology, and is currently on
the faculty of the University of Miami's Miller School of Medicine. GX
117, at 1, 10. Previously, Dr. Kennedy was a Fellow with the Pain
Therapy Unit of the Cleveland Clinic, served as the Director of Chronic
Pain Management at the University of Kentucky Medical Center, and, for
fourteen years, was the Medical Director of a multidisciplinary pain
medicine and rehabilitation practice. Id. at 1-2.
Dr. Kennedy has published several articles and book chapters on
pain management issues and has made several dozen presentations on pain
management issues at professional meetings.\4\ Id. at 3-7. In addition,
he is a member of several professional organizations including the
American Academy of Pain Medicine, the American Board of Pain Medicine,
the American Pain Society, the International Association for the Study
of Pain, the American Society of Addiction Medicine, the American Board
of Anesthesiology, and the American Society of Anesthesiology. Id. at
10; Tr. 22. Finally, Dr. Kennedy explained that he was familiar with
the Florida Board of Medicine's standards for prescribing controlled
substances to treat pain and that he had reviewed them prior to
preparing his report. Tr. 24-26; GX 76, at 5-6.
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\4\ He also co-edited and contributed to the State of Kentucky's
Guidelines for Prescribing Controlled Substances, 2nd Edition. GX
117, at 9.
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Thus, Dr. Kennedy was clearly qualified to provide expert
testimony. I therefore agree with the ALJ that Dr. Kennedy's testimony
was sufficiently reliable to constitute substantial evidence on the
issue of whether Respondent acted within the usual course of
professional practice and had a legitimate medical purpose in
prescribing controlled substances to the patients whose files he
reviewed and reject this exception.
Next, Respondent contends that Dr. Kennedy's opinion testimony is
entitled to no weight because it was based on only seventeen patient
charts, which Respondent maintains were not randomly selected and is
too small a sample to draw sufficient conclusions about the validity of
his prescribing practices. Resp. Exc. at 2. Based on Dr. Kennedy's
testimony that `` `[i]t might not be fair' '' to `` `cherry-pick[]' ''
a small and non-random sample of charts out of a physician's patients
because this might not provide `` `a reasonable representation of what
the practice was actually like,' '' Respondent argues that ``[e]ven
improper prescribing practices reflected in a small and non-random
sample of 17 charts * * * may be `an administrative issue for education
with the Board of Medical License' '' and not necessarily justify the
revocation of Respondent's medical license (or DEA registration). Id.
(quoting Tr. 645).
However, even acknowledging that two of the seventeen files
reviewed by Dr. Kennedy with respect to Respondent were not randomly
selected (one being that of an undercover officer), the ALJ found
credible the Diversion Investigator's testimony that the files were not
specially selected to enhance the strength of the Government's case.
ALJ at 5 (citing Tr. 768). More importantly, the requirement of Federal
law that a prescription ``must be issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of his
professional practice,'' 21 CFR 1306.04(a), applies to each and every
prescription issued by a practitioner. Thus, contrary to the Expert's
understanding, in determining whether a practitioner has committed acts
which render his registration ``inconsistent with the public
interest,'' 21 U.S.C. 824(a)(4), the Government is not required to
randomly select the files which it will base its case on.
For example, where the Government has developed information that
particular patients are drug dealers or engaged in self-abuse, it is
not required to ignore the files pertaining to these patients and base
its case on a random sample of files. Rather, it can select the files
pertaining to those patients and base its case entirely on them.
Moreover, where the Government has seized files, it can review them and
choose to present at the hearing only those files which evidence a
practitioner's most egregious acts. Of course, where, as here, the
Government's case relies so heavily on a chart review, the practitioner
can put on his own evidence and argue that the Government's evidence
does not establish that he violated the prescription requirement; the
practitioner can also argue that even
[[Page 19388]]
though the Government has made out a prima facie case, his conduct was
not so egregious as to warrant revocation. See Paul Caragine, 63 FR
51592 (1998) (granting restricted registration where practitioner did
not engage in intentional misconduct, patients had legitimate medical
conditions requiring treatment, and practitioner accepted
responsibility and testified as to remedial measures he had
undertaken). See also Dewey C. MacKay, 75 FR at 49977 (revoking
registration based on intentional acts of diversion to two patients);
Krishna-Iyer, 74 FR at 463 (holding that DEA can revoke based on a
single act of diversion); Medicine Shoppe-Jonesborough, 73 FR at 386 &
n.56; Alan H. Olefsky, 57 FR 928, 929 (1992) (revoking registration
based on physician's single act of presenting two fraudulent
prescriptions to pharmacist where physician failed to acknowledge
wrongdoing).\5\ Accordingly, there is no merit to Respondent's
exception.
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\5\ Consistent with DEA's longstanding precedent, see ALJ at 17,
a respondent is also entitled to put on evidence as to his
acceptance of responsibility and any remedial measures he has
undertaken to prevent the re-occurrence of similar acts.
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Finally, Respondent takes exception to the ALJ's findings that he
violated Florida's standards for prescribing controlled substances.
Resp. Exceptions at 4-5. More specifically, Respondent contends that he
complied with the standards set forth under Florida regulations and
that he ``took a complete medical history and conducted a physical
evaluation that was documented,'' that he maintained ``medical records
documenting the patient's intensity of pain, current and past
treatments for pain, and the effect of pain on physical and
psychological function.'' Id. at 4-5. He further argues that ``[h]e set
out a written treatment plan, discussed the risks and benefits of
controlled substances and conducted periodic reviews'' as also required
by Florida's regulations. Id. at 5.
While it is true that Dr. Kennedy acknowledged that he was not
familiar with the specific standard imposed by the State of Florida for
excessive prescribing and that he had not reviewed any Florida Medical
Board decisions addressing the issue of what is an adequate medical
history, see ALJ at 15, in his report Dr. Kennedy discussed at length
the Florida Board of Medicine's Standards for the Use of Controlled
Substances for the Treatment of Pain, Fla. Admin. Code 64B8-9.013.\6\
See GX 76, at 5-6.
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\6\ Even after Gonzales v. Oregon, 546 U.S. 243 (2006), several
courts of appeals, including the Eleventh Circuit, ``have applied a
general-practice standard when determining whether the practitioner
acted in the `usual course of professional practice.''' United
States v. Smith, 573 F. 3d 639, 647-48 (8th Cir. 2009); see also id.
at 648 (discussing United States v. Moore, 423 U.S. 122 (1975);
``Thus informed by the Supreme Court and other controlling and
persuasive precedent, we believe that it was not improper to measure
the `usual course of professional practice' under Sec. 841(a)(1)
and [21 CFR] 1306.04 with reference to generally recognized and
accepted medical practices * * * .''). To similar effect, the
Eleventh Circuit has held that ``[t]he appropriate focus * * * rests
upon whether the physician prescribes medicine `in accordance with a
standard of medical practice generally recognized and accepted in
the United States.' '') (United States v. Merrill, 513 F.3d 1293,
1306 (11th Cir. 2008) (quoting Moore, 423 U.S. at 139)).
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In any event, Respondent produced no evidence that his
recordkeeping and prescribing complied with the standards of the
Florida Medical Board. Moreover, there is substantial evidence to
support the conclusion that Respondent was not engaged in legitimate
medical practice and was diverting drugs.
As Dr. Kennedy explained, the patients whose files he reviewed were
relatively young (with an average age of 36), and most were from out-
of-state, with some travelling up to 1200 miles,\7\ even though
Respondent had no specialized training in pain management. Id. at 15-
16. Yet, Respondent did not obtain reports from the prescription
monitoring programs run by the States where his patients lived. Id. at
1-2; 14. Moreover, Respondent did not obtain adequate medical histories
and perform adequate physical examinations; he also never obtained
medical records from other treating physicians (or even contacted them)
for any of the patients whose files are in evidence. Id. at 4, 8-9.
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\7\ Of the seventeen patients, only four were from Florida. Of
the remaining patients, five were from Kentucky, three were from
Ohio, two were from Tennessee and West Virginia, and one was from
Georgia. GX 76, at 1.
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As Dr. Kennedy explained, while ``[t]he chart was set up to give
the appearance of a legitimate medical practice in an attempt to
justify the initial and continued prescription and dispensing of high
dose multiple controlled substances (`drug cocktails'),'' and that
while ``on the surface [the charts] were adequate for evaluating and
treating a patient,'' on closer review, ``the actual contents in the
charts, clearly evidence just the opposite'' as the charts were ``very
difficult * * * to read [with] many sections * * * left blank or
incompletely filled in.'' Id. at 15. Continuing, Dr. Kennedy explained
that ``[t]he notes were not within the standard of care; all were
outside the boundaries of professional practice, lacking significant
information and ignoring significant history that was present.'' Id.
Moreover, Respondent's failure to obtain his patients' medical records
``was well outside the boundaries of medical practice and below the
standard of medical care,'' especially because the patients were
receiving ``very high dose[s]'' of controlled substances. Id.
The evidence further shows that this case is not simply a matter of
inadequate record keeping. While Respondent apparently required his
patients to obtain an MRI, in multiple instances the MRI was obtained
before the patient was even evaluated by Respondent, and generally, no
other imaging studies such as x-rays or CT scans were done.\8\ Id. at
14-15.
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\8\ Dr. Kennedy explained that referring a patient to obtain an
MRI prior to having some contact is unusual and medically
inappropriate. Tr. 71-73.
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Moreover, notwithstanding the doses the patients were seeking,
Respondent rarely referred a patient to another physician or health
care professional for a consultation.\9\ As Dr. Kennedy explained,
``[a]lternative opinions should have been sought in order to better
diagnose and treat; not to do so was outside the boundaries of
professional practice and not within the standard of care.'' Id. at 14.
Dr. Kennedy thus concluded that Respondent's ``diagnoses were usually
very vague and/or without medical merit'' and were done in an
``attempt[] to justify what controlled substances he prescribed.'' Id.
at 15.
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\9\ In only two of the seventeen files is there an indication
that Respondent referred the patient to another physician.
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Dr. Kennedy also observed that while Respondent performed urine
drug screens, he ignored the results even when they were inconsistent
with other information provided by the patients such as when a patient
tested positive for controlled substances which he had previously
indicated that he was not currently taking. See id. at 11, 14.
Moreover, the drug screens were rarely performed other than at the
patient's initial visit and lacked quality controls.\10\ Id. at 14.
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\10\ Dr. Kennedy explained that the urine drug screens did not
indicate the temperature and specific gravity of the specimen,
whether the giving of the sample had been observed, or the type of
drug screen used. GX 76, at 14; Tr. 100-01.
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Although the charts indicate that Respondent discussed doing yoga
and stretching, using an anti-inflammatory diet, and taking several
over-the-counter supplements (fish oil and glucosamine chondroitin),
Respondent's treatment plan primarily involved prescribing high doses
of controlled substances with the same regimen of drugs (oxycodone and
Xanax) prescribed in nearly every case. Id. at 4, 6-7, 13. And while
Respondent referred two patients to
[[Page 19389]]
their primary care physicians because they had high blood pressure, see
GXs 78, 79; he never referred any patients for consultations with
specialists, or for physical, occupational, or mental health therapy.
GX 76, at 11.
Dr. Kennedy noted that Respondent frequently prescribed ``drug
cocktails'' of two strengths of oxycodone immediate release and a high
dose of Xanax, a benzodiazepine. Id. at 4, 9, 13. While Dr. Kennedy
acknowledged that prescribing an additional strength of oxycodone could
be legitimate if it was done to treat breakthrough or episodic pain on
an as-needed basis, with respect to M.B., who received prescriptions
for oxycodone 30 mg. and 15 mg., ``there was no specific reason stated
in the medical record'' for prescribing both drugs. Id. at 9.
Dr. Kennedy further noted that while the typical starting dose of
Xanax is 0.25 to 0.5 mg., once to twice per day, Respondent prescribed
Xanax 2 mg., twice per day, to fifteen of the seventeen patients
(including M.B.); another patient B.R. (GX 87) received Xanax 2 mg.
once per day.\11\ Id. at 9-10; GXs 78-86, 88-93. Moreover, Respondent
prescribed this dose even for patients who had not been on the drug
either before or recently and ``no matter the [patient's] age or
clinical situation.'' GX 76, at 10. While Xanax is used as an anti-
anxiety agent, Respondent's medical records did not support the
prescribing because ``[h]e did not list * * * many important factors
that could cause anxiety * * * such as depression, life stressors,
psychosocial situation, caffeine intake, sleep disturbance [and]
previous medical evaluation;'' he also did not refer these patients for
evaluation by a mental health professional. Id. With respect to M.B.,
Dr. Kennedy observed not only that ``there was no specific reason
stated in the medical record'' for prescribing Xanax, but also that
Respondent's prescribing of a very high dose of the drug ``was clearly
not within the boundaries of professional practice.'' Id. at 9-10.
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\11\ The remaining patient, L.A., received Valium 10 mg. GX 77.
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Dr. Kennedy further noted that beginning with M.B.'s first visit,
Respondent ``prescribed very high initial and subsequent high doses of
oxycodone and Xanax'' and that these drugs ``were prescribed
excessively and inappropriately without medical justification.'' Id. at
9. Sections of the history and physical examination form ``were grossly
incomplete or missing entirely,'' and Respondent did not identify
``past treating and prescribing physicians'' and communicate them
regarding M.B.'s previous treatment (and obtain medical records) even
though M.B. had indicated that he had previously seen a doctor and had
physical therapy for his condition. Id. at 9; GX 78, at 16.
While M.B. apparently told Respondent that he was taking 210 to 240
oxycodone 30 mg. per month, which he had obtained ``off the street,''
and he also tested positive for the drug in a urine drug screen (UDS)
done at his initial visit, Respondent prescribed 180 Roxicodone 30 mg.,
60 Roxicodone 15 mg., and 60 Xanax 2 mg. to M.B. at each of the seven
visits he made between August 20, 2009 and February 4, 2010. GX 78, at
7, 9, 13, 18-24.
M.B.'s statement that he was getting ``large quantities of
oxycodone 30 mg. pills `off the street''' was a clear ``warning sign''
that he was ``at high risk for drug abuse, addiction and/or
diversion.'' GX 76, at 12; see also id. at 8. Yet, as Dr. Kennedy
observed, Respondent ``did not appropriately act on the initial UDS''
and M.B.'s admission that he had obtained drugs off the street by
requiring him to undergo ``[f]urther testing.'' Id. at 11. Indeed,
``[t]here were no other UDS tests obtained [after the initial visit]
nor other toxicology testing.'' Id. Dr. Kennedy further noted that
Respondent ``did not obtain any pharmacy drug profiles [from] where
[M.B.] had his prescriptions filled,'' his chart did not indicate where
he was filling his prescriptions, and he did not obtain prescription
monitoring reports from States where M.B. may have filled
prescriptions. Id. He also did not obtain prescription monitoring
reports for any of the other sixteen patients. Id.
Finally, Dr. Kennedy explained that the ``drug cocktails''
Respondent prescribed of ``very potent, high doses'' of oxycodone and
Xanax (or Valium), id. at 11, are ``attractive to `patients' who abuse,
are addicted and/or divert (sell or trade) their prescribed controlled
substances. They might take them all together to achieve a `high,' sell
some for cash, or trade some for other drugs they prefer.'' Id. at 9.
Dr. Kennedy also noted that ``[w]hen opioids and benzodiazepines are
used in combination, the potential for [a] drug overdose and death is
increased,'' and ``[t]he risk of abuse, addiction and/or diversion is
also significantly increased.'' Id. at 7. As Dr. Kennedy observed,
``[t]hese `drug cocktails' were clearly not for any legitimate medical
purpose.'' Id. at 13.
As Dr. Kennedy concluded, Respondent ``was not engaged in the
practice of medicine,'' and ``[t]he vast majority of his prescriptions
for controlled substances w[as] not for a legitimate medical purpose
and w[as] beyond the boundaries of professional practice.'' Id. at 18.
His ``routine and excessive prescription of multiple controlled
substances * * * and lack of arriving at a valid medical diagnosis and
treatment most likely caused harm to the patients he saw as well as to
other people in their communities.'' Id. I therefore reject this
exception as well.
I therefore also reject Respondent's Exception to the ALJ's
ultimate finding that Respondent has committed acts which render his
registration inconsistent with the public interest. Resp. Exc. at 5.
Because the record establishes that Respondent has repeatedly violated
Federal law by issuing controlled substance prescriptions which lacked
a legitimate medical purpose and were issued outside of the usual
course of professional practice, 21 CFR 1306.04, and Respondent has
offered no evidence establishing that he has accepted responsibility
for his misconduct and that he has reformed his practice, see Steven M.
Abbadessa, 74 FR 10077, 10081 (2009), I adopt the ALJ's recommendation
that Respondent's registration be revoked.
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, AD7585865, issued to Jacobo Dreszer, M.D.,
be, and it hereby is, revoked. I further order that any pending
application of Jacobo Dreszer, 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
Sean M. Ellsworth, 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 AD7585865, of Jacobo Dreszer, M.D.
(Respondent), as a practitioner, pursuant to 21 U.S.C. 824(d), alleging
[[Page 19390]]
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 \12\ 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.\13\ The immediate suspension of the
Respondent's COR has remained in effect throughout these proceedings.
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\12\ 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. 31.
\13\ Pursuant to an order issued on April 15, 2010, with the
consent of the Respondent, ALJ Ex. 9, 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,\14\ 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
\15\ surrounding the manner in which American Pain is operated, and the
manner in which its physicians, including Respondent, engaged in the
practice of medicine. Id. The Government also alleges that Respondent's
former patients have apprised law enforcement personnel that ``they
were able to obtain prescriptions for controlled substances from [the
Respondent] for other than a legitimate medical purpose and with the
intention of selling the controlled substances and/or personally
abusing the drugs.'' Id. Lastly, in its Prehearing Statement, the
Government further alleges that one of the Respondent's patients died
from an overdose of oxycodone and alprazolam \16\ one day after
obtaining prescriptions for those same controlled substances from a
visit to the Respondent at American Pain. Id.
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\14\ A schedule II controlled substance.
\15\ The majority of which are supported by no evidence
introduced by the Government during the course of these proceedings.
\16\ A schedule IV 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.\17\ Id. at 721. Under Langston's supervision, DEA
diversion investigators catalogued the prescriptions seized at Boca
Drugs (Boca Drugs Prescription Log). Govt. Ex. 118. However, inasmuch
as the Boca Drugs Prescription Log fails to distinguish between the
Respondent, and one of the other co-Respondents (his son), the document
is of no utility in reaching a disposition of the present case.
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\17\ Although GS Langston testified that DEA immediately
suspended the COR that had been issued to Boca Drugs, Tr. at 715,
and that a voluntary surrender by that registrant followed a day
later, id. at 776, no evidence has been presented that would lend
that fact any particular significance related to any issue that must
or should be found regarding the disposition of the present case.
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GS Langston also testified that, on March 3, 2010, a criminal
search warrant was executed on the American Pain Clinic simultaneously
with the OSC/ISO that initiated the present case. Tr. at 735. According
to Langston, the items seized from American Pain included a sign that
had been posted in what she believes to have served as the urinalysis
waiting room. 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
\18\ or OUTSIDE the STATE OF FLORIDA.
---------------------------------------------------------------------------
\18\ 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.\19\ Govt. Ex.
119 at 2.
---------------------------------------------------------------------------
\19\ Although GS Langston testified that she did not actually
take the photographs taken during the search warrant execution at
American Pain, she did provide sufficient, competent evidence to
support the admission of the photographs that were ultimately
received into evidence. Tr. at 737, 739-41.
---------------------------------------------------------------------------
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
[[Page 19391]]
investigators reviewed the seized files with a view towards choosing
approximately fifteen files for each doctor with the aspirational
criteria that each would reflect at least three to four visits by
that doctor with a patient. Each investigator was empowered to place
a chart on the selected pile, and when the target number (or about
that number) was reached for each physician, the selection effort
relative to that physician was deemed accomplished. Id. at 765.
Langston credibly testified that there was no effort to specially
select files under some prosecution-enhancement or ``cherry
picking'' purpose. Id. at 768.
Langston also explained DEA's Automated Record Consolidated
Ordering System (ARCOS) 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. 71.
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. 72-74. Review of the PMP
report data reflects that during the time period of February 1, 2006
through February 11, 2010, pharmacies filled 229 controlled
substance prescriptions issued over the Respondent's signature to
seventy-three patients located in West Virginia, 135 similar
prescriptions provided to fifty-three Kentucky-based patients were
filled between January 1, 2009 and April 4, 2010, and 144 such
prescriptions pertaining to sixty-three 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 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. As discussed above, the fact that the
Boca Drugs Prescription Log prepared by the agents does not
distinguish between prescriptions authorized by the Respondent and
another registrant of the same name deprives the document of
virtually any relevance regarding the enforcement action against
this Respondent.\20\
---------------------------------------------------------------------------
\20\ Remarkably, although this unfortunate aspect of this
document was brought to light during the course of the hearing, Tr.
at 732, no effort on the part of the Government was made to provide
additional details or explanation that might tend to differentiate
between the respondents.
---------------------------------------------------------------------------
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 \21\ 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 6:00 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.
---------------------------------------------------------------------------
\21\ SA Burt described the pole cameras as ``covert cameras that
are installed to observe the activity in the clinic.'' Tr. at 816.
Burt testified that he was able to use a laptop to access the live
video feed from the cameras after inputting a user name and
password. The camera video was also recorded 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 \22\ 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.
---------------------------------------------------------------------------
\22\ Tr. at 910.
---------------------------------------------------------------------------
Based on his review of some (but not all) \23\ 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'' \24\ for these office visits, and
the six doctors at the clinic saw ``anywhere from 200 upward to 375
patients a day'' \25\ in this manner.\26\ Id. at 882-83 (emphasis
supplied).
---------------------------------------------------------------------------
\23\ 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.
\24\ Later on cross-examination, SA Burt admitted that the
clinic also accepted payment via credit card. Tr. at 916.
\25\ 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.
\26\ 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); Keller v. Sullivan, 928 F.2d 227,
230 (7th Cir. 1991); Calhoun v. Bailar, 626 F.2d 145, 149 (9th Cir.
1980).
---------------------------------------------------------------------------
SA Burt also testified regarding his review of some \27\ of the
video and audio recordings made by an undercover agent (UC) who
assumed the name Luis Lopez, capturing activity inside of American
Pain.\28\ In those recordings, Burt observed who he believed to be
an American Pain employee inside the facility standing up in a
waiting room full of patients and directing them ``not to have their
prescriptions filled out of state, not to go out into the parking
lot and snort their pills,'' and directing the patients to have
their prescriptions filled ``in house'' (meaning at American Pain),
at ``a pharmacy they have in Orlando, Florida,'' or at ``a pharmacy
they have down the street,'' which, in Burt's view, was a reference
to Boca Drugs. Id. at 825-26. Burt further testified that the
purported employee on the recording told the patients to ``obey all
the traffic laws; do not give the police a reason to pull you
over.'' Id. Although Burt testified as to the contents of these
recordings, the physical recordings were not offered into evidence
by the Government or made available to opposing counsel.
---------------------------------------------------------------------------
\27\ Tr. at 1002-05.
\28\ 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.
---------------------------------------------------------------------------
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
[[Page 19392]]
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 testified regarding the drug overdose deaths of TY
and SM after obtaining controlled substances from American Pain.\29\
Burt's record testimony indicates that DEA Task Force Officer \30\
(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.\31\ Likewise, the record evidence concerning SM did not
implicate prescribing activity by the Respondent.
---------------------------------------------------------------------------
\29\ 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.
\30\ 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.
\31\ See Tr. at 836-53 (addressing exclusion of Govt. Ex. 27 and
associated testimony).
---------------------------------------------------------------------------
Perhaps among the more striking aspects of SA Burt's performance
on the witness stand is the anticipated testimony which he did not
provide. When viewed in its entirety, SA Burt's record testimony was
stunningly sparse when compared with his proposed testimony as
noticed in the Government's prehearing statement.\32\ 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.
---------------------------------------------------------------------------
\32\ 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.\33\ Dr. Kennedy, who testified that he is
board certified by the American Board of Pain Medicine and the
American Board of Anesthesiology,\34\ was offered and accepted as an
expert in the field of pain medicine. Id. at 39.
---------------------------------------------------------------------------
\33\ Dr. Kennedy's CV was admitted into evidence. Govt. Ex. 117.
\34\ Tr. at 17.
---------------------------------------------------------------------------
Dr. Kennedy testified that after a review of a group of selected
patient files from those seized at the Respondent's practice that
were to him provided by the Government, he concluded that the
Respondent's physical examinations, treatment plans, and patient
histories were below the standard fixed by the Florida Medical Board
and that that controlled substances was not for a legitimate medical
purpose. Id. at 579-82.
Dr. Kennedy took professional issue with several aspects of the
Respondent's patient care as reflected in the charts regarding the
prescribing of controlled substances. It is apparent from his
testimony that Dr. Kennedy's analysis is restricted to those matters
which can be gleaned from an examination of the written word in that
subset of the Respondent's patient charts provided by the Government
for his review, and that limitation perforce circumscribes the
breadth of his input. That being said, Dr. Kennedy highlighted
numerous features in the Respondent's chart documentation that he
found wanting, or at least remarkable.
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.
Id. at 357.
Dr. Kennedy also prepared a report in connection with the
Government's case against the Respondent, which is dated April 30,
2010, and was admitted into evidence. Govt. Ex. 76; Tr. at 579. The
report 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).
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 MB,\35\ one of the
Respondent's patients.
---------------------------------------------------------------------------
\35\ At the request of the Government, a protective order was
issued that is designed to minimize the risk of the dissemination of
identifying information related to patients and their relatives
associated with this case. Accordingly, initials have been
substituted for the names of individuals within the protection of
the protective order throughout the body of this decision. ALJ
Ex.15.
---------------------------------------------------------------------------
Dr. Kennedy's report makes it unambiguously clear that, in his
opinion, all seventeen of the Respondent's charts that he reviewed
suffered from the same shortcomings.\36\
[[Page 19393]]
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 [MB] referenced and discussed
in this report in detail, [and that] there were no significant
differences that affected [his] conclusions and summary.'' Govt. Ex. 76
at 2.
---------------------------------------------------------------------------
\36\ 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.
---------------------------------------------------------------------------
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''; \37\ (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; \38\ (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''; \39\ (4)
contained medication contracts that were ``not always signed'' and
``listed criteria that was not followed by the doctors at American
Pain; \40\ (5) failed to adequately document the efficacy of the
prescribed medication; (6) did not set forth a ``diagnostic plan except
to obtain an occasional MRI, the results of which made no difference in
the `treatment' ''; \41\ (7) reflected ``no therapeutic plan, except to
use controlled substances to `treat' the subjective complaint of `pain'
which was inadequately described''; \42\ (8) reflected ``no real
therapeutic goals * * * for improvement of quality of life (activities
of daily living, work, sleep, mood)''; \43\ (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''; \44\ (10) reflected ``a gross lack of past
medical records in all charts reviewed and in some cases none at all'';
\45\ and, (11) demonstrated controlled substance patient monitoring
practices that were ``not within the standard of care and was outside
the boundaries of professional practice.'' \46\
---------------------------------------------------------------------------
\37\ Govt. Ex. 76 at 4.
\38\ Govt. Ex. 76 at 4. In Dr. Kennedy's opinion, the Respondent
``prescribed, at the first visit, very high initial doses of
controlled substance combinations despite not being within the
standard of care for histories, physical examinations and/or absent
past medical records.'' Id. at 7.
\39\ Govt. Ex. 76 at 4.
\40\ Govt. Ex. 76 at 3. As an example of the failure to adhere
to the terms of the medication contract, Dr. Kennedy cites a
contract term that provides notice that the physician may stop
prescribing opioids or change treatment if pain or activity
improvement is not demonstrated, and points out that pain and
activity levels are routinely not documented in treatment notes. Id.
at 3-4. 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. at 4.
\41\ Govt. Ex. 76 at 7. In Dr. Kennedy's opinion, Respondent in
effect, acted as a `barrier' for [MB] to receive appropriate medical
evaluation and treatment. In other words, the very potent, high
doses of opioids (oxycodone) and benzodiazepine (Xanax) could mask
or cover up [MB's] underlying disease process(s), making them more
difficult to diagnose, and allowing the disease(s) to unnecessarily
worsen. Without an accurate diagnosis[] and no plan to obtain one,
[the Respondent] was masking the symptoms. Id. at 10-11.
\42\ Govt. Ex. 76 at 7.
\43\ Govt. Ex. 76 at 7.
\44\ Govt. Ex. 76 at 7.
\45\ Govt. Ex. 76 at 15. MB's chart did not contain any past
medical records, save for a Lumbar report from an MRI performed six
weeks before MB's first clinic visit to see the Respondent. Id. at
8.
\46\ Govt. Ex. 76 at 14.
---------------------------------------------------------------------------
Dr. Kennedy found the Respondent's controlled substance patient
monitoring to be deficient in numerous respects. From the reviewed
patient charts, Dr. Kennedy gleaned that an initial, in-office urine
drug screen was frequently executed during the patients' initial visit
to the office but repeated only occasionally. Govt. Ex. 76 at 14. It
was Dr. Kennedy's observation that even a drug screen anomaly did not
alter the seemingly inexorable continuation of controlled substance
prescribing from the Respondent. Id. For instance, Dr. Kennedy notes
that MB's patient file contains a notation about the patient getting
Roxicodone ``off the street,'' along with an initial positive
urinalysis screen for oxycodone, yet the Respondent continued to
prescribe MB with additional Roxicodone during his initial and
subsequent visits. Id. at 8-9, 11; see also Govt. Ex. 87 at 4, 9; 90 at
3, 9; 91 at 4, 8; 93 at 5, 10 (similar notations involving other
patient's acquiring controlled substances ``off the street''). Dr.
Kennedy also noted that the Respondent did not utilize out-of-office
toxicology tests, or obtain out-of-state prescription monitoring
program or outside pharmacy drug profiles. Furthermore, the charts
contained only rare evidence of contact with primary care physicians,
treating physicians, pharmacists, or other health care providers. Id.
The identified shortcomings of controlled substance patient
monitoring systems was of particular significance where Dr. Kennedy
identified specific evidence that he identified as ``red flags'' of
possible or likely diversion. Red flags noted by Dr. Kennedy in the
reviewed charts included the relatively young age of the Respondent's
chronic pain patients,\47\ incomplete history information provided by
the patients, periodically significant gaps between office visits,\48\
referrals from friends, relatives, or advertising, but not other
physicians,\49\ 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.\50\
---------------------------------------------------------------------------
\47\ Govt. Ex. 76 at 16.
\48\ Govt. Ex. 76 at 13.
\49\ Govt. Ex. 76 at 8, 15.
\50\ Govt. Ex. 76 at 16.
---------------------------------------------------------------------------
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. 76 at 3, 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).
Id. at 16. Significantly, however, when asked, Dr. Kennedy acknowledged
that he conducts his own current medical practice on a cash-only basis.
Tr. at 151.
A review of the seventeen patient files that informed the analysis,
findings and 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. For instance, in terms of evidence
related to therapeutic plans, it is notable that Respondent's patient
files contain at least some indications of recommended treatment
modalities in addition to the Respondent's exclusive use of
[[Page 19394]]
controlled substances for pain management. For example, Respondent
included notations in the records of referring patients to see a
``PCP,'' or primary care physician, for elevated blood pressure. Govt.
Exs. 78 at 1-3, 6; 79 at 1. Furthermore, some of the patient history
and physical exam forms contain some effort in documenting medication
efficacy. Govt. Exs. 83 at 7; 92 at 2.
An examination of the reviewed patient charts does reveal the
presence of other red flags that should have inspired additional
diligence or inquiry on the part of the Respondent. LA's patient file,
for example, contains a form indicating a positive UDS for oxycodone
and benzodiazepine from 5/18[/09], yet on the same date, the medication
contract signed by LA is blank in the section where a patient is
supposed to list any medications they are currently taking; likewise,
the similarly worded section on the ``Patient Comfort Assessment
Guide'' form also has no medications listed. Govt. Ex. 77 at 12-13, 30;
see also Govt. Exs. 78 at 13-14, 32; 86 at 14-15, 30; 89 at 8-9, 22
(similar issues). CR's patient file, on the other hand, indicates a
positive UDS for ``THC'' in addition to benzodiazepine and hydrocodone,
yet the patient does not disclose marijuana as a ``medication'' he is
currently taking on any of the relevant forms, and, in fact, this
positive test is not addressed by the Respondent in any discernible
manner in the chart. Govt. Ex. 79 at 9. Patient KL's 7/17/09 UDS
indicates a negative test for all listed substances, yet on two
different forms dated 7/13/09 he indicates he is currently taking two
strengths of oxycodone along with Xanax. Govt. Ex. 82 at 13-14, 31. The
UDS form in patient GE's file reflects circled positive results for
benzodiazepines, opiates, and oxycodone. This is noteworthy in that the
currently-taking list of medications includes seven other drugs, but
not these three. Govt. Ex. 80 at 9, 24-25. Patient BR's UDS form, on
the other hand, lists a positive test result for oxycodone only on July
24, 2009, yet the patient states she is also currently taking Xanax
elsewhere on the medical forms from the same date. Govt. Ex. 88 at 11-
12, 25; see also Govt. Exs. 90 at 9-10, 22; 92 at 8-9; 93 at 5, 10-11,
26 (same issue). 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.
In addition to the lack of adequately completed forms in some
patient files noted by Dr. Kennedy, other patient files appear to be
missing key documentation altogether. See Govt. Ex. 92 (no pain
management agreement, medication contract, or diversion policy
present).
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. 76 at 16.
On cross examination, Dr. Kennedy agreed that he assumed, for the
purposes of his analysis, that where the Respondent's charts reflected
an entry or a procedure, that the event actually occurred. Tr. at 654.
Kennedy also acknowledged that every one of the patient files he
reviewed contained at least a complaint of chronic pain symptoms by the
patient and MRI results that could support such a diagnosis. Id. at
655-57.
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,\51\ he was unable to identify
the documentation standard in the Florida Administrative code with any
degree of particularity, and he also acknowledged that he was not aware
of what the standard is in Florida Medical Board administrative
decisions regarding the overprescribing of medication or what
constitutes an adequate medical history. Id. at 149-51, 233, 304.
While, overall, Kennedy presented testimony that appeared candid and
knowledgeable, there were areas in his written report that rang of
hyperbole and over-embellishment. The reasoning behind some of the
seemingly critical observations in the written report, such as the
``cash basis'' of the Respondent's practice and the absence of doctor
referrals among the reviewed patient files, did not well survive the
crucible of cross examination at the hearing. However, overall, Dr.
Kennedy's testimony was sufficiently detailed, plausible, and
internally consistent to be considered credible, and, consistent with
his qualifications, he spoke persuasively and with authority on some
relevant issues within his expertise, and notwithstanding the
Respondent's objections relative to his Florida-related experience, he
is currently an assistant professor teaching at a Florida Medical
School. It may well be that the greatest and most significant aspect of
Dr. Kennedy's opinion is that on the current record, it stands
unrefuted. Thus, his opinion is the only expert opinion available for
reliance in this action.\52\ 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.
---------------------------------------------------------------------------
\51\ Tr. at 628.
\52\ The Respondent did not testify on her own behalf.
---------------------------------------------------------------------------
The Analysis
Pursuant to 21 U.S.C. Sec. 824(a)(4), the Deputy Administrator
\53\ 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'':
---------------------------------------------------------------------------
\53\ This authority has been delegated pursuant to 28 CFR
0.100(b) and 0.104.
---------------------------------------------------------------------------
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
[[Page 19395]]
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f).
``[T]hese factors are considered in the disjunctive.'' Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003). Any one or a combination of
factors may be relied upon, and when exercising authority as an
impartial adjudicator, the Deputy Administrator may properly give each
factor whatever weight she deems appropriate in determining whether an
application for a registration should be denied. JLB, Inc., d/b/a Boyd
Drugs, 53 FR 43945 (1988); England Pharmacy, 52 FR 1674 (1987); see
also David H. Gillis, M.D., 58 FR 37507, 37508 (1993); Joy's Ideas, 70
FR 33195, 33197 (2005); Henry J. Schwarz, Jr., M.D., 54 FR 16422
(1989). Moreover, the Deputy Administrator is ``not required to make
findings as to all of the factors * * *.'' Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (DC
Cir. 2005). The Deputy Administrator is not required to discuss
consideration of each factor in equal detail, or even every factor in
any given level of detail. Trawick v. DEA, 861 F.2d 72, 76 (4th Cir.
1988) (the Administrator's obligation to explain the decision rationale
may be satisfied even if only minimal consideration is given to the
relevant factors and remand is required only when it is unclear whether
the relevant factors were considered at all). The balancing of the
public interest factors ``is not a contest in which score is kept; the
Agency is not required to mechanically count up the factors and
determine how many favor the Government and how many favor the
registrant. Rather, it is an inquiry which focuses on protecting the
public interest * * *.'' Jayam Krishna-Iyer, M.D., 74 FR 459, 462
(2009).
In an action to revoke a registrant's DEA COR, the DEA has the
burden of proving that the requirements for revocation are satisfied.
21 CFR 1301.44(e). Once DEA has made its prima facie case for
revocation of the registrant's DEA Certificate of Registration, the
burden of production then shifts to the Respondent to show that, given
the totality of the facts and circumstances in the record, revoking the
registrant's registration would not be appropriate. Morall, 412 F.3d at
174; Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v. U.S.
Dept. of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989); Thomas E.
Johnston, 45 FR 72, 311 (1980). Further, ``to rebut the Government's
prima facie case, [the Respondent] is required not only to accept
responsibility for [the established] misconduct, but also to
demonstrate what corrective measures [have been] undertaken to prevent
the reoccurrence of similar acts.'' Jeri Hassman, M.D., 75 FR 8194,
8236 (2010).
Where the Government has sustained its burden and established that
a registrant has committed acts inconsistent with the public interest,
that registrant must present sufficient mitigating evidence to assure
the Deputy Administrator that he or she can be entrusted with the
responsibility commensurate with such a registration. Steven M.
Abbadessa, D.O., 74 FR 10077 (2009); Medicine Shoppe-Jonesborough, 73
FR 364, 387 (2008); Samuel S. Jackson, D.D.S., 72 FR 23848, 23853
(2007). Normal hardships to the practitioner, and even the surrounding
community, that are attendant upon the lack of registration are not a
relevant consideration. Abbadessa, 74 FR at 10078; see also Gregory D.
Owens, D.D.S., 74 FR 36751, 36757 (2009).
The Agency's conclusion that past performance is the best predictor
of future performance has been sustained on review in the courts, Alra
Labs. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as has the Agency's
consistent policy of strongly weighing whether a registrant who has
committed acts inconsistent with the public interest has accepted
responsibility and demonstrated that he or she will not engage in
future misconduct. Hoxie, 419 F.3d at 483; George C. Aycock, M.D., 74
FR 17529, 17543 (2009); Abbadessa, 74 FR at 10078; Krishna-Iyer, 74 FR
at 463; Medicine Shoppe, 73 FR at 387.
While the burden of proof at this administrative hearing is a
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S.
91, 100-01 (1981), the Deputy Administrator's factual findings will be
sustained on review to the extent they are supported by ``substantial
evidence.'' Hoxie, 419 F.3d at 481. While ``the possibility of drawing
two inconsistent conclusions from the evidence'' does not limit the
Deputy Administrator's ability to find facts on either side of the
contested issues in the case, Shatz, 873 F.2d at 1092; Trawick, 861
F.2d at 77, all ``important aspect[s] of the problem,'' such as a
respondent's defense or explanation that runs counter to the
Government's evidence, must be considered. Wedgewood Vill. Pharmacy v.
DEA, 509 F.3d 541, 549 (DC Cir. 2007); Humphreys, 96 F.3d at 663. The
ultimate disposition of the case must be in accordance with the weight
of the evidence, not simply supported by enough evidence to justify, if
the trial were to a jury, a refusal to direct a verdict when the
conclusion sought to be drawn from it is one of fact for the jury.
Steadman, 450 U.S. at 99 (internal quotation marks omitted).
Regarding the exercise of discretionary authority, the courts have
recognized that gross deviations from past agency precedent must be
adequately supported, Morall, 412 F.3d at 183, but mere unevenness in
application does not, standing alone, render a particular discretionary
action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (DC Cir. 2008)
(citing Butz v. Glover Livestock Comm. Co., Inc., 411 U.S. 182, 188
(1973)), cert. denied, -- U.S. --, 129 S.Ct. 1033 (2009). It is well-
settled that since the Administrative Law Judge has had the opportunity
to observe the demeanor and conduct of hearing witnesses, the factual
findings set forth in this recommended decision are entitled to
significant deference, Universal Camera Corp. v. NLRB, 340 U.S. 474,
496 (1951), and that this recommended decision constitutes an important
part of the record that must be considered in the Deputy
Administrator's decision, Morall, 412 F.3d at 179. However, any
recommendations set forth herein regarding the exercise of discretion
are by no means binding on the Deputy Administrator and do not limit
the exercise of that discretion. 5 U.S.C. 557(b); River Forest
Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); Attorney
General's Manual on the Administrative Procedure Act 8 (1947).
Factors 1 and 3: The Recommendation of the Appropriate State Licensing
Board or Professional Disciplinary Authority and Conviction Record
Under Federal or State Laws Relating to the Manufacture, Distribution,
or Dispensing of Controlled Substances
In this case, it is undisputed that the Respondent holds a valid
and current state license to practice medicine. The record contains no
evidence of a recommendation regarding the Respondent's medical
privileges by any cognizant state licensing board or professional
disciplinary authority. However, that a state has not acted against a
registrant's medical license is not dispositive in this administrative
determination as to whether continuation of a registration is
consistent with the public interest.
[[Page 19396]]
Patrick W. Stodola, M.D., 74 FR 20727, 20730 (2009); Jayam Krishna-
Iyer, 74 FR at 461. It is well-established Agency precedent that a
``state license is a necessary, but not a sufficient condition for
registration.'' Leslie, 68 FR at 15230; John H. Kennedy, M.D., 71 FR
35705, 35708 (2006). Even the reinstatement of a state medical license
does not affect the DEA's independent responsibility to determine
whether a registration is in the public interest. Mortimer B. Levin,
D.O., 55 FR 9209, 8210 (1990). The ultimate responsibility to determine
whether a registration is consistent with the public interest has been
delegated exclusively to the DEA, not to entities within state
government. Edmund Chein, M.D., 72 FR 6580, 6590 (2007), aff'd, Chein
v. DEA, 533 F.3d 828 (DC Cir. 2008), cert. denied, ---- U.S. ----, 129
S.Ct. 1033 (2009). Congress vested authority to enforce the CSA in the
Attorney General and not state officials. Stodola, 74 FR at 20375.
Thus, on these facts, the fact that the record contains no evidence of
a recommendation by a state licensing board does not weigh for or
against a determination as to whether continuation of the Respondent's
DEA certification is consistent with the public interest.
Similarly, regarding Factor 3, while testimony was received at the
hearing 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/ISO, 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 common and distinct considerations.
Regarding Factor 2, the qualitative manner and the quantitative
volume in which a registrant has engaged in the dispensing of
controlled substances, and how long he has been in the business of
doing so are factors to be evaluated in reaching a determination as to
whether he should be entrusted with a DEA certificate. In some cases,
viewing a registrant's actions against a backdrop of how he has
performed activity within the scope of the certificate can provide a
contextual lens to assist in a fair adjudication of whether continued
registration is in the public interest.
There are two principal considerations embedded within a
consideration of this public interest factor. In considering a similar
factor under the List I chemical context, the Agency has recognized
that the level of experience held by those who will be charged with
recognizing and taking steps to minimize diversion factors greatly in
determining whether entrusting a COR will be in the public interest.
See Volusia Wholesale, 69 FR 69409, 69410 (2004); Xtreme Enters., Inc.,
67 FR 76195, 76197-98 (2004); Prachi Enters., 69 FR 69407, 69409
(2004); J&S Distribs., 69 FR 62089, 62090 (2004); K.V.M. Enters., 67 FR
70968, 70969 (2002). The Agency has also recognized that evidence that
a registrant may have conducted a significant level of sustained
activity within the scope of the registration for a sustained period is
a relevant and correct consideration, which must be accorded due
weight. However, this factor can be outweighed by acts held to be
inconsistent with the public interest. Experience which occurred prior
and subsequent to proven allegations of malfeasance may be relevant.
Evidence that precedes proven misconduct may add support to the
contention that, even acknowledging the gravity of a particular
registrant's transgressions, they are sufficiently isolated and/or
attenuated that adverse action against its registration is not
compelled by public interest concerns. Likewise, evidence presented by
the Government that the proven allegations are consistent with a
consistent past pattern of poor behavior can enhance the Government's
case.
In this case, the Respondent introduced no evidence regarding his
level of knowledge and experience, or even the quality or length of his
experience as a physician-registrant, but the Government has elected to
do so.
Regarding the Government's presentation, Agency precedent has long
held that in DEA administrative proceedings 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
introduced at the hearing is striking. For example, contrary to its
allegations, there was no evidence that the Respondent ``prescribe[d]
and dispense[d] inordinate amounts of controlled substances,'' that the
``majority'' of the Respondent's patients were ``from states other than
Florida,'' and there was no evidence that American Pain patients were
issued ``pre-signed prescriptions to obtain MRI[s],'' nor was there
evidence that individuals positioned outside the American Pain building
were there to ``monitor the activity of patients in the parking lot to
prevent patients from selling their recently obtained controlled
substances.'' Likewise, no evidence was introduced at the hearing that
could support the allegations that ``employees of American Pain []
frequently ma[d]e announcements to patients in the clinic advising them
on how to avoid being stopped by law enforcement upon departing the
pain clinic'' and ``frequently ma[d]e announcements [] advising
[patients], among other things, not to attempt to fill their
prescriptions at out-of-state pharmacies and warning them against
trying to fill their prescriptions at particular local retail
pharmacies.'' ALJ Ex. 1 (emphasis supplied).
In like fashion, the Government's prehearing statement proffered
that SA Burt would testify to several of the items described but not
established in the OSC/ISO. Among the list of allegations that were not
supported by any evidence introduced at the hearing, were
representations that SA Burt would testify concerning the following:
Law enforcement in Florida and [other states that correspond to
license plates seen in the American Pain parking lot] frequently
arrest people for illegal possession and/or illegal distribution of
controlled substances who have obtained the controlled substances
from American Pain;
American Pain hired individuals to ``roam'' the parking lot of
the clinic to dissuade people from selling their recently obtained
controlled substances on the property;
[[Page 19397]]
[The reason American Pain placed] signs within American Pain
warning individuals not to have their prescriptions filled at
Walgreens pharmacies [is] because Walgreens refuses to dispense the
prescriptions;
Walgreens has flagged all American Pain doctors and will not
fill any of their prescriptions;
[Physical exams at American Pain are] usually no more than a
blood pressure check and some bending and stretching;
Dismissed patients would be routed to other doctors within the
clinic;
[There was] co-mingling of [American Pain] physician's drugs;
[American Pain maintained] no inventories of drugs dispensed;
[Details surrounding] the death of [American Pain] patient OB
[where] [t]he cause of death was determined to be drug
intoxication--opiate and benzodiazepine;
[Information] from a confidential source [who indicated] that
she traveled to American Pain in order to obtain controlled
substances that were later sold in Kentucky for $25 per pill[,]
[that] [the American Pain physician she encountered] did not spend
any significant time conducting a physical examination of [her] [,]
[that she would simply ask questions regarding [her] well being and
would then ``stamp'' a prescription for [controlled substances][,] *
* * that on one visit [during a power failure a] security guard
working for the clinic instructed everyone to be patient and that
the doctors would be with them shortly to ``get your fix.''
ALJ Ex. 6 at 3-9.
To be clear, it is not that the evidence was introduced and
discredited; no evidence to support these (and other) allegations was
introduced at all. To the extent the Government had this evidence, it
left it home. While the stunning disparity between the allegations
proffered and those that were supported with any evidence does not
raise due process concerns, it is worthy of noting, without deciding
the issue, that Agency precedent has acknowledged the Supreme Court's
recognition of the applicability of the res judicata doctrine in DEA
administrative proceedings. Christopher Henry Lister, P.A., 75 FR
28068, 28069 (2010) (citing Univ. of Tenn. v. Elliot, 478 U.S. 788,
797-98 (1986) (``When an administrative agency is acting in a judicial
capacity and resolves disputed issues of fact properly before it which
the parties have had an adequate opportunity to litigate, the courts
have not hesitated to apply res judicata[.]'')
The evidence the Government did present raises issues regarding not
only Factor 2 (experience dispensing \54\ 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.
---------------------------------------------------------------------------
\54\ The statutory definition of the term ``dispense'' includes
the prescribing and administering of controlled substances. 21
U.S.C. 802(10).
---------------------------------------------------------------------------
While true that GS Langston convincingly testified about the course
of her investigation and laid an adequate foundation for numerous
database results, the Government provided no foundational context for
any relevant uses for those database results. Even apart from the
unfortunate reality that one of the databases contained data that could
not be directly tied to this Respondent as opposed to another with the
same last name, 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 8th largest practitioner
purchaser of oxycodone in the United States.''\55\ No evidence to
support that allegation (or its relevance) was ever brought forth at
the hearing. To the extent that fact may have been true or relevant, it
was never developed. What's more, the Florida Administrative Code
specifically eschews pain medication prescribing analysis rooted only
in evaluation of medication quantity. Fla. Admin. Code r. 64B8-
9.013(g). Lastly, there was no indication that despite Langston's
obvious qualifications to do so, that she or anyone else ever conducted
an audit of the controlled-substance-inventory-related recordkeeping
practices at American Pain.
---------------------------------------------------------------------------
\55\ ALJ Ex. 6 at 11-12.
---------------------------------------------------------------------------
SA Burt testified that, during a temporally limited period of time,
he observed some of the images captured by a pole camera positioned
outside American Pain, and that he observed what in his view was a high
percentage of vehicles in the parking lot with out-of-state license
tags. This testimony arguably provides some support for the
Government's contention that out-of-state patients (or at least
patients being dropped off by cars with out-of-state tags) were being
seen at the clinic, but his testimony did not provide much else in
terms of relevant information. In any event, recent Agency precedent
holds that details such as ``where [a registrant's] patients were
coming from,'' without additional factual development, can support a
``strong suspicion that [a] respondent was not engaged in a legitimate
medical practice'' but that ``under the substantial evidence test, the
evidence must `do more than create a suspicion of the existence of the
fact to be established.' '' Alvin Darby, M.D., 75 FR 26993, 26999, n.31
(2010) (citing NLRB v. Columbian Enameling & Stamping Co., 306 U.S.
292, 300 (1939).
Likewise, without additional details or at least some context,
Burt's testimony that individuals with ``staff'' written on their
shirts appeared to be directing patients into the clinic reveals
virtually nothing about the Respondent's prescribing practices. Tr. at
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,\56\ or advising them to comply with vehicle and traffic laws,\57\
does not shed illumination on the Respondent's prescribing practices.
There was no evidence that the Respondent knew that these isolated
incidents occurred, nor was there contextual evidence from which the
relevance to these proceedings could be gleaned. Even if this tribunal
was inclined to engage in the unsupported assignment of motives to the
actions of these employees, under these circumstances, such an exercise
could not constitute substantial evidence that could be sustained at
any level of appeal.
---------------------------------------------------------------------------
\56\ Tr. at 825.
\57\ Tr. at 826.
---------------------------------------------------------------------------
Burt's testimony regarding his conversations with Dr. Sollie, who
was formerly employed by American Pain, was also not received in a
manner that could meaningfully assist in the 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
[[Page 19398]]
apparently never explained to Burt,\58\ and that some patients were
intentionally evading the American Pain urinalysis process. Sollie did
not specifically name the Respondent or any physician as being
connected with his allegations of misconduct. Tr. at 853. 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.
---------------------------------------------------------------------------
\58\ Tr. at 898.
---------------------------------------------------------------------------
The Government's evidence targeted not only the Respondent's
experience practicing under Factor 2, but also his compliance with
applicable state and federal laws relating to controlled substances
under Factor 4. To effectuate the dual goals of conquering drug abuse
and controlling both legitimate and 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,\59\ which the
CSA defines as ``to deliver a controlled substance to an ultimate user
\60\ * * * by, or pursuant to the lawful order of a practitioner.'' 21
U.S.C. 802(10); see also Rose Mary Jacinta Lewis, 72 FR 4035, 4040
(2007). The prescription requirement is designed to ensure that
controlled substances are used under the supervision of a doctor, as a
bulwark against the risk of addiction and recreational abuse. Aycock,
74 FR at 17541 (citing Gonzales v. Oregon, 546 U.S. 243, 274 (2006);
United States v. Moore, 423 U.S. 122, 135, 142-43 (1975) (noting that
evidence established that a physician exceeded the bounds of
professional practice when he gave inadequate examinations or none at
all, ignored the results of the tests he did make, and took no
precautions against misuse and diversion)). The prescription
requirement likewise stands as a proscription against doctors
``peddling to patients who crave the drugs for those prohibited uses.''
Id. The courts have sustained criminal convictions based on the issuing
of illegitimate prescriptions where physicians conducted no physical
examinations or sham physical examinations. United States v. Alerre,
430 F.3d 681, 690-91 (4th Cir. 2005), cert. denied, 574 U.S. 1113
(2006); United States v. Norris, 780 F.2d 1207, 1209 (5th Cir. 1986).
---------------------------------------------------------------------------
\59\ 21 U.S.C. 823(f).
\60\ ``Ultimate user'' is defined as ``a person who has lawfully
obtained, and who possesses, a controlled substance for his own use
or for the use of a member of his household or for an animal owned
by him or by a member of his household.'' 21 U.S.C. 802(27).
---------------------------------------------------------------------------
While true that the CSA authorizes the ``regulat[ion] of medical
practice so far as it bars doctors from using their prescription-
writing powers as a means to engage in illicit drug dealing and
trafficking as conventionally understood,'' Gonzales, 546 U.S. at 266-
67, an evaluation of cognizant state standards is essential. Joseph
Gaudio, M.D., 74 FR 10083, 10090 (2009); Kamir Garces-Mejias, M.D., 72
FR 54931, 54935 (2007); United Prescription Servs., Inc., 72 FR 50397,
50407 (2007). In this adjudication, the evaluation of the Respondent's
prescribing practices must be consistent with the CSA's recognition of
state regulation of the medical profession and its bar on physicians
from peddling to patients who crave drugs for prohibited uses. The
analysis must be ``tethered securely'' to state law and federal
regulations in application of the public interest factors, and may not
be based on a mere disagreement between experts as to the most
efficacious way to prescribe controlled substances to treat chronic
pain sufferers. Volkman v. DEA, 567 F.3d 215, 223 (6th Cir. 2009)
(citing Gonzales, 546 U.S. at 272, 274).
Under the CSA, it is fundamental that a practitioner must establish
a bonafide doctor-patient relationship in order to act ``in the usual
course of * * * professional practice'' and to issue a prescription for
a legitimate medical purpose.'' Stodola, 74 FR at 20731; Shyngle, 74 FR
at 6057-58 (citing Moore, 423 U.S. at 141-43). The CSA looks to state
law to determine whether a bonafide doctor-patient relationship
existed. Stodola, 74 FR at 20731; Shyngle, 74 FR at 6058; Garces-
Mejias, 72 FR at 54935; United Prescription Servs., 72 FR at 50407. It
was Dr. Kennedy's uncontroverted opinion that his evaluation of chart
entries convinced him that they were so defective that the Respondent
did not establish a sufficient doctor-patient relationship to justify
the prescribing of controlled substances, and that ``this was not the
practice of medicine in [his] opinion.'' Tr. at 160-61.
Under Florida law, grounds for disciplinary action or denial of
state licensure include ``prescribing * * * any controlled substance,
other than in the course of the physician's professional practice,''
and prescribing such substances ``inappropriately or in excessive or
inappropriate quantities is not in the best interest of the patient and
is not in the course of the physician's professional practice, without
regard to his or her intent.'' Fla. Stat. Sec. 458.331(q) (2009).
Florida law further provides that grounds for such disciplinary action
also include:
Failing to keep legible, as defined by department rule in
consultation with the board, medical records that identify the
licensed physician * * * and that justify the course of treatment of
the patient, including, but not limited to, patient histories;
examination results; test results; records of drugs prescribed,
dispensed, or administered; and reports of consultations and
hospitalizations.
Id. Sec. 458.331(m).
In exercising its rulemaking function,\61\ 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:
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\61\ Rulemaking authority regarding the practice of medicine
within the State of Florida has been delegated to the Florida Board
of Medicine (Florida Board). Fla. Stat. Sec. 458.309(1) (2009).
(2) A licensed physician shall maintain patient medical records
in English, in a legible manner and with sufficient detail to
clearly demonstrate why the course of treatment was undertaken.
(3) The medical record shall contain sufficient information to
identify the patient, support the diagnosis, justify the treatment
and document the course and results of treatment accurately, by
including, at a minimum, patient histories; examination results;
test results; records of drugs prescribed, dispensed or
administered; reports of consultations and hospitalizations; and
copies of records or reports or other documentation obtained from
other health care practitioners at the request of the physician and
relied upon by the physician in determining the appropriate
treatment of the patient.
[[Page 19399]]
(4) All entries made into the medical records shall be
accurately dated and timed. Late entries are permitted, but must be
clearly and accurately noted as late entries and dated and timed
accurately when they are entered in to the record * * *.
Fla. Admin. Code r. 64B8-9.003 (2009).
With respect to defining the parameters of what constitutes
``professional practice'' in the context of pain management
prescribing, Florida state law provides:
Notwithstanding any other provision of law, a physician may
prescribe or administer any controlled substance under Schedules II-
V * * * to a person for the treatment of intractable pain,\62\
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.
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\62\ Florida defines ``intractable pain'' to mean ``pain for
which, in the generally accepted course of medical practice, the
cause cannot be removed and otherwise treated.'' Fla. Stat. Sec.
458.326 (2009).
Fla. Stat. Sec. 458.326 (2009). Moreover, the Florida Board has
adopted,\63\ 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
tenets 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.
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\63\ Pursuant to authority vested in the Florida Board by the
Florida legislature to promulgate rules regarding State standards
for pain management clinical practice specifically. Fla. Stat. Sec.
458.309(5) (2009).
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Like the Model Policy, which was promulgated ``to encourage the
legitimate medical uses of controlled substances for the treatment of
pain while stressing the need to safeguard against abuse and
diversion,'' Florida's regulation providing ``Standards for the Use of
Controlled Substances for Treatment of Pain,'' Fla. Admin. Code r.
64B8-9.013 (2009) (Florida Standards), recognizes that ``inappropriate
prescribing of controlled substances * * * may lead to drug diversion
and abuse by individuals who seek them for other than legitimate
medical use.'' The language employed by the regulation under the
preamble section titled ``Pain Management Principles'' makes clear that
the standards ``are not intended to define complete or best practice,
but rather to communicate what the [Florida Board] considers to be
within the boundaries of professional practice'' (emphasis supplied),
id. at 9.013(1)(g); thus, the plain text supports an inference that the
standards provide the minimum requirements for establishing conduct
that comports with the professional practice of controlled substance-
based pain management within the state. Likewise, the level of integral
range of acceptable practice that is built into the regulation
underscores the importance of seeking an expert professional opinion in
reaching a correct adjudication of whether a registrant has met the
applicable Florida standard. It is clear that in assessing whether the
controlled substance prescribing practices of a Florida practitioner
fall within the acceptable range of what constitutes being within the
bounds of being ``issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice,'' \64\ resort must be had to an expert.
---------------------------------------------------------------------------
\64\ 21 CFR 1306.04(a).
---------------------------------------------------------------------------
The Florida Standards direct that ``[p]hysicians should be diligent
in preventing the diversion of drugs for illegitimate purposes,'' id.
at 9.013(1)(d), and provide that the prescribing of controlled
substances for pain will be considered to be for a legitimate medical
purpose if based on accepted scientific knowledge of the treatment of
pain or if based on sound clinical grounds. All such prescribing must
be based on clear documentation of unrelieved pain and in compliance
with applicable state or federal law.
Id. at 9.013(1)(e) (emphasis supplied).
The Florida Standards further provide that the validity of
prescribing will be judged ``based on the physician's treatment of the
patient and on available documentation, rather than on the quantity and
chronicity of prescribing'' (emphasis supplied). Id. at 9.013(1)(g).
Furthermore, the Standards advise that physicians should not fear
disciplinary action for ``prescribing controlled substances * * * for a
legitimate medical purpose and that is supported by appropriate
documentation establishing a valid medical need and treatment plan''
(emphasis supplied), or ``for failing to adhere strictly to the
provisions of these standards, if good cause is shown for such
deviation'' (emphasis supplied). Id. at 9.013(1)(b), (f).
Although, as discussed above, the Florida Board instituted general
guidance applicable to all physicians regarding medical records, it
also 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 \65\ 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.
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\65\ The original Model Policy version of the guidelines does
not contain a reference to the need for a complete medical history,
instead only requiring a medical history generally. Thus, the
Florida Board has adopted a higher standard than the measure that
has been set in the Model Policy by the FSMB.
Id. at 9.013(3)(a).
Furthermore, the Florida Standards require a written treatment plan
that ``should state objectives that will be used to determine treatment
success, such as pain relief and improved physical and psychosocial
function, and should indicate if any further diagnostic evaluations or
other treatments are planned.'' Id. at 9.013(3)(b). Subsequent to the
initiation of treatment, ``the physician should adjust drug therapy to
the individual medical needs of each patient. Other treatment
modalities or a rehabilitation program may be necessary
[[Page 19400]]
depending on the etiology of the pain and the extent to which the pain
is associated with physical and psychosocial impairment.'' (emphasis
supplied). Id.
Another standard adopted by the Florida Board, under the subheading
``Informed Consent and Agreement for Treatment,'' is the directive that
[t]he physician should discuss the risks and benefits of the use of
controlled substances with the patient, persons designated by the
patient, or with the patient's surrogate or guardian if the patient
is incompetent. The patient should receive prescriptions from one
physician and one pharmacy where possible. If the patient is
determined to be at high risk for medication abuse or have a history
of substance abuse, the physician should employ the use of a written
agreement between the physician and patient outlining patient
responsibilities, including, but not limited to:
1. Urine/serum medication levels screening when requested;
2. Number and frequency of all prescription refills; and
3. Reasons for which drug therapy may be discontinued (i.e.,
violation of agreement).
Id. at 9.003(3)(c).
The Florida Standards contain a further requirement to periodically
review ``the course of pain treatment and any new information about the
etiology of the pain or the patient's state of health.'' Id. at
9.013(3)(d). The Florida Standards explain the importance of periodic
review in the following manner:
Continuation or modification of therapy depends on the
physician's evaluation of the patient's progress. If treatment goals
are not being achieved, despite medication adjustments, the
physician should reevaluate the appropriateness of continued
treatment. The physician should monitor patient compliance in
medication usage and related treatment plans.
Id.
Under the subheading ``Consultation,'' the Florida Board
promulgated the instruction that
[t]he physician should be willing to refer the patient as necessary
for additional evaluation and treatment in order to achieve
treatment objectives. Special attention should be given to those
pain patients who are at risk for misusing their medications and
those whose living arrangements pose a risk for medication misuse or
diversion. The management of pain in patients with a history of
substance abuse or with a comorbid psychiatric disorder requires
extra care, monitoring, and documentation, and may require
consultation with or referral to an expert in the management of such
patients.
Id. at 9.003(3)(e).
It is abundantly clear from the plain language of the Florida
Standards that the Florida Board places critical emphasis on physician
implementation of adequate safeguards in their practice to minimize
diversion and the need to document the objective signs and rationale
employed in the course of pain treatment utilizing the prescription of
controlled substances. Conscientious documentation is repeatedly
emphasized as not just a ministerial act, but a key treatment tool and
a vital indicator to evaluate whether the physician's prescribing
practices are ``within the usual course of professional practice.''
Here, the uncontroverted expert opinion of Dr. Kennedy, the only expert
opinion presented \66\ in these proceedings, reflects that the
documentation he reviewed in the Respondent's patient charts reflected
care that was markedly below the standard of care set by the Florida
Medical Board. Dr. Kennedy's expert assessment was consistent with the
state statutory and regulatory guidance. In Kennedy's view, the
Respondent's charts demonstrated minimalistic, incomplete, and
otherwise medically inadequate documentation of his contacts with
patients, and the prescribing rationale for his issuance of controlled
substance prescriptions to those patients for alleged pain management
purposes. The boilerplate-style, ``one high-dosage controlled
substances treatment plan fits all'' nature of nearly all of the
patient medical records at issue, at least in the view of the
uncontroverted expert, evidences a failure on the part of the
Respondent to conduct his practice of medicine in a manner to minimize
the potential of controlled substance abuse and diversion, and supports
a conclusion that he failed to even substantially comply with the
minimum obligations for professional practice imposed under the Florida
Standards--and without ``good cause [] shown for such deviation.'' Id.
at 9.013(1)(f).
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\66\ Respondent, in his brief, correctly points out that (for
reasons not readily apparent) the Government elicited no testimony
from Dr. Kennedy regarding any patient treated by the Respondent.
Respt's Br. at 10-11.
---------------------------------------------------------------------------
In his Post-Hearing Brief (Respondent's Brief), the Respondent's
counsel has prepared and submitted a thoughtful and detailed review of
one of the patient charts that was analyzed by Dr. Kennedy in his
report. Respt's Br. at 22-26. While counsel argues that the patient
chart entries were, at least by his interpretation of his client's
obligations, satisfactory, the expert's opinion at the hearing remained
unchanged. Even acknowledging, as this recommended decision does, that
Dr. Kennedy's presentation was not without its deficiencies, its
shortcomings do not render it so fundamentally defective as to
completely undermine his credibility and viability as within the scope
of what a litigant may depend upon.\67\ As recognized in the
Respondent's Brief, ``the [G]overnment, like any party in a contested
hearing, is free to hire an expert to advocate its position.'' Respt's
Br. at 12. Unfortunately, counsel's analysis is the product of a lay
evaluation of standards applicable to the nuanced and sophisticated
science that is the practice of medicine. Where his opinion and that of
the only accepted medical expert to provide an expert opinion conflict,
his opinion cannot and will not be afforded controlling deference.
Argument supplied by counsel (albeit a diligent and persuasive counsel)
that the relevant standards were satisfactorily applied as evidenced by
the protocols and procedures documented in the patient charts cannot
supplant the unrefuted view of an accepted expert witness.
---------------------------------------------------------------------------
\67\ Likewise, contrary to the position taken by the Respondent
in his brief (Respt's Br. at 7), Dr. Kennedy's opinions are not
invalidated by the size of the representative sample of files he
reviewed or the manner in which they were selected. Firstly, SA
Langston provided credible testimony regarding the selection
process, which although admittedly not a paradigm of scientific
sampling methodology, was likewise not designed to achieve a
particular result. Secondly, contrary to the assertion in the
Respondent's brief (Respt's Br. at 15), there is no baseline magic
number of files or registrant actions that must be examined to
support an expert opinion and ultimately an Agency determination as
to whether a registrant has committed acts inconsistent with the
public interest sufficient to merit adverse action relative to a DEA
COR. See Krishna-Iyer, 74 FR at 464.
---------------------------------------------------------------------------
The Respondent, who was in a unique position to conclusively refute
Dr. Kennedy's views and explain the format and nuances of the reviewed
documentation, elected not to testify in this matter. At a DEA
administrative hearing, it is permissible to draw an adverse inference
from the silence of the Respondent, even in the face of a Fifth
Amendment invocation. Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005)
(citing United States v. Hale, 422 U.S. 171, 176 (1975) (``silence
gains more probative weight where it persists in the face of
accusation, since it is assumed in such circumstances that the accused
would be more likely than not to dispute an untrue accusation.''));
Joseph Baumstarck, M.D., 74 FR 17525, 17528, n.3 (2009) (citing Ohio
Adult Parole Auth. v. Woodward, 523 U.S. 272, 286 (1998)). On the facts
of this case, where the allegations are of a nature that a registrant
would be more likely than not to dispute them if untrue, an adverse
inference based on the Respondent's silence is appropriate. Where, as
here,
[[Page 19401]]
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] professional practice.'' 21 CFR 1306.04(a).
Consideration of the evidence under the second and fourth factors
support the COR revocation sought by the Government in this case.
To the extent that the Respondent's prescribing practices fell
below the requisite standard in Florida, that conduct also impacts upon
the Fifth statutory factor. Under Factor 5, the Deputy Administrator is
authorized to consider ``other conduct which may threaten the public
health and safety.'' 21 U.S.C. 823(f)(5). Although this factor
authorizes consideration of a somewhat broader range of conduct
reaching beyond those activities typically associated with a
registrant's practice, an adverse finding under this factor requires
some showing that the relevant conduct actually constituted a threat to
public safety. See Holloway Distrib., 72 FR 42118, 42126 (2007).
The evidence establishes that the Respondent engaged in a course of
practice wherein he prescribed controlled substances to patients
irrespective of the patients' need for such medication and ignoring any
and all red flags that could or did indicate likely paths of diversion.
The testimony of Dr. Kennedy, the DEA regulations, and the Florida
Standards make clear that physicians prescribing controlled substances
do so under an obligation to monitor the process to minimize the risk
of diversion. The patient charts reflect that the Respondent, contrary
to his obligations as a DEA registrant, did not follow up in the face
of multiple red flags. The Respondent's disregard of his obligations as
a DEA registrant and Federal and state laws related to controlled
substances militate in favor of revocation.
By ignoring his responsibilities to monitor the controlled
substance prescriptions he was authorizing to minimize diversion, and
by participating in an insufficiently documented and thoughtful process
for the issuance of potentially dangerous controlled substances, the
Respondent created a significant potential conduit for the unchecked
diversion of controlled substances. See Holloway Distrib., 72 FR at
42124 (a policy of ``see no evil, hear no evil'' is fundamentally
inconsistent with the obligations of a DEA registrant). Agency
precedent has long recognized that ``[l]egally, there is absolutely no
difference between the sale of an illicit drug on the street and the
illicit dispensing of a licit drug by means of a physician's
prescription.'' EZRX, LLC, 69 FR 63178, 63181 (1988); Floyd A. Santner,
M.D., 55 FR 37581 (1988).
Agency precedent has consistently held that where, as here, the
Government has met its burden to establish a prima facie case that a
registrant has committed acts demonstrating that continued registration
is inconsistent with the public interest, acceptance of responsibility
is a condition precedent to continued registration. Jeri Hassman, M.D.,
75 FR 8194, 8236 (2010); Medicine Shoppe, 73 FR at 387. The record
contains no evidence that the Respondent has either acknowledged or
accepted responsibility for the misconduct at issue in these
proceedings.
Recommendation
Based on the foregoing, the evidence supports a finding that the
Government has established that the Respondent has committed acts that
are inconsistent with the public interest. A balancing of the statutory
public interest factors supports the revocation of the Respondent's
Certificate of Registration and a denial of his application to renew.
The Respondent has not accepted responsibility for his actions,
expressed remorse for his conduct at any level, or presented evidence
that could reasonably support a finding that the Deputy Administrator
should continue to entrust him with a Certificate of Registration.
Accordingly, the Respondent's Certificate of Registration should be
revoked and any pending applications for renewal should be denied.
Dated: August 10, 2010.
John J. Mulrooney, II,
U.S. Administrative Law Judge.
[FR Doc. 2011-8340 Filed 4-6-11; 8:45 am]
BILLING CODE 4410-09-P