[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19450-19466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8342]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-34]
Cynthia M. Cadet, M.D.; Decision and Order
On August 10, 2010, Administrative Law Judge (ALJ) John J.
Mulrooney, II, issued the attached recommended decision.\1\ The
Respondent did not file exceptions to the decision.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
Having reviewed the entire record including the ALJ's recommended
decision, I have decided to adopt the ALJ's rulings, findings of
fact,\2\ conclusions of law,\3\ and recommended Order.
---------------------------------------------------------------------------
\2\ The ALJ found that there is ``no evidence that the
Respondent `prescribe[d] and dispense[d] inordinate amounts of
controlled substances.'' ALJ at 27. While there is no evidence as to
the amounts Respondent may have dispensed directly, there is such
evidence, which is unrefuted, with respect to her prescriptions. The
Government's Expert specifically found that Respondent ``prescribed
very high initial and subsequent doses of oxycodone and Xanax to
[R.A.] excessively and inappropriately without adequate medical
justification.'' GX 55, at 9 (emphasis added). The Government's
Expert further noted that ``[t]he typical Xanax (alprazolam)
starting dose is 0.25 to 0.5 mg. once to twice per day,'' yet
Respondent prescribed ``high dose[s] of Xanax'' 2 mg. ``once to
three times per day to 12 of the 13 `patients' whose files [he]
reviewed'' without ``consider[ing] many important factors that cause
anxiety'' and any ``previous medical evaluation''; she also not
refer these patients ``to a mental health professional for
evaluation.'' Id. at 10. The Expert thus concluded that ``[t]he
treatment was with a very high dose of the controlled substance
Xanax'' and ``was clearly not within the boundaries of professional
practice.'' Id. Finally, the Expert provided unrefuted evidence that
Respondent prescribed ``drug cocktails'' of oxycodone and Xanax,
which ``were clearly not for any legitimate medical purpose.'' Id.
at 13. 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 26-27. 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 her
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 she dispensed controlled substance prescriptions
that were not ``within `the usual course of [her] professional
practice,' '' ALJ at 39 (quoting 21 CFR 1306.04(a)), and that ``the
evidence under the [experience] * * * factor[] support[s]'' the
revocation of her registration, is consistent with Agency precedent.
Id. at 40.
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 40 (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. Id. at 41.
The ALJ also opined that ``[i]t is clear that in assessing
whether the controlled substance prescribing practices of a Florida
practitioner fall within the acceptable range of what constitutes
being within the bounds of being `issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of
his professional practice,' resort must be had to an expert.'' ALJ
at 34 (quoting 21 CFR 1306.04(a)). While the ALJ properly noted the
importance of expert testimony in this case, in which the Government
primarily relied on a review of the medical charts, whether expert
testimony is needed 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.
---------------------------------------------------------------------------
[[Page 19451]]
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, BC8112637, issued to Cynthia M. Cadet,
M.D., be, and it hereby is revoked. I further order that any pending
application of Cynthia M. Cadet, 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.
Glenn B. Kritzer, 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 BC8112637, of Cynthia M. Cadet, M.D.
(Respondent), as a practitioner, pursuant to 21 U.S.C. 824(d), alleging
that such registration constitutes an imminent danger to the public
health and safety. The OSC/ISO also sought revocation of the
Respondent's registration, pursuant to 21 U.S.C. 824(a)(4), and denial
of any pending applications for renewal 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 her request, was conducted in Miami, Florida, on
July 7, 2010 through July 9, 2010.\4\ The immediate suspension of the
Respondent's COR has remained in effect throughout these proceedings.
---------------------------------------------------------------------------
\4\ Pursuant to an order issued on April 15, 2010, the hearing
in this matter was consolidated with the cases of four other
registrants who were working at the same clinic as the Respondent
and who were also issued OSC/ISOs on February 25, 2010, alleging
similar and related conduct.
---------------------------------------------------------------------------
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. Sec. Sec. 823(f) and
824(a)(4). The Respondent's DEA practitioner registration expires by
its terms on August 31, 2011.
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 she had been participating in at American
Pain, LLC (American Pain), has prescribed and dispensed inordinate
amounts of controlled substances, primarily oxycodone,\5\ under
circumstances where she 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 \6\ surrounding the manner in which American Pain had
been 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 little or no medical examination.'' Id.
Lastly, as an additional ground for the OSC/ISO, the Government cites
the death of one of Respondent's patients from an overdose of oxycodone
and alprazolam \7\ one day after obtaining prescriptions for those same
controlled substances from a visit to the Respondent at American Pain,
and notes that the investigation determined the deceased patient
``frequently made trips from his home in Kentucky to Florida pain
clinics with others for the purpose of acquiring controlled substances
for other than a legitimate medical purpose.'' Id.
---------------------------------------------------------------------------
\5\ A schedule II controlled substance.
\6\ The majority of which are supported by no evidence
introduced by the Government during the course of these proceedings.
\7\ A schedule IV controlled substance.
---------------------------------------------------------------------------
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.\8\ Id. at 721. Under Langston's supervision, DEA
diversion investigators catalogued the prescriptions seized at Boca
Drugs (Boca Drugs Prescription Log). Govt. Ex. 118. A review of the
data relative to the Respondent on the Boca Drug Prescription Log
reveals that from November 2, 2009 through November 25, 2009, 151
controlled substance prescriptions issued over the Respondent's
signature, to seventy-eight patients, only seven of whom resided in
Florida. The remainder of the patients had listed addresses in
Kentucky, Tennessee, Ohio, Georgia, West Virginia, Indiana, and
Missouri. The log also reflected that the Respondent wrote one non-
controlled substance prescription to a patient for cyclobenzaprine, a
muscle relaxant.
---------------------------------------------------------------------------
\8\ 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.
---------------------------------------------------------------------------
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.
[[Page 19452]]
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
\9\ or OUTSIDE the STATE OF FLORIDA.
---------------------------------------------------------------------------
\9\ 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.\10\ Govt. Ex. 119 at 2.
---------------------------------------------------------------------------
\10\ 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 a medical expert
procured by the Government. Tr. at 762. According to GS Langston, after
the execution of the warrant, the charts from the entire office were
placed into piles in alphabetical order, and not separated by
physician. Langston testified that she and three of her diversion
investigators reviewed the seized files with a view towards choosing
approximately fifteen files for each doctor with the aspirational
criteria that each would reflect at least three to four visits by that
doctor with a patient. Each investigator was empowered to place a chart
on the selected pile, and when the target number (or about that number)
was reached for each physician, the selection effort relative to that
physician was deemed accomplished. Id. at 765. Langston credibly
testified that there was no effort to specially select files under some
prosecution-enhancement or ``cherry picking'' purpose. Id. at 768.
Langston also explained DEA's Automated Record Consolidated
Ordering System (ARCOS) \11\ 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. 50.
---------------------------------------------------------------------------
\11\ GS Langston explained that through the ARCOS system,
``[d]rug manufacturers and distributors are required to report the
sale of certain controlled substances to DEA,'' and the system
``shows the history of a drug from the point of manufacture through
the distribution chain to the retail dispensing level.'' Tr. at 685-
86.
---------------------------------------------------------------------------
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. 51-53. Review of the PMP report data
reflects that during the time period of February 1, 2006 through
February 11, 2010, pharmacies filled 166 controlled substance
prescriptions issued over the Respondent's signature to fifty patients
located in West Virginia, 124 similar prescriptions provided to fifty-
one Kentucky-based patients were filled between January 1, 2009 and
April 4, 2010, and fifty-five such prescriptions pertaining to twenty-
eight 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.
GS Langston provided evidence that was sufficiently detailed,
consistent and plausible to be deemed credible in this recommended
decision.
SA Michael Burt testified that he has been employed by DEA since
March 2004 and has been stationed with the Miami Field Division (MFD)
since September 2004. Tr. at 813-14. Burt testified that he is the lead
case agent for DEA in the investigation of American Pain Clinic and has
participated in the investigation since the latter part of 2008.
According to Burt, American Pain, which was previously known by the
name South Florida Pain, has conducted business at four different
locations, and he surveilled the Boca Raton and Lake Worth locations
both in person and by periodic live review of video captured via pole
cameras \12\ set up outside the clinic. Id. at 815-17. These pole
cameras, which were in operation during a three week period from
January to February 2010, were initially in operation on a 24 hour
basis, but Burt testified that they were later activated only between
the hours of 7:00 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.
---------------------------------------------------------------------------
\12\ SA Burt described the pole cameras as ``covert cameras that
are installed to observe the activity in the clinic.'' Tr. at 816.
Burt testified that he was able to use a laptop to access the live
video feed from the cameras after inputting a username and password.
The camera video was also recorded to DVR. Id. at 821.
---------------------------------------------------------------------------
Based on these surveillance efforts, SA Burt testified concerning
various activities he observed occurring outside the Boca and Lake
Worth clinic locations, which were open to the public from 8 a.m. to 5
p.m. At the Boca location, Burt stated that on any given day, beginning
at 7 a.m. in the morning, automobiles could be seen pulling into the
parking lot and approximately twenty to thirty people were routinely
lined up outside of the clinic waiting to gain admittance.
Additionally, there was a steady stream of automobile and foot traffic
in and out of the clinic throughout the day. Id. at 817, 821. Burt
testified that in his estimation, approximately 80-90 percent of the
automobiles had out-of-State tags, predominantly from Kentucky, Ohio,
West Virginia and Tennessee. Id. at 817-18. Burt also observed security
personnel with ``staff'' written on their shirts \13\ riding around the
exterior of the building in golf carts and who, in Burt's assessment,
appeared to be directing patients into the American Pain facility. Burt
indicated his surveillance of the
[[Page 19453]]
Lake Worth location yielded similar observations. Id. at 818.
---------------------------------------------------------------------------
\13\ Tr. at 910.
---------------------------------------------------------------------------
Based on his review of some (but not all) \14\ of the audio and
video tapes made by agents and informers sent into the clinic by the
Government at various times, SA Burt also testified about his
understanding of the process by which patients obtained controlled
substance prescriptions at American Pain. According to Burt, after
entering the clinic, a patient would meet with the receptionist, who
would determine if the patient had an MRI. If not, the receptionist
would issue that individual an MRI prescription in exchange for a $50
cash payment, and the patient ``would be directed to a place to obtain
an MRI.'' Id. at 822. Burt testified that one such MRI location was
Faye Imaging, which was a mobile MRI trailer located behind a
gentlemen's club several miles away from American Pain. Id. at 822-23.
The cost for the MRI was $250, and the patient could pay an additional
fee ``to have the MRI expedited and faxed over to American Pain.'' Id.
at 823-24. Once the MRI was procured and faxed to American Pain, the
patient would return to the clinic and be seen by a doctor. According
to Burt, the clinic accepted what he referred to as ``predominantly
cash only'' \15\ for these office visits, and the six doctors at the
clinic saw ``anywhere from 200 upward to 375 patients a day'' \16\ in
this manner.\17\ Id. at 882-83 (emphasis supplied).
---------------------------------------------------------------------------
\14\ SA Burt conceded that although he is the designated lead
case agent for DEA, he did not review all the audio and video tapes
made in the case or even review the transcripts. Tr. at 1002-05.
\15\ Later on cross-examination, SA Burt admitted that the
clinic also accepted payment via credit card. Tr. at 916.
\16\ Inasmuch as the Government provided no information from
which any specific number of patients seen by any given clinic
doctor on any day could be derived, or any expert testimony
regarding a reasonable number of pain patients that could or should
be seen per day, the value of providing the raw number of patients
walking through the door at the clinic is negligible.
\17\ Burt further testified that the doctors were paid $75.00
per patient visit, id. at 884, but because he indicated that he
could not disclose his basis of knowledge for this information, this
portion of his testimony can be afforded no weight. 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 \18\ of the
video and audio recordings made by an undercover agent (UC) who assumed
the name Luis Lopez capturing activity inside of American Pain.\19\ In
those recordings, Burt observed who he believed to be an American Pain
employee inside the facility standing up in a waiting room full of
patients and directing them ``not to have their prescriptions filled
out of State, not to go out into the parking lot and snort their
pills,'' and directing the patients to have their prescriptions filled
``in house'' (meaning at American Pain), at ``a pharmacy they have in
Orlando, Florida,'' or at ``a pharmacy they have down the street,''
which, in Burt's view, was a reference to Boca Drugs. Id. at 825-26.
Burt further testified that the purported employee on the recording
told the patients to ``obey all the traffic laws; do not give the
police a reason to pull you over.'' Id. Although Burt testified as to
the contents of these recordings, the physical recordings were not
offered into evidence by the Government or made available to opposing
counsel.
---------------------------------------------------------------------------
\18\ Tr. at 1002-05.
\19\ The fact that these recordings were made during the course
of seven different office visits by an undercover agent to both the
Boca Raton and Lake Worth locations was established on cross-
examination. Tr. at 900, 985.
---------------------------------------------------------------------------
SA Burt also testified that he received information from Dr. Eddie
Sollie, a former physician employed during the time period American
Pain was doing business as South Florida Pain, who terminated his
employment at the Oakland Park clinic location in November or December
2008 after working there for approximately two and a half to three
months.\20\ Id. at 827, 898. During the course of an interview where
Burt was present, Dr. Sollie related various ``concerns about how the
practice was being handled or managed.'' Id. at 827-28. These concerns
included medical records being, in his opinion, annotated inadequately
by the doctors, and what he perceived as a lack of supervision during
patient urinalysis testing, where patients would ``go[] to the
bathrooms together, bringing items with them to the bathrooms that
could possibly disguise the urinalysis.'' According to Burt, Sollie
explained that he perceived that patients were substituting urine
produced by other persons that contained the metabolites 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.
---------------------------------------------------------------------------
\20\ On cross-examination, Burt admitted the Respondent never
worked at the South Florida Pain Clinic in Oakland Park, the
facility where Sollie had previously been employed. Id. at 1027.
---------------------------------------------------------------------------
The Government also presented evidence through the testimony of SA
Burt regarding the drug overdose deaths of TY and SM after obtaining
controlled substances from American Pain.\21\ Burt's record testimony
indicates that DEA Task Force Officer \22\ (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.\23\
---------------------------------------------------------------------------
\21\ 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.
\22\ 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.
\23\ See Tr. at 836-53 (addressing exclusion of Govt. Ex. 27 and
associated testimony).
---------------------------------------------------------------------------
SA Burt also testified that TFO Adams notified him about the
overdose death of SM, whose body was found at his Kentucky home. Id. at
854; Govt. Ex. 54 at 1. SM's death occurred on January 1, 2009, the day
after his first and only appointment with the Respondent. Govt. Ex. 69.
Pursuant to Burt's request, Adams provided him with a packet of various
documents pertaining to SM's death, including a narrative police
report, medical examiner's report and toxicology report, which were
admitted into evidence. Govt. Ex. 54. Respondent, through counsel,
introduced a more complete version of the report, obtained directly
from the Rockcastle County Sherriff's Office (RCSO), which was also
admitted into evidence (RCSO Investigation).\24\ Respt. Ex. 1.
---------------------------------------------------------------------------
\24\ Although SA Burt testified that he requested ``the complete
report'' and ``all the documents'' relating to SM's death from TFO
Adams, id. at 860, it was clear that the Government's version
omitted a discomforting number of pages that should have been
included. Respt. Ex. 1; Tr. at 1041-43. The Government's version
included a toxicology report that was not present in the
Respondent's version. Govt. Ex. 54 at 4-7.
---------------------------------------------------------------------------
[[Page 19454]]
The certificate of death contained in the RCSO Investigation
reflects the coroner's finding of ``acute Oxycodone and Alprazolam
intoxication'' as SM's cause of death. Govt. Ex. 54 at 2; Respt. Ex. 1
at 7-8. The RCSO Investigation includes a narrative report, which
states that the responding police officer reporting the incident
procured various statements and paperwork from the decedent's parents
indicating he ``had been going to a pain clinic in Ft. Lauderdale, FL
[t]o receive pain medication,'' copied said documents, and placed them
in his case file. Id. at 1. Record evidence of these copied materials,
absent from the Government's exhibit submission or Burt's testimonial
presentation, includes an American Pain business card listing ``1/28''
under the heading ``next appointment,'' and several prescription data
printouts reflecting that on December 31, 2008, a prescription for
oxycodone issued to SM by the Respondent was filled at Speedy Scripts
Pharmacy in Fort Lauderdale. Respt. Ex. 1 at 21. The Respondent's
patient chart pertaining to SM reflects that on the date of their first
and only encounter, she issued prescriptions for oxycodone (15 mg),
Roxicodone (30 mg), and Xanax (2 mg). Govt. Ex. 69 at 16. This is
consistent with patient receipts provided to RCSO personnel by SM's
mother. Respt. Ex. 1 at 17-22.
Also absent from the Government's version of the RCSO Investigation
is that several prescription vials were found on SM's body at the time
of his death. One empty prescription vial indicates that it had once
contained forty-five hydrocodone pills filled on December 2, 2008
(twenty-eight days prior to his death and twenty-seven days prior to
his first and only appointment with the Respondent), another empty
hydrocodone vial indicates that it was filled on November 21, 2008
(forty-one days prior to his death and forty days prior to his first
and only appointment with the Respondent), and a third vial of
tizanidine (a non-controlled substance) was filled on November 19, 2008
(forty-three days prior to his death and forty-two days prior to his
first and only appointment with the Respondent). Also found on the
Respondent was a vial with what appeared to be marijuana seeds, baggies
and a scale of a type that is commonly used in connection with drug
paraphernalia. Respt. Ex. 1 at 4.
Statements of interviews contained in the RCSO Investigation
reflect that SM's friends and family were aware that he had a pain-
killer addiction that had its origins in the treatment of pain symptoms
from an automobile accident and that he abused marijuana. Id. at 5, 25,
26. Witness statements also reflect that SM was emotionally upset by a
recent break up with a girlfriend. Id. at 4, 23-29.
Although the coroner unambiguously concluded that ``[a]cute
Oxycodone and Alprazolam intoxication'' was the cause of death,\25\ the
autopsy also reflected evidence that SM had ingested other controlled
substances, including marijuana and oxymorphone. Id. at 8; Govt. Ex. 54
at 4-7; Tr. at 1033-38.
---------------------------------------------------------------------------
\25\ Respt. Ex. 1 at 7; Govt. Ex. 54 at 2.
---------------------------------------------------------------------------
When viewed in its entirety, SA Burt's record testimony was
stunningly sparse when compared with his proposed testimony as noticed
in the Government's prehearing statement.\26\ Indeed, perhaps among the
more striking aspects of SA Burt's performance on the witness stand is
the anticipated testimony which he did not provide. 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.
---------------------------------------------------------------------------
\26\ 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.\27\ Dr. Kennedy, who testified that he is
board certified by the American Board of Pain Medicine and the American
Board of Anesthesiology,\28\ was offered and accepted as an expert in
the field of pain medicine. Tr. at 39.
---------------------------------------------------------------------------
\27\ Dr. Kennedy's CV was admitted into evidence. Govt. Ex. 117.
\28\ Tr. at 17.
---------------------------------------------------------------------------
Dr. Kennedy 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 charts lacked
the individualized treatment plans and the variety of diagnostic tools
required to meet the minimally acceptable standards of practice in the
State of Florida, that Respondent's prescribing practices and the
documentation present in those patient files fell below the standards
fixed by the Florida State Medical Board, and that the controlled
substance prescriptions contained in those files were not issued for a
legitimate medical purpose.\29\ Id. at 384-90.
---------------------------------------------------------------------------
\29\ At the consolidated hearing in this matter, the Government
elicited testimony from Dr. Kennedy regarding additional aspects of
practice that he found deficient regarding the prescribing practices
of other respondents. For example, Dr. Kennedy opined that the
prescribing of 30 mg of oxycodone to an opioid na[iuml]ve patient
would, in his opinion, be dangerous and improper. Similarly, Dr.
Kennedy provided his opinion that the practice of ordering of an MRI
prior to a physician meeting with a patient would be improper.
However, regarding the charts that Dr. Kennedy reviewed relative to
this Respondent, the government adduced no testimonial evidence
regarding issues such as opioid na[iuml]vet[eacute] or the timing of
MRI scripts, and it would be unfair, improper and illogical for an
Administrative Law Judge to extrapolate the testimony elicited
relative to the patients of other physician(s) to this Respondent.
See Gregg & Son Distribs., 74 FR 17517 n.1 (2009) (data should be
provided while record is open, and ``[t]o make clear, it is the
Government's obligation as part of its burden of proof and not the
ALJ's responsibility to sift through the records and highlight that
information which is probative of the issues in the proceeding'')
citing Southwood Pharms., Inc., 72 FR 36487, 36503 n.25 (2007). The
absence of testimonial support by Dr. Kennedy on these issues
relative to this Respondent does not adversely affect the weight to
be attached to the conclusions set forth in the reports he prepared
in connection with this Respondent which were received into
evidence. Govt. Exs. 28, 131.
---------------------------------------------------------------------------
At the hearing, Dr. Kennedy explained that he took professional
[[Page 19455]]
issue with several aspects of the Respondent's patient care as
reflected in the charts regarding the prescribing of controlled
substances. It is apparent from his testimony that Dr. Kennedy's
analysis is restricted to those matters which can be gleaned from an
examination of the written word in that subset of the Respondent's
patient charts provided by the Government for his review, and that
limitation perforce circumscribes the breadth of his testimony. That
being said, Dr. Kennedy highlighted numerous features in the
Respondent's chart documentation that he found wanting, or at least
remarkable.
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.
In his testimony, Dr. Kennedy related that, in his expert opinion,
although the information in the charts required a prudent physician to
seek out prior medical records and/or input from prior medical
providers, none of the Respondent's charts reflected any attempt to do
so. Id. at 525, 527-28.
Kennedy also explained the importance of establishing a
differential or working diagnosis on the first visit and modifying and
reviewing that diagnosis as more information and results become
available. Id. at 52. Similarly, a diagnostic plan is a systematic
methodology of eliminating possible causes of symptoms to allow the
treating physician to accurately determine what is causing them so that
a successful treatment plan can be developed. Id. at 52-53. In other
words, the diagnostic plan allows the treating doctor to eliminate or
confirm items on the differential diagnosis. Id. at 54. In Kennedy's
view, the Respondent's charts did not reflect an adequate, deliberative
differential diagnosis process. Id. at 477-78. The ultimate diagnosis
conclusion, at least in Kennedy's view, appears assumed by the
Respondent without supporting analysis. Id. at 478.
In Kennedy's view, the treatment plans in the Respondent's chart
were also infirm in that they were not sufficiently individualized. Id.
at 386. Although, on cross examination, Kennedy conceded that at least
one file recommended such things as yoga, stretching, vitamins and
smoking cessation,\30\ his testimony supported the conclusion that
every examined chart treated the patient primarily with controlled
substances. Id. at 386, 472. Kennedy observed that comparing the
patient charts,
---------------------------------------------------------------------------
\30\ Tr. at 542-44.
basically it's the same. [The patients are] given high-dose
oxycodone and two different strengths. The Roxicodone 15 milligrams
is twice a day. The Roxicodone 30 looks like it's been given six
times a day in one case and eight times a day in another. Xanax is
---------------------------------------------------------------------------
given at 2 miligrams.
Id. at 482.
Although Dr. Kennedy conceded that it is the judgment of the
examining physician that is generally relied upon in determining the
necessity and appropriateness of diagnostic testing,\31\ he also
testified that the Respondent's practice of routinely ordering magnetic
resonance imaging (MRI) procedures before a physician meets with the
patients was inappropriate because an MRI is not always required and
not always appropriate. Id. at 71-73, 153-54. In Kennedy's opinion, a
physician has an obligation to meet with the patient before including
this procedure as part of the utilized diagnostic tools. Id. Kennedy
noted that the Respondent's files reflected evidence that MRIs were the
predominant diagnostic tool and were ordered prior to the patient's
first interaction with her at a clinic visit. Id. at 385.
---------------------------------------------------------------------------
\31\ Tr. at 59.
---------------------------------------------------------------------------
While acknowledging that some standardization and utilization of
forms is not, standing alone, improper,\32\ Dr. Kennedy took issue with
what he perceived as flaws in the forms utilized by the Respondent to
document patient care. According to Dr. Kennedy, many of the forms used
by the Respondent omitted too much. Id. at 472-73, 486. The error was
not so much that every blank space was not filled in, but that
``important areas'' such as the pain scale were left blank. Tr. at 486.
---------------------------------------------------------------------------
\32\ Tr. at 74.
---------------------------------------------------------------------------
Dr. Kennedy prepared two reports in connection with the
Government's case against the Respondent, which are dated April 28 and
April 30, 2010, respectively, and both of which were admitted into
evidence. Govt. Exs. 55, 132; Tr. at 381-82. One of the reports
describes a general analysis of thirteen 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). Govt. Ex. 55. Although this
report purports to describe practices common to all thirteen files
reviewed by Dr. Kennedy, much of the analysis is directed toward a
chart prepared in connection with RA,\33\ one of the Respondent's
patients. A second report (Supplemental Chart Analysis) prepared by Dr.
Kennedy focuses on the chart of SM, the Kentucky-resident patient of
the Respondent described in the RCSO Investigation who died from an
overdose of the same variety of medications prescribed by the
Respondent on the day after his first appointment with her. Govt. Ex.
132; Resp. Ex. 1; Tr. at 854-57. The Supplemental Chart Analysis notes
that patient SM was seen by the Respondent at American Pain on December
31, 2008 and indicates the presence of a note found in patient SM's
file stating ``Deceased 12/31/08/1-1-09 O.D.'' Id. at 2.
---------------------------------------------------------------------------
\33\ 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.
---------------------------------------------------------------------------
Many of the observations and conclusions contained within the two
reports are remarkably similar. Dr. Kennedy's report makes it
unambiguously clear that, at least in his opinion, all fourteen of the
Respondent's charts that he reviewed suffered from the same
shortcomings. The Patient Charts Analysis states that the Respondent's
patient charts reviewed by Dr. Kennedy ``are essentially the same with
regard to review issues; as stated in the report of [RA] referenced and
discussed in this report in detail, [and that] there were no
significant differences that affected [his] conclusions and summary.''
Govt. Ex. 55 at 2. A like-worded proviso accompanies Dr. Kennedy's
analysis of
[[Page 19456]]
SM's patient chart in the Supplemental Chart Analysis. Govt. Ex. 132 at
1. When, on cross examination, Kennedy was directed to differences in
exact wording, patient statements regarding chief complaints and dosage
variations between patients,\34\ he explained that notwithstanding some
variation between some details, his concern was that among all the
files, at least in his view, ``the process is the same.'' Tr. at 477.
---------------------------------------------------------------------------
\34\ Tr. at 470-74.
---------------------------------------------------------------------------
It is interesting to note that the SM patient chart contains no
indication that the Respondent made any efforts to contact any prior
doctors, pharmacists or family members. Likewise, there is no
indication that any effort was made to query Kentucky PMP databases. A
check to any of these sources could have informed the Respondent that
another physician had recently prescribed oxycodone and other
medications to SM, that SM was, at least in the opinion of his family
and friends, addicted to pain medicine and was abusing marijuana, and
that SM was emotionally labile due to the recent estrangement he had
with his girlfriend. Unfortunately, because the Respondent made no
efforts to reach out for any of that information, she merely talked to
SM, prescribed controlled substances, and SM perished by an overdose of
the same variety of medication she prescribed.
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; \35\'' (2) reflected prescriptions, right from the
initial patient visit, that ``were almost entirely for controlled
substances, most often one or two immediate release oxycodone pills
with Xanax,'' and which were, in Dr. Kennedy's view, inappropriate and
more powerful than justified by the objective signs documented in the
written notes; \36\ (3) showed that ``the same or very similar `drug
cocktails' were prescribed [among all patients in the reviewed files]
in the same or very similar doses, [directions] * * * with a 30-day
supply,'' and were affixed to the prescription scripts with a few
prepared stamps utilized by all American Pain physicians that reflected
``drug, dose, sig (directions) and quantity dispensed; \37\'' (4)
contained medication contracts that were ``not always signed'' and
``listed criteria that was not followed by the doctors at American
Pain; \38\ (5) failed to document the efficacy of the prescribed
medication; (6) did not set forth a ``diagnostic plan, except to obtain
an occasional MRI, the results of which made no difference in the
`treatment;' ''\39\ (7) reflected ``no therapeutic plan, except to use
controlled substances to `treat' the subjective complaint of `pain'
which was inadequately described; \40\ (8) did not reflect ``real
therapeutic goals * * * for improvement of quality of life (activities
of daily living, work, sleep, mood); ''\41\ (9) did not reflect
``consultations with other physicians or specialists outside the
American Pain group [which] could have and in some cases should have
included orthopedics, neurology, neurosurgery, psychiatry, addiction
medicine and psychology; ''\42\ (10) reflected ``a gross lack of past
medical records in all charts reviewed and in some cases none at all;
\43\'' and, (11) demonstrated controlled substance patient monitoring
practices that were ``not within the standard of care and outside the
boundaries of professional practice.'' \44\
---------------------------------------------------------------------------
\35\ Govt. Ex. 55 at 4.
\36\ Govt. Ex. 55 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 [with] no apparent consideration given to
patient safety with initial or subsequent prescription of controlled
substance[s].'' Id. at 7.
\37\ Govt. Ex. 55 at 4.
\38\ As an example of the failure to adhere to the terms of the
medication contract, Dr. Kennedy cites a contract term that provides
notice that the physician may stop prescribing opioids or change
treatment if pain or activity improvement is not demonstrated, and
points out that pain and activity levels are routinely not
documented in treatment notes. Govt. Ex. 55 at 4. Similarly, Dr.
Kennedy references a medication contract warning that termination of
services may result from failure to make regular follow-up
appointments with primary care physicians, and notes that the
American Pain charts contain no notes from primary care physicians
or medical records generated by them. Id.
\39\ Govt. Ex. 55 at 7. In Dr. Kennedy's opinion, Respondent
in effect, acted as a `barrier' for [RA] to receive appropriate
medical evaluation and treatment. In other words, the very potent,
high doses of opioids (oxycodone) and benzodiazepine (Xanax) could
cover up [RA's] underlying disease process(s), making it more
difficult to diagnose, and allowing the disease(s) to unnecessarily
worsen. Without an accurate diagnosis, all [the Respondent] was
doing was, again, masking or covering up the symptoms.
Id. at 10.
\40\ Govt. Ex. 55 at 7.
\41\ Govt. Ex. 55 at 8.
\42\ Govt. Ex. 55 at 7.
\43\ Govt. Ex. 55 at 15. The only past medical record contained
in RA's chart was a report from an MRI conducted five months prior
to the patient's initial clinic visit with the Respondent. Id. at 8.
\44\ Govt. Ex. 55 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. 55 at 14. It
was Dr. Kennedy's observation that even a drug screen anomaly did not
alter the seemingly inexorable continuation of controlled substance
prescribing from the Respondent. Id. Dr. Kennedy also noted that the
Respondent did not utilize out-of-office toxicology tests, or obtain
out-of-State prescription monitoring program or outside pharmacy drug
profiles. Furthermore, the charts contained only rare evidence of
contact with primary care physicians, treating physicians, pharmacists,
or other health care providers. Id.
The identified shortcomings of controlled substance patient
monitoring systems was of particular significance where Dr. Kennedy
identified specific evidence that he identified as ``red flags'' of
possible or likely diversion. In addition to providing incomplete and/
or inconsistent information on his patient questionnaires, SM's file
reflected a positive urine screen test for the presence of
benzodiazepines, opiates, and oxycodone, significant potential
depression, and the failure to disclose information about his Kentucky-
based primary care and orthopedics treating physicians, and his
physical therapist. Govt. Exs. 69, 132 at 6. Other red flags noted by
Dr. Kennedy in the reviewed charts included the relatively young age of
the Respondent's chronic pain patients,\45\ incomplete history
information provided by the patients, periodically significant gaps
between office visits,\46\ referrals from friends, relatives, or
advertising, but not other physicians,\47\ and the fact that a
relatively high number of patients were traveling significant distances
to American Pain for pain treatment, although no physician employed at
that facility had any specialized training in pain management.\48\
---------------------------------------------------------------------------
\45\ Govt. Ex. 55 at 15.
\46\ Govt. Ex. 55 at 13.
\47\ Govt. Ex. 55 at 8, 15.
\48\ Govt. Ex. 55 at 16.
---------------------------------------------------------------------------
During the course of his testimony, Dr. Kennedy highlighted
evidence in the chart of patient RA reflecting that although he
disclosed to the Respondent that he was currently taking oxycodone and
Xanax, and had last been prescribed a dosage that should have still
been sufficient to supply him with medication on the day of his first
office
[[Page 19457]]
visit, the urinalysis conducted on that day reflected negative results.
Tr. at 548-56; Govt. Ex. 57 at 5, 7, 10, 26. Notwithstanding this
obvious anomaly, the Respondent issued prescriptions for Roxicodone in
15 and 30 mg doses and Xanax in a 2 mg dose. Govt. Ex. 57 at 19.
Furthermore, based on the disclosed prior prescription amount and date,
the issuance of these new prescriptions was at an earlier time than the
prior prescriptions should have run out. Id. at 552-55. RA's chart
reflects no inquiry, analysis, or even notation of these clear red
flags. Id. at 554-55. Failing to inquire about these issues, according
to Dr. Kennedy, fell below the standard of care that the Respondent
should have exercised. Id. at 555.
Similarly, Dr. Kennedy explained that regarding RR's patient chart,
the paperwork generated at the time of the first visit with the
Respondent reflected that he had been prescribed controlled substance
medications that should have, but did not, yield positive urinalysis
results. Id. at 556-60, 573-76; Govt. Ex. 63 at 8, 14, 17, 34.
Additionally, the patient examination form filled out by the Respondent
based on her interview with RR reflected a chief complaint that
included radicular symptoms extending to both legs, but the patient-
completed questionnaire reflected that he did not have those symptoms.
Tr. at 560-62; Govt. Ex. 63 at 8, 17. The chart did not contain
additional inquiry regarding why the controlled substances were
apparently not being taken by the patient or why the patient may not
have had the symptoms the controlled substances were being prescribed
to ameliorate. Dr. Kennedy testified that these discrepancies should
have, but did not result in additional due diligence on the part of the
physician. Tr. at 560-62.
Although Dr. Kennedy agreed during cross examination that a
possible explanation for a negative urinalysis could be that the
medication was not taken within a few days of the urinalysis, Id. at
567, this inquiry misses the point. The question is not whether there
could be a benign explanation from the patient, it is whether an
explanation of any type was sought by the registrant. Here, the
Respondent faced an obvious red flag of potential diversion and made no
effort to resolve the conflict as best as can be divined from the
patient file she kept. Dr. Kennedy reasonably characterized this type
of discrepancy as ``an inconsistency that should have been developed or
should have been explored.'' Id. at 571. Dr. Kennedy offered the
following explanation regarding the nature of the due diligence that
such inconsistencies should engender on the part of a physician:
The duty was to talk with the--the first thing you do is talk
with the person, the individual, the patient, and find out if they
have an explanation for that; was it a misunderstanding? Did they
mean what they wrote down? And find out exactly what's going on and
get their side, get their story, because your job is to advocate for
them, and also, to help them from doing any harm to themselves.
Id. at 573.
In his report, Dr. Kennedy also found it remarkable that each
American Pain patient file provided notice to its patients that
American Pain did not accept any form of health care insurance. Govt.
Ex. 55 at 3-4, 16. Dr. Kennedy's report set forth his opinion that this
practice was designed to ``effectively keep [the physicians at American
Pain] `off the radar' from monitoring by any private health care
insurance company as well as all State and Federal agencies (Medicaid
and Medicare respectively). Govt. Ex. 55 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.
Regarding the discomfiture that Dr. Kennedy expressed regarding
non-physician referrals in his report, during his testimony at the
hearing, he clarified that it was not unusual for a physician to treat
patients that have been referred by relatives and friends. Id. at 154.
Further, Kennedy conceded while in the course of his own medical
practice he has treated patients referred by family and friends, and
that in his report he was focusing on what he perceived as a lack of
any referrals by physicians in the files he reviewed, or what he
perceived as ``trends'' or ``patterns.'' Id. at 154-55. Given Dr.
Kennedy's acknowledgement that such referrals are not unusual, coupled
with the absence of any way to measure the relative percentage of
physician referrals in the Respondent's practice based on the record
evidence, the observations regarding referral sources are of limited
value here.\49\
---------------------------------------------------------------------------
\49\ Dr. Kennedy did not testify that a referral that emanated
from a source other than a physician could or should be a basis for
a diversion red flag on a given case. His opinion was limited to
culling some manner of a trend or pattern. In view of the fact that
the record contains no development of the numbers of files with non-
physician referrals versus the total number of files, or even an
acceptable metric upon which the issue could be evaluated, there is
very little useful analysis that can come from Dr. Kennedy's
observation regarding the files he reviewed.
---------------------------------------------------------------------------
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 [s]he was engaged in an efficient, ``[a]ssembly [l]ine''
business. H[er] ``patients'' were revenue streams, not true
patients. This business allowed h[er] to collect cas[h] for office
visits as well as being a ``[d]ispensing [p]hysician'' for
controlled substances. [Sh]e prescribed controlled substances so
that ``patients'' would return to h[er] office on a regular basis,
allowing h[er] 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''
[s]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. 55 at 16.
On cross examination at the hearing, Dr. Kennedy's attention was
directed to what would seem, at least to a lay person, to present as
including a significant level of detail set forth in the charts he
reviewed relative to the Respondent's patient documentation, including
both subjective complaints of discomfort and objective signs of medical
anomalies. Tr. at 497-98, 532-42. Undaunted, Dr. Kennedy (the sole
expert to testify at the hearing), remained committed to his position
that the manner in which the documentation was completed was
fundamentally insufficient and too omission-plagued for a physician to
adequately proceed to treat the patients with controlled substances.
Id. at 473-74, 489, 522, 525. Dr. Kennedy, more than once,
characterized the Respondent's patient charts as demonstrating ``gross
errors of omission.'' Id. at 522, 525.
The Supplemental Chart Analysis focused exclusively on SM's chart,
which contained information assembled on the date of his first and only
visit to the Respondent's practice, which occurred on the day before he
was pronounced dead of an overdose of the controlled substances
prescribed to him by the Respondent. Govt. Exs. 69 at 10, 132, 54;
Respt. Ex. 1. Among the deficiencies noted by Dr. Kennedy regarding
SM's chart was an absence of any efforts to communicate with SM's prior
physician or obtain prior medical records, and SM's failure to list any
medications on the applicable portion of the medication contract. Govt.
Ex. 132. Kennedy also opined that SM's failure to provide any contact
information regarding his prior physician, who, like SM was located in
Kentucky, should have presented a red flag to the
[[Page 19458]]
Respondent. Id. at 6. In his report, Kennedy characterized the
Respondent's patient evaluation and treatment regarding SM as ``very
clearly not within the standard of medical care.'' Id. at 7.
A review of the fourteen patient files \50\ 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. Contrary to Kennedy's
representations that the patients were all referred by friends, family,
and advertising, patient JA's file contains a representation by the
patient that he was referred to the clinic by a doctor. Govt. Ex. 56 at
28. The significance of this anomaly is, however, diminished
considerably by the fact that the doctor's name is never furnished by
JA or presented anywhere in the chart.
---------------------------------------------------------------------------
\50\ 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.
---------------------------------------------------------------------------
Regarding Dr. Kennedy's objections to what he perceives as a
virtually uniform pattern in the Respondent's therapeutic plans, the
record is not without exception. For example, Respondent included
notations in one patient's records referring him to see an oncologist
based on potential liver cancer concerns. Govt. Ex. 68 at 9.
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. GA's patient file
contains a notation about the patient getting Roxicodone, Xanax, and
Percocet ``off the street,'' a patient comfort assessment guide where
GA states that his current treatments or medicine include ``street
drugs,'' a medication contract that is signed but does not list any
current medications at all, along with an initial positive urinalysis
screen for opiates and oxycodone, yet the Respondent decided to
prescribe all three substances to GA during his initial and subsequent
visits. Govt. Ex. 58 at 8-9, 11, 35; see also Govt. Exs. 64 at 2; 66 at
6; 67 at 22 (similar notations involving other patients acquiring
controlled substances ``off the street'').
Patient JA's file also contains an indication that he had
previously received pain medications ``off the street,'' along with a
police incident report referring to the armed robbery of two
``Roxycotin'' (sic) prescriptions valued at $600 from the patient on
12/31/09 (the same date on which the Respondent provided them to him),
and which further contains a statement that ``[t]he victim completed a
written statement affidavit, but refused to pursue criminal charges at
this time.'' \51\ Govt. Ex. 56 at 2-3, 7.
---------------------------------------------------------------------------
\51\ Notably, however, there is no indication in the patient
file that the patient sought or received replacement prescriptions
from the Respondent.
---------------------------------------------------------------------------
JA's patient file also contains a form indicating a positive UDS
for oxycodone and benzodiazepine from 10/7/09, yet on the same date,
the patient comfort assessment guide and medication contract signed by
JA are both blank in the section where a patient is supposed to list
any medications he or she is currently taking. Govt. Ex. 56 at 13-14,
30; see also Govt. Exs. 59 at 9-10, 24; 61 at 7-8, 19; 66 at 11-12, 29
(similar issues). Patient RA's 11/2/09 UDS indicates a negative test
for all listed substances, yet on two different forms in his file which
appear to be from the same date, he indicates he is currently taking
oxycodone and Xanax. Govt. Ex. 57 at 10-11, 26; see also Govt. Exs. 63
at 14-15, 34; 67 at 9-10, 22 (similar issues). Patient RS's UDS form,
on the other hand, lists a positive test result for oxycodone and
benzodiazepine on 10/5/09, yet the patient states she is currently
taking only oxycodone on a medication contract signed on the same date.
Govt. Ex. 65 at 7, 18.
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,\52\ he was unable to identify
the documentation standard in the Florida Administrative code with any
degree of particularity, he also acknowledged that he was not aware of
what the standard is in Florida Medical Board administrative decisions
regarding the overprescribing of medication or what constitutes an
adequate medical history. Tr. at 149-51, 233, 304. While, overall,
Kennedy presented testimony that appeared candid and knowledgeable,
there were areas in his written report that rang of hyperbole and over-
embellishment. The reasoning behind some of the seemingly critical
observations in the written report, such as the ``cash basis'' of the
Respondent's practice and the absence of doctor referrals among the
reviewed patient files, did not well survive the crucible of cross
examination at the hearing. However, overall, Dr. Kennedy's testimony
was sufficiently detailed, plausible, and internally consistent to be
considered credible, and, consistent with his qualifications, he spoke
persuasively and with authority on some relevant issues within his
expertise, and notwithstanding the Respondent's objections relative to
his Florida-related experience, he is currently an assistant professor
teaching at a Florida Medical School. It may well be that the greatest
and most significant aspect of Dr. Kennedy's opinion is that on the
current record, it stands unrefuted. Thus, his opinion is the only
expert opinion available for reliance in this action.\53\ 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.
---------------------------------------------------------------------------
\52\ Tr. at 628.
\53\ The Respondent did not testify on her own behalf.
---------------------------------------------------------------------------
The Analysis
Pursuant to 21 U.S.C. 824(a)(4), the Deputy Administrator \54\ 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'':
---------------------------------------------------------------------------
\54\ This authority has been delegated pursuant to 28 CFR
0.100(b) and 0.104.
---------------------------------------------------------------------------
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal or local laws
relating to controlled substances.
[[Page 19459]]
(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. 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
[[Page 19460]]
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 her practice relative to prescribing and
dispensing controlled substances and acts allegedly committed in
connection with her 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 she has been in the business of
doing so are factors to be evaluated in reaching a determination as to
whether she should be entrusted with a DEA certificate. In some cases,
viewing a registrant's actions against a backdrop of how she 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 her
level of knowledge and experience, or even the quality or length of her
experience as a physician-registrant, but the Government has elected to
do so.
Regarding the Government's presentation, Agency precedent has long
held that in DEA administrative proceedings ``the parameters of the
hearing are determined by the prehearing statements.'' CBS Wholesale
Distribs., 74 FR 36746, 36750 (2009) (citing Darrel Risner, D.M.D., 61
FR 728, 730 (1996); see also Roy E. Berkowitz, M.D., 74 FR 36758,
36759-60 (2009) (``pleadings in administrative proceedings are not
judged by the standards applied to an indictment at common law'' and
``the rules governing DEA hearings do not require the formality of
amending a show cause order to comply with the evidence''). That being
said, however, the marked difference between the amount of evidence
that the Government noticed in its OSC/ISO and the amount that it
introduced at the hearing is striking. For example, contrary to its
allegations, there was no evidence that the Respondent ``prescribe[d]
and dispense[d] inordinate amounts of controlled substances,'' that the
``majority'' of the Respondent's patients were ``from states other than
Florida,'' and there was no evidence that American Pain patients were
issued ``pre-signed prescriptions to obtain MRI[s],'' nor was there
evidence that individuals positioned outside the American Pain building
were there to ``monitor the activity of patients in the parking lot to
prevent patients from selling their recently obtained controlled
substances.'' Likewise, no evidence was introduced at the hearing that
could support the allegations that ``employees of American Pain []
frequently ma[d]e announcements to patients in the clinic advising them
on how to avoid being stopped by law enforcement upon departing the
pain clinic'' and ``frequently ma[d]e announcements [] advising
[patients], among other things, not to attempt to fill their
prescriptions at out-of State pharmacies and warning them against
trying to fill their prescriptions at particular local retail
pharmacies.'' ALJ Ex. 1 (emphasis supplied).
In like fashion, the Government's prehearing statement proffered
that SA Burt would testify to several of the items described but not
established in the OSC/ISO. Among the list of allegations that were not
supported by any evidence introduced at the hearing, were
representations that SA Burt would testify concerning the following:
Law enforcement in Florida and [other states that correspond to
license plates seen in the American Pain parking lot] frequently
arrest people for illegal possession and/or illegal distribution of
controlled substances who have obtained the controlled substances
from American Pain;
American Pain hired individuals to ``roam'' the parking lot of
the clinic to dissuade people from selling their recently obtained
controlled substances on the property;
[The reason American Pain placed] signs within American Pain
warning individuals not to have their prescriptions filled at
Walgreens pharmacies [is] because Walgreens refuses to dispense the
prescriptions;
Walgreens has flagged all American Pain doctors and will not
fill any of their prescriptions;
[Physical exams at American Pain are] usually no more than a
blood pressure check and some bending and stretching;
[[Page 19461]]
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 University of Tennessee v. Elliot, 478 U.S.
788, 797-98 (1986) (``When an administrative agency is acting in a
judicial capacity and resolves disputed issues of fact properly before
it which the parties have had an adequate opportunity to litigate, the
courts have not hesitated to apply res judicata[.]'')
The evidence the Government did present raises issues regarding not
only Factor 2 (experience dispensing \55\ 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 her
practice complied with the law and/or was a threat to the public.
---------------------------------------------------------------------------
\55\ The statutory definition of the term ``dispense'' includes
the prescribing and administering of controlled substances. 21
U.S.C. 802(10).
---------------------------------------------------------------------------
While true that GS Langston convincingly testified about the course
of her investigation and laid an adequate foundation for numerous
database results, the Government provided no foundational context for
any relevant uses for those database results. Without some insight into
what types of results from these databases should be expected when
compared to similarly-situated registrants engaged in acceptable
prescribing practices, the raw data is without use. In short, there was
no evidence elicited wherein the percentage of the Respondent's in-
State to out-of State patients could be assessed, and no reasonable
measuring stick based on sound principles upon which to evaluate such
data. Likewise, there was no reliable yardstick upon which to measure
the amount of controlled substances reflected in the databases compared
to what a reasonable regulator would expect to see regarding a
compliant registrant. To the extent Langston possessed this information
(and she well may have) it was not elicited from her. The same could be
said of the allegation set forth in the Government's Prehearing
Statement that alleges that from a given period the Respondent ``was
the 12th largest practitioner purchaser of oxycodone in the United
States.'' \56\ 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.
---------------------------------------------------------------------------
\56\ 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,\57\ or advising them to comply with vehicle and traffic laws,\58\
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.
---------------------------------------------------------------------------
\57\ Tr. at 825.
\58\ 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 apparently never explained to Burt,\59\ and that
some patients were intentionally evading the American Pain urinalysis
process. Also, as highlighted in Respondent's Post-Hearing Brief
(Respondent's Brief), Sollie did not work at American Pain at the same
time the Respondent did,\60\ and did not specifically name any
physician as being connected with his allegations of misconduct.
Respt's Br. at 11. 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 this Respondent's authorization
to handle
[[Page 19462]]
controlled substances is in the public interest.
---------------------------------------------------------------------------
\59\ Tr. at 898.
\60\ Tr. at 1026-27.
---------------------------------------------------------------------------
The Government's evidence targeted not only the Respondent's
experience practicing under Factor 2, but also her 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 her
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,\61\ which the
CSA defines as ``to deliver a controlled substance to an ultimate user
\62\ * * * 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 she gave inadequate examinations or none at
all, ignored the results of the tests she 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).
---------------------------------------------------------------------------
\61\ 21 U.S.C. 823(f).
\62\ ``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,\63\ 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:
---------------------------------------------------------------------------
\63\ Rulemaking authority regarding the practice of medicine
within the State of Florida has been delegated to the Florida Board
of Medicine (Florida Board). Fla. Stat. Sec. 458.309(1)(2009).
(2) A licensed physician shall maintain patient medical records
in English, in a legible manner and with sufficient detail to
clearly demonstrate why the course of treatment was undertaken.
(3) The medical record shall contain sufficient information to
identify the patient, support the diagnosis, justify the treatment
and document the course and results of treatment accurately, by
including, at a minimum, patient histories; examination results;
test results; records of drugs prescribed, dispensed or
administered; reports of consultations and hospitalizations; and
copies of records or reports or other documentation obtained from
other health care practitioners at the request of the physician and
relied upon by the physician in determining the appropriate
treatment of the patient.
(4) All entries made into the medical records shall be
accurately dated and timed. Late entries are permitted, but must be
clearly and accurately noted as late entries and dated and timed
accurately when they are entered in to the record * * *.
Fla. Admin. Code r. 64B8-9.003 (2009).
With respect to defining the parameters of what constitutes
``professional practice'' in the context of pain management
prescribing, Florida State law provides:
Notwithstanding any other provision of law, a physician may
prescribe or administer
[[Page 19463]]
any controlled substance under Schedules II-V * * * to a person for
the treatment of intractable pain,\64\ 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.
---------------------------------------------------------------------------
\64\ 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,\65\ albeit in modified version, the Model Policy for the Use
of Controlled Substances for the Treatment of Pain (Model Policy), a
document drafted by the Federation of State Medical Boards (FSMB) to
provide professional guidelines for the treatment of pain with
controlled substances. The standards adopted by Florida share the key
tenants of the Model Policy's standards for pain management
prescribing, including the emphasis on diligent efforts by physicians
to prevent drug diversion, prescribing based on clear documentation of
unrelieved pain and thorough medical records, and compliance with
applicable Federal and State law.
---------------------------------------------------------------------------
\65\ Pursuant to authority vested in the Florida Board by the
Florida legislature to promulgate rules regarding State standards
for pain management clinical practice specifically. Fla. Stat. Sec.
458.309(5) (2009).
Like the Model Policy, which was promulgated ``to encourage the
legitimate medical uses of controlled substances for the treatment of
pain while stressing the need to safeguard against abuse and
diversion,'' Florida's regulation providing ``Standards for the Use of
Controlled Substances for Treatment of Pain,'' Fla. Admin. Code r.
64B8-9.013 (2009) (Florida Standards), recognizes that ``inappropriate
prescribing of controlled substances * * * may lead to drug diversion
and abuse by individuals who seek them for other than legitimate
medical use.'' The language employed by the regulation under the
preamble section titled ``Pain Management Principles'' makes clear that
the standards ``are not intended to define complete or best practice,
but rather to communicate what the [Florida Board] considers to be
within the boundaries of professional practice'' (emphasis supplied),
id. at 9.013(1)(g); thus, the plain text supports an inference that the
standards provide the minimum requirements for establishing conduct
that comports with the professional practice of controlled substance-
based pain management within the State. Likewise, the level of integral
range of acceptable practice that is built into the regulation
underscores the importance of seeking an expert professional opinion in
reaching a correct adjudication of whether a registrant has met the
applicable Florida standard. It is clear that in assessing whether the
controlled substance prescribing practices of a Florida practitioner
fall within the acceptable range of what constitutes being within the
bounds of being ``issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice,'' \66\ resort must be had to an expert.
---------------------------------------------------------------------------
\66\ 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 \67\ 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.
---------------------------------------------------------------------------
\67\ The original Model Policy version of the guidelines does
not contain a reference to the need for a complete medical history,
instead only requiring a medical history generally. Thus, the
Florida Board has adopted a higher standard than the measure that
has been set in the Model Policy by the FSMB.
---------------------------------------------------------------------------
Id. at 9.013(3)(a).
Furthermore, the Florida Standards require a written treatment plan
that ``should state objectives that will be used to determine treatment
success, such as pain relief and improved physical and psychosocial
function, and should indicate if any further diagnostic evaluations or
other treatments are planned.'' Id. at 9.013(3)(b). Subsequent to the
initiation of treatment, ``the physician should adjust drug therapy to
the individual medical needs of each patient. Other treatment
modalities or a rehabilitation program may be necessary depending on
the etiology of the pain and the extent to which the pain is associated
with physical and psychosocial impairment.'' (emphasis supplied). Id.
Another standard adopted by the Florida Board, under the subheading
``Informed Consent and Agreement for Treatment,'' is the directive that
[t]he physician should discuss the risks and benefits of the use
of controlled substances with the patient, persons designated by the
patient, or with the patient's surrogate or guardian if the patient
[[Page 19464]]
is incompetent. The patient should receive prescriptions from one
physician and one pharmacy where possible. If the patient is
determined to be at high risk for medication abuse or have a history
of substance abuse, the physician should employ the use of a written
agreement between the physician and patient outlining patient
responsibilities, including, but not limited to:
1. Urine/serum medication levels screening when requested;
2. Number and frequency of all prescription refills; and
3. Reasons for which drug therapy may be discontinued (i.e.,
violation of agreement.
Id. at 9.003(3)(c).
The Florida Standards contain a further requirement to periodically
review ``the course of pain treatment and any new information about the
etiology of the pain or the patient's state of health.'' Id. at
9.013(3)(d) The Florida Standards explain the importance of periodic
review in the following manner:
Continuation or modification of therapy depends on the
physician's evaluation of the patient's progress. If treatment goals
are not being achieved, despite medication adjustments, the
physician should reevaluate the appropriateness of continued
treatment. The physician should monitor patient compliance in
medication usage and related treatment plans.
Id.
Under the subheading ``Consultation,'' the Florida Board
promulgated the instruction that
[t]he physician should be willing to refer the patient as
necessary for additional evaluation and treatment in order to
achieve treatment objectives. Special attention should be given to
those pain patients who are at risk for misusing their medications
and those whose living arrangements pose a risk for medication
misuse or diversion. The management of pain in patients with a
history of substance abuse or with a comorbid psychiatric disorder
requires extra care, monitoring, and documentation, and may require
consultation with or referral to an expert in the management of such
patients.
Id. at 9.003(3)(e).
It is abundantly clear from the plain language of the Florida
Standards that the Florida Board places critical emphasis on physician
implementation of adequate safeguards in their practice to minimize
diversion and the need to document the objective signs and rationale
employed in the course of pain treatment utilizing the prescription of
controlled substances. Conscientious documentation is repeatedly
emphasized as not just a ministerial act, but a key treatment tool and
a vital indicator to evaluate whether the physician's prescribing
practices are ``within the usual course of professional practice.''
Here, the uncontroverted expert opinion of Dr. Kennedy, the only expert
witness to testify at these proceedings, reflects that the
documentation he reviewed in the Respondent's patient charts reflected
care that was markedly below the standard of care set by the Florida
Medical Board. Dr. Kennedy's expert assessment was consistent with the
State statutory and regulatory guidance. In Kennedy's view, the
Respondent's charts demonstrated minimalistic, incomplete, and
otherwise medically inadequate documentation of her contacts with
patients and the prescribing rationale for her 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 her practice of medicine in a manner to minimize
the potential of controlled substance abuse and diversion, and supports
a conclusion that she failed to even substantially comply with the
minimum obligations for professional practice imposed under the Florida
Standards--and without ``good cause [] shown for such deviation.'' Id.
at 9.013(1)(f). The same can be said of the multiple ignored red flags
of diversion risk, such as the seeking of premature controlled
substance prescription refills and the urinalysis anomalies highlighted
by Dr. Kennedy in his testimony.
In his brief, the Respondent's counsel has prepared and submitted a
thoughtful and detailed review of the patient charts analyzed by Dr.
Kennedy. Respt's Br. at 5-10. While counsel argues that the patient
chart entries were satisfactory, the expert's opinion at the hearing
remained unchanged. 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. An example of
the problem encountered here can be seen where counsel urges that the
medication contract clause requiring patients to follow-up with their
primary care physicians was somehow satisfied by the patient following
up with the Respondent. Id. at 7. Whether a pain specialist can serve
as (or morph into) a primary care physician sufficiently to satisfy a
medication contract term is beyond the expertise of this tribunal, and
requires the input of an expert witness. Also illustrative of the
potential risks of blurring the line between expert and lay opinion is
counsel's argument that regarding the reviewed charts, ``[s]ections
that were not filled in include details that are not necessarily
indicated for [the Respondent's] evaluation of a patient for chronic
pain therapy.'' Id. at 9. A lay person is simply not in a position to
contradict otherwise reliable expert testimony regarding which details
are ``necessarily indicated'' for inclusion in the chart of a pain
management specialist. Where the opinion of counsel offered through
argument and the opinion of the only accepted medical expert to provide
an expert opinion in these proceedings conflict, counsel's opinion
cannot and will not be afforded controlling deference. Argument
supplied by counsel (albeit a diligent and persuasive counsel) that the
relevant standards were satisfactorily applied as evidenced by the
protocols and procedures documented in the patient charts cannot
supplant the unrefuted view of an accepted expert witness.
The Respondent, who was in a unique position to conclusively refute
Dr. Kennedy's views and explain the format and nuances of the reviewed
documentation, elected not to testify in this matter. At a DEA
administrative hearing, it is permissible to draw an adverse inference
from the silence of the Respondent, even in the face of a Fifth
Amendment invocation. Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005)
(citing United States v. Hale, 422 U.S. 171, 176 (1975) (``silence
gains more probative weight where it persists in the face of
accusation, since it is assumed in such circumstances that the accused
would be more likely than not to dispute an untrue accusation.''));
Joseph Baumstarck, M.D., 74 FR 17525, 17528, n.3 (2009) (citing Ohio
Adult Parole Auth. v. Woodward, 523 U.S. 272, 286 (1998)). On the facts
of this case, where the allegations are of a nature that a registrant
would be more likely than not to dispute them if untrue, an adverse
inference based on the Respondent's silence is appropriate. Where, as
here, the Government, through its expert, has alleged that the
Respondent's charts do not reflect genuine analysis, but rather (at
least in its view and the opinion of its expert), a sort of sham-by-
check-box form designed specifically to present a false impression of a
compliant registrant, it is precisely the type of allegation that would
naturally all but oblige a registrant to spring to offer a
contradictory account. The Respondent's choice to remain silent in the
face of such allegations, where she
[[Page 19465]]
could have related her version of her 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 her 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 of the evidence, that the
prescriptions the Respondent issued in Florida were not issued within
``the usual course of [the Respondent's] professional practice.'' 21
CFR 1306.04(a). Consideration of the evidence under the second and
fourth factors support the COR revocation sought by the Government in
this case.
To the extent that the Respondent's prescribing practices fell
below the requisite standard in Florida, that conduct also impacts upon
the Fifth statutory factor. Under Factor 5, the Deputy Administrator is
authorized to consider ``other conduct which may threaten the public
health and safety.'' 21 U.S.C. 823(f)(5). Although this factor
authorizes consideration of a somewhat broader range of conduct
reaching beyond those activities typically associated with a
registrant's practice, an adverse finding under this factor requires
some showing that the relevant conduct actually constituted a threat to
public safety. See Holloway Distrib., 72 FR 42118, 42126 (2007).
Although admittedly not argued in the Government's brief, nowhere
is the application of this fifth public interest factor more
crystallized on this evidence than it is regarding the handling of SM.
Inasmuch as there is no question that multiple controlled substances
were identified in the decedent's body at the moment of death that were
prescribed by multiple physicians, it would be difficult-to-impossible
to precisely discern whether there was a specific one that could be
isolated as the sole cause of his demise. An analysis centered on which
physician's name appeared on the vial that produced the ultimately
fatal dose misses the point. Even if it were conclusively established
that a medication that was legitimately prescribed in the usual course
of a professional practice resulted in an adverse consequence--even
death--that fact alone would not necessarily decide the issue here. The
practice of medicine has not yet developed to a condition of such
mathematical precision that it is free of adverse consequences
resulting from good-faith efforts on the part of treating physicians.
The real focus of this aspect of this decision is not to conclusively
divine which medication ultimately was the most lethal, or even which
practitioner authorized it, but to evaluate whether the Respondent's
prescribing practices resulted in prescriptions which were not issued
in the usual course of a professional practice and whether her
prescribing practices contributed to SM's death. The patient chart
relative to SM reflected that no efforts were made to procure prior
medical records, information from family or friends, or even to perform
a Kentucky PMP database query. Performing the tasks that Dr. Kennedy
opined were required by a prudent practitioner would have revealed, at
a minimum, that SM had an addiction to pain killers, was abusing
marijuana, was receiving controlled substance prescriptions from
another physician and was in the midst of some manner of significant
emotional-psychological event. None of that was done. In the case of
SM, the Respondent did what she apparently routinely did: She
prescribed controlled substances without performing the steps that were
required to ensure that the prescriptions were being issued for a
legitimate medical purpose. In the case of SM, while it is possible,
even likely, that increased curiosity and professional attention and
action on the Respondent's part could have saved his life, that
determination is not required for a disposition of this case. While
experts could argue the point of which medication actually killed him,
there seems very little room for argument that the Respondent's poor
prescribing practices were very problematic relative to this decedent
and serve as a grave reminder of the potential consequences of failing
to take the steps required by a prudent registrant to ensure the safety
of the public. Consideration of the Respondent's conduct under Factor 5
balances significantly in favor of revocation.
The evidence establishes that the Respondent engaged in a course of
practice wherein she 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 her obligations as a DEA registrant, did not follow up in the face
of multiple red flags. The Respondent's disregard of her obligations as
a DEA registrant and Federal and State laws related to controlled
substances militate in favor of revocation.
By ignoring her responsibilities to monitor the controlled
substance prescriptions she 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
[[Page 19466]]
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 her application to renew.
The Respondent has not accepted responsibility for her actions,
expressed remorse for her conduct at any level, or presented evidence
that could reasonably support a finding that the Deputy Administrator
should continue to entrust her 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. 2011-8342 Filed 4-6-11; 8:45 am]
BILLING CODE 4410-09-P