[Federal Register Volume 75, Number 157 (Monday, August 16, 2010)]
[Notices]
[Pages 49956-49978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20211]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09-28]
Dewey C. Mackay, M.D.; Revocation of Registration
On February 26, 2009, I, the Deputy Administrator of the Drug
Enforcement Administration (DEA), issued an Order to Show Cause and
Immediate Suspension of Registration to Dewey C. MacKay, M.D.
(Respondent), of Brigham City, Utah. The Show Cause Order proposed the
revocation of Respondent's DEA Certificate of Registration, AM9742380,
which authorizes him to dispense controlled substances as a
practitioner, as well as the denial of any pending applications to
renew or modify the registration, on the ground that his ``continued
registration is inconsistent with the public interest, as that term is
defined in 21 U.S.C. 823(f) and 824(a)(4).'' ALJ Ex. 1, at 1. The Order
also immediately suspended Respondent's registration on the ground that
his continued registration during the pendency of the proceeding
``constitutes an imminent danger to public health and safety.'' Id.
The Show Cause Order alleged that ``[f]rom June 2005 to the
present,'' Respondent ``issued numerous purported prescriptions for
controlled substances without a legitimate medical purpose and outside
the usual course of professional practice.'' Id. at 1-2. As evidence of
his allegedly ``unlawful prescribing practices,'' the Order alleged
that: (1) On four occasions, M.R., a patient of his who cooperated with
the DEA, visited Respondent and, while she ``did not exhibit any
verifiable medical indication warranting the prescribing of controlled
substances,'' Respondent ``issued prescriptions for controlled
substances to her'' and did so even after
[[Page 49957]]
M.R. told him that ``she shared her controlled substances with another
person''; (2) Respondent issued prescriptions for opioids ``to at least
four patients after engaging in unwelcome and inappropriate sexual
activity * * * and without conducting any type of reasonable physical
evaluation,'' that ``this prescribing pattern indicates'' that he
issued ``prescriptions for controlled substances in exchange for
receiving sexual favors'' and that the prescriptions were ``without a
legitimate medical purpose and outside the scope of professional
practice''; (3) a ``qualified medical expert'' reviewed M.R.'s medical
file and concluded that Respondent's ``evaluation of M.R. was
inadequate to justify the prescribing of controlled substances for her
conditions,'' and that the expert had also reviewed nine of
Respondent's patient files ``selected at random'' and concluded that
his ``actions encouraged the abuse of controlled substances and allowed
their misuse''; (4) the same expert ``determined that, with respect to
four patients who died while under [his] care, the controlled
substances [Respondent] prescribed were present in their systems and
contributed to their deaths'' and that ``there was no justification for
[his] long-term prescribing of controlled substances to these
individuals''; and (5) since the execution of a search warrant at his
office on June 5, 2008, Respondent had ``continued to prescribe opioids
in extraordinarily large amounts,'' which was ``consistent with
[Respondent's] prior practice of prescribing controlled substances
without a legitimate medical purpose and outside the usual course of
professional conduct.'' Id. at 2.
By letter of March 6, 2008, counsel for Respondent timely requested
an expedited hearing in the matter, ALJ Ex. 2, at 1; and the matter was
placed on the docket of the Agency's Administrative Law Judges (ALJ).
Thereafter, Respondent objected to the Government's having scheduled
the hearing to be held in Arlington, Virginia on April 28, 2009, on the
ground that it would deny him Due Process; he also moved to have the
venue of the hearing changed to Utah. ALJ Ex. 12. While the Government
had initially argued against changing the location, ALJ Ex. 33, at 1;
following Respondent's filing of his motion, it retreated from its
earlier position and withdrew its objection to holding the hearing in
Salt Lake City, Utah. ALJ Ex. 17. However, the ALJ denied Respondent's
motion on the ground that he had failed to provide ``sufficient
justification'' to change the location of the hearing. ALJ Ex. 18, at
5. Thereafter, Respondent also moved for the ALJ to recuse himself on
the ground that he had ``demonstrated partiality and bias against both
[him] and [his] counsel'' based, in part, on his pre-hearing rulings
and several exchanges which occurred during two conference calls. ALJ
Ex. 19, at 7-8. On March 30, 2009, the ALJ denied both motions. ALJ Ex.
18, at 2, 5-6; ALJ Ex. 20.
Thereafter, on April 7, 2009, the United States District Court for
the District of Utah set aside the Order of Immediate Suspension, and
further ordered that the hearing be held in the District of Utah. ALJ
Ex. 33, at 1. The hearing was then rescheduled for April 28-30, 2009.
Id. at 2. The District Court also rejected Respondent's request for an
Order that the ALJ recuse himself. ALJ Dec. at 2.
Following additional procedures, the ALJ conducted a hearing in
Salt Lake City, Utah, from April 28, 2009 through May 1, 2009. At the
hearing, both parties elicited testimony and introduced documentary
evidence for the record. The Government also introduced audio-
recordings into the record. Following the hearing, both parties
submitted briefs detailing their proposed findings of fact, conclusions
of law, and argument.
On July 31, 2009, the ALJ issued his recommended decision (ALJ).
With respect to the first of the five public interest factors, see 21
U.S.C. 823(f), (the recommendation of the appropriate State licensing
board or professional disciplinary authority), the ALJ found that the
record contained no evidence of a recommendation of any such licensing
board or disciplinary authority and thus concluded that this factor
``does not weigh for or against a determination as to whether
continuation of the Respondent's DEA certification is consistent with
the public interest.'' ALJ at 94. As to the third factor (Respondent's
conviction record under Federal or State laws relating to the
manufacture, distribution or dispensing of controlled substances), the
ALJ noted that the record ``contains no evidence that the Respondent
has ever been convicted of any crime related to the manufacture,
distribution, or dispensing of controlled substances'' and concluded
that this ``weighs in the Respondent's favor.'' Id. at 96. The ALJ
noted, however, that the ``probative value'' of this finding is
``somewhat diminished by the myriad of considerations that are factored
into a decision to initiate, pursue, and dispose of criminal
proceedings by Federal, State, and local prosecution authorities.'' Id.
The ALJ then considered together factors two (Respondent's
experience in dispensing controlled substances), four (Respondent's
compliance with applicable State, Federal or local laws relating to
controlled substances), and five (such other conduct which may threaten
the public health and safety). Id. More specifically, the ALJ concluded
that Respondent violated numerous provisions of Utah State law.
First, the ALJ concluded that Respondent met with K.D. and wrote
her controlled substance prescriptions after ``touching her in
inappropriate, intimate, even sexual ways,'' thereby violating Utah
Code Ann. Sec. 58-1-501(2)(k), which makes sexual abuse and
exploitation ``unprofessional conduct.'' Id. at 101. Next, with respect
to patients K.D., M.R. and M.P., the ALJ concluded that Respondent
``routinely'' violated Utah Code Ann. Sec. 58-1-501(2)(m)(i) in that
he ``routinely issued prescriptions without first obtaining information
`sufficient to establish a diagnosis, to identify conditions, and to
identify contraindications to the proposed treatment.' '' Id. He
further found that ``Respondent's recordkeeping was not merely sloppy
or scant, [but that] the records reflect things that never happened, do
not monitor medication efficacy, and do not comply with the
documentation levels even minimally required by Utah Admin. Code R156-
37-602(1)\1\ and/or the Model Policy, which has been incorporated into
Utah law by Utah Administrative Code R156-1-502.''\2\ Id. at 104.
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\1\ This provision provides, in pertinent part:
Records of * * * prescribing * * * controlled substances shall
be kept according to State and Federal law. Prescribing
practitioners shall keep records reflecting the examination,
evaluation and treatment of all patients. Patient medical records
shall accurately reflect the prescription or administration of
controlled substances in the treatment of the patient, the purpose
for which the controlled substance is utilized and information upon
which the diagnosis is based.
\2\ Under a regulation of the Utah Division of Occupation and
Professional Licensing, it is ``unprofessional conduct'' for a
``prescribing practitioner'' to ``fail[] * * * to follow the Model
Policy for the Use of Controlled Substances for the Treatment of
Pain, 2004, established by the Federation of State Medical Boards.''
Utah Admin. Code R156-1-502(6).
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Next, with respect to K.D., the ALJ found that Respondent had
continued to prescribe controlled substances to her ``after she
confided her concerns that she felt she was addicted to prescription
drugs and wanted treatment,'' and that doing so violated Utah's
regulation which prohibits ``knowingly prescribing controlled
substances to a drug-dependent person.'' Id. at 104-05 (citing Utah
Admin. Code R156-37-502(6)). The ALJ also found that even if Respondent
considered himself to be prescribing narcotics for maintenance
[[Page 49958]]
purposes to K.D., he violated 21 CFR 1306.07, as Respondent lacked the
``requisite special registration'' to so prescribe controlled
substances. Id. at 105.
The ALJ further found that ``[b]ecause the controlled substance
prescriptions that * * * Respondent wrote were not preceded by even
cursory physical examinations or even the minimum level of treatment
and progress information,'' he violated 21 CFR 1306.04(a). Id. Finally,
the ALJ determined that ``[b]ecause * * * Respondent routinely ignored
obvious indications of abuse of controlled substances by his patients
and took no real steps to address that abuse,'' Respondent violated his
``obligations to guard against and provide effective controls against
the diversion of controlled substances in accordance with 21 CFR
1301.71(a) and Utah Administrative Code R156-37-502(2).'' Id. The ALJ
thus concluded that ``under the Fourth public interest factor,
consideration of the Respondent's disregard of State and Federal laws
related to controlled substances in the course of his controlled
substance prescribing practices militates in favor of the revocation of
his Certificate of Registration.'' Id.\3\
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\3\ The ALJ also apparently considered this conduct relevant in
assessing Respondent's experience in dispensing control substances
(which it is) although he did not explicitly state as much.
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As for the fifth factor, the ALJ indicated that ``Respondent's
trading of physical intimacy for controlled substance prescriptions
with K.D., the abysmal and misleading character of his patient-care
documentation, the virtual ignoring of blatant indications of diversion
exhibited by some of his patients, his practice of prescribing
controlled substances without examining or even minimally questioning
his patients beyond ascertaining which controlled substances they
desired * * * are [all] practices that impact upon the public health
and safety.'' Id. at 106. The ALJ also cited Respondent's repeated
requests of K.D. during her undercover visits as to whether she was
wearing a wire and working for DEA. Id. at 107. As he noted, ``these
repeated inquiries'' not only ``reflect[] * * * Respondent's poor
judgment and naivet[eacute],'' they also ``demonstrate consciousness of
guilt.'' Id. Furthermore, the ALJ determined that ``Respondent's
persistence in conducting his practice in this manner [in trying to
ascertain whether the patient was working for DEA instead of asking the
appropriate medical questions to formulate a basis for prescribing the
controlled substances which he prescribed] reflects an astounding
absence of any kind of remorse or acceptance of responsibility.'' Id.
at 108.
The ALJ also found that Respondent's ``unprofessional conduct'' in
not following the documentation requirements imposed by the Model
Policy ``constitutes sufficient justification, even standing alone, to
support a revocation of the Respondent's DEA registration as contrary
to the public interest.'' Id. at 108-09. Moreover, the ALJ further
found that Respondent's failure ``to react to multiple `red flags' of
drug abuse and/or misuse demonstrated by his patients'' violated Utah
Administrative Code R156-37-502 by ```fail[ing] to maintain controls
over controlled substances which would be considered by a prudent
practitioner to be effective against diversion * * * of controlled
substances.''' Id. at 109.
The ALJ thus concluded that ``the Government ha[d] established that
the Respondent has committed acts that are inconsistent with the public
interest.'' Id. at 114. Because Respondent ``has not accepted
responsibility for his actions, expressed remorse for his conduct at
any level, or presented evidence that could reasonably support a
finding that the Deputy Administrator should continue to entrust him
with a registration,'' the ALJ recommended that I revoke Respondent's
registration and deny any pending applications to renew his
registration. Id.
On August 24, 2009, Respondent filed Exceptions to the ALJ's
decision. Therein, Respondent argues that the record lacks substantial
evidence to support the allegations that nine patients were
``improperly treated,'' that he engaged in ``sexual impropriety,'' and
that his ``care caused the death of a patient.'' Resp. Exceptions, at
2. Respondent also contends that ``the ALJ disregard[ed] reliable
testimony of [Respondent's] witnesses and afford[ed] the Petitioner's
(or `DEA') witnesses an unsupportable amount of deference,'' that he
engaged in ``a one sided assessment of the evidence rather than
weighing disputed evidence offered in response by [Respondent], and * *
* ignore[d] evidence that [was] not disputed, that [was] supportive of
[Respondent],'' and that the ``recommended decision [was] rife with
bias and written in the tone of an advocate rather than an impartial
ALJ.'' Id. at 2-3. Respondent further claims that the ALJ did not, in
fact, ``weigh'' the statutory factors. Id. at 7-8.
On August 25, 2009, the ALJ forwarded the record to me for final
agency action. Having carefully reviewed the record as whole, as well
as Respondent's Exceptions,\4\ I concur with the ALJ's ultimate
conclusion that Respondent has committed acts which render his
continued registration inconsistent with the public interest and that
he has failed to provide evidence sufficient to establish why he can be
entrusted with a registration. Accordingly, I will adopt the ALJ's
recommendation, revoke Respondent's registration and deny any pending
applications to renew his registration.
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\4\ I have carefully considered Respondent's exceptions
pertaining to the ALJ's evaluation of the evidence in making my
factual findings.
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However, before proceeding to make my factual findings, the record
in this matter contains a motion to recuse the ALJ, which is
accompanied by the affidavits of Respondent's two counsels. See ALJ Ex.
19. Under 5 U.S.C. 556(b)(3), ``[o]n the filing in good faith of a
timely and sufficient affidavit of personal bias or other
disqualification of a presiding or participating employee, the agency
shall determine the matter as a part of the record and decision in the
case.''
Respondent's motion is based largely on exchanges that occurred
during what appears to have been a somewhat heated conference call, the
ALJ's having rejected several of his motions, and the Government's
alleged tainting of the ALJ by sending him a letter which references an
allegation of sexual impropriety on Respondent's part. ALJ Ex. 19, at
1-9; see also ALJ Ex. 10, at 1. I conclude, however, that Respondent's
affidavits are insufficient to establish that the ALJ was personally
biased against Respondent or his counsels.
As for the ALJ's conduct of the conference call, the allegations
that he cut off one of the lawyers and asked him if he had ever
practiced administrative law (which, according to the ALJ, happened
when he attempted to explain to Respondent's lawyers the limited scope
of discovery in the proceeding, see ALJ at 3 n.3.), is hardly so far
outside of the norms of judicial conduct as to overcome the presumption
of impartiality that attaches to the ALJ's conduct of the proceeding.
See Liteky v. United States, 510 U.S. 540, 555-556 (1994) (``Not
establishing bias or partiality * * * are expressions of impatience,
dissatisfaction, annoyance, and even anger, that are within the bounds
of what imperfect men and women, even after having been confirmed as
Federal judges sometimes display. A judge's ordinary efforts at
courtroom administration--even a stern and short-tempered judge's
ordinary
[[Page 49959]]
efforts at courtroom administration-remain immune.'').\5\
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\5\ To make clear, having reviewed the transcript, there is no
evidence that the ALJ conducted himself with anything other than the
temperament which is expected of a judicial officer.
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Nor is the contention made persuasive by the ALJ's having ruled
against Respondent on several issues. As the Supreme Court has further
explained, ``judicial rulings alone almost never constitute a valid
basis for a bias or partiality motion.'' Id. at 555 (citing United
States v. Grinnell Corp., 384 U.S. 563, 583 (1966)). Notably,
Respondent did not challenge any of these rulings in his exceptions.
Finally, the allegation that the ALJ was impermissibly tainted because
the Government sent a letter to the ALJ seeking a subpoena which set
forth that a patient had ``alleged that [he] subjected her to
inappropriate sexual activity,'' ALJ Ex. 10, ignores that in every case
an ALJ is required to read the Order to Show Cause and the allegations
contained therein (as well as other documents such as pre-hearing
statements which disclose what a potential witness may testify to). A
judge, however, is presumptively able to distinguish between what is an
allegation and what has been proved with evidence.
I therefore hold that the ALJ properly denied Respondent's recusal
motion. I further note that when Respondent sought injunctive relief on
the same issue in the District Court, the Court denied the motion.
Findings of Fact
Respondent currently holds DEA Certificate of Registration
AM9742380, which authorizes him to dispense controlled substances in
schedules II though V as a practitioner.\6\ ALJ Ex. 6, at 10. While
Respondent's registration was to expire on January 31, 2008, on
December 18, 2007, Respondent filed a renewal application. Because
Respondent's renewal application was timely filed, in accordance with
the Administrative Procedure Act, I find that Respondent's registration
has remained in effect pending the issuance of this Decision and Final
Order. See 5 U.S.C. 558(c).
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\6\ In accordance with 5 U.S.C. 556(e), I have taken official
notice of the registration records of the Agency pertaining to
Respondent. In accordance with this provision and DEA's regulation,
Respondent ``is entitled * * * to an opportunity to show the
contrary'' by filing a motion for reconsideration within twenty (20)
days of the date this order is served by being placed in the mail.
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Respondent holds a physician's license issued by the State of Utah
and is a board-certified orthopedic surgeon. RX 12. Sometime around
2001, Respondent underwent cardiac bypass surgery, which apparently
resulted in damage to his hand. Tr. 1307. Thereafter, Respondent
gradually reduced the number of surgeries he performed, and in 2006,
ceased performing surgeries altogether. Id. at 1308-09. As his surgical
practice decreased, Respondent commenced seeing chronic pain patients,
id., and by February 2007, eighty-five percent of his practice involved
pain patients. Id. at 504, 1307.
According to P.E., his former office manager, who had worked for
him from March 1986 until February 2007, Respondent, as a pain
management doctor, was seeing an average of 90 to 100 patients a day,
and he would see the patients for three to five minutes each. Id. at
506-07. See also id. at 1583 (testimony of Investigator that T.S., an
employee of Respondent stated during an interview that Respondent ``saw
between 85 and 90 patients per day'' and that he ``did not perform any
physical examinations'' because he was a pain management doctor). By
contrast, Dr. Perry Fine, who testified for Respondent as an expert in
pain management, stated that in an eight-hour day (with a 30-minute
lunch break), he could see ``maybe 24, 30 patients at the most.'' Id.
at 782. P.E. further testified that it ``was not part of the routine
procedure'' to take the patient's vital signs ``on each visit'' and
that when there was ``a lull in the patient flow,'' Respondent would
``pick up the charts and write the prescriptions before the patients
arrived.'' Id. at 513; see also id. at 538 & 542 (testimony of former
employee J.N.).
DEA initiated an investigation of Respondent upon receiving
information from the Box Elder Narcotics Strike Force, which had, in
its own investigation, interviewed several individuals, conducted
several undercover operations, and determined that Respondent was
issuing unlawful controlled substance prescriptions. Id. at 940-41; see
also 21 CFR 1306.04(a). In addition to interviewing several former
patients of Respondent, DEA executed search warrants on or about June
5, 2008, and on January 22, 2009, when it obtained various patient
records. Tr. 1065. DEA also obtained the cooperation of two persons
(M.R. and K.D.), who agreed to perform undercover visits with
Respondent. Id. at 942, 944.
The four undercover visits of M.R. occurred on October 9, November
27, December 24, 2007 and January 29, 2008. The four undercover visits
of K.D. occurred on November 3, November 24, December 1, and December
22, 2008. In addition there was a recorded telephone conversation
between K.D. and Respondent on November 20, 2008. During the course of
the investigations, DEA Investigators obtained various patient records
which were entered into evidence. Before proceeding to analyze the
evidence pertaining to the specific patients, a review of the parties'
evidence regarding what practices satisfy the longstanding requirement
of Federal law that a prescription ``must be issued for a legitimate
medical purpose by an individual practitioner acting in the usual
course of his professional practice,'' 21 CFR 1306.04(a), is warranted.
The Parties Evidence Regarding the ``Usual Course of Professional
Practice''
Both parties put on extensive evidence on the issue of whether
Respondent's prescriptions were issued in the usual course of
professional practice and were for a legitimate medical purpose. Dr.
Bradford D. Hare testified for the Government, and Dr. Perry Fine for
Respondent.\7\ Both Drs. Hare and Fine also submitted written
affidavits, regarding their reviews of the medical files of additional
patients as well as the requirements for writing legitimate
prescriptions for controlled substances under Federal and State law.
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\7\ Dr. Lynn Webster, although qualified as an expert witness in
medicine and pain medicine, did not present substantial testimony on
pain medicine and testified only about the death of Respondent's
patient D.W.
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Dr. Bradford D. Hare, who has practiced medicine since 1975, is an
anesthesiologist who is board-certified in pain medicine and has nearly
thirty years of experience in the specialty of pain management. Tr. 34-
35. Dr. Hare holds both an M.D. and a Ph.D. in pharmacology, which he
received from the University of Utah. Id. at 35; GX 23, at 1. At the
time of the hearing, Dr. Hare practiced pain management at the
University of Utah's Pain Treatment Center, where he is also the
Director of the Fellowship Program at the University's Pain Management
Center.\8\ Tr. 37; GX 23, at 2. He also holds the positions of Vice
Chairman of Pain Management Services, Department of Anesthesiology, and
Associate Professor of Anesthesiology and Pharmacology, both at the
University of Utah. GX 23, at 2. Dr. Hare has published extensively in
professional journals and in book chapters, and has made numerous
presentations on pain management. GX 23, at 12-25. He also serves as a
consultant to the Utah Division of
[[Page 49960]]
Professional Licensing (DOPL) and currently is a member of its
Diversion Committee. Id. at 2-3. Dr. Hare was qualified as expert
witness in pain management practice in Utah and in prescribing
controlled substances in pain management practice. Id. at 40-41.
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\8\ Dr. Hare continues to see patients two days a week and also
teaches on the clinical staff of the University of Utah Operating
Room Anesthesiology Staff. GX 23, at 5; Tr. 37.
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Dr. Hare testified that Utah has adopted the Federation of State
Medical Boards May 2004 Model Policy for the Use of Controlled
Substances for the Treatment of Pain (hereinafter, Model Policy), the
essential provisions of which are set forth below.\9\ Dr. Hare
testified that in the usual course of professional practice, prior to
prescribing a controlled substance for treating pain, a patient
presents a medical complaint which the physician then evaluates. Id. at
43-44. According to Dr. Hare, the evaluation and proper diagnosis
requires both taking a medical history and performing a physical
examination. Id. at 44.
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\9\ The Model Policy states that:
The Board will consider prescribing * * * controlled substances
for pain to be for a legitimate medical purpose if based on sound
clinical judgment. All such prescribing must be based on clear
documentation of unrelieved pain. To be within the usual course of
professional practice, a physician-patient relationship must exist
and the prescribing should be based on a diagnosis and documentation
of unrelieved pain.
GX 9, at 3. The Model Policy then states that ``[t]he Board will
judge the validity of the physician's treatment of the patient based
on available documentation, rather than solely on the quantity and
duration of medication administration.'' Id.
With respect to evaluation of a patient, the Model Policy
provides that:
A medical history and physical examination must be obtained,
evaluated, 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 pain on physical and psychological
function, and history of substance abuse. The medical record also
should document the presence of one or more recognized medical
indications for the use of a controlled substance.
Id.
As for the physician's treatment plan, the Model Policy states:
The written treatment plan 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.
After treatment begins, 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.
Id. at 4.
The Model Policy also states that ``[t]he physician should
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. Continuing, the Model Policy states that ``[o]bjective
evidence of improved or diminished function should be monitored * *
*. If the patient's progress is unsatisfactory, the physician should
assess the appropriateness of continued use of the current treatment
plan and consider the use of other therapeutic modalities.'' Id.
Finally, the Model Policy states that ``[t]he physician should
keep accurate and complete records to include[:] 1. the medical
history and physical examination, 2. diagnostic, therapeutic and
laboratory results, 3. evaluations and consultations, 4. treatment
objectives, 5. discussion of risks and benefits, 6. informed
consent, 7. treatments, 8. medications (including date, type, dosage
and quantity prescribed), 9. instructions and agreements and 10.
periodic reviews.'' Id.
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Taking the medical history includes asking the patient questions
about what causes the pain, when did it occur, what treatments the
patient has had, and what things alleviate or increase the pain. Id.
The history should also include the patient's ``medication history''
and any ``history of substance abuse'' as required by the Model Policy.
Id. at 54. Moreover, the patient's medical records should be obtained
and reviewed. Id. at 46.
Dr. Hare testified that the physical examination includes taking
the patient's vital signs, blood pressure, temperature, and heart rate;
listening to the patient's heart and lungs; performing a neurological
examination, which ``involves checking reflexes * * * [and] the
sensation particularly from one side of the body to the other'' and
which merges into the musculoskeletal examination; and a
musculoskeletal examination, which is used to determine the patient's
strength and whether he/she has lost strength due to the complaint. Id.
at 49-51. Dr. Hare further testified that even if a patient brings her
medical records to the initial visit, and those records show that
another physician has recently performed a physical exam, a physician
should still conduct his own examination because he might make
different findings than the previous physician or find that a new
problem has developed. Id. at 52. However, the physician need not
repeat diagnostic tests such as x-rays, MRIs and labs. Id. at 53.
The diagnosis ``dictate[s] the type of treatment that [was] most
appropriate.'' Id. at 44-45. For instance, there are various types of
pain such a neuropathic, diabetic neuropathic, and musculoskeletal. Id.
While ``there are some types of pain where opioid medications are a
primary type of treatment[,] [t]here are other types of pain [such] as
neuropathic pain * * * where one would not start with * * * opioids.''
Id. Moreover, musculoskeletal pain ``responds best to physical therapy
* * * better than pain medicine.'' Id.
Dr. Hare stressed that the Model Policy requires certain
documentation for using controlled substances to treat pain with
controlled substances, such as a proper medical history which includes
a patient's history of substance abuse and information regarding prior
medications. Id. at 54. Dr. Hare also testified that in the ``usual
course of professional practice for pain management,'' a physician must
document in the patient's medical record the steps discussed above
``prior to issuing a controlled substance prescription.'' Id. at 55. He
further testified that the ``usual course of professional practice''
includes establishing a treatment plan at the first visit, as well as
asking the patient for a pain rating which is typically done using ``a
zero to ten scale'' and which is repeated at subsequent visits. Id. at
56-57.
To evaluate the effectiveness and appropriateness of the treatment
plan, at follow-up visits, the physician should ask whether the
prescribed treatment, including any medications, helped, and whether
the medication is causing side effects. Id. at 56-58. A physician
should document the patient's response to these questions; if the
physician decides to change the medication, the reason for the change
should be documented. Id. at 58-59. Moreover, if the patient develops
additional problems such as anxiety or the inability to sleep, the
physician should document the problem, the treatment plan for the
particular problem, and the reason for prescribing any additional drug.
Id. at 59. While Dr. Hare testified that it is ``never appropriate
under * * * any circumstances'' for a physician to touch a patient in a
sexual manner, he then added that ``there could be the situations where
there's a romantic involvement, but * * * just like in any other
professional setting, if something like that would occur, it has to be
put out in public.'' Id. at 60.
Dr. Perry Fine is a physician who is board-certified in
anesthesiology, and holds subspecialty certifications in pain
management as well as hospice and palliative care. Id. at 614; RX 11,
at 1. Dr. Fine is a professor of anesthesiology at the University of
Utah and is also on the faculty of its Pain Research Center. Tr. 610.
After completing a residency in anesthesiology at the University of
Utah and a pain medicine fellowship at the University of Toronto, he
joined the faculty of the University of Utah. Id. at 611. At the time
of the hearing, Dr. Fine served on the Board of Directors of both the
American Academy of Pain Medicine and the American Pain Foundation. Id.
at 615. He has also published extensively on pain management and
anesthesiology and has done numerous presentations. RX 11, at 9-57. Dr.
Fine was also qualified
[[Page 49961]]
as an expert in pain management practice and prescribing. Tr. 611-12.
Based on some of the records he reviewed, Dr. Fine maintained that
Respondent's ``prescribing practices * * * were done in the usual and
customary routine of a physician-patient relationship,'' id. at 622,
whatever that means. Dr. Fine testified that, based on the evidence he
reviewed, Respondent ``saw these patients * * * in a professional
medical environment. He'd established a relationship with them, with
recurrent visits and follow-up appointments, to evaluate the effective
therapy, and to fulfill the obligations of prescribing controlled
substances.'' Id. He also maintained that in several of the cases he
reviewed, Respondent had consulted with other clinicians and that his
``interpretation of that is that certainly met with approval within
that local community standard.'' Id. at 624. Dr. Fine also testified
that there is ``no'' test for pain, and that ``[t]here are really only
two ways to evaluate whether a patient has pain or not. One is what
they tell you, and the other is by behaviors.'' Id. at 627-28. Dr. Fine
then explained that there are ``a number of tools we use to try and
have patients rate their pain intensity,'' including ``verbal
descriptor scales, numerical scales, [and] pictorial scales.'' Id. at
628.\10\ He also maintained that what a patient tells a physician is
``certainly a large component of what constitutes * * * at least on a
first-run basis, what we would consider to be the most valid or
reliable indicator of a patient's pain experience.'' Id.
---------------------------------------------------------------------------
\10\ According to Dr. Fine, behaviors are used to assess pain in
``pre-verbal children or mentally incapable children or adults, or
in patients with advanced dementing illness who can't verbally
report.'' Tr. 628.
---------------------------------------------------------------------------
On cross-examination, Dr. Fine acknowledged that in the ``usual
course of professional practice'' in pain management, ``the patient
presents with * * * an essentially, a compelling case, based upon their
history and physical findings, and whatever corroborating laboratory or
imaging studies may be required, depending upon the patient's
circumstances.'' Id. at 704. Moreover, ``within the course of their
professional conduct,'' the physician must make ``a reasonable effort
to * * * try and understand what risks there might be of misuse, abuse,
diversion, addiction, tolerance, dependence, all the various
pharmacological and sort of social responsibility issues that come with
prescribing.'' Id. at 704-05. A treatment plan is then initiated which
``is appropriate to the level of risk, and monitors that patient
accordingly.'' Id. at 705.
While Dr. Fine acknowledged that obtaining and documenting a
patient's history is part of the usual course of professional practice
for prescribing a controlled substance, he then maintained that ``in
the usual course of medical education, the details of the pain history
are not spelled out under law, so much as spelled out under best
practices.'' Id. at 706. Continuing, he maintained that ``what we hope,
of course, is that best practices become standard over the course of
time'' but then claimed that ``for physicians'' in the middle of their
careers, ``the opportunity to inculcate that level of skill or
expertise simply has been lacking.'' Id. He then asserted that while
``ideally, and under best practices,'' the ``usual course of
professional practice'' requires that ``a medical history documents
activities that [the patient reports] exacerbate or mitigate the
pain,'' this is ``not necessarily so.'' Id. at 707. He then maintained
that in a medical record, ``you would rarely see a line item that said
what exacerbates the pain, what relieves the pain.'' Id. at 708.
Continuing his answer, Dr. Fine then stated that physicians ``might
describe the pain in other ways. They may give it a numerical score.
They may just say the patient has pain; they may not even say that.''
Id. When then asked if the usual course of professional practice
requires documenting the frequency and intensity of the reported pain,
he responded, ``That's highly desirable. I teach that; I wish everybody
did it * * * . It's simply not yet the standard of care.'' Id.
As to Utah's adoption of the Model Policy as part of its
regulations, Dr. Fine opined that ``I think it holds up a standard that
would be desirable * * *. But very few physicians in the State would
make that grade.'' Id. at 708-09. When asked whether the CSA's ``usual
course of professional practice'' standard is an objective standard or
what most physicians do, Dr. Fine answered:
I think it's a desirable standard that's been put forth for very
good reason, and supported by people who have expertise in pain
medicine and want to both optimize the health and well-being of
individual patients, and limit the * * * adverse consequence of
problematic prescribing. But I daresay that in terms of in practice,
how it's actualized, we could not call that standard in the way * *
* [i]n a tort sense, what constitutes a standard of practice in the
community, in the region, in the nation.
Id. at 709.
However, when asked whether it would be in the usual course of
professional practice ``if most physicians prescribe controlled
substances without ever performing a physical exam,'' \11\ Dr. Fine
answered that ``it is certainly a requirement, in terms of meeting
reasonable standards of practice and standards of care, that some form
of physical examination in proportion to or pursuant to the problem in
front of the physician'' be done. Id. at 710-11. Dr. Fine then
acknowledged that documenting the findings of a physical exam is part
of the usual course of professional practice. Id. at 712. However, he
then maintained that, notwithstanding the Model Policy's statement that
``the effect of pain on physical and psychological function'' should be
documented, this is only ``a highly desirable evaluative point. But not
necessarily what most people do most of the time.'' Id. He then
asserted that the ``usual course of professional practice'' standard
does not ``get[] to that granular a level.'' Id. at 713.
---------------------------------------------------------------------------
\11\ While this question is not very clear, Dr. Fine's answer
was clear.
---------------------------------------------------------------------------
When asked whether the ``usual course of professional practice''
required documenting a patient's history of substance abuse, Dr. Fine
acknowledged that ``a history of substance abuse, active addiction, * *
* chemical dependency, or known diversion is highly problematic'' and
that there is ``a professional obligation to at least acknowledge
[that] and have a plan that manages that.'' Id. at 713-14. He also
acknowledged that the ``usual course of professional practice''
requires that a physician document in a patient's medical record one or
more recognized medical indications for prescribing a controlled
substance. Id. at 714.
Dr. Fine further testified that a physician's recitation of a
patient's complaint does not, by itself, constitute a diagnosis. Id. at
725. While he then acknowledged that the usual course of professional
practice requires that a physician document a diagnosis before
prescribing a controlled substance, he then maintained that ``chronic
pain is a legitimate diagnosis, for which there is no corroborative
test other than what the patient says'' and that a physician ``is under
absolutely no obligation to rule out every single potential cause of
that problem.'' Id. In his affidavit, Dr. Fine further stated, ``[i]n
large part, chronic pain diagnosis and treatment relies on a patient's
self-reporting to the physician, and a doctor is absolutely entitled to
rely on the patient's self-report of pain.'' RX 36, at 3. He also
stated:
It is my medical opinion that an experienced orthopaedic
surgeon, such as [Respondent], who had seen a patient routinely over
a period of time, would not necessarily need to conduct a
comprehensive
[[Page 49962]]
physical examination or exhaustive work-up on every visit from the
patient during the maintenance phase of treatment. Much of the
diagnosis and treatment of chronic pain involves observational
analysis by the physician including affect and pain related behavior
during interview, watching the patients' [sic] gait, ability to sit
down, ability to get up, ability to ambulate, etc.
Id.
Dr. Fine also testified that with chronic pain, ``the diagnosis * *
* oftentimes sound[s] like it came out of the patient's mouth.'' Tr.
726. He maintained that this is justified because the ``International
Classification of Diagnoses'' \12\ includes a code for ``arm pain''
even though ``there could be a hundred different causes of arm pain.''
Id. However, Dr. Fine then admitted that while ``arm pain'' could be a
diagnosis, the physician would have to do a physical exam and, in his
own words, ``before you do that, you take more history'' before
prescribing a controlled substance. Id. at 726-27.
---------------------------------------------------------------------------
\12\ Apparently, Dr. Fine was referring to the International
Classification of Diseases, a publication of the World Health
Organization.
---------------------------------------------------------------------------
As to the usual course of professional practice for follow-up
visits, Dr. Fine testified that in his own practice, he utilizes ``the
four As'' to evaluate his patients and that this is ``what we teach''
to doctors around the country. Id. at 764-67. He further testified that
these guidelines were published some four to five years earlier, id. at
767, and they were now ``very commonly used.'' Id. at 764. ``The four
As'' stand for ``analgesia, activities, adverse effect, [and] aberrant
drug-related behaviors.'' Id. at 765. Dr. Fine clarified that
``analgesia'' means ``analgesic efficacy''; that ``activities'' is
``really about [a patient's] functional capacities''; that ``adverse
effects'' are the effects caused by taking a controlled substance; and
``aberrant behavior * * * would include anything that indicated misuse,
abuse, drug-seeking behavior, * * * missed appointments * * * not
following through with recommendations for physical therapy, behavioral
therapy, [and] referrals.'' Id. at 765-66.
When then asked whether it is ``the usual course of practice to
fail to ask a patient about the efficacy of [an] opioid that is being
prescribed over a period of four months, when [the physician] see[s]
that patient each month?''; Dr. Fine answered: ``I can't speak to DEA
requirements. I would say that it certainly would be a reasonable
expectation in the course of conventional medical practice.'' Id. at
768-69. He then acknowledged that during at least one of the follow-up
visits, he would expect the physician to ask his patient if the
medicine was helping, if her pain had worsened, if there were any
activities which increased her pain, and if anything reduced her
pain.\13\ Id. at 769.
---------------------------------------------------------------------------
\13\ Dr. Fine testified that a physician is not obligated to see
a patient every time that he writes a controlled substance
prescription for her. Id. at 757.
---------------------------------------------------------------------------
As to whether the ``usual course of professional practice''
included documenting a change to an existing controlled-substance
prescription, Dr. Fine testified that ``[i]t's recommended'' and that
``it would be a good practice.'' Id. at 722. However, he indicated that
he would ``have trouble elevating [that] to an absolute requirement or
necessity.'' Id.
As to whether, when a patient presents a new pain complaint, the
``usual course of professional practice'' requires obtaining the
history of the injury and performing a physical exam on that area, Dr.
Fine stated that ``[t]aking * * * a reasonable history and examination
of any new problem would be considered a reasonable practice * * *
[t]hat's necessary * * * to do a professional job as a doctor.'' Id. at
724. However, the physician could ``refer the patient to someone else
if [the condition is] beyond [his] expertise.'' Id. Here again, the
evaluation should ``include a history, physical examination and
laboratory tests or imaging studies,'' although Dr. Fine maintained
that the ``obligation is not to do any of those * * * with any rigor
outside of the necessity of making that which is necessary to make a
reasonable diagnosis.'' Id. at 724-25.
After acknowledging that it would be a ``sign of doctor-shopping''
if a pharmacy called and reported that a patient had filled ``the same
exact prescription for Oxycontin from two other doctors in the last
week,'' Dr. Fine stated that ``in our practice, we run'' DOPL (State
prescription monitoring) reports ``as a matter of course,'' and do so
even if there is no concern that a particular patient is seeking drugs
from other physicians. Id. at 718-19. Dr. Fine testified that if a
report showed that a patient is getting a controlled substance from
multiple physicians, it ``may be'' an indication of doctor shopping,
but the report ``doesn't signal a diagnosis or a conclusion in and of
itself.'' Id. at 719. He later testified that checking the DOPL
database when regularly prescribing large amounts of opioid analgesics
would ``reflect best practices, but a minority, a small minority of
practitioners * * * were using the database on a regular basis.'' Id.
at 813.
As to whether ``it is in [the] usual course of professional
practice'' to discuss with a patient why she is seeking a refill before
a prior prescription should have run out, Dr. Fine testified that a
physician should ``inquire, to try and understand the motivation for
that.'' Id. at 721. He also acknowledged that if a patient routinely
seeks early refills with no explanation, this is a ``red flag'' for
diversion or abuse. Id. He also acknowledged that if a physician
obtains information that a patient is sharing controlled substances
with others, the ``usual course of professional practice'' requires the
physician to address the issue with the patient. Id. at 721-22.
Dr. Fine agreed that the ``usual course of professional practice''
included, in the event of a documented history of overdose, that the
physician should be ``taking certain steps to ensure that narcotics are
not going to be * * * abused.'' Id. at 738. However, he also indicated
that where the documented history indicated an overdose from methadone,
it would not necessarily signal an addiction but could instead be
simple misuse of medication or an accident: ``Again, it's a
differential diagnosis.'' Id. at 737. He did agree that, if a physician
knew of an overdose event and did not include it anywhere in the
patient's medical record, this would not be in the ``usual course of
professional practice.'' Id. at 745-46.
The Government then asked Dr. Fine several hypothetical questions
regarding the propriety of a physician prescribing to a patient with
whom he engages in sexual relations. Dr. Fine testified that it is not
within the ``usual course of professional practice'' for a physician to
``invite a patient to a motel room for a topless massage,'' and after
giving her a topless massage, to issue her a prescription for a
controlled substance. Id. at 751. Although he initially answered ``no''
to the question whether it would be outside of the course of
professional practice to go to the home of his patient, have her take
off her clothes, digitally penetrate her vagina, and then issue her a
controlled substance prescription, Dr. Fine eventually acknowledged
that it is also not within the usual course of professional practice to
continue to issue controlled substances to this person. Id. at 753.
As a follow-up, the Government asked Dr. Fine whether, if it was
true that Respondent had engaged in the above described acts, this
would change his opinion as to whether Respondent's ``prescribing of
controlled substances was in the usual course of professional
practice?'' Id. at 762-63. While Dr. Fine
[[Page 49963]]
answered ``yes,'' he then stated: ``[b]eyond that, it would require far
more granularities towards understanding the relationship.'' Id. at
763. While Dr. Fine did not have ``much favorable'' to say ``about
sexual impropriety,'' he then stated ``my personal opinions are not
what matters. What matters is what really happened, and what the
standards are as viewed by the Code of Ethical Conduct within the
jurisdiction. And that would not be viewed as within the Code of
Ethical Conduct.'' Id. Dr. Fine then acknowledged that he would change
his opinion about the propriety of Respondent's prescribing of
controlled substances to the person he had met at a hotel room and
given the topless massage to (and on another occasion, digitally
penetrated) if these events did, in fact, occur. Id. at 763-64.
While the ALJ acknowledged his ``impressive credentials,'' the ALJ
found that ``Dr. Fine's testimony was marked by a significant level of
consistent equivocation regarding the appropriate standards.'' ALJ at
83. More specifically, the ALJ observed that although Dr. Fine
``acknowledg[ed] that State law and regulations inform[ed] his expert
opinions, [his] testimony reflected a persistent, intentional
reluctance to explain the correct standard of care and patient file
documentation.'' Id. The ALJ further noted that while Dr. Fine was
``repeatedly and directly queried about the correct practices in clear
and concise terms, [he] consistently declined to provide direct
answers.'' Id. at 87. Continuing, the ALJ explained that ``[f]or hours
on the witness stand, Dr. Fine adhered to the logically inconsistent
position that although he teaches correct standards of care and has
even created mnemonic tools to assist practitioners in remembering
them, these standards are * * * only some sort of best-practices
guidelines based on his anecdotal awareness that some practitioners may
fall below the proper standard.'' Id. Relatedly, the ALJ found that
``[w]hen repeatedly queried about the proper standard [for] prescribing
medications and documenting patient files, he persistently answered
with variations upon a theme that there are substandard physicians
practicing medicine who do not adhere to the correct standard.'' Id. at
88-89.
As the ALJ also noted, when asked to give an opinion (based on his
review of the transcripts of the undercover visits) as to the propriety
of Respondent's prescribing during these visits, Dr. Fine testified
that he ``discounted them as not being particularly useful,'' and that
without video recordings of the visit, he really could not compare what
happened with ``what was documented [in the patient's record] as
supposedly occurring on that date''; and he therefore could not draw
any ``further conclusions.'' Id. at 878-79.
As the ALJ found, Dr. Fine ``intentionally avoid[ed] direct answers
that did not favor the Respondent's position.'' ALJ at 88. Moreover,
the ALJ found that Dr. Fine's testimony was ``evasive'' and ``bias[ed]
in favor of assuming the correctness of the actions of any doctor.''
Id. at 90. Having personally observed Dr. Fine's testimony, the ALJ
findings are entitled to substantial deference. See Universal Camera
Corp. v. NLRB, 340 U.S. 474 (1951). His conclusion that Dr. Fine's
testimony should be given less weight than Dr. Hare's is well supported
by the record. ALJ at 90.
The Patient Specific Evidence
M.R.
M.R. was a patient of Respondent from May 2004 through January 29,
2008. GX 25, at 21, 34. At her initial visit, M.R., who was then
twenty-three years old, presented with ``wrist pain.'' Id. at 34. Under
the heading ``PHYSICAL EXAM,'' the record reads as follows: ``She has
wrist pain. Neurologically intact.'' \14\ Id. According to the M.R.'s
record, at this visit Respondent recommended that she use ibuprofen.
Id.
---------------------------------------------------------------------------
\14\ Respondent frequently employed the phrase ``neurologically
intact'' in his patients' progress notes. According to Dr. Fine this
means that Respondent could have performed a number of types of
tests or alternatively made some rather casual observations to make
this determination:
In the most specific sense of the word, you would do a very
detailed examination of the cranial nerves. Motor findings, for
which there are many, many different tests. Anything from gross
muscle-strength testing to electromyography.
Sensory examination, which in fact may include multiple
modalities. And coordination. Those would be the main * * *
contributors.
On the other--that's at the most micro-level. At the macro-
level, it simply might be the observation--for instance, my standing
here observing you, and having interacted with you, saying to the
best of my ability, you are neurologically intact.
Tr. 732.
---------------------------------------------------------------------------
At the hearing, M.R. testified that the wrist pain she reported was
false and that she simply went to Respondent to obtain prescriptions
for Lortab (a schedule III controlled substance which contains
hydrocodone and acetaminophen, see 21 CFR 1308.13), which she had used
recreationally ``off and on,'' because she liked ``the buzz'' and ``the
high'' and wanted to ``have that high all the time.'' Tr. 272-74. M.R.
had previously received Lortab prescriptions from a Dr. D. of Logan,
Utah. Id. at 274. She apparently obtained prescriptions from Dr. D. and
Respondent at the same time and was ultimately discharged from Dr. D.'s
practice for doctor-shopping. Id.
According to M.R., Respondent's initial physical examination of her
consisted solely of his grabbing both of her wrists and holding them
for about ten seconds, after which he handed her a prescription. Id. at
272. M.R. indicated that Respondent did not ask about the severity of
her pain or do any further examination such as a range-of-motion test
or take an x-ray. Id. at 273. As noted above, the medical record for
the visit indicates only that she would use ibuprofen, a non-controlled
drug. GX 25, at 34. However, the medical record indicates that at
M.R.'s second visit (June 23, 2004), Respondent diagnosed her as having
``BILATERAL WRIST PAIN,'' with his physical examination finding that
she had ``diffuse tenderness over the dorsum of the wrist'' and also
``low back pain where she had an epidural.'' Id. On this date, although
the current medication is listed as ibuprofen, the ``PLAN'' indicated
that M.R. ``was given a refill of LORTAB 7.5 (60).'' Id. (emphasis
added).
M.R. testified that Respondent never discussed alternative
treatments to the use of opioids, although the record of the initial
visit and every visit thereafter, indicates that M.R. was to ``continue
conservative treatment.'' Id. at 275; GX 25, at 21-34. M.R. also
testified that, while she complained of wrist pain two or three times,
she ``never really'' had to ``mention anything, just walk in and he'd
give [me] a refill. He didn't ask.'' Tr. 277. M.R. further testified
that a bit later she complained of back pain to Respondent, but this
pain was also a feigned condition; M.R. also admitted that she was
engaged in drug-seeking behavior. Id. at 277, 282. At the time,
Respondent had her stand, bend over, and then stand up straight again,
in a sequence that perhaps lasted ten seconds. Id. at 277. At the third
visit, however, Respondent increased both the strength and quantity of
the Lortab to 90 tablets of 10 mg. strength. GX 25, at 34.
In M.R.'s medical record, bilateral wrist pain was reported as the
diagnosis through September 20, 2006. GX 25, 26-34. In this period,
Respondent prescribed Lortab, as well as both Xanax (alprazolam) and
Valium (diazepam), which are schedule IV controlled substances (see 21
CFR 1308.14(c)); the progress notes for the visits, however, contain no
indication of a new medical complaint or diagnosis which supported
prescribing either Xanax or Valium. See id. at 26-29.
The entry for October 18, 2006, indicated that M.R.'s chief
complaint
[[Page 49964]]
was ``bilateral wrist pain.'' Id. at 26. Under the Physical Exam
heading, Respondent indicated only that ``she continues to have
bilateral wrist pain and chronic low back pain. She is having low back
pain.'' Id. Respondent indicated his ``IMPRESSION'' as both Bilateral
Wrist Pain and Low Back Pain and issued a refill for Lortab 10 mg. He
also prescribed Valium. Id. at 26. Respondent also indicated that he
would get ``x-rays of the low back on her return.'' Id.
The entry for the next appointment (November 20, 2006), replicated
verbatim the entry for the previous visit with the exception of the
statement regarding x-rays, which was not included. Id. However, there
is no indication that x-rays were obtained. See id. The entry for
M.R.'s December 20, 2006 visit was identical to that of November 20
except for the notation that Respondent would no longer prescribe
Valium. Id.
The entry for the following visit, January 15, 2007, listed both
wrist pain and low back pain under ``IMPRESSIONS,'' and under
``PHYSICAL EXAM,'' noted that ``[s]he continues to have low back pain.
She has diffuse tenderness L4 to S1. She is also having wrist pain.''
Id. at 25. However, the entry for M.R.'s next visit, February 12, 2007,
completely omitted all mention of wrist pain. Id. Moreover, it repeated
verbatim the notation under the physical exam section of January 15,
adding only the adjective ``chronic'' before ``low back pain'' in both
the diagnosis and physical exam sections. Id. The same complaint,
physical exam, and impression are repeated for subsequent visits until
March 29, 2007, when Respondent added to the physical exam findings
that M.R. was ``neurologically intact'' and indicated as his impression
both ``CHRONIC LOW BACK PAIN'' and ``DEGENERATIVE DISC DISEASE
LUMBOSACRAL SPINE.'' Id. at 24. At this visit, Respondent also resumed
prescribing Valium for M.R. Id.
Between March 29, 2007, and January 29, 2008, M.R. saw Respondent
eight times. The progress notes for these visits contain the same
complaint, history, physical exam findings (although the last three
visits also added ``degenerative disc disease'' to this section),
impressions, and treatment plan (invariably 90 tablets of Lortab 10
with one refill and ``she will continue conservative treatment'' and
``will follow up as needed'').\15\ Id. at 21-24.
---------------------------------------------------------------------------
\15\ Under the entry for M.R.'s last visit (January 29, 2008),
there is a handwritten notation which states: ``5-25-08 I will no
longer see pt. DCM'').
---------------------------------------------------------------------------
M.R.'s medical record contains two signed Controlled Substance
Contracts, one dated March 29 (with no year indicated) and another
dated December 10, 2005. Id. at 4, 19. Although not identical, both
contracts stated that controlled substances ``have a high potential for
misuse, addiction, and are closely controlled by the State and Federal
government.'' Id. Both contracts also included a paragraph stating that
the patient understands that if she violates the contract, ``treatment
may be terminated'' and that the violation ``may also be reported to
other physicians, medical facilities and legal authorities.'' Id. The
contracts also included a clause by which the patient promised to
``help'' herself through ``better health habits such as exercise,
weight control, minimal use of alcohol and to stop smoking.'' Id. The
record also contained entries in the progress notes to the effect that
Respondent asked M.R. if she was obtaining controlled substances from
other physicians on three occasions, February 27 and April 3, 2006, and
also February 12, 2007. Id. at 25, 28, 29.
M.R. estimated that at 95% of her appointments with Respondent, he
just issued her a prescription without any discussion of her medical
condition. Tr. 286. With respect to her purported back condition, M.R.
testified that ``I just told him that my back hurt.'' Id. at 279. When
asked whether Respondent had physically examined her back, M.R.
answered: ``One time he did have me stand up and then just bend over,
and I was standing straight back up again. That was it. Nothing more
than that ever.'' Id. M.R. further explained that the exam lasted
``[n]o longer than 10 seconds. Long enough to stand up, bend over, and
stand back up again.'' Id. Moreover, Respondent took neither x-rays nor
ordered other diagnostic tests of her back. Id. at 280. Indeed, M.R.
testified that she ``didn't really need to complain'' to Respondent
about having back pain, ``because he didn't ask if you were in pain.''
Id.
As for the Valium prescriptions, M.R. testified that ``[t]he first
time I got them, I'm sure I asked for them. But after that he just
asked if I needed a refill and I'd say yes and I'd get my refill. That
was it.'' Tr. 285.
At the time that M.R. agreed to wear a wire on undercover visits
for DEA, she had been charged with six felony counts of obtaining
prescriptions under false pretenses. Id. at 302-03. M.R. acknowledged
that she had worn the wire hoping to reduce the charges, which were
eventually dismissed. Id. at 291-92. The ALJ found M.R.'s testimony
``credible insofar as it describes the manner in which Respondent
interacted with her during their treatment relationship and during the
times he prescribed controlled substances to her.'' ALJ at 13. Here
again, the ALJ personally observed M.R. testify and was in the best
position to observe her demeanor. Moreover, having reviewed the
recordings and transcripts of M.R.'s undercover visits, I find that
they support her credibility. Accordingly, I adopt the ALJ's
credibility findings with respect to M.R.\16\
---------------------------------------------------------------------------
\16\ In his exceptions, Respondent argues that I should reject
M.R.'s testimony (and the ALJ's credibility finding with respect to
her) because: (1) She violated her controlled substance contract in
which she agreed not to seek drugs from other doctors, (2) ``she
could not remember specifics from'' an undercover visit which had
occurred only one year earlier but could remember whether he had
performed physicals exams at visits which occurred four years
previously, (3) that she had been charged with six felony counts,
and that after she assisted the investigations, the charges were
dismissed and that she ``has everything to gain by testifying for
the DEA, and motive to falsely implicate'' him, and (4) that she
admitted under oath that she lied to Respondent about being in pain
in order to obtain narcotics. See Resp. Exceptions at 11-16.
Respondent's contentions ignore that the ALJ observed M.R.
testify and was thus able to observe her demeanor. In any event, his
first and fourth reasons beg the question of what one would expect a
drug-seeking patient to do. More importantly, as discussed in my
legal conclusions, it is clear that at a certain point Respondent
clearly knew that M.R. was not a legitimate patient and cannot claim
to have been duped.
As for the contention that she could not recall ``specifics''--
a reference to whether Respondent asked her a particular question at
one of the undercover visits--that a witness does not remember every
single aspect of a year-old conversation does not render her entire
testimony incredible. Finally, as for the contention that M.R. had
reason to lie about Respondent because she was facing six felony
counts, similar arguments are made to the factfinder (whether judge
or jury) in nearly every criminal case and appellate courts rarely
find them reviewable, let alone persuasive. In addition, much of her
testimony is supported by the transcripts of the undercover visits.
I thus reject his exceptions to M.R.'s testimony.
---------------------------------------------------------------------------
M.R.'s Undercover Visits
On October 9, 2007, M.R. made her first undercover visit to
Respondent, and brought along a DEA undercover officer (UC) who used
the cover name of ``Rebecca.'' See GX 10, at 10. The visit began with
M.R. asking Respondent to ``see'' Rebecca. Id. Respondent said he would
require a referral from Rebecca's ``regular doctor'' and that he would
also require ``old records.'' Id. However, after declining to see her,
he asked, ``what do you need to come in for?'' Id. at 10-11. The UC
stated that a Dr. Stack had been giving her medications in May or June
but that she ``can't get it from him anymore,'' that she couldn't
``function without'' the medication, and that at present she has ``been
just having to kinda rely on friends to help [her] out.'' Id. at 11.
After the UC stated that she
[[Page 49965]]
had gotten Lortab and OxyContin from Dr. Stack, Respondent asked her
whether she had insurance and whether she had a job. Id. Respondent
then stated that because the UC did not ``fit the * * * rules,'' she
was not his ``first choice'' as a patient. Id. Continuing, he stated
that he was ``not a hundred percent opposed trying to help'' the UC and
added that ``there's no way [the UC] can afford OxyContin'' without a
job or insurance. Id. at 11-12. Respondent told the UC to get a job,
``then give us a call, and we'll see if we can help.'' Id. at 12. A bit
later he commented that without the UC having a job or insurance, it
would be ``irresponsible'' for him to prescribe OxyContin. Id. at 12-
13.
Immediately thereafter, the UC said, ``I do have money today. Could
you do a Lortab for me today?'' Id. After doing an apparent double-
take, Respondent insisted that the UC needed to make an appointment,
get a referral and bring her records before he could prescribe for her.
Id.
Although M.R. had no interaction with Respondent other than in her
effort to refer Rebecca, she emerged from the appointment with a
prescription for ninety Lortab 10mg. GX 14, at 1. Her medical record
for that date indicates the Lortab prescription, with one refill. GX
25, at 22. While the record also bears the previously noted refrain
used by Respondent for his physical examination findings--``She has
chronic low back pain. She has diffuse tenderness L4-S1. Neurologically
intact''--nothing in the transcripts or recording indicates that
Respondent conducted a physical examination of her back that would
reveal tenderness. See id. Moreover, the recording and transcripts make
clear that Respondent never asked about M.R.'s pain level, medical
condition, side effects from the medication or whether M.R. was
continuing with whatever ``conservative treatment'' he had noted in the
numerous progress notes.\17\
---------------------------------------------------------------------------
\17\ As his treatment ``PLAN,'' the record for this visit reads
(as many entries do), that M.R. ``will continue conservative
treatment'' and that she ``will follow up as needed.'' GX 25, at 22.
---------------------------------------------------------------------------
At the second undercover visit (November 27, 2007), Respondent
asked M.R., ``How are you today?'' GX 11, at 3. M.R. replied, ``Good.
How are you?'' Id. Respondent did not inquire about M.R.'s pain, and
there is no evidence that he performed a physical examination although
he indicated having done so in M.R.'s medical record. GX 25, at 22.
Respondent asked M.R., ``You want a refill again?''; she replied:
``Yeah.'' GX 11, at 3. M.R. then mentioned her friend Rebecca and asked
whether, if she provided information on her job and insurance,
Respondent could issue a prescription for her. Id. at 3-4. Respondent
declined, saying that ``[t]he law requires her to have a face-to-face
with the doctor.'' Id. at 4.
M.R. then stated that she ``ended up having to share a little bit
with [Rebecca] last time my prescription.'' Id. After M.R. asked
whether that was ``okay to do?''; Respondent answered: ``It's against
the law.'' Id. M.R. then asked, ``Oh, is it?'' Respondent replied:
``Just don't, uh, don't tell me about it.'' Id.
M.R. again asked for a prescription for Rebecca, this time offering
$140, but Respondent stated: ``No, it's * * * not a money thing, it's
the law thing.'' Id. at 5. Later, Respondent said that he ``wouldn't
mind seeing'' the UC, but then he remembered that she had gone to Dr.
Stack, who ``poisoned a lot of people [and is] in jail.'' Id. at 6-7.
Respondent commented that ``anybody that's * * * been coming from that
office, we've been staying away from.'' Id. at 7. Again, without any
discussion of M.R.'s medical condition or any apparent physical
examination, M.R. emerged from the appointment with a prescription for
ninety Lortab 10mg. GX 14, at 2.
At M.R.'s third undercover visit (on December 24, 2007), Respondent
opened the visit by noting that she was in after only one month, but
that after this visit, he wanted her to not come back for two months
because he was giving her a prescription plus a refill. GX 12, at 3, 9.
Respondent then asked, ``Lortab ten?'' and M.R. answered, ``Yeah.'' Id.
After the sound of paper tearing from a pad, Respondent asked, ``You
been doing okay?'' Id. M.R. replied, ``Yeah. I'm doing good.'' Id. at
4, 9. After Respondent and M.R. exchanged Christmas greetings,
Respondent concluded the visit and told M.R. to ``[t]ake care.'' Id. at
4, 9-10. Once again, without any meaningful inquiry regarding her pain,
Respondent issued M.R. a prescription for ninety Lortab 10mg., with one
refill. GX 14, at 3. M.R.'s patient record does not record a visit for
December 24, but an entry for December 20, 2007 carried over the
information from the prior visit verbatim, including the description of
a physical exam. GX 25, at 22.
On the fourth undercover visit (January 29, 2008), Respondent began
the appointment by asking, ``How are you today?'' GX 13, at 8. M.R.
answered, ``Good. How are you?'' Id. Respondent said, ``Good,'' then
asked ``Lortab, ten 90?'' and ``You want a refill on it?'' Id.
Respondent inquired whether M.R. was ``getting pills from any other
doctor'' and whether she was ``abusing them, selling them, [or] buying
them?'' Id. When M.R. responded in the negative, Respondent further
asked whether M.R. was ``doing anything illegal?''; she answered,
``No.'' Id. at 9. Respondent never inquired about her pain level, about
side effects, or about her functional capacity, and the recording does
not indicate that a physical examination was performed, yet M.R.
emerged from the visit with another prescription for ninety Lortab 10s
and one refill. GX 14, at 4. Respondent also never mentioned that M.R.
was back a month earlier than he had indicated for her, yet he wrote
another prescription for a controlled substance with one refill. M.R.'s
medical record for that date again repeats verbatim the record from the
prior visit, including a physical exam that found ``diffuse tenderness
L4 to S1.'' GX 25, at 21.
Dr. Hare reviewed both M.R.'s medical record and the transcripts of
the visits; his opinion was set forth in a letter which was entered
into evidence. See GX 44. Dr. Hare noted that at M.R.'s initial visit,
``[n]o history was obtained at that time, even in regards to the
occurrence of the wrist pain and its characterization.'' GX 44, at 1.
He also noted that ``[n]o further tests were ordered and the physical
examination was only that she was `neurologically intact,' no details
of any neurological exam were listed.'' Id. Dr. Hare remarked that
about one month after the initial Lortab 7.5 prescription, Respondent
increased M.R.'s prescription from 60 to 90 tablets and the strength to
Lortab 10mg. ``with no indication of benefit from the prior
prescriptions.'' Id. Moreover, ``[e]ven though the pain apparently
persisted unchanged, no further tests were ordered.'' Id. According to
Dr. Hare, while the note indicated that M.R. was ``told to continue
`conservative treatment' * * * this was not initiated by [Respondent]
nor described by him, i.e. immobilization, ice, etc.'' Id.
With respect to M.R.'s February 27, 2006 visit, Dr. Hare found that
``the note for bilateral wrist pain is essentially the same with the
exception that the patient is said to be on Valium 5 mg. but [there] is
no indication that she had been previously prescribed this medication
by Dr. MacKay. At the time of this visit though, she was given a
prescription for Valium 5 mg. tablets.'' Id. Moreover, at the next
visit, Respondent indicated that M.R. was taking Valium 10 mg. and gave
her a prescription for this strength of the drug. Id. at 2.
Dr. Hare then observed that on May 24, Respondent switched M.R.
``from Valium to Xanax, even though there was no description of the
reasons for the
[[Page 49966]]
Valium previously.\18\ There was no follow up as to efficacy and there
was no reason for switching to Xanax.'' Id. Dr. Hare then noted that
M.R. ``remained on Lortab and Xanax throughout the next several visits
but then was switched back to Valium on August 30, 2006 for reasons
that aren't described and no diagnosis is included.'' Id.
---------------------------------------------------------------------------
\18\ In testimony, Dr. Hare indicated that Valium was an anti-
anxiety drug which could be used as a muscle-relaxant for a few days
to a week. Tr. 146. Xanax is also an anti-anxiety drug but a
``shorter acting, shorter lasting drug than Valium.'' Id. at 147.
---------------------------------------------------------------------------
Next, Dr. Hare noted that on January 15, 2007, M.R.'s chief
complaint changed from wrist pain to low back pain, and on subsequent
visits the wrist pain (which she had purportedly complained of for
nearly three years at that point) was no longer a problem. Id. As for
M.R.'s complaint of back pain, Dr. Hare observed that:
there is no additional physical examination other than describing
``tenderness'' to define this problem nor were there any other tests
such as x-rays, MRI's, or other diagnostic tests done to better
understand this complaint. The patient was just treated with
continuing doses of Lortab as had been previously prescribed for
wrist pain. With the substitution of Low Back Pain, the notes
otherwise seem to be largely the same as they were when the patient
had wrist pain.
Id.
Dr. Hare then explained that the March 29, 2007 ``note indicated
that the patient has `degenerative disc disease, lumbosicral [sic]
spine' and yet there is no physical exam or other diagnostic tests done
to identify this as a problem. This diagnosis remains in his notes
throughout the remainder of his care for her.'' Id. Dr. Hare also
observed that ``[f]rom March 29, 2007 through January 29, 2008 the
clinic notes are almost identical, verbatim. There is no apparent
change in her condition and there is no indication that she is getting
any benefit from [Respondent's] treatment. There is no further testing
of any sort done nor are any consultations sought despite the
persistence of pain.'' Id.
Dr. Hare concluded that neither M.R's. complaint of bilateral wrist
pain or low back pain ``was adequately evaluated.'' Id. He further
explained that ``[n]o history was obtained, inadequate physical
examination was done, no tests were ordered to better understand these
problems and despite the lack of information [Respondent] chose to
treat these problems aggressively with controlled substances.'' Id. at
2-3. Dr. Hare concluded that ``the continuing prescriptions of
controlled substances were not warranted.'' Id. at 3.
As for Respondent's recordkeeping, Dr. Hare observed that:
[Respondent's] clinic notes appear to be computer generated,
basically ``rubber stamped,'' or ``fill in a blank,'' type notes
that do not really reflect the patients [sic] change in condition.
There is no indication that the patient was getting any benefit from
[Respondent's] treatment [and] there is no indication of updated
physical examinations or further evaluations for the above described
problems. Without some indication that the patient has improved with
treatment, there is not justification for the continued prescribing
of controlled substances. The clinic notes reflect a number of
inaccuracies in terms of current medications and previous
prescriptions, another indication that these notes were computer
generated and did not necessarily reflect the patient's current
status.
Id. (emphasis added).
Ultimately, Dr. Hare concluded that Respondent's evaluation of M.R.
``was inadequate to justify the prescribing of controlled substances
for her conditions.'' Id. Noting that there was no medical
justification in M.R.'s chart for the benzodiazepines (Valium and
Xanax) Respondent prescribed, Dr. Hare observed that ``that there can
be dangerous and detrimental interactions between Benzodiazepines and
Opioid medications'' such that, absent any description that would
``justify the prescribing of Valium and Xanax,'' Dr. Hare concluded
that Respondent's prescribing was ``below the standard of care for the
evaluation of the patient for the above described medical conditions
and the treatment he prescribed.'' Id.
In his testimony, Dr. Hare explained that in the usual course of
professional practice, a physician documents the reasons for a change
from one benzodiazepine to another (e.g., a switch from Valium to
Xanax, or vice versa), yet M.R.'s patient record has no such
documentation. Tr. 148. He also testified that the physical examination
and history were not consistent with the usual course of professional
practice, which requires more detail. Id. at 157. He further noted that
there was a DOPL report in M.R.'s file for January to April 2007, which
showed that she was also receiving hydrocodone (Lortab) from Dr. D. (as
found above), yet Respondent apparently did not alter his prescribing
practice for her. Id. at 161-63. He testified that he ``did not believe
the medical records support the long-term prescribing of controlled
substances to this patient'' and that there was ``insufficient
evaluation for both her wrists and her low-back problems to allow such
prescribing.'' Id. at 164.
Dr. Fine did not offer any testimony specific to M.R. even though
he reviewed her patient file and the transcripts of her undercover
visits. Tr. 619 & 872. As found above, Dr. Fine was unwilling to
express an opinion on the validity of Respondent's prescribing to M.R.
during the undercover visits because he was unable to view ``a full
audiovisual recording of these visits [and] compare them to the
[patient] records.'' Id. at 878-79. He indicated that without knowing
the context of the physician-patient relationship he just couldn't
``make sense out of'' the transcripts. Id. at 875.
I conclude that Dr. Fine's testimony is patently disingenuous. As
did the ALJ, I find credible Dr. Hare's testimony regarding
Respondent's prescribing to M.R.
K.D.
K.D. first saw Respondent in November 2004, complaining of a neck
injury that was caused by a July 2003 auto accident.\19\ GX 26, at 118.
Previously, a Dr. M. had diagnosed her as having cervical spine disease
and a pinched nerve. Tr. 345. K.D. testified that at her initial visit,
Respondent did not take her heart rate, blood pressure, or weigh her,
and he performed no physical examination beyond looking at her neck.
Id. at 349; 345-46. Moreover, he did not ask about the severity of her
pain or order diagnostic tests such as x-rays. Id. at 346, 348.
According to K.D.'s records, Respondent found that ``[s]he has diffuse
pain in the neck areas, into the shoulders and headaches[,] * * *
diffuse tenderness in the cervical spine C3 to C7[,] * * * tenderness
in the trapezius area[,]'' and that she was ``neurologically intact.''
GX 26, at 118.
---------------------------------------------------------------------------
\19\ On cross-examination, K.D. clarified that she had
experienced more than three months of pain prior to consulting
Respondent. Tr. 441.
---------------------------------------------------------------------------
In contrast to K.D.'s testimony, Respondent noted in her record
that ``[x]-rays of the cervical spine taken are essentially normal with
some straightening and loss of the lordotic curve.'' Id. He then
diagnosed her as having ``cervical strain July 2003 motor vehicle
accident with flare up residuals.'' Id. Respondent indicated that
K.D.'s treatment plan would include ``physical therapy''; he also
prescribed 60 Lortab 7.5 mg. (hydrocodone), 60 Soma, 60 Fioricet, and
indicated that she would ``continue conservative treatment'' with a
``follow up in three weeks.''\20\
---------------------------------------------------------------------------
\20\ The progress notes for K.D's first three visits list her
name as ``Terri'' rather than Kerri, the name which is used
throughout the rest of this voluminous record. See generally GX 26.
It is further noted that the cover of the file is labeled with the
type-written name of Terri, with the letter K handwritten over the
T. No argument has been raised that these progress notes were for a
different patient.
---------------------------------------------------------------------------
[[Page 49967]]
As early as her third visit, K.D. reported that ``her prescriptions
and purse [were] stolen.'' Id. at 117. Respondent then gave her a new
prescription for 60 Lortab. Id.
Respondent treated K.D. with various narcotics which, over the
course of his prescribing to her, were of increasing strength and
quantities. More specifically, through September 2006, Respondent
usually prescribed Lortab; however, at some visits he prescribed
Percocet 5 mg., or Percocet 10 mg., which are schedule II controlled
substance containing oxycodone. GX 26, at 113-118. However, on November
6, 2006, Respondent gave her a prescription for sixty tablets of
OxyContin 40 mg.; he also noted that ``[t]he METHADONE made her itch to
the point that she could not tolerate it over the weekend.'' Id. at
108. Yet there is no indication in her record that he had previously
prescribed methadone for her.
At the next visit, Respondent refilled her OxyContin 40 mg.
prescription and gave her a prescription for Lortab 10. Id. at 107.
Subsequently, he wrote more prescriptions for OxyContin 40 mg. and
Percocet 10 mg., although at times he indicated that the latter was for
hydrocodone 10/325, a different controlled substance. Id. at 105-06.
Subsequently, on March 9, 2007, Respondent stopped writing Percocet
prescriptions and started issuing prescriptions for oxycodone 15 mg.
(as well as OxyContin 40 mg.). Id. at 104. This prescribing pattern
generally continued through the course of K.D.'s visits with
Respondent. Id. at 91-105. However, in July 2007, Respondent gave her a
prescription for Demerol, another schedule II controlled substance. Id.
at 102. Moreover, in November 2007, Respondent again increased the
quantity of oxycodone IR (from 120 tablets of 15 mg. strength to 90
tablets of 30 mg. strength, which was eventually increased to 120
tablets). On various occasions, he also gave her prescriptions for
Lortab. In addition, Respondent prescribed several schedule IV
controlled substances to K.D. including Ambien, Xanax and Valium. Id.
at 91-98, 100-01; Tr. 348.
K.D. testified that Respondent did not ask her about her pain at
every visit and that, if her pain was discussed, it was because she
raised the subject and not because Respondent asked her about her pain
or its severity. Id. at 348-49. She further testified that Respondent
never performed physical examinations at subsequent visits and that she
received at least one controlled substance prescription per visit. Id.
at 349.
At an appointment in the summer of 2006, K.D. asked Respondent
about getting a referral to a physical therapy practice with a masseuse
on its staff. Id. at 360. Respondent asked K.D. if she ``would like a
massage'' and then asked for her cell phone number. Id. at 350. He then
stated that he would get a motel room in another town, and call for
her. Id. Several weeks later, Respondent called K.D. and told her where
to meet him. Id.
On or about September 23, 2006, K.D. met Respondent at the motel
and, after entering his room, removed both her top and bra. Id.
Respondent massaged her for 30-45 minutes. Id. at 351. After K.D. put
on her clothes, Respondent explained that because he had diabetes he
was unable ``to perform certain sexual activities.'' Id. at 351. He
then took out his prescription pad and asked her ``what prescriptions
[she] needed.'' Id. Respondent then gave her a prescription for ninety
tablets of Percocet 7.5 mg., a schedule II controlled substance. Id.;
see also GX 39 (prescription signed by Respondent dated September ``9-
25-06'').\21\ Not surprisingly, K.D. and Respondent did not discuss her
pain or medical condition. Id. at 353.\22\
---------------------------------------------------------------------------
\21\ The label attached by the dispensing pharmacy indicates,
however, that the prescription was actually filled on September 23,
2006. GX 39.
The Government also entered into evidence a confirmation
receipt, which showed that Respondent took a room at the Bestrest
Inn, a motel in Ogden, Utah, on September 23, 2006, see GX 16; motel
personnel told a DEA Investigator that Respondent had purchased the
room for that night. Tr. 1146. An Investigator further testified
that K.D. had provided investigators with an account of the visit
that was generally consistent with the layout of the motel. Id. at
1019. The Government also entered into evidence a floor plan of the
hotel, on which K.D. identified the room she had been in with
Respondent as one of four rooms. GX 15; Tr. 1019-21.
\22\ K.D.'s medical record has entries for September 22, 24, and
25, 2006. The September 22 entry indicates that a prescription for
ten Lortab 10s was called in to a pharmacy. GX 25, at 109. The
September 24 entry indicates that K.D. ``called over the weekend
needing more medication. She was given a prescription for PERCOCET
7.5/500 mg. (90), AMBIEN 10 mg. (30) and FIORCET (60).'' Id. The
entry for September 25 indicates that ``[p]atient failed to show for
appointment.'' Id. A DOPL report for KD for the period shows only
that she filled a prescription from Respondent for hydrocodone 10
mg/APAP on September 22 and a prescription from Respondent for
Endocet 7.5 on September 23, a drug which is the same formulation as
Percocet. GX 37, at 3.
---------------------------------------------------------------------------
K.D. also met Respondent on four or five other occasions ``at a
friend's house.'' Id. at 354. During each encounter, Respondent again
gave her a massage and afterward, gave her a controlled substance
prescription. Id. at 354, 355. Prior to one of these encounters, which
occurred in March 2008, K.D. called Respondent to tell him that she was
back in town and wanted more drugs. Id. at 355. Respondent agreed to
meet K.D. at her friend's house after he got off from work, and upon
meeting her, asked her if she ``would like a full body massage.'' Id.
K.D. agreed and removed all of her clothes and laid down on a bed. Id.
After massaging her upper body and legs, Respondent rubbed her
vaginal area and digitally penetrated her. Id. at 356. After five
minutes or so of this latter activity, K.D. faked an orgasm to end the
session. Id. K.D. got dressed, and Respondent then gave her a
prescription for oxycodone IR 30 mg., as well as $75 to $100 ``to
fill'' her prescription. Id. at 357; GX 38, at 1 (signed RX). K.D. then
filled the prescription. Id. at 358. During the encounter (as well as
the others that occurred outside of Respondent's office), there was no
discussion of her condition or her pain. Id. at 361.
K.D. testified that she agreed to the March 2008 meeting so she
``would get [her] pain medication.'' Id. at 396. She also stated that,
while she had regular appointments at which she obtained medications,
she agreed to meet Respondent outside of his office to obtain
additional narcotics. Id.
K.D.'s medical record does not reflect either an office visit or
the issuance of a prescription as having occurred on March 10, 2008,
the date of the prescription. Rather, her record contains an entry for
January 31, 2008, during which K.D. reported that she was ``moving out
of state to take care of her mother'' and ``will not be coming back,''
and at which Respondent indicated that his physical exam found that
``[s]he has chronic low back pain'' with ``diffuse tenderness L4 to
S1,'' ``degenerative disc disease'' and was ``[n]eurologically
intact.'' GX 26, at 98. Respondent gave her prescriptions for both 150
oxycodone IR (30 mg.) and Ambien. Id. K.D.'s record then contains an
entry for an office visit which occurred on April 9, 2008, during which
Respondent again found that she had ``chronic low back pain'' and
``diffuse tenderness L4 to S1.'' Id. at 97. At the visit, Respondent
gave her prescriptions for sixty tablets of OxyContin 40 mg., 120
tablets of oxycodone IR (30 mg.), 30 tablets of Ambien, and Fioricet.
Id. at 97.
K.D.'s medical record contains a letter from Respondent to her,
dated December 20, 2007, which stated that she had told Respondent that
her insurance company would not approve her OxyContin prescription. GX
26, at 50. Respondent wrote that ``we gave you
[[Page 49968]]
Methadone to try and help you,'' \23\ but the ``State of Utah reported
that [the OxyContin prescription] was indeed filled at WalMart Pharmacy
in Harrisville.'' Id. Respondent wrote, ``This represents an abuse
situation and I will no longer be able to see you.'' Id. However, as
found above, Respondent continued to prescribe controlled substances to
K.D. notwithstanding this incident and did so on numerous occasions
thereafter.\24\
---------------------------------------------------------------------------
\23\ This prescription is reflected in an entry of December 13,
2007, in which Respondent wrote, ``That prescription was torn up by
a pharmacist instead she was given methadone, 10 mgs.'' GX 26, at
55, 99. K.D. testified that she had used up her OxyContin too
quickly so Respondent was going to give her methadone; she had not
reported to Respondent that the prescription was torn up by the
pharmacist. Tr. 377.
\24\ K.D. testified that Respondent never told her that he was
dismissing her from his practice; rather, he told her that she must
use just one doctor. Tr. 379.
---------------------------------------------------------------------------
K.D.'s medical record also contains a January 23, 2008 fax from the
Box Elder Narcotics Task Force. Id. at 43-49. The fax included a
document, which stated that K.D. was obtaining controlled substances
from five prescribers (and twelve different pharmacies), as well as a
DOPL report for the period of December 20, 2006 to December 20, 2007,
which showed the same. Id. at 43, 46-49. In another fax, which is dated
January 25, 2008, Respondent wrote to the Box Elder Narcotics Strike
Force that: ``We talked about her. I did talk to her as per our
conversation. She promises 1 doctor, 1 pharmacy, as of the first part
of Jan. Let's monitor her closely for [indecipherable].'' Id. at
42.\25\
---------------------------------------------------------------------------
\25\ Another DOPL report, dated April 8, 2008, showed that K.D.
filled a prescription from Respondent for various controlled
substances from Respondent including oxycodone on March 10, 2008, as
well as for Ambien (Zolpidem), which was written by another
physician. GX 26, at 41.
---------------------------------------------------------------------------
K.D.'s medical record contains a signed Controlled Substances
Contract, which is dated September 23, 2005. Id. at 36. While one of
the terms of the contract was that Respondent would not replace a
prescription which was ``lost, misplaced, stolen or * * * use[d] up
sooner than prescribed,'' id., K.D. testified that on May 12, 2008,
where the medical record indicated that her medications had been
stolen, Respondent restricted her to using one pharmacy. Id. at 380; GX
26, at 97. According to K.D., ``I had run out of my medication early,
and I called [Respondent] and told him. And he instructed me to make a
false police report, and tell the police that my medication had been
stolen, and to bring that.'' Tr. 381; see GX 43 (police report of May
12, 2008).\26\
---------------------------------------------------------------------------
\26\ K.D.'s medical record also indicates that Respondent
discussed with her whether she was getting narcotics from other
physicians and/or more than one pharmacy on six occasions: August
24, 2005; February 1 and November 6, 2006; February 5 and March 5,
2007; and January 16, 2008. Id. at 54, 61, 63, 65, 69-70, 72.
However, given the numerous instances in which Respondent falsified
records, these notations are of questionable accuracy.
---------------------------------------------------------------------------
In addition, K.D. testified that there were several falsifications
in her medical record. While an entry for July 11, 2008, indicates that
K.D. was having a ``right knee scope by a physician in Ogden'' and that
she received another thirty tablets of oxycodone 30 mg. IR from
Respondent, K.D. testified that she never had arthroscopic surgery on
her right knee and that she had neither knee problems nor complained of
such. Tr. 375-76. Moreover, while many of the notes for her visits list
her chief complaint as ``chronic low back pain,'' GX 26, K.D. testified
that she has never suffered from chronic low back pain and never told
Respondent that she did. Tr. 374. While K.D. maintained that some of
the prescriptions she obtained from Respondent were necessary to treat
her pain, she maintained that she used a ``huge percentage'' of them
``for recreational use.'' Id. at 391-92.
K.D. became addicted to pain medication, id. at 392, and asked
Respondent to take her off of OxyContin and give her methadone instead.
Id. at 393. Respondent, however, told her that methadone hurts people,
and he continued to write her prescriptions for OxyContin. Id.
On four occasions in November and December 2008, K.D., who had
agreed to cooperate with DEA Investigators, visited Respondent while
wearing a recording device. With regard to these activities, K.D.
testified that nothing was promised her in exchange for her testimony,
and that, at the time of the hearing, she was incarcerated in a county
jail for violating her probation which had been imposed because she had
violated a protective order involving her ex-husband. Id. at 390-91.
Moreover, while K.D. was generally required to give the
Investigators the prescriptions she obtained, after the first
undercover visit (November 7, 2008), the Investigator had her go into a
pharmacy and fill a prescription for oxycodone 40 mg. Tr. 1064. The
pharmacy, however, only partially filled the prescription. Id. While
K.D. turned over the drugs to the Investigators, she later went back
and filled the rest of the prescription without telling them. Id.
K.D. also admitted that in November 2008, she had sold on the
street seventy tablets of OxyContin for $2400, which she had obtained
using a prescription issued by Respondent.\27\ Id. Moreover, on cross-
examination, K.D. admitted that after the visit on December 22, 2008
(during which she received a prescription for 120 tablets of oxycodone
IR 30 mg.), she called Respondent's office, told them she had lost the
prescription, and obtained a replacement which she then filled.\28\ Id.
at 408; see GX 37 (DOPL report), at 9. K.D. stated that she considered
this prescription to be ``legitimate,'' because she was having pain
that day. Tr. 406. The following week, K.D. was given a drug test which
she flunked. Id. at 1171. She was re-incarcerated and DEA stopped using
her as an informant.\29\ Id.
---------------------------------------------------------------------------
\27\ DEA learned of this in January 2009, apparently from K.D.
Tr. 1142. As of the hearing, the matter had not been further
investigated or referred to either Federal or State prosecutors. Id.
at 1142-43.
\28\ K.D. was then residing in a work-release facility. Tr.
1141.
\29\ The ALJ provided an extensive explanation for why he found
K.D.'s testimony credible. ALJ at 28-31. Among other things, the ALJ
noted that other evidence corroborated her testimony regarding the
March 2008 encounter at the motel.
It is disturbing that K.D. was able to obtain an extra
prescription from Respondent which she apparently sold on the street
while she was cooperating with the investigation. However, K.D.
freely admitted having done so during her testimony. Again, the ALJ
personally observed K.D.'s testimony and found her testimony to
generally be credible. I find no reason to reject this finding. See
Resp. Exceptions at 26.
---------------------------------------------------------------------------
K.D.'s undercover visits were recorded; the recordings along with
transcripts for three of the visits were admitted into evidence by the
Government. On November 3, 2008, after an initial discussion regarding
a domestic violence incident with her ex-husband, Respondent asked
K.D.: ``Now, are you getting pills from other doctors?'' GX 19, at 6.
K.D. answered, ``No, I've been in Kansas.'' Id. She indicated that for
the past two months she had ``been in a lot of pain.'' Id. at 7. After
replying ``I'll bet you have,'' Respondent asked, ``What do you want to
do?'' Id. K.D. said, ``I want my, all my--I need all my meds. I need my
oxycontin, my [roxicet], my juraset.'' After a brief discussion of
whether her insurance company had approved the OxyContin, Respondent
asked: ``Okay, so you want--got you down for 40 mg., 90 of them?'' Id.
K.D. answered affirmatively. Id. Respondent than asked: ``And then what
else?'' Id. at 8. K.D. told him 120 Roxicet 30 mg., 60 Fioricet, and
Ambien. Id. at 8. Continuing, K.D. complained that ``I can't believe
you forgot this, this is just not cool * * * You forgot what I take.''
Id. Respondent asserted that, to the contrary, ``I make the patient
tell me, to make sure they understand what they're
[[Page 49969]]
getting,'' and added that ``[i]t's just my little trick.'' Id.
Respondent then asked K.D. if she was ``a plant from the police or
the DEA?''; a lengthy conversation ensued in which Respondent
complained that his office had been under investigation for sixteen
months. Id. at 9-12. During this part of the conversation, K.D. asked
if she was going to get in trouble, and Respondent answered: ``Just as
long as you're not abusing drugs. You're not getting narcotics from any
other doctor?'' Id. at 10. He also complained that DEA had ``actually
sent people in with wires'' and had interviewed 100 of his patients to
find out if he was ``selling pills to them.'' Id. at 11-12. Respondent
further asserted that his former partner had ``turned'' him ``in,'' id.
at 12, because he ``sued me, and then to cover up this lawsuit he had
filed against me, * * * he called the DEA in on me.'' Id. at 13. After
venting about the lawyers involved in the suit, id. at 13-14,
Respondent complained that the Government had seized all of his records
and various assets and labeled him a terrorist. Id. at 16. After a
discussion regarding K.D.'s mother, who had been put in an `` `old
folks' home,'' id. at 20-23, the visit ended. During the visit,
Respondent gave prescriptions for 90 tablets of OxyContin 40 mg., 120
tablets of oxycodone IR 30 mg., 30 tablets of Ambien, and 60 tablets of
Fioricet. GX 17, at 1-4. As is clear from the transcript and recording,
Respondent did not physically examine K.D. and did not ask about her
pain level, the efficacy of the previously prescribed medications,
possible side effects, or her functional capacities.
K.D.'s patient record for November 3, 2008, states, however, that
Respondent conducted a physical examination during which he found:
``She has chronic low back pain. She has degenerative disc disease and
diffuse tenderness L4 to S1.'' GX 26, at 92. The record also states
that K.D. ``stated that she has been suffering.'' Id. Finally, the
record states that K.D. ``will continue conservative treatment''
although neither the recording nor the transcript contain evidence that
her continuation of such treatments was discussed. Id.
K.D.'s next undercover visit occurred on November 24, 2008. GX 20.
K.D.'s meeting with Respondent began with a discussion of her insurance
and whether the insurer had approved a full prescription. GX 20, at 4.
K.D. complained that she had ``bought twenty at first, and then, yeah--
they, they held it back first, `cause they only approved that twenty.
And then, I had to go back and call and--twenty a year--which is
complete bulls* * *'' Id. Respondent then asked whether she had gotten
the full prescription; K.D. answered, ``yes.'' Id. Respondent stated
that he could not write a refill in ``less than four weeks'' so that it
would be the first of December before he could again write the
prescription. Id. K.D. insisted, ``I just need my meds.'' Id.
Respondent replied that he could give her sixty oxycodone tablets
instead to carry her through Thanksgiving, and that she could then come
back and he would not charge her for the new prescription. Id. at 4-5.
Respondent then asked: ``And you're not working with the DEA, or
wearing a wire, right?'' Id. at 5. K.D. answered, ``no,'' and
Respondent complained about the ``pressure'' DEA was applying. Id.
Respondent explained that it was this pressure ``that's why I, I just
can't do it. 'Cause the * * * law says * * * four weeks.'' Id. K.D.
then replied: ``Does that mean you're not seeing me no more, either?''
Id. Respondent asked, ``What?'' and K.D. repeated, ``That means you're
not seeing me no more, either? You can't see me no more? Can't talk to
me no more? I can't believe you!'' Id. Respondent replied, ``I can't, I
can't, yeah. It's * * * crazy.'' Id. at 6. K.D. said, ``That's--this is
insane to me,'' and Respondent replied, ``Yeah.'' Id. K.D. stated
``you'll be okay, though. I think''; Respondent answered, ``I think
so'' plus some inaudible comment. Id.
Next, K.D. asked when she had to come back and whether Respondent
would charge her. Id. Respondent stated that while he would bill K.D.'s
insurance he would not charge her a co-pay. Id. Respondent and K.D.
then agreed that her next visit would be ``next Monday,'' which was
December 1. Id.; see also id. at 9. Respondent then affirmed that he
would not charge her the co-pay and added, ``I'll give you sixty of the
oxy 30s to get by and we'll * * * fill everything next week.'' Id. at
7.
The conversation turned to Respondent's dispute with his former
partner and the latter's purported motivation for reporting him to the
Agency. Id. K.D. then made an appointment with Respondent's office
assistant for an appointment on December 1, 2008. Id. at 9. At the
visit, Respondent gave K.D. a prescription for sixty tablets of
oxycodone IR 30 mg. GX 17, at 5.
Once again, K.D.'s medical record indicates that Respondent
performed a physical exam at this visit, during which he found that
``[S]he has chronic low back pain. She has degenerative disc disease
and diffuse tenderness L4 to S1.'' GX 26, at 92. However, neither the
transcript nor the recording of the visit contain any evidence
suggesting that a physical exam was performed. In addition, the
progress note states that K.D. ``denie[d] getting narcotics from any
other physician'' although neither the transcript nor the recording
indicate that Respondent asked her anything of the sort. Id. The
progress note also states that K.D. ``will continue conservative
treatment'' although no alternative form of treatment was discussed in
the course of the visit. Id.
K.D.'s third undercover visit took place on December 1, 2009. After
a few inaudible exchanges between them, Respondent asked K.D., ``today,
what do you need?'' GX 21, at 5. K.D. responded: ``Everything. My
Oxycontin, my Roxicet, my Fioricet, my Ambien, and I have been so
stressed out, so I was going to see if I could get some Xanax, too. I
don't know if I can do that with the Ambien, or if I have to substitute
them.'' Id. Respondent made an inaudible comment, and K.D. indicated
that she was ``going through some sh-t.'' Id. Respondent then asked
her, ``how many Ambien, or, uh, Xanax do you want?'' Id. They settled
on thirty. Id. Respondent then warned K.D. that with Xanax, Ambien,
Klonopin and Soma, she would ``run the risk of over sedating.'' Id.
After K.D. stated that the Christmas holidays stressed her out,
Respondent asked her how she was doing at her job. Id. at 6. K.D.
replied: ``I'm not making any money. I just barely went back to work,
and I am just * * * freaking out * * * I have no more--I have--I'm just
stressed out.'' Id. To this Respondent replied, ``I told you about all
my money, didn't I?'' Id. He then stated: ``They took * * * over a
million dollars from me. And they haven't said anything, or given it
back, or done anything.'' Id. When K.D. asked, ``So I--I can't get
Christmas help from you this year?''; Respondent offered to ``give
[her] every dollar in my wallet, but it's only three dollars.'' Id.
A bit later, Respondent asked K.D. for her ``newest phone number''
and stated that ``if anything goes better for me, I'll * * * give you a
call.'' Id. at 7. K.D. then complained that the back of her neck was
swollen and stated, ``I need a massage.'' Id. Respondent replied,
``Right through there, yeah,'' and K.D. responded, ``That means no more
massages? No more help--at all?'' Id. Respondent laughed. Id. A bit
later, Respondent said, ``Well, let's see if things get any better for
us here.'' Id. at 8.
After Respondent assured K.D. that he would call her if things got
better for him, she asked if one of his employees ``get[s] mad that I
close the door?'' Id. Respondent answered: ``She does. She
[[Page 49970]]
thinks your [sic] doing nasty things in here.'' Id. K.D. replied: ``no,
I would never do that * * * Well, not in the office. That's why she
gets all--yeah, I can tell she does not like that. But I don't like to
talk about my, and your personal business in front--yeah, I mean like
[inaudible.]'' Id. Respondent's reply was inaudible. Id. K.D. then
stated that when she closed the door, the employee ``kind of gave [her]
a dirty look'' and didn't like her ``at all.'' Id. at 9. Respondent
said that his employee did not ``trust'' K.D. and that his ``mother
said never trust anybody with a tattoo.'' Id. K.D. then acknowledged
that she has two tattoos. Id.
Respondent inquired whether K.D. ``still live[d] in that same
place?'' Id. K.D. answered, ``yeah,'' and added that she was going to
be kicked out because the house was being foreclosed on. Id. She then
explained that while her ``stuff'' was still at the house she was
actually ``living at one of those little Budget Inn places.'' Id. at 9-
10. After K.D. and Respondent discussed that neither of them had gone
shopping due to money problems, Respondent said, ``I am going to give
you all the money I have * * * My three dollars.'' Id. at 11. K.D.
noted that this would allow her to get ``two gallons'' of gas and
thanked Respondent, who apparently again complained about the
investigation. Id. K.D. said, ``So you better * * * call me,'' and
Respondent replied, ``We'll win.'' Id. After K.D. told Respondent that
he was ``a friend,'' the two exchanged farewell wishes. Id. at 11-12.
At the visit, Respondent gave K.D. prescriptions for 90 tablets of
OxyContin 40 mg., 120 tablets of oxycodone 30 mg., 30 tablets of Xanax,
and 60 tablets of Fioricet. GX 17, at 6-7. The progress note for this
visit again states that K.D. ``comes in for follow up of chronic low
back pain,'' and that Respondent had performed a physical examination
and found that that K.D. ``has degenerative disc disease and diffuse
tenderness L4 to S1,'' GX 26, at 91, although neither the transcript
nor the recording suggests that Respondent performed even a perfunctory
physical examination. Moreover, the note states that K.D. ``denies
getting narcotics from any other physician'' and that she ``stated that
this controls her pain well'' although neither the transcript nor the
recording provides any evidence that Respondent and K.D. discussed
either issue during this visit. Id. The record also states that K.D.
``will continue conservative treatment'' although no discussion of such
treatments took place in the course of the visit. Id.
On either December 18 or 22, 2008, K.D. made a fourth undercover
visit; an audio recording of the visit was entered into evidence. GX
48.\30\ The ALJ found that this visit shared many of the same
characteristics of the other three visits. ALJ at 24. Respondent asked
K.D. to tell him what she needed, and K.D. requested several controlled
substances. GX 48. K.D. took the opportunity to thank Respondent for a
$250.00 gift.\31\ Id. During the visit, Respondent agreed to postdate
prescriptions for K.D. because of an issue related to her insurance.
Id. The visit ended with Respondent again bemoaning the investigation.
Id.
---------------------------------------------------------------------------
\30\ While the prescriptions Respondent gave K.D. are dated 12-
22-08, on two of them the date of 12-18-08 was crossed out. GX 17,
at 8 & 11. Other evidence suggests that the visit occurred on
December 18, including the discussion of the need to post-date the
prescriptions and K.D.'s patient record. See GX 26, at 91. The
transcript was not entered into evidence. ALJ at 24 n. 41.
\31\ In discussing this visit, the ALJ found that ``[i]n the
Respondent's version of the transcript, K.D. alludes to swelling on
her neck, says she is [in] pain, and makes something of an effort to
induce the Respondent to provide a massage.'' ALJ at 24 (citing RX
13, at 5). It is not clear why the ALJ cited RX 13 as evidence of
the December 22 visit, as he had previously noted that it was a
transcript of the December 1 visit. See id. at n.40. Moreover,
having carefully read RX 13, it is noted that it tracks verbatim,
with only minor differences, the Government's transcript of the
December 1 visit. Compare RX 13 with GX 21. Furthermore, while the
ALJ noted that in the recording of the December 22 visit, K.D.
thanked Respondent for a $250 gift, RX 13 contains no such
discussion. I thus find that RX 13 is a transcript of the December
1st, and not the December 22nd, visit.
---------------------------------------------------------------------------
K.D.'s patient record contains no entry for December 22, 2008. See
generally GX 26. An entry for December 18, 2008, however, shares many
of the features of the other entries, such as a Physical Exam section
that reads: ``She has chronic low back pain. She has degenerative disc
disease and diffuse tenderness L4 to S1. Neurologically intact.'' GX
26, at 91. Consistent with the other undercover visits, the audio
recording reflects no indication that any tests were conducted that
would support any of the findings set forth in the treatment notes. The
note also indicates that K.D. ``denies getting narcotics from any other
physician'' and ``stated this controlled her pain well.'' Id. Again,
however, the recording contains no indication that Respondent and K.D.
discussed how the prescriptions were affecting her pain level and
functionality.
At the visit, K.D. ``was given OXYCONTIN 40 (90), OXYCODONE 30 mg.
IR (120), FIORCET [sic] (60) and XANAX 1 mg. (30).'' Id.; see also GX
17, at 8 (RX for 120 oxycodone IR 30 mg.), 9 (RX for 90 OxyContin 40
mg.), 10 (RX for 30 Xanax 1 mg.), and 11 (RX for 60 Fioricet). The note
also states that ``She will continue conservative treatment.'' Id.
An addendum of the same date states that Respondent wrote ``all
four'' prescriptions for K.D., but that she returned ``stating that she
did not get the ROXICET prescription.'' Id. Respondent wrote, ``I will
give her the benefit of the doubt this time and rewrite the ROXICET. I
will check a DOPL in a few weeks to see if she doubled her prescription
refill.'' Id. As found above, K.D. admitted in testimony that on that
day, she had returned to Respondent's office without telling her DEA
handlers, obtained an additional prescription, which she then filled at
a drugstore across the street from Respondent's practice. Tr. 408.
In a letter of March 25, 2009, Dr. Hare provided an extensive
analysis of Respondent's prescribings to K.D. GX 46. Therein, Dr. Hare
found that Respondent's initial evaluation of K.D. for neck pain
``consisted of a very brief history and a rather superficial
examination,'' in which he stated that she was ``neurologically
intact'' without providing ``details as would be expected of the
neurologic exam (reflexes sensory and strength examination).'' Id.
Respondent prescribed Lortab 7.5 and Soma, as well as Fioricet, which
the patient was reportedly taking. Id.
Dr. Hare noted that at K.D.'s third visit (December 17, 2004),
``the patient reported that her medications were stolen and
[Respondent] promptly reissued her medications.'' Id. Dr. Hare observed
that Respondent saw K.D. at two to three week intervals, yet he
prescribed in a way that would ``suggest one month medication
supplies.'' Id. Next, Dr. Hare observed that in May 2005, K.D. reported
that she had been assaulted by her husband and brought a police report
(GX 26, at 81-82), which indicated that K.D. had a problem with
substance abuse, and yet, despite this and the ``early refills,''
Respondent ``did not seem fazed and continued to prescribe for her
without concern.'' Id. Moreover, ``the next year [Respondent] gradually
escalated her doses and sometime changed from Lortab to Percocet with
no explanation.'' Id.
Next, Dr. Hare observed that on September 11, 2006, K.D.'s chief
complaint changed to low back pain and that ``there is no mention of
her neck pain any longer.'' Id. He also noted that in Respondent's
physical exam findings, ``tenderness in the back [was] substituted for
cervical tenderness.'' Id. He further noted that while oxycodone 15 mg.
was substituted for her previous medications because they (Lortab and
Percocet) were upsetting her stomach, shortly thereafter she was
``again
[[Page 49971]]
receiving Lortab and then * * * Percocet.'' Id. at 2.
Dr. Hare noted that the following month (October 20, 2006), a
handwritten note signed by one of Respondent's staff stated that a
pharmacy had called and reported that K.D. was ``getting multiple
prescriptions from multiple doctors.'' Id. Dr. Hare observed that the
entry for the November 1, 2006 visit indicates that Respondent
discussed the matter with the patient and that K.D. ``claimed this was
a matter of identity theft by a roommate,'' and that on November 6,
2006, Respondent reportedly ``set up a plan for `one physician
prescribing and one pharmacy for refills.' '' Id. Dr. Hare noted,
however, that Respondent ``[i]mmediately began prescribing a
significantly larger dose [sic] the pain medication for her,'' which
``consisted of OxyContin 40'' mg. Id. Dr. Hare also noted that K.D.'s
record stated that methadone was causing side effects but that ``there
is no indication in her notes that she had ever received [m]ethadone
from'' Respondent. Id. Dr. Hare also observed that K.D. saw Respondent
``approximately every three weeks for refills of what were apparently
30 day prescriptions for'' narcotic controlled substances and that
``there were continued incidents of her over using her medications or
early refills for various reasons.'' Id
Dr. Hare next noted that in March 2007, despite K.D's. having
reported re-injuring her neck in a recent motor vehicle accident, the
chief complaint is still listed as low back pain, and there is no
mention of neck pain. Id. On March 9 and 27, Respondent indicated his
concern that K.D. had run out of Percocet early, and, in mid-April,
when K.D. again complained of back pain and that because of an ``
`awful week' '' and `` `extreme pain' '' she had overused her
medication, Respondent gave her new prescriptions which `` `must last
four weeks.' '' Ten days later, K.D. reported her medication as stolen,
and Respondent, indicating that there had been problems in the past,
placed her on probation. Id. Dr. Hare observed that Respondent had also
placed K.D. on probation in November 2006 ``but he does not seem to
recall those past problems.'' Id.
In June 2007, Respondent began to list degenerative disc disease as
a diagnosis ``but he had not done any further evaluation of her that
could confirm such a diagnosis.'' Id. Although K.D. ``complained of
some neck pain, numbness, tingling, and weakness in her arms for about
a two week period, [Respondent] did not perform any additional
neurologic examination which would be appropriate in diagnosing a new
neurologic issue.'' Id. The following month ``there apparently is no
longer any problem with her neck or any neurologic issues.'' Id. Dr.
Hare noted that Respondent had prescribed various drugs including
Demerol (also a schedule II controlled substance) and opined that
``there is really no explanation for these prescriptions in terms of
trying to address a specific problem.'' Id.
Next, Dr. Hare noted that in October 2007, K.D. had again run ``out
of her medications early after about two weeks.'' Id. at 2. Dr. Hare
again observed that an October 11 note referred to refilling a
methadone prescription, but that her record contains ``no indication *
* * that she ha[d] ever been prescribed this medication before and
certainly not in the immediate past.'' Id. at 3. Dr. Hare further noted
that Respondent gave her a prescription for Valium but that ``there was
no explanation for'' this. Id.
Dr. Hare found that in December 2007, K.D. told Respondent that her
insurance company would not cover OxyContin, that a pharmacist had torn
up the prescription, and that she ``need[ed] a different medication.''
Id. Dr. Hare noted that a DOPL report a few weeks later indicated that
K.D. had, in fact, filled that prescription. Id. Dr. Hare noted that in
January 2008, the medical record states that `` `the patient denies
getting refills from other doctors but she has been using several
pharmacies,' '' yet Respondent ``again remark[ed] about putting her on
probation with one doctor and one pharmacy handling her
prescriptions.'' Id. Dr. Hare then observed that ``[t]his is at least
the third or fourth time she is put on probation with no consequence.''
Id.
Next, Dr. Hare observed that an entry for late January indicated
that K.D. ``was moving out of state and * * * will not be coming back
for treatment at his office.'' Id. However, ``[h]e continued to
prescribe for her'' and actually increased the amount of oxycodone and
gave ``no explanation.'' Id. Dr. Hare further noted that Respondent
``was aware of the patient's deception in filling the OxyContin
prescription in December and yet he continued to prescribe for her.''
Id. Dr. Hare also noted that while Respondent sent K.D. a letter on
December 20, 2007, in which he described an ``abuse situation,'' he
continued to see K.D. and prescribed controlled substances to her at
three separate visits in January 2008.
Next, Dr. Hare observed that ``[e]venthough [sic] his records would
indicate that he terminated care with her in January,'' in March 2008,
Respondent again prescribed to K.D. Id. Dr. Hare noted that ``[t]here
are no clinical records for this visit'' (in fact, this prescription
was issued after one of the massage encounters).
Id. Dr. Hare noted that on May 23, 2008, only eleven days after
receiving new prescriptions, K.D. reported that she had run out of her
medications early, and Respondent gave her new prescriptions. Id. Dr.
Hare noted that on May 29, 2008, K.D. again claimed that her
medications were stolen and that Respondent ``state[d] he will see her
early and refill her medications for a month[,] but that they will need
to last that full time.'' The record indicates ``she will not come in
earlier than 30 days or I will not see her again.'' Id. Dr. Hare noted,
however, that there were still more early refills including one for
OxyContin, which occurred only ``17 days after her last prescription.''
Id. at 4.
Dr. Hare then summarized the numerous problems he found with
respect to Respondent's prescribing practices. Id. More specifically,
``[t]here is an inadequate history and physical evaluation to justify
prescribing chronic controlled substance prescriptions and particularly
in escalating amounts.'' Id. Relatedly, when Respondent made a major
diagnosis change from cervical spine pain to low back pain, ``there was
no significant additional evaluation done to try to delineate the
problem or other means for treatment suggested.'' Id.
Moreover, there was frequently no justification in her chart for
prescribing particular drugs and/or Respondent's changing K.D.'s
medications. Id. Nor was there ``documentation or indication of patient
improvement even with dramatic increases in the medications, such as
OxyContin and Oxycodone.'' Id.
Next, there were ``many signs and outright indications'' of overuse
and abuse such as K.D.'s ``reports of stolen medications and other
excuses for early refills on many occasions.'' Id. Moreover, even
though Respondent documented an ``abuse situation,'' he ``ignored these
overt signs of problems * * * and continued prescribing to her without
any apparent concern.'' Id. In addition, Respondent never performed
toxicology screens on K.D. Id. He also never enforced his rule that
``one doctor [was] to prescribe and one pharmacy [was] to fill'' the
prescriptions. Id.
Dr. Hare observed that while Respondent had indicated that K.D.
would ``continue conservative treatment,'' there was no evidence (such
as notes from a physical therapist) that such treatments ``ever
occurred.'' Id. Dr. Hare also found that the progress ``notes are
remarkably identical from visit to
[[Page 49972]]
visit for long periods of time even with inaccuracies, i.e.[,] the
current medications which are listed as Hydrocodone and Fioricet for
many, many months even when the patient has not been on these
medications.'' Id. Moreover, the ``notes do not contain any new
information, such as the response to treatment of the side effects to
the medications, or other important issues.'' Id. Dr. Hare opined that
``[t]his would be consistent with record falsification.'' Id.
In an addendum, Dr. Hare noted that he had reviewed the transcripts
and recordings of K.D.'s undercover visits. Id. at 5. Dr. Hare found
that during these visits, K.D. ``requested medications which for the
most part were granted as written prescriptions.'' Id. Moreover,
``during those visits,'' ``[n]o medical history was obtained [and] no
physical examination was done. The conversations were almost entirely
social [with] little pertaining to patient care.'' Id. Continuing, Dr.
Hare opined that ``[a]s the chart notes for these visits indicate a
physical exam the same as the other notes, this raises the question as
to whether physical exams were ever performed. The notes corresponding
to the recordings are falsified. It is likely the other[] clinic notes
were also falsified.'' Id.
In summary, Dr. Hare concluded that that Respondent's care for K.D.
``was deficient in many parameters,'' that his prescribing of
controlled substances for her was ``done poorly and in a substandard
fashion,'' and his prescribing ``encouraged overuse of medications and
possible diversion of these medications.'' Id. at 4-5. Dr. Hare also
found that ``[t]here was [a] clear indication that the patient was
overusing and likely abusing her medications and yet this never seemed
to deter [Respondent] in his prescribing.'' Id. Finally, Dr. Hare
concluded that, although he ``assume[d]'' Respondent was paid for his
services, ``a deviation from standard care such as this would suggest
other `rewards' for [him] such as drugs or sexual favors.'' \32\ Id.
---------------------------------------------------------------------------
\32\ Dr. Hare also opined that the conversations with K.D.
``became inappropriately personal with her personal phone number and
place of residence given to Respondent'' and that ``[o]n one
occasion he gave her $250 in cash.'' GX 46, at 5. Dr. Hare explained
that ``[t]his would appear to cross the line of professional
behavior and suggest an inappropriate relationship with a patient
receiving controlled substances.'' Id.
---------------------------------------------------------------------------
Based on his review of K.D.'s medical record and the transcripts
and recordings of her four undercover visits as well as her numerous
early refills, lost prescriptions, and stolen prescriptions, Dr. Hare
testified that he was concerned that she was abusing her medications.
Tr. 165-66. He also testified that several times Respondent obtained a
DOPL report which showed that K.D. was using multiple doctors to obtain
controlled substances, and yet in each instance, Respondent reacted as
if it were ``the first time it ever happened, and the whole process
start[ed] over again.'' Id. at 168. Dr. Hare testified that K.D.'s
medical records ``were really quite superficial on the initial
evaluation, very little in the way of history or physical exam was
done,'' there was ``essentially nothing to follow-up to chart her
progress,'' and ``nothing to explain changes in medication.'' Id. at
169. When asked whether the prescriptions were issued ``within the
usual course of professional practice and for a legitimate medical
purpose,'' Dr. Hare testified that ``the evaluation * * * and the
record don't support the long-term prescribing of controlled
substances'' and that ``the records indicate an ongoing problem of drug
misuse, abuse.'' Id.
With respect to the undercover visits, Dr. Hare testified that the
findings of the physical exams were repeated ``verbatim'' and that
there was no indication that Respondent actually performed a physical
examination at ``any of those visits.'' Id. at 173. He also opined that
the long term prescribing of controlled substances was not supported by
a legitimate medical purpose. Id. at 174. He further testified that in
the usual course of professional practice, a physician engaged in pain
management would have done ``an adequate evaluation of the patient to
set the base'' and would have to ``closely monitor the patients'' when
there are ``multiple indications of abuse'' such as in K.D.'s case. Id.
at 175. Moreover, he then opined that if ``the patient didn't comply to
[sic] the plan, then the patient should be discharged from care.'' Id.
at 176.
Although Dr. Fine testified that he had reviewed both K.D.'s
medical record and a letter by Dr. Hare regarding his review of K.D.'s
medical record, Id. at 618, Dr. Fine offered no testimony on direct
examination about his review of K.D.'s record. As he did with M.R., on
cross-examination, Dr. Fine declined to offer an opinion about the
transcripts of the undercover visits claiming he needed a video
recording to put the visit in context. Id. at 873-74. However, in
response to the Government's hypothetical questions regarding the
propriety of prescribing controlled substances to a patient with whom
he had a sexual relationship, he acknowledged that this conduct was
unethical and outside of the usual course of professional practice. Id.
at 763-64.
Other Evidence
Dr. Hare also reviewed the files of ten additional patients of
Respondent--D.W. (GX 47), P.A. (GX 28), J.B. (GX 29), T.D (GX 30), S.G.
(GX 31), J.H. (GX 32), S.J., A.M. (GX 33), S.N. (GX 34), and W.S. (GX
36)--and provided a letter summarizing his review. GX 45. Dr. Hare also
testified about several of these patients individually. Dr. Fine
similarly reviewed Respondent's medical records for these patients,
provided an affidavit that was entered into evidence, and testified
about the results of his review. See RX 36. Moreover, several of the
patients either submitted affidavits in support of Respondent or
testified on his behalf. However, for reasons explained in the
DISCUSSION section of this decision, in light of my findings with
respect to M.R. and K.D., I find it unnecessary to make findings
regarding these patients.
Respondent also submitted nineteen affidavits from fellow
physicians within his community in support of his continued
registration. RX 9. Three of these individuals--Dr. Carlos Dribble, Dr.
Thomas Matthews, and Dr. Richard Dunn--also testified, offering their
opinion that it is in the ``best interest'' of the local community that
Respondent retain his registration. See, e.g., Tr. 1215 (Dr. Dibble);
id. at 1229 (Dr. Matthews); id. at 1246 (Dr. Dunn). However, while
several of the physicians who provided affidavits and two of the
physicians who testified had family members who had been patients of
Respondent, only one, Dr. Beard, had been a patient of Respondent, and
this was years earlier for fractures, and not pain management. RX 9N,
at 28. While these individuals stated that they had referred patients
in the past and would continue to refer patients in the future, none of
their testimony was based on personal knowledge of Respondent's
prescribing practices with respect to M.R. and K.D.
Finally, I further note that Respondent did not testify in this
proceeding.
Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
a registration to ``dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). With respect to a practitioner, the Act requires the
consideration of the
[[Page 49973]]
following factors in making the public interest determination:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id. Sec. 823(f).
``These factors are * * * considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or
a combination of factors, and may give each factor the weight [I]
deem[] appropriate in determining whether a registration should be
revoked.'' Id.; see also Volkman v. DEA, 567 F.3d 215, 222 (6th Cir.
2009). While I must consider each factor, I am ``not required to make
findings as to all of the factors.'' Volkman, 567 F.3d at 222; see also
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v.
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).\33\
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\33\ As I recently explained, ``this is not a contest in which
score is kept; the Agency is not required to mechanically count up
the factors and determine how many favor the Government and how many
favor the registrant. Rather, it is an inquiry which focuses on
protecting the public interest,'' and thus, ``what matters is the
seriousness of the registrant's misconduct,'' Jayam Krishna-Iyer, 74
FR 459, 462 (2009); and whether he has demonstrated that the
continuation of his registration is consistent with the public
interest.
---------------------------------------------------------------------------
The Government has the burden of proof. See 21 CFR 1301.44.
However, once the Government's establishes its prima facie case that
the registrant has committed acts which render his registration
inconsistent with the public interest, the burden shifts to the
Respondent to show why the continuation of his registration is
consistent with the public interest. See Medicine Shoppe-Jonesborough,
73 FR 364, 387 (2008) (citing cases).
Having considered all of the factors, I acknowledge that Respondent
holds a valid medical license from the State of Utah and that there is
no ``recommendation'' one way or the other from the State Board as to
whether Respondent should retain his registration (factor one).
Moreover, it is also undisputed that Respondent had not been convicted
of an offense related to controlled substances under either Federal or
State law (factor three).
In enacting the CSA, Congress vested this Agency with ``a separate
oversight responsibility [apart from that which exists in State
authorities] with respect to the handling of controlled substances.''
Mortimer B. Levin, 55 FR 8209, 8210 (1990). DEA has therefore long
recognized that it has ``a statutory obligation to make its independent
determination as to whether the granting of [a registration] would be
in the public interest.'' Id. Accordingly, ``DEA has long held * * *
that a State's failure to take action against a registrant's medical
license is not dispositive in determining whether the continuation of a
registration is in the public interest.'' Jayam Krishna-Iyer, 74 FR
459, 461 (2009); see also Levin, 55 FR at 8210 (holding that
practitioner's reinstatement by State board ``is not dispositive'' in
public interest inquiry). Thus, that the Utah Department of
Professional Licensing has taken no action with respect to Respondent's
medical license is of no consequence in determining whether his
continued registration is consistent with the public interest.
Likewise, while a history of criminal convictions for offenses
involving the distribution or dispensing of controlled substances is a
highly relevant consideration, there are any number of reasons why a
registrant may not have been convicted of such an offense, and thus,
the absence of such a conviction is of considerably less consequence in
the public interest inquiry. Krishna-Iyer, 74 FR at 461; Edmund Chein,
72 FR 6580, 6593 n.22 (2007). Accordingly, that Respondent has not been
convicted of an offense related to the distribution or dispensing of
controlled substances is not dispositive of whether the continuation of
his registration is consistent with the public interest.
The primary focus of this proceeding is--as the Government
alleged--his unlawful controlled substance prescribing practices under
both Federal and State law, see 21 CFR 1306.04(a), and whether he
engaged in various practices which ``encouraged the abuse of controlled
substances and allowed their misuse.'' Show Cause Order at 2. This
conduct is clearly relevant in assessing Respondent's experience in
dispensing controlled substances (factor two), his compliance with
applicable laws related to controlled substances (factor four), and
whether he engaged in ``other conduct which may threaten public health
and safety'' (factor five). 21 U.S.C. 823(f). Accordingly, I turn to
whether the evidence relevant under these factors establishes that
Respondent has committed acts which render his ``registration
inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Controlled
Substance Laws
Under a longstanding DEA regulation, a prescription for a
controlled substance is not ``effective'' unless it is ``issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' 21 CFR 1306.04(a). This
regulation further provides that ``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 issuing it, shall be subject to the penalties
provided for violations of the provisions of law related to controlled
substances.'' Id. See also 21 U.S.C. 802(10) (defining the term
``dispense'' as meaning ``to deliver a controlled substance to an
ultimate user by, or pursuant to the lawful order of, a practitioner,
including the prescribing and administering of a controlled
substance'') (emphasis added).
As the Supreme Court has explained, ``the prescription requirement
* * * ensures patients use controlled substances under the supervision
of a doctor so as to prevent addiction and recreational abuse. As a
corollary, [it] also bars doctors from peddling to patients who crave
the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S.
243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143
(1975)).
Under the CSA, it is fundamental that a practitioner must establish
and maintain 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.'' Laurence T.
McKinney, 73 FR 43260, 43265 n.22 (2008); see also Moore, 423 U.S. at
142-43 (noting that evidence established that physician ``exceeded the
bounds of `professional practice,' '' when ``he gave inadequate
physical examinations or none at all,'' ``ignored the results of the
tests he did make,'' and ``took no precautions against * * * misuse and
diversion''). Consistent with the CSA's recognition of the State's
primary role in regulating the practice of medicine, the Act generally
looks to State law and standards of medical practice to determine
whether a doctor and patient have established (and are maintaining) a
bonafide doctor-patient relationship. See Kamir Garces-Mejias, 72 FR
54931, 54935 (2007); United Prescription Services, Inc., 72 FR 50397,
50407
[[Page 49974]]
(2007); see also Volkman, 567 F.3d at 223. But see 21 U.S.C. 829(e)
(requiring in-person examination by physician in order for pharmacy to
lawfully dispense controlled substances through the Internet).
Except for in circumstances not relevant here, under Utah law it is
``unprofessional conduct'' for a licensed physician to issue ``an order
or prescription for a drug * * * without first obtaining information in
the usual course of professional practice, that is sufficient to
establish a diagnosis, to identify conditions, and to identify
contraindications to the proposed treatments[.]'' Utah Code Ann. Sec.
58-1-501(2)(m). Under Utah law, it is also ``unprofessional conduct''
for a licensed physician to ``sexually abus[e] or exploit[] any person
through conduct connected with the licensee's practice under this title
or otherwise facilitated by the licensee's license.'' Id. Sec. 58-1-
501(2)(k).
The rules promulgated under the Utah Controlled Substances Act
further define ``[u]nprofessional conduct'' to include:
(2) Violating any Federal or State law relating to controlled
substances;
* * *
(4) failing to maintain controls over controlled substances
which would be considered by a prudent practitioner to be effective
against diversion, theft, or shortage of controlled substances;
* * *
(6) knowingly prescribing, selling, giving away, or
administering, directly or indirectly, or offering to prescribe,
sell, furnish, give away, or administer any controlled substance to
a drug dependent person, as defined in Subsection 58-37-2(s), except
for legitimate medical purposes as permitted by law[.] \34\
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\34\ Under Utah law, the term ``[d]rug dependent person means
any individual who unlawfully or habitually uses any controlled
substance to endanger the public morals, health, safety, or welfare,
or who is so dependent upon the use of controlled substances as to
have lost the power of self-control with reference to the
individual's dependency.'' Utah Code Ann. Sec. 58-37-2(s).
Utah Admin. Code r.156-37-502. See also id. r.156-67-502 (Utah Medical
Practice Act Rule) (`` `Unprofessional conduct' includes * * *
knowingly prescribing * * * any controlled substance as defined in
Title 58, Chapter 37 to a drug dependent person, * * * unless permitted
by law and when it its prescribed, dispensed or administered according
to a proper medical diagnosis and for a condition indicating the use of
that controlled substance is appropriate.'').
In addition, the Utah Controlled Substance Rules require that
``[p]rescribing practitioners shall keep accurate records reflecting
the examination, evaluation and treatment of all patients. Patient
medical records shall accurately reflect the prescription or
administration of controlled substances in the treatment of the
patient, the purpose for which the controlled substance is utilized and
information upon which the diagnosis is based.'' Id. r.156-37-602(1).
The rule also requires that ``[a] practitioner shall not prescribe or
administer a controlled substance without taking into account the
drug's potential for abuse, the possibility the drug may lead to
dependence, the possibility the patient will obtain the drug for a
nontherapeutic use or to distribute to others, and the possibility of
an illicit market for the drug.'' Id. r.156-37-603(2).
Finally, under the ``General Rule'' of the Utah DOPL, ``
`[u]nprofessional conduct' '' also includes ``failing, as a prescribing
practitioner, to follow the `Model Policy for the Use of Controlled
Substances for the Treatment of Pain', 2004, established by the
Federation of State Medical Boards, which is hereby adopted and
incorporated by reference.'' Id. r.156-1-502(6). As noted above, with
respect to the evaluation of a patient, the Model Policy provides that:
A medical history and physical examination must be obtained,
evaluated, 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 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.
GX 9, at 3.
With respect to the physician's treatment plan, the Model Policy
provides that:
The written treatment plan 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.
After treatment begins, 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 and the
extent to which the pain is associated with physical and
psychosocial impairment.
Id. at 4.
With respect to the physician's monitoring and supervision of his
patient, the Model Policy states that ``[t]he physician should
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. Continuing, the policy provides that ``[o]bjective
evidence of improved or diminished function should be monitored * * *
If the patient's progress is unsatisfactory, the physician should
assess the appropriateness of continued use of the current treatment
plan and consider the use of other therapeutic modalities.'' Id.
Finally, the Model Policy states that ``[t]he physician should keep
accurate and complete records to include[:] 1. the medical history and
physical examination, 2. diagnostic, therapeutic and laboratory
results, 3. evaluations and consultations, 4. treatment objectives, 5.
discussion of risks and benefits, 6. informed consent, 7. treatments,
8. medications (including date, type, dosage and quantity prescribed),
9. instructions and agreements and 10. periodic reviews.'' Id.
Applying these standards, the record clearly establishes numerous
violations of both the CSA's prescription requirement and State law.
More specifically, while the evidentiary standard applicable in this
proceeding is the preponderance standard, Steadman v. SEC, 450 U.S. 91,
100-01 (1981), there is clear and convincing evidence that Respondent
engaged in the knowing or intentional diversion of controlled
substances.\35\
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\35\ As numerous courts have noted with respect to whether a
violation of the prescription requirement constitutes an act of
intentional diversion, there must be ``proof that the practitioner's
conduct went `beyond the bounds of any legitimate medical practice,
including that which would constitute civil negligence.' '' United
States v. McIver, 470 F.3d 550, 559 (4th Cir. 2006) (quoted in
Laurence T. McKinney, 73 FR 43260, 43266 (2008)). As the Fourth
Circuit further explained, ``the scope of unlawful conduct under
Sec. 841(a)(1) [requires proof that a physician] used `his
authority to prescribe controlled substances * * * not for treatment
of a patient, but for the purpose of assisting another in the
maintenance of a drug habit' or some other illegitimate purposes,
such as his own `personal profit.' '' Id. (quoted at 73 FR at
43266). See also United States v. Feingold, 454 F.3d 1001, 1010 (9th
Cir. 2006) (``[T]he Moore Court based its decision not merely on the
fact that the doctor had committed malpractice, or even intentional
malpractice, but rather on the fact that his actions betrayed any
semblance of legitimate medical treatment.'').
To make clear, this is not a criminal trial, but rather, a
proceeding brought under sections 303 and 304 of CSA to protect the
public interest. While proof of intentional or knowing diversion is
highly consequential in these proceedings, the Agency's authority to
act is not limited to those instances in which a practitioner is
shown to have engaged in such acts. See Paul J. Caragine, Jr., 63 FR
51592, 51601 (1998) (``Just because misconduct is unintentional,
innocent or devoid of improper motivation, does not preclude
revocation or denial [of a registration]. Careless or negligent
handling of controlled substances creates the opportunity for
diversion and could justify revocation or denial.''). Accordingly,
under the public interest standard, DEA has authority to consider
those prescribing practices of a physician, which, while not rising
to the level of intentional or knowing misconduct, nonetheless
create a substantial risk of diversion.
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[[Page 49975]]
Among the patients to whom he intentionally diverted controlled
substances are M.R. and K.D. M.R. testified that her complaints of
wrist and back pain were false and were done so in order to obtain
controlled substance prescriptions. While a physician is entitled to
believe a patient's complaint, he still must comply with the
fundamental requirements necessary to establish a legitimate doctor-
patient relationship and properly diagnose his patient.
As the medical records show and as Dr. Hare testified, at the
initial visit, Respondent did not obtain a history ``even in regards to
the occurrence of the wrist pain and its characterization,'' his
physical exam was limited to finding that M.R. was neurologically
intact and grabbing her wrist, and no further tests were ordered. Thus,
from the outset, Respondent did not comply with the Model Policy's and
Utah's requirement for obtaining, evaluating and documenting M.R.'s
medical history and physical examination, which mandates that the
medical record ``document the nature and intensity of the pain, current
and past treatment for pain, underlying or coexisting disease or
conditions, the effect of pain on physical and psychological function''
and substance abuse history. While it is true that he did not prescribe
Lortab to her until the second visit (which occurred a month later),
the only additional finding related to her wrist pain made at the
second visit was that she had ``diffuse tenderness over the dorsum of
the wrist.''
When M.R. also complained of back-pain, which too was a feigned
complaint, Respondent's physical exam lasted all of ten seconds and was
limited to having her stand up, bend over, and then stand up straight
again. Respondent nonetheless prescribed Lortab to her. As Dr. Hare
observed, Respondent's evaluation of M.R.'s pain complaints ``was
inadequate to justify the prescribing of controlled substances for her
conditions.'' It is thus clear that Respondent did not comply with
Utah's standards for prescribing controlled substances for pain and
that he lacked a legitimate medical purpose and acted outside of the
usual course of professional practice and violated the CSA's
prescription requirement. 21 CFR 1306.04(a).
There is ample evidence to infer that Respondent knew full well
that M.R. was not a legitimate pain patient. More specifically, she
testified that she ``never really'' had to mention anything to get a
refill, and that she ``didn't really need to complain'' about being in
pain ``because he didn't ask if you were in pain.'' She further
testified that at 95% of her appointments, he just issued her a
prescription whether for Lortab or either Valium or Xanax without
discussing her medical condition. Moreover, Respondent issued her
numerous prescriptions for Valium and Xanax which are unsupported by
any documentation of a medical purpose. In addition, M.R.'s patient
file contains a DOPL report which indicated that M.R. was obtaining
controlled substances from another physician at the same time she was
actively seeing him.
Then there is the evidence pertaining to M.R.'s undercover visits.
For example, while at the first of these visits Respondent refused to
prescribe to an undercover Agent whom M.R. introduced to him, he
nonetheless gave M.R. a refill for 90 tablets of Lortab 10 without
doing something as basic as asking her about her pain level. The
transcript further shows that Respondent did not perform even a
perfunctory physical exam, and yet he fabricated M.R.'s patient record
to indicate that he had conducted a physical examination in which he
found that she ``has diffuse tenderness L4-S1'' and was
``neurologically intact.''
At the second undercover visit, his inquiry was limited to asking
M.R., ``how are you today?'' Again, Respondent made no inquiry
regarding her pain level and once again fabricated the patient record
to indicate that he had performed a physical exam when he had not.
Moreover, during the visit M.R. told him that she had shared some of
her drugs with the Agent who had accompanied her at the previous visit
and asked him if this was ``okay.'' While Respondent initially told
M.R. that this was ``against the law,'' he then stated, ``Just * * *
don't tell me about it.'' Thus, Respondent was clearly aware that M.R.
was diverting drugs, and yet he gave her another prescription for 90
Lortab. He also made clear that his reason for declining to see the
undercover Agent was because she had stated that she had previously
gone to another physician who had been jailed for drug dealing and that
he was ``staying away from'' persons who had gone to that physician.
It is thus clear that Respondent knew that M.R. was not a
legitimate pain patient and that she was seeking the controlled
substances for illicit purposes (whether to self-abuse or sell to
others is irrelevant). Yet he continued to prescribe to her. And even
following these two visits, when it cannot be disputed that he knew
that she was not a legitimate pain patient, he wrote her additional
prescriptions at both her third and fourth undercover visits for 90
Lortab, each of which also authorized a refill.
With respect to M.R., Dr. Fine (Respondent's expert) offered only
the disingenuous testimony that he could not opine on the validity of
Respondent's prescribings during the undercover visits without ``a full
audiovisual recording of these visits'' and that, without knowing the
context of the physician-patient relationship, he couldn't ``make sense
out of'' the transcripts. Contrary to Dr. Fine's testimony, it is
possible to make sense out of the transcripts. What they manifest is
that Respondent's prescribings to M.R. ``betrayed any semblance of
legitimate medical treatment,'' Feingold, 454 F.3d at 1010, were well
outside of the usual course of professional practice, and lacked a
legitimate medical purpose. In short, Respondent knowingly and
intentionally dealt drugs to M.R. and violated Federal law in doing so.
21 U.S.C. 841(a)(1).
As for K.D., while she testified that she had a legitimate pain
condition, she also acknowledged that a ``huge percentage'' of the
prescriptions she obtained from Respondent were ``for recreational
use.'' Moreover, even if is true that she was still suffering pain at
the time of her initial visit, Dr. Hare noted that ``there is an
inadequate history and physical evaluation to justify prescribing
chronic controlled substance prescriptions and particularly in
escalating amounts.'' Indeed, as K.D. testified, Respondent's physical
exam was limited to looking at her neck; he did not order diagnostic
tests such as x-rays and did not even ask her about the severity of her
pain. Moreover, as Dr. Hare noted, when Respondent changed his
diagnosis from cervical spine pain to low back pain, ``there was no
significant additional evaluation done to try to delineate the problem
or other means for treatment suggested.''
Beyond this, throughout the course of his prescribing to her,
Respondent escalated the prescriptions from Lortab 7.5 mg, a schedule
III controlled substance, to OxyContin 40 mg., a schedule II controlled
substance; he also frequently prescribed either more Lortab or Percocet
simultaneously with these prescriptions. Yet, as Dr. Hare explained,
there was no ``documentation or indication of patient improvement even
with [the] dramatic increase in the medications, such as OxyContin and
Oxycodone.''
[[Page 49976]]
Moreover, as Dr. Hare observed, Respondent escalated his
prescribing notwithstanding that there were ``many signs and outright
indications'' of overuse and abuse. These include K.D.'s claims that
her medications were stolen (which occurred as early as her third
visit); a police report for a domestic disturbance in May 2005, which
indicated that she had a problem with substance abuse; a December 2007
letter in which Respondent recounted that he would no longer see her
because she had claimed that her insurance would not pay to fill an
OxyContin prescription and needed a prescription for another drug, but
then filled the OxyContin prescription; a report from a local narcotics
task force, which included a DOPL report, showing that she was getting
controlled substances from five different prescribers; K.D.'s seeking
early refills (which he provided) even after he received the DOPL
report; and K.D.'s continuing to see him even after she had reported
that she was moving out of state. Notwithstanding each of these
incidents, Respondent continued to prescribe to K.D.
To make clear, this is not a case of doctor who was merely
indifferent to the warning signs that his patient was abusing or
selling drugs. Rather, the record demonstrates that Respondent
continued to prescribe to K.D. even after he was aware of some of these
incidents, because he was using his prescribing authority to receive
sexual favors from her.
As the evidence shows, on multiple occasions beginning in September
2006 and lasting through March 2008, Respondent engaged in sexual
activities with K.D., which included giving her topless massages and
digitally penetrating her, in exchange for controlled substance
prescriptions. As even Dr. Fine acknowledged, Respondent's conduct
``would not be viewed as within the Code of Ethical Conduct,'' and it
would not be within the usual course of professional practice for a
physician, who had engaged in such conduct, to issue controlled
substance prescriptions to that person. Tr. 763-64. Indeed, the conduct
is so far outside the bounds of professional practice as to constitute
evidence of intentional diversion.
K.D. also made several undercover visits. While at the first of
these visits (Nov. 2008), Respondent asked her if she was getting pills
from other doctors, he was then already aware that he was under
investigation, complained that DEA had ``actually sent people in with
wires,'' and also asked her if she was ``a plant from the police or the
DEA.'' Given the context of the conversation (as well as all the other
evidence regarding his relationship with her), it is reasonable to
conclude that Respondent's reason for asking K.D. whether she was
getting pills from other doctors was not because he was concerned that
she was a drug abuser or drug dealer, but rather, that he would be
caught.
While K.D. stated at this visit that she had ``been in a lot of
pain,'' his response was limited to stating, ``I'll bet you have,''
with no further inquiry as to her pain level and how it was affecting
her ability to function, the efficacy of what Respondent had previously
prescribed, and any side effects. In addition, Respondent fabricated
K.D.'s medical record to indicate that he had performed a physical exam
when he did not. Respondent nonetheless gave her prescriptions for 90
tablets of OxyContin 40 mg., 120 tablets of oxycodone IR 30 mg., and 30
tablets of Ambien.
At the next undercover visit, Respondent again asked K.D. if she
was ``working with the DEA, or wearing a wire?'' This, of course, is
not the type of conversation one would expect to occur in the usual
course of an office visit involving a legitimate patient and doctor.
While at this visit, Respondent stated that he could not refill one of
her previous prescriptions (likely the OxyContin 40) because it was
``less than four weeks,'' he then gave her a prescription for 60
tablets of oxycodone IR 30 mg. (also a schedule II drug, which is
nearly as potent as OxyContin 40 mg.) to supply her until the following
week. At this visit, Respondent did not ask her a single question about
her purported medical condition and K.D. made no statements about being
in pain. Moreover, once again Respondent falsified her medical record
to indicate that he had performed a physical exam when he had not done
so.
At the next undercover visit, Respondent asked K.D. what she needed
and she replied with a shopping list of drugs including ``My OxyContin,
my Roxicet, my Fioricet, my Ambien, and I have been so stressed out, so
I was going to see if I could get some Xanax too.'' While K.D.
complained that she was going though some ``sh-t,'' Respondent asked
how many Xanax she wanted, a question not typically asked of a patient
by a physician in the usual course of professional practice but one
which is consistent with drug dealing. While there was no discussion of
how the previously prescribed drugs affected her pain level, functional
capacities, and whether she had experienced any side effects,
Respondent gave her new prescriptions for 90 OxyContin 40 mg., 120
Oxycodone 30 mg., and 30 Xanax. And again, K.D.'s record indicates that
at this visit Respondent performed a physical exam although the
transcript contains no evidence that he did so.
As for K.D.'s final undercover visit which likely occurred on
December 18 (only 17 days after the previous visit), the recording
contains no indication that Respondent performed a physical exam on her
although he indicated in her record that he had done so. There is also
no indication in the recording that K.D. and Respondent discussed how
the prescriptions were affecting her pain level and functionality
although he indicated in her medical record that the prescriptions
controlled her pain well. Once again, Respondent asked K.D. what she
needed, and K.D. requested several controlled substances. Respondent
then gave her prescriptions for 90 OxyContin 40 mg. (so much for the
law which he had previously stated required four weeks between
prescriptions) as well as 120 oxycodone 30 mg. and 30 Xanax.\36\
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\36\ In his exceptions, Respondent argues that K.D. testified
that ``she was in fact in real pain during the final undercover
visit, [and] she felt the prescription was legitimate because she
had legitimate pain.'' Resp. Exc. at 27. Even if K.D. was in pain,
this does not make the prescriptions Respondent issued at this visit
lawful because he did not ask K.D. a single question about the
nature and intensity of her pain and thus had no clinical basis for
concluding that the prescriptions, which were for multiple drugs,
were medically necessary to treat her pain. In addition, at this
visit, Respondent also gave K.D. a prescription for Xanax. Yet K.D.
did not testify that she had anxiety, the medical condition which
Xanax is typically prescribed for. In sum, at this visit, K.D.
presented a shopping list of drugs and in issuing the prescriptions,
Respondent abdicated his role as a physician. I thus reject
Respondent's contention.
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As Dr. Hare opined, in the usual course of professional practice, a
physician engaged in pain management would have adequately evaluated
his patient ``to set the base,'' which Respondent did not do. Moreover,
when, as in K.D.'s case, there are ``multiple indications'' that a
patient is abusing controlled substances, a physician must ``closely
monitor the patient[],'' and discharge a patient who did not comply
with the plan.
Of course, Respondent did none of these things in the course of his
prescribing to K.D. I thus agree with Dr. Hare's conclusion that
Respondent issued to K.D. numerous prescriptions which were not
``within the usual course of professional practice and for a legitimate
medical purpose.'' 21 CFR 1306.04(a). And I further conclude that the
totality of the evidence with respect to K.D. not only establishes that
Respondent violated the CSA's prescription requirement, but also that
he did so knowingly and intentionally. 21 U.S.C. 841(a)(1).
[[Page 49977]]
Consistent with DEA precedent, my findings that Respondent
intentionally diverted to M.R. and K.D. and did so on multiple
occasions are sufficient to hold that the Government has made a prima
facie showing that Respondent has committed acts which render his
registration inconsistent with the public interest. As I have
previously noted, the Agency has revoked other practitioner's
registration for committing as few as two acts of diversion, see
Krishna-Iyer, 74 FR at 463 (citing Alan H. OIefsky, 57 FR 928, 928-29
(1992)), and the Agency can revoke based on a single act of intentional
diversion. Accordingly, there is no need to make findings regarding the
other patients.
In his post-hearing brief, Respondent argues that he presented the
testimony of three physicians (as well as the affidavits of sixteen
others) to the effect that he should be allowed to keep his
registration because of the benefit he provides to his local community.
Resp. Summation Br. at 26. Respondent also cites an unpublished
decision of the Eleventh Circuit, which vacated my Decision and Order
in Jayam Krishna-Iyer, M.D., 71 FR 52148 (2006), on the ground that I
``did not consider any of Petitioner's positive experience in
dispensing controlled substances.'' Id. (quoting Krishna-Iyer v. DEA,
249 Fed. Appx. 159, 160 (11th Cir. 2007)). According to Respondent,
``[a] better assessment of [his] medical practice and habits can be
ascertained from [his] numerous positive experiences in prescribing
controlled substances, some of which were recounted by the patients
themselves * * * at the hearing.'' Id. at 3.
However, as I noted in my Decision on remand in Krishna-Iyer, the
Eleventh Circuit ``did not cite to any decision of either this Agency
or another court defining the term `positive experience.' Nor did the
Court offer any guidance as to the meaning of this term, which is not
to be found in the'' CSA. 74 FR at 460. Accordingly, in Krishna-Iyer, I
assumed that the physician's controlled-substance prescribings to every
other patient in the course of her medical career ``constitute[d]
`positive experience,' '' whatever that means. Id. at 461. However, as
I noted therein, ``[h]er prescribings to thousands of other patients
[did] not * * * render her prescribings to the undercover officers any
less unlawful, or any less acts which `are inconsistent with the public
interest.' '' Id. at 463. See also Medicine Shoppe-Jonesborough, 73 FR
364, 386 & n.56 (2008) (noting that pharmacy ``had 17,000 patients,''
but that ``[n]o amount of legitimate dispensings can render * * *
flagrant violations [acts which are] `consistent with the public
interest.' ''), aff'd, Medicine Shoppe-Jonesborough v. DEA, 300 Fed.
Appx. 409 (6th Cir. 2008).
This is so because under the CSA, ``registration is limited to
those who have authority to dispense controlled substances in the
course of professional practice.'' Krishna-Iyer, 74 FR at 463. Because
``patients with legitimate medical conditions routinely seek treatment
from licensed medical professionals, every registrant can undoubtedly
point to an extensive body of legitimate prescribing over the course of
[his] professional career.'' Id.
In Krishna-Iyer, I further explained that ``evidence that a
practitioner has treated thousands of patients [without violating the
CSA] does not negate a prima facie showing that a practitioner has
committed acts inconsistent with the public interest. While such
evidence may be of some weight in assessing whether a practitioner has
credibly shown that she has reformed her practices, where a
practitioner commits intentional acts of diversion and insists she did
nothing wrong, such evidence is entitled to no weight.'' Id.
Accordingly, even assuming, without deciding, that Respondent's
prescribing practices to all of his other patients (including those
whose medical records were reviewed by the Government's expert) fully
complied with the CSA and Utah law, these prescribings do not refute
the evidence showing that he intentionally diverted to M.R. and K.D. in
violation of both the CSA and Utah law.\37\ I thus reject Respondent's
arguments and conclude that the Government has established a prima
facie case that his continued registration is ``inconsistent with the
public interest.''\38\ 21 U.S.C. 823(f).
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\37\ As for the evidence provided by Respondent's fellow
practitioners, none of them have personal knowledge of his
prescribing practices with respect to M.R. and K.D. The evidence is
thus not probative of whether he violated the CSA and Utah law in
prescribing controlled substances to them.
\38\ In light of my findings under factors two and four, I
conclude that it is not necessary to make findings under factor
five.
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Sanction
Under Agency precedent, where, as here, ``the Government has proved
that a registrant has committed acts inconsistent with the public
interest, a registrant must `present[] sufficient mitigating evidence
to assure the Administrator that [he] can be entrusted with the
responsibility carried by such a registration.' '' Medicine Shoppe-
Jonesborough, 73 FR at 387 (quoting Samuel S. Jackson, 72 FR 23848,
23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988)).
Moreover, because ``past performance is the best predictor of future
performance, ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995),
[DEA] has repeatedly held that where a registrant has committed acts
inconsistent with the public interest, the registrant must accept
responsibility for [his] actions and demonstrate that [he] will not
engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also
Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006);
Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v.
DEA, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]''
by DEA to be an ``important factor[]'' in the public interest
determination).
As noted above, Respondent did not testify in this proceeding. It
has long been settled, however, that the Fifth Amendment privilege does
not preclude the Agency from drawing an adverse inference based on a
registrant's failure to testify in a proceeding under sections 303 and
304 of the Act. Cf. Baxter v. Palmigiano, 425 U.S. 308, 318-20 (1976);
see also The Lawsons, Inc., 72 FR 74334, 74339 (2007); United
Prescription Services, Inc., 72 FR 50397, 50409 n.31 (2007). Based on
Respondent's failure to testify, I further conclude that Respondent
does not accept responsibility for his misconduct, and therefore, he
has not rebutted the Government's prima facie showing that his
continued registration is inconsistent with the public interest. See
Krishna-Iyer, 74 FR at 464.
Respondent nonetheless argues that the revocation of his
``registration is an extreme penalty and a limited restriction of his
DEA registration is likely more appropriate.'' Resp. Summation Br.
Findings at 31. As support for his contention, Respondent cites several
agency decisions which granted a restricted registration to a
practitioner. See id. at 31-32. None of these cases support Respondent.
In Larry L. Kompus, 55 FR 30990, 30991-92 (1990), the physician's
misconduct, which involved trading controlled substances for sexual
favors, had occurred ``more than ten years'' earlier. Moreover, in
contrast to Respondent, the physician ``acknowledged the wrongfulness
of his actions and ha[d] shown remorse for them.'' Id.
Likewise, in William P. Jerome, 61 FR 11867, 11867-68 (1996), there
was extensive evidence of the physician's misconduct which also
involved trading controlled substances (both samples and prescriptions)
for sexual favors and trading controlled substances for other
controlled substances and/or cash. Id.
[[Page 49978]]
However, the physician had committed the acts at least six years
earlier. Id. Most importantly, in addition to presenting evidence of
his rehabilitation, the physician admitted that he had violated Federal
law and ``testified as to his remorse for his past misconduct and his
determination that he [would] not engage in such conduct in the
future.'' Id. at 11870. The case thus provides no comfort to
Respondent.
In another portion of his brief, Respondent cites three additional
cases in which the Agency granted a restricted registration to a
practitioner. See Resp. Summation Br. at 26-27 (citing Karen A. Kruger,
69 FR 7016 (2004); Wesley G. Harline, 65 FR 5665 (2000); Paul J.
Caragine, Jr., 63 FR 51592 (1998)). However, none of these cases
support granting Respondent a restricted registration.
In Caragine, unlike here, there was no evidence of intentional
diversion and the physician testified that he had undergone training to
help him better identify and manage drug-seeking patients.\39\ See 63
FR at 51601. Likewise, in Harline, there was no evidence of intentional
diversion. Indeed, the Agency specifically held that the prescriptions
in dispute were issued for a legitimate medical purpose and thus did
not violate the CSA. See 65 FR at 5671. Furthermore, the practitioner
admitted that he had violated State law and gave assurance that he
would not do so in the future. Id. Finally, Kruger involved a
practitioner who wrote fraudulent prescriptions to obtain drugs for
self-abuse and not to divert to others. The practitioner, however,
readily admitted her misconduct and provided evidence that she had
undergone treatment.
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\39\ In Krishna-Iyer, I made clear that while there may be a few
isolated decisions that suggest that a practitioner who has
committed only a few acts of diversion may regain his registration
``without having to accept responsibility for his misconduct, the
great weight of the Agency's decisions is to the contrary.'' 74 FR
at 464 (citation omitted). I explained that ``[b]ecause of the grave
and increasing harm to public health and safety caused by the
diversion of prescription controlled substances, even where the
Agency's proof establishes that a practitioner has committed only a
few acts of diversion, this Agency will not grant or continue the
practitioner's registration unless he accepts responsibility for his
misconduct.'' Id. I further held that to the extent any decision of
this Agency suggests otherwise, it is overruled. Id. at n.9. Thus,
were a case to present facts similar to those of Caragine, I would
likely deny the practitioner's application.
As I also noted in Krishna-Iyer: ``The diversion of controlled
substances has become an increasingly grave threat to this nation's
public health and safety. According to The National Center on
Addiction and Substance Abuse (CASA), `[t]he number of people who
admit abusing controlled prescription drugs increased from 7.8
million in 1992 to 15.1 million in 2003.' '' 74 FR at 463 (quoting
National Center on Addiction and Substance Abuse, Under the Counter:
The Diversion and Abuse of Controlled Prescription Drugs in the U.S.
3 (2005) [hereinafter, Under the Counter]). CASA also found that
``[a]pproximately six percent of the U.S. population (15.1 million
people) admitted abusing controlled prescription drugs in 2003, 23
percent more than the combined number abusing cocaine (5.9 million),
hallucinogens (4.0 million), inhalants (2.1 million) and heroin
(328,000).'' Id. (quoting Under the Counter at 3). Finally, CASA
found that ``[b]etween 1992 and 2003, there has been a * * * 140.5
percent increase in the self-reported abuse of prescription
opioids,'' and in the same period, the ``abuse of controlled
prescription drugs has been growing at a rate twice that of
marijuana abuse, five times greater than cocaine abuse and 60 times
greater than heroin abuse.'' Id. (quoting Under the Counter at 4).
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In contrast to these cases, Respondent does not remotely meet the
Agency's standards for obtaining a restricted registration. His failure
to testify precludes a finding that he has accepted responsibility for
his misconduct. His misconduct is egregious; that he continued to
provide unlawful prescriptions even when he knew he was under
investigation renders it especially so. Thus, even if Respondent
provided treatment to some legitimate patients and those patients
benefitted from his treatment of them, the evidence with respect to
M.R. and K.D. establishes that he is still a drug dealer.
In short, Respondent has not rebutted the Government's prima facie
case that he has committed acts which ``render his registration * * *
inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).
Accordingly, I conclude that the public interest requires that his
registration be revoked and his pending application be denied. And
because of the egregiousness of his misconduct, I conclude that the
public interest requires that his Order be effective immediately. See
21 CFR 1316.67.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as by 28 CFR 0.100(b) & 0.104, I order that DEA
Certificate of Registration, AM9742380, issued to Dewey C. MacKay,
M.D., be, and it hereby is, revoked. I further order that any pending
application to renew or modify the registration be, and it hereby is,
denied. This Order is effective immediately.
Dated: August 3, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-20211 Filed 8-13-10; 8:45 am]
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