[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Notices]
[Pages 8194-8237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3305]
[[Page 8193]]
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Part II
Department of Justice
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Drug Enforcement Administration
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Jeri Hassman, M.D.; Denial of Application; Notice
Federal Register / Vol. 75, No. 35 / Tuesday, February 23, 2010 /
Notices
[[Page 8194]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 06-62]
Jeri Hassman, M.D.; Denial of Application
On June 1, 2006, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration issued an Order to
Show Cause to Jeri Hassman, M.D. (Respondent), of Tucson, Arizona. The
Show Cause Order proposed the denial of Respondent's application for a
new DEA Certificate of Registration as a practitioner, authorizing her
to dispense controlled substances in schedules II through V, on the
grounds that the Respondent had ``been convicted of a felony under the
Controlled Substances Act, [had] materially falsified [her]
application, and ha[d] committed such other acts as would render [her]
registration under 21 U.S.C. 823 inconsistent with the public
interest.'' ALJ Ex. 1, at 1 (citing 21 U.S.C. 824(a)(1)(2) and (4),
824(a) and 823).
More specifically, the Show Cause Order alleged that on November 1,
2002, DEA had immediately suspended Respondent's DEA registration on
the ground that she ``regularly engaged in the practice of prescribing
excessive amounts of controlled substances * * * to patients for no
legitimate medical purpose.'' Id. at 1-2. The Show Cause Order next
alleged that patients to whom she had prescribed controlled substances
had died of overdoses. Id. at 2-3.
Next, the Show Cause Order alleged that Respondent ``prescribed
excessive quantities of controlled substances to patients, including
frequent early refills'' to a number of other patients. Id. at 3. The
Show Cause Order alleged that Respondent:
generally failed to adequately evaluate patients, failed to conduct
complete physical examinations, failed to obtain adequate histories,
failed to include pain ratings, failed to determine the exact
location or character of the pain, failed to obtain information
concerning previous treatment from other physicians or medication
used.
Id. In addition, the Show Cause Order stated that ``[d]espite these
inadequate evaluations, [Respondent] immediately prescribed controlled
substances to these patients.'' Id.
The Order to Show Cause also alleged that Respondent was ``made
aware of possible diversion incidents but continued to prescribe
controlled substances for patients who were engaged in diversion.'' Id.
at 4. The Show Cause Order related five known incidents involving (1)
F.L. and his son B.L., both patients of Respondent; (2) & (3) J.O. and
her husband W.O., both patients of Respondent; (4) M.H., P.H., and
A.B., a mother and two ``daughters'', all patients of Respondent; and
(5) S.R., a patient of Respondent. Id. at 4-6.
The Show Cause Order further alleged that on January 29, 2004,
Respondent pled guilty to ``four felony violations of 18 U.S.C. 3
involving controlled substances: Accessory After the Fact to Possession
of Controlled Substances by Misrepresentation, Fraud, Forgery,
Deception or Subterfuge, 21 U.S.C. 843(a)(3).'' Id. at 6.
Next, the Show Cause Order alleged that on March 10, 2004,
Respondent ``entered into a Consent Agreement with the Arizona Medical
Board (the Board), in which the Board found that [Respondent] failed in
many ways to properly care for [her] patients, including the
prescribing of excessive amounts of controlled substances.'' Id.
According to the Show Cause Order:
The Board also found that [Respondent] failed to conduct
physical examinations, failed to obtain adequate patient histories
and failed to obtain prior medical records. The Board also found
that [her] patient notes often did not provide sufficient
information to support the diagnoses, justify the treatments,
accurately document the results, or indicate advice and cautionary
warnings provided to the patients.
* * * Under the Consent Agreement the Board found [Respondent]
guilty of unprofessional conduct and placed [Respondent's] Arizona
medical license on probation for two years from the effective date
of the Consent Agreement.
Id.
Finally, the Show Cause Order alleged that Respondent materially
falsified her application, when, on January 28, 2005, Respondent
applied for her DEA registration, she marked ``no'' to question 4(d),
which ``asked, in pertinent part, whether [Respondent] had ever had a
State professional license revoked, suspended or placed upon
probation.'' Id.
Respondent timely requested a hearing on the allegations, ALJ Ex.
2, and the matter was placed on the docket of the Agency's
Administrative Law Judges (ALJ). Following pre-hearing procedures, a
hearing was held on January 22-26, 2007 and February 27 to March 2,
2007, in Tucson, Arizona. Moreover, on March 13, 2007, the ALJ
conducted a transcribed telephone conference at which Respondent gave
her closing argument. Thereafter, both parties filed post-hearing
briefs.
On October 9, 2008 the ALJ issued her Opinion and Recommended
Decision (ALJ). With respect to factor one (the recommendation of the
State licensing board), the ALJ noted that, while Respondent has twice
been placed on probation and either censured or reprimanded, she
currently holds an active, unrestricted medical license, and that this
factor weighs in favor of her continued registration. ALJ at 147-48.
With respect to factor two (Respondent's experience in dispensing
controlled substances) and factor four (Respondent's compliance with
applicable laws relating to controlled substances), the ALJ concluded
that the Government had established that Respondent issued
prescriptions to two persons (H.T. and R.T.) which lacked a legitimate
medical purpose. ALJ at 150. The ALJ reasoned, however, that these were
``only two patients out of more than 900 whom Respondent was treating
at that time,'' and thus the Government had not shown that
``Respondent's overall medical practices [were] consistently lacking in
legitimate purpose.'' Id. at 150.
The ALJ specifically rejected the evidence of the Government's
Expert with respect to twenty-three other patients, noting that various
physicians who testified on behalf of Respondent had disagreed with the
conclusions of the Government's Expert. Id. at 151. According to the
ALJ, this was ``not to minimize the seriousness of the Respondent's
cavalier attitude toward handling controlled substances during 2001 and
2002, but rather to demonstrate that it is not clear that her general
treatment practices were lacking in medical purpose.'' Id.
In support of her conclusion, the ALJ cited various areas in which
she maintained ``that there was no clear consensus in the medical
community regarding which practices were required to meet the standard
of care during 2001 and 2002.'' Id. According to the ALJ, these areas
included the role of physical examinations in treating chronic pain
patients, the use of laboratory tests, the need to refer patients to
other doctors as part of the course of treatment, appropriate dosage
levels of controlled substances for treating chronic pain, and the
propriety of prescribing both long and short-acting opioids
simultaneously. Id.
The ALJ also rejected the Government's contention that Respondent's
falsification of H.T.'s medical record (who performed multiple
undercover visits and wore a recording device) justified the denial of
her application. Id. at 153-55. While acknowledging that ``[i]t is
indeed disturbing that the Respondent apparently altered H.T.'s medical
chart to include a physical examination that
[[Page 8195]]
was not reflected in the recorded interaction between the Respondent
and H.T.,'' id. at 153, the ALJ concluded ``that a single instance does
not rise to the level of [a] pervasive pattern of falsification.'' Id.
at 155. In this regard, the ALJ also noted that Respondent was working
with another physician to improve her recordkeeping practices.\1\ Id.
at 155-56. The ALJ did not, however, expressly find whether the
evidence under factors two and four satisfied the Government's prima
facie burden.
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\1\ The ALJ also noted that a 2002 DEA Audit of controlled
substances which Respondent physically dispensed had found that
Respondent was unable to account for 150 dosage units out of a total
of 7,560 dosage units which were on hand. Id. at 153. DEA
Investigators also found that Respondent had failed to keep
receiving records for samples of controlled substances which her
office received, that the records did not contain all of the
information required by regulations, and that some records may have
been missing because Respondent was not aware that she was required
to keep them for two years. Id. I agree with the ALJ that these
deficiencies are not sufficient by themselves to justify denying her
application.
Finally, the ALJ rejected the Government's contention that
Respondent had materially falsified her application because she
answered ``no'' to the question whether her State license had ever
been sanctioned. Id. at 160. The ALJ found that Respondent had
attached to her application a letter from the Arizona Medical Board
which indicated that she would ``continue to be monitored every six
months until the end of her probation in March 2007.'' Id. (quoting
GX 3, at 4). According to Respondent, based on the wording of the
letter she believed that she--and not her medical license--had been
placed on probation by the Board. Id. In light of Respondent's
having provided the letter with her application, as well as her
having truthfully answered the other questions on the application, I
agree with the ALJ that she ``lacked the intent to deceive the''
Agency. Id. at 161.
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The ALJ further found that Respondent had been convicted of four
counts of the felony offense of ``Accessory After the Fact to
Possession of Controlled Substances by Misrepresentation, Fraud,
Forgery Deception or Subterfuge,'' and that the convictions could be
considered as either an offense ``under Federal * * * laws relating to
the * * * dispensing of controlled substances,'' 21 U.S.C. 823(f)(4),
or as ``[s]uch other conduct which may threaten the public health and
safety.'' Id. Sec. 823(f)(5); see also id. at 158. While the ALJ found
that Respondent's convictions ``could * * * weigh in favor of denial of
the * * * application,'' id. at 158, she also did not address whether
this factor established the Government's prima facie case.
The ALJ further found that Respondent had ``engaged in extensive
remedial training,'' that she has ``improved skills now available to
her, including the use of risk assessment tools and [the] collection of
extensive addiction histories on each patient,'' and that she would
continue to consult with another pain management expert. Id. at 161-62.
The ALJ also found it significant that the State Board would conduct
regular reviews of her medical charts and quarterly compliance reports.
Id. at 162. Finally, the ALJ found that ``Respondent's willingness to
admit her past mistakes, accept responsibility for her actions, and
remedy her professional deficiencies should weigh heavily in favor of
granting her application.'' Id. at 162. The ALJ thus recommended that I
grant Respondent a new registration subject to the conditions that she
continue her mentoring arrangement with a pain management specialist
for a period of three years and also submit the quarterly reports
required by the State Board to the Agency. Id. at 163.
On November 3, 2008, the Government filed its exceptions to the
ALJ's decision; and on November 28, 2008, Respondent submitted her
response to the Government's exceptions. On December 22, 2008, the ALJ
forwarded the record to me for final agency action.
Having considered the entire record in this matter, including the
ALJ's decision and the parties' briefs, I adopt the ALJ's conclusion of
law with respect to the allegations of material falsification. I also
agree with the ALJ that Respondent's prescriptions for H.T. lacked a
legitimate medical purpose. I reject, however, the ALJ's conclusions
with respect to factors two and four.
The ALJ's failure to acknowledge that the Government established a
prima facie case for denying the application was largely based on her
conclusion that the Government had only proved that Respondent issued
unlawful prescriptions to two patients and that it had not shown that
her ``other medical practices [were] consistently lacking in legitimate
purpose.'' The ALJ's reasoning is erroneous for several reasons.
First, it is inconsistent with Agency precedent, which holds that
proof of as few as two acts of diversion satisfies the Government's
prima facie burden under the public interest standard and supports the
revocation of a practitioner's registration when she fails to accept
responsibility for her misconduct. See Alan H. Olefsky, 57 FR 928, 928-
29 (1992); see also Sokoloff v. Saxbe, 501 F.2d 571, 576 (2d Cir.
1974). The record here, however, supports the conclusion that
Respondent knowingly issued multiple prescriptions to H.T. which lacked
a legitimate medical purpose and violated Federal law. Moreover, while
the ALJ stated that she had made extensive findings to place
Respondent's treatment of various patients in context, ALJ at 151 n.34,
she nonetheless frequently ignored relevant evidence establishing
numerous other instances in which Respondent issued prescriptions which
clearly violated the prescription requirement of Federal law. 21 CFR
1306.04(a).
Second, the ALJ's reasoning ignores longstanding precedent that the
Agency's authority to revoke a registration or deny an application is
not limited to those instances in which a practitioner intentionally
diverts. Rather, a practitioner who ignores the warning signs that her
patients are either personally abusing or diverting to others, commits
acts inconsistent with the public interest even if her conduct is
merely reckless or negligent. See Paul J. Caragine, Jr., 63 FR 51592
(1998). My review of the patient records establishes numerous instances
in which Respondent ignored obvious warning signs that her patients
were either personally abusing or diverting. Relatedly, the ALJ did not
make detailed findings regarding the frequency of Respondent's issuance
of new prescriptions even though this was one of the significant issues
in this matter. Moreover, I reject the ALJ's conclusion that Respondent
only falsified H.T.'s patient record once and conclude that substantial
evidence supports the finding that on six different occasions she
falsified his patient record to indicate that she had performed a
physical exam when she had not.
While I acknowledge that Respondent has undertaken some measures to
improve her practice, I am compelled to reject the ALJ's findings that
she has willingly ``admit[ted] her past mistakes,'' and ``accepted
responsibility for her actions.'' ALJ at 162. As explained more fully
below, with respect to the prescriptions she issued to H.T., Respondent
continues to deny that she did anything wrong. Moreover, in her
testimony, Respondent maintained that there is nothing wrong with
persons using a controlled substance that has not been prescribed to
them but to family members and that she did not know what the term
``early refill'' meant even though this was one of the central issues
in this case. Accordingly, I conclude that Respondent has not rebutted
the Government's prima facie showing that granting her a registration
would be ``inconsistent with the public interest.'' 21 U.S.C. 823(f).
Respondent's application will therefore be denied. As ultimate
factfinder, I make the following findings.
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Findings 2
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\2\ In this document I take official notice of several material
facts because the record is unclear. Under the Administrative
Procedure Act (APA), an agency ``may take official notice of facts
at any stage in a proceeding--even in the final decision.'' U.S.
Dept. of Justice, Attorney General's Manual on the Administrative
Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979).
In accordance with the APA and DEA's regulations, Respondent is
``entitled on timely request to an opportunity to show to the
contrary.'' 5 U.S.C. 556(e); see also 21 CFR 1316.59(e). To allow
Respondent the opportunity to refute the facts of which I take
official notice, Respondent may file a motion for reconsideration
within fifteen days of service of this order which shall commence
with the mailing of the order.
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Respondent graduated from New York University Medical School in
1981. Tr. 1346. She has been board-certified in physical medicine and
rehabilitation since 1988, and she has practiced medicine in the State
of Arizona since 1986. Id. Respondent practices as a physiatrist, a
physician who specializes in physical medicine and rehabilitation. Id.
Respondent formerly held DEA registration BH1192359. ALJ Ex. 1, at
1. In August 2001, the Arizona Medical Board initiated an investigation
of Respondent in response to two complaints from health care plans and
one complaint from a pharmacy concerning Respondent's prescribing of
controlled substances. GX 73, at 4. In July 2001, in response to
complaints received from Tucson area pharmacists about Respondent's
prescribing of controlled substances, DEA also initiated an
investigation. GX 70, at 3. On May 16, 2002, DEA, along with law
enforcement officers from other agencies, executed a search warrant at
Respondent's registered location, Calmwood Medical in Tucson, Arizona.
Id. at 20-21. On November 1, 2002, my predecessor immediately suspended
Respondent's DEA registration. ALJ Ex. 1, at 1.
On March 26, 2003, a Federal grand jury indicted Respondent,
charging her with numerous violations of Federal law. See GX 5.
Thereafter, Respondent and the Government agreed to a plea bargain; and
on January 29, 2004, Respondent pled guilty to four counts of Accessory
After the Fact to Possession of Controlled Substances by
Misrepresentation, Fraud, Forgery, Deception, or Subterfuge. GX 6, at
1.
The Consent Agreement With the Arizona Medical Board
On March 10, 2004, following the entry of the plea agreement on
January 29, 2004, Respondent entered into a Consent Agreement For
Decree of Censure And Probation with the Arizona Medical Board (``the
Board''). See GX 73. In the consent agreement, the Board noted that its
staff had reviewed twenty-three patient charts and that the Board's
outside consultants had reviewed these charts and were critical of
Respondent's practices in prescribing opioids. Id. at 4. The Board
specifically found that: (1) Respondent ``often failed to obtain
adequate medical histories or perform adequate physical examinations''
before prescribing controlled substances to the patients, (2) that much
of her ``medical histories came from information provided by the
patients themselves,'' (3) that in some cases she ``failed to further
substantiate actual diagnoses and physical findings with prior medical
records,'' and (4) that sometimes she ``failed to obtain histories of
previous drug abuse or monitor for signs of current drug abuse.'' Id.
at 4.
The Board also found that in prescribing controlled substance
medications, ``Respondent [often] failed to maintain adequate records
on the patients.'' Id. More specifically, the Board found that
Respondent's ``written notes often did not provide sufficient
information to support the diagnoses, justify the treatments,
accurately document the results and indicate advice and cautionary
warnings provided to the patients.'' Id. The Board also found that
Respondent ``may have inappropriately prescribed higher than indicated
doses of long- and short-acting opioid medication.'' Id. The Board
further concluded that Respondent had engaged in ``unprofessional
conduct'' under Arizona law for various reasons including, inter alia,
that she had failed or refused to maintain adequate medical records and
had engaged in conduct or practices ``that is or might be harmful or
dangerous to the health of the patient or the public.'' Id. at 6.
Respondent was censured and placed on probation for two years with her
office management and record-keeping practices under monitoring. Id.
The Consent Agreement also provided for another two years of probation
at the time that ``her DEA Certificate is restored.'' Id. at 7.
Respondent completed her initial probation on March 10, 2006. RX 30.
Respondent submitted a letter from the Arizona Medical Board, dated
December 23, 2004, indicating that she was in compliance with the terms
of the order and that Respondent ``has the Board's support to pursue
her DEA reinstatement.'' RX 53. The letter, however, also stated that
``at no time [had Respondent] attempted to divert medications for non-
medical purposes.'' Id.\3\ She also submitted a letter from the Board
dated January 8, 2007, which indicated that her probation terminated on
March 10, 2006, but that new two-year probation would commence ``when
her DEA certificate is restored.'' RX 30. The letter indicated that
Respondent's ``license is currently active without restriction and she
is off probation.'' Id.
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\3\ As explained below, the record in this matter establishes
instances in which Respondent did divert for non-medical purposes.
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The Consent Agreement also had required Respondent to complete ten
hours of Continuing Medical Education (CME) in ``the principles and
practices of pain management or addiction medicine'' before applying
for a new DEA registration. GX 73, at 7. Respondent completed twelve
hours of the required CME by April 2004. RX 53. ``Since January 2004,
she has also acquired 51.25 hours in a wide range of topics relating to
pain management.'' Id.\4\
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\4\ In June 2006, the Arizona Medical Board also reprimanded
Respondent and placed her on probation for two years for performing
``excessive joint and soft tissue injections without adequate
indications and for inadequate documentation of the quantities of
pharmaceuticals injected.'' GX 7, at 12.
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Respondent applied for her DEA Certificate of Registration on
January 28, 2005. ALJ Ex. 1, at 6.
Respondent's Prescribing Practices
The Expert Testimony
Both parties put on extensive testimony relevant to the issue of
whether Respondent's prescriptions were issued in the usual course of
professional practice and were for a legitimate medical purpose.\5\ The
Government's expert was Dr. Bradford D. Hare \6\; Respondent's experts
were Dr.
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Jennifer Schneider,\7\ who testified as an expert in pain management,
and Marylee O'Connor, a Doctor of Pharmacy, who testified as both a
fact witness and expert witness on pharmacy although she was not
formally qualified as such. See Tr. 1137.\8\
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\5\ While much of the testimony of both parties' experts was
couched as to what practices were required to meet the standard of
care, numerous courts have recognized that such testimony is
relevant in determining whether a physician acted in the usual
course of professional practice and for a legitimate medical purpose
in prescribing a controlled substance. See United States v.
Feingold, 454 F.3d 1001, 1012 n.3 (9th Cir. 2006) (in criminal case,
jury can appropriately ``consider the practitioner's behavior
against the benchmark of acceptable and accepted medical
practice''); see also United States v. Alerre, 430 F.3d 681, 691
(4th Cir. 2005) (in criminal case, ``evidence that a physician's
performance has consistently departed from accepted professional
standards supports the proposition that the physician was not
practicing medicine, but was instead cloaking drug deals under the
guise of a professional medical practice'').
\6\ Dr. Hare is an associate professor of anesthesiology and
pharmacology at the University of Utah School of Medicine, where he
is also the director of the pain management fellowship and the vice
president of the Department of Pain Management Services. Tr. 144-45;
GX 47. He is fellowship-trained and board-certified in pain
management. Tr. 145. He has an M.D., special certifications from the
Board of Anesthesiology and Pain Management, and a Ph.D. in
pharmacology. Id.; see also GX 47. He has performed research in pain
management and is currently engaged in the practice of pain
management. Tr. 147-48; see also GX 47.
\7\ Dr. Schneider is board-certified in internal medicine, is
certified by the American Society of Addiction Medicine, and is a
diplomate of the American Academy of Pain Management. Tr. 807; see
also RX K-1, at 1; RX 43, at 1. Respondent hired Dr. Schneider
several months after the DEA executed its search warrant to mentor
Respondent in record-keeping and in pain management. Tr. 808.
\8\ Respondent also introduced a written report from Dr. Sharon
Weinstein, an Associate Professor of Anesthesiology, Neurology and
Oncology at the University of Utah and the Director of Pain Medicine
and Palliative Care at the University of Utah's Huntsman Cancer
Institute. RX 32, at 1. Dr. Weinstein did not, however, testify at
the hearing.
In her report, Dr. Weinstein criticized ``Dr. Hare's judgment
of [Respondent's] pain management practices [as] appear[ing] to be
based at least in part upon * * * assumptions that are erroneous as
stated,'' and than listed what she attributed as being his
assumptions. Id. at 2. It is unclear, however, the extent to which
Dr. Weinstein has accurately characterized Dr. Hare's assumptions,
and in any event, many of her criticisms rely on snippets taken from
his opinions and ignore extensive other evidence in the patient
files that he relied upon.
Dr. Weinstein also opined ``that the prescriptions by
[Respondent] were written in the usual course of professional
practice and for legitimate medical purposes.'' Id. at 1. Because
Dr. Weinstein did not testify and was thus not subject to cross-
examination, her opinion lacks probative force.
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In her decision, the ALJ concluded ``that there was no clear
consensus in the medical community regarding what practices were
required to meet the standard of care during 2001 and 2002.'' ALJ at
151. The ALJ's finding paints with too broad a brush. While it is true
that there were some issues on which the parties' experts disagreed
(e.g., the scope of an appropriate physical examination, the need to
order diagnostic testing, appropriate dosing levels), there was
substantial agreement as to what practices are necessary to meet the
standard of care.\9\
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\9\ Respondent disputed the validity of Dr. Hare, who practiced
in Utah, opining on the standard of care applicable to an Arizona
practitioner. Tr. 1420-21. Even if the standard of care varies from
one State to another (rather than simply between competing schools
of thought within a medical practice specialty), Dr. Hare and Dr.
Schneider (who practices in Arizona) had significant areas of
agreement.
Respondent also disputed whether her prescribing practices
should be evaluated under the standard of care applicable to a pain
management specialist rather than the standard applicable to a
physiatrist. Resp. Br. at 195. In her brief, Respondent apparently
contends that the standard of care applicable to a physiatrist did
not require her to obtain other provider's medical records or to
obtain addiction histories on her patients prior to prescribing
controlled substances. See id. The short answer to this contention
is that the Arizona Medical Board specifically found that
``Respondent failed to further substantiate actual diagnoses and
physical findings with prior medical records,'' and ``failed to
obtain adequate histories of previous drug abuse.'' GX 73, at 4. The
Board further cited these findings as evidence that Respondent had
engaged in unprofessional conduct under Arizona law. Id. at 6.
Respondent's contention is therefore meritless.
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Initial Visit
Dr. Hare testified that at the initial visit, he asks the patient
to characterize the pain and rate it on a scale of 1 to 10. Tr. 155.
Dr. Hare also obtains the patient's medical history and ``drug
history''; as part of the latter, Dr. Hare gathers information on the
patient's history of substance abuse including the use of both
prescription and illicit drugs. Id. at 158. As Dr. Hare testified, he
would ``be more cautious'' in handling a patient with a ``significant
drug abuse history.'' Id. at 158. Dr. Hare also explained that he tries
to get records from other physicians who have treated the patient, as
well as the results of diagnostic studies. Id. at 156-57.
Dr. Hare then performs a physical examination focusing on the area
of the body where the pain is occurring, but which also involves a more
general examination. Tr. 152-53. The examination includes ``a
neurologic examination, an examination for strength, an examination for
reflexes, an examination for tenderness, changes in sensitivity of the
skin, tenderness in muscles, a whole range of different things, again
depending on the nature of what the pain complaint is.'' Id. at 153.
Moreover, his examination would include ``the vital signs, in other
words[,] blood pressure, respiratory rate, heart rate, comments about
just general appearance of the patient.'' Id. Also, as part of his
physical examination, Dr. Hare checks a patient's heart, chest and
abdomen.\10\ Id. at 154.
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\10\ Dr. Hare proceeded to distinguish different types of pain
and the treatments appropriate to them. For instance, myofascial
pain, characterized by ``tender spots in the muscles'' and which is
usually the result of ``an injury of some sort,'' does not respond
well to opioid medication although opioid medication may take the
``edge off a bit.'' Id. at 159. Dr. Hare also discussed neuropathic
pain, ``pain that's due to nerve injury,'' and stated that it ``is a
type of pain again that is first treated not with opioids but * * *
with drugs like tricyclic antidepressants or the anticonvulsive
agents.'' Id. at 160.
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Dr. Schneider (Respondent's expert) testified that in her practice,
she will not treat a patient absent ``old records.'' Tr. 854. Dr.
Schneider explained that the day before the initial visit, her office
calls ``to remind'' patients that if they do not bring records with
them, their physician will be called at the visit and asked to fax the
records. Tr. 854-55. However, she noted that Respondent, as a
physiatrist, would often have the first visit after an injury so that
there would not be prior records of treatment of a particular injury
and so ``it's less essential to start out on day one with old
records.'' Tr. 855.
Dr. Schneider likewise testified as to the importance of obtaining
a patient's substance abuse history. According to Dr. Schneider, a
patient who has a history of substance abuse can still be prescribed
opioids for chronic pain, but the history is a ``relative
contraindication'' for such treatment. Tr. 881. A physician thus needs
to ``get a careful history and * * * have much more stringent
monitoring,'' but, depending on ``the nature of the previous substance
abuse, on how long it's been since the person last abused the substance
and what kind of treatment they had for it,'' a physician could still
safely prescribe controlled substances. Tr. 881-82.
Dr. Schneider testified that her initial appointment usually takes
45 minutes. Tr. 863-64. In that time, she goes through ``the four As.''
Tr. 864. The first ``A'' is analgesia, and Dr. Schneider asks for a
pain rating on a scale of 1-10. Id. The second ``A'' is activities of
daily living, about how the patient is functioning, as ``treating
chronic pain is a lot about function, at least as much as about pain
relief.'' Id. The third ``A'' is adverse effects, such as side effects.
Id. The fourth and final ``A'' is aberrant drug related behaviors,
which is ``anything that's out of the ordinary, like if they say I need
an early refill.'' Tr. 865.
Dr. Schneider also testified that it is medically appropriate for a
physician to prescribe based on a ``focused physical exam.'' Tr. 870.
According to Dr. Schneider, when a physician sees ``somebody for a
particular problem, and this is not just in pain, but this is in any
field, you limit your exam to that part.'' Id. The exam is ``called a
focused physical exam because it is limited to the part of the body
that the person is having trouble with.'' Id.\11\ While the parties
thus disagree as to the proper scope of a physical exam, I assume
without deciding that a focused physical exam is adequate to diagnose a
patient.\12\
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\11\ Dr Schneider also testified that there is no lethal blood
opioid level for non-opioid-na[iuml]ve patients, and that insurance
companies are often the reason why prescriptions may be written for
high volume with low dosing. Tr. 904, 909-11.
\12\ As one of the grounds for her finding that ``there was no
clear consensus'' regarding what was required to meet the standard
of care, the ALJ noted that ``Dr. Hare concluded that the
Respondent's failure to always perform physical examinations or
order tests to verify symptoms constituted inadequate treatment of
the patient for whom she prescribed controlled substances. Yet, Dr.
Weinstein found that Dr. Hare's conclusion rested on the erroneous
assumption that all painful conditions would be objectively
verifiable by a physical exam or test results.'' ALJ at 52.
It is unclear, however, whether the ALJ was referring to Dr.
Hare's testimony regarding the need for the initial exam or for
follow-up exams when patients report new symptoms. If the ALJ's
comment was referring to whether a patient should be physically
examined at the initial visit, even Dr. Schneider indicated that the
exam is part of the standard of medical practice. To the extent the
ALJ was referring to the need for a physician to perform a physical
exam on a subsequent visit when a patient reports new symptoms,
obviously the necessity of performing a further physical exam
depends upon the patient's symptoms and complaint. Accordingly,
whether an exam was required to meet the accepted standard of
medical practice cannot be evaluated outside of the context of a
specific patient.
---------------------------------------------------------------------------
[[Page 8198]]
At the first visit, the physician should create a treatment plan.
Id. at 170. According to Dr. Hare, he ``[t]ypically'' does not
prescribe opioids on the first visit because he lacks other physicians'
records, test results, and the opportunity to consult with other
members in his practice group. Id. at 164. However, it appears this may
be also because Dr. Hare and the other physicians in his practice
``oftentimes see the patient as a group,'' and after evaluating the
patient, discuss among themselves whether they ``have something to
offer that patient.'' Id. Accordingly, to the extent Dr. Hare's
testimony suggests that is outside of the course of professional
practice to prescribe a controlled substance at a patient's first
visit, it is not conclusive.
It was undisputed, however, that ``the appropriateness of
prescribing [controlled substance] medications * * * depends on the
level of medical documentation.'' Id. at 228. According to Dr. Hare,
``[w]ithout the appropriate documentation it's inappropriate to
prescribe the controlled substances.'' Id. at 229.
Titration of Dosing and Follow-up Visits
Both Dr. Hare and Dr. Schneider testified that when any medication
has been prescribed, there will be follow-up visits at which the
physician questions the patient about whether there has been
improvement in his pain level and functionality, whether there have
been side effects, and the continuing benefits of taking the
medication. Id. at 172 & 181 (testimony of Dr. Hare); id. at 864 & 949
(Dr. Schneider's testimony that she reviews the four ``A''s with her
patients at every visit). At follow-up visits, the physician should
question the patient as to whether he is using the medication
appropriately.\13\ Id. The physician should document the patient's
response to medication, functionality, and adverse effects in the
patient chart. Id. at 173; id. at 865 & 951.
---------------------------------------------------------------------------
\13\ Dr. Hare also testified that he asks his patients about
their mood and sleep as chronic pain patients ``almost uniformly * *
* have problems with anxiety and depression.'' Tr. 172. He indicated
that the failure to monitor sleep and mood could cause a physician
to ``miss the boat'' in medicating with opioids. Id. at 182.
---------------------------------------------------------------------------
Moreover, both parties' expert were in agreement that when a
patient is currently not on opioids they should be started at a low
dose and titrated up slowly to achieve pain relief while minimizing the
side effects such as nausea and sedation. Tr. 971-72; see also id. at
177 (testimony of Dr. Hare that ``you don't want to increase too
quickly for fear of overshooting and getting the patient in trouble''
by causing ``dangerous side effects'').
Dr. Hare noted that in the event that the medication is increased,
the usual increase is in the amount of 50 percent of the prior dosage.
Id. at 176. However, according Dr. O'Connor, it is acceptable to
titrate at a rate of ``no more than 50% to 100% every 5 or more days''
so long as the increase in the dose does not cause adverse effects. RX
8, at 2. Moreover, because people respond differently to opioids, there
can be great variability as to the dose necessary to alleviate a
patient's pain. Tr. 972. In treating unrelieved pain, ``there is no
dose which is too high unless the patient has toxicity or side
effects.'' RX 9, at 2.\14\
---------------------------------------------------------------------------
\14\ According to Dr. Hare, if a patient states that the
medications are not working well, ``then we'd have to decide whether
we've just undershot the prescribing or we're dealing with a pain
problem that isn't going to respond to pain medicine.'' Id. at 174.
In the latter case, he would ``make plans to back off on these
opioids and look at other ways to manage the pain.'' Id. While this
testimony suggests the existence of a dispute over the maximum
dosage levels, it is not necessary to resolve this dispute.
---------------------------------------------------------------------------
Managing Patients Who Are Receiving Controlled Substances
Both Drs. Hare and Schneider testified as to the importance of
setting boundaries with patients who are receiving controlled
substances through the use of written agreements. Tr. 161. As Dr.
Schneider testified: ``I have all my patients sign an agreement [which]
lays down the rules and it says that they're [the patients] not to make
any changes in their medications without first consulting me.'' \15\
Id. at 876. Dr. Schneider further explained that if she gives a patient
permission to increase his dose, she documents it. Id. at 877.\16\ If a
patient comes in reporting that he took more medication than
prescribed, Dr. Schneider asks why and if the response is not
reasonable, her ``reaction is * * * to build more structure around
them.'' Id. Sometimes this involves having a family member administer
the medication, id. at 878; it may also involve writing very small
prescriptions and having more frequent visits. Id. at 879. Similarly,
Dr. Hare noted that ``if a patient has overused medication,'' a
physician needs to find out why, and if the patient does not offer a
``good reason, the physician should counsel the patient to use his
medication as prescribed and ``hold them to it.'' \17\ Id. at 163.
---------------------------------------------------------------------------
\15\ Dr. Schneider further explained that there is a ``loss of
control thing that is part of addiction [and] an addict who wants
more medication is not going to be willing to call me in the office
and leave a message and have me call him back four hours later to
tell him that yes, you can take another pill because you're having
more pain.'' Id. at 876.
\16\ Subsequently, Dr. Schneider testified that ``three'' to
``five years'' ago, a lot of people were not aware of pain
agreements and were not using them. Tr. 1012-13. Dr. Hare, however,
testified that the agreements had been in use for as ``as long as''
he could remember and in excess of fifteen years. Id. at 187-88. I
further note that the record contains a pain management agreement
signed by a patient of Respondent in July 2001. See RX 72, at 3-4.
Whether or not the usual course of professional practice requires
that the physician enter into a written agreement setting forth her
expectations and what rules her patient must follow while being
treated, it is undisputed that a physician must carefully monitor
her patients' use of controlled substances.
\17\ The record contains a copy of a pain management agreement
Respondent used in treating R.T. GX 72, at 3-4. The agreement reads
in relevant part:
I understand that if I break this Agreement, my doctor will stop
prescribing these pain-control medicines.
In this case, my doctor will taper off the medicine over a
period of several days, as necessary, to avoid withdrawal symptoms.
Also, a drug-dependence treatment program may be recommended.
I will communicate fully with my doctor about the character and
intensity of my pain, the effect of pain on my daily life, and how
well the medicine is helping to relieve the pain.
I will not use any illegal controlled substances, including
marijuana, cocaine, etc.
I will not share, sell or trade my medication with anyone.
I will not attempt to obtain any controlled substances,
including opioid pain medicines, controlled stimulants, or
antianxiety medications from any other doctor.
I will safeguard my pain medicine from loss or theft. Lost or
stolen medicines will only be replaced at the doctor's discretion.
* * *
I agree to use -------- Pharmacy, located at ------------,
Telephone number ------------, for filling prescriptions for all my
pain medicine.
* * *
I agree that I will submit to a blood or urine test if requested
by my doctor to determine my compliance with my program of pain
control medicine.
I agree that I will use my medicine at a rate no greater than
the prescribed rate and that use of my medicine at a greater rate
will result in my being without medication for a period of time.
I will bring all unused medicine to every office visit.
GX 72, at 3a-3b.
---------------------------------------------------------------------------
[[Page 8199]]
Both Drs. Hare and Schneider testified that they require their
patients to agree to obtain their medications only from themselves and
not from other physicians.\18\ Id. at 161; id. at 963. Dr. Schneider
testified that if she found out that a patient was obtaining drugs from
another source, she would question the patient and determine the
circumstances. Id. at 962. Moreover, if the patient was obtaining the
drugs from another physician, she would call the physician and remind
him that ``the patient has a contract with'' her, which the other
physician knows about because she sends reports to him, and that she
tells the other physician that he ``cannot be prescribing for the
patient.'' Id. at 963. Dr. Schneider added that if the patient does it
again, she ``may discharge them.'' Id. at 964.
---------------------------------------------------------------------------
\18\ Dr. Hare further explained that his agreement provides the
patients with instructions for obtaining refills and also
establishes rules for dealing with a patient's claim that his
medication was lost or stolen. Id. at 161. According to Dr. Hare,
the agreement ``makes it clear that we may or may not choose to
refill the medications under those circumstances.'' Id. Continuing,
he explained that his practice is ``usually pretty flexible'' the
first time a patient reports that his medication has been lost or
stolen and will issue a new prescription while counseling the
patient. Id. at 162. If, however, it happens again, it raises a
concern that the patient is ``overusing their medicine'' and
``perhaps diverting them.'' Id.
---------------------------------------------------------------------------
Dr. Schneider further testified that if a patient is giving drugs
to a family member, she counsels them that this is a felony offense and
she is ``certainly not going to replace a pill that [a patient] ha[s]
one less of because [she] gave it to a family member.'' Id. at 1007.
Moreover, she documents the incident in the patient record. Id. at
1008. Dr. Schneider also noted that it is especially ``egregious'' when
a patient is buying drugs on the street. Id. at 1006.
With respect to requests for early refills, Dr. Hare testified that
``we try to come up with a plan that's going to meet the patient's
needs until the time of the next visit,'' including ``a reasonable type
of medicine,'' and ``a reasonable amount of medication.'' Id. at 163.
Dr Hare further explained that ``[w]e do our refills on a 30-day
basis,'' and we set ``the dates that the refill is supposed to occur *
* * so we have all of that information in our records'' and that this
allows for the physician ``to quickly access * * * and determine when a
refill is appropriate'' and ``when it's not.'' Id. at 164.
To similar effect, Dr. Schneider testified that when a patient ask
for early refills, she discusses with the patient why the refill is
needed and documents this in the patient record. Id. at 949. Moreover,
Dr. Schneider may decline to refill the prescription. She also noted
that she has a page in her charts in which every prescription and the
date of its issuance is recorded so that a refill request can be
properly evaluated to determine whether it is too early.\19\ Id.
---------------------------------------------------------------------------
\19\ Dr. Schneider also testified that many doctors ``simply
write down the prescription they wrote that day in the body of the
records, meaning that the next time the patient comes, they've got
to be rifling back through to see what was the last one.'' Tr. 1001.
---------------------------------------------------------------------------
Dr. Schneider testified that when an anonymous phone call is
received which indicates that a patient is either selling or abusing a
drug, ``[y]ou have to look into it * * * You have to pursue all these
angles.'' Id. at 830. According to Dr. Schneider, ``there are some
times when the information has a lot of validity and you have to follow
it, and when the doctor doesn't that's a bad scene.'' Id. As to a
patient using ``somebody's prescription that happened to be around the
house because they had a bad headache or whatever,'' Schneider
testified that ``counseling them, and advising them, and warning them
and so forth may be enough.'' Id. at 836. However, if in truth it is a
situation of ``an active addiction problem,'' the physician needs to
inform the patient that the addiction will interfere with the
prescribing and ``that they need to get some help with their addiction
problem.'' Id.
Dr. Schneider further testified that there are ``many sets of tools
on the Internet to help pain specialists assess their patients for a
history of addiction and for addiction issues and on how to monitor
them and how to follow them.'' Id. at 824. In addition, a physician
should use such measures as pill counts (i.e., requiring patients to
bring in their prescriptions to determine whether they are taking them
as prescribed) and random drug screening through either blood or urine
tests to determine whether the patient is taking the prescribed
medication and/or taking illicit drugs. See GX 72, at 4 (requiring that
Respondent's patients agree to ``submit to a blood or urine test * * *
to determine my compliance with my program of pain control medicine''
and that they ``bring all unused pain medicine to every office
visit'').\20\
---------------------------------------------------------------------------
\20\ In her testimony, Dr. Schneider vaguely suggested that in
2001-2002, the use of urine drugs screens was not generally accepted
as required by the standard of care. Tr. 1013. In August 1998,
however, Dr. Schneider published an article in which she noted that
required her patients to ``obtain urine drug screens when asked.
This feature of the contract prevents any refusals from the patient
and lets me request a urine screen at any suspicion of drug
addiction problems.'' Jennifer P. Schneider, Management of Chronic
Non-Cancer Pain: A Guide To Appropriate Use Of Opioids, 4 J. Care
Mgmt. 10, 18 (Aug. 1998). Therein, Dr. Schneider also noted the role
of asking a patient ``to bring in partly-used medication containers
for a pill count'' in assessing whether the patient has lost control
over his/her drug use. Id. at 13. In accordance with 5 U.S.C.
556(e), I take official note of Dr. Schneider's article and reject
her suggestion that urine drug screens were not required to meet the
standard of care in prescribing controlled substances by a pain
specialist. Moreover, the Arizona Board found that Respondent had
failed to monitor her patients for signs of current drug abuse. GX
73, at 4.
Dr. Schneider also contended that in 2001-2002, urine drugs
screens were difficult to interpret, in part because of the
difference between opioids (which are semi-synthetic or synthetic)
and opiates (which are derivatives of morphine), and that the
opioids would not show up on a standard urine drug screen and that
the physician had to specifically request that the lab test for
them. Tr. 892. Putting aside whether a competent physician should
have known the difference between opioids and opiates and how to
properly screen for them, in her article she also noted that urine
drugs screens were useful in determining whether a patient is
abusing illicit drugs. Were it the case that Respondent required her
patients to undergo urine drug screens and mistakenly failed to
request the correct test, it would be a relevant consideration.
However, Respondent rarely required her patients to undergo urine
drug screens.
---------------------------------------------------------------------------
Dr. Schneider testified that it is important for a doctor to
communicate with other doctors. Tr. 853. Dr. Schneider sends a copy of
her notes on ``every visit'' to the primary care physician. Id. If she
knows of a patient's ``ongoing relationship with some other specialist
related to their pain problem,'' she also sends a copy of the notes
from every visit. Id. After making a referral to a specialist, she also
requests ``a copy of that report and of imaging studies.'' Id.
Alleged General Practices
At the request of the DEA Investigators, Dr. Hare reviewed the
medical records of Respondent's patients.\21\ GX 46. In his first
report (January 15, 2003), Dr. Hare indicated that he had reviewed the
records of eight patients and found that Respondent's care exhibited
the following ``general problems'':
---------------------------------------------------------------------------
\21\ In a subsequent report, Dr. Hare reviewed the medical
records for an additional seven patients. See GX 46A.
---------------------------------------------------------------------------
Respondent ``failed to adequately evaluate'' patients by
not obtaining an adequate ``pain history'' and by not ``obtaining[ing]
information from previous treatment such as records of treating
physicians and the previous medications used.'' GX 46, at 1. These
would ``have allowed [Respondent] to determine if there had been
problems with medications or patient compliance.'' Id.
Despite the fact that ``[t]he information in
[Respondent's] records was insufficient to make a proper diagnosis,''
Respondent ``prescribed Controlled Substances.'' Id.
Respondent ``did not properly track the use of
medications.'' Id. at 2. She did
[[Page 8200]]
not ``comment on the lack of patient compliance'' when patients used
controlled substances ``in excess of the prescribed amounts.'' Id.
Rather, she ``usually increased the amount of the prescription to meet
the patient's use of medication, rather than exercising any control
over the patient's consumption.'' Id.
Respondent switched from one controlled substance to
another, ``based on patient request, not on what was reasonable
therapeutically.'' Id.
On cross-examination, Respondent admitted that she failed to take
addiction histories. Tr. 2344. However, when asked whether she
routinely failed to obtain prior medical records, she stated that
``there is no obligation or rule that you have to get medical
records.'' Id.; but see GX 73, at 4 (State Board's finding that
``Respondent failed to further substantiate actual diagnoses and
physical findings with prior medical records.''). She stated that in
many cases she did get parts of medical records. Id. at 2345. She
admitted that others might not always be able to ``glean'' her
rationale for increasing opioid dosages from her records. Id. at 2346.
When asked whether she often issued early refills on controlled
substance prescriptions without documenting the reason in her medical
records, Respondent said that she did not know what the term ``early
refill'' meant. Id. at 2345-46. She indicated that she did not find
doing frequent MRIs useful, that with chronic pain that was just a
waste of medical resources. Id. at 1381.
Respondent testified that she always did an evaluation on new
injury cases, that there was always a physical examination, and that it
was always documented. Id. at 2347-48. She testified that she did not
ignore that some patients had histories of addiction and that she did
not ignore warning signs of addiction or abuse. Id. at 2348-49. She
admitted that she was not in contact with primary care physicians in
all cases, but she also justified that in the case of J.N., noting that
her primary care physician wasn't practicing due to a licensing issue.
Id. at 2349. Respondent admitted that on occasion she failed to
document the reason for increasing an opioid dose. Id. at 2351.
Respondent also stated that she did not believe in reprimanding
patients when she found out that they were giving their controlled
substances to another person. Id. at 2393-94. She compared the
situation to one where a diabetic patient is not following his diabetic
diet. Id.
Evidence Regarding Specific Patients
J.N.
On September 11, 2000, J.N., who was then forty-three years old and
who undergone a cervical fusion in 1994, started treating with
Respondent. GX 9, at 1. She ``had been sexually assaulted and suffered
[a] cervical fracture and needed emergency surgery.'' Id. Her pain had
recently worsened, and Respondent noted in her medical record that she
``need[ed] another cervical fusion.'' Id. J.N. had been on disability
since 1994. Id.
There is no indication in J.N.'s patient record that Respondent
inquired about any history of substance abuse at the initial visit. Id.
at 1-2. At the first visit, Respondent performed a physical exam and
diagnosed J.N. as having ``[s]evere neck pain,'' ``left upper extremity
pain,'' and ``signs of left cervical radiculopathy.'' Id. at 2.
Respondent gave J.N. a free trial of 21 tablets of OxyContin 40 mg q8h
\22\ (one tablet every eight hours), 50 tablets of Oxycodone IR ``1-2
q4h PRN for breakthrough pain,'' and a prescription for 60 tablets of
Xanax 0.5 mg twice a day, with one refill, although nothing in the
patient record documented that J.N. experienced anxiety. Id. at 2.
Respondent was to ``[r]echeck in 1 week.'' Id.
---------------------------------------------------------------------------
\22\ The record establishes that ``q'' means every, and that
``h'' means hour(s), and ``hs'' at bedtime. See Tr. 1122 & RX L, at
6; Tr. 1151 & GX 9, at 8; Tr. 1165 & GX 13, at 6; Tr. 1175. Thus,
``q4h'' means every four hours, ``q6h'' means every six hours,
``q8h'' means every eight hours, and ``q12h'' means every twelve
hours. See Tr. 1122 & RX L, at 6; Tr. 1175; id. at 1151 & GX 9, at
8. In addition, the abbreviation ``BID'' means ``twice a day,'' Tr.
355 & RX 13, at 1; ``TID'' means ``three times a day,'' Tr. 403 & RX
13, at 1; and ``QID'' means ``four times a day.'' Id. at 358 & GX
22, at 18. The abbreviation ``PRN'' means ``as needed.'' Id. at
1174. It is also undisputed that prescribing in excess of 4 grams or
4000 mg. per day of drugs containing acetaminophen risks liver
toxicity. See id. at 403-04.
---------------------------------------------------------------------------
On September 15, Respondent noted that J.N. ``is better on the
OxyContin and Oxycodone. She feels less pain,'' yet Respondent
increased the OxyContin prescription to 60 (160 mg.) tablets, with one
tablet to be taken every eight hours, (a twenty-day supply), which was
a four-fold increase in the dosage over the initial prescription. Id.
Respondent also issued prescriptions for 50 milliliters of Oxyfast 20
mg/ml, ``1-2 ml q4h PRN breakthrough pain,'' 360 tablets of MS Contin
100 mg., (4 tabs q8h), as well as 100 milliliters of morphine elixir
``20 mg/ml 5 ml q6h PRN breakthrough pain.'' Id. at 2-3. Respondent
noted that the latter two prescriptions were being issued in ``[i]n
case Pima insurance doesn't cover'' the other medications. Id.
Respondent also increased the dosage of Xanax four-fold to 2 mg. twice
a day, again without any finding regarding anxiety. Id.
J.N. returned on October 5 and reported that she was ``much better
than she has been because of the MS Contin,'' and Respondent wrote
prescriptions for MS Contin at the same dosing and also MSIR (morphine
sulfate immediate release) ``30 mg 6qh PRN breakthrough pain
120,'' to ``recheck in one month.'' Id. at 3. Respondent also
added a prescription for ten tablets of Dilaudid 4 mg., 1-2 four times
a day. Id. On October 25, J.N. reported that the medications helped
with her pain and with sleep and that she would like more Dilaudid. Id.
She also reported having had an EMG/NCV with a Dr. L. on September 14,
but did not know the results. Id. at 4. Respondent wrote prescriptions
for Dilaudid, MS Contin, MSIR, as well as Fioricet for ``headache.''
\23\ Id. at 4. J.N. continued on Dilaudid, MS Contin, Xanax and
Fioricet through June 14, 2001. Id. at 4-9.
---------------------------------------------------------------------------
\23\ The patient record also indicated that Respondent issued
her a prescription for Amoxicillin, a non-controlled drug.
---------------------------------------------------------------------------
J.N.'s patient record includes a Discharge Summary from University
Medical Center in Tucson, Arizona, which was faxed to Respondent on
January 16, 2001. Notably, the first page states that JN had a
``history of IV heroin abuse''. Id. at 13. Continuing, the Summary
stated that ``she quit several years ago, but started using again one
week ago because of increasing abdominal pain.'' Id. at 13-14. The
Summary also noted that a urine toxicology screen was ``positive for
opiates, barbiturates, benzodiazepines, and marijuana.'' Id. at 15.
The Discharge Summary listed five medical problems J.N. had
including ``Chronic pain/narcotic addiction.'' Id. at 15-16. The
Summary specifically noted that J.N. was ``preoccupied with her pain
medications, requesting p.r.n. medications frequently'' and was
``resistant to weaning attempts.'' Id. Moreover, while the hospital
offered J.N. ``drug abuse placement,'' she ``refused,'' stating that
``she was not an addict, and was only unable to get off Morphine due to
her medical condition.'' Id. at 16. The Summary also noted that on
discharge, J.N. was given MS Contin, Dilaudid and Xanax in the doses
that she had been receiving from Respondent and in quantities that
would last until she could see her pain specialist. Id.
While the patient record indicates that Respondent was notified on
[[Page 8201]]
December 4, 2000 that J.N. had been hospitalized, GX 9, at 5, she did
not obtain the Discharge Summary for another month. Moreover, J.N.'s
medical record contains a note dated January 24, 2001, that Respondent
``received records from UMC and discharge diagnosis was sludge in
gallbladder''; the note contains no mention of either the results of
the drug screen done by the hospital or of J.N's statement to the
hospital staff that she had recently started using heroin again. Id. at
6.
J.N.'s record contains no indication that Respondent attempted to
monitor her use of controlled substances through drug screens and pill
counts. See generally id. Moreover, the medical record contains no
indication that Respondent questioned J.N. about her use of marijuana,
heroin, or the barbiturate (which Respondent had not prescribed to
her).
On subsequent visits, Respondent primarily prescribed 120 tablets
of Dilaudid 4 mg. (QID--one tablet four times a day), 180 tablets of MS
Contin 200 mg. (two tablets every eight hours), Xanax 2 mg. (BID -one
tablet twice a day), and Restoril (temazepam) (two tablets at bed
time).\24\ Id. at 5-9. After J.N.'s hospitalization, all of the MS
Contin prescriptions and all but two of the Dilaudid prescriptions were
for a quantity equaling 30 days of dosing. See id. Approximately half
of the Dilaudid and MS Contin prescriptions were refilled at least five
days early, with some being refilled as early as eight or nine days
before the previous prescription would have run out. See id. (Rxs for:
180 MS Contin on 12/18, 1/11, 2/1, 2/26, 3/20, 4/19, and 5/14; for 120
Dilaudid on 1/11, 2/1, 2/26, 3/20, 4/19, and 5/14).
---------------------------------------------------------------------------
\24\ Both Xanax (alprazolam) and Restoril (temazepam) are
benzodiazepines and schedule IV depressants. See 21 CFR 1308.14(c).
---------------------------------------------------------------------------
J.N. died of an overdose on June 18, 2001. According to a police
report, ``several syringes were found at the scene,'' as well as
various drugs including hydromorphone and morphine sulfate.\25\ GX 8,
at 18. The police also found a white powder in the living room and were
told by J.N.'s boyfriend that the two of them would mix ``her
prescription medication with water and inject it using the used
syringes.'' GX 8, at 19. Moreover, in an interview with investigators,
J.N.'s boyfriend stated that she would crush up the Dilaudid
(hydromorphone) she obtained from Respondent and inject it. GX 43, at
11. J.N.'s boyfriend also related that ``[s]he didn't have veins'' and
that it was very hard to get blood from her. Id. at 22. Yet there is no
indication in J.N.'s medical record that Respondent ever noticed this.
See generally GX 9.
---------------------------------------------------------------------------
\25\ According to the police report, twenty syringes were found,
several of which had been opened. GX 8, at 18-19. In addition to
hydromorphone and morphine sulfate, the police found Duramorph,
methocarbamol, Pancrease, Zyprexa, Naproxen, and Cimetidine. Id. at
18.
---------------------------------------------------------------------------
The Medical Examiner determined that the cause of J.N.'s death was
``acute intoxication due to the combined effects of opiates,
cyclobenzaprine, and amitriptyline.'' GX 8, at 2. Respondent disputed
the Medical Examiner's conclusion. One of her experts (Dr. Schneider)
maintained that it was not ``black and white that a morphine overdose
was her cause of death,'' and indicated (in response to Respondent's
question whether her opinion would change if J.N. had been on the same
dose of extended release morphine for the previous ten months), that
unless J.N. had ``suddenly taken a lot more'' of the drug, she would
question whether J.N.'s death was caused by a morphine overdose. Tr.
921-22. Dr. Schneider was not asked, however, whether her opinion would
be different if J.N. had taken the drug intravenously.
Relatedly, another of Respondent's experts (Dr. O'Connor) testified
that J.N.'s taking of the cyclobenzaprine and amitriptyline (neither of
which was prescribed by Respondent) would have ``certainly'' caused her
to have a heart attack. Id. at 1154. Yet the Medical Examiner did not
note any evidence of a heart attack. See generally GX 8. Moreover, when
Respondent asked her whether there are ``any interactions between
opiates, such as morphine, and * * * amitriptyline or
cyclobenzaprine,'' the witness answered:
Certainly in [an] opioid-na[iuml]ve patient, if they took * * *
Tylenol with codeine, and then they took some cyclobenzaprine or
flexeril on top of that * * * they might get more sleepy. The same
goes for amitriptyline or tricyclics. In an opioid-tolerant patient,
no.
Tr. 1157. The expert's testimony does not make clear whether her answer
as to the effect that would occur in an opioid-tolerant patient applies
to a patient taking opiates other than Tylenol with codeine, a drug
which is far less potent than either MS Contin 200 mg. or Dilaudid.
Furthermore, the Medical Examiner did not conclude that J.N.'s death
was caused solely by her use of morphine, but rather, the combined
effects of opiates and the other two drugs.\26\ GX 8, at 2.
---------------------------------------------------------------------------
\26\ Respondent also introduced into evidence an article
discussing a survey of blood levels of opiates in opioid-tolerant
patients. See RX 39. More specifically, Respondent pointed to a
table which indicated that a patient with a Morphine SR blood level
of 2837 ng/ml, a level which was higher than that found in JN (2374
ng/ml) following her death, was capable of functioning. Compare RX
39, at 4 with GX 8, at 10. Respondent did not, however, offer any
evidence that she conducted blood tests of J.N. while she was alive
to show what level she was functional act.
---------------------------------------------------------------------------
In any event, it is not necessary to resolve the factual dispute.
Even if J.N's intravenous use of either Dilaudid or MS Contin did not
contribute to her death--it just being a coincidence that syringes and
crushed medication were found in the vicinity of her body--the evidence
nonetheless clearly established that she was abusing drugs, that
Respondent had reason to know that she was abusing drugs, and that
Respondent failed to properly supervise her use of controlled
substances.
With respect to the discharge summary, which clearly indicated that
J.N. was abusing drugs, Respondent testified that she failed to read
the entire hospital discharge summary because it ``was a lot of
pages.'' Tr. 2367. According to Respondent, she ``looked at the
beginning'' and ``looked at the end'' of the document but that the
reference to J.N.'s heroin abuse was ``buried in'' the report. Id. at
1850 & 2367-68.\27\
---------------------------------------------------------------------------
\27\ Respondent testified that, despite being aware of the
addiction history, the attending physician had continued the
medications that she prescribed for JN--MS Contin 400 mg., Dilaudid
2 mg., and immediate release morphine 30 mg. Tr. 2368; GX 9, at 13.
The Respondent was also listed as J.N.'s pain specialist in the
discharge report. GX 9, at 13.
---------------------------------------------------------------------------
The discharge summary was, however, only five pages in length (and
the fifth page did not contain any medical information). See GX 9, at
13-17. Moreover, the reference to J.N.'s ``history of IV heroin abuse''
was on the bottom of the first page. See id. at 1.
In her testimony, Respondent also maintained that that she was
unaware that J.N. had crushed and injected her medication until she
inferred it from a question DI Llenas asked her the day of the search
warrant in May 2002. Tr. 2377. Yet other evidence indicated that J.N.
had no veins and that it was difficult to draw blood from her,
something which Respondent apparently never noticed.
With respect to J.N.'s initial visit, Dr. Hare concluded that
Respondent ``failed to obtain [an] adequate history * * * and [that]
she did not obtain records from * * * the neurologist, by whom the
patient had been evaluated,'' that she conducted a ``minimal and
inadequate physical examination,'' and that ``the evaluation was
inadequate to allow proper diagnosis and therefore the prescribing of
controlled substances.'' GX 46, at 4. As to J.N.'s second visit, Dr.
Hare's review of her patient record noted that her ``already large dose
of
[[Page 8202]]
OxyContin'' was ``dramatically increased'' ``six-fold'' \28\ on
September 15, 2000, ``despite the patient's improvement.'' Id. He also
noted that the strength of the alternative prescription that was
written for MS Contin 100 mg. would ``translate to about 8 times the
original OxyContin [sic] dose.'' \29\ Id. at 5.
---------------------------------------------------------------------------
\28\ Dr. Hare noted that the OxyContin 160 mg. was to be taken
every four hours, but the patient chart indicated only every eight
hours. I find that the dose increase was four-fold, not six-fold.
\29\ In a patient narrative that Respondent wrote on C.O., which
was included in C.O.'s medical record, Respondent wrote of her
prescribings that ``[t]he dose was increased by approximately 50%-
100% at a time, when necessary, as is the appropriate way to titrate
opioids.'' GX 36, at 35.
---------------------------------------------------------------------------
Dr. Hare further noted that on January 11, 2001, the patient record
``indicate[d] that the patient's [niece] died and that the patient was
quite distressed.'' Id. He also remarked that ``[t]his was the very
first mention in the records of anxiety and depression, even though the
patient had been treated with Xanax for a considerable period of time
prior to this.'' Id. Dr. Hare also noted that on several occasions
Respondent prescribed medications for J.N. that other doctors, in other
specialties, had previously prescribed for J.N., without attempting to
coordinate care with those physicians. Id.
Dr. Hare also observed that Respondent did not notice signs of
abuse, did not acknowledge the Discharge Summary's information about
J.N.'s current abuse and history of substance abuse, and failed to
treat J.N. for depression or give a psychiatric referral.\30\ Id. at 6.
Dr. Hare thus concluded that Respondent's care of J.N. was
``substandard'' and ``probably negligent.'' Id. at 6.
---------------------------------------------------------------------------
\30\ Respondent testified that she made efforts to refer J.N. to
a psychiatrist but did not record that in the patient file. Tr.
2356.
---------------------------------------------------------------------------
With respect to J.N. (as well as three other patients N.F., W.F.,
and C.O.), Dr. Schneider observed in her report that:
All had evidence of ``aberrant drug-related behaviors'' which
should have been pursued but weren't, and all received early refills
without adequate documentation. These charts certainly showed
problems which indicated that [Respondent] needed additional
education about obtaining an addiction history, careful monitoring,
and review of the ``big picture.''
RX K-1, at 6.
W.F.
W.F. first visited Respondent in September 2001. At that time he
was a disabled 44-year-old veteran. GX 13, at 1. W.F. had been in a
severe jeep accident in 1973 while in the Marine Corps, fracturing his
pelvis, femur, right wrist and left mandible. Id.; Tr. 1958. He walked
with crutches. GX 13, at 1.
At the first visit, W.F. brought in an impairment rating from the
Veteran's Administration (VA) establishing that he was disabled. Id.
Respondent did not, however, contact the VA to obtain copies of his
treatment records. Id. Nor is there any indication in the patient
record that Respondent inquired about W.F.'s substance abuse history at
the initial visit, nor is there any indication that she asked for pain
ratings. See id. Respondent's physical exam involved observing W.F.
walk with his crutches, noting that he had ``severe pain with lumbar
range of motion,'' ``tenderness over bilateral lumbar paraspinals,''
and ``tenderness over [his] right wrist and pain with right wrist range
of motion.'' Id.
W.F.'s patient file includes several letters which advised
Respondent that he had a history of substance abuse. The first letter,
which was dated January 8, 2002, was written by Dr. H.G., a
psychiatrist with Cope Behavioral Health. GX 13, at 13. Therein, Dr.
H.G. explained that W.F. was ``currently under court ordered treatment
by the Psychiatric Security Review Board which mandates that all [of]
his medications are to be prescribed by either psychiatrists at Cope *
* * or by the VA.'' Id. The letter further states that W.F.'s ``case
manager * * * has recently learned that [he] was receiving narcotics &
psychotropics from your office; unfortunately, this history has
repeated itself to poor outcomes in the past for [W.F.] (addiction
issues).'' Id.
On January 24, 2002, Dr. H.G. sent another letter to Respondent.
Id. at 15. Therein, he indicated that it was permissible for Respondent
to prescribe for W.F. because he could not get an appointment at the VA
until April. Dr. H.G. noted, however, that ``[a]lthough he currently
denies symptoms of abuse, please be aware he has had narcotics
addiction problems in the past.'' Id. at 15.
Finally, on January 28, 2002, J.G., a case manager at Cope
Behavioral Health, indicated that Cope had ``received a phone call this
afternoon from a family member of [W.F.], who is concerned that [W.F.]
might be abusing his pain meds.'' Id. at 17.
The patient record contains some indication that on January 29,
2002, Respondent discussed addiction issues with W.F., as Respondent
wrote: ``[p]atient insists that the medications help with the pain, and
he cannot function without the medications.'' Id. at 5. Respondent
wrote prescriptions for 100 Methadone 10 mg. 1-2 QID (one to two
tablets four times a day) and 100 Roxicodone 30 mg. q4h PRN (one tablet
every four hours as needed for pain). Id. at 6. Respondent issued the
same prescriptions on February 11, 2002. Respondent had also previously
written prescriptions for temazepam with multiple refills on October
29, 2001, and December 17, 2001. Id. at 3, 5.
On February 24, 2002, W.F. was found dead. The Medical Examiner's
report concluded that W.F. ``died of undetermined cause. Possibilities
include seizure related and drug intoxication.'' GX 11, at 2. A
toxicology report found that W.F. had a temazepam level of 1148 ng/ml;
id. at 14, however, the Medical Examiner subsequently indicated in a
letter to Respondent that this level of the drug ``would not be
expected to cause death.'' RX 52. The Medical Examiner also found that
``[o]ther drugs identified in his body were in too low a concentration
to allow me to come to the conclusion that death was likely the result
of the combination of drugs, including Temazepam.'' Id. Relatedly, the
toxicology tests found only a small amount of oxycodone and no presence
of methadone in W.F. GX 11, at 9-15.
Dr. Hare observed that at the initial visit, Respondent did not
obtain an adequate medical history and did not inquire about substance
abuse issues. GX 46, at 3. Also, ``the physical examination was minimal
and inadequate to characterize various pain complaints.'' Id. Dr. Hare
also faulted Respondent, who then knew of the history of substance
abuse, for not limiting W.F.'s medication and not ``requesting
toxicology screens * * * to determine if he was using medications other
than those she prescribed, or actually using the medication she was
prescribing.'' Id. at 4. Dr. Hare further noted that the toxicology
report done as part of the autopsy ``was negative for opioids which he
had been prescribed in sizable amounts'' and that ``[t]he lack of
opioids would suggest that the patient was diverting significant
portions or the entire prescriptions.'' Id.\31\ He concluded that
Respondent's care was ``substandard and inappropriate regarding the
controlled substance prescriptions.'' Id.
---------------------------------------------------------------------------
\31\ The ALJ's findings contrast this with an excerpt from Dr.
Weinstein's report in which she wrote: ``Dr. Hare states,
`considering the huge amounts of medications and lack of side
effects, the patient was likely diverting,' an inference that cannot
be made from therapeutic information alone.'' ALJ at 82. I note that
this comment was made in response to the patient file of a patient
other than W.F. Given that the toxicology screen found no evidence
of methadone, a drug with a very long half life, it is reasonable to
infer that W.F. was not been taking the medication prescribed but
rather was diverting it. Moreover, W.F. was identified by Dr.
Schneider as a patient who had likely engaged in aberrant drug-
related behavior. RX K-1, at 6.
---------------------------------------------------------------------------
[[Page 8203]]
On cross-examination, Respondent testified that she had heeded the
psychiatrist's warning about the past heroin addiction and also his
``judgment'' that pain medications were appropriate.\32\ Tr. 2382. She
admitted that she never did an addiction history. Id. In her testimony,
Respondent did not, however, respond to Dr. Hare's contention that her
physical exam was minimal and inadequate.
---------------------------------------------------------------------------
\32\ Relatedly, the ALJ quoted Dr. Weinstein's report that
Respondent ``had received communication from a treating
psychiatrist, agreeing that the medications she was prescribing for
their mutual patient were appropriate.'' ALJ at 80 (FOF 289; quoting
RX 32, at 3). Dr Weinstein also wrote, ``In this instance,
[Respondent] had a concurring opinion from a psychiatrist for her
management plan.'' RX 32, at 3.
This is a fundamental mischaracterization of the evidence as
there is no indication in W.F.'s file that Respondent had a plan to
manage his use of controlled substances. Moreover, Dr. H.G.'s letter
merely stated that because W.F. could not see the VA for another
three months, he was ``in agreement that he should see you until his
appointment.'' GX 13, at 15. Moreover, Dr. H.G. and his staff
repeatedly cautioned Respondent about W.F.'s narcotics abuse
history. See id. at 13-15. This is hardly a concurrence in whatever
prescriptions Respondent would write.
---------------------------------------------------------------------------
The ALJ credited Respondent's testimony that oxycodone is a short-
acting medication and that half of it is gone after two hours. ALJ at
82 (citing Tr. 2165). The ALJ also credited Respondent's testimony that
it was ``quite possible that a patient could take a level of less than
five,'' and that this ``doesn't mean that a person is not taking his or
her oxycodone.'' Id. Respondent did not, however, address why there was
no methadone, a medication with a much longer half-life than oxycodone,
in W.F. at the time of his death.
W.F. was one of those patients about whom Dr. Schneider concluded
that there was ``evidence of `aberrant drug-related behaviors', which
should have been pursued but weren't.'' RX K-1, at 6. Dr. Schneider
further noted W.F. had ``received early refills without adequate
documentation and explanations,'' and that Respondent's charts
indicated that Respondent ``needed additional education about obtaining
an addiction history, careful monitoring and review of the big
picture.'' Id.
M.D. and S.R.
M.D. and S.R., who were both patients of Respondent, were unmarried
but lived together. M.D. first visited Respondent on May 21, 2001, when
he complained of having ``fallen off a bicycle'' and of a ``back and
leg injury.'' GX 17, at 1. M.D. further related that another physician
had prescribed to him OxyContin 80 mg. (at a dosing of one tablet every
twelve hours), Oxyfast, and methadone, but that the physician had left
the office and that he had been off the drugs for several months. Id.
Respondent did not, however, attempt to contact the other physician's
office to verify the statement and/or to obtain treatment records.
Respondent's physical exam noted that M.D. was a ``lethargic male
in no acute distress with antalgic limp, favoring left lower
extremity,'' ``pain with range of motion of the left ankle,''
``tenderness over bilateral thoracic and lumbar paraspinals,'' and
``decreased lumbar range of motion associated with pain.'' Id.
Respondent did not, however, otherwise indicate how severe M.D's pain
was. Id. Respondent also had M.D. sign a pain contract and issued him
prescriptions for 60 OxyContin 80 mg. q12h, 30 milliliters of Oxyfast,
and 30 tablets of Oxycodone 5 mg. PRN. Id.
Later the same day, Respondent documented having received a phone
call (apparently from a pharmacy) reporting that M.D. was ``known to
forge prescriptions and was arrested.'' Id. at 2. Respondent notified
the pharmacy where M.D. had indicated on the pain contract that he
would fill his prescriptions not to fill them. Id. M.D., however,
filled the OxyContin prescription at a Walgreen's pharmacy. Id.
On June 8, 2001, M.D. returned to Respondent seeking a new
OxyContin prescription. Id. M.D. reported that he was taking double the
dose of the OxyContin. Id. He also did not remember what had happened
at the pharmacy which had reported him to Respondent. Id. Respondent
refused to issue the prescription. Id.
There are no further visits recorded in M.D.'s patient record. Id.
The record indicates, however, that on October 8, 2001, the patient
pharmacy manager at Tucson Medical Center reported that M.D. had been
admitted to the hospital in a coma seven days earlier and had in his
possession methadone 40 mg. tablets which were contained in a
prescription bottle; the label indicated that the prescription was for
Dilaudid 4 mg. and had been issued by Respondent to S.R.\33\ Id.
---------------------------------------------------------------------------
\33\ On January 6, 2002, M.D. was found dead at his residence.
GX 18, at 3. The Medical Examiner found that M.D.'s death was caused
by ``opiate, cocaine and methadone intoxication.'' Id. at 2.
Respondent had not seen M.D. in seven months.
---------------------------------------------------------------------------
S.R. first saw Respondent on August 3, 2001, complaining of
abdominal and pelvic pain. GX 15, at 1. S.R. reported that she had a
history of interstitial cystitis and active hepatitis C, but apparently
she did not bring records about either condition with her. See id. S.R.
indicated that she was taking Xanax and Vicodin, which she obtained
from another doctor. Id. She also stated that she was taking her
deceased husband's OxyContin and Dilaudid.\34\ Id.
---------------------------------------------------------------------------
\34\ This incident of diversion furnished the basis of one of
the counts of Accessory After the Fact in Respondent's plea
agreement. See GX 6, at 7.
---------------------------------------------------------------------------
Respondent's physical exam indicated that S.R. was ``in moderate
distress,'' that she had ``pain with ambulation and limp,'' and had
``tenderness over [her] abdomen.'' Id. Respondent diagnosed S.R. as
having ``interstitial cystitis and chronic pain,'' as well as Hepatitis
C. Id. Respondent discussed the risks and benefits of long-acting
opioids, including addiction and side effects, and prescribed Dilaudid
2 mg. ``QID 30,'' OxyContin 10 mg. ``q12h 30,'' and
Xanax 0.5 mg. ``TID PRN 90.'' Id. There is no indication that
Respondent contacted the physician who had prescribed Vicodin and Xanax
to her. See id. Moreover, there is no indication as to why she
prescribed Xanax, an anti-anxiety drug. Nor did she counsel S.R. about
the use of her deceased husband's medications. Tr. 2353.
S.R. returned seventeen days later, reported that she was out of
Dilaudid and OxyContin, and asked for stronger medication. GX 15, at 1-
2. Respondent found that S.R. had ``pain with ambulation and limp'' and
``tenderness over [her] abdomen.'' Id. at 2. Respondent increased both
the strength and quantity of the Dilaudid to 4 mg. ``QID 60,''
and the strength of the OxyContin to 20 mg., with the same dosing and
number of tablets (``q12h 30''). She also issued a new
prescription for Xanax, 0.5 mg., TID PRN 90. Id. at 2.
On September 4, 2001, S.R. again saw Respondent. Respondent noted
that S.R.'s urologist had ``diagnosed interstitial cystitis,'' and that
she needed to ``obtain records from Dr. [M].'' Id. Respondent also
noted that while S.R. ``gets abdominal pain,'' ``she is more
comfortable.'' Id. Respondent again wrote prescriptions for Dilaudid
and OxyContin, doubling the strength of the latter to 40 mg. with the
same dosing instruction of ``q12h.'' Id.
On September 18, S.R. complained of ``continued pain'' and wanted a
higher dose of OxyContin even though she was ``more comfortable.'' Id.
Respondent doubled the strength of the OxyContin to 80 mg. ``q12h
30'' and also wrote a prescription for 60 Dilaudid 4 mg. Id.
at 3. Respondent noted that she ``sent another request for records from
Dr. [M].'' Id.
On October 2, Respondent discontinued OxyContin in favor of MS
Contin, 100 mg. ``q8h 100,'' which was ``less expensive,'' and
also wrote a
[[Page 8204]]
prescription for Dilaudid. Id. She also issued S.R. a prescription for
100 Xanax (1 mg.), with two refills, which was double the strength of
the previous prescription, after S.R. had claimed that ``the pills got
wet and they dissolved.'' Id. Respondent also noted that S.R. ``has
severe anxiety and needs the Xanax'' and was complaining of abdominal
pain. Id. The next day Respondent gave S.R. a prescription for 200
Methadone 10 mg. ``3 tabs QID'' for pain when S.R. returned, having not
filled the MS Contin prescription due to its cost. Id.
On October 8, Respondent received the phone call described above
reporting that M.D. had been admitted in a coma seven days earlier. Id.
at 4. At S.R.'s next visit, which was on October 12, Respondent
``explained to [her] that she must be very careful with her
medications.'' Id. According to the patient record, S.R. ``denie[d]
that [M.D.] could have ever gotten his [sic] medications.'' Id.
Respondent reported that S.R. was still complaining of abdominal pain
and issued her a new prescription for 60 Dilaudid 4 mg. Id. Moreover, a
week later, Respondent issued S.R. a new prescription for 200 Methadone
10 mg. Respondent did not institute any kind of monitoring on S.R.'s
use of her medication. Id.
On November 2, S.R. returned ``complaining of abdominal pain.'' Id.
Respondent referred her to another physician ``for interstitial
cystitis treatment and work-up.'' Id. Respondent also wrote S.R.
prescriptions for 60 Dilaudid 4 mg. and 200 Methadone 10 mg. Id.
On November 19, S.R. returned to obtain more ``prescriptions, and
[was] very irate that they weren't ready.'' Id. Respondent explained
she would not write prescriptions for more opioids without further
documentation of S.R.'s condition. Id. at 5. Respondent also noted that
S.R. had indicated that she had not seen the physician who was to
evaluate her for cystitis because her primary care doctor had not
authorized the visit. Id.
On December 4, the patient record indicates that S.R. ``HA[d]
CALLED FOR THE PAST 3 DAYS REQUESTING RX--EVERYONE HAS EXPLAINED TO HER
THAT UNTIL MEDICAL RECORDS ARE RECEIVED TO CONFIRM HER CONDITION RX
WILL NOT BE WRITTEN PER [Respondent].'' Id. S.R. offered money for the
prescriptions and said that she would go back to Detroit to pick up her
medical records ``BUT NEED[ED] MEDS TO GO.'' Id. Respondent told her to
go to her primary care physician to get the prescriptions. Id. The
final entry, December 14, indicates that S.R.'s medical records were
printed out for her to pick up. Id.
Dr. Hare did not review M.D.'s patient file, but he did review
S.R.'s. Dr. Hare found that Respondent performed only a ``minimal''
physical examination and did not insist on getting documentation of the
diagnosed interstitial cystitis and hepatitis until she had treated
S.R. for several months. GX 46A, at 13. He indicated that Respondent's
``evaluation of the patient was insufficient to justify the prescribing
of controlled substances.'' Id. at 14. Dr. Hare further found that
Respondent ``escalated opioid doses by patient request, not because of
favorable responses.'' Id. While he found that it was ``unlikely'' that
Respondent's prescribing contributed to S.R.'s death, he suggested that
Respondent's prescribing ``perpetuated an ongoing drug abuse problem.''
Id.
J.R.
J.R. (GX 24) had been convicted of distributing marijuana. Tr.
1995. Respondent maintained, however, that he had turned his life
around and was proud of that. Id. J.R. first visited Respondent at her
Calmwood Medical clinic in August 1999, but she had treated him at
another clinic previously and had not transferred those medical records
into his chart. See GX 24, at 1.
Respondent maintained that J.R. needed to take ``a very high dose
of OxyContin'' in order to work, and that without the medication, the
migraine headaches were so bad he could not function. Tr. 1996-97.
Respondent testified that she thought J.R. was a legitimate patient.
Id. at 1997.
The ALJ also credited the testimony of Dr. O'Connor that she saw
J.R. ``when he picked up his prescribed medications at Wilmot
Pharmacy'' and he ``was functional, his words were never slurred, and
he appeared `fine.' '' ALJ at 106. There is, however, no evidence in
the record that Dr. O'Connor ever worked at Wilmot Pharmacy, see Tr.
1107-08, where J.R. picked up nearly all of his prescriptions. GX 23;
see also RX 8 (affidavit of Dr. O'Connor indicating places of
employment which do not include Wilmot Pharmacy). Moreover, Dr.
O'Connor testified that she ``remember[ed] how I talked to him on the
phone several times.'' Tr. 1129. At no point did Dr. O'Connor testify
that she had actually seen J.R. when he picked up his
prescriptions.\35\ Id. at 1129-30. I therefore reject the ALJ's
finding.
---------------------------------------------------------------------------
\35\ Dr. O'Connor also testified that she was aware of J.R.'s
diagnosis and his work situation. Tr. 1129-30. With respect to the
latter, she maintained that it was ``just general patient knowledge.
You ask them what they do, how their life is, to assess any
addiction factors or anything else like that.'' Id. at 1130. Again,
there is no evidence that Dr. O'Connor worked at the pharmacy where
J.R. filled his prescriptions. Her testimony is not credible.
---------------------------------------------------------------------------
At J.R.'s first visit recorded in the patient file, August 25,
1999, Respondent noted that he suffered ``chronic severe migraine
headaches,'' and that he ``has been on opioids with good relief.'' \36\
GX 24, at 1. She also noted that he was on ``methadone because it is
inexpensive.'' Id. That day she prescribed Oxycodone IR ``2 tabs q8h
180'' (a thirty-day supply), Percodan 200 (with no dosing
instruction), OxyContin 40 mg. ``4 tabs q8h 360 (a thirty-day
supply), and methadone 5 mg. ``QID 60 (a fifteen-day supply).
Id. On September 15, twenty-one days later, Respondent again prescribed
to J.R. Oxycodone IR ``2 tabs q8h 180 (a thirty-day supply),
Percodan 200, OxyContin 40 mg. ``4 tabs q8h 360'' (a
thirty-day supply), and methadone 5 mg. ``QID 60'' (a fifteen-
day supply). Id. J.R.'s record also indicated that on September 22 (a
week later), she issued ``replacement prescriptions,'' but gave no
reason for doing so. Id.
---------------------------------------------------------------------------
\36\ It is unclear, however, whether Respondent had previously
treated J.R. for migraines.
---------------------------------------------------------------------------
On October 20, J.R. again visited Respondent. Respondent wrote
prescriptions for Oxycodone IR ``2 tabs q8h 180'' (a thirty-
day supply), Percodan 200, OxyContin 40 mg. ``4 tabs q8h
360'' (a thirty-day supply), and Methadone 10 mg. ``QID
60.'' Id. No reason was cited for increasing the Methadone.
See id. On November 11 (twenty-two days later), J.R. returned and
reported that he had taken ``extra medicine this week because of low
back pain,'' which ``started a few days ago.'' Id. at 2. Respondent
wrote him prescriptions for Methadone 10 mg. ``QID 60,''
Oxycodone IR ``2 tabs q8h 180'' (a thirty-day supply),
OxyContin 40 mg. ``4 tabs q8h 360'' (a thirty-day supply), and
``OxyContin 100.'' Id. at 2. The patient chart indicates that
the prescriptions for Oxycodone and the 360 OxyContin 40 mg. were for
the Patient Assistance Program (PAP), with the 100 extra OxyContin ``to
fill now until medications arrive in the mail.'' Id. On November 18,
Respondent wrote another prescription for OxyContin 40 mg. ``4 tabs q8h
360'' (a thirty-day supply). Id.
On December 13, Respondent wrote the same prescriptions for 360
OxyContin 40 mg., 60 Methadone 10 mg., 180 Oxycodone IR, and 200
Percodan. Id. The record indicates that the Oxycodone prescription was
for PAP, and Respondent additionally wrote a prescription for Valium 10
mg.
[[Page 8205]]
``TID 60 with three refills'' (an eighty-day supply), and for
Fioricet.\37\ Id. The patient record gives no indication at to what
medical purpose supported the prescribing of the Valium. Id.
---------------------------------------------------------------------------
\37\ Fioricet is not a controlled substance.
---------------------------------------------------------------------------
On January 4, 2000, Respondent wrote that J.R. ``continues on
Oxycodone IR and OxyContin around the clock for excellent control of
migraine headaches.'' Id. She wrote the usual prescriptions for 360
OxyContin 40 mg. (thirty-day supply), 60 Methadone 10 mg., 200 Percodan
and 180 Oxycodone IR (thirty-day supply), the latter ``for PAP.'' Id.
at 3.
On January 21 (seventeen days later), J.R. returned and received
two prescriptions for 360 OxyContin 40 mg. (two thirty-day supplies;
``[o]ne prescription to be mailed to PAP, and other one to be filled
locally''), and prescriptions for Methadone, Percodan and Oxycodone IR
(again a thirty-day supply of the latter for PAP). Id. On February 7
(again after only seventeen days), Respondent again wrote two
prescriptions for 360 tablets of OxyContin 40 mg., with one to be
filled locally and one to be sent to PAP. Id. At the same visit,
Respondent also wrote prescriptions for 180 Oxycodone IR (for PAP), 60
Methadone, and 200 Percodan. Id. at 4.
After just another fifteen days, on February 22, 2000, J.R.
reported ``a severe headache on Sunday, February 20.'' Id. Respondent
planned to ``[c]ontinue same dose of medications,'' but ``[i]f he has
another severe headache within the next 3 months,'' she planned to
``increase his dose by probably about 60-80 mg per day.'' Id. She again
wrote two prescriptions for 360 OxyContin 40 mg. (each a thirty-day
supply), one ``to be mailed to PAP, and other one to be filled
locally.'' Id. She also prescribed 100 Methadone 10 mg., 200 Percodan,
and 180 Oxycodone IR (the latter for PAP, a thirty-day supply).
Twenty days later, on March 13, J.R. returned with another report
of a ``severe headache,'' having taken ``extra of the OxyContin and
Oxycodone IR, and also methadone.'' Id. Respondent decided to increase
both the OxyContin and Oxycodone IR and wrote two prescriptions for
both drugs with one to be sent to the PAP: OxyContin 40 mg. ``5 tabs
q8h 450'' (a thirty-day supply), and Oxycodone IR ``4 tabs q8h
360'' (a thirty-day supply). Id. at 5. She also wrote
prescriptions for an increased dosage of Methadone 10 mg. (``3 tabs TID
100'') and for Percodan (``2 tabs q4h 200''). Id. The
next day, for no reported reason, Respondent wrote two new
prescriptions for OxyContin and Oxycodone IR, backdating them to March
5. Id. No mention was made of whether J.R returned the prescriptions
which she wrote the day before. See generally id.
Eight days later, on March 22, J.R. returned and reported that he
would be going to ``a rally in California,'' and that he needed ``extra
medications for control of migraine headaches.'' Id. Respondent
prescribed Methadone 10 mg. ``3 tabs TID 30'' (3-4 days
supply) and OxyContin 40 mg. ``5 tabs q8h 30'' (two-day
supply). Id.
On April 12 (twenty-one days later), J.R. again reported a severe
headache and that he was taking ``extra medications.'' Id. Respondent
again wrote two prescriptions each for a thirty-day supply of 450
OxyContin 40 mg. and 360 Oxycodone IR, as well as Methadone 10 mg.
``TID 100'' and 200 Percodan. Id. at 6.
On May 2 (twenty days later), the patient record states that J.R.
``needs to increase his OxyContin because he had a severe headache for
3 days.'' Id. Respondent wrote a prescription for OxyContin 80 mg.
``q8h 270'' (a thirty-day supply) and noted that the next day,
she would write prescriptions for OxyContin and Oxycodone IR for the
PAP. Id.
On May 8 (six days later), Respondent wrote two prescriptions for
OxyContin: one for 270 tablets of 80 mg. strength for PAP (a thirty-day
supply based on her dosing instruction of 3 tabs q8h) and one for 450
tablets of 40 mg. strength (also a thirty-day supply). Moreover,
Respondent wrote prescriptions for 360 Oxycodone IR (2 tabs q8h, a
sixty-day supply) for PAP, as well as a 180 Oxycodone IR (2 tabs q8h, a
thirty-day supply). Id. at 7.
On May 15, (a week later), Respondent wrote additional
prescriptions which were to be filled by PAP: 270 tablets of OxyContin
80 mg. and 360 tablets of Oxycodone IR ``to remail.'' Id. Two days
later, Respondent gave J.R. prescriptions for a one-week supply of both
OxyContin 40 mg. (126 tablets) and Oxycodone IR (84 tablets), the
latter being a ``free 1 week trial.'' Id.
On May 31, Respondent wrote prescriptions for Percodan ``q4h PRN
200,'' Methadone 10 mg. ``QID 120'' (a thirty-day
supply), OxyContin 40 mg. ``5 tabs q8h 540 (a thirty-six day
supply) and Oxycodone IR ''4 tabs q8h 360'' (a thirty-day
supply). Id.
On June 9, when J.R. complained ``of worse headaches,'' Respondent
concluded that ``we need to increase the OxyContin dose again'' because
he ``doesn't tolerate any lower dose of OxyContin.'' Id. at 8. She
again wrote for OxyContin 80 mg. ``3 tabs q8h 270'' (thirty-
day supply). Six days later, on June 15, Respondent wrote prescriptions
for OxyContin 80 mg. ``3 tabs q8h 360'' (thirty-day supply),
Methadone 10 mg. ``QID 120'' (a thirty-day supply), OxyContin
40 mg. ``5 tabs q8h 540'' (a thirty-six day supply, with no
explanation of why J.R. needed both 40 and 80 mg. OxyContin), and
Oxycodone IR ``4 tabs q8h 360'' (thirty-day supply). Id. The
final sentence in the record for that date is ``For PAP program,'' but
it does not indicate whether that is just the Oxycodone or all the
prescriptions. Id.
This pattern of early prescribing and not explaining seemingly
duplicative dosages continues in the treatment of this patient through
its conclusion in April 2002. Notwithstanding the large quantities of
drugs she was prescribing to J.R., there is no indication in the
medical record that Respondent ever required him to undergo blood or
urine tests to determine whether he was actually taking the drugs. Nor
did she require him to bring in his medications for pill counts.
Subsequent to Respondent's treatment of J.R., his next doctor (Dr.
H.) wanted to reduce the amount of controlled substances that he was
prescribed, as Dr. H. suspected diversion. GX 70, at 35-36. Dr. H. also
told a DI that a third doctor who later treated J.R was surprised that,
when J.R. reported running out of medication, he was not experiencing
withdrawal symptoms. Id. at 36. That doctor reportedly referred J.R.
for detoxification treatment. Id.
Respondent asserted that Dr. H. had given contradictory statements
by saying that he was ``positive [J.R.] is diverting and selling all of
those medications, and not taking them, and yet he is exhibiting signs
of withdrawal.'' Tr. 1994. The record indicates, however, that Dr. H.
had been told by the third physician that J.R. was not ``exhibiting any
signs of withdrawal.'' GX 70, at 36. According to Respondent, J.R.
ultimately self-declared as a heroin addict in order to get methadone.
Tr. 2001.
Regarding J.R., Dr. Hare observed that while Respondent had
previously treated him at another clinic, there were no records from
the clinic ``indicating evaluation to confirm the diagnosis of migraine
headache or to further characterize his headaches,'' and that there
were no ``records from other physicians or record of treatment with''
non-opioid medications even though migraines ``typically respond to a
number of non-controlled substance medications'' which should have been
tried first. GX 46, at 13.
[[Page 8206]]
Relatedly, Dr. Schneider testified that in treating a migraine
headache of a recurring nature, a CAT scan should be ordered even
though it will probably be ``completely normal.'' Tr. 872. There is,
however, no evidence in the patient record that Respondent ordered a
CAT scan for J.R.
Dr. Hare further noted that Respondent was giving J. R. ``duplicate
prescriptions for OxyContin, one to fill immediately and one to send to
the Patient Assistance Program, and yet Respondent did not seem aware
that she was giving him twice the amount of medication.'' \38\ GX 46,
at 14. He further noted that, while in March 2000, J.R. was only
periodically having worse headaches, Respondent increased the dosing of
both the OxyContin (long-acting) and Oxy IR (short-acting), when ``an
increase in short-acting medications would have been a more appropriate
step, if any change was indicated.'' Id. Finally, Dr. Hare concluded
that there was ``no treatment plan,'' and that ``[a]ny time this
patient wanted to increase medications, he did, and [Respondent]
accommodated him by increasing the prescriptions.'' GX 46, at 14-15.
---------------------------------------------------------------------------
\38\ Dr. Hare also noted that J.R. was being prescribed
methadone because ``it is inexpensive, and yet the methadone was
only a small part of the patient's total opioid intake, particularly
as compared to OxyContin.'' GX 46, at 13-14.
---------------------------------------------------------------------------
N.F.
N.F. had previously been identified by two faxnets issued to Tucson
area pharmacies by the Arizona State Board of Pharmacy as having
allegedly engaged in doctor shopping and calling in fraudulent
prescriptions for Lortab (hydrocodone). GX 35; Tr. 287-89. The faxnets
were dated May 8, 2000, and April 13, 2001. GX 35, at 1-2.
In February 2003, a DEA Investigator interviewed N.F., who admitted
to being addicted and to having gone initially to Respondent to ``feed
her addiction.'' GX 70, at 38. N.F. told the Investigator that a
pharmacist had called Respondent in N.F.'s presence and told Respondent
that he did not want to fill a prescription Respondent had written
because he believed N.F. had a drug problem. Id. According to the DI's
declaration, Respondent continued to prescribe for N.F. for another
sixteen months after receiving the phone call and ``never questioned
[N.F.] about her medical history.'' Id. at 39.
N.F.'s first visit with Respondent was on November 13, 2000, after
the first faxnet, which alleged that N.F. was engaged in doctor
shopping. See GX 34, at 1; GX 35, at 1-2. N.F. told Respondent that her
vehicle had been rear ended in March 2000 and that she was experiencing
neck, shoulder, and back pain. GX 34, at 1. There is no indication in
N.F.'s record that Respondent inquired about her substance abuse
history. See generally id. at 1-2. N.F. complained of numbness in her
left mid-thigh, muscle spasms and headaches. Id. at 1. Respondent
performed a physical exam, which the Government's Expert concluded was
adequate, and diagnosed her as having a ``post acute cervical sprain
and acute lumbar sprain. Postpartum.'' Id. at 2; GX 46, at 10.
Respondent issued N.F. a prescription for thirty tablets of Vicodin ES
with two refills, gave her samples of Skelaxin, recommended a program
of physical therapy, and indicated that she would take Vioxx, which
apparently had been prescribed after a knee surgery a year earlier. GX
34, at 2.
According to N.F.'s patient file, later that day, ``Rachel from
Albertson's * * * called regarding multiple doctors prescribing Vicodin
ES for'' her. Id. According to the note, Albertson's ``will cancel the
refills.'' Id.\39\ Notwithstanding this phone call, four days later
Respondent gave N.F. a prescription for 30 tablets of Lortab 7.5/500
mg. (1-2 q4h to take as needed but maximum of eight tablets per day),
another combination drug which (like Vicodin) contains hydrocodone and
acetaminophen, with two refills. Id. at 3. Respondent also wrote
additional prescriptions for Lortab with two refills on November 28.
Id. On December 1, however, Albertson's again called and told
Respondent that N.F. wanted an early refill, which Respondent approved.
Id.
---------------------------------------------------------------------------
\39\ The ALJ gave N.F.'s interview with the DI ``little weight''
because ``[n]either N.F. nor the pharmacist testified at the
hearing,'' and N.F. had a ``history of questionable truthfulness,
honesty, and completeness'' and had ``fail[ed] to tell the
Respondent of her addiction.'' ALJ at 78 n.17. The ALJ also noted
that ``there is no evidence that the Respondent was made aware of
N.F.'s addiction issues during the course of treatment.'' Id.
I credit N.F.'s interview because the patient file corroborates
her story regarding the pharmacist who called Respondent and
reported that she was obtaining Vicodin prescriptions from multiple
doctors. GX 34, at 2. I also expressly reject the ALJ's finding that
there is no evidence that Respondent was aware of N.F.'s addiction
during the course of treating her as it is clear that Respondent had
reason to know of N.F.'s potential addiction on the same day as the
initial visit when the pharmacist told her that she was a doctor
shopper. As for the ALJ's reasoning that N.F.'s statement is not
credible because she ``fail[ed] to tell Respondent of her
addiction,'' one would hardly expect a person who seeks drugs to
abuse them to tell a doctor the real reason she wanted the drugs.
---------------------------------------------------------------------------
On December 8, Respondent increased the Lortab prescription to
forty tablets with two refills. Id. at 4. On December 22, Respondent
re-issued the Lortab prescription with two refills. Id. at 5.
Thereafter, N.F. began a pattern of seeking early refills. On
January 2, Respondent issued N.F. a prescription for forty Lortab with
three refills (with the same dosing). Id. While the prescription and
refills should have lasted until January 22, on January 16, N.F.
complained that she still had severe neck pain and Respondent issued
another prescription for forty Lortab 7.5/500 with three refills. Id.
at 6. However, on January 25, nine days later, Respondent issued a new
prescription (again for 40 tablets with three refills) but which
increased the strength of the Lortab to 10/500.\40\ Id.
---------------------------------------------------------------------------
\40\ Due to the toxicity of acetaminophen, 4000 mg. is the
maximum recommend daily dose. Tr. 403-04.
---------------------------------------------------------------------------
From early on in Respondent's treatment of her, N.F. displayed a
pattern of requesting early refills, which Respondent did not appear to
notice as she always wrote the prescriptions as requested. For
instance, on January 16, 2001, Respondent wrote a prescription for
``Lortab 7.5/500 1-2 q6h PRN 40 with 3 refills,'' which should
have lasted at least twenty days. Id. However, on January 25, just nine
days later, when N.F. complained that the medication wasn't ``strong
enough,'' Respondent increased the dose to ``Lortab 10/500 40
with 3 refills,'' which should again have lasted twenty days, assuming
that the dosing remained the same. Id.
However, N.F. returned on February 7, complaining of recent
headaches and pain in both her neck and back. Respondent again issued
her a prescription for ``Lortab 10/500 40 with 3 refills.''
Id. On February 16, Respondent issued N.F. another prescription for 40
tablets of Lortab 10/500 with three refills. Id. at 7.
On April 25, Respondent switched N.F. from Lortab to Percocet (a
drug combining oxycodone and acetaminophen), and approximately two
weeks later added Percodan, a drug combining oxycodone with aspirin.
Id. at 9-10. Four days later, Respondent changed from Percodan to
oxycodone 5 mg. and continued to prescribe Percocet. Respondent
prescribed both drugs on several occasions. Id. at 11-12.
On June 11, N.F. visited Respondent. According to N.F.'s file, she
had ``suffered [a] burn'' in her ``right thoracic area,'' but did not
``remember burning herself.'' Id. at 12. Respondent continued to
prescribe oxycodone and Percocet throughout the summer months. Id. at
12-14. Respondent, however, stopped prescribing the Percocet in late
July when N.F. complained that it made her sick. Id. at 15. By
September 11, N.F. was taking 30
[[Page 8207]]
oxycodone tablets per day, and Respondent switched her prescription to
100 tablets of Roxicodone 30 mg. (q4h PRN). Id. at 17.
An entry in N.F.'s patient record for September 19, 2001, indicates
that she was to move to Illinois at the end of the week and that she
could not fill the Roxicodone prescription because of its cost. Id. at
18. On this date, Respondent wrote a prescription for 100 tablets of
oxycodone 5 mg. (3-4 q4h PRN). Id.
Two days later, N.F. returned. N.F. told Respondent that she was
not ``moving until next Friday,'' and ``would like to get Roxicodone.''
Id. Respondent issued a prescription for another 100 tablets of
oxycodone 5 mg. Id. On September 27, however, Respondent gave N.F. a
prescription for 100 tablets of Roxicodone 30 mg (1-2 q4h PRN). Id.
On October 2, N.F. was ``back here to pick up her truck.'' Id.
Respondent gave her another prescription for 100 Roxicodone 30 mg. q4h.
Id.
A note dated October 5 indicates that ``[p]atient's brother to pick
up prescription for Roxicodone 30 mg q4h PRN 100.'' Id. at 18-19.
Moreover, a note dated October 9 indicates that N.F.'s cousin was to
pick up a similar prescription for another 30 tablets of Roxicodone 30
mg. Id. at 19. Another note dated October 12, again indicated that
N.F.'s cousin had picked up the prescription. Id.
On October 15, N.F. was back in town ``to testify for the state''
and reported that ``[s]he ha[d] moved to Joliet.'' Id. N.F. reported
that she had continued pain but that she wanted to decrease her
Oxycodone intake. Id. Respondent issued her a prescription for 200
tablets of Roxicodone 5 mg. (2-3 tabs q4h PRN) and indicated that N.F.
``will see another doctor in Illinois.'' Id.
On October 17, N.F. was back to see Respondent and underwent
therapy. Id. Notwithstanding that just two days earlier N.F. had stated
that she wanted to reduce her oxycodone intake, Respondent gave her a
prescription for 100 tablets of Roxicodone 15 mg., 2-3 tab q4h PRN. Id.
The dosing instruction was thus even greater than the dosing
instructions of several of the previous prescriptions Respondent had
written. Id. Notwithstanding N.F.'s claims of having moved to Joliet,
she continued to appear at Respondent's office multiple times each
month through May 10, 2002, to obtain prescriptions. See id. at 19-33.
At no point is there documentation that Respondent questioned N.F.
about why she was still coming in for prescriptions if she had moved.
See id. Instead, she authorized early refills. See id. at 18-19.
According to DI Llenas' Declaration, N.F. told her that ``for
approximately one month'' she had told Respondent ``that she was moving
to Illinois.'' GX 70, at 39. During that time, individuals ``pos[ing]
as family members'' would go to Respondent's office to obtain refill
prescriptions for N.F. Id. N.F. did this in order ``to obtain early
refills, under the guise that the `family members' needed time to mail
the prescriptions to Ms. [F.] in Illinois.'' Id.
On October 17, 2001, in addition to the Roxicodone 15 mg. that N.F.
was already taking (``2-3 tabs q4h PRN 100''), Respondent
prescribed 30 Vicodin for ``dental pain.'' \41\ GX 34, at 19. There is,
however, no evidence that Respondent referred N.F. to a dentist, who
could properly diagnose the cause of her condition. Nor, given the
Roxicodone that Respondent was prescribing, is it clear why N.F. would
need to take Vicodin as well.
---------------------------------------------------------------------------
\41\ Respondent also prescribed penicillin for a dental
infection.
---------------------------------------------------------------------------
On October 19 (two days later), Respondent issued N.F. a
prescription for 200 tablets of Roxicodone 15 mg. (1-2 q4h). Id.
Moreover, on October 24 (five days later), Respondent issued N.F. a
prescription for 200 tablets of Roxicodone 5 mg (3-4 tablets q4h). Id.
On October 26 (two days later), N.F. was back again, complaining of
additional symptoms including tingling and numbness, and that her right
hand was turning purple. Id. Respondent did not conduct a neurologic or
vascular exam and instead gave her another prescription for Roxicodone;
the prescription was for 50 tablets 30 mg.-strength \1/2\ tab q4h PRN.
Id. at 20; see also GX 46, at 11.
On October 29 (three days later), Respondent gave N.F. another
prescription for 100 tablets of Roxicodone 30 mg. q4h. GX 34, at 20.
While the prescription should have lasted sixteen days, on November 1,
Respondent gave N.F another prescription (to be filled the next day),
for 100 tablets of Roxicodone 30 mg. q4h. Id. On November 5, Respondent
gave N.F. a prescription for 200 tablets of Roxicodone 5 mg. (3-4 q4h),
and indicated in the patient record that N.F. could not fill the
prescription because the pharmacy did not have the drug. Id. Yet there
is no indication that Respondent checked with the pharmacy or asked
N.F. to return the prescription. Id.
While this prescription should have lasted eight days, on November
7 (two days later) Respondent issued N.F. another prescription for 100
tablets of Roxicodone 30 mg. 1-2 q4h PRN. Id. at 21. Five days later
(on November 12), Respondent gave N.F. another prescription for 100
Roxicodone. Id.
On November 14, N.F., who apparently had not moved to Illinois
after all--although at no point does it appear that Respondent
questioned her about this--returned to Respondent and reported that she
``had a motor vehicle accident at 6:30 this morning'' with ``increased
neck pain.'' Id. Respondent noted that N.F. ``has increased muscle
spasm and difficulty sleeping secondary to the motor vehicle
accident,'' which had occurred earlier that day. Id. Respondent gave
N.F. a new prescription for 100 Roxicodone 30 mg., to be filled on
November 19. Id.
On November 19, N.F. reported that she had lost her prescription.
Id. Respondent noted that she had called TMC pharmacy and that the
prescription had not been filled. Id. She also indicated that N.F.'s
insurance would not cover another prescription if the prescription had
already been filled. Id. Respondent wrote another prescription for 100
Roxicodone 30 mg. Id.\42\
---------------------------------------------------------------------------
\42\ As Dr. Hare noted, ``this does not exclude the possibility
that [N.F.] was paying for the prescriptions herself.'' GX 46, at
11. Moreover, N.F. could have filled the prescription at another
pharmacy.
---------------------------------------------------------------------------
On November 21 (two days later), N.F. needed more ``medications
before * * * the weekend.'' Id. Respondent noted that N.F. had
``increased tenderness and muscle spasm'' and gave her a prescription
for 200 Roxicodone 5 mg. (5-6 tabs q4h PRN).'' Id. at 22. On November
26, N.F. told Respondent that she had ``been beaten up by her neighbors
over the Thanksgiving weekend'' and that ``[t]hey stole her medications
and her money.'' Id. Respondent further noted that N.F. ``has a police
report.'' Id. It is unclear, however, whether N.F. showed the report to
Respondent.
Dr. Hare noted further incidents of suspicious behavior on the part
of N.F. For example, on January 24, 2002, N.F. reported that she had
taken her children roller skating and had ``increased soreness ever
since.'' Id. at 24. Respondent gave N.F. a new prescription for 100
tablets of Roxicodone and increased the dosing from 1-2 tablets every
four hours to 3-4 tablets every four hours. Id.
Dr. Hare again found that Respondent ``inadequately evaluated'' the
patient and that N.F.'s ``condition did not warrant [c]ontrolled
[s]ubstance prescriptions.'' GX 46, at 12. In addition, Dr. Hare opined
that N.F. ``was placed on excessive medication and took more than
prescribed and [with] no clear
[[Page 8208]]
benefit''; that ``[c]hanges were made and new medications added with no
explanations''; that N.F. ``escalated her use of medication with no
clear benefit, and prescriptions were increased to accommodate her'';
and that with the ``medication amounts and uses patterns such as
[N.F.'s], abuse and diversion of these medications ha[ve] to be
suspected. '' Id. Dr. Hare further observed that ``[n]o drug screen was
done to see if the patient was using these medications, or other
medications not prescribed by'' Respondent. Id.
Respondent's expert, Dr. Schneider, included N.F. as one of the
patients for which there was ``evidence of `aberrant drug-related
behaviors' which should have been pursued but weren't.'' RX K-1, at 6.
As explained above, N.F.'s chart was among those that ``showed problems
which indicated that [Respondent] needed additional education about
obtaining addiction history, careful monitoring, and review of the `big
picture.' '' Id.
Indeed, the patient record indicates that Respondent made
absolutely no attempt to monitor N.F. even though she received
information as early as the day of N.F.'s first visit that she was a
doctor shopper. See GX 34. In addition, Respondent ignored other
evidence of suspicious behavior on N.F.'s part such as her continued
visits even when she she had supposedly moved to Illinois, her
suffering a second-degree burn but not remembering why, and her claim
that her neighbors had beaten her and stolen her medications and
money.\43\
---------------------------------------------------------------------------
\43\ In her findings for NF, the ALJ also relied on Dr.
Weinstein's criticism in her letter that Dr. Hare ``describe[d]
titration of opioid medications as dosages being `dramatically
increased,' `aggressive,' and given in `huge amounts,' without
noting subsequent stabilization of dosages.'' ALJ at 78. However,
Dr. Weinstein's criticism was not directed specifically at Dr.
Hare's findings on N.F. While Dr. Hare did at one point write that
N.F. herself increased ``her use of hydrocodone (Lortab by this
time) to excessive amounts,'' Dr. Hare did not so characterize
Respondent's prescribing. GX 46, at 11.
---------------------------------------------------------------------------
C.O.
C.O. first treated with Respondent on March 5, 1999, complaining of
neck and lower back pain from an industrial injury. GX 36, at 1. He was
28 years old. Id. His last visit with Respondent was on June 29, 2001.
Id. at 34.
According to C.O.'s medical record, several weeks before he started
treating with Respondent, C.O. had been in an industrial accident
during which the brakes on a man-lift failed and the lift hit the
ground hard. Id. at 1. C.O. went to the emergency room, where x-rays
were taken of his lumbar and cervical spines, as well as his right
knee; the x-rays were, however, negative. Id. The emergency room gave
him a prescription for Vicodin. Id.
At the first visit, C.O. complained of severe pain in both his back
and neck, with a pins-and-needles sensation in his right leg, including
his foot, and a dull aching in his back. Id. He also complained of
headaches and that his fingers were stiff and numb. Id. at 1-2. With
respect to the initial visit, the Government's expert concluded that
Respondent's physical exam was adequate but noted that she had not
taken a history of his medication use and possible substance abuse. GX
46, at 12. Respondent prescribed 40 Lortab 7.5/500 with two refills and
physical therapy. GX 36, at 2.
On March 10, Respondent noted that C.O. was ``complaining of severe
neck pain and low back pain''; the next day, she noted that he was
``taking 1 [frac12] of the Lortab 7.5.'' Id. at 3. Respondent then gave
C.O. a prescription for 40 tablets of Lortab 10/500 with two refills.
Id.
On March 17, C.O. returned to Respondent's practice and was seen by
a Family Nurse Practitioner (F.N.P.). Id. According to the progress
note, C.O. reported that he was out of medications, needed more, and
had gone through 40 Lortab in six days. Id. The F.N.P. further recorded
that ``Patient requesting pain medication refill--he has two refills
left. He swears he does not. Asking him to bring in bottle.'' Id.
On March 19, C.O. returned and saw Respondent. Id. C.O. said that
he had refilled the Lortab 7.5 two times and that he had no refills on
the Lortab 10 even though the progress note for March 11 indicated that
Respondent had authorized two refills. Id. He also said that he was
taking up to 12 Lortab per day. Id. At this level, C.O. was exceeding
by 2000 mg. the recommended maximum limit of 4000 mg. of acetaminophen
per day.
On March 22, C.O. returned and complained of continued pain between
his shoulder blades. Id. C.O. reported that he had only three Lortab
7.5 mg. remaining. Id. The progress note also indicates that C.O. had
no refills on the Lortab 10. Id. Respondent performed a physical exam
and found that C.O ``ha[d] no obvious pain with ambulation.'' Id. at 4.
She also found that he had ``generalized tenderness over [his] mid
thoracic area and complains of mid back pain with range of motion of
the shoulders.'' Id. Respondent prescribed thirty tablets of OxyContin
20 mg. q8h (1 tablet every eight hours).
C.O. returned on March 26 (five days later), saw the F.N.P., and
reported that his back pain was worse. Id. The F.N.P. observed that
C.O.'s ``speech is slightly slurred.'' Id. She also noted that C.O. had
``just t[aken] two OxyContin 20 at 4 p.m. today,'' which was twice the
dose prescribed by Respondent. Id. The F.N.P. physically examined
Respondent and did not find anything abnormal. Id. The F.N.P. further
noted that she would ``not refill OxyContin,'' but would ``speak with''
Respondent. Id. The same day, Respondent gave C.O. a new prescription
for 60 tablets of OxyContin 20 mg. (2q8h). Id. at 5. On April 2,
Respondent gave C.O. an additional prescription for 60 OxyContin 20 mg.
(2q8h). Id.
On April 9, C.O. saw the F.N.P. and complained that the ``pain
medication is not working anymore,'' that his neck, shoulder, and the
base of his spine were stiff, and that his back felt tight. Id. He also
reported that he started taking three tablets, three times a day, which
was again in excess of the prescribed dose. Id. With the exception of
the F.N.P.'s finding that C.O.'s mid-back muscles were tense and that
he complained of low back pain on forward flexion, the physical exam
was normal. Id. The F.N.P. further noted that C.O. had ``used 390 pain
pills in 35 days''; she further recommended that C.O. ``decrease pain
medication use.'' Id. at 6. Finally, the F.N.P. noted that she
discussed C.O.'s treatment with Respondent and that C.O. should undergo
an MRI of his cervical spine. Id. There is no indication in C.O.'s file
that he went for this MRI. See generally id.
On April 12, C.O. saw Respondent and complained of continued pain
in his neck and back. Id. He also denied ``any side effects from the
OxyContin'' and maintained that it ``allow[ed] him to work.'' Id.
Respondent wrote him a new prescription for OxyContin 20 mg.,
increasing the number of tablets to 100 and the dosing to three tablets
every eight hours. C.O. saw Respondent approximately every nine to ten
days and complained of stiffness and pain; Respondent continued to
issue him the same prescription until his visit of June 16. Id. at 7-8.
At this visit, Respondent decided to lower the dosing of the OxyContin
to 2qam, 3qpm, and 2qhs because three months had passed since he was
injured and ``he should be able to tolerate a lower dose.'' Id. at 9.
At C.O.'s next visit (June 28), Respondent wrote the same prescription.
Id.
On July 12, Respondent gave C.O. another prescription for OxyContin
20 mg. Id. However, she reduced the quantity to 84 tablets and the
dosing to two tablets every eight hours. Id. Moreover, on both July 14
and July 19, C.O. reported that he had increased pain since Respondent
had lowered the dose; Respondent did not, however, change the dose. Id.
at 9-10. In the July 19 note,
[[Page 8209]]
Respondent also indicated that C.O. had undergone MRIs of both his
thoracic and lumbar spines, and that each exam was negative. Id. at 10.
On July 26, however, C.O. complained of severe pain. Respondent
gave him a new prescription for 130 tablets of OxyContin and increased
the dosing to three tablets, three times a day. Id. at 11, 13. At the
next visit (August 9), Respondent gave C.O. a new prescription for 130
tablets of OxyContin 20mg. (3 q8h). Id. at 14. Respondent also gave him
a prescription for 30 Percocet, but did not document why. Id. Moreover,
on August 16, C.O. reported that he was taking four tablets every eight
hours. Id. Respondent then issued a prescription for 100 tablets and
increased the dosing to four tablets every eight hours. Id. Respondent
also wrote another prescription for 30 Percocet. Id. The progress note
contains no indication, however, as to whether she asked C.O. about how
he was using the Percocet.
On August 23, Respondent gave C.O. a new prescription which
increased the strength of the OxyContin to 40 mg., but which reduced
the dosing to two tablets every eight hours. Id. At C.O.'s next visit
(September 1), he again reported that he had increased his dosing from
two tablets to three tablets every eight hours; C.O. claimed that three
tablets relieved his pain but that two tablets did not. Id. Respondent
performed a physical exam and noted that C.O. had chronic neck and mid
back pain, that he had less lower back pain, and a continued muscle
spasm. Id. Respondent gave C.O. a prescription for 70 tablets of
OxyContin and increased the dosing to three tablets every eight hours;
she also gave him a prescription for 60 Percocet. Id.
Respondent continued to prescribe OxyContin 40 mg. (3 q8h) until
October 22, when she decided to discontinue the drug and instead
prescribed 200 tablets of MS Contin 60 mg. (3 q8h). Id. at 17. No
explanation for the change was given. See id. At C.O.'s next visit
(which was on October 29), Respondent was back to prescribing OxyContin
40 mg., and gave him a prescription for 200 tablets (3 q8h). Id. The
October 29 entry does not indicate why Respondent changed back to
OxyContin. Id.
On November 19, C.O. saw Respondent and reported that the MS Contin
did not help with the pain, that he was taking nine tablets a day, and
that the pain was ``getting worse.'' Id. Respondent performed a
physical exam and concluded that C.O. still had neck and back pain
secondary to the February accident. Id. at 18. Respondent gave him
prescriptions for 225 tablets of OxyContin 40, with a dosing of ten
tablets per day (3 qam, 4 qpm, 3 qhs).
On December 10, C.O. again saw Respondent and complained of various
pains. In the note, Respondent indicated that C.O. ``would like to
increase the OxyContin to 4 tabs q8h.'' Id. Respondent performed a
physical exam which ``show[ed] no obvious pain with ambulation, but he
complains of pain.'' Respondent also found that CO ``has tenderness
over bilateral cervical paraspinals, bilateral thoracic muscles and
bilateral lumbar paraspinals'' and ``has hypertonicity of spinal
muscles.'' Id. Respondent concluded that C.O. had chronic neck, mid-
back and lower-back pain'' and gave him a new prescription for 252
tablets of OxyContin 40 mg. and increased the dosing to four tablets
every eight hours. Id. at 19. She also gave him a prescription for 50
tablets of Lortab 10/500 (q6h PRN) for breakthrough pain with two
refills. Id.
On December 27, C.O. again saw Respondent. While the note for the
visit indicated that C.O. ``ha[d] been sick with the flu,'' it did not
document that C.O. complained of any pain. Id. at 19. Moreover,
Respondent performed a physical exam which found that he had
``generalized tenderness over bilateral thoracic and lumbar
paraspinals.'' Id. C.O., however, ``ha[d] no pain with ambulation'' and
had a ``full range of motion of both upper and lower extremities.'' Id.
Respondent again concluded that C.O. had ``chronic neck pain, mid back
pain and low pack pain,'' and gave him prescriptions for 252 tablets of
OxyContin 40 mg. (4 q8h), 50 Lortab 10/500 (q6h PRN) with two refills,
and 50 Percocet 10/650. Id.
On January 21, Respondent again saw C.O. and stated that ``this
dose of 160 mg.'' every eight hours worked and that while he had some
stiffness, he was able to ``handle the pain as long as he takes the
OxyContin.'' Id. He also ``denie[d] any mental changes or ever feeling
euphoria from the medications.'' Id. Following a physical exam in which
she noted that he had general tenderness over his cervical, thoracic
and lumbar paraspinals, normal ambulation without pain, and pain with
both the cervical and lumbar range of motion, Respondent reissued the
three previous prescriptions for 252 OxyContin 40 mg., 50 Percocet 10/
650, and 50 Lortab 10/500 with two refills. Id.
Three days later, Respondent noted that C.O.'s insurance had
``denied coverage for any medications'' and that he had undergone ``an
independent medical examination by [another physician] in early
December.'' Id. at 21. Respondent indicated that C.O. had been unable
to fill the OxyContin prescription ``because of the cost'' and wrote
him a new prescription for 50 tablets. Id. The note does not indicate,
however, what happened to the original prescription or whether C.O. had
partially filled it. Id.
Respondent continued to treat C.O. through June 29, 2001, and
generally prescribed the same drugs (OxyContin 40 mg., Lortab 10/
500,\44\ Percocet 5/325 \45\) with the same dosing as before. See
generally GX 36. According to the record, at the September 8, 2000
visit, C.O. reported that he had obtained a job on a cruise ship. Id.
at 28.
---------------------------------------------------------------------------
\44\ Respondent also prescribed Percocet along with Lortab.
\45\ Respondent last prescribed Percocet on June 19, 2000. GX
36, at 26. On several occasions (including January 21, February 9,
March 3, March 29, and May 1, 2000), Respondent prescribed both
Lortab with three refills, and Percocet. Id. at 20-26.
---------------------------------------------------------------------------
At C.O.'s next visit (October 10), he reported having injured his
back and neck on the ship. Id. at 28. Respondent's physical exam
``show[ed] no obvious pain with ambulation'' and found ``minimal
tenderness over lower cervical paraspinal and over lumbar
paraspinals.'' Id. at 29. Respondent also did a neurological exam of
his upper and lower extremities; the exams were normal. Id. Respondent
then issued four prescriptions for OxyContin 40 mg. (each dosing at
four tablets every eight hours); the quantities were for 168 on two of
the scripts, with 84 and 80 on the remaining two. Id. She also gave
C.O. a prescription for 350 Lortab 10/500 (q4h PRN) with no refills.
Id.
On October 31, C.O. returned to Respondent and told her that he
would be going on a ship ``in a few days and be gone for almost 13
weeks.'' Id. C.O. also told Respondent that he had not filled the two
prescriptions for 168 OxyContin. Id. She performed a physical exam
which found that C.O. had slight stiffness with ambulation and with
lumbar range of motion. Id. She also found tenderness over his
cervical, thoracic and lumbar paraspinals. Id. Respondent gave him a
prescription for 60 OxyContin 40mg (4 q8h), and 360 Lortab 10/500 (q4h
PRN) with three refills. Id. Moreover, on November 3, Respondent gave
C.O. a prescription for another 60 OxyContin 40 mg. Id. at 30.
Five days later (on November 8), C.O. had still not gone on the
ship. Id. C.O. told Respondent that he still had neck and back pain and
that he would ``be on the ship until January 22, 2000.'' Id. Respondent
performed a physical exam in which she found ``minimal tenderness over
[his] cervical, thoracic and lumbar spine.'' Id. Respondent issued him
four prescriptions for OxyContin 40 mg (4 q8h); the quantities
[[Page 8210]]
were 372, 280, 144 and 92 tablets. Id. Respondent also gave him a
prescription for 350 Lortab 10/500 with no refills. Id.
On December 22, C.O. returned to Respondent seeking another
prescription for OxyContin. Id. According to the note, C.O. ``ran out
of medications this Sunday'' and claimed ``that he tore up the
prescriptions.'' Id. Respondent noted that C.O. ``show[ed] very slurred
speech,'' and concluded that ``he probably took excess Soma.'' Id. She
referred him to the ``emergency room or for drug testing.'' Id.
Notwithstanding that C.O. had previously told Respondent that he
would be working on a cruise ship until late January, there is no
indication that Respondent questioned him as to why he was back so
soon. Id. Indeed, according to a pharmacy profile which listed
prescriptions C.O. had filled at Tucson area pharmacies, he had filled
prescriptions for controlled substances on November 21, 22, and 27, as
well as December 6, 21, and 22, 2000. GX 37, at 2.
On December 27, C.O. returned to Respondent seeking more OxyContin.
GX 36, at 30. Respondent decided to taper C.O. down on the OxyContin to
three tablets every twelve hours (for a total of 240 mg. of oxycodone)
and wrote him prescriptions for sixteen and eight tablets.\46\ Id. at
31. Respondent issued additional prescriptions for OxyContin 40 mg. in
smaller quantities with the same dosing instruction on January 3, 8, 15
and 22; at the January 15 visit, Respondent also gave him a
prescription for 100 Lortab 10/500 with two refills. Id.
---------------------------------------------------------------------------
\46\ There is no indication as to whether Respondent followed up
to determine whether C.O. went to the emergency room or for the drug
test.
---------------------------------------------------------------------------
On February 5, 2001, C.O. complained that he could not afford
OxyContin and would like more Lortab and Soma. Id. Respondent told C.O.
that there was a daily maximum dose of acetaminophen, which is used in
Lortab. Id. Instead, Respondent prescribed 200 tablets of Roxicodone 5
mg. (5-6 q3h PRN). Id. Based on this prescription, C.O. would have
taken a maximum of 240 mg. of oxycodone per day.
On February 14, Respondent gave him a prescription for 100 tablets
of Roxicodone 30 mg., but the dosing instructions were not, however,
recorded in C.O.'s record. Id. Respondent also gave C.O. a prescription
for 100 Lortab 10/500 with five refills; this prescription thus
authorized the dispensing of 600 tablets. Id. Based on the maximum
daily recommended safe dose of acetaminophen of 4000 mgs., the Lortab
should have lasted seventy-five days.
By February 20, however, Respondent was prescribing two tablets of
Roxicodone 30 mg. every 3 hours, for a total dosage of 480 mg. of
oxycodone a day; this was the same daily amount of oxycodone as
Respondent had been dosing on December 22.\47\ Id. There is no
indication in the February 20 note that C.O. had complained of worse
pain or that Respondent had examined him. Id.
---------------------------------------------------------------------------
\47\ On February 20, Respondent gave CO three 50-tablet
prescriptions for Roxicodone 30 mg. GX 36, at 32.
---------------------------------------------------------------------------
Respondent issued additional prescriptions for Roxicodone 30 mg. on
March 9 (50 tablets) and 13 (three 50-tablet prescriptions), although
she reduced the dosing to one to two tablets every four hours for a
maximum daily dose of 360 mg. of oxycodone. Id. On March 27, Respondent
gave C.O. not only a prescription for 50 Roxicodone 30 mg., but also
for 100 Lortab 10/500 with five refills, even though the previous
Lortab prescription (Feb. 14) with refills should have lasted seventy-
five days or until late April. Id. There is no indication in the March
27 note that Respondent even recognized this.
Respondent issued additional Roxicodone prescriptions and by April
17, was back to prescribing 480 mg. of oxycodone a day. Id. On April
27, C.O. was again out of Lortab even though the March 27 prescription
with refills should have lasted well into June. Id. at 33. Respondent
noted that she told him that he could not take more than eight Lortab a
day and that there would be ``no more acetaminophen containing
medications at least for now.'' Id. Respondent, however, gave C.O. a
new prescription for 100 tablets of Roxicodone 30 mg., 1-2 tablets
every three hours. Id.
Respondent continued to prescribe Roxicodone to C.O. and noted on
May 11, that he was taking ``approximately 16 Roxicodone per day.'' Id.
Between May 11 and June 29, Respondent issued eight prescriptions for
100 Roxicodone 30 mg. Id. at 33-34. Moreover, on June 8, Respondent
indicated that she was ``discontinu[ing] Lortab and start[ing] Norco10/
325 1-2 q4h PRN 100 with five refills, maximum twelve per
day.'' Id. at 34. This was an even greater dose of hydrocodone than
before, and yet the note for June 8 contains no medical reason for
issuing the prescription. Id.
Respondent issued additional prescriptions for 100 tablets of
Roxicodone on June 18, 25 and 29. Id. On July 3, C.O. entered drug
rehab. Id.
Following this entry Respondent wrote a two-page plus narrative of
how she had treated C.O. Id. at 35-37. Therein, she maintained that she
had closely ``watch[ed] his intake of Lortab'' because of ``the
danger'' associated with taking too much acetaminophen.\48\ Id. at 36.
Respondent also wrote:
---------------------------------------------------------------------------
\48\ Respondent observed that she ``would not allow his daily
dose of acetaminophen to go above 4000 mg.'' GX 36, at 36. Id.
If [C.O.] did in fact become ``addicted'' to either Roxicodone
or Soma, it was not because I neglected to try to avoid that. He had
a true injury, he was truly in pain and he truly required the
medication to function. In rare instances, patients become
``addicted'' to medications that were prescribed appropriately. I do
not know if this is the case with [C.O.], since I have had not
follow up information on him since June 2001.
[C.O.] suffered no harm or injury as a result of the
medications.\49\
---------------------------------------------------------------------------
\49\ In describing her treatment of C.O., Respondent maintained
that it was C.O.'s overuse of Soma which caused him ``to have
slurred speech on 2 occasions.'' GX 36, at 36. The first of these
incidents was on March 26, 1999, when C.O. told the F.N.P. that he
had taken double the dose of OxyContin that was prescribed. Id. at
4. Moreover, in the progress notes for this visit, there is no
indication that C.O. was either asked about his Soma use or stated
that how many tablets he had taken. Id. at 4-5. Moreover, while
Respondent indicated in the note the second incident of slurred
speech that ``he probably took excess Soma,'' Respondent did not
follow through as to whether C.O. had undergone drug testing. Id. at
30.
---------------------------------------------------------------------------
Id. at 37.
With respect to C.O., Dr. Hare concluded that Respondent's
evaluation was inadequate ``to justify prescribing [c]ontrolled
[s]ubstances,'' and that while Respondent had developed ``an acceptable
treatment plan in 07/99 * * * to wean the patient from medications, * *
* the medications were continued and increased.'' GX 46, at 13. Dr.
Hare further noted that Respondent ``exerted little control over the
prescriptions,'' that ``[t]he patient self-escalated drug doses, and
then [Respondent] increased the prescription to match his use.'' Id.
Moreover, ``[t]here were no consequences for excessive medication over-
use, and dangerous amounts were prescribed in general, and toxic doses
of acetaminophen were prescribed on several occasions.'' Id. Finally,
Dr. Hare opined that ``[t]here seemed to be no plan; he was changed
from medication to medication, strength to strength, dose to dose with
no pattern or explanations.'' Id.
In her report, Dr. Schneider likewise concluded that C.O.'s chart
``had evidence of aberrant drug-related behaviors which should have
been pursued but weren't.'' RX K-1, at 6 (int. quotations omitted). Dr.
Schneider further noted that C.O. had ``received early refills without
adequate documentation and explanation,'' and
[[Page 8211]]
that his chart ``indicated that [Respondent] needed additional
education about obtaining an addiction history, careful monitoring, and
review of the big picture.'' Id. (int. quotations omitted).
N.S.
On February 20, 2001, N.S., an eighteen-year-old college student,
first presented at Respondent's practice. GX 57, at 1. N.S. complained
of lower back pain, ``especially since going to [the] University of
Arizona,'' and rated his pain level as ``4'' on a scale of 0 to 10. GX
57, at 1 & 5. N.S. denied that the ``pain radiat[ed] to both lower
extremities,'' ``denie[d] numbness and tingling or weakness of both
lower extremities,'' and denied ``bowel and bladder problems.'' Id. at
1. N.S. ``complain[ed] of problems with getting comfortable'' and of
pain with sitting. Id.
Respondent performed a physical exam. She found that N.S. ``has
normal ambulation without pain,'' that he was ``able to walk on heels
and on toes without pain and hop on either foot without pain.'' Id.
Moreover, the ``straight leg raising test was negative bilaterally,''
and N.S. had ``no pain with bringing heel to buttocks bilaterally.''
Id. N.S. did, however, have ``minimal low back pain with lumbar
flexion.'' Id. Finally, Respondent performed a neurological exam of
N.S.'s lower extremities and found that he had ``normal motor strength,
sensation and deep tendon reflexes.'' Id.
Respondent diagnosed that N.S. had a ``history of episodes of low
back pain,'' with a ``[r]ecent increase in low back pain secondary to
poor mattress and poor positioning.'' Id. She recommended a treatment
plan of joint mobilization and physiotherapy; she also prescribed 30
tablets of OxyContin 20 mg., one tablet to be taken every twelve hours.
Id. at 2.
Two days later, N.S. complained that the OxyContin was not working.
Id. He also told Respondent that he had ``doubl[ed] up on [the] dose,
but [that] didn't work either.'' Id. Respondent then told him to try
three tablets at a time. Id.
Four days later, N.S. complained that he still had low back pain
and now claimed that his pain level was a six. Id. at 2 & 5. He also
stated that the ``OxyContin helps if he takes 60 mg. and [that] he
would like something for breakthrough pain.'' Id. at 2. Respondent then
gave him a prescription for 180 tablets of OxyContin 20 mg., with three
tablets to be taken every twelve hours, as well as a prescription for
50 tablets of oxycodone 5 mg., one tablet to be taken every four hours
as needed. Id.
On March 6, N.S. reported that the OxyContin \50\ and physical
therapy (including joint mobilization) were helping his pain and that
his pain level was a four. Id. at 3 & 5. Respondent performed a
physical exam which found that ``[h]e has slight stiffness with lumbar
range of motion.'' Id. at 3. She also found that ``[h]e has tenderness
and hypertonicity over bilateral lumbar paraspinals, but improvement in
lumbar range of motion.'' Id. As her impression, Respondent again
indicated: ``history of episodes of low back pain. Recent increase in
low back pain secondary to poor mattress and poor positioning.'' Id.
For N.S.'s treatment plan, Respondent recommended that he continue the
physiotherapy and joint mobilization. Id. She also recommended that he
continue taking the OxyContin (the previous prescription was for a
thirty-day supply). Id. She also gave him a prescription for 50 tablets
of Roxicodone. Id. However, she increased the strength of the
Roxicodone from five to fifteen mg., and the dosing from one tablet
every four hours to one tablet every three hours. Id.
---------------------------------------------------------------------------
\50\ On March 2, N.S. complained that the OxyContin was causing
``slight nausea.'' GX 57, at 2.
---------------------------------------------------------------------------
The last entry in N.S.'s medical record is dated March 19, 2001,
and reports that N.S.'s father called and said that NS ``was too
sedated at home and obviously took too many.'' Id. at 3. The father
also reported that N.S. ``has history of depression.'' Id.
In an interview with a DEA Investigator, N.S. admitted that he had
gone to Respondent ``in order to obtain OxyContin prescriptions.'' GX
70, at 39. N.S. also told the Investigator that ``[h]is primary purpose
was drug seeking,'' and that ``his back pain was only secondary.'' Id.
N.S.'s father confirmed to the DI that he had called Respondent and
expressed his concern about his son's being overly medicated and having
``nod[ded] out in a conversation.'' Id. at 39. According to N.S.'s
father, Respondent stated that because his son ``was of legal age, he
could make his own decisions [and] that she had every right to
prescribe whatever medications she deemed necessary.'' Id. at 39-40.
Thereafter, N.S.'s father persuaded him to stop seeing Respondent. Id.
at 40.
Dr. Hare concluded that Respondent had ``reasonably evaluated''
N.S. GX 46, at 15. He also concluded the plan of care was reasonable
``with the exception of the medication [she] prescribed.'' Id.
According to Dr. Hare, ``[b]ased on [her] findings, there seemed to be
no indication for opioids, and certainly not * * * in the aggressive
doses she prescribed.'' Id.
Dr. Hare also noted that while N.S. ``had denied taking previous
medications[,]'' he ``rapidly self-escalated the medications to a large
amount.'' Id. Dr. Hare further explained that ``[i]n a patient not
tolerant to opioid, this dose of OxyContin, coupled with the minimal
findings for a pain problem, would not be well tolerated and could have
fatal consequences. The fact that the patient tolerated these large
doses * * * indicated that he was not opioid-na[iuml]ve, or he was not
taking the medication.'' Id.
Finally, Dr. Hare observed that N.S.'s ``minimal response to a
rather large initial dose would raise serious questions about opioid
responsiveness of the pain problem.'' Id. Continuing, Dr. Hare
explained that N.S.'s ``insistence on escalating the dose would
indicate an effect sought for mood or a medication-abuse situation.''
Id.
In her testimony, Respondent acknowledged that N.S.'s father had
called her and expressed his concern that his son was taking excessive
medication. Tr. 2173. Respondent did not respond to any of Dr. Hare's
observations regarding the medical appropriateness of her prescribing
OxyContin to N.S. Id. at 2172-73.
F.L. and B.L.
F.L. and B.L. were father and son. The records in evidence document
Respondent's treatment of F.L. between August 16, 1999 and March 30,
2001, shortly before his death on April 17 due to complications from
diabetes. See GX 49. The record does not, however, reflect when F.L.
began seeing Respondent. See id. at 1.
In addition to having diabetes, F.L. was a recovering alcoholic.
Tr. 2123. He had chronic pancreatitis and a lumbar spine condition; his
diabetes had led to a below-the-knee amputation of one of his legs. Id.
Respondent treated F.L. with a variety of drugs including large doses
of OxyContin and Oxy IR. For example, on August 16, 1999, Respondent
gave F.L. prescriptions for: (1) 1200 tablets of OxyContin 40 mg.,
twenty tablets to be taken every twelve hours; (2) 4080 tablets of Oxy
IR, with seventeen tablets to be taken every three hours; (3) 140
Percocet; and (4) 200 Percodan. GX 49, at 1. On both February 21 and
March 30, 2001, Respondent gave F.L. prescriptions for: (1) 1320
tablets of OxyContin 40 mg., with 22 tablets to be taken every twelve
hours; (2) 4800 tablets of Oxycodone IR, with twenty tablets to be
taken every three hours; (3) 280 Percocet, and (4) 400 Percodan. Id at
15. The note for March
[[Page 8212]]
30 indicated that the script for 4800 tablets of Oxycodone IR was to be
filled through the ``PAP program''; \51\ the note also indicates that
Respondent gave F.L. an additional prescription for 500 tablets of this
drug ``to fill locally'' and an additional prescription for 280
Percocet.\52\ Id. The prescriptions Respondent issued to F.L. totaled
approximately 7,000 dosage units a month.\53\
---------------------------------------------------------------------------
\51\ While the note for F.L.'s last visit does not indicate that
prescription for 1320 tablets of OxyContin was to be filled through
the PAP program, an earlier note indicated that F.L. was ``on [the]
PAP program for the OxyContin and Oxycodone IR.'' GX 49, at 3. I
therefore find that the oxycodone prescription was also to be filled
by PAP.
\52\ The Government's Expert did not discuss Respondent's
prescribing to F.L. in either of his reports, see GX 46 & 46A. Nor
did he testify regarding Respondent's prescribing to him. See
generally Tr. 144-229.
\53\ F.L.'s patient record is devoid of any evidence that
Respondent subjected him to pill counts or drug screens, even though
on several occasions he stated that he had lost medications or
prescriptions. See generally GX 49.
---------------------------------------------------------------------------
In October 2000, Respondent also commenced to treat B.L. (F.L.'s
son) in October 2000 for Attention Deficit Disorder and an eating
disorder. GX 50, at 1-2. Respondent prescribed several controlled
substances including Ritalin and Dexedrine (both stimulants) to him.
Id. at 1-2.
On April 23, 2001 (six days after F.L.'s death), B.L. visited
Respondent. Id. at 4. During the visit, Respondent gave B.L. a
prescription for 200 tablets of Dexedrine 10 mg. Id. at 4-5. In her
testimony, Respondent maintained that she had questioned B.L. as to
what had happened to the last shipment of OxyContin from the PAP to his
father. Tr. 2126. (In her testimony, Respondent did not address whether
she questioned B.L. regarding the other PAP prescription--for 4800
tablets of Oxycodone IR). According to Respondent's testimony, B.L.
``didn't really answer [her], and [she] didn't know.'' Tr. 2126.
Continuing, she added that ``''I never got an answer from him what [as
to] what happened,'' and in any case, ``I didn't know when that last
shipment came,'' and did not ``know how to contact'' the company
(Purdue Frederick).\54\ Id. Several months later, B.L. was hospitalized
for drug addiction or dependence. GX 50, at 5.
---------------------------------------------------------------------------
\54\ Several months earlier, however, Respondent had contacted
the same PAP (Purdue Frederick) with respect to another patient
J.R., after his application was denied. See GX 24, at 22-24. As the
record indicates, Respondent knew the phone numbers.
---------------------------------------------------------------------------
In her plea agreement, Respondent admitted that during B.L.'s April
23 office visit, she had prescribed to him 200 tablets of Dexedrine 10
mg. and that after B.L. ``informed [her] that he had accepted delivery
of a prescription for his recently deceased father, FL, another patient
of [hers,] in order to possess the prescribed controlled substance * *
* OxyContin 40 mg.'' GX 6A, at 7. Moreover, in the agreement,
Respondent admitted that she ``upon learning this information from * *
* B.L., [she] did knowingly * * * fail to rescind the prescriptions for
Dexedrine for B.L.'' \55\
---------------------------------------------------------------------------
\55\ In the plea agreement, Respondent agreed that these ``facts
accurately describe my conduct in connection with the offenses to
which I am pleading guilty.'' GX 6A, at 6.
The incident involving B.L. was the second of the four counts of
Accessory After the Fact to Possession of Controlled Substances by
Misrepresentation, Fraud, Forgery, Deception or Subterfuge'' to
which Respondent pled guilty. See GX 6A (Plea Agreement; citing 18
U.S.C. 3 & 21 U.S.C. 843(a)(3)).
---------------------------------------------------------------------------
Respondent did not document her discussion with B.L. regarding his
father's OxyContin in his medical record. GX 50, at 4-5; Tr. 2360.
While Respondent admitted that this was a shortcoming, she claimed she
did not document the ``diversion'' because she lacked information to
conclude that a diversion had taken place. Tr. 2359-60. I find,
however, that Respondent's admission as part of the plea agreement
precludes the relitigation of the issue of whether she knew that B.L.
had obtained the OxyContin tablets dispensed pursuant to his father's
prescription.\56\
---------------------------------------------------------------------------
\56\ The medical record does show, however, that Respondent did
not prescribe any more controlled substances to B.L. after the April
23 visit.
---------------------------------------------------------------------------
W.O. and J.O.
W.O. and J.O. were husband and wife. Respondent began treating W.O.
in September 2000 for neck and low back pain from two motor vehicle
accidents, one in June 2000 and the second in August 2000. GX 53, at 1.
She began treating J.O. in October 2000 for neck and low back pain from
a motor vehicle accident of September 2000. GX 51, at 1. At the initial
visit of each, Respondent prescribed Percocet. GX 51, at 2; GX 53, at
2. Respondent also prescribed OxyContin and Soma to both J.O. and W.O.
at numerous visits.\57\
---------------------------------------------------------------------------
\57\ Respondent prescribed OxyContin 20 mg. to J.O. at her
initial visit, GX 51, at 2; she started prescribing OxyContin 40 mg.
to both J.O. and W.O. a week after their first visits. GX 51, at 1-
2; GX 53, at 1-3. In early November, Respondent increased the dosing
of the OxyContin from one tablet every twelve hours to one tablet
every eight hours for both J.O. and W.O. without providing any
explanation in their medical records as to why doing so was
medically necessary. See GX 51, at 2 & 4; GX 53, at 4-5.
---------------------------------------------------------------------------
On November 13, 2000, J.O. saw Respondent and reported that their
house had been burgled and that all of her and W.O.'s medications had
been stolen. GX 51, at 4. J.O., however, brought a police report with
her. Id. Respondent wrote a replacement prescription for 60 tablets of
OxyContin 40 mg., with one tablet to be taken every eight hours.\58\
Id. While this prescription should have lasted twenty days, only four
days later, Respondent gave J.O. another prescription for 21 tablets of
OxyContin 40 mg, as well as 60 tablets of Oxycodone IR (1-2 tablets
every four hours for breakthrough pain). Id. Moreover, on November 21,
after only four more days, Respondent gave J.O. a prescription for
another 100 tablets of OxyContin 40 mg., with the same dosing of one
tablet every eight hours. This was followed by additional prescriptions
for OxyContin 40 mg. December 20 (100 tablets); December 29 (50
tablets), January 12 (100 tablets of OxyContin 80 mg.). Id. at 5.
Throughout the next four months, Respondent prescribed to J.O.
OxyContin and either Oxycodone IR, Percocet, or Oxycodone.\59\
---------------------------------------------------------------------------
\58\ Respondent also issued to W.O. prescriptions for Percocet,
oxycodone 5 mg. and Oxyfast 20 mg./ml., and Roxicodone 30 mg. at
various visits. After being on Roxicodone for several months, W.O.
complained that it was expensive, and Respondent started prescribing
methadone. GX 53, at 17. On September 21, W.O. also complained about
the cost of Dilaudid; Respondent discontinued prescribing the drug
and increased the methadone. Id. at 19. However, on November 1 and
14, she again prescribed Dilaudid, only to stop prescribing the drug
at the November 26 visit. Id. at 20. However, while Respondent had
increased the dosing of methadone when she initially discontinued
the Dilaudid, id. at 19; she did not decrease the methadone dosing
when she resumed prescribing the Dilaudid. Id. at 20.
As for Percocet, on October 3, Respondent issued W.O. a
prescription for 300 Percocet ``to fill October 20.'' Id. Yet on
October 19, she issued W.O. another prescription for 300 Percocet.
Id. at 19-20. The file contains no explanation as to why the latter
prescription was needed.
\59\ Here again there were frequent instances in which
Respondent issued new prescriptions when J.O. should have had ample
medication remaining from previous prescriptions. For example, on
March 9, 2001, Respondent gave J.O. a prescription for 200 tablets
of Roxicodone 30 mg., with one tablet to be taken every three hours.
GX 51, at 14. While this prescription should have lasted twenty-five
days, on March 21 (only twelve days later), Respondent gave J.O. a
prescription for another 100 tablets with the same dosing. Id. at
15. And while these two prescriptions should have lasted until
approximately April 15, Respondent gave her another prescription for
100 tablets on April 3. Id. at 16.
---------------------------------------------------------------------------
On November 13, 2000, Respondent also saw W.O., performed a
physical exam on him, and gave him a prescription for 100 tablets of
Percocet. GX 53, at 5. Later that day, she wrote a replacement
prescription for 100 Percocet in W.O.'s name, (which she apparently
gave to J.O.) based on J.O.'s report that their medications had been
stolen. Id. There is no indication, however, that Respondent asked J.O.
about what time the robbery had
[[Page 8213]]
occurred and whether W.O. had even had time to fill the first
prescription she wrote on that day.
Thereafter, on November 17, Respondent gave W.O. a prescription for
21 tablets of OxyContin 40 mg (q8h--a week's supply), and 60 tablets of
oxycodone (1-2 q4h). Id. Respondent wrote W.O. additional prescriptions
for 100 tablets of OxyContin 40 (q8h--a thirty-three day supply) on
November 20, as well as on December 8 and December 15. Id. at 7. On
January 8, 2001, she doubled the dosing and gave him a prescription for
100 tablets of OxyContin 80 (q8h). Id. at 9. On January 18, she issued
another prescription for 100 tablets of OxyContin 40 and doubled the
dose to two tablets every eight hours; yet, on January 31, the dosing
of the prescription was back to one table of OxyContin 40 every eight
hours. Id. at 11. Moreover, on February 12, while W.O.'s low back pain
was then a ``zero,' she gave him another prescription for 100 tablets
of OxyContin 40 and increased the dosing back to two tablets every
eight hours. Id. at 13.
On May 14, 2001, Respondent switched W.O. from OxyContin to
Dilaudid because of the former's cost, GX 53, at 17; on May 18, 2001,
she did the same for J.O. GX 51, at 17. At their respective visits,
Respondent wrote W.O. prescriptions for Dilaudid 8 mg. ``2 tabs QID
100'' and 300 Percocet; she wrote J.O. prescriptions for
Dilaudid 4 mg. ``4 tabs QID 200,'' as well as for 100
Roxicodone (1-2 q3h) and 200 Percocet. GX 53, at 17; GX 51, at 17.
Moreover, on June 25 and 26, Respondent started prescribing methadone
10 mg, with four tablets to be taken four times a day, to both J.O. and
W.O.\60\ GX 51, at 18; GX 53, at 17.
---------------------------------------------------------------------------
\60\ On July 17, Respondent doubled J.O.'s dose of methadone to
eight tablets, four times a day. GX 51, at 18. There is, however, no
indication in J.O.'s patient file explaining the basis for doing so.
See id.
---------------------------------------------------------------------------
On November 9, Respondent wrote J.O. a prescription for 200
Percocet q4h PRN, which was to be filled on November 14 (along with
prescriptions for Dilaudid and Methadone). GX 51, at 20. However, on
November 15, 2001, W.O. (J.O.'s husband) came to Respondent's office to
pick up a replacement prescription for the November 9 prescription,
which had been altered. Id. W.O. ``insist[ed that the] prescription was
ripped in his pocket even though the other 2 prescriptions were
unripped.'' Id. Respondent had the pharmacy mail the prescription to
her and found that the ``fill date of November 14 was obviously torn
out.'' Id. Respondent did not write a replacement prescription. Id.
On November 21, J.O. went back to Respondent and asked for a
replacement prescription for the Percocet. Id. Respondent ``explained
``the modification of prescription and that it was illegal.'' Id. J.O.
claimed that she knew nothing about the modification of the
prescription and that it was W.O. who had picked it up and dropped it
off at the pharmacy. Id.
The notation for this visit also states that Respondent had
``received anonymous call that [J.O.] selling Percocet.'' Id.
Respondent told J.O. that she ``would not and could not'' write
controlled substance prescriptions for her anymore. Id. at 21.
Respondent placed J.O. on a tapering schedule for methadone and did not
prescribe other controlled substances thereafter. Id. However, at
J.O.'s very next visit, December 3, 2001, J.O. ``had more pain on the
Methadone only.'' Id. Respondent then abandoned the plan to taper J.O.
off the methadone and increased her dose. Id.
On March 4, 2002, J.O. brought to Respondent a consent agreement
she had entered into with the State Nursing Board. Id. at 22.
Apparently, the Nursing Board had initiated a disciplinary proceeding
against J.O. because she had abused medications and taken some from a
nursing home at which she worked. Id. Under the Consent Agreement, J.O.
needed to have Respondent ``notify the nursing board about what
medications she is on.'' Id. At the visit Respondent gave J.O. a
prescription for 600 methadone 10 mg. Id. at 22.
On March 12, J.O. appeared ``need[ing] half of [the] methadone
prescription because she gave [W.O] half of them.'' \61\ Id. Respondent
obliged and issued her a prescription for 300 tablets of methadone. Id.
Respondent further noted that that she and J.O. had ``discussed
problems with [W.O.], but [Respondent] didn't tell her what he did.''
Id. According to W.O.'s patient file, on February 27, 2002, Respondent
had received a phone call from G.A. stating that W.O. had stolen
approximately 100 OxyContin tablets from him. GX 53, at 21.
---------------------------------------------------------------------------
\61\ On February 25, W.O. had picked up a prescription for 600
tablets of Methadone. GX 53, at 21. W.O. did not return to
Respondent's office after that.
---------------------------------------------------------------------------
On April 16, Respondent wrote a letter to the Arizona State Board
of Nursing, listing J.O.'s medications. GX 51, at 24. Notwithstanding
the report she had previously received that J.O. was selling her
medication, the incident with the torn prescription, and J.O.'s having
admitted to giving half of a methadone prescription to W.O., Respondent
wrote that she was ``aware of [the] history of this nurse's diversion
of drugs in the past, but there is no evidence of continuation of this
behavior.'' Id.\62\
---------------------------------------------------------------------------
\62\ This was the fourth count of diversion in the plea
agreement, which Respondent failed to report to law enforcement
authorities. See GX 6A, at 8.
---------------------------------------------------------------------------
With respect to her prescribing to W.O. and J.O., Respondent
testified that after receiving the phone call which reported that J.O.
was selling Percocet, she stopped prescribing the drug to her and
prescribed methadone to her, which she maintained has a low risk of
abuse and diversion, Tr. 2162, notwithstanding its inclusion on
schedule II, which indicates that it ``has a high potential for
abuse.'' 21 U.S.C. 812(b)(2)(A). She also maintained that she had
stopped treating W.O. after she received the phone call from G.A. Tr.
2162. While Respondent testified that J.O. had told her she was going
to get a divorce, id., J.O.'s file indicates that she had given half of
her methadone to W.O. after she told Respondent that she had left him.
GX 51, at 22. Moreover, Respondent did not explain why she subsequently
wrote the Nursing Board that there was no evidence that J.O. was
continuing to divert drugs. See Tr. 2160-63.
There is likewise no evidence that Respondent attempted to monitor
J.O. through such measures as pill counts and drug screens after
receiving the report that she was selling her controlled substances.
Moreover, the medical record contains no documentation that Respondent
counseled J.O. as to the illegality of her giving her methadone to W.O.
M.H., P.H., and A.B.
P.H. started seeing Respondent in January 1999 for low back pain,
which she had suffered for six years after her ``dog knocked her off
the couch while she was sleeping.'' GX 55, at 1. A.B., who lived with
P.H., first saw Respondent on November 27, 2000, complaining of right
leg pain. See GX 56, at 1; Tr. 2129. M.H., the mother of P.H.,
initially treated with Respondent in July 2001, suffering left thoracic
pain at the time. GX 54, at 1; Tr. 2129. M.H. had undergone lumbar
surgery in 1989. GX 54, at 1.
Respondent initially treated P.H. with Percocet and a non-
controlled muscle relaxant (first Skelaxin, then Flexeril, and then
Robaxin), as well as physical therapy. GX 55, at 2 & 5. On April 7,
1999, P.H. saw Respondent and told her
[[Page 8214]]
that ``her Percocet was stolen approximately 2 weeks ago, and [that]
she has only had Darvocet N100 to take for the past 2 weeks.'' Id. at
4. While Respondent had not prescribed Darvocet (a schedule IV
controlled substance, see 21 CFR 1308.14) to P.H., there is no
indication that Respondent asked P.H. from whom she had obtained this
drug. Id. at 7-8.
Throughout the first six months that Respondent treated P.H., she
prescribed Percocet and muscle relaxants. See id. at 1-6. On September
1, 1999, Respondent noted that ``[t]he OxyContin 10 60 made
her nauseated.'' Id. at 6. P.H.'s record contains no indication as to
what date she prescribed OxyContin to her. Id. At this visit,
Respondent wrote P.H. another OxyContin prescription as well as a
prescription for 250 Percocet. Id. at 7.
On May 12, 2000, a pharmacist called Respondent and told her that
two days earlier P.H. had filled a prescription for 42 Percocet which
had been issued by Dr. K., her primary care physician Id. at 11. While
at P.H.'s next visit (June 12), Respondent questioned her about the
incident,\63\ on or about October 10, Respondent received another call
from a pharmacy which reported that every two weeks, P.H. was obtaining
84 Vicodin tablets from Dr. K. Id. at 13.
---------------------------------------------------------------------------
\63\ According to the note, P.H. told Respondent that she had
obtained the prescription from Dr. K. because she was not going to
see Respondent ``for a few more days.'' GX 55, at 11. P.H. also told
Respondent that she did not fill the latter's prescription until May
15. Id. There is, however, no indication that Respondent contacted
Dr. K. to determine the extent to which P.H. was obtaining other
prescriptions or to coordinate their prescriptions. Id.
---------------------------------------------------------------------------
Once again, there is no indication that Respondent contacted Dr. K.
to coordinate their prescribing. Moreover, on October 10, Respondent
changed the prescription from 250 tablets of Percocet to 90 tablets of
OxyContin 20 mg., one tablet to be taken every eight hours.\64\ Id. at
13.
---------------------------------------------------------------------------
\64\ None of the progress notes preceding this date indicate
what the dosing of the Percocet was. The first note indicating the
dosing is not dated until April 11, 2001. GX 55, at 1-17.
---------------------------------------------------------------------------
P.H. returned nine days later and Respondent noted that she had
``severe tenderness over [her] lumbar muscle area.'' Id. at 13. While
Respondent found that P.H. ``has pain and stiffness with ambulation,''
a finding which was essentially the same as at the previous visit
(``pain with ambulation'' and ``stiffness and pain with lumbar range of
motion''), she concluded that P.H. now had ``severe low back pain'' and
increased the strength of the OxyContin four-fold to 80 mg. and
prescribed 90 tablets, with the same dosing of one tablet every eight
hours. Id.
On November 9, P.H. again saw Respondent. Id. at 14. Respondent
noted that her physical exam showed less pain and stiffness with
ambulation and that P.H. had less swelling over her lower lumbar area.
Id. Respondent gave her another prescription for 90 tablets of
OxyContin 80 mg. (q8h), along with Robaxin. Id. On November 14 (five
days later), P.H. was back and complaining that the OxyContin was
``causing severe drowsiness'' and ``increased swelling over [her]
lumbar spine.'' Id. Respondent now found that P.H. had ``severe pain
with ambulation,'' ``swelling over lower lumbar spine,'' and ``severe
tenderness over [her] lumbar spine.'' Id. Respondent concluded that
P.H. had a ``poor response to long acting opioids'' and told her to
discontinue the OxyContin. Id. She then gave P.H. prescriptions for 200
Percocet and 200 oxycodone 5 mg. (2-3 q4h) PRN. Id. at 14-15.
Respondent issued additional prescriptions for 200 Percocet on
December 11, and January 9, and for 200 oxycodone 5 mg. (with the same
dosing of 2-3q4h) on December 11, January 9, and January 22. Id. at 14-
15. On February 6, Respondent noted that while P.H. was ``still with
low back pain,'' she was ``doing better in general'' and that the
``physical exam shows she is in less distress with less pain with
ambulation.'' Id. at 15. Respondent gave her a prescription for 200
Percocet as well as 100 Roxicodone. Id. The Roxicodone prescription
was, however, for the 30 mg. strength and gave a dosing of one tablet
every eight hours and thus increased the amount of the drug from a
maximum of 90 mg. (18 5 mg. tablets) to 240 mg. (eight 30 mg. tablets)
per day. Id.
On February 28, Respondent gave P.H. additional prescriptions for
both 200 Percocet and 100 Roxicodone 30 mg., and on March 8, she gave
P.H. an additional prescription for Roxicodone 30 mg. Id. at 16. On
March 20, Respondent noted that P.H. ``continues on medications with
good pain relief,'' that she had only ``slight swelling'' and had
``slight pain with ambulation.'' Id. Respondent gave P.H. new
prescriptions for 200 Percocet and 100 Roxicodone 30 mg (q3h); she also
added a prescription for 100 oxycodone 5 mg. (3-4 q3h). Id.
On March 27, P.H. was complaining of severe pain, that her hips
were ``locked up,'' that it was ``the third time in less than 2 weeks
that she had bad pain,'' and that ``the Roxicodone isn't working.'' Id.
Respondent performed a physical exam and noted that P.H. had
``stiffness antalgic wide based ataxic gait,'' ``tenderness over [her]
bilateral lumbar paraspinals,'' ``swelling'' over [her] ``lumbar
spines,'' and ``pain with lumbar range of motion, which is limited.''
Id. Respondent diagnosed P.H. as having chronic low back pain and
doubled the dosing of the Roxicodone 30 mg. to two tablets every three
hours. Id. at 16-17. Three days later, Respondent noted that P.H. had
blacked out and ``has been having a lot of blackouts.'' Id. at 17.
On April 2, Respondent gave P.H. another prescription for 100
Roxicodone 30 mg. with the same dosing. Id. At the next visit (April
11), P.H. also complained of right calf pain. Id. Respondent diagnosed
P.H. as having a right calf muscle spasm (in addition to low back pain)
and gave her prescriptions for 100 Roxicodone 30 mg., 200 Percocet, and
100 oxycodone 5 mg. Id. Respondent issued additional prescriptions for
Roxicodone 30 mg. on April 30 and May 3, for oxycodone 5 mg. on April
24, and for Percocet on May 3. Id. at 17-18.
On May 15, P.H. again saw Respondent and indicated that she had an
appointment to see a dermatologist, Dr. H., in two weeks for a
condition (bulbous pemphigoid) which had been diagnosed by a physician
at an emergency room. Id. at 18. Respondent's physical exam indicated
that P.H. had a ``severely antalgic gait,'' and ``open sores over
burning and both lower extremities and [a] severe sore over [her] right
foot.'' Id. Respondent diagnosed P.H. as having bulbous pemphigoid and
chronic low back pain, and gave her a prescription for 500 tablets of
Roxicodone 30 mg., with five tablets to be taken even four hours as
needed. Id. Respondent thus increased the dosing of Roxicodone from
approximately 480 mgs. to 900 mgs. of oxycodone per day. Id. There is
no evidence that Respondent ever consulted with the dermatologist that
P.H. saw for the condition. See id. at 18-19. According to the
Government's expert, these ``superficial skin lesions * * * would not
be justification for anything other than mild analgesics.'' GX 46A, at
9.
Throughout June and July, Respondent continued to prescribe
approximately 900 mgs. per day of Roxicodone. GX 55, at 18-19. She also
gave P.H. prescriptions for 200 Percocet on June 4, June 18, July 2,
and July 18. Id. As Dr. Hare noted with respect to the Percocet
prescriptions, a review of P.H.'s ``prior prescriptions would [have]
indicate[d] that she was using 14 tablets/day which could result in
acetaminophen toxicity, [and] the Percocet would be totally unnecessary
with the amount of Roxicodone the patient was receiving.'' GX 46A, at
9.
[[Page 8215]]
Respondent initially treated A.B. for right leg pain with oxycodone
(dosage strength not indicated) and Percocet, as well as Zanaflex, a
non-controlled drug. GX 56, at 1-2. Respondent's initial evaluation
indicated that A.B. was already taking Percocet and Robaxin (a non-
controlled drug), id. at 1, but Respondent ``did not document the
effects of the medications.'' GX 46A, at 10. Nor is there any
indication that she contacted the physician who had presumably
prescribed these drugs to A.B. to obtain records of prior treatment. GX
56, at 1-2. Moreover, while A.B. reported that an MRI of her lumbar
spine had indicated that she had a herniated nucleus pulposus, A.B. did
not know at what level the disk was, id. at 1, and there is no evidence
that Respondent even attempted to obtain the MRI report. Id.; see also
GX 46A, at 10.
On January 9, 2001, Respondent added OxyContin 10 mg. and
prescribed 60 tablets, with one tablet to be taken every twelve hours
(and which should have lasted 30 days). GX 56, at 2-3. She also gave
A.B. prescriptions for 200 Oxycodone 5 mg. and 100 Percocet. Id.
Respondent further noted that there would be a ``recheck in one
month.'' Id. Yet only thirteen days later, A.B. was back and
complaining of a severe migraine, right leg pain, and a severe
inverting of her foot. Id. at 3. Respondent gave her additional
prescriptions for 200 oxycodone 5 mg. and 100 Percocet. Id. Respondent
also gave her another prescription for 60 OxyContin and doubled the
strength of the drug to 20 mg. Id. However, the dosing remained the
same, and thus the OxyContin should have lasted thirty days.
On February 6, A.B. returned. Id. While the note for this visit
indicated that A.B. had pain with right straight leg raising test,
there is no other indication as to the extent of A.B.'s pain and there
is no indication that she was still complaining of migraines. Id. at 3-
4. Respondent gave A.B. a new prescription for 60 tablets of OxyContin
20 mg., and increased both the Percocet and Oxycodone prescriptions to
150 and 300 tablets respectively. Id. Again, there is no indication as
to why A.B. already needed another OxyContin prescription.
On February 21, A.B. apparently called Respondent and reported that
she had undergone a lumbar laminectomy a week earlier, that she was in
severe pain, and had only been given 20 Percocet for post-operative
pain. Id. Respondent gave her prescriptions for 60 tablets of OxyContin
(doubling the strength to 40 mg.), with one tablet to be taken every
twelve hours, and 200 tablets of oxycodone 5 mg. Id. As the
Government's Expert noted, there was ``no indication that the patient
had already used all of the previous OxyContin prescription and this
was not accounted for by'' Respondent. GX 46A, at 11. Moreover, on
February 28, Respondent gave A.B. another prescription for 150 tablets
of Percocet. GX 56, at 4.
On March 9, Respondent gave A.B. additional prescriptions for 60
OxyContin 40 mg. and 200 oxycodone 5 mg. Id. at 4. Again, even though
the previous OxyContin prescription should have lasted thirty days if
taken as prescribed and only sixteen days had passed, there is no
indication that Respondent questioned A.B. as to why she needed more of
the drug. Id.
On March 20, A.B returned. Id. At this visit, Respondent noted that
A.B. had supination of her right lower extremity with ambulation and
that muscle spasm had returned there; she also noted that A.B. had
chronic low back pain. Id. Respondent then gave A.B. a prescription for
60 tablets of OxyContin and doubled the strength from 40 to 80 mgs. Id.
at 5. She also gave A.B. prescriptions for 200 oxycodone 5 mg. and 150
Percocet. Id.
In April, Respondent received a note (apparently from the surgeon
who performed the laminectomy) that A.B. was complaining that the
symptoms she had before her back surgery had returned. Id. Moreover,
her surgeon was going to repeat an MRI and ``get an EMG/NCV of [her]
right lower extremity to rule out neuropathy.'' Id. However, according
to a June 4 note, the MRI of her brain was normal. Id. at 6. A.B. was
to also get another MRI of her lumbar spine, but there is no indication
in the record that she did so. Id.
At the June 4 visit, Respondent noted that A.B. ``complains of
problems with sleeping, and would like to take 2 OxyContin at night
instead of 1.'' Id. Respondent issued her a prescription for 90 tablets
of OxyContin 80 mg., with one to be taken in the morning and two to be
taken at night (also a thirty-day supply if taken as prescribed). Id.
On June 26, Respondent increased the dosing to two tablets every twelve
hours of OxyContin (120 tablets or a thirty-day supply). Id. at 7. At
both June visits, she also gave A.B. prescriptions for 100 tablets of
Roxicodone 30 mg. and 150 Percocet. Id. at 6-7. On July 18, Respondent
gave A.B. new prescriptions (in the same quantity and dosing) for each
of these three drugs. Id.
At M.H.'s initial visit on July 23, 2001, Respondent diagnosed her
as having shingles and gave her prescriptions for 60 tablets of both
OxyContin 20 mg. (q12h) and Percocet (1-2 q4h). GX 54, at 1. On July
27, M.H. returned to Respondent and reported that her ``[i]nsurance
wouldn't cover OxyContin or MS Contin.'' Id. at 2. There is no
indication in the file that Respondent requested that M.H. return or
destroy the OxyContin prescription. Id. Respondent did, however, give
her a prescription for another 100 Percocet. Id.
On July 30, 2001, a local pharmacist called Respondent and told her
that the day before A.B. had picked up an OxyContin prescription for
M.H. and paid cash for the drugs. GX 56, at 7. The pharmacist observed
A.B. walk past M.H.'s car to a silver sports car and place the unopened
bag through the window of the sports car. Id. at 7-8.
The pharmacist further told Respondent that A.B. had come to the
pharmacy the day after the incident to pick up a prescription. Id. at
8. The pharmacist asked A.B. ``if she knew anyone who owned a silver
sports car.'' Id. A.B. answered ``no,'' but when the pharmacist
recounted the incident of the day before, A.B. stated that ``her mother
said that that was her nephew, and that [A.B.] just forgot.'' Id.
According to A.B.'s patient record, A.B. ``told the pharmacist not to
make a big deal about it.'' Id.\65\
---------------------------------------------------------------------------
\65\ This was the first count in the plea agreement. See GX 6,
at 7.
---------------------------------------------------------------------------
M.H. returned to Respondent's office on August 10. GX 54, at 2.
According to the note for the visit, M.H. explained that it was P.H.
and not A.B. who had passed the OxyContin to the silver car and that
the drugs had been for M.H.'s nephew, who she claimed had pain. Id.
M.H. also told Respondent that she was ``never going to buy the
OxyContin, because it [was] too expensive,'' and that her nephew had
``paid for it.'' Id. M.H. ``promised this would never happen again, and
she understood the severity of the situation.'' Id.
On August 3, P.H., who Respondent was treating for both knee and
back pain with Percocet and Roxicodone, saw Respondent. GX 55, at 20.
According to the progress note, P.H. ``ha[d] given Percocet to her
mother and sister and wants more Percocet.'' Id. While Respondent did
not issue any prescriptions at this visit, there is no indication that
she counseled P.H. regarding this. See id.
On August 5, both P.H. and A.B. were in an auto accident. GX 55, at
20; GX 56, at 8. On August 17, P.H. again saw Respondent, who again
concluded that she had a knee injury and low back pain. GX 55, at 20.
Respondent again prescribed Percocet (200 tablets, 1-2
[[Page 8216]]
q4h), and Roxicodone 15 mg. (1000 tabs 10 q4h). Id. Notably, while this
was P.H.'s first visit since M.H. had told Respondent that P.H. had
been the one who had obtained the OxyContin and delivered it to M.H.'s
nephew, there is no indication in P.H.'s record that Respondent
counseled her about the incident. See id.
On August 23, P.H.'s file contains a note indicating that
Respondent had again spoken with the pharmacist who reported the July
29 diversion incident. Id. Once again, the pharmacist ``insist[ed] that
[P.H.] and [A.B.] are selling'' their medications. Id.
On August 27, P.H. again saw Respondent and was accompanied by A.B.
Id. at 21. Respondent wrote P.H. a prescription for the balance of the
Roxicodone prescription that she had written on August 17, which P.H.
had been unable to fill completely. Id. at 20-21. There is, however, no
indication in P.H.'s file that Respondent questioned P.H. about whether
she was selling her medications. Id. Moreover, while the pharmacist had
insisted that A.B. was also selling medications, there is no indication
in A.B.'s patient file that Respondent had counseled her not to do so.
Respondent testified that although she did not notate it in any
file, A.B. and P.H. were present when she counseled M.H. about the
diversion. Tr. 2355. The ALJ did not credit this testimony. Nor do I.
As found above, Respondent counseled M.H. about the incident on August
10th. A.B., however, had been in a motor vehicle accident on August
5th, and according to the August 17 entry in her patient file, A.B. was
then ``at Healthsouth Rehabilitation [I]nstitute with `brain swelling.'
'' GX 56, at 8. A.B. was not discharged until August 23rd. Id. A.B.
thus could not have been present when Respondent counseled M.H. I
further conclude that the lack of documentation in A.B. and P.H.'s
files conclusively establishes that Respondent did not counsel either
one of them regarding the July 30 incident or any other diversion
incidents.
Following the incidents, Respondent continued to treat P.H. for
injuries she incurred during the August 5 motor vehicle accident. On
October 29, Respondent concluded that P.H. had reached maximum medical
improvement with respect to the injuries she incurred in the accident
and ceased treating her for them. GX 55, at 25. Respondent, however,
continued to treat her for low back pain, phlebitis in her left calf (a
condition which she diagnosed on Oct. 15), and bulbous pemphigoid. Id.
For these conditions, Respondent prescribed 200 tablets of Percocet and
500 tablets of Roxicodone 15 mg. (with 10 tablets to be taken every 4
hours). Id.
On December 21, Respondent noted in P.H.'s record: ``faxed refill
request from Bashas' [pharmacy] for Vicodin prescribed by Dr. H.
[P.H.'s dermatologist] denied.'' Id. at 27; see also id. at 18. Here
again, there was evidence that P.H. had either obtained or attempted to
obtain controlled substance prescriptions from other physicians. Id. at
27. And once again, there is no documentation that Respondent
questioned P.H. about other controlled substance prescriptions she had
obtained or that Respondent had contacted the prescribing physician to
coordinate their prescribing to P.H. Id.
Respondent also introduced two letters into evidence from a Dr.
Kaplan, the primary care physician for A.B. and P.H., apparently to
show that he approved of Respondent's prescribing to them. Tr. 2131; RX
B & C. Respondent further indicated that Dr. Kaplan had to authorize
her prescriptions for the insurance plan that the two were on. Tr.
2131.
Dr. Kaplan's letter regarding P.H. simply says that he ``was aware
that she was receiving chronic high dose narcotic analgesic therapy for
chronic pain from'' Respondent. RX C. The letter does not, however, say
that Respondent's prescribing to P.H. was medically appropriate. See
id.
In contrast to the letter he wrote about P.H., Dr. Kaplan stated
that A.B. ``has been receiving appropriate analgesic medications from
[Respondent] during 2001 and 2002.'' RX B. While Dr. Kaplan stated that
his chart notes confirmed that he had been aware that Respondent had
been treating A.B. since early 2001, he did not claim that he had
reviewed the entire course of Respondent's prescribing to A.B. See id.
In a letter dated October 22, 2002, Respondent's own expert, Dr.
Schneider, who was mentoring Respondent, noted that P.H. ``has an
addiction history'' and instructed Respondent to ``[f]ind out to what
was she addicted and how recent.'' RX D-6, at 2. Dr. Schneider also
noted that P.H. ``attends COPE,'' and instructed Respondent to find out
``if they know about her opioid treatment.'' Id. P.H., however, died
before Dr. Schneider sent the letter. Id.
Dr. Hare reviewed the patient files of P.H. and A.B. GX 46A, at 8-
12. With respect to P.H., Dr. Hare observed that she was ``a patient
with multiple complain[t]s which were not adequately evaluated by
[Respondent] and yet she continued to prescribe increasing amounts of
controlled substances, particularly opioids with no apparent
improvement in the patient's condition.'' Id. at 10. Moreover, ``[e]ven
though there were numerous `red flags' regarding the patient's misuse
of medication, including use of the prescriptions in excess of the
prescribed amounts, possible diversion of medication and the admitted
sharing of medication with relatives, Respondent continued to prescribe
unabated. Any reasonable physician would have noted these strong
warning signs and investigated these problems while not prescribing
further for this patient.'' Id.
With respect to A.B., Dr. Hare observed that she ``presented as a
patient with many problems which were not properly diagnos[ed] and
evaluated by'' Respondent. Id. at 12. Dr. Hare further noted that,
while ``there were a number of indications of overuse of medications''
including ``early prescriptions,'' as well as ``clear reports of
diversion,'' Respondent continued to prescribe to her.\66\ Id.
---------------------------------------------------------------------------
\66\ In her findings, the ALJ writes, ``Yet Dr. Weinstein
credibly wrote that Dr. Hare's premise that `medication abuse and
diversion are related to the amount of medication prescribed to an
individual patient' was false.'' ALJ at 87. However, Dr. Hare's
finding of ``red flags'' was not related solely to the amount of
medication prescribed but to the reported behavior of diversion.
---------------------------------------------------------------------------
H.T.
H T. was the patient name for an FBI informant who started treating
with Respondent at her prior clinic in May 1998. GX 71, at 16.
Initially, H.T. was treated for continuing lower back pain with
physiotherapy and other methods; Respondent did not, however, prescribe
controlled substances to him. See generally GX 71. According to H.T.'s
record, during this phase of Respondent's treatment of him, she did her
last physical exam of him on March 8, 2000. Id. at 7.
After a lengthy absence, H.T. returned to Respondent's office in
February 2002 and met with C.M., a chiropractor who worked with
Respondent. GX 60. H.T. mentioned that he had been living in Montana
and doing roofing work, and that ``a couple of times when [he] was
roofin[g], [he] had a little twinge'' or ``twitch back there.'' Id. at
4. H.T. added, however, that he was feeling good. Id. While Respondent
saw H.T. at this visit, she did not prescribe any drugs to him. Id.
H.T. returned on March 4.\67\ GX 61. During the visit, H.T. told
Respondent
[[Page 8217]]
that when he was working ``in Montana I had a sore back sometimes. But
I just think it was because I was working.'' Id. at 12. H.T.
subsequently told Respondent he had ``been feeling really good'' and
denied that the pain went down his leg. Id. at 12-13. H.T. then told
Respondent that one of his friends had a relative who was doctor and
that the doctor had given him Percocet Tens (10 mg.). Id. at 15-16.
H.T. then asked Respondent if she could give him Percocet Tens. Id. at
16-17. Respondent tried to persuade H.T. to take Percocet Fives (5
mg.). Id. at 17. H.T. insisted that he wanted the Percocet Tens. Id. at
21. After telling H.T. that because the Percocet Tens were new and half
of the area pharmacies didn't stock it, Respondent asked him whether he
wanted to try forty or sixty tablets. Id. H.T. said sixty, id., and
Respondent gave him a prescription for sixty tablets of Percocet 10/
325. Id. at 26. Respondent told H.T. to take only six tablets a day,
because the Tylenol (acetaminophen) is ``a bad thing.'' Id. at 27.
Continuing, Respondent stated that the ``the other stuff is a fun
thing'' and that H.T. could also try pure oxycodone. Id.
---------------------------------------------------------------------------
\67\ In her response to the Government's Exceptions, Respondent
challenges the authenticity of the transcripts of the recordings of
H.T.'s undercover visits. I reject her challenge noting that the
underlying tapes had previously been provided to either her or her
attorney in the course of the criminal proceeding, that the
transcripts were mailed to her on December 28, 2006, and the hearing
did not convene until January 22, 2007. See Tr. 45. While Respondent
maintained that she got the transcriptions ``late,'' she did not
establish on what date she received them. Id. Accordingly, I
conclude that Respondent had more than adequate time to compare the
transcripts with the underlying tapes and to prepare a motion
setting forth those instances (were there any) in which the
transcripts did not accurately reflect the content of the tapes.
---------------------------------------------------------------------------
The patient record indicates that a physical examination was
performed, but there is no such indication in the transcript from that
visit. Compare GX 71, at 7-8, with GX 61. According to the patient
file, Respondent found that H.T. ``ha[d] slight pain with lumbar range
of motion and especially has pain with lumbar extension combined
rotation,'' and diagnosed him as have ``chronic biomechanical low back
pain.'' GX 71, at 8. There is, however, no indication in the transcript
of the visit that Respondent performed a physical exam on H.T. See GX
61.
On March 11, H.T. returned to Respondent. GX 62. During the visit,
H.T. told Respondent that he had ``just tested positive'' for Hepatitis
C and wanted to change to pure oxycodone from Percocet, which contains
acetaminophen. GX 62, at 4. H.T. told Respondent that changing the
prescription to pure oxycodone would make him ``pretty happy.'' Id. at
4. Respondent asked H.T. if he wanted sixty tablets; H.T. said he
``would love'' to get sixty. Id. at 6. Respondent wrote H.T. a
prescription for sixty tablets of Roxicodone 5 mg. GX 71, at 8.
Three days later, on March 14, H.T. returned to Respondent.
Respondent asked him to rate his back pain, and suggested ``three,
four, five, six?'' GX 63, at 3. H.T. replied: ``ya know, the Doc always
sa-, helps me, He puts em down so he can get the insurance company
payin[g].'' Id. Respondent replied: ``Okay, five,'' and H.T. agreed
stating: ``Five. I've got worse.'' Id.
H.T. asked Respondent for 120 oxycodone, stating that he was going
to be gone all of the next week and maybe for a part of the week after
that. Id. at 6. Respondent then asked H.T. whether he liked the
oxycodone; H.T. replied that he ``like[d] it, but I had to eat `em like
M & M's,'' because they were ``only fives.'' Id. After explaining to
Respondent that she had previously prescribed only 5 mg. tablets, H.T.
added that he ``was eatin[g] them codones like candy until I noticed
they were just five milligramers.'' Id. at 7.
Respondent then asked whether H.T. wanted to stick with the fives
because they ``are the cheapest.'' Id. H.T. stated that he wanted
``something that's stronger.'' Id. Respondent then asked whether he
wanted fifteens; H.T. replied that he would ``be much happier with
fifteens.'' Id. at 7-8. Respondent then explained that ``the price
breaks at a hundred'' so that she would ``write a hundred'' because the
pharmacist could just give him a box and not have to count out extra
pills. Id. at 9. H.T. then added that oxycodone fives ``didn't make me
feel as good as those ten Percocets * * * [u]ntil I ate a few more.''
Id.
According to H.T.'s patient record, Respondent wrote a prescription
for 100 tablets of Roxicodone 15 mg. GX 71, at 8. The patient record
also indicates that Respondent performed a physical exam. Id. Again,
however, the transcript of the visit does not reflect a physical
examination. See generally GX 63.
On March 25, H.T. went back to see Respondent. GX 64. According to
the transcript, Respondent asked H.T. why he needed to see her because
it had not been two weeks since the last visit. Id. at 4. H.T. told
Respondent that he was there to beg her to give him some OxyContin
forties (40 mg.), that an acquaintance had told him that he had ``gotta
try and get her to give you some of them OxyContin,'' and the
acquaintance had told him that the OxyContin were ``really good.'' Id.
at 4-5.
Respondent then asked H.T. if he wanted to try the ten milligram
OxyContin; H.T. replied: ``Ten? He had forties.'' Id. at 5. After H.T.
repeated that his acquaintance had gotten forties, Respondent explained
that the forties were ``for him'' and that ``there's ten, twenty,
forty, and eighty,'' which are four of the different strengths of the
drug. Id. at 6. H.T. then suggested that ``we split difference,'' and
Respondent said ``twenty.'' Id. Respondent next asked if H.T. could
take ``one of the fifteens and it's fine?'' Id. H.T. replied that he
``probably ate six a day'' and asked ``is that too many?'' Respondent
then suggested that ``it helped and it's for your back.'' Id. While
H.T. initially said ``well yeah Doc'' and laughed, he shortly added
that ``my back feels great, but, I like these,'' and then asked ``is
that a bad thing?'' Id. at 7.
After discussing how H.T. was paying for his drugs, H.T. asked
Respondent ``How many you gonna give me?'' Id. Respondent replied:
``Well, a month would be sixty. You're supposed to take one every
twelve hours.'' Id. at 8. H.T. replied ``really,'' and Respondent asked
him whether he wanted sixty or thirty tablets. Id. H.T. answered that
he was ``hopin[g] you'd give me a hundred'' but that ``sixty sounds
really good'' and laughed. Id. Respondent then suggested that H.T. ``go
through your insurance'' and asked him if he was still driving the
truck. Id. H.T. replied that ``if I drive, I'll still do em.'' Id.
Respondent then stated: ``Alright. Your back is still * * * bad, but
the adjustments help.'' Id. Respondent then wrote H.T. a prescription
for 60 tablets of OxyContin 20 mg. (q12h), a thirty-day supply if taken
as prescribed. GX 71, at 9.
According to the progress note prepared by Respondent for this
visit, Respondent performed a physical exam which showed that H.T.
``has pain with lumbar range of motion and stiffness with lumbar range
of motion.'' Id. Respondent also indicated that she discussed the
``risks and benefits of long acting opioids'' with H.T., ``including
risks of addiction and side effect,'' and that a ``pain contract was
signed.'' Id. But as the transcript makes clear, Respondent did not
perform a physical exam on this date. Nor is there any indication in
the transcript that Respondent discussed the addiction risks with H.T.
Finally, the transcript does not include any evidence that suggests
that Respondent had H.T. sign a pain contract at this visit. Indeed,
the record establishes that Respondent did not have H.T. sign a pain
agreement until April 23, and that she had him back-date the agreement
to March 25. See GX 67, at 7-8.
On April 4 (ten days later), H.T. returned to Respondent's office.
GX 65. After making small talk about their respective ages, Respondent
asked H.T.
[[Page 8218]]
if he ``like[d] the Oxycoton [sic]?'' Id. at 4. H.T. answered
affirmatively, and Respondent asked him: ``That's what you want?'' Id.
H.T. answered: ``Yes, please.'' Id.
Respondent then noted that she had given H.T. a month's supply at
the previous visit and asked him if he was ``takin[g] more of it
then.'' Id. H.T. answered affirmatively and subsequently stated that he
had taken 50 tablets in seven days, or ``about seven a day.'' Id. at 5.
Respondent then asked H.T. if he ``want[ed] [a] stronger pill'' or
if he wanted her ``to write that you take more of em.'' Id. H.T. asked:
``Do they got `em stronger?'' Id. Respondent answered that ``[t]hey
have a forty milligram.'' Id. H.T. answered ``Sure!'' Id. Respondent
stated: ``Let's try that. But if you're taking seven, that's ah, four.
Okay, let's try three a day.'' Id. H.T. then told Respondent: ``You are
so good to me.'' Id. H.T. then asked Respondent if she had to write
something every time he visited, and Respondent said ``I've always had
to write somethin[g].'' Id. at 6.
Respondent then asked H.T.: ``what's your number today?'' Id. H.T.
replied: ``tell me, what do I look like. You know, you, you guys always
help me with my insurance. That's to keep the insurance pay, company
payin[g].'' Id. Respondent replied that she did not know, and H.T.
asked her if he ``look[ed] like a seven.'' Id. When Respondent replied
that he ``look[e]d like a zero,'' H.T. laughed and said: ``That means
on a pain level, right?'' Id. H.T. then went to see the
chiropractor.\68\ At the visit, Respondent gave H.T. a prescription for
90 tablets of OxyContin 40 mg., with a dosing of one tablet every eight
hours. GX 71, at 9. The prescription thus not only doubled the strength
of the previous prescription but also increased the quantity by another
30 tablets. Based on the dosing instruction, the prescription would
last for 30 days.
---------------------------------------------------------------------------
\68\ During his time with the chiropractor, the chiropractor
said that H.T. was ``doin[g] great,'' and H.T. agreed that he was
``feeling great.'' GX 65, at 8.
---------------------------------------------------------------------------
In the progress note for this visit, Respondent indicated that H.T.
had ``continued low back pain,'' and that she had performed a physical
exam, which ``show[ed] that he has pain [and stiffness] with lumbar
range of motion.'' Id. She also noted that he was ``doubling up on the
OxyContin'' and was ``even taking more than double.'' Id.
On April 11, one week later, H.T. again saw Respondent and
requested a refill prescription, indicating that he would be going out
of town for two weeks. GX 66, at 5. As the previous prescriptions would
last for 30 days and only one week had passed, H.T. did not need
another prescription if he was only going to be gone two weeks. After
some small talk, Respondent asked H.T. ``do you want the OxyContin?'';
H.T. answered: ``Yeah.'' Id. at 8-9. Respondent then noted
(incorrectly) that H.T. had ``just got it March 25th''; before
Respondent could complete her next sentence H.T. replied: ``I know. I
got a maybe about um, fifty left. But I'm gonna be gone for two weeks I
think.'' Id. at 9. Respondent and H.T. then discussed when the latter
would be leaving, how many pills he had left, and whether his insurance
would cover it because he was ``so early.'' Id.
Respondent eventually agreed, however, to write H.T. a prescription
for twenty-milligram strength and asked him if he ``want[ed] ninety?''
Id. at 11. H.T. replied: ``Oh, please. I probably been eatin[g] a few
more of those than three a day, okay?''; he then added that he wanted
``to be totally honest with'' Respondent. Id. After an unintelligible
comment by Respondent, H.T. reiterated that he only had ``fifty left.''
Id. Respondent then asked H.T. whether he would be out of town ``for
two weeks,'' and H.T. stated that he was ``pretty sure'' that he would
be gone ``for two weeks.'' Id. at 12. Respondent then gave H.T. a
prescription for another 90 tablets of OxyContin 40 mg. (also q8h).
Id.; see also GX 71, at 10. H.T. then told Respondent:'' You're okay,
Doc,'' and Respondent replied: ``I know * * * You caught me at a soft
moment.'' GX 66, at 12.
On April 23, H.T. returned to Respondent and again sought more
OxyContin. GX 67, at 6-7. After discussing with H.T. whether he was on
the forty or eighty-milligram strength tablets, Respondent asked him if
he had signed a pain management agreement at the last visit. Id. at 7.
After H.T. replied that he did not think so, Respondent told him that
he needed to do so and to date the agreement March 25, 2002. Id. at 8.
Respondent then explained some of the requirements of the pain
agreement. Id. at 8-12.
Respondent and H.T. then discussed how many tablets she had given
him at some of the previous visits. Id. at 12-13. Respondent noted that
she had given him 90 tablets and asked him if he was ``takin[g] more
than three a day?'' Id. at 14. When H.T. answered ``[y]eah,''
Respondent asked him if he was ``out of `em.'' Id. H.T. then asked:
``[i]s that a bad thing?'' and added that he had ``a few left.'' Id.
Respondent then told H.T.: ``They're watchin' me, Hal.'' Id. at 15.
H.T. asked: ``They're what?'' Respondent replied: ``I gave you ninety
of the forties. I gave you ninety, wait a sec. I gave you on ni-, on
the fourth and the eleventh.'' Id. H.T. then said: ``I told you I got
the * * * constitution of * * * a mammoth. And you have the heart of a
mammoth.'' Id. H.T. then added that ``I'd never tell you none of them
stories about losing' `em or anything. I just tell ya the truth. I'd
just like a few more of those okay?'' Id.
Following a discussion of what to put in his medical record,
(Compare id. with GX 71, at 10), Respondent asked him if he could
``taper down a little?'' because she had given him 90 tablets and a
week after that, another prescription because he was ``going out of
town.'' Id. at 16. H.T. asked ``is that a bad thing?,'' and Respondent
explained: ``Well, they're watching me, so, I, I can't do it again
until this investigation's over.'' Id. After H.T. asked who was
watching her, Respondent answered that the State medical board was. Id.
H.T. then told Respondent that he did not want to get her in trouble,
that if the Board came to him, he would ``have nothing but nice things
to say about'' her, and that he would not be coming in with Morley
Safer from Sixty Minutes. Id. at 17.
Later in the conversation, Respondent asked H.T. to make his drugs
``last a little more'' and added: ``[u]ntil my investigation is over.''
Id. at 18. H.T. initially agreed to, but added that ``I hate like
though when it says just take three'' and that ``there's a part of me
that want to take one more than or two more than.'' Id. H.T. then
suggested that if Respondent gave him the ``bigger ones, they'd last
longer.'' Id. Respondent replied that ``[f]orty is good enough.'' Id.
Respondent then suggested that H.T. try Celebrex, an anti-
inflammatory which is not a controlled substance. Id. at 19. H.T.
replied that ``[t]he only pain in my life is the ache in my heart when
I'm around you visions of loveliness that work here.'' Id. Apparently,
Respondent then gave H.T. a prescription for Celebrex, see GX 71, at
19; and H.T. asked if she could give him ``some more'' OxyContin. GX
67, at 19.
When Respondent said that she couldn't because she had recently
given him 90 tablets, H.T. complained that ``I only got a few of those
left.'' Id. at 20. Respondent then told H.T. she was giving him the
Celebrex and that she had given him 90 OxyContin ``on the eleventh,''
which ``was like eleven days ago,'' and he was ``taking nine a day''
when he was ``supposed to take three a day.'' Id. After H.T. complained
that he was going to ``run out,'' Respondent told him that he had to be
good until next
[[Page 8219]]
week.\69\ Id. at 20-21. H.T.'s record also reflects a physical
examination, without corroboration from the transcript of the visit.
Compare GX 71, at 10, with GX 67.
---------------------------------------------------------------------------
\69\ The patient record indicated that Respondent performed a
physical exam at the April 23 visit. GX 71, at 10.
---------------------------------------------------------------------------
On April 29, H.T. again saw Respondent. GX 68. H.T. told Respondent
he did not fill the Celebrex and asked: ``What do I need an anti-
inflammatory for?'' Id. at 6. Respondent answered ``It's for pain,''
and added that he ``should try it.'' Id. H.T. then replied: ``Doc, you
know between you and me my pain level is non-existent, but, I really
like them Oxyco[ntin]. Them make me feel good.'' Id.
Respondent then asked H.T. ``if you're not using `em for pain
what're ya using `em for?'' Id. H.T. replied: ``Cause life is painful,
ya know, just that, the heartache and the psoriasis and all that other
stuff.'' Id. Respondent then asked H.T. if he was ``using it to just
make you feel like, mellow?'' Id. When H.T. replied (laughingly),
``what should I say no?,'' Respondent answered: ``I can't prescribe `em
for that reason.'' Id. at 7. When H.T. told Respondent to ``put down
that I'm in a lot of pain then, okay?,'' Respondent answered: ``But
you're not in a lot.'' Id. Respondent then noted that she had given him
90 tablets, and yet he was out of the drugs ``by the end of the week''
and that he was ``getting addicted to `em.'' Id. at 8-9. H.T. insisted,
however, that he was not getting addicted because he had the
``metabolism of an elephant'' and had ``quite a body mass.'' Id. at 9-
10.
While Respondent again maintained that she could not keep filling
the prescriptions for the reasons H.T. wanted the drugs, she then told
him that she could not do it because she was being ``watched like a
hawk now because * * * everybody thinks I'm writing too many
prescriptions for people.'' Id. at 10. H.T. then told Respondent that
she did not ``have to worry about'' him. Id.
Respondent then suggested that she ``could cut down the dose'' and
asked H.T.: ``You want a small dose?'' Id. Respondent also told H.T.
that ``Forties is a high dose.'' Id. Respondent subsequently told H.T.
that she had given him ``a month's supply on April eleventh'' and that
``[i]t's not a month.'' Id. at 11. H.T. insisted that it was ``pretty
dang near though?'' Id. Respondent told him that he would have to wait
until May 11th. Id.
H.T. then asked Respondent for a prescription to last until May 11.
Id. Respondent asked H.T. what had happened to the 100 tablets of
oxycodone 15 mg. which she had given him in March. Id. at 12. H.T. told
Respondent that they were ``like aspirin'' and that OxyContin ``was
better than them.'' Id. Respondent then insisted that if H.T. read the
news, he would know that ``[e]verybody's all afraid of'' OxyContin, and
that ``we have to live with rules.'' Id.
When H.T. reminded Respondent that she had told him that he would
be able to get a new prescription ``this week,'' Respondent replied:
``you * * * unfortunately told me why you were taking `em. Has nothing
to do with your back pain and that's the only reason you should be
taking `em.'' Id. at 13. Respondent then told H.T. to ``[w]ait till May
eleventh. Then at least you'll have a month.'' Id. Respondent then
added that she was ``gonna cut and give [him] twenties.'' Id. H.T.
replied: ``Twenty. How can you do that?'' and Respondent answered:
``Hal, wait till my investigation's over.'' Id. at 14.
On May 15, H.T. again saw Respondent. GX 69. H.T. told Respondent
that he `love[d] those pills'' and added that while she had told him
``to wait till the eleventh,'' he had ``been so good'' and that it was
then ``past the eleventh.'' Id. at 2. Respondent told H.T. that the
pills were ``supposed to be for back pain.'' Id. H.T. replied he was
``getting into that mode, doc,'' asked if she had seen him ``come in
here kinda all kinked over and everything,'' and added that his
``modality [was] messed up'' and that ``homeostasis [wa]s unaligned.''
Id. H.T. then facetiously added that he had ``great internal and mental
stress'' because he had abandonment issues as a child and his wife had
divorced him and run off with a bald guy (who was considerably older)
more than fifteen years earlier. Id. at 2-3.
H.T. then offered to be a character witness for Respondent in the
board investigation. Id. at 4. When Respondent said that the board
would say that she had been giving him drugs and that he was a drug
addict, H.T. interjected that he had not been getting drugs from her
for that long. Id. at 5. Respondent then observed that she had first
put him ``on twenties then you like the forties.'' Id. H.T. responded
that he had the metabolism of a mammoth, and that he would not ask her
``again until thirty-five days or whatever.'' Id. Respondent then asked
H.T. if he wanted to ``take three a day?''; H.T. said ``sure.'' Id. at
5-6. Respondent then asked H.T. if he was taking the Celebrex; H.T.
said that he had filled the prescription but that it did ``not really''
help. Id. at 6.
Following a discussion of whether H.T. was going to the pharmacy
that he said he would use in the pain agreement, H.T. suggested that he
fill his prescriptions in Mexico. Id. at 7. Respondent said that she
did not think that he would be able to fill the prescriptions in
Mexico, ``especially OxyContin.'' Id. at 8. H.T. then told Respondent
that if you went to the border towns such as Nogales, people would come
up to him ``trying to hustle you for everything,'' and that one such
individual had tried to sell him Viagra. Id. H.T. added that he asked
this individual about buying OxyContin, and that the individual offered
to sell him twenty-milligram tablets for ``two dollars a milligram.''
Id. H.T. also added that this individual ``wanted to sell everything.
Vicodin, ah, Viagra, ah, he was just like a walkin[g] PDR.'' Id. at 9.
Shortly thereafter, Respondent issued H.T. a prescription for 90
tablets of OxyContin 40 mg. GX 71, at 11. After he again offered to be
a witness for Respondent in the Board's investigation, H.T.'s visit
with Respondent ended. GX 69, at 10.
The entry in H.T.'s patient record for this visit indicated that
Respondent performed a physical exam and found that he had ``pain'' and
``stiffness with lumbar range of motion.'' GX 71, at 11. Respondent
also indicated that she had performed a ``neurological exam of both
lower extremities [which] showed normal motor strength, sensation and
deep tendon reflexes.'' Id. Again, however, the transcript lacks any
indication that Respondent performed the tests she documented as part
of her physical exam.
In her Response to the Government's Exceptions, Respondent also
contended that H.T.'s loud laughter would have drowned out evidence of
the physical examinations she claims to have performed. Response to
Exceptions at 2. Respondent also maintained that ``after four years of
these physical exams, there are necessarily fewer specific directions
to the patient,'' and that H.T. knew the routine for her focused
physical examination and did not have to be told what to do. Id.
Respondent's arguments are not persuasive. As for her contention
that he knew her routine after so many years of exams, the record
establishes that on March 4, 2002 (the date she started prescribing
controlled substances to him), she had not physically examined him
since March 8, 2000, a period of nearly two years. See GX 71, at 7.
Between these exams, H.T. had been physically examined by at least two
other physicians (on May 31, 2000 and January 24, 2001) for the same
condition. See id. at 23 & 27. It is therefore exceedingly unlikely
that H.T.
[[Page 8220]]
would have remembered Respondent's routine for performing a physical
exam.
Moreover, the transcripts of H.T.'s various visits do not contain
even a trace of the prompting that a physician would use in performing
a physical exam. As for Respondent's further contention that H.T.'s
laughter drowned out her directions when she performed an exam, the
instances of laughter (and by whom) were noted in the transcripts and
were quite limited. Finally, while Respondent maintains that ``[t]he
actual audio tape contains lots of loud laughing by H.T.,'' she did not
identify specific examples of this in her briefs. I thus conclude that
Respondent failed to physically examine H.T. on March 4, 14, and 25,
April 4 and 23, and May 15, 2002. I further find that Respondent
falsified H.T.'s medical record for these six visits by indicating that
she had performed a physical exam when she did not.\70\
---------------------------------------------------------------------------
\70\ Dr. Hare reviewed H.T.'s patient file. Dr. Hare remarked
that when H.T. returned in March 2002, Respondent's physical
examination was ``minimal,'' and Respondent did not inquire as to
the physician who had prescribed the Percocet to him. GX 46A, at 2.
Dr. Hare further noted that Respondent started H.T. at ``one of the
stronger doses of Percocet,'' and Dr. Hare questioned why she did
not begin with a lower dose. Id. On March 11, 2002, when Respondent
switched H.T. from Percocet to oxycodone, she did not notate her
reasoning in the file. Id. At that time H.T. was taking
approximately nine tablets of Percocet a day, in excess of the
prescribed amount. On March 14, when he returned, he was taking
approximately 20 tablets/day, ``2/3 oxycodone at a time,'' without
any indication of improvement in his pain. Id. On April 4, when
Respondent noted that H.T. was ``doubling up on OxyContin, even
taking more than double,'' Respondent wrote for OxyContin 40 mg.,
one each eight hours. Id. Dr. Hare noted that one week later, when
H.T. indicated he would be going out of town for two weeks,
Respondent again wrote for 90 OxyContin 40 mg. Id. He noted that the
``same information and the same physical examination is stated in
the chart'' for both April 23 and the subsequent visit on May 15.
Id.
Dr. Hare concluded that ``the history and the physical were
inadequate to allow prescribing of a control [sic] substance.'' Id.
at 3. Respondent ``rapidly escalated the dose'' without any
documentation that the pain responded to opioid medication, and the
patient ``consistently used the medication in excess of her
prescriptions.'' Id. For Dr. Hare, ``[t]his should have been an
indication to [Respondent] that the patient was non-compliant and
using medication in excess, raising the likelihood of abuse or
diversion.'' Id.
---------------------------------------------------------------------------
The gist of Respondent's testimony with respect to H.T. was that
she was duped. For example, Respondent testified that H.T. ``was always
a very loud, obnoxious patient,'' that he ``was a three-time convicted
felon who somehow made a deal with the FBI to become * * * [a]
`mole,''' and that he carried a ``Tri-Care insurance card, which
identified him as E-8, enlisted man 8, which is a pretty high rank for
an enlisted person.'' Tr. 2068. According to the Respondent,
``[d]octors being human, we give some credibility to a person based on
their credentials.'' Tr. 2068-69. See also Tr. 2316 (``In my mind [the
prescriptions were] for a legitimate medical purpose, but obviously,
when I'm confronted with the fact * * * that the person I thought I was
prescribing to was lying to me and faking, then one can't but help but
then conclude based on that retrospectively that that was not for a
legitimate medical purpose.'').
Continuing this theme, Respondent complained that H.T. presented
``a true * * * a seemingly true insurance card'' such that the
insurance company would have received payments ``[s]o there was no
question, to us, that he was telling the truth * * * about who he
was.'' Tr. 2071. She also testified that his visits followed September
11, 2001, and that there ``was certainly a new-found respect for the
military after 9/11'' such that she ``afforded him some deference.''
Tr. 2072.
Respondent further claimed that ``we kept thinking that he was
coming because he had back pain'' and that ``all of our documentation
and our conversations with him were assuming that he was having back
pain.'' Id. at 2073. Yet she also acknowledged that there were several
times when she ``wanted to'' put him on ``maintenance care'' and have
him come less frequently because his back was ``much better.'' Id. at
2072. Respondent claimed that ``it's really hard for a doctor to just
get rid of patients'' and ``the fact that we didn't like him is not a
reason to get rid of him.'' Id. at 2072-73.
Moreover, Respondent testified that at the visit when H.T. asked
for Percocet, he did not present any ``significant change'' in his
condition and that his ``physical exam was never very significant.''
Id. at 2075. She claimed that she ``trusted him'' and that ``when he
asked [her] for Percocet * * * he needed it'' even though he ``was
using words very unusually.'' Tr. 2075-76.
Respondent testified that ``in retrospect'' she ``should have been
suspicious because he's laughing'' as they talked.\71\ Id. at 2074.
Respondent maintained, however, that medical professionals are ``not
trained to be suspicious of people'' or ``to figure out inconsistencies
in what people tell us.'' Id. at 2075. But she then acknowledged that
H.T. never had neurological symptoms or that there was ``any reason to
suspect he had a herniated disc and needed to have surgery or any
emergency procedure.'' Id. at 2075-76. Finally, while Respondent
admitted on cross-examination that the prescriptions she issued to H.T.
lacked a legitimate medical purpose, this was because he ``was not a
true chronic pain patient'' and ``the fact that everything he was
presenting to me was not correct.'' Id. at 2322.
---------------------------------------------------------------------------
\71\ The transcripts reflect, however, that Respondent
frequently found H.T. to be amusing.
---------------------------------------------------------------------------
The transcripts of H.T.'s visits make plain that Respondent's
testimony is self-serving and disingenuous. For example, at the March
4, 2002 visit when H.T. returned and requested Percocet, he indicated
that he had had ``a sore back'' only ``sometimes,'' and that was when
he was working. He also made clear that he had ``been feeling really
good'' and denied that the pain went down his leg. Moreover, he asked
for a specific drug--Percocet 10/325. Finally, when Respondent
counseled him about the risk of taking too many tablets because of the
drug's acetaminophen content, which she characterized as ``a bad
thing,'' she then added that ``the other stuff [the oxycodone] is a fun
thing.'' Moreover, Respondent did not physically examine him even
though she had not seen him in nearly two years. In short, Respondent
knew that H.T. was not seeking the Percocet to treat a legitimate pain
complaint.
At subsequent visits, H.T. made additional comments which made
clear that he was engaged in drug-seeking. For example, at the March 11
visit, H.T. told Respondent that changing his prescription to oxycodone
would make him ``pretty happy,'' and when Respondent asked if he wanted
60 tablets, H.T. told her that he ``would love'' to get 60. Moreover,
H.T. told Respondent that he was eating the oxycodone 5 mg. tablets
``like candy'' and ``M & Ms.'' Moreover, Respondent did not perform a
physical exam even though she indicated that she had in H.T.'s record.
At the March 25 visit, H.T. told her that he was there to beg her
to give him some OxyContin 40s. And when Respondent commented that it
was o.k. that H.T. was taking six fifteen-milligram Roxicodone tablets
a day because it was for his back, H.T. laughed and added that his back
felt great but that he liked the drugs.
Throughout these visits, H.T. also presented a pattern of seeking
additional drugs, as well as more powerful drugs, well before the
previously issued prescriptions would have run out. Moreover, after she
gave H.T. a prescription for another 90 tablets of OxyContin 40 mg.
(merely a week after a previous prescription for the same strength and
quantity, which should have lasted thirty days based on the dosing
instruction), H.T. told her
[[Page 8221]]
``You're okay, Doc,'' to which Respondent replied: ``I know * * * You
caught me at a soft moment.''
When H.T. sought more OxyContin at the next visit (April 23), H.T.
did not claim that he was in pain and told her that he never made up
any stories about losing the drugs and that he was telling the truth
and just wanted to get ``a few more.'' Moreover, Respondent told H.T.
that she could not write another prescription so soon because the State
Board was investigating her. Furthermore, later in this visit H.T. told
Respondent that he did not have pain (``the only pain in my life is the
ache in my heart when I'm around you visions of loveliness that work
here'').
At the next visit, H.T. once again made clear that his ``pain level
is non-existent.'' When Respondent questioned H.T. further as to why he
wanted the drugs, H.T. made plain that he was seeking the drugs to
abuse them and not to treat pain. Respondent further told H.T. that she
could not give him a new prescription until at least a month had passed
from the previous prescription and that he should wait until the
investigation was over.
Finally, at the last visit, H.T. once again made clear that he was
seeking the drugs to abuse them and not to treat pain. Moreover, he
also told Respondent that he had tried to buy OxyContin on the street
in Mexico and even cited the price per milligram. Respondent
nonetheless gave him another prescription for 90 tablets of OxyContin
40 mg.
It is thus clear that Respondent knew that H.T. was not seeking the
drugs to treat a legitimate pain condition, but rather to abuse them.
Respondent was in no sense duped by H.T. as to his reason for seeking
the drugs; indeed, she clearly knew that he was seeking the drugs for
an illicit purpose.
K.Q.
Respondent treated K.Q. as early as 1992, but her patient record in
evidence starts in 1997.\72\ Tr. 2097; GX 58, at 2. On March 17, 1997,
K.Q., who was then a 37-year-old female, visited Respondent. Id. K.Q.
complained of ``low back pain radiating to right lower extremity and
numbness right lower extremity'' after having fallen down in a grocery
store some three to four days earlier. Id.
---------------------------------------------------------------------------
\72\ According to Respondent, the earlier records had been
archived. Tr. 2097.
---------------------------------------------------------------------------
K.Q. was on disability and had been in two prior motor vehicle
accidents. Id. K.Q. had been diagnosed two years earlier with
``pseudotumor cerebri'' and was still being treated for this condition
by another physician, Dr. S. Id. K.Q. had had ``dozens of LPs \73\ to
drain CSF fluid.'' Id. She was also still treating with Dr. L., who was
prescribing Percocet to her, apparently for either a bulging or
herniated disk at L2-3. Id.
---------------------------------------------------------------------------
\73\ Lumbar punctures.
---------------------------------------------------------------------------
In her medical history, Respondent noted that K.Q. was taking
Lorcet, a schedule III controlled substance which contains hydrocodone;
Xanax, a schedule IV controlled substance; as well as two non-
controlled drugs, Prozac and Mevacor. Id. There is, however, no
indication in the progress note as to who was prescribing these other
drugs. Id.
Respondent performed a physical examination and diagnosed K.Q. as
having chronic low back pain and muscle spasm, with a temporary
exacerbation of pain, cervical pain, and muscle tenderness. Id. at 2-3.
As part of the treatment plan, Respondent gave K.Q. a prescription for
20 Percocet. Id. at 3. She also recommended that K.Q. get ``cervical
and lumbar x-rays,'' cervical and lumbar range of motion testing to
accurately document ROM deficits and motion [K.Q.'s] progress through
rehabilitation, and a ``[c]omprehensive program of joint mobilization
and physiotherapy.'' Id. There is no indication in the progress note,
however, that Respondent contacted Dr. L., who reportedly was still
treating her and prescribing Percocet, or Dr. S., to determine what
drugs they were prescribing to K.Q. and to coordinate her prescribing.
K.Q. underwent physical therapy the same day, as well as on the
next two days. Id. at 4. During her March 19 visit, K.Q. sought a
prescription for 90 Percocet ``because of a price break and because she
got a check from the church made out for exact amount of 90 Percocet.''
Id. Respondent wrote a prescription for 90 Percocet. Id. After this,
K.Q. did not appear for any more physical therapy sessions. Id.
Moreover, there is no entry in the progress notes indicating that x-
rays were done. Id. at 3-4.
On October 27, more than seven months after her last visit, K.Q.
reappeared. Id. at 4. She complained of ``severe low back pain, mid
back pain and headaches,'' and reported that she was ``on OxyContin and
Duracet, as well as either Xanax or Valium.'' Id. K.Q. said she saw Dr.
L. every two weeks but had missed her October 1 appointment and had
missed getting her prescriptions and that Dr. L. was out of town until
November 3. Id. K.Q. and Respondent apparently did not discuss why, if
K.Q. was seeing Dr. L. every two weeks, she had not seen him in the
middle of October. Moreover, there is no indication that Respondent
contacted Dr. L.'s office to verify whether he was away (or whether
there was no one else in his practice who was covering for him).
After a physical examination, Respondent diagnosed K.Q. as having
chronic low back pain and myofascial pain. Respondent then prescribed
60 OxyContin 20 mg. BID, 90 Xanax 1 mg. TID, and 30 Duracet 10 TID. Id.
at 5. Respondent discussed the risks and benefits of long-acting
opioids with K.Q., that any early renewals would be at her discretion,
that ``any doses changes need[ed] to be order[ed] by'' her, that K.Q.
should undergo a program of joint mobilization and physiotherapy two
times per week with a recheck in three weeks. Id. Respondent also noted
that K.Q. should ``[c]ontinue care with Dr. [L].'' Id. Notably, there
is no explanation as to why Respondent prescribed Xanax other than that
K.Q. told her that she was taking it.
Later that day, the pharmacy called to tell Respondent that
``[t]here is no medication Duracet.'' Id. Moreover, there are no
progress notes (as there were in March) indicating the dates, if any,
on which K.Q. underwent physical therapy. Compare id. at 4 with id. at
5.
On November 17, K.Q. returned and again complained of ``severe low
back pain'' and a ``shooting pain'' in her right leg. Id. K.Q.
indicated that she had neck pain associated with migraine headaches.
Id. She also told Respondent that she was currently taking OxyContin 40
mg. in the morning and OxyContin 20 mg. in the evening, as well as ``a
muscle relaxant called `Durect.' '' Id. Respondent gave K.Q. samples of
Zanaflex 4 mg. and prescriptions for 90 tablets of OxyContin 20 mg. ``2
q AM and 1 q PM'' (a thirty-day supply), and 90 tablets of Xanax 1 mg.
``TID'' (also a thirty-day supply). Id. at 6. Again, notwithstanding
that K.Q. had told Respondent that she was taking a drug that
Respondent had not prescribed to her, there is no indication that
Respondent contacted any of the others physicians whom K.Q. was seeing.
Twelve days later, on November 29, Respondent phoned in a
prescription for thirty Vicodin when KQ reported that her ``purse was
stolen.'' Id. Respondent had not previously prescribed Vicodin (or any
other medication containing hydrocodone) to K.Q. While this was another
indication that K.Q. was obtaining drugs from multiple physicians or
from the street, again there is no indication that Respondent even
questioned K.Q. as to who the source of the Vicodin was. Id. Nor is
[[Page 8222]]
there any indication that Respondent required K.Q. to present a police
report.
On December 8, K.Q. returned and complained of severe low back
pain, neck pain, and headaches. Id. She also complained of numbness and
of a shooting pain in her right lower extremity. Id. Following a
physical exam which was limited to palpating her right upper trapezius
muscle and lumbar area, Respondent wrote her prescriptions for another
90 tablets of both OxyContin 20 mg. (2 qam and 1 qpm) and Xanax (1
tablet three times a day). Id. Notably, the prescriptions she issued on
November 17 should have lasted another nine days (until December 17).
Respondent also noted that she ``need[ed] to discuss case with Dr. L.''
Id. There is, however, no indication in the patient file that
Respondent ever called Dr. L.
On December 23, K.Q. needed a three-month prescription for
OxyContin and Xanax ``to mail away for.'' Id. Respondent obliged and
wrote her prescriptions for 279 tablets of OxyContin and 270 tablets of
Xanax. Id. at 7.
About one month later, on January 20, 1998, K.Q. returned,
complained of severe low back pain, and indicated that she had ``taken
slightly more of OxyContin.'' Id. K.Q. told Respondent that she had
``never mailed away for the [three] month supply of the OxyContin'' but
apparently had for the Xanax, as she did not need another prescription
for the latter. Id. Respondent did not perform a physical exam on K.Q.
Nor did she question how she had managed to continue taking OxyContin
and done so at an increased dose when the last prescription Respondent
issued to her (prior to the one she claimed not to have filled) was on
December 8, six weeks earlier. Nor did she ask K.Q. to return the
OxyContin prescription she issued on December 23. Id.
On February 2, Respondent discontinued the OxyContin and placed
K.Q. on Duragesic patches. Id. at 8. She also noted that K.Q. was
``very depressed,'' diagnosed her as having depression, and gave her a
prescription for 90 Valium 10 mg.\74\ Id. Respondent did not indicate
in the record why she was switching K.Q. from Xanax, a drug which is in
the same class as Valium. Moreover, given the size of the previous
Xanax prescription (a three-month supply which was written in late
December), the Xanax should have lasted until late March.
---------------------------------------------------------------------------
\74\ At K.Q.'s March 17 visit, Respondent noted that she was
taking Prozac, a non-controlled drug prescribed for depression. It
does not appear that Respondent attempted to contact whoever had
treated K.Q. with the Prozac.
---------------------------------------------------------------------------
On March 2, after a brief trial of the Duragesic patches, K.Q.
complained that patches did not work well and ``want[ed] back on the
OxyContin.'' Id. at 9. Respondent, who did not perform a physical exam,
diagnosed K.Q. as having both chronic pain and fibromyalgia and gave
her prescriptions for 60 OxyContin 40 mg. (BID) and 90 Valium 10 mg.
(TID).\75\ Id.
---------------------------------------------------------------------------
\75\ Respondent also gave her a prescription for Zanaflex.
---------------------------------------------------------------------------
Sixteen days later, on March 18, K.Q. returned and ``complain[ed]
of severe pain for past 2 weeks'' and reported that she had been
``taking extra medications, including extra Valium and OxyContin.'' Id.
Respondent's physical exam found that she had ``multiple areas [of]
pain and tenderness to palpation.'' Id. Respondent doubled the dosing
of the OxyContin 40mg. to two tablets every twelve hours; the progress
note does not, however, indicate how many tablets she prescribed. Id.
Respondent also gave her a prescription for 120 tablets of Valium (TID
and HS). Id.
On March 27, K.Q. complained that she had not voided or had a bowel
movement in three days. Id. Respondent found her bladder distended and
referred her to an emergency room for a bladder catheterization and
evaluation. Id. at 10. On March 31, K.Q. returned and told Respondent
that she ``believe[d] that the nurse took her OxyContin.'' Id.
Respondent gave her a new prescription for 180 OxyContin 40 mg. (q8h),
as well as for 30 Halcion (triazolam), a schedule IV controlled
substance. 21 CFR 1308.14(c).
On April 14, K.Q. wanted to try a medication other than OxyContin
because she thought it caused nausea, vomiting and headaches. Id. at
10. According to Dr. Hare, ``it would be unusual for [a] patient to
suddenly start having side-effects after 6 months of treatment with the
medication.'' GX 46A, at 4. K.Q. also told Respondent that she was
changing to an insurance plan that ``would not pay for the OxyContin,''
GX 58, at 11; and that she had previously taken methadone. Id.
Respondent then wrote K.Q. a prescription for methadone 10 mg. ``2 tabs
QID'' (eight tablets a day) but did not indicate in the patient record
the quantity. Id. Respondent also gave her a prescription for another
120 tablets of Valium. Id. There is no indication, however, that
Respondent questioned K.Q. regarding her prior use of methadone;
whether it was prescribed to her, and if so, who treated her; why was
she taking it (methadone is prescribed both for pain and
detoxification/maintenance treatment); and when she had previously
taken it.
K.Q. next visited on May 1, and reported that she was taking up to
120 mg. methadone per day, one and one-half times the prescribed daily
dose. Id. Although K.Q. reported that she was ``doing better'' on the
methadone, and the physical exam found she had less distress, less pain
with lumbar ranger of motion and ambulation, Respondent gave her a
prescription for 300 tablets and doubled her dose to four tablets, four
times a day. Id. She also wrote her a prescription for 120 Xanax 1 mg.
``TID'' (a forty-day supply if taken as directed) and noted that K.Q.
would discontinue use of Valium. Id.
On May 20 (nineteen days later), Respondent again wrote K.Q. a
prescription for 120 tablets of Valium 10 mg. ``QID.'' Id. at 12.
Respondent did not indicate in the progress note why she was switching
K.Q. back to Valium. Id. Respondent also wrote K.Q. another
prescription for 300 methadone 10 mg. Id.
On June 5, K.Q. reported that while she was taking the recommended
dosage of four tablets, four times a day, she had only ten Methadone
tablets remaining. Id. K.Q. told Respondent that ``she believe[d] some
workmen may have `gotten into' her medications.'' Id. Once again, there
is no indication that Respondent questioned K.Q. as to how this could
have happened. Id. Respondent counseled K.Q. that ``she needs to lock
up her medications,'' and K.Q. agreed to. Id. She then wrote K.Q.
another prescription for 300 tablets of methadone 10 mg. ``4 tabs
QID.'' Id.
On June 19 (two weeks later), K.Q., who had recently twisted her
ankle, wanted to switch off of methadone. Id. at 16. Apparently,
another doctor told K.Q. that because she had pseudotumor cerebri,
methadone could cause a side effect. Id. K.Q. also told Respondent that
she would like to switch to MS Contin, because she could not afford
OxyContin. Id.
Respondent performed a physical exam and found that K.Q.'s right
ankle had slight swelling and that she had ``severe numbness of [her]
right lateral thigh and lateral calf.'' Id. Respondent noted her
impression as ``post mild right ankle sprain.'' Id. Respondent also
diagnosed K.Q. as having ``chronic numbness right lower extremity
secondary to right lumbar radiculopathy vs myofascial pain,'' id., but
according to Dr. Hare, there was no evidence in the chart to support
the diagnosis. GX 46A, at 5. Respondent wrote K.Q. a prescription for
180 tablets of MS
[[Page 8223]]
Contin 60 mg. ``2 tabs q8h,'' a thirty-day supply. GX 58, at 16.
Three days later, K.Q. told Respondent that ``they only filled 100
of the MS Contin.'' Id. Respondent did not, however, document the
reason for the partial filling. Id. K.Q. also told Respondent that she
was taking 3-4 tablets every eight hours, one and one-half to twice the
prescribed dose. Id. There is no indication in the record that
Respondent counseled K.Q. regarding her self-escalating the dose of the
medication or that she questioned her as to whether it was necessary to
address her pain. Id. Respondent then gave K.Q. another prescription
for MS Contin 100 mg. ``2 tabs q8h 180,'' a thirty-day supply.
Id. at 16-17.
On July 10, K.Q. returned to Respondent and told her that her left
knee had gone out thirteen days earlier. Id. at 17. K.Q. told
Respondent that she had seen Dr. H.'s physician assistant, who told her
to wear a knee brace and stay on bedrest for four weeks. Id. K.Q. also
told Respondent that she would see Dr. H. on July 20. Id. Respondent
performed a physical exam on K.Q.'s knee and found slight swelling and
that she had severe pain with knee range of motion. Id. Respondent
concluded that K.Q. had possibly re-injured her meniscus and injected
her knee with a combination of Marcaine and Depomedrol. Id. She also
gave her new prescriptions for 240 tablets of MS Contin 100 mg., which
increased the dosing to two tablets every six hours (from every eight
hours) and a prescription for 120 Valium (one tablet four times a day).
Id.
Less than two weeks later, on July 23, K.Q. complained that she had
had ``a bad last few weeks and request[ed] increasing her MS Contin.''
Id. Respondent gave her another prescription for 240 tablets of Ms
Contin 100 mg. and increased the dosing to three tablets every six
hours. Id. Yet even at this increased dosing, the prescription issued
on July 10 should have lasted another week. Id.
The following day, K.Q. saw Respondent and complained of severe
knee pain. Id. at 17-18. K.Q. told Respondent that she had been to the
emergency room twice in the last three weeks because of the dislocation
of her left patella (she had not mentioned an ER visit at her July 10
visit with Respondent). Id. at 17. K.Q. also told Respondent that Dr.
L. had advised her that she was ``not a candidate for [a] cartilage
transplant.'' \76\ Id. at 18. Once again, there is no indication that
Respondent contacted the doctor who had evaluated K.Q. to determine
what treatment he had recommended and whether he had prescribed any
controlled substances for her knee pain.
---------------------------------------------------------------------------
\76\ During a physical exam, Respondent found that K.Q. showed
eversion of her left eye and Respondent diagnosed her with an
``exacerbation of pseudotumor'' in addition to degenerative joint
disease in her left knee. GX 58, at 18. Respondent sent her to the
emergency room where she had a spinal tap. Id.
---------------------------------------------------------------------------
On August 6, K.Q. called Respondent and complained of ``severe
headaches and pain'' and requested an ``increase in her MS Contin and
[a] change to Xanax.'' Id. at 17. She also ``complain[ed] of symptoms
of pseudotumor.'' Id. Respondent wrote her a prescription for 120
tablets of MS Contin 100 and increased the dosing to six tablets every
eight hours (a fifty percent increase); she also wrote K.Q. a
prescription for 150 Xanax (1 mg. q6h and 2 mg. qhs). Id. at 19.
Respondent wrote K.Q. additional prescriptions for 120 MS Contin 100
(with the same dosing) on August 14, 20, and 27.\77\ Id.
---------------------------------------------------------------------------
\77\ Respondent wrote K.Q. additional prescriptions for 270
tablets of MS Contin 100 mg. on September 2 and 25 with the same
dosing of six tablets every eight hours. GX 58, at 20.
---------------------------------------------------------------------------
On the latter date (Aug. 27), Respondent also wrote K.Q. a
prescription for 120 Valium (TID and HS) with one refill. Id.
Respondent did not, however, indicate in the record why K.Q. was being
switched back to Valium. Id. On September 25, Respondent wrote K.Q.
another prescription for 120 Valium (QID--a thirty day supply) even
though the August 27 prescription had included a refill. Id. at 20.
Respondent did not indicate in the record why K.Q. already needed more
Valium.
On October 5, K.Q. indicated that she had ``been taking extra MS
Contin for her headaches.'' Id. Respondent again increased her
prescription to 336 tablets of MS Contin 100 mg., with a dosing of
eight tablets every eight hours, a two-week supply. Id. at 20.
Nine days later, on October 14, K.Q. reported taking the MS Contin
``every 6 hours instead of every 8'' and that she had ``only 4 tabs
left.'' Id. at 21. As Dr. Hare observed, K.Q.'s consumption of MS
Contin indicated that she was taking 37 pills a day, and not the 24
tablets that Respondent had prescribed and was even in excess of what
K.Q. had told her (32 per day). GX 46A, at 5.
Respondent's response to this information was to give K.Q. a
prescription for 600 tablets of MS Contin 100 mg. and to increase the
dosing to ten tablets every eight hours. GX 58, at 21. Moreover, while
the previous Valium prescription (which Respondent wrote on September
25), should have lasted another eleven days, Respondent wrote K.Q.
another prescription for 120 tablets (QID), increasing the dosing from
four to six tablets per day. Id.
Two weeks later, K.Q. was back and complaining of ``severe
headaches,'' ``vomiting up the medications,'' and severe knee pain
because she had ``hit her left knee against the dashboard.'' Id. K.Q.
also complained that she was taking generic MS Contin, and that it was
``much weaker than the brand MS Contin'' and that she had ``to take
much more of these to get any effect.'' Id. Respondent issued her
another prescription for 600 tablets of MS Contin 100 mg.; while the
note states ``12 tabs,'' it does not indicate the frequency. Id.
Respondent also gave her a prescription for 90 tablets of Xanax 1 mg.
(TID). Id. Once again, there was no indication as to why Respondent was
changing K.Q. back to Xanax. Id.
On November 5, K.Q. was back and told Respondent that she had
received only 400 tablets of MS Contin. Id. at 22. Respondent further
noted that K.Q. had brought ``in the bottle of the MS Contin and she
has at least 100 left.'' Id. Respondent wrote her a prescription for
200 tablets of methadone 10 mg., with four tablets to be taken every
six hours, to last ``for approximately 11-12 days.'' Id. Respondent
also wrote a prescription for 120 tablets of Valium, with two tablets
to be taken every eight hours, and with two refills. Id. Again,
Respondent did not indicate why she was changing from MS Contin to
methadone and from Xanax (which had been prescribed just a week
earlier) back to Valium.
On November 18, K.Q. returned and complained that the methadone did
not ``help as much as the MS Contin'' and made her more tired. Id.
Respondent gave her two prescriptions for 300 tablets of MS Contin 100
mg., one of which was dated November 18, the other being dated November
25. Id. Respondent gave K.Q. additional MS Contin prescriptions until
December 31, when she told Respondent that ``she would like to try the
OxyContin again because it helps with the headaches.'' Id. at 24.
Respondent had not prescribed OxyContin since March 31st (nine months
earlier) and on April 14, had discontinued prescribing the drug when
K.Q. complained that it was causing headaches. See id. at 10.
Respondent wrote K.Q. prescriptions for 180 tablets of OxyContin 40 mg
(three tablets every eight hours); 300 tablets of a extended-release
morphine 100 mg. (twelve tablets every eight hours), and 100 Valium 10
mg., (two tablets TID) with two refills. Id. at 24. This represented a
[[Page 8224]]
fifty-percent increase in K.Q.'s intake of morphine alone (not to
mention the oxycodone), and yet there is no indication in the progress
note that K.Q. had complained that her pain was worse. Id.
On January 11, 1999, Respondent gave K.Q. two additional
prescriptions for 300 tablets of extended release morphine 100 mg.
(with the same dosing), as well as a trial 100 milligrams of morphine
elixir for headaches. Id. Notwithstanding that only eleven days earlier
she had given K.Q. a prescription for 100 Valium with two refills, she
also wrote a prescription for 100 Xanax 1 mg. (two tablets, three times
a day) with one refill. Id.
Respondent issued K.Q. additional prescriptions for extended
release morphine on January 26 and February 3, and for 60 OxyContin on
the latter date. Id. at 24-25. On February 11, Respondent wrote
additional prescriptions (dated Feb. 11 and 18) for 300 tablets of MS
Contin 100 mg. (twelve tablets every eight hours) and for 100 tablets
of Xanax 1-2 tablets three times a day PRN with one refill. Id. at 25.
On March 4, Respondent switched K.Q. back to Valium but did not
indicate how many tablets she prescribed. Id. at 26. She also wrote two
more prescriptions for 300 tablets MS Contin. Id.
On March 18, Respondent wrote K.Q. two more prescriptions for 300
MS Contin 100 mg., as well as 100 tablets of OxyContin 40 mg. (one
tablet every twelve hours). Id. at 27. While Respondent indicated at
this visit that K.Q. ``had a bad headache,'' the progress note does not
state that this was medical justification for the new OxyContin
prescription. Id. at 26-27. K.Q. was not, however, able to fill the
prescription ``because of insurance'' and returned it to Respondent at
her next visit (March 30). Id. at 27. On this date, Respondent wrote
her two more prescriptions for 300 tablets of MS Contin 100 mg. (12
q8h, or 36 tablets per day), and a prescription for 50 milliliters of
morphine elixir 20mg./5ml. Id. As Dr. Hare noted, by this point K.Q.
was taking 50 tablets per day of MS Contin. GX 46A, at 6.
Respondent continued to prescribe both MS Contin and morphine
elixir to K.Q. over the ensuing months, along with additional
prescriptions for either Xanax or Valium. See GX 58, at 33-38.\78\ On
September 30, however, Respondent began prescribing methadone 10 mg.
again (three to four tablets, four times a day) when K.Q. claimed that
she could not find generic MS Contin because it was no longer being
manufactured. Id. at 38.
---------------------------------------------------------------------------
\78\ On April 29, Respondent wrote K.Q. a prescription for 120
tablets of Xanax 1 mg., with two tablets to be taken twice a day (a
thirty-day supply). GX 58, at 33. On May 12, Respondent was back to
writing her a prescription for Valium 10 (2 tabs TID) with 2
refills, but did not indicate the quantity. Id. at 34.
On August 19, Respondent wrote an additional Valium
prescription for 100 tablets (two tablets, three times a day) with
three refills. Id. at 38. Two weeks later (on September 3), she
wrote another prescription for 100 tablets of Valium 10, with the
same dosing, with three refills. Id. On September 13, Respondent
went back to writing K.Q. a prescription for 120 tablets of Xanax
1mg. (two tablets, two times a day) with two refills. Id. Again, no
reason was stated for changing from Valium to Xanax. See id. On
September 29, a pharmacy called to clarify the dosing of the Xanax;
Respondent told the pharmacist to change it back to two tablets,
three times a day. Id. On October 25, Respondent was back to
prescribing 100 Valium (two tablets, three times a day) with three
refills. Id. at 39. Again, no reason was stated for the change. Id.
While this prescription with refills should have lasted 66 days, on
December 1, Respondent gave her a prescription for 100 Xanax 1 mg.
(2 tablets TID) with two refills. Id. at 40, 138.
On December 21, Respondent wrote K.Q. a prescription for 180
tablets of Valium 10 mg. (2 tabs TID), with three refills. Id. While
on January 7 K.Q. told Respondent that she had not filled the
prescription and obtained a prescription for another 180 tablets (2
TID) with three refills, even if this was true, no explanation was
given for why the prescription was issued given that she had issued
a Xanax prescription three weeks earlier. Id. at 41, 138-39.
On February 16, notwithstanding that the January 7 prescription
and refills should have lasted four months, Respondent gave K.Q.
another prescription for 180 tablets of Valium at the same dosing
with the three refills. Id. at 48. Moreover, on April 25, Respondent
gave K.Q. another prescription for 180 tablets of Valium at the same
dosing with three refills even though the February 16 prescription
should have lasted until the middle of June. Id. at 50. This was
followed by a May 12 prescription for 180 Valium (2 TID), id., and a
July 14 prescription for 100 tablets with a dosing of 1-2 tablets
twice a day and three refills. Id. at 50-51. On September 18,
Respondent wrote K.Q. another prescription with the same quantity,
dosing and refills, as the July 14 prescription. Id. at 52.
---------------------------------------------------------------------------
On October 7, K.Q. reported that she was ``[d]oing better'' and
``without side effects,'' id. at 39, even though the methadone was
prescribed at ``a dose far less than that of MS Contin.'' GX 46A, at 6.
While K.Q. had reported that she was ``[d]oing better,'' Respondent
increased the dosing to four to five tablets, four times a day. GX 58,
at 39. However, on November 8, K.Q. complained that the methadone made
``her too fatigued.'' Id. Respondent went back to prescribing MS Contin
100 mg. (300 tablets, with twelve tablets to be taken every eight
hours) and gave her prescriptions which were dated November 8 and 15.
Id. at 40. According to the Government's expert, the MS Contin dose
``would have 6 times the analgesic effect as the methadone'' K.Q. had
been switched from. GX 46A, at 6.
Nine days later, K.Q. complained of severe headaches and Respondent
gave her more prescriptions for 300 tablets of MS Contin 100 mg., as
well as for 100 tablets of immediate-release morphine 30 mg., one
tablet every two hours as needed for breakthrough pain. Id. at 137.
Respondent wrote additional prescriptions for these drugs on December 1
and 21. Id. at 138. In addition, on December 21, Respondent wrote a
prescription for 270 tablets of OxyContin 80 mg., with a dosing of
three tablets every eight hours. Id.
In early February, K.Q. told Respondent that her insurance would
not cover the MS Contin. Id. at 48. Respondent resumed prescribing
methadone 10 mg., and wrote her a prescription for 300 tablets with a
dosing of four tablets, four times a day. Id. This again was at a dose
that was ``much lower tha[n] that of the MS Contin.'' GX 46A, at 7. At
the next visit (Feb. 16), K.Q. was nonetheless ``OK on the [m]ethadone
now.'' GX 58, at 48. Respondent gave her another prescription for 300
methadone (as well as one to be filled on March 2) and additional
prescriptions for 200 immediate-release morphine (1 q2h) and for 180
Valium (2 TID) with three refills. Id.
At her next visit (March 13), K.Q. reported that she was taking
eight tablets, three times a day, which was a fifty-percent increase
over the prescribed daily dosing. Id. Respondent increased the dosing
of her prescription to the amount she was taking and gave her two
prescriptions for a total of 600 tablets, as well as two prescriptions
for a total of 200 tablets of immediate-release morphine. Id. at 49.
This basic pattern of prescribing methadone, Valium, and immediate-
release morphine continued until June 19 when K.Q. told Respondent that
``she is going to discontinue MS Contin and wants Percocet.'' Id. at
50. K.Q. had not, however, received an MS Contin prescription from
Respondent in four to five months. Id. at 48. Respondent did not
further question K.Q. about whether she had continued to use MS Contin
and wrote her a prescription for 100 Percocet. Id. at 50.
Over the next four months, Respondent continued to prescribe
methadone, Percocet, and Valium to K.Q. Id. at 50-53. With respect to
the Percocet, Respondent gave K.Q. prescriptions for 100 tablets on
September 6, 11, 18, and 25, as well as on October 2, 9, 16, 23, and
30. Id. at 51-53. The size and frequency of the prescriptions suggest
that K.Q. was taking 100 tablets every seven days and fourteen tablets
a day, and consuming 4643 mgs. of acetaminophen a day, an amount well
in excess of the
[[Page 8225]]
recommended daily maximum of 4000 mgs.
Moreover, on October 30, Respondent prescribed (in addition to the
Percocet and methadone) 20 tablets of Demerol (meperidine), another
schedule II opiate. See 21 CFR 1308.12(c)(18). GX 58, at 53. The
progress note, however, contains no explanation as to why the Demerol
prescription was medically necessary. Id.
Two days later on November 1, K.Q. was admitted to St. Mary's
Hospital behavioral health unit ``for [a] psychotic episode'' and was
``manic, rambling, labile, tearful and with auditory hallucinations.''
Id. According to the report documenting her admission, Catalina
Behavioral Health had sent her to St. Mary's and upon her admission,
K.Q. ``said [that] she cannot stop crying,'' ``present[ed] with pressed
speech, flight of ideas,'' was ``very difficult to interview,'' and
needed a psychiatric evaluation. RX Z, at 1.
Relatedly, the discharge summary noted that K.Q. had been referred
by Catalina because she ``had been progressively becoming agitated,
over talkative, confused, disorganize[ed] [in] thought, rambling in her
speech, and unable to sleep.'' Id. at 3. The report from Catalina was
that K.Q. ``has been self medicating and this is contributing to her
mood transient problems.'' Id.
The discharge summary stated that K.Q. had ``denie[d] previous
psychiatric hospitalization except for one time that she was admitted
at the Westchester when she had attempted to quit narcotics back in
1997.'' Id. While K.Q. apparently denied the use of alcohol and
recreational drugs and maintained that her opiates had been prescribed
by Respondent and another doctor, she also reported ``being seen in
pain clinics and didn't want to elaborate any further.'' Id. at 4.
The report further noted that while she was hospitalized, K.Q.
engaged in ``some medication seeking behavior.'' Id. at 5. In addition,
the summary reported that ``[t]he patient admits to being cognizant
that her narcotics are a lot; she wants to try to get off of them,
however not at the expense of being in pain.'' \79\ Id. at 4.
---------------------------------------------------------------------------
\79\ The psychiatrist diagnosed K.Q. as having ``[u]nresolved
issues related to the death of her child,'' ``[n]oncompliance with
treatment,'' ``[u]ntreated depression,'' and ``[d]ramatic mood
swings, probably secondary to untreated depression and PTSD in
addition to opioids on extreme high doses.'' RX Z, at 5.
---------------------------------------------------------------------------
As to this incident, Respondent testified that ``the staff
believ[ing] [K.Q.] was overmedicated'' was not mentioned in the phone
call from the unit or in the hospital's record. Tr. 2106. Apparently,
the statement at the bottom of the first page of the discharge summary
``that the patient has been self medicating and this is contributing to
her mood transient problems'' and the diagnosis that her dramatic mood
swings were ``probably secondary * * * to opioids on extreme high
doses'' did not express the staff's belief with sufficient clarity. RX
Z, at 1 & 5.
Respondent also maintained that the hospital maintained K.Q. on her
pain medications. Tr. 2106; but see RX Z, at 5 (``For the time being we
will continue patient on similar narcotic medications,'' and suggesting
a ``pain medical consult for issues regarding her pain management'').
Given the short amount of time K.Q. was hospitalized (approximately
five days), it is not as if the hospital had the time to try to taper
her intake of the drugs.
On November 13, K.Q. went back to see Respondent. GX 58, at 53.
While the progress note contains a brief discussion of her stay in the
hospital, there is no indication that Respondent asked her about ``the
cause of the hospitalization even though the symptoms [she] experienced
could have been caused by excessive medication or withdrawal from
medication.'' GX 46A, at 7. At the visit, Respondent prescribed Demerol
(20 tablets), Percocet (100 tablets) and methadone 10 mg. (200 tablets)
(when a prescription for 100 methadone 40mg. could not be filled). GX
58, at 53.
Respondent prescribed these three drugs on November 21 and 29, as
well as on December 6; on December 12, she wrote for 100 Percocet and
more Demerol. Id. at 53-54. The next day, Respondent wrote K.Q. a
prescription for 100 oxycodone. Id. The note does not indicate the
reason for the prescription, the strength, or the dosing. Id. at 54.
Moreover, on December 19, Respondent wrote K.Q. additional
prescriptions for 100 tablets of Percocet and OxyContin. Id. Again, the
note did not indicate the reason for the OxyContin, the strength, or
the dosing.
On January 15, Respondent noted that she had talked with K.Q.'s
parents ``regarding [her] overuse of medications and * * * sedation.''
Id. at 55. Respondent initially agreed to prescribe only two to four
days of medication at a time. Id.
On January 18, Respondent prescribed 30 tablets of Dilaudid (QID),
another schedule II drug, a seven-day supply based on the dosing. Id.
at 56. Once again, Respondent did not indicate the reason for
prescribing the drug. See also GX 46A, at 7. Moreover, on February 20,
Respondent increased the dosing of the Dilaudid to four tablets, four
times a day, a four-fold increase. Id. Again, there was no explanation
for the increase in the dosing. GX 58, at 55.
Respondent continued to prescribe methadone, Roxicodone, Dilaudid,
Valium, and Xanax \80\ throughout most of 2001. On October 3, K.Q.
complained of increased neck pain and increased the dosing of the
Roxicodone from four to six tablets to eight to ten tablets every four
hours (and gave her two prescriptions for a total of 600 tablets) and
added a prescription for 60 tablets of MSIR (morphine sulfate immediate
release, one tablet every four hours PRN). Id. at 62.
---------------------------------------------------------------------------
\80\ On August 9, Respondent gave K.Q. a prescription for 100
Valium 10mg. (q4h) with five refills. GX 58, at 61. On October 9,
four days after K.Q. reported that she had been in what appears to
have been a minor automobile accident (given the limited findings of
Respondent's physical exam and the fact that she did not change the
dosing of K.Q.'s pain medications), Respondent discontinued the
Valium and gave her a prescription for 90 Xanax 1 mg. (q8h) with
three refills. Id. at 62-63. Only nine days later, Respondent gave
K.Q. another Xanax 1mg. prescription, which was for 60 tablets with
two refills and which doubled the dosing to two tablets every eight
hours PRN. Id. at 63. There is no indication, however, as to whether
she contacted the pharmacy that dispensed the October 9 prescription
to cancel the refills. Id. Moreover, while the October 18
prescription with its refills should have lasted thirty days, on
November 6, Respondent wrote K.Q. another prescription for 180
tablets (at the same dosing) with three refills. Id. at 64.
---------------------------------------------------------------------------
On October 9, K.Q. returned and reported that four days earlier she
had been in an automobile accident in which her car's ``[a]irbags
deployed.'' Id. at 62. K.Q. complained of bruising of her upper
extremities and that her pain had increased; K.Q. was wearing a knee
brace. Id. at 63. Respondent performed a physical exam which found K.Q.
``awake and alert'' and with ``minimal stiffness with cervical range of
motion.'' Id. Respondent did not, however, indicate that she observed
any bruising on K.Q. See id. Respondent concluded that K.Q. had an
``exacerbation of pain'' and wrote her prescriptions for 200 methadone
10 mg. (eight tablets, three times a day) and for 120 tablets of MSIR
39 mg. (one tablet every four hours as needed for pain), as well as for
ninety Xanax (q8h) with three refills. Id.
Three days later, Respondent gave K.Q. another prescription for 200
methadone 10 mg., with the same dosing, even though the previous
prescription should have lasted until October 17.\81\ Id. On October
18, K.Q. again saw Respondent, whose only finding on physical
examination was that she had ``slight pain and stiffness with cervical
range of motion.'' Id. Respondent gave K.Q. prescriptions for 400
tablets of methadone 10 mg. (with
[[Page 8226]]
the same dosing of eight tablets, three times a day), 200 tablets of
MSIR 30 mg. (with an increased dosing of one tablet every three hours),
400 tablets of Roxicodone, and another 60 tablets of Xanax (which
doubled the dosing to 2 q8h) with two refills. Id. Respondent did not
indicate why she was increasing the dosing of the Xanax and the MSIR.
Id. Nor did she indicate why it was medically necessary to issue
another MSIR prescription when the previous prescription should have
lasted until October 29. Id.
---------------------------------------------------------------------------
\81\ Respondent also wrote K.Q. a prescription for 200
Roxicodone (8-10 q4h) at this visit. Id.
---------------------------------------------------------------------------
On November 6 and 19, Respondent wrote K.Q. additional
prescriptions for 200 and 100 tablets of MSIR 30 mg. (q3h),
respectively. Id. at 64. As the October 18 prescription should have
lasted at least until November 12, the November 6 prescription was six
days early. And as the November 6 prescription should have lasted at
least until December 1, the November 19 prescription was twelve days
early.
On December 20, 2001, another of Respondent's patients, who
performed security at the apartment complex where K.Q. lived, told
Respondent that K.Q. ``is selling her meds to people in her apartment
complex.'' Id. at 65. This person further stated that ``several people
have told her that [K.Q.] has approached them with drugs to sell, and
this is an ongoing problem.'' Id. According to the patient record,
``the complex [was] considering action.'' Id. Later that day,
Respondent wrote K.Q. a letter terminating her as a patient. Id.
In summarizing his findings regarding Respondent's treatment of
K.Q., Dr. Hare observed that K.Q.:
Was prescribed control[led] substances without adequate evaluation
or followup. There were many indicators that she was consistently
over-using her medication and yet [Respondent] took no steps to
correct this. In fact she prescribed more medication. Despite
warnings that the patient was over medicated, Respondent continued
to prescribe[] unabated. Respondent never took steps to control
K.Q.'s medication use or to even do blood or urine tests to
establish that she was in fact taking the medication. Reports of
diversion that [Respondent] received should have come as no
surprise, yet [Respondent] seemed oblivious that [K.Q.] was misusing
her medication. Clearly this is substandard care. [Respondent's]
prescribing encouraged overuse and/or diversion of medication.
GX 46A, at 7-8.
Respondent's Efforts at Rehabilitation
Pursuant to the consent agreement she entered into with the Arizona
Medical Board, Respondent took ten hours of Continuing Medical
Education (CME) in the principle and practice of pain management or
addiction medicine. RX 53, GX 73. Respondent also took an additional
51.25 hours of CME in a range of topics related to pain management. RX
53.
In 2002, in response to the State's Board investigation, Respondent
also entered an arrangement under which Dr. Schneider mentored her. Tr.
808. More specifically, over a period of several months, Dr. Schneider
met with Respondent on a weekly basis to review the medical records of
those patients she had seen that week and to whom she had prescribed
opioids. Id. Dr. Schneider advised her as to how to improve her
documentation and management of these patients. RX K-1, at 2. Dr.
Schneider testified that she now considered Respondent to be ``one of
the most knowledgeable people about addiction issues in the
community.'' Tr. 812.
Respondent testified that in the event she was granted a new
registration, she would limit her practice to musculoskeletal pain and
would use opioid risk assessment tools and addiction histories to
evaluate her patients. Id. at 2412. Respondent also testified that she
``intended to use urine drug screening a lot more frequently'' and that
she would continue to consult with Dr. Schneider regarding her
patients.\82\ Id.
---------------------------------------------------------------------------
\82\ Dr. Schneider testified that she had volunteered to mentor
Respondent for three years in connection with a settlement offer
that was made in the course of these proceedings and that she would
be willing to mentor Respondent for three years as a condition of
her receiving her DEA registration. Tr. 860-62.
---------------------------------------------------------------------------
At the hearing, Respondent also submitted a list of 29 patients she
had fired. See RX 37. However, all but six of the patients were fired
after the Medical Board began investigating her.\83\ See id.
---------------------------------------------------------------------------
\83\ Moreover, most of the patients' records are not in the
record and thus the circumstances prompting the firings (and whether
Respondent ignored any earlier warning signs) are not established.
Accordingly, to the extent Respondent offered this document as
evidence that she is capable of properly monitoring her patients, it
is of limited probative force.
---------------------------------------------------------------------------
Moreover, substantial portions of Respondent's testimony undercut
her claim that she has reformed. For example, while Respondent
testified that she was not saying ``that each and every prescriptions I
ever write is 100 percent perfect,'' that ``my medical records are
perfect or fully comprehensive,'' and that ``there wasn't room for
improvement on my part,'' as noted above, she emphatically denied
having done anything wrong with respect to any of the prescriptions she
issued to H.T. Tr. 2305-06. Relatedly, she also denied that she
falsified H.T.'s medical records.
Moreover, her testimony regarding several other issues raises
serious questions as to what she has learned from this experience. With
respect to patient S.R., who admitted to taking her deceased husband's
controlled substance medications, Respondent testified that she ``did
not see that it would cause any potential harm to'' her. Id. at 2353.
Speaking generally of a person taking a controlled substance that had
been prescribed not to them but to a spouse, she testified:
There's just continuing medical care, and to me, it seems no
harm to the patient, I might add. I've never seen an example where
bad came, any harmful outcome, but I see it time and time again,
dozens of times.
Id. at 2395.
Later, Respondent added:
Our party line as a physician is don't take anyone else's
prescriptions, period, whether it's controlled or not controlled. Of
course, I know at issue here is only controlled, and then controlled
has an extra layer on top of it, meaning it's a felony to do it. But
really as a physician, from a medical standpoint, it refers to all
prescriptions.
The party line is don't use anyone else's prescriptions, don't
use expired medications, et cetera, et cetera, but the fact is
people do use each other's prescription medications, and almost
always there's no harm because people know * * * They know what they
are taking. People develop, certainly develop, an area of knowledge
about their medications.
Id. at 2400-01.
Moreover, when asked by the Government whether she had ``often
issued early refills on prescriptions without documenting the reason
why?,'' Respondent answered:
The record speaks for itself there, and there are many reasons
why a prescription is not filled on, for instance, the thirtieth day
on a 30-day supply. The definition [of] early refill, if a persons
says, well, if you go to the pharmacy on day 29, that's considered
an early refill, so the definition of early refill is questionable
and not clear and not well-agreed upon. So it would be difficult for
me to answer that question unless you are defining for me terms such
as that.
Id. at 2345.
Relatedly, when asked a follow-up question as to whether she had a
definition of the term ``early refill,'' Respondent answered:
No, not really. It was a DEA term, early refill. With
physicians, there never was any lesson about early refills in
medical school. That's not anything that was covered, so no, I have
no definition.
Id. at 2346. Apparently, Respondent had not asked Dr. Schneider to
explain what the term means, even though the latter had noted with
respect to six of the patient files she reviewed that they ``all
received early refills without adequate
[[Page 8227]]
documentation and explanation.'' RX K-1, at 6.
Respondent also disagreed that she had ``ignored the fact that some
of [her] patients had addiction histories.'' Id. at 2348. Finally, she
``absolutely disagreed'' that she had ``ignored warning signs that a
patient might be'' addicted to, or abusing drugs. Id. at 2348-49.
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
``[t]he Attorney General may deny an application for [a practitioner's]
registration if he determines that the issuance of such registration
would be inconsistent with the public interest.'' 21 U.S.C. 823(f). In
making the public interest determination, the Act requires the
consideration of the following factors:
(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.
``[T]hese 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 an application for a registration
should be denied. Id. Moreover, I am ``not required to make findings as
to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir.
2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).
The Government bears the burden of proving that the requirements for
registration are not satisfied. 21 CFR 1301.44(d).
Having considered all of the factors, I conclude that the
Government has made out a prima facie case that issuing Respondent a
new registration would be inconsistent with the public interest. In
particular, I conclude that the Government's evidence with respect to
Respondent's experience in dispensing controlled substances (factor
two) and record of compliance with applicable controlled substance laws
(factor four), is far more extensive than the ALJ acknowledged it to be
and establishes numerous instances in which Respondent improperly
dispensed controlled substances. While in some instances, Respondent
may have been only gullible or naive, in other instances (H.T.) she
engaged in intentional diversion as well as falsified medical records
or acted with deliberate ignorance of a patient's real purpose in
seeking the prescriptions. While I have carefully considered all of
Respondent's various contentions, including her evidence that she has
reformed her prescribing practices, I conclude that Respondent has not
rebutted the Agency's prima facie showing because she has refused to
acknowledge her wrongdoing with respect to her most egregious acts.
Factor One--The Recommendation of the State Licensing Board
While Respondent has twice been sanctioned by the Arizona Medical
Board for unprofessional conduct including the improper prescribing of
controlled substances, it is undisputed that she currently holds an
active State license. The Agency has long held, however, that a
practitioner's reinstatement by a State board ``is not dispositive''
because ``DEA maintains a separate oversight responsibility with
respect to the handling of controlled substances and has a statutory
obligation to make its independent determination as to whether the
granting of [a registration] would be in the public interest.''
Mortimer B. Levin, 55 FR 8209, 8210 (1990); see also Jayam Krishna-
Iyer, 74 FR 459, 461 (2009).
Respondent also relies on a letter from a Senior Compliance Officer
with the Arizona Board which states that she ``has the Board's support
to pursue her DEA reinstatement.'' RX 53; see also Resp. Br. 157.
Continuing, the letter stated that Respondent ``at no time attempted to
divert medications for non-medical purposes.'' RX 53. Even assuming
that the letter represents the official view of the Board (and not
simply the view of one of its employees), the evidence presented in
this proceeding establishes that Respondent engaged in far more
egregious conduct than the evidence which apparently was presented to
the Board. I thus conclude that, at most, this factor is entitled to
nominal weight in the public interest analysis.
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 ``[a]n 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 relating to controlled
substances.'' Id. As the Supreme Court recently 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)).
While many cases under the public interest standard involve
practitioners who violated the prescription requirement and did so
intentionally, the Agency's authority to deny an application (or to
revoke an existing registration) is not limited to those instances in
which a practitioner intentionally diverts a controlled substance. See
Paul J. Caragine, Jr., 63 FR 51592, 51601 (1998). As my predecessor
explained in Caragine: ``Just because misconduct is unintentional,
innocent or devoid of improper motivation, [it] does not preclude
revocation or denial. Careless or negligent handling of controlled
substances creates the opportunity for diversion and [can] justify''
the revocation of an existing registration or the denial of an
application for a registration. Id. at 51601. A practitioner's failure
to properly supervise her patients to prevent them from personally
abusing controlled substances or selling them to others constitutes
conduct ``inconsistent with the public interest'' and can support the
denial of an application or the revocation of an existing registration.
Id.; see also Gonzales, 546 U.S. at 274.
The ALJ concluded that the Government had proved that Respondent's
prescriptions to H.T. were ``not issued for a legitimate medical
purpose.'' ALJ at 150. I agree and note that, at no time during any of
his visits with Respondent occurring between February and April 2002,
did H.T. complain that he was in pain. On six occasions, however,
Respondent gave H.T. prescriptions for schedule II narcotics including
Percocet 10, Roxicodone (oxycodone) in both five-
[[Page 8228]]
and fifteen-mg. strength, and OxyContin in both twenty- and forty-mg.
strength.
Substantial evidence also supports the conclusion that Respondent
knew that H.T. was not seeking the drugs to relieve pain but to abuse
them. Respondent did not perform a physical exam of H.T. at any of the
visits at which she issued the prescriptions, yet falsified H.T.'s
medical records to indicate that she had done so. Moreover, in addition
to his failure to ever complain of being in pain, H.T. made numerous
statements which made clear that he was seeking the drugs to abuse
them.
These included, inter alia: (1) H.T.'s statements that he liked
oxycodone but was eating them ``like M & Ms'' or ``candy''; (2) that he
would be ``happier with fifteens''; (3) that an acquaintance had told
him that he had ``gotta try and get her to give you some * * *
OxyContin''; (4) that he was ``hopin[g] you'd give me a hundred''
tablets of OxyContin; (5) ``My back feels great, but I like these'' and
asking ``is that a bad thing?''; (6) ``Doc, you know between you and me
my pain level is non-existent, but I really like them Oxy[C]ontin. They
make me feel good''; (7) ``I'd never tell you none of them stories
about losing 'em or anything. I just tell ya the truth. I'd just like a
few more of those, okay?''; (8) H.T. relating that he had asked someone
on the street in Nogales, Mexico about buying OxyContin and stating the
price per milligram.
Finally, Respondent made numerous statements which show that she
knew H.T. was seeking the prescriptions for non-medical reasons. These
included, inter alia: (1) Respondent's statement that Tylenol ``is a
bad thing'' but ``the other stuff [in Percocet, oxycodone] is a fun
thing''; (2) asking H.T. whether he ``like[d] the Oxy[C]ontin?''; (3)
asking H.T. ``do you want the OxyContin?''; (4) after giving H.T a
prescription for ninety OxyContin 40 mg., responding to H.T.'s
statement that ``You'r[e] okay, Doc,'' with ``You caught me at a soft
moment''; (5) Respondent stating that the State Board was watching her
and telling H.T. to wait ``until my investigation is over''; (6)
Respondent stating that she could not keep prescribing to H.T. for the
reasons he wanted the drugs and again telling him to wait until her
investigation was over, yet prescribing 90 tablets of OxyContin 40 mg.
on a subsequent visit.
As the evidence makes plain, Respondent issued H.T. six
prescriptions for schedule II controlled substances which were outside
of the usual course of professional practice and lacked a legitimate
medical purpose. 21 CFR 1306.04(a). Moreover, Respondent clearly knew
that H.T. was not seeking the drugs to treat pain, but rather to abuse
them.
The ALJ concluded, however, that H.T. (and R.T.\84\) were the only
patients to whom Respondent issued unlawful prescriptions. As found
above, however, the patient records establish numerous other instances
in which Respondent violated the CSA's prescription requirement.
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\84\ The ALJ also found that Respondent had issued refills to
R.T. which lacked a legitimate medical purpose. ALJ at 150. In light
of the extensive and more egregious evidence of Respondent's
prescribing to other patients, I conclude that it is not necessary
to discuss R.T. further.
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Respondent gave K.Q. numerous prescriptions for both schedule II
narcotics as well as schedule IV benzodiazepines. Many of these
prescriptions were issued well before previous prescriptions for either
the same or similar drugs would have run out if K.Q. had taken them in
accordance with Respondent's dosing instructions.
For example, on December 31, 1998, Respondent gave K.Q. a
prescription for 100 Valium with two refills. Based on the dosing of
two tablets, three times per day, the prescription should have lasted
50 days if taken as prescribed. Yet on January 11, 1999 (just eleven
days later), Respondent issued K.Q. prescriptions for 100 Xanax with
one refill.
Moreover, as discussed in footnote 79, on August 19, 1999,
Respondent wrote K.Q. a prescription for 100 tablets of Valium with
three refills and thus authorized the dispensing of 400 tablets. Based
on the dosing of two tablets, three times a day, the prescription with
refills should have lasted approximately 66 days. Yet on September 3
(only fifteen days later), Respondent wrote K.Q. another prescription
for 100 tablets of Valium with three refills and the previous dosing.
Ten days later, Respondent wrote K.Q. a prescription for 120 tablets of
Xanax with two refills and a dosing of two tablets, two times a day.
Respondent did not indicate why she was switching from Valium to Xanax.
While Respondent changed the dosing of the Xanax to two tablets, three
times a day after being contacted by a pharmacist, even at this
increased dosing the prescriptions with refills should have lasted 60
days. Yet on October 25, Respondent was back to prescribing Valium and
issued K.Q. a prescription for 100 tablets (dosing at two tablets,
three times per day) with three refills.
Here again, the prescriptions should have lasted approximately 66
days if taken as prescribed. Yet on December 1 (thirty-six days later),
Respondent was back to prescribing 100 Xanax (two tablets, three times
a day) with two refills. Not even three weeks later, however,
Respondent returned to prescribing 180 tablets of Valium (two tablets,
three times a day) with three refills. Again, Respondent provided no
explanation for why she had changed drugs.
On January 7, Respondent gave K.Q. a prescription for another 180
tablets of Valium with the same dosing and three refills after the
latter claimed that she had not filled the December 21 prescription.
Respondent did not, however, inquire as to what had happened to the
previous prescription. Moreover, even if K.Q. was not obtaining drugs
pursuant to the December 21 prescription, the January 7 prescription
should have lasted four months or until early May. Yet on February 16,
Respondent gave K.Q. another prescription for 180 Valium at the same
dosing with three refills (which should have lasted until the middle of
June), and on April 25, Respondent gave K.Q. an additional prescription
for 180 tablets with the same dosing and three refills (which ignoring
all the previous prescriptions should have lasted until late August).
This was followed by a May 12 prescription for 180 Valium at the same
dosing, and a July 14 prescription for 100 tablets with a lowered
dosing (of 1-2 tablets twice a day) but also with three refills.
Given Respondent's repeated issuance of these prescriptions,
frequently months before the previous prescriptions would have run out,
her prescribings cannot be attributed to negligence in failing to check
K.Q.'s record. Rather, the frequency of the prescribings supports the
conclusion that Respondent was deliberately ignorant as to why K.Q. was
seeking the prescriptions and thus can be charged with knowledge that
the prescriptions were not for a legitimate medical purpose. See United
States v. Katz, 445 F.3d 1023, 1031 (8th Cir. 2006) (knowledge can be
inferred when a practitioner is put ``on notice that criminal activity
was particularly likely and yet * * * failed to investigate those
facts'') (other citations and quotations omitted).
Furthermore, Respondent had other reasons to know that K.Q. was
engaged in drug-seeking behavior. At the first visit, K.Q. reported
that she was being treated by two other physicians, one of whom was
prescribing Percocet to her, and that she was also taking Lorcet and
Xanax. Respondent gave her a prescription for twenty Percocet and yet
did nothing to contact these other
[[Page 8229]]
physicians to determine what they were prescribing and to coordinate
their prescribings. Moreover, two days later, Respondent gave K.Q. a
prescription for 90 Percocet based on K.Q.'s representation that there
was a price-break on the drug and that she had gotten a check from a
church made out for the exact amount of 90 Percocet. Respondent did not
indicate in K.Q.'s record, however, why the prescription was medically
necessary, and I conclude that prescription lacked a legitimate medical
purpose.
K.Q. engaged in other scams to obtain drugs, including claiming
that she had missed an appointment with another physician (who was
prescribing OxyContin to her and either Xanax or Valium) and that the
physician was out-of-town. Respondent did not, however, even bother to
pick up the phone and call the doctor to determine if this was true.
Respondent then prescribed OxyContin, Xanax and ``Duracet,'' the same
drugs which K.Q. had told her she was currently taking only to be told
by the pharmacy that there was no such drug as Duracet. Moreover, at
the next visit, K.Q. told her that she was taking ``a muscle relaxant
called Durect'' even though Respondent had not prescribed a muscle
relaxant to her. Yet this did not prompt Respondent to investigate
further.
This was followed not even two weeks later by a phone call from
K.Q. reporting that her purse (which contained Vicodin) had been
stolen. Respondent dutifully called in a prescription for 30 Vicodin
even though Respondent had not prescribed this drug to K.Q. Nor did she
question K.Q. as to who the source of the Vicodin was. Moreover, two
months later, K.Q. claimed that she had not mailed away a prescription
Respondent had issued to her at her last visit for a three-month's
supply of OxyContin, even though the last prescription before the
three-month one was for a thirty-day supply, had been issued six weeks
earlier, and K.Q. had reported that she taking more than the
recommended dosing.\85\
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\85\ On another occasion, K.Q. reported that she had previously
taken methadone, a drug which is used not only to treat pain but to
treat addiction as well. Yet Respondent did not inquire as to who
had prescribed it to her and why. On another occasion, K.Q. reported
that ``she believe[d] that some workmen may have gotten into her
medications.'' While Respondent did counsel her to lock up her
medications, the incident did not prompt Respondent to institute any
type of monitoring of K.Q.
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Respondent thus had ample reason to know early on in her treatment
of K.Q. that the latter was engaging in drug-seeking behavior.
Moreover, on various occasions throughout her treatment, K.Q. reported
that she had self-escalated the dosing of various narcotics. Typically,
Respondent did not question K.Q. as to whether it was necessary to do
so to address her pain. Notably, much of K.Q.'s problematic behavior
had occurred prior to Respondent's issuance of the Xanax and Valium
prescriptions discussed above.
During another period of her prescribing, Respondent gave K.Q. nine
prescriptions at approximately weekly intervals for 100 tablets of
Percocet, a drug which contains a minimum of 325 mg. of acetaminophen
no matter what strength of oxycodone it contains. If K.Q. had consumed
100 tablets every week, she would have been taking approximately
fourteen tablets and consuming 4643 mgs. of acetaminophen, an amount
well in excess of the recommended daily maximum of 4000 mgs. because of
its potential to cause liver toxicity. Respondent did not, however,
direct that K.Q. undergo liver function tests.
Moreover, after K.Q. was hospitalized for a psychotic episode,
Respondent received reports which indicated that she had seen not only
Respondent and another doctor, but was also going to pain clinics and
did not want to elaborate further. The discharge summary also stated
that K.Q. was ``self medicating'' and was engaging in ``some medication
seeking behavior.'' Even after receiving this information, as well as a
subsequent phone call from K.Q.'s parents reporting that she was
overusing her medications, Respondent continued to prescribe to her and
did nothing to monitor her use of the drugs. Respondent also gave her
early refills on various drugs including methadone, MSIR, and Xanax
(including a prescription which was issued for 60 tablets with two
refills only nine days after giving her a prescription for 90 Xanax
(q8h) with three refills). She also prescribed additional drugs (such
as Dilaudid) and increased the dosing of various drugs (including
increasing the dosing of Dilaudid four-fold at a single visit) without
any medical justification. While Respondent eventually terminated K.Q.
(more than a year after her hospitalization) after being told by
another patient that she was selling her medications, it is clear that
many of the controlled substance prescriptions which Respondent issued
to K.Q. lacked a legitimate medical purpose and were issued outside of
the usual course of professional practice. 21 CFR 1306.04(a); GX 46A,
at 8.
Respondent also issued numerous prescriptions to J.R., who had
previously been convicted for distributing marijuana, for schedule II
drugs including methadone, 360 tablets of OxyContin 40 mg., 180 tablets
of Oxycodone IR, and 200 tablets of Percodan. The medical purpose for
the prescriptions was initially to treat J.R.'s migraine headaches;
subsequently J.R. also complained of lower back pain.
While at the first visit in the patient file (8/25/99), Respondent
issued prescriptions for OxyContin and Oxycodone IR \86\ which should
have lasted thirty days based on the dosing instructions, only twenty-
one days later, Respondent issued additional prescriptions for the same
quantities and dosing of both OxyContin 40 mg. and Oxycodone IR, and
for the same quantity of Percodan. A week later, Respondent gave J.R.
replacement prescriptions but gave no reason for doing so.
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\86\ There was no dosing instruction listed for the Percodan.
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On October 20, Respondent issued additional prescriptions for
thirty-day supplies of OxyContin 40 mg. (360 tabs) and Oxycodone IR
(180 tabs), which were re-issued eight days early on November 11. While
the latter prescriptions were to be sent to a Patient Assistance
Program (PAP), Respondent added a separate prescription for 100
OxyContin to be filled locally while J.R. waited for the PAP
prescription to arrive. Respondent wrote additional prescriptions for
360 Oxycontin 40 mg. and 180 Oxycodone IR (and 200 Percodan) on
December 13 and January 4 of the following year.
Only seventeen days after the latter prescription, on January 21,
Respondent gave J.R. two more prescriptions, each of which was for 360
tablets of OxyContin 40, one to be filled locally and one to be filled
by the PAP. On both February 7 (again after only seventeen days) and
February 22 (after only fifteen days), Respondent issued J.R. two more
prescriptions (one to be filled locally, the other by the PAP), each
for 360 tablets of OxyContin 40 mg. Thus, during February alone,
Respondent gave prescriptions which authorized the dispensing of 1440
tablets, which was four times the quantity required based on her dosing
instruction. At the visits, Respondent also issued additional
prescriptions for 180 Oxycodone and 200 Percodan, which were invariably
early, typically by nearly two weeks.
On March 13, based on J.R.'s report of a severe headache,
Respondent wrote two prescriptions for both 450 tablets of OxyContin 40
mg. and 360 Oxycodone IR and increased the dosing of both drugs
(including doubling the dosing of the Oxycodone IR). Moreover, the next
day, Respondent wrote J.R. further
[[Page 8230]]
prescriptions for 450 OxyContin 40 mg. and 360 Oxycodone IR, which she
backdated to March 5 with no explanation. See 21 CFR 1306.05(a) (``All
prescriptions for controlled substances shall be dated as of, and
signed on, the day when issued * * *.''). Thus, in the month of March,
Respondent gave J.R. prescriptions which authorized the dispensing of
three times the amount of both OxyContin and Oxycodone IR that her
dosing instructions called for.
Respondent's pattern of early and duplicative prescribing did not
end there. On April 12, Respondent wrote J.R. two more prescriptions
for 450 OxyContin 40 mg. and 360 Oxycodone IR. While these drugs should
have lasted until the middle of June, on May 2 (twenty days later),
Respondent gave J.R. a prescription for 270 OxyContin 80 mg. and noted
that the next day, she would write additional prescriptions for
OxyContin and Oxycodone IR.
Six days later, Respondent wrote J.R. two more prescriptions for
OxyContin: one for 270 tablets of 80-mg. strength for the PAP and one
for 450 tablets of 40-mg. strength presumably to be filled locally;
both of the prescriptions were for a thirty-day supply. Moreover,
Respondent wrote prescriptions for 360 Oxycodone IR for the PAP (a
sixty-day supply) and 180 Oxycodone IR (a thirty-day supply). Yet on
May 15, Respondent wrote two more prescriptions (purportedly to be re-
mailed) which were to be filled by the PAP--one for 270 tablets of
OxyContin 80 mg. and one for 360 tablets of Oxycodone IR. This was
followed two days later by prescriptions for 126 tablets of OxyContin
40 mg. (a further one-week supply) and 84 tablets of Oxycodone IR.
Finally, on May 31, Respondent wrote J.R. prescriptions for 540 tablets
of OxyContin 40 mg. (a thirty-six day supply based on the dosing), and
360 tablets of Oxycodone IR (a thirty-day supply based on the dosing).
Accordingly, in this month alone, Respondent gave J.R.
prescriptions authorizing the dispensing of 1080 tablets of OxyContin
80 mg. and approximately 1116 tablets of OxyContin 40 mg. While
Respondent's dosing instructions varied between a total of 600 and 720
milligrams a day, even using the larger figure, a single 270 tablet
prescription of 80 mg. strength was enough to provide J.R. with a
thirty-day supply. Yet Respondent gave J.R. prescriptions for 80-
milligram tablets totaling four times this amount (120-days supply) and
the prescriptions for 40-milligram tablets provided another sixty-two
day supply.
Similarly, during this month, Respondent gave J.R. multiple
prescriptions for Oxycodone IR which likely totaled 1700 dosage
units.\87\ Here again, even using the largest dosing she prescribed for
this drug during the month (four tablets, every eight hours or twelve
tablets a day), a single 360-tablet prescription was enough to provide
J.R. with a thirty-day supply. Respondent's prescriptions thus provided
J.R. with more than 4.5 times the amount of drugs he was to take.
Similar patterns of prescribing continued throughout the course of
Respondent's treatment of J.R.
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\87\ It is noted that Respondent did not document the
prescriptions she indicated that she would write on May 3 for the
PAP. However, during this period, the prescriptions Respondent gave
J.R. for the PAP were typically for 360 tablets of Oxycodone IR, and
for either 270 tablets of OxyContin 80 mg. or 450 tablets of
OxyContin 40 mg. Given the total quantities of drugs she was
dispensing, whether Respondent wrote the former or latter OxyContin
prescription is not significant.
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In her brief, Respondent cites a written report from her pharmacy
expert to contend that her prescribings to J.R. complied with the
prescription requirement. Resp. Br. at 132 (quoting RX 33, at 6). More
specifically, Respondent's expert noted that ``patient assistance
programs are riddled with problems and delays, and it is common
practice for physicians to write the patient extra medications to avoid
the more significant problem of the patient going without
medications.'' RX 33, at 6. Continuing, the expert asserted that
Respondent ``did the medically responsible thing by writing enough to
ensure that [J.R.] would not run out of medications, and she accounted
for all of the medications she prescribed, and they were all part of
his overall dose.'' Id.
I reject these arguments for several reasons. First, J.R.
repeatedly came in at intervals well short of thirty days and thus
there was little risk that he would run out of medication. Second, even
assuming that it is medically appropriate for a physician to initially
issue two prescriptions to a patient, when, due to legitimate financial
or insurance considerations, that patient must use a PAP, a physician
who issues multiple prescriptions still has the duty to ensure that the
issuance of the prescriptions in this manner does not create an undue
risk of diversion and abuse by accounting for her previous
prescriptions. Put another away, before she issues additional
prescriptions, the physician must ensure that the new prescriptions are
in fact then necessary to treat a legitimate medical condition.
Moreover, the evidence does not support her expert's contention
that she ``accounted for all of the medications she prescribed, and
they were all part of his overall dose.'' Id. at 6. As explained above,
the evidence shows that Respondent repeatedly issued J.R. prescriptions
which authorized him to obtain drugs in quantities far in excess of
what was necessary for a thirty-day supply based on her own dosing
instructions. Nor is there evidence that Respondent even questioned
J.R. regarding whether he had obtained his PAP prescriptions. For that
matter, even the prescriptions Respondent issued J.R. for local filling
were several times what was necessary for a thirty-day supply.
Accordingly, even if the initial prescriptions Respondent gave to J.R.
to treat his migraine headaches were issued for a legitimate medical
purpose, many of the subsequent prescriptions were not. Here again,
Respondent acted with deliberate ignorance of the likely purpose of the
prescriptions.
With respect to other patients, even Respondent's expert (Dr.
Schneider) observed that they had engaged in `` `aberrant drug-related
behaviors,' `which should have been pursued but weren't,' '' including
``early refills without adequate documentation and explanations.'' RX
K-1, at 6. These patients included J.N., N.F., W.F., and C.O.
With respect to J.N., the evidence establishes that Respondent did
not ask her about her substance abuse history even though both Drs.
Hare and Schneider agreed that a physician needs to do ``a careful
history.'' Tr. 881. Moreover, at the first visit, Respondent prescribed
Xanax to J.N. even though she had not diagnosed her as having anxiety.
At the next visit, which was only four days later, Respondent increased
the dosing of the OxyContin four-fold even though J.N. had reported
less pain. Moreover, this increase in dosing far exceeded what both
Drs. Hare and O'Connor testified to as the acceptable titration rate
(50 to 100 percent). At the same visit, Respondent also increased four-
fold the dosing of J.N.'s Xanax even though she made no findings as to
why the drug was medically necessary.
Two months later, J.N. was hospitalized. While in the hospital,
J.N. admitted that she had a ``history of IV heroin abuse'' and that
she had started using the drug a week earlier. Moreover, a urine
toxicology screen found that J.N. was ``positive for opiates,
barbiturates, benzodiazepines, and marijuana,'' and the discharge
summary stated that she was pre-occupied with her pain medications. (In
addition, J.N.'s boyfriend told investigators that she did not have
veins, a classic sign of IV drug
[[Page 8231]]
abuse, and that it was very difficult to draw blood from her.)
The information regarding J.N.'s admission of IV heroin abuse and
the positive urine screens for both illicit drugs (marijuana) and drugs
Respondent had not prescribed to her (barbiturates) was contained in
the discharge summary which Respondent eventually received. According
to Respondent, she did not notice this information because the summary
``was a lot of pages'' to read (even though the medical information was
limited to four pages), and the reference to J.N.'s IV heroin abuse was
``buried in'' the report (even though it was printed on the bottom of
the first page). Relatedly, Respondent offered no credible explanation
as to why she had not noticed the condition of J.N.'s veins.
Examined in isolation, Respondent's failure to read the discharge
summary might be viewed as simply evidence of medical malpractice.
However, after J.N.'s release from the hospital she sought numerous
early refills of both Dilaudid and MS Contin, with some being sought
and obtained as early as eight or nine days before previous
prescriptions should have run out. Again, however, Respondent did not
notice. The evidence taken as a whole (including the failure to take
J.N.'s substance abuse history, the increase in OxyContin dosing at a
rate far in excess of the acceptable titration rate, the increase in
Xanax dosing without any indication as to why it was medically
necessary, the failure to contact other physicians who were treating
her to coordinate prescribing, and the early refills), supports the
conclusion that many of Respondent's prescriptions for J.N. were issued
outside of the ``usual course of * * * professional practice'' and
lacked a ``legitimate medical purpose.'' 21 CFR 1306.04(a).
In a written submission, Respondent's pharmacy expert opined that
people refill prescriptions early for such legitimate reasons as
``vacations,'' not ``run[ning] out * * * over the weekend,'' ``because
it is much more convenient to pick it up then, and because they are
undermedicated.'' RX 33, at 4. Respondent's expert also maintains that
``just because a chronic pain patient is receiving their medication
early does not necessarily mean that they have taken all of their
medication.'' Id.
As for the last contention, while that may be true, even Dr.
Schneider has written that ``[f]requent requests for early refills''
are a ``sign[ ] of possible drug addiction.'' RX 36, at 3. Moreover,
Respondent never requested that J.N. bring in her prescriptions for a
pill count. Furthermore, with respect to J.N.'s early refills, one does
not need to refill a prescription eight days (or even five days) early
to avoid running out on a weekend. Nor is there any indication that
Respondent issued any of the early refills because J.N. was going on
vacation. Finally, while it is acknowledged that a patient may run out
of medications because the prescribed quantity and dosing are not
adequate to address a patient's pain, Respondent made no such
contention with respect to J.N., who, of course, was abusing drugs by
injecting them.\88\
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\88\ As for the expert's claim that patients legitimately seek
early refills for their own convenience, the physician is still
obligated to properly supervise her patient's use of a controlled
substance and can accommodate both interests by indicating a fill
date on the prescription (e.g., ``Do Not Fill Until [Date]'').
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As for N.F., on the date of her first visit, Respondent was told by
a pharmacist that N.F. was a doctor shopper. While Respondent cancelled
the refills she had authorized, four days later Respondent gave her
another prescription for Vicodin with two refills. Thereafter, N.F.
began seeking early refills, with many of them being sought more than a
week early. Respondent repeatedly complied with N.F.'s requests for
drugs, escalated the strength and dosing of the prescriptions, and
ignored numerous warning signs that N.F. was addicted.
For example, at one visit, N.F. reported that she had burned
herself but did not remember how she had done so. Later on, N.F. told
Respondent that she was moving to Illinois. Yet even after telling
Respondent this, N.F. continued to return multiple times each month for
the next seven months. While N.F. initially told Respondent such
stories as she was back to pick up her truck, or that she was in town
to testify for the State but that she had moved, Respondent apparently
never questioned N.F. as to why she was still coming in months later.
During this period, Respondent also wrote N.F. prescriptions and
allowed N.F.'s purported family members to pick up the prescriptions.
In the month of October alone, Respondent wrote prescriptions on
October 2 (100 Roxicodone 30 mg. q4h--a sixteen-day supply), October 5
(same Rx), October 9 (30 Roxicodone 30 mg.--another five-day supply),
October 15 (200 Roxicodone 5 mg. 2-3 q4h--an eleven-day supply),
October 17 (100 Roxicodone 15 mg. 2-3 q4h--a five-day supply), October
19 (200 Roxicodone 15 mg. 1-2 q4h--a sixteen-day supply), October 24
(200 Roxicodone 5 mg. 3-4 q4h--an eight-day supply), October 26 (50
Roxicodone 30 mg. \1/2\ q4--a sixteen- day supply), October 29 (100
Roxicodone 30 mg. q4h--a sixteen-day supply).
This pattern continued in the ensuing months with N.F. engaging in
additional scams, such as claiming that she had lost her prescription
and that her neighbors had beaten her up and stolen her drugs.
Moreover, during the October 17 visit, N.F. complained of dental pain
and Respondent issued her an additional prescription for 30 tablets of
Vicodin. Notably, she did not refer N.F. to a dentist who could
properly diagnose and treat her condition. Nor did Respondent explain
why a Vicodin prescription was necessary given the Roxicodone
prescriptions.
While Dr. Schneider opined that N.F.'s chart showed that Respondent
needed additional education about ``careful monitoring'' of patients
and reviewing ``the big picture,'' this ignores that Respondent knew
from the date of N.F.'s first visit that she had engaged in drug-
seeking behavior. Respondent therefore cannot credibly claim that she
was duped by N.F. Moreover, even ignoring the early refills N.F. sought
and obtained for the Vicodin prescriptions in the first months of her
seeking drugs from Respondent, the size and frequency in relation to
the dosing instructions of the subsequent Roxicodone prescriptions
amply demonstrated that N.F. was engaged in drug-seeking behavior and
that the prescriptions were not for a legitimate medical purpose and
violated the CSA. 21 CFR 1306.04(a). Moreover, the size and frequency
of the prescriptions support the further conclusion that Respondent was
deliberately ignorant as to the likely purpose of the prescriptions.
W.F. was treated by Respondent for only approximately five months
before his death. At the initial visit, W.F. brought in an impairment
rating from the Veterans Administration, and yet Respondent did not
contact the VA to obtain W.F.'s treatment records. She also did not
inquire with W.F. regarding his past substance abuse before prescribing
various narcotics to him including Percocet, OxyContin, and Dilaudid.
Respondent, however, was subsequently informed on two occasions by
a psychiatrist who was treating W.F. that the latter had a history of
narcotic addiction problems. Respondent was also notified by a case
manager who worked at the psychiatrist's practice that the practice had
received a phone call from a family member expressing concern that W.F.
might be abusing his pain medicines. While Respondent indicated in his
medical record that she had discussed
[[Page 8232]]
W.F.'s addiction issues with him (who told her that the drugs helped
with the pain), she continued to prescribe narcotics to him including
both methadone and Roxicodone 30 mg. and yet his record contains no
indication that Respondent planned to institute such measures as pill
counts or toxicology screens to monitor his use of the drugs. Finally,
the Government's Expert not only noted Respondent's failure to contact
the VA to obtain other records and to take a substance abuse history,
but also that her physical exam was minimal and was not adequate to
diagnose his various pain complaints. Respondent admitted that she did
not do a substance abuse history (testifying that at the time she did
not know what questions to ask, Tr. 2382), and offered no testimony on
the issue of the adequacy of her physical examination. While
Respondent's conduct in prescribing to W.F. may not have been as
egregious as it was with respect to the patients above, she still acted
outside of the usual course of professional practice in prescribing
controlled substances to him and thus violated the CSA's prescription
requirement in doing so.
With respect to C.O., who was also identified by Respondent's
Expert as a patient who had engaged in aberrant drug-related behavior,
the Government's Expert acknowledged that Respondent's initial physical
exam was adequate. However, Respondent again failed to inquire as to
his past substance abuse.
C.O. rapidly escalated his use of drugs and engaged in drug-seeking
behavior; once again, Respondent did nothing to control him. For
example at the first visit, Respondent gave him a prescription for 40
Lortab 7.5/500 with two refills, a prescription which thus authorized
the dispensing of 120 tablets and which, based on the maximum daily
dose of acetaminophen of 4000 mg., should have lasted fifteen days.
Five days later, Respondent, however, gave him another prescription for
40 Lortab 10/500 with two refills. A week later when C.O. saw a nurse
practitioner, he reported that he was out of medication and needed more
even though he had at least two refills left. C.O. swore, however, that
he did not have any refills. Two days later, C.O. told Respondent that
he was taking up to twelve Lortab per day.
Three days later, Respondent performed a physical exam finding no
obvious pain with ambulation but noted generalized tenderness and that
he complained of mid-back pain with range of motion of his shoulders.
Respondent changed his prescription to 30 OxyContin 20 mg., with one
tablet every eight hours. Four days later, C.O. returned, saw the nurse
practitioner and claimed his back pain was worse. His speech was
slurred, and he indicated that he had recently taken twice the
prescribed dose. Upon finding nothing abnormal in her physical exam,
the Nurse Practitioner spoke with Respondent about refilling C.O.'s
OxyContin prescription; Respondent then wrote C.O. a new prescription
for 60 tablets and doubled the dosing and apparently did so without
even seeing C.O. C.O. repeatedly escalated his use of OxyContin
(although Respondent briefly reduced his dose, only to increase it
again).
Subsequently, C.O. claimed that he had gotten a job on a cruise
ship and that he would be going on the ship in a few days for thirteen
weeks. While Respondent gave him prescriptions for 60 OxyContin 40 mg.
and 360 Lortab 10/500 with three refills, he was back three days later
(at which visit he obtained another prescription for 60 OxyContin 40
mg.) and again only five days later, at which visit he obtained four
additional OxyContin prescriptions (for 372, 280, 144 and 92 tablets)
and one prescription for 350 Lortab, with no refills.
After only six weeks (and six weeks before the thirteen-week period
on the ship would have ended), C.O. returned, showed very slurred
speech, and sought another prescription for OxyContin because he had
run out. While Respondent referred him to get a drug test, there is no
indication that he complied. Respondent also did not question C.O. as
to why he was back so soon from the ship. C.O. had, however, filled
prescriptions at Tucson pharmacies on multiple occasions during the
period in which he claimed that he would be on the cruise ship.
While Respondent decided to taper down C.O.'s OxyContin, she
continued to prescribe Lortab and eventually started prescribing
Roxicodone to him. Notably, while Respondent briefly reduced the dosing
of Roxicodone to 240 mg. per day, fifteen days later she was back to
prescribing 480 mg. a day, which was the same dose as the OxyContin she
had previously prescribed. Moreover, at one of these visits, Respondent
had given him a prescription for 100 Lortab (10/500) with five refills,
which thus authorized the dispensing of 600 tablets. While this
prescription should have lasted at least 75 days, after only six weeks
Respondent gave C.O. another Lortab prescription for the same quantity
and refills. C.O. used up (whether by taking or selling is irrelevant)
this prescription and the refills in a month's time. Although
Respondent then temporarily stopped prescribing Lortab to him (because
of its acetaminophen content), she continued to prescribe Roxicodone to
C.O. Approximately two months later, C.O. entered drug treatment.
Here again, early on in the course of C.O.'s seeing Respondent,
there was evidence that he had rapidly self-escalated his use, had
sought early refills, and engaged in other scams to obtain more drugs.
When Respondent referred him for a drug test, there is no evidence that
he complied or that she even sought to determine whether he had gone
for the test. Moreover, after C.O. had represented that he was going to
be away for thirteen weeks, Respondent did not question him as to why
he was back to see her after only six weeks and continued prescribing
to him. Later, she refilled his Lortab prescription approximately six
weeks early, and, even though C.O. used up this prescription in a
month's time, she continued to prescribe to him. As Dr. Hare noted,
Respondent did little to supervise and control C.O.'s use of controlled
substances. Accordingly, even if it was medically appropriate initially
to prescribe controlled substances to C.O., it is clear that many of
the prescriptions she wrote were not issued for a legitimate medical
purpose and thus violated the CSA.
N.S. was an eighteen-year-old college student who complained of
lower-back pain since enrolling at the University of Arizona. Even
though N.S. rated his pain as only a four on a scale of one to ten,
Respondent's physical exam found that he had a normal neurological exam
and could perform a variety of movements without pain, with the
exception of his incurring minimal low back pain with lumbar flexion,
and Respondent had concluded that the cause of his back pain was a
``poor mattress and poor positioning,'' at N.S.'s first visit,
Respondent gave him a prescription for OxyContin 20 mg. (with one
tablet to be taken every twelve hours). Moreover, two days later, N.S.
returned and told Respondent that he had doubled up on the dose but
that hadn't worked. Respondent then told him to take three tablets at a
time. This was followed four days later by Respondent's issuance of a
prescription for 180 tablets of OxyContin 20 mg., as well as 50 tablets
of oxycodone 5 mg. (one tablet every four hours) after he asked for
something for breakthrough pain.
Approximately a week later, Respondent gave N.S. an additional
prescription for 50 tablets of Roxicodone which increased the strength
from five to fifteen milligrams and the dosing to one tablet every
three
[[Page 8233]]
hours, a four-fold increase in the daily amount of this drug. Moreover,
she did so even though N.S. had reported a substantially lower pain
level from the visit at which she had added the two previous
prescriptions.
With respect to N.S., Dr. Hare observed that, while Respondent had
reasonably evaluated N.S., her findings did not support prescribing
opioids ``and certainly not * * * in the aggressive doses she
prescribed.'' GX 46, at 15. Dr. Hare further observed that N.S. had
rapidly self-escalated his dosing ``to a large amount,'' and the fact
that he tolerated these doses suggested that he was either ``not
opioid-na[iuml]ve, or [that] he was not taking the medication.'' Id. I
further note that Respondent increased N.S.'s dosing nearly four-fold
(from 40 mg. to 150 mg. a day) in only four days, a rate which exceeded
by several times the acceptable rate of titration as testified to by
both parties' experts. See RX 8, at 2 (testimony of Respondent's expert
that ``no more than 50% to 100% every 5 or more days'' is acceptable).
Dr. Hare also noted that Respondent had further increased the amount of
Roxicodone at the subsequent visit even though N.S. was reporting less
pain. Finally, Respondent did not specifically address any of Dr.
Hare's findings with respect to N.S. Based on the above, I conclude
that, even if Respondent was duped by N.S. and believed that he was in
pain, she acted outside of the usual course of professional practice in
prescribing controlled substances to him.
Respondent also prescribed to both M.D. and S.R., who lived
together. At his first visit, M.D. complained that he had fallen off a
bicycle and injured his back and leg. He also reported that another
physician had previously prescribed to him OxyContin 80 mg., Oxyfast
and methadone, but that he had been off these medications for several
months because the prescribing physician had ``left the office.''
Respondent did not attempt to contact the office of M.D.'s previous
physician to determine whether his statement was true and/or to obtain
his treatment records. Nor did she obtain a pain rating and indeed,
during the physical found that he was not in acute distress.
Following a physical exam, Respondent issued M.D. prescriptions for
60 OxyContin 80 mg. (q12h) (the second strongest formulation of the
drug), 30 oxycodone 5 mg., and Oxyfast. Later that day, a pharmacist
called and told Respondent that M.D. was known to forge prescriptions
and had been arrested; Respondent told the pharmacist not to fill the
prescriptions. M.D., however, had managed to get the OxyContin filled
at another pharmacy. At M.D.'s next visit, he again sought OxyContin.
Respondent did, however, question Respondent about the incident at the
pharmacy and as to why he had gone to a different pharmacy than the one
he had put on his pain contract. Respondent then refused to give him a
new prescription, and, after that, M.D. did not go back to her.
Subsequently, Respondent received a phone call reporting that a
week earlier, M.D. had been admitted to a local hospital in a coma and,
upon his admission, had in his possession a prescription vial which
contained methadone 40 mg. tablets; the vial's label indicated that it
had originally contained Dilaudid which Respondent had prescribed to
S.R.
Respondent had first treated S.R. approximately nine weeks earlier
when she complained of abdominal and pelvic pain and reported that she
had a history of cystitis and active hepatitis C. S.R. also indicated
that another physician had prescribed Xanax and Vicodin for her and
that she was taking her late husband's leftover OxyContin and Dilaudid.
Respondent's physical exam was limited to noting that she had pain with
ambulation, that she limped, and that she had tenderness over her
abdomen. As the Government's expert noted, Respondent's physical exam
was minimal, she did not obtain records from other physicians who had
treated S.R. before prescribing, and her evaluation was inadequate to
justify prescribing the controlled substances which she did (OxyContin,
Dilaudid, and Xanax). Apparently, Respondent did not find troubling
S.R.'s use of drugs which had not been prescribed to her (OxyContin and
Dilaudid).
Two weeks later, Respondent gave S.R. new prescriptions for all
three drugs even though the original Xanax prescription (90 tablets TID
PRN) should have lasted thirty days and S.R. was to come in for a
recheck in two weeks. Moreover, the Xanax prescriptions she issued on
this date provided for 90 tablets with two refills (a total of 270
tablets--a ninety-day supply if taken as directed). Yet six weeks
later, S.R. claimed that her Xanax had gotten wet and that the pills
had dissolved and could not be taken. Even if the story was true, S.R.
should still have had a refill for 90 tablets left. Respondent
nonetheless gave her a new prescription for 100 tablets of Xanax with
two refills.
Respondent subsequently counseled S.R. about the incident involving
M.D., and S.R. denied that he could have gotten her medications.
Moreover, after S.R. failed to go to another doctor on a referral,
Respondent refused to write any more prescriptions for her until she
obtained more documentation of her condition.
While Respondent's conduct in prescribing to M.D. and S.R. was not
as egregious as her prescribing to the patients discussed above, I
nonetheless conclude that the prescriptions were issued outside of the
usual course of professional practice and lacked a legitimate medical
purpose. While Dr. Hare did not offer an opinion specific to M.D., both
parties' experts were in agreement that when a patient is not currently
on opioids, they should be started at a low dose and titrated up
gradually to achieve pain relief while minimizing adverse side effects.
At his first visit, M.D. admitted that he had not been on opioids for
several months. Yet Respondent started him out with a daily dose of 160
mg. of OxyContin plus other drugs, which was the same dose that M.D.'s
previous doctor had supposedly prescribed although whether this was in
fact the case is unknown because Respondent never even attempted to
contact this physician. While M.D. claimed to have back and leg
injuries, Respondent did not even obtain pain ratings from him. While I
note that Respondent told the pharmacy not to fill his prescriptions
upon being informed that he was known to forge prescriptions, the
prescriptions should never have been written in the first place.
As for S.R., Respondent did not find it troubling that she was
taking two powerful and highly abused narcotics--Dilaudid and
OxyContin--for which she did not have prescriptions. Not only was
Respondent's physical examination minimal, she did not obtain records
from other treating physicians including the one who supposedly had
prescribed Xanax and Vicodin to S.R. before she prescribed Dilaudid,
Oxycontin, and Xanax for her. Indeed, it appears that her diagnosis was
based largely on S.R.'s representation as to her condition. Respondent
also gave S.R. early refills. While Respondent eventually refused to
write more prescriptions for her, it should not have taken three months
to conclude that S.R. was seeking drugs to abuse them.
Respondent also prescribed to W.O. and J.O., a married couple, each
of whom claimed to have been injured in various (but different) motor
vehicle accidents. As found above, Respondent issued both persons
numerous prescriptions for schedule II drugs including OxyContin,
Roxicodone and Percocet well before previously issued prescriptions
would have run out, with some prescriptions being issued only
[[Page 8234]]
days after earlier prescriptions were issued and weeks early. Moreover,
on various occasions, Respondent increased the dosing of both persons'
medications without providing any explanation in their respective
medical records. Indeed, at one visit, Respondent doubled the dosing of
W.O.'s OxyContin prescription even though he had rated his lower back
pain as ``zero.''
Moreover, W.O. and J.O. engaged in other problematic behavior
including J.O.'s claiming that their house had been burglarized and
that all of their medications had been stolen, W.O.'s attempt to alter
a Percocet prescription issued to J.O. by tearing out the fill date,
J.O.'s reported selling of Percocet, and J.O.'s giving 300 tablets of
methadone to W.O. although she had previously told Respondent that she
had left W.O. Finally, during the course of treating J.O., Respondent
received information from the State Nursing Board that J.O. had been
subjected to disciplinary proceedings because she had abused
medications and taken some from a nursing home where she worked;
Respondent received this information before J.O. gave W.O. half of her
methadone prescription. Yet Respondent continued to prescribe to her
for several months thereafter. Finally, notwithstanding the various
reports she had received, Respondent falsely wrote the State Nursing
Board that there was ``no evidence'' that J.O. was continuing to divert
drugs.
Accordingly, even if Respondent's initial prescriptions to J.O. and
W.O. were issued in the usual course of professional practice and for a
legitimate medical purpose, it is clear that many of the subsequent
prescriptions she issued to J.O. and W.O. did not comply with the
prescription requirement. Moreover, whether Respondent's conduct in
writing the letter to the State Board is considered under factor two
(the experience factor) or under factor five (such other conduct which
may threaten public health and safety), it does not reflect well on her
candor.
Respondent also ignored evidence of problematic behavior engaged in
by P.H., M.H. (P.H.'s mother) and A.B. (who lived with P.H.). For
example, several months after Respondent started treating P.H., the
latter reported that her Percocet had been stolen two weeks earlier and
that she had only Darvocet N100 to take following the theft. Respondent
had not, however, prescribed this drug to P.H., yet Respondent did not
question her as to how she had obtained this drug. Several months
later, P.H. complained that the OxyContin she was taking made her
nauseous. P.H.'s medical record contained no indication that Respondent
had previously prescribed OxyContin to P.H. Yet Respondent did not
question P.H. as to how she had gotten this drug.
Eight months after this incident, Respondent was called by a
pharmacist and told that P.H. had filled a prescription for Percocet
(which Respondent was then prescribing to her) which had been issued by
another doctor. While Respondent questioned P.H. about the incident,
she did not contact the other doctor to discuss the extent to which
P.H. was obtaining other prescriptions and to coordinate their
prescribing. Five months later, Respondent received another phone call
from a pharmacist and was told that P.H. was obtaining 84 Vicodin
tablets every two weeks from the same doctor who had prescribed
Percocet to her. Again, however, there is no indication that Respondent
contacted this doctor.
Subsequently, P.H. was diagnosed by an emergency room physician as
having a skin condition and told Respondent that she had an appointment
to see a dermatologist in two weeks. According to the Government's
Expert, the condition did not justify ``anything other than mild
analgesics,'' yet Respondent nearly doubled the dosing of Roxicodone
from 480 mg. to 900 mg. a day. Moreover, there is no evidence that
Respondent ever contacted the dermatologist to coordinate any
prescribing that might be necessary to treat the condition.
Furthermore, during this period, Respondent issued Percocet
prescriptions to P.H. in amounts and at a frequency that would be toxic
if P.H. was actually taking the drug according to Respondent's own
evidence regarding the maximum daily dose. P.H. was subsequently
identified by her own mother (M.H.) as the person who had passed the
OxyContin which had been prescribed to M.H. to the latter's nephew
during the July 29, 2001 diversion incident.
At A.B.'s initial visit, she reported that she was taking Percocet
and a non-controlled drug. Here again, Respondent did not contact the
physician who had prescribed the drugs to her. Moreover, while A.B.
reported that an MRI had shown that she had a herniated disk, there is
no evidence that Respondent attempted to obtain the MRI report. Shortly
thereafter, A.B. began to seek early refills which Respondent typically
approved without any documentation of her questioning A.B. as to why
she needed the refills, which in some instances were as many as
seventeen days (on a thirty-day Rx) early.\89\
---------------------------------------------------------------------------
\89\ In one instance, A.B. sought a refill of OxyContin and
oxycodone a week after having undergone back surgery. A.B.
complained that she had only been given 20 Percocet and was in
severe pain, and Respondent wrote prescriptions for 60 Oxycontin 40
mg. and 200 oxycodone 5 mg. Here, again, she did not coordinate her
prescribing with A.B.'s surgeon.
It is acknowledged that a patient may seek an early refill
because a previous prescription does not adequately address
legitimate pain. But as Respondent's own records indicate (and as
Dr. Schneider testified), it is the physician--and not the patient--
who is responsible for deciding whether a change in the dose is
medically necessary. See GX 56, at 3 (Respondent writing in A.B.'s
chart: ``Any dose changes need to be ordered by me.'').
Notwithstanding the above statement (which appeared in numerous
other charts), Respondent rarely exercised control over her patients
and repeatedly acceded to the self-escalation they engaged in.
---------------------------------------------------------------------------
At M.H.'s first visit, Respondent diagnosed her with shingles and
gave her a prescription for 60 tablets of OxyContin 20 mg. While four
days later M.H. returned and told Respondent that her insurance
wouldn't cover the drug, Respondent did not ask her to return or
destroy the prescription. Two days later, either P.H. or A.B. picked up
the prescription and passed it to M.H.'s nephew who was in another car.
While Respondent counseled M.H. about the incident at a subsequent
visit (which was a criminal act), there is no credible evidence that
she ever discussed the incident with P.H. and A.B. Moreover, while
three weeks later the same pharmacist who reported the July 29 incident
again told Respondent that he believed P.H. and A.B. were selling their
drugs, once again there is no indication that Respondent questioned
either P.H. or A.B. after receiving this additional report. Respondent,
however, continued to prescribe to them and instituted no measures such
as pill counts and drug screens to monitor them.
Following the incident, Respondent continued to prescribe Percocet
and Roxicodone to P.H. Several months later, Respondent again received
information suggesting that P.H. had either obtained or was attempting
to obtain Vicodin from another physician (P.H.'s dermatologist). Yet
the same day she received this information, Respondent again prescribed
200 tablets of Percocet and 500 tablets of Roxicodone and did not
question P.H. about whether she was obtaining additional controlled
substance prescriptions from other doctors. Nor did she contact the
other physician. Subsequently, Respondent added Dilaudid and continued
to prescribe the other drugs to her as well. Respondent did not have
P.H. sign a pain contract
[[Page 8235]]
until May 2002, at which time she was aware that she was being
investigated.
Here again, even assuming that these three patients initially
presented with legitimate medical conditions which required treatment
with controlled substances and that Respondent had a legitimate medical
purpose in prescribing to them, Respondent nonetheless violated the
prescription requirement because she failed to properly supervise her
patients in their use of controlled substances. See Gonzales, 546 U.S.
at 274 (``the prescription requirement * * * ensures patients use
controlled substances under the supervision of a doctor so as to
prevent addiction and recreational abuse''). She repeatedly ignored
that these patients were obtaining drugs from other doctors or the
street; she prescribed drugs for conditions that were putatively being
treated by other physicians and yet did not contact the other
physicians to coordinate their prescribings; she issued new
prescriptions well before previous prescriptions should have run out
and did so without even questioning the patients as to why they already
needed additional medication; she did not even counsel A.B. and P.H.
after receiving reports that they had engaged in criminal acts and were
selling their medications; she prescribed Percocet to P.H. in
quantities that would have been toxic if she was actually taking the
drug (as opposed to selling it); and she did nothing to monitor P.H.,
A.B. and M.H.'s use of their medications. Thus, even if these patients
initially presented to Respondent legitimate medical complaints,
Respondent repeatedly acted outside of the usual course of professional
practice in the course of prescribing to them.
As the forgoing demonstrates, in numerous instances beyond those
identified by the ALJ, Respondent issued prescriptions which violated
the CSA's prescription requirement. With respect to several of the
patients, Respondent did so either knowing or having reason to know
that the prescriptions were not being sought for a legitimate medical
purpose.
This conduct was more than enough to establish the Government's
prima facie case to deny Respondent's application. Indeed, DEA has
revoked a practitioner's registration for as few as two incidents of
diversion and has done so where the conduct was far less egregious than
that in which Respondent engaged. See, e.g., Alan H. Olefsky, 57 FR 928
(1992) (revoking registration of practitioner who presented two
fraudulent prescriptions); see also Sokoloff v. Saxbe, 501 F.2d 571,
574 (2d. Cir. 1974) (upholding revocation based on three acts of
unlawful distribution).
The ALJ's reasoning that the Government had only shown that
Respondent's prescribing to ``two patients out of more than 900''
lacked a legitimate medical purpose, and that her ``overall medical
practices are not consistently lacking in legitimate purpose,'' ALJ at
150, is thus erroneous. More disturbingly, this reasoning has been
previously--and expressly--rejected by the Agency. See, e.g., 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.' ''); Caragine, 63 FR at 51600
(``[E]ven though the patients at issue are only a small portion of
Respondent's patient population, his prescribing of controlled
substances to these individuals raises serious concerns regarding [his]
ability to responsibly handle controlled substances in the future.'').
I therefore conclude that the evidence relevant to Respondent's
experience in dispensing controlled substances and her record of
compliance with applicable laws related to controlled substances
establishes prima facie that granting Respondent's application would be
``inconsistent with the public interest.'' 21 U.S.C. 823(f).
Factor Five--Such Other Conduct Which May Threaten Public Health or
Safety
Respondent also prescribed controlled substances to F.L. and B.L.,
who were father and son. As found above, F.L., who suffered from
chronic pancreatitis, lower back pain and diabetes (which led to the
amputation of one of his lower legs) was receiving approximately 7000
dosage units a month of schedule II drugs including OxyContin 40 mg.,
OxyIR, Percocet and Percodan, and was obtaining some of the drugs
through the Purdue Frederick (who manufactured both OxyContin and Oxy
IR) Patient Assistance Program. At the last visit before his death,
Respondent issued him prescriptions for 1320 tablets of OxyContin 40
mg. and 4800 Oxycodone IR, which were to be filled through the PAP
program.\90\
---------------------------------------------------------------------------
\90\ To make clear, while F.L.'s prescriptions were very large,
there is no evidence establishing that the prescriptions were issued
in violation of 21 CFR 1306.04.
---------------------------------------------------------------------------
Six days after F.L.'s death, B.L., who was obtaining Dexedrine--a
schedule II amphetamine and stimulant, presumably for fatigue and to
prevent weight gain,\91\ saw Respondent and obtained another
prescription for Dexedrine. Moreover, as found above, during this
visit, B.L. admitted to Respondent that he had accepted the delivery of
the 1320 OxyContin 40 mg. tablets dispensed pursuant to his father's
prescription. Respondent admitted to this fact in her plea agreement
and that she had also failed to rescind the Dexedrine prescription she
issued to B.L. Based in part on this conduct, Respondent ultimately
pled guilty to violating 18 U.S.C. 3.
---------------------------------------------------------------------------
\91\ While the progress notes indicate that Respondent was
treating B.L. for weight gain and an eating disorder, there is no
indication in any of the progress notes as to his height and weight.
---------------------------------------------------------------------------
In this proceeding, Respondent vigorously contested whether she
committed any crime in failing to report B.L.'s diverting of the
prescription to law enforcement authorities. In this regard, Respondent
put forward evidence that there is no requirement that a physician
report a patient's act of diversion to the authorities. See RX O.\92\
Whether her conduct constituted a crime was an issue that should have
and could have been litigated in the criminal proceeding (and with
respect to B.L., it was not just her failure to report but also her
failure to rescind the prescription which was the basis for
conviction).\93\ In any event, in light of the extensive and egregious
evidence found under factors two and four, Respondent's conviction with
respect to this incident adds very little to the Government's case.
---------------------------------------------------------------------------
\92\ As support for this proposition, Respondent also cited a
document entitled: Prescription Pain Medicines: Frequently Asked
Questions and Answers for HealthCare Professionals, and Law
Enforcement Personnel. RX T. DEA never published the document in the
Federal Register, because it ``was not an official statement of the
agency,'' and ``withdrew the document because it contained
misstatements.'' 69 FR 67170 (2004).
\93\ This is not a close case and therefore I need not consider
whether a practitioner's failure to report an act of diversion by a
patient is grounds for denying an application.
---------------------------------------------------------------------------
Sanction
Under longstanding 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 [she] can be
entrusted with the responsibility carried by such a registration.''
Medicine Shoppe, 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),
[[Page 8236]]
[DEA] has repeatedly held that where a registrant has committed acts
inconsistent with the public interest, the registrant must accept
responsibility for [her] actions and demonstrate that [she] 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).
Relatedly, a respondent's lack of candor is an important and
typically dispositive consideration in determining whether she has
accepted responsibility for her misconduct. See id. (``Candor during
DEA investigations, regardless of the severity of the violations
alleged, is considered by the DEA to be an important factor when
assessing whether a physician's registration is consistent with the
public interest'' and noting that physician's ``lack of candor and
failure to take responsibility for his past legal troubles * * *
provide substantial evidence that that his registration is inconsistent
with the public interest.''). See, e.g., Prince George Daniels, 60 FR
at 62887.
Finally, to rebut the Government's prima facie case, an applicant/
registrant is required not only to accept responsibility for her
misconduct, but also to demonstrate what corrective measures she has
undertaken to prevent the re-occurrence of similar acts. Jayam Krishna-
Iyer, 74 FR 459, 464 & n.8 (2009). Both conditions are essential
requirements for rebutting the Government's prima facie showing that
granting an application or continuing an existing registration would be
``consistent with the public interest.'' 21 U.S.C. 823(f).
In her recommended decision, the ALJ asserted that Respondent
``took full responsibility for her actions and the consequences that
followed those actions.'' ALJ at 155. Not so. Indeed, with respect to
her most egregious misconduct as established on this record--her six
prescribings of various schedule II narcotics to H.T., knowing that he
was not seeking the drugs to treat a legitimate medical condition but
rather to abuse them--Respondent denied any failing on her part and
maintained that she was duped. Relatedly, Respondent also denied that
she had falsified H.T.'s medical records (which she did on six
occasions) to indicate that she had done a physical exam when she had
not.
With respect to her falsification of H.T.'s patient record, the ALJ
explained that although this ``does not reflect well upon Respondent's
propensity for truthfulness, * * * a single instance does not rise to
the level of the pervasive pattern of falsification that was present
in'' another DEA proceeding, see ALJ at 155 (citing Jayam Krishna-Iyer,
71 FR 52148, 52155-56 (2006)), ``particularly in light of the
Respondent's substantial rehabilitation since then.'' Id.
The ALJ's reasoning ignores that Respondent falsified H.T.'s record
six different times in order to provide a justification for prescribing
controlled substances. Thus, Respondent's acts of falsification were,
in fact, even more extensive than that engaged in by Krishna-Iyer, who
was shown to have falsified patient records on three separate
occasions. Whether a practitioner's falsifications involve a single
patient multiple times or multiple patients a single time is
irrelevant.
Moreover, throughout this proceeding, Respondent has continued to
deny that she falsified H.T.'s records. In her brief, she contends that
she performed physical exams but that the transcripts do not reflect
them because H.T. ``was quite familiar with the routine of bending over
to touch his toes, allowing me to palpate his lumbar muscles, sitting
on the exam table and lifting his legs, having me test his ankle
strength and allowing me to lift his leg in a straight leg raising
test'' and that after all of the exams she had performed on him (when
she had not examined him in nearly two years), ``there are necessarily
fewer specific directions to the patient'' (in fact, there were no
directions to H.T. related to any of the above parts of the exam).
Respondent's Resp. to Gov.'s Exc. at 2. As found above, Respondent's
contention is patently absurd and disingenuous. Given the scope of the
falsifications, it buttresses the conclusion that Respondent has failed
to accept responsibility for her misconduct.\94\
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\94\ On the issue of Respondent's propensity for truthfulness, I
further note Respondent's letter to the Arizona Nursing Board in
which she falsely stated that there was ``no evidence'' that J.O.
was continuing to divert drugs. Respondent made this statement
notwithstanding that J.O. had previously admitted to giving 300
tablets of methadone to her husband, that Respondent had received
reports that J.O. was selling Percocet, and the incident in which
her prescription had been altered.
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Nor is this the only evidence that supports the conclusion that
Respondent has failed to accept responsibility. With respect to patient
J.N., whose admission of IV heroin abuse and positive-drug-test results
for various illicit drugs were contained in a discharge summary,
Respondent offered nothing but excuses for failing to read the report.
See Tr. 2367-68 (contending that four-page report ``was a lot of
pages'' and that the reference to J.N.'s heroin abuse was ``buried in''
the report when it was at the bottom of the first page).
In other instances, Respondent did not even address the propriety
of her prescribings to other patients even though the prescribings were
clearly at issue. For example, on the first day she prescribed to N.F.,
a patient who engaged in a variety of obvious scams including claiming
that she had moved to Illinois, Respondent was told by a pharmacist
that N.F. was a doctor shopper. Yet in her testimony, Respondent did
not even address why she prescribed to her.
While one of Respondent's generic arguments is that she was duped
by her patients, see Resp. Proposed Findings at 192 (``Being duped by
professional con-men does not indicate that I am a threat to the public
interest''), she cannot credibly contend that she was duped by N.F.
when she was told by a pharmacist on day one that N.F. was a doctor
shopper and yet continued to prescribe to her. Nor can Respondent
credibly claim to have been duped in the case of K.Q., who repeatedly
sought and obtained prescriptions for Xanax and Valium not merely days,
but months early.
As the forgoing demonstrates, Respondent has failed to accept
responsibility for many of her most egregious acts of misconduct. As I
recently explained, even where the Government's proof establishes that
a practitioner has committed only a few acts of diversion--and in this
case the record demonstrates that Respondent committed numerous acts
inconsistent with the public interest--an applicant/registrant is not
entitled to be registered absent a substantial showing that she has
accepted responsibility. See Krishna-Iyer, 74 FR at 464.\95\
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\95\ Respondent also contends that her practices between the
service of a search warrant in May 2002 and November 2002, when she
lost her registration, ``are very significant and highly relevant in
determining whether my having a registration is in the public
interest.'' Resp. Prop. Findings at 200. As I have previously
explained, evidence of one's compliance with Federal law may ``be
entitled to some weight in assessing whether a registrant/applicant
has demonstrated that she can be entrusted with a new registration
where the Government's proof is limited to relatively few acts and a
registrant puts forward credible evidence that she has accepted
responsibility for her misconduct.'' Krishna-Iyer, 74 FR at 464.
Here, however, the record establishes that Respondent committed
not merely a few, but rather numerous acts that were inconsistent
with the public interest and that she has not accepted
responsibility for her misconduct. Of further note, while Respondent
was clearly aware that the State Board was investigating her, she
nonetheless prescribed more Oxycontin to H.T. and falsified his
records. Respondent's willingness to violate Federal law, even at a
time when she knew she was under investigation, and falsify records
to provide a medical reason to justify a drug deal, provides ample
reason to give no weight to this evidence.
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[[Page 8237]]
Finally, while Respondent maintains that she has undergone
extensive remedial training including CME and working with a mentor to
improve her record-keeping and management of patients, her testimony
suggests that she has learned little from the experience. For example,
even though Respondent's mentor had specifically identified various
patients as having ``received early refills without adequate
documentation and explanation,'' RX K-1, at 6, Respondent testified
that she could not answer the question as to whether she had issued
early refills without documenting the reason why, because the
definition of the term is ``not clear and not well agreed upon.'' Tr.
2345. Even more disturbing is her testimony that it is not harmful for
a patient to use a controlled substance (in the case of this patient,
no less than OxyContin) which had not been prescribed to them but to a
family member. Amplifying her views, Respondent claimed that this is
``just continuing medical care'' and causes ``no harm to the patient''
because people ``develop an area of knowledge about their
medications.'' Id. at 2395 & 2401. In her view, the notion that a
person should not take a controlled substance that has not been
prescribed to her is simply ``our party line as a physician,'' and that
there is ``almost always * * * no harm because people know * * * what
they are taking.'' Id. at 2400-01.
As I have noted in other cases,\96\ 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.'' National Center on Addiction and Substance
Abuse, Under the Counter: The Diversion and Abuse of Controlled
Prescription Drugs in the U.S. 3 (2005). Moreover, ``[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.
Relatedly, ``[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. at 4.
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\96\ See, e.g., Krishna-Iyer, 74 FR at 464; Southwood
Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007).
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Moreover, according to the Substance Abuse and Mental Health
Services Administration's (SAMHSA) 2007 National Survey on Drug Use and
Health, more than half (56.5%) of ``individuals aged 12 or older who
used prescription opioid pain relievers nonmedically in the past year *
* * acquired these drugs from a friend or relative for free.'' U.S.
Dept. of Justice, National Prescription Drug Threat Assessment 2009 6
(April 2009).\97\ Furthermore, ``data from a 2006 study released in the
June 2008 edition of the American Journal of Public Health indicated
that 22.9 percent of 700 participants in the study `loaned' their
medications to someone else, and 26.9 percent `borrowed' someone else's
prescriptions medication.'' Id. at 15-16. Finally, ``[n]early 22
percent of'' the participants in this study ``reported sharing
prescription pain medications.'' Id. at 16.
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\97\ I also take official notice of the findings of the SAMSHA
Survey.
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Intra-family diversion is thus an important contributor to the
diversion and abuse of controlled substances. It is manifest that
notwithstanding her remedial efforts, Respondent still does not
comprehend the seriousness of this problem. Because Respondent has
utterly failed to demonstrate that she can be entrusted with a new
registration, I am compelled to reject the ALJ's conclusion that
granting her application would be consistent with the public interest.
Respondent's application will therefore be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b) & 0.104, I order that the application of Jeri B.
Hassman, M.D., for a DEA Certificate of Registration as a practitioner
be, and it hereby is, denied. This order is effective March 25, 2010.
Dated: February 2, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-3305 Filed 2-22-10; 8:45 am]
BILLING CODE 4410-09-P