Registrant Actions - 2012
[Federal Register Volume 77, Number 62 (Friday, March 30, 2012)]
[Notices]
[Pages 19322-19338]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7619]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-59]
Daniel B. Brubaker, D.O.; Decision and Order
On April 29, 2011, Administrative Law Judge (ALJ) Timothy D. Wing
issued the attached recommended decision. Neither party filed
exceptions to the decision.
Having reviewed the record as a whole, I have decided to adopt the
ALJ's recommended rulings, findings of fact, and conclusions of law in
their entirety. Accordingly, I also adopt the ALJ's recommended order.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b), I hereby order that the application of Daniel B.
Brubaker, D.O., for a DEA Certificate of Registration as a
practitioner, be, and it hereby is, denied. This order is effective
immediately.
Dated: March 16, 2012.
Michele M. Leonhart,
Administrator.
Frank Mann, Esq., for the Government
Ronald Kaldor, Esq., for the Respondent
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge
I. Introduction
A. The Order To Show Cause
Timothy D. Wing, Administrative Law Judge. This proceeding is an
adjudication pursuant to the Administrative Procedure Act (APA), 5
U.S.C. Sec. 551 et seq., to determine whether the Drug Enforcement
Administration (DEA) should deny a physician's application for a DEA
Certificate of Registration (COR) as a practitioner pursuant to 21
U.S.C. Sec. 823(f). Without this registration Respondent, Daniel B.
Brubaker, D.O. (Respondent), of Fresno, California, will be unable to
lawfully prescribe, dispense or otherwise handle controlled substances
in the course of his practice.
On May 27, 2010, the DEA Deputy Assistant Administrator, Office of
Diversion Control, issued an Order to Show Cause (OSC) to Respondent,
giving Respondent notice of an opportunity to show cause as to why the
DEA should not deny Respondent's application for registration on
grounds that his registration would be inconsistent with the public
interest as that term is used in 21 U.S.C. Sec. 823(f).
In substance, the OSC alleges that Respondent prescribed controlled
substances to patients for no legitimate medical purpose and with
"extreme deviations from the standard of care." The OSC further
alleges that Respondent was arrested for driving under the influence of
controlled substances on June 13, 2008, and that toxicology results
revealed the presence of the controlled substances marijuana,
modafinil, oxazepam and temazepam, for which Respondent lacked a
prescription.
B. Prehearing Proceedings
Because conduct by Respondent's counsel prior to hearing played a
prominent role in the constriction of evidence that Respondent was
permitted to present at hearing, I address the prehearing proceedings
in some detail.
Respondent, through his counsel Ronald Kaldor, Esq., requested a
hearing on June 25, 2010. On July 6, 2010, I issued an Order for
Prehearing Statements directing the Government to file a prehearing
statement by July 13, 2010, and Respondent to file a prehearing
statement by July 20, 2010. The Order for Prehearing Statements
itemized numerous instructions designed to give the parties notice,
inter alia, of the grounds upon which claims and defenses would be
based, the identity and location of witnesses and the contents of their
testimony, and the exhibits each party intended to introduce into
evidence. The overriding purpose of prehearing statements in
registration proceedings pursuant to section 304 of the Controlled
Substances Act (CSA) is to provide parties with an opportunity to
fairly and adequately prepare for hearing. See generally CBS Wholesale
Distribs., Inc., 74 Fed. Reg. 36,746 (DEA 2009).
The Government timely filed its prehearing statement on July 13,
2010. Respondent filed a document entitled "Respondent's Prehearing
Statements" on July 20, 2010. Although filed within the deadline for
exchanging prehearing statements, this filing was deficient in numerous
regards: Respondent failed to identify a single witness, summarize
witness testimony, or describe any documents to be potentially offered
as exhibits. Arguing that Respondent had impliedly withdrawn his
request for a hearing by failing to file a compliant prehearing
statement, the Government moved to terminate proceedings on July 22,
2010. After providing Respondent an opportunity to respond to the
Government's motion, I found that although Respondent's initial
prehearing statement of July 20, 2010, was "substantially deficient
and does not comply with the directions set forth in the Order for
Prehearing Statements or 21 C.F.R. Sec. 1316.57, I do not find at this
time that Respondent's actions constitute a waiver of hearing." (Mem.
to Counsel and Order, July 30, 2010.) I ordered Respondent to file a
compliant supplemental prehearing statement no later than August 3,
2010.
On August 3, 2010, Respondent filed a supplemental prehearing
statement. This document, too, was deficient in numerous respects. For
instance, Respondent vaguely outlined the testimony of his witnesses
instead of "stat[ing] what the testimony will be rather than merely
listing the areas to be covered," as required by the Order for
Prehearing Statements. Respondent also failed to provide addresses for
three witnesses. In addition, although the Order for Prehearing
Statements directed that "[i]f Respondent intends to testify,
Respondent must be identified as a witness, and a summary of the
testimony * * * must be provided," Respondent's August 3, 2010
supplemental prehearing statement did not list Respondent as a witness.
I issued a Prehearing Ruling on August 6, 2010. The Prehearing
Ruling noted that any testimony not summarized in prehearing
statements, and any documents not listed therein, could be excluded at
hearing. The Prehearing Ruling also set a deadline of October 4, 2010,
for the filing of supplemental prehearing statements; set November 8,
2010, as the deadline for filing any anticipated motions and exchanging
documents intended to be offered as exhibits at hearing; and set
November 15, 2010, as the deadline for providing the Administrative Law
Judge (ALJ) with copies of all such documents.\1\
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\1\ On November 15, 2010, the Government timely filed its
exhibits in compliance with the August 6, 2010 Prehearing Ruling.
Prior to hearing, Respondent did not file any exhibits with the ALJ,
and the Government represents, and Respondent does not challenge,
that Respondent did not serve on the Government any of the seven
documents listed in his August 3, 2010, supplemental prehearing
statement.
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On October 28, 2010, the Government filed a Motion of Government to
File Supplemental Prehearing Statement Out of Time, seeking to
eliminate several Government exhibits and add the curriculum vitae (CV)
of the Government's expert witness. The Government represented that
Respondent did not object, and I granted the Government's motion on
October 29, 2010.
On November 12, 2010, a telephonic Supplemental Prehearing
Conference
[[Page 19323]]
was held with Government counsel and Respondent's counsel. At the
Supplemental Prehearing Conference, counsel for Respondent withdrew
Respondent's expert witness, Thomas O'Laughlin, M.D., and indicated
Respondent's desire to obtain a replacement expert. Respondent also
indicated his desire to call Respondent to testify as a witness,
despite the fact that Respondent's prehearing statement and
supplemental prehearing statement did not list Respondent as a
witness.\2\ Counsel for the Government indicated, however, that from
previous conversations with counsel, the Government was on notice of
Respondent's intention to call Respondent as a witness.\3\
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\2\ The July 6, 2010 Order for Prehearing Statements states:
"If Respondent intends to testify, Respondent must be listed as a
witness, and a summary of the testimony * * * must be provided."
\3\ Counsel also suggested that James Hambuechen, previous
Government counsel, requested a subpoena for Respondent's testimony.
The record, however, reveals no such subpoena or request.
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In addition, counsel for Respondent stated that Respondent no
longer intended to call Karen Fu, LMFT, as a witness.\4\ Finally,
counsel for Respondent stated that he intended to provide addresses for
Respondent's witnesses Stephen Duvall, Anita Peralda and "Jerry
MCDonadl" [sic] (Resp't Supp. PHS at 2), and that he intended to
indicate with specificity, albeit belatedly by approximately forty
days,\5\ their proposed testimony.
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\4\ Ms. Fu's name appears as a potential witness in Respondent's
August 3, 2010 "Supplemental Respondent's Prehearing Statements."
\5\ The July 6, 2010 Order for Prehearing Statements set forth a
deadline of July 20, 2010, for the filing of Respondent's prehearing
statement. Per the August 6, 2010 Prehearing Ruling, supplemental
prehearing statements were due on October 4, 2010.
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Counsel for Respondent further indicated his intention to file a
(second) supplemental prehearing statement on Monday, November 15,
2010, embracing the changes and updates to witness information
discussed supra. Counsel for Respondent acknowledged that the August 6,
2010 Prehearing Ruling set the deadline for supplemental prehearing
statements at October 4, 2010, and set the deadline for filing motions
at November 8, 2010. Counsel for Respondent accepted responsibility for
missing these deadlines, but attributed this failure to a lack of
familiarity with the "federal rules."
I issued a Supplemental Prehearing Ruling on November 12, 2010,
summarizing the Supplemental Prehearing Conference and ordering
Respondent to file a proposed second supplemental prehearing statement,
accompanied by a separate motion to accept late filing supported by a
statement of good cause, no later than November 15, 2010.
On Wednesday, November 17, 2010, Respondent filed, two days out of
time, a document entitled "Second Supplemental Respondent's Prehearing
Statement," along with a Motion to Accept Late Filing, also filed two
days out of time. On November 19, 2010, the Government filed its
Opposition to Respondent's Motion to Accept Late Filing, Motion to
Terminate Proceedings or, in the alternative, Motion In Limine.
Pursuant to the August 6, 2010 Prehearing Ruling, Respondent had three
business days after service of the Government's motions to file a
response. Respondent did not respond.\6\
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\6\ Counsel for Respondent had indicated that "I will be out of
my office on vacation . . . from November 22 to November 29 and will
not be able to access any communications." (Resp't Mot. Late
Filing, Nov. 17, 2010, at 2.) Under the circumstances, I declined to
construe this unsworn statement as a motion to extend the three-day
deadline for responding to motions, established by the August 6,
2010 Prehearing Ruling. Even so construed, I found there was no good
cause for extending the filing deadline. First, counsel for
Respondent's duty of diligence requires that he designate alternate
counsel during his anticipated absence. Second, "if one can find
time to take vacation, he can also find time to file a . . .
pleading . . .." Kamir Garces-Mejias, 72 Fed. Reg. 54,931-02,
54,933 (DEA 2007).
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Ruling on Respondent's Motion to Accept Late Filing of his proposed
supplemental prehearing statement on November 30, 2010, I found that
Viewed as a whole, Respondent's failures are serious and present
the specter of real prejudice to the Government. Because
Respondent's motion to accept late filing was itself filed late
without good cause, because the motion was not supported by good
cause, and because the proposed second supplemental prehearing
[statement] is noncompliant with the Order for Prehearing
Statements, I reject the filing of Respondent's second supplemental
prehearing statement.
(Mem. and Order, Nov. 30. 2010, at 9.)
Turning to the Government's Motion to Terminate, I found that
"although the deficiencies in Respondent's counsel's handling of
Respondent's case are indeed serious, they cannot support a finding
that Respondent has actually withdrawn or waived his request for a
hearing." (Id. at 11.)
Addressing the Government's Motion in limine, I found that fairness
and Agency precedent required the constriction of the evidence that
Respondent could permissibly present at hearing, in light of
Respondent's numerous, repeated and prejudicial failures to comply with
the Order for Prehearing Statements and subsequent Orders, as detailed
above and analyzed in my November 30, 2010 ruling. I therefore ordered
that with the exception of Respondent himself, no witness would be
permitted to testify who was not named either by the Government in its
prehearing statement, as duly supplemented on October 28, 2010, or by
Respondent in Respondent's supplemental prehearing statement filed
August 3, 2010; that Respondent would not be permitted to introduce
documentary evidence regarding the prescribing, dispensing or
administering of controlled substances to any of the patients named in
the Government's prehearing statement, as supplemented; that Respondent
would not be permitted to introduce documentary evidence that he
legally consumed, or had legal authority to possess and consume, the
controlled substances found in his system following his arrest on June
13, 2008; and that Respondent would not be permitted to introduce any
documentary evidence of any kind or manner, absent a specific showing
of good cause at hearing. Respondent was not precluded from seeking
admission of documents related to issues such as witness credibility or
rebuttal of evidence.\7\
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\7\ See Mem. Order, Nov. 30, 2010, at 14 n.10. At hearing
Respondent only offered, and subsequently withdrew, Respondent's CV.
I indicated the document would in any case be excluded in accordance
with an earlier ruling. (Tr. 299-300.) Respondent did not provide a
copy of the CV to this tribunal, and consequently no copy is
included in the record.
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On December 3, 2010, Respondent filed Respondent's Motion In
Limine, seeking to prevent the Government's expert witness, Dr. James
L. Gagné, from testifying at the hearing. In support of his
motion, Respondent stated he interpreted my November 30, 2010 ruling on
the Government's motion in limine to "limit the testimony of
Respondent in his defense," arguing that the Government's expert
should not be permitted to testify because otherwise "Respondent will
be precluded from a fair opportunity to defend himself and from
receiving his due process rights . . . ." (Resp't Mot. in Limine, Dec.
3, 2010, at 1.) Inasmuch as Respondent filed his motion two business
days before the hearing, Respondent's motion was resolved on the record
at the beginning of the hearing. After giving each party an opportunity
to be heard, I denied Respondent's motion as meritless.\8\ (Transcript
(Tr.) 21.)
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\8\ Respondent's testimony at hearing spans approximately 181
transcript pages. (See Tr. 300-481.)
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Following prehearing procedures, a hearing was held in Fresno,
California, between December 7, 2010, and December 8, 2010, with the
Government represented by counsel and Respondent
[[Page 19324]]
represented by counsel. Both parties called witnesses to testify and
both had the opportunity to introduce documentary evidence, although
the evidence Respondent was ultimately permitted to introduce was
limited by my November 30, 2010 ruling as noted above. After the
hearing, both parties filed proposed findings of fact, conclusions of
law, and argument.\9\ All of the evidence and post-hearing submissions
have been considered, and to the extent the parties' proposed findings
of fact have been adopted, they are substantively incorporated into
those set forth below.
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\9\ In a December 27, 2010 letter to counsel, the Office of
Administrative Law Judges advised that briefs would be due by 4 p.m.
Eastern Daylight Time on January 25, 2011. The Government timely
filed its brief. Respondent filed his brief on January 26, 2011, and
on January 27, 2011, filed a motion to accept the late filing. In
the absence of an objection from the Government, and inasmuch as it
appeared no prejudice would result, I granted Respondent's motion.
(See Ruling on Resp't Mot. to Accept Late Filing, Apr. 28, 2011.)
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II. Issue
Whether the record establishes by substantial evidence that
Respondent's application for a DEA COR, assigned control number
W09177610C, should be denied because Respondent's registration would be
inconsistent with the public interest as that term is used in 21 U.S.C.
Sec. 823(f).
III. Evidence and Incorporated Findings of Fact \10\
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\10\ In addition to the evidence discussed in this Section,
additional evidence and findings of fact are discussed in later
Sections of this Recommended Decision.
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I find, by a preponderance of the evidence, the following facts:
A. Stipulated Facts
Respondent applied for a DEA registration as a practitioner in
Schedules II through V on or around August 26, 2009. (ALJ Ex. 4.)
Respondent surrendered his previous DEA registration on August 21,
2008. (Id.)
B. The Government's Evidence
DEA Diversion Investigator Jack L. Lewis (DI Lewis) has been a DEA
Diversion Investigator for five years. (Tr. 271.) DI Lewis received
training as a diversion investigator at a DEA training facility in
Quantico, Virginia. (Tr. 272.)
Dr. James Laurent Gagné (Dr. Gagné) is a physician.
(Tr. 27.) He resides in Valley Village, California and received a
bachelor's degree from Columbia University and a medical degree from
Albert Einstein College of Medicine of Yeshiva University in Bronx, New
York. (Gov't Ex. 4.) He is board certified in internal medicine,
addiction medicine and pain medicine and presently sees several hundred
patients. (Tr. 28.) Approximately one third of them are pain management
patients. (Tr. 197.) He estimates that he prescribes opiates to
approximately half of his pain patients. (Tr. 203.)
Among other certifications, Dr. Gagné holds Diplomates from
the National Board of Medical Examiners and the American Board of
Internal Medicine. (Gov't Ex. 4; see Tr. 29.) He is certified in
addiction medicine by the American Society of Addiction Medicine, and
holds a Diplomate from the American Board of Pain Medicine. (Gov't Ex.
4; see Tr. 31.) Dr. Gagné is a member of nineteen professional
associations, including the International Association for the Study of
Pain, the American Pain Society, the Western Pain Society, the American
Association for Pain Medicine, the American Society for Addiction
Medication and the California Society for Addiction Medicine. (Gov't
Ex. 4.)
Dr. Gagné completed an internship and his first medical
residency at Lincoln Hospital, Albert Einstein College of Medicine
between 1973 and 1975. (Gov't Ex. 4; Tr. 32.) He completed a second
residency at Kaiser-Permanente Medical Center in Santa Clara,
California in 1976. (Gov't Ex. 4.) Between 1976 and the present, Dr.
Gagné has served in a variety of positions ranging from Clinical
Medical Director, UCLA Pain Control Unit in Los Angeles, to Chairman of
the Department of Medicine at the Verdugo Hills Hospital in Glendale,
California. (Gov't Ex. 4; see Tr. 32-34.)
Presently, Dr. Gagné is an associate physician at a
Glendale, California primary care internal medicine group and a
consulting physician at a Malibu, California recovery home. (Gov't Ex.
4.) He previously taught as an Assistant Professor of Family Medicine
at USC Keck School of Medicine from 2000 to 2008. (Gov't Ex. 4; Tr.
30.) Dr. Gagné has also given numerous lectures, authored
various publications and participated in continuing medical education
programs. (Gov't Ex. 4; Tr. 35-36.) He has served as an expert reviewer
for the California Medical Board and has served as an expert witness on
two cases for the United States Department of Justice. (Tr. 36-39.)
Dr. Gagné was qualified and I have accepted him as an expert
witness, without objection, in the profession of internal medicine,
addiction medicine and pain management medicine in the State of
California. (Tr. 39-40; Gov't Ex. 4.)
DEA Investigation of Respondent's Prescribing Practices
Dr. Gagné testified to being familiar with California and
federal law regarding the prescribing of controlled substances. (Tr.
40.) To issue a prescription for controlled substances within the usual
course of a physician's professional practice, there must be a genuine
and valid physician-patient relationship. (Tr. 40-41.) The physician
must keep a medical record, determine the patient's history and
symptoms, conduct a physical examination and document laboratory
findings. (Tr. 41.) When prescribing drugs with side-effects, the
physician must make a risk-benefit assessment. (Tr. 41.) Standards can
differ depending on whether a patient is seeking treatment on an
emergency basis, but Dr. Gagné testified that none of the nine
patients of Respondent whose files Dr. Gagné reviewed sought
treatment on an emergency basis. (Tr. 41-42.)
Dr. Gagné defined "chronic pain" as a painful condition
lasting more than three months after the acute illness giving rise to
the pain has been resolved. (Tr. 42, 209.) In determining whether a
patient is truly suffering from chronic pain, a physician must trust
the patient but also must compare objective evidence with a patient's
subjective complaints because some patients exaggerate symptoms. (Tr.
43.) A physician must listen both to what the patient says and to what
the patient does not say, to "learn[] some of the implications and
context and things that people are not saying but are kind of present
in the room." (Tr. 207.) In treating a pain patient, a physician must
obtain several aspects of a patient's history, to include the patient's
present illness, past medical history, social history, psychiatric
history, family history, review of symptoms and addiction history.\11\
(Tr. 43-44.) In obtaining this information,\12\ Dr. Gagné called
the following components essential: How the pain began, the course of
the illness, the course of treatment and diagnostic procedures and the
patient's current symptoms, including neurological symptoms. (Tr. 45-
46.) When prescribing controlled
[[Page 19325]]
substances, it is critical to obtain a list of the patient's prior
medications. (Tr. 47.) Among other reasons, a patient's history of
medication gives a physician a "sense of the appropriateness of the
patient's use of the controlled substances and whether they're likely
to be a problem." (Tr. 48.)
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\11\ In the case of a patient using marijuana or other illicit
drugs, Dr. Gagné "would take 100 percent full-fledged
addiction history." (Tr. 56-57.)
\12\ As for the amount of time it takes to gather this
information from the patient, Dr. Gagné testified that "I am
very much of an outlier, so I take longer than most of my
colleagues. And it takes me one or two hours [which is] not the
standard of practice, that's how I do it." (Tr. 206.) Moreover, it
is not necessarily required or advisable to obtain all this patient
information at once or in a single visit. (Tr. 206.)
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It is also important to collaborate with a patient's previous
physicians to verify that a patient has truthfully represented the
amount of medication she has taken in the past. (Tr. 48.) The
importance of obtaining a patient's prior medical records, and ordering
X-rays or MRIs, varies with the patient based on the complexity of the
illness and the previous course of treatment. (Tr. 48-49, 54.) The
importance of obtaining such documentation increases when prescribing
controlled substances because among therapies, controlled substances
are unique in that some patients "will engage in substantial
misdirection, lying, and manipulation to obtain them." (See Tr. 51.)
Conducting a physical examination is also critical prior to
prescribing controlled substances. (Tr. 52.) In addition to at least
one comprehensive "head to toe" exam, a physician should conduct a
"relatively-detailed orthopedic-style examination or rheumatologic-
style evaluation." (Tr. 52.) In a patient with lower back pain, for
instance, such an examination might include watching the patient walk
and observing range of motion, checking for tenderness or deformity of
the spine, checking the neurologic function for weakness or lack of
sensation and checking muscles and joints for spasm or tenderness. (Tr.
52.) Prescribing controlled substances without an office visit by the
patient is something
that mostly you don't do, but there are circumstances in which you
have a long-term patient who's stable, where the drug doses aren't
changing, and there's absolutely no problem at all, and you know
very well that they're doing well, and they're not going to come in
and telling you they're crashing or they need more or this or that.
(Tr. 222.)
The upshot, Dr. Gagné explained, is that before prescribing
controlled substances, "there has to be enough information in the
record to be meaningful, it has to add up to something. Or if you
don't, you refer somebody out for * * * evaluation and then you base
your treatment on a specialist's evaluation." (Tr. 213.)
Documenting the various steps described above in a patient's
medical record is important. Although it is not practical to document
every word spoken or action taken at a patient consultation, the
medical community nevertheless presumes that "if it's not in the
medical records, it's assumed not to have happened." \13\ (Tr. 54.)
Dr. Gagné elaborated that the burden of proof is on the
physician: "[T]he standard is that a competent physician can pick up
the medical record and understand without too much trouble what
happened." (Tr. 214.) Physicians who treat a patient based on an
analysis not documented in the patient's medical chart are "subjecting
themselves to high risk of problems down the road." (Tr. 216.)
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\13\ For instance, a doctor should have a serious discussion
with a chronic pain patient about the possibility of physical
therapy, and document the conversation in the record. (Tr. 59.)
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Dr. Gagné also clarified that there is a difference between
a diagnosis and a symptom. Low back pain, for instance, is not a
diagnosis of an illness but is instead a symptom that can be due to at
least a dozen causes. (Tr. 56.) When patients seek controlled
substances, it is important to perform an independent diagnosis
regarding any possible addiction. (Tr. 56.)
Dr. Gagné recognizes the validity of opiates in the
treatment of chronic pain and relies on opiates to treat some of his
patients. (Tr. 57-58.) But even when a patient is in pain and the pain
is confirmed by a doctor, it is not necessarily appropriate to
prescribe opiates in all instances; other treatments may be more
effective.\14\ (Tr. 57-58.) When prescribing controlled substances, the
physician should give the lowest dose consistent with a beneficial
clinical outcome and periodically review the treatment's efficacy. (Tr.
59-60.) Although there is a legitimate "role for dose finding," it is
inappropriate to blindly increase a dosage when a given dosage isn't
working. (Tr. 60.) Increasing a dosage on the sole grounds that a
patient requests an increase is inappropriate without an assessment of
the patient's symptoms, function, sleep, mood and other factors. (Tr.
61.)
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\14\ Dr. Gagné also cautioned that "there is not one
single medical or scientific study that shows that opiates are safe
or effective in the treatment of chronic pain." (Tr. 57.)
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As signals indicating the potential addiction to or diversion of
controlled substances, Dr. Gagné identified a number of "red
flags." When a red flag occurs, "one needs to sort out what's going
on before continuing to prescribe the medications * * * there are kinds
of red flags where you simply have to stop, you can't continue to
prescribe controlled drugs." (Tr. 64-65.) Red flags include a patient
asking for larger doses; a claim that "my dog ate my prescription,"
that the patient dumped the prescription down the toilet, that the
prescription was stolen or other "dramatic stories of how my drugs
suddenly disappeared and I need more"; a patient requesting an advance
supply due to anticipated travel when the patient later tries to refill
the prescription before the extra dosage should have been consumed;
evidence that the patient has obtained controlled substances from more
than one physician or is using more than one or two pharmacies;
increasingly bizarre statements about the need for opiates; and missing
appointments frequently. (Tr. 62-64.) Moreover, a patient who
exaggerates the type of medication she has previously taken under the
care of a prior doctor poses the sort of red flag that requires a
physician to "stop prescribing controlled substances until you sort
out what's going on." (Tr. 63.) A patient who uses illicit drugs is a
"huge red flag" and "it would be very inappropriate to prescribe
controlled prescription medications to such a patient absent other
extremes." (Tr. 63.) A patient's reluctance to provide medical records
or claims of frequent injuries are also red flags. (Tr. 64.)
As "yellow flags" that could signal addiction or diversion, Dr.
Gagné identified instances of patients requesting brand-name
drugs instead of settling for generic alternatives; patients who pay by
cash; patients who use marijuana for medicinal purposes \15\ (Tr. 62-
64); and a prescribing physician writing "DAW" or "dispense as
written" on a prescription.\16\ (Tr. 93.)
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\15\ Dr. Gagné elaborated that in California, where
marijuana may legally be prescribed for medical purposes, a doctor
must first establish a medical diagnosis and also conduct an
addiction history, given the drug's high addiction potential. (Tr.
77-78.)
\16\ This practice can indicate a potential for diversion, as
follows. (Tr. 94.) With respect to OxyContin and Vicodin ES, for
example, there is no difference therapeutically between the brand
name and the generic version. (Tr. 94.) Although some patients
believe the brand name is more effective, requesting a brand name
"can be a way of showing customers who are buying the drugs
secondarily that this is the real thing, because generics are pretty
nondescript tablets, and you don't know what you're getting." (Tr.
94.)
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Dr. Gagné also identified various controlled substances.\17\
Oxycodone is a powerful opiate with a high abuse potential. (Tr. 49.)
Oxydose and Oxyfast are varieties of oxycodone.\18\ (Tr. 49, 113.)
Hydrocodone is another powerful opiate with a lower strength but high
abuse potential. (Tr. 49.) Norco is a brand name of hydrocodone mixed
with Tylenol or acetaminophen. (Tr. 49.)
[[Page 19326]]
Kadian is a time-release form of morphine and Actiq is a brand name of
fentanyl. (Tr. 49.) Xanax is a highly-addicting and frequently abused
opiate. (Tr. 39, 78.) Valium is diazepam, a benzodiazepine and sedative
with moderate addiction potential. (Tr. 50.) Dilaudid is "the most
powerful opiate that I'm aware of with an incredibly high addiction
potential." (Tr. 50.) Phenergan is a powerful sedative with anti-
nausea properties, and codeine is an opiate with moderate abuse
potential. (Tr. 50.)
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\17\ See generally 21 U.S.C. Sec. 812 (establishing five
schedules of controlled substances); 21 C.F.R. Sec. 1308.11-15 (2010) (listing the controlled substances in Schedules I--V).
\18\ Dr. Gagné's also testified that OxyContin is a brand
of oxycodone, an opiate and a controlled substance. (Tr. 39, 114,
126.)
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Based upon a review of nine of Respondent's patient files offered
at hearing,\19\ Dr. Gagné opined that "there were some patients
where there was nothing that really approached what I consider anything
like medical care, and others where it was more like medical care."
(Tr. 215-16.) As detailed in a later Section of this Recommended
Decision, Dr. Gagné opined that Respondent's prescribing of
controlled substances to his patients was characterized by
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\19\ The record reflects some variance on the number of files
reviewed. The OSC indicated that Dr. Gagné reviewed ten of
Respondent's files. (ALJ Ex. 1.) Dr. Gagné's written report
states that "eight" patient files were reviewed, but substantively
addresses nine patients. (Gov't Ex. 3 at 1.) Testimony at hearing
also indicated there was "yet another file that Dr. Gagné
reviewed" (Tr. 288) but that was not included in this particular
case, reflecting a total of ten files reviewed by Dr. Gagné.
---------------------------------------------------------------------------
grossly inadequate medical records and virtually a complete absence
of clinical information. No meaningful history, no meaningful
physical examination, no past medical history, no family history, no
review of systems, et cetera, nothing. No physical exam worthy of
the name * * *. there were structures in the chart that had those
titles, but the data was absent. Another reason is patients who it
became clear were grossly misusing their medications or getting them
from multiple sources. At that point there can no longer be a
legitimate medical purpose of continuing controlled drugs. Or when a
patient is being admitted [or referred] to rehabilitation facility
for drugs * * * you don't keep just prescribing the same old
controlled drugs you always were.
(Tr. 223-24.)
C. Respondent's Evidence
Daniel B. Brubaker, D.O. (Respondent) is an osteopathic physician.
(E.g., Tr. 204.) Respondent was previously registered with DEA as a
practitioner and surrendered his registration on August 21, 2008. (ALJ
Ex. 4.) Respondent subsequently applied for a new COR following the
execution of a search warrant at his office. (E.g., Tr. at 273-74.) The
number associated with Respondent's application is W09177610C. (Gov't
Ex. 1.)
Respondent attended Elizabethtown College in Pennsylvania and
graduated from Philadelphia College of Osteopathic Medicine in 1974.
(Tr. 300.) He undertook clinical and pathological training and
completed a residency at the University of Pittsburgh. (Tr. 300.)
Respondent is board certified in anatomic pathology, clinical pathology
and immunohematology and holds certifications for various procedures.
(Tr. 301.) He possesses seventeen years of experience in transfusion
and transplantation medicine, has served as medical director of three
different blood centers and has completed continuing medical education
units since beginning his medical career. (See Tr. 301-02.) Respondent
has also taught medical students, residents and interns at the
University of Oklahoma and UCLA and has published in twenty-five peer-
reviewed journals, including articles on innovative approaches to
making blood transfusions safer. (Tr. 301-02, 310.)
Respondent also testified to his medical history. He developed
cancer of the colon in late November 2000, which was resolved by
chemotherapy and surgery in 2004. (Tr. 307.) Because the cancer had
metastasized to his liver, Respondent underwent surgery to remove the
right lobe of his liver in February 2002. (Tr. 307.) In 2004,
Respondent underwent surgery for sleep apnea. (Tr. 311.) In 2005,
Respondent underwent an invasive inpatient operation to perform three
ablations to address atrial fibrillation. (Tr. 312.)
Respondent further testified to marital and family issues, and his
own related mental health issues. In 2004, Respondent was divorced.
(Tr. 313.) In 2006, Respondent and his ex-wife disputed the custody of
their son. (Tr. 313-14.) At that time, Respondent was experiencing
depression. (Tr. 314.) As a result of the custody dispute, Respondent
was permitted to see his son for three hours. (Tr. 314.) Thereafter,
Respondent was not permitted to see his son. (See Tr. 314.)
Turning to Respondent's medical practice, Respondent testified that
in or around 1997, Respondent went into private practice as an
internist. (Tr. 304-05.) For approximately ten years he performed
workers' compensation assessments. (Tr. 305.) During this time
Respondent worked under a grant from the National Institutes of Health
to develop an in vitro bleeding time test. (Tr. 306.)
From 2000 to the present, Respondent has taken pain management
courses with the American Academy of Pain Management. (Tr. 308.) In
2004 or 2005, Respondent purchased a medical practice in Fresno,
California and began treating pain management patients at a time when
approximately five or six area physicians practiced pain management.
(Tr. 307, 315; 310.) The practice slowly evolved to the point where
most of his patients were pain management patients. (Tr. 309.)
Respondent testified to experiencing managerial difficulties and theft
during the early years of this practice. (Tr. 316-20.)
Paul J. Markowitz (Dr. Markowitz), a board-certified psychiatrist,
testified on behalf of Respondent. (Tr. 258.) Dr. Markowitz received a
bachelor's degree and subsequently completed the M.D.-Ph.D. program at
Case Western Reserve University in Cleveland, Ohio. (Tr. 256.)
Following an internship at the University Hospitals of Cleveland, Dr.
Markowitz completed a post-doctoral fellowship in
neuropsychopharmacology at Oxford through the National Science
Foundation. (Tr. 257.) Following two years working at the Cleveland
Clinic and a residency at the University Hospitals of Cleveland, Dr.
Markowitz worked as a professor. (Tr. 257.) In approximately 2000 Dr.
Markowitz moved to California, where he has practiced for the past ten
years. (Tr. 257.) His practice consists of a sixty-hour week, with
twenty or twenty-five hours devoted to seeing patients and the balance
of his time spent on research trials. (Tr. 258.) Respondent became a
patient of Dr. Markowitz in 2005. (Tr. 259.)
David Smiley Purvis (Mr. Purvis), who testified on behalf of
Respondent, is a licensed clinical social worker. (Tr. 292.) He holds a
bachelor's degree from Fresno State University and in 1985 received a
master's degree in social work. (Tr. 292.) Mr. Purvis testified to
having counseled Respondent on a weekly basis on anger and frustration
management since approximately May 2008. (Tr. 292, 294.) He explained
that Respondent's divorce and lack of contact with his son, for whom
Respondent cares deeply, were a very difficult and emotional experience
for Respondent. (Tr. 293.) Mr. Purvis also testified to having visited
Respondent's practice location to observe how Respondent treated pain
management patients, based on Mr. Purvis's own professional and
personal\20\ interest in how doctors treat pain management. (Tr. 294-
95.) Respondent expressed interest in how his own therapy with Mr.
Purvis
[[Page 19327]]
could help Respondent's patients. (Tr. 297.)
---------------------------------------------------------------------------
\20\ Mr. Purvis explained that his wife was on "very, very
serious medications" to treat pain arising out of a 2005 airplane
crash. (Tr. 295, 297.)
---------------------------------------------------------------------------
IV. The Parties' Contentions
A. The Government
The Government urges that Respondent's registration would be
inconsistent with the public interest and states as follows. (Tr. 8.)
First, Respondent repeatedly issued large quantities of highly-
addictive controlled substances to patients without a legitimate
medical purpose and outside the usual course of professional practice.
(Tr. 8-9.) Some of these patients were suspected drug abusers, addicts
and dealers, and yet Respondent continued to supply them with
narcotics. (Tr. 9.) Second, Respondent has misused controlled
substances, having been arrested while driving under the influence of
controlled substances, and having tested positive for several
controlled substances, including marijuana. (Tr. 8.)
The Government argues in its post hearing brief that "factors two,
four and five are relevant in determining whether Respondent's
application * * * should be denied." (Gov't Br. at 25.) The Government
argues in substance that Respondent has been responsible for the
diversion of large quantities of controlled substances by prescribing
"controlled substances to patients without a legitimate medical
purpose and/or outside the course of professional practice." (Id.) The
Government further argues that Respondent "arguably violated Federal
and state law prohibiting the unauthorized use of marijuana and
prescription drugs." (Id. at 28 (citing 21 U.S.C. Sec. 844).) The
Government argues that "Respondent's complete failure to admit fault
or accept responsibility weighs heavily in the public interest
determination." (Id. at 28.) Finally, the Government argues that
Respondent has provided no facts demonstrating mitigating circumstances
and due to Respondent's lack of credibility, his testimony should be
given no weight. (Id. 29-31.)
B. Respondent
Respondent argues that he is a competent, capable, able physician
who is nothing like the image that the Government has portrayed. (Tr.
11.) Respondent denies having prescribed large amounts of controlled
substances without a legitimate medical purpose. (Tr. 12.) Moreover,
Respondent contends that the Government's expert witness, Dr.
Gagné, has a different approach to pain management than does
Respondent. (Tr. 12.)
Respondent also argues that evidence of medical and domestic issues
affecting Respondent during the time period in question should inform
an interpretation of Respondent's conduct. (Tr. 12.) In his post
hearing brief, Respondent further argues that the voluntary surrender
of his registration on August 21, 2008, is not a ground to support
denial. (Resp't Br. at 8.) Similarly, Respondent argues that the "sole
conviction for a 'wet and reckless' misdemeanor," in light of
Respondent's medical and personal history, does not support a denial of
his application for registration. (Id. at 8-9.)
Respondent argues that Factors One and Three are inapplicable.
Respondent maintains the major issue is his clinical treatment of nine
patients, and notes there "were specific mistakes which Respondent
made in treating those patients." (Id. at 9.) Respondent argues in
substance that there is "little conclusive evidence" of Respondent
acting with disregard to the health of his patients or public, and that
the record contains substantial evidence that Respondent "was
improving his pain and medical practice protocols." (Id.) Respondent
"acknowledges that his record-keeping can improve" but argues that he
"had significant difficulties with office staff, burglaries and has
taken a remedial records course." (Id.)
V. Discussion
A. The Applicable Statutory and Regulatory Provisions
The CSA provides that any person who dispenses (including
prescribing) a controlled substance must obtain a registration issued
by the DEA in accordance with applicable rules and regulations.\21\ "A
prescription for a controlled substance to be effective must be issued
for a legitimate medical purpose by an individual practitioner acting
in the usual course of his professional practice. The responsibility
for the proper prescribing and dispensing of controlled substances is
upon the prescribing practitioner" with a corresponding responsibility
on the pharmacist who fills the prescription.\22\ It is unlawful for
any person to possess a controlled substance unless that substance was
obtained pursuant to a valid prescription from a practitioner acting in
the course of his professional practice.\23\ In addition, I conclude
that the reference in 21 U.S.C. Sec. 823(f)(5) to "other conduct
which may threaten the public health and safety" would as a matter of
statutory interpretation logically encompass the factors listed in
Sec. 824(a).\24\
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\21\ 21 U.S.C. Sec. 822(a)(2); 21 U.S.C. Sec. 802(10).
\22\ 21 C.F.R. Sec. 1306.04(a).
\23\ 21 U.S.C. Sec. 844(a).
\24\ See Kuen H. Chen, M.D., 58 Fed. Reg. 65,401, 65,402 (DEA
1993).
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B. The Public Interest Standard
Pursuant to 21 U.S.C. Sec. 823(f), the Deputy Administrator may
deny an application for a DEA COR if she determines that such
registration would be inconsistent with the public interest. In
determining the public interest, the Deputy Administrator is required
to consider the following factors:
(1) The recommendation of the appropriate state licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing or conducting research
with respect to controlled substances.
(3) The applicant's conviction record under federal or state laws
relating to the manufacture, distribution or dispensing of controlled
substances.
(4) Compliance with applicable state, federal or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
As a threshold matter, the factors specified in Section 823(f) are
to be considered in the disjunctive: the Deputy Administrator may
properly rely on any one or a combination of those factors, and give
each factor the weight she deems appropriate, in determining whether a
registration should be revoked or an application for registration
denied. See David H. Gillis, M.D., 58 Fed. Reg. 37,507, 37,508 (DEA
1993); see also D & S Sales, 71 Fed. Reg. 37,607, 37,610 (DEA 2006);
Joy's Ideas, 70 Fed. Reg. 33,195, 33,197 (DEA 2005); Henry J. Schwarz,
Jr., M.D., 54 Fed. Reg. 16,422, 16,424 (DEA 1989). Application of the
public interest factors requires an individualized determination and
assessment of prescribing and record-keeping practices that are
"tethered securely to state law . . . and federal regulations."
Volkman v. DEA, 567 F.3d 215, 223 (6th Cir. 2009). Additionally, in an
action to deny a registrant's COR, the DEA has the burden of proving
that the requirements for revocation are satisfied.\25\ The burden of
proof shifts to the respondent once the Government has made its prima
facie case.\26\
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\25\ See 21 C.F.R. Sec. 1301.44(e) (2010).
\26\ See Medicine Shoppe--Jonesborough, 73 Fed. Reg. 364, 380
(DEA 2008); see also Thomas E. Johnston, 45 Fed. Reg. 72,311, 72,311
(DEA 1980).
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[[Page 19328]]
C. The Factors To Be Considered
Factors 1 and 3: The Recommendation of the Appropriate State Licensing
Board or Professional Disciplinary Authority and Conviction Record
Under Federal or State Laws Relating to the Manufacture, Distribution
or Dispensing of Controlled Substances
In this case, regarding Factor One, it is undisputed that
Respondent currently holds a valid unrestricted osteopathic medical
license in California, but Respondent's license has been the subject of
a "review [by] the California Medical Board with regard to the
appropriateness of [Respondent's] care" (Tr. 71), the results of which
are unknown.\27\ While not dispositive, Respondent's possession of a
valid unrestricted osteopathic medical license in California does weigh
in favor of a finding that Respondent's registration would not be
inconsistent with the public interest. See Robert A. Leslie, M.D., 68
Fed. Reg. 15,227, 15,230 (DEA 2003) (state license is a necessary, but
not a sufficient condition for registration, and therefore, this factor
is not dispositive).
---------------------------------------------------------------------------
\27\ No further evidence or testimony was offered with regard to
the status or outcome of the state review.
---------------------------------------------------------------------------
Regarding Factor Three, there is no evidence that Respondent has
ever been convicted under any federal or state law relating to the
manufacture, distribution or dispensing of controlled substances. I
therefore find that this factor, although not dispositive, see Leslie,
68 Fed. Reg. at 15,230, weighs against a finding that Respondent's
registration would be inconsistent with the public interest.
Factors 2 and 4: Respondent's Experience in Handling Controlled
Substances; and Compliance With Applicable State, Federal or Local Laws
Relating to Controlled Substances
In this case, there is indeed evidence that Respondent has failed
to remain in compliance with applicable federal and state law relating
to controlled substances, and that his past experience in dispensing
controlled substances with regard to nine patients was inconsistent
with the public interest. The evidence at hearing centered in
substantial part on nine patient files previously seized from
Respondent's office on August 21, 2008.\28\ (ALJ Ex. 1; Tr. 336-38.) In
addition to the patient files, the Government presented the testimony
and written report of a medical expert witness, Dr. Gagné, with
regard to his review of the nine patient files along with his opinion
as to whether Respondent issued prescriptions in each instance for a
legitimate medical purpose and in the usual course of professional
practice. The patient files related to office visits with Respondent
occurring at various dates between 2006 and 2008.\29\ Respondent
testified as to his standard of care and treatment for each of the nine
patients, along with his past experience, among other testimony.
---------------------------------------------------------------------------
\28\ Testimony at hearing revealed that the process for
selecting nine of Respondent's patient files began with the seizure
of approximately seventy patient files pursuant to a search warrant,
all of which were "individuals that were known to have been either
drug dealers or drug abusers and their associates." (Tr. 287.) A
California Medical Board Investigator then selected the files to be
reviewed by Dr. Gagné based on the "file structure" and the
fact that the "files appeared to be incomplete." (Tr. 287.)
\29\ As discussed below, however, not every prescription for
controlled substance that Respondent issued is associated with an
office visit.
---------------------------------------------------------------------------
Evaluation of Respondent's prescribing conduct in this case is
governed by applicable federal and state law. The applicable standard
under federal law is whether a prescription for a controlled substance
is "issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional practice."
21 C.F.R. Sec. 1306.04(a). The standard of care refers to that
generally recognized and accepted in the medical community rather than
a standard unique to the practitioner. Robert L. Dougherty, M.D., 76
Fed. Reg. 16,823, 16,832 (DEA 2011) (citing Brown v. Colm, 11 Cal.3d
639, 642-43 (1974)). Although it is recognized that state law is a
relevant factor in determining whether a practitioner is acting in the
"usual course of professional practice," it is also appropriate in
the context of an inquiry under federal law to also consider
"generally recognized and accepted medical practices" in the United
States. Bienvenido Tan, M.D., 76 Fed. Reg. 17,673, 17,681 (DEA 2011).
The applicable standards under California law may be found in
various provisions of the California Business and Professional Code as
well as the California Health and Safety Code. Mirroring federal law in
substantial part, California law provides that:
[a] prescription for a controlled substance shall only be issued for
a legitimate medical purpose by an individual practitioner acting in
the usual course of his or her professional practice. The
responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner, but a
corresponding responsibility rests with the pharmacist who fills the
prescription.
Cal. Health & Safety Code Sec. 11153(a). Except as authorized by Cal.
Bus. & Prof. Code Sec. 2241,\30\ "no person shall prescribe for, or
administer, or dispense a controlled substance to, an addict, or to any
person representing himself or herself as such. * * *" Cal. Health &
Safety code Sec. 11156(a).
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\30\ Sec. 2241 authorizes a practitioner to "prescribe,
dispense, or administer" controlled substances to an addict "for a
purpose other than maintenance on, or detoxification from"
controlled substances. Moreover, "a person whose drug-seeking
behavior is primarily due to the inadequate control of pain is not
an addict. * * *" Cal. Health & Safety Code Sec. 11156(b)(2).
---------------------------------------------------------------------------
Additionally, state law "governing licentiates of the Osteopathic
Medical Board of California is found in the Osteopathic Act and in
Chapter 5 of Division 2, relating to medicine." Cal. Bus. & Prof. Code
Sec. 3600. Relevant provisions of Chapter 5 include: "Prescribing,
dispensing, or furnishing dangerous drugs\31\ * * * without an
appropriate prior examination and a medical indication, constitutes
unprofessional conduct." Id. Sec. 2242(a). "A physician * * * may
prescribe * * * prescription drugs * * * to an addict for purposes of
maintenance [or] detoxification. * * *" only as set forth pursuant to
specified provisions of law limiting continuing treatment to programs
licensed by California. Id. Sec. 2441(b); Cal. Health & Safety Code
Sec. 11217. This requirement does not apply "during emergency
treatment, or where the patient's addiction is complicated by the
presence of incurable disease, serious accident, or injury, or the
infirmities of old age." Cal. Health & Safety Code Sec. 11217(h).
---------------------------------------------------------------------------
\31\ "Dangerous drugs" are broadly defined to include any
"drug * * * that by federal or state law can be lawfully dispensed
only on prescription. * * *" Cal. Bus. & Prof. Code Sec. 4022.
---------------------------------------------------------------------------
Turning to the evidence in the instant case, the testimony and
written report of the Government's medical expert, Dr. Gagné,
centered on a file review for patients [D.A.], [L.G.], [R.G.H.],
[A.L.], [L.M.], [K.P.], [D.S.], [A.W.] and [T.W.].\32\ With regard to
patient [D.A.], Dr. Gagné noted in his report that the medical
file consisting of five pages arguably "establishes the minimal
documentation necessary to treat a medical problem," but also noted
the "record omits the detail necessary to form a medical diagnosis,
and there is no basis for the diagnosis stated." (Gov't Ex. 3 at 2.)
Dr. Gagné further noted that the "standard of practice for
patient records is to document all important aspects of the patient
encounter, including: History, current medications, physical
examination, tests, assessment, and plan." (Id.) Based on a review of
[D.A.]'s medical record, Dr. Gagné found
[[Page 19329]]
the "record contains many of these elements in skeletal form," and
further noted as a "glaring omission" with regard to Respondent's
authorization of medicinal cannabis "the absence of a psychiatric or
addiction history or any notation as to the patient's response to
cannabis to date." (Id. at 3.) Dr. Gagné also noted the
prescription for a large quantity of OxyContin to be "an extreme
deviation from the standard of practice, as is the absence of an
adequate evaluation to support such a prescription on a medical
basis." (Gov't Ex. 3 at 2-3; Gov't Ex. 8 at 5.)
---------------------------------------------------------------------------
\32\ To protect patient privacy, patient initials are used in
this Recommended Decision.
---------------------------------------------------------------------------
Consistent with his written report, Dr. Gagné testified at
hearing that in his opinion Respondent prescribed controlled substances
to patient [D.A.] without a legitimate medical purpose and outside of
the usual course of professional practice because there was an
inadequate medical evaluation. (Tr. 79-80.) Dr. Gagné explained
that it is outside of the usual course of professional practice to
prescribe OxyContin without an appointment and without a treatment plan
or some basis for issuing the prescription, which were lacking here.
(Tr. 74-75.) Respondent's prescription for 180 OxyContin 40 mg was
dated January 7, 2007, but the patient file contains no record of an
office visit on that day, which occurred approximately four weeks after
the previous appointment. (Tr. 74; Gov't Ex. 3 at 2.) Dr. Gagné
indicated that "[t]here may be a medical purpose for prescribing
OxyContin (chronic pain), but the record is completely inadequate as to
why this is needed rather than a less dangerous alternative." (Gov't
Ex. 3 at 2.) Dr. Gagné further opined that there is no
documented basis, such as an MRI or CT scan report, to support
Respondent's diagnosis of annular tears in lumbar disks; without a
basis for diagnosis there can be no basis for treatment. (Tr. 72-73.)
On cross-examination, Dr. Gagné elaborated on the level of
detail required for a medical history and physical examination, noting
that "best practice is different from the standard practice, and it's
different from the minimal standard one must meet in order to prescribe
any treatment appropriately." (Tr. 212.)
Respondent testified in substance that he initially saw patient
[D.A.] on the evening of December 6, 2006, for a cannabis
recommendation, and on January 3, 2007, for a pain management visit.
(Tr. 345, 351.) Respondent indicated his practice was to see four or
five cannabis recommendation patients two evenings per week, and if the
patient requested to establish treatment with Respondent on an ongoing
basis, the patient would be required to make another appointment during
the day. (Tr. 345.) Respondent explained that he was able to determine
that patient [D.A.] had "annular tears" by experience rather than
with imaging such as an MRI. (Tr. 346-47.) In sharp contrast, Dr.
Gagné testified that an "annular tear is a finding that one
would obtain on imaging, probably an MRI or a CT scan, and no imaging
was present in this file." (Tr. 73.) Respondent further explained his
ability to diagnose "annular tears" from a variety of physical
examination tests he performed, stating that the reason none of the
tests were documented in the file was due to "bouts of epicondylitis
in my right elbow" that limited his writing ability, among other
reasons. (Tr. 348.) Somewhat inconsistently, Respondent also testified
that he has "had five of my charts reviewed by the University of
California Davis, and they had no problems with what I was doing."
(Tr. 349.) Respondent agreed with Dr. Gagné insofar as the
prescription dated January 3, 2007, did not have a corresponding chart
entry associated with it. (Tr. 352.) Respondent testified that he
prepared a chart "every single time," but testified to the
possibility the file was incomplete because of a staff error. (Id.)
With regard to patient [D.A.], I do not find Respondent's testimony
fully credible, particularly given Dr. Gagné's credible
testimony that diagnosis of an annular tear would require imaging.
Respondent's attempt to justify his findings based on "experience"
and "testing" finds no objective support in the medical file or other
record evidence. To the contrary, other patient files in this record
contradict Respondent's assertion that he prepares a patient chart
"every single time." I accept Dr. Gagné's findings and
opinions regarding Respondent's deviations from the standard of care
for [D.A.], as described above, which are well supported and consistent
with the evidence of record.
In the case of patient [L.G.], Dr. Gagné noted in his report
a medical file consisting of approximately 126 pages, commenting that
"this is an average sort of workup for a primary care physician
treating a pain problem," but noted a number of blank pain management
forms and concluded that the "physical examination is completely
inadequate." (Gov't Ex. 3 at 4.) Dr. Gagné noted that
"immediately starting the patient on a high-dose OxyContin is
extremely inappropriate without more information." (Id.) Dr.
Gagné concluded that the medical records for patient [L.G.] are
a "substantial departure from the standard of practice," further
characterizing the departure as a difficult choice between "simple and
extreme departures" but ultimately characterizing it as a simple
departure.\33\ Finally, Dr. Gagné opined that Respondent's
"[p]rescribing controlled drugs (including opiates) to an addict [and]
[p]rescribing sedating drugs to someone having recurrent falls and
automobile accidents and altered mental status, presumably due to the
drugs being prescribed" was an extreme departure from the standard of
care. (Gov't Ex. 3 at 9.)
---------------------------------------------------------------------------
\33\ While not relevant to Respondent's prescribing practices,
Dr. Gagné characterized Respondent's failure to evaluate,
treat or refer patient [L.G.] to a psychiatrist regarding [L.G.]'s
depression as a simple departure. (Gov't Ex. 3 at 9.)
---------------------------------------------------------------------------
Dr. Gagné testified consistent with his report, stating that
in his opinion prescribing controlled substances to patient [L.G.]
"was inappropriate, it was without a medical basis, it was somebody
having recurring problems as a result of the substances, falls and
automobile accidents, and there was no medical basis." (Tr. 108.) Dr.
Gagné further testified that "[i]t was clear from the medical
record" that [L.G.] was a drug addict. (Tr. 82.) [L.G.]'s urine
toxicology screen showed drugs of abuse. (Tr. 83.) In particular, the
patient file indicates that [L.G.] tested positive for methamphetamine,
opiates, oxycodone and amphetamines even though a review of the patient
file reveals the patient was not being prescribed amphetamine or
methamphetamine. (Tr. 98; See Gov't Ex. 9 at 4-5.) \34\ Despite the
evidence of drug addiction or drug abuse, Respondent did not take an
addiction history for [L.G.] (Tr. 82.) And on February 20, 2008, the
same day [L.G.] tested positive for methamphetamine and amphetamines,
for which the patient lacked a prescription, Respondent issued a
prescription for OxyContin, Roxicodone and an anti-inflammatory drug at
the same levels the patient had previously been receiving. (Tr. 98-99.)
Dr. Gagné testified that Respondent therefore acted
inappropriately, because the patient's positive test results for
methamphetamine and amphetamines should have been "the type of red
flag that is a full stop, meaning that one
[[Page 19330]]
must stop providing controlled drugs and reevaluate the situation."
(Tr. 99.)
---------------------------------------------------------------------------
\34\ Although the transcript reflects that Dr. Gagné
referred to Government Exhibit 8, that file does not relate to
patient [L.G.] and the pages referenced are inconsistent with a
toxicology report. (See Gov't Ex. 8 at 4-5 (patient file for
[D.A.]).) Under the circumstances it seems more likely that Dr.
Gagné intended to identify Government Exhibit 9. See Gov't
Br. at 6 n.4 (acknowledging that Government failed to correct
misstatement at hearing).
---------------------------------------------------------------------------
Respondent testified that the pages of the medical chart for [L.G.]
were not in the usual order but recalls first treating [L.G.] in
December 2006. (Tr. 357.) Respondent acknowledged that he began a
practice of urine drug testing toward the end of [L.G.]'s treatment,
and that was when he first discovered improper drug use based on a
positive test for methamphetamine, opiates, oxycodone and amphetamines.
(Tr. 368; Gov't Ex. 9 at 4.) Respondent stated his intent was to refer
[L.G.] to counseling and treat the patient's pain (Tr. 370) but that
stopping the opioids immediately would have caused withdrawal. (Tr.
371.) A February 20, 2008 follow-up consult report states: "Patient
took methamphetamine in her coffee a few days ago. She hasn't injected.
She does it once to twice a week." (Gov't Ex. 9 at 32.)
Notwithstanding this information, Respondent continued to prescribe
controlled substances to [L.G.] until August 14, 2008. (Tr. 371.)
Respondent further explained that between 2005 and 2008 he was on "a
learning curve" and by 2008 "I was getting much better at it. * * *"
(Tr. 373.) Respondent also testified that he did not treat [L.G.]'s
depression with antidepressants, stating that "I'm not sure why I
didn't do that at the time." (Tr. 374.)
I find Respondent's testimony with regard to patient [L.G.] not
entirely credible insofar as he maintains his practice was getting much
better by 2008. There is simply no credible evidence of record
reflecting substantial improvement in Respondent's prescribing
practices and compliance with applicable law. Additionally,
Respondent's explanations that he intended to both refer [L.G.] to
counseling and treat her pain is not credible. There is no evidence
that a referral was made or any meaningful follow-up in that regard by
Respondent. The testimony of Dr. Gagné, supported by [L.G.]'s
patient file, reflects a prescribing pattern that is a substantial
departure from the standard of care under federal and state law. Dr.
Gagné's opinion that Respondent's conduct with regard to
"[p]rescribing controlled drugs (including opiates) to an addict [and]
[p]rescribing sedating drugs to someone having recurrent fall * * *, "
among other issues, constituted an extreme departure from the standard
of care, is fully supported by the objective evidence of record.
The medical chart pertaining to patient [R.G.H.] consisted of
approximately seventy-seven pages. Dr. Gagné commented that the
documentation on the first visit of February 22, 2007, "fills in all
the blanks" but "is skeletal and grossly inadequate." (Gov't Ex. 3
at 9.) Dr. Gagné documented his review of a series of ongoing
office visits by patient [R.G.H.] with Respondent from March 2007 to
August 2008, concluding that Respondent had engaged in a number of
extreme departures from the standard of care, to include inadequate
medical records, prescribing controlled drugs (opiates) to an addict
and using opiates with an inadequate evaluation or consideration of
therapeutic alternatives. (Id. at 12.)
Dr. Gagné testified that [R.G.H.]'s patient file reflected a
number of prescriptions for controlled substances for which there was
no corresponding appointment with Respondent. (Tr. 112-117.) Dr.
Gagné was of the opinion that Respondent's issuance of
prescriptions without a corresponding appointment "was highly
inappropriate and without a medical purpose." (Tr. 118.) Additionally,
the patient file for [R.G.H.] included an undated notation indicating
positive for "Ecstasy", "Amph", Methamph", "Benzo" and
"Methadone." (Gov't Ex. 10 at 1.) There is no other record evidence
in the patient file further explaining the note, other than a July 9,
2008 follow-up treatment report noting: "Diversion: States [R.G.H.] is
not diverting?" (Id. at 14) and a July 22, 2008 report noting:
"Diversion: Possibly." (Id. at 13.) Dr. Gagné also testified
in substance that [R.G.H.] clearly became addicted to powerful
controlled substances and Respondent continued to prescribe controlled
substances for [R.G.H.] after the addiction became apparent. (Tr. 110.)
Dr. Gagné testified to a number of "red flags" in the patient
file suggestive of diversion or addiction. (See Tr. 110.)
Respondent testified that he initially saw [R.G.H.] on an
unscheduled visit while [R.G.H.] was with [R.G.H.]'s mother, for a non-
pain management matter, and Respondent referred [R.G.H.] to a
specialist for treatment. (Tr. 376-77.) Respondent testified he next
saw [R.G.H.] for a pain management appointment on February 22, 2007,
when he diagnosed [R.G.H.] with "lumbar disc problems from a motor
vehicle accident." (Tr. 378.) Respondent testified to prescribing
various controlled substances to [R.G.H.] at the initial appointment,
as well as follow-up appointments, but was uncertain at various points
in his testimony as to actions taken because of a lack of information
in the chart. For example, when asked why he did not continue to
prescribe Soma on a follow-up visit, Respondent indicated "I'm not
sure," further testifying that he would not ordinarily put information
in a patient's chart if medication was reduced, and "sometimes" put a
note in the chart for an increase. (Tr. 380.) When asked why he added
Actiq during an April 24, 2007 follow-up appointment, Respondent
testified that it was "probably for breakthrough pain," and further
explained that the only time he would prescribe Actiq was for
"breakthrough pain or migraine headaches." (Tr. 381-82.)
Respondent's testimony with regard to prescribing Actiq is
inconsistent with his follow-up chart for the April 24, 2007
appointment. (Gov't Ex. 10 at 26-27.) There is no reference to
"migraine headaches" other than a note in the history section
indicating [R.G.H.] went to the emergency room after "feeling really
tired, sick, headache, etc." (Id. at 26.) Similarly, there is no
reference in the chart to the addition of Actiq, nor any reference to
problems with breakthrough pain. To the contrary, the pain scale is
circled in the "moderate" pain category. (Id.) In fact the "Interval
History" form bearing a signature consistent with [R.G.H.]'s name for
the date of the appointment describes how [R.G.H.] has been doing since
the last appointment which [R.G.H.] marks as "same." (Id. at 27.)
Respondent's explanation for prescribing Actiq to [R.G.H.] is simply
not credible.
Respondent next testified to believing that [R.G.H.] was "using *
* * and diverting" controlled substances, stating "I was prescribing
OxyContin to her, and she was obviously not taking it since it wasn't
in her urine." (Tr. 384.) Respondent initially testified he did not
know when [R.G.H.] was tested because a lot of things "are missing
from this chart possibly because they were friends," further
explaining that [R.G.H.] was friends with members of Respondent's
staff. Respondent's testimony suggested that his medical assistant had
taken documents out of the chart, but in the same sentence Respondent
said he "was not sure" and had "no way of knowing it." (Tr. 385.)
Moreover, somewhat inconsistent with his initial statement that he did
not know when [R.G.H.] was tested, Respondent next testified based on
his chart notes of July 22, 2008, that he was aware of the urine test
results on that date and refilled [R.G.H.]'s medications, elaborating
that "I only refilled it one time" which would be within the thirty-
day discharge period for a patient. (Tr. 386)
I find Respondent's testimony that he only refilled [R.G.H.]'s
prescription for controlled substances one time on July 22, 2008, and
subsequently discharged [R.G.H.], palpably not credible. The
[[Page 19331]]
unequivocal evidence of record reflects that rather than discharge
[R.G.H.], Respondent continued to treat and refill [R.G.H.]'s
prescriptions for controlled substances on August 6 and August 20,
2008, even though he knew [R.G.H.] was "using and diverting." (Gov't
Ex. 10 at 12, 34.) Dr. Gagné found the August 6 and August 20,
2008 prescriptions concerning and opined that they were issued outside
the scope of usual professional practice in light of the patient's
acknowledged addiction. (Tr. 123.) He observed:
Having someone self-identify as an addict and be referred to
addiction treatment produces an absolute contraindication to
provision of any controlled drug whatsoever unless one is working
with the diversion--or the addiction treatment program and does so
under their direction. So you would need to have close coordination
of care. And there's no evidence that any discussion was had with
anybody else about her addiction.
(Tr. 122.) Dr. Gagné opined that Respondent's controlled
substances prescriptions were without medical foundation or basis and
constituted prescribing to an addict. (Tr. 123.) I accept the findings
and opinions of Dr. Gagné as noted above, which are well
supported and consistent with other credible evidence of record.
Turning next to the medical chart of patient [A.L.], Dr.
Gagné noted in his report that it consisted of approximately
fifty-four pages covering the time period from June to December 2006.
(Gov't Ex. 3 at 12.) Dr. Gagné noted that the initial visit
resulted in a prescription dated June 22, 2006, for "180 OxyContin
80mg, 120 Actiq 1600 mcg, and 60 10-mg Valium" along with another
prescription with the same date for "another 120 Actiq 1600 mcg and
sixty Valium." (Id.) Dr. Gagné further commented that "[t]his
is an enormous amount of medication and constitutes overprescribing on
its face." (Id. at 13.) A comparative review of the two June 22, 2006
prescriptions from the patient file reveals that one bears in capital
letters the word "VOID," as well as a line through it, indicating
that only one prescription was actually issued. (Gov't Ex. 11 at 23-
24.) Accordingly, I give no weight to Dr. Gagné's specific
finding of overprescribing on its face.
In his report, Dr. Gagné also commented that the "initial
two visits are an extreme example of form without content," noting
"no good-faith attempt to obtain an adequate history, evaluate for
possible addiction, detail precise symptoms, determine neurologic
status, or perform an adequate physical evaluation." (Id.) After
reviewing chart information for patient [A.L.] surrounding a September
20, 2006 follow-up visit, Dr. Gagné commented that this "has
now become bizarre," noting in part that the file contained a
Controlled Substance Utilization Review & Evaluation System (CURES)
report dated September 5, 2006, showing another doctor was prescribing
to [A.L.] 90 OxyContin 80 mg once a month from March 22 to July 21,
2006. Dr. Gagné referenced a final office visit dated December
14, 2006, in which the patient chart for [A.L.] contains a notation
from Respondent regarding the patient's abuse of drugs and medications,
stating
I am upset and really let him know it. He kept making excuses.
And I stopped the excuses. I will fill his meds, have him come back
in a month. He has to come back with a drug treatment facility--
phone number, etc., then I may discharge. I will make that decision
next time.
(Id. at 14; see Gov't Ex. 11 at 25.) \35\
---------------------------------------------------------------------------
\35\ I give no weight to Dr. Gagné's reference in his
written report to Respondent's credibility. (Gov't Ex. 3 at 14.)
---------------------------------------------------------------------------
Consistent with his written report, Dr. Gagné's testimony
emphasized that Respondent's prescribing of controlled substances to
[A.L.] was not in the context of a good-faith physician-patient
relationship, there was no medical purpose served and the prescriptions
were not issued in the usual course of professional practice. (Tr.
137.) In support of this conclusion, Dr. Gagné explained that
[A.L.] tested positive for metabolites of methadone, Soma, marijuana
and benzodiazepines, based on a specimen given November 16, 2006, and a
report printed November 21, 2006. (Gov't Ex. 11 at 48-53; Tr. 130-33.)
The patient file contains a printed toxicology report containing a
handwritten notation indicating that "Benzo prescribed--last time was
August," which Dr. Gagné interpreted as referring to three
months before [A.L.] underwent the drug test. (Gov't Ex. 11 at 53; see
Tr. 130-31.) Dr. Gagné further testified that although this
handwritten comment did not raise any concerns because it can be
appropriate for patients to take medication intermittently, three other
handwritten comments are concerning. (Tr. 131.) The toxicology report
reflects a handwritten notation next to "methadone" stating "Not
Prescribed by me--stated a Family Member Gave to Him;" next to
Carisoprodol, a note appears stating "not Prescribed;" next to
Cannabinoids, a note states "not Prescribed or Made Legal." (Gov't
Ex. 11 at 53; see Tr. 131.)
Dr. Gagné further testified that these notes "confirm[ ]
that we have a problem here" with respect to Respondent's prescribing
practices. (Tr. 131.) Respondent received [A.L.]'s toxicology report at
least as early as December 14, 2006 (Gov't Ex. 11 at 48; Tr. 132),
confronted the patient about [A.L.]'s abusive drug habits (Gov't Ex. 11
at 25; Tr. 133), but nevertheless prescribed to [A.L.] 240 OxyContin 80
mg and 90 Roxicodone 30 mg on that day (Gov't Ex. 11 at 46; Tr. 132).
Dr. Gagné testified that Respondent issued the December 14, 2006
prescriptions outside the usual course of professional practice in
light of "evidence that the patient is not only abusing drugs but has
additional sources of opiates." (Tr. 134.)
Respondent testified with varying levels of certainty and
specificity with regard to his prescribing practices for patient [A.L.]
(Tr. 387-395.) For example, when asked why there was a discrepancy in
the chart as to an initial visit date of June 22, 2006, but a
medication agreement was dated June 26, Respondent replied "I don't
know." (Tr. 394.) In terms of specifics of what he might do
differently in the future, Respondent testified "I think I'd be better
educated in abuse * * * " (Tr. 395.) As to the issue of diversion,
Respondent testified that "I noticed that he was either using or
diverting. And we got a CURES Report that showed that * * * [A.L.] was
discharged within six or so visits as well, but there's no discharge
letter in this chart. And I know for a fact he was discharged. I know
he was discharged." (Tr. 393.) But the evidence contradicts
Respondent's testimony. The evidence reflects that after the September
5, 2006 CURES report which Respondent acknowledges as confirmation of
"using or diverting," Respondent continued to prescribe controlled
substances on four additional occasions.\36\ Additionally, contrary to
Respondent's testimony that [A.L.] was discharged, a phone message note
in [A.L.]'s chart dated January 17, 2007, states: "[A.L.] need his
oxy. All the paperwork you asked for. Per Dr. B 1/17/07 just bring in
paperwork will speak to rehab place 1st before meds are given." (Gov't
Ex. 11 at 22.) This note directly contradicts Respondent's assertion
that [A.L.] had been discharged.
---------------------------------------------------------------------------
\36\ September 20, October 20, November 16 and December 14,
2006. (Gov't Ex. 11 at 32, 28 & 25.)
---------------------------------------------------------------------------
For the foregoing reasons, I find Respondent's testimony with
regard to patient [A.L.] not credible. Dr. Gagné's conclusions
and opinion of extreme deviations in Respondent's compliance with the
standard of care as to patient [A.L.] pertaining to the absence of a
good-faith medical evaluation prior to prescribing controlled drugs,
prescribing controlled drugs to someone
[[Page 19332]]
Respondent knew or should have known was an addict and prescribing
controlled drugs without a legitimate medical purpose, are fully
consistent with the objective evidence of record. I also accept Dr.
Gagné's opinion as to a "simple deviation for the standard of
practice" as it pertains to [A.L.]'s medical records. (Gov't Ex. 3 at
14.)
With regard to patient [L.M.], the patient chart consisted of
sixty-three pages covering the period from July 2006 to April 2007. Dr.
Gagné testified that based on his review of the chart,
"medications were not given in a good-faith manner or for a legitimate
medical purpose." (Tr. 139.) Dr. Gagné noted in his report that
the initial July 12, 2006 consultation note indicated: "diagnosis is
'chronic pain from fractured ankle,' and the treatment two OxyContin 80
mg every 12 hours and two Norco 10/325 three times a day." (Gov't Ex.
3 at 15.) Dr. Gagné commented that the chart did not "qualify
as a good-faith medical evaluation" and there was no basis for
prescribing large quantities of opiates." (Id.) Of note, Dr.
Gagné stated "[c]ertainly the dose of opiates provided would be
fatal in an opiate-na[iuml]ve patient." (Id.) In summary, Dr.
Gagné found the overall chart contained "elements of the
history and physical exam" but there was "no meaningful content,"
and therefore "the records themselves reflect a simple deviation from
the standard of practice." (Id. at 17.) Additionally, Dr. Gagné
found extreme deviations from the standard of practice given the
absence of a good-faith medical evaluation prior to prescribing
controlled drugs, prescribing controlled drugs without legitimate
medical purpose and overprescribing much larger doses of opiates than
was indicated clinically. (Id.)
Respondent testified that he could not explain the absence from the
chart of items such as past medical history, review of alcohol or drug
abuse, and work history. (Tr. 395-96.) Respondent stated he would
ordinarily gather that information. Respondent explained that he was
deceived by patients, but doing better now, "although I'm not seeing
any pain management patients * * * ." (Tr. 397.) Respondent further
testified that if given a DEA registration, he would never again
prescribe OxyContin but was unsure if he would engage in pain
management. (Tr. 398.) Respondent testified that he believes he first
discovered [L.M.] was engaging in duplicitous conduct "when we got the
CURES Report." (Tr. 398.) Respondent next stated the "patient was
discharged as well" but "believed [L.M.] was discharged soon after *
* * ." the urine test and CURES report. (Tr. 399.) In contrast,
Respondent testified on cross-examination that he did not know when he
received the CURES report, claiming he did not see the report or "it
wasn't in the chart until later." (Tr. 460.)
The patient file for [L.M.] contains a CURES report dated September
22, 2006, bearing a handwritten notation consistent with the word
"file." (Gov't Ex. 12 at 56.) \37\ A review of [L.M.]'s chart reveals
no other reference to receipt of the CURES report.\38\ Contrary to
Respondent's testimony, [L.M.] was not discharged. Rather, Respondent
continued to prescribe controlled substances on successive follow-up
visits dated: October 20, 2006; November 17, 2006; December 15, 2006;
January 11, 2007; January 30, 2007; and February 28, 2007. (Gov't Ex.
12 at 23-33.) In fact, the chart contains a "communication log" dated
April 24 to 27, 2007, confirming conversations consistent with
notations by a staff member in Respondent's office, indicating [L.M.]
was "asking for refill of Oxyfast was told had to ask Dr., come back
tomorrow." (Id. at 15.) A subsequent entry reflects [L.M.] "came back
in late p.m. advised per doctor needs to have drug screen 1st before
new RX," to which [L.M.] questioned the need, stated [L.M.] was unable
to provide a urine sample and indicated an intention to return the next
day. (Gov't Ex. 12 at 15.) The entry the next day indicated [L.M.]
"never returned." (Gov't Ex. 12 at 15.) [L.M.]'s return to
Respondent's office in April of 2007 for a "refill" is inconsistent
with Respondent's assertion that [L.M.] had been discharged, at any
time. Clearly, [L.M.] did not believe [L.M.] had been discharged and
the chart notations suggest that Respondent had not discharged [L.M.],
which if true would have precluded the necessity of a urine screen.
---------------------------------------------------------------------------
\37\ The CURES Report is dated September 22, 2006 and reflects
various prescriptions for [L.M.] between March 30, 2006 and August
10, 2006, listing four other prescribers in addition to Respondent.
\38\ A urine drug screen report for [L.M.] is dated November 22,
2006. (Gov't Ex. 11 at 54.)
---------------------------------------------------------------------------
Accordingly, I find Respondent's testimony with regard to [L.M.]
not credible based in part on various factual inconsistencies, as well
has his numerous non-responsive and evasive answers to questions posed
on both direct and cross-examination. (See Tr. 396-99; 457-60.) I
accept Dr. Gagné's findings and opinions regarding Respondent's
deviations from the standard of care for [L.M.], as described above,
which are well supported and consistent with the evidence of record.
The evidence and testimony pertaining to patient [K.P.] included a
patient chart consisting of forty-one pages covering the time period
January to July 2007. The patient chart includes prescriptions for
various controlled substances dated: January 11, 2007; February 8,
2007; February 15, 2007; February 16, 2007; March 6, 2007 ("to pick up
on March 14"); March 6, 2007; March 30, 2007; April 20, 2007; April
30, 2007; May 16, 2007; June 8, 2007; June 18, 2007; July 3, 2007; July
12, 2007; and July 12, 2007. (Gov't Ex. 13 at 24-38.) The patient chart
reflects an initial consultation report dated January 11, 2007, with
follow-up reports dated: February 8, 2007; March 6, 2007; March 30,
2007; May 16, 2007; June 8, 2007; June 19, 2007; and July 5, 2007. (Id.
at 5-15.)
Dr. Gagné commented in his written report that based on
chart documentation relating to the initial January 11, 2007
consultation,
the information in this visit constitutes an inadequate basis
for treating any disease or condition and does not in my view
reflect a good-faith medical evaluation. There is no real diagnosis
and no basis for a diagnosis of "annular tears." \39\ The amount
of medication prescribed is egregious: 750 mg/day of oxycodone.
Finally, there is no information in the chart from any other
physician, including the doctor who presumably referred the patient.
---------------------------------------------------------------------------
\39\ The January 11, 2007 consult chart reflects "current
medications Dose/Freq" as "OxyContin 80 x 180;" "Roxicodone 30 x
540." (Gov't Ex. 13 at 15.) This quantity reflected [K.P.]'s self-
reported current medications which Respondent recorded. (Tr. 460.)
Dr. Gagné noted in his report that this would reflect a daily
dose of 1020 mg of oxycodone, which would be a "staggering dose"
if accurate. (Gov't Ex. 3 at 17.)
---------------------------------------------------------------------------
(Gov't Ex. 3 at 18.) The chart information for the February 8, 2007
follow-up visit reflects an increase in medication at the request of
[K.P.], noting "pt would like to [uarr] oxy to 240" (Gov't
Ex. 13 at 13.) A corresponding prescription "dated 2/8/07 is for 240
OxyContin 80 mg (taken as four every 12 hours) and 240 Roxicodone 30
mg, for a total of 1,200 mg daily." (Id.) The evidence also reflects
two additional prescriptions issued to [K.P.] on February 15 and 16,
2007, with no associated clinic note present in the chart. (Id. at 35-
36.) Dr. Gagné noted the prescription dated "2/15/07 is for 150
Actiq 1600 mcg * * * and ten 100-mcg/hour fentanyl patches [and] yet
another prescription on 2/16/07 is for another sixty OxyContin."
(Gov't Ex. 3 at 18.) Dr. Gagné commented in his report that
there "is no legitimate medical purpose for this medication. Anyone
who actually took this much would be at risk
[[Page 19333]]
for extreme opiate side effects, including seizure and death." (Id.)
Consistent with his report, Dr. Gagné testified that the
indication in [K.P.]'s patient file that the patient was receiving 540
Roxicodone 30 mg from another doctor constitutes a "huge red flag full
stop * * * when you see something like that, you can't prescribe
controlled drugs until you sort out what's going on." (Tr. 162.) Dr.
Gagné also noted that the patient file contains the notation
"Patient of Dr. [W.]'s," with no corresponding evidence that
Respondent consulted with or obtained records from Dr. [W.] (Tr. 162-
63.) The patient file also indicates that [K.P.] rated [K.P.]'s level
of aerobic exercise as moderate, which raises a red flag because
"[i]t's inconsistent with somebody who has extreme pain requiring
stupendous doses of opiates." (Tr. 163.) The patient file further
reflects a notation by Respondent "Need to do drug screen," but the
record contains no evidence that a drug screen was performed and
further reflects that Respondent later prescribed Roxicodone, fentanyl,
Dilaudid and two prescriptions for OxyContin in July of 2007. (Tr. 163,
164.) To Dr. Gagné, this "reinforces the impression that
there's no legitimate medical purpose underway here." (Tr. 163-64.)
Dr. Gagné further testified that Respondent's prescribing
behavior with respect to [K.P.] was "completely inconsistent" with
someone who is concerned that a person is diverting drugs. (Tr. 163.)
Dr. Gagné opined that in prescribing to [K.P.] Respondent
overlooked the high probability of diversion, lacked a good-faith
medical evaluation and issued prescriptions outside the usual course of
professional practice. (Tr. 165.)
Respondent testified in substance that [K.P.] came to him from Dr.
[W.] who Respondent described as "doing pain management in town, who I
got a lot of patients from and who I discovered were abusing their
medications. In fact, there's at least a handful of patients I reduced
their medications significantly." (Tr. 401.) Respondent further
testified regarding the current level of medication [K.P.] self-
reported, stating this "is what Dr. [W.] had a lot of patients on. And
it is absurd." (Tr. 461.) Respondent could not explain the absence of
records from Dr. [W.] in the patient chart, stating that "most all my
charts have records from Dr. [W.]" (Tr. 401.) Respondent suggested
that the absence of records were not due to a lack of request on his
part, but due to staff problems in his office at the time. "It was--it
was a problem in the office that I had so much turnover between 2003
and 2007. You know how costly it is and how difficult it is to keep
training new help. * * *" (Tr. 403-04.) Respondent's knowledge that
"a lot" of patients from Dr. [W.] were abusing their medications, and
that Dr. [W.] was prescribing absurd amounts of medications, at a
minimum should have caused Respondent to have a heightened level of
scrutiny in the case of [K.P.] Instead, the patient chart is
effectively devoid of any evidence that Respondent took any reasonable
action to meet his "responsibility for the proper prescribing * * * of
controlled substances." \40\
---------------------------------------------------------------------------
\40\ 21 C.F.R. Sec. 1306.04(a).
---------------------------------------------------------------------------
Respondent also testified with regard to dosage levels, stating
that he first prescribes the medication and then over a three or four
month period evaluates the patient's medical problems and determines if
an increase or decrease is warranted. (Tr. 402.) That testimony is
inconsistent with Respondent's treatment of [K.P.], because the
objective chart information indicates Respondent increased [K.P.]'s
medication less than thirty days from the initial consult visit,
notably at the patient's request, rather than for a stated medical
reason. In fact, on the "Interval History" form bearing [K.P.]'s
signature for the February 8, 2007 appointment, which asks the patient
to assess how the patient has been doing since the last visit with
regard to back pain, [K.P.] notes "same." (Gov't Ex. 13 at 14.)
Respondent also testified that he had gone through "these records
about a half dozen times" and noticed "yesterday" that several
signatures relating to prescriptions for [K.P.] were not his,
apparently suggesting that people other than Respondent wrote the
prescriptions. (Tr. 404-05.) Referring to page numbers of prescriptions
contained in Government Exhibit 13, Respondent elaborated further on
direct examination: "The prescription on 38 is not my signature";
"Page 34 is not my signature"; "The one on page 31 is not my
signature. I'm not sure about 29 * * * I can't really tell." (Tr. 405-
06.) On cross-examination, Respondent presented conflicting testimony.
Respondent acknowledged his signature with regard to most
prescriptions,\41\ but testified initially that "34 looks like it's
mine" but later testified "Looks like it's not mine." (Tr. 465,
466.) Directly contradicting his earlier testimony with regard to page
twenty-nine, Respondent testified "That appears to be mine." (Tr.
465.) Similarly, Respondent directly contradicted his earlier testimony
with regard to page 38, testifying "It's mine." (Tr. 467.)
Respondent's testimony with regard to the questionable signatures for
three other prescriptions was vague: "This one I can't tell * * * I do
not know" (Tr. 466 (Page 31).); "I'm not sure" (Id. (Page 35).); "I
can't tell on that." (Tr. 467 (Page 37).)
---------------------------------------------------------------------------
\41\ Page numbers referenced herein refer to page numbers on
bottom center of Government Exhibit 13, consistent with the
presentation of evidence at hearing. Respondent acknowledged his
signature on pages twenty-four to thirty, thirty-three, thirty-six
and thirty-eight. (Tr. 465-67.) No testimony was offered with regard
to the March 30, 2007 prescription. (Gov't Ex.13, at 32.)
---------------------------------------------------------------------------
I do not find credible Respondent's testimony suggesting that
several signatures on prescriptions issued to [K.P.] may be forged.
There is no objective evidence of record to support the suggestion that
someone else forged Respondent's signature, and Respondent's
conflicting testimony on something as fundamental as recognition of his
own signature, particularly with regard to the prescriptions reproduced
in Government Exhibit 13 at pages twenty-nine, thirty-four and thirty-
eight, is plainly incredible. I also do not find credible Respondent's
testimony suggesting his staff may have been at fault for the lack of
follow-up or documentation in the patient chart. There is simply no
evidence to support the assertion and Respondent's demonstrated lack of
credibility in numerous specific portions of his testimony casts
significant doubt on his entire testimony.
I accept Dr. Gagné's conclusions and opinion of extreme
deviations in the standard of care for patient [K.P.] pertaining to
Respondent's: Grossly inadequate medical records, including no visit at
all for several prescriptions; prescribing of controlled drugs without
a legitimate medical purpose; lack of a good-faith medical evaluation
prior to prescribing controlled drugs; and overlooking of the high
probability of diversion. (Gov't Ex. 3 at 19.) As to the last point,
Respondent not only overlooked but in fact knowingly accepted a high
probability of diversion by admittedly accepting what he agreed was an
"absurd" level of dosing for [K.P.] (Tr. 461.)
I do not, however, accept Dr. Gagné's conclusion and opinion
with regard to Respondent's "prescribing controlled drugs to an addict
or to someone he should have known was an addict." There is no
reference in [K.P.]'s patient chart to drug use or addiction. Any
opinion or conclusion in that regard by Dr. Gagné is mere
speculation.\42\
---------------------------------------------------------------------------
\42\ Dr. Gagné also speculates that the "only reason I
can fathom for someone requesting all this medication is so [K.P.]
can sell it," which notably conflicts with his opinion as to
addiction. (Gov't Ex. 3 at 18.) I give no weight to these comments
as to [K.P.]'s specific intent. Intent aside, the evidence is fully
consistent with a high probability of diversion.
---------------------------------------------------------------------------
[[Page 19334]]
The evidence as to patient [D.S.] included a patient chart
numbering thirty-one pages covering the time period from October 2007
to January 2008. The chart includes a "Consultation" note dated
October 29, 2007, stating "Pt was seen during cannibus nite [sic],"
with no other entries for history of present illness, current
medications, physical exam or diagnosis, among other fields. (Gov't Ex.
14 at 31.) The patient chart also contains a copy of a prescription
dated October 24, 2007 \43\ for "180 Norco 10/325 with two refills,
180 soma with two refills, and a pint of Phenergan with Codeine"
although there is no corresponding entry in the chart documenting a
clinical visit consistent with the prescribed medication. (Gov't Ex. 3
at 20.) A follow-up report dated December 15, 2007, under "History of
Present Illness" stated "med refill" and included a diagnosis of
"Lumbar disc degeneration, chronic pain, depression." (Id.; Gov't Ex.
14 at 30.) A copy of a prescription \44\ dated December 15, 2007 is for
180 OxyContin 80 mg, 180 Norco 10/325, 180 soma, a pint of Phenergan
with codeine, and 60 Zoloft 100 mg. (Gov't Ex. 3 at 20; see Gov't Ex.
14 at 2 & 25.)
---------------------------------------------------------------------------
\43\ The date could arguably read October 29, 2007, coinciding
with chart information of an office visit for "cannabis night."
(Gov't Ex. 14 at 24.) Further confusing the issue, Respondent's
counsel asked Respondent to describe this patient "when she
presented in your office apparently October 27th, '07," to which
Respondent replied in context stating that he first saw [D.S.] on
December 15, 2007. (Tr. 408.) In any event, there is no supporting
chart information for prescribing controlled substances on October
29, 2007. (See Gov't Ex. 14 at 31.)
\44\ Notes related to the prescription reflect that Respondent
prescribed a three-month supply because the patient stated "she was
going to Texas to see family & would not be back for 3 mo." (Gov't
Ex. 14 at 30.) Dr. Gagné commented in his report that
"[g]iving someone who is depressed and possibly suicidal enough
controlled and sedating medication to kill themselves and then
planning not to see them for three months is extraordinarily poor
care to say the least." (Gov't Ex. 3 at 20.)
---------------------------------------------------------------------------
The testimony and report by Dr. Gagné include findings and
opinions as to extreme deviations from the standard of practice:
Grossly inadequate medical records, including no visit at all when
Respondent wrote one prescription; prescribing large quantities of
dangerous, potentially lethal sedating medications to a depressed
patient for whom no assessment was made for suicidal ideation or
intent; absence of good-faith medical evaluation prior to prescribing
controlled drugs; prescribing controlled drugs without a legitimate
medical purpose; prescribing controlled drugs to an addict or to
someone Respondent should have known was an addict; and overlooking a
high probability of diversion. (Gov't Ex. 3 at 21.) Dr. Gagné
testified in substance that Respondent prescribed "large quantities of
controlled drugs with multiple refills with no legitimate medical
purpose." (Tr. 148, 154.) He also testified that Respondent's
diagnosis of lumbar disc disease and chronic pain lacks a medical
basis. (Tr. 148-49.)
Respondent testified in substance to first seeing [D.S.] on
December 15, 2007, and said the patient "was in for pain medications
and cough and colds." (Tr. 408.) Respondent testified that he noted on
[D.S.]'s chart "that she doesn't have her pain managed" but did not
"understand why" he stated that. (Id.) Respondent then explained that
he was "really putting the history of present illness down" noting
that [D.S.] had injured [D.S.]'s back while lifting. (Id.) Respondent
further explained that he diagnosed lumbar disc degeneration, chronic
pain and depression, and "I ordered an X-ray be done on her." (Id.)
Inconsistent with Respondent's testimony, the corresponding chart does
not reflect a contemporaneous order of an X-ray but rather includes a
January 15, 2008 order for a "Lumbar spine X-ray Multiview." (Gov't
Ex. 14 at 26.)
By way of explanation for prescribing a three-month supply,
Respondent testified: "And then I gave her a three-month supply where
she stated she was going to Texas to visit family. And I trusted that
was the truth, and so I wrote it out for three months or enough for
three months." (Tr. 409.) Respondent testified in substance that,
other than [D.S.], he has not had a patient on an initial visit ask for
a three-month supply, and even for longstanding patients it is "not
usually something that I normally do." (Tr. 411-12.) Respondent
explained that in retrospect he would have questioned [D.S.]
differently and "I wouldn't prescribe it." (Tr. 412.) Respondent
further acknowledged that with regard to his initial evaluation of
[D.S.] "there is room for improvement" but never suspected at the
time of [D.S.]'s first visit that [D.S.] was an addict or was diverting
the medication. (Id.)
The evidence of record is consistent with Respondent's testimony
that he normally does not prescribe a three-month supply. Respondent
also testified that in January 2008 when [D.S.] came in on an
unscheduled walk-in visit, [D.S.] was discharged. (Tr. 410.) A follow-
up patient chart report is consistent with Respondent's testimony,
reflecting in part a notation: "No longer Seeing Patient. I think this
patient has scammed me" and another notation: "Patient threatened me
to have my license revoked." (Gov't Ex. 14 at 29.)
Although I find Respondent's testimony partially credible as noted
above, there is no testimony or other evidence of record addressing in
any way the October 24, 2007 prescription signed by Respondent, nor
does any credible testimony or evidence rebut the findings of the only
expert witness in the case, Dr. Gagné, concerning his findings
and opinions of extreme deviations from the standard of practice for
patient [D.S.] Accordingly, I accept the findings and opinions of Dr.
Gagné pertaining to extreme deviations from the standard of
practice as noted above, with the exception of Dr. Gagné's
opinion that Respondent prescribed "controlled drugs to an addict or
to someone he should have known was an addict." (Gov't Ex. 3 at 21.)
There is insufficient evidence of record to support such a finding as
to patient [D.S.]
The patient record for [A.W.] included a patient chart numbering
205 pages covering the time period from November 2005 to August 2008.
Dr. Gagné's initial findings and opinion regarding the
prescribing practices for [A.W.] differed in some respects from his
testimony at hearing. Dr. Gagné stated in his written report
that he is "of two minds about this case," noting at one point that
Respondent "treats the patient's symptoms without establishing a
medical diagnosis," but also stating shortly thereafter "I did feel
the diagnoses at the initial visit of plantar fasciitis and possible
facet arthropathy had some basis." (Gov't Ex. 3 at 24.) Dr.
Gagné further stated in his report: "I do not see
overprescribing or sense the patient is abusing or diverting the
medications." (Id.) Dr. Gagné's report also included a notation
consistent with the foregoing, to include a review of records
pertaining to [A.W.]'s January 2007 hospital admission, where Dr.
Gagné noted: "Chemistries are unremarkable, as is the
urinalysis." (Id. at 22 (interpreting Gov't Ex. 15 at 189-205).)
On direct examination, Dr. Gagné testified in substance that
although "I had not spotted this in my initial review," there was a
urine drug screen dated January 2007 that was positive for cocaine.
(Tr. 181-82.) Dr. Gagné further testified in substance that this
report was in the patient chart but Respondent "had not ordered it * *
* [so] we have no idea [if] it was something that he saw [but] I think
there's plenty of evidence of doctor shopping and other aberrant
medication behaviors." (Tr. 182.) Dr.
[[Page 19335]]
Gagné's reference to "plenty of evidence" was a reference to
other aspects of his testimony on direct examination that highlighted
chart information inconsistent with prescribing for a legitimate
medical purpose. For example, Dr. Gagné was of the opinion that
Respondent issued various prescriptions for controlled substances for
other than a legitimate medical purpose or outside the usual course of
professional practice. (Tr. 170-78.) The patient record for [A.W.]
reflects additional warning signs. Dr. Gagné testified that
[A.W.]'s medical record in multiple instances contains evidence of
phone calls from other clinics to the extent that [A.W.] "has been
getting pain medications referred by multiple physicians and three
different pharmacies." (Tr. 179.) Upon specific questioning about an
April 2006 chart note and a July 2008 letter, Dr. Gagné
testified that "this is clear-cut evidence of * * * doctor shopping."
(Tr. 179; see Gov't Ex. 15 at 7 & 72.) Moreover, Dr. Gagné
stated that a note by Respondent that "History of Present Illness: She
gives me very little information to obtain those records" would
"absolutely" give a practitioner cause for concern before prescribing
opiates. (Tr. 180.) Additionally, [A.W.]'s patient file indicates that
the patient requested--and Respondent denied--early refills. (Tr. 180.)
Another yellow flag is an indication that the patient requested a brand
name medication. (Tr. 180-81.) And significantly, a drug screen report
also showed that [A.W.] tested positive for cocaine, and there is no
evidence that Respondent discharged the patient for using illegal
substances.\45\ (Tr. 181-82.)
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\45\ Moreover, Dr. Gagné testified that Respondent did
not order the drug screen that there is no indication whether
Respondent saw the drug screen report. (Tr. 182.) But because the
drug screen report was in Respondent's patient file for [A.W.], I
find that Respondent was on inquiry notice of the contents of the
report, even if he did not possess actual knowledge of it. There is
no indication that the drug screen report was added to the patient
file after the file left Respondent's custody and control following
the execution of a warrant at Respondent's registered location
(e.g., Tr. 324), and counsel for Respondent did not object to the
report's admission at hearing. (Tr. 183.)
---------------------------------------------------------------------------
Respondent testified in substance with regard to [A.W.] that [A.W.]
"came to me from the other practice in central Fresno" where
Respondent believed a full history and physical had been conducted.
(Tr. 414.) Respondent testified that he did not "recall if I had
[A.W.] on OxyContin from the other office or whether I just started
treating [A.W.] then with OxyContin." (Id.) Respondent also testified
that staff should have obtained prior records but did not, and
acknowledged in retrospect that he should have done another history and
physical examination. (Id.) Respondent testified that he never believed
[A.W.] was drug seeking when he began treatment and never determined
that [A.W.] was diverting. (Tr. 416; 421.) Respondent further testified
that he does not consider therapeutic alternatives with every patient
but does have a mission statement to "use as many different modalities
as possible to help the patient with pain." (Tr. 422.)
Respondent's testimony with regard to his knowledge of possible
diversion by [A.W.] is not consistent with the objective evidence of
record, as early as April 2006. Dr. Gagné testified that the
January 2007 lab report finding [A.W.] positive for cocaine, and
related chart information, does not indicate whether Respondent was
aware of such a finding, particularly because it was not ordered by
Respondent. Standing alone, the possibility of overlooking such a
finding is not unreasonable, and in fact Dr. Gagné overlooked it
in his initial file review. The same cannot be said for the April 2006
chart notation and the July 19, 2008 letter addressed to Respondent.
The chart contains a prescription log bearing an entry dated April 10,
2006:
Margie from central Valley Clinic called to inform us that
patient is getting Valium, Lortab & Soma from their office. Also she
says that patient uses Valium, Lortab & Soma from their office. Also
she says that patient uses various pharmacies using different
insurances to refill [A.W.]'s meds.
(Gov't Ex. 15 at 7.) A second entry dated April 19, 2006, states:
Patient given a RX for [O]xy[C]ontin since we had to reschedule
appt. [A.W.] was advise[d] to keep [A.W.]'s appt. This is the last
Rx because [A.W.] will be discharged per Dr. Brubaker.
(Id. (emphasis added).)
Clearly Respondent was aware of diversion issues related to [A.W.]
no later than April 19, 2006, because he had instructed his staff that
[A.W.] was to be discharged. Notably, patient chart notes on and after
April 10, 2006, make no reference to the known issue of diversion, or
to discharge. To the contrary, a follow-up report dated July 11, 2006,
notes in part "No evidence of abuse * * * ." (Id. at 139.) A letter
addressed to Respondent from the pharmacy benefit manager Wellpoint
Next Rx dated July 19, 2008, is further to the point, stating in
relevant part: "Our pharmacy claim records indicate that your patient
listed above has had pain medications prescribed by you and at least 2
other physicians and have filled prescriptions in at least 3 different
pharmacies in a 3-month period." (Id. at 72.) This evidence
unequivocally contradicts Respondent's testimony suggesting he had no
knowledge of diversion by [A.W.] Rather, the July 19, 2008 letter
confirms [A.W.]'s ongoing diversion of controlled substances consistent
with information known to Respondent in April 2006. As with other
material portions of Respondent's testimony, I find Respondent's
relatively brief testimony on this issue not credible.
Dr. Gagné concluded in his written report for patient [A.W.]
that Respondent's medical records are "a substantial departure from
the standard of practice," further characterizing it as a simple
rather than extreme departure. (Gov't Ex. 3 at 25.) Dr. Gagné
also concluded that "the final simple departure from the standard of
practice is using opiates without consideration of therapeutic
alternatives." (Id.) I accept the findings and opinions of Dr.
Gagné with the exception of his opinion that there is no
evidence of "overprescribing" or evidence that "the patient is
abusing or diverting the medications," as reflected in his written
report. That finding is inconsistent with the objective chart
information, as early as April 2006, and Dr. Gagné credibly
testified that he had overlooked the information for purposes of his
written report.
The evidence as to patient [T.W.] included a patient chart
numbering forty-six pages covering the time period from September 2006
to January 2007. Dr. Gagné noted that the initial visit resulted
in a diagnosis of chronic hip, back and leg pain from stress fracture
and that Respondent's "recommended treatment is 'herbal meds.' " (Id.
(citing Gov't Ex. 16 at 42).) The chart contains a corresponding
prescription dated September 20, 2006, "for 180 OxyContin 20 mg, three
every 12 hours, 120 Norco 10/325, 1-2 every 4 hours as needed, and 90
Xanax 2 mg, one 3 times a day." (Gov't Ex. 16 at 39.) Dr. Gagné
commented in his report that "[t]here is no basis in this record for
any but the most minimal treatment; there is certainly no legitimate
medical purpose to prescribe such enormous quantities of opiates, which
would be fatal in an opiate-na[iuml]ve person." (Gov't Ex. 3 at 25;
see Gov't Ex. 16 at 39.) The patient chart contains a November 1, 2006
prescription for "120 Dilaudid 8 mg, 120 Norco 10/325, and 90 Xanax 2
mg," with no evidence of a corresponding clinic visit. (See Gov't Ex.
3 at 25.)
Dr. Gagné's report outlines additional visits by [T.W.] with
corresponding controlled substances prescriptions, noting finally that
a
[[Page 19336]]
"Consultation" note dated 1/31/07 is clearly not a patient
visit: "Discovered in the Fresno Bee [newspaper] that this patient
has been selling drugs of abuse and [T.W.]'s pain meds and cannabis.
This type of behavior ruins treatment for other patients. I hope
[T.W.]'s put away for 10+ years. [T.W.] sure had me fooled. This
patient has note in the computer now to never be seen again, ever."
(Id. at 26 (citing Gov't Ex. 16 at 8).) Dr. Gagné's findings and
opinion with regard to Respondent's standard of practice for [T.W.]
included extreme departures in the following areas: grossly inadequate
medical records, including no visit at all when Respondent wrote one
prescription; absence of a good faith medical evaluation prior to
prescribing controlled drugs; prescribing controlled drugs without a
legitimate medical purpose; prescribing controlled drugs to an addict;
\46\ and overlooking a high probability of diversion. (Id. at 27; see
Tr. 189.) Elaborating on his report, Dr. Gagné testified that
[T.W.]'s patient file reflects that Respondent prescribed Dilaudid to
[T.W.] on November 1, 2006, without an associated patient consultation,
and without mention in the medical notes that Respondent wrote such a
prescription. (Tr. 184-85.) Nor is there any mention of Dilaudid in
contemporaneous patient notes. (Tr. 185.) Dr. Gagné opined that
there is no record that would justify the prescription. (Tr. 185.) The
record further reflects a significant increase in an OxyContin
prescription from 20 mg, 180 count on September 20, 2006, to 80 mg, 300
count on November 21, 2006. (Tr. 186.) The record associated with
[T.W.]'s November 21, 2006 doctor's appointment does not justify
increasing the patient's OxyContin by that amount. (Tr. 186.) Dr.
Gagné testified that the entire situation "has a trolling-for-
drugs quality." (Tr. 186.) Dr. Gagné further found it unusual
that on the day Respondent increased the dose to 300 pills a month,
Respondent wrote "Stable on 5 OC two 12 H," because the patient was
not yet taking that many pills. (Tr. 187.) Patient [T.W.]'s medical
file also contains references to MRI and X-ray reports that are not
contained in the patient's medical file. (Tr. 187.)
---------------------------------------------------------------------------
\46\ In support of this opinion, Dr. Gagné notes in his
report [T.W.]'s self-reported "huge marijuana habit" which is
"telegraphing that he's an addict." (Gov't Ex. 3 at 26.)
---------------------------------------------------------------------------
Respondent testified he initially saw [T.W.] on September 20, 2006,
for a "cannabis recommendation." (Tr. 424; Gov't Ex. 16 at 41.)
Respondent further testified that he did not learn who was prescribing
[T.W.]'s current medications, stating "I don't really do that for
cannabis recommendations." \47\ Respondent testified in substance that
he normally handled cannabis recommendations at night, but after review
of [T.W.]'s chart information testified that [T.W.] must have come in
during the afternoon for a cannabis recommendation and pain management
visit. (Tr. 426 & 435-36.) Respondent testified that during the initial
consult with [T.W.] he prescribed the same medications [T.W.] had
stated [T.W.] was already prescribed. (Tr. 427.) Respondent provided no
credible explanation for the November 1, 2006 prescription that is not
associated with a corresponding clinical visit, other than to refer to
the November 21, 2006 note.\48\ (Tr. 428.) Respondent testified
consistent with the November 21, 2006 chart note that his plan was to
have [T.W.] obtain an X-ray, adding: "[T.W.] never did it, so I
discharged [T.W.]" (Tr. 428.) On the issue of suspecting [T.W.] may be
diverting, Respondent testified: "Intuitively I felt there was
something wrong with this patient, and I couldn't in just a few visits
really tell what--what [T.W.] was up to. But in retrospect, he was one
of the patients that sold, along with one other patient that sold * * *
." (Tr. 429.)
---------------------------------------------------------------------------
\47\ Respondent qualified his testimony, stating that he
currently determines who is prescribing medications for a new
patient, but was not doing so at the time of [T.W.]'s initial visit.
(Tr. 424.)
\48\ Reference to the November 21, 2006 chart note is irrelevant
to the November 1, 2006 prescriptions, which precede the November
21, 2006 visit. In any event, there is another prescription for
controlled substances associated with the November 21, 2006 visit.
(See Gov't Ex. 16 at 36.)
---------------------------------------------------------------------------
I do not find Respondent's testimony credible. Contrary to his
assertion that he "discharged" [T.W.] because of lack of an X-ray
following the November 21, 2006 appointment, the patient chart reflects
a follow-up note dated January 15, 2007, stating in part "Refill med
Patient stable * * * Need to repeat CT scan * * * ." (Gov't Ex. 16 at
9.) There is no credible evidence of record to support the suggestion
that [T.W.] was discharged by Respondent at any point prior to the
January 31, 2007 chart note indicating [T.W.] had been arrested for
"selling." \49\ Accordingly, I accept the findings and opinions of
Dr. Gagné pertaining to extreme deviations from the standard of
practice as noted above, which are well supported and consistent with
other credible evidence of record.
---------------------------------------------------------------------------
\49\ There is evidence of Respondent's lack of truthfulness with
regard patient [T.W.] after January 31, 2007. Apparently following a
telephone conversation with staff members of the facility detaining
[T.W.], Respondent wrote a letter to "Physician's at the Prison &
His attorney" stating in relevant part, "I saw [T.W.] a few visits
in my office where I prescribed [T.W.] [X]anax * * * for anxiety * *
* wellbutrin * * * for ADHD * * * Norco 10/325 * * * ." (Gov't Ex.
16 at 16; see Tr. 432.) On cross-examination Respondent stated he
was confused and did not "understand what was transpiring between
the prison doctor and myself at this time." (Tr. 433.) Respondent
admitted he wrote the letter and the statement as to prescribed
medications was "not a true statement." (Id.)
---------------------------------------------------------------------------
In addition to the foregoing, Respondent also testified at various
points that the nine patient files admitted as evidence may be
incomplete, or may otherwise have been altered, but offered no credible
evidence to support this suggestion.\50\ Respondent suggested staff
problems may have been the cause, but testified that "overall I'm
responsible because I'm the physician, owner of the practice; but when
you have difficulties with staff, they can burn you, they can burn you
bad." (Tr. 353.) I do not find credible Respondent's testimony
suggesting that his files would have been complete but for staff
neglect or tampering. As an initial matter, there is no objective
evidence of record to support Respondent's claim. To the contrary, as
discussed above, the objective record in numerous instances calls into
question the accuracy of Respondent's chart entries, Respondent's
testimony, or both.\51\ Additionally, the overall credibility of
Respondent's testimony was significantly undermined in numerous other
material areas, making it less likely that Respondent's unsupported
claims of tampering are true. In any event, Respondent is ultimately
responsible for the proper prescribing and dispensing of controlled
substances. 21 CFR Sec. 1306.04.
---------------------------------------------------------------------------
\50\ For example, Respondent testified at one point that "a lot
of things, I think are missing from this chart possibly because they
were friends. And the MA took it out and excluded it. I'm not sure.
I have no way of knowing it." (Tr. 385.) Respondent also testified
to a March 2007 theft of a computer containing prescription
information. (Tr. 316-19.)
\51\ See, e.g., Tr. 73 (finding annular tears absent medical
imaging); Tr. 394 (unexplained discrepancy in patient file as to
initial visit date and medication agreement); Tr. 424 (recording
"current medications" on patient representations alone, absent
corroboration from other prescriber); Gov't Ex. 15 at 7, 139
(notations in chart of "no evidence of abuse * * *" when
Respondent in fact did have such evidence).
---------------------------------------------------------------------------
Respondent also testified that he never received copies of the
fifty to seventy files seized by the police in August 2008, and
maintained that he was unaware the files had been returned to his
attorney. (Tr. 325-26.) On the issue of seized files, DI Lewis
testified that after the patient files were seized from Respondent
pursuant to a search warrant, two copies were made and one "copy of
these records w[as] returned through [Respondent's] attorney at the
time, and a second copy was provided to the Medical Board of
California." (Tr.
[[Page 19337]]
289.) The issue of whether Respondent ever received copies of his
patient files from his then-attorney is not directly relevant to the
instant case, because it is undisputed that Respondent received copies
of the patient files discussed herein well in advance of hearing.\52\
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\52\ At no time during pre-hearing proceedings did Respondent
raise by motion or otherwise this issue of unavailable files despite
numerous opportunities to do so, as more fully explained in the
procedural portion of this Recommended Decision. Respondent's
suggestion in testimony that the missing files impeded his ability
to take care of his patients is not a relevant issue in the instant
proceeding, even if true, because Respondent's misconduct at issue
in this proceeding predated the seizure of the nine patient files
discussed above. (Tr. 325.)
---------------------------------------------------------------------------
For the foregoing reasons, I find by substantial evidence that
Respondent issued a substantial number of controlled substance
prescriptions for other than a legitimate medical purpose and outside
the usual course of professional practice, in violation of federal and
state law.\53\ This finding weighs heavily in favor of a finding under
Factors Two and Four of 21 U.S.C. Sec. 823(f) that Respondent's
registration would be inconsistent with the public interest.
---------------------------------------------------------------------------
\53\ See 21 CFR Sec. 1306.04(a); 21 U.S.C. Sec. 841(a)(1); and
Cal. Health & Safety code Sec. Sec. 11217; 11153(a) and 11156(a);
Cal. Bus. & Prof. Code Sec. Sec. 2241; 2442(a) and 3600.
---------------------------------------------------------------------------
Factor 5: Such Other Conduct Which May Threaten the Public Health and
Safety
Under Factor Five, the Deputy Administrator is authorized to
consider "other conduct which may threaten the public health and
safety." 5 U.S.C. Sec. 823(f)(5). The Agency has accordingly held
that "where a registrant has committed acts inconsistent with the
public interest, the registrant must accept responsibility for his or
her actions and demonstrate that he or she will not engage in future
misconduct. Patrick W. Stodola, 74 Fed. Reg. 20,727, 20,734 (DEA
2009).\54\ A "[r]espondent's lack of candor and inconsistent
explanations" may serve as a basis for denial of a registration. John
Stanford Noell, M.D., 59 Fed. Reg. 47,359, 47,361 (DEA 1994).
Additionally, "[c]onsideration of the deterrent effect of a potential
sanction is supported by the CSA's purpose of protecting the public
interest." Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,094 (DEA
2009).
---------------------------------------------------------------------------
\54\ See also Hoxie v. DEA, 419 F.3d 477, 484 (6th Cir. 2005)
(decision to revoke registration "consistent with the DEA's view of
the importance of physician candor and cooperation.")
---------------------------------------------------------------------------
There was evidence presented at hearing pertaining to "other
conduct which may threaten the public health and safety." 5 U.S.C.
Sec. 823(f)(5). The OSC alleges that Respondent was arrested for
driving under the influence of controlled substances on June 13, 2008,
and that toxicology results revealed the presence of the controlled
substances marijuana, modafinil, oxazepam and temazepam, for which
Respondent lacked a prescription. The Government's evidence at hearing
included the testimony of DI Lewis, along with related alcohol and
toxicology reports and California Highway Patrol arrest reports. (Gov't
Exs. 6 & 7.) DI Lewis testified in substance that based on his
investigation, including a review of a CURES Report, there were
corresponding prescriptions for identified controlled substances in
Respondent's system with the exception of temazepam and marijuana. (Tr.
278-79.)
Respondent argues in substance that the "sole conviction for a
'wet and reckless' misdemeanor, to which Respondent pleaded guilty, and
which there is little evidence of any drugs for which he did not have a
valid prescription," as a single error, "is not any indication of
impairment or abuse, nor is there any other evidence of impairment or
abuse." (Resp't Br. at 8-9.) Respondent presented testimony from Dr.
Markowitz, who testified in substance that he is board-certified and
currently practicing psychiatry. (Tr. 257-58.) Dr. Markowitz testified
that he began treating Respondent in 2005, noting that Respondent was
"pretty severely depressed at the time," for which Dr. Markowitz
prescribed medications and Respondent "improved markedly pretty
quickly." (Tr. 259.) Dr. Markowitz diagnosed Respondent with major
depression along with generalized anxiety disorder, noting past
stressors of divorce, health, child visitation and financial issues.
(Tr. 260.) Dr. Markowitz further testified that upon review of the
toxicology document (Gov't Ex. 6) he prescribed two of the listed
medications, namely clorazepate, sold under the trade name Tranxene,
and Provigil, referred to on the toxicology report as "modafinil."
(Tr. 263-64.) Dr. Markowitz also opined that Respondent is not
"depressed at this time" and "from a psychiatric perspective, I
don't have any issues with his ability to practice." (Tr. 265.)
David Smiley Purvis also credibly testified to counseling
Respondent on a weekly basis since May 2008 for anger and frustration
management issues related to family matters. (Tr. 292-93.)
Respondent presented testimony in response to the June 2008 arrest,
along with testimony explaining his health and other personal issues
leading up to his August 2008 surrender of registration. Respondent
testified in substance to having serious health issues and surgery
between 2000 and 2002, as well as surgery again in 2004, and a heart
condition in 2005 that involved inpatient treatment. (Tr. 307.)
Additionally, Respondent testified to personal problems impacting his
life including a 2004 divorce with custody issues involving his child.
(Tr. 313-14.) Respondent further testified to ongoing issues with
depression, staff problems in his office, and two break-ins and thefts
from his office in 2007.
Turning to the June 2008 arrest, Respondent testified to pleading
to a "wet reckless" charge,\55\ and then took six months of classes
which "were about alcohol addiction." \56\ (Tr. 330.) Respondent
testified that he was taking three medications at the time:
"Provigil," "Tranxene," and an antidepressant which Respondent
thinks was "Pristiq." (Tr. 328.) Respondent testified that all three
were prescribed by Dr. Markowitz. Respondent's counsel then reminded
Respondent that Dr. Markowitz only identified two prescriptions, "but
you mentioned you were on three medications," to which Respondent
stated "[w]ell the third one was the metabolite of benzodiazepine."
\57\
---------------------------------------------------------------------------
\55\ No further evidence or explanation at hearing of term "wet
reckless" was offered, although as a matter of California practice
the term refers to violations of Cal. Veh. Code Sec. 23103.5 (West
2009). See, e.g., People v. Claire, 280 Cal. Rptr. 269, 271 n.2
(Cal. Ct. App. 1991) ("For the sake of convenience, we adopt this
sodden terminology.").
\56\ Respondent presented testimony regarding events surrounding
his arrest for driving under the influence, including testimony of
consumption of "one" glass of "ale." I note that Respondent's
testimony differs in various respects from the California Highway
Patrol report, including notations in the police reports that
Respondent admitted to drinking two beers. (See Gov't Ex. 7 at 2,
10.) In any event, given the absence of other evidence or
explanation for the discrepancies, I generally accept the testimony
of Respondent that this was an isolated incident involving
consumption of a relatively small quantity of alcohol. I also accept
Respondent's testimony that he completed a class on alcohol
addiction.
\57\ Respondent's answer regarding the "third" prescription is
at best non-responsive. Whether or not the third one was a
metabolite of benzodiazepine does not respond to the substantive
issue of whether Respondent had a prescription for the controlled
substance, nor does it explain Respondent's earlier testimony that
he thinks it was "Pristiq." No other testimony or evidence was
offered.
---------------------------------------------------------------------------
I find by a preponderance of the evidence that Respondent used
controlled substances, namely temazepam and marijuana, without a valid
prescription and contrary to state and federal law in or about June
2008.\58\
[[Page 19338]]
Respondent's argument that he was prescribed all of the controlled
substances in his system is directly contradicted by the credible
testimony of Dr. Markowitz and DI Lewis. I find no evidence of any
alcohol or other non-prescribed controlled substance use by Respondent
after June 2008, which is consistent with Dr. Markowitz's testimony and
opinion that Respondent is not currently suffering from depression.
---------------------------------------------------------------------------
\58\ Gov't Ex. 6 at 3; 21 U.S.C. Sec. 844(a); 21 CFR Sec.
1306.04(a); Cal. Bus. & Prof. Code. Sec. 4060.
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Agency precedent has "long held that a practitioner's self-abuse
of a controlled substance is a relevant consideration under factor five
and has done so even when there is no evidence that the registrant
abused his prescription writing authority." Tony T. Bui, M.D., 75 Fed.
Reg. 49,979, 49,989 (DEA 2010). Respondent's unlawful conduct in June
2008, which was associated with his use of alcohol and non-prescribed
controlled substances, is clearly an "indication of impairment or
abuse" at least in June 2008, and Respondent's argument to the
contrary is without merit. That said, Respondent's conduct appears to
be a relatively isolated event. Respondent testified to completing a
class on alcohol addiction and there is no evidence to support a
finding of alcohol or controlled substance abuse after June of 2008.
See Azen v. DEA, 1996 WL 56114 at *2 (9th Cir. Feb. 9, 1996)
(impressive evidence of rehabilitation and continued abstinence
important consideration). Accordingly, I find Respondent's conduct in
June 2008 to be inconsistent with the public interest and a relevant
consideration weighing somewhat against registration.\59\ See David E.
Trawick, D.D.S., 53 Fed. Reg. 5326, 5326 (DEA 1988) (holding that
"offences or wrongful acts committed by a registrant outside of his
professional practice, but which relate to controlled substances may
constitute sufficient grounds" for denying relief favorable to
Respondent, where Respondent had history of alcohol and controlled
substances abuse).
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\59\ In light of the absence of other evidence of controlled
substance and alcohol abuse, the passage of time, and Respondent's
attendance at alcohol addiction classes, I give this issue little
overall weight for purposes of my recommended decision.
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Because the Government has made out a prima facie case against
Respondent, a remaining issue in this case is whether Respondent has
adequately accepted responsibility for his past misconduct such that
his registration might nevertheless be consistent with the public
interest. See Patrick W. Stodola, 74 Fed. Reg. 20,727, 20,734 (DEA
2009). Respondent argues generally that the Government has failed to
demonstrate that granting Respondent a new registration would be
inconsistent with the public interest. But across various dimensions,
the record reveals that Respondent has not sustained his burden in this
regard. In fact, as discussed above, Respondent's testimony in numerous
material instances was not credible and reflected an overall lack of
admission of past misconduct, let alone acceptance of responsibility.
The passage of time since Respondent's misconduct is of no consequence
with regard to the issue of acceptance of responsibility. "DEA has
long held that '[t]he paramount issue is not how much time has elapsed
since [his] unlawful conduct, but rather, whether during that time * *
* Respondent has learned from past mistakes and has demonstrated that
he would handle controlled substances properly if entrusted with a' new
registration." Robert L. Dougherty, M.D., 76 Fed. Reg. 16,823, 16,835
(DEA 2011) (citing Leonardo V. Lopez, M.D., 54 Fed. Reg. 36,915, 36,915
(DEA 1989) and Robert A. Leslie, M.D., 68 Fed. Reg. 15,227, 15,227 (DEA
2003)). Respondent's testimony with regard to his June 2008 misconduct,
and his misconduct pertaining to Factors Two and Four, clearly indicate
a complete lack of acceptance of responsibility.
I find that Respondent's lack of credibility during numerous
material portions of his testimony weighs heavily in favor of denying
Respondent's application. See Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir.
2005) (DEA properly considers physician's candor, forthrightness in
assisting investigation and admitting of fault as important factors in
determining whether registration is consistent with public interest).
In light of the foregoing, Respondent's evidence as a whole fails to
sustain his burden to accept responsibility for his misconduct and
demonstrate that he will not engage in future misconduct. I find that
Factor Five weighs heavily in favor of a finding that Respondent's
registration would be inconsistent with the public interest.
VI. Conclusion and Recommendation
After balancing the foregoing public interest factors, I find that
the Government has established by substantial evidence a prima facie
case in support of denying Respondent's application for registration,
based on Factors Two, Four and Five of 21 U.S.C. Sec. 823(f). Once DEA
has made its prima facie case for revocation or denial, the burden
shifts to the respondent to show that, given the totality of the facts
and circumstances in the record, revoking or denying the registration
would not be appropriate. See Morall v. DEA, 412 F.3d 165, 174 (D.C.
Cir. 2005); Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v.
United States Dep't of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989);
Thomas E. Johnston, 45 Fed. Reg. 72, 311 (DEA 1980).
Additionally, where a registrant has committed acts inconsistent
with the public interest, he must accept responsibility for his actions
and demonstrate that he will not engage in future misconduct. See
Patrick W. Stodola, 74 Fed. Reg. 20,727, 20,735 (DEA 2009). Also,
"[c]onsideration of the deterrent effect of a potential sanction is
supported by the CSA's purpose of protecting the public interest."
Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,094 (DEA 2009). An
agency's choice of sanction will be upheld unless unwarranted in law or
without justification in fact. A sanction must be rationally related to
the evidence of record and proportionate to the error committed. See
Morall v. DEA, 412 F.3d 165, 181 (D.C. Cir. 2005). Finally, an "agency
rationally may conclude that past performance is the best predictor of
future performance." Alra Laboratories, Inc. v. DEA, 54 F.3d 450, 452
(7th Cir. 1995).
I recommend denial of Respondent's application for a COR. I find
the evidence as a whole demonstrates that Respondent has not accepted
responsibility and his registration would be inconsistent with the
public interest. Respondent's overall lack of candor while testifying
at hearing is fully consistent with a denial of Respondent's
application for a DEA COR.
Dated: April 29, 2011.
Timothy D. Wing,
Administrative Law Judge.
[FR Doc. 2012-7619 Filed 3-29-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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