Registrant Actions - 2011
[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Notices]
[Pages 17673-17694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7394]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09-12]
Bienvenido Tan, M.D.; Denial of Application
On October 31, 2008, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Bienvenido Tan, M.D. (Respondent), of Newhall,
California. The Show Cause Order proposed the denial of Respondent's
application for a DEA Certificate of Registration as a practitioner, on
the ground that ''his registration is inconsistent with the public
interest.'' ALJ Ex. 1, at 1.
More specifically, the Show Cause Order alleged that on April 12,
2007, Respondent ''voluntarily surrendered [his] controlled substances
privileges'' when he was under investigation for illegally distributing
controlled substances, and that in February 2008, he had applied for a
new registration. Id. The Order alleged that ''[l]aw enforcement
personnel conducted at least eleven (11) undercover visits'' to
Respondent's office between October 2006 and March 2007 and that on
several occasions, he had prescribed Lorcet and Vicodin, schedule III
controlled substances which contain hydrocodone, as well as alprazolam,
a schedule IV controlled substance, to them ''with cursory or no
medical examinations, and without a legitimate medical purpose.'' Id.
(citing 21 CFR 1306.04).
The Show Cause Order further alleged that a medical expert had
reviewed Respondent's files and ''found 'strong
[[Page 17674]]
evidence for inappropriate prescribing of controlled [substances]'' and
that his ''prescribing was 'an extreme departure from the standard of
care expected of a licensed practicing physician.'" Id. at 2. The
Order also alleged that Respondent had admitted to investigators that
he ''authorized an employee to dispense controlled substances to [his]
patients in violation of state law.'' Id. at 1 (citing Cal. Bus. &
Prof. Code Sec. 4170).
By letter of November 4, 2008, Respondent timely requested a
hearing and the matter was placed on the docket of the Agency's
Administrative Law Judges (ALJs). Following pre-hearing procedures, an
ALJ conducted a hearing from March 24 through March 26, 2009 in Los
Angeles, California. At the hearing, both parties called witnesses to
testify and submitted documentary evidence. Thereafter, both parties
filed post-hearing briefs.
On January 8, 2010, the ALJ issued her recommended decision (also
ALJ). Therein, the ALJ considered the evidence relevant to the five
public interest factors. See 21 U.S.C. 823(f).
As to factor one--the recommendation of the appropriate State
licensing board--the ALJ found that the Medical Board of California
(''the Board'') had not made a recommendation in this matter. ALJ at
34. The ALJ then noted that the Board had brought a proceeding against
Respondent based on its review of three patient files (which are not at
issue in this proceeding), but had found that ''cause did not exist to
discipline the Respondent's medical license 'for prescribing without a
good faith examination and medical indication, as to all three
patients.'" Id. The ALJ noted, however, that the Board found that
''cause did exist to discipline Respondent's medical license 'for
maintaining inadequate records' for one of the three patients'' and
that the Board ''publicly reprimanded the Respondent 'for his
departures from the standard of care regarding his medical record
keeping' of that specific patient.'' Id. at 34. The ALJ did not make a
finding as to whether this factor weighed for or against a finding that
Respondent's registration was inconsistent with the public interest.
See id.
The ALJ then considered factors two and four--the applicant's
experience in dispensing controlled substances and his compliance with
applicable Federal, State, or local laws related to controlled
substances--together. Under these factors, the ALJ considered evidence
pertaining to various undercover visits by a Special Agent (SA) and
Confidential Informant (CI), Respondent's dispensing practices, his
office procedures, and his recordkeeping. Id. at 35-39.
With respect to the undercover visits, the ALJ did not make
findings as to whether the prescriptions Respondent issued to the SA or
CI violated the CSA's prescription requirement. Id. at 36-37. Instead,
the ALJ observed that ''[t]he primary concern regarding the Respondent
is his dispensing practices.'' Id. Noting that the evidence showed that
''Respondent is dispensing multiple times more dosage units than the
patient should consume, if taking the medication as prescribed,'' the
ALJ explained that ''either the patient is at risk of taking an
overdose of the controlled substances, or the patient is diverting the
controlled substances to the illicit market.'' Id. at 37. ''Based on
this factor alone,'' the ALJ concluded that ''the Government has
established a prima facie basis for denying * * * Respondent's
application for a DEA registration.'' Id. at 38.
The ALJ further found that Respondent ''is allowing unlicensed
office staff to fill and dispense controlled substances.'' Id. She also
found that Respondent did not require his pain patients to undergo
urine or blood screens to determine whether they were actually using
the drugs he prescribed and to determine whether they were taking drugs
obtained either from other doctors or on the street. Id. The ALJ
concluded that this ''allows diversion of such medications without
detection by * * * Respondent.'' Id.
The ALJ also found relevant Respondent's continuing to prescribe
controlled substances without obtaining his patient's medical records.
Id. She further noted that Respondent increased dosages without
performing physical examinations, and that in some cases, he continued
to prescribe controlled substances to patients for ''almost a year''
without seeing them. Id. at 38-39. Finally, she noted that while in
some cases, he had indicated ''his desire to decrease the dosage units
of controlled substances,'' he would ''oftentimes without even seeing
the patient * * * return to the higher dosage without recording his
treatment plan or otherwise explaining the higher dosage in the
patient's records.'' Id. at 39. The ALJ, therefore, concluded that
these factors support a finding that Respondent's registration is
inconsistent with the public interest.\1\
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\1\ With respect to factor three--Respondent's record of
convictions for offenses related to the dispensing or distribution
of controlled substances--the ALJ noted that there is no evidence
that he has been convicted of an offense within this factor. ALJ at
39.
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Turning to factor five--such other conduct which may threaten the
public health and safety--the ALJ reviewed the reports of each party's
experts (who had examined various patient records) regarding the
standard of care for prescribing controlled substances. Id. at 39-43.
The ALJ noted that she had ''a problem with the conclusions of both
expert witnesses.'' Id. According to the ALJ, this was so because the
Government's expert had opined that Respondent's care was ''markedly
below the accepted standards of licensed physicians in the United
States today,'' thus suggesting that he had not applied the standard
applicable under California law, id. at 40-41, and Respondent's expert
had opined that he should be compared against ''physicians of similar
age, training, and background,'' which ''is not the standard followed
in California.'' Id. at 41.
The ALJ noted, however, that in preparing his report, the
Government's Expert had relied on the Medical Board of California's
''Guidelines for Prescribing Controlled Substances for Pain.'' Id. at
42. Because the Government's Expert's conclusions were ''more
consistent with the California requirements for determining the
standard of care,'' she found persuasive his findings that Respondent's
charting practices were ''extremely deficient,'' that there were
''inadequate records of consultation requests for further medical
evaluations,'' and that ''it would not be safe [for a patient] to
ingest the quantity of controlled substances received in that short of
a period of time'' as occurred between the dates on which Respondent
dispensed controlled substances to the various patients. Id. at 40, 43.
The ALJ thus found that this ''factor * * * weighs in favor of denying
the Respondent's application,'' and that ''[i]n total * * * the
Government has met its burden of proof in presenting a prima facie case
for denying the Respondent's application for a DEA registration.'' Id.
at 43.
The ALJ then discussed various facts she deemed favorable to
Respondent. These included that he ''was not dispensing controlled
substances for monetary gain,'' that he ''refused to prescribe
Oxycontin because of its addictive properties,'' that he ''refused to
prescribe controlled substances for recreational purposes,'' and that
because he had a major increase in patients, he did not see them as
often as necessary and did not keep careful track of his refills. Id.
at 43-44. The ALJ further noted that ''Respondent credibly testified
that, if given a DEA registration, he would use the CURES
[[Page 17675]]
database \2\ and he would limit his prescribing of controlled
substances to the PDR \3\-defined limits.'' Id. at 44. The ALJ
nonetheless concluded that ''this does not go far enough'' because
Respondent had failed ''to address his use of unlicensed individuals to
dispense controlled substances,'' as well as what ''procedures he would
put in place to monitor his patients to ensure they were consuming the
controlled substances as prescribed.'' Id. at 44-45. Thus, the ALJ
recommended that ''Respondent's application for a DEA registration * *
* be denied at this time.'' Id. at 45.
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\2\ CURES is a database maintained by the State of California,
Bureau of Narcotics Enforcement, from which doctors may obtain
Patient Activity Reports (PARs) showing a patient's controlled
substance prescriptions and who prescribed them. GX 39; Tr. 104.
Dispensers of controlled substances, including pharmacies and
physicians who dispense, must report to CURES. Id. Thus, the PARs
allow a physician to determine whether a patient is receiving
controlled substances from other doctors and is thus engaged in
doctor shopping. Id. at 103.
\3\ The PDR, or Physician's Desk Reference, contains
manufacturers' recommendations as to the dosing of drug products. RX
D, at 3.
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On January 28, 2010, Respondent filed Exceptions to the ALJ's
Decision; these Exceptions have been considered and are discussed
throughout this decision. Respondent also requested that the ALJ reopen
the record and admit his Exhibit A, which is a sworn statement signed
by him and dated January 27, 2010, addressing the ALJ's findings that
he had failed to address several critical deficiencies identified in
the proceedings. Resp. Exceptions at 10.
On February 16, 2010, the ALJ denied Respondent's request, noting
that Respondent should have been aware of ''the Agency's longstanding
rule'' that where "'the Government has made out a prima facie case
that a practitioner has committed acts which render his registration
inconsistent with the public interest, the relevant inquiry is whether
a practitioner has put forward 'sufficient mitigating evidence to
assure the Administrator that he can be entrusted with the
responsibility carried by such a registration.'" Order Denying
Respondent's Request to Reopen the Record and Include ''Exhibit A,'' at
2 (citations omitted). The ALJ further explained that ''this inquiry
looks to whether the registrant has accepted responsibility for his
misconduct and undertaken corrective measures to prevent the re-
occurrence of similar acts.'' Id. While noting that ''[t]he evidence
might have proven material when considering whether or not Respondent's
continued registration would be a threat to the public interest,'' the
ALJ noted that the evidence was available at the time of the hearing
and that Respondent had the ''burden of persuasion'' on the issue. Id.
at 4. She therefore denied Respondent's request to reopen the record.
Id. Finding no error, I adopt the ALJ's ruling denying Respondent's
request to reopen the record.
Thereafter, on February 18, 2010, the ALJ forwarded the record to
me for final agency action. Having reviewed the record in its entirety
and considered Respondent's Exceptions, I adopt the ALJ's findings
except as expressly noted herein. I also adopt her recommendation that
I deny Respondent's application. As the ultimate finder of fact, I make
the following findings.
Findings
Respondent has been a licensed physician and surgeon in the State
of California since 1959; he was 83 years old at the time of the
hearing. ALJ Ex. 3, at 1; Tr. 553. Respondent previously held a DEA
Certificate of Registration, which authorized him to dispense
controlled substances in schedules II through V. GX 2. However, on
April 12, 2007, Respondent voluntarily surrendered his registration.
Id. On February 29, 2008, Respondent applied for a new registration;
this application is at issue in this proceeding. ALJ Ex. 3, at 2; GX 1.
Until 1998, Respondent primarily practiced as a surgeon. During
this period, he also had a family practice with four offices and
operated a dispensary on the premises of his practice for thirty to
forty years. Tr. 562, 570, 598. From 1968 through 1998, he owned and
operated Newhall Community Hospital, where he was the Medical Director
and also a staff surgeon. Id. at 599, 602. During the course of his
surgical career, Respondent had occasion to prescribe pain medications;
while running the hospital he often had discussions with colleagues on
pain medicine issues. Id. at 597, 602.\4\
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\4\ Respondent excepted to the ALJ's Decision arguing that it
''neglect[ed] to recognize Respondent's medical training as a
surgeon and his years of experience with pain management as a
surgeon and as the chair of the Newhall Community Hospital and as a
participant in hospital peer review proceedings dealing with pain
management.'' Resp. Exc., at 4.
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In 1998, Respondent opened his current family practice. Tr. 563.
While he is not formally trained in pain management, in 2003 he
attended a 5-day course on pain management. Id. at 564, 638. At that
course, he learned about Pain Management Agreements and Patient Comfort
Assessment Guide tools, which he began to utilize in his practice. Id.
at 307-09.
The State Board Proceeding
On June 20, 2006, the Medical Board of California (the Board) filed
a seventeen-count accusation against Respondent's medical license based
on his treatment of patients P.P., D.F., and K.Z. RX A, at 2; RX V. The
allegations included, inter alia, that Respondent had prescribed
various drugs without performing adequate physical examinations and
taking adequate histories, that he had committed negligent and
incompetent acts, and that he had failed to maintain adequate records.
RX V.
On April 2, 2007, a State ALJ rejected all of the allegations
except for that which alleged that Respondent's recordkeeping with
respect to K.Z. was inadequate. RX A, at 18. The State ALJ thus
recommended that Respondent be ''publicly reprimanded * * * for his
departures from the standard of care regarding his medical record
keeping of patient K.Z.'' Id. at 22. On May 4, 2007, the Board adopted
the State ALJ's decision. Id. at 1. Of note, in this proceeding, the
Government does not rely on Respondent's treatment of any of these
three patients.\5\
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\5\ In his decision, the State ALJ found that Respondent had
told patient K.Z. that he could take Vicodin at the rate of up to
twelve tablets per day. RX A, at 6. The ALJ also found that one of
the Board's experts had observed that at one point, K.Z. would have
been consuming ''approximately nine grams of Acetaminophen'' per day
and that the expert ''considered any quantity over four grams of
Acetaminophen [per day] troubling.'' Id. at 10. While the State ALJ
found that the Physician's Desk Reference (''PDR'') states that
"'[t]he total 24 hour dose [of Vicodin] should not exceed five
tablets,'" id. at 13, he did not make any further finding as to
whether there is an appropriate maximum dose of drugs containing
acetaminophen such as Vicodin and simply concluded that the Board
had failed to show that Respondent's ''off-label dosage instructions
departed from the standard of care.'' Id. at 20. This is not the
same as saying--as Respondent testified--that the Board found that
the maximum safe dosage of Vicodin ES is twelve tablets per day, and
of Lorcet, eighteen tablets per day. Tr. 299-300. Indeed, according
to one of the findings of the State ALJ's decision,
''[a]cetaminophen is potentially toxic if between 7.5 to 10 grams
are consumed daily for one to two days.'' RX A, at 14 (citation
omitted).
However, for the purpose of resolving this proceeding, I accept
the premise that Respondent had a good faith belief that a patient
can safely consume up to 9 to 10 grams per day of acetaminophen.
However, even accepting this, there was ample other evidence
including an expert's report establishing the need to perform
regular blood tests to determine how ingesting this much of the drug
is affecting a patient's liver function.
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The DEA Investigation
In either August or September 2006, DEA's Los Angeles Field
Division received information from a confidential source that
Respondent was
[[Page 17676]]
unnecessarily prescribing hydrocodone to the ''younger, mid-twenties
population.'' Tr. 24. Thereafter, a DEA Diversion Investigator (DI)
obtained reports from the Controlled Substance Utilization Review and
Evaluation System (CURES), the State's prescription monitoring program
showing prescriptions issued for schedule II through IV controlled
substances, as well as ARCOS, a DEA database which monitors the sale of
Schedule III and IV controlled substances from manufacturers and
distributors. Id. at 25-27; GX 39. While the CURES report showed
''minimal activit[y],'' Tr. 26, the ARCOS report showed that between
2004 and 2006, Respondent's purchases of hydrocodone had increased from
63,600 tablets to 388,000, and that between January 1 and April 11,
2007, Respondent purchased 221,000 such tablets. Id. at 26-27; GX 4.\6\
According to the DI, such large hydrocodone purchases were not
consistent with a family practice or even with the operation of a
typical family pharmacy, which he estimated might purchase 100,000
hydrocodone tablets per year. Tr. 44. Among physician purchasers of
hydrocodone in the Los Angeles area, Respondent ranked second; the
ARCOS database could not be queried, however, as to a ranking for
physicians who also operate their own dispensaries. Id. at 28-30, 34,
43-44.
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\6\ Respondent testified that during these years, his practice
was growing. Tr. 282. In 2004, he had 1,740 patients; in 2005, he
had 1,970 patients; in 2006, he had 2,320 patients; and in 2007, he
had 2,353 patients. Id. He indicated that the reason for this
increase was that prior to his heart surgery in 2003, he had
retained a physician's assistant at his practice. Id. at 283.
However, on losing patients after the heart surgery, he had
dismissed the physician's assistant. Id. He attributed the
subsequent growth of his practice to the fact that the patients were
able to see him instead of just a physician's assistant. Id. at 284.
Respondent further testified that with the increase in patients, he
also experienced an increase in pain patients and therefore
increased his purchases of Vicodin and other opioids. Id. The ALJ
''generally f[ou]nd the Respondent's testimony credible.'' ALJ at 10
n.4.
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During the investigation, the DEA sent an undercover special agent
(SA) using the name of ''Kim Jackson'' to Respondent in an attempt to
obtain controlled substances. Tr. 51. The SA wore a wire and was
monitored by a DI. Id. at 52.
At the SA's first undercover visit with Respondent on October 3,
2006, she told Respondent that she had just moved from Montana and had
been getting Vicodin, a Schedule III controlled substance which
contains hydrocodone and acetaminophen, from a physician there. Tr.
187, 192 (playing of GX 47 in hearing); GX 47; RX AA, at 1 (transcript
of visit); see 21 CFR 1308.13(e). When Respondent asked her why she was
taking the Vicodin, she responded, ''It just made me feel better.'' Tr.
193; GX 47; RX AA, at 1. Respondent then said, ''No, you know, I don't
prescribe Vicodin for recreational purposes or to feel better * * *
because Vicodin is a controlled drug and it is specifically for
specific pains, you know?'' Tr. 193-94; GX 47; RX AA, at 1. The SA then
inquired whether ''if [her] back hurt'' would ''be a way to get'' the
drug. Tr. 194; GX 47; RX AA, at 1. Respondent replied: ''Yeah, what
happened to your back?'' Tr. 194; GX 47; RX AA, at 1. The SA answered:
''I don't really specifically remember anything happening to it. But if
it hurt, would Vicodin help it?'' Tr. 194; GX 47; RX AA, at 1.
Respondent answered in the affirmative.
Respondent then inquired about the doctor in Montana who had
prescribed the Vicodin and whether that physician had obtained
additional studies given her report of back pain. Tr. 194-95; GX 47; RX
AA, at 1-2. The SA indicated that the doctor in Montana performed a
physical examination but did not take x-rays or order any other tests.
Tr. 195; GX 47; RX AA, at 2. Respondent then noted that it was
''unusual'' for someone as ''young'' as the SA to be having back pain,
and asked: ''where in your back are you having the pains?'' Tr. 195; GX
47; RX AA, at 2. The SA answered: ''I don't specifically have it, I was
just asking you if that would be a reason someone would have it?'' Tr.
195; GX 47; RX AA, at 2. Respondent next stated, ''well you know, if it
is for that reason for now * * * I can give you a prescription * * *
which Vicodin are you using? Extra strength?'' Tr. 196; GX 47; RX AA,
at 2. The SA told Respondent that she was getting 10 mg. strength. Tr.
196.
Shortly thereafter, Respondent then asked, ''Which part of your
back are you hurting * * * show me where?'' Tr. 196; GX 47; RX AA, at
2. The SA responded, ''Here.'' Tr. 196; GX 47; RX AA, at 2. She then
elaborated, ''it's not really sensitive.'' Tr. 196; GX 47; RX AA, at 2.
When Respondent asked her how long she had been having the pain, the SA
replied, ''A couple years I guess.'' Tr. 196; GX 47; RX AA, at 2.
Respondent indicated that he would write for thirty tablets of 10 mg.
Vicodin (Vicodin ES) but that ''we have to have more documentation as
to * * * why this [sic] controlled drugs * * * are being prescribed for
you, you know?'' Tr. 196; GX 47; RX AA, at 2.
Regarding her having pointed to her lower back and her statement
that she had had pain for a ''couple years I guess,'' the SA testified
that she had told Respondent several times that she ''was not in pain''
and that she wanted Vicodin ''because it made me feel good.'' Tr. 216.
The SA further testified that Respondent was trying to provide her
''with a story--oh, okay, yes, that works--back pain.'' Id. The SA also
testified that Respondent did not appear to be hard of hearing as she
was never asked to repeat herself. Id. While the SA acknowledged that
Respondent may have been skeptical of whether she had pain, she
testified that ''right after that, he agreed to give me the Vicodin
without further examination or questions.'' Id. at 217.
Respondent then indicated that he could either give her a
prescription or that she could buy the medication from his dispensary.
Tr. 197; GX 47; RX AA, at 3. The SA opted to buy her Vicodin from the
dispensary. Tr. 197; GX 47; RX AA, at 3. Respondent instructed her to
take the Vicodin as one tablet every eight hours. Tr. 198; GX 47; RX
AA, at 3. The SA's visit with Respondent lasted approximately six
minutes. Tr. 192, 199.
The SA received a paper bag containing Vicodin from the
receptionist. Tr. 201. According to the SA, she did not receive
anything in writing from Respondent notifying her that she had the
option of obtaining the medication either with a prescription from a
pharmacy or from his dispensary. Id. at 201. When the DIs later counted
the pills, there were thirty-five tablets, not thirty. Id. at 202.
According to the patient record, Respondent observed a ''muscle
spasm.'' GX 14, at 4. In her testimony, the SA stated that Respondent
examined her back ''for maybe five seconds, at which time he touched me
two to three times, lightly.'' Tr. 200. She also testified that
Respondent never mentioned back spasms to her and that she never
mentioned that she had back spasms to him. Id. The SA further testified
that in examining her, Respondent never saw her skin as he did not lift
the garment covering her back. Id. at 213.
In his testimony, Respondent asserted that when he touched the SA's
back, he noticed muscle spasms, which confirmed his ''impression that
she did [have] back pain.'' Tr. 404. Respondent also testified that
usually when he detects muscle spasms in a pain patient, he does not
mention it to the patient but only notes it in the patient record as
the observation is a ''confirmation for [his] own information.'' Id. at
319. According to Respondent, a physical examination of the back
largely ''is by palpation of the back muscles.'' Id. at 486. He further
maintained that, in checking for muscle spasms, it is preferable to
touch through light clothing rather than to touch skin directly so as
to avoid cold hands triggering a muscle spasm. Id. at 320.
[[Page 17677]]
Regarding the SA's visit, Respondent testified that in almost fifty
years of practicing medicine he had never had a patient claim to not
have pain yet request pain medication; nor had a patient who initially
claimed to not have pain later claim to have pain. Id. at 404-05.
According to Respondent, ''I don't believe, nor do I remember, that she
told me that she did not have any back pain.'' Id. at 405.
The ALJ found that ''Respondent credibly testified that he believed
she was suffering from back pain for the past two years. He believed he
saw muscle spasms, which would be consistent with back pain.'' ALJ at
7. The ALJ did not explain how Respondent would have seen muscle spasms
given the SA's testimony that he did not lift the garment that was
covering her back. Nor did she reconcile her credibility findings with
the actual conversation which was recorded during the visit which shows
that Respondent had agreed to provide the Vicodin before the Agent had
made any representation that she had back pain.
If taken as instructed, the thirty pills that the SA should have
received would have lasted a minimum of ten days. On October 19, the SA
phoned Respondent's office and requested a refill of Vicodin and asked
for sixty pills instead of the thirty of her initial prescription. Tr.
202. The receptionist told her to call back after 3:00 to confirm
whether the refill was approved. Id. When the SA called back, she was
told that the refill had been approved; the SA picked up the
prescription the following day. Id. at 203.
If taken as prescribed, the refill should have lasted a minimum of
twenty days. Eighteen days later, on November 7, the SA called for
another refill and asked for 120 Vicodin because she was going out of
town. Id. This time, the SA was not told to call back to verify whether
the refill had been approved. Id. Two days later, the SA obtained the
drugs. Id.
At an appointment on December 1, 2006, the SA told Respondent that
Vicodin made her nauseous and requested OxyContin. Tr. 203-04; RX Z, at
2. Respondent stated that OxyContin had worse side effects and that he
would give her Lorcet (another hydrocodone drug) instead. Tr. 204; RX
Z, at 3. He also recommended that she get massaged with warm olive oil
and use a heating pad on her back. RX Z, at 3-4. The SA received 120
Lorcet from Respondent's staff on that day. Tr. 204. The SA also
testified that although she had been asked to bring her medical records
during the phone call in which she made her initial appointment, she
never did and was never again asked to bring them. Id. at 205. On
cross-examination, the SA testified that she did not receive early
refills. Id. at 226.
R.E., who had reported Respondent to the DI, also agreed to wear a
wire and visit Respondent; a portion of the recording of his initial
visit was played at the hearing. Tr. 55; GX 47. On October 13, 2006,
R.E. visited Respondent. GX 12, at 3. R.E. complained of stiffness in
his neck which he had had for ''a couple of years'' duration and said
that he had been taking Norco, a drug which contains 10 mg. hydrocodone
and 325 mg. acetaminophen. Tr. 60-61, 68; GX 12, at 3, GX 47. R.E. also
indicated that he had tried acupuncture and ''[a] little yoga.'' Tr.
63. He also complained that it was hard for him to fall asleep. Id. at
64.
During the visit, Respondent touched R.E. lightly on the neck a
couple of times. While Respondent noted the presence of muscle spasms
in R.E.'s patient record, the recording of the visit contains no
comment by Respondent which indicates that he had found that R.E. had a
muscle spasm. GX 12, at 3; Tr. 60-67. The DI also testified that when
he interviewed R.E. after the visit, R.E. never mentioned that
Respondent had said that he had muscle spasms. Tr. 122. Respondent
advised R.E. to use a heating pad and to get someone to massage the
muscles for him. Id. at 63. Respondent also told R.E. he could either
provide, or write a prescription for, 60 Vicodin ES, as well as 60
Xanax (alprazolam) to help him sleep. Id. at 64. R.E. opted to buy the
drugs from Respondent's dispensary and Respondent instructed him to
take one Vicodin ES every eight hours and one Xanax at night for sleep
and another during the day ''if you need it.'' Id. at 65, 174; GX 12,
at 3.
If taken as directed, the Vicodin ES thus should have lasted twenty
days; the Xanax should have lasted thirty days. On October 20, one week
later, R.E. obtained a refill of 120 Vicodin ES. GX 12, at 5. According
to R.E.'s patient record, on November 9, R.E. did a follow-up
appointment with Respondent at which time Respondent switched him to
Lorcet and dispensed to him 120 tablets, with the instruction to take
one tablet every six hours. GX 12, at 5.
While this quantity would have provided a thirty-day supply if
taken as directed, on December 1 (twenty-two days later), R.E. obtained
a refill of 150 Lorcet, 30 tablets more than the previous refill. While
if taken as directed, this refill would have lasted thirty-seven days,
only six days later on December 7, Respondent approved refills for
another 150 Lorcet with the same dosing instructions, as well as for 60
Xanax. Id. at 6.
On February 27, 2007, R.E. received refills for 150 Lorcet (again a
thirty seven-day supply) and 60 Xanax, with the same dosing
instructions. Id. On March 13, R.E. obtained another refill for 150
Lorcet and Respondent changed the dosing instruction to one tablet
every four hours. Id. However, there are no notes indicating that
Respondent had talked with R.E. and learned of any change in his
condition that would support an increase in the dosing. Beside
Respondent's initials on the phone message requesting the refill is the
message: ''Need visit & agreement.'' Id. at 9. A note saying ''No
Refill'' three times in a row followed by ''NEEDS TO BE SEEN,'' dated
March 19, 2007 appears in R.E.'s patient record. Id. at 7.
A CURES Patient Activity Report (PAR) indicates that R.E. received
hydrocodone/apap 7.5 mg./300 mg. from another doctor on November 8,
2006; Vicodin ES the following day from another doctor; and Suboxone
\7\ from another doctor on November 22. GX 44, at 2. On December 6,
2006, R.E. received more hydrocodone/apap 7.5 mg./300 mg., as well as
diazepam, from yet another doctor; on February 13 and March 5, 2007, he
received Suboxone from the same physician who had issued the
prescription filled on November 22. Id.
---------------------------------------------------------------------------
\7\ Suboxone is a drug which is used to detoxify addicts from
narcotics. Tr. 111.
---------------------------------------------------------------------------
R.E. had disclosed to DEA Investigators his consumption of
Suboxone. Tr. 126. The DI testified that during the time that R.E.
worked as a confidential informant, he had no reason to believe that
R.E. was improperly consuming controlled substances.\8\ Id. at 179.
---------------------------------------------------------------------------
\8\ The record does not indicate at what point DEA became aware
that R.E. was obtaining controlled substance prescriptions from
other doctors or what course of action investigators took as a
result. Because my findings regarding Respondent's prescribing to
R.E. are based on the recording of his visit (which was played into
the record) and his patient file, R.E.'s credibility is not in
issue.
---------------------------------------------------------------------------
The investigators subsequently obtained warrants to search
Respondent's office and residence. Id. at 70. On April 12, 2007, the
warrants were executed and the authorities seized approximately one
hundred patient records which were selected based on these persons
having received large quantities of hydrocodone, Xanax, and Valium; the
DIs also seized the patient files for the SA and CI. Id. at 90-91.
During the search of Respondent's residence, the DIs interviewed him.
Id. at 71.
[[Page 17678]]
In the interview, Respondent indicated that he had approximately
two thousand patients, including approximately fifty pain patients for
whom he either wrote prescriptions or dispensed medication. Id. at 72.
Respondent related that he took primarily cash patients and some
MediCal patients but he did not take patients with private insurance.
Id. at 90.
Respondent further stated that an employee, H.C., filled the
prescriptions at his dispensary. Id. at 73. According to the DI, H.C.
was not licensed in California to dispense drugs. Id. Respondent told
the DIs that those patients who wanted refills would call his office,
that he reviewed the requests, and that where appropriate, he approved
a refill. Id. He further stated that he would authorize a refill
approximately once a month. Id. The DI testified that Respondent's
statement as to the frequency of his authorizing of refills was not
consistent with what he observed in the patient files. Id. at 73-74.
As discussed below, the various patient records include slips
memorializing the refill requests his patients phoned in. Respondent
testified that upon reviewing these slips, he would instruct his staff
to note on the slip when the patient had last received a refill
(indicated by ''LR'') and/or the date when he/she had last been seen
(indicated by ''LS''). Id. at 337-38. He further testified that he used
follow-up visits to obtain ''information as to how that patient is
doing at the particular moment'' which he would use ''either to keep
the medications the same, lower it, or increase it.'' Id. at 337.
Respondent further testified that H.C. repackages pain medications
into smaller bottles and labels them with pre-labeled dosing
instructions. Id. at 306, 328. H.C. then brings the pain medication to
''the girl in front who in turn gives them to the patient who pays [for
the drug] up front.'' Id. at 328.\9\
---------------------------------------------------------------------------
\9\ Respondent later identified this individual as the
receptionist, who first takes a patient's payment. Tr. 592.
---------------------------------------------------------------------------
Respondent admitted, however, that he did not personally supervise
the receptionist as she delivered the controlled substances to his
patients. Id. at 593. He also testified that his pharmacy, including
his manner of dispensing medication to patients, was inspected by the
Medical Board on two separate occasions and that he was not cited for
any infractions. Id. at 328-29. Respondent was not present during one
of the inspections. Id. at 329.
The DI also obtained additional PARs from CURES. These reports
showed that four additional patients whose prescriptions were at issue
in the proceeding obtained controlled substances from other physicians
during the same period in which they obtained controlled substances
from Respondent. Id. at 108-11; GXs 41, 42, 44, 45. California
authorizes a licensed physician to obtain PARs ''so that well-informed
practitioners can and will use their professional expertise to evaluate
their patients' care and assist patients who may be abusing controlled
substances.'' GX 39, at 2.
Respondent testified that he was unaware of the availability of
PARs until he saw the documents the Government was presenting in this
proceeding. Tr. 343. He testified that, should his registration be
restored, he would use the database when a patient is requesting
refills too quickly, when a patient reports at his initial visit that
he has already been on controlled substances, as well as thirty days
after having prescribed controlled substances to a patient. Id. at 344,
557-58.
The Expert Reports on the Standard of Care and Usual Course of
Professional Practice
At the hearing, neither party offered the testimony of an expert
witness. However, each party submitted into evidence a report from a
physician who had reviewed at least some of the patient files in
question. GX 6; RX D. While neither party's witness was formally
qualified as an expert (as would likely be the case if they had been
called to testify), both parties referred to the physicians as experts
and the ALJ treated them as such, as do I.
The Government's Expert was Rick Chavez, M.D. Dr. Chavez, who holds
a B.A. from Stanford University and obtained his M.D. from the U.C.L.A.
School of Medicine, is the founder and Medical Director of The P.A.I.N.
Institute and is an Assistant Clinical Professor of family medicine at
the U.C.L.A. School of Medicine. GX 6, at 33; GX 5. Dr. Chavez holds
board certifications in family practice, pain management, and addiction
medicine. GX 5, at 1. He is a member of the American Academy of Pain
Management, the Society for Pain Management, the American Society of
Interventional Pain Physicians, the American Pain Society, and the
American Academy of Addiction Psychiatry. Id. at 8.
In addition to his medical practice, since 2001 Dr. Chavez has
served as a Consultant/Physician Reviewer for the California Board of
Medical Quality Assurance. Id. In this capacity, he reviews cases
involving pain management, family medicine, addiction medicine, and
general medical quality.\10\ Id.
---------------------------------------------------------------------------
\10\ Dr. Chavez also has extensive experience in conducting
utilization review and case management, which involves monitoring
the activities of primary care physicians for excessive or
unwarranted use of services in pain management, neurosurgery,
plastic surgery, orthopedics, podiatry, and general surgery. GX 5,
at 3-4. He has also ''developed guidelines for surgical, orthopedic,
plastic surgery and pain management procedures to ensure appropriate
utilization and quality of care.'' Id. at 4.
---------------------------------------------------------------------------
Respondent's Expert was William A. Norcross, M.D. Dr. Norcross
received a B.S. from Ursinus College and his M.D. from the Duke
University School of Medicine and holds board certification in family
practice and geriatric medicine. RX D, at 5. At the time of the
hearing, he was the Director of the University of California--San
Diego's Physician Assessment and Clinical Education (PACE) Program and
a Professor of Clinical Family Medicine at the University's School of
Medicine. Id. at 6. However, Dr. Norcross is not board-certified in
pain management.
In their respective reports, Dr. Chavez reviewed fifteen patient
files; \11\ Dr. Norcross reviewed four patient files. See GX 6; RX D.
In their reports, both Dr. Chavez and Dr. Norcross opined as to whether
Respondent had met the standard of care. However, Dr. Chavez provided
an extensive discussion of what steps Respondent was required to take
in order to meet the standard of care and discussed the Medical Board
of California's Guidelines for Prescribing Controlled Substances for
Pain (Guidelines), which were first adopted in 1994.\12\ GX 6, at 16.
By contrast, Dr.
[[Page 17679]]
Norcross's report discussed only whether he believed Respondent's
''charting and clinical decision making,'' as well as his prescribing
of drugs beyond the maximum recommended daily dosage listed in the
Physician Desk Reference, met the standard of care. RX D.
---------------------------------------------------------------------------
\11\ Dr. Chavez reviewed the patient records of W.C., J.D.,
R.A., M.T., B.W., S.M., M.H., D.M., ''Kim Jackson,'' R.E., E.A.,
J.N., M.D., J.W., and S.R. GX 6, at 2. Dr. Norcross reviewed the
patient files of W.C., J.D., R.A., and M.T.; these files include
three of the patients who, according to the PARs obtained by the
Government, had obtained controlled substances from other physicians
during the period in which Respondent prescribed to them. RX D, at
1; GX 41-43.
\12\ In his discussion of the standard of care, Dr. Chavez noted
that the Board has promulgated Guidelines for Prescribing Controlled
Substances for Pain, a copy of which was attached to the
Government's Post-Hearing Brief. Gov't Post. Hrng. Br., App. E.
These were adopted by the Board in 1994, GX 6, at 16, and were
subsequently revised in 2003. Id. at 16; App. E, at 1. I take
official notice of the fact that the Board adopted the revised
Guidelines on August 1, 2003. The Guidelines are intended ''to
improve effective pain management in California, by avoiding under
treatment, over treatment, or other inappropriate treatment of a
patient's pain and by clarifying the principles of professional
practice that are endorsed by the Medical Board so that physicians
have a higher level of comfort in using controlled substances,
including opioids, in the treatment of pain.'' Id. at 1 (emphasis
added).
The Guidelines state that ''[t]he Medical Board expects
physicians and surgeons to follow the standard of care in managing
patients.'' Id. Under the heading ''History/Physical Examination,''
it provides that ''[a] medical history and physical examination must
be accomplished. This includes an assessment of the pain, physical
and psychological function; a substance abuse history; history of
prior pain treatment; an assessment of underlying or coexisting
diseases or conditions; and the documentation of the presence of a
recognized medical indication for the use of a controlled
substance.'' Id. at 2 (emphasis added).
---------------------------------------------------------------------------
According to Dr. Chavez, ''[a]ccepted standards of medical practice
require that physicians obtain a sufficient history and perform a
focused physical exam when evaluating patients in chronic pain.'' GX 6,
at 17. Furthermore, ''[b]efore prescribing narcotic analgesic
medications[,] the physician should have an understanding as to the
probable diagnosis and a picture of the overall general health of the
patient.'' Id.
Dr. Chavez explained that a physician must obtain a history of the
condition, which includes determining the onset of the pain, the
''[e]xact location and character of pain'' and use either ''a visual
analogue'' or a ''1-10 scale'' to measure the pain level. Id. The
physician must assess the degree of the patient's functional and
physical impairment, which includes the patient's physical and
psychological function, documentation of the presence of recognized
medical indications for the use of controlled substances, and a
substance abuse history with the latter being ''a basic requirement.''
Id. at 17-18. In addition, the physician should do a review of prior
pain treatment and medications and determine the patient's ''response
to previous treatment,'' as well as review the patient's medical
records and test results from prior treatment. Id. Moreover, the
physician must determine whether the patient has any coexisting or
underlying conditions. Id. at 18.
Dr. Chavez further explained that ''[b]ased on the patient's
complaints, the physician must determine the most likely reasons for
the patient's pain complaint'' and that ''[d]etermining the exact Pain
Generator or source of pain requires a thorough focused exam which
correlates with historical data.'' Id. Continuing, Dr. Chavez observed
that ''[h]alf of all patients in chronic pain suffer from 1 or more
other medical conditions and thus, may have multiple different
diagnoses. Therefore, assessment of cardiac, renal, hepatic, GI,
pulmonary, and psychiatric status are imperative before prescribing
opiate analgesics and other medication which may not be indicated in
particular medical conditions, or which may affect end-organ
function.'' Id. Moreover, ''[i]t is of utmost importance that the
physician keep an accurate and complete medical record with thorough
documentation at every visit for each chronic pain patient.'' Id. Dr.
Chavez also explained that a patient may require further testing to
verify a presumed diagnosis and to assess major organ systems because
prescribing certain drugs, including those containing Tylenol
(acetaminophen), ''in a patient who may develop end organ damage may be
contraindicated.'' Id. at 19.
In this regard, Dr. Chavez further observed that ''[p]atients on
large doses of medications which might cause serious side effects must
have regular blood chemistries drawn in order to assess end-organ
function and a baseline measurement of function. It is crucial for the
treating physician to recognize early on whether any evidence of
medication induced organ dysfunction is present.'' Id. at 29.
According to Dr. Chavez, once the physician makes a diagnosis, a
treatment plan should be created which lists, inter alia, the
objectives of treatment, how the success of the treatment plan will be
evaluated, and whether any further tests or consultations with
specialists are required. Id. at 20-21. In addition, ''the prescribing
physician should have discussed the risks and benefits of the use of
controlled substances with the patient and have [obtained] a signed
medication agreement with the patient, within the first [three] visits,
which spells out the requirement for continued opioid therapy.'' Id. at
20-21. Dr. Chavez further noted that ''[c]hronic pain treatment
requires more than the use of opiate analgesic medications.'' Id. at
30.
Dr. Chavez observed that ''[i]t is not considered good medical
practice to allow refills on addictive medications in pain patients
unless they have been under the care of the physician for [a] long-term
and/or are well-known to the prescribing physician.'' Id. at 20.
Continuing, he explained that ''[f]requent visits and re-evaluation of
the situation are necessary'' and that ''[i]t is prudent to see the
opiate treated chronic pain patient once every 1 to 3 months.'' Id. He
also explained that a ''[p]eriod of titration of medication and
physician follow-up is necessary to determine [the] effectiveness of
therapy or [to] re-evaluate whether the presumed diagnosis is
correct.'' Id. at 22.
In his review of the patient files, Dr. Chavez found that ''for
each patient receiving opiate analgesic(s), anti-anxiety, muscle
relaxant(s), or sleep agents for chronic pain therapy,'' Respondent's
''charts did not exhibit [the] clear presence of'' ''[a] thorough
history,'' ''[a] thorough focused physical exam,'' and ''[a] thorough
past historical review.'' Id. at 30. Moreover, not one of the charts
had evidence that Respondent had ''[b]egun a diagnostic work-up or
thoughtful discussion to verify the presumed diagnosis and probable
pain generator(s),'' \13\ or that the patients had ''been placed on a
multi-modality pain treatment and management program with appropriate
use of other non-addictive medications'' and consideration of other
treatment modalities. Id.
---------------------------------------------------------------------------
\13\ Dr. Chavez stated that while it is not expected that a
physician can conduct all the ''recommended evaluations on the first
visit,'' ''by the 2nd, 3rd, or 4th visit patient charts should have
many of the basic standards of care during the course of
treatment.'' GX 6, at 30.
---------------------------------------------------------------------------
According to Dr. Chavez, ''[c]hronic pain treatment requires more
than use of opiate analgesic medication and, therefore, on chart
review, one should see evidence of discussion of other therapies and
offer recommendations regarding behavioral therapy, psychological
therapy and support, physical therapy, exercise, weight loss, and other
modalities.'' Id. There should also ''be plans for appropriate
specialty consultation, diagnostic studies * * * and drug screens to
rule out illicit drug use or diversion,'' as well as ''medication
contracts or agreements.'' Id.
Dr. Chavez observed that ''the patient medication agreement that
[Respondent] did have in the chart did not seem to be followed like it
should have been.'' Id. at 30. More specifically, the terms of
Respondent's pain management agreement included that the patient ''will
submit to a blood or urine test if requested by my doctor to determine
my compliance with my program of pain control medicine,'' and that the
patient ''will use [his] medicine at a rate no greater than the
prescribed rate and that use of * * * medicine at a greater rate will
result in * * * being without medication for a period of time.'' GX 7
at 10.
Dr. Chavez noted, however, ''that there is no consistent refill
rate'' in the charts, and that ''[s]ome refills occurred within two
days of the last refill which would mean that large quantities of
opiates had * * * been ingested during that time.'' GX 6, at 30. He
also observed that ''not one of the patients had a urine
[[Page 17680]]
drug screen done to verify that they were indeed ingesting the
medication as opposed to diverting it.'' Id. at 30-31. He also further
found that Respondent ''did not do any significant medical workup on
any of the patients.'' Id. at 31.
Dr. Chavez also noted that while under the California guidelines
''there is no maximum or minimum of medication limitations as long as
[the] amounts provided match a safe dosing schedule,'' he further
opined that ''if the maximum exceeds the manufacturer's (pharmaceutical
company; PDR) recommendations, then, generally, one may conclude that
misuse or diversion of opiates or other addictive drugs may be
occurring.'' Id. at 31-32. Dr. Chavez then explained that ''the normal
maximum dosage of Norco would be two tablets every four hours or a
maximum of 12 tablets per day, and for Vicodin ES 7.7/750[,] a maximum
of 4-6 per day because of the amount of Tylenol [acetaminophen]
involved,'' which ''generally should not exceed 4000 milligrams per
day.'' Id. at 32.
According to Dr. Chavez, while ''most of the quantities
[Respondent] prescribed'' would be ''reasonable and appropriate'' if
''given on a monthly interval,'' he noted that ''[m]any of the refills
occurred within 2 to 7 days of the last refill'' and that ''[i]n many
cases, it would have been impossible * * * to use this quantity of
controlled medications within that short of period of time.'' Id. at
32. In Dr. Chavez's opinion, ''[t]his should have been a red flag for
possible drug diversion and/or abuse.'' Id.
Dr. Chavez opined that ''[b]ased on the types and quantities of
medications prescribed, the younger age range of many of [Respondent's]
patients,\14\ the frequency of prescriptions, the excessive quantities
of medications, and irregular refill dates, there is substantial
evidence to indicate the probability of abuse or diversion of opiate
medications in the majority of the patient charts reviewed.'' Id. at
31. He also opined that ''[t]he fact that [Respondent] so freely
prescribed these drugs without a thorough evaluation of these patients
is not an acceptable approach to pain management.'' Id.
---------------------------------------------------------------------------
\14\ According to Dr. Chavez, ''[p]atients between the ages of
21 and 39 who suffer with chronic pain and who are on chronic opiate
therapy are not that prevalent, even in a busy 'Pain Practice.'"
GX 6, at 32. Moreover, the majority of patients ''in this age group
can be treated with non-opiate and non-addictive medications for the
most part.'' Id.
---------------------------------------------------------------------------
Continuing, Dr. Chavez noted that ''[n]ot one chart had evidence of
the physician undertaking a workup in evaluation of the underlying
medical problem'' and ''[t]he 15 charts reviewed lacked any objective
evidence or chart notes justifying the use of opiate therapy to the
level exhibited on the charts evaluated.'' Id. at 32. Dr. Chavez also
observed that the charts demonstrated no ''effort to try nonaddictive
medications or offer alternative modalities of treatment.'' Id. Dr.
Chavez then opined that ''[t]he medical care and treatment provided by
[Respondent] are markedly below the accepted standards of treatment for
licensed physicians in the United States today. The represents an
EXTREME DEPARTURE from the standard of care expected of a licensed
practicing physician in the U.S. today.'' Id. at 33 (caps in original).
In addition to the four patient records indicated above, Dr.
Norcross reviewed Dr. Chavez's report on Respondent and the Board's
decision referenced above. RX D, at 1. Dr. Norcross indicated he had
formed certain opinions based on these materials and also on his
''personal knowledge'' of Respondent in that he had known Respondent
''for almost 4 years in [Dr. Norcross's] capacity as a teacher, helping
[Respondent] to improve the quality of his prescribing and record-
keeping.'' Id. Further, Dr. Norcross had ''also served as a witness in
[Respondent's] Medical Board of California matter.'' Id.
Dr. Norcross concurred with Dr. Chavez that Respondent's ''medical
record-keeping still has room for improvement'' and that his ''charting
of the patient history and physical examination would not be 'thorough'
by the standards Dr. Chavez cite[d].'' Id. at 2. However, he then
asserted that Respondent should be ''judge[d] * * * against the
standard of care defined by 'the community of licensees,' and within
that group, against physicians of similar age, culture, experience,
training background, and clinical environment.'' Id. at 2. Continuing,
Dr. Norcross opined that ''if compared to other older generation
general practitioners who were not the beneficiaries of a full 3-year
residency training program and were providing care to an underserved
patient population, I believe [Respondent's] charting and clinical
decision making are well within the middle of that Bell Curve.'' Id.
Dr. Norcross further opined that as to the four patients whose
medical records he reviewed, ''there was a plausible source of pain,
and [Respondent] provided enough history and enough examination, that
the diagnosis was clear in all cases.'' Id. With respect to Dr.
Chavez's criticism as to the lack of ''laboratory tests and imaging
studies'' as well as consultations with specialists, Dr. Norcross
explained that he understood the costs of these were a ''deterrent[] *
* * for a significant portion of [Respondent's] patient population''
because they do not have insurance. Id.
Respondent, however, produced no credible evidence that any of the
specific patients whose files were reviewed by Dr. Chavez lacked the
financial resources to pay for these tests and/or consultations.\15\
Moreover, given that some of these patients had the ability to purchase
more drugs (and sometimes multiple drugs) on numerous occasions within
a month, it seems likely that they had the ability to pay for some
tests and/or consultations.
---------------------------------------------------------------------------
\15\ On this issue, Respondent's testimony was generally vague.
With respect to patient M.T. (GX 19), who complained of lower back
pain, Respondent stated that he did not do any additional diagnostic
studies because ''actually in talking to him it sounds like he's a
patient of very limited means and to get the x-rays and all of the
other studies would cost him a lot of money which he cannot
afford.'' Tr. 384. Yet M.T.'s record contains no indication that
Respondent discussed this issue with him. See generally GX 19. With
respect to M.H. (GX 13), who complained of migraines, Respondent
acknowledged that ''there could have been a lot more studies'' but
the patient ''would have to incur considerable expense.'' Tr. 397.
Here again, there is no evidence in M.H.'s record that Respondent
discussed the issue with him.
---------------------------------------------------------------------------
Dr. Norcross did, however, agree with Dr. Chavez's ''point that
physicians should, as a general rule, limit their prescribing habits,
for all drugs, not just opiates, to the manufacturer's prescribing
limits, even though responsible physicians can, and do, prescribe
medications, including pain medications, 'off label' in appropriate
cases.'' Id. at 3. Dr. Norcross further noted that he had advised
Respondent that ''it was [his] strong recommendation [to] limit his
prescribing to the * * * recommended daily maximum dosage, even though
other reasonable physicians do engage in 'off label' prescribing in
appropriate cases'' and that ''there are epidemiological studies
regarding liver toxicity supporting the PDR dosage recommendations.''
Id. According to Dr. Norcross' report, he had ''reviewed this'' with
Respondent, who had ''committed himself to doing this henceforth,
notwithstanding the 'off label,' dosage levels discussed in the
[Board's] decision.'' Id.
While the ALJ ''ha[d] a problem with the conclusions of both of the
expert[s],'' she held that Dr. Chavez's findings were entitled to more
weight because ''they are more consistent with the California
requirements for determining the standard of care to be levied against
the Respondent's practices.'' ALJ at 43. I agree with the ALJ's
conclusion although I disagree with her reasoning to the extent it
suggests that Dr. Chavez erroneously ''seemed to infer that there
[[Page 17681]]
is a national standard of care.'' Id. at 40; see also id. (noting that
''[i]n California * * * a doctor is held to the standard of skill or
care prevailing in the medical profession in the locality in which he
practices'') (citing Inouye v. Black, 238 Cal.App.2d 31, 33 (Cal. Ct.
App. 1965)).
In his Exceptions, Respondent contends that the ALJ ''completely
ignore[d] the standard of care set by the California Supreme Court and
ratified by the California Medical Board'' that "'a physician is
required to possess and exercise, in both diagnosis and treatment, that
reasonable degree of knowledge and skill which is ordinarily possessed
and exercised by other members of his profession in similar
circumstances.'" Resp. Exceptions at 7 (quoting Landeros v. Flood, 17
Cal. 3d 399, 408 (1976)). According to Respondent, the standard applied
by the ALJ ''has long been repudiated * * * in favor of the 'similar
circumstances' standard articulated by'' his expert. Id. at 7-8.
Both the ALJ's reasoning and Respondent's contention ignore,
however, that the standard applicable under Federal law is whether the
prescriptions were ''issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice.'' 21 CFR 1306.04(a). In United States v. Moore, 423 U.S. 122,
138-39 (1975), the Supreme Court upheld the conviction of a physician
for unlawful distribution of methadone based on a jury instruction that
allowed the jury to find him guilty if he dispensed the drug ''other
than in good faith for detoxification in the usual course of a
professional practice and in accordance with a standard of medical
practice generally recognized and accepted in the United States.''
(emphasis added).
Moreover, even after Gonzalez v. Oregon, 546 U.S. 243 (2006),
several courts of appeals ''have applied a general-practice standard
when determining whether the practitioner acted in the 'usual course of
professional practice.'" See United States v. Smith, 573 F.3d 639,
647-48 (8th Cir. 2009); see also id. at 648 (discussing Moore; ''Thus
informed by the Supreme Court and other controlling and persuasive
precedent, we believe that it was not improper to measure the 'usual
course of professional practice' under Sec. 841(a)(1) and [21 CFR]
1306.04 with reference to generally recognized and accepted medical
practices. * * * ''); see also United States v. Merrill, 513 F.3d 1293,
1306 (11th Cir. 2008) (quoting Moore, 423 U.S. at 139) (''The
appropriate focus is not on the subjective intent of the doctor, but
rather it rests upon whether the physician prescribes medicine 'in
accordance with a standard of medical practice generally recognized and
accepted in the United States.'").
Of further significance, post-Gonzales, the Ninth Circuit has
expressly recognized that ''both the Supreme Court and this Circuit
have previously approved jury instructions that refer to a national
standard of care.'' United States v. Feingold, 454 F.3d 1001, 1009 (9th
Cir. 2006).-- As these cases make clear, the opinion of the
Government's Expert that Respondent's treatment of the patients whose
files he reviewed was ''markedly below the accepted standards of
treatment for licensed physicians in the United States today'' and
''represents an EXTREME DEPARTURE from the standard of care expected of
a licensed practicing physician in the U.S. today'' is clearly
admissible and probative of whether Respondent's prescriptions were
''issued for a legitimate medical purpose'' and whether he acted
''within the usual course of professional practice.'' 21 CFR
1306.04(a).\16\
---------------------------------------------------------------------------
\16\ State Board regulations and/or guidelines are, of course,
relevant in determining what practices are necessary for a physician
to act in the usual course of professional practice. See Volkman v.
DEA, 567 F.3d 215 (6th Cir. 2009). This, however, is not a case
where a State rule or guideline expressly allows a physician to act
in a manner which is in conflict with the accepted standards of
medical practice throughout the country. Nor is it a case in which
the Attorney General seeks to declare illegal conduct which is
clearly permitted under State law. See Gonzalez, 546 U.S. at 258.
---------------------------------------------------------------------------
In any event, the record establishes that Dr. Chavez serves as a
consultant/physician reviewer to the California Board on pain
management and is thus clearly familiar with the standards of medical
practice related to prescribing controlled substances to treat chronic
pain patients in California. Moreover, in his report, Dr. Chavez made
clear that he had analyzed Respondent's prescribing pursuant to the
California guidelines.\17\ See GX 6, at 31.
---------------------------------------------------------------------------
\17\ While Respondent argues that the Guidelines do not have the
''force of law,'' Exceptions at 5, they are nonetheless relevant in
assessing what practices are necessary to dispense controlled
substances for a legitimate medical purpose and in the usual course
of professional practice. Moreover, Federal courts have repeatedly
upheld convictions under 21 U.S.C. 841 based on expert testimony as
to the accepted standards of professional practice even though these
standards may not have been promulgated in State board regulations.
I thus reject Respondent's exception.
---------------------------------------------------------------------------
Most importantly, in his report, Dr. Chavez provided an extensive
discussion of the accepted standards of medical practice for
diagnosing, treating, and monitoring chronic pain patients. By
contrast, Dr. Norcross is not even board certified in pain management.
With the exception of his conclusory assertion that Respondent had done
enough of a history and examination so that his diagnosis was clear
with respect to the four patient files he reviewed (in contrast to the
fifteen files Dr. Chavez reviewed), he did not otherwise identify how
Dr. Chavez had misstated the accepted standards of medical practice.
Indeed, Dr. Norcross apparently agreed with Dr. Chavez's opinion
regarding the inappropriateness of prescribing controlled substances
containing acetaminophen in quantities exceeding the manufacturer's
recommended limits, as well as Dr. Chavez's opinion as to the
inadequacy of Respondent's medical records. Finally, Dr. Norcross
failed to address numerous other deficiencies identified by Dr. Chavez
such as Respondent's failure to do blood chemistries to assess organ
function, his failure to discuss the risks and benefits of taking
controlled substances, his failure to create treatment plans, his
failure to recommend other treatment modalities, his failure to require
frequent visits to re-evaluate his patients and the efficacy of the
therapy, his failure to take substance abuse histories, the frequency
of his refills, and his failure to enforce his pain management
agreements. Thus, I conclude that Dr. Chavez's report is entitled to
significant weight and Dr. Norcross's report is entitled to little
weight.
The Patient Files and Respondent's Testimony Regarding Them
Before discussing the patient file evidence, several issues must be
resolved. The ALJ found that ''Respondent expects his patients to rely
upon his verbal dosing information, [and] not the instructions found on
the prescription labels on the bottle, for controlled substances.'' ALJ
at 12. The ALJ further that Respondent ''credibly testified that ten
grams of acetaminophen is the safe limit for daily intake'' and
presumably credited his testimony that ''the maximum safe dose of
Vicodin-ES [which contains 750 mg. of acetaminophen] is 12 tablets per
day'' and that the maximum safe dose of Lorcet, which contains 500 mg.
of acetaminophen,\18\ ''18-20 tablets per day.'' Id.
---------------------------------------------------------------------------
\18\ While in his testimony, Respondent asserted that Lorcet
contains only 500 mg. of acetaminophen per tablet, Tr. 301-02, the
Government attached to its post-hearing brief a copy of the PDR
listing for the drug which shows that each tablet contains 650 mg.
of acetaminophen. Gov. Br. at Appendix A. In his Reply Brief,
Respondent conceded that ''Lorcet contains 650 mg. of
acetaminophen.'' Resp. Reply Br. at 7. For the purpose of this
decision, I assume that Respondent had a good faith but mistaken
belief that a Lorcet tablet contains 500 mg. of acetaminophen.
---------------------------------------------------------------------------
[[Page 17682]]
In his testimony, Respondent maintained that, notwithstanding the
dosing instructions for the prescriptions which were on the bottles and
presumably recorded in his patient files, he actually expected his
patients to take more than this because they would develop tolerance
and require more of the drug to achieve pain relief. Tr. 310, 567.
According to Respondent, the dosing instruction written on the bottle
was ''the least number of pills * * * that [his patients are] supposed
to take,'' and he expected his patients to rely on what he told them
they could safely take, which was up to nine to ten grams of
acetaminophen per day, an amount which equates to twelve Vicodin ES
tablets (a tablet containing 750 mg. of acetaminophen) and 18-20
tablets of Lorcet (a tablet containing 500 mg. of acetaminophen). Id.
at 298-302, 305, 569. However, when asked why he did not just put his
oral instruction on the prescription vials, he gave the rather evasive
answer that it was because he did not ''know what is the effect of
tolerance in all that.'' Id. at 568.
It is not clear whether the ALJ found this specific testimony
credible.\19\ On the one hand, as noted above, the ALJ found that
''Respondent expect[ed] his patients to rely upon his verbal dosing
information'' and not the instructions on the label of the bottle
containing the drugs he dispensed. ALJ at 12. She also found credible
his testimony ''that ten grams of acetaminophen is the safe limit for
daily intake,'' and apparently, also his testimony as to the maximum
daily amount of Lorcet (18-20 tablets) and Vicodin-ES (12 tablets)
which can be safely taken. Id.
---------------------------------------------------------------------------
\19\ It is noted that the ALJ ''generally f[ound] the
Respondent's testimony credible.'' ALJ at 10 n.4.
---------------------------------------------------------------------------
On the other hand, the ALJ devoted an extensive portion of her
decision to analyzing the quantities of drugs Respondent dispensed to
specific patients, how long these drugs should have lasted ''if taken
as instructed'' or if ''taken as prescribed.'' See, e.g., ALJ at 13-14
(''The Respondent instructed [R.A.] to take one pill every four hours.
If taken as instructed, this amount of pills [2,850 dosage units of
Vicodin ES] would have lasted 475 days. Therefore, 475 days worth of
medication was distributed over 267 days.''). Apparently, the ALJ based
her finding that ''Respondent instructed [R.A.] to take one pill every
four hours'' on the notations in R.A.'s chart. See GX 8, at 10. It also
appears that she relied on the dosing information contained in the
charts for the other patient files she analyzed and for which she
concluded that Respondent had dispensed controlled substances in
quantities that far exceeded the amounts which he prescribed to them.
See ALJ at 37 (''when data is compiled concerning investigated
patients, the Respondent is dispensing multiple times more dosage units
than the patient should consume, if taking the medication as
prescribed.'').
Respondent excepts to these findings, noting that the ALJ found
that he "'credibly testified' that ten grams of acetaminophen is the
maximum daily safe dosage'' and thus the maximum safe daily dosage of
Vicodin ES ''should be corrected to 12 * * * rather than 5'' tablets;
he further argues that the ALJ failed to acknowledge his testimony
''that he did not expect the patients to follow the label directions,
but to consume the medication dispensed over the period of time between
refills'' and that it is therefore ''not fair to characterize the[]
labels as "'instructions to patients.'" Id. at 2-4.
Respondent is correct that there is an inconsistency between the
ALJ's finding regarding the amounts of Lorcet and Vicodin he told his
patients they could take and her analysis of Respondent's dispensings.
I conclude, however, that it is not necessary to resolve the issue
because even assuming that Respondent's testimony regarding his
instructions to the patients was credible,\20\ he offered no similar
testimony with respect to his prescribing of Xanax and Valium (i.e.,
that he told them they could take more than what he prescribed). Thus,
in determining whether he was dispensing excessive amounts of Xanax and
Valium, I base my findings on the dosing regime which he noted in the
respective patient's chart. Moreover, even with respect to his
dispensing of Lorcet and/or Vicodin, there is still evidence that he
failed to properly monitor the amount of these drugs his patients were
receiving.
---------------------------------------------------------------------------
\20\ There is reason to question the credibility of Respondent's
testimony regarding the amounts of drugs he told his patients they
could take. During the Special Agent's undercover visit, Respondent
told her to take one Vicodin ES ''every eight hours.'' Tr. 198. When
the Agent repeated this instruction, Respondent replied: ''Yeah.
Take one every eight hours, if necessary.'' Id. At no time did he
tell her that she could safely take up to twelve tablets. See id.
Likewise, the recording of R.E.'s visit indicates that Respondent
told him to take one tablet of the Vicodin ''every eight hours.''
Id. at 65. Here again, there is no indication that Respondent told
R.E. that he could take up to twelve tablets.
---------------------------------------------------------------------------
E.A.
E.A. was a food server and plumber who complained of back pain. Tr.
497; GX 7, at 3. He was twenty-two years old at the start of his
treatment with Respondent. GX 7, at 2. The patient record bears no
indication that Respondent took a substance abuse history. See id.
Beginning on September 15, 2005, E.A. saw Respondent eight times at
roughly monthly intervals. Tr. 503;\21\ GX 7, at 3, 5, 13, 27, 29, 32,
33, 34.
---------------------------------------------------------------------------
\21\ Respondent testified that there were five monthly
examinations; the chart however indicates that there were eight: on
September 15, October 14, November 23, and December 22, 2005, as
well as on January 18, February 27, April 17, 2006, and one on which
the date is undecipherable. GX7, at 3, 5, 13, 27, 29, 32, 33, 34.
---------------------------------------------------------------------------
At the initial appointment, Respondent noted that E.A. had fallen
about one year earlier and that he had no x-rays or other studies from
that time. GX 7, at 3. Respondent observed ''lumbar area muscle spasms
and tenderness'' and jotted down ''chronic back pain? intractable?''
Id. He prescribed Lorcet, to be taken once every four hours, and
dispensed 90 tablets, a fifteen-day supply if taken in accordance with
the dosing instruction recorded in the patient file. Id. Respondent
testified that at the exam the following month, E.A.'s condition
remained unchanged and that this ''fortifie[d]'' his earlier assessment
that the pain was ''intractable'' and ''chronic.'' Tr. 504.
Respondent testified that he advised E.A. to use a heating pad and
also to lose weight. Tr. 505, 510. He did not, however, document this
in E.A.'s chart. See generally GX 7. He also testified that while other
tests could have been administered to E.A., they probably would not
have yielded information that would have altered his treatment of the
patient. Tr. 618.
On September 19, only four days after E.A.'s initial visit,
Respondent provided a refill for 90 Lorcet. GX 7, at 3. If taken
according to the instructions in E.A.'s chart, the initial prescription
should have lasted fifteen days. If, however, E.A. actually took
eighteen to twenty tablets per day, the initial prescription would have
lasted four to five days.
E.A. received refills of 120 Lorcet with the same dosing
instruction on September 26, October 4, 14, 21 and 28; November 23;
December 1, 8, 15, 22 and 29; January 5, 12, 18 and 26; and February 2
and 7, 2006. GX 7, at 5, 31-34. Yet, throughout this period, there is
no evidence that Respondent ever performed tests on E.A. to determine
whether the high amount of acetaminophen he was supposedly consuming
was affecting his liver function.
On November 23, 2005, E.A. signed a Pain Management Agreement. Id.
at 9-
[[Page 17683]]
10. Also, at some unknown date, E.A. completed a Patient Comfort
Assessment Guide in which he indicated that Lorcet gave him complete
relief of his pain. Id. at 7. He further indicated that he was at that
time experiencing pain of 9 on a scale of 1 to 10, that Lorcet relieved
his pain, and that not taking Lorcet exacerbated his pain. Id.
On February 2, 2006, E.A. received a refill for 150 Lorcet, an
increase in the quantity with the same dosage noted in his file of one
tablet every four hours. Id. at 31. Based on Respondent's claim that he
expected his patients to take up to 18-20 tablets per day in accordance
with his oral instructions, the refill would have lasted a minimum of
seven days. E.A. obtained additional refills for 150 Lorcet on February
7 and 13. Id. Yet E.A. did not obtain another refill until February 27,
two weeks later, which suggests that E.A. was not consuming 18-20
Lorcet per day. Id. His next refill of 150 Lorcet (7.5 to 8 \1/3\-day
supply) came ten days later on March 6. Id.
On March 13, in addition to dispensing 150 Lorcet, Respondent
dispensed 60 Valium, a thirty-day supply based on the dosing noted in
the chart of one tablet every twelve hours. Respondent did not see E.A.
on this day and the medical record contains no indication of
Respondent's medical justification for dispensing Valium.
At approximately weekly intervals through mid-April, E.A. obtained
150 Lorcet.\22\ On April 17, E.A. had an appointment with Respondent,
who noted in his chart that he ''Need[s] reduction in the amount of
meds.'' Id. at 27. On that date, Respondent dispensed only 60 Lorcet to
E.A. with the usual dosage instruction of one every four hours. Id.
---------------------------------------------------------------------------
\22\ The dates of these refills were March 20 and 27; April 3
and 10, 2006. GX 7, at 27 & 30.
---------------------------------------------------------------------------
There is no record of a further appointment or refill until
December 8, 2006, nearly eight months later. On this date, E.A.
obtained 150 Lorcet, to be taken once every six hours (a decrease in
dosage from the previous refill; however, a 7.5 to 8-day supply based
on Respondent's testimony of the maximum daily safe amount), as well as
120 Valium (a sixty-day supply). Id. at 17. Through January 22, 2007,
E.A. obtained refills of each of these drugs in the same amounts at 3-4
day intervals for a total of twelve refills of each.\23\ Id. at 15-17.
These refills were clearly early, especially in the case of the Valium,
with a sixty-day supply being obtained every three to four days. E.A.
was therefore consuming hydrocodone and Valium in amounts far in excess
of the maximum daily dosage, or he was diverting a substantial portion,
if not all of the medication.
---------------------------------------------------------------------------
\23\ The dates of these refills were December 11, 15, 18, 19,
26, and 29; January 2, 8, 12, 15, 19, and 22. GX 7, at 15-17.
---------------------------------------------------------------------------
On January 25, Respondent dispensed a refill of 150 Lorcet but no
Valium. On both January 29 and February 2, Respondent dispensed refills
for 150 Lorcet and 80 Valium; and on February 5, he dispensed another
150 Lorcet. Id. at 14, 16. An entry in the chart for February 8, 2007
reads: ''Refill Refused per [Respondent], Lorcet 150 * * *
available 2/19/07.'' Id. at 14.
Notwithstanding the note in the chart, on February 16, E.A. again
received another 150 Lorcet (7.5 to 8 \1/3\-day supply) and 30 Valium
(a fifteen-day supply). Id. E.A. apparently attempted to obtain more
Lorcet on February 20, as a note in the chart reads ''Too soon Per
[Respondent].'' Id. Three days later, one week from his last Valium
refill, he obtained another 30 Valium, thus receiving the refill one
week early. Id. at 11.
On March 20, E.A. obtained another 150 Lorcet, this time at the
dosage of two tablets every four hours. Id. The chart does not indicate
any reason for the increase in the dosage. E.A. obtained additional
refills of 150 Lorcet on March 29 and April 2. Id. On April 6, he
obtained a further 120 Lorcet (six-day supply), and on April 9, another
150 Lorcet, at which point the prescribing record ends. Id. at 12.
In his testimony, Respondent conceded that E.A. received early
refills on April 2, 6, and 9. Tr. 524. However, as the above indicates,
even assuming that E.A. consumed the Lorcet at the rate of 18 to 20
tablets a day, E.A.'s record is replete with instances of early
refills. Although at times Respondent limited the refills (mostly
during the period leading up to the MBC proceeding), Respondent
repeatedly dispensed Lorcet in amounts that were well in excess of what
he stated was the maximum safe daily dose and Valium in amounts that
were well in excess of his dosing regime.
Of ninety-eight refills E.A. ordered by telephone, only eleven bore
any notation suggesting that Respondent had actually checked to see
when E.A. had last been seen or when he had last obtained a refill. GX
7, at 37-53. Moreover, there is no evidence that Respondent ever
required E.A. to submit to a urine or blood test to ensure that he was
consuming the medication prescribed for him. Nor is there evidence that
Respondent ever tested E.A. to ensure that the drugs were not damaging
his liver.
M.D.
M.D., who was then twenty years old, first consulted with
Respondent on June 29, 2006, complaining of back and ear pain. Tr. 440-
41; GX 10, at 7. M.D. had worked in the film industry as a fighter and
at some point had been kicked in the left ear. Tr. 440-441; GX 10, at
7. Respondent diagnosed M.D. as having ''chronic back pain intractable
and otitis external.'' Tr. 441; GX 10, at 7. According to the patient
record, M.D. had previously taken Lorcet for pain relief. Tr. 440-41;
GX 10, at 7. The patient history contains no indication that Respondent
took a substance abuse history. See generally GX 10.
Respondent dispensed 90 Lorcet to be taken once every four hours
and advised M.D. to have his left ear canal irrigated. See id. at 7.
According to Respondent's testimony, the Lorcet was for relief of the
''chronic back pain which was intractable.'' Tr. 441. M.D. did not see
Respondent again until sometime in mid-February 2007, more than eight
months later.\24\ GX 10, at 15. However, he received refills of Lorcet
throughout this period. Id. at 9-16.
---------------------------------------------------------------------------
\24\ See GX 10, at 17. The date of this appointment is not
decipherable.
---------------------------------------------------------------------------
By August 1, 2006, Respondent had increased the quantities of the
refills from 90 to 120 tablets, and shortly thereafter, a clear pattern
of early refills indicative of diversion or abuse/overconsumption
developed. Id. at 9. Under Respondent's assumption that a patient could
safely take eighteen to twenty Lorcet per day, the refill of 120 Lorcet
should have lasted at least six days. However, on both August 4 and 7,
M.D. sought and obtained refills. Id. at 9-10. While M.D. then obtained
three refills at roughly one-week intervals, beginning in September, he
obtained refills on September 1, 5, 11, 15, 19, 22, and 26; October 6,
10, 16, 19, 24, 27, and 31; and November 3, 7, and 10. GX 10, at 10-12
& 14.
Although M.D. obtained his next two refills at a slower rate (on
November 17 and 27), he then obtained refills on December 1, 5, 8, 12,
15, 18 and 21. GX 10, at 13-14. After two refills at approximately a
weekly interval over the Christmas and New Year's period (on December
28 and January 5, 2007), \25\ he then obtained refills on January 9,
12, 15, 18, 22, 23, 25, and 29; as well as on February 5 and 8. GX 10,
at 16.
---------------------------------------------------------------------------
\25\ The dates of these refills were December 28 and January 5,
2007. GX 10, at 13.
---------------------------------------------------------------------------
Then, on some date prior to February 19 (likely February 15, but
which is not
[[Page 17684]]
clear from the record,\26\) E.A. came in for an examination and
received his usual 120 Lorcet, as well as 60 Xanax, with one tablet to
be taken twice a day (and thus a thirty-day supply). Id. at 6. In the
Pain Management Agreement he signed on February 15, M.D. agreed to
submit to urine or blood testing. Id. at 5-6.
---------------------------------------------------------------------------
\26\ On this date, E.A. signed a Pain Management Agreement. GX
10, at 6.
---------------------------------------------------------------------------
On February 19, M.D. obtained 120 Lorcet and 60 Xanax (a thirty-day
supply based on the dosing of one tablet every twelve hours) from
Respondent. And on March 1 and 9, M.D. received 120 Lorcet and 90 Xanax
(a forty five-day supply based on the same dosing). Id. at 17.
M.D.'s file contains a phone message date March 13, which states:
''Deputy Drake, regarding [M.D.], 3-10-07, was detain[ed] [with] large
amount of pain meds.'' Id. at 19. On the same date, under Respondent's
initials is a note written out on a prescription form: ''Per Deputy
Drake= Narcotics detective will be calling--what [M.D.] had was legally
dispensed/given to him. May last 10 days supply.'' Id. From this note,
it is clear that Respondent did not believe that M.D. was consuming
eighteen to twenty Lorcet per day, but rather only twelve tablets, thus
making the early refills even more pronounced.
Neither the phone message nor the note makes mention of Xanax,
which M.D. had also obtained at a frequent rate. In his testimony,
Respondent indicated that he could not remember what the maximum daily
dosage for Xanax was. Tr. 578.
Of fifty-five refill requests M.D. called in, only twelve of the
messages bore any information suggesting that Respondent had bothered
to check either the last time he had seen M.D. or the last time he had
approved a refill for him. GX 10, at 20-29. Nor is there any evidence
that Respondent ever requested a urine or blood test from M.D. to
confirm whether he was consuming his medication or to check his liver
function.
S.M.
S.M., who was then twenty-three years old, first saw Respondent on
July 21, 2006, complaining of neck and shoulder pain and indicating a
history of concussion. Tr. 525-26; GX 15, at 2. Respondent diagnosed
him as having arthropathy of the left shoulder, cervical muscle spasm
with pain, possible whiplash, and anxiety. Tr. 527; GX 15, at 2. The
patient record bears no indication that Respondent's patient history
took a substance abuse history. See generally GX 15.
At the initial visit, Respondent dispensed 90 Lorcet to be taken
once every six hours and 60 Xanax, 1 mg., one tablet to be taken twice
a day. Id. at 2. S.M. obtained refills of 90 Lorcet on July 27, as well
as on August 1 and 7. Id. at 25.
S.M. provided records from prior physicians indicating whiplash and
a concussion in 1995 and neck and back pain going back to 2002 along
with treatment with Vicodin. Id. at 9, 13, 23.
On August 11, S.M. saw Respondent again and Respondent dispensed
120 Lorcet. Id. at 25. From August 2006 through February 2007, S.M. did
not display a pattern of receiving early refills (if the length of time
a refill should last is calculated based on Respondent's oral
instruction that a patient could take eighteen to twenty Lorcet per
day). See id. at 26-29. However, a different picture emerges after
S.M.'s appointment of February 16, 2007.
On that day, S.M. signed a Pain Management Agreement and completed
a Patient Comfort Assessment Guide. Id. at 4-7. In his Patient Comfort
Assessment Guide, S.M. indicated that he obtained ''Complete Relief''
from pain with the Lorcet. Id. at 4. At this visit, Respondent
dispensed 120 Lorcet but with a written dosing instruction of one every
four hours instead of one every six hours. Id. at 29.
S.M. did not obtain a refill for nearly another two weeks, on March
1. Id. at 30. However, he obtained his next eleven refills on March 5,
9, 12, 16, 19, 23, 26, and 30; and April 2, 6, and 9. GX 15, at 30-31.
There is no evidence that Respondent ever requested that S.M. undergo a
urine or blood test to determine whether he was consuming the
controlled substances or to assess whether the medication was affecting
his liver function.
In his testimony, Respondent admitted that this patient chart
exhibited early refills. Tr. 542. Of forty-five telephonic requests for
refills, only sixteen message slips bore any notation related to the
last time the patient had been seen or the last time the patient had
received a refill. GX 15, at 32-42.
D.M.
D.M., who was then twenty-two years old, first saw Respondent on
July 7, 2005. GX 16, at 3. D.M. complained of pain in his left knee
caused by a torn meniscus and reported that he had taken Vicodin for
it. Id.; Tr. 412. It is not clear from the chart whether D.M. had
undergone surgery. GX 16, at 3. Respondent testified that he was not
sure whether D.M. had had surgery on the knee and that it could have
been repaired surgically. Tr. 415.\27\ D.M. also reported insomnia. Tr.
413; GX 16, at 3. Again, the patient history bears no indication that
Respondent took a substance abuse history. See generally id.
---------------------------------------------------------------------------
\27\ A telephonic refill request indicates that D.M. had knee
surgery; Respondent wrote ''Need copy of knee surgery 1\1/2\; years
ago done in San Diego.'' GX 16, at 56. However, the patient file
contains no indication that this information was ever received.
Respondent excepted to the ALJ's finding that Respondent was unclear
on this point, maintaining that it was ''unfair to characterize this
testimony as indicating uncertainty that surgery had occurred'' in
view of ''Respondent's acknowledged hearing difficulties.'' Resp.
Exc., at 4-5. I find no reason to disturb the ALJ's finding as his
testimony is clear on this point. See Tr. 415.
---------------------------------------------------------------------------
At the initial visit, Respondent dispensed 60 Vicodin ES, one
tablet to be taken every six hours, and 30 Xanax, 1 mg., to be taken
twice a day. GX 16, at 3. Based on Respondent's testimony that twelve
tablets of Vicodin ES was the maximum safe dose and assuming that D.M.
consumed them at this rate, the Vicodin ES prescription would have
lasted a minimum of five days.
On July 11 (four days later) D.M. returned for a second examination
and reported that the Vicodin ES was causing abdominal pain. Id.
Respondent switched him to Lorcet and dispensed 120 tablets with the
dosing instruction to take one tablet every six hours. Id. D.M. also
obtained a refill of his Xanax prescription, even though the previous
prescription should have lasted for another eleven days. Id. Respondent
dispensed additional refills of 30 Xanax to D.M. on July 15, 22, and
29; August 4, 11, 16, 22, and 26; and September 1. Id. at 16, 23.
Beginning on September 6, Respondent doubled the quantity of the Xanax
refills to 60 tablets; however, he did not change the dosing of one
tablet twice per day and thus this refill should have lasted thirty
days. Id. at 24. Nonetheless, Respondent dispensed 60-tablet refills to
D.M. on September 12, 19, and 26. Id. at 21, 24. This was followed by
refills for 90 tablets on October 3, and refills for 60 tablets on
October 10, 17, and 24. Id. at 21-22.
On October 13, D.M. requested more Lorcet, claiming he had broken a
toe. GX 16, at 53. While initially Respondent wrote ''too soon,'' he
ultimately approved the refill. Id. Respondent did not, however, order
x-rays or require that D.M. come in for a visit to confirm that he had,
in fact, broken his toe.
On November 7, 2005, D.M. received a refill for 120 Lorcet at the
increased dosage of two tablets to be taken every four hours. Id. at
20. However, Respondent did not examine D.M., and no reason was
documented in the record to support the increase in dosage. Id.
[[Page 17685]]
D.M. also received 60 Valium, to be taken twice a day, instead of
Xanax. Id. The phone message from this date indicates that ''Xanax
hurts his stomach.'' Id. at 54. D.M. continued to receive refills of
the Lorcet and Valium at approximately weekly intervals through his
next two examinations which occurred on November 17, 2005 and January
4, 2006. Id. at 18-20.
According to D.M.'s record, he received 60 Valium on November 17,
23, and 29, as well as on December 6, 13, 22, and 27. Id. at 19-20.
Respondent testified that he dispensed only the 10 mg. strength of
Valium and that the maximum daily dosage of this strength is two
tablets per day. Tr. 579. D.M. was obtaining refills for a thirty-day
supply of Valium at approximately weekly intervals.\28\
---------------------------------------------------------------------------
\28\ Respondent excepted to the use of two tablets of Valium per
day as the maximum daily dosage, based on two occasions in the
hearing where Respondent indicated that a patient could actually
take more than two per day. Resp. Exc., at 4. However, I reject the
exception because Respondent did not testify that he told his
patients that they could take more Valium than what he noted as his
dosing instruction.
---------------------------------------------------------------------------
D.M. obtained more refills of 120 Lorcet and 60 Valium on January
10, 16, 23, and 30; February 6, 13, 20, and 27; March 7, 13, 20, 27,
and 31; and April 4 and 7, 2006.\29\ GX 16, at 17-18, 25. Even
crediting Respondent's testimony regarding his instructions to his
patients as to the maximum daily dosage of Lorcet, D.M. still received
numerous refills of Valium which were weeks early.
---------------------------------------------------------------------------
\29\ The message slip for March 31, however, indicates that D.M.
reported his medication as stolen. GX 16, at 42. I note that there
is no indication that Respondent requested that D.M. present a
police report in confirmation of this allegation.
---------------------------------------------------------------------------
On April 14, 2006, Respondent examined D.M.\30\ Id. at 25.
Respondent recorded ''left knee pain on flexion extension'' and a
diagnosis of ''[h]ypertension'' and ''arthropathy'' of the left knee.
Id. Respondent additionally noted, ''Reduce pain med dosage,'' and
dispensed only 60 Lorcet to be taken once every six to eight hours as
well as the usual 60 Valium to be taken twice per day. Id.
---------------------------------------------------------------------------
\30\ D.M. apparently called in for another refill on this date,
and Respondent refused it with the note, ''No--I want to talk to
him.'' GX 16, at 43.
---------------------------------------------------------------------------
On April 20 and 27, D.M. obtained refills of 60 Lorcet and 60
Valium. Id. at 28. Moreover, on May 5, 11, 18, 19, and 23, D.M.
obtained 120 Lorcet, suggesting that Respondent had already ended his
plan to reduce the amount of Lorcet that D.M. was to take; D.M. also
received 60 Valium tablets on each of these dates. Id. Here again, even
ignoring the Lorcet refills, it is clear that the Valium refills were
weeks early.
Respondent dispensed more refills for Lorcet (120 tablets) and
Valium (60 to 90 tablets) to D.M. on June 9, 15, 23, 27, and 30; and
July 5, 7, 11, 14, 18, 21, 25, 28, and 31. Id. at 29-30, 40.\31\
Notably, each of the Valium refills from June 30 through July 28 was
for 90 tablets, and thus each refill provided a 45-day supply. Id.
---------------------------------------------------------------------------
\31\ According to a phone message, D.M. also requested a refill
on June 19, which was denied as ''[t]oo soon.'' GX 16, at 57.
---------------------------------------------------------------------------
On August 8,\32\ D.M. obtained 120 Lorcet but no Valium, and on
August 12, he obtained 150 Lorcet.\33\ Id. at 40. On August 21, he
obtained only 120 Lorcet, and the following day, 60 Valium. Id. On
August 24 and 29, as well as on September 5, he obtained refills of 120
Lorcet, but no Valium. Id.
---------------------------------------------------------------------------
\32\ This follows on a request for a refill on an unidentified
date, where Respondent wrote that it was ''[t]oo soon for refill''
but ''ok for Monday \8/7\.'' GX 16, at 44.
\33\ D.M. apparently requested a refill on August 10, which
Respondent refused, saying that August 14 would be okay. GX 16, at
45.
---------------------------------------------------------------------------
On September 7, D.M. received refills of both Valium (twelve days
early based on the last refill) and Lorcet, the latter being only two
days after his previous Lorcet refill.\34\ Id. at 39. This was followed
by refills of 120 Lorcet on September 11 and 14; on the latter date, he
also received 60 Valium even though he had received his previous refill
only seven days earlier. Id.
---------------------------------------------------------------------------
\34\ D.M. apparently requested a refill on September 1, but
Respondent indicated, ''No. Too soon for refill ok on \9/5\ Tues.''
GX 16, at 45.
---------------------------------------------------------------------------
On both September 18 and 21, D.M. obtained 150 Lorcet; instead of
Valium, he obtained 60 Xanax.\35\ Id. D.M.'s file contains no evidence
pertaining to the shift from Valium to Xanax, which he had previously
complained hurt his stomach. On September 22, D.M. obtained 120 Lorcet;
on September 25, he obtained 150 Lorcet as well as 60 Valium. Id.
---------------------------------------------------------------------------
\35\ The record of phone requests indicates that D.M. requested
a refill on September 20 but that Respondent refused, because it was
too early. GX 16, at 50. On September 22, just two days later and
one day after receiving a refill, D.M. phoned in another request
indicating that he ''[h]a[d] no more meds.'' Id. Respondent approved
that request although no explanation was provided as to why D.M. had
run out of medication. Id.
---------------------------------------------------------------------------
D.M. received further refills of 120 Lorcet on October 2, 5, and 9;
on the latter date, he also obtained 60 Valium. Id. at 38. Yet only
three days later on October 12, he obtained another 150 Lorcet and 60
Valium. Id.
While the dates of the next two dispensings are indecipherable,
they appeared to have occurred sometime before October 23. On these
occasions, D.M. obtained 120 Lorcet and 60 Valium and 150 Lorcet and 60
Valium. Id. Thereafter, D.M. did not obtain another Valium prescription
until January 2007. Id. at 33. However, in this period, he obtained
refills of either 150 Lorcet or 120 Lorcet at largely three to four-day
intervals.\36\
---------------------------------------------------------------------------
\36\ D.M. obtained these refills on October 23 (120 tablets), 26
(150), and 30 (120); November 2 (150), 6 (120), 9 (150), 13 (120
plus 60 Xanax), 20 (120), 22 (120), and 30 (150); December 3 (120),
7 (150), 11 (120), 14 (150), 18 (150), 21 (150), and 28 (150);
January 2 (120), 8 (120), 11 (150), and 15 (120). GX 16, at 33, 35,
37-38.
---------------------------------------------------------------------------
On January 18, 2007, D.M. obtained another 150 Lorcet and 30 Valium
(fifteen-day supply). Id. at 33. Seven days later, on January 25, he
again obtained refills of 150 Lorcet and 30 Valium. Id. This was
followed by refills for 120 Lorcet on January 29, February 1 and 5, as
well as refills of 30 Valium on both January 29 and February 5. Id.
Only three days later on February 8, he obtained 150 Lorcet, and on
February 15, he obtained 90 Lorcet and another 30 Valium. Id. The next
day, Respondent dispensed 30 Xanax to D.M., to be taken twice a day.
Id. at 13.
On February 27, D.M. obtained another 90 Lorcet. Id. On March 5,
D.M. received a refill for 60 Xanax (thirty-day supply) and the next
day, another 90 Lorcet. Id. On March 12, he obtained another 120
Lorcet, with the new dosing instruction to take two tablets every four
hours. Id. This was followed by additional refills on March16 for 90
Lorcet; on March 20, 23, and 30 for 120 Lorcet; on April 2 for 150
Lorcet; and on April 5 and 9, for 120 Lorcet. Id. at 13-14.
In all, D.M. phoned in for refills 146 times. On only twenty
message slips is there a notation regarding the last time D.M. had been
seen or had received a refill. GX 16, at 41-63. Although on rare
occasions, Respondent denied D.M.'s request for a refill, there is no
evidence that he ever required D.M. to undergo a urine or blood test.
The CURES Report for D.M. indicates that he received controlled
substances and Suboxone from other prescribing physicians while he was
treated by Respondent. Specifically, on October 10, November 11 and 27,
December 12, 2006, and January 8, 2007, D.M. obtained Suboxone from
three different prescribing physicians. GX 45. Moreover, on February 12
and 15, 2007, he obtained hydrocodone/apap from yet another physician.
Id. However, Dr. Chavez did not offer any opinion as to whether (or
under what circumstances) checking the CURES database is required to
meet the accepted standard of medical practice.
[[Page 17686]]
J.N.
J.N., who was then twenty-four, first saw Respondent on May 18,
2006. GX 17, at 3. J.N. complained of lower back pain radiating down
into his thigh. Tr. 484; GX 17, at 3. Although he had no history of
trauma, he also indicated that he had taken Lorcet for his back in the
past. Tr. 484; GX 17, at 3. Upon physical examination, Respondent
observed muscle spasms and diagnosed J.N. as having a ''muscular
ligament strain lumbar back muscles.'' Tr. 484; GX 17, at 3. He also
noted that J.N. was ''overweight'' and testified that being overweight
commonly contributes to lumbar strain.\37\ Tr. 488; GX 17, at 3. J.N.'s
patient record contains no indication that Respondent obtained a
substance abuse history. See GX 17. Respondent dispensed 60 Lorcet,
with one tablet to be taken once every six hours, a fifteen-day supply
if taken in accordance with the dosing instruction recorded in J.N.'s
chart, but only a three-day supply if taken according to his oral
instructions. GX 17, at 3.
---------------------------------------------------------------------------
\37\ With respect to patient E.A., Respondent also testified
that he always advises about weight loss when appropriate. Tr. 510.
---------------------------------------------------------------------------
Four days later on May 22, J.N. obtained a refill of 90 Lorcet,
with one tablet to be taken once every four hours, and on both May 29
and June 5, he received refills of 120 Lorcet. Id. On the latter date,
Respondent also dispensed 30 Xanax to him, with one tablet to be taken
twice a day. Id. However, J.N.'s patient file has no indication as to
why Respondent added the Xanax.
On September 12, Respondent dispensed 150 Lorcet to J.N., as well
as 30 Valium, with one tablet to be taken twice a day. Id. at 15.
Respondent did not document in the file why he had changed J.N. to
Valium from Xanax. Thereafter, there was a gap of two months between
refills. See id. at 9-15.
On November 2 and 7, J.N. obtained refills of 180 Lorcet; on
November 13 and 17, he received refills of 150 Lorcet; and on November
27 and December 7, he received further refills for 180 Lorcet. Id. at
9. On the latter date, he also obtained 30 Valium, his first Valium
refill since September but with no indication provided in the medical
record as to why the drug was medically necessary.\38\ Id. Moreover,
although the December 7 Lorcet refill should have lasted at least nine
days, just four days later on December 11, J.N. obtained another 180
Lorcet. Id.
---------------------------------------------------------------------------
\38\ Respondent conceded on cross-examination that he prescribed
the Valium without doing a physical examination. Tr. 580.
---------------------------------------------------------------------------
On December 19, J.N. obtained another 180 Lorcet and 60 Valium, the
latter providing a thirty-day supply. Id. at 8. On January 4, 2007,
J.N. obtained refills for 180 Lorcet and 30 Valium, the latter refill
occurring two weeks early. Id. On both January 9 and 12, 2007, J.N.
obtained additional refills for both 180 Lorcet and 30 Valium. Id.
On January 18, J.N. obtained refills for both 180 Lorcet and 30
Valium; on this date, he also obtained 60 Xanax (a thirty-day supply
based on the dosing instruction). Id. at 10. Yet there is no indication
in J.N.'s patient file as to why Respondent authorized the simultaneous
dispensing of Xanax and Valium. Id.
Just four days later on January 22, J.N. obtained another 180
Lorcet and 30 Valium. Id. Thereafter, J.N. obtained refills for 180
Lorcet and 90 Valium (a forty-five day supply) on January 25 and 29, as
well as on February 1. Id.
Only four days later on February 5, J.N. obtained a further 180
Lorcet and 120 Valium (a sixty-day supply). Id. On February 19, J.N.
obtained refills of both 180 Lorcet and another 120 Valium. Id. at 11.
J.N.'s record ends three days later with an entry of ''cancel,'' which
is initialed by Respondent. Id.
On cross-examination, Government counsel asked Respondent about the
numerous refills he dispensed to J.N. for Valium. Tr. 580-84. Noting
Respondent's testimony that the maximum daily dosage of Valium was two
tablets per day and that where there was a refill of ninety tablets
after just four days, J.N. must have been consuming twenty Valium
tablets per day, Government counsel asked Respondent whether ''a person
can function on 20 Valium a day?'' Id. at 581-82. Respondent answered,
''[n]o,'' and that taking this much would cause ''[s]omnolence and
disorientation.'' Id.
Although Respondent testified that it was best to see pain patients
at least every six months, in the nine-month period in which he
dispensed controlled substances to J.N., Respondent examined him only
at his initial visit. Tr. 434; cf. GX 17, 1-23. On redirect, Respondent
testified that J.N. had developed a tolerance to Valium and that he
never observed J.N. having side effects like somnolence. Tr. 616.
However, this seems rather unlikely given that Respondent only examined
J.N. once.
While J.N. called in refill requests forty-six times, on only
thirteen occasions did Respondent note either the last time he had been
seen or when he had last obtained a refill. GX 17, at 16-23. There is
also no evidence that Respondent ever requested a urine or blood test
to confirm whether Respondent was consuming the medication and to check
his liver function.
S.R.
S.R., who was twenty-four, first saw Respondent on June 1, 2006. GX
18, at 3. She reported that she had back pain as a result of a car
accident one year earlier; she also indicated that she had tried Motrin
for the pain but that it had not worked. Tr. 431, GX 18, at 3.
Respondent diagnosed a ''muscular ligament strain [of the] lumbar back
muscles'' and dispensed 60 Lorcet, to be taken once every six hours.
Tr. 433; GX 18, at 3. The patient record, however, contains no
indication that Respondent took a substance abuse history. See GX 18.
On June 8, S.R. obtained a refill for 90 Lorcet, as well as a
prescription for 30 Xanax, the latter being a fifteen-day supply under
the dosing instruction of one tablet every twelve hours. Id. at 3.
S.R's record, however, contains no indication of Respondent's medical
reason for adding the Xanax. Id.
Only five days later on June 13, S.R. obtained refills for 120
Lorcet and another 30 Xanax. Id. at 5. Just six days later on June 19,
S.N. obtained 150 Lorcet, 30 Xanax, as well as 30 Valium, with both the
Xanax and Valium to be taken twice a day (and therefore a fifteen-day
supply of each). Id. The file, however, bears no indication as to
Respondent's medical justification for prescribing the Valium.
Just four days later on June 23, S.R. obtained another 150 Lorcet
and another 60 Valium, a thirty-day supply of the latter. Id. On June
27, after just another four days, S.R. obtained another 150 Lorcet and
30 Xanax. Id.
On July 13, S.R. received a refill of 150 Lorcet, and on July 17,
120 Lorcet. Id. at 6. This was followed by refills for 150 Lorcet on
July 20, 25, and 28. Id.
On August 1, S.R. obtained refills of only 90 Lorcet and 30 Xanax.
Id. On August 4, S.R. sought additional refills for Lorcet and Valium
but was turned down as ''too soon.'' Id. at 20. However, a phone
message slip states that the refills would be ''Ok by 08/7/6.'' Id. On
August 7, she obtained another 90 Lorcet. Id.
An undated phone message indicates that S.R. sought refills of 120
Lorcet, 30 Xanax and 30 Valium. Id. at 19. While Respondent turned down
the refills as ''too soon,'' he indicated that refills were ''ok for 8/
14/06.'' Id.
On August 15, S.R. obtained 150 Lorcet, as well as 30 Valium. Id.
at 8. She obtained additional refills of 150 Lorcet on August 21 and
25, as well as on September 1, 7, and 11. Id. Moreover, in September 7,
she obtained an
[[Page 17687]]
additional 30 Valium (a fifteen-day supply), and on September 11, she
also obtained 30 Xanax (a fifteen-day supply). Id.
On September 26, S.R. obtained another 150 Lorcet as well as 60
Xanax. Id. This was followed by refills for 150 Lorcet on October 2,
10, 16, 20, 24, and 30, as well as November 6, 10, 17, and 22. Id. at
7-9. In addition, on November 22, S.R. obtained 60 tablets of both
Xanax and Valium, each refill being a thirty-day supply based on the
dosing instructions. Id. at 9.
While on November 27, when S.R. received a further 180 Lorcet, she
did not obtain a refill of either the Xanax or Valium, on both December
4 and 8, she received refills of both 180 Lorcet and 30 Valium
(fifteen-day supply). Id. Thus, the December 8 refills were early as to
both the Lorcet and Valium.
On December 14, S.R. obtained another refill of 180 Lorcet. Id.
Only four days later on December 18, S.R. obtained another 180 Lorcet,
as well as both 60 Xanax (a thirty-day supply) and 60 Valium (also a
thirty-day supply), the latter refill being weeks early. Id. Only three
days later on December 21, S.R. obtained another 180 Lorcet and 30
Valium. Id. at 12. S.R. obtained additional refills for both 180 Lorcet
and 30 Valium on December 26, as well as on January 2, 12, 16, and 19,
2007. Id.
On January 22, S.R. obtained refills of 180 Lorcet, 60 Xanax, and
30 Valium. Id. at 11. Only three days later on January 25, she obtained
a further 180 Lorcet and 60 Valium, and on January 29, 180 Lorcet and
90 Valium. Id. And just three days later on February 1, 2007, she
obtained another 180 Lorcet. Id.
One week later, a note dated February 8, 2007 states: ''[s]hould
reduce Lorcet 90 q 2 wks. Needs visit.'' Id. However, on
February 15, S.R. obtained another 90 Lorcet and 30 Valium; there is,
however, no documentation in her file that she was examined by
Respondent prior to the dispensings. Id. Only five days later on
February 20, 2007, S.R. obtained 120 Lorcet (again with no indication
of a visit with Respondent) and 120 tablets of Valium, her largest
refill of this drug. Id. at 13. The patient record concludes at this
point.
Respondent treated S.R. for eight months but examined her only at
the initial visit. Of fifty-one refill requests S.R. phoned in, only
eleven phone messages contain any notation suggesting that the dates of
her previous refills had been checked. Id. at 15-23. There is no
indication that Respondent ever had S.R. complete a Pain Medication
Agreement or that he performed blood or urine tests either to determine
whether she was taking the medication and/or to check her liver
function.
B.W.
B.W., who was then thirty-four, first saw Respondent on February
21, 2006. GX 20, at 8. He complained of pain in his lower back from
lifting heavy building materials while working on his home patio. Id.;
Tr. 543. In the physical examination, Respondent observed ''muscle
spasms,'' and he diagnosed the cause of Respondent's pain as ''acute
musculo-lig[ament] strain lumbar back muscles.'' GX 20, at 8; Tr. 547.
Respondent dispensed 60 Vicodin ES, to be taken once every six hours.
GX 20, at 8. The patient record bears no indication that Respondent
took a substance abuse history. See id.
B.W. did not see Respondent again until August 25, 2006, and during
this period, he did not obtain any refills. Id. On this date, B.W. told
Respondent that he had hurt his back the day before while lifting a
couch. Id.; Tr. 549. Respondent again noted that he had observed muscle
spasms in B.W.'s lumbar region and he diagnosed the cause of B.W.'s
pain as ''[a]cute M/L strain lumbar back muscles.'' GX 20, at 8.
Respondent again dispensed 60 Vicodin ES, with one tablet to be taken
every six hours. Id. On August 29, B.W. called requesting a refill
''claim[ing] his housekeeper threw away his meds.'' Id. at 9.
As noted above, the ALJ credited Respondent's testimony that he
told his patients they could safely take up to twelve Vicodin ES per
day; each refill of 60 Vicodin ES would therefore have lasted a minimum
of five days. On this assumption, B.W.'s patient chart thus does not
record a pattern of early refills until November 2006. See Id. at 9-10.
However, on November 3, 6, and 9, B.W. obtained refills of 60 Vicodin
ES. Id. at 10. On November 13, he obtained a refill of 120 Vicodin ES
(a ten-day supply but with the dosing noted in the chart as one tablet
every six hours), which he refilled only four days later on November
17.\39\ Id. While B.W. did not obtain a refill until November 27, he
then obtained additional refills of 120 Vicodin ES on December 1, 7,
11, and 15. Id. Although B.W. did not obtain another refill until
December 26, he then obtained more refills of 120 Vicodin ES on
December 29, as well as on January 2, 4, 8, 11, 15, 18, 22, and 25; and
February 5, 8, and 12, 2007. Id. at 11-12. Id. at 13.
---------------------------------------------------------------------------
\39\ However, Respondent's note on the phone message for this
refill indicates that it should not be picked up until November 20.
GX 20, at 22.
---------------------------------------------------------------------------
The phone message for the latter refill request states that B.W.
''[n]eed[ed] [a] visit.'' Id. at 18. However, on February 15, 19, and
22, B.W. received more refills of 90 Vicodin ES without appearing for a
visit. Id. at 13.
On March 6, B.W. was examined by Respondent, who dispensed 90
Vicodin ES with the dosing instruction of one tablet every four to six
hours as needed. Id. at 15. B.W. obtained more refills for 90 Vicodin
ES on March 12, 15, and 19, and for 120 Vicodin on March 22 and 30, as
well as on April 3, 6, and 10, 2007, when the patient file ends. Id. at
14-15.
In his testimony, Respondent conceded that the refills between
March 15 and April 10 were early.\40\ Tr. 557. However, numerous other
refills were also early.
---------------------------------------------------------------------------
\40\ According to a Patient Activity Report obtained from CURES,
from the time of B.W.'s August 2006 appointment with Respondent
through the April 10, 2007 refill, B.W. was obtaining hydrocodone/
apap 5 mg./500 mg. and 7.5 mg./750 mg. from ten other physicians. GX
46, at 7-8. Moreover, during the period prior to B.W.'s August 2005
visit, he obtained the same drugs from at least seven different
physicians. Id. at 5-6.
---------------------------------------------------------------------------
B.W. called in requests for refills forty-nine times. Yet on only
twelve of the forms documenting these requests was the date of B.W.'s
last visit and/or refill noted. GX 20, at 16-26. Nor is there any
evidence that Respondent ever did blood or urine tests on B.W. to
confirm whether he was taking the medication and/or to check his liver
function.\41\
---------------------------------------------------------------------------
\41\ On B.W.'s March 6, 2007 visit, Respondent obtained a signed
Pain Management Agreement and B.W. completed a Patient Comfort
Assessment Guide. GX 20, at 3-6.
---------------------------------------------------------------------------
J.W.
J.W., who was then twenty-four, first saw Respondent on March 6,
2006, complaining of back pain. GX 21, at 12. According to Respondent,
J.W. had neck and back spasms. Id.; Tr. 435-36. J.W.'s record contains
medical records documenting his treatment for neck and back pain by two
other physicians as well as a chiropractor, which included
prescriptions for Norco (hydrocodone 10mg./apap 325 mg.) and Xanax.\42\
GX 21, at 4-10; Tr. 435. J.W. was still being treated by an orthopedist
and a chiropractor. Tr. 436-37. J.W.'s patient record contains no
indication that Respondent took a substance abuse history. See GX 21,
at 12.
---------------------------------------------------------------------------
\42\ Norco contains 10 mgs. hydrocodone and 325 mgs.
acetaminophen. Tr. 68.
---------------------------------------------------------------------------
At that first visit, Respondent dispensed 90 Lortab (noting in
J.W.'s record that one tablet was to be taken
[[Page 17688]]
every four to six hours), as well as 90 Xanax, one tablet to be taken
twice per day and thus a 45-day supply. Id. On March 16, J.W. obtained
both 90 Lorcet and 60 Xanax, the latter being more than a month early.
Id. at 17. Just five days later on March 21, J.W. received 90 more
Lorcet and another 30 Xanax. Id.
Six days later on March 27, J.W. received 120 Lorcet and another 30
Xanax. Id. He received refills for 120 Lorcet on April 6, 21, and 27;
May 11, 19, and 29; as well as June 8 and 23; he also received 30 Xanax
on each of these dates except for on May 11 and 19, when he received 90
tablets on each date, and on June 23, when he obtained 60 tablets. See
id. at 14-15, 17.
J.W. received 180 Lorcet and 90 Xanax from Respondent on July 5,
13, 24, and 31, and August 7. Id. at 14. Thereafter, J.W. obtained 180
Lorcet from Respondent on August 21 and 28; September 7, 12, 19, and
28; October 3, 10, 12, 16, 23, and 30; November 2, 6, 10,\43\ 21, 27,
and 30; and December 4, 7, 12, and 26 (but only 90 tablets this date)
and 28. Id. at 14, 18-19.
---------------------------------------------------------------------------
\43\ There are actually two entries for November 10; both of
which indicate that J.W. received 180 Lorcet and 120 Xanax.
---------------------------------------------------------------------------
As for the Xanax, on August 21, J.W. obtained only 30 tablets. Id.
at 14. Thereafter, he obtained the Xanax in the following quantities by
date: August 28 (120); September 7 (60), 12 (120), 19 (120), and 28
(120); October 3 (120), 10 (180), 12 (90), 16 (180), 23 (180), and 30
(180); November 2 (120), 6 (180), 10 (120), 21 (90), 27 (90), and 30
(90); and December 4 (90), 7 (60), 12 (60), 26 (180), and 28 (60). Id.
at 18-21. In each entry, the Xanax dosing was noted as one tablet every
twelve hours. See id.
During 2007, J.W. continued to receive early refills of both Lorcet
and Xanax. With respect to Lorcet, he obtained 90 tablets on January 2
and 9; 180 tablets on January 15; another 90 tablets on January 18;
followed by 180 tablets on January 22, 25, 29; as well as on February 1
and 5. Id. at 20 & 22. As for Xanax, J.W. obtained 60 tablets on
January 2; 180 tablets on January 9; 30 tablets on January 15; 60
tablets on January 18, 22, and 25; 90 tablets on January 29; 120
tablets on February 1; and 30 tablets on February 5. Id.
The patient record ends with an entry dated February 8, 2007, which
reads, ''Pt. requests too much meds--Needs visit to discuss lowering
amounts.'' GX 21, at 22. When asked whether J.W.'s not coming in for
the needed visit indicated that he had been abusing the drugs,
Respondent answered, ''Not necessarily.'' Tr. 439. Respondent testified
that ''what [he] was thinking * * * is that [J.W] probably had gone
back to the orthopedic consultant who is also trying to treat him for
the same type of pain.'' Id.
During the eleven-month period in which Respondent dispensed
controlled substances to J.W., Respondent examined him only once. While
J.W. called in refill requests fifty-one times, in only nine instances
is there evidence that Respondent checked either the last time J.W. had
been seen or the date of his last refill. Id. at 24-32. J.W. never
entered a Pain Medication Agreement with Respondent. Nor did Respondent
ever test J.W.'s urine or blood.
Summary
As Dr. Chavez noted, none of the patients files reviewed above
documents that Respondent had discussed with the patient the risks and
benefits of taking the controlled substances he dispensed to them.
Similarly, none of the files contains a treatment plan with stated
objectives for assessing the efficacy of the treatment. While some of
the files contained signed Pain Medication Agreements, there is no
evidence that Respondent ever enforced them by requiring his patients
to undergo urine or blood testing. Moreover, while Respondent dispensed
large quantities of opiate medications containing acetaminophen, he
never performed tests to assess what effect the medication was having
on his patients' liver function.\44\
---------------------------------------------------------------------------
\44\ There is also no evidence that Respondent attempted to
coordinate his prescribing activities with other physicians who were
still treating his patients and might be prescribing controlled
substances to them.
---------------------------------------------------------------------------
Respondent regularly dispensed refills without regard to when he
had last dispensed the drugs to a patient. While he also testified as
to the importance of follow-up visits to monitor how his patients were
doing and to adjust their medication regime, he dispensed numerous
refills to the above patients and did so for months on end without
conducting follow-up examinations. Indeed, he dispensed numerous
refills to patients (J.N., S.R., and J.W.) for an extensive period of
time (9 months, 8 months, and 11 months, respectively) even though they
never returned for a second examination. See GXs 17, 18, 21.
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
the Attorney General ''shall register practitioners * * * to dispense *
* * controlled substances in schedule II, III, IV, or V, if the
applicant is authorized to dispense * * * controlled substances under
the laws of the State in which he practices.'' 21 U.S.C. 823(f).
However, the statute also provides that the Attorney General ''may deny
an application for such registration if he determines that the issuance
of such a registration is inconsistent with the public interest.'' Id.
In determining consistency with the public interest, the statute
requires that the following factors be considered:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id.
''These factors are considered in the disjunctive.'' Robert A.
Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a
combination of factors and may give each factor the weight I deem
appropriate in determining whether to deny an application for a
registration. Id. Moreover, I am ''not required to make findings as to
all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005);
see also Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005).
The Government has the burden of proof. 21 CFR 1301.44(e). However,
where the Government makes out a prima facie case to deny an
application, the burden shifts to the Respondent to show why granting
its application would be consistent with the public interest. See
Steven M. Abbadessa, 74 FR 10077, 10081 (2009); Arthur Sklar, 54 FR
34623, 34627 (1989).
Factor One--the Recommendation of the State Licensing Board
As the ALJ noted, the State Board has not made a recommendation in
this matter. ALJ at 34. The ALJ further noted that in a proceeding
involving Respondent's treatment of three patients who are not at issue
here, the Board concluded that cause did not exist to find that he
prescribed without a good faith examination and medical indication for
each of the three patients. Id. The Board found, however, that
Respondent had failed to maintain adequate medical records with respect
to one of the patients and issued a public reprimand.
Ultimately, I conclude that this factor neither supports nor
refutes a finding
[[Page 17689]]
that issuing Respondent a new registration would be inconsistent with
the public interest. While possessing a State license is a statutory
prerequisite for holding a registration under the CSA, see 21 U.S.C.
Sec. 823(f), DEA has long held that a practitioner's possession of
State authority to dispense controlled substances is not dispositive of
the public interest inquiry. See Mortimer B. Levin, 55 FR 8209, 8210
(1990) (''DEA maintains a separate oversight responsibility with
respect to the handling of controlled substances and has a statutory
obligation to make its independent determination as to whether the
granting of [an application] would be in the public interest.''); see
also Jayam Krishna-Iyer, 74 FR 459, 461 (2009).
Factors Two and Four--The Applicant's Experience in Dispensing
Controlled Substances and Compliance With Applicable Laws Related to
Controlled Substances
Under a longstanding DEA regulation, a prescription for a
controlled substance is not ''effective'' unless it is ''issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' 21 CFR 1306.04(a). This
regulation further provides that ''[a]n order purporting to be a
prescription issued not in the usual course of professional treatment *
* * is not a prescription within the meaning and intent of [21 U.S.C.
Sec. 829] and * * * the person issuing it, shall be subject to the
penalties provided for violations of the provisions of law relating to
controlled substances.'' Id.
As the Supreme Court recently explained, ''the prescription
requirement * * * ensures patients use controlled substances under the
supervision of a doctor so as to prevent addiction and recreational
abuse. As a corollary, [it] also bars doctors from peddling to patients
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon,
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122,
135 (1975)).
While many cases under the public interest standard involve
practitioners who intentionally or knowingly violated the CSA's
prescription requirement, the Agency's authority to deny an application
(or to revoke an existing registration) is not limited to those
instances in which a practitioner intentionally diverts a controlled
substance. See Paul J. Caragine, Jr., 63 FR 51592, 51601 (1998). As my
predecessor explained in Caragine: ''[j]ust because misconduct is
unintentional, innocent or devoid of improper motivation, [it] does not
preclude revocation or denial. Careless or negligent handling of
controlled substances creates the opportunity for diversion and [can]
justify'' the revocation of an existing registration or the denial of
an application for a registration. 63 FR at 51601. Accordingly, a
practitioner's failure to properly supervise his patients to prevent
them from personally abusing controlled substances or selling them to
others constitutes conduct ''inconsistent with the public interest''
and can support the denial of an application for registration, or the
revocation of an existing registration. Id.; see also Gonzales, 546
U.S. at 274.
In her decision, the ALJ did not address whether the prescriptions
Respondent wrote during the undercover visits of the Special Agent and
informant were issued in the usual course of professional practice and
for a legitimate medical purpose. See ALJ at 35. Id.
With respect to the Special Agent's visit, from the beginning of
the encounter, Respondent knew that she was not seeking Vicodin to
treat a legitimate medical condition as, after the Agent told him that
she took the drug because ''[it] just made me feel better,'' he
replied: ''I don't prescribe Vicodin for recreational purposes or to
feel better * * * because Vicodin is a controlled drug and it is
specifically for specific pains, you know?'' Moreover, when the Agent
asked him whether if her ''back hurt'' would justify a prescription,
and he asked ''what happened to your back,'' the Agent replied that
nothing had really happened to it. When Respondent then asked her
''where in your back are you having the pains,'' the Agent again
replied: ''I don't specifically have it, I was just asking you if that
would be a reason someone would have it?'' Even though at this point
the Agent had made no representation that she had pain, Respondent
stated that ''if it is for that reason, for now * * * I can give you a
prescription'' and asked ''which Vicodin are you using?''
It is true that Respondent then asked the Agent to show him which
part of her back was hurting and the Agent pointed to her lower back;
however, she then added that ''it's not really sensitive.'' It is also
true that Respondent then asked the Agent how long she had the back
pain, to which she answered: ''A couple of years I guess.'' Yet
Respondent undertook no further inquiry as to the origin and cause of
the pain, what activities made it worse, how intense it was, and if it
was affecting her ability to function. He did not take a substance
abuse history even though the Agent had indicated that she had
previously been on Vicodin and that she took the drugs because they
made her feel better. As the Agent testified, she believed that
Respondent was trying to provide her with what he needed to hear to
justify prescribing the Vicodin.
The physical exam Respondent performed was superficial, lasting all
of five seconds, and was limited to touching the SA's back a few times
without even lifting up her clothing.\45\ Respondent's subsequent
statement--after indicating that he would give the Agent a prescription
for 30 Vicodin ES--that ''we have to have more documentation as to why
these controlled drugs are being prescribed for you'' further suggests
that he knew full well that he did not have a legitimate medical
purpose for issuing the prescription.
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\45\ The ALJ found credible Respondent's testimony that ''he
believed he saw muscle spasms, which would be consistent with back
pain.'' ALJ at 7. I reject the ALJ's finding because she did not
reconcile this testimony with the Agent's testimony that he did not
even lift the garment that was covering her back.
The ALJ also found that Respondent ''credibly testified that he
believed [the Agent] was suffering from back pain for the past two
years.'' Id. at 7. However, the Agent had previously stated several
times that she did not have pain and Respondent agreed to give her a
prescription immediately after she stated: ''I don't specifically
have it.'' Moreover, even after this, the Agent said her back was
''not really sensitive'' and her answer that she had pain ''a couple
of years I guess'' was equivocal at best. This was then followed by
Respondent's statement that ''we'' need to have more documentation
to justify prescribing Vicodin. As the Agent testified, she believed
that Respondent needed her to indicate that she had back pain to
justify his prescribing of Vicodin. The nature of the conversation
and Respondent's failure to comply with the accepted standards of
medical practice for evaluating his patient establish that
Respondent was not practicing medicine in good faith, but rather,
that this was prescribing with a wink and a nod. I therefore reject
the ALJ's finding.
---------------------------------------------------------------------------
In addition, while in his testimony, Respondent maintained that he
diagnosed the Agent as having back spasms and wrote this on the
progress note he prepared, he never communicated this to the Agent. It
is strange that a physician would not discuss his diagnosis with his
patient. Likewise, he did not discuss the risks and benefits of taking
Vicodin with the Agent. Finally, Dr. Chavez concluded that Respondent's
treatment of each of the fifteen patients whose files he reviewed
constituted ''an EXTREME DEPARTURE from the standard of care expected
of a licensed practicing physician in the U.S. today.'' GX 6, at 33.
Based on the above, I conclude that Respondent lacked a legitimate
medical purpose and acted outside of the usual
[[Page 17690]]
course when he prescribed Vicodin to the Agent. He therefore violated
the prescription requirement of Federal law. 21 CFR 1306.04(a).
By contrast, at R.E.'s initial visit, he complained that he
suffered neck pain and had for a couple of years; he also complained of
difficulty sleeping. Respondent's questioning of R.E. regarding his
condition was somewhat more detailed (although still lacking according
to Dr. Chavez) than it was with the Agent and at no point in the
encounter did R.E. suggest that he did not have pain. Moreover, while
the record suggests that Respondent did only a superficial physical
exam, and again, he did not discuss his diagnosis with R.E., he did
recommend alternative treatments.
I need not decide whether the prescriptions Respondent gave R.E. at
the initial visit violated 21 CFR 1306.04(a) because it is clear that
the subsequent Lorcet refills which Respondent authorized far exceeded
what he had determined was medically necessary to treat R.E.'s
condition. More specifically, Respondent's initial dispensing of 60
Vicodin should have lasted twenty days if taken at the prescribed
dosage of one tablet every eight hours.\46\ Yet only one week later on
October 20, R.E. obtained a refill for 120 tablets; this prescription
should have lasted forty days (or until November 29) as Respondent did
not change the dosing. However, on November 9, which was nearly three
weeks early, Respondent dispensed to R.E. 120 Lorcet, which was a
different drug.
---------------------------------------------------------------------------
\46\ As found above, the recording of the visit contains no
indication that Respondent told R.E. he could take more than the
prescribed amount.
---------------------------------------------------------------------------
Respondent changed the dosing of the Lorcet to one tablet every six
hours; thus, this dispensing provided a thirty-day supply. However, on
December 1, more than a week early, Respondent dispensed an even larger
refill, increasing the amount to 150 tablets. And while this refill
should have thirty-seven days (or until January 7), on December 7,
Respondent dispensed another refill for 150 tablets.
None of these refills was supported by documentation of a plausible
reason for it in the patient file. Given that R.E.'s requests were not
merely days but weeks early, there was substantial reason to believe
that he was either abusing the drugs or diverting them. Indeed, this
should have been apparent by, if not the first, then R.E.'s second
refill request. Yet Respondent did not recognize this problem until
several months later.\47\ I therefore conclude that Respondent acted
outside of the usual course of professional practice and lacked a
legitimate medical purpose when he dispensed the Vicodin and Lorcet
refills to R.E. and therefore violated Federal law. 21 CFR 1306.04(a).
---------------------------------------------------------------------------
\47\ R.E. apparently did not seek a refill from Respondent
between December 7, 2006, and February 27, 2007. Notwithstanding
this nearly three-month hiatus, Respondent resumed dispensing to him
on the latter date without examining him (providing another 150
Lorcet, also a thirty-seven day supply) and did so again only two
weeks later, at which time he increased the dosing to one tablet
every four hours without examining him.
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The record also supports the conclusion that Respondent's
dispensings of controlled substances to the other patients lacked a
legitimate medical purpose and were issued outside of the usual course
of professional practice. Id. As Dr. Chavez noted, none of the charts
he reviewed contained sufficient documentation to ''justify[] the use
of opiate therapy to the level exhibited on the charts.''
While Respondent testified that he had told his patients that they
could take Lorcet and Vicodin ES in quantities amounting to nine to ten
grams per day of acetaminophen, in his report, Dr. Chavez noted the
potential toxicity of patients consuming in excess of four grams per
day of acetaminophen and that blood chemistries must be regularly
performed in order to monitor liver function. Yet in none of the files
Dr. Chavez reviewed (and which are discussed above) is there evidence
that Respondent performed blood tests to assess a patient's liver
function and to determine whether the large quantities the patient was
purportedly consuming were causing liver damage. Moreover, in none of
the files is there evidence that the patients were referred for
consultations with specialists and/or additional diagnostic testing. He
did not take substance abuse histories. Nor did he ever require his
patients to provide a urine sample.
With respect to many of the patients, Respondent authorized refills
for them for months on end without requiring that they appear for a
followup visit. As Dr. Chavez noted, many of the refills Respondent
dispensed occurred at such rapid intervals that ''[i]n many cases, it
would have been impossible * * * to use this quantity of controlled
medications within that short of period of time.'' GX 6, at 32.
Thus, even crediting Respondent's dubious testimony regarding his
dosing instruction for Lorcet and Vicodin, there is still ample
evidence that he dispensed refills for both of these drugs, as well as
Xanax and Valium, that were excessive and were not justified by a
legitimate medical purpose. For example, on December 8, 2006, E.A.
received 120 Valium tablets, which, according to the dosing noted in
E.A.'s file, should have lasted sixty days. Yet Respondent proceeded to
dispense an additional 120 Valium to E.A. on December 11, 15, 18, 19,
26, and 29; as well as on January 2, 8, 12, 15, 19, and 22, 2007.
Moreover, on January 29 and February 2, Respondent dispensed additional
refills of 80 Valium; he also dispensed an additional thirty tablets on
both February 16 and 23. Thus, between December 8, 2006 and February 8,
2007, Respondent dispensed to E.A. more than thirteen times the amount
of Valium which he had concluded was medically necessary. These amounts
suggest that E.A. was selling the Valium.
During the same period, Respondent dispensed refills for 150 Lorcet
to E.A. on December 8, 11, 15, 18, 19, 26, and 29; January 2, 8, 12,
15, 19, 22, 25, and 29; and February 2 and 5. Even crediting
Respondent's testimony that he told his patients that they could safely
take up to 20 tablets of Lorcet per day, during the 8.5-week period
between December 8 and February 5, E.A. had a medical need for 1,200
tablets. Yet Respondent dispensed 2,550 tablets to him. Moreover,
notwithstanding the extraordinary quantities of Lorcet Respondent was
dispensing to E.A., he never did a blood test.
It is acknowledged that E.A.'s record contains two notes during the
month of February indicating that Respondent had refused refills as too
early. However, given the frequency and quantities of these refills,
especially for the Valium which provided a 60-day supply, it should
have been obvious well before this point that E.A. was either abusing
and/or selling the drugs. And even after this, Respondent provided E.A.
with additional refills, which even he conceded were early. Moreover,
Respondent rarely, if ever, reviewed E.A.'s record to determine when he
had last authorized a refill and/or seen him. In short, Respondent's
dispensings to E.A. manifest an egregious failure to properly monitor
his patient to ensure that he was not abusing the drugs or selling
them.
M.D. repeatedly obtained early Lorcet refills from Respondent. For
example, in the winter of 2006-2007, M.D. obtained refills for 120
Lorcet on December 1, 5, 8, 12, 15, 18, 21, and 28; January 5, 9, 12,
15, 18, 22, 23, 25, and 29; as well as February 5 and 8. Even assuming
that Respondent told M.D. that he could take 20 tablets per day--a
questionable assumption in light of the note Respondent made following
M.D.'s
[[Page 17691]]
arrest that a narcotics detective would be calling and that the 120
tablets that had been recently dispensed to him was a ten-day supply--
these nineteen refills should have lasted 114 days rather than a little
more than two months. Indeed, based on Respondent's note, the supply
should have lasted 190 days or slightly more than six months.
M.D. also obtained unwarranted refills of Xanax from Respondent. On
February 15, 2007, Respondent dispensed 60 Xanax to him.\48\ Four days
later, Respondent dispensed another 60 Xanax, a thirty-day supply based
on the dosing noted in the record of one tablet every twelve hours.
This was followed by additional dispensings of 90 tablets on March 1
and 9, with the same dosing instruction of one tablet every twelve
hours.
---------------------------------------------------------------------------
\48\ It is not clear what the dosing was for this prescription.
---------------------------------------------------------------------------
Here again, Respondent dispensed controlled substances in
quantities which far exceeded the amount he had determined was
medically necessary to treat a patient's condition. And once again, it
is clear that Respondent failed to properly monitor his patient to
ensure that the patient was not abusing or selling the drugs.\49\
---------------------------------------------------------------------------
\49\ Only twelve of some fifty-five telephone requests for
refills indicated that Respondent had checked the date of M.D.'s
previous refill or last office visit.
---------------------------------------------------------------------------
While S.M. did not seek early refills of Lorcet (at least if it is
assumed that he took twenty tablets per day) during the initial seven
months of his seeing Respondent, beginning in March of 2007, he did.
More specifically, Respondent dispensed 120 Lorcet to him on March 1,
5, 9, 12, 16, 19, 23, 26, and 30; as well as on April 2, 6, and 9,
2007. These dispensings totaled 1,440 tablets in a forty-day period,
and were enough to provide 72 days worth of medication if they were
taken at a rate of 20 tablets per day.
At the hearing, Respondent admitted that some of these refills were
too early. Again, Respondent failed to properly monitor his patient to
ensure that he was not abusing drugs and/or selling them.
D.M. received numerous refills for both Xanax and Valium that were
typically weeks early. Respondent dispensed 30 Xanax, which provided a
fifteen-day supply based on the dosing instruction, to D.M. on July 7,
11, 15, 22, and 29; August 4, 11, 16, 22, and 26; and September 1.
Then, with no change in the dosing, he dispensed 60 tablets (a thirty-
day supply) to D.M. on September 6, 12, 19, and 26; as well as on
October 10, 17, and 24; and 90 tablets on October 3. In just this
period, which was not even four months long, Respondent dispensed 840
tablets to D.M., a quantity which was enough to treat him for nearly
fourteen months.
Respondent then switched to Valium, dispensing 60 tablets, with a
dosing of one tablet to be taken every twelve 12 hours (a thirty-day
supply), to D.M. on November 7, 17, 23, and 29; December 6, 13, 22, and
27 (all in 2005); January 10, 16, 23, and 30; February 6, 13, 20, and
27; March 7, 13, 20, 27, and 31; April 4, 7, 14, 20, and 27; May 5, 11,
18, 19, and 23; June 9, 15, 23, and 27; and July 5, 7, 11, 14, 18, 21,
25, 28, and 31 (on both July 7 and 28, the refills were for 90
tablets). Most of Respondent's dispensings of a thirty-day day supply
were more than three weeks early; the dispensings of 90 tablets were
even earlier. Moreover, the dispensings totaled 2,640 tablets and
provided 1,320 days worth of medication in a nine-month (approximately
270-day) period.
In September 2006, D.M. also began obtaining clearly excessive
refills for Lorcet. Specifically, he obtained refills for 120 or 150
Lorcet on September 5 (120), 7 (120), 11 (120), 14 (120), 18 (150
tablets), 22 (120), and 25 (150); October 2 (120), 5 (120), 9 (120), 12
(150), date undecipherable (120), date undecipherable (150), 23 (120),
26 (150), and 30 (120); November 2 (150), 6 (120), 9 (150), 13 (120),
20 (120), 22 (120), and 30 (150); December 3 (120), 7 (150), 11 (120),
14 (150), 18 (150), 21 (150), and 28 (150). In each of these months,
Respondent dispensed between 300 and nearly 600 more tablets than the
amount which Respondent claimed he told his patients they could safely
take (600 to 620 a month).
As the evidence shows, even in the initial months of Respondent's
relationship with D.M., there was ample reason to believe that D.M. was
either abusing the Xanax or selling it to others. Indeed, although
D.M.'s refill requests became even more brazen in their frequency,
Respondent rarely rejected any of his 146 refill requests and continued
to dispense controlled substances to him until he surrendered his
registration. Respondent's dispensings to D.M. manifest a complete
abdication of his obligation to properly supervise his patient ''to
prevent addiction and recreational abuse.'' Gonzalez, 546 U.S. at 274.
It is clear that these prescriptions lacked a legitimate medical
purpose and were issued outside of the usual course of professional
practice and thus violated Federal law. 21 CFR 1306.04(a).
J.N. also received excessive refills of both Lorcet and Valium.
Between November 2, 2006 and February 19, 2007, Respondent dispensed
sixteen refills for 180 Lorcet and 2 refills for 150 Lorcet for a total
of 3,180 tablets, with most of the refills being dispensed within three
to five days of the previous refill. Even if Respondent told J.N. that
he could take up to twenty tablets of Lorcet per day, the quantity he
dispensed in this period would have provided enough medication for 159
days and was thus well in excess of what Respondent's dosage
recommendation required.
Moreover, on twelve occasions beginning on December 7, 2006 and
ending on February 19, 2007, Respondent dispensed a total of 750 Valium
tablets to J.N. According to the dosing instruction of one tablet every
twelve hours, the dispensings would have provided 375 days of
medication and thus provided nearly five times the amount of Valium
which Respondent had determined was medically necessary. Moreover, on
January 18, Respondent dispensed not only 30 Valium but also 60 Xanax
to J.N.; J.N.'s record, however, contains no explanation as to why both
drugs, which are benzodiazepines and schedule IV depressants, were
medically necessary. See 21 CFR 1308.14(c).
Here again, it is clear that Respondent failed to properly monitor
the amount of controlled substances his patient was seeking. It also
clear that Respondent acted outside of the usual course of professional
practice and lacked a legitimate medical purpose in dispensing
controlled substances to J.N. 21 CFR 1306.04(a).
From the beginning of his relationship with S.R., Respondent
dispensed Lorcet, Xanax, and Valium in amounts that substantially
exceeded what his dosing regime called for. For example, in the first
two months Respondent dispensed 720 tablets of Lorcet, 120 tablets more
than was necessary based on the twenty tablets per day maximum dose. He
dispensed 30 Xanax to S.R at her second visit, a fifteen-day supply
based on his dosing instruction, only to do so again four days later
and a third time, six days after the second dispensing. On the same day
as the third Xanax dispensing, he also dispensed 30 Valium (also a
fifteen-day supply), and only four days later, he dispensed another 60
Valium. Notably, Respondent did not note in the patient record a
medical reason for prescribing either the Xanax or the Valium.
While S.R.'s file indicates that during August, Respondent turned
down two
[[Page 17692]]
refill requests,\50\ beginning in October, S.R. successfully escalated
her requests. In this month, S.R. obtained Lorcet refills totaling 900
tablets, nearly 300 tablets more than was required if she was taking 20
tablets per day; in November, she obtained 780 Lorcet, 180 tablets more
than was necessary to provide the maximum dose. More striking, in
December, she obtained 1,080 tablets (480 more than needed), and in
January, she obtained 1,260, more than double what was needed.
---------------------------------------------------------------------------
\50\ One of these was only three days after a prior refill, thus
begging the question of what use S.R. was making of the drugs she
was seeking.
---------------------------------------------------------------------------
Moreover, between November 22 and January 29, Respondent dispensed
fourteen refills of Valium to S.R. for a total of 570 tablets, a
quantity sufficient for 285 days. On three separate dates during this
period, Respondent also dispensed refills of 60 Xanax for a total of
180 tablets (a 90-day supply). Notably, many of these Lorcet and Xanax
refills occurred only three to four days after a previous refill.
As noted above, S.R.'s file indicates that he twice rejected refill
requests. However, in each instance, he subsequently approved refills
only a few days later and apparently never asked why his patient was
seeking refills so early. During the eight months in which he dispensed
drugs to her, he saw her only at the initial visit. Once again, the
evidence is clear that Respondent failed to properly monitor his
patient to ensure that she was not abusing the drugs or selling them.
Again, I hold that Respondent repeatedly acted outside of the usual
course of professional practice and lacked a legitimate medical purpose
when he dispensed Lorcet, Xanax, and Valium to S.R. 21 CFR 1306.04(a).
B.W. sought an early refill four days after obtaining a Vicodin
prescription, claiming that his housekeeper had thrown away his
medication. B.W. did not otherwise begin to demonstrate a pattern of
seeking early refills until several months later when, in November
2006, Respondent dispensed to him six refills totaling 540 tablets of
Vicodin ES, an amount which based on the testimony that twelve tablets
was the maximum safe daily dose, was 200 tablets more than was
medically necessary to treat him for that month.\51\ In December,
Respondent dispensed to B.W. six more refills, each for 120 tablets,
for a total of 720 tablets, an amount which was nearly double the
monthly number of tablets (372) that Respondent testified could be
safely taken.
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\51\ The first November refill occurred on November 3; B.W. had
obtained a refill for 60 tablets on October 31. The first three
November refills were for 60 tablets each; beginning on November 13,
Respondent doubled the quantity to 120 tablets.
---------------------------------------------------------------------------
In January 2007, Respondent dispensed eight more 120 tablet refills
for a total of 960 tablets, an amount which was nearly 600 tablets more
than could be safely taken (372). This was followed by six dispensings
for a total of 510 tablets in February, providing approximately 170
tablets beyond what could be safely taken (336), and six dispensings in
March for a total of 600 tablets, approximately 230 tablets more than
necessary (372). Finally, in the first ten days of April 2007,
Respondent dispensed three refills for a total of 360 tablets, the last
refill occurring two days before Respondent surrendered his
registration.
At no time did Respondent perform blood tests to determine how the
medication was affecting B.W.'s liver function. Moreover, beginning in
November 2006, B.W. had clearly escalated his refill requests and yet
Respondent authorized doubling the quantity of the refills to 120
tablets. Respondent did so without doing a follow-up evaluation and
continued to dispense to B.W. for several months thereafter before
concluding in February 2007 that B.W. needed to be seen. Even then, he
dispensed additional refills until early March, when he finally saw
B.W.
In his testimony, Respondent conceded that the refills that
occurred between March 15 and April 10, 2007 were early. However, in
fact, nearly all of the refills between November 2006 and April 10,
2007 were early. Notably, during this period, B.W. was obtaining
hydrocodone drugs from ten other physicians.
Here again, the quantities of Vicodin ES which B.W. sought and
obtained from Respondent were indicative of self-abuse and/or selling
to others. Once again, I conclude that Respondent failed to properly
supervise his patient and that he lacked a legitimate medical purpose
and acted outside of the usual course of professional practice in
dispensing the refills. 21 CFR 1306.04(a).
Respondent examined J.W. only at his initial visit of March 6,
2006, yet dispensed refills to him for eleven months before finally
concluding that he was requesting ''too much meds'' and that a second
visit was needed ''to discuss lowering [the] amounts.'' While J.W.'s
Lorcet refills were not initially problematic (based on the twenty
tablet per day max), from the outset the Xanax refills were excessive.
At the first visit, Respondent dispensed to J.W. 90 Xanax, a forty
five-day supply based on the dosing instruction of one tablet every
twelve hours. Yet only ten days later, Respondent dispensed another 60
tablets to him (a thirty-day supply); this was followed by two more
refills, each for 30 tablets during the month. In March 2006 alone,
Respondent dispensed 210 Xanax to J.W., an amount which provided 105
days' worth of the drug.
During the course of Respondent's dispensing, his dosing
instruction remained unchanged. Yet each month Respondent dispensed to
J.W. quantities of Xanax far in excess of what his dosing instructions
established was medically necessary (assuming he actually had a
condition warranting the drug). In April, he dispensed 180 tablets; in
May and June, 150 (each month); in July, 360; in August, 150; in
September, 420; in October, 810; in November, 690; in December, 450; in
January 2007, 540; and in February, 150 (although J.W. made only two
refills requests in this month). Thus, from the outset, J.W. sought and
obtained 2.5 to 3 times the monthly amount of Xanax which was medically
necessary. And even after J.W. had become increasingly brazen and
sought first seven, and then fourteen times the monthly amount of drug
that Respondent's dosing regime required, Respondent continued to
dispense grossly excessive quantities to him and did so for months.
Likewise, by October, J.W.'s requests for Lorcet refills had become
increasingly brazen, with some requests occurring within two to four
days of a previous refill. In October, Respondent dispensed 1,080
Lorcet tablets to J.W., an amount which was 460 tablets more than
necessary if J.W. actually needed the maximum 20 tablets per day to
treat a legitimate medical condition. In November, Respondent dispensed
to J.W. another 1,080 tablets; in December, 810; in January, 990; and
in the first five days of February, 360. Again, Respondent approved
multiple refills within only a few days after approving a previous
refill. And again, at no time during the course of his dispensing
Lorcet to J.W., did Respondent do blood tests.
Given the frequency of the refills and quantities that he
dispensed, it is incredible that it took Respondent eleven months to
finally recognize that something was amiss and require that J.W. appear
for a second visit. Once again, Respondent failed to properly monitor
his patient. Moreover, even assuming that Respondent's evaluation of
J.W. was adequate to support the initial prescriptions of Xanax and
Lorcet, it is clear that most of the refills
[[Page 17693]]
he dispensed were not medically necessary and therefore lacked a
legitimate medical purpose and were issued outside of the usual course
of professional practice. 21 CFR 1306.04(a).
The record here thus manifests an egregious failure by Respondent
to properly supervise his patients to ensure that they were not abusing
the drugs and/or selling them to others. See Gonzales, 546 U.S. at 274.
In short, Respondent completely abdicated his role as a physician. I
further hold that the Government has clearly met its prima facie burden
of showing that Respondent's registration would be inconsistent with
the public interest.\52\
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\52\ The Government also proved that Respondent violated
California law by allowing unlicensed employees to dispense the
controlled substances to his patients. See Cal. Bus. & Prof. Code
Sec. 4170(a). Respondent admitted to the DI that one of his
employees repackaged the controlled substances into vials which she
labeled and that his receptionist would then deliver the controlled
substances to his patients. He also admitted that he did not
personally supervise his receptionist deliver the drugs to the
patients. Tr. 593.
Section 4170 of the California Business and Profession Code
provides in relevant part that ''[n]o prescriber shall dispense
drugs * * * to patients in his or her office or place of practice
unless * * * [t]he dangerous drugs * * * are dispensed to the
prescriber's own patient, and the drugs * * * are not furnished by a
nurse or physician attendant.'' Id. Sec. (a)(1); see also id. Sec.
(a)(5) (requiring prescriber to ''personally dispense[] the
dangerous drugs * * * to the patient''). While the statute allows a
certified nurse-midwife, a nurse practitioner, a physician assistant
or a naturopathic doctor to ''hand to a patient of the supervising
physician * * * a properly labeled prescription drug prepackaged by
a physician,'' id. Sec. (a)(8), neither H.C. nor the receptionist
hold any of these licenses.
While Respondent contended that the Medical Board had inspected
his pharmacy twice and found no violations, Respondent was not
present during one of the inspections, and the record does not
establish, whether at either inspection, the inspectors observed the
actual manner in which Respondent dispensed the drugs. Moreover, the
Government cited two Medical Board decisions holding physicians in
violation of section 4170 because they allowed either unlicensed
office staff (or employees who did not fall within the exceptions of
subsection (a)(8)) to dispense drugs to their patients. See Tan Shin
Lee, M.D., Stipulated Surrender of License and Order, Ex. A, at 4,
17-18; adopted by Tan Shin Lee, M.D., Decision (Med. Bd. Cal. 2008)
(Gov. Br., at app. H); Albert Peter Giannini, Jr., M.D., Stipulation
in Settlement and Order, at 3 (Med. Bd. Cal. 2001); adopted by
Albert Peter Giannini, Jr., M.D., Decision (Med. Bd. Cal. 2001)
(Gov. Br., at app. G). I thus conclude that Respondent violated
California law when he allowed unlicensed personnel to dispense
controlled substances to his patients.
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Sanction
Under longstanding Agency precedent, where, as here, ''the
Government has proved that a registrant has committed acts inconsistent
with the public interest, a registrant must 'present sufficient
mitigating evidence to assure the Administrator that [he] can be
entrusted with the responsibility carried by such a registration.'"
Medicine Shoppe-Jonesborough, 73 FR 363, 387 (2008), aff'd, 3000 Fed.
Appx. 409 (6th Cir. 2008) (quoting Samuel S. Jackson, 72 FR 23848,
23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988))).
''Moreover, because 'past performance is the best predictor of future
performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995),
[DEA] has repeatedly held that where a registrant has committed acts
inconsistent with the public interest, the registrant must accept
responsibility for [his] actions and demonstrate that [he] will not
engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also
Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006);
Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v.
DEA, 419 F.3d at 483 (''admitting fault'' is ''properly consider[ed]''
by DEA to be an ''important factor[]'' in the public interest
determination).\53\
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\53\ Relatedly, an applicant's/registrant's lack of candor is an
important and typically dispositive consideration in determining
whether he has accepted responsibility for her misconduct. See
Hoxie, 419 F.3d at 483 (''Candor during DEA investigations,
regardless of the severity of the violations alleged, is considered
by the DEA to be an important factor when assessing whether a
physician's registration is consistent with the public interest''
and noting that physician's ''lack of candor and failure to take
responsibility for his past legal troubles * * * provide substantial
evidence that his registration is inconsistent with the public
interest.''). See also Craig H. Bammer, 73 FR 34327, 34328 (2008);
Prince George Daniels, 60 FR 62884, 62887 (1995).
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Finally, an applicant/registrant is required not only to accept
responsibility for his misconduct, but also to demonstrate what
corrective measures he has undertaken to prevent the re-occurrence of
similar acts. Jayam Krishna-Iyer, 74 FR 459, 464 (2009). Both
conditions are essential requirements for rebutting the Government's
prima facie showing that granting an application or continuing an
existing registration would be ''inconsistent with the public
interest.'' 21 U.S.C. 823(f).
In her decision, the ALJ noted various facts which she deemed
favorable to Respondent even though she ultimately concluded that he
had not rebutted the Government's prima facie case. Several of these
facts are not even supported by the record; others are insubstantial
and do little to minimize the egregious nature of Respondent's
misconduct.
First, the ALJ asserted that ''Respondent was not dispensing
controlled substances for monetary gain.'' ALJ at 48. As support for
this finding, the ALJ cited the testimony of the DI that he did not
find significant amounts of money in Respondent's home or office and
found no indication of abnormally large cash transfers or other
evidence of trafficking. Id. Respondent did, however, charge for the
pills he dispensed even if he did not charge the street price for
drugs;\54\ in any event, the price he charged is of little relevance in
determining whether the refills were issued in the usual course of
professional practice and lacked a legitimate medical purpose. Even if
Respondent had charged nothing for a prescription (or given a patient a
free manufacturer's sample), if he acted outside of the usual course of
professional practice and lacked a legitimate medical purpose in doing
so, the dispensing would still be unlawful.
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\54\ There was testimony that in the Los Angeles area, Vicodin
sold on the street for up to $5 per tablet. Tr. 141.
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Next, the ALJ found that Respondent had refused to prescribe
OxyContin because of its addictive properties. ALJ at 43. However,
given the extensive scope of the early and unwarranted refills he
authorized for such highly abused drugs as Lorcet, Vicodin, Xanax, and
Valium, the ALJ's finding does not mitigate the egregiousness of his
misconduct.
Based on the initial conversation between the Special Agent and
Respondent, the ALJ found that he ''refused to prescribe controlled
substances for recreational purposes.'' ALJ at 43. Yet, within a minute
or so of his claiming that he did not prescribe for recreational
purposes, he agreed to write a prescription to the Special Agent for
Vicodin even though the Agent had yet to make any representation that
she had pain. Thus, he was willing to prescribe for recreational
purposes provided the Agent eventually said the magic words.
The ALJ also found that Respondent ''stopped dispensing refills
when a patient failed to keep a scheduled appointment'' and that he
''often times refused to dispense early refills.'' Id. As to the first
assertion, the evidence showed, however, that Respondent rarely
required his patients to appear for follow-up visits and that he
authorized refills for months on end (frequently on a weekly or shorter
basis) without requiring a visit. And contrary to the ALJ's second
assertion, Respondent rarely refused a refill request, and even when he
initially did so, he frequently approved it within a few days.
The ALJ noted that ''in multiple cases * * * Respondent actually
dispensed controlled substances at the rate he directed his patients to
consume them.'' Id. Beyond the fact that one would
[[Page 17694]]
expect a practitioner who is properly supervising his patients to
rarely, if ever, do otherwise, the record establishes numerous
instances in which Respondent dispensed both hydrocodone drugs and
schedule IV depressants (Xanax and Valium) in quantities which far
exceeded his dosing instructions. Indeed, the ALJ's assertion is
refuted repeatedly by her own findings which show that the quantities
of the various drugs he dispensed greatly exceeded what the patients
required in the course of legitimate medical treatment.
Next, the ALJ noted that ''Respondent seemed to understand the need
for a pain management contract, even though he had not implemented any
procedures to verify compliance with that agreement.'' Id. at 44. This,
however, does not mitigate his misconduct because, as the latter part
of this finding make plain, Respondent's pain management contracts were
not worth the paper they were written on as he never enforced them.\55\
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\55\ The ALJ also noted that Dr. Norcross stated that Respondent
''met the standard of care for a physician of his age and
training.'' ALJ at 44. However, as explained above, the issue is
whether Respondent acted in the usual course of professional
practice and had a legitimate medical purpose in issuing the
prescriptions. See 21 CFR 1306.04(a). Moreover, Dr. Chavez provided
an extensive explanation for his opinion that Respondent's
prescribing practices represented an extreme departure from the
accepted standards of medical practice and of medication
prescribing.
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Finally, the ALJ noted that Respondent had acknowledged that ''he
had a problem'' because ''between February and March of 2007, he was
preparing for the Board's proceeding, and after that, he had a major
increase of his patients'' thus leading ''to his failure to keep
careful track of the frequency and quantities'' of his refills. ALJ at
44. However, Respondent's failure to properly monitor his patients was
not limited to the February-March 2007 time frame, as he issued many
refills, which were clearly unwarranted, well before then. Indeed, most
of the evidence discussed above involved his dispensings prior to this
period and he admitted to only a few instances of early refills.\56\ I
thus conclude that Respondent has not fully accepted responsibility for
his misconduct.
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\56\ While Respondent conceded that he dispensed a limited
number of early refills to E.A. and S.M., this was only a small
portion of the early refills he issued to these two persons. Most
significantly, he also failed to accept responsibility for numerous
early and unwarranted refills he dispensed to other patients.
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It is acknowledged that Respondent testified that, if granted a new
registration, he would use the CURES database if he ''feel[s]'' that a
patient is requesting refills ''too frequently'' and that he would
limit his prescribing of drugs to the PDR limits.\57\ Tr. 344-45. He
also claimed that he would hire additional help and instruct his staff
to keep better track of his patients' refill requests. Yet it is
entirely unclear at what point he would ''feel'' that a patient's
refill requests were being made ''too frequently.'' As for his promise
to not exceed the PDR limits, the record shows that he repeatedly
issued refills which were excessive even when evaluated under his own
understanding as to a drug's maximum daily safe dosing limit.
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\57\ While I note this, I agree with Respondent that the record
in this matter does not establish that the accepted standard of
medical practice requires a physician who prescribes controlled
substances to check his patient in a prescription monitoring program
database to determine whether he/she is a doctor shopper. See Resp.
Prop. Findings, at 8-9.
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Thus, while I have considered Respondent's proposed reforms, the
record here does not inspire confidence in his ability or willingness
to properly implement them. Indeed, even ignoring the illegality of the
prescription he issued to the Special Agent, the record amply
demonstrates that Respondent acted with reckless disregard for his
obligation to properly supervise his patients to ensure that they were
not abusing and/or selling to others the controlled substances he
dispensed. His conduct was egregious and likely caused great harm to
public health and safety. Accordingly, I hold that Respondent has not
rebutted the Government's prima facie case. Respondent's application
will therefore be denied.\58\
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\58\ Respondent also contends that the public interest analysis
requires the Agency to ''balance the need to prevent possible abuse
by a few isolated patients against the public harm caused by denying
* * * DEA registration privileges to an important provider of
healthcare (and pain management) services in a poor, mostly indigent
community.'' Resp. Reply Br. at 2. DEA has previously rejected this
contention as unworkable and lacking any support in the statutory
factors. See Gregory D. Owens, 74 FR 36751, 36757 & n.22 (2009)
(''The residents of this Nation's poorer areas are as deserving of
protection from diverters as are the citizens of its wealthier
communities, and there is no legitimate reason why practitioners
should be treated any differently because of where they practice or
the socioeconomic status of their patients.'').
In his Reply Brief, Respondent also asserts ''that the few
patients who receive[d] slightly excessive amounts of pain
medication were not representative of a larger number, and were a
minuscule portion of [his] practice.'' Resp. Reply Br. at 7. Beyond
the fact that Respondent mischaracterizes the evidence regarding the
amounts of pain medication he dispensed and entirely ignores the
extraordinary number of unlawful Valium and Xanax refills he
dispensed, DEA has repeatedly rejected the argument that revocation
of a registration or denial of an application is unwarranted where a
practitioner's misconduct only involves a small number of patients.
See Jayam Krishna-Iyer, 74 FR 459, 463 (2009). DEA has revoked a
practitioner's registration based on a physician's simultaneous
presentation of two fraudulent prescriptions to a pharmacist, see
Alan H. Olefsky, 57 FR 928, 928-29 (1992), and DEA can revoke based
on a single act of diversion. In short, Respondent's misconduct is
egregious and he has not rebutted the Government's prima facie case.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b) and 0.104, I hereby order that the application of
Bienvenido Tan, M.D., for a DEA Certificate of Registration be, and it
hereby is, denied. This order is effective April 29, 2011.
Dated: March 22, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-7394 Filed 3-29-11; 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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