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Jayam Krishna-Iyer, M.D.; Revocation of Registration
FR Doc E6-14568 [Federal Register: September 1, 2006 (Volume 71,
Number 170)] [Notices] [Page 52148-52159] From the Federal Register
Online via GPO Access [wais.access.gpo.gov] [DOCID:fr01se06-70]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 03-8]
Jayam Krishna-Iyer, M.D.; Revocation of Registration
Introduction and Procedural History
On October 17, 2002, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Jayam Krishna-Iyer, M.D. (Respondent), of Clearwater,
Florida. The Show Cause Order proposed to revoke Respondent's DEA
certification of registration, No. AK2006648, as a practitioner on the
grounds that Respondent had committed acts which rendered her continued
registration inconsistent with the public interest. See 21 U.S.C.
824(a)(4). The Show Cause Order also proposed to deny any applications
for renewal or modification of her registration.
The Show Cause Order alleged that between March 24, 1999, and June
24, 1999, the Pinellas County, Florida, Sheriff's Office had conducted
four undercover visits to Respondent's medical office. In essence, the
Show Cause Order alleged that during three of the visits, Respondent had
met with three different undercover operatives who had told her that
they were not currently in pain but that they were users of various
controlled substances such as Lorcet and Vicodin. See Show Cause Order
at 2-3. The Show Cause Order further alleged that Respondent had issued
prescriptions for controlled substances without performing a physical
exam. See Id. The Show Cause Order alleged that Respondent had indicated
in the patient records for each undercover operative that they had
complained of pain when each had "clearly stated that they were not in
pain.'' Id. at 3. The Order also alleged that that Respondent had told
the undercover operatives that she could offer them a detox program or
could "arrange an appropriate treatment plan.'' Id. at 3.
The Show Cause Order further alleged that on the second visit of one
of the undercover operatives, the operative had been seen by a nurse
practitioner, Ben Mastridge. While Mastridge told him that Respondent
would not prescribe narcotics if the operative was not in pain, he
nonetheless issued him a prescription, which had been pre- signed by
Respondent, for Lorcet, Xanax, and Soma. See Id. at 2. The Order further
alleged that Mastridge had offered "to initiate Methadone
[[Page 52149]]
treatment, but the [operative] preferred simply to attempt to reduce
his Lorcet addiction.'' Id.
Based on the above, the Show Cause Order alleged that Respondent had "prescribed
controlled substances without a legitimate medical purpose in violation
of Federal law.'' Id. at 4. The Show Cause Order further alleged that
Respondent "operated a narcotic treatment program without obtaining a
separate registration for that purpose.'' Id.
On January 26, 2000, a federal search warrant was executed at
Respondent's office. During the search, the authorities seized the
medical records for the undercover operatives.
Thereafter, on June 21, 2000, a federal grand jury indicted
Respondent on five counts of illegal distribution of various controlled
substances in violation of 21 U.S.C. 841(a)(1). Resp. Ex. 110. These
counts specifically alleged that Respondent had, on various dates, "knowingly
and intentionally dispense[d] and distribute[d], outside the usual
course of medical practice, and without a legitimate medical purpose,''
the drugs Lorcet, Vicodin and Vicodin ES (each being a Schedule III
controlled substance), and Xanax (a Schedule IV controlled substance).
Id. at 1-3. An additional count of the indictment alleged that
Respondent had conspired to distribute Schedule III and Schedule IV
controlled substances in violation of 21 U.S.C. 841(a)(1). See 21 U.S.C.
846. See also Resp. Exh. 110, at 1.
The United States Attorney offered Respondent pre-trial diversion.
The agreement specifically provided that the period of supervision would
last for no more than twelve (12) months, and that if Respondent
fulfilled the conditions of the agreement, the charges would be
dismissed. As part of the diversion agreement, Respondent also entered a
medical supervision agreement. Under this agreement, Respondent was to
submit the name of a monitoring physician for the approval of the United
States Attorney; the monitoring physician was required to review
twenty-five (25) percent of Respondent's patient records on a random
basis and all records involving her prescribing of controlled substances
to determine the appropriateness of the prescriptions. Respondent
satisfactorily completed the supervision period and the indictment was
dismissed.
As stated above, on October 17, 2002, this proceeding was initiated.
Respondent requested a hearing.\1\ The case was assigned to
Administrative Law Judge (ALJ) Mary Ellen Bittner, who conducted a
hearing in Tampa, Florida, on July 1 and 2, and August 5 and 6, 2003. At
the hearing, both the Government and Respondent called witnesses and
introduced documentary evidence. Following the hearing, both the
Government and Respondent submitted post-hearing briefs.
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\1\ Respondent also sought to enjoin the
proceeding. The district court, however, denied her motion for an
injunction.
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On April 15, 2005, the ALJ issued her recommended decision. The ALJ
found that the Government had shown by a preponderance of the evidence
that Respondent had, in each of the three instances involving the
undercover operatives, prescribed controlled substances without a
legitimate medical purpose and outside of the usual course of medical
practice. See ALJ Dec. at 39-41. The ALJ further found that Respondent
had "unlawfully presigned prescriptions for controlled substances.'' Id.
at 41. The ALJ also found that the Government had not proved by a
preponderance of the evidence that Respondent had conducted a narcotic
treatment program without the required registration. Id. Finally, the
ALJ found that Respondent had refused to acknowledge her misconduct in
prescribing the controlled substances, see id. at 43, and was "unwilling
or unable to accept the responsibilities inherent in a DEA
registration.'' Id. at 44. The ALJ thus recommended that Respondent's
registration be revoked.
Following the ALJ's decision, Respondent submitted an 87 page brief (Resp.
Exceptions). Respondent's brief raised numerous challenges to the ALJ's
findings of fact and conclusions of law. Respondent also claimed (1)
That DEA's pursuit of this proceeding violates the pre- trial diversion
agreement, (2) that DEA should be estopped from contending that
Respondent's continued registration is inconsistent with the public
interest because of assertions the Government purportedly made in the
criminal proceeding, and (3) that the DEA proceeding is a vindictive and
retaliatory prosecution in violation of the Due Process Clause of the
Constitution.
Having considered the record as a whole, I hereby issue this decision
and final order adopting the ALJ's findings of fact and conclusions of
law except as expressly noted herein. I have also reviewed Respondent's
various claims and find them to be without merit. For reasons set forth
below, I concur with the ALJ's conclusion that Respondent's continued
registration would be inconsistent with the public interest. I therefore
adopt the ALJ's recommendation that Respondent's registration be revoked
and that any pending applications for renewal or modification be denied.
Findings of Fact
Respondent obtained her doctor of medicine degree in 1975 from
Calicut University Medical College, in Kerala, India. Following a one
year residency in New Delhi, Respondent attended the University Rene
Descartes in Paris, France, from 1977 through 1981. There, she obtained
additional training in anesthesia, critical care, and pain medicine.
Respondent then moved to Pittsburgh, Pennsylvania, where she served a
residency in anesthesia at Allegheny General Hospital from 1981 until
1984. Because Respondent had already trained in anesthesia, she spent
most of her time in pain management. Upon completion of her residency,
Respondent moved to Clearwater, Florida, and took a position as an
anesthesiologist at the Belleair Surgery Center (Belleair).\2\
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\2\ Respondent is board certified in
anesthesiology and pain management.
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Respondent worked at Belleair from 1984 until 1999, and eventually
became its medical director. While at Belleair, Respondent treated
chronic pain patients and in 1994 or 1995, opened her own clinic. In
1999, Respondent left Belleair to concentrate on her pain management
practice. Respondent testified at the hearing that she had approximately
800 to 1000 recurring patients and saw around 3,000 patients per year.
Respondent has between fifteen and eighteen employees, and during the
spring of 1999, employed Ben Mastridge, a Certified Addiction Registered
Nurse. According to Respondent, Mastridge identified patients who were
addicted to narcotics and helped patients address their mental health
issues.
The Criminal Investigation
In September 1998, Dale Carnell, a prescription fraud detective with
the Pinellas County Sheriff's Office, contacted Ira Wald, a Diversion
Investigator (DI) assigned to DEA's Tampa office. Detective Carnell told
the DI that the Sheriff's Office had received "numerous complaints''
about Dr. Iyer. Tr. 101-102. The DI proceeded to contact Walgreen's, a
pharmacy chain, and obtained from it a printout of Dr. Iyer's controlled
substance prescriptions for the previous twelve (12) months. Id. at 141.
The DI testified that the printout
[[Page 52150]]
was "the most voluminous'' he had seen in his twenty-three years as a
DI, Id. at 102 & 142, that it "was many hundreds of pages,'' Id. at
140, and that it "weighed five or six pounds.'' Id. at 141.
Based on the printout, the DI and Detective Bernie McKenna of the
Pinellas Sheriff's Office decided to conduct undercover visits to
Respondent's office. The first visit was conducted by Mr. Chris Massey,
an informant for the local authorities who was then on probation
following his guilty plea for having obtaining hydrocodone prescriptions
by fraud.
The First Undercover Visit
On March 24, 1999, Massey went to Respondent's clinic and was seen by
her. During the visit, Massey wore a wire; a transcript of his
conversation with Respondent was admitted into evidence. According to
the transcript, Respondent asked Massey who had sent him to see her. See
GX-2, at 1. Massey told Respondent that he had been referred by a
customer of his window tinting business. See id. Respondent then asked
Massey, "[w]here is your pain?'' Id. Massey answered: "I'm not really in
pain. He [the customer] said to come up. He said, you know, you're real
understanding, just come up and be honest with you. I, uh, I had a
shoulder surgery about 4\1/2\ years ago.'' Id.
Respondent asked: "[r]ight shoulder?'' Massey answered that "the
problem was more or less cured.'' Id. at 1-2. Massey then told
Respondent that "I was wanting to take Lorcet and Soma.'' Id. at 2.
Massey also told Respondent that "I have been taking it * * * [e]ver
since then,'' an apparent reference to the surgery. Id. Massey added
that he was "sick of going to look for em.'' Id.
Respondent then told Massey: "Okay, look. We can, look, we can help
you anyway.'' Id. In response, Massey then stated, "I mean I'm being
honest, I mean I'm not really in--I don't--I mean they make me feel
good, make me get work done, I mean I'm not abusing them.'' Id.
Following a discussion of how many pills Massey was taking per day,
Respondent told Massey "[w]e'll give you your medicine. The question for
you is this--you can tell--you can tell me that you want to come out of
drugs. We have intensive detox, we can help you.'' Id.
Later in the conversation, Respondent asked Massey "who gives you the
medicine now?'' Id. at 3. Massey replied, "I've been getting them from
my girlfriend but me and her just split up.'' Id. Respondent then asked
Massey what his job was and again asked about his shoulder. Massey told
Respondent, "I mean like I said, it's not, it doesn't bother me.'' Id.
Respondent then asked Massey, "what do you take, Lorcet 10?'' Id. at
4. After Massey told her that he took Lorcet 10/650, Respondent stated: "Lorcet
10/650. See, this is a shame then that you have to take the medicine for
the habit, you know.'' Id. Respondent once again asked Massey who had
referred him. Massey told Respondent that his name was Bill and that he
did not know Bill's last name, but that "he's been going to you for a
while you know, you're real understanding.'' Id. After stating that "this
is a pain center, you know,'' Respondent added: "We don't want to give
out drugs. So that's why we have to have a psychologist and a substance
abuse counselor.'' Id. In response, Massey said "Right.'' Respondent
then added: "We have massage therapist, physical therapist and everybody
here, you know. But you are honest, you are telling the truth, and we
are here to help you.'' Id. Massey replied: "That's what he said, he
said if you're honest with her, you know, go in there and tell her
you're not in pain. This is your problem. You've been taking them.'' Id.
Respondent then asked Massey how many Lorcets he was taking per day.
Massey told her four. Respondent stated "that's 124 a month'' and told
him not to lose his medicine or run out of it because she would not call
in a refill. Id. at 5. Massey then paid Respondent $175. Id. Respondent
then told Massey, "I'd be happy to see patients like you,'' and then
told him that she could give him a refill on his SOMA prescription. She
would not, however, give Massey a refill on the Lorcet. Respondent then
gave Massey a prescription for 120 Lorcet 10 with no refill and 60 SOMA
with one refill.\3\ See Gov. Exh. 3.
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\3\ The ALJ found that "Respondent * * * said
that she would give him sixty Soma, but would not list any refills on
the prescription until she knew him better and knew that he was not
abusing the medication.'' ALJ Dec. at 10. In light of the actual
prescriptions written, I conclude that Respondent's statement that "Sorry
there's no refill on it[,]'' was made in reference to the Lorcet.
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The Government submitted into evidence the medical record which
Respondent prepared for Massey's visit. Under the heading "Chief
Complaint,'' the History and Physical record states:
Complains of neck and shoulder pain for the last several years. This
began since he had surgery about 3-4 years ago. He complains of ongoing
pain and has been taking Lorcet and Soma for a long time. He is having
difficulty coming off of this and would like to get rid of the narcotics
if he can. It is very difficult because of his daily activities etc. He
has ongoing right shoulder pain and discomfort. Sometimes it is
manageable and when the pain gets worse he has to take the medication as
soon as possible.
Gov. Exh. 4, at 1.
The second page of this document records the findings of a physical
exam although Respondent admitted that she never performed one on
Massey. See Tr. 495. Under the heading "Musculoskeletal,'' the record
states: "Bilateral paracervical muscle spasms at the C6-7 area.
Decreased range of motion of the right shoulder.'' Id. The record also
includes the diagnosis of "chronic right shoulder pain.'' Id.
The medical records also include a questionnaire on which a patient
indicates such information as the nature and source of his pain. The
first question on this form is "How long have you had this pain?'' Gov.
Exh. 4, at 13. Massey left this blank. See id. Massey apparently did
make a mark on both the front and back drawings of the human body in the
area of the right shoulder. See id. Item 2 of this form directs the
patient to "circle all the words that best describe your pain'' and
lists twenty-four adjectives that describe pain. Id. Massey did not
circle any of these words. See id.
Respondent testified that she understood the mark that Massey had
made in the shoulder region to indicate that he was "suffering from
chronic pain injury'' and that the marks were "the location area of the
pain.'' Tr. 481. Respondent testified that Massey was not a typical pain
patient as most of her patients "have been to many doctors, many
operations and had been through many treatments.'' Id. at 482. She
further testified that she "thought maybe he's suffering from chronic
pain, something manageable that which may not have to be maintained on
lots of oral narcotics'' because "[i]t's not difficult pain for the
patient.'' Id.
Later on direct examination, Respondent was asked what she understood
Massey's statement that "I'm not really in pain'' meant. Id. at 483.
Respondent answered that because Massey was "already on medications[,] [m]aybe
he doesn't have pain at that time when I see him in the office,'' but
that if he wasn't taking the medication, "[p]ain would be there.'' Id.
Respondent further testified that she believed that Massey's statement
that he had undergone shoulder surgery four and a half years earlier to
mean that he had developed a calcification in his shoulder which leads
to chronic pain even though the pain "can be intermittent.'' Id. at
483-84. Later, however, Respondent testified that it was her impression
that Massey had a
[[Page 52151]]
work-related shoulder sprain although she acknowledged that Massey "did
not say that.'' Id. at 489. Respondent also testified that chronic pain
patients may see her on days that they do not have pain. Id. at 490
Respondent further testified that Massey's statement that "the
problem was more or less cured'' meant to her that the problem was "more
or less cured for the surgeon, but the pain persists.'' Id. at 484.
Moreover, Respondent testified that Massey's comment that he had been
taking Lorcet and Soma since the surgery meant that he was taking
medications "[t]o control the pain, so that they [the patient] can have
a decent, normal life.'' Id. at 485. As for Massey's comment that he was
being honest, that the drugs made him feel good and get work done, and
that he was not abusing them, Respondent testified that "[e]ven today
when people take narcotics they feel ashamed of themselves'' and that "maybe
he's ashamed of telling me he has to take pain medication to have a very
active pace of living.'' Id. at 485-86. She then stated: "he's not
abusing, that he's not taking too many, that he's taking the [drugs] to
control the daily activities of living.'' Id. at 486. Respondent added: "Drug
addicts don't take three, four [pills] a day to get work done. * * *
Drug addicts take to get high and they don't do their job. They sit at
home and watch TV.'' Id.
Respondent testified that "[o]ur job is to believe the patient.'' Id.
at 491. Respondent was then asked what she meant when she told Massey, "[t]his
is a shame then that you have to take the medicine for the habit.'' Id.
Respondent answered: "See, whenever there is a pain, they take a pain
pill to feel better. So, there are other habits we can create with them
like the physical therapy, home exercises, so they don't have to depend
on that habit of taking a pill for every little thing.'' Id.
Respondent further testified that Massey appeared honest to her. Id.
494. When asked whether it was significant that Massey "was honest with
you and didn't exaggerate his symptoms or seek additional--more
medication than he was taking,'' Respondent answered: "Yes, he's not a
drug-seeking person.'' Id.
Respondent then admitted that she had not conducted a physical exam
and that it was not "proper'' to record the results of an exam that was
never done. Id. at 496. When asked why she filled in the form, she
answered that it was "the end of the day when I was preparing--looking
at the charts because the blanks, probably I filled in what I could have
seen.'' Id. at 497. Respondent insisted, however, that the comments she
entered on the record as Massey's "Chief Complaint'' were based on what
Massey told her. Id.
The ALJ found disingenuous Respondent's testimony that she thought
Massey had told her that he was not in pain because he was then taking
medication. See ALJ Dec. at 40. I agree and note that the ALJ observed
Respondent's testimony and was in the best position to evaluate her
credibility on these issues of historical fact. See Universal Camera
Corp. v. NLRB, 340 U.S. 474, 496 (1951). Indeed, Respondent's story is
implausible and inconsistent. Respondent testified that Massey was not "a
typical pain patient,'' and indeed, showed up without a referral. Given
this, it is strange that Respondent proceeded to prescribe controlled
substances without performing a physical exam and did so notwithstanding
that Massey told Respondent numerous times that he was not in pain and
that he was taking the drugs because they made him feel good. Indeed, in
light of Respondent's testimony that she found Massey to be honest, and
that it was her job "to believe the patient,'' it is puzzling that she
did not accept Massey's statements that he was not in pain and was
taking the drugs because they made him feel good.
Massey's statement that his girlfriend had been the source of his
drugs begs the question of why, if he truly was in pain, he had obtained
his drugs that way rather than through legitimate means. Furthermore,
Respondent's statements that (1) "[w]e'll give you your medicine * * *
you can tell me that you want to come out of drugs,'' (2) that "this is
a shame * * * that you have to take the medicine for the habit,'' and
(3) "we don't want to give out drugs * * * that's why we have * * * a
psychologist and a substance abuse counselor,'' demonstrate that
Respondent understood that Massey was not seeking the prescription to
treat pain, but rather to abuse them.
Finally, the ALJ found that "the descriptions of the alleged pain
that Respondent wrote in [Massey's record was] not--by any stretch of
the imagination--based on what [he] told her.'' ALJ Dec. 43. That is
putting it charitably. The record was false. As Dr. Rafael Miguel (one
of the Government's experts) explained, the record was likely created
because Respondent knew exactly what she had done--prescribed a
controlled substance without a legitimate medical purpose--and thus did
so "to justify the opioid prescriptions.'' Gov. Exh. 18, at 2.
The Second Undercover Visit
On April 22, 1999, Massey returned to Respondent's office for a
follow-up visit. Massey did not see Respondent during this visit.
Instead, he saw Ben Mastridge, a Certified Addiction Registered Nurse.
After Mastridge asked Massey how he was "pain wise,'' Massey initially
stated that "it's into my joint there,'' that he had been put on Lorcet "years
ago for a shoulder surgery,'' but then added "I'm not in no pain.'' Gov.
Exh. 6, at 2. Massey used similar language several times to convey his
condition to Mastridge. See id. at 2-3. Notwithstanding the double
negative in Massey's statements, Mastridge clearly understood that
Massey did not have pain. See id. at 3. (Mastridge stating "if you're
not having pain then you don't need'' narcotics.).
Mastridge and Massey discussed what drugs the latter was taking;
Mastridge suggested that "I can give you like an Ativan \4\ or
something.'' Id. Massey told Mastridge that "I don't want no mind
medication.'' Id. Massey also told Mastridge that he could "function
without'' the Lorcet, but that he took it "to work and to get, you know
to get chores done on work days.'' Id. Massey then suggested that if
Mastridge put him "on Xanax we could probably level me out a little
bit.'' Id. Massey also told Mastridge that he took the Soma because he
was "so used to taking them'' and that he was not having muscle spasms.
Id. at 4.
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\4\ Ativan, or Lorazepam, is a Schedule IV
controlled substance. 21 CFR 1308.14(c).
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Mastridge then told Massey that "using narcotics when there is no
pain isn't acceptable.'' Id. Mastridge added that "just to prescribe * *
* narcotics because you're physically dependent on it * * * that's,
that's that's unacceptable.'' Id. Mastridge then suggested that "we can
come up with a plan [to] decrease by one pill every, one pill a day
every two weeks * * * and see how you do.'' Id. at 5. Mastridge also
suggested that he could put Massey on "just methadone and decrease the
Lorcet or we can * * * just decrease the Lorcet.'' Id. at 6. Massey told
Mastridge that he was "definitely not going to go without the Lorcet.''
Id.
Later in the conversation, Massey again told Mastridge that his
shoulder was "cured,'' and added that he was "over the cocaine and all
the stuff I went through in my early days,'' but that "these pills make
me feel good.'' Id. at 8. Mastridge told Massey that he was going to
give him a prescription for Xanax because it "will help to take the edge
off of bringing the coke down.'' Id. at 9. Mastridge further stated that
"we
[[Page 52152]]
are going to put down that you are starting the detox program and it
will run over a period of fifty to ninety days'' and that Massey had
agreed to start the program "over the next 60 days.'' Id. at 10.
Massey then told Mastridge that "I don't have no physical problem''
and "it's just I like these pills.'' Id. Mastridge replied that "as far
as the physical dependence on it goes * * * we can come up [with] other
treatment options once we try some things here.'' Id. Mastridge then
told Massey that he would be getting 105 Lorcet tablets, which he should
take three times a day, 90 Soma, which he should take three times a day,
and Xanax .5, which he should take twice a day. Id. at 10-11.
Massey then asked whether "oxycontin or dilaudid would be easier on
my body?'' Id. at 11. Mastridge answered that "it is not legal to
prescribe narcotics long term if there is no pain,'' and that "it's
easier to take you down off the Lorcet than it would be off the
oxycontin because of the types of doses.'' Id. When Massey suggested
that oxycontin 10 tablets were available, Mastridge replied that "the
bottom line is you need to be off the narcotics.'' Id. at 11-12.
Mastridge then gave Massey the prescriptions for Lorcet, Soma, and
Xanax discussed above and a questionnaire, which he instructed him to
complete in the waiting room. Id. at 12-13. Observing that the
prescriptions were pre-signed, Massey asked Mastridge, "So what do you
do? You just fill these out and the doctor already signs them?'' Id. at
13. Mastridge answered: "Yes.'' Id. Massey then stated, "I thought that
the Doctor had to fill the prescriptions out and sign it.'' Id.
Mastridge replied: "Oh no, no * * * as long as she is in the building I
am being supervised and as long as I'm being supervised, I can do
anything that she can do because she signs her name to the treatment
agreement, there's a place for her to sign it, too.'' Id.
The Government entered into evidence the patient chart for Massey's
April 22nd visit. The chart states that the patient "report[s] no
current pain.'' Gov. Ex. 4, at 3. The chart also states that Massey
reported "good sleep, appetite'' and that he had agreed to start
outpatient "detox over [the] next 60 days.'' Id. In addition, the
questionnaire which Massey completed on this visit asked whether, "[d]uring
the past month,'' he had "been bothered by any illness, bodily disorder,
pains, or fears about your health?'' Id. at 6. Massey checked the box
for "none of the time.'' Id.
Mr. Mastridge did not testify in this proceeding. Respondent did,
however, testify regarding this visit. In her testimony, Respondent
acknowledged that at the time of the visit, Mr. Mastridge was not
authorized under Florida law to dispense a controlled substance. Tr.
641. Respondent attempted to justify her conduct testifying that she "was
in the office,'' that Mastridge "never saw the patient alone,'' and that
"I was right there.'' Id. at 641-42. Respondent admitted, however, that
she was "[n]ot in the same room'' when Mastridge issued the
prescriptions for Lorcet, Soma, and a new drug Xanax. Id. at 642.
The Third Undercover Visit
On May 12, 1999, Detective Jeff Esterline of the Pinellas Sheriff's
Office went to Respondent's office to conduct an undercover visit. Using
the name Jeff Scott, Esterline told Respondent that he had recently
moved from Iowa and that he worked as an electrician's helper.
Respondent asked Esterline what had happened to his back. See Gov. Ex.
9, at 1. Esterline told Respondent that he had been referred by Chris
Massey, that Massey had seen her before, and had "said you were a good
doctor to come to.'' Id. at 2. Respondent then told Esterline to "[t]ell
me about your pain.'' Id. Esterline stated: "I don't have any pain
really, I didn't know if they would let me in to talk to you if I didn't
tell them something, so I don't have any pain, really.'' Id. Esterline
added that he was taking four to five Vicodin a day. Id. Respondent
asked Esterline how he got his drugs. Esterline stated that he had been "getting
them from a friend.'' Id.
Respondent then told Esterline that her clinic offered a detox
program. Id. She then asked, "you don't have pain but you are taking
vicodin? Why were you taking vicodin?'' Id. After Respondent repeated
her question, Esterline told her that he had "started taking them quite
a while ago'' and that he thought he "function[ed] a lot better with
them.'' Id. at 3. When Respondent asked if he got the drug from friends,
Esterline answered in the affirmative. Id.
Respondent then asked Esterline if he "want[ed] to go to substance
abuse program or do you want to be maintained on the vicodin?'' Id.
Esterline answered that he would like to remain on drugs as he felt like
he functioned "real well'' while taking them. Id.
Respondent then warned Esterline that narcotics "are habit forming''
and can cause liver damage. Id. Esterline responded that he didn't think
he had any problems and that he had started taking them when his mother
had died a year and a half earlier. Id. He added that "I feel, just feel
like I function real well with them'' and "I don't abuse them.'' Id.
Respondent then told Esterline: "you don't have to start if you don't
want to be on vicodin'' and "there is no reason you should be on it.''
Id. at 4. Esterline responded that "I feel like I, I function better,''
and that "I don't think I'm not taking so many of them that I feel like
I have a real problem, but I just function better, just keeps me even.''
Id.
Respondent then stated that "[i]f you didn't get vicodin, you know,
you know it is okay, too, right?'' Id. She added that "we don't want to
start you on some narcotics that you don't have to be on it.'' Id.
Esterline responded that Massey "said that you know if I just was honest
with you that you know, that that you'd helped him.'' Id. Respondent
then stated that she thought she remembered Massey but didn't know. Id.
Respondent also told Esterline that her assistant Ben Mastridge "can
help you to get off narcotics. He can do a methadone, whatever.'' Id.
Esterline replied that he "was just hoping to get'' Vicodin and again
told Respondent that he took three or four a day. Id. Respondent advised
Esterline that drugs could be toxic, that he could build up a tolerance
to them and that "the more you take the more you need,'' and then asked
him if he was "willing to take all these risks?'' Id. Esterline stated
that he was and that the drug helped him to "function better.'' Id.
Respondent then referred to various potential causes of pain. Esterline
once more stated that "I don't really have any problem, I don't really
have any pain,'' and again added that "I feel like I function better''
when taking the drugs. Id.
Respondent then asked Esterline if he "would like to start on the
vicodin?'' Id. at 5. Esterline told Respondent "Yeah, that's what I was
here for.'' Id. Respondent told Esterline to "[s]tart with the four a
day,'' and that her employee Ben Mastridge "can counsel you with
medication and narcotics and everything.'' Id.
Later on, Respondent stated "[s]o you don't want to come out to the
narcotic clinic, you know this is for the people to come here so they
don't do drugs, you know, and too, maybe I'm sympathetic to the people
that allow themselves to slip into drugs.'' Id. Respondent then told
Esterline that "narcotics are good and bad,'' and that "[y]ou don't want
to get hooked on drugs.'' Id. Esterline again told Respondent that he
did not think that he was addicted, that he went to
[[Page 52153]]
work every day, and that the drugs made him "feel better.'' Id.
Respondent then asked Esterline if he had been on vicodin "for a
while?'' Id. at 6. When Esterline answered "yes,'' Respondent asked him
if he could "confirm it'' by bringing in "left over [prescription]
bottles'' he had gotten through other doctors. Id. Esterline told her
that he had "been having trouble getting them for so long'' and offered
to look at home for the bottles. See Id. at 6. Respondent then again
told Esterline that "[y]ou don't want to make a new habit'' and get "hooked
on drugs.'' Id. Esterline reassured Respondent that he was not addicted.
See Id.
Respondent then stated that she would give him a prescription for 60
Vicodin ES with two refills and that the drugs "should easily last you
for 1 month.'' Id. Respondent then suggested that Esterline make an
appointment to see Mastridge. Id. She also told Esterline that her
clinic had a massage therapist and a physical therapist and that "you
need to feel good-you're taking it just to feel good.'' Id. at 7.
Esterline paid $180 for the visit. Gov. Ex. 10.
The government entered into evidence various patient records
pertaining to Detective Esterline's visit. Describing Esterline's chief
complaint, the "History and Physical'' record states: "He has a terrible
pain in his neck. This started 1\1/2\ years ago. Ever since his mother's
death, he has had ongoing pain. He does a lot of construction work,
wiring, etc., which makes the condition worse.'' Gov. Ex. 11, at 1. The
entry for Esterline's Musculoskeletal system likewise states: "chronic
pain.'' Id.
The records also include a questionnaire used by patients to report
their symptoms and other information relevant in diagnosing and treating
their condition. The first question on the form is "How long have you
had this pain?'' Id. at 2. Esterline wrote "none.'' The form also lists
twenty-four adjectives to describe pain and instructs the patient to "circle
all the words that best describe your pain.'' Id. Esterline did not
circle any word. See Id.
The form also contains front and back representations of the human
body, on which patients are instructed to shade the area where they have
pain. See Id. The forms have several small markings in the area of the
neck. Id. Detective Esterline testified that he did not make the
markings. Tr. 58. Respondent maintained that he did. Id. at 519.
Respondent testified that she "probably'' "missed'' Detective
Esterline's answer of "none'' to the question "How long have you had
pain?'' Tr. 523. She further testified that Esterline was not typical of
the pain patients she sees because "[h]e has a soft tissue injury, neck
pain. He didn't have any x-ray or MRI.'' Id. She added that a typical
patient would be "a construction worker, car accident patient who had an
MRI x-ray workup'' and that Esterline hadn't "had anything done.'' Id.
at 524.
Respondent's counsel then asked her about Esterline's statements that
he didn't have any pain, that he had indicated he did because he did not
think the office staff would let him in otherwise, that he was taking
four to five Vicodin a day, and that he did so because he functioned
better when he took them. Respondent testified that "some patients are
very reluctant to admit that they need Vicodin to control their pain,''
and that he was "taking medications to be able to do his job.'' Id. at
526-27. Respondent also testified that she believed that Respondent had
obtained his Vicodin through a lawful prescription. Id. at 528.
Respondent further testified that she asked Esterline what type of work
he did "to find out whether he's having pain because of the type of job
he does,'' and that electricians (the job Esterline said he had)
commonly have neck pain. Id. at 529.
When asked on direct what Esterline meant when he said "I don't
really have any pain,'' Respondent answered: "He's contradicting
himself[,]'' and that "he is in pain, but when he takes medications he
doesn't have any pain.'' Id. at 530. When asked whether Esterline had "in
any way exaggerated his symptoms?,'' Respondent answered "No''; when
asked whether he appeared to be honest, Respondent answered "yes.'' Id.
at 531. Respondent also testified that Esterline did not seek more
medication than he was currently taking and that he seemed like a
patient who was seeking treatment for chronic pain. Id. at 532.
Respondent admitted on cross-examination that she did not conduct a
physical examination on Esterline. Id. at 645. She also testified that
her handwritten notes for the physical exam were based on what she "would
have done with a patient'' with neck pain. Id. at 533-34. She further
admitted that it was inappropriate to make these notations. Id. at 534.
She testified, however, that she believed her prescribing of controlled
substances to Esterline was within the standard of care. Id. at 537.
Here, again, the ALJ, who personally observed Respondent testify,
found disingenuous Respondent's testimony that she thought Esterline was
not in pain because he was taking medication. See ALJ at 40. I agree and
further note that it is strange that a patient who is "honest,'' does
not "exaggerate his symptoms,'' told Respondent multiple times that he
did not have pain, and that he took the drugs because they helped him
function better, would then be disbelieved as to why he was taking the
drugs. Furthermore, while Respondent testified that she believed
Esterline had obtained the drugs through a lawful prescription,
Esterline told her at least twice that he had gotten them through
friends and that he had also been "having trouble getting them for so
long.'' Finally, Respondent made several incriminating statements such
as when she asked Esterline if he "want[ed] to go to substance abuse
program or do you want to be maintained on the vicodin?,'' and stated "maybe
I'm sympathetic to the people that allow themselves to slip into
drugs.''
The Fourth Undercover Visit
On June 24, 1999, Detective Randall Keys of the Tampa Police
Department,\5\ using the name Ronald Briers, made an undercover
visit to Respondent's office. Respondent asked him if he had abdominal
pain. Gov. Ex. 12, at 1. Keys told Respondent that he did not have pain,
but that he "had to put something down on'' the form. Id. Keys then
added that "[a] friend of mine suggested that I come to talk to you
about it.'' Id. Respondent asked: "About what? Detox?'' Id. Keys told
Respondent, "I need some * * * vicodin.'' Id.
---------------------------------------------------------------------------
\5\ Detective Keys was then assigned to a DEA
task force. Tr. 70.
---------------------------------------------------------------------------
Respondent asked Keys why he needed vicodin. Id. Keys answered, "Well
it, basically it makes me feel better. It just kind of takes the edge
off.'' Id. After discussing Keys' job, Respondent stated: "We do not
give drugs out to people. And now, if you want to go to substance abuse
program, we have Ben [Mastridge] here for you.'' Id. Denying that he was
addicted, Keys stated again that the drug "just kind of helps me.
Just--it just takes the edge off.'' Id.
After stating that she did not want "to promote the intake of
drugs,'' Respondent asked Keys who had sent him. Keys told her Chris
Massey. Id. at 2. Respondent reiterated that "We don't want to give
drugs out to people, you know, and ruin our reputation.'' Id. Respondent
then suggested that Keys try her acupuncture program. Id. Respondent
declined, stating that he did not "have any pain or anything like that''
and that he took the Vicodin because "they just take the edge off.'' Id.
Respondent and Keys discussed how many he took a day. Id. Keys said
three.
[[Page 52154]]
Respondent then asked Keys where he got the drug. Id. At first, Keys
said that he got it from a person, but when asked how much he paid for
it, Keys said it was actually from "like a family member who has a
prescription.'' Id. at 3. Respondent then told Keys that "[t]his is a
real test for me'' and "we don't want to give narcotics to like creating
drug use.'' Id.
Thereupon, Respondent apparently summoned Ben Mastridge to the
examining room. After again discussing Chris Massey, Respondent briefed
Mastridge on Keys' situation telling him that Keys took "about 2 to 3
vicodin a day'' and that "now he's wondering whether we will be able to
promote or support his pain with the 3 Vicodin a day.'' Id. After
telling Mastridge that they had not discussed "[t]he issue of people
coming here asking for a drug,'' Respondent then told Keys that "Ben is
our AR and he does my detoxification for narcotics. He is the director
for narcotics program.'' Id.
Shortly thereafter, Mastridge asked Keys how many Vicodin he was
taking and how long had he been taking the drug? Id. Keys answered that
he usually took about three and had been doing it for six months. Id.
Mastridge then asked Keys whether the Vicodin had been prescribed to
him. Id. at 4. Keys answered "no.'' Id. Respondent then told Keys that "we
want to help people with pain,'' to which Keys responded "Right.'' Id.
Respondent then stated that "we don't want to promote a drug habit.''
Id. Keys responded: "No, I understand.'' Id. Mastridge then told Keys "[j]ust
throwing pills at the situation, that's where people end up taking--if
they are taking 3 Vicodin a day now, in 6 or 8 or 12 months they're
taking 15 of them a day.'' Id.
After discussing the need to provide "some sort of concurrent
treatment to go along with [the vicodin] to address the source of the
pain,'' Id., Mastridge asked "is it muscle spasms that are actually
going on here?'' Id. at 5. Respondent interjected, "Pain, pain, you're
right.'' Id. Mastridge continued stating: "What, what's the source of
the pain? I guess that's what the ultimate question is. And since you
weren't diagnosed by anybody in primary care or anything.'' Id.
Respondent replied: "I guess he feels no pain, he just feels better.''
Id. Mastridge then asked Keys, "You just feel better?'' Keys answered, "They
just kind of mellow you out I guess * * * it makes me feel okay.'' Id.
After discussing various treatments available at her clinic,
Respondent told Keys that she was going to give him a prescription for
60 vicodin, see Id, and Mastridge told Keys that they would discuss his
condition and "the best course of treatment'' during his next visit. Id.
Respondent then explained the costs for the clinic's various services
and added "[i]t's a way of letting you know * * * we will not be
supporting just a drug habit.'' Id. at 6. Respondent then told Keys that
Ben "will write the prescription for you too, He writes my
prescriptions. When you see him, you don't have to see me.'' Id.
The government entered into evidence various patient records
pertaining to Detective Keys' visit. The History and Physical record
describes the patient complaint as: "Ronald Bryers presents to my office
with low-back pain and anterior abdominal pain, which is ongoing. He
works as an automobile detailer, getting under cars, etc., and the
constant physical labor makes the pain worse. * * * He has had this pain
for the past several years.'' Govt. Exh. 14, at 1.
The document also reports the results of a physical exam. Under the
musculoskeletal heading, the record states that "[m]inimal paralumbar
muscle spasm is noted, with minimal facet tenderness.'' Id. The report
also contains a diagnosis of "chronic low-back pain.'' Id. Respondent
admitted, however, that she did not perform a physical exam on Keys, Tr.
647, and Keys testified that he did not believe that he had discussed
his medical history with Respondent. Id. at 84.
Respondent testified that Detective Keys was seeing her for abdominal
and lower back pain but that "[h]is history was kind of not clear to
me.'' Id. at 541. Moreover, Keys was a "very unusual'' patient. Id.
Respondent explained: "Patients come to me after being diagnosed, after
being treated. * * * I wonder, what is he doing in my office without
being diagnosed and we don't want to be a clinic where we give out
medications for reasons not needed.'' Id. at 546.
Respondent testified that because she "didn't feel right,'' Id. at
541, she sought out Mr. Mastridge to assist her in evaluating Keys
because of Mastridge's knowledge of substance abuse and psychological
problems. Respondent testified that she thought that Mastridge could
help her diagnose whether Keys was "taking medicine to control the pain
or for any behavioral problems.'' Id. at 542.
Respondent testified that Keys' statement that he took Vicodin
because it took "the edge off'' meant that the drug took the "[e]dge off
the pain,'' and that the term "edge off'' is commonly used in the pain
context. Id. at 544. As for Keys' statements that he didn't have pain,
Respondent testified that she thought this was because he was "on pain
medication,'' that "people do not have to have the pain all the time,''
and that pain levels can fluctuate. Id. at 545. She further stated that
even though Keys may not have had pain at the time of his visit, "they
wouldn't come to my pain clinic if [they] don't have the pain.'' Id.
Respondent also testified that when she discussed with Mastridge
doing narcotics detoxification, she meant "medication reduction.'' Id.
at 549. She further testified that when she told Keys that "we want to
help people with pain'' and that "we don't want to promote a drug
habit,'' she understood Keys' answers as meaning that he was in pain and
was agreeing to her proposed treatment. Id.
Respondent admitted that because she had not performed a physical
exam, she should not have filled out the form as she did but maintained
that the patient record's "history part is true.'' Id. at 647.
Respondent testified that the physical exam part of the record was "missing''
"because I went and got Ben [Mastridge] because this patients [sic] were
not my true pain patients,'' Id. at 647-48, and that she had made it up "because
of the confused cases brought to me.'' Id. at 648-49.
Respondent added: "I don't see patients like this at all in the
office. These are like the strange weirdos coming to my office.'' Id. at
648. Respondent further testified that she was "astonished to see
patients like [Keys] in the pain clinic'' and that "[t]hese are not my
typical pain patients.'' Id.
Respondent was then asked whether it was within the standard of care
in the State of Florida to prescribe controlled substances without
performing a physical exam. In response, Respondent testified: "that's
what we learn when we go to medical school. Take a history and physical
examination. Chronic pain, these patients who are very difficult to
evaluate. Physical examination is part of our job.'' Id. at 650. Upon
further questioning Respondent added that performing a physical exam "is
the standard of practice. That's our Rule No. 1.'' Id. at 651.
Respondent then denied, however, that she had intentionally and
knowingly dispensed controlled substances. See Id. at 652. She
testified:
Intentionally I did not dispense medication, I did not distribute
outside of the usual course of medical practice. In the context of the
clinical pain management, I knew the medication not to transfer, not to
sell the drug to the street or anything. My intention here is believe
the patient, give them the benefit of chronic pain, and
[[Page 52155]]
evaluate them, and do what is appropriate for them.
Id. at 652-53.
As with the other undercover visits, the ALJ did not find credible
Respondent's assertion that she prescribed Vicodin to Keys because she
believed his use of the drug was the reason he was not in pain. See ALJ
Dec. at 40. Again I agree. The transcript of the visit provides
substantial evidence that Respondent knew that Keys was seeking drugs
for illegitimate use. Not only did Keys state that he did not have pain
and that the drug took the "edge off,'' when Mastridge asked what the
source of Key's pain was, Respondent stated: "I guess he feels no pain,
he just feels better.'' Shortly thereafter, Respondent explained the
costs for the clinic's various services and added that "we will not be
supporting just a drug habit.'' Finally, I am perplexed as to why if a
patient is a "strange weirdo'' and causes astonishment because he is not
a "typical pain patient,'' a physician would then proceed to write a
prescription for a controlled substance without performing a physical
exam as required by "Rule No. 1.'' \6\
---------------------------------------------------------------------------
\6\ I acknowledge that in December 1999, the investigators
attempted an additional undercover visit. Respondent's receptionist
refused to admit the officer because he did not have a referral. See
Resp. Ex. 46.
---------------------------------------------------------------------------
The Expert Testimony
Both the Government and Respondent introduced expert opinion evidence
on the subject of Respondent's prescribing practices. Dr. Daniel
Frazier, M.D., of Tampa, Florida, a Board Certified Family Practice
Physician with more than thirty years of experience, and an Assistant
Clinical Professor of Family Practice at the University of South Florida
(USF) College of Medicine, reviewed the tapes and transcriptions of the
undercover visits. In a statement dated February 1, 2001, Dr. Frazier
declared that "[i]t is inappropriate to prescribe pain medication in
uncontrolled environments,'' and that "[t]he physician must determine
the level of pain that he/she is treating by means of examination and
discussion with the patient.'' Gov. Exh. 16. Dr. Frazier further stated
that "the physician must closely monitor the patient to see that there
is a medical need'' for a controlled substance. Id.
Dr. Frazier concluded that Respondent "was not in control of the
patients; the patients were in control of'' her. Id. Moreover, "[t]he
patients actively sought pain pills for non-appropriate reasons and the
patients were given the pain medication without examination or
significant review of their symptoms. Such care on the part of the
physician constitutes inappropriate medical treatment[,]'' and "a
failure to appropriately practice medicine within the acceptable
standard of care.'' Id. I credit Dr. Frazier's statement.
The government also submitted the statement of Rafael Miguel, M.D. At
the time of his review, Dr. Miguel was a Professor and Interim Chairman
of the Department of Anesthesiology, as well as the Director of the Pain
Management Program at the USF College of Medicine. Dr. Miguel clearly
states that he reviewed the medical records, transcripts of the
undercover visits, and Respondent's pre-hearing statements. Gov. Exh.
18, at 1.\7\ Dr. Miguel stated that "[t]here is no currently accepted
therapeutic use of opioids but for the relief of pain. Administering
opioids to patients with no pain is inappropriate and clearly
constitutes practice below the standard of care.'' Gov. Exh. 18, at 2.
---------------------------------------------------------------------------
\7\ I note and reject Respondent's contention that
the ALJ did not know what Dr. Miguel based his opinion on. See Resp.
Br. 39-40. The factual basis for Dr. Miguel's opinion is clear from
his statement. See Gov. Exh. 18, at 1. Moreover, Respondent could have
sought to subpoena Dr. Miguel to testify if there was any dispute as
to the factual basis of his opinion. 21 CFR 1316.52(d). She did
not.
---------------------------------------------------------------------------
Dr. Miguel observed that "[i]f the concern was that patients were
drug abusers and the intent was to wean them from opioids, this should
have been done in an addiction treatment facility with trained
personnel. * * * Addiction is a complex problem and physical dependence
is a small part of the pathophysiology of the disease.'' Id. Dr. Miguel
further explained that "[p]rescribing opioids to known addicts is
inappropriate and clearly constitutes practice below the standard of
care.'' Id.
Finally, Dr. Miguel discussed Respondent's failure to perform
physical exams and record keeping practices. According to Dr. Miguel, "the
documentation does not concur with the reported complaints. While the
reported complaints did not include pain, high levels of pain
interfering with daily life were documented. This was apparently done to
justify the opioid prescriptions.'' Id. Dr. Miguel also stated that "[i]t
does not appear that the patients were physically examined, yet there is
documentation of heart and lung sounds, abdominal palpitation, even
paracervical muscle spasms and decreased range of motion in joints
impossible to assess without a physical exam.'' Id. Dr. Miguel concluded
that "[t]his may constitute medical fraud and is clearly practice below
the standard of care.'' Id. I likewise credit Dr. Miguel's statement.
Respondent introduced a statement of Walter E. Afield, M.D., a
psychiatrist. Dr. Afield stated that he had reviewed Dr. Frazier's
statement and was "not in agreement.'' Resp. Ex. 55. He asserted that "based
on statements made to the doctor, there are sufficient reasons for
prescribing the medications in question.'' Id. In Dr. Afield's opinion,
Respondent "felt these patients were dependent on these medications to
function and were functioning and that they needed to be placed in a
medically supervised program to detoxify the patients and find
alternative treatments for them.'' Id. Dr. Afield further stated that
his "[r]eview of the entire record of the patient indicates those
medicines were given within the parameters of her specialty.'' Id.
I agree with the ALJ's declination to credit Dr. Afield's statement
for several reasons. First, while Dr. Afield has had a distinguished
career in psychiatry, it is not clear what expertise he has in the area
of pain management or the general diagnosis and treatment of physical
injuries. If his opinion was offered as an expert in treating addiction,
I note that Respondent maintained repeatedly that she prescribed the
drugs to all three patients because she believed the patients were in
pain and not because she was treating an addiction.
Second, his opinion is vague and it is not clear whether he viewed
Respondent's prescribing to be appropriate because the patients were in
pain or because they were addicted. Indeed, to the extent Dr. Afield's
statement that "the patients were dependent on these medications to
function'' and that the patients "needed to be placed in a medically
supervised program to detoxify them,'' was intended to suggest that
Respondent's prescribing was appropriate because the patients were
addicted, it is clearly wrong because the CSA prohibits the prescribing
of controlled substances for this purpose. See 26 CFR 1306.04(c) ("A
prescription may not be issued for the dispensing of narcotic drugs
listed in any schedule for `detoxification treatment' or `maintenance
treatment.' ''). DEA's regulations make clear that a physician who is
not registered to conduct a narcotics treatment program may administer,
but not prescribe, "not more than one day's medication'' of narcotics
for up to three days to a person suffering "acute withdrawal systems
when necessary while arrangements are being made for referral for
treatment.'' 26 CFR 1306.07(b). A physician cannot,
[[Page 52156]]
however, issued a prescription for this purpose. Third, to the extent
he believed that Respondent prescribing was appropriate because the
undercover operatives were in pain, Dr. Afield stated that he "review[ed]
the entire record of the patient.'' Id. It is undisputed, however, that
Respondent falsified the medical records of the three undercover
operatives and there is nothing in the statement that suggests that Dr.
Afield relied on non-falsified records. An expert opinion based on
falsified records is obviously not probative of the issues.
Fourth, Dr. Afield's statement does not address why it would be
appropriate to prescribe a controlled substance without performing a
physical exam. This is especially noteworthy in light of Respondent's
acknowledgement that performing a physical exam is "Rule 1.'' Respondent
also called as a witness Robert A Guskiewicz, M.D. Dr. Guskiewicz is the
Director of the Pain Fellowship Program and a Clinical Assistant
Professor in the Department of Anesthesiology, University of Florida
College of Medicine. Resp. Exh. 57. Dr. Guskiewciz also served as the
court monitor under the pre-trial diversion agreement.
Dr. Guskiewicz testified that in his opinion Respondent had
legitimately prescribed controlled substances to all three undercover
visitors. Tr. 813. He further testified that his opinion was based on
the indications of pain on the patient questionnaires that were
completed by the undercover visitors. Id. at 814. Dr. Guskiewicz added
that Massey had indicated that "he did have pain in the past,'' and that
the medications he had used had "helped to improve his function in doing
his job.'' Id. He also testified that the same was true for the patients
portrayed by Detectives Esterline and Keys. Dr. Guskiewicz stated that
while "[t]here was some vagueness,'' he could determine that the
medications had helped these patients improve their functionality. Id.
at 815. Dr. Guskiewicz also testified that he teaches his students to "give
the patient the benefit of the doubt,'' Id. at 824, but to provide them
with a "limited supply of medications'' such as either a two-week or
one-month supply, and to "do our due diligence.'' Id. at 825.
On cross-examination, Dr. Guskiewicz was asked "[w]hat is required of
a physician who wanted to establish a course of treatment?'' Id. at 818.
Dr. Guskiewicz answered: "[p]hysical examination, assessment and
diagnosis.'' Id. Later in the cross-examination, Dr. Guskiewicz was
asked a series of questions related to whether he knew that Respondent
had made up the part of the record that supposedly were the findings of
a physical exam. One of the questions was whether it was "outside of the
practice in the state of Florida'' to falsify a patient record. See Id.
at 827. Dr. Guskiewicz testified that "[n]ot performing the examination
would not be outside the practice, but saying you performed the
examination when you did not would be.'' Id. Dr. Guskiewicz
acknowledged, however, that the assumption that a person comes to a pain
management clinic because they are in pain does not relieve a physician
from the responsibilities of performing a physical exam and inquiring
into the patient's medical history. Id. at 829.
The ALJ declined to credit Dr. Guskiewicz's opinion that Respondent
had properly prescribed controlled substances. I likewise decline to
credit Dr. Guskiewicsz's opinion on this point. As an initial matter, I
note that Dr. Guskiewicsz's opinion was based, in part, on the fact that
Massey had indicated that he had "pain in the past.'' But Massey also
stated that he had had shoulder surgery four and a half years ago and
that the "problem was more or less cured.'' Thus, Massey's statements do
not provide an adequate basis for concluding that a patient is still in
pain, or would be in pain but for the taking of a controlled substance.
Indeed, I note that Respondent did not do "due diligence'' by
performing a physical exam even when she admitted that the undercover
patients were "not typical'' or were "strange weirdos.'' Furthermore,
Dr. Guskiewicz eventually, although apparently with some reluctance,
conceded that it is essential to perform a physical exam before
prescribing a controlled substance. Thus, Dr. Guskiewicz appears to have
rendered his opinion on direct examination regarding Respondent's
prescribing to the undercover patients without considering material
facts.
Other Evidence
I note that Respondent did comply with the terms of the pre-trial
diversion agreement and that the United States Attorney dismissed the
indictment. I also note that Respondent retained the services of a
private investigation firm to review her patient records and determine
which patients were likely substance abusers and should be discharged
from her practice. I also note that the private investigation firm
developed procedures to address, and trained Respondent's employees in,
such matters as spotting drug abusers, doctor shopping, failed drug
tests, claims of lost, stolen or destroyed medications, prescription
fraud and forgery, and patients with a drug-related criminal history.
The private investigation firm conducted criminal history checks on more
than 500 people and interviewed nearly 280 patients and their
associates. I further acknowledge that one of Respondent's private
investigators testified that prescription drug abusers would target
foreign doctors, that they would provide forged medical records such as
MRI reports, and that most of the patients he interviewed admitted to
lying to Respondent to obtain narcotics. I note, however, that none of
the undercover operatives used false records to induce Respondent to
prescribe to them and that none of them claimed to be in pain.
Respondent testified that she had discharged or not accepted "may be
in the hundreds'' of patients. Id. at 426. She also testified that she
stopped pre-signing prescriptions and that she was no longer accepting
patients without a referral. Id. at 470.
Finally, Respondent called several patients to testify on her behalf.
In general, the patients testified that Respondent's treatments had
greatly helped them to control their pain and had helped them improve
their functionality. Respondent also submitted numerous letters from
patients that were to similar effect.
Discussion
Respondent's Challenges to the Proceeding
Before analyzing this case under the public interest factors, see 21
U.S.C. 823(f), I note that Respondent has raised several challenges
to DEA's authority to bring this proceeding. Therefore, I will address
these claims to determine whether any of them have merit.
Respondent's first contention is that this proceeding "violates the
plain terms, meaning and understanding of the'' pre-trial diversion
agreement she entered into with the United States Attorney. Resp. Br.
72. In particular, Respondent asserts that "the Government agreed that
it would dismiss the charges against [Respondent] (assuming [her]
compliance with the [a]greement) and that she would continue to practice
pain management including the prescribing of Schedule II-V controlled
substances.'' Id. at 71. Respondent thus contends that this proceeding
violates "the understanding that Dr. Iyer would continue to practice
pain management and to prescribe'' controlled substances.
[[Page 52157]]
I disagree. Nothing in the plain language of the agreement manifests
the government's assent that Respondent would be able to continue
prescribing controlled substances without being held to account by DEA,
or purports to waive DEA's authority to seek the revocation of her
registration. See Resp. Exh. 52. Nor is there any merit to Respondent's
contention that this proceeding violates the understanding of the
parties. Respondent got exactly what she bargained for--a dismissal of
the federal indictment. Immunity from a DEA revocation proceeding was
not part of the deal. Beyond that, the United States does not waive its
sovereign authority by implication. Cf. United States v. Cherokee Nation
of Oklahoma, 480 U.S. 700, 707 (1987) ("[A] waiver of sovereign
authority will not be implied but instead must be `surrendered in
unmistakable terms.' '') (quoting Bowen v. Public Agencies Opposed To
Social Security Entrapment, 477 U.S. 41, 52 (1986) (int. quotations and
other citation omitted)).
Furthermore, a United States Attorney does not have authority to bind
the Drug Enforcement Administration from instituting proceedings seeking
the revocation of a registration under the Controlled Substances Act. As
the Eleventh Circuit has observed in a case involving the INS, which was
then a sister agency of DEA in the Department of Justice, "Congress did
not expressly grant the United States Attorney authority to bind the
INS, or any other governmental agency.'' San Pedro v. United States, 79
F.3d 1065, 1069 (11th Cir. 1996).
Rather, Congress vested the authority to revoke a registration in the
Attorney General, see 21 U.S.C. 823(f) & 824(a), and this authority
has been delegated exclusively to the Administrator and Deputy
Administrator of DEA. 28 CFR 0.100(b) & 0.104. Therefore, a United
States Attorney cannot enter into either a pre-trial diversion agreement
or a plea bargain that binds DEA from instituting revocation proceedings
without DEA's express written authorization. See United States v.
Fitzhugh, 801 F.2d 1432, 1434-35 (DC Cir. 1986) (rejecting contention
that plea agreement implicitly prohibited DEA proceeding noting that
AUSA lacked authority to bind DEA); Noell v. Bensinger, 586 F.2d 554,
559 (1978) ("Neither the prosecutor nor the district court * * * had the
authority to speak for the'' DEA.); Cf. San Pedro, 79 F.3d at 1069-70;
United States v. Igbonwa, 120 F.3d 437, 444 (3d Cir. 1997) ("[T]he
United States Attorney's Office lacks the authority to make a promise
pertaining to deportation in the prosecution of a criminal matter that
will bind INS without its express authorization.'').
Respondent's estoppel arguments based on the diversion agreement are
equally unpersuasive. Respondent asserts that DEA is estopped from
seeking the revocation of her registration because she "relied on the
government's representations in the * * * Diversion Agreement that it
was in the interest of the United States and in the interest of justice
that she continue to practice pain management and to prescribe
narcotics.'' Resp. Br. 72. Respondent further contends that "[i]f she
had known that the Government would seek to revoke her DEA Certificate,
she would not have given up her right to a speedy trial and would not
have entered the Pretrial Diversion Program.'' Id.
As an initial matter, I note that the diversion agreement's "interest
of the United States'' language is part of the standard diversion
agreement form, which is used for a wide variety of federal crimes, and
is thus boiler plate. The language is clearly not a reference to the "public
interest'' standard that Congress had directed me to apply in
administering the CSA.
More importantly, it well settled that the United States "may not be
estopped on the same terms as any other litigant.'' Heckler v. Community
Health Services of Crawford Cty., Inc., 467 U.S. 51, 60 (1984). But "even
assuming that the Government is ever subject to estoppel, a `private
party surely cannot prevail without at least demonstrating that the
traditional elements of an estoppel are present.' '' Lyng v. Payne, 476
U.S. 926, 935 (1986) (quoting Heckler, 467 U.S. at 61). Most
significantly, the Supreme Court has explained that "[a]n essential
element of any estoppel is detrimental reliance on the adverse party's
misrepresentations.'' Id. (citing Heckler, 467 U.S. at 59).
Here, Respondent has produced no evidence of affirmative misconduct
by the government that induced her to enter into the diversion
agreement. Indeed, it would be strange to make such an argument in light
of the fact that Respondent was represented in the criminal proceeding
by a former United States Attorney for the Middle District of Florida
(See Resp. Exh. 64), who was presumably well aware of the limits on a
United States Attorney's power to bind an agency such as DEA and the
Eleventh Circuit's case law holding that a United States Attorney has no
such authority. See San Pedro, 79 F.3d at 1069-70. Thus, even if the
United States Attorney had made a representation that DEA would not seek
to revoke her registration, it would have been unreasonable for
Respondent to rely on it.
Moreover, Respondent has not established detrimental reliance because
Respondent cannot show that she is worse off for having accepted
pre-trial diversion. Even if Respondent had gone to trial and been
acquitted, DEA could still have sought to revoke her registration. See
United States v. One Assortment of 89 Firearms, 465 U.S. 354, 359- 62
(1984). As the Court explained therein: "an acquittal on criminal
charges does not prove that the defendant is innocent; it merely proves
the existence of a reasonable doubt as to his guilt.'' Id. at 361.
A jury verdict in a criminal action does "not negate the possibility
that a preponderance of the evidence could show that'' one had engaged
in illegal activity. Id. at 362. Thus, "it is clear that the difference
in the relative burdens of proof in * * * criminal and civil actions
precludes the application of the doctrine of collateral estoppel.'' Id.
See also Helvering v. Mitchell, 303 U.S. 391, 397 (1938) ("That
acquittal on a criminal charge is not a bar to a civil action by the
Government, remedial in its nature, arising out of the same facts on
which the criminal proceeding was based has long been settled.''). Thus,
Respondent's estoppel contentions are meritless.
Finally, Respondent argues that this proceeding violates the Due
Process Clause because it is vindictive and was initiated to retaliate
against her for exercising various rights including her right to
complain about governmental conduct. See Resp. Br. 81. There is,
however, "a presumption of regularity'' that supports prosecutorial
decision-making, and where probable cause exists the decision to bring a
charge "generally rests entirely'' in the prosecutor's "discretion.''
United States v. Armstrong, 517 U.S. 456, 464 (1996) (int. quotations
and citations omitted); see also Hartman v. Moore, 126 S.Ct. 1695, 1699
(2006) (plaintiff in retaliatory prosecution action must plead and prove
a lack of probable cause).
Here, there clearly was probable cause to believe that Respondent had
committed several violations of the Controlled Substances Act and that
her continued registration would be inconsistent with the public
interest. The grand jury's indictment of Respondent provides an
independent determination of probable cause although such a
determination is not required to initiate a show cause proceeding.
Moreover, the evidence in this case clearly establishes probable cause.
[[Page 52158]]
Finally, as far as any claim that the proceeding was brought to
retaliate against Respondent for complaining about the conduct of a DEA
employee, the decision to initiate a Show Cause Proceeding is made by
senior officials at DEA headquarters and not by field personnel.
Respondent has not come forward with any objective evidence that
established that this proceeding was brought to retaliate against her.\8\
I thus find this contention unpersuasive as well.
---------------------------------------------------------------------------
\8\ Respondent's further contention that the
proceeding was brought to penalize her for having successfully
completed the pre- trial diversion agreement is also unpersuasive.
Given that Respondent had been indicted for multiple violations of the
CSA, and that one of the grounds for revoking a registration is that a
registrant has been convicted of a felony under the CSA or any other
federal law relating to controlled substances, see 21 U.S.C.
824(a)(2), it makes sense to delay the administrative proceeding until
the criminal case has been resolved. A Show Cause Proceeding based on
a felony conviction typically takes far less than the four days of
hearings that it took to litigate this case and requires substantially
less in terms of agency resources.
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The Public Interest Factors
The Controlled Substances Act provides that a practitioner's
registration "may be suspended or revoked * * * upon a finding that the
registrant * * * has committed such acts as would render [her]
registration * * * inconsistent with the public interest.'' 21 U.S.C.
824(a)(4). In making this determination, the Act requires that I
consider the following factors:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id. Sec. 823(f).
"These factors are considered in the disjunctive.'' John H. Kennedy,
M.D., 71 FR 35705, 35708 (2006); Robert A. Leslie, M.D., 68 FR 15227,
15230 (2003). I "may rely on any one or a combination of factors, and
may give each factor the weight I deem appropriate in determining
whether a registration should be revoked.'' Leslie, 68 FR at 15230. In
this matter, I have considered the entire record including the evidence
of Respondent's efforts to improve her practice's procedures.
Nonetheless, I remain deeply troubled by Respondent's disingenuous
insistence that she had a legitimate medical purpose for prescribing the
controlled substances to each of the undercover operatives. I therefore
conclude that revocation of Respondent's registration is necessary to
protect the public interest.
Factor One--The Recommendation of the State Medical Board
It is undisputed that the Florida state authorities did not suspend
or revoke Respondent's state medical license. This factor thus supports
a finding that Respondent's continued registration would be in the
public interest. It is well established, however, that a "state license
is a necessary, but not a sufficient condition for [DEA] registration,''
and thus the fact that Respondent retains her state license is not
dispositive. Kennedy, 71 FR at 35708.
Factor Two--Respondent's Experience in Handling Controlled
Substances
For the reasons stated above in the findings section, I agree with
the ALJ that in each of the undercover visits, Respondent violated
federal law and DEA regulations by prescribing controlled substances
without a legitimate medical purpose. See
21 CFR 1306.04(a). As the ALJ found, Respondent's contention that
she prescribed controlled substances to each of the three operatives
because she believed that their taking the drugs was the reason they
were not in pain is disingenuous. Indeed, as explained above,
Respondent's testimony was frequently inconsistent or implausible.
Moreover, in each case she failed to conduct a physical exam and
falsified medical records.
For example, Respondent testified that she thought Chris Massey was
honest. Yet she prescribed controlled substances to him notwithstanding
that he told her repeatedly that he was not in pain. Furthermore,
Respondent made several statements to Massey that indicate that she knew
he was seeking the drugs to abuse them. Massey also told her that his
girlfriend had been the source of his drugs.
The same can be said about Respondent's conduct and testimony
regarding Detective Esterline's visit. Respondent testified that
Esterline was "honest'' and did not "exaggerate his symptoms.''
Notwithstanding that Esterline told her several times that he did not
have pain, that he took the drugs because they helped him function, and
told her twice that he got the drugs from friends, Respondent
nonetheless gave him a prescription for a controlled substance. Here,
again Respondent made several incriminating statements, such as when she
asked Esterline whether he wanted "to go to [a] substance abuse
program'' or "be maintained on the Vicodin?,'' and when she stated "maybe
I'm sympathetic to the people that allow themselves to slip into
drugs.'' In short, Respondent knew that Esterline was seeking the drugs
to abuse them and not to treat pain.
Detective Keys told Respondent that he did not have pain and at one
point during the visit, Respondent stated to Mr. Mastridge that "I guess
he feels no pain, he just feels better.'' Keys also told Respondent that
he was getting the drugs from non-legitimate sources. Respondent also
made several other incriminating statements such as when she told Keys
that "we will not be supporting just a drug habit.''
Respondent further violated federal law and DEA regulations by giving
Ben Mastridge pre-signed prescriptions and allowing him to issue them to
a patient she had not attended to. While I agree with the ALJ that this
conduct of Respondent violated 21
CFR 1306.05(a), see ALJ Dec. at 42, this is not simply a matter of
prescription forms being improperly completed.
The record makes clear that Mastridge was not authorized under
Florida law to prescribe controlled substances. See Tr. 641-42. He was
therefore without authority to prescribe under the CSA and, of course,
was not registered to do so. See
21 U.S.C. 823(f); 21
CFR 1306.03. Nonetheless, Mastridge issued prescriptions under
Respondent's signature for two controlled substances, Lorcet and Xanax.
Significantly, he exercised independent medical judgment by decreasing
the dosage of Massey's Lorcet prescription and by giving him a
prescription for a new drug, Xanax, which he stated was for the purpose
of taking "the edge off of bringing the coke down.''
Indeed, there is substantial evidence in the record that Respondent
delegated her prescribing authority to Mastridge. This includes
Respondent's statement to Det. Keys that Ben "will write prescriptions
for you too, He writes my prescriptions. When you see him, you don't
have to see me.'' See Gov. Exh. 12, at 6. Moreover, when Massey stated
to Mastridge that "I thought that the Doctor had to fill the
prescription out and sign it,'' Mastridge replied "no,'' and added that "as
long as she is in the building I am being supervised and * * * I can do
anything that she can do because she signs her name to the treatment
agreement.'' See Gov. Exh. 6, at 13.
While DEA's regulations authorize "a secretary or agent'' to prepare
a prescription form for the practitioner's
[[Page 52159]]
signature, 21
CFR 1306.05(a), the CSA does not authorize a practitioner to
delegate her authority to prescribe a controlled substance to another
employee. Respondent clearly delegated her authority to prescribe
controlled substances to Mastridge, who lacked authority to prescribe a
controlled substance. This constitutes a serious violation of the Act.
See United States v. Singh, 390 F.3d 168, 184-87 (2d Cir. 2004)
(affirming criminal conviction of physician for aiding and abetting
illegal distribution of controlled substances where physician gave
pre-signed blank prescription pads to nurses, who although not
authorized to prescribe, wrote patients prescriptions for controlled
substances).\9\
---------------------------------------------------------------------------
\9\ Respondent asserts that her conduct in
pre-signing prescriptions "was not willful or knowing, but was done in
good faith and only after advising the nurse first of the parameters
of the prescription.'' Resp. Br. 62. Respondent did not, however,
testify that she met with Mastridge and discussed what controlled
substances Mastridge was to prescribe for Massey on the April 22nd
visit. Respondent's testimony contains only vague generalities on the
subject of Mastridge's prescribing. See Tr. 469-72.
As for Respondent's contention that she believed in
good faith that it was legal to do so, there are numerous DEA final
orders sanctioning registrants for engaging in this practice. See,
e.g., Walter S. Gresham, M.D., 57 FR 44213, 44214 (1992); Maimoona
Hakim Husain, M.D., 54 FR 16173, 16174 (1989); William T. McPhail,
M.D., 53 FR 47275, 47276 (1988); Richard T. Robinson, M.D., 53 FR
15153, 15154 (1988); James Beale, M.D., 53 FR 15149, 15150 (1988). I
therefore reject Respondent's contention.
---------------------------------------------------------------------------
Factor Three--Respondent's Conviction Record
It is undisputed that Respondent has never been convicted of
violating any federal or State law relating to the manufacture,
distribution, or dispensing of controlled substances. While this factor
is not dispositive, it does support a finding that Respondent's
continued registration would not be inconsistent with the public
interest.
Factor Four--Respondent's Compliance With Applicable Federal, State,
or Local Controlled Substances Laws
As explained above under factor two, Respondent violated 21 U.S.C.
829(b), and 21
CFR 1306.04, when she prescribed controlled substances without a
legitimate medical purpose to the undercover operatives. While I agree
with the ALJ that Respondent's pre-signing of prescriptions violated 21
CFR 1306.05(a), I further find that Respondent violated Federal law by
giving the prescription forms to Mr. Mastridge and delegating to him the
authority to prescribe controlled substances when he was not registered
to do so under Federal law and could not lawfully prescribe them under
State law. See 21
CFR 1306.03(a). This factor thus supports a finding that
Respondent's continued registration would be inconsistent with the
public interest.
Factor Five--Other Conduct Which May Threaten Public Health and
Safety
As I recently held, DEA precedents establish that "an applicant's
acceptance of responsibility for [her] prior misconduct is a highly
relevant consideration under this factor.'' Kennedy, 71 FR35709; see
also Barry H. Brooks, 66 FR 18305, 18309 (2001); Prince George Daniels,
D.D.S., 60 FR 62884, 62887 (1995); Carmel Ben-Eliezer, M.D., 58 FR
65400, 65401 (1993). Here, the ALJ found that Respondent had refused to
accept responsibility for her misconduct in prescribing controlled
substances to the three undercover visitors when there was no legitimate
medical purpose for doing so. See ALJ Dec. at 43.
I recognize that Respondent admitted that she should not have given
pre-signed prescription forms to Mr. Mastridge, that she should have
performed a physical exam on the patients, and that she should not have
created false records. Respondent, however, persisted in maintaining
that she had validly prescribed controlled substances to the undercover
operatives. For example, when cross-examined about whether she had
knowingly and intentionally distributed a controlled substance to
Detective Keys, Respondent insisted that she had not. When asked whether
she had committed this offense she testified: "No, it says here, did
knowingly. No, it's not true. Patients come to us in chronic pain. I
assume they have pain.'' Tr. 652. Respondent further testified that:
Intentionally I did not dispense medication, I did not distribute
outside of the usual course of medical practice. In the context of the
clinical pain management, I knew the medication [was] not to transfer,
not to sell the drug to the street or anything. My intention here is
believe the patient, give them the benefit of chronic pain, and evaluate
them, and do what is appropriate for them.
Id.
I am deeply troubled by Respondent's testimony and her evident
misapprehension of a registrant's obligations under the CSA. Contrary to
Respondent's understanding, a practitioner violates the Act by
prescribing a controlled substance without a legitimate medical purpose.
It is no less a violation that the "patient'' will personally use the
drug rather than sell it on the street.
I recognize the substantial measures undertaken by Respondent to
reform her practice. But in the case of a practitioner, the most
important control against diversion is the individual registrant
herself. When the individual registrant's conduct is the source of the
problem, and that registrant refuses to acknowledge her responsibilities
under the law, all of the aforementioned reforms will still not
adequately protect public health and safety.
Therefore, I conclude that factor five supports a finding that
Respondent's continued registration would threaten public health and
safety and indeed, that this factor is dispositive in determining that
her continued registration is inconsistent with the public interest.
Order
Accordingly, pursuant to the authority vested in me by 21
U.S.C. 823(f) and 824(a)(4),
as well as 28 CFR 0.100(b) and 0.104, I hereby order that DEA
Certificate of Registration, No. AK2006648, issued to Respondent Jayam
Krishna-Iyer, M.D., be, and it hereby is, revoked. I further order that
any pending applications for renewal or modification of such
registration be, and they hereby are, denied. This order is effective
October 2, 2006.
Dated: August 22, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-14568 Filed 8-31-06; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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