[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.
---------------------------------------------------------------------------
\1\ Respondent also sought to enjoin the proceeding. The
district court, however, denied her motion for an injunction.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\2\ Respondent is board certified in anesthesiology and pain
management.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\4\ Ativan, or Lorazepam, is a Schedule IV controlled substance.
21 CFR 1308.14(c).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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