FR Doc E8-31412[Federal Register: January 6, 2009 (Volume 74,
Number 3)] [Notices] [Page 459-464] From the Federal Register
Online via GPO Access [wais.access.gpo.gov] [DOCID:fr06ja09-49]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 03-8]
Jayam Krishna-Iyer, M.D.; Suspension of Registration;
Granting of Renewal Application Subject to Condition
On September 1, 2006, I, the Deputy Administrator of the Drug
Enforcement Administration, ordered that the DEA Certificate of
Registration issued to Jayam Krishna-Iyer, M.D. (Respondent), of
Clearwater, Florida, be revoked. Jayam Krishna-Iyer, M.D., 71 FR
52148, 52159 (2006). The Order also denied Respondent's pending
application for renewal of her registration.
As grounds for the Order, I noted that Respondent had issued
prescriptions for controlled substances to three separate
undercover operatives notwithstanding that each of the
operatives had indicated that he was not in pain, and had told
Respondent that he was obtaining controlled substances from
non-legitimate sources such as friends. Id. at 52158. I further
noted that Respondent had failed to conduct a physical exam on
each of the undercover operatives and had falsified each
operative's medical record to indicate that she had done an
exam. Id. I also noted that Respondent had made statements
during each operative's visit indicating that she knew that the
operative was seeking the drugs to abuse them and not to treat
pain. Id. Finally, I noted that Respondent had pre-signed
prescriptions and given them to a registered nurse in her
employ, and that she allowed the nurse to issue prescriptions to
one of the operatives even though she did not attend to the
operative during the visit and the nurse lacked authority under
both Federal law and Florida law to prescribe controlled
substances. Id.
In the decision, I noted that Respondent had undertaken
substantial measures to reform her practice including hiring a
private investigation firm to review patient records to
determine which patients were likely substance abusers and
should be discharged from her practice; the firm also developed
procedures for recognizing drug abusers, doctor shoppers,
prescription fraud, patients with a drug- related criminal
history, and dealing with claims of lost and stolen medications.
Id. at 52156. I also noted that the firm had conducted extensive
criminal history checks on Respondent's patients and that she
had discharged a large of number of patients. Id.
While I recognized the substantial measures that Respondent
had undertaken to reform her practice, I adopted the ALJ's
finding that Respondent failed to accept responsibility for her
misconduct based on her testimony that she did not intentionally
or knowingly distribute a controlled substance to the undercover
operatives because she knew the drugs would not be sold on the
street. Id. at 52159. As I explained in the Order, "[i]t is no
less a violation that the 'patient' will personally use the drug
rather than sell it on the street.'' Id. I further concluded
that because Respondent had "refuse[d] to acknowledge her
responsibilities under the law,'' the reforms she had undertaken
would "still not adequately protect public health and safety,''
and that this finding was dispositive as to whether her
continued registration would be consistent with the public
interest. Id.
Thereafter, Respondent filed a petition for review in the
U.S. Court of Appeals for the Eleventh Circuit. On September 25,
2007, following briefing and oral argument, the Court vacated
the Agency's Order in an unpublished opinion. Krishna-Iyer v.
DEA, No. 06-15034 (11th Cir. 2007), Slip Op. at 3. The Court
declared:
In considering Petitioner's experience in dispensing
controlled substances under factor 2, the DEA identified only
four visits by three undercover 'patient,' who were all
attempting to make a case against her. The DEA failed to
consider Petitioner's experience with twelve patients whose
medical charts were seized by the DEA, or with thousands of
other patients. In short, the DEA did not consider any of
Petitioner's positive experience in dispensing controlled
substances. This is an arbitrary and unfair analysis of
Petitioner's experience.
Id. The Court therefore vacated the Order and remanded the
case for reconsideration, directing that "DEA should pay
particular attention to the entire corpus of Petitioner's record
in dispensing controlled substances, not only the experience of
[the] undercover officer.'' Id. The Court further ordered that "[t]he
five factors should * * * be re- balanced.'' Id.
On September 15, 2008, the Parties submitted a joint motion
which proposed a resolution of the matter. More specifically,
the Parties propose that I "issue a new final Order consistent
with the direction of the * * * Court of Appeals.'' Joint Motion
at 2. The Parties also request that were I to find that "revocation
or suspension is still an appropriate outcome,'' that the
sanction be limited "to suspension of [her] registration for the
time'' that the Final Order remained in effect. The Parties also
requested that I direct that Respondent's pending renewal
application be acted upon expeditiously. Finally, the Parties
represented that if I concurred with their proposed resolution,
they would enter into a Memorandum of Agreement (MOA) under
which Respondent's registration will be renewed subject to the
condition that for a one year period, she file monthly reports
with the Agency's Miami Field Division providing information
regarding her prescribing of controlled substances.
Attached to the Joint Motion was Respondent's statement. In
her
[[Page 460]]
statement, Respondent: (1) "Acknowledge[d] wrongdoing for
failing to conduct physical examinations of the three undercover
patients in this case''; (2) "acknowledge[d] wrongdoing for
improperly indicating on the charts of the undercover patients
that she had conducted a physical examination of'' them; and (3)
"acknowledge[d] that she had presigned various prescriptions and
* * * understands that this was improper.'' Respondent's
Statement at 1. Respondent also apologized for her conduct with
respect to each of the above actions and promises that she will
not engage in similar conduct in the future.\1\ Id. Respondent
also stated that she has reviewed the Agency's earlier decision,
that she "has reexamined her conduct with respect to the three
undercover patients in light of the [Agency's] decision and has
re-evaluated the transcripts of the visits of the undercover
patients in light of the * * * decision.'' Id. Respondent
further stated that "she regret[ed] that she prescribed the
medications which she prescribed to the undercover patients''
and "apologized * * * for her conduct.'' Id. Respondent also
promised that "such conduct has not occurred since [the
undercover visits] and will not occur again.'' \2\
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\1\ With respect to the pre-signing of
prescriptions, Respondent stated that "she had not engaged in
such conduct since being advised by the DEA that such conduct
was improper and promises that she will not in the future.''
Respondent's Statement at 1. \2\ Respondent also expressed
regret and apologized for doctor- shopping and inappropriate
diversion of drugs at her clinic. Respondent's Statement at 2.
I acknowledge (as I did in the original decision) the
extensive efforts Respondent has undertaken to prevent the
diversion and abuse of drugs by her patients. I also
acknowledge Respondent's successful completion of the one-year
period of monitoring of her practice.
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Findings
I incorporate by reference my findings of fact contained in
the original order and found at pages 71 FR at 52149-56. As
previously found, and as Respondent acknowledges, she issued
controlled substance prescriptions to three undercover
operatives without performing physical examinations on them and
falsified medical records to indicate that she had performed a
physical exam. Moreover, Respondent prescribed controlled
substances to the undercover operatives even though each of them
represented that they were not in pain and were obtaining the
drugs from non-legitimate sources such as friends or family
members. Moreover, during each of the visits, Respondent made
statements that indicated that she knew the patients were
seeking the drugs to abuse them and not to treat a legitimate
medical condition. See id. at 52150 (Respondent stating during
first undercover visit: "Lorcet 10/650. See, this is a shame
then that you have to take the medicine for the habit.''); id.
at 52152 (after acknowledging that second undercover operative
had told her that he was taking four to five Vicodin a day even
though he did not have pain, and was taking them because he "functioned
better,'' Respondent asked him if he "want[ed] to go to
substance abuse program or * * * be maintained on the vicodin?'');
id. (stating to second undercover operative "maybe I'm
sympathetic to the people that allow themselves to slip into
drugs''); id. at 52154 (during visit of third operative, when
asked by her nurse, "what's the source of the pain?,'' replying:
"I guess he feels no pain, he just feels better.''); id.
(stating to third visitor: "we will not be supporting just a
drug habit'').
Having reviewed--for a second time--the twelve patient files
that were seized during the January 26, 2000 search, I further
find that Respondent discharged five of these patients prior to
the search. More specifically, I find that: (1) Respondent
discharged K.L. on February 2, 1998, upon her office's being
notified that she had altered a prescription; (2) Respondent
discharged R.H. on February 11, 1999, for various reasons
including his having claimed that his drugs had been lost or
stolen, and his coming in early to obtain new prescriptions
claiming that he was going out of town; (3) Respondent
discharged J.B. on December 1, 1998, after her office was
notified that she had been arrested for photocopying
prescriptions and presenting them for filling to multiple
pharmacies; (4) Respondent discharged R.S. on December 2, 1999,
after being called by his mother who reported that he was
abusing his medications; and (5) Respondent discharged J.L. on
January 24, 2000, after an anonymous caller reported to
Respondent's office that he was simultaneously receiving
treatment at a methadone clinic. See RX 21, at 4, 17, 23, 24
& 34
As stated above, the Court of Appeals vacated the original
Order on the ground that it failed to consider "any of'' what it
termed [Respondent's] "positive experience in dispensing
controlled substances.'' Slip. Op. at 3. The Court specifically
noted that I had not considered Respondent's experience with the
twelve patients whose charts were seized in a search of her
office, "or with thousands of other patients.'' Id. at 3.
The Court of Appeals did not cite to any decision of either
this Agency or another court defining the term "positive
experience.'' Nor did the Court offer any guidance as to the
meaning of this term, which is not to be found in the Act.
For the purpose of resolving this matter, I therefore
assume-- without deciding--that the twelve patient charts
establish that Respondent's prescribing of controlled substance
to these individuals constitutes "positive
experience''--whatever that means.\3\
[[Page 461]]
Moreover, although there is absolutely no evidence in the
record regarding the propriety of Respondent's prescribing of
controlled substances to the "thousands of other patients'' she
has treated, for the purpose of resolving this matter, I again
assume that her prescribings to these individuals constitutes "positive
experience.''
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\3\ Having carefully re-reviewed the charts,
it should be noted that some of the files suggest that this is
an assumption which is highly favorable to Respondent. Under
agency precedent, DEA's authority to suspend or revoke a
registration is not limited to those instances in which a
practitioner intentionally diverts. See Paul J. Caragine, Jr.,
63 FR 51592 (1998). A practitioner who ignores the warning
signs that her patients are either personally abusing or
diverting controlled substances commits "acts inconsistent
with the public interest,'' 21
U.S.C. 824(a)(4), even if she is merely gullible or
na[iuml]ve. 63 FR at 51600. The twelve patient charts cited by
Respondent as evidence of her "positive experience'' included
numerous instances in which Respondent appears to have ignored
warning signs that the patient was either abusing or diverting
controlled substances.
For example, according to Respondent's
evidence, "[o]n 10/05/99 a notation written in [C.A.'s]
progress notes states, 'That the patient called to say that a
[D.M.] will call and tell you I'm selling my drugs.' It was
later discovered that the patient was in jail for violation of
probation and marijuana.'' RX 21, at 2. In her testimony,
Respondent did not address what action she took in response to
this unusual phone call. See Tr. 433-34. Moreover, the actual
progress note for C.A.'s October 5 visit is missing. Also
missing are the progress notes for numerous other office
visits which occurred (according to Respondent's billing
records) on October 7 and 25, November 8 and December 17.
On July 28, 1998, Respondent issued a
prescription for a drug (Soma) to C.C. RX 21, at 8. That same
day, Respondent's office received a phone call from a
Walgreens pharmacy reporting that two days earlier, C.C. had
filled a prescription for the same drug which was issued by a
different physician. Id. C.C. was thus clearly engaged in
doctor shopping.
Respondent saw C.C. three days later and yet
there is no indication in the progress note that she even
questioned him about the incident and whether he was seeing
other doctors. RX 90, at 29. At this visit, Respondent issued
him a prescription for Dilaudid, a schedule II controlled
substance. Id. C.C. also demonstrated a consistent pattern of
coming in early. Respondent nonetheless continued to prescribe
controlled substances to him and did not discharge him until
approximately a year and a half after the Walgreen's incident.
RX 90, at 1.
Respondent had previously discharged R.H.
based on a drug test which showed that he was "positive for
drug dependency.'' RX 92, at 22. Respondent, however, accepted
him back into her practice. Id. It is acknowledged that upon
his return to her practice, Respondent counseled R.H. that if
he returned "to the same state of medications taking'' as "in
the past, we will not be not be able to continue.'' Id. During
the visit, Respondent issued him a prescription for Dilaudid.
Id.
Two days later, however, R.H. returned to
Respondent and complained that he could only get part of his
prescription filled and that he had come back to get the
balance of forty tablets. Respondent "continued his
prescription for Dilaudid,'' id. at 21, even though the
original prescription was still valid under Federal law. After
a number of additional visits, in early October, R.H. came in
and represented that his drugs had been ruined because he
lived in a duplex and the landlord's hot water heater had
failed and flooded the whole house. Id. at 16. As Respondent
noted, R.H. had brought in "the whole bottle of Dilaudid with
water in it. I cannot tell if it is just a powder or
medicine.'' Id. Respondent issued R.H. a new prescription
notwithstanding the likely implausibility of his story and his
past record as a drug abuser. Id. Nor is there any evidence
that she attempted to verify whether the substance in the
bottle was in fact Dilaudid. In addition, R.H. made numerous
early visits, and on another occasion, obtained prescriptions
for Oxycontin and Percocet after having claimed that he lost a
prescription for Dilaudid. Id. at 9.
While Respondent discharged J.B. on December
1, 1998, and represents that J.B. was discharged after being
arrested for photocopying prescriptions, see RX 21, at 4; the
online records of the Pinellas County, Florida courts indicate
that she had been convicted on July 10, 1996, of attempting to
obtain a controlled substance by fraud, and that on June 9,
1998, a new complaint charging her with obtaining or
attempting to obtain a controlled substance by fraud had been
filed against her. Moreover, J.B. made numerous early visits,
a classic behavior of drug seekers. See RX 93.
R.C. came in on October 21, 1998, nine days
after his initial visit with Respondent, and told her that he
had to come in early because he was going to New York for four
weeks and would run out of medicine while he was out of town.
RX 94, at 12. Yet eight days later, R.C. was back to see
Respondent and seeking additional narcotics because he was "going
to Puerto Rico for some relief work.'' Id. at 11. However,
during R.C.'s initial visit, R.C. had stated that he was "on
disability'' and was "not working.'' Id. at 13. Respondent
nonetheless issued him new prescriptions. Id. at 11. While it
is unclear whether R.C. told Respondent that he would be gone
for six weeks or six months, R.C. went back to see Respondent
on November 18 and 24, as well as on December 1, 1998. Id. at
15.
On August 21, 1998, Respondent gave B.B. a
prescription for Dilaudid (and Soma) for pain in various body
parts and indicated that she would be seen "next month for the
followup.'' RX 99, at 7. On September 2 (eleven days later),
B.B. returned to Respondent and reported that "she is going to
Miami for about three to four weeks for her deposition.'' Id.
at 6. Respondent "continued[d] her prescriptions for Dilaudid
and Soma.'' Id. Twelve days later, B.B. returned to
Respondent. Id. at 5. According to the progress note: B.B. "is
going to Miami for her case. She will be gone four to six
weeks. She came in early today because she does not have
enough medicine for four to six weeks. " Id. Respondent issued
B.B. additional prescriptions for Dilaudid (and Soma) and
indicated that she would be seen again in a month. Id. Ten
days later, B.B. returned again to Respondent. Id. at 4.
According to the progress note, B.B. "came early today because
she will be evacuated from the Fort Lauderdale area. No more
court cases.'' Id. B.B. also told Respondent that the pharmacy
had called and told her that "they could not fill the
prescription, because it was unreadable,'' (as if the pharmacy
would not have called Respondent to verify the script) and
that B.B. "could not get the prescription back from the
pharmacy, so she does not have any medicine [because] she had
to leave it in Fort Lauderdale.'' Id.
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Discussion
Section 304(a) of the Controlled Substances Act (CSA)
provides that a registration to "dispense a controlled
substance* * * may be suspended or revoked by the Attorney
General upon a finding that the registrant* * * has committed
such acts as would render his registration under section
823 of this title inconsistent with the public interest as
determined under such section.'' 21
U.S.C. Sec. 824(a)(4) (emphasis added). With respect to a
practitioner, the Act requires the consideration of the
following factors in making the public interest determination:
(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).
[T]hese factors are * * * considered in the disjunctive.''
Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well
settled that 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.'' Id.;
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, I am "not
required to make findings as to all of the factors.'' See Hoxie,
419 F.3d at 482; see also Morall v. DEA, 412 F.3d 165, 173-74
(D.C. Cir. 2005).59
As explained below, I adhere to my initial findings regarding
factors one through four. As found in the original Order, the
State of Florida took no action against Respondent's state
medical license and Respondent has not been convicted of an
offense under either Federal or State laws relating to
controlled substances. 71 FR at 52158-59. DEA has long held,
however, that a State's failure to take action against a
registrant's medical license is not dispositive in determining
whether the continuation of a registration is in the public
interest. See, e.g., Mortimer B. Levin, 55 FR 8209, 8210 (1990)
(holding that practitioner's reinstatement by state board "is
not dispositive''; "DEA maintains a separate oversight
responsibility with respect to the handling of controlled
substances and has a statutory obligation to make its
independent determination as to whether the granting of [a
registration] would be in the public interest''). Nor is the
fact that a registrant/applicant has not been convicted of a
controlled substance offense dispositive of whether the
continuation of her registration is in the public interest. See
also Edmund Chein, 72 FR 6580, 6593 n.22 (2007).
Pursuant to the Court of Appeals' judgment, I have
re-considered the additional evidence pertaining to Respondent's
"positive experience.'' Having done so, I again conclude that
Respondent violated Federal law and regulations in issuing the
prescriptions to the undercover operatives. I also conclude that
Respondent violated Federal law and regulations when she
pre-signed prescriptions (which she gave to her nurse) and
delegated to him her authority to prescribe controlled
substances, even though he was not registered to prescribe under
Federal law and could not lawfully prescribe controlled
substances under state law. I therefore conclude that Respondent
committed acts inconsistent with the public interest and which
support the suspension or revocation of her registration. 21
U.S.C. 824(a)(4).
However, Respondent has now credibly acknowledged that her
prescribing to the undercover operatives and her pre-signing of
the prescriptions was improper. She has also credibly stated
that she has not engaged in such conduct since the events at
issue here and has promised that she will not do so in the
future.\4\ I therefore further conclude that Respondent has
accepted responsibility for her misconduct and can be entrusted
with a new registration subject to the condition agreed to by
the parties.
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\4\ In the original Order, I acknowledged
that Respondent had undertaken substantial measures to reform
her practice. 71 FR at 52156 & 52159.
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Factor Two and Four--Respondent's Experience in Dispensing
Controlled Substances and Record of Compliance With Applicable
Controlled Substance Laws
Under a longstanding DEA regulation, a prescription for a
controlled substance is not "effective'' unless it is "issued
for a legitimate medical purpose by an individual practitioner
acting in the usual course of his professional practice.'' 21
CFR 1306.04(a). Under the CSA, it is fundamental that a
practitioner must establish a bonafide doctor-patient
relationship in order to act "in the usual course of * * *
professional practice'' and to issue a prescription for a "legitimate
medical
[[Page 462]]
purpose.'' See United States v. Moore, 423 U.S. 122 (1975);
see also 21 CFR 1306.04(a) ("an order purporting to be a
prescription issued not in the usual course of professional
treatment * * * is not a prescription within the meaning and
intent of [21 U.S.C. 829] and * * * the person issuing it, shall
be subject to the penalties provided for violations of the
provisions of law related to controlled substances'').
As the Supreme Court recently explained, "the prescription
requirement* * * ensures patients use controlled substances
under the supervision of a doctor so as to prevent addiction and
recreational abuse. As a corollary, [it] also bars doctors from
peddling to patients who crave the drugs for those prohibited
uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing
Moore, 423 U.S. 122, 135 & 143 (1975)).
In this matter, the Government's presentation largely focused
on two allegations: (1) That Respondent lacked a legitimate
purpose in issuing the prescriptions to the undercover
operatives, and (2) that Respondent pre-signed blank
prescriptions which she gave to her nurse and allowed him to
prescribe drugs even though the nurse was not authorized under
either Federal or State law to prescribe controlled substances.
Whether this conduct is evaluated under factor two--the
experience factor, or factor four--the compliance factor, or
both, is of no legal consequence. In establishing its prima
facie case, the fundamental question is whether Respondent "has
committed such acts as would render [her] registration * * *
inconsistent with the public interest.'' 21
U.S.C. 824(a)(4). As explained above, this Agency has long
held--and other courts of appeals have at least implicitly
recognized--that findings under a single factor are sufficient
to support the revocation of a registration. See Hoxie, 419 F.3d
at 482; Morall, 412 F.3d at 173-74.
In short, this is not a contest in which score is kept; the
Agency is not required to mechanically count up the factors and
determine how many favor the Government and how many favor the
registrant. Rather, it is an inquiry which focuses on protecting
the public interest; what matters is the seriousness of the
registrant's misconduct.\5\
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\5\ The Court of Appeals interpreted my
prior decision as "[b]alancing the factors and according 'dispositive'
weight to factor five.'' Slip. Op. at 5. This suggests that
the factors that favored Respondent's continued registration
(factors one and three) were in equipoise with the factors
that did not support her continued registration. They were
not. As explained above, even if Respondent's conduct had been
discussed under a single factor, the conduct still would have
established a prima facie case that her continued registration
was inconsistent with the public interest. Factor five was
dispositive because once the Government established a prima
facie case, the burden shifted to the Respondent to
demonstrate that her continued registration was consistent
with the public interest.
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As previously found, on three separate occasions, undercover
operatives went to Respondent seeking prescriptions for
controlled substances. Each of the operatives stated that they
were not in pain and that they had been obtaining controlled
substances from such non- legitimate sources as a "girlfriend''
(first visitor), "a friend'' (second visitor) and "a family
member who has a prescription'' (third visitor). 71 FR at 52150,
52152, and 52154. Respondent did not perform a physical
examination on any of the three operatives, even though she
acknowledged that performing a physical exam "is the standard of
practice'' and "our Rule No.1.'' Id. at 52154. Moreover, she
falsified each operative's medical record to indicate that she
had performed a physical exam. Id. at 52150 (first visitor),
52153 (second visitor), & 52154 (third visitor).
Most significantly, Respondent's statements as recorded on
the wire amply demonstrate that she knew that the operatives
were seeking the drugs not for the purpose of treating a
legitimate medical condition, but to abuse them. See 71 FR at
52150 (stating to first visitor: "this is a shame * * * that you
have to take the medicine for the habit,'' "you can tell me that
you want to come out of drugs''); id. at 52152 (asking second
visitor: "you don't have pain but you are taking vicodin?'' and
do you "want to go to substance abuse program or do you want to
be maintained on the vicodin?''); id. (stating to second
visitor: "maybe I'm sympathetic to the people that allow
themselves to slip into drugs''); id. at 52154 (during visit of
third operative, when asked by her nurse, "what's the source of
the pain?'', replying: "I guess he feels no pain, he just feels
better.''); id. (stating to third visitor: "we will not be
supporting just a drug habit'').
In various briefs, Respondent maintains that at the time of
the search, she had already discharged 6 of the 12 patients "for
various reasons including non-compliance with the Prescription
Pain Medication Agreement, criminal acts or arrest.'' Resp.
Exceptions to ALJ Dec. at 42. She contends that this is
exculpatory evidence of her intent to not improperly prescribe
drugs. Id.
As found above, it is true that five of the patients whose
files were seized had been discharged before the search was
conducted. Yet even assuming that this evidence is relevant as
to Respondent's intent with respect to her prescribings to the
undercover operatives, it is not more probative of her intent
during the visits than the evidence as to what actually occurred
during those visits. Indeed, even if the operatives' initial
statements to Respondent were ambiguous as to why they were
seeking the drugs, Respondent did not perform a physical exam on
any of the operatives (yet falsified the records to indicate
that she had done so) and her subsequent statements during the
visits made clear that she had resolved any doubt as to why the
operatives were seeking the drugs. In short, the evidence is
clear that Respondent issued prescriptions to each of the
undercover operatives knowing that they were seeking controlled
substances for the purpose of abusing them and not to treat a
legitimate medical condition.\6\ I thus conclude that Respondent
lacked a legitimate medical purpose and thus violated Federal
law and DEA regulations when she issued the prescriptions to the
undercover operatives.
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\6\ I acknowledge that some courts allow a
defendant in criminal matters to admit evidence of her "prior
good acts'' to prove she lacked criminal intent. See United
States v. Thomas, 134 F.3d 975, 979 (9th Cir. 1998); United
States v. Garvin, 565 F.2d 519, 521-22 (8th Cir. 1977).
Putting aside that this is not a criminal proceeding and the
Federal Rules of Evidence do not apply, Respondent made no
showing that the factual circumstances surrounding her
discharging of these patients were similar to the
circumstances involved in the undercover visits. Indeed, in
four of the five instances, the patients had been caught by
others engaging in problematic behavior such as criminal acts
present altering or photocopying prescriptions, (K.L. and J.B.),
that the patient was receiving drugs from another clinic (J.L.),
or a report from the patient's mother that he was abusing
drugs (R.S.). RX 21, at 4, 23, 24 and 34.
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In her exceptions, Respondent argued that "her treatment of
each of the [twelve] patients [whose files were seized] was
proper,'' and that the "Government presented no evidence
suggesting that the treatment of those twelve patients was
anything but proper.'' Id. Respondent also contends that she "properly
treated thousands of patients for chronic pain,'' and that "the
Government was unable to present any evidence that there was any
problem with any non-undercover patient.'' Id. at 64. Relatedly,
the Court of Appeals has instructed that the experience factor
be reconsidered "pay[ing] particular attention to the entire
corpus of Petitioner's record in dispensing controlled
substances.'' Slip Op. at 3.
As stated above, for the purpose of resolving this matter, I
have assumed that Respondent's prescribings of
[[Page 463]]
controlled substances to every other person she has treated
constitute "positive experience.'' Her prescribings to thousands
of other patients do not, however, render her prescribings to
the undercover officers any less unlawful, or any less acts
which "are inconsistent with the public interest.'' 21 U.S.C.
Sec. 823(f).
In enacting the CSA, Congress recognized that "[m]any of the
drugs included within [the CSA] have a useful and legitimate
medical purpose and are necessary to maintain the health and
general welfare of the American people.'' 21
U.S.C. 801(1). Moreover, under the CSA, a practitioner is
not entitled to a registration unless she "is authorized to
dispense * * * controlled substances under the laws of the State
in which [she] practices.'' 21
U.S.C. 823(f). Because under law, registration is limited to
those who have authority to dispense controlled substances in
the course of professional practice, and patients with
legitimate medical conditions routinely seek treatment from
licensed medical professionals, every registrant can undoubtedly
point to an extensive body of legitimate prescribing over the
course of her professional career.
Thus, in past cases, this Agency has given no more than
nominal weight to a practitioner's evidence that he has
dispensed controlled substances to thousands of patients in
circumstances which did not involve diversion. See, e.g.,
Caragine, 63 FR at 51599 ("[T]he Government does not dispute
that during Respondent's 20 years in practice he has seen over
15,000 patients. At issue in this proceeding is Respondent's
controlled substance prescribing to 18 patients.''); id. at
51600 ("[E]ven though the patients at issue are only a small
portion of Respondent's patient population, his prescribing of
controlled substances to these individuals raises serious
concerns regarding [his] ability to responsibly handle
controlled substances in the future.'').
While in Caragine, my predecessor did consider "that the
patients at issue ma[de] up a very small percentage of
Respondent's total patient population,'' he also noted--in
contrast to the prescribings at issue here--"that [those]
patients had legitimate medical problems that warranted some
form of treatment.'' Id. at 51601. Moreover, in contrast to this
case, in Caragine, there was no evidence that the practitioner
had intentionally diverted. Id. See also Medicine Shoppe--
Jonesborough, 73 FR 364, 386 & n.56 (2008) (noting that
pharmacy "had 17,000 patients,'' but that "[n]o amount of
legitimate dispensings can render * * * flagrant violations
[acts which are] 'consistent with the public interest.' ''),
aff'd, Medicine Shoppe-Jonesborough v. DEA, slip. op. at 11 (6th
Cir. Nov. 13, 2008). Indeed, DEA has revoked other
practitioners' registrations for committing as few as two acts
of diversion. See Alan H. Olefsky, 57 FR 928, 928-29 (1992)
(revoking registration based on physician's presentation of two
fraudulent prescriptions to pharmacy and noting that the
respondent "refuses to accept responsibility for his actions and
does not even acknowledge the criminality of his behavior'').
See also Sokoloff v. Saxbe, 501 F.2d 571, 576 (2d Cir. 1974)
(upholding revocation of practitioner's registration based on
nolo contendere plea to three counts of unlawful distribution).
Accordingly, evidence that a practitioner has treated
thousands of patients does not negate a prima facie showing that
the practitioner has committed acts inconsistent with the public
interest. While such evidence may be of some weight in assessing
whether a practitioner has credibly shown that she has reformed
her practices, where a practitioner commits intentional acts of
diversion and insists she did nothing wrong, such evidence is
entitled to no weight. As I held in the original decision, I
again conclude that Respondent's dispensings to the undercover
officers and her pre-signing of prescriptions and unlawful
delegation of her prescribing authority to her nurse, establish
a prima facie case that her continued registration is "inconsistent
with the public interest.''
Under longstanding Agency precedent, where, as here, "the
Government has proved that a registrant has committed acts
inconsistent with the public interest, a registrant must 'present
sufficient mitigating evidence to assure the Administrator that
[he] can be entrusted with the responsibility carried by such a
registration.' '' Medicine Shoppe, 73 FR at 387 (quoting Samuel
S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53
FR 21931, 21932 (1988))). "Moreover, because 'past performance
is the best predictor of future performance,' ALRA Labs, Inc. v.
DEA, 54 F.3d 450, 452 (7th Cir. 1995), [DEA] has repeatedly held
that where a registrant has committed acts inconsistent with the
public interest, the registrant must accept responsibility for
[her] actions and demonstrate that [she] will not engage in
future misconduct.'' Medicine Shoppe, 73 FR at 387; see also
Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709
(2006); Prince George Daniels, 60 FR 62884, 62887 (1995). See
also Hoxie v. DEA, 419 F.3d at 483 ("admitting fault'' is "properly
consider[ed]'' by DEA to be an "important factor[]'' in the
public interest determination).
In this matter, I previously revoked Respondent's
registration because notwithstanding all of the measures she had
undertaken to reform her practice, she was the person with the
prescribing authority and had refused to acknowledge her
responsibility under the law. 71 FR at 52159. Had this case come
back to me with the same evidentiary record as before, I would
again revoke her registration. Respondent, however, has now
acknowledged wrongdoing with respect to both her prescribings to
the undercover operatives, as well as her pre-signing of
prescriptions and delegation of her prescribing authority to her
nurse, who could not legally prescribe a controlled substance
under either the CSA or Florida Law. Moreover, Respondent's
registration was effectively suspended for a period of
approximately one year. I therefore conclude that the parties'
proposed resolution of this matter is in the public interest.
* * * * *
The diversion of controlled substances has become an
increasingly grave threat to this nation's public health and
safety. According to The National Center on Addiction and
Substance Abuse (CASA), "[t]he number of people who admit
abusing controlled prescription drugs increased from 7.8 million
in 1992 to 15.1 million in 2003.'' National Center on Addiction
and Substance Abuse, Under the Counter: The Diversion and Abuse
of Controlled Prescription Drugs in the U.S. 3 (2005). Moreover,
"[a]pproximately six percent of the U.S. population (15.1
million people) admitted abusing controlled prescription drugs
in 2003, 23 percent more than the combined number abusing
cocaine (5.9 million), hallucinogens (4.0 million), inhalants
(2.1 million) and heroin (328,000).'' Id. Relatedly, "[b]etween
1992 and 2003, there has been a * * * 140.5 percent increase in
the self-reported abuse of prescription opioids,'' and in the
same period, the "abuse of controlled prescription drugs has
been growing at a rate twice that of marijuana abuse, five times
greater than cocaine abuse and 60 times greater than heroin
abuse.'' Id. at 4.\7\
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\7\ According to a recent newspaper article,
"[p]rescription painkiller and anti-anxiety drugs now kill
about 500 people a year in the Tampa Bay area, triple the
number killed by illegal drugs such as cocaine and heroin.''
Chris Tisch & Abbie Vansickle, Deadly Combinations, St.
Petersburg Times (Feb. 17, 2008), at 1. This article further
noted that while at the time of publication, the figures for
the year 2007 were not complete, "the area is on pace for
about 550 deaths,'' and that "prescription drug overdoses are
likely to overtake car crashes as the leading cause of
accidental death.'' Id. In contrast, in 2006, 433 people died
of prescription drug overdoses, and in 2005, 339 died. Id.
According to the Circuit Judge who runs the Pinellas County
drug court, "This has become an epidemic.'' Id.
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[[Page 464]]
While some isolated decisions of this Agency may suggest that
a practitioner who committed only a few acts of diversion was
entitled to regain his registration even without having to
accept responsibility for his misconduct, see Anant N. Mauskar,
63 FR 13687, 13689 (1998), the great weight of the Agency's
decisions are to the contrary. In any event, the increase in the
abuse of prescription controlled substances calls for a
clarification of this Agency's policy. Because of the grave and
increasing harm to public health and safety caused by the
diversion of prescription controlled substances, even where the
Agency's proof establishes that a practitioner has committed
only a few acts of diversion, this Agency will not grant or
continue the practitioner's registration unless he accepts
responsibility for his misconduct.\8\ Put another way, even
where the Government proves only a few instances of illegal
prescribing in the "entire corpus'' of a practitioner's
experience, the Government has nonetheless made out a prima
facie case and thus shifted the burden to the registrant to show
why he should be entrusted with a new registration.\9\
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\8\ Depending upon the facts and
circumstances, a registrant/ applicant may also be required to
show what corrective measures he/ she has instituted to
prevent such acts from re-occurring. \9\ To the extent Mauskar,
or any other decision of this Agency suggests otherwise, it is
overruled.
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I have abided by the judgment of the Court of Appeals in this
matter. However, some may interpret the Court's decision as
suggesting that "the entire corpus'' of a practitioner's record
in dispensing controlled substances can outweigh a
practitioner's intentional acts of diversion where DEA only
proves that a few acts of diversion have occurred.
The Court's decision was not published and the Court did not
instruct the Agency as to how much weight the entire corpus
should be given. Nor did the Court explain whether "the entire
corpus'' should be considered as part of the Government's prima
facie case, or as part of the registrant's rebuttal of the
Government's case.
DEA therefore does not interpret the decision as altering the
manner in which similar arguments have been dealt with in prior
cases. While such evidence may have some probative value, it
does not negate a prima facie showing that a
registrant/applicant has committed acts that are inconsistent
with the public interest. It may, however, be entitled to some
weight in assessing whether a registrant/applicant has
demonstrated that she can be entrusted with a new registration
where the Government's proof is limited to relatively few acts
and a registrant puts forward credible evidence that she has
accepted responsibility for her misconduct.
Order
Pursuant to the authority vested in me by 21
U.S.C. 823(f) & 824(a),
as well as 28 CFR 0.100(b) & 0.104, I hereby order that the
DEA Certificate of Registration issued to Jayam Krishna-Iyer,
M.D., be, and it hereby is, suspended. I further order that the
suspension shall be retroactive and limited to the period
beginning on October 2, 2006, and ending on October 2, 2007,
when her registration was restored pursuant to the judgment of
the Court of Appeals. I further order that the application of
Jayam Krishna-Iyer, M.D., for renewal of her registration be,
and it hereby is, granted subject to the condition that she file
monthly reports with the Special Agent in Charge (or his
designee) of the Miami Field Division for a period of one year.
The reports shall list all controlled substances prescribed by
the patient's name, the date, the name of the drug, its
strength, the quantity prescribed, and the number of refills
authorized. The reports shall be due no later than the tenth day
of the subsequent month and shall list all patients in
alphabetical order.\10\ Failure to comply with the terms of this
Order shall be grounds for the suspension or revocation of
Respondent's registration. This Order is effective immediately.
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\10\ If a patient received multiple
prescriptions, all prescriptions issued to the patient within
the calendar month shall be listed before the prescriptions
for the next patient are reported.
Dated: December 19, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-31412 Filed 1-5-09; 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).
