[Federal Register: February 12, 2004 (Volume 69, Number 29)]
[Notices]
[Page 7016-7018]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12fe04-90]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 02-24]
Karen A. Kruger, M.D.; Grant of Restricted Registration
On January 4, 2002, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Karen A. Kruger, M.D. (Respondent), proposing to
deny her application for a DEA Certificate of Registration pursuant to
21 U.S.C. 823(f).
By letter dated April 9, 2002, the Respondent through her legal
counsel requested a hearing on the issues raised by the Order to Show
Cause. Following prehearing procedures, a hearing was held on December
10, 2002, in Chicago, Illinois. At the hearing, both parties called
witnesses to testify, and the Respondent also testified on her behalf.
Both parties also introduced documentary evidence. After the hearing,
both parties submitted written proposed findings of fact, conclusions
of law, and argument.
On April 23, 2003, Administrative Law Judge Mary Ellen Bittner
(Judge Bittner) issued her Opinion and Recommended Ruling, Findings of
Fact, Conclusions of Law and Decision (Opinion and Recommended Ruling),
recommending that Respondent's application for registration be granted
subject to certain conditions. Neither party filed exceptions to Judge
Bittner's opinion, and on May 28, 2003, Judge Bittner transmitted the
record of these proceedings to the then-Acting Administrator.
The Acting Deputy Administrator has considered the record in its
entirety, and pursuant to 21 CFR 1316.67, hereby issues her final order
based upon findings of fact and conclusions of law as hereinafter set
forth. The Acting Deputy Administrator adopts in full the recommended
ruling, findings of fact, conclusions of law and decision of the
Administrative Law Judge. Her adoption is in no manner diminished by
any recitation of facts, issues, or conclusions herein, or of any
failure to mention a matter of fact or law.
The record before the Acting Deputy Administrator shows that the
Respondent received her medical degree from the Medical College of
Wisconsin and is board certified in internal medicine and
anesthesiology and board eligible in critical care medicine. The
Respondent testified during the DEA hearing that she practiced as an
anesthesiologist from 1986 until September 1999, and that during that
period, there were no medical malpractice actions brought against her,
nor did she lose staff privileges at any hospital.
The Respondent testified that in the early 1980s, she began taking
diethylpropion, prescribing the drug to herself. Diethylpropion, a
Schedule IV controlled substance, is used primarily for weight loss.
Specifically, the Respondent testified that she called prescriptions
into pharmacies under fictitious names, went to the pharmacies
pretending to be the persons in whose names she had issued the
prescriptions, and paid cash for and picked up the prescriptions. The
Respondent further testified that while the recommended dosage for
Tenuate (a brand name product containing diethylpropion) is one 75 mg.
tablet daily, she developed a tolerance to the drug and eventually
increased her use of the drug to as many as fifty tablets per day. The
Respondent testified that she initially took Tenuate for weight
control, but then began using it also for its properties as a
stimulant.
The Government presented the testimony of a medical investigator
and controlled substances inspector for the Illinois Department of
Professional Regulation (IDPR). The inspector testified that an
investigation of the Respondent was initiated in December 1999 as a
result of information received from DEA regarding a pharmacist's
concern over the Respondent's apparent prescribing of diethylpropion to
three individuals at the same address.
In response to the above information, the IDPR inspector and a DEA
diversion investigator interviewed the Respondent at her residence in
Chicago on December 14, 1999. When informed of allegations that she had
improperly prescribed controlled substances, the Respondent replied
that as an anesthesiologist she rarely had occasion to prescribe, but
she had prescribed Tenuate to six to ten friends. When asked by the
IDPR inspector to identify these persons, the Respondent admitted that
she had not prescribed to friends for about the last year, and instead,
had issued prescriptions in fictitious names and then picked up the
medications from the dispensing pharmacies herself.
During the interview, the Respondent also admitted during the
interview that she telephoned bogus prescriptions to many chain and
independent pharmacies in Chicago and its suburbs, using approximately
forty different names, and that she took as many as 40 to 60 tablets
per day for purposes of weight loss and to maintain alertness. The
Respondent further admitted that she was probably psychologically
addicted to diethylpropion, but willing to accept treatment for her
addiction. The Respondent was then provided contact information for a
physician involved with Illinois' Physician Assistance Program.
As part of its investigation of Respondent, DEA obtained from the
Walgreens Company a printout of prescriptions that the Respondent
called into various Walgreens pharmacies in the Chicago area. That
printout, along with additional evidence presented at the hearing,
revealed that between September 19, 1998 and September 4, 1999,
Chicago-area Walgreens pharmacies filled more than 170 prescriptions
that Respondent authorized for diethylpropion 75 mg. These unlawfully
issued prescriptions resulted in the aggregate dispensing of
approximately 5,500 dosage units of the controlled substance. The
Respondent testified during the hearing that she also acquired
diethylpropion from other area pharmacies.
On August 2, 2000, Respondent, represented by counsel, appeared at
an Informal Conference with representatives of the IDPR. Following the
conference, Respondent and the IDPR entered into a Consent Order, which
the Director of the IDPR approved on March 22, 2001. The Consent Order
specified, in substance, that Respondent's Illinois Controlled
Substance License would be placed on probation for six months; she
would comply with the terms of an aftercare agreement into which she
entered on August 31, 2000, with the Illinois Professionals Health
Program; Respondent would abstain from the use of alcohol and/or mood
altering or psychoactive drugs except as prescribed by her primary care
or treating physician; Respondent would attend Alcoholics Anonymous
and/or Narcotics Anonymous meetings and Caduceus meetings at least
twice per week; Respondent would undergo monitored random urine screens
at least once per month within twenty-four hours of a request by the
Illinois Professionals Health Program; and Respondent would continue
therapy with her psychiatrist. The Consent Order further required
various reports and provided that violation of any of its terms by the
Respondent would constitute grounds for the IDPR to file
[[Page 7017]]
a complaint to revoke her medical license.
At the DEA hearing, the Respondent called as a witness the Chief of
Investigations for IDPR's probation section. The witness testified that
the probation on Respondent's Illinois controlled substance license
terminated in compliance, i.e., that during the course of the probation
the IDPR did not become aware of any violations of the terms of the
March 22, 2001, Consent Order. The witness acknowledged however that
although he recalled receiving required reports from the Respondent's
aftercare program, he did not recall reviewing them. The Respondent
later testified that her case manager and physician monitor were
responsible for the quarterly reports, but that copies were not
provided to her. Respondent also testified that she had brought to the
hearing prepared quarterly reports of drug screens; however, these
reports were not made a part of the record by either party.
The Respondent testified that she has not taken diethylpropion and
has not written any controlled substance prescriptions at all since
December 14, 1999. She also testified that she contacted her monitoring
physician, who referred her to Elmhurst Medical Guidance Services in
Elmhurst, Illinois, a suburb of Chicago, and that she underwent
``partial inpatient'' treatment there from August 2000 until January
2001. The Respondent further testified that she has continued to attend
meetings at Elmhurst Medical Guidance Services on Wednesday nights.
On the date of the hearing in this proceeding, the Respondent's
medical license and controlled substance license were ``non-renewed''
status. Subsequently, counsel for Respondent advised counsel for the
Government and Judge Bittner that Respondent's licenses had been
renewed and provided copies of the licenses. Finally, the Respondent
testified that she intends to resume the practice of anesthesiology and
needs a DEA registration in order to do so, and that if her application
for registration is granted, she is willing to accept such conditions
as submitting to drug screens, limiting her prescribing to drugs used
in anesthesiology, and a prohibition on handling diet drugs.
Pursuant to 21 U.S.C. 823(f), the Acting Deputy Administrator may
deny an application for a DEA Certificate of Registration if she
determines that granting the registration would be inconsistent with
the public interest. Section 823(f) requires that the following factors
be considered in determining the public interest:
(1) The recommendation of the appropriate state licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing or conducting research
with respect to controlled substances.
(3) The applicant's conviction record under federal or state laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable state, federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health or
safety.
These factors are to be considered in the disjunctive; the Acting
Deputy Administrator may rely on any one or a combination of factors
and may give each factor the weight she deems appropriate in
determining whether a registration should be revoked or an application
for registration denied. See Henry J. Schwartz, Jr., M.D., 54 FR 16422
(1989).
As to factor one, the recommendation of the appropriate state
licensing board or professional disciplinary authority, the Acting
Deputy Administrator finds that while the Respondent's Illinois
Controlled Substance License was placed on a six month period of
probation pursuant to a consent order with the IDPR, the record in this
proceeding demonstrates that the Respondent has satisfactorily complied
with the terms of her probation. In addition, the Respondent is fully
licensed as a physician and surgeon in Illinois with controlled
substance handling privileges in that state. The Acting Deputy
Administrator agrees with Judge Bittner's finding that while the
Respondent's licensures to practice medicine and to handle controlled
substances are not determinative in this proceeding, the Respondent's
successful completion of probation and the renewal of her state
professional licenses weigh in favor of granting her application for
DEA registration.
Factors two and four, Respondent's experience in handling
controlled substances and her compliance with applicable controlled
substance laws, are also relevant in determining the public interest in
this mater. Evidence was presented at the DEA hearing that the
Respondent has prescribed diethylpropion to herself since the early
1980s. The record further established that these prescriptions were
issued in the names of fictitious individuals.
In addition, the Respondent's use of fictitious names on the face
of prescriptions was in violation of 21 CFR 1306.04 and 1306.05, in
that these prescriptions were not issued for a legitimate medical
purpose nor did the prescriptions bear the full name and address of a
patient. As noted in Judge Bittner's Opinion and Recommended Ruling,
the Respondent's use of fictitious prescriptions was also in violation
of Illinois law prohibiting the acquiring or obtaining possession of
controlled substances by misrepresentation, deception, or subterfuge.
Like Judge Bittner, the Acting Deputy Administrator finds the
Respondent's personal illicit use of controlled substances relevant
under factors two and four, and weighs in favor of a finding that the
Respondent's registration would be inconsistent with the public
interest.
Factor three, the applicant's conviction record under federal or
state laws relating to the manufacture, distribution, or dispensing of
controlled substances, is not relevant for consideration here, since
there is no evidence that the Respondent has ever been convicted of any
crime related to controlled substances.
With respect to factor five, other conduct that may threaten the
public health and safety, the Acting Deputy Administrator finds this
factor relevant to the lack of detail surrounding the Respondent's
rehabilitation, and the Respondent's conduct in unlawfully obtaining
controlled substances. The Acting Deputy Administrator shares the
concern of the Government regarding the scant nature of evidence
involving the Respondent's recovery from drug abuse. The Acting Deputy
Administrator is also deeply disturbed by the apparent long duration
the Respondent's drug use, as well as her dishonest conduct in
obtaining controlled substances. Therefore, the Acting Deputy
Administrator finds the Respondent's history of drug abuse relevant
under factor five, and further weighs in favor of a finding that the
grant of her application for registration would be inconsistent with
the public interest.
Based on the foregoing, adequate grounds exist for the denial of
the Respondent's pending application for DEA registration. Having
concluded that there is a lawful basis upon which to deny the
Respondent's application, the question remains as to whether the Deputy
Administrator should, in the exercise of his discretion, grant or deny
the application. Ray Roya, 46 FR 45842 (1981). Like Judge Bittner, the
Acting Deputy Administrator concludes that it would not be in the
public interest to deny the Respondent's pending application.
The Acting Deputy Administrator finds significant the Respondent's
ready willingness to cooperate with law enforcement authorities when
[[Page 7018]]
questioned about allegations of her improperly prescribing. During a
December 1999 interview with DEA and IDPR investigators, the Respondent
admitted that he used fictitious names on prescriptions to acquire
controlled drugs and that she abused controlled substances for several
years. With respect to the above referenced interview, the Acting
Deputy Administrator also finds significant the Respondent's stated
willingness to seek treatment for her drug abuse. It appears from the
record that the Respondent demonstrated the same openness and resolve
in confronting her problems with drug abuse during her testimony at the
administrative hearing.
The Acting Deputy Administrator also finds significant the
Respondent's participation in inpatient drug treatment and her
continued participation in meetings at the Elmhurst Medical Guidance
Services. The Respondent has also successfully completed the
probationary terms imposed upon her state controlled substance license.
There is no evidence in the record of any misuse of controlled
substances by the Respondent since 1999, nor is there evidence of any
further disciplinary action brought against the Respondent with respect
to her handling of controlled substances. It appears from these
positive developments that the Respondent has acknowledged her past
problems with drug abuse and is willing to take steps to further insure
her recovery.
However, given the concerns about the Respondent's past mishandling
of controlled substances, a restricted registration is warranted. This
will allow the Respondent to demonstrate that she can responsibly
handle controlled substances. Accordingly, the Acting Deputy
Administrator adopts the following restrictions upon the Respondent's
DEA registration as recommended by Judge Bittner:
1. Respondent's controlled substance handling authority shall be
limited to the administering and prescribing of controlled substances
used in the practice of anesthesiology;
2. Respondent shall not write any prescriptions for herself, and
shall not obtain or possess for her use any controlled substance except
upon the written prescription of another licensed medical professional.
In the event that another licensed medical professional prescribes a
controlled substance for the Respondent, Respondent shall immediately
notify the Special Agent in Charge of the DEA's nearest office, or his
designee; (a) that she is about to obtain a specified controlled
substance for her personal use, and (b) the reasons the controlled
substance is being prescribed.
3. For at least two years from the date of the entry of a final
order in this proceeding, Respondent shall continue to submit to random
drug testing under the auspices of the Illinois Department of
Professional Regulation or its designee and shall continue to
participate in meetings at Elmhurst Medical Guidance Services or in an
equivalent program.
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in her by
21 U.S.C. 823 and 28 CFR 0.100(b), hereby orders that the application
for DEA Certificate of Registration submitted by Karen A. Kruger, M.D.
be, and it hereby is, granted, subject to the above described
restrictions. This order is effective March 15, 2004.
Dated: January 20, 2004.
Michele M. Leonhart,
Acting Deputy Administrator.
[FR Doc. 04-3129 Filed 2-11-04; 8:45 am]
BILLING CODE 4410-09-M