[Federal Register Volume 69, Number 29 (Thursday, February 12, 2004)]
[Notices]
[Pages 7016-7018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3129]


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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