[Federal Register Volume 59, Number 156 (Monday, August 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19817]


[[Page Unknown]]

[Federal Register: August 15, 1994]


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DEPARTMENT OF JUSTICE
[Docket No. 93-67]

 

Robert J. Kilian, M.D.; Continuation of Registration and 
Reprimand

    On July 15, 1993, the Deputy Assistant Administrator (then-
Director), Office of Diversion Control, Drug Enforcement Administration 
(DEA), directed an Order to Show Cause to Robert J. Kilian, M.D. 
(Respondent), proposing to revoke his DEA Certificate of Registration, 
BK0304131, as a practitioner under 21 U.S.C. 824(a)(4), and to deny any 
pending applications under 21 U.S.C. 823(f). The Order to Show Cause 
alleged that the continued registration of Respondent would be 
inconsistent with the public interest.
    Respondent requested a hearing on the issues raised in the Order to 
Show Cause. The matter was docketed before Administrative Law Judge 
Paul A. Tenney. Following prehearing procedures, a hearing was held in 
Houston, Texas on December 16, 1993.
    On March 16, 1994, Judge Tenney issued his findings of fact, 
conclusions of law, and recommended ruling in which he recommended that 
Respondent's registration be continued and that he be given a formal 
reprimand. No exceptions were filed to this opinion, and on April 22, 
1994, the administrative law judge transmitted the record of the 
proceedings to the Administrator.
    The Deputy Administrator has considered the record in its entirety 
and, pursuant to 21 CFR 1316.67, enters his final order in this matter, 
based on findings of fact and conclusions of law as hereinafter set 
forth.
    The administrative law judge found that Respondent received a 
medical degree from the University of Texas Medical Branch in 1967. 
Respondent subsequently completed an orthopedic surgery residency, and 
began private medical practice in Lake Jackson, Texas in 1972. 
Respondent is board-certified in orthopedic surgery, and a member of 
the American Academy of Orthopedic Surgeons and of the American Academy 
of Pain Management.
    The administrative law judge found that on March 5, 1991, a DEA 
undercover agent visited Respondent's medical office in Lake Jackson. 
The undercover agent asserted that he had various knee, neck, and 
shoulder problems due to a past car accident and asked for chloral 
hydrate and Valium, both Schedule IV controlled substances. The 
undercover agent mentioned that his previous doctor had told him that 
he no longer needed medication and had stopped giving him these 
substances approximately three and a half weeks earlier. Respondent 
conducted a physical examination limited to the agent's knee and the 
prescribed a non-controlled anti-inflammatory, as well as, chloral 
hydrate and Valium.
    The undercover agent returned to Respondent's office on March 26, 
1991, and stated that he had not used the anti-inflammatory and that 
his knee was not hurting, but that the Valium helped him to relax after 
exercise workouts. Respondent did not perform any physical examination, 
but did authorize another prescription for Valium and chloral hydrate. 
The undercover agent returned on May 14, 1991, and stated that the 
medications made him ``feel good'' and asked for larger quantities, but 
Respondent refused to prescribe the larger amounts. Subsequently, on 
May 20, June 6, and July 3, 1991, DEA agents visited a local pharmacist 
and asked that the pharmacist telephone Respondent for refill 
authorization for the prescriptions issued to the undercover agent. On 
each occasion, agents picked up 14 dosage units of chloral hydrate and 
30 dosage units of Valium which had been authorized by Respondent.
    On August 28, 1991, the undercover agent visited Respondent and 
complained of pain in his knee and shoulder. He asked for pain 
medication and steroids. Respondent provided the patient with chloral 
hydrate and Valium, as well as, Lortab, a Schedule II narcotic 
controlled substance, but refused to prescribe steroids.
    On August 1, 1991, another DEA undercover agent visited 
Respondent's medical office and requested Valium. The undercover agent 
stated that he had no real problem, but that he had used some of the 
other undercover agent's Valium after running at the gym and that it 
had helped to relax him. Respondent did not examine the agent, but gave 
him a prescription for Valium to be taken after working out. Respondent 
refused to prescribe chloral hydrate to the agent. On September 11, 
1991, the second undercover agent returned to Respondent's office and 
received another prescription for Valium. He also requested Tylenol 
with codeine, which Respondent refused to provide.
    The administrative law judge found that Respondent testified that 
he uses Valium in his practice as a muscle relaxant, and believes that 
it is not addictive when used in the dosages he prescribes. Respondent 
testified that he felt he was treating the second undercover agent for 
post-exercise muscle spasm. Respondent also testified that if 
medication helps patients with their recreation by making them ``more 
comfortable'' so that they can exercise, then he will prescribe that 
medication.
    At the hearing in this matter, the Government introduced the expert 
testimony of a Houston orthopedic surgeon. The Government medical 
expert testified that his review of the patient records of the 
undercover agents indicated that either they did not have a specific 
complaint or that their complaints were minimal. He noted that 
Respondent continued to prescribe the same strength and quantity of 
medication even when the first undercover agent stated that he was 
doing better. Furthermore, the expert found that the medical histories 
and physical examinations performed by Respondent were limited and not 
properly documented, and that he found no medical indications that 
would warrant the use of either chloral hydrate, a sleep medication, or 
Valium, which he called an addictive and commonly abused drug. He 
stated that in his opinion there was little detail as to why the first 
undercover agent was treated with medication and that the second 
undercover agent did not demonstrate muscle spasm. The Government 
medical expert concluded that Respondent's prescribing practices were 
not for a legitimate medical purpose nor in the usual course of 
professional conduct.
    Respondent introduced the testimony of a pain management 
specialist. The pain management specialist testified concerning the 
proper therapeutic use of chloral hydrate and Valium. He also testified 
that with the low daily dosages of Valium given to the undercover 
agents by Respondent, it would be highly unlikely that addiction would 
result. He concluded that Respondent made a reasonable diagnosis and 
prescribed a reasonable orthopedic treatment regimen that would be in 
the course of usual practice.
    Respondent also introduced the testimony of an orthopedic surgeon. 
He testified that he completed orthopedic residency with Respondent at 
the University of Texas Medical Branch. The orthopedic expert testified 
as to the usual conduct of orthopedic physical examination and the 
proper therapeutic use of Valium. He testified also that he would not 
prescribe Valium for muscle tightness, but if it helped the patient, it 
would be appropriate over a short period of time with close monitoring 
of the patient. He concluded that Respondent's prescriptions were 
reasonable and appropriate and had a valid and legal medical purpose.
    The administrative law judge assigned substantial weight to the 
testimony of Respondent's orthopedic expert witness. Judge Tenney found 
that the prescriptions issued to the first undercover agent between 
March and August were issued for a legitimate medical purpose. However, 
Respondent treated the undercover agent for over five months and 
continue to prescribe Valium without an office visit. Judge Tenney 
further found that Respondent's treatment of the second undercover 
agent with Valium lacked a legitimate medical purpose since the patient 
gave no indication of pain and was not physically examined.
    The administrative law judge found that Respondent and the Texas 
State Board of Medical Examiners (Board) entered an Agreed Order on 
November 19, 1993. The order stated that during 1984 through 1992, 
Respondent prescribed controlled substances to fifteen patients and 
``failed to take adequate histories, to take further diagnostic studies 
as indicated, maintain a comprehensive pain and drug abuse management 
plan, appropriately document the medical records to justify treatment, 
and perform periodic examinations to justify the continuance of such 
drug therapy.'' The Board publicly reprimanded Respondent and ordered 
that he maintain adequate medical records, provide for monitoring of 
his practice and complete a remedial pharmacology course and fifty 
hours of Continuing Medical Education Courses annually.
    Under 21 U.S.C. 824(a)(4), the Deputy Administrator of the Drug 
Enforcement Administration may revoke the registration of a 
practitioner if he determines that such registration would be 
inconsistent with the public interest as determined under 21 U.S.C. 
823.
    Pursuant to 21 U.S.C. 823(f), ``[i]n determining the public 
interest, the following factors shall be considered:
    (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 and 
safety.''
    It is well established that these factors are to be considered in 
the disjunctive, i.e., the Deputy Administrator may properly rely on 
any one or a combination of factors, and give each factor the weight he 
deems appropriate. Henry J. Schwarz, Jr., M.D., 54 FR 16422 (1989).
    Of the stated factors, the administrative law judge found that the 
Government established a prima facie case for revocation under 21 
U.S.C. 823(f)(2), (4) and (5). Judge Tenney found that the evidence 
supported a finding that Respondent's experience with regard to 
dispensing controlled substances included violations of 21 CFR 
1306.04(a) with respect to the undercover agents. Judge Tenney found 
that the persuasive expert testimony indicated that Valium is 
appropriate for treatment for short periods of time and when closely 
monitored.
    The administrative law judge concluded that Respondent had 
prescribed Valium for long periods of time with inadequate monitoring, 
but stated that Respondent argued convincingly that the Agreed Order 
with the Board provides a level of assurance that the ``public 
interest'' will be protected.
    The Deputy Administrator adopts the findings of fact, conclusions 
of law, and recommended ruling of Administrative Law Judge Tenney in 
its entirety. The Deputy Administrator agrees that the public interest 
can be adequately protected if Respondent carries out the mandates of 
the Board Agreed Order. In taking this action, the Deputy Administrator 
expects that Respondent will continue to be in full compliance with the 
November 19, 1993 Agreed Order between Respondent and the Texas Board 
of Medical Examiners.
    Pursuant to 21 U.S.C. 829, 21 U.S.C. 842(a), and 21 CFR 1306.04(a), 
a prescription for controlled substances, in order to be effective, 
must be issued for a legitimate medical purpose and in the usual course 
of professional medical practice. The Deputy Administrator concludes 
that Respondent's prescribing practices regarding the undercover agents 
included violations of the Controlled Substances Act. Therefore, the 
Deputy Administrator finds that a reprimand is appropriate in this 
case, and orders that Respondent, Robert J. Kilian, M.D., be, and he 
hereby is, reprimanded.
    Accordingly, the Deputy Administrator of the Drug Enforcement 
Administration, pursuant to the authority vested in him by 21 U.S.C. 
823 and 824 and 28 CFR 0.100(b) and 0.104 (59 FR 23637), hereby orders 
that DEA Certificate of Registration, BK0304131, issued to Robert J. 
Kilian, M.D., be and it hereby is, continued, and that any pending 
applications, be, and they hereby are, granted. This order is effective 
August 15, 1994.

    Dated: August 8, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-19817 Filed 8-12-94; 8:45 am]
BILLING CODE 4410-09-M