[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: 94-19815]


[[Page Unknown]]

[Federal Register: August 15, 1994]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE
[Docket No. 93-45]

 

Demetrius Pawlyszyn, M.D.; Revocation of Registration

    On April 12, 1993, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Demetrius Pawlyszyn, M.D., (Respondent), of 
Cleveland, Ohio. The Order to Show Cause sought to revoke Respondent's 
DEA Certificate of Registration, AP2933011, and deny any pending 
applications for registration. The Order to Show Cause alleged that 
Respondent's continued registration would be inconsistent with the 
public interest as that term is used in 21 U.S.C. 823(f).
    The Order to Show Cause asserted in part that Respondent's 
continued registration would be inconsistent with the public interest 
in light of the Ohio State Medical Board's (Board) concern regarding 
Respondent's prescribing practices; Respondents' continued prescribing 
of narcotics and other controlled substances without adequate medical 
examination and without adequate medical justification; Respondent's 
prescribing of controlled substances to individuals cooperating with 
DEA in May and June of 1990; Respondent's July 1990 indictment in the 
Cuyahoga County Common Pleas Court on numerous counts of illegally 
processing drug documents and drug trafficking; Respondent's 
prescribing of controlled substances in June and July of 1991 to 
individuals working with the Cuyahoga County Sheriff's Office without 
adequate medical justification; Respondent's prescribing of controlled 
substances to an undercover agent of the Medina County Drug Task Force 
without a physical examination and in the absence of a legitimate 
medical justification; Respondent's October 1992 indictment in the 
Cuyahoga County Common Pleas Court on 62 counts of drug trafficking and 
13 counts of illegal processing of drug documents.
    Respondent, through counsel, requested a hearing on the allegations 
raised in the Order to Show Cause and the matter was placed on the 
docket of Administrative Law Judge Paul A. Tenney. On January 4 and 5, 
1994, a hearing was held in Cleveland, Ohio. On April 18, 1994, the 
administrative law judge issued his findings of fact, conclusions of 
law, and recommended ruling. Respondent filed exceptions to the 
recommended ruling on June 13, 1994. On June 20, 1994, the 
administrative law judge transmitted the record in this proceeding to 
the Deputy Administrator. Having considered the record in its entirety, 
and pursuant to 21 CFR 1316.67, the Deputy Administrator hereby issues 
his final order in this matter based upon the findings of fact and 
conclusions of law set forth below.
    At the hearing, a DEA investigator testified that in August 1989, 
she began an investigation of Respondent after receiving complaints 
about Respondent from an anonymous telephone caller. Later that month, 
the investigator visited several pharmacies near Respondent's medical 
office and reviewed prescriptions written by Respondent. The 
investigator noted that Respondent had written numerous prescriptions 
for two and three members of the same family an that Respondent had a 
pattern of writing combinations of prescriptions for each patient. The 
typical combination included prescriptions for Tylenol #4 with codeine, 
a Schedule III controlled substance, Hycodan, another Schedule III 
controlled substance, and Valium, a Schedule IV controlled substance.
    The DEA investigator contacted an investigator with the Board in 
September 1989. The Board investigator stated that the Board had held 
three informal hearings between June 1982 and August 1983 relating to 
Respondent's excessive prescribing of controlled substances. The 
hearings also addressed Respondent's prescribing controlled substances 
to known drug addicts and the numerous complaints that the Board had 
received from pharmacists concerned about Respondent's prescribing 
practices. The Cuyahoga County Sheriff's Office (Sheriff's Office) 
received similar complaints.
    The DEA investigator was informed that in 1982, the Board entered 
into a Consent Agreement with Respondent. The agreement provided that 
Respondent ``shall not prescribe Schedule II drugs, Tussionex, and 
Talwin except for patients over fifty (50) years of age and in 
emergency cases for patients of all ages.'' The DEA investigator 
testified at the hearing in this matter that Respondent subsequently 
wrote prescriptions for Talwin to four individuals, each under the age 
of 50.
    In 1990, a joint investigation was initiated between DEA and the 
Sheriff's Office. An individual cooperating with the Sheriff's Office 
agreed to assist in the investigation and on May 5, 1990, visited 
Respondent's office. The individual was equipped with a transmitter and 
the entire visit was monitored by the DEA investigator. The DEA 
investigator did not hear any indication that Respondent conducted a 
physical examination, nor did she hear Respondent question the 
individual about her medical history or allergies. Respondent supplied 
the individual with prescriptions for Tylenol #4 with codeine, Valium, 
Soma, and Hycodan, and charged $25.
    The same individual returned to Respondent's office on June 1, 
1990, again wearing a transmitter which was monitored by the DEA 
investigator. Respondent told the individual that it had not been 30 
days since her last visit. Nonetheless, Respondent provided the 
individual with new prescriptions for Tylenol #4 with codeine, Hycodan, 
and Valium. The individual returned to Respondent's office on July 6, 
1990. Respondent announced in the waiting room that he would not see 
anyone who had visited less than 30 days prior. When he saw the 
individual, Respondent told her that a drug enforcement agency was 
investigating her and that he could not help her. Respondent suggested 
that she return in about a year.
    A State search warrant was executed at Respondent's office on July 
13, 1990. Respondent was arrested on July 17, 1990, and charged with 
eight counts of illegally processing drug documents in violation of 
Ohio Revised Code Section 2925.03.
    In September 1990, another cooperating individual visited 
Respondent's office. When Respondent asked the individual what the 
problem was, the individual stated that he had back pain. Respondent 
then asked the individual what he wanted and the individual requested 
60 Vicodin, a Schedule III controlled substance. Respondent then wrote 
the individual a prescription for 30 Vicodin. No physical examination 
was conducted. The same individual returned to Respondent's office on 
October 24, 1990, this time wearing a transmitter. The visit was 
monitored by the DEA investigator. Respondent told the individual that 
he had to be careful because the police were all over and had been to 
his office. Without asking the individual to undress, Respondent ran 
his hands up and down the individual's back and then wrote him a 
prescription for Darvocet, a Schedule IV controlled substance.
    On June 4, 1991, a third cooperating individual visited 
Respondent's office. The individual wore a transmitter and the visit 
was monitored by the DEA investigator. Respondent asked the individual 
if he wanted Vicodin. The individual replied affirmatively and was 
given a prescription for Vicodin. The DEA investigator did not hear any 
indication that a physical examination had taken place.
    At the hearing in this matter, a narcotics officer with the Medina 
County Drug Task Force testified that he visited Respondent's office in 
an undercover capacity on August 21, 1991. The agent was introduced to 
Respondent by one of Respondent's patients. Respondent met with the 
patient and the undercover agent in his office. The entire visit was 
taped. Respondent asked the agent ``What's your problem?'' The agent 
replied that he was ``okay'' but had suffered from back pain in the 
past. When asked what he wanted, the agent told Respondent he wanted 
Vicodin. Respondent then asked if he wanted the regular or extra 
strength. The agent replied that he wanted extra strength and 
Respondent wrote the prescription for him. No physical examination was 
conducted; in fact, Respondent never got up from his chair during the 
visit. Respondent charged $25 for the prescription. Respondent told the 
agent that he could not return until 30 days had passed. The entire 
visit lasted less than four minutes.
    The agent returned to Respondent's office on September 20, 1991. 
The agent was taken to an examining room where Respondent felt around 
the agent's torso, waist, shins, and ankles. Respondent refused to 
provide the agent with a prescription, stating that he (Respondent) 
would need an x-ray of the agent. Respondent told the agent that 
``people may phone police or something'' and that he (Respondent) ``had 
to cover.''
    In October, November, and December of 1992, numerous individuals 
provided law enforcement officers with statements regarding 
Respondent's prescription writing. Many of the individuals stated that 
they were addicted to drugs and went to see Respondent because he would 
provide them with prescriptions. Some individuals stated that they 
would obtain several prescriptions from Respondent once or twice a 
month. The visits often lasted less than 10 minutes. On individual 
stated that he continued to see Respondent because it was ``easy'' 
while another individual stated that ``you said what you had to say in 
order to get what you needed.'' Yet another individual stated that he 
started going to Respondent because he heard that Respondent was a 
``writer.''
    On October 21, 1992, Respondent was indicted in the Cuyahoga County 
Common Pleas Court on 75 counts of drug trafficking and illegal 
processing of drug documents. In preparation for Respondent's criminal 
trial, the DEA investigator and Board investigators conducted a 
pharmacy survey for prescriptions written by Respondent. Over one 
seven-month period, the investigators found that Respondent had written 
at least 4,801 prescriptions for controlled substances. During the 
criminal trial, a medical expert testified that after reviewing 33 of 
Respondent's patient files, he concluded that Respondent had engaged in 
abusive prescription practices for controlled substances. The doctor 
also testified that the combinations of drugs prescribed by Respondent, 
often on a monthly basis, did not constitute good medical practice. 
Because some of the drugs prescribed contained the same active 
ingredient, the doctor stated that there would be no therapeutic reason 
for prescribing both. On March 24, 1993, Respondent was acquitted of 
all counts following a bench trial.
    The DEA investigator continued her investigation despite 
Respondent's acquittal. In November 1993, the DEA investigator went to 
a local pharmacy and reviewed all prescriptions written by Respondent 
between June 1, 1993, and November 29, 1993. During this time period, 
Respondent wrote 2,801 prescriptions, 2,393 of which were for 
controlled substances. At another local pharmacy, the DEA investigator 
discovered that Respondent had written 1,205 prescriptions between 
March 1, 1993 and November 30, 1993. Of these prescriptions, 988 were 
for controlled substances.
    Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy 
Administrator may revoke a DEA Certificate of Registration or deny an 
application for registration if he determines that the registration 
would be inconsistent with the public interest. Section 823(f) requires 
that the following factors 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; and (5) such other conduct which may threaten 
the public health and safety.
    The Deputy Administrator may rely on any one or any combination of 
these factors when determining whether an application should be denied 
or a registration revoked. See Neveille H. Williams, D.D.S., 51 FR 
17556 (1986); Anne L. Hendricks, M.D., 51 FR 41030 (1986). The 
administrative law judge correctly found that factors (1), (2), (4), 
and (5) were relevant to a determination of whether Respondent's 
continued registration would be in the public interest.
    Although the Board did not revoke Respondent's medical license, it 
did hold several hearings to address Respondent's indiscriminate 
prescribing practices. The Board entered into a Consent Agreement with 
Respondent, an agreement with which Respondent refused to comply. 
Respondent's prescribing practices are clearly a danger to both his 
patients and the public and evidence a serious lack of understanding of 
the possible abuse and diversion of these powerful controlled 
substances. Despite Respondent's acquittal of all criminal charges, his 
failure to abide by the Board's Consent Agreement and his pattern of 
prescribing without conducting an examination and in the absence of 
legitimate medical need demonstrate that he cannot be trusted to comply 
with the laws relating to controlled substances. Finally, Respondent's 
incriminating statements to the undercover agent indicate his knowledge 
of the illegality of his acts.
Responsent's conduct constitutes a grave and alarming threat to the 
public health and safety.
    In his exceptions to the recommended decision of the administrative 
law judge, Respondent argues that the Government failed to meet its 
burden of proof. Respondent claims that he ``has had no problem with 
the Medical Board since'' the Consent Agreement signed in 1982. In 
light of the overwhelming evidence presented at the administrative 
hearing, the Board's failure to revoke Respondent's medical license, 
while considered by the administrative law judge and the Deputy 
Administrator, is inapposite. The administrative law judge found, and 
the Deputy Administrator agrees, that the Government met its burden of 
proof with respect to factors (1), (2), (4), and (5) of 21 U.S.C. 
823(f).
    The Deputy Administrator agrees with the administrative law judge 
that, after considering the applicable factors pursuant to 21 U.S.C. 
823(f), Respondent's continued registration would not be in the public 
interest and adopts his recommended decision in its entirety. 
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 Demetrius Pawlyszyn's DEA Certificate of Registration, AP20333011, 
be, and it hereby is, revoke, and that any pending applications for 
registration be, and they hereby are, denied. This order is effective 
September 14, 1994.

    Dated: August 8, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-19815 Filed 8-12-94; 8:45 am]
BILLING CODE 4410-09-P