[Federal Register Volume 61, Number 7 (Wednesday, January 10, 1996)]
[Notices]
[Pages 728-731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-339]
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DEPARTMENT OF JUSTICE
[Docket No. 94-40]
Darrell Risner, D.M.D., P.S.C.; Granting of Restricted
Registration
On March 18, 1994, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Darrell Risner, D.M.D., P.S.C., (Respondent) of
Barbourville, Kentucky, notifying him of an opportunity to show cause
as to why DEA should not deny his application for registration as a
practitioner under 21 U.S.C. 823(f) as being inconsistent with the
public interest. Specifically, the Order to Show Cause alleged that:
1. An investigation by the Kentucky State Police in 1989
revealed that in 1988 and 1989, [the Respondent] wrote numerous
prescriptions for Percodan and Percocet, Schedule II controlled
substances, using the names of fictitious individuals or individuals
who did not receive the prescriptions.
2. On June 12, 1989, [the Respondent] surrendered [his] DEA
Certificate of Registration, #AR1091482.
[[Page 729]]
3. As a result of [his] unlawful prescribing practices, on July
13, 1992, [he] pled guilty in the Knox County (Kentucky) Circuit
Court to one count of facilitation to obtain a Schedule II
controlled substance, and [was] sentenced to 24 months unsupervised
probation, fined court cost[s] and ordered to perform community
service.
4. Effective August 15, 1989, [he] entered into an agreed order
with the Kentucky Board of Dentistry in which [his] dental license
was suspended for six months followed by three years probation, and
[he was] prohibited from prescribing controlled substances during
the probationary period.
On April 18, 1994, the Respondent, through counsel, filed a timely
request for a hearing, and following prehearing procedures, a hearing
was held in Arlington, Virginia, on November 29, 1994, before
Administrative Law Judge Mary Ellen Bittner. At the hearing both
parties called witnesses to testify and introduced documentary
evidence, and after the hearing, counsel for both sides submitted
proposed findings of fact, conclusions of law and argument. On May 31,
1995, Judge Bittner issued her Opinion and Recommended Ruling,
recommending that the Respondent's application be granted with
restrictions applicable for a period of two years commencing on the
effective date of his registration. Neither party filed exceptions to
her decision, and on July 5, 1995, Judge Bittner transmitted the record
of these proceedings to the Deputy Administrator.
The Deputy Administrator has considered the record in its entirety,
and pursuant to 21 CFR 1316.67, hereby issues his final order based
upon findings of fact and conclusions of law as hereinafter set forth.
The Deputy Administrator adopts, in full, the Opinion and Recommended
Ruling, Findings of Fact, Conclusions of Law and Decision of the
Administrative Law Judge, and his adoption is in no manner diminished
by any recitation of facts, issues and conclusions herein, or of any
failure to mention a matter of fact or law.
The Deputy Administrator finds that the Respondent is licensed to
practice dentistry in Kentucky, where he has three offices and provides
dental services to low income communities in Barbourville, Cumberland,
and Hyden. Besides the Respondent's offices, these communities had
available limited alternative dental care. The Respondent testified
that his patients do not have access to fluoridated water and did not
have training on how to care for their teeth. Consequently, many of his
patients suffered serious and painful dental conditions. The Respondent
further stated that because he did not have a DEA registration, he had
to prescribe non-controlled medication to his patients. However, these
drugs sometimes were not as effective in alleviating pain as controlled
substances, and in some cases, such drugs exacerbated his patients'
other medical conditions. Consequently, the Respondent could not
adequately treat some of his patients, and his only available
alternative was to send them to an emergency room to obtain the needed
medication. However, some patients had difficulty getting to a hospital
with emergency facilities, because of the distances they would need to
travel in this rural area of Kentucky.
A retired Kentucky State Police trooper (Trooper) testified before
Judge Bittner, stating that he had been assigned to the state police
Narcotics Division, and on January 20, 1989, he had opened an
investigation in response to a complaint received from the Kentucky
Board of Pharmacy. The complaint advised that the Respondent had
obtained Schedule II drugs from a pharmacy in Barbourville, Kentucky.
The Trooper testified that on February 28, 1989, he obtained
approximately 29 prescriptions for Percocet or Percodan signed by the
Respondent, and that many of these prescriptions were for ``Dennis
Smith.'' The parties stipulated that Percocet and Percodan contain
oxycodone, a Schedule II controlled substance.
The Trooper then interviewed the Respondent, who said that ``Dennis
Smith'' was a fictitious name, and that he had written the
prescriptions and had had them filled himself in order to have the
drugs on hand to dispense without charge to his patients in his Hyden
office. The Respondent testified that he saw patients at that location
in the evening, and that there were no local pharmacies open evenings
where his patients could fill prescriptions for pain medication. He
also testified: ``I know it's wrong, and I realize it was a bad error
in judgment; but I did it.''
The Trooper then testified that he contacted Dr. Thompson of the
Kentucky Board of Dentistry (Dental Board), and on March 24, 1989, he
and Dr. Thompson met with the Respondent. During that interview, the
Respondent denied using any of the Percocet or Percodan himself and
offered to take a drug test. He also told the Trooper that he had
written controlled substance prescriptions for his wife and her parents
for pain relief, but that he had not kept any medical records for his
wife. He produced a medical file for his mother-in-law, but it did not
indicate that he had prescribed her controlled substances. The
Respondent testified before Judge Bittner that he also had failed to
maintain a proper medical record for his father-in-law, and that he
failed to maintain proper records for his family members because he
usually treated them on weekends when staff members were not in the
office to assist with recordkeeping.
On May 12, 1989, the Knox County Circuit Court grant jury indicted
the Respondent on four felony counts of obtaining a Schedule II
controlled substance by deception and fraud, and one felony count of
failing to keep records of Schedule II controlled substances. On July
13, 1992, the Commonwealth's Attorney added an additional misdemeanor
count of facilitation to obtain a Schedule II controlled substance by
fraud. On that same day, the Respondent pled guilty to the misdemeanor
count, and the court accepted the plea and sentenced him to 24 months
unsupervised probation, costs, and community service consisting of
accepting without charge all referrals for dental work from the
Kentucky Department of Social Services. The Respondent testified that
for two years, from July 13, 1992, to July 13, 1994, he provided free
dental care to approximately 150 patients, at a value of approximately
$28,000.00.
In June of 1989, the Respondent appeared before the Dental Board,
and on June 12, 1989, he voluntarily surrendered his DEA registration.
On July 27, 1989, the Dental Board entered an Agreed Order suspending
the Respondent's dental license for six months, placing his license on
probation for three years following the suspension, and ordering him to
pay a civil penalty of $500.00. The conditions of probation included,
among other things, that the Respondent would not prescribe any
controlled substances and that he would submit to random drug
screenings. During the third year of his probation, the Respondent
underwent drug screenings, and the results were negative. The
Respondent testified that he had complied with the Agreed Order, and
that since the end of the probationary period on February 15, 1993, his
dental license had not been subject to any restrictions.
On February 15, 1993, the Respondent applied for a new DEA
registration in Schedule II non-narcotic and in Schedules III through
V. One of the questions on that application asks whether the applicant
has
Ever been convicted of a crime in connection with controlled
substances under State or Federal law, or ever surrendered or had a
Federal controlled substance registration revoked, suspended,
restricted or
[[Page 730]]
denied, or ever had a State professional license or controlled
substance registration revoked, suspended, denied, restricted or
placed on probation?
The Respondent had answered that question as ``yes,'' and on the
back of the application, in response to the requirement to explain an
affirmative answer, he had written:
I surrendered my DEA license #AR1091482 to the Kentucky Board of
Dentistry in July 1989. I was placed on three years probation which
ended February 15, 1993. This was due to prescription
irregularities.
However, the Respondent did not mention his conviction.
Finally, the Respondent testified before Judge Bittner, stating
that he had learned his lesson and that he would not make the same
``error judgments'' again. He stated that if his DEA registration
was restored, he would be willing to maintain a log of patients who
received controlled substances, keep copies of prescriptions in
patient charts, and undergo drug screening to provide assurances
that he was handling controlled substances appropriately. He also
testified that his application should be amended, for he was no
longer requesting to be registered to handle Schedule II non-
narcotic substances. He merely asked to be registered to handle
controlled substances from Schedules III through V.
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may 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.
(5) Such other conduct which may threaten the public health or
safety.
These factors are to be considered in the disjunctive; the Deputy
Administrator may rely on any one or a combination of factors and may
give each factor the weight he deems appropriate in determining whether
a registration should be revoked or an application for registration
denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-42, 54 FR 16,422
(1989).
In this case, the Deputy Administrator agrees with Judge Bittner
that all five factors are relevant in determining whether the
Respondent's registration would be inconsistent with the public
interest. As to factor one, ``recommendation of the appropriate State
licensing board,'' the Kentucky Dental Board, after reviewing the
Respondent's conduct, suspended his license, and according to the terms
of the Agreed Order, subsequently placed the Respondent on probation.
Of equal significance, the Respondent served out the terms of his
probation, and as of February 15, 1993, his probationary period ended,
and his dental license has not been subject to any restrictions since
that time.
As to factor two, the Respondent's ``experience in dispensing * * *
controlled substances,'' factor three, his ``conviction record'' as
related to controlled substances, and factor four, the Respondent's
``[c]ompliance with applicable State, Federal, or local laws relating
to controlled substances,'' it is undisputed that the Respondent
obtained and handled Schedule II controlled substances in violation of
State and Federal law and DEA regulations, and that he pled guilty to a
criminal offense involving controlled substances. Further, DEA
regulations levy recordkeeping requirements, such as a requirement that
the Respondent use and maintain a DEA Form 222, order form, for each
distribution of a Schedule II controlled substance per 21 CFR 1305.03,
and maintain inventories and other dispensing records per 21 CFR
1304.03(b), 1304.04(g) and 1304.24. However, the Respondent failed to
maintain records in compliance with these provisions.
As to factor five, ``[s]uch other conduct which may threaten the
public health or safety,'' the Government argued that ``[w]hat is
disturbing about the [Respondent's conduct] is not only the dishonest
and unlawful nature of falsifying prescriptions, but the fact that
legitimate means were available to [the] Repondent to adequately and
lawfully treat his patients.'' Further, the Government argued that as
to future conduct, the Respondent continued to be less than forthright
as evidenced by his 1993 DEA application wherein he failed to disclose
his criminal conviction. However, Judge Bittner commented upon this
allegation by noting:
In certain contexts, [the] Respondent's failure to state on his
application form that he had been convicted of a drug-related crime
might be sufficient grounds to * * * deny an application. In the
instant case, however, I note that [the] Respondent stated that he
had surrendered his DEA registration and that the Dentistry Board
had put him on probation for ``prescription irregularities,'' so the
Government was clearly aware from the application that he had
engaged in some form of misconduct, and it does not appear that
[the] Respondent attempted to conceal his conviction. In addition,
it is also well established that the parameters of the hearing are
determined by the prehearing statements, and although [the]
Respondent's application was at all times available to the
Government, the Government did not specify in its prehearing
statement or indicate at any time prior to the hearing that [21
U.S.C.] Sec. 824(a)(1) was at issue in this proceeding; and [the]
Respondent therefore had no notice that this matter might be
litigated. In these circumstances, I find that [the] Respondent's
failure to mention his conviction on his application is not a basis
for denying him a registration.
As to this point, the Deputy Administrator agrees with Judge Bittner's
conclusion.
Further, the Deputy Administrator also agrees with Judge Bittner's
conclusion that ``[i]t is undisputed that Respondent's obtaining and
handling of Schedule II controlled substances violated State and
Federal law and DEA regulations, and I find that his falsification of
prescriptions, using prescriptions to obtain controlled substances for
general dispensing and failure to record dispensings of controlled
substances constitute grounds for denying his application for DEA
registration.''
However, in mitigation, Judge Bittner also found the Respondent's
testimony credible. Specifically, that the Respondent dispensed the
improperly obtained controlled substances to patients for legitimate
medical purposes, and that he credibly acknowledged his wrongdoing and
was willing to accept the responsibilities inherent in a DEA
registration. Finally, Judge Bittner noted that ``although evidence
that a DEA registration would assist a practitioner in caring for his
patients does not, standing alone, establish that the registration
would be in the public interest, such evidence should be considered,
and it is clear from the record here that [the] Respondent's lack of a
DEA registration adversely affects his ability to effectively treat his
patients.''
Therefore, the Deputy Administrator agrees with Judge Bittner that
the public interest is best served by granting the Respondent's amended
application, subject to restrictions. Accordingly, the Deputy
Administrator of the Drug Enforcement Administration, pursuant to the
authority vested in him by 21 U.S.C. 823, and 28 CFR 0.100(b) and
0.104, hereby orders that the application for a DEA Certification of
Registration in Schedules III through V of Darrell Risner, D.M.D.,
P.S.C., be granted subject to the following restrictions: (1)
[[Page 731]]
the Respondent shall not administer or dispense, other than by
prescribing, any controlled substance; and (2) the Respondent shall
maintain a log of all controlled substance prescriptions and submit
such logs on a quarterly basis, to the Resident Agent in Charge of the
DEA Louisville, Kentucky, Resident Office, or a selected designee. The
restrictions will run for a period of two years commencing on the
effective date of the Respondent's registration. It hereby is so
ordered. This order is effective upon publication in the Federal
Register.
Dated: December 28, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 96-339 Filed 1-9-96; 8:45 am]
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