[Federal Register Volume 64, Number 151 (Friday, August 6, 1999)]
[Notices]
[Pages 42983-42986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20231]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 98-27]
Roger Lee Kinney, M.D.; Grant of Restricted Registration
On March 17, 1998, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Roger Lee Kinney, M.D. (Respondent) of Sapulpa,
Oklahoma, notifying him of an opportunity to show cause as to why DEA
should not deny his application for registration as a practitioner
pursuant to 21 U.S.C. 823(f), for reason that his registration would be
inconsistent with the public interest.
By letter dated April 15, 1998, Respondent, through counsel,
requested a hearing on the issues raised by the Order to Show Cause.
Following prehearing procedures, a hearing was held in Tulsa, Oklahoma
on July 21, 1998, before Administrative Law Judge Gail A. Randall. At
the hearing, both parties called witnesses to testify and introduced
documentary evidence. After the hearing, both parties submitted
proposed findings of fact, conclusions of law and argument. On January
22, 1999, Judge Randall issued her Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision, recommending that Respondent's
application for registration be granted subject to various conditions.
Neither party filed exceptions to Judge Randall's opinion, and on April
12, 1999, Judge Randall 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 recommended rulings,
findings of fact, conclusions of law and decision of the Administrative
Law Judge. His 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 Deputy Administrator finds that Respondent graduated from
medical school in 1966, and entered private practice in Sapulpa,
Oklahoma in 1967, as a general or family practitioner. He has been a
staff member at the only local hospital for approximately 30 years.
There are 14 active staff positions at the hospital and it serves a
fairly rural area consisting of approximately 58,000 people.
During the early 1980s, Respondent purchased and ingested cocaine.
The record is not clear as to the extent of Respondent's abuse of
cocaine. However according to Respondent, he last ingested cocaine on
August 8, 1985. There is also some evidence in the record that in 1981,
Respondent dispensed and distributed Preludin, a Schedule II controlled
substance, not in the usual course of his professional practice or for
legitimate medical or research purposes.
In 1985, a federal grand jury charged Respondent with an 82-count
indictment, which include counts for illegal distribution of a
controlled substance, conspiracy to distribute cocaine, and income tax
evasion. According to Respondent, he pled guilty to at least 14 felony
counts, among them, conspiracy, illegal distribution, and tax evasion,
and he was sentenced to four years incarceration. However, the Deputy
Administrator is unable to determine exactly what charges Respondent
was convicted of, since no judgment order was entered into evidence.
Further, while Respondent pled guilty to some charges and he admitted
in his 1990 application for a DEA Certificate of Registration that he
has been convicted of illegal distribution of controlled substances
``which stemmed from a problem of substance abuse,'' the Government did
not present any evidence of the underlying fact of the investigation
which led to Respondent's indictment and ultimate conviction.
Therefore, the Deputy Administrator is unable to determine the extent
and severity of Respondent's unlawful conduct.
Respondent consented to the suspension of his medical license
during the period of his incarceration. Thereafter, on February 24,
1986, the Oklahoma State Board of Medical Examiners (Board) suspended
Respondent's medical license. While incarcerated, Respondent
participated in a drug rehabilitation program. His sentence was later
reduced to three years incarceration because of his
[[Page 42984]]
cooperation with the Government, and he ultimately served approximately
20 to 22 months of his sentence before being released.
Upon his release, Respondent spent four months at a halfway house,
where he was subject to random drug testing six times per month.
Following his stay at the halfway house, Respondent was on court-
ordered probation for four years, during which time he was randomly
tested for drugs once or twice a month. According to Respondent, he
never failed any of these drug tests, and the Government presented no
evidence to the contrary. Following his incarceration, Respondent
participated for several years in an impaired physicians group that met
weekly. Respondent testified that he stopped participating in any drug
rehabilitation programs or support groups in 1995, ``because I didn't
seem to have any inclination to do drugs anymore.''
On May 19, 1987, the Board conditionally reinstated Respondent's
medical license and placed it on probation for five years. Among the
conditions imposed by the Board were that Respondent could not
prescribe, administer or dispense controlled substances without
specific approval from the Board; that he would submit to biological
fluid testing at his expense; and that he would abstain from personally
using alcohol or any controlled substance unless lawfully prescribed by
his physician. Thereafter, on October 19, 1987, the Board modified its
previous order, thereby allowing Respondent to prescribe, administer or
dispense controlled substances ``for emergency room in-patients under
the conditions that a fully licensed physician countersign the order
within 36 hours and * * * that no controlled dangerous substances may
be taken off the premises of the emergency room by any patient.''
Respondent complied with these conditions.
As a result, the Board terminated Respondent's probation effective
October 26, 1989. In its ``Order Terminating Probation,'' the Board
commended Respondent for his compliance with the terms and conditions
of his probation. Once his probation was terminated, there were no
restrictions on Respondent's ability to prescribe, dispense or
administer controlled substances in the hospital, using the hospitals's
DEA registration number. The pharmacist at the hospital testified that
Respondent has never asked her to fill a controlled substance
prescription for one of Respondent's outpatients.
On January 31, 1990, the Oklahoma State Bureau of Narcotics and
Dangerous Drugs Control (OBN) found that Respondent was addicted to
cocaine and had been convicted of a felony; denied Respondent's request
for a state controlled substance registration at that time; but granted
the registration with an effective date of June 1, 1990. There is no
evidence that Respondent has misused his state controlled substance
license since it was reinstated.
On June 8, 1990, Respondent submitted an application for a DEA
Certificate of Registration. In investigating this application, a DEA
investigator visited 16 area pharmacies to gather information
Respondent's prescribing habits. During the course of this pharmacy
survey, the investigator discovered a prescription written by
Respondent on December 11, 1991, for Tussi-Organidin, a Schedule V
controlled substance. Tussi-Organidin is a cough syrup that contains
codeine phosphate. There is also a non-controlled substance called
Tussi-Organidin DM, which contains dextromethorphan rather than
codeine. Since Tussi-Organidin is a controlled substance, Respondent
was not authorized at that time to issue a prescription for it for a
clinic patient; but, he was authorized to prescribe Tussi-Organidin DM.
Further, Respondent was authorized at that time to issue a prescription
for Tussi-Organidin in a hospital setting. Therefore, is it possible
that Respondent simply forgot to put the ``DM'' on the prescription for
Tussi-Organidin. Had ``DM'' been written on the prescription, it would
have been for a non-controlled substance and it would have been
lawfully prescribed by Respondent for his clinic patient.
In investigating the origin of this prescription, the investigator
was told by an unnamed person ``to discount it being written by Dr.
Kinney * * * [it] was going to be changed to another physician's name
and DEA number.'' Respondent was not informed that the prescription as
written was inaccurate, and DEA did not contact the patient as part of
the investigation. According to Respondent, the individual had been a
patient of his for a number of years.
As a result of this investigation, an order to Show Cause was
issued proposing to deny Respondent's 1990 application for a DEA
Certificate of Registration. Before the case could proceed to a hearing
however, Respondent withdrew his application. DEA has not conducted any
investigation of Respondent since this 1991 investigation.
At some point following his reinstatement by the Board, Respondent
practiced medicine part-time at a medical clinic owned by the local
hospital. While there, Respondent prescribed injectable Nubain, a non-
controlled substance, to his patients. At some point, the clinic
manager told Respondent that she would no longer maintain a supply of
Nubain because of Respondent's past licensing history. Because there
are very few non-controlled analgesics that can be substituted for
Nubain, Respondent began purchasing injectable Nubain from pharmacies
to administer to his patients.
When Respondent left the clinic and only practiced at the hospital,
he stopped purchasing Nubain, because the hospital pharmacy maintained
a supply of it. In addition, the clinic where Respondent currently
works also purchases Nubain for clinic use. According to Respondent, he
has never self-administered Nubain, and the Government did not present
any evidence that Respondent was using or abusing Nubain, or that he
was unlawfully prescribing it for his patients.
Respondent submitted another application for registration with DEA
dated October 16, 1996. According to Respondent, it is becoming
increasingly difficult for him to treat patients, since he is unable to
participate in many managed care programs without a DEA registration.
Currently, Respondent has staff privileges at the local hospital.
At the hospital, Respondent also performs surgery, serves as
anesthesiologist, works in the emergency room, and is the director of
the Skilled Nursing Unit. Typically, Respondent is in surgery five days
a week as the primary surgeon or the practicing anesthesiologist. Also,
Respondent currently works at a clinic that is owned by the hospital.
Presently, Respondent tries to treat his clinic patients without
the use of controlled substances. However, if a controlled substance is
necessary, Respondent refers patients directly to another physician who
is considered the ``patriarch'' of the hospital or Respondent asks him
to consult on a case and to prescribe a controlled substance for the
patient if necessary. However, this physician is 93 years old with
significant health problems, and will likely not be practicing for too
much longer. If Respondent does not have his own DEA registration and
this other physician retires, Respondent will need to find another
physician to examine his patients and prescribe controlled substances
when necessary.
Respondent's handling of controlled substances at the hospital is
subject to
[[Page 42985]]
several levels of review. Respondent's orders have never been
questioned or reversed. Respondent has been ``in good standing'' with
the hospital at all time.
The number of patients requiring medical care in the Sapulpa area
has increased significantly in recent years. If Respondent is not
granted a DEA registration, medical care in Sapulpa would suffer since
he would be unable to treat a number of patients because he is not
allowed to participate in managed care programs.
Based upon Respondent's testimony at the hearing, it is clear that
he recognizes the unlawfulness of his prior conduct and appreciates the
consequences of such activities.
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an
application for a DEA Certificate of Registration, if he determines
that 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 and
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., 54 FR 16422 (1989).
Regarding factor one, it is undisputed that the Board suspended
Respondent's medical license in 1986, but hen conditionally reinstated
it in 1987 and placed it on probation for five years. Then in 1989, the
Board lifted the restriction from Respondent's medical license and
terminated the probationary period. It is also undisputed that the OBN
initially denied Respondent's application for a state controlled
substance registration, but then granted him such a registration in
June 1990. Thus, Respondent has had an unrestricted medical license in
Oklahoma since 1989 and has been authorized to handle controlled
substances in that state since 1990. As Judge Randall stated, ``[b]y
reinstating both these licenses, over eight years ago, the Board and
the OBN have asserted their belief that the Respondent is not a threat
to the health or safety of the citizens of Oklahoma.''
Factors two and four, Respondent's experience in handling
controlled substances and his compliance with applicable controlled
substance laws, are clearly relevant in determining the public interest
in this matter. Respondent admitted that he purchased and abused
cocaine in the early 1980's. However, according to Respondent he has
been drug-free since 1985.
In addition, based upon his guilty pleas to a number of criminal
charges, there is evidence that Respondent illegally distributed
Preludin in the early 1980s. However, without any evidence of the
underlying facts that led to Respondent's guilty pleas, the Deputy
Administrator is unable to determine the extent and severity of this
illegal activity. Nonetheless, the Government has established that at
least to some extent, Respondent improperly handled controlled
substances and violated relevant controlled substance laws in the early
1980s.
More recently, the Government presented evidence that in 1991,
Respondent issued a prescription for the controlled substance Tussi-
Organidin to a clinic patient, when he was not authorized to do so. As
Judge Randall stated, ``[c]onsiderd alone, this assertion satisfies the
Government's prima facie burden.'' However like Judge Randall, the
Deputy Administrator finds Respondent's evidence concerning this
allegation compelling. Respondent was authorized to prescribe Tussi-
Organidin in a hospital setting using the hospital's DEA registration
number. Further, he was authorized to prescribe Tussi-Organidin DM, a
non-controlled substance, to his clinic patients. Since this was the
only improper prescription found during the DEA in investigator's
survey of 16 pharmacies, Respondent's contention is credible that he
simply forgot to write ``DM'' on the prescription for his clinic
patients. As Judge Randall noted, ``the seizure of only one
prescription indicates that there was no pattern of unauthorized
prescribing by the Respondent during this time frame.'' The Deputy
Administrator agrees with Judge Randall that ``the existence of this
single prescription dated in 1991 for Tussi-Organidin lends little
support to the Government's position that granting the Respondent's
application in 1999 is inconsistent with the public interest.''
The Deputy Administrator finds that while Respondent's behavior in
the early 1980s is troubling, it is also significant that other than
the one prescription in 1991, there have been no allegations of any
improper handling of controlled substances. In fact, Respondent has
been handling controlled substances in a hospital setting using the
hospital's DEA registration number for a number of years without any
problems or questionable conduct.
As to factor three, it is undisputed that Respondent was convicted
of charges related to the illegal distribution of a controlled
substance and conspiracy. Respondent was incarcerated for 20 to 22
months, and after spending four months in a halfway house, he was
placed on probation for four years. Respondent successfully completed
his probation.
Regarding factor five, the Government argues that Respondent's
purchase of Nubain during 1990 and 1991, is evidence of other conduct
which may threaten the public health and safety. The Government
contends that Respondent's explanation, that he purchased the Nubain to
administer to his patients, was not credible. However, the Government
has the burden of proof in these proceedings. The mere fact that
Respondent purchased Nubain is not evidenced of any wrongdoing. The
Government did not present any evidence that Respondent's purchase of
this non-controlled substance was improper. To the contrary, Respondent
was authorized to handle Nubain at that time. Respondent explained that
he purchased the Nubain because the clinic where he was then employed
stopped stocking the drug, and he ceased purchasing Nubain once it
became available to him to dispense to his patients at the hospital.
Also relevant under this factor is Respondent's abuse of cocaine.
While it is troubling that Respondent stopped actively participating in
a recovery program in 1995, he has not illegally used drugs since
August 1985.
The Deputy Administrator concludes that Respondent's conduct in the
early 1980s and his lack of ongoing participation in a recovery program
warrants concern as to whether Respondent can be trusted to responsibly
handle controlled substances. However, Respondent has accepted
responsibility for his past misconduct; he has complied with all of the
terms of his criminal probation, as well as the restrictions placed on
his medical license by the Board; there is only one instance of
questionable prescribing since the early 1980s; and he has not abused
controlled since 1985.
[[Page 42986]]
Additionally, the Deputy Administrator finds it significant that
without a DEA registration, Respondent is unable to effectively
contribute to the medical care of the Sapulpa community. There are only
14 active physicians employed by the sole hospital responsible for the
care and treatment of approximately 58,000 people. Because Respondent
cannot independently handle controlled substances and is unable to
participate in managed care programs, the other physicians at the
hospital must handle more than their share of the patients.
The Deputy Administrator concludes that based upon a review of the
record, denial of Respondent's application is not warranted. However,
the Deputy Administrator concurs with Judge Randall's conclusion that
although, ``the Respondent should be allowed the opportunity to
demonstrate that he can now handle the responsibilities of a DEA
registrant, * * * the public interest would best be served by
monitoring the Respondent's handling of controlled substances during
the first registration period.'' Imposing conditions upon Respondent's
registration, ``will allow the Respondent to demonstrate that he can
responsibly handle controlled substances in his medical practice, yet
simultaneously protect the public by providing a mechanism for rapid
detection of any improper activity related to controlled substances.''
Steven M. Gardner, M.D., 51 FR 12576 (1986).
Therefore, the Deputy Administrator agrees with Judge Randall's
recommendation that Respondent's application for registration be
granted, pursuant to the following restrictions for three years from
the date of issuance of the DEA Certificate of Registration:
(1) On a quarterly basis, Respondent shall provide the DEA Oklahoma
City Resident Office with a log of his handling of controlled
substances outside of the Bartlett Hospital setting. This log should
include at a minimum the date the controlled substance was prescribed,
administered, or dispensed; the patient's complaint; the name, dosage,
and quantity of the controlled substance prescribed, administered, or
dispensed; and the date that the medication was last prescribed,
administered, or dispensed to that patient, as well as the amount last
provided to that patient. If no controlled substance are prescribed,
administered, or dispensed during a given quarter, Respondent shall
indicate that fact in writing, in lieu of submission of the log.
(2) Respondent shall notify the DEA Oklahoma City Resident Office
of any action taken by any state upon his medical license or upon his
authorization to handle controlled substance in any state. Such
notification shall occur within 30 days of any state action.
(3) Respondent shall notify the DEA Oklahoma City Resident Office
within 30 days of any change in his employment.
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, hereby orders that the
application for registration submitted by Roger Lee Kinney, M.D., be,
and it hereby is, granted subject to the above described restrictions.
This order is effective upon the issuance of the DEA Certificate of
Registration, but no later than September 7, 1999.
Dated: July 27, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-20231 Filed 8-5-99; 8:45 am]
BILLING CODE 4410-09-M