[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