[Federal Register Volume 59, Number 137 (Tuesday, July 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17417]


[[Page Unknown]]

[Federal Register: July 19, 1994]


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DEPARTMENT OF JUSTICE
[Docket No. 92-70]

 

Jay Wheeler Cranston, M.D.; Revocation of Registration

    On July 10, 1992, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Jay Wheeler Cranston, M.D. (Respondent), of 
Kent, Ohio, proposing to revoke Respondent's DEA Certificate of 
Registration, AC0808076, and to deny any pending applications for 
registration as a practitioner under 21 U.S.C. 823(f). The Order to 
Show Cause alleged that Respondent's continued registration is 
inconsistent with the public interest, as that term is used in 21 
U.S.C. 823(f) and 824(a)(4).
    Respondent timely filed a request for a hearing on the issues 
raised in the Order to Show Cause and the matter was docketed before 
Administrative Law Judge Mary Ellen Bittner. Following prehearing 
procedures, a hearing was held, beginning on February 24, 1993, in 
Cleveland, Ohio.
    On December 21, 1993, Judge Bittner issued her opinion and 
recommended ruling, findings of fact, conclusions of law and decision, 
recommending that Respondent's DEA Certificate of Registration be 
revoked and that any pending applications for renewal be denied. 
Respondent filed exceptions pursuant to 21 CFR 1316.66. Shortly 
thereafter, Judge Bittner transmitted the entire record to the then-
Acting Administrator, including Respondent's exceptions. The Government 
moved to reopen the proceedings and file a response to Respondent's 
exceptions because the Government was given inadequate time to respond. 
This request was granted and the Government filed a response to 
Respondent's exceptions. Respondent filed a reply to the Government's 
response which was received by DEA on February 28, 1994. The Government 
then filed a motion to strike this pleading based upon the grounds that 
it was not authorized under 21 CFR 1316.66. The Deputy Administrator 
agrees with the Government's contention and has not considered this 
pleading.
    The Deputy Administrator has carefully considered the record and 
adopts the opinion and recommended decision of the administrative law 
judge. Pursuant to 21 CFR 1316.67, the Deputy Administrator hereby 
issues his final order in this matter.
    The Deputy Administrator finds that Respondent was employed as a 
physician in 1972 at the Kent State University (KSU) Health Center, 
located in Kent, Ohio. For most of the time period in issue, Respondent 
was the physician-in-charge of the KSU Health Center.
    An investigation was initiated in 1989, when the KSU Police 
Department obtained information that a student was boasting that he was 
able to obtain drugs from Respondent by deception at the KSU Health 
Center. The KSU Police Department interviewed the KSU Health Center 
pharmacist who alerted the campus police to other illegal activity, 
relating to controlled substances, taking place at KSU. The KSU Police 
then contacted the State of Ohio Pharmacy Board (Pharmacy Board) and 
DEA. This joint investigation led to the discovery of a diverse number 
of controlled substance violations committed within the University, and 
for the most part, involving Respondent.
    Various Schedule II, III and IV narcotic and non-narcotic 
controlled substances were stored at the KSU athletic department's two 
training rooms for some period of time prior to the 1989 investigation. 
Respondent wrote ``prescriptions'' for these controlled substances in 
the name of the head trainer or the athletic department. Based upon 
these ``prescriptions'' the controlled substances were then transferred 
from the KSU Health Center to the athletic training rooms. Although the 
KSU Health Center had a DEA registration, the training room facilities, 
which were located quite a distance from the health center, did not 
have DEA registrations. When Respondent was interviewed about this 
arrangement he indicated that he thought the training rooms were an 
extension of the health facility, but he later admitted that the 
practice ``was not entirely proper.'' The athletic trainer, testifying 
on behalf of Respondent, noted that he had on many occasions questioned 
Respondent about the practice, but Respondent ignored the inquiries.
    Respondent also issued standing orders to the athletic trainers to 
administer controlled substances to injured athletes even though a 
physician could not be contacted until after the drug was given to the 
athlete. When Respondent was interviewed about this practice by a KSU 
policeman, he initially explained that trainers were instructed to 
administer controlled substances to athletes only in the presence of a 
physician. When Respondent was told that the police had received other 
information from the head athletic trainer, Respondent admitted that 
trainers were authorized to provide medication to athletes in 
situations where a physician could not be contacted.
    The head athletic trainer did keep an informal record of the 
receipt and dispensing of controlled substances from the training 
rooms. No such records were kept at the KSU Health Facility itself nor 
did Respondent attempt to reconcile the records kept by the head 
athletic trainer. Although athletes were required to submit to random 
urine tests during this period, the tests did not screen for certain 
controlled substances that were stored at the athletic training rooms.
    Between 1986 and 1989, Respondent wrote a number of 
``prescriptions'' for controlled substances, including cocaine, 
morphine and Seconal. These ``prescriptions'' were issued to students 
who obtained the drugs from the KSU Health Center pharmacy and then 
used the controlled substances for both animal and human research. The 
KSU psychology department had its own separate DEA registration and the 
department supervised the students' controlled substance research. The 
``prescriptions'' issued by Respondent did not indicate a DEA number 
nor an address; most did not indicate the reason for issuing the 
``prescription''; and many of these prescriptions did not have the 
student's name but were simply written for ``Taylor Research''. (Dr. 
Taylor was a KSU psychology professor.) One of the psychology 
professors did discuss with Respondent the possibility of using DEA 
official order forms to transfer the Schedule II controlled substances 
from the KSU Health Center to the psychology department, but Respondent 
dismissed this suggestion.
    DEA conducted an audit of the KSU psychology department in 1989 
which revealed a 60 milliliter overage of morphine. There were no 
records to verify where this morphine was procured. DEA discovered that 
the discrepancy was based upon the morphine ``prescriptions'' that 
Respondent issued for the research experiments. The investigation of 
the psychology department uncovered that the students disposed of 
unused controlled substances by pouring any excess down a drain. There 
were, however, no records of such disposal and no way to verify if all 
excess substances were destroyed in this manner. In addition, 
Respondent authorized three prescriptions for Schedule II controlled 
substances with the notation ``outdated''. These controlled substance 
prescriptions were also issued to the psychology department for the 
purpose of conducting research experiments.
    While Respondent was in charge of operating the KSU Health Center, 
he allowed three physician assistants to diagnose and write 
prescriptions for various medications, including controlled substances. 
The physician assistants were given initial training and supervision by 
a physician. After such training was deemed complete by Respondent, the 
physician assistants could issue Schedule III, IV and V controlled 
substances to treat students without supervision by a physician.
    Respondent expressed misgivings about this system when he was 
questioned by the KSU police in 1989. He admitted that prescriptions 
signed by physician assistants could not be honored in a pharmacy other 
than the KSU Health Center Pharmacy. In fact the health center 
pharmacy's records showed that such prescriptions were issued by a 
physician rather than a physician assistant. The KSU Health Center 
pharmacist questioned Respondent about this arrangement, but Respondent 
convinced him that the system should continue.
    As early as 1985, Respondent was instructed by the Dean of Student 
Affairs to have physicians supervise the physician assistants instead 
of allowing the assistants to issue prescriptions independently. After 
some initial hesitation, Respondent complied by countersigning such 
prescriptions. Such countersigning, however, was accomplished well 
after the prescription was issued to the student/patient. In any event, 
after this particular dean left the university, Respondent stopped 
countersigning the physician assistants' prescriptions and continued 
this practice until 1989 when he was confronted by the KSU Police 
Department and the DEA.
    Respondent treated a student in 1986. Sometime later, this student 
was being treated by an off-campus psychiatrist. Respondent 
occasionally issued controlled substance prescriptions to this student 
at the request of the treating psychiatrist. In January 1989, 
Respondent received a handwritten list of drugs on the treating 
psychiatrist's letterhead which was unsigned. The list of drugs 
included methylphenidate (spelled ``methyilfenidayt'') and Librium, 
Schedules II and IV controlled substances, respectively. Based upon 
this person's representation that it was a valid prescription by his 
psychiatrist, Respondent issued this ex-student a prescription for 
these controlled substances. Only after Respondent was confronted with 
a report from a dormitory resident director that he heard this person 
boasting that he was able to obtain drugs from Respondent by deception, 
did Respondent contact the psychiatrist who informed Respondent that 
the ``prescription'' was, indeed, not authentic.
    Another person, who was a student at KSU from 1967 to 1976, was 
treated by Respondent from about 1975 to 1986 or 1987. Respondent 
indicated that he treated this person for chronic anxiety. Respondent 
prescribed Valium for this person on a consistent basis, despite being 
warned by a pharmacist in 1983 that this person ``bugged'' physicians 
to obtain controlled substances he desired and despite Respondent's own 
admission in 1985 that he was prescribing too much Valium to this 
person. He often issued these prescriptions based only on telephone 
conversations with this individual, who lived fifty miles from the KSU 
campus.
    In 1990, Respondent was interviewed by a DEA investigator about the 
Valium prescriptions he issued to this ex-student and if Respondent 
suspected this individual was addicted. Respondent replied that he had 
no reason to suspect such a problem because the individual had 
reassured Respondent that he was not addicted and that Respondent 
believed there was a difference between abuse and addiction.
    In December of 1987, Respondent asked another KSU Health Center 
physician to issue Respondent a prescription (which was undated) for 
forty dosage units of Percodan, a Schedule II controlled substance, in 
anticipation of surgery. Respondent altered this prescription by 
changing it to fifty dosage units of Demerol, another Schedule II 
controlled substance. During a subsequent Pharmacy Board hearing, the 
physician who signed the prescription believed, but was not absolutely 
certain, that he signed the prescription before it was altered. In any 
event, Respondent admitted that he was the one who altered the 
prescription.
    Respondent wrote two prescriptions, for Percodan and Demerol, both 
Schedule II controlled substances, in his own name in 1988. The purpose 
of these prescriptions was to supply his own medical bag. In December 
of 1990, Respondent issued as prescription for Ritalin, a Schedule II 
controlled substance and authorized two refills. Schedule II 
prescriptions are not allowed to be refilled. Respondent testified at 
the hearing that he had no explanation for issuing the prescription 
with two refills other than it was simply a mistake.
    Although no criminal or administrative action by any state or 
Federal agency was initiated against Respondent prior to these 
proceedings, DEA and the Pharmacy Board did take action against other 
participants involved in the controlled substance violations occurring 
throughout the university. In October 1989, the Pharmacy Board filed an 
accusation against the KSU Health Center pharmacy and its pharmacist 
alleging violations, including: filling and maintaining prescriptions 
known to have been written by physician assistants; filling and 
maintaining an altered prescription for a Schedule II controlled 
substance; providing controlled substances to the athletic department 
pursuant to prescriptions; and providing controlled substances to the 
psychology department pursuant to prescriptions. Following a hearing in 
May of 1990, the Pharmacy Board found that these violations occurred 
and that the university pharmacy and pharmacist were responsible for 
such violations. The pharmacist was fined $500.00 and placed on 
probation for five years. The pharmacy also was placed on probation for 
the same period of time.
    In August of 1990, DEA entered into a memorandum of understanding 
with the KSU Psychology Department, in which the department agreed to 
use DEA official order forms to obtain Schedule I and II controlled 
substances; maintain proper records for receipt and disposition of 
controlled substances; and generally comply with the Controlled 
Substances Act and its attendant regulations.
    Also, in August of 1990, DEA entered into a memorandum of 
understanding with the KSU Health Service, in which the service agreed 
to terminate the practice of distributing controlled substances to the 
athletic facilities; to fill only those prescriptions signed by 
physicians who were properly registered with DEA to issue them; to not 
dispense controlled substances for research activities via 
prescriptions or documents purporting to be prescriptions; to not 
distribute controlled substances for physicians' medical bags; and to 
maintain valid prescription and other records required by the 
Controlled Substances Act and its attendant regulations.
    In evaluating whether Respondent's continued registration by the 
Drug Enforcement Administration would be inconsistent with the public 
interest, as that term is used in 21 U.S.C. 824(a)4), the Deputy 
Administrator considers the factors enumerated in 21 U.S.C. 823(f). 
They are as follows:
    (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.
    In determining whether a registrant's continued registration is 
inconsistent with the public interest, the Deputy Administrator is not 
required to make findings with respect to each of the factors listed 
above. Instead, the Deputy Administrator has the discretion to give 
each factor the weight he deems appropriate, depending upon the facts 
and circumstances of each case. See David E. Trawick, D.D.S., Docket 
No. 88-69, 53 FR 5326 (1988).
    The Deputy Administrator concurs with the opinion and recommended 
decision of the administrative law judge and finds that factors two, 
four and five apply. Respondent, by writing unauthorized prescriptions 
in order to distribute controlled substances to an unregistered 
location, violated 21 CFR 1306.04(b). Respondent allowed athletic 
trainers to dispense Schedule III and IV controlled substances to 
athletes without any supervision by a physician in violation of 21 
U.S.C. 829(b). The prescriptions written by Respondent for the 
psychology department for purposes of conducting research on animals 
and humans violated 21 CFR 1306.04 (a) and (b). Such ``prescriptions'' 
were not for individual patients, were not in the course of 
Respondent's practice and were not for the purpose of dispensing to an 
ultimate user as defined under 21 CFR 1306.02(f). Respondent authorized 
physician assistants to issue and sign controlled substance 
prescriptions to patients without direct supervision of a physician in 
violation of 21 CFR 1306.03 and 1306.05(a).
    By issuing a prescription to a student based upon an unsigned 
document on which one of the controlled substances was misspelled, 
Respondent again dispensed controlled substances in violation of 21 
U.S.C. 829 (a) and (b). Respondent also issued Valium prescriptions to 
an ex-student over a long period of time well after Respondent was 
aware that this person was abusing this controlled substance. Although 
Respondent's initial treatment with Valium of this person may have been 
justified, the continued prescribing of Valium was not proper under 21 
CFR 1306.04(a). Respondent authorized unregistered athletic training 
room facilities to store and dispense controlled substances in 
violation of 21 CFR 1301.12. Respondent also violated applicable 
Federal law when he wrote several Schedule II controlled substance 
prescriptions in 1988 for the purpose of supplying his medical bag. 21 
CFR 1306.04(b).
    By allowing physician assistants to prescribe controlled 
substances, Respondent's actions violated applicable state law, Ohio 
Administrative Code 4731-4-03(C) and 4731-4-01(A). Allowing the 
psychology department to use controlled substances which were outdated 
also violated applicable state law, Ohio Administrative Code, 4729-9-
01)B) and Ohio Revised Code 3715.52 (A) and (C).
    The Deputy Administrator finds that Respondent committed these long 
standing systemic violations despite warnings and, in one case, despite 
an order to desist from the unlawful behavior. Respondent often 
rationalized and tried to justify these violations to investigators as 
well as during the hearing. Respondent, for example, made an 
unsupported assertion that other universities employed similar systems 
with regard to storing and dispensing controlled substances from their 
athletic training rooms.
    The administrative law judge in her opinion and recommended ruling, 
findings of fact, conclusions of law and decision recommended that 
Respondent's DEA registration be revoked. In his exceptions to the 
administrative law judge's ruling, Respondent argues that such action 
is not appropriate due to the fact that the state medical board took no 
action against Respondent nor were any criminal changes filed against 
Respondent based upon these acts. Revocation of a registration based 
upon the public interest is intended to allow DEA to take action when 
other law enforcement or regulatory agencies have not taken action. The 
Deputy Administrator notes that action has been taken against other 
registrants involved in these activities even though Respondent was a 
key player, if not the initiator, in all of these illegal practices.
    Respondent also argues that his actions did not result in 
diversion. Respondent's conduct, however, resulted in controlled 
substances being stored, dispensed and utilized outside of the closed 
system created by DEA registration. Under these circumstances, the 
potential for diversion of controlled substances is increased. It is 
not a valid defense to violate controlled substance laws and then, in 
hindsight, claim that such violations are of no matter because no 
illicit use of controlled substances actually resulted. If no actual 
abuse of the controlled substances occurred, it was in spite of, and 
not because of, Respondent's illegal actions. Moreover, Respondent's 
actions of prescribing controlled substances based upon an obviously 
forged document and the continual prescribing of Valium to an ex-
student when Respondent knew this person was abusing Valium, can 
certainly be characterized as diversion.
    Respondent additionally argues that DEA has not alleged, much less 
proven, any violations since 1989 (with the exception of the December 
1990 Schedule II prescription which authorized two refills) and 
therefore revocation is not justified. This argument fails to account 
for the fact that Respondent continually ignored warnings and even 
directives that his conduct was unlawful. It was not until various 
agencies initiated investigations that the university made any 
substantial changes to comply with applicable controlled substance 
laws. Moreover, Respondent's continual rationalizations and 
disingenuous statements both at the hearing and to investigators, gives 
DEA no assurance that he will not resume his cavalier behavior 
regarding controlled substances.
    Under these circumstances, the Deputy Administrator cannot be 
assured that the public interest will be protected if Respondent is 
allowed to retain his registration at this time. The Deputy 
Administrator concurs with the administrative law judge's 
recommendation and also orders that a new application for registration 
shall be considered no earlier than one year after the effective date 
of this final order and only after a convincing showing by Respondent 
of his rehabilitation.
    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, AC0808076, previously issued to 
Jay Wheeler Cranston, M.D., be, and it hereby is, revoked, and any 
pending applications for the renewal of such registration, be, and they 
hereby are, denied. Furthermore, no new application will be considered 
until at least one year from the effective date of this final order. 
This order is effective August 18, 1994.

    Dated: July 13, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-17417 Filed 7-18-94; 8:45 am]
BILLING CODE 4410-09-M