[Federal Register Volume 60, Number 235 (Thursday, December 7, 1995)]
[Notices]
[Pages 62887-62891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29770]
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DEPARTMENT OF JUSTICE
[Docket No. 93-39]
William F. Skinner, M.D., Continuation of Registration
On April 5, 1993, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to William F. Skinner, M.D., (Respondent) of Santa
Monica, California, notifying him of an opportunity to show cause as to
why DEA should not revoke his DEA Certificate of Registration,
AS7287534, under 21 U.S.C. 824(a)(4), and deny any pending applications
under 823(f), as being inconsistent with the public interest.
Specifically, the Order to Show Cause alleged that:
(1) During the period April 1987 through November 1988, the
Respondent prescribed, administered, and dispensed excessive amounts of
controlled substances to a single patient, including Demerol, Dilaudid,
Xanax, Ativan, Percodan, Tylenol with Codeine, Valium, Percocet,
Methadone, and Doriden, without a legitimate medical purpose and while
not acting in the usual course of professional practice; and
(2) During the same time period, the Respondent prescribed narcotic
drugs to the same narcotic dependent patient for the purpose of
maintenance treatment, and engaged in detoxification treatment of the
patient without holding a separate DEA registration to conduct a
narcotic treatment program.
On April 27, 1993, the Respondent, through counsel, filed a timely
request for a hearing. On February 23, 1994, the case was consolidated
for hearing with Michael S. Gottlieb, M.D., Docket No. 93-53, and
Michael J. Roth, M.D., Docket No. 94-10. Following prehearing
procedures, a hearing was held in Los Angeles, California, on March 29-
30 and May 10-12, 1994, before Administrative Law Judge Paul A. Tenney.
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 October 17, 1994, Judge Tenney issued his Findings of Fact,
Conclusions of Law, and Recommended Ruling, finding that Respondent's
registration was not inconsistent with the public interest, and
recommending that no action be taken against Respondent, Dr. Skinner.
On November 8, 1994, the Government filed exceptions to Judge Tenney's
opinion, and on December 7, 1994, the Respondent filed his response to
the Government's exceptions. On December 12, 1994, Judge Tenney
transmitted the record of these proceedings to the Deputy
Administrator.
The Deputy Administrator has considered the filings of the parties
and the record in its entirety, and pursuant to 21 C.F.R. 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 of Judge Tenney,
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 as a physician in the State of California, and that he had
served as the medical director of the St. John's Hospital Chemical
Dependency Center from 1981
[[Page 62888]]
to 1990. He is registered with the DEA as a practitioner authorized to
handle controlled substances in Schedule II through V.
The DEA's allegations concern the Respondent's treatment of one
patient, ``Patient A'', from March 1986 through October 1988. During
this time period, Patient A had a number of significant physical
conditions which caused pain, including pressure on the nerves from
cervical degenerative joint disease; degenerative osteoarthritis of the
lumbar vertebrae above a previous area where fusion surgery had been
performed; spinal stenosis which occurs when the spinal canal narrows,
at times putting pressure on a nerve with pain and muscle spasms;
severe temporal mandibular joint degenerative disease; compression
fracture of the patient's spine at L-1 and L-2; and trochanteric
bursitis of the hip. Also during this time period, Patient A had a
series of accidents which caused her acute pain: An automobile accident
in which she was a passenger, resulting in a whiplash injury to her
neck; an accident resulting in a knee injury; a fall down a spiral
staircase, resulting in back strain; and a fall on a marble floor,
resulting in a compression fracture of her spine. The record contains
no evidence that drug intoxication caused any of these accidents.
During the time period of March 1986 through October 1988, the
Government contended that the Respondent prescribed controlled
substances to Patient A for other than a legitimate medical purpose and
not in the usual course of his professional practice. Beginning March
20, 1986, the Respondent prescribed Demerol to Patient A. Demerol is a
brand name for a medication containing meperidine hydrochloride, a
Schedule II controlled substance. During the remainder of 1986, the
Respondent prescribed Demerol and Percodan or Percocet, and
occasionally he prescribed other Schedule II substances, such as
Dilaudid, Doriden, and Tuinal. For example, from May 13 through
December 26, 1986, the Respondent prescribed 1,604 tablets of Percodan
or Percocet, and from March 20 through December 26, 1986, he prescribed
approximately 30,000 milligrams of Demerol. This prescription practice
continued into 1987 and 1988. However, also as a part of his
prescription pattern, the Respondent tapered the amount of narcotics
prescribed after the incidents of acute pain following the injuries
suffered as a result of the various accidents. Dr. Smith, Dr. Ling, and
Dr. Margoles testified that such tapering was within the usual course
of professional practice.
Also throughout this time period, the Respondent used various non-
narcotic methods of treating Patient A's pain. Specifically, he ordered
bed rest, traction, hot packs, ultrasound, steroids, biofeedback,
massage, electrocane, a cervical collar, facet blocks, physical
therapy, acupuncture, and non-narcotic drugs. The Respondent also
referred Patient A to numerous specialists, including Dr. Dodge, a
neurosurgeon, Dr. Horacek, an orthopedic surgeon, and Dr. Woods, a
neurologist.
However, Dr. Skinner was the primary treating physician for Patient
A, and his treatment records were included in the record of this case.
The medical records recounted the Respondent's observations,
examination results, and the prescriptions issued as a result of his
house calls to Patient A. Further, the medical records also contain
hospital test results, hospital admission, treatment and discharge
records, and consultation reports. For example, the medical records
show that Patient A was hospitalized during this time period. On July
26, 1988, following a CAT scan, Dr. Joyce issued a report, writing that
Patient A had a mild compression fracture at L1, mild stenosis at L2-3,
moderate stenosis at L3-4, and a post-posterior bony fusion from L4 to
the sacrum. Patient A was discharged on August 18, 1988. Again on
September 29, 1988, Patient A was admitted to the hospital by Dr.
Skinner, and she was discharged on October 4, 1988, with a diagnosis of
a compression fracture, osteoporosis, and congenital scoliosis. On
October 17, 1988, Patient A was again admitted with a complaint of
severe left leg pain, and on October 23, 1988, she was discharged with
the diagnosis of acute back pain secondary compression fracture of L1,
acute lumbosacral spinal sprain and strain secondary to severe
osteoarthritis at L2-3 with neuroforaminal narrowing, sciatica
(resolved) and osteoporosis with high risk of possible spontaneous hip
fracture.
Further, as Judge Tenney noted, ``[t]here is a `debate' or
difference of opinion between those [physicians who] specialized in
addiction medicine and those in pain management regarding the use of
narcotics for the treatment of severe pain.'' He also noted that Dr.
Smith and Dr. Ling, the Government expert witnesses, were primarily
experts in addiction medicine, and Dr. Margoles and Dr. Brechner, the
Respondent's expert witnesses, were primarily experts in pain
management. Dr. Smith and Dr. Margoles agreed that there exists a
difference of opinion within the medical community as to the
appropriate level of prescribing of controlled substances for the
treatment of chronic pain patients. Also significant is the fact that
the opinions of Dr. Brechner, Dr. Dodge, Dr. Horacek, and Dr. Woods
were supported by either their personal examination, treatment, or
both, of Patient A during the relevant time period, whereas the
opinions of Dr. Smith and Dr. Ling were based upon their review of
Patient A's treatment records and prescription documentation.
Initially, the Government presented evidence from expert witnesses
who had concluded that Patient A was addicted to controlled substances,
and that the Respondent had prescribed medications to Patient A to
maintain her addiction. On March 3, 1990, Dr. Smith wrote in a report
for the District Attorney: ``[the] spectrum of medications [prescribed
to Patient A] was not justified by the medical pathology and, in fact,
the medications caused the patient far more harm than benefit. The
dosage of medication was clearly excessive and the duration over the
several month period as outlined in the medical records was both
excessive and not justified by the medical pathology.'' He concluded
that ``[a]s a result of this analysis it is my opinion then, that Dr.
Skinner and his colleagues were not prescribing a narcotic medication
primarily for the management of pain but, in fact, were maintaining her
addiction.'' During the hearing before Judge Tenney, Dr. Smith, after
reviewing the quantities of controlled substances prescribed on
selected dates, testified that those quantities were excessive in light
of the standard therapeutic dosage. He then restated the conclusion he
had reached in his 1990 letter to the District Attorney.
Based upon his review of Patient A's treatment record and relevant
pharmacy records, Dr. Ling, a medical expert in the areas of neurology,
psychiatry, addiction, and pain medicine, opined that the Respondent's
prescribing practices did not meet the standard of care of the average
practitioner with experience in the field of chemical dependency. He
also testified that, in 1988, the standard of care was not to prescribe
a large amount of narcotics, for such practice could result in the
patient's developing a tolerance to controlled substances. He
testified: ``You'd be treating the tolerance. You'd be treating
addiction, you're no longer treating the [diagnosed medical
condition].''
Both Dr. Smith and Dr. Ling concluded that Patient A was an addict
who was opiate dependent and
[[Page 62889]]
benzodiazipine dependent. However, Dr. Ling also testified that he
believed a drug dependent patient was entitled to treatment for pain,
that Patient A was in pain, and that the Respondent was treating her in
good faith.
The Respondent presented evidence from consulting physicians who
had concluded that Patient A was not an addict, but that she was
dependent upon controlled substances for treatment of her chronic and
sometimes acute pain. Specifically, Dr. Margoles, a medical expert in
pain management, testified, after having reviewed Patient A's medical
history and having interviewed her twice, that throughout the years
1986 to 1988, Patient A had experienced intractable pain as a result of
numerous medical problems and degenerative changes. He concluded that
Patient A was a chronic pain patient, as opposed to an opioid abuser,
and that she sought and was given medications to control her pain, not
for euphoria. He found that, although Patient A had received an
increase in amounts of opioids prescribed for her use, such an increase
had resulted from the severity of her pain, not from addiction. He
testified: ``It was obvious that the medication was being used to keep
her going in her professional career.'' He also summarized the
distinction between the use of pain medication to enable a patient with
pain to function, and the use of narcotics to simply maintain an
addict, as follows: ``the chronic pain patient * * * [is] goal
oriented, they're working, they're functioning. They've got something
in mind, they've got a goal. They're working, they've got a job.
Narcotic maintenance is usually, as far as I'm concerned, * * * just
keeping a person * * * from going through withdrawal symptoms.'' Also,
he noted that there was no evidence in Patient A's records of abstinent
syndrome, clinical or laboratory evidence of toxicity, nor evidence
that she had sought drugs in order to obtain euphoria. Dr. Margoles
testified that the lack of toxicity evidence meant that the ``patient
obviously tolerated the medication that she had, that was used in her
case, and evidently benefitted her [,] and [that] she had no toxic side
effects * * * no slurred speech, inability to have cognitive speech,
straight speaking.''
Finally, Dr. Margoles noted that in the 1980's, guidelines were
established in prescribing controlled substances for chronic
conditions. These guidelines were indorsed by various medical and legal
groups, to include the California Board of Medical Quality Assurance
and the California Bureau of Narcotic Enforcement. Dr. Margoles
testified that the Respondent's prescribing to Patient A met these
standards.
The Respondent also presented an affidavit from Dr. Dodge, a
consulting neurosurgeon involved with the treatment of Patient A from
1986 through 1988, who wrote:
In my opinion, although the amounts of drugs were large compared
to the average patient, they were necessary in order to treat the
patient's pain. Although the patient clearly had a drug dependence
problem, I do not believe the pain was controllable by other means
besides narcotics. The amounts of narcotics tended to increase at
the time of the acute events * * *. Dr. Skinner and the other
physicians responsible for her care always attempted to minimize the
amounts of drugs that she took and sought to detoxify her from those
drugs when the acute phase of pain and muscle spasm from the
injuries passed.
In my opinion, Dr. Skinner and the other physicians responsible
for her care did not violate the standard of practice in prescribing
narcotic analgesics to this patient.
Further, is an affidavit, Dr. Woods, a neurologist who treated
Patient A from January 1987 to January 1988, made similar observations
as Dr. Dodge, and concluded: ``In my opinion, Dr. Skinner and the other
physicians responsible for her care did not violate the standard of
practice in prescribing narcotic analgesics to this patient, in that
the drugs were prescribed to control the patient's pain not to maintain
her addiction.''
As to the legitimacy of the quantities of the controlled substances
prescribed, Dr. Brechner, a medical expert in the field of pain
management and anesthesiology, testified that in 1988, he was consulted
concerning an aspect of Patient A's treatment, for he had performed a
facet block procedure to aid in the diagnosis of the source of Patient
A's back pain. In the course of performing that procedure, he
administered narcotic analgesics, observing that Patient A had ``an
extraordinary tolerance to narcotics, even when potentiated with the
tranquilizers.'' Dr. Brechner also noted that Patient A suffered from
severe chronic pain and from periods of acute, intractable pain. Dr.
Brechner concluded that Patient A had received narcotics prescribed in
amounts that were ``extraordinary compared to the average patient,''
because of her extreme tolerance for narcotics, and that she needed the
narcotics in the amounts prescribed in order to control her pain. He
testified that prescribing the narcotics in lower doses was not
effective, and thus, she was not ``over-dosed.'' Also, Dr. Brechner
testified that alternative means of treatment were tried to control
Patient A's pain, but that he did not believe such treatment was
effective alone in treating the pain resulting from her acute pain-
inducing incidents, such as the automobile accident or the fall down
the stairway. Finally, Dr. Brechner testified that the doctors treating
Patient A prescribed narcotics for a legitimate medical purpose, to
treat her pain, and not to maintain her condition as an addict.
Also, the Respondent testified that he had begun treating Patient A
at the request of Dr. Roth in 1983. Dr. Skinner testified extensively
about the acute pain incidents experienced by Patient A through 1988,
the consulting physicians' diagnoses resulting from these incidents,
and the various narcotic and non-narcotic treatment regimen implemented
to control her pain. He also stated that there was no evidence that
drug intoxication caused any of Patient A's acute events, and that he
had made an extra effort to insure her lack of toxicity throughout his
treatment of her. Further, Dr. Skinner testified that all narcotics
were either administered in the hospital or under the supervision of a
private duty nurse selected by him from the nursing staff of the
Chemical Dependency Center at Saint John's Hospital, and that the
nurses were familiar with Patient A's case, her tolerances, and with
treating patients who had Patient A's type of problems. As a result of
his treatment of Patient A, Dr. Skinner concluded that she was not an
addict: ``She did not demonstrate typical findings of addiction
behavior * * * never did she evidence toxicity, never did she evidence
any abstinence withdrawal syndrome, and never did she evidence, while
under my care at home or in the hospitals, any evidence of street-like
drug seeking behavior.'' He also stated that, given Patient A's medical
condition, he did not believe that he over-prescribed controlled
substances to her. Further, he testified that in prescribing
medications to Patient A, he would taper her off the medicines to try
to control her tolerance levels. He strongly denied prescribing
controlled substances to Patient A to maintain an addiction, stating:
``if it [is] your contention that I was maintaining an addict, what
motive would I possibly have for that? It's against all the training
that I have; it's against everything that I have done in treating
chemical dependency patients.''
Also, as to the Respondent's recordkeeping practices, he testified
that he was aware that tabloid newspapers would pay clerks at the
hospital to copy celebrity patient records, such as Patient A's, and to
send the records to the tabloids. Therefore, the Respondent stated he
was careful in his records to document conditions and prescriptions
[[Page 62890]]
made to Patient A, while remaining in compliance with federal laws of
confidentiality.
As to his future practice, the Respondent stated that if he
encountered a medically complex patient similar to Patient A, he would
refer that patient to a chronic pain management specialist. He also
testified concerning his current practice and the need for his DEA
Certificate of Registration.
Pursuant to 21 U.S.C. 824(a)(4) and 823(f), the Deputy
Administrator may revoke or suspend the Respondent's DEA Certificate of
Registration and deny any pending application for such registration, if
he determines that the continued 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 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 16422
(1989).
In this case, factors two, four, and five are relevant in
determining whether the Respondent's continued registration would be
inconsistent with the public interest. As to factor two, the
Respondent's ``experience in dispensing * * * controlled substances,''
and factor four, the Respondent's compliance with ``Federal, State, or
local law,'' the Government contends that during March 1986 through
October 1988, the Respondent prescribed controlled substances in the
treatment of Patient A not for a legitimate medical purpose and not in
the usual course of his professional practice, in violation of State
and Federal law. Specifically, the Government argues that controlled
substances were prescribed to Patient A during these periods to
maintain her addiction, and that the amount of narcotics prescribed far
exceeded what Patient A needed for pain relief.
An ``addict'' is defined in 21 U.S.C. 802(1) as ``any individual
who habitually uses any narcotic drug so as to endanger the public
morals, health, safety, or welfare, or who is so far addicted to the
use of narcotic drugs as to have lost the power of self-control with
reference to [one's] addiction.'' There was no dispute that very high
does of narcotic analgesics were administered to Patient A, but the
evidence also demonstrated that she had a high tolerance to the
controlled substances and required this dosage to effectively treat her
pain. Patient A's medical records and the statements and testimony of
medical experts established that Patient A had several injuries and was
plausibly experiencing severe and chronic pain.
Further, the evidence did not adequately establish that Patient A
was an ``addict.'' No evidence was presented to show that Patient A had
acted to ``endanger the public morals, health, safety, or welfare,'' or
that she had a compulsion to use drugs, had lost control over the
drugs, or that she continued to use the drugs in spite of adverse
consequences. Also, medical testimony was presented to establish that,
although considered, there was no evidence of abstinent syndrome,
slurred speech, inability to have cognitive speech, nor clinical or
laboratory evidence of toxicity. However, there was expert testimony to
establish that use of the controlled substances helped Patient A to
function and participate in her professional activities in spite of
chronic pain. Although the Respondent did not deny that Patient A had
experienced chemical dependency for the control of her pain, he did
testify that he was not prescribing controlled substances to Patient A
to maintain an addiction, for she had not presented any addictive
behavior to him. Therefore, the Deputy Administrator concurs with Judge
Tenney's finding that the ``preponderance of the evidence demonstrates
that although Patient A was prescribed a large amount of controlled
substances, these were prescribed by Dr. Skinner for a legitimate
medical purpose and in the usual course of his professional practice.''
The Government also asserted that the Respondent's practices
violated California Health and Safety Code Sections 11153 and 11154.
Pursuant to Section 11153(a), a ``prescription for a controlled
substance shall only be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his or her
professional practice,'' and a prescription issued ``for an addict or
habitual user of controlled substances, which is issued not in the
course of professional treatment * * * but for the purpose of providing
the user with controlled substances, sufficient to keep him or her
comfortable by maintaining customary use'' would not be a legal
prescription pursuant to this section. Section 11154 provides in
relevant part that ``[e]xcept in the regular practice of his or her
profession, no person shall knowingly prescribe, administer, dispense,
or furnish a controlled substance to or for any person * * * which is
not under his or her treatment for a pathology or condition other than
addiction to a controlled substance * * * .''
The Respondent asserted that he had prescribed controlled
substances to Patient A in good faith, and that such prescribing was an
absolute defense to an allegation of violation of these State law
provisions. Dr. Ling testified that he accepted that the Respondent
believed Patient A was in pain, and that he was treating her in good
faith. Dr. Margoles also testified to the Respondent's good faith
treatment of Patient A.
The Deputy Administrator agrees with the conclusion of Judge
Tenney, that the Respondent did not violate these State code
provisions. See People v. Lonergan, 219 Cal. App. 3d 82, 90 (1990)
(acting in ``good faith,'' as defined by California Health and Safety
Code 11210, exempts a physician from criminal liability under the
provision of 11153). In response to the Government's exceptions
relevant to the standard applicable in this administrative proceeding,
the Deputy Administrator also finds that the preponderance of the
evidence was against a finding that Patient A was an ``addict'', and
supports the conclusion that the Respondent had prescribed controlled
substances to Patient A for a legitimate medical purpose, treating her
pain, while acting in the usual course of his professional practice.
Thus, the evidence does not support a finding that the Respondent
violated the cited State law.
Next, the Government asserted that from April 1987 through November
1988, the Respondent performed detoxification or maintenance treatment
of a narcotic drug-dependent patient without obtaining a registration
for that purpose, in violation of Federal law. Pursuant to 21 U.S.C.
802(30), ``detoxification treatment'' is--
the dispensing for a period not in excess of one hundred and eighty
days of a narcotic drug in decreasing doses to an individual in
order to alleviate adverse physiological or psychological effects
incident to withdrawal
[[Page 62891]]
from the continuous or sustained use of a narcotic drug and as a method
of bringing the individual to a narcotic drug-free state within such
period.
Further, the statute defines ``maintenance treatment'' as the
dispensing, ``for a period in excess of twenty-one days, of a narcotic
drug in the treatment of an individual for dependence upon heroin or
other morphine-like drugs.'' 21 U.S.C. 802(29). However, the applicable
implementing regulation states in pertinent part:
This section is not intended to impose any limitations on a
physician * * * to administer or dispense narcotic drugs in a
hospital to maintain or detoxify a person as an incidental adjunct
to medical or surgical treatment of conditions other than addiction,
or * * * to persons with intractable pain in which no relief or cure
is possible or none has been found after reasonable efforts.
21 CFR 1306.07(c).
The preponderance of the evidence supports a finding that the
Respondent was tapering the drugs prescribed to Patient A after acute
pain resolved. Dr. Ling, as well as others, testified that such
tapering would be appropriate under such circumstances. Further, the
record does not establish that Patient A experienced ``adverse
physiological or psychological effects incident to withdrawal'' nor
that, in fact, Patient A exhibited behavior consistent with the finding
that she was an ``addict.'' Therefore, the Deputy Administrator agrees
with Judge Tenney, that the ``Respondent made a reasonable effort to
manage the patient's intractable pain and limit the patient's use of
controlled substances in terms of treatment of [Patient A's] other
medical conditions, and did not prescribe controlled substances to her
primarily to wean her from dependence on narcotic analgesics.'' Thus,
the Respondent was not maintaining Patient A's addiction nor
detoxifying Patient A without a prior registration.
Finally, the Government argued that from March 1986 through October
1988, the Respondent failed to keep adequate medical records of his
treatment of Patient A, and thus, his prescriptions were not issued for
a legitimate medical purpose nor in the usual course of professional
practice in violation of 21 CFR 1306.04, and California Health and
Safety Code Sections 11168, 11190, and 11191. Yet the Government failed
to cite to any specific inadequacies of the Respondent's records in
either their proposed findings of fact or in the exceptions filed to
the Administrative Law Judge's recommended decision.
Pursuant to 21 CFR 1304.03(c), a ``registered individual
practitioner is not required to keep records of controlled substances
in Schedules II, III, IV, and V which are prescribed in the lawful
course of professional practice, unless such substances are prescribed
in the course of maintenance or detoxification treatment of an
individual.'' Further, a ``registered individual practitioner is not
required to keep records of controlled substances listed in [Schedules
II through V] which are administered in the lawful course of
professional practice unless the practitioner regularly engaged in the
dispensing or administering of controlled substances and charges
patients, either separately or together with charges for other
professional services, for substances so dispensed or administered.''
21 CFR 1304.03(d). Here, the Respondent prescribed controlled
substances to Patient A, but the record does not indicate that he
``regularly dispensed'' those substances to her nor that he prescribed
them ``in the course of maintenance or detoxification treatment.'' The
Deputy Administrator thus agrees with Judge Tenney's conclusion that
``the Government failed to prove that Respondent kept inadequate
records. No violation of the Federal statute is found.''
As for violations of State law, California Health and Safety Code
Section 11190 provides that a practitioner who issues a prescription of
a controlled substance classified in Schedule II must make a record for
each transaction which shows the name and address of the patient, the
date of the transaction, the ``character, including the name and
strength, and quantity of controlled substances involved'', and the
pathology and purpose for which the prescription was issued. The
Government did not cite to any specific instances where the Respondent
failed to provide this required information. Thus, after reviewing the
record, the Deputy Administrator agrees with Judge Tenney's conclusion
that the ``DEA did not prove that there were recordkeeping violations
by a preponderance of the evidence.''
As to factor five, ``such other conduct which may threaten the
public health and safety,'' the Government argued that the Respondent's
pattern of prescribing to Patient A caused a threat to the public
health and safety. As Judge Tenney noted, this is an unusual case for
it involved the Respondent's prescribing practices for a single
patient, and no evidence was provided to show a pattern of excessive
prescribing to any other patients. Further, as to that single patient,
the Deputy Administrator concurs with Judge Tenney's finding that the
``overriding purpose of [the] Respondent's prescribing practices was
the treatment of Patient A's pain,'' a legitimate medical purpose. In
the balance, the Deputy Administrator finds that it is in the public
interest for the Respondent to retain his DEA Certificate of
Registration.
However, the Deputy Administrator notes with concern the large
quantities of controlled substances prescribed to Patient A over an
extended period of time. Yet the conflicting expert opinion evidence
presented leads to the conclusion that the medical community has not
reached a consensus as to the appropriate level of prescribing of
controlled substances in the treatment of chronic pain patients. Given
this dispute, the Deputy Administrator is reluctant to conclude that
the Respondent's prescribing of controlled substances to Patient A
lacked a legitimate medical purpose or was outside the usual course of
professional practice. It remains the role of the treating physician to
make medical treatment decisions consistent with a medical standard of
care and the dictates of the Federal and State law. Here, the
preponderance of the evidence established that the Respondent so acted.
Therefore, the Deputy Administrator finds that the public interest
is best served by taking no action with respect to the continued
registration of the Respondent. 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 21 CFR 0.100(b) and 0.104,
hereby orders DEA Certificate of Registration AS7287534, issued to
William F. Skinner, M.D., be, and it hereby is, continued, and that any
pending applications be, and they hereby are, granted. This order is
effective January 8, 1996.
Dated: November 30, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-29770 Filed 12-6-95; 8:45 am]
BILLING CODE 4410-09-M
