Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices 62887

Finally, the Deputy Administrator

agrees with Judge Tenney’s finding as to

the relevancy of the Respondent’s

testimony before him concerning the

cocaine incident and factor five, ‘‘other

conduct which may threaten the public

health or safety.’’ Specifically, the

Deputy Administrator finds that the

Respondent’s lack of candor in his 1994

testimony as to the full extent of his

involvement in the cocaine incident

creates concern about his future

conduct. The record discloses that the

Respondent was quite involved in the

cocaine distribution and conspiracy, as

evidenced by the stipulated testimony

of the undercover Agent involved firsthand in the incident, and by the fact

that the Respondent pled guilty to the

charges of conspiracy to distribute

cocaine and unlawfully distributing

cocaine. His failure to take

responsibility for his past misconduct

causes concern about his commitment

to protecting the ‘‘public health and

safety’’ in the future, should he be

granted a DEA Certificate of

Registration.

However, the Government’s

establishment of its case does not end

the inquiry, for the Respondent has

submitted extensive evidence of his

rehabilitative efforts. The issue then

becomes whether the Respondent has

offered sufficient proof of rehabilitation

to mitigate the egregious conduct

established by the Government, such

that the DEA can now find that granting

the Respondent’s application for a

Certificate of Registration would be

consistent with the ‘‘public interest.’’

See Shatz v. United States Dept. of

Justice, 873 F.2d 1089, 1091 (8th Cir.

1989) (holding that, in a case such as

this, the Respondent has the burden to

prove rehabilitation).

Again, the Deputy Administrator

agrees with Judge Tenny’s findings as to

the weight to be given the Respondent’s

rehabilitative evidence, for the

Respondent’s evidence concerning his

rehabilitative efforts, to include his

commitment to performing good deeds

through a variety of Christian ministries,

was credible. However, the

Respondent’s November 1994 testimony

concerning his conduct surrounding the

May 1, 1986, cocaine transaction was

indeed troubling, for despite the plea

and conviction, the Respondent

continued to minimize his involvement

and resulting responsibility for the

conspiracy and cocaine distribution

incidents. As Judge Tenny noted, ‘‘the

Respondent’s inability to be completely

candid at the hearing causes sufficient

doubt as to whether he is fully

rehabilitated.’’ Further, the Deputy

Administrator also notes the lack of

evidence of continuing education

relevant to controlled substances,

evidence which would have been

helpful in light of the Respondent’s

experience in prescribing Didrex

without understanding its

characteristics.

Therefore, the preponderance of the

evidence supports denial of the

Respondent’s application at this time. If

the Respondent reapplies and submits

evidence of his continuing rehabilitative

efforts, such as evidence of completion

of educational courses at least partially

focused upon the handling of controlled

substances, then his application may

receive more favorable consideration.

See, e.g., Shatz, 873 F.2d at 1092

(suggesting that ‘‘careful consideration’’

be given to any future application for

registration, and in particular, to ‘‘any

additional evidence in support of [a]

claim of rehabilitation’’); Sokoloff v.

Saxbe, 501 F.2d 571, 576 (2d Cir. 1974)

(stating that ‘‘permanent revocation’’ of

a DEA Certificate of Registration may be

‘‘unduly harsh’’)

Therefore, the Deputy Administrator

finds that the public interest is best

served by denying the Respondent’s

application at this time. Accordingly,

the Deputy Administrator of the Drug

Enforcement Administration, pursuant

to the authority vested in him by 21

U.S.C. 823, and 21 C.F.R. 0.100(b) and

0.104, hereby orders that the

Respondent’s application for a DEA

Certificate of Registration be, and it

hereby is, denied. This order is effective

January 8, 1996.

Dated: November 30, 1995.

Stephen H. Greene,

Deputy Administrator.

[FR Doc. 95–29771 Filed 12–6–95; 8:45 am]

BILLING CODE 4410–09–M

[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
62888 Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices

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
Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices 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 ‘‘overdosed.’’ 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
62890 Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices

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
Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices 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

NATIONAL ARCHIVES AND RECORDS

ADMINISTRATION

Records Schedules; Availability and

Request for Comments

AGENCY: National Archives and Records

Administration, Office of Records

Administration.

ACTION: Notice of availability of

proposed records schedules; request for

comments.