[Federal Register Volume 60, Number 233 (Tuesday, December 5, 1995)]
[Notices]
[Pages 62262-62267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29487]



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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 94-10]


Michael J. Roth, M.D.; Continuation of Registration

    On October 27, 1994, the Deputy Assistant Administrator (formerly 
Director), Office of Diversion Control, Drug Enforcement Administration 
(DEA), issued an Order to Show Cause to Michael J. Roth, 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, AR8354425, 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 March 1988 through December 1989, the 
Respondent prescribed, administered, and dispensed excessive amounts of 
controlled substances to a single patient, including Demerol, Dilaudid, 
Xanax, Ativan, Percordan, Tylenol with Codeine, Valium, Percocet, 
Methodone, and Doriden, without a legitimate medical purpose and while 
not acting in the usual course of professional practice;
    (2) During the same time period, the Respondent further prescribed 
narcotic drugs to the same narcotic dependent patient for the purpose 
of maintenance treatment, and engaged in detoxification treatment of 
that patient without holding a separate DEA registration to conduct a 
narcotic treatment program; and
    (3) During the period January 1991 through February 1993, the 
Respondent prescribed excessive amounts of controlled substances to two 
patients, including Chloral Hydrate, Ativan, Dalmane, Tylenol with 
Codeine, and Fiorinal, without a legitimate medical purpose and while 
not acting in the usual course of professional practice.
    On November 19, 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 William J. Skinner, M.D., Docket No. 93-39. 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 the Government and the Respondent 
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 

[[Page 62263]]
issued his Findings of Fact, Conclusions of Law, and Recommended 
Ruling, finding that the Respondent's registration was not inconsistent 
with the public interest, and recommending that no action be taken with 
respect to the Certificate of Registration of Respondent, Dr. Roth. The 
Government filed exceptions to his decision, and the Respondent filed 
responses 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 record in its entirety 
and the filings of the parties, and pursuant to 21 CFR 1316.67, hereby 
issues his final order based upon findings of fact and conclusions of 
law as hereinafter set forth. The Deputy Administrator adopts, in full, 
the opinion 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 and surgeon in the State of California. The 
DEA's allegations concern the Respondent's treatment of two patients, 
``Patient A'' and ``Patient B.'' Patient A had a number of significant 
physical conditions which caused severe 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, in some cases putting pressure on a nerve; 
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.
    During the time period of March through October 1988, the 
government contended that the Respondent prescribed controlled 
substances to Patient A for other than a legitimate medical purpose. 
During this period, Dr. Skinner was the primary treating physician for 
Patient A. The Respondent and Dr. Michael Gottlieb were partners in a 
medical practice in Los Angeles, and Dr. Gottlieb would care for 
Patient A when Dr. Skinner was not available, and the Respondent cared 
for Patient A when neither Dr. Skinner nor Dr. Gottlieb was available. 
Respondent testified that he did not keep independent medical records 
of the patient while he was in partnership with Dr. Gottlieb, but when 
he issued prescriptions to Patient A, he followed the medical regimen 
established by Dr. Gottlieb and Dr. Skinner.
    During the period of March 26, 1988, through October 13, 1988, the 
Respondent prescribed Schedule II controlled substances to Patient A on 
13 occasions, and Schedules III through V controlled substances to 
Patient A on 23 occasions. The Respondent testified that when Patient A 
was in acute pain, he would prescribe Percodan, but that he would then 
try to taper her off that substance once the acute pain diminished. In 
July 1988, Patient A suffered a fall and injured her back. Dr. Gottlieb 
admitted the patient to the hospital on July 25, 1988, with a diagnosis 
of severe degenerative disc disease with marked fact hypertrophy from 
L3 to S1, a history of sciatica and foot drop, premature atrial 
contractions, and degenerative disc disease of the cervical spine. Dr. 
Gottlieb noted on the patient's history that she was currently using 
Percodan, Ativan, and Xanaz. Percodan, a Schedule II controlled 
substance, contains oxycodone and aspirin; Ativan, a Schedule IV 
controlled substance, contains lorazepam; and Xanaz, a Schedule IV 
controlled substance, contains alprazolam. Upon admission to the 
hospital, Dr. Gottlieb ordered, and Patient A was given, 150 milligrams 
(mg.) of Demerol and 1 mg. of Ativan. Demerol is a brand name for 
meperidine hydrochloride and is a Schedule II controlled substance.
    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, and the Respondent ordered administration of 100 mg. of Demerol, 
and then issued a prescription 70 Percodan. On August 25, 1988, the 
Respondent prescribed 20 Percodan and 5 Dilaudid. Dilaudid is a brand 
name of hydromorphone hydrochloride and is a Schedule II controlled 
substance.
    During the period from September 1, 1988, to October 13, 1988, the 
Respondent prescribed to Patient A 210 Percodan and 300 mg. of Demerol. 
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. On October 31, 1988, Patient A was admitted to the Betty Ford 
Clinic with an initial diagnosis of opiate, alcohol, sedative, and 
amphetamine dependent (continuous), and she was discharged on December 
10, 1988.
    As Judge Tenney noted, ``[t]here is a `debate' or difference of 
opinion between those 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 relevant prescription 
documentation.
    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 testified, after reviewing the 
quantities of controlled substances prescribed on selected dates, that 
those quantities were excessive in light of the standard therapeutic 
dosage. He then adopted the conclusion reached in his 1990 letter to 
the District Attorney.
    Dr. Ling, a medical expert in the areas of neurology, psychiatry, 
addiction, and pain medicine, opined that, based upon his review of 
Patient A's treatment record and pharmacy records, the Respondent's 
prescribing practices 

[[Page 62264]]
during 1988 did not meet the standard of care of the average 
practitioner. He stated, ``If this was the only records there [were], 
then I don't think it meets the standard of care.'' 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 a controlled substance: ``You'd be treating 
the tolerance. You'd be treating addiction, you're no longer treating 
the [diagnosed medical condition].'' Further, Dr. Ling recommended that 
a physician treating a patient with a potential drug dependency problem 
should consult with a specialist in drug addiction. Both Dr. Smith and 
Dr. Ling concluded that Patient A was an addict who was opiate 
dependent and benzodiazipine dependent.
    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 to treat her chronic and sometimes 
acute pain. Specifically, after having reviewed Patient A's medical 
history and having interviewed her twice, Dr. Margoles, a medical 
expert in pain management, testified, 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 received an increase in 
amounts of opioids prescribed for her use, such an increase resulted 
from the severity of her pain, not addiction. ``It was obvious that the 
medication was being used to keep her going in her professional 
career.'' Also, he noted that there was no evidence in the patient's 
records that she sought drugs in order to obtain euphoria, no evidence 
of abstinent syndrome, nor clinical or laboratory evidence of toxicity. 
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.''
    As to the Respondent's specific involvement in 1988, Dr. Mangoles 
also opined that the 13 prescriptions Dr. Roth wrote during a seven 
month period were needed to control the patient's pain problems. He 
also noted that the Respondent appeared ``to be tapering her down all 
the time,'' and that such tapering was within the usual course of 
professional practice. Dr. Smith agreed with Dr. Margoles concerning 
the propriety of tapering Patient A, under the circumstances. Further, 
Dr. Margoles testified that the Respondent ``acted in good faith and 
prescribed medication that was adequate for a given diagnosis and 
following good faith examination.''
    Finally, Dr. Margoles noted that in the 1980's, guidelines were 
established in prescribing controlled substances for chronic 
conditions. These guidelines were endorsed 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. Thus, he concluded that the Respondent prescribed controlled 
substance in the appropriate course of his professional conduct, and 
not for the purpose of maintaining Patient A's condition as an addict.
    Also, the Respondent produced 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, in 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.
    Further, Dr. Skinner, the Medical Director of St. John's Chemical 
Dependency Center from 1981 to 1990, and a medical expert in chemical 
dependency, testified that he had begun treating Patient A at the 
Respondent's request 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 

[[Page 62265]]
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.''
    The Respondent also testified before Judge Tenney, stating that 
Patient A was ``opiate dependent'' or ``opiate reliant,'' but not 
addicted. ``I don't feel she was addicted to the medication from the 
point of view that she needed the medication every so many hours as an 
addict would for maintenance of the use of the drug. But she relied on 
the medication to take away her pain. In that sense, I'm saying she was 
reliant on the medication. But she could go days without having 
medication, even weeks, when her pain wasn't bad. Then the pain would 
get bad and she was reliant, again, on the medication to take away the 
pain.'' He concluded by stating that, although he was not the primary 
treating physician during 1988, he issued prescriptions in good faith 
and as part of the regimen established by her primary treatment 
physicians. Further, he affirmed that he did not issue any 
prescriptions for the purpose of enabling Patient A to reach a state of 
euphoria.
    As to his prescribing practices during 1991 through 1993, the 
Respondent testified that Patient A complained that her pain was 
causing her insomnia. He first referred Patient A to the sleep clinic 
at Cedars Sinai Hospital, but she did not follow up on that referral. 
Next, the Respondent consulted with the director of that clinic and 
used the treatment regimen he suggested to try to provide Patient A 
relief from both her insomnia and her pain. The recommended regimen 
involved trying to rotate insomnia medications to determine what 
medication would provide Patient A relief. He prescribed 
benzodiazepines, to include Restoril, Prosom, Chloral Hydrate, and 
Dalmane. The Respondent testified that he would give Patient A three 
prescriptions at one time for small dosages of different substances, 
stating ``the reason that we gave her the three medications at one time 
was to give her the alternative to try one and if one didn't work to 
try a second.'' The Respondent testified that he cautioned Patient A 
about the addictive nature of these substances, and Patient A affirmed 
that she was just trying to get some sleep so she could work. The 
Respondent affirmed that it was never his intention that Patient A 
would take all three prescribed medications at the same time, and that 
``[Patient A] knew absolutely that that wasn't the indication.'' 
Finally, the Respondent testified that he was prescribing these 
substances in good faith to assist Patient A in trying to obtain some 
sleep, not to obtain a state of euphoria.
    Dr. Margoles agreed with the Respondent, testifying that Patient A 
needed the medications prescribed during this time period to control 
her pain and to help her sleep, given the pain she was experiencing. 
Dr. Smith, however, testified generally about sedative-hypnotic 
dependence, and, after reviewing the prescriptions issued during 1992 
through 1993, he concluded that the Respondent's prescriptions to 
Patient A were beyond therapeutic use and were issued for the purpose 
of sustaining her addiction. However, undisputed in the record was the 
Respondent's testimony that Patient A's medical records reflecting his 
treatment of her during this time period had been stolen from the 
Respondent's office. Acknowledging the lack of medical records, Dr. 
Smith admitted that if he had been able to review the medical records 
``[he] could have a better understanding of what was going on in the 
physician's mind and whether it was appropriate prescribing.''
    However, the Respondent submitted letters written between September 
1990 and February 1993, reflecting his referral of Patient A to other 
physicians for consultation. Dr. Ling, after reviewing the consulting 
physician's opinions, conceded that the letters supported the 
Respondent's opinion that Patient A suffered intractable pain during 
this time period. Dr. Ling also testified that he did not see any 
overall strategy for the treatment of Patient A, but he conceded that, 
lacking the medical treatment record, he could not render an opinion as 
to whether the Respondent's medical practices were consistent with the 
skill and knowledge of the average practitioner.
    Also in dispute was the adequacy of the medical treatment records 
for Patient A during the 1988 time period. The Respondent testified 
that, since he shared a practice with Dr. Gottlieb, he had not kept a 
separate medical record, but rather he had followed the treatment 
regimen of Dr. Gottlieb and Dr. Skinner. Dr. Smith testified that Dr. 
Gottlieb's treatment records did not meet the usual medical standard of 
practice regarding prescription of controlled substances. Yet Dr. 
Brechner also reviewed Patient A's treatment records provided by Dr. 
Skinner and Dr. Gottlieb, as well as the hospital records, and he 
testified that the acute and chronic medical conditions were well 
documented in the medical records. Also, Dr. Margoles testified that 
the records sufficiently supported the Respondent's prescribing 
practices, for Dr. Gottlieb's records included diagnoses and a 
treatment plan for Patient A. Finally, there was no expert witness 
testimony to establish that the Respondent's recordkeeping practices, 
under the circumstances, failed to meet the usual medical standard.
    As to Patient B, the Government's attorney stated on the record 
that ``the government will really not submit any argument to the issue 
of . . . whether Patient B had legitimate medical conditions that were 
being treated,'' but noted that the Respondent's recordkeeping 
practices as to Patient B were deficient. Patient B's medical chart was 
of record, and in it the Respondent had listed several diagnoses, 
including ``migraine v. cluster'' headaches and insomnia. The 
Respondent also testified that a cluster headache could incapacitate 
someone and could cause insomnia. Three times in June, twice in July, 
and once in September 1992, the Respondent prescribed Fiorinal, a 
barbiturate containing butalbital, a Schedule III controlled substance, 
for Patient B's headaches. For Patient B's insomnia condition, the 
Respondent prescribed Prosom, a triazolobensodiazepine derivative, 
which is a Schedule IV controlled substance. The Respondent also 
testified that Patient B's medical problems were documented in his 
medical record, and that given the small amount of medication 
prescribed for Patient B, he felt it was not relevant to go into a 
long, lengthy work-up for this patient.
    Dr. Margoles testified that Fiorinal was a medication that was used 
to control cluster headaches, and that the Respondent prescribed this 
medication to Patient B in appropriate dosages. He also testified that 
the Prosom was prescribed to Patient B in appropriate dosages to help 
him sleep, and that there was no evidence in the medical records that 
Patient B sought either of these medications for the purpose of 
euphoria. Therefore, he concluded that the medications were prescribed 
for a legitimate medical purpose and in the appropriate course of 
normal medical practice.
    Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy 
Administrator may revoke a DEA Certificate of 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.

[[Page 62266]]

    (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 the periods March 
through October 1988, and 1991 through 1993, 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 
doses 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 establish 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 a chemical dependency, he 
testified that he was not prescribing controlled substances to Patient 
A to maintain an addiction, for she did not present any addictive 
behavior to him. Therefore, the Deputy Administrator concurs with Judge 
Tenney's finding that Patient A is a chronic pain patient being 
maintained on opioids for treatment of pain, and that she is not an 
``addict.''
    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 prescribing in good faith was an 
absolute defense to an allegation of violation of these 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 establishes that the Respondent prescribed controlled 
substances to Patient A for a legitimate medical purpose while acting 
in the usual course of his professional practice, and thus, he did not 
violate the cited State law.
    Next, the Government asserted that 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 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. (Emphasis added).

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) (emphasis added). 
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 C.F.R. 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 

[[Page 62267]]
``Respondent made a reasonable effort to manage the patient's 
intractable pain and limit the use of controlled substances in terms of 
treatment of [Patient A's] other medical conditions, and did not 
prescribe controlled substances primarily to wean the patient from 
dependence on narcotic analgesics.'' Thus, the Respondent was not 
maintaining Patient A's addiction nor detoxifying Patient A without a 
proper registration.
    Next, the Government asserts that the Respondent violated 21 C.F.R. 
1306.04 and California Health and Safety Code 11168, 11190, and 11191, 
by failing to keep adequate medical records in the course of his 
treatment of Patient A during 1988, and 1991 through 1993. The primary 
treatment records during 1988 were the records of Dr. Skinner and Dr. 
Gottlieb, and there was no dispute that Dr. Roth did not maintain 
separate treatment records recording his treatment of Patient A during 
this time period. Although Dr. Smith testified that Dr. Gottlieb's 
records were inadequate, Dr. Margoles and Dr. Brechner testified that 
the records sufficiently supported the Respondent's prescribing 
practices, for Dr. Gottlieb's records included diagnoses and a 
treatment plan for Patient A. Further, the Respondent testified that he 
merely followed the treatment regimen of Dr. Gottlieb and Dr. Skinner 
when he ``covered'' for them in treating Patient A. No expert witness 
testimony was presented to discredit the Respondent's professional 
practice of recordkeeping under these circumstances.
    As to the records from 1991 through 1993, the Respondent testified, 
and no evidence was presented to the contrary, that Patient A's 
treatment records covering his treatment of her during this time period 
were stolen from his office. Further, the Deputy Administrator concurs 
with Judge Tenney's finding that the Respondent's explanation for the 
missing records was credible. Given the loss of these medical records, 
the hearing record is devoid of evidence sufficient to establish the 
inadequacy of the Respondent's contemporaneous recordkeeping practices. 
Thus, the Deputy Administrator agrees with Judge Tenney's conclusion 
that the inadequacies of the medical records were not clearly 
supported.
    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. 
Also, a relevant factor in determining the public's interest is the 
nature of the Respondent's current practice, for the Respondent 
testified that the majority of his patients in 1994 were living with 
AIDS and in many cases in need of controlled substances to relieve 
their incurable pain. In the balance, the Deputy Administrator finds 
that it is in the public interest for the Respondent to retain his DEA 
Certificate of Registration.
    Yet the Deputy Administrator notes with concern the large 
quantities of controlled substances prescribed to Patient A over an 
extended period of time. However, 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 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 C.F.R. 0.100(b) and 
0.104, hereby orders DEA Certificate of Registration AR8354425, issued 
to Michael J. Roth, M.D., be, and it hereby is, continued, and that any 
pending applications, be, and they hereby are, granted. This order is 
effective January 4, 1996.

    Dated: November 24, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-29487 Filed 12-4-95; 8:45 am]
BILLING CODE 4410-09-M