[Federal Register Volume 60, Number 241 (Friday, December 15, 1995)]
[Notices]
[Pages 64449-64452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30578]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 94-30]
Harold R. Schwartz, M.D.; Denial of Application
On March 2, 1994, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Harold R. Schwartz, M.D., (Respondent) of
Houston, Texas, notifying him of an opportunity to show cause as to why
DEA should not deny his application for registration as a practitioner
under 21 U.S.C. 823(f), as being inconsistent with the public interest.
Specifically, the Order to Show Cause alleged that:
(1) In February 1992, a DEA audit of a Houston area pharmacy, and a
subsequent review of prescription records, revealed that in 1991 and
early 1992, the Respondent routinely prescribed combinations of Tylenol
with codeine, Valium, and Phenergan with codeine, to numerous
individuals when he knew or should have known that the combination of
these drugs was highly abused on the streets.
(2) On March 24, April 7, and April 21, 1992, the Respondent
prescribed 24 Tylenol No. 4 and 18 Valium 10 mg. to an undercover
officer for no legitimate medical reason.
(3) Following the execution of a Federal search warrant at the
Respondent's office of July 7, 1992, the Respondent voluntarily
surrendered his DEA Certificate of Registration, AS0873198, as well as
his State of Texas Controlled Substances Registration Certificate.
However, on February 1, 1993, his Texas Controlled Substances
Registration Certificate was reinstated.
On March 31, 1994, the Respondent, through counsel, filed a timely
request for a hearing, and following prehearing procedures, a hearing
was held in Houston, Texas, on November 9, 1994, before Administrative
Law Judge Mary Ellen Bittner. 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 March 2, 1995, Judge Bittner issued
her Opinion and Recommended Ruling, recommending that the Respondent's
application be denied. Neither party filed exceptions to her decision,
and on April 5, 1995, Judge Bittner transmitted the record of these
proceedings to the Deputy Administrator.
The Deputy Administrator has considered the record in its entirety,
and pursuant to 21 CFR 1316.67, hereby issues his final order based
upon findings of fact and conclusions of law as hereinafter set forth.
The Deputy Administrator adopts, in full, the Opinion and Recommended
Ruling, Findings of Fact, Conclusions of Law and Decision of the
Administrative Law Judge, 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 of law.
The Deputy Administrator finds that on January 19, 1993, the
Respondent Prepared an Application for Registration under the
Controlled Substances Act of 1970 as a practitioner for handling
controlled substances in Schedules II through V. The Respondent has
practiced medicine in Houston, Texas, since 1951. At the hearing before
Judge Bittner, the Respondent testified that he maintained a solo
practice in internal medicine consisting mostly of poor patients, some
of whom were covered by Medicare or Medicaid. The Respondent further
stated that his wife had died in 1987, and that he resided with his
son, who suffered from panic disorder and was unable to leave home.
[[Page 64450]]
He testified that he was the sole provider for his son.
At the hearing, a DEA Diversion Investigator testified that during
an audit of a Houston Pharmacy on January 27, 1992, he discovered that
several individuals had received prescriptions from the Respondent for
a combination of Tylenol No. 4 or Phenergan with codeine, and Valium or
Xanax. The Investigator testified that the prescriptions were unusual
because of the combination of substances prescribed, and because many
of the prescriptions were written to different patients claiming the
same address. Further, the Respondent had issued these prescriptions to
individuals who were also receiving prescriptions for controlled
substances from other physicians. Tylenol No. 4 with codeine, Phenergan
with codeine, Valium, and Xanax are all controlled substances. The
investigator also stated that the combination of controlled substances
prescribed by the Respondent were popular with crack cocaine users, who
take these drugs to ease the ``high'' induced by cocaine.
In February 1992, the Investigator performed surveys of
prescriptions issued by the Respondent from March 1991 through April
1992, at seven Houston-area pharmacies, finding that the Respondent
wrote seventy-nine prescriptions for a total of 3,851 dosage units of
controlled substances. As a result of this information, the
Investigator implemented an undercover investigation of the Respondent
with the assistance of a Detective from the Harris County, Texas,
Sheriff's Department. On all of the detective's undercover visits to
the Respondent's office, the Detective wore a transmitter, and
transcripts of his conversations with the Respondent were in evidence.
At the hearing, the Detective testified that on March 24, 1992, he
went to the Respondent's office, he did not complain of any medical
ailments, but that he did tell the Respondent that he wanted Tylenol
No. 4 because ``I just kinda chill out, I feel good, it makes me feel
real good.'' The Respondent took the Detective's blood pressure and
conducted a very brief examination. After providing the Detective with
a warning about the use of the controlled substances he had requested,
the Respondent gave the Detective a prescription for 24 Tylenol No. 4,
18 Valium 10 mg., and Procardia, a non-controlled substance, for high
blood pressure. The Respondent prescribed the Tylenol No. 4 for ``lower
back pain,'' although the Detective did not complain of this condition.
On April 7, 1992, the Detective again visited the Respondent, who
took his blood pressure, but did not examine him. The Respondent again
admonished the Detective about the addictive potential of Valium and
Tylenol No. 4, but then issued prescriptions for 18 Valium 10 mg., 24
Tylenol No. 4, and for a non-controlled substance. Also, on April 21,
1992, the Detective visited the Respondent, who again admonished him
regarding the use of Tylenol No. 4, asked him if he needed Valium, and
prescribed 18 Valium 10 mg., 24 Tylenol No. 4, and a non-controlled
substance. The Detective testified that the Respondent did not examine
him beyond taking his blood pressure, and when asked, the Detective had
told him that he did not have back pain.
On July 7, 1992, the Investigator executed a search warrant and a
grand jury subpoena, seizing various records from the Respondent's
office, to include the patient chart for the Detective as well as other
patients' charts. The Investigator informed the Respondent of the
reason for the execution of both the subpoena and the search warrant,
and following these discussions, the Respondent voluntarily surrendered
his DEA Certificate of Registration, as well as his Texas State
controlled substances registration.
At the hearing before Judge Bittner, Dr. Joseph Coppola, an
associate professor of emergency medicine and internal medicine at the
University of Texas Medical School, testified that on July 22, 1992, he
had reviewed several of the Respondent's records, including the
Detective's treatment record. Dr. Coppola then testified about his
findings as to individual patient's records, concluding that in six
instances the Respondent had prescribed controlled substances in
``inappropriate and [in some instances] dangerous'' combinations, and
that the Respondent's charts contained incomplete histories and lacked
physical examination notations adequate to justify the prescriptions
issued to the patients. Dr. Coppola stated that in some charts the
patient would make multiple visits, complain of the same symptoms each
visit, and yet the Respondent would prescribe controlled substances
without conducting tests or using other diagnostic techniques to
determine the cause of the patient's continuing condition. Dr. Coppola
testified that in some instances the patients' conditions did not
justify the controlled substances prescribed over the extended period
of time reflected in the patients' records. He observed that in many of
the cases he had reviewed, the controlled substances prescribed by the
Respondent were not appropriate, ``[b]ecause of their propensity toward
habituation, addiction, withdrawal syndromes, harm to the patient,
inability to perform normal, everyday functions to include driving an
automobile * * * certainly this combination of medications in a person
is detrimental and harmful on a long-term basis.'' Dr. Coppola stated
that in several instances the patients' records indicated that the
patients were exhibiting drug-seeking behavior.
Dr. Coppola, after reviewing the chart entries for the Detective,
testified that if he had had a patient who acted in the manner of the
Detective, ``[i]n a dignified, professional way, I would throw him out
of my office * * * because he is drug-seeking.'' Further, he testified
that Tylenol No. 4 and Valium were not substances prescribed to treat
high blood pressure, and that the transcripts of the Detective's
subsequent visits reinforced his opinion that the Detective was
engaging in drug-seeking behavior. Dr. Coppola also testified that the
Respondent's prescribing of controlled substances in the combinations
prescribed to the Detective, a non-addicted person, could result in
symptoms ranging from extreme somnolence, motor inability, respiratory
arrest, to even death. Finally, Dr. Coppola concluded that the
Respondent did not prescribe controlled substances in the usual course
of professional practice, nor for a legitimate medical purpose.
The Respondent testified that he prescribed tranquilizers as
stress-reducers for hypertensive patients, and that even if he had
known the Detective was a law enforcement officer he would have
prescribed Valium and Tylenol, because the Respondent ``found he was a
sick man.'' The Respondent also stated that Dr. Coppola was ``right to
a degree'' with respect to the Respondent's treatment of the other
patients, because the controlled substances he prescribed were
addictive, but he ``really didn't know that these were street
substances.'' He testified that he had not knowingly treated anyone who
used crack concaine, and he averred that he did not use very good
judgment: ``I was too trusting. I was taken advantage of.'' Further,
the Respondent conceded that he kept poor records, and that he would
not repeat his misconduct.
However, he also testified that he ``really didn't agree'' with the
Texas State Board of Medical Examiners' finding that he had prescribed
controlled substances to the Detective for a nontherapeutic purpose or
in a nontherapeutic manner. Further, he
[[Page 64451]]
stated that he had surrendered his controlled substances registrations
because the Investigator had advised him that he could probably avoid
action by a grand jury if he so acted, but that by signing the
surrenders, he had not intended to admit to any wrongdoing. Finally,
the Respondent testified about his need for his DEA Certificate of
Registration in order to continue effectively his medical practice.
The record also demonstrates that on December 15, 1992, the grand
jury had advised the Texas court that it had failed to find a bill of
indictment against the Respondent, and on February 1, 1993, the
Respondent's state privileges to handle controlled substances were
restored. Further, on March 18, 1994, the Respondent appeared before
the Medical Board, and on April 14, 1994, the Respondent and the
Medical Board entered into an Agreed Order. The Agreed Order reflected
that the Respondent had practiced medicine in Texas for forty-nine
years with no documented problems or disciplinary actions. However, the
Medical Board found that the Respondent had prescribed or administered
a drug or treatment ``that was nontherapeutic in nature or in the
manner in which [it] was administered or prescribed,'' and that he had,
thereby, violated the Medical Practice Act of Texas. The Medical Board
then ordered that the Respondent's medical license be restricted for
three years, and that various conditions be imposed upon his practice,
including that he attend at least fifty hours per year of continuing
medical education, to include at least six hours pertaining to
recordkeeping or risk management. Further, another physician was to
monitor or supervise his medical practice.
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny a
pending application for a DEA Certificate of Registration if he
determines that granting the registration would be inconsistent with
the public interest. Section 823(f) requires that the following factors
be considered:
(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., 54 FR 16422 (1989). In this
case, the Deputy Administrator agrees with Judge Bittner that factors
one, two, and four are relevant in determining whether granting the
Respondent's pending application would be inconsistent with the public
interest.
As to factor one, ``recommendation of the appropriate state
licensing board,'' relevant evidence includes the agreement signed by
the Respondent and the Medical Board, wherein the Medical Board found
that the Respondent's conduct in prescribing controlled substances to
the Detective violated the Medical Practice Act of Texas. In response,
in April 1994, the Medical Board placed restrictions upon the
Respondent's license to practice medicine, to include requiring the
acquisition of continued medical education. The restrictions are in
effect for three years. Further, the record demonstrates that the Texas
Department of Public Safety has reissued the Respondent's controlled
substances registration, but evidence detailing the circumstances
surrounding the reinstatement are not in the record.
As to factor two, ``the applicant's experience in dispensing * * *
controlled substances,'' the preponderance of the evidence demonstrates
that the Respondent dispensed controlled substances to a Detective
without a legitimate medical purpose and outside the usual course of
professional practice. Specifically, Dr. Coppola provided that
conclusion after reviewing the Detective's medical chart and the
transcript of the conversations between the Detective and the
Respondent preceding the Respondent's issuing prescriptions to the
Detective. Further, after reviewing medical charts and prescription
patterns in five other cases, Dr. Coppola also concluded that the
Respondent prescribed controlled substances to these patients in
``inappropriate and [in some instances] dangerous'' combinations,
despite the fact that these patients were exhibiting drug-seeking
behavior.
As to factor four, ``[c]ompliance with applicable State, Federal,
or local laws relating to controlled substances,'' the record reflects
that the Grand Jury declined to issue an indictment seeking criminal
prosecution against the Respondent after reviewing evidence of his
behavior during the same period as reviewed in this proceeding.
However, the Medical Board found that the Respondent's conduct did, in
fact, violate the Medical Practice Act of Texas, and it levied
discipline under that statute in response to its finding.
The Deputy Administrator has previously found that under Federal
law, for a controlled substance prescription to be valid, ``it must be
written by an authorized individual acting within the scope of normal
professional practice for a legitimate medical purpose.'' Harlan J.
Borcherding, D.O., 60 FR 28796, 28798 (1995). Although the Respondent
was authorized to prescribe controlled substances at the time he issued
prescriptions to the Detective, the preponderance of the evidence
demonstrates that the prescriptions of Valium and Tylenol No. 4 were
issued without a legitimate medical purpose and outside the scope of
normal professional practice. Specifically, the Detective dictated
which controlled substances he wanted and ultimately received, rather
than the Respondent, as the practitioner, determining the medication
appropriate for the clinical condition presented by the Detective. As
Dr. Coppola testified, such prescribing lacked a legitimate medical
purpose and was not in the usual course of professional medical
practice. See Borcherding, supra. Therefore, the Deputy Administrator
finds, in light of the foregoing, that the Government has met its
burden of proof as to factors one, two, and four.
However, the Respondent provided evidence of rehabilitation,
including the Texas Department of Public Safety's reinstatement of his
controlled substances registration in February 1993, and the agreement
with the Medical Board. Further, he acknowledged his recordkeeping
failings, and he requested consideration be given to his full
cooperation with the investigation. The Respondent also requested the
Deputy Administrator consider his lengthy medical career free of prior
disciplinary action, and his need for his DEA Certificate of
Registration.
However, even acknowledging the Respondent's rehabilitative
efforts, the Deputy Administrator agrees with Judge Bittner's
conclusions: ``With respect to the likelihood of a recurrence of
misconduct, I realize that Respondent asserted that he would be more
careful in the future. However, in light of both the extent of his
misconduct and his attempts to rationalize his behavior, I am not
persuaded that such conduct will not recur.'' The Respondent's
[[Page 64452]]
testimony disagreeing with the Medical Board's findings concerning his
past conduct, makes questionable his committment to change in his
future medical practices to include his prescribing of controlled
substances. Therefore, the Deputy Administrator finds that the public
interest is best served by denying the Respondent's application at the
present time. See, e.g., Sokoloff v. Saxbe, 501 F.2d 571, 576 (2nd Cir.
1974) (stating that ``permanent revocation'' of a DEA Certificate of
Registration may be ``unduly harsh'').
Accordingly, the Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in him by 21 U.S.C.
823, and 28 CFR 0.100(b) and 0.104, hereby orders that the pending
application of Harold R. Schwartz, M.D., be, and it hereby is, denied.
This order is effective January 16, 1996.
Dated: December 11, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-30578 Filed 12-14-95; 8:45 am]
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