[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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