[Federal Register Volume 62, Number 26 (Friday, February 7, 1997)]
[Notices]
[Pages 5842-5845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3082]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
[Docket No. 95-16]
Mark J. Berger, D.P.M.; Continuation of Registration With
Restrictions
On December 23, 1994, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Mark J. Berger, D.P.M. (Respondent) of
Riverwoods, Illinois, notifying him of an opportunity to show cause as
to why DEA should not revoke his DEA Certificate of Registration,
BB2461604, and deny any pending applications for renewal of such
registration as a practitioner under 21 U.S.C. 823(f), for reason that
his continued registration would be inconsistent with the public
interest pursuant to 21 U.S.C. 824(a)(4).
By letter dated January 17, 1995, the Respondent, acting pro se,
filed a timely request for a hearing, and following prehearing
procedures, a hearing was held in Chicago, Illinois on April 12, 1995,
before Administrative Law Judge Mary Ellen Bittner. At the hearing, the
Government called witnesses and introduced documentary evidence and
Respondent testified in his own behalf. After the hearing, the
Government submitted proposed findings of fact, conclusions of law and
argument, and Respondent submitted a post hearing brief. On April 11,
1996, Judge Bittner issued her Opinion and Recommended Ruling, Findings
of Fact, Conclusions of Law and Decision, recommending that
Respondent's DEA registration not be revoked, but be restricted in that
Respondent shall not prescribe, administer or otherwise dispense any
controlled substances for any member of his family or himself, and
shall handle controlled substances only in treating podiatric patients
and not for any purpose outside the usual practice of podiatry. Neither
party filed exceptions to Judge Bittner's Opinion and Recommended
Ruling, and on May 14, 1996, the record of these proceedings was
transmitted to the Deputy Administrator.
The Acting Deputy Administrator has considered 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 Acting Deputy Administrator adopts, in its entirety, the
Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law
and Decision of the Administrative Law Judge. 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 Acting Deputy Administrator finds that Respondent is a
podiatrist initially licensed to practice in the State of Illinois in
the early 1980's. However, as of at least March 1984, Respondent had
never been licensed to handle controlled substances in the State of
Illinois.
In March 1984, the Illinois Department of Registration and
Education (now known as the Department of Professional Regulation and
hereinafter referred to as DPR) received information from DEA that
Respondent had recently ordered 500 Quaalude tablets (the brand name
for methaqualone) after methaqualone had been rescheduled in Illinois
from Schedule II to Schedule I. As a result of this information, a DPR
investigator and a local police officer went to Respondent's office on
March 8, 1984, intending to conduct an administrative search and take
possession of the Quaalude tablets. Respondent acknowledged ordering
the Quaalude, but stated that he kept the tablets at his home due to
recent break-ins or attempted break-ins. Respondent was told that his
possession of Quaalude was illegal and he agreed to relinquish the
drugs after seeing his last patient of the day. Subsequently,
Respondent admitted that he had self-administered 1,000 to 1,500
Quaalude tablets over a period of approximately a year and a half to
relieve pain caused by an injury.
Respondent then consented to a search of his office, which revealed
an empty bottle labeled 100 Quaalude, an open bottle of Empirin with
codeine (a Schedule III controlled substance) with 79 tablets missing,
and an open bottle of diazepam (a Schedule IV controlled substance)
with 22 tablets missing. Respondent advised the officers that he had no
records for the dispensation of these controlled substance.
After being taken into investigative custody, Respondent consented
to the search of his home. This search revealed two empty 100-tablet
bottles and one empty 500-tablet bottle of Quaalude, two full 100-
tablet bottles of Quaalude, seven Empirin with codeine tablets, plant
material suspected to be cannabis, and drug paraphernalia.
A review of DEA order forms revealed that during the period
November 11, 1982 through January 23, 1984, Respondent ordered the
following controlled substances: 2,500 dosage
[[Page 5843]]
units of Quaalude, 100 dosage units of Empirin with codeine #3, 100
dosage units of Valium 5 mg., 100 dosage units of Valium 10 mg., 500
Dexedrine 5 mg., and 100 dosage units of Tenuate Dospan 75 mg.
Respondent did not maintain any records regarding these drugs in
violation of both state and Federal laws.
Respondent was subsequently charged in the Circuit Court of Cook
County, Illinois with one count of possession of cannabis with intent
to deliver, one count of possession of methaqualone with intent to
deliver, and one count of unlawful dispensing of methaqualone.
Following a bench trial, Respondent was convicted on June 18, 1984, of
possession of a controlled substance and sentenced to three years'
probation.
Respondent testified during the hearing before Judge Bittner that
in 1981 he had ruptured and then re-ruptured his Achilles tendon, and
that he took methaqualone to enable him to sleep. He further testified
that he never sold methaqualone or prescribed, administered or
dispensed it to anyone else and that he realizes in retrospect that he
should not have taken it.
On March 23, 1984, DPR filed a complaint against Respondent
alleging that Respondent obtained and self-administered controlled
substances when not properly registered to handle controlled substances
in the State of Illinois. On May 11, 1984, Respondent and DPR entered
into a Stipulation and Recommendation for Settlement pursuant to which
Respondent agreed that his license to practice podiatry would be
indefinitely suspended; he would not petition for restoration of his
license for at least nine months from the effective date of the
Podiatry Examining Committee's (Committee) order approving the
settlement; he would obtain counseling and rehabilitation; and he would
not apply for an Illinois controlled substance license for at least two
years after the effective date of the order. On June 20, 1984, the
Committee approved the Stipulation and Recommendation for Settlement,
and on July 11, 1984, the Director of DPR issued an order adopting the
terms of the settlement. Subsequently, on September 19, 1984,
Respondent surrendered his previous DEA Certificate of Registration.
Following the reinstatement of his state podiatry license and the
issuance of his license to handle controlled substances in the State of
Illinois, Respondent executed a new application dated February 27,
1990, for DEA registration as a practitioner in Schedules II through V.
On that application, Respondent answered ``yes'' to the question which
asked:
Have you ever been convicted of a crime in connection with
controlled substances under State or Federal law, or ever
surrendered or had a DEA registration revoked, suspended or denied,
or ever had a State professional license or controlled substance
registration revoked, suspended, denied, restricted or placed on
probation?
Applicants who respond affirmatively to this question are required
to explain their answers on the back of the application form.
Respondent's explanation referred to his lack of a separate state
license to handle controlled substance, and his arrest for ordering
controlled substances without the proper licensure. Respondent claimed
in his explanation that he ``did not knowingly violate the state
licensing requirement, since I did not know about it.'' Respondent's
explanation however, did not mention his conviction for possession of
methaqualone, the state's suspension of his license to practice
podiatry, or the surrender of his previous DEA Certificate of
Registration.
Following receipt of Respondent's application, the DEA Chicago
office issued a Notice of Hearing advising Respondent that there would
be an informal hearing regarding his application. This informal hearing
resulted in a memorandum of understanding being executed on August 30,
1990, by Respondent and representatives of the United States Attorney's
Office and DEA. The memorandum of understanding stated that the Notice
of Hearing had alleged that (1) Respondent had been the defendant in an
information charging him with three felony violations of the Illinois
Controlled Substances Act: possession of more than 30 grams of
methaqualone with intent to deliver, possession of cannabis with intent
to deliver, and unlawful dispensing of methaqualone; and (2) Respondent
had been found guilty of possession of a controlled substance and
sentenced to three years' probation. The memorandum of understanding
further stated that Respondent had been ``fully advised of the
prohibited acts which have occurred'' and had agreed to comply with the
provisions of the Controlled Substances Act (CSA) and its implementing
regulations and, more specifically, that he agreed that (1) he would
``prescribe and dispense controlled substances in strict accordance
with the [CSA] and the regulations issued thereunder''; (2) ``any
prescriptions written for controlled substances by the Respondent will
be for medical purposes and will be issued within the usual course of
professional practice for which the Respondent is registered with the
[DEA] and professionally licensed by the State''; (3) ``Respondent's
handling of controlled substances * * * shall be limited to controlled
drugs in Schedules III through V and that the Respondent not be allowed
to handle any controlled substance found in Schedule II for a period of
not less than one (1) year * * *''; and (4) when renewing his DEA
registration Respondent would ``answer fully and truthfully any
question regarding if the Respondent has ever been convicted of a crime
in connection with controlled substances under State or Federal law, or
ever surrendered or had a DEA registration revoked, suspended or
denied, or ever had a State professional license or controlled
substance registration revoke[d], denied, restricted or placed on
probation.''
Other than the memorandum of understanding, there is no other
evidence in the record as to what was discussed during the course of
the informal hearing. Shortly after execution of the memorandum of
understanding, Respondent was issued DEA Certificate of Registration
BB2461604, however there is nothing in the record to indicate what
schedules of controlled substances were listed on the Certificate of
Registration.
On June 28, 1993, Respondent executed a renewal application for DEA
registration BB2461604 in Schedules II through V. On this application,
Respondent had answered ``yes'' to the same question that he had
answered affirmatively on his 1990 application for registration.
Respondent testified that he had photocopied his 1990 explanation and
pasted it onto the back of the 1993 application, stating,
I was giving what I thought was more new information and I
wasn't omitting anything purposely. I thought conviction, surrender
of license, etc., was known to the DEA and there was no reason to
give a long, detailed explanation of that. I believe this was common
knowledge.
Certainly, I didn't falsify anything. I did omit things, but not
in a purposeful way. I would've gladly listed the things that I
thought the DEA would've wanted me [sic] on the application, had I
known that this is what they wanted. I didn't know that.
Respondent also testified that ``[t]he things that have happened,
11 years ago, I can't change that. And I'm not trying to exonerate my
involvement in that.'' However, Respondent further testified that,
``[f]or the past 11 years, I've been totally in accordance with the
law. And for the past five years, since receiving my DEA license, I've
been totally in accordance with the law.''
During the course of his testimony, Respondent stated that he had
never falsified any state application. On cross-
[[Page 5844]]
examination, Respondent conceded that he had been convicted of
attempted petty theft, a misdemeanor, 1970, yet he answered ``no'' on a
1982 DPR application to the question, ``Have you ever been convicted of
a criminal offense in Illinois or in another state or in federal court,
other than a minor traffic violation?'' Respondent explained that he
answered in the negative because he thought the question referred to
felony convictions only. As to the conviction, Respondent testified
that he was 18 years old, and that ``I shouldn't have been [convicted],
it wasn't even me,'' but upon his attorney's advice, he pled to a
misdemeanor.
Respondent contends in his brief that he was prejudiced because the
Government failed to provide him notice in advance of the hearing that
the 1982 DPR application would be at issue in these proceedings. At the
hearing, the Government offered into evidence the 1982 application and
a police report of the incident that led to his 1970 conviction. Judge
Bittner properly rejected the admission of these documents into
evidence since they were not supplied to Respondent in advance of the
hearing as required by the Administrative Law Judge's prehearing ruling
on March 29, 1995, and therefore did not consider the application as
affirmative evidence against Respondent. Judge Bittner did however,
allow Respondent to be cross-examined about the contents of the
documents. The Acting Deputy Administrator concurs with Judge Bittner's
conclusion that, ``a major issue in this proceeding was Respondent's
alleged misstatements on his application for DEA registration, and in
these circumstances * * * examination as to his truthfulness in other
applications was a proper subject of cross-examination, and that the
Government was entitled to use the prior application and police report
for impeachment purposes.''
The Government in its posthearing filing argues that Respondent
materially falsified two applications for registration and that such
falsification provides an independent statutory basis for revocation of
Respondent's DEA Certificate of Registration pursuant to 21 U.S.C.
824(a)(1). However, the Government did not assert that 21 U.S.C.
824(a)(1) was a basis for the proposed revocation in either the Order
to Show Cause or in any of its prehearing filings, and the issue in
this proceeding, agreed upon by the parties, makes no reference to
824(a)(1) as a basis for revocation. Therefore, the Acting Deputy
Administrator does not consider whether Respondent's registration
should be revoked pursuant to 21 U.S.C. 824(a)(1).
Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy
Administrator may revoke a DEA Certificate of Registration and deny any
pending applications, if he determines that he continued reigstration
would be inconsistent with the public interest. Section 823(f) requires
that he 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 and
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 be
denied. See Henry J. Schwartz, Jr., M.D., Docket No. 88-42, 54 FR
16,422 (1989).
Regarding factor one, it is undisputed that Respondent's license to
practice podiatry was suspended in 1984. However, it is also undisputed
that such license was restored sometime prior to his 1990 application
for DEA registration and that he was issued a state controlled
substance registration. From the evidence in the record, it appears
that Respondent has practiced without incident since being issued his
state licenses. Therefore, the Acting Deputy Administrator concurs with
Judge Bittner's conclusion that this factor weighs in favor of
Respondent's continued registration.
As to factor two, Respondent's experience in dispensing controlled
substances, it is uncontested that sometime in 1982 until his arrest in
March 1984, Respondent ordered and self-administered controlled
substances while not properly registered to handle controlled
substances in the State of Illinois. The Acting Deputy Administrator
concludes that the fact that Respondent dispensed controlled substances
without proper state licensure is properly considered under factor four
regarding Respondent's compliance with applicable state law. The Acting
Deputy Administrator concurs with Judge Bittner's conclusion that under
this factor, the question is whether Respondent's actions would have
been medically appropriate had he been properly registered with the
State.
Respondent claims that he had a legitimate medical reason for using
the drugs he ordered. The Acting Deputy Administrator concludes that
Respondent's use of methaqualone after January 1, 1984, when it was
rescheduled into Schedule I in the State of Illinois, was clearly
improper. However, the Acting Deputy Administrator agrees with Judge
Bittner that the record is insufficient to warrant a finding that
Respondent's self-administration of controlled substances prior to
January 1, 1984 was for no legitimate medical purpose. There is nothing
in the record concerning whether the substances are not appropriate to
treat the conditions for which Respondent used them, whether
Respondent's treatment of such conditions was outside the scope of his
practice of podiatry, or whether the self-administration of controlled
substances was impermissible in the State of Illinois.
Also relevant to this factor is the Respondent's uncontroverted
testimony that he never prescribed, administered, or otherwise
dispensed controlled substances to anyone else, and that he has
properly handled controlled substances since his DEA registration was
restored in 1990.
The Acting Deputy Administrator concurs with Judge Bittner's
conclusion regarding factor three. While Respondent was charged with
possession of controlled substances with intent to deliver and with
unlawful distribution of a controlled substance, he was ultimately
convicted of possession of methaqualone. Thus, Respondent has no
conviction record relating to the manufacture, distribution or
dispensing of controlled substances.
Regarding factor four, it is undisputed that during the events in
question in the early 1980's, Respondent failed to maintain records
regarding his handling of controlled substances in violation of both
Federal and state law. See 21 U.S.C. Secs. 827 and 842(a)(5) and I.R.S.
Chap. 56\1/2\ Sec. 1306. In addition, Respondent violated state law
from 1982 to March 1984, by handling controlled substances when not
properly registered by the State of Illinois and by possessing
methaqualone after January 1, 1984, when it was placed into Schedule I
in Illinois.
As to factor five, on his 1990 application for registration,
Respondent did not give a complete explanation for his affirmative
response to the questions about whether he had ever been
[[Page 5845]]
convicted of a controlled substance related crime, had ever surrendered
a DEA registration or had one revoked, suspended, denied, or had a
state professional license or controlled substance registration
revoked, suspended, denied, restricted or placed on probation.
Thereafter, Respondent was issued a Notice of Hearing which alleged
that Respondent had been charged with three felony violations of state
law and that he had been found guilty of one count of possession of a
controlled substance. As Judge Bittner correctly notes, ``[a]s far as
this record shows, the Notice of Hearing did not make any reference to
Respondent's explanation on his application of his answer to the
liability question.''
Respondent then participated in an informal hearing with DEA
personnel and a representative from the United States Attorney's
Office. Again as Judge Bittner correctly notes, ``there is no evidence
about the discussion at that meeting and, more specifically, about
whether any of the government personnel advised Respondent that his
statements on his [1990] application for DEA registration were
inadequate.''
Respondent ultimately entered into a memorandum of understanding in
August 1990 wherein he agreed to ``answer fully and truthfully'' the
questions on renewal applications. However, there is nothing in the
memorandum of understanding that documents that Respondent was told
that his previous explanation on the 1990 application was inadequate,
nor was there any testimony at the hearing as to whether the parties
discussed the meaning of this provision of the memorandum of
understanding.
Respondent was then issued a DEA registration. Given the lack of
evidence in the record that Respondent was advised that his answer in
1990 was inadequate, it is reasonable to accept Respondent's
explanation for giving the same answer on his 1993 renewal application.
Respondent testified, ``I figured if this was good enough the first
time, it's good enough the second time.'' Therefore, the Acting Deputy
Administrator concludes that while Respondent may have technically
violated the memorandum of understanding by failing to provide full and
truthful answers on future applications, such a violation is
understandable given that he was apparently not told his earlier
explanation was inadequate.
The Acting Deputy Administrator concurs with Judge Bittner's
conclusion that the Government has not established by a preponderance
of the credible evidence that Respondent's continued registration would
be inconsistent with the public interest. While Respondent handled
controlled substances from 1982 to March 1984 without proper state
authorization and failed to maintain the required records, these events
occurred over 12 years ago, and there is no evidence in the record that
Respondent has improperly handled controlled substances since being
issued a DEA registration in 1990. In addition, there is no evidence in
the record that Respondent was ever advised that the explanation on his
1990 application was not sufficient, and therefore his use of the same
explanation on his 1993 application is understandable.
Judge Bittner recommended that Respondent's registration not be
revoked, but that it be subject to the following restrictions:
(1) Respondent shall not prescribe, administer or otherwise
dispense any controlled substances for any member of his family or
himself.
(2) Respondent shall handle controlled substances only in treating
podiatric patients, and not for any purpose outside the usual practice
of podiatry.
Under the circumstances of this case, the Acting Deputy
Administrator finds Judge Bittner's recommended restrictions to be
reasonable. Therefore, the Acting Deputy Administrator concludes that
Respondent's DEA registration should be continued in Schedules II
through V subject to Judge Bittner's recommended restrictions. It
should be noted that it is unclear from the record, which schedules
Respondent is currently registered to handle. He applied for Schedule
II through V in 1990, however, the memorandum of understanding executed
in August 1990 states, ``[t]hat Respondent's handling of controlled
substances pursuant to his Federal controlled substances registration
upon issuance of such registration by the DEA, shall be limited to
controlled drugs in Schedules III through V and that Respondent not be
allowed to handle any controlled substance found in Schedule II for a
period of not less than one (1) year from the date of the execution of
the agreement.'' His 1993 renewal application, which is the subject of
this proceeding, indicates that Respondent wishes his registration to
be renewed in Schedules II through V. Regardless of Respondent's
current authorization, the Acting Deputy Administrator concludes that
in light of all of the evidence, Respondent should be registered in
Schedules II through V subject to the above-referenced restrictions.
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in him by
21 U.S.C. 823 and 824, and 28 C.F.R. 0.100(b) and 0.104, hereby orders
that DEA Certificate of Registration BB2461604, issued to Mark J.
Beger, D.P.M., be continued, and any pending applications be granted in
Schedules II through V, subject to the above restrictions. This order
is effective March 10, 1997.
Dated: January 30, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-3082 Filed 2-6-97; 8:45 am]
BILLING CODE 4410-09-M