[Federal Register Volume 64, Number 199 (Friday, October 15, 1999)]
[Notices]
[Pages 55962-55965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27004]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 97-22]
James C. LaJevic, D.M.D.; Revocation of Registration
On June 5, 1997, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to James C. LaJevic, D.M.D. (Respondent) of
Pittsburgh, Pennsylvania, notifying him of an opportunity to show cause
as to why DEA should not revoke his DEA Certificate of Registration,
BL4788064, pursuant to 21 U.S.C. 824(a)(1), and deny any pending
applications for renewal of such registration pursuant to 21 U.S.C.
823(f). The Order to Show Cause alleged that Respondent materially
falsified two applications for registration with DEA.
Respondent requested a hearing on the issues raised by the Order to
Show Cause, and the matter was docketed before Administrative Law Judge
Mary Ellen Bittner. During prehearing procedures, the issue was framed
to include not only the material falsification of applications as a
basis for the revocation of Respondent's DEA registration, but also
whether Respondent's continued registration would be inconsistent with
the public interest pursuant to 21 U.S.C. 823(f) and 824(a)(4).
Following prehearing procedures, a hearing was held in Pittsburgh,
Pennsylvania on March 10, 1998, and in Arlington, Virginia on August
18, 1998. At the hearing, both parties called witnesses to testify and
the Government introduced documentary evidence. After the hearing, both
parties submitted proposed findings of fact, conclusions of law and
argument.
On May 6, 1999, Judge Bittner issued her Opinion and Recommended
Ruling, Findings of Fact, Conclusions of Law and Decision, recommending
that Respondent's DEA Certificate of Registration be revoked, and any
pending applications be denied. On June 18, 1999, Respondent filed
exceptions to Judge Bittner's opinion and recommended decision, and on
July 9, 1999, the Government filed its response to Respondent's
exceptions. Thereafter, on July 15, 1999, 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. 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 Respondent has practiced
dentistry in Pittsburgh, Pennsylvania since 1976. While Respondent now
lives in Boulder City, Nevada, he still practices dentistry in
Pittsburgh approximately seven to ten days per month.
On September 10, 1990, the Commonwealth of Pennsylvania, Department
of State, Bureau of Professional and Occupational Affairs, State Board
of Dentistry (Dental Board) issued an Order suspending Respondent's
state dental license for a period of three months commencing on October
12, 1990. The Dental Board's action was based on Respondent's 1988
conviction in the United States District
[[Page 55963]]
Court for the Western District of Pennsylvania for income tax evasion.
On April 1, 1991, Respondent submitted an application for the
renewal of DEA Certificate of Registration AL6222296, which was
initially issued to Respondent in November 1974. Respondent answered
``No'' to the question on the application, hereinafter referred to as
the liability question, which asked, ``Has the applicant ever been
convicted of a crime in connection with controlled substances under
State or Federal law, or ever surrendered or had a Federal controlled
substance registration revoked, suspended, restricted or denied, or
ever had a State professional license or controlled substance
registration revoked, suspended, denied, restricted or placed on
probation?'' Respondent's registration was renewed.
Effective March 9, 1994, following a formal hearing, the Dental
Board issued an Adjudication and Order finding, among other things,
that Respondent (1) failed on two occasions to responsibly administer
the controlled substance Halcion, (2) failed to keep thorough and
adequate records of the administration of controlled substances in his
office, (3) failed to take into account the medical condition of his
patients when performing dental procedures, (4) failed to provide
patients with adequate information regarding treatment and controlled
substances, and (5) violated the standards of professional conduct by
self-prescribing Hydrodiuril, a hypertensive drug, for twelve years.
The Dental Board suspended Respondent's dental license for two years
beginning on April 8, 1994, but provided that one year of the
suspension was to be active and the remaining year of the suspension
was stayed and Respondent was paced on probation. In addition,
Respondent was fined $1,000.00.
Upon learning of Respondent's suspension, a DEA investigator sent
Respondent a letter dated May 13, 1994, providing Respondent with the
opportunity to voluntarily surrender his DEA Certificate of
Registration since he was not currently authorized to handle controlled
substances in Pennsylvania. DEA did not receive a response to this
letter, but the investigator did not pursue further administrative
action against Respondent's registration, since the registration
expired on March 31, 1994, with no renewal application being submitted.
In February 1996, an agent with the Pennsylvania Office of the
Attorney General, Bureau of Narcotics Investigation (BNI), interviewed
several local pharmacists to determine whether Respondent was issuing
controlled substance prescriptions using his expired DEA registration.
One pharmacist told the BNI agent that Respondent frequented his
pharmacy and had telephoned prescriptions for his personal use for
Valium, and for a cough syrup containing Hycodan, both controlled
substances. The pharmacist indicated that when he questioned Respondent
about the Valium prescription, Respondent indicated that it was for
office use only, and the pharmacist noted ``office'' on the
prescription. Respondent testified at the hearing that he never told
anyone that any presciption was for ``office use,'' and the Hycodan
cough syrup was something that he personally used for a cough.
On March 14, 1996, a search warrant was executed at Respondent's
office by state agents. During execution of the warrant, Respondent's
DEA Certificate of Registration AL6222296 which expired on March 31,
1994, was found in Respondent's desk drawer. Respondent told the BNI
agent that he knew that his previous DEA registration had expired since
several pharmacists had informed him of this in February 1996, and that
he had recently reapplied for a new Certificate of Registration.
Respondent offered no explanation as to why he had failed to renew his
previous registration, but he indicated that he continued writing
controlled substance prescriptions because his patients needed the
medication for pain. Respondent also told the BNI agent that he had
assumed that his DEA registration was automatically suspended when his
state dental license was suspended and believed that when his state
dental license was reinstated, so was his DEA registration. When asked
about the prescription for personal and office use, Respondent said
that he was not familiar with that pharmacy and never wrote
prescriptions for personal use.
During the course of the state investigation, the BNI agent found
60 controlled substance prescriptions issued or authorized by
Respondent using his expired DEA registration AL6222296.
After learning from several pharmacists that his previous DEA
registration had expired, Respondent submitted an application for a new
Certificate of Registration. In early March 1996, the Registration Unit
at DEA Headquarters received an application for registration from
Respondent that was signed but undated. Again Respondent indicated that
he had never had his State professional license or controlled
substances registration revoked, suspended, denied, restricted, or
placed on probation. In reviewing this application, a registration
assistant performed a routine computer database background check but
misspelled Respondent's name and as a result no adverse action was
noted. As a result, DEA issued Respondent DEA Certificate of
Registration BL4788064.
The local DEA investigator was surprised when he learned that
Respondent had been granted a registration because he had intended to
request an Order to Show Cause seeking to deny any application
submitted by Respondent. On August 30, 1996, DEA sent Respondent a
letter providing him with an opportunity to surrender his new DEA
Certificate of Registration. On September 3, 1996, Respondent called
the local DEA office to discuss the August 30, 1996 letter. Respondent
was told that DEA planned to take action against his new registration
based upon the falsification of his March 1996 application for
registration. The DEA investigator testified that in response,
Respondent explained that he had mistakenly answered ``No'' to the
liability question, believing that the question related only to the
suspension or probation of his DEA registration, and not his State
licensure. Respondent declined to surrender his registration, which
resulted in the Order to Show Cause that initiated these proceedings.
At the hearing in this matter, Respondent testified that he wrote
controlled substance prescriptions without a valid DEA registration
from March 1995 until February 1996, at which point he was told by a
pharmacist that his previous DEA registration was no longer valid.
Respondent stated that he had practiced dentistry for over 25 years and
had never before forgotten to renew his DEA registration. According to
Respondent when his dental license was suspended in 1994, state
personnel came to his office and removed the plaque with his dental
license which had his DEA registration taped to it. The plaque was
returned at the end of the year suspension and he resumed practicing.
Respondent also testified that he did not intentionally falsify his
DEA applications. He asserted that he had nothing to gain by falsifying
the applications and was confused by the liability question. According
to Respondent, he simply misread the question and believed that it only
pertained to suspensions based upon controlled substance violations.
The Deputy Administrator, in his discretion, may revoke a DEA
Certificate of Registration and deny any applications if the registrant
``has
[[Page 55964]]
materially falsified any application filed pursuant to or required by
this subchapter * * *.'' 21 U.S.C. 824(a)(1). In addition, the Deputy
Administrator may also revoke a DEA Certificate of Registration and
deny any pending applications for registration ``if he determines that
the issuance of such registration would be inconsistent with the public
interest.'' 21 U.S.C. 824(a)(4).
In determining the public interest, the Deputy Administrator is to
consider the following factors set forth in 21 U.S.C. 823(f):
(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. Schwarz, Jr., M.D., 54 FR 16,422 (1989).
First, pursuant to 21 U.S.C. 824(a)(1), a registration may be
revoked if the registrant has materially falsified an application for
registration. DEA has previously held that in finding that there has
been a material falsification of an application, it must be determined
that the applicant knew or should have known that the response given to
the liability question was false. See, Martha Hernandez, M.D., 62 FR
61,145 (1997), Herbert J. Robinson, M.D., 59 FR 6304 (1994).
It is undisputed that Respondent answered ``No'' to the liability
question on both his 1991 renewal application and his 1996 application
which asked whether his state medical license had been suspended or
placed on probation. Respondent admitted that he knew that his state
medical license had been suspended in 1990 and had been suspended and
then placed on probation in 1994, but he testified that he did know
that his answers to the liability questions were false because the
questions were confusing and he thought that the questions only dealt
with disciplinary actions relating to the improper handling of
controlled substances.
The Deputy Administrator concurs with Judge Bittner's conclusion
that Respondent materially falsified his applications of registration.
DEA has previously held that it is the registrant's ``responsibility to
carefully read the question and to honestly answer all parts of the
question.'' See Samuel Arnold, D.D.S., 63 FR 8687 (1998); Martha
Hernandez, M.D., 62 FR 61,145 (1997). Therefore, grounds exist to
revoke Respondent's registration pursuant to 21 U.S.C. 824(a)(1).
Respondent has consistently argued that he did not intentionally
answer the liability questions incorrectly. The Deputy Administrator
notes that if evidence existed that indicated that Respondent
intentionally falsified his applications, criminal charges could have
been brought against Respondent. But as has been previously noted,
negligence and carelessness in completing an application for
registration could be a sufficient reason to revoke a registration. See
Id. Clearly, Respondent was negligent and careless in completing his
applications, and Judge Bittner did not find Respondent's explanations
persuasive.
In his exceptions to Judge Bittner's opinion, Respondent argued for
the first time that he misread the question believing that it asked
whether there had ever been any disciplinary action against ``his State
professional license for controlled substance registration,'' rather
than ``his State professional license or controlled substance
registration.'' In its response to Respondent's exceptions, the
Government argued that Respondent's ``disingenuous belated argument
reinforces (Judge Bittner's) conclusion that Respondent was not
candid.'' The Deputy Administrator agrees with the Government.
Respondent seems to be grasping for any explanation as to why he
falsified his applications for registration. Had this truly been the
reason for Respondent's answer to the liability questions, Respondent
should have raised this at the hearing rather than for the first time
in his exceptions.
Next, the Deputy Administrator must consider whether Respondent's
continued registration would be inconsistent with the public interest.
As to factor one, it is undisputed that Respondent's dental license was
suspended by the state Dental Board in 1990, as suspended and then
placed on probation in 1994. The Deputy Administrator notes that some
of the reasons for the second suspension related to Respondent's
handling of controlled substances in his dental practice. But it is
also undisputed that Respondent has had an unrestricted license to
handle controlled substances in Pennsylvania since 1996. However, as
Judge Bittner stated, ``inasmuch as State licensure is a necessary but
not sufficient condition for a DEA registration, * * * this factor is
not determinative.''
As to factors two and four, Respondent's experience in handling
controlled substances and his compliance with applicable laws relating
to controlled substances, the Deputy Administrator has considered these
factors together. There is no question that Respondent has practiced
dentistry for 25 years. But, it is also undisputed that between April
1, 1994 and March 15, 1996, Respondent issued 60 controlled substance
prescriptions using an expired DEA registration, clearly a violation of
21 U.S.C. 843(a)(2). Respondent attempted to justify this conduct by
stating that he did not realize that his previous DEA registration had
expired until he was so advised by a local pharmacist. But, the Deputy
Administrator agrees with Judge Bittner that, ``[t]here is simply no
excuse for Respondent's failure to be aware of the status of his DEA
registration.'' Respondent knew that his DEA registration needed to be
renewed on a regular basis since he had consistently renewed his
registration in the past. His failure to do so on this occasion is
another example of his negligent and careless behavior. The record also
supports a conclusion that Respondent wrote a prescription for diazepam
for office use in violation of 21 CFR 1306.04(b).
Regarding factor three, there is no evidence that Respondent has
ever been convicted under State or Federal laws relating to controlled
substances.
As to factor five, the Deputy Administrator finds that Respondent's
inconsistent explanations for the falsification of his 1991 and 1996
applications for registration demonstrate Respondent's lack of candor.
Judge Bittner concluded that Respondent's DEA registration should
be revoked based upon the material falsification of his applications
and that his continued registration would be inconsistent with the
public interest. In his exceptions to Judge Bittner's opinion,
Respondent argued that revocation would be too harsh a sanction in
light of his ``administrative errors.''
The Deputy Administrator agrees with Judge Bittner. Revocation is
warranted in this case. Not only did Respondent materially falsify two
applications for registration, but he also authorized 60 controlled
substance prescriptions using an expired DEA registration. At the very
[[Page 55965]]
least, this lack of attention to detail demonstrates Respondent's
negligence and carelessness in his compliance with controlled substance
laws and regulations. Therefore, the Deputy Administrator finds that
Respondent's DEA Certificate of Registration must be revoked based upon
the material falsification of his applications for registration and
based upon a finding that Respondent's continued registration would be
inconsistent with the public interest.
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 28 CFR 0.100(b) and 0.104, hereby orders that DEA
Certificate of Registration BL4788064, issued to James C. LaJevic,
D.M.D., be, and it hereby is, revoked. The Deputy Administrator further
orders that any pending applications for registration, be, and they
hereby are, denied. This order is effective November 15, 1999.
Dated: October 7, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-27004 Filed 10-14-99; 8:45 am]
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