FR Doc E8-3873[Federal Register: February 29, 2008 (Volume
73, Number 41)] [Notices] [Page 11146-11148] From the Federal
Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29fe08-106]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Pamela Monterosso, D.M.D.; Denial of Application
On February 6, 2006, the Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration,
issued an Order to Show Cause to Pamela Monterosso, D.M.D.,
(Respondent) of New York, N.Y. The Show Cause Order proposed the
denial of Respondent's pending application for a DEA Certificate
of Registration as a practitioner on the ground that her "registration
would be inconsistent with the public interest.'' Show Cause
Order at 1 (citing 21
U.S.C. 823(f)).
The Show Cause Order specifically alleged that Respondent had
previously held a DEA registration at premises located in
Washington, DC, which she surrendered for cause in November
1997. Id. According to the allegations, in September 1997,
Respondent was
[[Page 11147]]
arrested for obtaining oxycodone, a schedule II controlled
substance, by use of a fraudulent prescription, and admitted to
investigators that she was abusing pharmaceutical controlled
substances. Id. The Show Cause Order alleged that following her
arrest, DEA investigators audited Respondent's handling of
controlled substances and found that she could not "produce
proper records to account for the dispensing of these
substances.'' Id. at 2. The Show Cause Order further alleged
that on October 22, 1997, the United States Attorney for the
District of Columbia filed an information which charged
Respondent with obtaining a controlled substance by fraud, a
violation of 21
U.S.C. 843(a)(3), and that Respondent subsequently pled
guilty to the charge and was sentenced to two years probation.
Id.
The Show Cause Order next alleged that in July 1998,
Respondent entered into a Consent Order with the Maryland Board
of Dental Examiners under which she was placed on probation for
three years. Id. The Show Cause Order further alleged that in
June 1999, the Maryland Board suspended Respondent's dental
license for a period of twelve months. Id.
The Show Cause Order alleged that between September 1998 and
March 1999, Respondent "fraudulently obtained narcotics from
Maryland pharmacies'' on six occasions. Id. The Show Cause Order
alleged that Respondent was subsequently arrested for obtaining
hydrocodone by fraud, and that in April 2000, Respondent was
convicted following her guilty plea on one count of violating
Maryland narcotics laws and was sentenced to twelve months
probation. Id.
The Show Cause Order also alleged that in June 2004,
Respondent failed to disclose her "post-1997 drug abuse, arrest,
and conviction'' to the New York State Board of Dentistry. Id.
The Show Cause Order further alleged that Respondent committed a
material falsification because she "failed to disclose [her]
2000 criminal conviction'' on the DEA application that is at
issue in this proceeding. Id.
Upon service of the Show Cause Order, Respondent, through her
counsel, requested a hearing and submitted a letter responding
to the allegations. The matter was assigned to Administrative
Law Judge (ALJ) Mary Ellen Bittner who ordered the parties to
file pre-hearing statements. While the Government timely filed
its statement, Respondent did not meet its May 30, 2006 filing
deadline. Accordingly, on July 13, 2006, the Government moved to
terminate the proceeding and requested that the ALJ find that
Respondent had waived her right to a hearing. Gov. Mot. for Summ.
Disp. at 1-2.
Upon receipt of the Government's motion, the ALJ issued a
memorandum offering Respondent the opportunity to respond by
July 31, 2006. Order Terminating Proceeding at 1. Respondent
failed to do so. On August 9, 2006, the ALJ found that
Respondent had waived her right to a hearing, granted the
Government's motion, and ordered that the proceeding be
terminated. Id.
On June 6, 2007, the case file was forwarded to me for final
agency action. Based on: (1) Respondent's failure to comply with
the ALJ's Order to submit her pre-hearing statement, and (2) her
failure to respond to the Government's motion for summary
disposition, I adopt the ALJ's finding that Respondent has
waived her right to a hearing. See 21
CFR 1301.43(d). I therefore issue this Decision and Final
Order without a hearing based on relevant material in the
investigative file and make the following findings.
Findings
On February 6, 2005, Respondent submitted an application for
a DEA Certificate of Registration as a practitioner. On the
application, Respondent was required to answer several questions
including whether she had "ever been convicted of a crime in
connection with controlled substances under state or federal
law?,'' and whether she had "ever surrendered or had a federal
controlled substance registration revoked, suspended, restricted
or denied?'' Respondent answered "yes'' to both of these
questions.\1\ Respondent offered the following explanation of
her "yes'' answers:
\1\ On the application, Respondent was also
asked whether she had "ever surrendered or had a state
professional license or controlled substance registration
revoked, suspended, denied, restricted, or placed on
probation?'' Respondent answered "no'' to this question.
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[O]n December 14, 1997 I [pled] guilty to one count of Rx
fraud in Washington D.C. under His Honor Judge Stanley Sporkin.
I was suffering from post partum depression after the birth of
my first & second child. I was told not to prescribe
narcotics until my treatment was completed, and my diagnosis
assured. * * * Full prescribing rights were given back to me. No
state license was ever revoked [or] suspended. No problems have
occurred since, and to the best of my knowledge the case was
expunged exactly 7 years later in 2004.
Based on Respondent's affirmative answers to the two
questions, her application was assigned to a Diversion
Investigator (DI) for further investigation. During the course
of her investigation, the DI determined that in December 1997,
Respondent had pled guilty to one count of obtaining oxycodone
by fraud, a violation of 21
U.S.C. 843(a)(3), in the U.S. District Court for the
District of Columbia, and that she had also surrendered her DEA
registration. Moreover, as a result of her conviction, in July
1998, the Maryland State Board of Dental Examiners entered into
a consent order with Respondent which placed her on probation
for a period of three years during which she was prohibited from
prescribing controlled substances.
The DI also determined that a DEA investigation had found
that on various dates between January 4, 1995, and August 28,
1997, Respondent had failed to document on order forms, the date
and quantity of schedule II controlled substances (oxycodone)
she had received. The same investigation also audited
Respondent's handling of controlled substances and found that
she was short 427 oxycodone tablets. As a result of this
investigation, Respondent entered into a civil settlement with
the Department of Justice and agreed to pay a civil penalty of
$15,000.
The DI further determined that in early 1999, Respondent was
arrested by officers of the Montgomery County, Maryland police
department, and charged with six additional offenses under
Maryland law related to controlled substances including
obtaining hydrocodone by fraud and the unlawful possession of
hydrocodone. While five of the six counts were dismissed, on
April 6, 2000, Respondent pled guilty to the unlawful possession
of a controlled substance for which she was fined and placed on
probation. Respondent satisfactorily completed her probation and
was granted probation before judgment.
In her request for a hearing, Respondent acknowledged that
she "did in fact obtain the schedule III controlled substance
hydrocodone from a pharmacy in Montgomery County.'' Resp. Req.
for Hearing at 1. Respondent asserts, however, that she "return[ed]
the pills to the pharmacist just 10 minutes later,'' but that
the pharmacist nonetheless filed a police report which led to
her arrest "364 days later.'' Id.
Respondent contends that "in the spring of 2000, in the
Montgomery County Court, the case was ruled nulle prosequi * * *
and was dropped.'' Id. Respondent further asserts that "[w]e
were advised by our legal counsel that a nol-pros decision meant
that [the] arrest was thrown out and future disclosure of the
event was neither
[[Page 11148]]
appropriate nor necessary,'' and that she "was told that this
decision meant, in laymen's terms, `that the arrest never
happened.' '' Id.\2\ Respondent further stated that she would
submit the transcript from the proceeding to the Agency, Id.,
but did not do so.
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\2\ Respondent also contended that while in
June 1999, the Maryland Board "did indeed suspend her dental
license for 12 months, [the suspension] was also stayed
immediately.'' Respondent's Req. for Hearing at 1. The record
contains, however, a copy of a June 2, 1999 consent order
under which Respondent voluntarily agreed not to practice
dentistry for a period of twelve months. This order contains
no indication that it was stayed. The Show Cause Order did
not, however, allege either that Respondent's "no'' answer to
the liability question regarding whether her state license had
been the subject of discipline or her statement that "[n]o
state license was ever revoked and/or suspended'' was
materially false. I therefore do not consider whether either
of these statements is grounds for the denial of her
application.
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Discussion
Section 303(f) of the Controlled Substances Act provides that
an application for a practitioner's registration may be denied
upon a determination "that the issuance of such registration
would be inconsistent with the public interest.'' 21
U.S.C. 823(f). In making the public interest determination,
the CSA requires the consideration of the following factors:
(1) The recommendation of the appropriate State licensing
board or professional disciplinary authority.
(2) The applicant's experience in dispensing * * *
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.
Id. "These factors are considered in the disjunctive.''
Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). I "may rely
on any one or a combination of factors, and may give each factor
the weight [I] deem[] appropriate in determining whether * * *
an application for registration [should be] denied.'' Id.
Moreover, I am "not required to make findings as to all of the
factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see
also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).
Furthermore, under Section 304(a)(1), a registration may be
revoked or suspended "upon a finding that the registrant * * *
has materially falsified any application filed pursuant to or
required by this subchapter.'' 21
U.S.C. 824(a)(1). Under agency precedent, the various
grounds for revocation or suspension of an existing registration
that Congress enumerated in section 304(a), 21 U.S.C. 824(a),
are also properly considered in deciding whether to grant or
deny an application under section 303. See Anthony D. Funches,
64 FR 14267, 14268 (1999); Alan R. Schankman, 63 FR 45260
(1998); Kuen H. Chen, 58 FR 65401, 65402 (1993). Thus, the
allegation that Respondent materially falsified her application
is properly considered in this proceeding, see Samuel S.
Jackson, 72 FR 23848, 23852 (2007), and is, if proved, an
adequate ground for denying her application.
On the Show Cause Order, the Government made two allegations
that Respondent engaged in material falsification. First, it
alleged that in June 2004, Respondent failed to disclose her "post-1997
drug, abuse, arrest, and conviction'' when she "appeared before
the New York State Board of Dentistry * * * as an applicant for
a license to practice dentistry.'' Show Cause Order at 2.
Respondent remains, however, licensed in good standing in the
State of New York. Under these circumstances, the allegation
that she failed to disclose to the New York Board of Dentistry
the second arrest and conviction (and thus procured her dental
license by fraudulent means) is a matter which should be
resolved in the first instance by the State and not DEA. The
allegation is therefore dismissed.
Respondent's statement on her DEA application is, however,
properly before the Agency. Even accepting Respondent's
statement that she was advised by her legal counsel that she was
not required to disclose her arrest and plea, DEA has long taken
the view that even when a court withholds adjudication and
ultimately dismisses the charge after the completion of
probation, the proceeding is still a conviction within the
meaning of the Controlled Substances Act. See Eric A. Baum,
M.D., 53 FR 47272, 47274 (1988); see also David A. Hoxie, 69 FR
51477, 51478 (1994).
Moreover, the failure to disclose such a conviction
constitutes a material falsification because it is "capable of
influencing'' the decision as to whether to grant an
application. See Kungys v. United States, 485 U.S. 759, 770
(1988) (int. quotation and other citation omitted). As DEA has
frequently noted, an applicant's answers to the various
liability questions are material because the Agency "relies upon
such answers to determine whether an investigation is needed
prior to granting the application.'' Martha Hernandez, M.D., 62
FR 61145, 61146 (1997). Respondent's failure to disclose the
2000 Maryland proceeding is material because the public interest
inquiry under section 303(f) requires, inter alia, that the
Agency examine her "experience in dispensing * * * controlled
substances,'' her "conviction record * * * relating to the * * *
dispensing of controlled substances,'' and her "[c]ompliance
with applicable State, Federal, or local laws relating to
controlled substances.'' 21
U.S.C. 823(f). Respondent was therefore required to disclose
the circumstances surrounding her subsequent arrest even if her
conviction was expunged. Her failure to do so constitutes
material falsification.
Furthermore, even crediting Respondent's statement that she
was advised by counsel that she need not disclose the Maryland
proceeding in the future, in her explanation she then proceeded
to make an affirmative and material misrepresentation when she
stated that "[n]o problems have occurred since'' the 1997
federal proceeding. The statement was clearly false and
Respondent had reason to know this to be so. I therefore
conclude that Respondent knowingly made a material false
statement in an attempt to obtain a favorable decision from the
Agency on Respondent's application and that granting Respondent
a new registration "would be inconsistent with the public
interest.'' 21 U.S.C. 823(f); see also e.g., Dan E. Hale, 69 FR
69402 (2004).
Order
Pursuant to the authority vested in me by 21
U.S.C. 823(f), as well as 28 CFR 0.100(b) & 0.104, I
order that the application Pamela Monterosso, D.M.D., for a DEA
Certificate of Registration as a practitioner, be, and it hereby
is, denied. This order is effective March 31, 2008.
Dated: February 15, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-3873 Filed 2-28-08; 8:45 am]
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