[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Notices]
[Pages 62902-62907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26485]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 18-21]
Decision and Order: Zelideh I. Cordova-Velazco, M.D.
On February 27, 2018, the Acting Assistant Administrator, Diversion
Control Division, issued an Order to Show Cause to Zelideh I. Cordova-
Velazco, M.D. (Respondent), of Puerto Rico. The Show Cause Order
proposed the denial of the Respondent's application for a DEA
Certificate of Registration in Puerto Rico as a practitioner, Control
No. W16052461C, on the grounds that Respondent materially falsified
that application. Order to Show Cause, at 1 (citing 21 U.S.C.
824(a)(1)).
With respect to the Agency's jurisdiction, the Show Cause Order
alleged that on June 16, 2016, Respondent applied for a DEA
Registration as a practitioner in schedules II through V at the
proposed business address of Hacienda Del Dorado, K1 Calle Delonix, Toa
Alta, Puerto Rico. Id. The Order also alleged that DEA assigned Control
No. W16052461C to the application. Id.
As to the substantive grounds for the proceeding, the Show Cause
Order alleged that Respondent previously held DEA Certificate of
Registration No. BC4141139 in Michigan. Id. at 2. In addition, the
Order alleged that Respondent ``voluntarily surrendered for cause''
that Registration ``on or about January 17, 2014.'' Id. The Order
further alleged that Respondent materially falsified her application
for a new DEA Registration in Puerto Rico on June 16, 2016 with respect
to two liability questions on the application. Id. The Order alleged
that the first material falsification was that the Respondent answered
``N'' when asked: ``Has the applicant ever surrendered (for cause) or
had a federal controlled substance registration, revoked, suspended,
restricted or denied, or is any such action pending?'' Id. The Order
alleged that the second material falsification was that Respondent
answered ``N'' when asked: ``Has the applicant ever surrendered (for
cause) or had a state professional license or controlled substance
registration revoked, suspended, denied, restricted, or placed
[[Page 62903]]
on probation, or is any such action pending?'' Id. The Order asserted
that these alleged material falsifications ``warrant the denial of your
application for registration.'' Id. (citing 21 U.S.C Sec. 824(a)(1)).
The Show Cause Order notified Respondent of her right to request a
hearing on the allegations or to submit a written statement while
waiving her right to a hearing, the procedures for electing each
option, and the consequences for failing to elect either option. Id. at
2-3 (citing 21 CFR 1301.43). The Order also notified Respondent of the
opportunity to submit a corrective action plan. Id. at 3 (citing 21
U.S.C. Sec. 824(c)(2)(C)).
After being served with the Order, Respondent filed a timely
``Request for Hearing'' on March 26, 2018 requesting a hearing on the
allegations. Request for Hearing (dated March 22, 2018) (hereinafter
Hearing Request). In her Hearing Request, Respondent states that she
``d[id] not recall that I indicate [sic] `no' to the questions'' in the
application and that she ``was helped by a friend in filling out the
application and probably by mistake and/or ignorance in understanding
the questions I answered `no.''' Id. at 2. Respondent also states that
she surrendered her Michigan medical license and ``accept[ed] a six
months and one day suspension, for being negligent, in not securing my
prescription pad'' and then ``voluntarily surrender[ed her] DEA license
to prescribe[] control[led] substance[s].'' Id. She also asserts that
``[i]f I would have known the consequences of accepting the suspension,
I would have litigated the case in Michigan, because I did nothing
wrong. There is no practical reason not to inform the suspension of
Michigan. The suspension appears online in the medical board data
bank.'' Id. She also ``request[ed] discovery in the present matter,
including [a] copy of the record and/or file with DEA.'' Id.
The matter was placed on the docket of the Office of Administrative
Law Judges and assigned to Administrative Law Judge Charles Wm. Dorman
(ALJ). Thereafter, on March 26, 2018, the ALJ entered an Order for
Prehearing Statements, directing the Government to file its Prehearing
Statement on April 10, 2018, and the Respondent to file hers on April
24, 2018. Order for Prehearing Statements, at 1. The Order also
directed the parties to participate in a telephonic prehearing
conference on April 25, 2018. Id. at 2. The Government filed its
Prehearing Statement on April 10, 2018, and Respondent filed, through
counsel, her Prehearing Statement on April 20, 2018.
In Respondent's Prehearing Statement, Respondent stipulated that
she voluntarily surrendered her Michigan medical license after being
informed of an investigation for improperly prescribing medication.
Respondent's Prehearing Statement, at 2. In addition, Respondent
stipulated that she was previously registered with DEA pursuant to DEA
Certificate of Registration No. BC4141139, and that she voluntarily
surrendered for cause that registration. Id. at 3.
On April 20, 2018, the Government filed a Motion for Summary
Disposition based upon the Respondent's material falsification of her
application for a DEA Registration in Puerto Rico on June 16, 2016.
Specifically, the Government alleged that there was no dispute of
material fact that Respondent materially falsified her application for
a DEA Registration when she answered ``N'' to the following liability
questions on the application: (1) ``Has the applicant ever surrendered
(for cause) or had a federal controlled substance registration,
revoked, suspended, restricted or denied, or is any such action
pending?''; and (2) ``Has the applicant ever surrendered (for cause) or
had a state professional license or controlled substance registration
revoked, suspended, denied, restricted, or placed on probation, or is
any such action pending?'' Government's Motion for Summary Disposition
(hereinafter ``Government's Motion'' or ``Govt. Mot.''), at 2.
On April 25, 2018, the ALJ held a telephonic prehearing conference
pursuant to 21 CFR 1316.55. The ALJ entered a Prehearing Ruling (PHR)
on April 26, 2018, reflecting that the parties had agreed to a series
of factual stipulations, including the fact that (1) on April 19, 2013,
the Michigan Board of Medicine suspended Respondent's Michigan medical
license for a minimum period of six months and one day; (2) in January
2014, Respondent ``voluntarily surrendered for cause'' a DEA
Registration that Respondent had previously held in Michigan; (3)
Respondent answered ``N'' when asked: ``Has the applicant ever
surrendered (for cause) or had a federal controlled substance
registration revoked, suspended, restricted or denied, or is any such
action pending?'' and (4) Respondent answered ``N'' when asked: ``Has
the applicant ever surrendered (for cause) or had a state professional
license or controlled substance registration revoked, suspended,
denied, restricted, or placed on probation, or is any such action
pending?'' PHR, at 1-2.
In his Prehearing Ruling, the ALJ also ordered Respondent to file a
response to the Government's Motion by May 4, 2018, and directed the
parties to attempt to draft additional ``mutually agreeable joint
stipulations'' by May 30, 2018. Id. at 2. On May 3, 2018, Respondent
filed her response to the Government's Motion and asserted that the
Government had failed to ``establish bad faith, negligence or
intentionally trying to mislead,'' and failed to prove that she ``is
unfit to practice medicine, and therefore, unfit to prescribe
medication.'' ``Respondent's Response to Government's Motion for
Summary Disposition and Respondant's [sic] `Motion for Summary
Disposition''' (Resp. Reply), at 4. In addition, Respondent attached a
certificate of good standing for her Puerto Rico medical license and a
copy of her license. Id., Attachment (Att.) 1-2. Additionally, she
attached her own sworn statement, in which she asserts that she
``misunderstood the questions.'' Id., Att. 3, at 2. She also argued
that approving her application was warranted because she holds an
active medical license in good standing and has never been sued for
malpractice. Id. at 3-4.
On May 8, 2018, after considering these pleadings, the ALJ entered
an Order recommending that I find that Respondent had failed to raise a
triable issue of material fact as to whether she had materially
falsified her application. Order Granting Government's Motion for
Summary Disposition and Recommended Rulings, Findings of Fact,
Conclusions of Law, and Decision (Recommended Decision or R.D.), at 8-
9. As a result, the ALJ granted the Government's Motion and recommended
that I deny Respondent's DEA application Control No. W1602461C. Id. at
12.
On May 17, 2018, Respondent filed her ``Request for
Reconsideration'' of the ALJ's Recommended Decision,\1\ and on the same
day the ALJ entered an Order Directing Government to Respond to
Respondent's Request for Reconsideration. In that Order, the ALJ noted
that there is no provision in DEA's regulations for either party to
request reconsideration of an ALJ's recommended decision, and thus the
ALJ would treat the request as Exceptions to the Recommended Decision.
Order Directing Government
[[Page 62904]]
to Respond to Respondent's Request for Reconsideration, at 1. The Order
directed the Government to file any response to Respondent's Exceptions
by May 22, 2018. According to the record, the Government filed no
Exceptions of its own nor any response to Respondent's Exceptions. On
June 4, 2018, the record was forwarded to my Office for Final Agency
Action.\2\
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\1\ On May 11, 2018, Respondent also filed a ``Supplemental
Motion Submitting Document'' enclosing ``a certified translation of
Resolution Num. 2017-118, issued by the Health Department Board of
Licensing and Medical Discipline of Puerto Rico, in the case of In
Re: Sr. Zelideh Cordova Velazco (Lic. #4865), Case No. Q-JDLM-2013-
41.'' Supplemental Motion Submitting Document, at 1.
\2\ Respondent submitted two post-certification filings. On June
12, 2018, Respondent filed her Request to Grant Motion for
Reconsideration As Unopposed, and on August 17, 2018, Respondent
filed her Second Request to Grant Motion for Reconsideration As
Unopposed. On June 12, 2018 and on August 20, 2018, respectively,
the ALJ issued Orders forwarding Respondent's post-certification
filings to my Office and noted that his ``jurisdiction over the case
terminated upon transmittal of the record to the Acting
Administrator.'' Order Forwarding Respondent's Motion to Acting
Administrator, at 1; Second Order Forwarding Respondent's Motion to
Acting Administrator, at 1. I find that the ALJ properly forwarded
Respondent's post-certification filings for my consideration
because, as the ALJ correctly notes, his jurisdiction over this
matter terminated when he certified and transmitted the record to my
Office.
Regarding the timing of Respondent's filings, neither the
Controlled Substances Act nor DEA's implementing regulations provide
for a supplemental filing by a party after the ALJ has certified the
record. However, the Agency has, on occasion, exercised its
discretion to consider such filings (however styled) after the ALJ
has certified and transmitted the administrative record to my
Office. E.g., Joe W. Morgan, D.O., 78 FR 61961, 61961 (2013)
(allowing Respondent's post-certification filing and ``treat[ing it]
as a motion for reconsideration''); Wesley G. Harline, M.D., 64 FR
72678, 72684-85 (1999) (allowing Respondent's post-certification
filing and treating it as a motion to reopen the record); Robert M.
Golden, M.D., 61 FR 24808, 24808 (1996) (same). Indeed, the Agency
has even exercised its discretion to consider motions for
reconsideration after the Agency has issued its final decision and
order. E.g., Lyle E. Craker, Ph.D., 76 FR 51403, 51405 (2011).
To justify consideration of her filings at this stage of the
case, Respondent must show that there has been an intervening change
of controlling law, the availability of new evidence, or the need to
correct a clear error or prevent manifest injustice. E.g., Foster v.
Sedgwick Claims Mgmt. Services, 842 F.3d 721, 735 (D.C. Cir. 2016)
(``A motion for reconsideration is discretionary and need not be
granted unless the district court finds that there is an intervening
change of controlling law, the availability of new evidence, or the
need to correct a clear error or prevent manifest injustice.'')
(citations and internal quotation marks omitted); Virgin Atl.
Airways v. Nat'l Mediation Bd., 956 F.2d 1245, 1255 (2d Cir.)
(same), cert. denied, 506 U.S. 820 (1992).
Here, Respondent claims in both filings that her Exceptions
should be deemed ``unopposed'' because the Government chose not to
respond to her Exceptions. Respondent failed to offer any other
basis in fact that her Exceptions were ``unopposed'' by the
Government. I am aware of no DEA regulation or Agency precedent
compelling a finding that a party who does not respond to an
opposing party's Exceptions to an ALJ's Recommended Decision is
deemed to have taken a position of ``unopposed'' to the opposing
party's Exceptions. Moreover, Respondent's claim is not the type of
intervening change in controlling law, newly available evidence, or
clear error that would justify consideration of her post-
certification filings under Agency precedent at this stage of the
case. For all these reasons, I do not consider Respondent's post-
certification filings.
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Having considered the entire record, including the ALJ's
Recommended Decision, I find that Respondent materially falsified her
application for DEA registration with respect to Liability Questions 2
and 3 on her 2016 application. I therefore adopt the ALJ's
recommendation that I deny Respondent's DEA Registration application. I
make the following factual findings.
Findings of Fact
Respondent is a physician who previously held an active medical
license, No. 43-01063034, in the State of Michigan. Ex. 4 to Govt. Mot.
On April 19, 2013, Respondent entered into a Consent Order with the
Michigan Board of Medicine in which she agreed to the suspension of her
medical license for a minimum period of six months and one day based on
her improper prescribing of controlled substances to home health
patients. See id.; see also R.D., at 10. Specifically, the Michigan
administrative complaint against Respondent alleged, among other
things, that she prescribed controlled substances, primarily oxycodone,
Xanax, and Phenergan with codeine, to 26 patients despite: ``failing to
document medical indication or necessity for these controlled
substances''; failing to document ``any physical examination or
clinical findings to justify the combination of'' controlled drugs
prescribed; failing to document an appropriate medical history; failing
to make ``any findings pertaining to pain assessment, level of
dysfunction from pain, treatment plan or diagnostic testing''; failing
to obtain ``a report from the Michigan Automated Prescription System'';
failing to conduct a toxicology screen; failing to monitor the
``patients' use of the controlled substances for drug dependency or
diversion''; failing to counsel the patients regarding the risks
associated with controlled substances; and consistently prescribing the
maximum dose of Xanax ``without documenting prior medication use or use
of Xanax.'' Ex. 4 to Govt. Mot., at 9-11.\3\
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\3\ The Consent Order recited that Respondent ``does not contest
the allegations of fact and law'' in the state administrative
complaint against her. Id. at 3.
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Respondent also previously held DEA Certificate of Registration No.
BC4141139. Ex. 3 to Govt. Mot. In January 2014, Respondent voluntarily
surrendered this registration for cause. Exs. 3, 5 to Govt. Mot.
On June 15, 2016, Respondent applied for a practitioner's
registration seeking authority to dispense controlled substances in
schedules II through V with a proposed business address of Hacienda Del
Dorado, K1 Calle Delonix, Toa Alta, Puerto Rico. Exhibits (Exs.) 1, 2
to Govt. Mot. DEA assigned Respondent's DEA registration application
Control No. W16052461C.\4\ DEA's Application for Registration includes
liability questions which an applicant must answer either affirmatively
(``Y'') or negatively (``N''). Exs. 1-3 to Govt. Mot. Liability
Question 2 on the DEA Application for Registration filed by Respondent
asks: ``Has the applicant ever surrendered (for cause) or had a federal
controlled substance registration revoked, suspended, restricted or
denied, or is any such action pending?'' Exs. 1-2 to Govt. Mot.
Respondent answered this question: ``N'' for no. Id. I find that this
answer was false.
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\4\ The ALJ recommended that I make this fact finding based on
the parties' stipulation that DEA assigned Control No. W16052461C to
Respondent's DEA application. R.D., at 3 (citing PHR, 1-2). In
addition, the record includes a notarized sworn statement by
Respondent that DEA assigned Control No. W16052461C to her. Att. 3
to Resp. Reply, at 1.
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Liability Question 3 on the DEA Application for Registration filed
by Respondent asks: ``Has the applicant ever surrendered (for cause) or
had a state professional license or controlled substance registration
revoked, suspended, denied, restricted, or placed on probation, or is
any such action pending?'' Id. Respondent answered this question: ``N''
for no. I find that this answer was also false.
Discussion
A. Standard for Denial of an Application for Registration
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.
[[Page 62905]]
(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). DEA precedent provides that
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.'' Richard D. Vitalis, 79
FR 68701, 68708 (2014) (citing Robert A. Leslie, M.D., supra).
Moreover, it is well established that 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 Kevin Dennis, M.D., 78 FR 52787, 52974
(2013); MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011).
``The provision of truthful information on applications is
absolutely essential'' to a determination of whether granting an
application is in the public interest. Peter H. Ahles, M.D., 71 FR
50097, 50098 (2006). ``Since DEA must rely on the truthfulness of
information supplied by applicants in registering them to handle
controlled substances, falsification cannot be tolerated.'' Bobby
Watts, M.D., 58 FR 46995, 46995 (1993). Accordingly, ``materially
falsifying an application . . . provides an independent and adequate
ground for denying an application.'' The Lawsons, Inc., 72 FR 74334,
74338 (2007); see also Richard A. Herbert, M.D., 76 FR 53942, 53945
(2011) (``Under the CSA, material falsification provides a separate and
independent ground for denying an application.'').\5\ One materially
false statement is enough to justify revocation or denial. Harold
Edward Smith, M.D., 76 FR 53961, 53964 (2011). The Government bears the
burden of proof in showing that the issuance of a registration is
inconsistent with the public interest. 21 CFR 1301.44(d). Having
considered the record, including the ALJ's Recommended Decision and
Respondent's Exceptions, I conclude that the Government was entitled to
summary disposition on the grounds that Respondent materially falsified
her application for a DEA Certificate of Registration.
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\5\ Under Section 304(a)(1) of the Controlled Substances Act
(CSA), 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). ``DEA has long held that 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.'' Richard D. Vitalis, D.O., 79 FR 68701, 68708 (2014)
(citing 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
his application is properly considered in this proceeding. Vitalis,
79 FR at 68708 (citing Samuel S. Jackson, 72 FR 23848, 23852
(2007)).
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B. Material Falsification
Here, as I have already noted, Respondent made two false statements
when she submitted her DEA Application for Registration in 2016 in
Puerto Rico. First, Respondent falsely stated in her response to
Liability Question 2 on her DEA Application for Registration that she
had never surrendered a DEA registration for cause when, in fact, she
had surrendered DEA Certificate of Registration No. BC4141139 in
Michigan for cause in January 2014. Second, Respondent falsely stated
in her response to Liability Question 3 on her DEA Application that she
has not had her state professional license revoked, even though in 2013
she had entered into a Consent Order with the Michigan Board of
Medicine agreeing to the suspension of her Michigan medical license.
Turning to whether these false statements were material, Agency
precedent establishes that ``[a] false statement is material if it `has
a natural tendency to influence, or was capable of influencing the
decision of the decision[-]making body to which it was addressed.' ''
Gilbert Eugene Johnson, M.D., 75 FR 65663, 65665 (2010) (quoting Kungys
v. United States, 485 U.S. 759, 770 (1998)). The false statement need
only have the capacity to influence the decision-making body; it does
not need to have exerted any actual influence. Alvin Darby, M.D., 75 FR
26993, 26998 (2010) (citing United States v. Alemany Rivera, 781 F.2d
229, 234 (1st Cir. 1985)). The Government must prove that the false
information is material by ``clear, unequivocal, and convincing''
evidence. Hoi Y. Kam, M.D., 78 FR 62694, 62696 (2013) (quoting Kungys,
485 U.S. at 772). Whether a falsification is material is a question of
law. Harold Edward Smith, M.D., 76 FR 53961, 53964 (2011) (citing
Kungys, 485 U.S. at 772).
As stated below, I find that the Respondent's answers to both
Liability Question 2 and Liability Question 3 were material. As far as
Liability Question 3 is concerned, DEA precedent holds that the failure
to disclose a prior suspension relating to the prescribing of
controlled substances is material, even where the suspension was no
longer effective at the time of the application: ``[E]ven where an
applicant currently holds unrestricted state authority to dispense
controlled substances, the failure to disclose state action against his
medical license may be material if the action was based on conduct (or
on the status arising from such conduct, i.e., a conviction for a
controlled substance offense or mandatory exclusion from federal health
care programs) which is actionable under either the public interest
factors or the grounds for denial, suspension, and revocation set forth
in section 824.'' Richard D. Vitalis, 79 FR at 681708 (2014).
Here, the Government has provided evidence demonstrating that the
underlying state investigation which prompted the suspension of
Respondent's Michigan medical license and the surrender of her DEA
registration concerned unlawful prescribing of controlled substances.
See Ex. 4 to Govt. Mot. Given that the allegations concern the unlawful
prescribing of controlled substances, I find that they are material
because they are ``capable of influencing'' the DEA's decision.\6\
Kungys, 485 U.S. at 770; Jose G. Zavaleta, M.D., 78 FR 27431, 27435
(2013); Smith, 76 FR at 53964. Likewise, Respondent's failure to
disclose her surrender for cause of her prior DEA registration in
Michigan in response to Liability Question 2 was also material
according to DEA precedent. Zavaleta, 78 FR at 27435 (failure to
disclose voluntary surrender of DEA registration following an
investigation into unlawful prescribing was ``clearly capable of
influencing'' the DEA's decision and was thus material); Smith, 76 FR
at 53964 (failure to disclose fact that the applicant had ``been
accused of writing unlawful prescriptions . . . [was] material to the
[DEA's] investigation and assessment of [the applicant's] experience in
dispensing controlled substances and his compliance with applicable
laws related to'' controlled substances).
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\6\ The Consent Order recited that Respondent ``does not contest
the allegations of fact and law'' in the state administrative
complaint against her. Id. at 3.
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In addition, the Government must show that Respondent ``knew or
should have known that [her] response[s] given to the liability
question[s] [were] false.'' Samuel S. Jackson, D.D.S., 72 FR 23848,
23852 (2007) (quoting Samuel Arnold, D.D.S., 63 FR 8687, 8688 (1998));
Merlin E. Shuck, D.V.M., 69 FR 22566, 22568 (2004). ``Under DEA
precedent, the Government is not required to show that the
falsification was intentional but only that the applicant `knew or
should have known that the response given to the
[[Page 62906]]
liability question was false.''' Alvin Darby, M.D., 75 FR 26993, 26999
(2010) (quoting The Lawsons, Inc., 72 FR 74334, 74339 (2007)).
In Richard Jay Blackburn, D.O., the Acting Administrator determined
that a copy of the state administrative complaint, the respondent's
letter to the state board ``surrendering his state license,'' the state
board's acceptance of the surrender, and a printout displaying the
status of respondent's state license were sufficient to demonstrate
that respondent ``knowingly falsified his application.'' 82 FR 18669,
18673 (2017). The DEA has found that material falsifications are
committed knowingly even where, as here, a respondent claims that he or
she misunderstood the questions. Darby, 75 FR at 26999.
Here, the Government attached a copy of the Respondent's 2016
application, a copy of the administrative complaint and Consent Order
issued by the Michigan Department of Licensing and Regulatory Affairs
against Respondent, and a copy of the form which Respondent signed
surrendering her Michigan DEA registration. See Exs. 1, 4-5 to Govt.
Mot. Additionally, the Government attached two notarized documents
signed by the Chief of DEA's Registration and Program Support Section
verifying the Respondent's DEA registration history and her responses
on her 2016 application. Exs. 2-3 to Govt. Mot. The Government's
evidence is the same type of evidence as that submitted in Blackburn
and therefore is sufficient to show that Respondent either knew or
should have known that her application was materially false. 82 FR at
18673. As a result, even if Respondent's statements that she
misunderstood the questions were true, I find that she should have
known under the facts in this case that her responses to the liability
questions in this case were false. See Darby, 75 FR at 26999.
Thus, I find that the Government has offered sufficient evidence to
show that the Respondent materially falsified her 2016 application for
a DEA registration in Puerto Rico.
C. Sanction
Once the Government makes a prima facie case for material
falsification, the next question ``becomes whether revocation [or
denial] is the appropriate sanction in light of the facts.'' Arnold, 63
FR at 8688. Although the Respondent acknowledges that the answers she
provided in response to Liability Questions 2 and 3 on her 2016
application were false, she explains that she did not intend to provide
false statements, but instead misunderstood the questions. Resp. Reply,
at 4-5; App. 3, at 2, para. 7.
Respondent's insistence that her undisputed false statements should
be excused because she ``misunderstood'' the liability questions is
misplaced. In her Request for Hearing, the Respondent merely stated the
following concerning her alleged misunderstanding of the questions: ``I
was helped by a friend in filling out the application and probably by
mistake and/or ignorance in understanding the questions I answered
`no.'' Resp. Request for Hearing, at 2. Later, in her Response to
Government's Motion for Summary Disposition, she further specified that
she ``misunderstood'' Liability Questions 2 and 3, but her purported
explanation disregards the actual wording of the questions. Att. 3 to
Resp. Reply, at 2. For example, as to Liability Question 2, Respondent
claims she misunderstood that question because her registration was
surrendered voluntarily, and was not revoked, suspended or denied. Id.
However, Liability Question 2 not only asked whether the applicant ever
had a registration ``revoked, suspended, restricted or denied,'' but
also expressly asked whether any registration had ever been surrendered
for cause. Ex. 1 to Govt. Mot. Moreover, Respondent stipulated that her
prior registration was surrendered for cause, so her negative answer
was clearly false, and her claimed ``misunderstanding'' of Liability
Question 2 rings hollow. See Shannon L. Gallentine, D.P.M., 76 FR
45864, 45866 (2011).
Similarly, Respondent's claim that she misunderstood Liability
Question 3 also ignores the question itself. Respondent explained her
``misunderstanding'' as to Liability Question 3 as follows: ``As to
question #3, again Ms. Cordova['s] Registration was not revoked,
suspended, denied, restricted, or placed on probation, nor is [sic] any
such action was pending when she voluntarily surrender [sic] her
Registration.'' Att. 3 to Resp. Reply, at 2. However, Liability
Question 3 actually inquires: ``Has the applicant ever surrendered (for
cause) or had a state professional license or controlled substance
registration revoked, suspended, denied, restricted, or placed on
probation, or is any such action pending?'' Ex. 1 to Govt. Mot.
(emphasis added). It is undisputed that Respondent's state professional
license for Michigan was suspended, and she clearly knew it was
suspended, because she is the one who agreed to that suspension in
writing when she entered into a Consent Order with the State of
Michigan Board of Medicine. Thus, Respondent's claimed misunderstanding
of Liability Question 3 is untenable on its face.
Moreover, applicants for DEA registrations bear ```the
responsibility to carefully read the question and to honestly answer
all parts of the question.''' Arnold, 63 FR at 8688 (quoting Martha
Hernandez, M.D., 62 FR 61145, 61147 (1997)). Allegedly misunderstanding
or misinterpreting liability questions does not relieve the applicant
of this responsibility. Hernandez, 62 FR at 61147-48 (concluding
applicant committed material falsification despite misinterpreting one
question); see also Gallentine, 76 FR at 45866. Additionally,
inadvertence is legally irrelevant in resolving a material
falsification case because the Government only needs to prove that
Respondent ```knew or should have known''' that the answers were false.
Richard A. Herbert, M.D., 76 FR 53942, 53956 (2011) (quoting The
Lawsons, Inc., 72 FR 74334, 74338 (2007)) (emphasis added). See, e.g.,
Zavaleta, 78 FR at 27436, 27438-39 (ruling respondent materially
falsified his application even where respondent testified that he made
mistakes in filling out the application and ``should have give[n] [his
applications] more careful review''). Thus, Respondent's defense of
inadvertence, even if it were true, is legally inconsequential in
deciding whether she materially falsified her 2016 application.
Furthermore, the evidence that Respondent now holds a valid medical
license in good standing in Puerto Rico is simply not relevant in terms
of resolving the allegation that she materially falsified her
application. Resp. Reply, at 3; Att. 1-2 to Resp. Reply; Hernandez, 62
FR at 61147. The same holds true of the evidence that Respondent has
never been sued for malpractice or been the subject of a professional
complaint, except for the Michigan action, in her 19-20 year career.
Resp. Reply at Att. 3, para. 8, 10. With respect to Liability Questions
2 and 3 of Respondent's DEA Application, a material false statement is
a material false statement regardless of her professional credentials.
Although lack of intent to deceive and history of licensure are
relevant in assessing the appropriate sanction, what is most
dispositive is the fact that Respondent has not accepted responsibility
for her materially false statements. See Lon F. Alexander, M.D., 82 FR
49704, 49728 (2017); Arthur H. Bell, 80 FR 50035, 50041 (2015) (finding
that applicant's failure to accept responsibility for materially
falsifying application was ``reason alone to
[[Page 62907]]
conclude that he cannot be entrusted with a new registration''). I have
considered the fact that Respondent currently holds a medical license
in good standing in Puerto Rico, and her sworn statement that she has
never been sued for malpractice and received only one professional
complaint in her 19-20 year career. Att. 1-2 to Resp. Reply; Att. 3 to
Resp. Reply, at 2-4. None of these facts outweighs Respondent's
materially false application, especially given her failure to disclose
extensive and serious allegations against her involving the unlawful
prescribing of controlled substances. See William M. Knarr, D.O., 51 FR
2772, 2773 (1986). Thus, I find that this mitigating evidence fails to
diminish the gravity of her failure to reveal the alleged misconduct in
her state of prior registration.
Accordingly, based upon the foregoing, I conclude that the
Government was entitled to summary disposition on the allegation that
Respondent materially falsified her application for a new DEA
registration.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28
CFR 0.100(b), I order that the application of Zelidah H. Cordova-
Velazco, M.D., for a DEA Certificate of Registration as a practitioner,
be, and it hereby is, denied. This Order is effective immediately.
Dated: November 20, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-26485 Filed 12-4-18; 8:45 am]
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