Registrant Actions - 2012
[Federal Register Volume 77, Number 202 (Thursday, October 18, 2012)]
[Notices]
[Pages 64128-64131]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25576]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Jose Gonzalo Zavaleta, M.D.; Denial of Application
On March 2, 2011, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause (Order) to Jose Gonzalo Zavaleta, M.D. (Applicant), of
Alexandria, Louisiana (La.). The Order proposed the denial of
Applicant's pending applications for DEA Certificates of Registration
as a practitioner, which he filed on April 19, 2010 (Control Number
W10020882C) and on December 9, 2010 (Control Number W10078290C), for
the registered location of 1217 Willow Glen
[[Page 64129]]
River Road, Alexandria, La., on the ground that his registration would
be "inconsistent with the public interest." Order at 1 (citing 21
U.S.C. 823(f)).
The Show Cause Order incorporated by reference the allegations of a
previous Show Cause Order which had been issued on February 23, 2009; a
copy of the latter was attached to the second Show Cause Order. Id. at
1-2. The first Show Cause Order had alleged that Applicant voluntarily
surrendered his DEA Certificate of Registration, BZ5998250, on March
26, 2008, after being charged with six counts of prescribing controlled
substances beyond authority and accepted medical treatment, in
violation of La. Rev. Stat. Ann. Sec. 40:971(C)(1)(2008) (effective
Aug. 15, 2006). Id. The first Order further alleged that Applicant
prescribed controlled substances to undercover agents with "cursory or
no medical examinations, and without a legitimate medical purpose in
violation of 21 U.S.C. Sec. 841(a)(1)," including a total of 75
dosage units of hydrocodone (including Lortab and/or Lorcet), which are
schedule III narcotics; 20 dosage units of Xanax, a schedule IV
controlled substance; and six ounces of Phenergan with codeine, a
schedule V narcotic cough syrup. Id. Finally, the first Order alleged
"[Applicant] facilitated the undercover officers' procurement of drugs
by fraudulent means" when he advised them to "provide false medical
information" to justify "illegitimate prescriptions." Id. at 2.
In addition to these allegations, the Second Show Cause Order
alleged that on June 24, 2010, Applicant had entered into a consent
agreement with the Louisiana State Board of Medical Examiners which had
found "that reasonable cause existed for recommending that a formal
Administrative Complaint be filed against [him], charging [him] with
violation of the Louisiana Medical Practice Act." Show Cause Order at
2. The Second Show Cause Order further alleged that "[t]o avoid the
filing of a formal Administrative Complaint, [Applicant] entered into a
consent order with the Board * * * in which [he] accepted a public
reprimand and various conditions [were] place upon [his] medical
license."
On March 7, 2011, the Second Show Cause Order, which also notified
Applicant of his right to either request a hearing on the allegations
or to submit a written statement in lieu of a hearing, the procedures
for doing so, and the consequence if he failed to do either, was served
on Applicant by certified mail addressed to him at the address listed
on his second and third applications. Id. at 2 (citing 21 CFR 1316.47;
21 CFR 1301.43). Since service of the Second Order, more than thirty
days have now passed and neither Applicant, nor anyone purporting to
represent him, has either requested a hearing or submitted a written
statement in lieu of a hearing. See 21 CFR 1301.43(b)-(d). Accordingly,
I find that Applicant has waived his rights to a hearing or to submit a
written statement. Id. 1301.43(d). I therefore issue this Decision and
Final Order without a hearing based on relevant material contained in
the investigative record submitted by the Government. I make the
following findings.
Findings
On July 27, 2011, I issued a Decision and Final Order denying
Respondent's application which he filed on July 28, 2008 and which was
the subject of the first Show Cause Order. See Jose Gonzalo Zavaleta,
M.D., 76 FR 49506 (Aug. 10, 2011). Therein, I made extensive findings
that are res judicata in this proceeding.
Applicant was previously the holder of DEA Certificate of
Registration, BZ5998250, which authorized him to dispense controlled
substances in schedules II through V as a practitioner at the
registered location of 5629 Jackson Street Ext., Alexandria, Louisiana.
76 FR 49506. However, on March 26, 2008, concurrent with Applicant's
arrest on state drug charges (the circumstances of which are set forth
below), he voluntarily surrendered his registration. Id. Applicant's
registration was then retired by DEA on March 27, 2008. Id.
On July 28, 2008, Applicant applied for a new DEA registration as a
practitioner in schedules IV and V; this application was denied by my
Order of August 10, 2011. Id. On April 19, 2010, Applicant filed a
second application for a practitioner's registration, seeking authority
to handle controlled substances in schedules II thorugh V at the
registered location of Rapides Primary Health Care Center, 1217 Willow
Glenn River Rd., Alexandria, La. 71302. GX 6, at 1. On his application,
Respondent stated that "the DA made me an offer for a program called
PTI and no DEA license for two years. Now, I have completed my part of
the deal, meaning I completed two years without [a] DEA license, and
now I want my unrestricted DEA license back." Id. On December 9, 2010,
Respondent filed a third application; this application was also for the
registered location of the Rapides Primary Health Care Center. GX 7.
Applicant first came to the attention of law enforcement on January
17, 2008, when Louisiana State Police received a call from a pharmacist
that he had authorized prescriptions for "excessive amounts of name
brand narcotics with no generic substitutions allowed." 76 FR at
49506. Upon receipt of this information, an undercover state trooper
(UC1) visited Applicant's clinic with audio/video recording equipment
on January 23, 2008. Id. When Applicant asked UC1 "why he was there,"
UC1 responded by requesting "[h]ydrocodone pain pills." Id. UC1
"initially denied that he was in pain but, after negotiating with
[Applicant], he agreed to falsely state that he was suffering from a
sexually transmitted disease," and Applicant recorded this false
information in UC1's medical file. Id. Then, Applicant, without any
physical examination to verify the claim of illness or symptoms, wrote
prescriptions for 15 Lortab \1\ pills and an antibiotic. Id. The
undercover agent paid $100 for the visit. Id.
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\1\ Lortab, which is a combination drug containing hydrocodone
and acetaminophen, is a schedule III controlled substance. 21 CFR
1308.13(e)(iv).
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Five days later, on January 28, 2008, UC1 returned to Applicant's
clinic seeking additional "pain pills." Id. However, Applicant denied
his request for more pain pills "because 'big brother' was watching
him." Id.
Thereafter, on January 30, February 8, and February 28, 2008, a
second state trooper (UC2) visited Applicant's clinic in an undercover
capacity, while equipped with an audio/video recording device. Id. At
UC2's first visit, Applicant issued her a prescription for
hydrocodone,\2\ notwithstanding UC2's "initially den[ying] she was in
pain" and "later stat[ing] she was in pain in order to obtain a
prescription for hydrocodone." Id. At her second visit on February 8,
Applicant provided prescriptions for hydrocodone and Phenergan with
codeine,\3\ the latter being a cough syrup, "even though she had no
cough or congestion and exhibited no such symptoms." Id. On UC2's
third visit, she requested and obtained from Applicant prescriptions
for hydrocodone and Xanax.\4\ Id. To justify issuing the prescriptions,
Applicant "coached" UC2 about what to say and recorded the coached
statements in her medical file. Id. At the
[[Page 64130]]
undercover visits, Applicant never "require[d] any medical records nor
did he conduct any physical examinations." Id.
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\2\ Hydrocodone is typically combined with acetaminophen. In
this formulation, it is a schedule III controlled substance. 21 CFR
1308.13(e)(iv).
\3\ Phenergan with codeine cough syrup consists of a combination
of promethazine and codeine; it is a schedule V controlled
substance. 21 CFR 1308.15(c).
\4\ Xanax (alprazolam) is a schedule IV controlled substance. 21
CFR 1308.14(c)(1).
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On March 20, 2008, after a state court judge issued a warrant for
Applicant's arrest, Louisiana State Police alerted DEA to the
investigation and pending arrest. Id. Thereafter, on March 26, 2008,
Applicant was arrested and charged with "six counts of prescribing
beyond authority and accepted medical treatment, a violation of
Louisiana Revised Statute 40:971C(1)." Id. Based on Applicant's
arrest, a DEA Diversion Investigator asked for the voluntary surrender
of his DEA registration; Applicant agreed and signed a DEA-104,
Voluntary Surrender of Controlled Substance Privileges.\5\ Id. at
49506-07.
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\5\ As part of the record in this matter, the Government
submitted a copy of the Consent Order applicant entered into with
the Louisiana State Board of Medical Examiners. GX 5. While therein,
Applicant "acknowledge[d] that the reported information could
provide the Investigating Officer with probable cause to pursue
formal administrative proceedings against him for violation of the
[Louisiana Medical Practice] Act," Applicant did not admit to any
of the allegations. Id. at 2. Accordingly, I do not rely on the
Consent Order to make any findings regarding violations of federal
law by the Applicant in prescribing to undercover agents.
However, I find that Respondent had a full and fair opportunity
to litigate the allegations of the first DEA Show Cause Order, even
if he did not avail himself of it. See Alan H. Olefsky, 76 FR 20025,
20031 (2011); Robert L. Dougherty 76 FR 16823, 16830 (2011).
Accordingly, those findings are res judicata in this proceeding.
Olefsky, 76 FR at 20031; Dougherty, 76 FR at 16830.
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Respondent has presented no evidence that he acknowledges his
misconduct and accepts responsibility for it.
Discussion
Section 303(f) of the Controlled Substances Act (CSA) 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 in the case of a practitioner,
Congress directed that the following factors be considered:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * 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.
"[T]hese factors are considered in the disjunctive." Robert A.
Leslie, 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 * * * to deny an application. 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) (citing
Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005)).
In this matter, while I have considered all of the factors, I
conclude that it is not necessary to make findings with respect to
factors one (the recommendation of the state licensing board), three
(applicant's conviction record) and five (such other conduct which may
threaten public health and safety). Having previously found that
Applicant has committed acts which render his registration
"inconsistent with the public interest," 76 FR at 49507 (quoting 21
U.S.C. 823(f), 824(a)(4)), and Applicant having failed to present any
evidence to rebut this conclusion, I will order that his pending
applications for registration be denied.
Factors Two and Four--Applicant's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
Under a longstanding DEA regulation, a prescription for a
controlled substance is not "effective" unless it is "issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice." 21 CFR 1306.04(a). This
regulation further provides that "an order purporting to be a
prescription issued not in the usual course of professional treatment *
* * is not a prescription within the meaning and intent of [21 U.S.C.
829] and * * * the person issuing it, shall be subject to the penalties
provided for violations of the provisions of law related to controlled
substances." Id.; see also La. Rev. Stat. Ann. Sec. 40:961(33) (2008)
(effective Aug. 15, 2004); \6\ La. Rev. Stat. Ann. Sec. 40:1238.2(A)
(2008) (effective Aug. 15, 2006).\7\
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\6\ Louisiana law defines the term "prescription" to mean "a
written request for a drug * * * issued by a licensed physician * *
* for a legitimate medical purpose, for the purpose of correcting a
physical, mental, or bodily ailment, and acting in good faith in the
usual course of his professional practice." La. Rev. Stat. Ann.
Sec. 40.961(33).
\7\ This statute provides that:
A prescription, in order to be effective in legalizing the
possession of legend drugs, shall be issued for a legitimate medical
purpose by one authorized to prescribe the use of such legend drugs.
An order purporting to be a prescription issued to a drug abuser or
habitual user of legend drugs, not in the course of professional
treatment, is not a prescription within the meaning and intent of
this Section. Any person who knows or should know that he or she is
filling such a prescription or order to a drug abuser or habitual
user of legend drugs, as well as the person issuing the
prescription, may be charged with a violation of this Section.
La. Rev. Stat. Ann. Sec. 40:1238.2(A).
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As the Supreme Court recently explained, "the [CSA's] prescription
requirement * * * ensures patients use controlled substances under the
supervision of a doctor so as to prevent addiction and recreational
abuse. As a corollary, [it] also bars doctors from peddling to patients
who crave the drugs for those prohibited uses." Gonzales v. Oregon,
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122,
135, 143 (1975)); see also La. Rev. Stat. Ann. Sec. 40:1238.2(A)
(2008) (effective Aug. 15, 2006).
Under the CSA, it is fundamental that a practitioner must establish
and maintain a bonafide doctor-patient relationship in order to act
"in the usual course of * * * professional practice" and to issue a
prescription for a "legitimate medical purpose." Laurence T.
McKinney, 73 FR 43260, 43265 n.22 (2008); see also Moore, 423 U.S. at
142-43 (noting that evidence established that physician "exceeded the
bounds of 'professional practice,'" when "he gave inadequate physical
examinations or none at all," "ignored the results of the tests he
did make," and "took no precautions against * * * misuse and
diversion"). The CSA generally looks to state law to determine whether
a doctor and patient have established a bonafide doctor-patient
relationship. See Kamir Garces-Mejias, 72 FR 54931, 54935 (2007);
United Prescription Services, Inc., 72 FR 50397, 50407 (2007); but see
21 U.S.C. Sec. 829(e)(2)(B) (providing federal standard for
prescribing over the internet).
Under the regulation of the Louisiana Board of Medical Examiners,
in the treatment of "intractable pain * * * a physician shall comply"
with the Louisiana Pain Rules, including the requirements that a
physician perform an "[e]valuation of the [p]atient" and make a
"[m]edical [d]iagnosis." La. Admin. Code tit. 46:XLV.6921(A) (2008).
"Evaluation of the patient shall initially include relevant medical,
pain, alcohol and substance abuse histories, an assessment of the
impact of pain on the patient's physical and psychological functions, a
review of previous diagnostics studies, previously utilized therapies,
an assessment of coexisting illnesses, diseases, or conditions, and an
appropriate physical examination." Id.
[[Page 64131]]
(emphasis added); see also Armstrong v. La. State Bd. of Med.
Examiners, 868 So. 2d 830, 840 (La.App. 4 Cir. Feb. 18, 2004)
(upholding two year suspension of physician's license; noting that when
prescribing controlled substances for relief of non-malignant pain is
"unaccompanied by appropriate testing, diagnosis, oversight and
monitoring * * * the physician falls below generally accepted standards
of care"); Pastorek v. La. State Bd. of Med. Examiners, 4 So. 3d 833
(La.App. 4 Cir. Dec. 17, 2008). The Board's rules further require that
a "medical diagnosis * * * be established and fully documented in the
patient's medical record." La. Admin. Code tit. 46:XLV.6921(A)(2)
(2008).
Louisiana law also prohibits a physician from "[a]ssist[ing] a
patient or any other person in obtaining a controlled dangerous
substance through misrepresentation, fraud, forgery, deception, or
subterfuge." La. Rev. Stat. Ann. Sec. 40:971.2 (2008) (effective Aug.
15, 2005). It is also unlawful for a physician to "prescribe * * *
legally controlled substances beyond his respective prescribing
authority or for a purpose other than accepted medical treatment of
disease, condition, or illness. Id., at Sec. 40:971(C)(1) (2008)
(effective Sept. 9, 1988).
As found in my Decision and Order of July 27, 2011, on four
occasions, Applicant prescribed drugs containing hydrocodone (including
Lortab and/or Lorcet), which are schedule III narcotics; Xanax, a
schedule IV controlled substance; and Phenergan with codeine, a
schedule V narcotic cough syrup; to Louisiana State Troopers acting in
undercover capacities. See 76 FR at 49508. Notably, Applicant issued
these prescriptions without conducting a physical examination at any of
the visits and the undercover agents received these prescriptions even
though they did not demonstrate conditions or symptoms that would
justify the prescriptions. Id.
Moreover, both undercover agents initially denied they were in
pain, but Applicant assisted the agents in obtaining controlled
substances by encouraging them to make false statements. See id. For
example, while he denied being in pain, UC1 asked Applicant for
"[h]ydrocodone pain pills," and then "negotiate[ed]" with Applicant
to "falsely state" he had a sexually transmitted disease. Id.
Likewise, Applicant also "coached" the second undercover agent on
what to say to "justify issuing the prescriptions and wrote her
coached statements in a medical file." Id. Therefore, Applicant failed
to establish a physician-patient relationship, lacked a legitimate
medical purpose, and acted outside of the usual course of professional
practice in prescribing controlled substances to the undercover agents
and thus violated Federal law. See id. (citing 21 CFR 1306.04(a); 21
U.S.C. 841(a)(1); see also Louisiana v. Moody, 393 So. 2d 1212, 1215
(La. 1981) (holding that physician furnished prescriptions for "other
than a legitimate medical purpose" based on evidence showing that
prescriptions were issued in response to specific requests of patients
and physician did not conduct physical examinations or take medical
histories)).
I therefore hold again that granting Applicant's applications for a
new registration "would be inconsistent with the public interest.\8\"
21 U.S.C. 823(f). Accordingly, I will order that Applicant's pending
applications be denied.
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\8\ As found above, Applicant stated in his second application
that "the DA made me an offer for a program called PTI and no DEA
license for two years," and that because he has "completed two
years without [a] DEA license," he "want[s] [his] unrestricted DEA
license back." GX 6. Respondent has presented no evidence that any
DEA official agreed to the deal he made with the district attorney,
and in any event, a state official has no authority to bind this
Agency. See Edmund Chein, 72 FR 6580, 6590 (2007) (Congress granted
the authority to determine whether a registration "is consistent
with the public interest" to "the Attorney General of the United
States, and that authority has been delegated solely to the
officials of [DEA]. State officials therefore lack authority to
resolve a matter pending before the Drug Enforcement
Administration" and cannot bind this Agency.) (citing 21 U.S.C.
824, 28 CFR 0.100(b), and Fourth Street Pharmacy v. DEA, 836 F.2d
1137, 1139 (8th Cir. 1988)); see also 21 U.S.C. 823(f)).
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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 applications (Control Numbers W10020882C
and W10078290C) of Jose Gonzalo Zavaleta, M.D., for a DEA Certificate
of Registration as a practitioner be, and they hereby are, denied. This
order is effective November 19, 2012.
Dated: October 8, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-25576 Filed 10-17-12; 8:45 am]
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