FR Doc E9-2331[Federal Register: February 4, 2009 (Volume 74,
Number 22)] [Notices] [Page 6056-6059] From the Federal Register
Online via GPO Access [wais.access.gpo.gov] [DOCID:fr04fe09-79]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Ladapo O. Shyngle, M.D.; Denial of Application
On April 15, 2008, the Deputy Assistant Administrator, Office
of Diversion Control, Drug Enforcement Administration, issued an
Order to Show Cause to Ladapo O. Shyngle, M.D. (Respondent), of
Tampa, Florida. 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 his
registration "would be inconsistent with the public
interest." Show Cause Order at 1.
More specifically, the Show Cause Order alleged that
Respondent had issued controlled-substance prescriptions to
customers of an internet site who were located throughout the
United States based on a questionnaire and/or telephone
consultation, and that these prescriptions lacked "a
legitimate medical purpose" and were issued "outside
the usual course of professional practice, in violation of 21
CFR 1306.04(a) and 21 U.S.C. 841(a)(1)." Id. The Order
further alleged that notwithstanding that his Florida medical
license had expired on August 24, 2002, Respondent continued to
issue prescriptions for controlled substances. Id. Relatedly,
the Order alleged that Respondent had violated other state laws
prohibiting the unauthorized practice of medicine by issuing
prescriptions for controlled substances to residents of States
where he was not licensed to practice. Id. at 1-2.
On or about April 19, 2008, the Show Cause Order was served
on Respondent by delivery to his residence. On May 14, 2008,
Respondent requested a hearing on the allegations and the matter
was placed on the docket of the Agency's Administrative Law
Judges (ALJ).
On the same date, Respondent also sought to withdraw his
application, explaining that the State of Florida had criminally
charged him with engaging in the unlicensed practice of
medicine, that he intended "to vigorously defend"
against this charge, and that in light of the pending
proceeding, it was premature for the Agency to consider his
application. On May 29, 2008, the Deputy Assistant Administrator
denied Respondent's request, reasoning that "the facts
supporting the Order to Show Cause will not be affected by the
outcome of the state prosecution" and that Respondent
"intend[ed] to continue professional medical practice and *
* * reapply for a * * * [r]egistration at the conclusion of the
state criminal case." Letter from Joseph T. Rannazzisi to
Respondent's Counsel (May 29, 2008).
Thereafter, on July 9, 2008, Respondent withdrew his request
for a hearing. The next day, the ALJ issued an order terminating
the proceeding.
Based on Respondent's letter withdrawing his request for a
hearing, I conclude that Respondent has waived his right to a
hearing. I therefore enter this Final Order without a hearing
based on relevant material contained in the investigate file,
see 21
CFR 1301.43, and make the following findings.
Findings
On October 3, 2005, Respondent applied for a DEA Certificate
of Registration as a practitioner which would authorize him to
dispense controlled substances in schedules II through V, at the
proposed location of 1493 Tampa Park Plaza, Tampa, Florida.
Respondent previously held a practitioner's registration which
was issued on December 11, 2000, and which expired on February
29, 2004.
On August 24, 2000, the Florida Department of Health issued a
"medical doctor restricted" license to Respondent. The
license expired, however, on August 24, 2002. Respondent did not
obtain another medical license until September 16, 2005, when
the Florida Department of Health issued him a "medical
doctor" license. This license remains in effect until
January 31, 2010. I further find that Respondent was not
licensed in any other State when he committed the acts at issue
here.
In 2002, Respondent was hired by Kenneth Shobola, the owner
of a Tampa, Florida medical clinic (the Kenaday Medical Clinic),
to perform consultations on persons who were seeking
prescriptions for controlled substances through Shobola's Web
sites. While Respondent saw some walk- in patients at the
clinic, in an interview with DEA Investigators, he admitted that
he saw only about five percent of the persons he prescribed to,
and that his contact with most of the patients was limited to a
telephone consultation which lasted five to ten minutes.
Based on the consultations, Respondent would then typically
issue a prescription for a schedule III controlled substance
containing hydrocodone; Respondent also issued prescriptions for
diazepam (Valium), a schedule IV controlled substance, 21
CFR 1308.14(c), and some non-controlled drugs. While the
prescriptions were initially filled at F & B Pharmacy
(another Tampa-based pharmacy which was operated by Olu Oyekoya),
F & B eventually pulled out of the arrangement and all of
the prescriptions were then filled by Ken Drugs, a pharmacy
owned by Shobola.
Respondent would perform up to twenty consultations a day for
Shobola's clinic. According to computer records obtained by
Investigators, Respondent issued over 3800 prescriptions which
were filled by Shobola's pharmacy. Approximately seventy-five
percent of the prescriptions were for hydrocodone, and between
the original prescriptions and refills, Respondent authorized
the dispensing of more than 500,000 dosage
[[Page 6057]]
units of the drug. Moreover, the prescriptions were issued to
persons in forty-one different States.
When asked by Investigators how he had established a
doctor-patient relationship with the patients he did not see,
Respondent maintained that he did so because he "actually
spoke to the patient on the phone," and that the Web site
which arranged the consultations had the patient's medical
records and "the driver's license to identify the
patient." Respondent admitted, however, that because of the
number of "consults," "seventy percent" of
the time he did not see a patient's medical records until after
he had issued the prescription. Respondent also admitted that
there were occasions when he never saw a patient's medical
records. Respondent even admitted that "we did do refills
for patients" who had not submitted records because
"the patient [was] already in the system, [and] we already
kn[ew] about this patient." \1\
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\1\ Respondent also acknowledged that a
patient had to have a physical exam at some point and
maintained that the clinic had hired either nurses or
paramedics to perform physical exams on patients. Even if
true, this does not aid Respondent for two reasons: (1)
Respondent has not established the circumstances in which it
may be lawful under the laws of the various States for a
physician to rely on a physical examination performed by a
nurse or paramedic, and (2) Respondent acknowledged that
seventy percent of the time he did not see the records until
after he prescribed. Respondent thus routinely prescribed
without any independent assessment and verification of his
patients' medical complaints.
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Respondent further stated that he was "not sure whether
the law actually gives specific guidelines as to what
constitutes the patient/ physician relationship because * * *
when the laws were drawn there was no internet." When asked
whether he was saying that he did not know if his prescribing
was legal because he did not know the law, Respondent replied:
"No, what I'm saying is * * * I think the law the way it
stands * * * makes a loophole available in terms of * * * what
constitutes [the] patient/doctor relationship, when you * * *
talk to the patient on the phone. * * * [T]hat is a leeway
that's provided and that's what I had in mind when I got
involved with * * * the whole thing."
Respondent acknowledged, however, that this method of
prescribing "certainly" opened the door to drug abuse
and that "providing medication through the internet has to
provide safeguards to make sure that the patients are genuine,
[that] they're not getting multiple drugs from different doctors
and that * * * they actually have the problem that they're
taking about." Moreover, Respondent stated to Investigators
that "the way we practiced * * * in Kennedy there's no way
you could get all of those [illegitimate patients] out of the
system * * * 100% of the time." Respondent further asserted
that "there was a good proportion of people that actually
needed help that got the help," but acknowledged that
"there were quite a few that [were] just doctor hopping or
* * * shopping for medication."
As examples of Respondent's prescribing, the Government
submitted copies of fourteen prescriptions which Respondent
issued for such drugs as Norco (10/325 mg.), Lortab (10/500
mg.), Vicoprofen (7.5/200 mg.), and Vicodin (7.5/750 mg.), all
of which are schedule III controlled substances containing
hydrocodone. Most of the prescriptions were issued between
October and December 2003, and were issued to patients in
California, Massachusetts, Ohio, Oklahoma, Tennessee, Wisconsin,
Washington (State), Mississippi, South Carolina, and Virginia.
Respondent also prescribed controlled substances to a married
couple (Mr. & Mrs. C.W.), who had used driver's licenses and
medical records of friends and family members, as well as
falsified medical records (including MRIs), in order to create
multiple identities and obtain larger quantities of drugs such
as hydrocodone and alprazolam. The C.Ws. both consumed and sold
the drugs.
Discussion
Section 303(f) of the Controlled Substances Act (CSA)
provides that "[t]he Attorney General may deny an
application for [a practitioner's] registration if he determines
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 Act 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.
[T]hese 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 a 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). Having considered all the factors, I find that
factors two and four provide ample support for the conclusion
that granting Respondent's application for a registration would
be "inconsistent with the public interest." \2\ 21
U.S.C. 823(f). Respondent's application will therefore be
denied.
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\2\ I acknowledge that there is no evidence
that the State of Florida has taken any action against
Respondent's authority under State law to prescribe controlled
substances. This Agency has long held, however, that a State's
failure to take action against a practitioner's authority to
dispense controlled substances is not dispositive in
determining whether the granting of an application for
registration would be consistent with the public interest. See
Mortimer B. Levin, 55 FR 8209, 8210 (1990). I further note
that Respondent alluded to his intention to vigorously contest
a pending criminal charge based on his having engaged in the
unlicensed practice of medicine. Under agency precedent, even
if Respondent is acquitted of the charge(s), the judgment
would not be dispositive in this proceeding, which focuses on
the public interest. Edmund Chein, 72 FR 6580, 6593 n.22
(2007).
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Factor Two and Four--Respondent's Experience in Dispensing
Controlled Substances and Record of Compliance With Applicable
Controlled Substance Laws
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
relating to controlled substances." Id. As the Supreme
Court recently explained, "the 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 (1975)).
Under the CSA, it is fundamental that a practitioner must
establish a bonafide
[[Page 6058]]
doctor-patient relationship in order to act "in the
usual course of * * * professional practice" and to issue a
prescription for a "legitimate medical purpose."
Moore, 423 U.S. at 141-43. At the time of the events at issue
here, the CSA generally looked 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); Dispensing and Purchasing Controlled Substances Over the
Internet, 66 FR at 21182-83.\3\
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\3\ On October 15, 2008, the President
signed into law the Ryan Haight Online Pharmacy Consumer
Protection Act of 2008, Public Law 110-425, 122 Stat. 4820
(2008). Section 2 of the Act prohibits the dispensing of a
prescription controlled substance "by means of the
Internet without a valid prescription," and defines, in
relevant part, "[t]he term 'valid prescription' [to]
mean[] a prescription that is issued for a legitimate medical
purpose in the usual course of professional practice by * * *
a practitioner who has conducted at least 1 in-person medical
evaluation of the patient." 122 Stat. 4820. Section 2
further defines "[t]he term 'in-person medical
evaluation' [to] mean[] a medical evaluation that is conducted
with the patient in the physical presence of the practitioner,
without regard to whether portions of the evaluation are
conducted by other health professionals." Id. These
provisions do not, however, apply to Respondent's conduct.
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Moreover, shortly after the CSA's enactment, the Supreme
Court explained that "[i]n the case of a physician [the
Act] contemplates that he is authorized by the State to practice
medicine and to dispense drugs in connection with his
professional practice." Moore, 423 U.S. at 140-41 (emphasis
added). Accordingly, "[a] physician who engages in the
unauthorized practice of medicine" under state laws
"is not a 'practitioner acting in the usual course of * * *
professional practice' " under the CSA. United Prescription
Services, 72 FR at 50407 (quoting 21 CFR 1306.04(a)). This rule
is supported by the plain meaning of the Act, which defines the
"[t]he term 'practitioner' [to] mean[] a physician * * *
licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices * * * to * * *
dispense * * * a controlled substance," 21
U.S.C. 802(21), and "[t]he term 'dispense' [to] mean[]
to deliver a controlled substance to an ultimate user * * * by,
or pursuant to the lawful order of, a practitioner." Id.
section 802(10). See also id. section
823(f) ("The Attorney General shall register
practitioners * * * to dispense * * * if the applicant is
authorized to dispense * * * controlled substances under the
laws of the State in which he practices.").
A controlled-substance prescription issued by a physician who
lacks the license or other authority required to practice
medicine within a State is therefore unlawful under the CSA. See
21
CFR 1306.04(a) ("An order purporting to be a
prescription issued not in the usual course of professional
treatment * * * is not a prescription within the meaning an
intent of" the CSA); Cf. 21
CFR 1306.03(a)(1) ("A prescription for a controlled
substance may be issued only by an individual practitioner who
is * * * [a]uthorized to prescribe controlled substances by the
jurisdiction in which he is licensed to practice his
profession[.]").
The investigative file establishes numerous instances in
which Respondent violated the prescription requirement of
Federal law as well as various state laws. As found above,
Respondent's initial Florida medical license expired on August
24, 2002, and Respondent did not obtain a new Florida license
until September 16, 2005. Thus, at the time Respondent
prescribed controlled substances to many of the customers of the
Kenaday Medical Clinic, he did not even have authority to
prescribe under Florida law, let alone the laws of the forty
other States where his patients resided. See Fla. Stat. Sec.
Sec. 456.065 (2003); 458.327(1)(a) (2003); see also, e.g., Cal.
Bus. & Prof. Code section 2052(a) (2003) (prohibiting
unlicensed practice of medicine); Cal. Health & Safety Code
section 11352(a) (2003) (prohibiting furnishing of a controlled
substance "unless upon the written prescription of a
physician * * * licensed to practice in this state"); Tenn.
Comp. R. & Regs. 0880-2.16 (2003) (requiring license to
"engage in the practice of medicine across state lines in
this State").
As the California Court of Appeal has noted, the
"proscription of the unlicensed practice of medicine is
neither an obscure nor an unusual state prohibition of which
ignorance can reasonably be claimed, and certainly not by
persons * * * who are licensed health care providers. Nor can
such persons reasonably claim ignorance of the fact that
authorization of a prescription pharmaceutical constitutes the
practice of medicine." Hageseth v. Superior Court, 59 Cal.
Rptr.3d 385, 403 (Ct. App. 2007). In issuing thousands of
prescriptions while lacking the authority to do so under the
laws of both Florida and the States where the patients resided,
Respondent acted outside of "the usual course of * * *
professional practice" and thereby violated the
prescription requirement of the CSA (as well as numerous state
laws). See Moore, 423 U.S. at 140-41; United Prescription
Services, 72 FR at 50407; 21 CFR 1306.03.
Respondent violated the CSA's prescription requirement for an
additional reason because he did not establish a bonafide
doctor- patient relationship with the customers of the Web site.
As Respondent admitted to the Investigators, with the possible
exception of the small number of customers who appeared at the
clinic, Respondent prescribed on the basis of a telephonic
consultation and did not personally conduct a physical exam and
take a medical history from the patients. In his interview with
the Investigators, Respondent gave two justifications for his
prescribing. First, Respondent maintained that the law did not
provide specific guidelines that addressed what constitutes a
valid doctor-patient relationship in the context of the
internet, asserting that those laws were enacted when
"there was no internet," and that he acted within a
loophole. Second, he maintained that the clinic had hired nurses
or paramedics who visited the patients and performed physical
exams on them.
As for his first contention, at the time Respondent issued
the prescriptions at issue here, numerous States had already
adopted laws or regulations, or had issued policy statements,
which made clear that Respondent's internet prescribing
practices were illegal. See, e.g., Cal. Bus. & Prof. Code
section 2242.1(a); Tenn. Comp. R. & Regs. 0880- 2.14(7)
(2003) ("Prerequisites to Issuing Prescriptions";
prohibiting the prescribing or dispensing of "any drug to
any individual, whether in person or by electronic means or over
the Internet or over telephone lines unless the physician, or
his/her licensed supervisee pursuant to appropriate protocols or
medical orders, has first done and appropriately documented, for
the person to whom a prescription is to be issued or drugs
dispensed * * * an appropriate history and physical
examination"); Ohio Admin. Code 4731-11-09(A) (2003)
("Except in institutional settings, on call situations,
cross coverage situations, situation involving new patients,
protocol situations involving nurses practicing in accordance
with standard care arrangements * * * a physician shall not
prescribe, dispense, or otherwise provide, or cause to be
provided, any controlled substance to a person who the physician
has never personally physically examined and diagnosed.");
Oklahoma State Board of Medical Licensure and Supervision,
Policy on Internet Prescribing (Ratified 01/25/01)
("Unprofessional conduct includes 'prescribing * * * a drug
* * * without sufficient examination and the
[[Page 6059]]
establishment of a valid physician/patient relationship' * *
*. The members of the Oklahoma Medical Board have interpreted
that a 'sufficient examination' and 'establishment of a valid
physician/ patient relationship' cannot take place without an
initial face to face encounter with the patient.")
(emphasis in original and quoting Okla. Stat. tit. 59, section
509-13). No more persuasive is Respondent's contention that his
prescribings were lawful because the clinic used nurses or
paramedics to perform physical examinations. Respondent did not
provide any evidence to the Agency that the clinic's purported
use of nurses to perform physical examinations was a lawful
practice under the exceptions recognized by any State.\4\
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\4\ Even if some States authorize a
physician to prescribe in some circumstances based on a
physical exam performed by a nurse, Respondent was required to
comply with the law of every State in which his patients
resided. In any event, Respondent did not establish that his
prescribing was lawful under the law of any State.
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Moreover, Respondent admitted to the Investigators that he
routinely prescribed before he obtained medical records and in
some cases he never reviewed records. Thus, even if some States
allowed a physician to prescribe based on an exam performed by a
nurse or paramedic in certain defined circumstances, a physical
examination is a prerequisite to establishing a valid
doctor-patient relationship. See Tenn. Comp R. & Regs
0880-2-.14(7). Generally, reviewing an examination conducted
after the issuance of a prescription is not the usual course of
professional practice.\5\ I thus conclude that Respondent lacked
a legitimate medical purpose and acted outside of the usual
course of professional practice in issuing the prescriptions.
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\5\ It is acknowledged that the States
generally allow a practitioner to issue a prescription in an
emergency situation before conducting a physical exam. See 49
Pa. Code Sec. 16.92(a). Some States also allow a practitioner
to issue a short term continuation prescription for a new
patient prior to a patient's first appointment, in an order
admitting a patient to a hospital, or for a patient of another
physician for whom the prescriber is taking calls. Tenn. Comp.
R. & Regs. 0880-2-.14(7)(b). None of these exceptions
apply here.
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Respondent's prescribing practices clearly resulted in the
diversion of controlled substances. As Respondent acknowledged
in the interview, "there were quite a few [patients] that
[were] just doctor hopping or * * * shopping for
medication." \6\ Indeed, as the record establishes,
Respondent prescribed to two people who used falsified records
and the driver's licenses of other persons, to obtain such
highly abused controlled substances as hydrocodone and
alprazolam, which they both personally abused and sold to
others. Given the thousands of prescriptions he issued in this
manner, there were likely numerous other instances in which he
prescribed to persons who were seeking the drugs for illicit
purposes.
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\6\ I reject as self-serving Respondent's
assertion that he believed that "a good proportion of
[the] people [he prescribed to] actually needed help"
because their original doctors had become "weary" of
continuing to prescribe narcotics to them. Notably, Respondent
did not identify a single instance in which he contacted the
original physicians of the patients to even determine whether
a patient had a legitimate medical condition which required
the continued prescribing of a controlled substance. As
Respondent himself recognized, internet prescribing invites
"doctor hopping" and "medication shopping"
by drug abusers and drug dealers. In short, as this Agency has
found in the course of numerous investigations, the risk of
diversion inherent in internet prescribing is extraordinary.
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It is therefore clear that Respondent committed acts which
establish that granting him a new registration would be
"inconsistent with the public interest." 21
U.S.C. 823(f).\7\ Respondent's application will therefore be
denied.
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\7\ In his request for a hearing, Respondent
"disagreed * * * that [the] prescriptions were issued
without a legitimate medical purpose and outside the usual
course of professional practice." While Respondent's
counsel further represented that he did not intend to "practic[e]
medicine in any way related to an Internet pharmacy,"
Respondent has not satisfied the Agency's standard for
obtaining a new registration, which requires that an applicant
accept responsibility for his misconduct and acknowledge his
wrongdoing. See, e.g., Medicine Shoppe--Jonesborough, 73 FR
364, 387 (2008) (collecting cases), aff'd, Medicine
Shoppe-Jonesborough v. DEA, slip op. at 9-10 (6th Cir. Nov.
13, 2008); Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir, 2005)
("admitting fault" is "properly consider[ed]"
by DEA to be an "important factor[]" in the public
interest determination).
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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 of Ladapo O. Shyngle, M.D., for a DEA Certificate of
Registration as a practitioner be, and it hereby is, denied.
This order is effective March 6, 2009.
Dated: January 27, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-2331 Filed 2-3-09; 8:45 am]
BILLING CODE 4410-09-P
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