Janet L. Thornton, D.O.; Dismissal of Proceeding, 50354-50356 [E8-19763]
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50354
Federal Register / Vol. 73, No. 166 / Tuesday, August 26, 2008 / Notices
that the case was not moot, he should
specifically address why he failed to file
a renewal application and what
collateral consequences attach as a
result of the suspension order.
On June 5, the Government filed its
brief. As relevant here, the Government
maintains that this proceeding is now
moot and that the matter should now be
dismissed. See Brief in Response to the
Order of the Deputy Administrator at
10. As of this date, Respondent has not
filed a brief.
In light of Respondent’s failure to
comply with the briefing order, his
failure to file a renewal application, and
his failure to provide any evidence of
his intent to remain in professional
practice or of other collateral
consequences that attached with the
issuance of the suspension order, I
conclude that this case is now moot.
Accordingly, the Order to Show Cause
will be dismissed.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824, as well as 21 CFR
0.100(b) and 0.104, I hereby order that
the Order to Show Cause issued to
Elmer P. Manalo, M.D., be, and it hereby
is, dismissed. This Order is effective
immediately.
Dated: August 18, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8–19773 Filed 8–25–08; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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Janet L. Thornton, D.O.; Dismissal of
Proceeding
On December 17, 2007, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Janet L. Thornton, D.O.
(Respondent), of Monument, Colorado.
The Show Cause Order sought the
revocation of Respondent’s DEA
Certificate of Registration, AT2730984,
as a practitioner, and the denial of any
pending applications to renew or
modify her registration, on two separate
grounds.
First, it alleged that Respondent had
entered into a series of stipulations with
the Colorado Board of Medical
Examiners under which she agreed that
she ‘‘will not practice medicine in the
State of Colorado.’’ Show Cause Order at
2. Relatedly, the Show Cause Order
alleged that Respondent’s ‘‘Colorado
medical license expired on May 31,
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2007, and has not been renewed,’’ and
that therefore Respondent lacks state
authority to handle controlled
substances, which is a prerequisite for
holding a DEA registration. Id.
Second, the Show Cause Order
alleged that on December 3, 2005, the
Colorado Board suspended
Respondent’s state medical license thus
resulting in her lacking authority to
handle controlled substances. Id. at 1.
The Show Cause Order alleged that
while her state license was suspended,
Respondent issued two prescriptions to
her neighbors: one in January 2006, for
Tussionex, a schedule III controlled
substance, and one in June 2006, for a
schedule III drug containing
hydrocodone. Id. at 1–2. Relatedly, the
Show Cause Order also alleged that in
2005, Respondent issued a prescription
for morphine to B.V., and that B.V. had
‘‘later informed investigators that he had
no knowledge of the * * * prescription
and was never dispensed the drug.’’ Id.
at 2.
On February 12, 2008, the Show
Cause Order was served on Respondent
by First Class Mail at her registered
location. On March 3, 2008, Respondent
filed a written statement in lieu of a
request for a hearing and expressly
waived her right to a hearing. See 21
CFR 1301.43(c). Thereafter, the
investigative file was forwarded to me
for final agency action.
Having considered the entire record
in this matter, including Respondent’s
statement, I hereby issue this Decision
and Final Order. I conclude that the
Government has not proved by
substantial evidence the allegations
regarding the prescriptions to B.V. or
that Respondent currently lacks state
authority to handle controlled
substances. While I find that
Respondent violated the Controlled
Substances Act by issuing prescriptions
for controlled substances following the
suspension of her Colorado license, I
further conclude that because the
violations were limited to two instances
and there is no evidence establishing
that Respondent had not previously
entered into a doctor-patient
relationship with the two persons who
received the prescriptions, the
Government’s proposed sanction of
revocation would be excessive. Because
the Government has not proposed an
alternative sanction, the Show Cause
Order will be dismissed.
Findings of Fact
Respondent holds DEA Certificate of
Registration, AT2730984, which
authorizes her to handle controlled
substances as a practitioner at her
registered location in Monument,
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Colorado. Respondent’s registration was
last renewed on October 18, 2005, and
does not expire until November 30,
2008.
In May 2005, an Inquiry Panel of the
Colorado State Board of Medical
Examiners ordered that Respondent be
evaluated by the Colorado Physician
Health Program. In re Janet L. Thornton,
Stipulation and Final Agency Order
(Col. St. Bd. Med. Exam’rs 2007).
Thereafter, on December 15, 2005, the
Board suspended Respondent’s state
medical license. Respondent’s state
license remained suspended until May
17, 2007, the date when Respondent
entered into a stipulation for the interim
cessation of practice, under which she
agreed to cease the practice of medicine.
Respondent subsequently agreed to two
additional amendments of the
stipulation which extended the initial
stipulation.
On October 25, 2007, Respondent and
the Board entered into a Stipulation and
Final Agency Order, which became
effective on November 16, 2007, upon
the Board’s approval. Id. at 7. According
to the Board’s Final Order, Respondent
has ‘‘continuously’’ held her state
license since April 10, 1986. Id. at 1.
In the Order, the Board imposed
certain practice restrictions on
Respondent. The first of these was that
‘‘Respondent shall not engage in any act
constituting the practice of medicine in
the state of Colorado unless such
practice occurs within a clinical setting
approved in advance by the Panel or
unless such practice occurs in a
hospital.’’ Id. at 5. The second
restriction was that ‘‘Respondent shall
order, dispense, administer or prescribe
any controlled substance or other
prescription medications only for
persons with whom Respondent has a
bona fide physician-patient relationship
and only within the context of
Respondent’s practice in a clinical
setting approved in advance by the
Panel or a hospital.’’ Id. Based on the
above, I find that contrary to the
Government’s contention, Respondent
retains authority to handle controlled
substances in Colorado.
As relevant to the Show Cause Order’s
allegations regarding her improper
prescribing, Respondent admitted in the
stipulation that she:
issued prescriptions and ordered
medications while her license was
suspended. Respondent had consulted with
an out-of-state attorney who stated that he
consulted Colorado attorneys and advised
her that she was authorized to issue
prescriptions and order medications in the
state of Colorado while her Colorado license
was suspended under the authority of out-ofstate licenses. The Panel finds that the out-
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of-state attorney’s interpretation of
Colorado’s Medical Practice Act was
erroneous.
Id. at 3.
The record establishes that on January
23, 2006, while her Colorado license
was suspended, Respondent issued a
prescription with one refill to D.V., her
neighbor in Colorado, for Tussionex
Extended Release, a schedule III
controlled substance which contains
hydrocodone. On June 6, 2006,
Respondent issued an additional
prescription to B.V., who was also her
neighbor, for thirty tablets of
hydrocodone/apap (10/500mg.) which
was to last five days.1 At the time she
issued both prescriptions, Respondent
was practicing in Texas, where she also
holds a medical license. While DEA
Investigators interviewed both D.V. and
B.V., there is no evidence establishing
that Respondent had not previously
entered into a legitimate doctor-patient
relationship with either person or that
the prescriptions were issued for other
than a legitimate medical purpose.
In support of her Response to the
Show Cause Order, Respondent
submitted a copy of a February 20, 2007
letter from Jeff Martin, a lawyer in
Tulsa, Oklahoma. This letter states that
Respondent:
asked me about writing occasional
prescriptions infrequently for Colorado
residents who were her neighbors using her
Texas and/or Oklahoma license even though
her Colorado license was summarily
suspended. I told her, as long as her Texas
and/or Oklahoma licenses were still valid
that she could still occasionally consult with
her neighbors and prescribe medicine. I still
believe this is accurate.
Later when I tried to help her find a lawyer
in Colorado, I asked two Colorado lawyers
who are knowledgeable in this area about
this and they believed she could continue
occasionally prescribing medicine also. I’m
sorry, but I no longer have the names and
phone numbers of the lawyers I spoke to.
sroberts on PROD1PC76 with NOTICES
Exhibit C to Respondent’s Response To
Order To Show Cause.
Respondent also attached to her
Response a copy of Col. Stat. § 12–36–
106, which defines the practice of
medicine under Colorado law and
provides for certain exemptions from
the licensing requirements. This statute
states that:
Nothing in this section shall be construed
to prohibit, or to require a license * * *
under this article with respect to, any of the
following acts:
* * *
(b) The rendering of services in this state
by a physician lawfully practicing medicine
1 While
the record shows that Respondent issued
several other prescriptions to B.V. and D.V., none
of these were for controlled substances. These
prescribings are not the concern of DEA.
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Jkt 214001
in another state or territory, whether or not
such physician is in Colorado, but if any
such physician does not limit such services
to an occasional consultation or cases * * *
such physician shall possess a license to
practice medicine in this state.
Colo. Stat. § 12–36–106(3)(b).
The Government also alleged that
Respondent had issued a prescription to
B.V. for morphine, but that B.V. denied
ever receiving the prescription. This
allegation is not, however, supported by
substantial evidence as there is no
evidence that Respondent ever issued a
morphine prescription to an individual
with these initials.2
Discussion
Under Section 304(a) of the
Controlled Substances Act (CSA), the
Attorney General may revoke or
suspend a registration to dispense a
controlled substance ‘‘upon a finding
that the registrant * * * has had [her]
State license or registration suspended,
revoked, or denied by competent State
authority and is no longer authorized by
State law to engage in the * * *
dispensing of controlled substances.’’ 21
U.S.C. 824(a)(3). Section 304(a) further
authorizes the Attorney General to
suspend or revoke a registration ‘‘upon
a finding that the registrant * * * has
committed such acts as would render
his registration under section 823 of this
title inconsistent with the public
interest as determined under such
section.’’ Id. § 824(a)(4).
In section 303(f) of the CSA, Congress
directed that the Attorney General
consider five factors ‘‘[i]n determining
the public interest.’’ 21 U.S.C. 823(f).
The factors are:
(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.
2 While there is evidence that Respondent issued
a morphine prescription to D.H., even if this
incident had been properly alleged, I would still
reject it as unsupported by substantial evidence.
While the record contains a summary of an
interview in which D.H. stated that he did not recall
receiving the morphine prescriptions, D.H.
subsequently prepared a letter in which he retracted
his earlier statement and acknowledged he ‘‘had
completely forgotten about the lower back and hip
pain that prompted me to ask for pain medication.’’
Exh. E to Respondent’s Resp. to Order to Show
Cause. The Government, which has the burden of
proof even when a case does not go to a hearing,
has not pointed to any additional evidence to
support the conclusion that D.H.’s initial story to
investigators is the more accurate version.
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50355
(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 a registration
should be revoked.’’ 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 set forth the applicable
law, I address each of the Government’s
contentions.
The Lack of State Authority
As found above, Respondent’s
Colorado medical license was
suspended on December 15, 2005.
Effective November 16, 2007—one
month before the Show Cause Order
was issued—the Colorado Board
restored Respondent’s license to
practice medicine and her authority to
prescribe controlled substances. While
Respondent’s authority to handle
controlled substances limits her practice
to a board-approved clinical setting or a
hospital, the Board’s Order make plain
that Respondent currently has authority
to handle controlled substances in
Colorado. The Government’s contention
to the contrary is therefore rejected.
The Public Interest Allegations
In United Prescription Services, Inc.,
72 FR 50397, 50407 (2007), I held that
‘‘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.
21 CFR 1306.04(a).3 As explained
therein, 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. § 802(10).
See also id. § 823(f) (‘‘The Attorney
General shall register practitioners
* * * to dispense * * * if the applicant
is authorized to dispense * * *
3 Under 21 CFR 1306.04(a), ‘‘[a] prescription for
a controlled substance to be effective must be
issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of
his professional practice.’’
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controlled substances under the laws of
the State in which he practices.’’).
As I noted in United Prescription
Services, 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.’’ United States v. Moore, 423
U.S. 122, 140–41 (1975) (emphasis
added) (quoted at 72 FR 50407). 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[.]’’).
In the Stipulation and Final Agency
Order, Respondent admitted that the
prescribings to B.V. and D.V.
constituted ‘‘prescribing * * * other
than in the course of legitimate
professional practice’’ under Colorado
law. See In re Thornton, Stipulation and
Final Agency Order, at 3. Accordingly,
I conclude that the prescriptions
Respondent issued to D.V. and B.V.
were issued outside of the course of
professional practice and thus also
violated Federal law. See 21 CFR
1306.04(a); Moore, 423 U.S. at 140–41;
United Prescription Services, 72 FR at
50407. The prescribings thus
constituted acts which render her
registration ‘‘inconsistent with the
public interest.’’ 21 U.S.C. 824(a)(4); see
also id. § 823(f)(2) & (4) (directing
consideration of registrant’s ‘‘experience
in dispensing controlled substances’’
and compliance with applicable federal
and state laws).
I nonetheless conclude that it would
be inappropriate to revoke Respondent’s
registration. With respect to the
allegations, the record establishes only
two instances in which Respondent
unlawfully prescribed controlled
substances. Moreover, while ordinarily
a practitioner cannot credibly claim
ignorance of state laws prohibiting the
unlicensed practice of medicine, United
Prescription Services, 72 FR at 50407;
the Colorado Board’s interpretation that
Respondent was not within the
exemption provided in Colo. Stat. § 12–
36–106(b)(3), and that she thus violated
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the State’s Medical Practice Act, appears
to have been a case of first impression.4
Moreover, the Government has failed
to show the absence of a legitimate
doctor-patient relationship between
Respondent and either person.
Relatedly, there is no evidence that the
prescriptions were written for other
than a legitimate medical purpose. In
short, the evidence does not remotely
suggest that Respondent was using her
prescription writing authority to deal
drugs. See Gonzales v. Oregon, 546 U.S.
243, 270 (2006).
Furthermore, the Colorado Board has
considered Respondent’s state law
violations and concluded that they do
not warrant the revocation of her
medical license. Under agency
precedent, I am not bound by the State
Board’s recommendation. Nonetheless,
because the only proven violations of
the CSA are based on her having
violated the Colorado Medical Practice
Act’s licensing provision and were
limited to two instances, I conclude that
Respondent’s violations do not warrant
the revocation or suspension of her
registration.
While in some instances, this Agency
has placed restrictions on a
practitioner’s registration, such
restrictions must be related to what the
Government has alleged and proved in
any case. Notably, in this matter the
Government has proposed no alternative
sanction to revocation. Accordingly, the
Order to Show Cause will be dismissed.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a), as well as 28 CFR
0.100(b) and 0.104, I hereby order that
the Order to Show Cause issued to Janet
L. Thornton, D.O., be, and it hereby is,
dismissed.
Dated: August 18, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8–19763 Filed 8–25–08; 8:45 am]
BILLING CODE 4410–09–P
4 While the Colorado Board found that
Respondent’s attorney’s interpretation of the
Medical Practice Act ‘‘was erroneous,’’ the Board’s
Order did not cite any prior decision holding that
Respondent’s conduct was illegal.
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This biweekly notice includes all
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Agencies
[Federal Register Volume 73, Number 166 (Tuesday, August 26, 2008)]
[Notices]
[Pages 50354-50356]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19763]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Janet L. Thornton, D.O.; Dismissal of Proceeding
On December 17, 2007, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Janet L. Thornton, D.O. (Respondent), of Monument,
Colorado. The Show Cause Order sought the revocation of Respondent's
DEA Certificate of Registration, AT2730984, as a practitioner, and the
denial of any pending applications to renew or modify her registration,
on two separate grounds.
First, it alleged that Respondent had entered into a series of
stipulations with the Colorado Board of Medical Examiners under which
she agreed that she ``will not practice medicine in the State of
Colorado.'' Show Cause Order at 2. Relatedly, the Show Cause Order
alleged that Respondent's ``Colorado medical license expired on May 31,
2007, and has not been renewed,'' and that therefore Respondent lacks
state authority to handle controlled substances, which is a
prerequisite for holding a DEA registration. Id.
Second, the Show Cause Order alleged that on December 3, 2005, the
Colorado Board suspended Respondent's state medical license thus
resulting in her lacking authority to handle controlled substances. Id.
at 1. The Show Cause Order alleged that while her state license was
suspended, Respondent issued two prescriptions to her neighbors: one in
January 2006, for Tussionex, a schedule III controlled substance, and
one in June 2006, for a schedule III drug containing hydrocodone. Id.
at 1-2. Relatedly, the Show Cause Order also alleged that in 2005,
Respondent issued a prescription for morphine to B.V., and that B.V.
had ``later informed investigators that he had no knowledge of the * *
* prescription and was never dispensed the drug.'' Id. at 2.
On February 12, 2008, the Show Cause Order was served on Respondent
by First Class Mail at her registered location. On March 3, 2008,
Respondent filed a written statement in lieu of a request for a hearing
and expressly waived her right to a hearing. See 21 CFR 1301.43(c).
Thereafter, the investigative file was forwarded to me for final agency
action.
Having considered the entire record in this matter, including
Respondent's statement, I hereby issue this Decision and Final Order. I
conclude that the Government has not proved by substantial evidence the
allegations regarding the prescriptions to B.V. or that Respondent
currently lacks state authority to handle controlled substances. While
I find that Respondent violated the Controlled Substances Act by
issuing prescriptions for controlled substances following the
suspension of her Colorado license, I further conclude that because the
violations were limited to two instances and there is no evidence
establishing that Respondent had not previously entered into a doctor-
patient relationship with the two persons who received the
prescriptions, the Government's proposed sanction of revocation would
be excessive. Because the Government has not proposed an alternative
sanction, the Show Cause Order will be dismissed.
Findings of Fact
Respondent holds DEA Certificate of Registration, AT2730984, which
authorizes her to handle controlled substances as a practitioner at her
registered location in Monument, Colorado. Respondent's registration
was last renewed on October 18, 2005, and does not expire until
November 30, 2008.
In May 2005, an Inquiry Panel of the Colorado State Board of
Medical Examiners ordered that Respondent be evaluated by the Colorado
Physician Health Program. In re Janet L. Thornton, Stipulation and
Final Agency Order (Col. St. Bd. Med. Exam'rs 2007). Thereafter, on
December 15, 2005, the Board suspended Respondent's state medical
license. Respondent's state license remained suspended until May 17,
2007, the date when Respondent entered into a stipulation for the
interim cessation of practice, under which she agreed to cease the
practice of medicine. Respondent subsequently agreed to two additional
amendments of the stipulation which extended the initial stipulation.
On October 25, 2007, Respondent and the Board entered into a
Stipulation and Final Agency Order, which became effective on November
16, 2007, upon the Board's approval. Id. at 7. According to the Board's
Final Order, Respondent has ``continuously'' held her state license
since April 10, 1986. Id. at 1.
In the Order, the Board imposed certain practice restrictions on
Respondent. The first of these was that ``Respondent shall not engage
in any act constituting the practice of medicine in the state of
Colorado unless such practice occurs within a clinical setting approved
in advance by the Panel or unless such practice occurs in a hospital.''
Id. at 5. The second restriction was that ``Respondent shall order,
dispense, administer or prescribe any controlled substance or other
prescription medications only for persons with whom Respondent has a
bona fide physician-patient relationship and only within the context of
Respondent's practice in a clinical setting approved in advance by the
Panel or a hospital.'' Id. Based on the above, I find that contrary to
the Government's contention, Respondent retains authority to handle
controlled substances in Colorado.
As relevant to the Show Cause Order's allegations regarding her
improper prescribing, Respondent admitted in the stipulation that she:
issued prescriptions and ordered medications while her license
was suspended. Respondent had consulted with an out-of-state
attorney who stated that he consulted Colorado attorneys and advised
her that she was authorized to issue prescriptions and order
medications in the state of Colorado while her Colorado license was
suspended under the authority of out-of-state licenses. The Panel
finds that the out-
[[Page 50355]]
of-state attorney's interpretation of Colorado's Medical Practice
Act was erroneous.
Id. at 3.
The record establishes that on January 23, 2006, while her Colorado
license was suspended, Respondent issued a prescription with one refill
to D.V., her neighbor in Colorado, for Tussionex Extended Release, a
schedule III controlled substance which contains hydrocodone. On June
6, 2006, Respondent issued an additional prescription to B.V., who was
also her neighbor, for thirty tablets of hydrocodone/apap (10/500mg.)
which was to last five days.\1\ At the time she issued both
prescriptions, Respondent was practicing in Texas, where she also holds
a medical license. While DEA Investigators interviewed both D.V. and
B.V., there is no evidence establishing that Respondent had not
previously entered into a legitimate doctor-patient relationship with
either person or that the prescriptions were issued for other than a
legitimate medical purpose.
---------------------------------------------------------------------------
\1\ While the record shows that Respondent issued several other
prescriptions to B.V. and D.V., none of these were for controlled
substances. These prescribings are not the concern of DEA.
---------------------------------------------------------------------------
In support of her Response to the Show Cause Order, Respondent
submitted a copy of a February 20, 2007 letter from Jeff Martin, a
lawyer in Tulsa, Oklahoma. This letter states that Respondent:
asked me about writing occasional prescriptions infrequently for
Colorado residents who were her neighbors using her Texas and/or
Oklahoma license even though her Colorado license was summarily
suspended. I told her, as long as her Texas and/or Oklahoma licenses
were still valid that she could still occasionally consult with her
neighbors and prescribe medicine. I still believe this is accurate.
Later when I tried to help her find a lawyer in Colorado, I
asked two Colorado lawyers who are knowledgeable in this area about
this and they believed she could continue occasionally prescribing
medicine also. I'm sorry, but I no longer have the names and phone
numbers of the lawyers I spoke to.
Exhibit C to Respondent's Response To Order To Show Cause.
Respondent also attached to her Response a copy of Col. Stat. Sec.
12-36-106, which defines the practice of medicine under Colorado law
and provides for certain exemptions from the licensing requirements.
This statute states that:
Nothing in this section shall be construed to prohibit, or to
require a license * * * under this article with respect to, any of
the following acts:
* * *
(b) The rendering of services in this state by a physician
lawfully practicing medicine in another state or territory, whether
or not such physician is in Colorado, but if any such physician does
not limit such services to an occasional consultation or cases * * *
such physician shall possess a license to practice medicine in this
state.
Colo. Stat. Sec. 12-36-106(3)(b).
The Government also alleged that Respondent had issued a
prescription to B.V. for morphine, but that B.V. denied ever receiving
the prescription. This allegation is not, however, supported by
substantial evidence as there is no evidence that Respondent ever
issued a morphine prescription to an individual with these initials.\2\
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\2\ While there is evidence that Respondent issued a morphine
prescription to D.H., even if this incident had been properly
alleged, I would still reject it as unsupported by substantial
evidence. While the record contains a summary of an interview in
which D.H. stated that he did not recall receiving the morphine
prescriptions, D.H. subsequently prepared a letter in which he
retracted his earlier statement and acknowledged he ``had completely
forgotten about the lower back and hip pain that prompted me to ask
for pain medication.'' Exh. E to Respondent's Resp. to Order to Show
Cause. The Government, which has the burden of proof even when a
case does not go to a hearing, has not pointed to any additional
evidence to support the conclusion that D.H.'s initial story to
investigators is the more accurate version.
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Discussion
Under Section 304(a) of the Controlled Substances Act (CSA), the
Attorney General may revoke or suspend a registration to dispense a
controlled substance ``upon a finding that the registrant * * * has had
[her] State license or registration suspended, revoked, or denied by
competent State authority and is no longer authorized by State law to
engage in the * * * dispensing of controlled substances.'' 21 U.S.C.
824(a)(3). Section 304(a) further authorizes the Attorney General to
suspend or revoke a registration ``upon a finding that the registrant *
* * has committed such acts as would render his registration under
section 823 of this title inconsistent with the public interest as
determined under such section.'' Id. Sec. 824(a)(4).
In section 303(f) of the CSA, Congress directed that the Attorney
General consider five factors ``[i]n determining the public interest.''
21 U.S.C. 823(f). The factors are:
(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 a registration should be
revoked.'' 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 set
forth the applicable law, I address each of the Government's
contentions.
The Lack of State Authority
As found above, Respondent's Colorado medical license was suspended
on December 15, 2005. Effective November 16, 2007--one month before the
Show Cause Order was issued--the Colorado Board restored Respondent's
license to practice medicine and her authority to prescribe controlled
substances. While Respondent's authority to handle controlled
substances limits her practice to a board-approved clinical setting or
a hospital, the Board's Order make plain that Respondent currently has
authority to handle controlled substances in Colorado. The Government's
contention to the contrary is therefore rejected.
The Public Interest Allegations
In United Prescription Services, Inc., 72 FR 50397, 50407 (2007), I
held that ``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. 21 CFR
1306.04(a).\3\ As explained therein, 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. Sec. 802(10). See also id.
Sec. 823(f) (``The Attorney General shall register practitioners * * *
to dispense * * * if the applicant is authorized to dispense * * *
[[Page 50356]]
controlled substances under the laws of the State in which he
practices.'').
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\3\ Under 21 CFR 1306.04(a), ``[a] prescription for a controlled
substance to be effective must be issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of
his professional practice.''
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As I noted in United Prescription Services, 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.'' United States v. Moore, 423 U.S. 122, 140-41
(1975) (emphasis added) (quoted at 72 FR 50407). 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[.]'').
In the Stipulation and Final Agency Order, Respondent admitted that
the prescribings to B.V. and D.V. constituted ``prescribing * * * other
than in the course of legitimate professional practice'' under Colorado
law. See In re Thornton, Stipulation and Final Agency Order, at 3.
Accordingly, I conclude that the prescriptions Respondent issued to
D.V. and B.V. were issued outside of the course of professional
practice and thus also violated Federal law. See 21 CFR 1306.04(a);
Moore, 423 U.S. at 140-41; United Prescription Services, 72 FR at
50407. The prescribings thus constituted acts which render her
registration ``inconsistent with the public interest.'' 21 U.S.C.
824(a)(4); see also id. Sec. 823(f)(2) & (4) (directing consideration
of registrant's ``experience in dispensing controlled substances'' and
compliance with applicable federal and state laws).
I nonetheless conclude that it would be inappropriate to revoke
Respondent's registration. With respect to the allegations, the record
establishes only two instances in which Respondent unlawfully
prescribed controlled substances. Moreover, while ordinarily a
practitioner cannot credibly claim ignorance of state laws prohibiting
the unlicensed practice of medicine, United Prescription Services, 72
FR at 50407; the Colorado Board's interpretation that Respondent was
not within the exemption provided in Colo. Stat. Sec. 12-36-106(b)(3),
and that she thus violated the State's Medical Practice Act, appears to
have been a case of first impression.\4\
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\4\ While the Colorado Board found that Respondent's attorney's
interpretation of the Medical Practice Act ``was erroneous,'' the
Board's Order did not cite any prior decision holding that
Respondent's conduct was illegal.
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Moreover, the Government has failed to show the absence of a
legitimate doctor-patient relationship between Respondent and either
person. Relatedly, there is no evidence that the prescriptions were
written for other than a legitimate medical purpose. In short, the
evidence does not remotely suggest that Respondent was using her
prescription writing authority to deal drugs. See Gonzales v. Oregon,
546 U.S. 243, 270 (2006).
Furthermore, the Colorado Board has considered Respondent's state
law violations and concluded that they do not warrant the revocation of
her medical license. Under agency precedent, I am not bound by the
State Board's recommendation. Nonetheless, because the only proven
violations of the CSA are based on her having violated the Colorado
Medical Practice Act's licensing provision and were limited to two
instances, I conclude that Respondent's violations do not warrant the
revocation or suspension of her registration.
While in some instances, this Agency has placed restrictions on a
practitioner's registration, such restrictions must be related to what
the Government has alleged and proved in any case. Notably, in this
matter the Government has proposed no alternative sanction to
revocation. Accordingly, the Order to Show Cause will be dismissed.
Order
Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well
as 28 CFR 0.100(b) and 0.104, I hereby order that the Order to Show
Cause issued to Janet L. Thornton, D.O., be, and it hereby is,
dismissed.
Dated: August 18, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-19763 Filed 8-25-08; 8:45 am]
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