[Federal Register Volume 73, Number 166 (Tuesday, August 26, 2008)]
[Notices]
[Pages 50354-50356]
From the Federal Register Online via the Government Publishing 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.
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    \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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    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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