[Federal Register: August 26, 2008 (Volume 73, Number 166)]
[
Notices]               
[Page 50354-50356]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au08-91]                         

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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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