On November 3, 2009, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Christopher Henry Lister, P.A. (Respondent), of Hesperia, California. The Order proposed the revocation of Respondent's DEA Certificate of Registration, ML0817900, as a practitioner, and the denial of any pending applications to renew or modify his registration, on the ground that he had committed acts which render his registration inconsistent with the public interest. Show Cause Order at 1 (citing 21 U.S.C. 823(f) & 824(a)(4)).
The Show Cause Order alleged that Respondent violated Federal law by issuing controlled substance prescriptions “outside [of] the usual course of professional practice,” which lacked a “legitimate medical purpose, and that he violated California law because he issued the prescriptions “without an appropriate prior examination and a medical indication.” Id. at 1-2 (citing 21 CFR 1306.04(a) & Cal. Bus. & Prof. Code § 2242(a)). More specifically, the Order alleged that on June 16, 2009, an undercover agent purchased through an intermediary a prescription for 60 tablets of OxyContin 80 mg., and that Respondent “never met or * * * much less conducted a physical examination” of, the person for whom he wrote the prescription. Id. at 2.
Next, the Show Cause Order alleged that on June 25, 2009, an undercover agent purchased though an intermediary prescriptions for 90 tablets of OxyContin 80 mg., which were written in the names of four different persons, and that Respondent had never met or conducted a physical examination of any of these persons. Id. Finally, the Show Cause Order alleged that on October 8, 2009, an informant purchased from Respondent prescriptions for OxyContin 80 mg., Xanax 2 mg., Valium 10 mg., and Lortab 10/500 mg., which were post-dated for October 29, 2009, and written in the names of three different persons he never physically examined. Id.
Based on the above, I further concluded that Respondent's continued registration during the pendency of the proceeding would “constitute an imminent danger to the public health and safety.” Id. Therefore, pursuant to my authority under 21 U.S.C. 824(d), I immediately suspended Respondent's registration. Id. The Order further explained that Respondent had the right to request a hearing on the allegations, the procedure for doing so, and that if he failed to do so, the scheduled hearing would be cancelled and he would be deemed to have waived his right to a hearing. Id.
On November 5, 2009, a DEA Special Agent personally served Respondent with the Order to Show Cause and Immediate Suspension of Registration. Moreover, on November 6, 2009, Government Counsel served a copy of the Order on Respondent by First-Class Mail to him at his registered location.
More than thirty days have now passed since the service of the Order to Show Cause and Immediate Suspension, and neither Respondent, nor anyone purporting to represent him, has requested a hearing. I therefore find that Respondent has waived his right to a hearing, 21 CFR 1301.43(d), and issue this Decision and Final Order without a hearing based on the record submitted by the Government. I make the following findings.
Respondent is the holder of DEA Certificate Registration, ML0817900. Respondent last renewed his registration on April 2, 2008; the registration does not expire until March 31, 2011.
Respondent also holds a Physician Assistant (PA) License issued by the Physician Assistant Committee of the Medical Board of California. On November 6, 2009, the Executive Officer of the Physician Assistant Committee filed a petition for an interim order of suspension of Respondent's state license. On November 12, 2009, a state Administrative Law Judge (ALJ) granted the petition and immediately suspended Respondent's PA license. The ALJ also ordered that Respondent appear for hearing on November 30, 2009, to show cause why the interim order suspending his license “should not remain in full force and effect pending the issuance of a final decision by the Medical Board of California.” Interim Order of Suspension at 2, Portman v. Lister (Cal. Office. of Admin. Hearings, No. 1E-2008-195465).
On November 30, 2009, a hearing was held before another state ALJ. Following the hearing, the ALJ found that:
[o]n October 8, 2009, a Bureau of Narcotics Enforcement confidential informant (CI) met with respondent at the CI's residence. The meeting was monitored by a DEA agent. During the meeting the CI provided respondent with a list of names and asked respondent to prescribe OxyContin, Xanax, Ambien, and Valium to the listed individuals in exchange for $750 in cash. Respondent did as requested, and took the $750 cash payment.
Order of Interim Suspension at 2, In re Lister.
Based on this finding, the ALJ concluded “that respondent has engaged in acts constituting violations of the Medical Practice Act” and that the State had “show[n] that permitting [him] to continue to engage in the profession for which [his] license was issued will endanger the public health, safety, or welfare.” Id. at 3 (citing Cal. Gov. Code § 11529(a)). In a footnote, the ALJ further explained that “[b]y prescribing dangerous drugs and controlled substances to the CI without an appropriate medical examination and without any medical indication * * * Respondent violated [various] provisions of the Medical Practice Act” including, inter alia, Cal. Bus. & Prof. Code § 2242(a) (“furnishing dangerous drugs without examination”), and Cal. Health & Safety Code § 11153(a) (“prescribing controlled substances without a legitimate medical purpose”). Id. at n.6. The ALJ thus granted the Start Printed Page 28069State's petition and ordered that Respondent's license remain “suspended until final resolution of the underlying Accusation.” Id. at 4.
Section 304(a) of the Controlled Substances Act (CSA) provides that a registration to “dispense a controlled substance * * * may be suspended or revoked by the Attorney General 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.” 21 U.S.C. 824(a)(4). With respect to a practitioner, the CSA requires the consideration of the following factors in making the public interest determination:
(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. § 823(f).
“[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).
While I have considered all of the factors, I conclude that it is not necessary to make findings as to factors three and five. As explained below, I conclude that the finding of the state ALJ that Respondent violated California law by prescribing controlled substances without performing an appropriate medical examination and without a legitimate medical purpose is dispositive in assessing his experience in dispensing controlled substances (factor two) and his compliance with State and Federal laws related to controlled substances (factor four). The state ALJ's finding further establishes that Respondent has committed acts which render his continued registration “inconsistent with the public interest.” 21 U.S.C. 824(a)(4).
Factors 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 related to controlled substances.” Id. See also 21 U.S.C. 802(10) (defining the term “dispense” as meaning “to deliver a controlled substance to an ultimate user by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance”) (emphasis added).
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, 143 (1975)).
Under the CSA, it is fundamental that a practitioner must establish and maintain a bonafide doctor-patient relationship in order to act “in the usual course of * * * professional practice” and to issue a prescription for a “legitimate medical purpose.” Laurence T. McKinney, 73 FR 43260, 43265 n.22 (2008); see also Moore, 423 U.S. at 142-43 (noting that evidence established that physician “exceeded the bounds of `professional practice,' ” when “he gave inadequate physical examinations or none at all,” “ignored the results of the tests he did make,” and “took no precautions against * * * misuse and diversion”). Moreover, the CSA generally looks to state law to determine whether a doctor and patient have established a bona fide doctor-patient relationship. See Kamir Garces-Mejias, 72 FR 54931, 54935 (2007); United Prescription Services, Inc., 72 FR 50397, 50407 (2007).
Under California law, except for in circumstances not applicable here, “[p]rescribing, dispensing, or furnishing dangerous drugs * * * without an appropriate prior examination and a medical indication, constitutes unprofessional conduct.” Cal. Bus. & Prof. Code § 2242(a). California law further adopts nearly verbatim the CSA's prescription requirement. See Cal. Health & Safety Code § 11153(a) (“A prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice.”).
Here, a state ALJ found that, on October 8, 2009, Respondent violated both of these provisions of California law when he sold prescriptions for OxyContin, a schedule II controlled substance, as well as Xanax, Ambien, and Valium (all of which are schedule IV controlled substances), to a confidential informant working for the California Bureau of Narcotics Enforcement in exchange for $750 in cash. While Respondent did not appear at the state hearing, the state ALJ found that he “was properly noticed of the date, time and place of the hearing.” Order of Interim Suspension, at 1. Accordingly, I hold that the state ALJ's finding is entitled to preclusive effect in this proceeding. See University of Tennessee v. Elliot, 478 U.S. 788, 797-98 (1986) (“When an administrative agency is acting in a judicial capacity and resolves disputed issues of fact properly before it which the parties have had an adequate opportunity to litigate, the courts have not hesitated to apply res judicata[.]”) (int. quotations and citations omitted). Based on the state ALJ's findings, I further conclude that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in issuing each of the prescriptions and thus violated Federal law as well. See 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1).
I thus conclude that Respondent has committed acts which render his registration “inconsistent with the public interest.” 21 U.S.C. 824(a)(4). Accordingly, Respondent's registration will be revoked.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 824(a)(4), as well as 28 CFR 0.100(b) & 0.104, I order that DEA Certificate of Registration, ML0817900, issued to Christopher Start Printed Page 28070Henry Lister, P.A., be, and it hereby is, revoked. I further order that any pending application of Christopher Henry Lister, P.A., to renew or modify his registration, be, and it hereby is, denied. This Order is effective immediately.Start Signature
Dated: May 6, 2010.
Michele M. Leonhart,
1. It is further noted that because the State has imposed an order of interim suspension against Respondent's PA license, he does not have authority to dispense controlled substances and thus does not meet an essential requirement for holding a registration under the CSA. See, e.g., John B. Freitas, 74 FR 17524, 17525 (2009); 21 U.S.C. §§ 823(f) & 824(a)(3).Back to Citation
[FR Doc. 2010-11950 Filed 5-18-10; 8:45 am]
BILLING CODE 4410-09-P