A recent United States Supreme Court decision clarified the mens rea requirements for the prosecution of doctors accused of illegally prescribing controlled substances pursuant to the Controlled Substances Act. In prosecutions under 21 U.S.C. § 841, the Government now must prove beyond a reasonable doubt that a doctor knowingly or intentionally prescribed a controlled substance outside the usual course of professional practice.

In the consolidated cases of Ruan v. United States, two medical doctors were accused and convicted of illegally dispensing and distributing drugs in violation of 21 U.S.C. § 841, a provision of the Controlled Substances Act that makes it a federal crime, except as authorized, to knowingly or intentionally manufacture, distribute, or dispense a controlled substance. Ruan v. United States, Nos. 20-1410 and 21-5261, 2022 WL 2295024, at *1-2 (June 27, 2022). The Court assumed that doctors are authorized to prescribe controlled substances if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Id. at 2-3; 21 CFR § 1306.04(a).

At issue in the doctors’ trials were the proper mens rea jury instructions. Id. at *3-4. The Government argued that the doctors were guilty because their prescriptions failed to comply with the regulatory standard for a valid prescription. Id. at *3. Conversely, the defendant doctors argued that their prescriptions did comply with the standard, and that, even if not, they did not knowingly or intentionally deviate from the standard, so they did not violate the statute. Id. Ultimately, the question the Court faced was whether the Government only has to prove that a prescription was in fact not authorized, or if the Government must prove that the doctor actually knew or intended that the prescription was unauthorized. Id. at *2. The Court held the latter. Id. at *4.

The Court considered whether the “knowingly or intentionally” mens rea applied to the “except as authorized” clause. Id. at *2. The Court’s interpretation relied on the “longstanding presumption, traceable to the common law, that Congress intends to require a defendant to possess a culpable mental state.” Id. at *5. Here, dispensing a controlled substance not as authorized is the crime under § 841, not the dispensation itself. Id. at *6. The Court reasoned that authorization “plays a ‘crucial’ role in separating innocent conduct—and, in the case of doctors, socially beneficial conduct—from wrongful conduct.” Id. Applying the mens rea to the authorization clause helps to separate wrongful from innocent acts, consistent with the purpose of such provisions, the Court concluded. Id. 

This Court’s standard is not an objective one. Rather, criminal liability turns on a doctor’s subjective beliefs, not those of a reasonable doctor. Id. at *12-13. Once the defendant doctor in an § 841 prosecution satisfies her initial burden of production by producing evidence of authorization (i.e., that the doctor believed the prescription was prescribed in the usual course of professional practice), the burden of proving lack of authorization shifts back to the Government, who must prove beyond a reasonable doubt that she knowingly or intentionally prescribed controlled substances in an unauthorized manner. Id. at *2, 11. However, the Court noted that the Government’s burden can be met through utilizing circumstantial evidence – i.e., the further a doctor’s asserted beliefs deviate from the usual course of professional practice, the more likely a jury will be to find that the doctor intentionally prescribed controlled substances in an unauthorized manner. Id. at *14-15. Notwithstanding, the Government must still carry its burden to prove lack of authorization beyond a reasonable doubt. Id. at *15.

It is unclear how the Court’s decision impacts the related criminal liability of pharmacists, which is also described at 21 CFR § 1306.04. Although the responsibility for the proper prescribing and dispensing of controlled substances lies with the prescribing practitioner, “a corresponding responsibility rests with the pharmacist who fills the prescription.” 21 CFR § 1306.04. The regulation sets forth that “[a]n order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. § 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” 21 CFR § 1306.04.

Our healthcare attorneys are available to answer your specific questions about the new law. Please reach out to your Lashly & Baer attorney with any questions.

Prepared by:

Richard W. Hill

rhill@lashlybaer.com
Phone: 314-436-8317

Lashly & Baer acknowledges summer associate, Victoria R. Cheyne, who is a contributing author to this summary and legal alert.

This summary and legal alert is an overview of the new guidance.  It is not intended to be, and should not be construed as, legal advice for a specific factual situation.