## Facts

- Two licensed, DEA-registered physicians, Dr. Xiulu Ruan and Dr. Shakeel Kahn, were prosecuted under the Controlled Substances Act (CSA), 21 U.S.C. § 841(a)(1), for unlawfully dispensing controlled substances.
- Section 841(a)(1) criminalizes knowingly or intentionally dispensing controlled substances “[e]xcept as authorized.”
- A DEA regulation states a prescription is “authorized” only if it is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. 21 C.F.R. § 1306.04(a).
- Ruan operated a pain clinic and pharmacy and issued exceptionally high volumes of opioid prescriptions; the government alleged prescriptions were issued without legitimate medical purpose and outside standard medical practice.
- At trial, Ruan sought a jury instruction allowing acquittal if he subjectively acted in good faith (believing his prescribing complied with professional practice); the court instead instructed using an objective “reasonable doctor” type standard, and he was convicted.
- Kahn was similarly accused of issuing large quantities of Schedule II drugs outside legitimate practice; the trial court instructed that good faith was irrelevant if conduct was outside the usual course of professional practice, and he was convicted.
- The Eleventh and Tenth Circuits affirmed, approving instructions that allowed conviction without requiring proof that the physicians subjectively knew or intended their prescribing was unauthorized.

## Issues

1. In a prosecution of a physician under 21 U.S.C. § 841(a)(1), does the statute’s “knowingly or intentionally” mens rea apply to the “except as authorized” clause?
2. After a physician produces evidence that prescribing was authorized, must the government prove beyond a reasonable doubt that the physician knew or intended the prescribing was unauthorized, rather than merely showing an objective deviation from professional norms?

## Decision

- The Supreme Court held that § 841(a)(1)’s “knowingly or intentionally” mens rea applies to the “except as authorized” clause.
- Once a defendant produces evidence that the conduct was authorized, the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.
- The Court rejected jury-instruction approaches that effectively permit conviction based on an objective standard without requiring subjective knowledge or intent regarding lack of authorization.
- The Court vacated the judgments and remanded for further proceedings.

## Legal Principles

- Mens rea terms in federal criminal statutes are ordinarily read to apply to elements that separate innocent from wrongful conduct; for physicians, the “except as authorized” clause performs that function.
- In § 841(a)(1) cases involving registered physicians, the government must prove subjective culpability: that the defendant knew or intended the prescriptions were not authorized (i.e., not for a legitimate medical purpose and not in the usual course of professional practice).
- A physician bears only a burden of production to introduce evidence of authorization; the burden of persuasion remains on the government to prove knowing or intentional unauthorized conduct beyond a reasonable doubt.
- A purely objective “departure from accepted medical practice” standard, standing alone, is insufficient to establish criminal liability under § 841(a)(1).

## Conclusion

The Court required proof that a physician knowingly or intentionally prescribed controlled substances without authorization under the CSA, vacating convictions based on jury instructions that allowed liability grounded solely on objective departures from professional norms.


Ruan v. United States, 597 U.S. 450 (2022)