Ruan v. United States

Supreme Court of the United States · 2022 · Criminal Law

597 U.S. 450 (2022)

Updated August 1, 2026

Criminal Lawmens reaauthorization21 U.S.C. §84121 U.S.C. §885scienterknowingly or intentionallyexcept as authorized

Facts

Xiulu Ruan and Shakeel Kahn were licensed doctors registered to prescribe controlled substances. The Government charged each under 21 U.S.C. §841 for unlawfully dispensing and distributing controlled substances through prescriptions alleged not to be authorized under 21 CFR §1306.04(a), which requires a legitimate medical purpose and action in the usual course of professional practice. At trial, each doctor argued that the prescriptions were valid or, at minimum, that he did not knowingly or intentionally deviate from the authorization standard. The trial courts instead gave objective or good-faith instructions tied to reasonable medical practice, and both juries convicted.

Issue

In a prosecution under 21 U.S.C. §841 against a doctor who prescribes controlled substances, does the statute's knowingly-or-intentionally mens rea apply to the phrase except as authorized? After the defendant produces evidence of authorization, must the Government prove beyond a reasonable doubt that the doctor knew or intended that the prescriptions were unauthorized?

Rule

Under 21 U.S.C. §841, the statute's "knowingly or intentionally" mens rea applies to the "except as authorized" clause. Once a defendant satisfies the burden of production by producing 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.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

Dr. Nina Patel, a licensed physician in Phoenix, writes prescriptions for controlled pain medication. At trial under 21 U.S.C. §841, she introduces patient files and testimony showing she was registered to prescribe and treated patients in a clinical setting, but the government proves only that her prescribing patterns fell outside generally accepted medical standards.

If Dr. Patel has satisfied her burden of producing some evidence of authorization, which is the best statement of what the government must prove to obtain a conviction?

Explanation. Once the defendant produces evidence that her conduct was authorized, §841's 'knowingly or intentionally' mens rea applies to the authorization issue. The government must prove beyond a reasonable doubt that the defendant knew she was acting in an unauthorized manner or intended to do so. The majority rejected an objective reasonable-doctor, negligence, or burden-shifting approach.