On June 27, 2022, the U.S. Supreme Court decided Ruan v. United States, No. 20-1410, and Kahn v. United States, No. 21-5261, in a consolidated ruling. The Court held that when a criminal defendant is authorized to dispense controlled substances — such as a doctor who may lawfully prescribe medications — prosecutors must prove beyond a reasonable doubt that the defendant intended to act or knew he or she was acting in an unauthorized manner by distributing substances to support a conviction for unlawful distribution under 21 U.S.C § 841.

In each of the consolidated cases, the defendants were medical doctors who had issued prescriptions for controlled substances. Both held the necessary licenses to issue such prescriptions. But each was charged with a criminal violation of 21 U.S.C. § 841, which prohibits distribution of controlled substances “except as authorized.” The Government argued that the specific prescriptions at issue were outside the bounds of the doctors’ authority. The question presented, therefore, was whether it is “sufficient for the Government to prove that a prescription was in fact not authorized,” or whether it “must . . . prove that the doctor knew or intended that the prescription was unauthorized.”

Applying established principles of mens rea, the Court held that, “once a defendant meets the burden of producing evidence that his or her conduct was ‘authorized,’ the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.” The Court ruled that the “knowingly or intentionally” requirement was necessary because a legal authorization to prescribe and distribute controlled substances “plays a ‘crucial’ role in separating innocent conduct — and, in the case of doctors, socially beneficial conduct — from wrongful conduct.” This “strong scienter requirement helps to diminish the risk of ‘overdeterrence,’ i.e., punishing acceptable and beneficial conduct that lies close to, but on the permissible side of, the criminal line.”

The Supreme Court declined to decide whether its new standard was satisfied by the jury instructions in the cases and remanded to allow the lower courts to consider that question.

Justice Breyer delivered the opinion of the Court, in which Chief Justice Roberts and Justices Sotomayor, Kagan, Gorsuch, and Kavanaugh joined. Justice Alito filed an opinion concurring in the judgment, in which Justice Thomas joined and Justice Barrett joined in part.

DOWNLAOD OPINION OF THE COURT