The government must prove beyond a reasonable doubt that a physician knowingly or intentionally acted in an unauthorized manner to convict under the Controlled Substance Act
Ruan v. United States, 597 U.S. __, No. 20–1410, 2022 WL 2295024 (June 27, 2022)
The federal government separately charged Doctors Xiula Ruan and Shakeel Kahn with unlawful dispensing and distribution of drugs in violation of the Controlled Substances Act (CSA), 21 U.S.C. § 841, which makes it a federal crime, “[e]xcept as authorized[,] . . . for any person knowingly or intentionally . . . to manufacture, distribute, or dispense . . . a controlled substance.” They were convicted at separate trials and their convictions (and sentences in excess of 20 years) were affirmed on appeal. The Tenth Circuit affirmed Dr. Kahn’s conviction, holding that his subjective belief that he was meeting a patient’s needs was not a complete defense because his conviction could be upheld on the ground his conduct was objectively outside the usual course of professional practice. The Eleventh Circuit similarly upheld Dr. Ruan’s conviction, rejecting his claim that the government failed to prove that he subjectively knew the prescriptions were unlawful. The Eleventh Circuit held the government may prove either that Dr. Ruan (1) subjectively knew a prescription was issued for an illegitimate purpose, or (2) issued a prescription objectively inconsistent with usual medical practice. The U.S. Supreme Court granted petitions for writs of certiorari and consolidated the two cases to decide what mens rea applies to § 841’s authorization exception.
The Supreme Court reversed both convictions, holding that—once the defendant meets an initial burden of producing evidence of authorized conduct—a conviction under the CSA requires the government to prove beyond a reasonable doubt the physician knowingly or intentionally acted in an unauthorized manner. The government had argued the scienter clause only required proof of “knowingly or intelligently” distributing a controlled substance. But the Court held the scienter clause also applies to the “except as authorized” clause, even though the former does not immediately precede the latter, because a lack of authorization distinguishes wrongful from proper conduct. If “knowingly” does not modify “unauthorized,” then the CSA would criminalize and over-deter innocent and socially beneficial conduct. The severe penalties attached to a CSA conviction further support broad application of the strong scienter requirement.
A concurring opinion by three Justices viewed the CSA “authorization” provision as an affirmative defense, to which a mere preponderance of the evidence standard of proof should apply.