Following separate jury trials, Dr. Xiulu Ruan and Dr. Shakeel Kahn were each convicted of dispensing controlled substances without authorization under 21 U.S.C. § 841. The defendants each made requests for jury instructions that would have indicated that the Government was required to prove that they knew their acts were unauthorized. Both trial courts rejected these requests, however, instead instructing the juries that the doctors could be convicted if their actions were not in line with the standards of a reasonable physician, i.e. whether the prescriptions were issued for a legitimate medical purpose and within the usual course of a professional medical practice. The defendants appealed, and the Eleventh Circuit upheld both convictions.
Reviewing the statutory construction de novo, The Supreme Court vacated both convictions and remanded. The Court held that the “knowingly or intentionally” mens rea articulated in § 841 applies also to the “except as authorized” clause of the statute, which allows authorized practitioners to dispense controlled substances. As a result, if a defendant meets their burden of production to show that they are generally “authorized” to dispense controlled substances, the Government must then prove that they “knowingly or intentionally” acted in an unauthorized manner on the matter charged.
Justice Alito wrote separately, concurring in the judgment because of precedent interpreting the precursor statute to § 841, but disagreeing with the reasoning of the majority. He asserted that the authorization clause creates not an element of the offense but an affirmative defense to it and so the mens rea need not be the same.
Certiorari to the Court of Appeals for the Eleventh Circuit
Opinion by Breyer, joined by Roberts, Sotomayor, Kagan, Gorsuch, and Kavanaugh
Concurrence by Alito, joined by Thomas and joined in part by Barrett
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