In Ruan v. United States, No. 20-1410 (June 27, 2022), the Supreme Court unanimously held, for the crime of prescribing controlled substances outside the usual course of professional practice in violation of 21 U.S.C. § 841, the mens rea “knowingly or intentionally” applies to the statutes “except as authorized” clause. 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. Ruan was consolidated with Kahn v. United States, No. 21-5261. Justice Breyer delivered the 9 to 0 opinion of the Court. Justice Alito filed a concurring opinion, joined by Justices Thomas and Barrett.
Petitioners Xiulu Ruan and Shakeel Kahn are medical doctors licensed to prescribe controlled substances. Each was tried for violating 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.” A federal regulation authorizes registered doctors to dispense controlled substances via prescription, but only if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR §1306.04(a). At issue in Ruan’s and Kahn’s trials was the mens rea required to convict under §841 for distributing controlled substances not “as authorized.” Ruan and Kahn each contested the jury instructions pertaining to mens rea given at their trials, and each was ultimately convicted under §841 for prescribing in an unauthorized manner. Their convictions were separately affirmed by the Courts of Appeals.
Reversing the 11th in Ruan’s case, and the 10th in Kahn’s case, Justice Breyer’s opinion starts this way:
A provision of the Controlled Substances Act, codified at 21 U. S. C. §841, makes it a federal crime, “[e]xcept as authorized[,] . . . for any person knowingly or intentionally . . . to manufacture, distribute, or dispense . . . a controlled substance,” such as opioids. 84 Stat. 1260, 21 U. S. C. §841(a) (emphasis added). Registered doctors may prescribe these substances to their patients. But, as provided by regulation, a prescription is only authorized when a doctor issues it “for a legitimate medical purpose . . . acting in the usual course of his professional practice.” 21 CFR §1306.04(a) (2021).
In each of these two consolidated cases, a doctor was convicted under §841 for dispensing controlled substances not “as authorized.” The question before us concerns the state of mind that the Government must prove to convict these doctors of violating the statute. We hold that the statute’s “knowingly or intentionally” mens rea applies to authorization. After a defendant produces evidence that he or she was authorized to dispense controlled substances, the Government must prove beyond a reasonable doubt that the defendant knew that he or she was acting in an unauthorized manner, or intended to do so.
The consolidated opinion is available here; oral argument here; merits briefing in Ruan here; merits briefing in Kahn here.