On June 27, 2022, the United States Supreme Court clarified the “knowingly or intentionally” standard for criminal prosecutions against doctors accused of overprescribing addictive medications in violation of the Controlled Substances Act.

In Ruan v. United States and Kahn v. United States, federal prosecutors accused two licensed doctors of illegally prescribing large volumes of opioid painkillers to patients. The cases arose under 21 U.S.C. § 841, which makes it a crime:

(1) except as authorized;

(2) knowingly or intentionally;

(3) to manufacture, distribute, or dispense… a controlled substance.

For background, the prosecution must prove that the defendant “knowingly” broke the law–that is, the defendant had a culpable mental state, known as scienter. Scienter is the degree of knowledge necessary to find a person criminally responsible for their acts. The issue before the Supreme Court was whether the jury instruction for “knowingly” was  an “objective” or  “subjective” standard for knowledge. A subjective standard asks what this defendant knew, whereas an objective standard asks what a “hypothetical reasonable defendant” would have known under the same circumstances.

According to the defense, the doctors knew they were prescribing opioid painkillers, but subjectively believed the prescriptions were “authorized” under the Controlled Substances Act because the prescriptions were “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice” as defined in applicable regulations. The prosecution persuaded the trial courts that defendants’ subjective knowledge was not the test. The trial courts applied a standard of “objectively reasonable good-faith effort” or “objective honest effort” to the authorization clause of § 841, asking juries to decide not whether a doctor subjectively knew the prescriptions were not for a legitimate medical purpose, but whether a “hypothetical reasonable doctor” objectively would have known the prescriptions were unauthorized.

The doctors were convicted under the prosecution’s objective view of the knowledge element, but the Supreme Court sided with the doctors, reasoning that the prosecution’s standard would turn a defendant’s criminal liability on the mental state of a hypothetical “reasonable” doctor, rather than on the mental state of the defendant himself. Specifically, the Supreme Court observed that the criminal law’s primary concern is to punish the “vicious will” and that doctors are normally encouraged “to prescribe the medications that their patients need.” Accordingly, the Court concluded that a doctor’s prescribing controlled substances to a patient is not a crime unless the prosecution proves beyond a reasonable doubt that the doctor subjectively knew a prescription was unauthorized under the Controlled Substances Act.