Opinion: Ruan v. United States, 20-1410 (2024)

**Opinion: Ruan v. United States, 20-1410**

Ruan v. United States, 20-1410. The Court held that once a doctor who is charged with dispensing controlled substances produces evidence that his conduct was “authorized,” the Government must prove beyond a reasonable doubt that the doctor knowingly or intentionally acted in an unauthorized manner. The Controlled Substances Act, 21 U.S.C. §841, makes it a crime “except as authorized, . . . for any person knowingly or intentionally . . . to manufacture, distribute, or dispense . . . a controlled substance.” A prescription for a controlled substance is only “authorized” when a doctor issues it “for a legitimate medical purpose . . . acting in the usual course of his professional practice.” Doctors Xiulu Ruan and Shakeel Kahn were separately charged with violating §841. At their trials, the Government argued that the doctors’ prescriptions were not written for legitimate purposes in the usual course of professional practice. The doctors argued that the prescriptions were authorized, and they sought to argue that even if the prescriptions were not authorized, they did not knowingly or intentionally deviate from that standard. The trial courts declined to instruct the juries that they could only convict if the defendants acted knowingly or intentionally with respect to authorization. Instead, the judges instructed the juries not to convict if the doctors acted in “good faith.” The Tenth and Eleventh Circuits affirmed the doctors’ convictions. In an opinion by Justice Breyer, the Court vacated and remanded.

The Court held that if a defendant produces evidence that his conduct was authorized, the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner. “With few exceptions, wrongdoing must be conscious to be criminal.” Courts presume a scienter requirement even when a criminal statute is silent on mens rea. When a statute includes a mens rea such as “knowingly,” that term may modify not only the words following it, but other words that distinguish wrongful from innocent acts. For example, the Court has previously applied mens rea requirements to other “authorization” provisions, provisions prohibiting the “knowing” violation of a separate statute or subsection, and similar provisions that distinguish wrongful from innocent conduct. The Court observed that in prosecutions under §841, lack of authorization is often what separates wrongfulness from innocence. The fact that a doctor dispenses drugs via prescription is not inherently illegitimate; doctors are expected to prescribe necessary medications. It is the unauthorized prescription that renders the doctor’s conduct wrongful. Thus, applying the statute’s “knowingly or intentionally” mens rea helps advance the statute’s purpose by separating wrongful from innocent acts and diminishing the risk of “overdeterrence” by punishing acceptable conduct that lies close to the criminal line. Finally, §841 carries severe penalties, which counsels in favor of a strong scienter requirement.

The Court rejected the Government’s arguments to the contrary. Even assuming that the “except as authorized” clause is not strictly an element of the offense (because the Government generally is not required to disprove potential exceptions or affirmative defenses), that does not resolve the issue. If a defendant meets his initial burden of production by showing evidence of authorization, the burden shifts to the Government to persuade the jury that the conduct was unauthorized. The authorization clause is “sufficiently like an element” to “warrant similar legal treatment” regarding mens rea. The Government argued that rather than use the subjective “knowingly or intentionally” standard, the Court should apply a “good-faith effort” standard where, if a defendant meets his burden of production, the Government must prove only that the defendant did not make an “objectively reasonable attempt to ascertain and act within the bounds of professional medicine.” The Court was unconvinced. The statute does not use words like “good faith,” “objective,” or “reasonable,” and criminal liability would depend on a hypothetical “reasonable doctor” rather than the defendant’s own mental state. Although the “knowingly or intentionally” standard may allow “bad-apple doctors” to escape liability due to their idiosyncratic views, such an argument could be made in many cases imposing scienter requirements.

Justice Alito concurred in the judgment, joined by Justice Thomas and in part by Justice Barrett. Justice Alito wrote that the authorization clause creates an affirmative defense that the defendant must prove, but the majority created a “new hybrid” with some characteristics of an element and some characteristics of an affirmative defense. The concurrence disagreed that a mens rea requirement should be read into the authorization clause based on the four factors the majority identified: the statutory text, the role authorization plays in distinguishing blameworthy and innocent conduct, the seriousness of the crime, and the “vague, highly general language of the regulation defining prescribing authority.” This multifactor test regarding the prosecutor’s burden may lead to “confusion and disruption.” Justice Alito argued that the statute should be interpreted in light of its history, and the predecessor to §841 was interpreted to allow doctors to write prescriptions “in good faith.” The concurrence would hold that “a doctor who acts in subjective good faith”―in other words, a doctor who believes that the prescription is “a valid means of pursuing a medical purpose” rather addiction or abuse―may invoke the affirmative defense.