A provision of the Controlled Substances Act, codified at 21 U. S. C. §841, makes it a federal crime, “[e]xcept as au- thorized[,] . . . for any person knowingly or intentionally . . . to manufacture, distribute, or dispense . . . a controlled sub- stance,” such as opioids. 84 Stat. 1260, 21 U. S. C. §841(a). Registered doctors may prescribe these substances to their patients. But 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).

Xiulu Ruan and Shakeel Kahn were both licensed doctors. The Government charged them of unlawfully dispensing and distributing drugs in violation of Section 841 in separate cases. The two proceeded to trial. The doctors argued their dispensation of drugs was lawful because they dispensed them with valid prescriptions. The Government argued the prescriptions were not valid because they were not “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). The doctors argued their prescriptions did comply with this standard and, if not, they did not knowingly or intentionally deviate from this standard.

The district court rejected Ruan’s requested jury instruction that would have required the Government to prove that he subjectively knew his prescriptions fell outside of his prescribing authority. It instructed the jury, instead, it could convict Ruan if he did not “in good faith as part of [their] medical treatment of a patient in accordance with the standard of medical practice generally recognized and accepted in the United States.” The court further instructed the jury that a doctor violates Section 841 when his “actions were either not for a legitimate medical purpose or were outside the usual course of professional medical practice.” The jury convicted Ruan. The Eleventh Circuit affirmed, ruling that a doctor’s “subjectiv[e] belief that he is meeting a patient’s needs by prescribing a controlled substance” is not a “complete defense” to a Section 841 prosecution.

In Kahn’s trial, the district court instructed the jury that it should not convict if it found that he had acted in “good faith,”defined as “an attempt to act in accordance with what a reasonable physician should believe to be proper medical practice.” The court also instructed the jury that “good faith” was a “complete defense” because it “would be inconsistent with knowingly and intentionally distributing and/or dispensing controlled substances outside the usual course of professional practice without a legitimate medical purpose.” The jury still convicted Kahn. The Tenth Circuit affirmed, holding that the Government must prove that a doctor “either: (1) subjectively knew a prescription was issued not for a legitimate purpose; or (2) issued a prescription that was objectivity not in the usual course of professional practice.”

The Supreme Court granted certiorari to decide the issue of what state of mind the Government must prove to convict doctors of violating the statute. Is it enough to prove that a prescription was in fact not authorized or does  it have to prove that the doctor knew or intended that the prescription was unauthorized.

Consciousness of wrongdoing is a principle “as universal and persistent in mature systems of [criminal] law as belief in freedom of the human will and a consequent ability and duty of the normal individual to choose between good and evil.” Consequently, criminal statutes generally require a culpable mental state. Courts have read into criminal statutes that are “silent on the required mental state””that mens rea which is necessary to separate wrongful conduct from ‘otherwise innocent conduct.’” When a statute is not silent as to mens rea but instead includes a general scienter provision, the presumption applies with equal or greater force to the scope of that provision. Thus, “knowingly,” for instance, is usually read to modify not only the words directly following it, but also those other statutory terms that “separate wrongful from innocent acts.”

Section 841 contains a general scienter provision—“knowingly or intentionally.” In Section 841 prosecutions, the lack of authorization is often what separates wrongfulness from innocence. In prosecutions against physicians, it is the fact that the doctor issued an unauthorized prescription that renders his conduct unlawful, not the fact of the dispensation itself. So, authorization plays a crucial role in separating innocent conduct from wrongful conduct. A strong scienter requirement helps to diminish the risk of “overdeterrence,” i.e., punishing acceptable  and beneficial conduct that lies close to, but on the permissible side of the criminal line.

The Court held that the statute’s “knowingly or intentionally” mens rea applies to the “except as authorized” clause of Section 841. This means that once a defendant doctor produces evidence that he was “authorized” to dispense controlled substances, the Government must prove beyond a reasonable doubt that he knew that he was acting in an unauthorized manner, or intended to do so.

Ruan v. United States