On June 27, in Ruan v. United States, the U.S. Supreme Court held that the mens rea necessary to support a Controlled Substances Act (CSA) violation also applies to the affirmative defense. Inasmuch as the sentence at issue in the CSA is syntactically similar to the operative sentences in the federal Anti-Kickback Statute (AKS), the case may have wide-reaching implications for False Claims Act (FCA) cases based on an AKS violation.1
In Ruan, two physicians were separately convicted of violating a CSA provision that makes it unlawful, “[e]xcept as authorized[,] . . . for any person knowingly or intentionally . . . to manufacture, distribute, or dispense . . . a controlled substance.” 21 U.S.C. § 841. Each of the physicians argued that they lawfully dispensed the opioids because they were dispensed pursuant to valid prescriptions. A regulation provides that, “to be effective,” a prescription “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR § 1306.04(a). One of the doctors argued that whether he met this standard should be judged by his subjective intent. The trial court instead set forth a more objective standard, instructing the jury that a doctor acts lawfully when he prescribes “in good faith as part of his medical treatment of a patient in accordance with the standard of medical practice generally recognized and accepted in the United States.” With respect to the other doctor,...
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