Last week, the Supreme Court (“the Court”) ruled that the provision of the federal Controlled Substances Act (the “Act”) that criminalizes the distribution of a controlled substance “unless authorized” includes a mens rea requirement. The Court ruled that once a defendant prescriber produces evidence that he was authorized to dispense a controlled substance by issuing a prescription, prosecutors must prove beyond a reasonable doubt that the prescriber knew he was acting in a manner unauthorized or intended to do so. .
21 USC § 841(a) criminalizes the knowing or intentional distribution of a controlled substance, “except as authorized” by the subchapter. According to Drug Enforcement Administration (DEA) regulations, a prescription is “authorized” only when a prescriber dispenses it “for a legitimate medical purpose” while acting in the ordinary course of their professional practice. See 21 CFR § 1306.04(a).
The petitioners, Ruan and Kahn, in this consolidated case were both physicians licensed to prescribe controlled substances. At their respective lawsuits, the government argued that their prescriptions did not comply with the requirement of 21 CFR § 1306.04(a) that prescriptions must be issued for legitimate medical purposes by an individual practitioner acting within the scope of usual in his professional practice. The applicants argued that their prescriptions met the standard and, even if they did not, they did not knowingly or intentionally deviate from it. Ruan and Kahn were ultimately convicted separately under the federal controlled substances law for prescribing in violation of 21 USC § 841. The petitioners challenged the mens rea component of jury instructions at their trials, but the convictions were upheld by the Eleventh and Tenth Circuits, respectively.
Judge Breyer, writing for the Court, held that the “knowingly or intentionally” language of 21 USC § 841 applies to the concept of “authorization.” Thus, when prosecuting a prescriber for the unauthorized distribution of a controlled substance, the government must prove beyond a reasonable doubt that the prescriber “knowingly or intentionally” acted in an unauthorized manner.
In arriving at its decision, the Court noted that, generally speaking, the criminal law seeks to punish “vicious will” and, with few exceptions, “a wrongdoing must be aware of being criminal”. Thus, criminal laws must be interpreted as requiring the defendant to have possessed a culpable mental state, even when those laws are silent on the question of intent. Here, because the term “knowingly” has been included in the statute, it must be interpreted as modifying other statutory terms which distinguish wrongful acts from innocent acts, such as the Act’s requirement that an order must be ” authorised” before being issued. Going forward, to secure a criminal conviction under 21 U.S.C § 841, once a defendant has met the burden of producing proof that his or her conduct was “authorized”, the government has the burden of proving that the accused knew or intended that his conduct was unauthorized. The Court remanded the respective cases for further processing.
The move is a potential victory for practitioners who may face increased scrutiny over their prescribing practices and is part of a long series of cases related to the opioid crisis affecting many suppliers, manufacturers and distributors of controlled substances.
It’s less clear how this ruling may affect companies involved in opioid cases, but there is speculation that the ruling could limit the liability of corporations involved in the distribution of opioids. These entities may be able to make a convincing case that they also lacked the requisite intent and relied in good faith on third parties to ensure that orders or purchases were valid. . For example, they may argue that the government must prove that prescribers acted with unlawful intent before holding a pharmacy responsible for filling allegedly unlawful prescriptions.
For example, a large national retailer was granted a stay of action against it pending the Court’s decision in this case after arguing that such a decision could thwart the theory of government liability against the retailer.
It remains to be seen whether the Court’s decision in this case could extend to other areas of healthcare fraud, such as the Anti-Kickback Statute or the False Claims Act, given that these laws also require the government to prove knowledge or intent of wrongdoing. . It also remains to be seen whether this could impact parallel state regulatory actions against prescribers, manufacturers, and distributors, particularly if those states adopted language similar to the DEA regulation.