Supreme Court Rules Prescriber Intent Matters under the Controlled Substances Act

By Sarah Wirskye - On

In Xiulu Ruan V. United States, No. 20–1410 (June 27, 2022), the Supreme Court ruled that under the Controlled Substances Act for prescribing of opioids and other addictive drugs, the government must show that doctors knew they lacked a legitimate medical purpose. In this case petitioner doctors Xiulu Ruan and Shakeel Kahn successfully appealed their convictions under the Controlled Substances Act, 21 U. S. C. §841.

Section 841 makes it a crime, “[e]xcept as authorized[,] . . . for any person knowingly or intentionally … to manufacture, distribute, or dispense . . . a controlled substance.” A federal regulation authorizes registered doctors to prescribe controlled substances only if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR §1306.04(a). At issue in Petitioners’ trials was the mens rea or intent standard in the jury instructions to convict under §841 for distributing controlled substances that were not “as authorized.” Both were convicted under §841 for prescribing in an unauthorized manner, and their convictions were separately affirmed.

The Court held that the §841 “knowingly or intentionally” intent standard applies to the statute’s “except as authorized” clause. Once a defendant meets the burden of producing evidence that his or her conduct was “authorized,” the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner. In holding such, the Court emphasized that criminal law generally seeks to punish conscious wrongdoing. The Court distinguished this statute from criminal statutes in which a presumption of scienter does not apply, such as a regulatory or public welfare offense that carries only minor penalties. The Court rejected the government’s proposed substitute intent standard of an “objectively reasonable good-faith effort” or “objective honest-effort standard” and cited the statutory language in §841 in doing so. The Court further noted that it has rejected similar suggestions in other criminal contexts. (Citing Elonis v. United States, 575 U. S. 723 (2015)).

This is an important ruling under the Controlled Substances Act. The Court’s reasoning, however, is broader that than just the Controlled Substances Act and should be applied to all criminal statues with similar language. This case is clearly a step in the right direction regarding the erosion of the mens rea requirement in white collar criminal and healthcare fraud statutes.

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