Client Alerts
August 01, 2022

A Victory for Prescribers: Government Now Subject to Heightened Standard of Proof

Stites & Harbison Client Alert, August 1, 2022

by Stites & Harbison, PLLC

In a recent win for healthcare practitioners, the Supreme Court in Ruan v. United States held that, to convict individuals of violating the Controlled Substances Act, the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner. The decision resolves a split among federal circuit courts. As a result of the split, healthcare practitioners were held to different standards related to the requisite state of mind for conviction under the CSA solely based on the location of their practice. In other words, a physician convicted in one state could have avoided conviction in another. The Supreme Court’s adoption of a universal standard cures this injustice.

The CSA makes it a federal crime for any person “[e]xcept as authorized[,] . . . [to] knowingly or intentionally . . . manufacture, distribute, or dispense . . . a controlled substance.” 21 USC § 841(a). Practitioners may dispense controlled substances pursuant to a prescription, as long as the prescription is authorized. Prescriptions for controlled substances are only considered “authorized” when “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR § 1306.04(a). Prior to applying the Ruan standard, courts will require defendants to produce evidence that they were authorized to dispense controlled substances, such as via an authorized prescription.

The circuit split involved three distinct standards of proof as to a practitioner’s state of mind. For instance, the Ninth Circuit in U.S. v. Feingold found that the government must prove that a practitioner in fact distributed controlled substances, that such distribution fell outside the usual course of professional practice and lacked a legitimate medical purpose, and “that the practitioner acted with intent to distribute the drugs and with intent to distribute them outside the course of professional practice.” 454 F.3d 1001 (9th Cir. 2006). With respect to intent, the court characterized it as a “doctor’s intent to act as a pusher rather than a medical professional.” The Eleventh Circuit rejected the “drug pusher” narrative, as well as the good faith defense, in holding that a court must evaluate a practitioner’s acts on an objective, rather than subjective, basis. US v. Ruan, 966 F.3d 1101 (11th Cir. 2020) (overruled). Specifically, the court found that the term “drug pusher,” as that term is “conventionally understood,” is not representative of practitioners in an established medical practice and concluded that acting as a “drug dealer or pusher” is unnecessary for a CSA conviction. Finally, the Second Circuit adopted a hybrid standard. It embraced a showing of a practitioner’s “good faith belief, based on a standard of objective reasonableness” as a complete defense to criminal liability in CSA prosecutions. US v. Wexler, 522 F.3d 194 (2d Cir. 2008). Considering the inherent unfairness in subjecting practitioners to different intent standards, the Supreme Court’s resolution of the split was long overdue and necessary to ensure consistency in CSA prosecutions.

Although DOJ prosecutions will likely remain high due to the current administration’s commitment to ending the opioid epidemic, the heightened burden on the prosecution to obtain a conviction should provide healthcare practitioners with some peace of mind. Now, healthcare practitioners prescribing and dispensing controlled substances are free to focus on meeting the needs of their patients with less fear of criminal convictions. In effect, the Ruan standard should protect practitioners who sincerely believe that they are prescribing and dispensing controlled substances in an authorized manner against conviction under the CSA.

Related Capabilities
Health Care Insurance Regulatory