On Nov. 5, 2021, the U.S. Supreme Court consolidated and granted certiorari to a pair of cases involving physicians who were criminally prosecuted for prescribing controlled substances (specifically, opioids) in violation of the Section 841(a)(1) of the Controlled Substances Act (“CSA”). The consolidated cases—Ruan v. United States and Kahn v. United States—present questions regarding the requisite state of mind for a jury to convict a prescriber under the CSA and the availability and nature of a “good faith” defense to criminal liability under the statute. By agreeing to hear these cases, the Court positions itself to resolve, or at minimum weigh in on, the current circuit splits regarding these issues.

Under the CSA, as interpreted by the Supreme Court in United States v. Moore, 423 U.S. 122 (1975), practitioners who are registered to legally prescribe controlled substances can nonetheless be found to have violated the CSA if they prescribe in a manner that “fall[s] outside the usual course of professional practice.” However, petitioners argue that the state of mind necessary to convict varies by circuit. Judicial willingness to issue a specific jury instruction on the availability of a “good faith” defense similarly varies.

Petitioners argue that some federal circuits could permit negligent conduct or malpractice (typically the basis for civil actions and state-based regulatory action) to serve as sufficient bases for criminal liability through the courts’ interpretations of the CSA and through foreclosure of a “good faith” defense. In essence, they argue that, in some circuits, any deviation from the usual course of professional practice could result in criminal liability.

Petitioners assert chilling effect from muddled standards

Petitioners and amici raise concerns that, in addition to the risk of unequal application of the law across circuits, conflation of negligence or malpractice with criminal conduct could result in unintended consequences. These could include chilling innovation in the practice of medicine, discouraging practitioners from treating patients for whom controlled substances are an integral part of their treatment plans, or deterring practitioners from prescribing controlled substances altogether. These outcomes could effectively limit patients’ access to necessary medical care.

Amicus brief raises questions of state vs. federal power

Petitioners and amici also raise potential federalism questions, suggesting that federal enforcement actions against practitioners potentially stray into the realm of State police power. Traditionally, regulation of the medical profession has been the province of the States and state medical boards. However, in their amicus brief, two professors of health law and policy assert that “any construction of the CSA that would permit the federal government to intrude on a state’s right to regulate medical practice must be grounded in” a clearly expressed congressional intent to do so.

Supreme Court opinion could have wide-ranging effects

Ultimately, the Court’s decision could provide needed clarity for prescribers who rely on the prescription of controlled substances to treat their patients. Although DOJ has directed particular enforcement attention toward pain management practitioners in light of the ongoing opioid epidemic, a wide array of other controlled substance prescribers may find it worthwhile to monitor developments in this case. These include drug rehabilitation centers that utilize controlled substances such as methadone and buprenorphine to combat opioid dependence, prescribers of widely used stimulant medications, such as those prescribed for the treatment of ADHD, and prescribers of anabolic steroids, including testosterone.