HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Tuesday, May 10, 2022

Brief of Amici Curiae Professors of Health Law and Policy in Support of Petitioner, Ruan v. United States (Merits Stage)

Jennifer D. Oliva (Seton Hall University), Kelly K. Dineen Gillespie (Creighton University), Brief of Amici Curiae Professors of Health Law and Policy in Support of Petitioner, Ruan v. United States (Merits Stage), SSRN (2022):

Prescribing controlled substances for the benefit of patients is an everyday and essential practice for physicians and other authorized prescribing practitioners. Despite dominant public narratives about the harms of prescribed controlled substances, these compounds are neither harmful nor useful absent context. In fact, they are essential to modern medicine; a reality acknowledged by Congress in the initial sentences of the CSA. Indeed, prescribed controlled substances are a critical component of appropriate, ethical, and evidence-based care for patients with a range medical needs and conditions beyond pain and opioid use disorder, from treating patients with severe COVID-19 respiratory failure to regulating wakefulness for pilots.



Like all medications, prescribed controlled substances also carry the potential for harm, including the risk that those drugs may be diverted for use by others without medical supervision. Practitioners have professional legal and ethical duties to carefully weigh the potential benefits and harms to their patients, and to prescribe controlled substances in a way that reduces the likelihood of diversion. These prescribing decisions are fraught with peril, including legal peril, in ways that prescribing other potentially harmful drugs are not—especially considering the responses to the drug overdose crises in the United States. Over the last decade, legal and institutional actors have implemented blunt, reactive policies with the singular goal of reducing controlled substances prescriptions. As prescribing rates have plummeted during the last decade, the harms to patients in need of care and safe access to medication have significantly increased.

CSA Section 841(a)(1) prosecutions carry a significant possibility of federal imprisonment—the most severe of the many legal and quasi-legal remedies available to address problematic prescribing. Until recently, Section 841(a)’s scienter requirement, which demands a knowing departure from the usual course of professional practice, constrained such prosecutions. But the CSA has been weaponized against practitioners in reaction to the overdose crisis. Federal practitioner investigations and prosecutions have increased while the standards for conviction under Section 841(a)(1) have steadily eroded.

Prosecutorial and judicial statutory reconstruction to convict practitioners more easily is not the cure for drug related morbidity and mortality. As we previously explained, and as the petitioners have described in the consolidated cases here, the Tenth and Eleventh Circuits have effectively eliminated Section 841(a)(1)’s mens rea requirements as applied to prescribers. While the government must prove intentional or knowing distribution of controlled substances for non-prescribers under Tenth and Eleventh Circuit precedent, the government may convict any prescriber of felony distribution without proof that those prescribers had any knowledge of “all the facts that make [their] conduct illegal.” McFadden v. United States, 576 U.S. 186, 194–95 (2015). Practitioners can face decades in prison for nothing more than deviations from accepted medical standards, including mistaken, foolish, negligent, and reckless prescribing (good faith medical error).

The text and history of the CSA and this Court’s relevant precedent all support the conclusion that Section 841(a)(1) was designed to punish practitioners who engage in intentional or knowing illicit drug distribution by using their authorization to prescribe as a subterfuge for diverting drugs. The statute was not intended to remedy poor or even harmful medical decision-making. The Tenth and Eleventh Circuits’ constructive rewriting of the CSA as applied to practitioners harms patients with legitimate medical need for controlled substances, forces practitioners to act unethically to protect themselves from legal sanction at the expense of the well-being of the patient, imperils the evolution of patient care, and implicates significant federalism concerns. We respectfully request that this Court clarify the scienter requirements of Section 841(a)(1) and reject the legal exceptionalism embraced by several federal circuits that have determined to apply good faith to the actus rea rather than the mens rea requirements of the statute. The CSA’s reach should only extend to practitioners who knowingly or intentionally (i.e., not with subjective good faith) depart from their controlled substances authorization to prescribe outside the usual course of professional practice, thereby transforming legitimate prescribing into unlawful distribution. This the most coherent interpretation of the line between otherwise lawful activity (prescribing as authorized) and criminal distribution under Section 841(a)(1).

https://lawprofessors.typepad.com/healthlawprof_blog/2022/05/brief-of-amici-curiae-professors-of-health-law-and-policy-in-support-of-petitioner-ruan-v-united-sta.html

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