Brief of Amici Curiae Professors of Health Law and Policy in Support of Petitioner, Ruan v. United States, No. 20-1410

35 Pages Posted: 11 May 2021

See all articles by Jennifer D. Oliva

Jennifer D. Oliva

Seton Hall University School of Law

Kelly K. Dineen

Creighton University School of Law

Date Written: May 7, 2021


Controlled substances hold a special place at the intersection of medicine, law, and society. No decisions are as fraught with peril in medicine than whether, how, how much, and for how long to prescribe controlled substances, especially during an opioid crisis. These decisions implicate not just the benefits and risks to the patients to whom drugs are prescribed, but also the risks to third parties who use diverted drugs without medical supervision. The later consideration is as far as Congress intended federal law enforcement to reach into the regulation of medical practice, an area that falls squarely within the States’ police powers.

The Eleventh, Fourth, and Tenth Circuits have recently construed the CSA in a manner that permits the government to convict a prescriber of a felony for nothing more than deviations from accepted medical standards, including behavior akin to mere negligence. These circuits have criminalized prescribing negligence by (1) permitting convictions when prescriptions deviate from accepted medical practices without considering whether the practitioner acted without a legitimate medical purpose (also referred to as “beyond the bounds of medical practice”), and (2) constructively refusing to extend to practitioners a good faith defense. These approaches criminalize mistaken or negligent prescribing for which there are already myriad civil, administrative, and even lesser criminal remedies.

The constructive rewriting of the CSA as applied to practitioners runs afoul of the text and purpose of the CSA, conflicts with this Court’s controlling case law, imperils the evolution of medicine and patient care, and implicates significant federalism concerns. We respectfully request that this Court clarify that the CSA’s reach only extends to practitioners who prescribe knowingly or intentionally (i.e., not in good faith) without a medical purpose outside the usual course of professional practice. The questions implicated by the instant petition and those in United States v. Naum, No. 20-1480, are what the government must prove to convict a prescribing practitioner under CSA Section 841(a)(1). Consequently, this Court should consolidate the instant petition and Naum and grant certiorari in both cases.

Suggested Citation

Oliva, Jennifer and Dineen, Kelly K., Brief of Amici Curiae Professors of Health Law and Policy in Support of Petitioner, Ruan v. United States, No. 20-1410 (May 7, 2021). Available at SSRN: or

Jennifer Oliva (Contact Author)

Seton Hall University School of Law ( email )

One Newark Center
Newark, NJ 07102
United States


Kelly K. Dineen

Creighton University School of Law ( email )

2500 California Plaza
Omaha, NE 68178
United States

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