The amici argue that the government’s prosecution of Dr. Ruan, and physicians in similar cases, dangerously conflates medical error with criminal intent. They begin by situating the issue in the broader dual crises of untreated pain and rising opioid-related deaths, noting that while law enforcement is vital in combating illicit trafficking, its narrow enforcement lens is ill-suited to complex medical judgment. The brief contends that the government improperly uses the “standard of care” as a proxy for the Controlled Substances Act’s requirement that prescriptions be issued for a “legitimate medical purpose in the usual course of practice.” This approach, they argue, effectively strips away the statute’s mens rea requirement, turning cases of negligence or disagreement over medical practice into criminal liability and exposing physicians to wrongful conviction. Amici emphasize that under criminal law, intent must apply to all material elements, citing Liaparota and Flores-Figueroa to argue that the government must prove not just that a prescription was outside the standard of care, but that the physician knew at the time of writing that it was unlawful. They further maintain that a meaningful good faith defense, with both subjective and objective components, must be available to physicians who make honest, reasonable efforts to treat patients. Finally, amici warn of the broader harms to the health care system: fear of prosecution deters physicians from prescribing necessary medications, leaving patients in pain, driving some toward illicit and dangerous alternatives, and ultimately worsening both the opioid crisis and the undertreatment of pain. In their view, cases of mere error, negligence, or poor practice should be handled through civil or administrative channels, not criminal courts.
2021 | Federal Juristiction