United States Supreme Court Says More Than Mere Negligence Is Needed to Prosecute Physicians for Over-Prescribing Controlled Substances

By: Jesse Adam Markos, Esq.

Wachler & Associates, P.C

On June 27, 2022, three days after the U.S. Supreme Court overturned nearly 50 years of settled law in a direct assault on women’s rights and reproductive freedom, the Court issued an important decision for physician autonomy in a consolidated case ruling in Ruan v. United States. In that case, the Court raised the burden of proof for federal prosecutors seeking to hold physicians accountable under the Controlled Substances Act for the rise in addiction and death during the opioid crisis. While many of these prosecutions have certainly been laudable, others have involved treatment that was not so clearly egregious, treating what, at worst, could have been medical malpractice or standard of care violations, as criminal matters.

In each of the consolidated cases, the defendants were physicians licensed to prescribe controlled substances. Each was charged with violating 21 U.S.C. § 841, which makes it a federal crime to distribute or dispense controlled substances “except as authorized.” A federal regulation authorizes registered doctors to dispense controlled substances via prescription, but only if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR §1306.04(a).

At issue was the mensrea required to convict under §841 for distributing controlled substances not “as authorized.” The juries were not instructed to consider the physicians’ “good-faith defense,” i.e., that they were prescribing the controlled substance “legitimately” to treat pain based upon a good-faith assessment of the patient’s condition and medical necessity. The question then presented to the United States Supreme Court was whether it is “sufficient for the Government to prove that a prescription was in fact not authorized,” or whether it “must . . . prove that the doctor knew or intended that the prescription was unauthorized.”

The Court held that, “once a defendant meets the burden of producing evidence that his or her conduct was ‘authorized,’ the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.” In other words, the prosecutor must prove that the physician subjectively knew that his or her prescriptions were, in fact, outside of the scope of his or her prescribing authority. The Court reasoned that the “knowingly or intentionally” requirement was necessary because a legal authorization to prescribe and distribute controlled substances “plays a ‘crucial’ role in separating innocent conduct — and, in the case of doctors, socially beneficial conduct — from wrongful conduct.”

In short, the Court resoundingly rejected any effort to prosecute physicians for the alleged unlawful distribution of controlled substances based on a standard similar to negligence. As such, the Ruan decision is a welcome development for those seeking to prevent law enforcement from practicing medicine. The increasing criminalization of physician conduct has had a very real chilling effect on care as many physicians have become increasingly reluctant and afraid to try to help their patients in pain. Many such patients have been forced to suffer in pain. And in the most tragic situations, some of those patients, lacking other options, have purchased counterfeit or illegal medication that, unbeknownst to them, is laced with deadly fentanyl.