In one of the final cases of a tumultuous term at the Supreme Court, the Justices ruled against DOJ in a decision that could have wide ranging effects not just for physicians and other prescribers, but for drug control laws more generally. In Xiulu Ruan v. U.S., No. 20-1410 (Jun. 27, 2022), the Court considered the convictions of two physicians for violating the Controlled Substances Act, 21 U.S.C. § 841 because, DOJ contended, and the respective juries found, that their prescriptions were “not authorized.” (The relevant statute makes it a federal crime to “[e]xcept as authorized[,]….knowingly or intentionally…dispense…a controlled substance.” Id.). One physician was sentenced to 20 years imprisonment; a second to 25 years. Each, at trial, had contended that their prescriptions were authorized, that they had the requisite credentials to write prescriptions, including DEA and state board registrations, and that they were properly licensed. DOJ, meanwhile, had argued that the physicians were operating “pill mills” and, accordingly, their prescriptions were not “authorized.”

The Court agreed with the physicians, finding that “[a]fter a defendant produces evidence that he or she was authorized to dispense controlled substances, the Government must prove beyond a reasonable doubt that the defendant knew that he or she was acting in an unauthorized manner, or intended to do so.” Xiulu, Slip. Op. at 2 (emphasis added). Because the Court of Appeals had failed to consider this requirement, the opinions of the Courts of Appeals were vacated.

The Court’s holding comes as a blow to DOJ’s efforts to prosecute physicians and other prescribers for similar conduct in light of the country’s opioid crisis. For years, DOJ has sought to broaden its statutory authority and charge physicians and others associated with pill mill activity or who, in DOJ’s view, are “over prescribing” opioids. Results have been, at best, mixed. The nation’s opioid epidemic continues, with some estimates suggesting opioid overdoses account for 80,000 deaths each year. Meanwhile, legitimate prescribers are often reluctant to prescribe opioid medication (even for patients with severe pain) for fear of being caught up in DOJ’s widening net. Now at least those prescribers can rest a bit easier knowing that, in any case against them, the government will have to prove beyond a reasonable doubt that they knew what they were doing was unauthorized.