The U.S. Supreme Court is poised to issue what could be a monumental decision in the Court’s Controlled Substances Act (“CSA”) jurisprudence as applied to the nation’s opioid epidemic. At issue in Ruan v. United States is the requisite intent the government must prove to convict a physician under the CSA for the unlawful distribution of controlled substances.
The outcome in Ruan could have significant implications for prescribers, including whether their risk of criminal liability is actually higher than a narcotics trafficker distributing heroin or cocaine. More specifically, to convict a drug trafficker, federal prosecutors must prove beyond a reasonable doubt that the trafficker knowingly and intentionally manufactured, transported, or distributed narcotics. If the government prevails in Ruan, the government would de facto have to show only that a prescribing physician was negligent in misprescribing opioids.
Concerns about ever-expanding prosecutorial discretion and the erosion of the criminal law’s traditional “guilty mind” requirement have focused significant attention on the case.
A Mini Survey of the CSA’s Statutory Scheme
Per the implementing regulations of 21 U.S.C. § 841(a)(1), a physician may lawfully prescribe controlled substances only if they are prescribed for “a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Even a first-time offender could face decades in prison for misprescribing a Schedule II controlled substance, such as oxycodone, hydrocodone, hydromorphone, methadone, or fentanyl, in violation of the CSA.
The Government’s Case Against Dr. Ruan
In 2016, a federal grand jury returned an indictment charging Dr. Xiulu Ruan, a Drug Enforcement Administration (“DEA”)-registered pain management physician, with, among other things, “knowingly and unlawfully distribut[ing] and dispens[ing] . . . Schedule II Controlled Substances . . . outside the usual course of professional medical practice and not for a legitimate medical purpose, in violation of Title 21, United States Code, Section 841(a)(1).”
The government at trial presented evidence that Dr. Ruan and his business partner issued nearly 300,000 controlled substance prescriptions in a four-year period. Some of these prescriptions allegedly were signed without Dr. Ruan even seeing the patient. The government also presented evidence that Dr. Ruan increased prescriptions of a biopharma company’s fentanyl drug a hundredfold after he and his business partner invested in it.
The DOJ is increasingly using a “data focused approach” to identify economic crime and corporate misconduct, according to a DOJ official. In