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Healthcare Practice
Recent Decisions Related
to Prosecutions Under the Controlled Substances Act –
By Jim Hoover
On June 27, 2022, the Supreme Court of the United States (SCOTUS) heard an appeal emanating from a conviction of a local doctor in Mobile, Alabama and a different conviction of a doctor in Wyoming for violating the Controlled Substances Act (CSA). The case is Ruan v. United States, No. 20-1410 (June 27, 2022).
The opinion heavily scrutinized a particular sentence in the CSA. 21 U.S.C. § 841 makes it a federal crime for any person except as authorized to knowingly or intentionally manufacture, distribute or dispense a controlled substance. As provided by the regulatory framework, a prescription is only authorized when a doctor issues the prescription “for a legitimate medical purpose . . . acting in the usual course of his/her professional practice.” The Department of Justice (“DOJ”) argued that “knowingly or intentionally” merely refers to the knowing or intentional distribution of a controlled substance. However, the Supreme Court held that once a defendant-doctor meets the burden of producing evidence that his or her conduct was “authorized,” the DOJ “must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner” in order to secure a conviction for improper prescribing.
The justices specifically examined the convictions of Dr. Xiulu Ruan of Alabama and Dr. Shakeel Kahn of Wyoming, who are each serving prison sentences of more than 20 years. Both physicians actively practiced medicine and possessed licenses permitting them to prescribe controlled substances. The DOJ charged each of them with unlawfully dispensing and distributing drugs in violation of the CSA. Each doctor argued that the drugs were dispensed pursuant to a valid prescription and were for a legitimate medical purpose by each of them acting in the usual course of their professional practice. The doctors further argued that each of their prescriptions complied with the above standard, and even if the prescriptions did not, the doctors did not knowingly or intentionally deviate from this standard.
In Dr. Ruan’s case, the Eleventh Circuit Court of Appeals held that a doctor’s subjective belief that he/she is meeting a patient’s medical needs by prescribing controlled substances is not a complete defense. Rather, the Eleventh Circuit held that whether a doctor-defendant acts in the usual course of his professional practice must be evaluated based upon an objective standard, not a subjective standard.
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“Pill Mill” Cases
Jim Hoover
FDCC ANNUAL INSIGHTS 2023