The U.S. Supreme Court unanimously agreed that in prosecuting cases against physicians under the Controlled Substances Act (CSA), if the alleged physician demonstrates that his or her conduct is authorized per the CSA, the government must prove beyond a reasonable doubt that the physician knowingly and intentionally acted in an unauthorized manner. This changes the criminal intent requirement under the CSA from an objective standard to the subjective intent of the prescriber. 21 U.S.C. § 841 states that “[e]xcept as authorized[,] …” it is a violation of the CSA “for any person knowingly or intentionally … to manufacture, distribute, or dispense … a controlled substance.”
The petitioners in Xiulu Ruan v. United States, Xiulu Ruan and Shakeel Kahn, were convicted of violating the CSA when prescribing opioids in a manner outside the usual course of professional practice. In Ruan’s initial trial, Ruan asked for a jury instruction that required the government to prove that he substantially knew that his written prescriptions fell outside the scope of the usual course of the medical practice, arguing that he held a subjective belief that he was meeting a patient’s medical needs when prescribing opioids. Instead, the trial court used an objective standard, instructing jurors that Ruan’s actions were considered violations when his actions either were not for a legitimate medical purpose or were outside the usual course of professional medical practice, disregarding his discernment for the proper treatment of his patients. Kahn’s trial closely mirrored the same conflict over the proper standard when convicting under the CSA.
The Supreme Court took issue with the distinction between authorized and unauthorized, which the Court reasoned is a thin line between lawful mainstream medical treatment and an unusual but effective treatment that could automatically be considered a violation of federal law. Commonly, a prescription is authorized when it is issued for a legitimate medical purpose in the usual course of professional practice. Consequently, if the prescription was not in the usual course of professional practice, the prescribing physician is subject to a federal violation under the CSA. The Court disagreed with the United States, asserting that the phrase “except as authorized” is prior to the “knowingly or intentionally” statement. Therefore, if the physician falls into an authorized exception to the CSA, the authorized action is not reliant on the objective standard interpretation. The Court further reasoned that “we expect, and indeed usually want, doctors to prescribe the medications that their patients need.” Ultimately, the Court now requires juries in CSA prosecution cases to examine whether the physician believed the actions were legitimate in the treatment of the patient.
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