Last June, in the consolidated cases of Ruan v. United States and Kahn v. United States, the U.S. Supreme Court considered the mens rea required to convict a physician charged with illegal distribution of narcotics under the Controlled Substances Act. The Court held that: "After 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."  A health care professional acts in an authorized manner under statute's controlling regulation when he or she acts in the "usual course of professional practice for a legitimate medical purpose." The vote was 9-0 on the need to reverse the judgments of the 11th Circuit (in Ruan) and the 10th Circuit (in Kahn), because both courts "evaluated the jury instructions under an incorrect understanding of [Title 18 U.S. Code] §841's scienter requirements," but the vote was 6-3 on the majority's specific holding. Justice Alito, joined by Justice Thomas and, far the most part, Justice Barrett, concurred in the result only. They did not join the majority's holding that, once the defendant meets the burden of producing any evidence that he or she was authorized to write prescriptions, the burden of proving beyond a reasonable doubt that the defendant intended to act, or knew he or she was acting, "in an unauthorized manner" falls on the government. But all nine Justices agreed that at least a portion of the jury instructions in each trial were defective because they injected objective reasonableness requirements into their good faith definitions. The Court sent the cases back to their respective circuits to determine, under the correct scienter requirements, whether: 1) the offense instructions as a whole were correct as a matter of law, and 2) whether any error in the instructions was harmless.

The supplemental briefs and replies have now been filed in each case, and are attached below. In Ruan, the harmless error analysis is complicated by the defendant's conviction on counts other than illegal distribution. In Kahn, a key focus of the government and defense briefs is the difference, if any, between knowingly or intentionally acting in an unauthorized manner (that is, outside the usual course of professional practice without a legitimate medical purpose) and knowingly or intentionally acting outside or beneath the relevant standard of care. The government maintains that there is no difference between the two concepts, which is an extremely doubtful position in light of the language and reasoning of both the majority and concurring opinions. This issue is really the elephant in the room in the post-Ruan/Kahn world. The Supreme Court originally granted certiorari to resolve a circuit split, but a split still exists, because some circuit courts have long approved instructions equating standard of care with authorized practice, while others have held that an intentional violation of the standard of care is not the same as acting with no legitimate medical purpose outside the scope of a medical practice. Attached below are the briefs on remand in Ruan and Kahn.

Shakeel Kahn's Supplemental Brief on Remand U.S. v. Shakeel Kahn-Government's Supplemental Brief on Remand U.S. v. Shakeel Kahn-Appellant's Supplemental Reply Brief Ruan Supplemental Brief on Remand Ruan and Couch Supplemental Brief of Appellee United States  Ruan CA11 Supplemental Reply Brief on Remand (10.13 final)  

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