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The U.S. Supreme Court gave two doctors found guilty of misusing their licenses in the midst of the U.S. opioid epidemic to write thousands of prescriptions for addictive pain medications another chance to challenge their convictions.

Xiulu Ruan and Shakeel Kahn are medical doctors licensed to prescribe controlled substances. Each was tried for violating 21 U. S. C. §841, which makes it a federal crime, “[e]xcept as authorized[,] . . . for any person knowingly or intentionally . . . to manufacture, distribute, or dispense . . . a controlled substance.”

A federal regulation authorizes registered doctors to dispense controlled substances via prescription, but only if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR §1306.04(a).

At issue in Ruan’s and Kahn’s trials was the mens rea – or state of mind – required to convict under §841 for distributing controlled substances not “as authorized.”

Ruan and Kahn each contested the jury instructions pertaining to mens rea given at their trials, and each was ultimately convicted under §841 for prescribing in an unauthorized manner. Ruan, who practiced in Alabama, and Kahn, who practiced in Arizona and then Wyoming, were sentenced to 21 and 25 years in prison, respectively, in separate criminal cases.

Their convictions were separately affirmed by the Courts of Appeals for the 10th and 11th circuits.

Both doctors appealed their convictions to the U.S. Supreme Court which overturned their convictions in the combined case of Xiulu RUAN, Petitioner v. United States and Shakeel Kahn, Petitioner v. United States. Nos. 20-1410 and 21-5261. (June 2022)

The question before the Supreme Court concerned the state of mind that the Government must prove to convict these doctors of violating the statute. The cases concerned the good faith defense available to defendants charged under the U.S. Controlled Substances Act.

The Government argued that requiring it to prove that a doctor knowingly or intentionally acted not “as authorized” will allow bad-apple doctors to escape liability by claiming idiosyncratic views about their prescribing authority.

Ultimately SCOTUS held that the statute’s “knowingly or intentionally” mens rea applies to authorization. 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.

Additionally, the court rejected the “bad-apple” argument, that the additional burden on the government to prove would allow doctors to escape criminal liability much more easily, by stating that such an argument could be applied to almost all cases.

The court vacated the decisions and remanded the cases for further proceedings in its 9-0 ruling. On remand, the 10 Circuit has now issued its published opinion in the case of United States v Shakeel Kahn – 19-8054 (February 2023).

During his testimony at trial, Dr. Kahn did not contest the fact that he wrote the relevant prescriptions, nor did he contest that the testifying patients were abusing or selling their medications. The central issue put to the jury in Dr. Kahn’s trial was his intent in issuing the charged prescriptions.

It concluded that the jury instructions issued in Dr. Kahn’s case are inconsistent with the mens rea standard set by the Supreme Court. Each of Dr. Kahn’s convictions was impacted by erroneous instructions in a way that prejudiced him, and, therefore, it remand with directions to vacate his convictions on all counts, and remand for a new trial.