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High Court Sides With Docs Accused of ‘Pill Mill’ Operations

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WASHINGTON — The Supreme Court on Monday ruled unanimously in support of two doctors convicted of prescribing opioids without a “legitimate” medical purpose, arguing that there should be a higher standard of proof in prosecuting such cases.

A provision of the Controlled Substances Act (CSA) declares it a federal crime for a person to knowingly or intentionally distribute or dispense controlled substances, such as opioids, “except as authorized.”

At the core of the consolidates cases in Ruan v. United States — brought by Xiulu Ruan, MD, of Alabama, and Shakeel Kahn, MD, of Wyoming and Arizona — is the question: At what point does prescribing powerful and addictive painkillers to a patient become a criminal act? Or more specifically, is criminal intent necessary to convict physicians for distributing substances outside of medical norms.

In the opinion, authored by Justice Stephen Breyer, the Court ruled that “once a defendant meets the burden of producing evidence that his or her conduct was ‘authorized,’ the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.”

Both physicians were found guilty of dispensing controlled substances not as authorized, and their convictions were upheld after appeals. Ruan was sentenced to 21 years in federal prison and Kahn to a 25-year sentence for charges that included prescribing that resulted in a patient’s death.

Lower courts have applied differing standards when determining whether to charge individual doctors with criminal liability. In Ruan’s case, a jury convicted him in a ruling that prohibited a “good faith” defense — defined as being “in accordance with what a reasonable physician should believe to be proper medical practice” — and an appeals court rejected his request to vacate the decision based on the argument that he was denied the ability to leverage this good-faith defense.

The 9-0 decision sends the case back to a federal appeals court for further proceedings, to determine if jury instructions on criminal intent were adequately described and whether any errors in the instructions were harmless.

Breyer’s opinion — joined by Chief Justice John Roberts and Justices Sonia Sotomayor, Elena Kagan, Neil Gorsuch, and Brett Kavanaugh — dismissed the government’s argument that “bad-apple doctors” could escape liability by “claiming idiosyncratic views about their prescribing authority.”

Justice Samuel Alito, Jr., in a concurring opinion joined by Justices Clarence Thomas and Amy Coney Barrett, stated that the Court “errs” in placing on the government the burden to “prove beyond a reasonable doubt” that a defendant had criminal intent when acting in an unauthorized manner.

“A doctor who acts in subjective good faith in prescribing drugs is entitled to invoke the CSA’s authorization defense,” Alito wrote. “A doctor who knows that he or she is acting for a purpose foreign to medicine — such as facilitating addiction or recreational drug abuse — is not protected by the CSA’s authorization to distribute controlled substances by prescription. Such doctors may be convicted of unlawfully distributing or dispensing a controlled substance.”

Former prosecutors raised concerns over Monday’s decision.

“This will have a chilling effect on how the [Justice Department] assesses what cases to prosecute,” said former federal prosecutor Sean B. O’Connell, in a statement shared with the Washington Post, noting that ongoing investigations will need to be reevaluated to determine if there’s enough evidence to meet the Court’s new bar.

  • Shannon Firth has been reporting on health policy as MedPage Today’s Washington correspondent since 2014. She is also a member of the site’s Enterprise & Investigative Reporting team. Follow

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