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The Supreme Court on Monday unanimously ruled that prosecutors need to prove that doctors knowingly prescribed drugs in aberrant ways to win convictions against them for unlawful distribution of controlled medicines.

The decision came in a case brought by two doctors who were sentenced to decades in prison for unlawfully prescribing opioids. The doctors had argued they were acting in “good faith” trying to provide care for their patients.

Laws and regulations allow doctors to prescribe controlled substances, including opioids as well as medications for conditions like anxiety and ADHD, “for a legitimate medical purpose” in ways that fit with “the usual course of his professional practice.” At issue in the case was what threshold doctors had to cross for their prescribing patterns to go beyond treatment into what is effectively drug dealing.


Lawyers for the doctors argued that physicians should not be convicted if they reasonably believed their prescribing patterns fit within professional norms and they were trying to meet the individual needs of their patients — that they can indeed make a good faith defense. The government, however, maintained that some prescribing patterns were so far out of the bounds and so clearly did not have legitimate medical purposes that it amounted to a dangerous crime, no matter what the prescriber claimed their intent was.

The court found that in these cases, intent matters for prescribing to be considered criminal.


“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,” said the opinion, written by Justice Stephen Breyer.

The case drew the attention of advocates for pain patients and some health policy experts, who argued that opening the door to more aggressive prosecutions might put a chill on prescribing of opioid painkillers, even when such medications are warranted. The ongoing scrutiny of opioids has already caused some clinicians to pull back or stop prescribing entirely, with surveys showing many primary care physicians won’t take on patients who are on opioids for chronic pain. Already, pain patients have reported they’ve been unable to get the medication they need or have seen their doses slashed in dangerous ways or cut off entirely. An easier bar to clear for a prosecution of a prescriber could only exacerbate that, advocates argued.

“We want doctors treating patients in pain or patients who have opioid use disorder or ADHD or any of these conditions not to be deterred from meeting the genuine needs of their patients,” said Kate Nicholson, the executive director of the National Pain Advocacy Center.

A group of health law experts argued in a petition that doctors could still be penalized for practicing outside medical norms — through losing their prescribing abilities or being sued for malpractice — but that criminal prosecution should be limited for intentional bad actors. Doctors need to be able to provide individualized care instead of worrying whether their medical conclusions fit with someone else’s standard, they argued.

Under the Controlled Substances Act, providers are able to prescribe drugs that it would be a crime for anyone else to distribute. But in a 1975 decision, the Supreme Court ruled that doctors can still be convicted under the CSA if they prescribed in ways “outside the usual course of professional practice.”

The issue was that courts, in the decades since, interpreted that ruling differently, with some finding that the government needed to prove that the prescriber knowingly violated best practices. But more recently, following the overprescribing of opioids and the takeoff of the overdose crisis, courts started upholding convictions of doctors who were found guilty for prescribing in dangerous ways, regardless of intent.

The arguments concerned the cases of two physicians. Xiulu Ruan of Alabama was sentenced to 21 years in prison in 2017 after being found guilty of running what the Justice Department called a pill mill, while Shakeel Kahn of Wyoming was sentenced to 25 years in prison in 2019 for crimes including drug distribution resulting in death. Their cases were consolidated for the Supreme Court.

The court did not throw out the convictions of the two physicians. Instead, it told appeals courts to review the jury instructions from the original criminal cases to see if they comported with the new ruling. 

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