The legal landscape may have shifted this summer with a ruling by the Supreme Court of United States in two cases where physicians had been found guilty by lower courts “for dispensing controlled substances not ‘as authorized.’”
SCOTUS Ruling May Give Physicians Relief From Drug Convictions
Under 21 U.S.C. §841, it a federal crime, “except as authorized[,]…for any person knowingly or intentionally…to manufacture, distribute, or dispense…a controlled substance.” However, under 21 CFR §1306.04(a) doctors are authorized to dispense controlled substances by prescription if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”
The physicians, Xiulu Ruan, M.D. and Shakeel Kahn, M.D., had both been convicted and sentenced for prescribing opioids not “as authorized.” They each appealed based on the jury instructions pertaining to mens rea.
In a 9-0 opinion, the Supreme Court held 21 U.S.C. Section 841’s “‘knowingly or intentionally’ mens rea applies to the ‘except as authorized’ clause. This means that in a §841 prosecution in which a defendant meets his burden of production under §885, the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.”
Additionally, the Supreme Court vacated the judgments of the Courts of Appeals below and remanded the cases for further proceedings.
The past few years the Department of Justice has been cracking down on doctors prescribing opioids in an unauthorized manner. This ruling may impact the breadth of prosecution available under the Controlled Substances Act.
This ruling may impact more than just future prosecutions. A month after the decision, Chief United States District Judge Michael Urbanski issued a standing order appointing the Federal Public Defender’s office to “represent eligible defendants seeking post-conviction relief” under the two cases. According to the standing order, after the Supreme Court’s decision the Federal Public Defender’s office began receiving calls from a few individuals “who may be impacted by these decisions.”

Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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