Doctors who treat pain patients have long been concerned over being investigated and prosecuted and with the government accelerating its actions against opioid “pill mills” that concern has been increasingly justified. It has produced a reluctance to prescribe at levels that actually diminish their patients’ pain, and patients often feel that doctors are viewing them presumptively as drug-seekers.

On June 27, however, the Supreme Court unanimously sided with doctors, holding that prescribers who honestly believe that their prescriptions are within the usual course of professional practice will be shielded from criminal liability.

The ruling came in the appeals of Drs. Xiulu Ruan and Shakeel Kahn, who had been convicted of unlawfully dispensing opioid painkillers.

At their trials, the district courts had instructed jurors that if doctors prescribed opioids outside the recognized standards of medical practice that they could be convicted under the Controlled Substances Act, which makes it a crime for any person to “knowingly or intentionally” dispense a controlled substance unless they are a licensed health care professional acting within “the usual course of professional practice.” Specifically, the good faith of a practitioner that such prescribing was medically valid was not to be considered.

The doctors appealed and the 10th and 11th Circuits affirmed the instructions that the jurors had been given, and the doctors’ sentences of 21 and 25 years were upheld.

In their arguments at the Supreme Court the doctors urged adopting a subjective good-faith standard so that if a medical practitioner sincerely believed that their prescriptions were within the usual course of professional practice that they could not be convicted of violating the law – that a doctor who is mistaken or even negligent is different from one who is mis-prescribing on purpose, which is what the law is directed to.  Dr. Kahn’s lawyer summed this up as “The question under (section) 841 (of the CSA) is not whether a doctor was a bad doctor but whether he was a drug dealer”.

The government argued that a subjective good-faith standard would be no standard at all in a setting in which dangerous drugs were involved, and it urged the Court to instead adopt an objective good-faith standard based on what a “reasonable doctor” would do. What it was saying was that acting as an actual doctor would protect someone under the law.

Consistent with concerns expressed by several justices during Oral Argument that the objective standard left open too many chances for close calls that could then result in prison time, the Court held that the subjective standard was appropriate.

Writing for the majority, Justice Breyer held that once a doctor produced evidence that they were authorized to prescribe opioids that prosecutors needed to prove beyond a reasonable doubt that they then knowingly or intentionally acted in an unauthorized manner.

That does not mean that the actual convictions, which included charges of issuing nearly 300,000 prescriptions and taking kickbacks to prescribe fentanyl spray and selling prescriptions for cash, were reversed in the actual cases.  Those cases were instead sent back to be reviewed on appeal under this requirement.

However, there is a very significant implication for doctors who do follow proper rules, who evaluate patients individually, see them regularly, who only resort to the strongest drugs after other methods and lower doses have failed, and who have records that substantiate all of that, proving their belief that the treatment was medically valid.

They are now entitled to have jurors determine if the prescribing was within authorized guidelines by virtue of them, as the doctor, believing that it was necessary.

Admittedly, this is still not protection against an investigation or case.  However, it is hoped that with this constraint on prosecutions that doctors may now be more willing to properly prescribe controlled medications to the patients who truly need them.