Supreme Court Weighs When Opioid Prescribing By Physicians Turns Criminal

• Published date: 08 March 2022
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Criminal Law, Food and Drugs Law, Crime
• Law Firm: Dinsmore & Shohl
• Author: Ms Lindsay K. Gerdes and Madeline R. Pinto

On March 1, the Supreme Court will hear oral arguments on a serious issue facing medical practitioners: When can their care turn criminal in the context of prescribing opioids? The Court's decision will have broad implications not only for the many physicians and other practitioners who prescribe opioids, but also for the millions of patients who suffer from pain every day. The inconsistent decisions from lower courts on this issue has left good doctors wondering when their judgment may be called into question and their freedom on the line.

Dinsmore attorneys are closely monitoring this issue and will follow the oral arguments before the Supreme Court. We will keep clients apprised of any major developments that may affect their businesses or health care practices.

Medical practitioners derive their prescribing authority from the Controlled Substances Act (CSA), which makes it unlawful "except as authorized ... for any person [to] knowingly or intentionally ... distribute ... a controlled substance."¹ Drug Enforcement Administration regulations further mandate that prescriptions "must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice."² Innocent prescribing mistakes, differences of opinion on prescribing, or even negligence, should not amount to criminal liability.

In 1975, the Supreme Court held that doctors could be convicted under the CSA when "their activities fall outside the usual course of professional practice."³ But in the decades since, courts have interpreted that decision differently. Some have adopted a subjective good-faith standard and hold that practitioners cannot be convicted if they sincerely and honestly believe that their prescriptions were within the usual course of professional practice.⁴ Others have adopted an objective good-faith standard and hold that a practitioner cannot be convicted if they "reasonably believed" that their prescription was within the usual course of professional practice.⁵ A minority of courts have rejected any consideration of good faith and found it irrelevant to criminal liability.⁶

Given that the statute requires the "knowingly or intentionally" unauthorized distribution of a controlled substance, the Supreme Court is expected to permit the good-faith defense. The only question remains: To what extent? If a doctor honestly believed the prescription was for a legitimate medical purpose, should that absolve the conduct, or should...