This month we look at an important recent United States Supreme Court decision which is being hailed as a victory for prescribers. It heightens the standard of proof that the government needs to show in order to successfully prosecute physicians who prescribe inordinate amounts of pain medication.

Facts of the Case

Two physicians were convicted (in separate cases) of violating the Controlled Substances Act (CSA), 21 U.S.C. §841, which makes it a crime “except as authorized […] for any person knowingly or intentionally […] to manufacture, distribute, or dispense […] a controlled substance.” Physicians may dispense controlled substances by prescription if the prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

The two physicians, Dr R and Dr K were separately charged with violating the CSA. One physician argued that whether he met this standard should be judged by his subjective intent (what he personally intended). The judge in that case instead set out a more objective standard and instructed the jury that a physician acts lawfully when he prescribes “in good faith as part of his medical treatment of a patient in accordance with the standard of medical practice generally recognized in the United States.” (This is an objective measure rather than looking at the physician’s subjective intent.) After trial, the physician was convicted and sentenced to a lengthy prison sentence.

In the case of the second physician, the judge instructed the jury (also using an objective standard) that in order for the physician to argue “good faith” as a defense, he must have “acted in an honest effort to prescribe for patients’ medical conditions in accordance with generally recognized and accepted standards of practice.” The second doctor was also convicted and sentenced to jail.

Each doctor appealed. One appealed in the 10th Circuit Court of Appeals, arguing that the trial court had erred by instructing the jury that the doctor’s “good faith” must be “reasonable”, an objective standard that doesn’t require that the defendant knew or intended for his actions to be outside professional practice. The Court of Appeals rejected this argument, holding that the CSA requires the prosecution to prove that the defendant physician either “(1) subjectively knew a prescription was issued not for a legitimate medical purpose; or (2) issued a prescription that was objectively not in the usual course of professional practice.”

The second physician appealed in the 11th Circuit Court of Appeals and similarly had his conviction affirmed. Both physicians appealed to the Supreme Court, and the cases were consolidated into one.

The question presented to the Supreme Court was “whether a physician alleged to have prescribed controlled substances outside the usual course of professional practice may be convicted under Section 841(a)(1) [of the Controlled Substances Act] without regard to whether, in good faith, he “reasonably believed” or “subjectively intended” that his prescriptions fall within the course of professional practice.” In other words, the Supreme Court was asked to decide what the mens rea or “culpable mental state” should be in order to criminally convict a physician for a violation of the Controlled Substances Act.