On The Docket
David B. Brushwood, BSPharm, JD
According to DEA regulations, pharmacists cannot “knowingly” dispense controlled substances pursuant to a prescription that was not issued for a “legitimate medical purpose” or was not issued by an individual practitioner acting “in the usual course of his professional practice.” This is generally referred to as the “corresponding responsibility” rule. If you find this language confusing, then you are in good company, along with the Supreme Court of the United States (SCOTUS). Fifteen years ago, they called the language “ambiguous” with “generalities susceptible to more precise definition and open to varying constructions.”
On June 27, 2022, SCOTUS released a legal opinion that interpreted this language and that vacated the criminal convictions of two physicians who are alleged to have illegally prescribed opioids. This was one of the final opinions authored by Justice Stephen Breyer. The opinion is not an easy read, which is typical of Justice Breyer. The opinion restricts federal power, which is not typical of Justice Breyer. The opinion reports a 9–0 unanimous decision in favor of the physicians and adverse to the United States Department of Justice (DOJ), which is virtually unheard of in recent times (both the unanimity and the adversity to DOJ).
Background
The SCOTUS case consolidated the appeals of an Alabama physician who was sentenced to 20 years in prison and a Wyoming physician who was sentenced to 25 years in prison. Both physicians contended that the judges presiding over their cases had erred by not allowing the juries to consider that the physicians did not subjectively believe they were prescribing opioids illegally. The government countered that an objective standard had been appropriately presented to the juries, and that the judges had not erred in rejecting subjective belief as a valid defense.
Rationale
The SCOTUS ruling does not consider the guilt or innocence of the physicians. The court considered only whether the physicians should be granted new trials due to an error by the judges in not allowing the juries to consider a subjective belief standard.
The SCOTUS ruling criticized the government’s position that “would turn a defendant’s criminal liability on the mental state of a hypothetical ‘reasonable’ doctor, not on the mental state of the defendant himself or herself.” The court concluded that to obtain a criminal conviction, the government must prove that “a defendant knew or intended that his or her conduct was unauthorized.” The “objectively reasonable” standard was rejected by SCOTUS as inapplicable to the circumstance of opioid prescribing.
Discussion
This case is about physicians, but it is also about pharmacists. The DEA regulation states that a pharmacist cannot “knowingly” honor an unlawfully issued prescription. If a prescription is lawful under the SCOTUS interpretation (prescriber did not know or intend that her/his conduct was unauthorized), then there is nothing unlawful for a pharmacist to know of. The pharmacist’s responsibility corresponds with that of the prescriber. A pharmacist cannot violate DEA regulations by knowingly honoring an illegal prescription if the prescription is legal. It is impossible for a pharmacist to know that a legal prescription is illegal if the prescription isn’t illegal.
The SCOTUS ruling applies to criminal prosecutions. The same standard that applies to physicians would extend to pharmacists in a criminal prosecution, because the regulation that was interpreted by SCOTUS applies to pharmacists as well as to physicians. Pharmacists who are criminally prosecuted for unlawful controlled substance dispensing would likely be allowed to assert the subjective belief defense.
Whether the rationale of the SCOTUS ruling will be extended to civil cases related to the denial or revocation of a pharmacy’s DEA registration is an open question. Many legal precedents have been expanded beyond the narrow constraints of the original case in which they were established. It is not a stretch to think that a pharmacist’s subjective belief would now be relevant in DEA civil cases. ■