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Thursday, May 2, 2024

Walmart: SCOTUS decision destroys DOJ's opioid lawsuit

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Walmart store. | Stock Photo

Walmart and the Justice Department disagreed on the impact of a U.S. Supreme Court decision requiring prosecutors to prove doctors “knowingly” wrote invalid opioid prescriptions, with Walmart arguing the ruling obliterated the government’s civil lawsuit accusing it of failing to block millions of illegal opioid prescriptions, while Justice saying the decision bolstered its case.

Both sides were ordered to submit a status report to U.S. District Judge Colm F. Connolly two weeks after the Supreme Court handed down its decision in Ruan v. U.S., which reversed the conviction of a doctor for writing invalid opioid prescriptions. In that decision, the majority ruled that the federal Controlled Substances Act contains a provision requiring prosecutors to prove guilty knowledge, not just that a doctor violated professional standards by writing opioid prescriptions.

Judge Connolly halted the government’s civil lawsuit against Walmart last November until decisions in Ruan and a companion case were handed down, saying he needed to see how the Supreme Court defined an “authorized” prescription issued in the “usual course” of medicine. The Justice Department argues Walmart and other pharmacy chains violated their duties under the Controlled Substances Act by filling prescriptions without independently verifying that they were authorized. 

In a July 11 joint filing with the court, Walmart and the government were diametrically opposed on what to do next. Walmart said it urged Justice to dismiss its case, while Justice argued the Supreme Court affirmed an objective standard for judging prescriptions that fit its allegations in the lawsuit. 

The section of federal law detailing the duties of pharmacies contains the word “knowingly,” meaning the same standard of knowing wrongdoing applies to them as to doctors, Walmart argued. Justice Samuel Alito’s concurrence, uncontested by the majority, says “mere deviations from objective professional norms” are not enough to fall outside the “usual course” test. 

“Instead the pharmacist must cease acting as one at all, such as by pursuing objectives `alien’ to the profession,” the company said.

“Regardless of whether that standard is viewed as an objective test, a subjective test, or both, the complaint does not come close to satisfying it, through `circumstantial evidence’ or otherwise,” Walmart argued. 

The government countered that the majority didn’t adopt Justice Alito’s more stringent test for illegal prescribing and the decision makes clear prosecutors can use circumstantial evidence to prove prescribers deviated from objective professional standards. 

Back in November, Judge Connolly justified a stay of the case, saying the Ruan decision will determine “what it means for a prescriber to depart from the usual course of medical practice in writing prescriptions; the answer to that question will shed considerable light on what it means for a pharmacist to depart from the usual course of pharmacy practice when filling them.”

The actual decision, however, leaves questions about how much evidence prosecutors must have to prove a pharmacist filled an invalid prescription. The “usual course” of practice is an objective standard, the majority ruled, and the jury can weigh evidence such as the reasonability of a prescriber’s explanations in order to convict. The standards of proof in civil cases are lower than in criminal cases, moreover, where the jury must find guilt beyond a reasonable doubt. 

Walmart proposed the judge issue an order requiring the parties to submit supplemental briefs in August. Walmart also argued against allowing the government to amend its complaint, saying it had five years to assemble its case already. 

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