The U.S. Department of Justice has thrown a curveball into Johnson & Johnson’s high-stakes False Claims Act battle, telling the Third Circuit on Wednesday that a district judge committed errors in both jury instructions and post-trial rulings tied to the eye-popping $1.6 billion FCA judgment against J&J’s Janssen unit.
While the government did not intervene to prosecute the case itself, it filed a brief as a neutral amicus on trial-management issues and as an intervenor on constitutional challenges. In its filing, the DOJ conceded the mammoth award is not legally ironclad but flatly rejected J&J’s constitutional attacks.
Errors in Jury Instructions
According to the DOJ, U.S. District Judge Zahid N. Quraishi misstated reimbursement criteria in his jury instructions, telling jurors that Medicare only covers FDA-approved drugs or those supported in medical compendia. In reality, the DOJ noted, Medicare can reimburse off-label prescriptions even when not specifically approved for an indication.
The government said Janssen had failed to object to the oversight during trial, meaning a new trial should be considered only if the lapse was “highly prejudicial.” Still, it urged the Third Circuit to exercise “extreme caution” before tossing the verdict.
