Two Strikes Was Enough in California Federal Court
Litigation attorney Eric Alexander published a blog for Drug & Device Law examining Mizuno v. Sanofi Vaccines U.S. Inc., a decision from the U.S. District Court for the Eastern District of California that dismissed all claims against prescription drug manufacturers without leave to amend. The court found the plaintiff's claims were barred by California's two-year statute of limitations and preempted under federal law. In particular, the court held that the plaintiff failed to allege newly acquired evidence that would have permitted a labeling change through the U.S. Food and Drug Administration's (FDA) Changes Being Effected (CBE) process, resulting in dismissal of the failure-to-warn claims. The court also determined the negligent design claim was preempted because manufacturers cannot unilaterally alter a drug's design and rejected the implied warranty claim because California does not recognize such claims for prescription drugs. Eric highlights the decision as a notable example of a California federal court applying preemption principles at the motion-to-dismiss stage and declining to give a plaintiff another opportunity to replead deficient claims.