Can a generic drugmaker be held liable for failure-to-warn claims because its version of a popular drug gained U.S. Food and Drug Administration recognition as the industry standard?
That’s the theory plaintiffs lawyers in Atlanta have been pushing in a wrongful death suit against generic manufacturer Mylan and brand-name giant Pfizer. The plaintiffs argued that because Mylan’s maximum strength anti-seizure drug, phenytoin, had become the “reference listed drug” in a particular dosage class, they should be able to avoid dismissal under the U.S. Supreme Court’s decision last June in Pliva v. Mensing . In Mensing , the justices ruled 5-4 that state-law tort claims against generics are pre-empted because generics must follow federal labeling guidelines approved for brand-name manufacturers.
