The U.S. Supreme Court has decided that generics makers can't be sued under state law over failure-to-warn allegations. That's a big victory for Teva Pharmaceutical Industries, Mylan's UDL Laboratories and Actavis, which had faced appeals court rulings that would have allowed them to be sued under state law.
But it's also a victory for other generics makers, of course, who can stop worrying that they'll face legal action over their drug labeling. Copycat drugs carry labels that mimic those on their branded counterparts. But the plaintiffs in those suits had claimed the generics firms were liable for leaving cautionary language about their injuries off those labels.
This is yet another twist in the saga about preemption, a.k.a. the idea that federal drug approvals should shield drugs from state-court lawsuits. Federal law requires generics to have the same labels as branded drugs, Reuters notes. And the generics makers had argued that the FDA's approval of their products--and the law requiring those approved products to have identical labels--should shield them from liability.
And the court agreed. Justice Clarence Thomas, who wrote the majority opinion, said that the rules about generics labels directly conflict with the claims in state lawsuits. Incidentally, the high court's ruling came in spite of a brief from the Obama administration supporting the opposite view.
- read the Reuters news