Does federal law preempt punitive damages claims against drug manufacturers who have satisfied FDA approval and labeling requirements?  That is the first question raised in this cert. petition filed by Novartis Pharmaceuticals in Novartis Pharmaceuticals Corp. v. Fussman. 

The plaintiff brought suit in federal district court, asserting a failure-to-warn claim under North Carolina law.  The plaintiff claimed Novartis failed to adequately warn of risks associated with the cancer drugs Aredia and Zometa.  A jury awarded $287,000 in compensatory damages and $12.6 million in punitive damages.  The district court reduced the punitive damages award to $1.3 million under a North Carolina statute that caps punitive damages at three times compensatory damages.

Novartis appealed to the Fourth Circuit, arguing that federal law bars punitive damages in state law failure to warn cases against drug manufacturers who have complied with all FDA requirements.  The Fourth Circuit disagreed and affirmed the punitive damages award in an unpublished opinion.

Novartis filed a petition for certiorari and the plaintiff waived his right to file a response.  But the Supreme Court, after considering the petition, requested a response from the plaintiff.  Yesterday, the Washington Legal Foundation filed an amicus brief in support of the petition.  See their press release here.

To track the status of this petition, you can view the Supreme Court’s online docket here.