A woman who claims a defective heart pump caused her husband's death has lost her bid to revive a products liability suit against the pump's manufacturer now that a divided panel of the 3rd U.S. Circuit Court of Appeals has ruled that all her state law claims are expressly pre-empted by the federal Medical Device Amendments. Federal circuits have split on when and how to apply pre-emption in the context of the FDA's "pre-market approval" process.
FDA's Approval of Medical Device Bars Products Suit
The Legal Intelligencer
July 22, 2004