Administration Pushes Pre-Emption Following High Court Victory
The Bush administration saw its stance on federal pre-emption validated in yesterday’s U.S. Supreme Court ruling barring lawsuits against the makers of preapproved medical devices. Now it will seek to expand the ruling in a new case relating to drug company liability.
The U.S. Supreme Court ruled yesterday in Riegel v. Medtronic that manufacturers of medical devices that have won a rigorous pre-market approval from the Food and Drug Administration cannot be sued for injuries caused by the devices. Justice Antonin Scalia wrote for the majority that the lawsuit would disrupt the federal scheme for evaluation of new devices.
A new Supreme Court case accepted for argument next term asks whether drug companies are shielded from liability when their medications receive FDA approval, the New York Times reports. The administration “will continue its push for pre-emption” in that case, Wyeth v. Levine, the story says.
The court will take up yet another FDA pre-emption case Monday that seeks approval for a state lawsuit alleging a pharmaceutical company withheld information from the FDA during the approval process for a diabetes drug. The case is Warner-Lambert Co. v. Kent.
Law professor Catherine Sharkey of New York University law school told the Washington Post that pre-emption is a hot issue in products liability lawsuits. The disputes have produced “the fiercest battle in products liability litigation today,” she said.
