In Wake of Court Ruling, Congress Renews Device Preemption Attack

The day after the U.S. Supreme Court ruled in Wyeth v. Levine that FDA regulations do not shield drugmakers from suits involving state tort laws, legislation was reintroduced in the House to end preemption protection for PMA-approved devices. The bill, H.R. 1346, would amend Section 521 of the Federal Food, Drug and Cosmetic Act by adding: “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”
Devices & Diagnostics Letter