Draft Anti-Preemption Bill Would Legislatively Reverse Riegel Decision

March 17, 2008

Last month, we reported on the U.S. Supreme Court’s 8-1 decision in Riegel v. Medtronic, in which the Court provided a definitive decision preempting state tort law claims for medical devices subject to an approved Premarket Approval Application.  Immediately after the decision was issued, some members of Congress threatened to introduce legislation that would have the effect of overturning the Riegel decision.  Representative Henry Waxman (D-CA) vowed that Congress will “pass legislation as quickly as possible to fix this nonsensical situation,” and House Energy and Commerce Health Subcommittee Chair Rep. Frank Pallone (D-NJ) stated that the Riegel decision “shows why it is more necessary than ever for Congress to step in and restore the protections that patients are entitled to if they are the victim of a life-altering accident caused by a medical device.” 

A 2-page draft bill, styled as the “Medical Device Safety Act of 2008,” is being circulated on Capitol Hill.  The bill (apparently originating from Rep. Pallone) would amend § 521 of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to add a new subsection, titled “No Effect on Liability Under State Law,” which states: “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.” If enacted, the amendment would apply to any civil action pending or filed on the date of the enactment of the Medical Device Safety Act of 2008.  Furthermore, the bill, if enacted, would be retroactive to the enactment of the Medical Device Amendments of 1976, which added FDC Act § 521.

By Kurt R. Karst    

Categories: Medical Devices