New Legislation Could Challenge Supreme Court's Preemption Ruling
BY LAUREN UZDIENSKI, MARCH 26, 2008
Last month, the Supreme Court ruled in Riegel v. Medtronic that FDA approval pre-empted product-liability lawsuits in state courts. The landmark decision was a vote of support for the FDA's authority, but it raised concerns about the implications for patient rights.
In response, Congressmen Frank Pallone (D-NJ) and Henry Waxman (D-CA) announced plans to introduce a new bill that would challenge the Medtronic ruling, amending the Federal Food, Drug and Cosmetic Act to include the subsection "No Effect on Liability Under State Law," which would read, "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."
Pallone has said that the Medtronic ruling "denies patients any legal recourse if they are a victim of a faulty medical device." If the Pallone/Waxman bill is passed, the new language would again permit patients to sue device manufacturers in state courts, regardless of the product's FDA status. The new legislation is expected to be introduced next month.
