FDAnews Device Daily Bulletin

House Anti-Preemption Bill Introduced, FDA Questioned on Preemption

July 1, 2008

As legislators try to reverse a Supreme Court preemption ruling for medical devices, a House committee is questioning the FDA, alleging the agency changed its position on preemption.

Reps. Frank Pallone (D-N.J.) and Henry Waxman (D-Calif.) last week introduced a bill that would reverse the court’s decision that provided preemption against state tort suits for FDA-approved medical devices.

The Supreme Court ruled earlier this year that the federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by devices with FDA premarket approval. In Riegel v. Medtronic, the court found that such claims are barred by a preemption clause.

The House bill would add a subsection to the FDCA stating, “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.”

Also last week, the House Committee on Oversight and Government Reform wrote a letter to FDA Commissioner Andrew von Eschenbach requesting documents to explain what it views as a change in the FDA’s historic support of state tort suits.

At a committee hearing in May, Deputy Commissioner for Policy Randall Lutter said state product liability suits challenge the agency’s determinations of safety and effectiveness. However, former FDA Commissioner David Kessler testified that under previous administrations, the FDA’s position was that such suits complemented its regulation, the committee’s letter says.