FDAnews Device Daily Bulletin

Allowing unchecked federal preemption of state device and drug liability laws will harm device and drug safety, former FDA Commissioner David Kessler told the House Committee on Oversight and Government Reform last week.

Preemption has been an issue for lawmakers since the Supreme Court’s Feb. 20 ruling in Riegel v. Medtronic, which limits devicemakers’ liability under state laws for products with FDA premarket approval. A similar drug-related case — Wyeth v. Levine — is scheduled for the court’s term beginning in October.

The hearing produced sharp partisan exchanges between members of the committee. In his opening statement, Rep. Henry Waxman (D-Calif.) slammed preemption as a “radical legal doctrine being advocated by the pharmaceutical and device industries and the FDA” that would deprive injured patients of the right to seek compensation and would remove “one of the most powerful incentives for safety — the threat of liability.”
 
Supporting the FDA’s view was John Calfee of the American Enterprise Institute, who argued that state lawsuits to compensate injured patients amount to using the tort system as if it were an insurance system, driving up healthcare prices. Counter to the claims of its backers, litigation will not improve information for patients and physicians, he added.

Industry group AdvaMed also supports preemption. Uniform FDA safety standards prevent “a patchwork approach to regulation where medical devices may have different standards depending upon the state in which you live,” it said in a statement.

“The assertion that companies have no liability when patients are injured by medical devices is simply not true,” the group said. “There are a host of civil and criminal penalties manufacturers are subject to for failing to follow FDA requirements.”