Life Sciences

Senators to introduce anti-preemption bill

Pharma Compliance Alert, June 11, 2008

Medical device makers benefited from a Supreme Court ruling in favor of preemption, but now two U.S. Senators want to legislate that victory away. Any anti-preemption bill could also affect a pharmaceutical preemption case the Supreme Court is scheduled to hear this fall.
 
Frank Pallone (D-NJ) and Henry Waxman (D-CA) plan to introduce a bill that explicitly states FDA regulation does not preempt a patients’ right to sue medical device makers under state laws, according to a CongessDaily article.
 
The planned legislation comes after a February Supreme Court ruling that medical device makers are immune from liability for personal injuries if their devices passed the FDA’s most stringent pre-marketing review. The Committee on Oversight and Government Reform, chaired by Waxman, held a hearing on preemption in May.
 
During his opening remarks, Waxman said people who have been injured by a product other than pharmaceuticals and medical devices have the ability to sue for damages. Preemption would remove the threat of litigation, one of the most powerful incentives for safety, he contends.
 
Waxman further criticized the medical device and pharmaceutical industries by claiming some companies have hidden and manipulated important safety data; failed to report serious adverse events; and failed to disclose known defects.
 
The legislation, if proposed and passed, could be bad news for the pharmaceutical and medical device industries and would reverse a recent judicial trend in favor of preemption.
 
The Third Circuit Court of Appeals ruled the failure-to-warn claims conflicted with, and were therefore preempted by, the FDA’s regulatory actions in a case involving Pfizer and GlaxoSmithKline in April.

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