A proposed federal rule that would grant immunity from product liability lawsuits to drug and medical device makers that fail to warn about their products’ dangerous side effects on certain consumers has drawn objections from a trial lawyers group.
The Washington-based American Assn. for Justice yesterday filed an objection with the U.S. Food and Drug Administration over its wording of a preamble to a proposed agency rule on warning-label requirements. The preamble would pre-empt state product liability lawsuits by women who are pregnant or breast-feeding, even if a warning label fails to disclose the dangerous side-effects for those women if they use those products.
“AAJ believes that the FDA must revise its preamble in the final rule to eliminate any reference to the pre-emption of product liability lawsuits,” the association wrote in its protest letter. “This language contradicts express Congressional intent. If a court defers to the FDA’s opinion on pre-emption, drug manufacturers will have complete immunity from lawsuits brought by women and families who were injured by dangerous drugs and will prevent them from seeking recourse.”
The association also stated that the U.S. Supreme Court ruled in a 1996 case, Medtronic vs. Lohr, that pre-empting state statutes on product liability is permissible only when a defendant can show the lawsuit against it conflicts with federal pre-emption rules.
This fall, the Supreme Court is scheduled to review how the federal pre-emption issue applies in pharmaceutical product liability cases in Wyeth vs. Levine. In that case, the court will address whether FDA drug-labeling requirements pre-empt state law product liability claims that assert that different labeling judgments were necessary to make the drugs reasonably safe for use.