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FDA's Failure-to-Warn Pre-emption

By Tresa Baldas
May 31, 2007

Nearly one year after the U.S. Food and Drug Administration issued a pre-emption on filing failure-to-warn actions over federally approved drugs, rulings across the nation show a clear division over the issue.

The FDA declared that it possessed the pre-emptive power in the preamble to new rules for drug labeling issued on June 30, 2006. The pre-emption attempts to ban plaintiffs from filing the lawsuits if the drug has FDA approval. Plaintiffs' attorneys call the FDA pre-emption camouflaged tort reform, while defense counsel argue that a qualified arm of the federal government should call the shots on drug safety ' not judges and juries.

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