Lawyers Question FDA's Changes To Labeling Rules

Law360, New York (September 4, 2008, 12:00 AM EDT) -- An association of trial lawyers has said a proposal by the U.S. Food and Drug Administration that would change drug labeling for pregnant and lactating women would lessen the success of product liability lawsuits involving those women — traditionally one of the riskiest liability areas for drug manufacturers.

In a brief filed with the FDA, the American Association for Justice takes issue with preamble language in the proposed rule referencing the preemption of product liability lawsuits. The arguments in the association's comments echo a debate on...
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