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Ibuprofen ‘Regulatory History’ Pre-empts Failure-To-Warn Claims In State Court – CHPA

This article was originally published in The Tan Sheet

Executive Summary

FDA regulations and decisions on ibuprofen labeling indicate the agency would not approve warnings plaintiffs seek for Motrin, preventing J&J/McNeil from making the changes without violating federal law, which pre-empts state laws, according to CHPA’s amicus brief in the firm’s appeal of a verdict in Massachusetts.

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