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

 
• By Malcolm Spicer

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.

A damages claim against Motrin provides a platform to apply to non-monograph OTC products a Supreme Court ruling on whether FDA-approved labeling for Rx drugs pre-empts personal injury claims under state law, the Consumer Healthcare Products Association argues.

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