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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Another Motrin Failure-To-Warn Decision Rejects Pre-emption Defense
Massachusetts’ supreme court says no “clear evidence” showed “FDA would not have approved a warning on OTC ibuprofen labels stating that redness, rash, and blisters may lead to a life-threatening disease.” McNeil’s failed appeal of a verdict in Children’s Motrin litigation adds to rulings that reject federal pre-emption against failure-to-warn complaints.
Another Motrin Failure-To-Warn Decision Rejects Pre-emption Defense
Massachusetts’ supreme court says no “clear evidence” showed “FDA would not have approved a warning on OTC ibuprofen labels stating that redness, rash, and blisters may lead to a life-threatening disease.” McNeil’s failed appeal of a verdict in Children’s Motrin litigation adds to rulings that reject federal pre-emption against failure-to-warn complaints.
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