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In Brief

This article was originally published in The Tan Sheet

Executive Summary

Jury orders McNeil to pay $63M in TEN suit; Marshals seize Globe All Wellness products; USP forms supplement adulteration panel; FDA warnings for GMPs flow; Hurricane Sandy impact knocks GNC revenue; Icahn takes Herbalife stake; U.K. shuts down melatonin ad.

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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.

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

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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