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.

A recent ruling against Johnson & Johnson and its McNeil PPC Inc. subsidiary in litigation about Children’s Motrin labeling further muddies the waters about OTC firms’ reliance on federal pre-emption against personal injury claims under state law.

The Massachusetts Supreme Judicial Court upheld a trial court’s verdict that McNeil/J&J could not claim that FDA regulatory history pre-empted its responsibility to warn about toxic epidermal necrolysis and Steven-Johnson Syndrome, skin disorders linked to the use of ibuprofen that caused a 7-year-old girl

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