Freeman v. Hoffman-La Roche, Inc.
Nebraska Supreme Court
618 N.W.2d 827 (2000)
Freeman (plaintiff) took Accutane for acne for under two months and alleged it caused ulcerative colitis, inflammatory polyarthritis, and visual impairment, suing manufacturer Hoffman-La Roche (defendant) on multiple theories including design defect, failure to warn, and fraudulent misrepresentation. The trial court sustained Hoffman-La Roche's demurrer based on prior Nebraska precedent granting drug manufacturers blanket immunity from design-defect claims whenever the drug was properly manufactured, labeled, and the FDA application was truthful.
Whether FDA approval of a properly manufactured, labeled, and truthfully-applied-for prescription drug categorically immunizes the manufacturer from design-defect liability.