Federal court dismisses woman's product liability claim against Genentech over withdrawn drug
Vicki Marsh sued Genentech after she suffered complications including meningitis and a collapsed lung after taking the drug Raptiva. Raptiva, sold to treat psoriasis, was withdrawn from the market in 2009 because its T-cell suppression effect too often caused life-threatenening adverse side effects. Marsh argued that Genentech had not adequately tested the drug before marketing it, and that it had not provided adequate warnings or withdrawn the drug prompty upon learning of its dangers.
The Federal Court dismissed Marsh's claim, finding that since the drug was initially approved by the FDA, under Michigan's broad product liability law, the manufacturer was immune from negligence claims, even if the drug was improperly approved or later withdrawn from the market. Michigan is the only state that adopted this "reform," making Michigan residents the only citizens in the U.S. who cannot seek redress from the manufacturer if a pharmaceutical is rushed to market with inadequate or even fraudulent testing and warnings.
The Court held that under existing precedent, the victim's claim is quashed by the immunity statute, even if the manufacturer does not comply with the restrictions imposed upon it by the FDA at the time of approval.