If a pharmaceutical manufacturer fully informs the FDA of all material information bearing on a drug's potential risk and seeks approval to warn of that risk on the label (as the district court and Court of Appeals both found), but the FDA formally denies the request without mandating any alternative warning, may the manufacturer nonetheless be held liable under state law for failure to warn of that risk?

Whether a pharmaceutical manufacturer can be held liable under state law for failure to warn when the FDA formally denies a proposed warning label change