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

Six years ago, this Court unanimously vacated the Third Circuit’s ruling imposi ng a heightened standard for preemption, and remanded to apply a two-part test asking if (i) “the drug manuf acturer fully informed the FDA of the justifications for the warning required by state law,” and (ii) “the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” Merck Sharp & Dohme Corp. v. Albrecht , 587 U.S. 299, 303 (2019). On remand, the district court found both parts of the test satisfied. But the Third Circuit again rejected preemption, this time by adopting a “heavy” evidentiary presumption under which the record must be read “in a manner that di sfavors pre-emption,” thus foreclosing a court’s consider ation of extrinsic evidence (such as the FDA’s contemporaneous statements and even its later representations in court), and allowing preemption only if the FDA’s action is “abundantly clear” on its face. Pet.App.66a. The question presented thus remains: 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 fo rmally 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?