Merck Sharp & Dohme Corp. v. Albrecht

Absence of “clear evidence that the FDA would not approve a change to a label, the Court will not conclude that it was impossible… to comply with both federal and state requirements.”

Petitioner manufactures a drug that treats and prevents osteoporosis in postmenopausal women. The Petitioner’s drug label did not warn of the then-speculative risk of atypical femoral fractures associated with the drug. Respondents brought suit, arguing that the Petitioner had a legal duty to warn the Respondents of the atypical femoral fracture risks associated with the drug. Petitioner argued that the failure to warn claim should be dismissed as it was pre-empted by federal law and asserted that the FDA would have rejected the attempt to change the label. The district court agreed with the Petitioner and granted summary judgment. The Third Circuit Court of Appeals recognized that under Wyeth v. Levine, 555 U.S. 555 decision, a state-law failure-to-warn claim is pre-empted where there is “clear evidence” that the FDA would not have approved a change to the label, In Wyeth, the Supreme Court held that in absence of “clear evidence that the FDA would not approve a change to a label, the Court will not conclude that it was impossible… to comply with both federal and state requirements.” Applying Wyeth, the Court held that the Petitioner fell short of supplying the FDA with proper analysis concerning the specific dangers for the warning label when they did not provide the FDA of the justifications for the specific warnings of the risk of atypical femoral fractures associated with the drug. The Court additionally held that the question of agency disapproval is one for a judge to decide because judges are better equipped to evaluate the nature and scope of an agency’s determination and decisions on regulatory contexts. VACATED AND REMANDED.