Merck Sharp & Dohme Corp. v. Albrecht

Merck Sharp & Dohme (defendant) makes Fosamax, an osteoporosis drug. The FDA approved Fosamax's label in 1998 without a warning about unusual thigh-bone stress fractures, even though Merck scientists suspected a theoretical link. Merck applied in 2008 to add a fracture warning, but the FDA rejected that application since the evidence wasn't yet conclusive; the FDA didn't require the warning until 2010. Between 1999 and 2010, more than 500 women (plaintiffs) who took Fosamax and suffered stress fractures sued Merck for failure to warn under state law. Merck argued federal law preempted these claims because the FDA had already rejected the 2008 label-change request. The trial court agreed and granted summary judgment for Merck; the appellate court reversed, holding a jury should decide whether the FDA would likely have approved the change.