On May 20, 2019, U.S. Supreme Court held that whether “clear evidence” exists that the Food and Drug Administration (FDA) considered and rejected a drug manufacturer’s request to alter its label is a question for the trial judge, not for the jury. The high court vacated the Third Circuit’s opinion and remanded the case for further consideration in light of its ruling. The decision marks a victory for WLF, which filed an amicus curiae brief in the case arguing that the FDA’s action preempted the manufacturer’s liability under state tort law. The case arose from a multi-district litigation combining lawsuits by more than 1,200 users of Fosamax, an FDA-approved prescription drug for treating osteoporosis in older woman. When Merck—the maker of Fosamax—learned of studies suggesting a possible link between long-term Fosamax use and an unusual type of thigh-bone fracture, it sought the FDA’s permission to warn of that risk on Fosamax’s label. But after reviewing all the available scientific data, the FDA rejected Merck’s revised label while it studied the issue more closely. Nonetheless, Fosamax users who suffered thigh-bone fractures successfully sued Merck under state tort law for failing to adequately warn of their injuries.


US Supreme Court decision

WLF Amicus Brief