Preempt State Liability for Branded Drug Label: WLF
In an amicus brief submitted to the Supreme Court, Washington Legal Foundation (WLF) says the court should decide that federal law preempts a state law failure-to-warn claim in cases where it can be shown that FDA rejected a drug manufacturer’s request to change its label to include the specific warning needed to avoid liability. The case arises from a multi-district litigation combining lawsuits brought by more than 1,200 users of Merck’s Fosamax (alendronate sodium) to treat osteoporosis in older women.
WLF says that when Merck learned of studies suggesting a possible link between long-term Fosamax use and an unusual type of thigh bone fracture, it sought FDA permission to warn of that risk on the Fosamax label. After reviewing all the available scientific data, FDA rejected the label revision while it studied the issue more closely. Fosmax users who suffered thigh bone fractures sued Merck under state tort law for failing to adequately warn of their injuries.
Although Merck successfully argued in the multi-district litigation that the only way it could avoid state law liability would be to violate federal law by misbranding Fosamax with a label that FDA had rejected, the Third Circuit Court of Appeals disagreed and held that a reasonable jury could find that FDA might have approved a differently worded label and thus the question of preemption is one for a jury and not the court. It also held that Merck must prove its preemption defense by a “clear and convincing evidence” standard of proof.
WLF says that in looking at what FDA might have done, rather than at what it actually did, the 3rd Circuit diluted the Supreme Court preemption decision in Wyeth v. Levine beyond all recognition. “As the record shows and the government itself has confirmed, FDA’s rejection of Merck’s proposed label turned solely on the available scientific data, not on Merck’s choice of words,” the brief says.