Eight years ago, hundreds of people around the country filed suits against the drug manufacturer Merck Sharp & Dohme Corporation (“Merck”). In those suits it was alleged that a drug Merck produced to treat osteoporosis, Fosamax, caused those taking the drug to suffer femur fractures.
Under state tort law (tort law being among the more exciting topics of this blog), the people bringing suits against Merck allege that the FDA-approved drug label failed to adequately warn of the risks of femur fractures. Eventually, over 1,000 people joined in a consolidated multi-district litigation in the U.S. District Court for the District of New Jersey.
The district court dismissed the claims of the suits, citing preëmption under Wyeth v. Levine, 555 U.S. 555 (2009), which holds that state-law failure-to-warn claims are moot when there is “clear evidence” the FDA would not have approved the warning the plaintiffs insisted were necessary.
However, the U.S. Court of Appeals for the Third Circuit overturned that ruling by noting that (in America) preëmption is an affirmative defense and that Merck has failed to prove it was entitled to such a defense (as a matter of law). Moreover, the Court of Appeals found that the plaintiffs had produced sufficient evidence under the Wyeth standard, that a reasonable jury would have found that the FDA would have approved an appropriately worded warning.
Whether a state-law failure-to-warn claim alleging the insufficiency of brand-name drug labeling is preëmpted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., when the Food and Drug Administration, after the drug manufacturer provided it with the relevant scientific data, rejected the manufacturer’s application to modify its labeling to warn about the risk underlying the tort claim.