First Circuit Joins a Growing Consensus About Claims Seeking “Major Change”

The First Circuit recently issued an opinion touching on two threshold questions common in mass tort cases: standing and preemption. Gustavsen v. Alcon Labs., Inc., No. 17-2066, 2018 WL 4057381 (1st Cir. Aug. 27, 2018). It joined a growing consensus among the federal appellate courts that state law claims involving a “major change” to a drug or medical device are preempted by federal Food and Drug Administration (FDA) regulations. It also weighed in on a possibly emerging circuit split regarding the standard for assessing standing in a pharmaceutical case. This decision highlights the importance of paying close attention to those changes deemed “major” by the FDA regulations when pleading claims and asserting defenses.