Labeling Preemption for Generics Could Be Threatened in Appeals

Generic-drug makers are seeing product liability cases thrown out left and right, with judges ruling they’re not required to change labels to reflect new safety concerns until after the brand drugmaker changes its labeling. But they shouldn’t rejoice just yet as a so-called reference listed drug (RLD) theory of liability could come to life in an appellate case, an attorney tells WDL.
Washington Drug Letter