The Ripples Of The Fosamax Reversal

If we were to recap briefly our reactions to the Levine decision and ten years of decisions attempting to apply it, then we might say something like this. The Court’s creation of a clear evidence standard for conflict preemption in the context of warnings claims for branded drugs was both novel and misguided. The Court gave more credence to the CBE mechanism as a way to change the label, at least temporarily, without FDA approval than FDA ever had. Over time, courts took baby steps to recognizing that some warnings claims—even the fundamental claims underlying a litigation—should not proceed where the label plaintiffs wanted would not have passed muster with FDA at the time. Facts like FDA’s rejection of the same proposed label, FDA’s statements about the lack of an association with the risk at issue, the lack of new evidence to justify submitting a CBE, and FDA’s pronouncements that a CBE could not be used for a certain type of labeling change allowed courts to find that the high standard had been met. The endorsement of complimentary conflict preemption principles in some Supreme Court cases and rejection of the presumption against preemption in others helped emboldened courts to find warnings claims preempted. This trend might have peaked in a series of Fosam...