Cerveny v. Aventis


(10th Cir., filed September 19, 2016): Arguing that courts must ask whether federal law authorized the defendant to do what the plaintiff claims state law required when assessing conflict preemption.  Also argues that federal law authorizes a drug manufacturer to change its FDA-approved label only in limited circumstances.

Court ruled in favor of ATRA's position

On May 2, 2017, the Court ruled in favor of ATRA’s position and affirmed the lower court’s decision granting summary judgment. The Court held that the FDA’s rejection of a citizen petition containing arguments virtually identical to the plaintiffs’ constitutes “clear evidence” that the FDA would not have approved plaintiffs’ proposed warning. 

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