Cerveny v. Aventis

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(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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SCOTUS Should Affirm Federal Law Supremacy With FDA Authority Case

The U.S. Supreme Court has a chance to rein in state court rulings that impose liability on pharmaceutical companies that go beyond, and even contradict, the federal regulatory process of the FDA, according to Tiger Joyce, president of the American Tort Reform Association. He explains why it is imperative the high court review a case involving Janssen Pharmaceuticals.