Products liability defense attorneys, particularly in the drug and device arena, have long been familiar with the doctrine of federal preemption and have invoked it to defeat state law claims that sought to impose requirements on drug and device manufacturers that differed from or added to the requirements imposed by the Food and Drug Administration (FDA). Federal preemption in this area has disposed of not just traditional design defect claims, but also claims based on the labeling and warranties involved with a particular product.
Preemption in Drug and Device Cases
In 2001, the United States Supreme Court recognized in Buckman Co. v. Plaintiff's Legal Committee, 531 U.S. 341, 353 (2001), that allowing state law claims that attempted to circumvent federal preemption, such as fraud-on-the-FDA claims, would call into question, and in fact conflict with, the complex regulatory scheme established by the FDA. The Court held therefore that because the federal statutory scheme "amply empowers the FDA to punish and deter fraud against the Administration, and that this authority is used by the Administration to achieve a somewhat delicate balance of statutory objectives," state law claims that tread into this same territory are impliedly preempted by the statutory scheme underlying the FDA's authority. Buckman, 531 U.S. at 348.