Relying on the Supreme Court’s decision in Riegel, the U.S. District Court for the Northern District of Illinois recently held that the Food and Drug Administration’s (“FDA”) extensive premarket approval (“PMA”) process for Class III medical devices preempts state law causes of action for injuries allegedly caused by those devices. Link v. Zimmer Holdings, Inc., No. 06 C 5438 (N.D. Ill. Nov. 26, 2008).
The decision involved a knee replacement device manufactured by Zimmer Holdings, Inc. (“Zimmer”) that, according to the plaintiff, resulted in a faulty knee replacement surgery. The plaintiff alleged state law claims of strict liability, negligence and breach of warranty based on the alleged injuries incurred as a result of the allegedly faulty surgery.
The court stated that the Medical Device Amendments (“MDA”) to the Federal Food, Drug and Cosmetic Act expressly preempt state requirements relating to safety and effectiveness that differ from or add to any federal requirement for the particular device in question. As in Riegel, the court acknowledged (1) the rigorous, individualized PMA process of Class III medical devices, (2) the FDA’s careful analysis of the competing interests related to a particular medical device and (3) the extensive post-approval submissions required by the FDA. The court stated that the application of different common law standards would necessarily undermine the FDA’s analysis. Therefore, any state law claims differing from the relevant federal requirements were preempted if the manufacturer complied with the PMA process and received FDA approval.
Accordingly, the court granted the defendant's motion for summary judgment on all counts.
For a full copy of the decision, please click here.
For a previous post on the Riegel decision, please click here.
For a post on Levine preemption case currently pending before the United States Supreme Court, please click here.