David Ferrera publishes op-ed on impact of Riegel v. Medtronic Inc.Print PDF
David Ferrera, a partner in the firm’s Litigation Department and a member of the Product Integrity and Toxic Torts practice group, published “Court serves public interest” in The National Law Journal on March 17. The op-ed discusses the impact of Riegel v. Medtronic Inc., a recent case in which the U.S. Supreme Court determined that the FDA was better positioned than a state court to weigh the benefits and costs of new treatments and reconcile the interest in protecting public safety with the sometimes competing interest in protecting the market for new devices.
David notes that at issue in this case was the meaning of the pre-emption clause contained in the Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetic Act, which created the federal regulatory system for medical devices. That clause bars any state from establishing a requirement for a device "which is different from, or in addition to, any requirement" established under the MDA. The Supreme Court’s decision focused on the fact that the medical device in question underwent an exhaustive premarket approval (PMA) process, which includes an extensive review by FDA scientists and engineers that averages 1,200 hours assessing the device. David opines that the Riegel decision serves the public interest because, for these limited number of complex medical devices (roughly 1%), FDA experts are better positioned than a jury of lay-people to render a decision about their appropriate design and labeling.