David Ferrera publishes “Congress should leave device approvals to FDA experts”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 “Congress should leave device approvals to FDA experts” in Mass High Tech on March 28. The article discusses Riegel v. Medtronic Inc., a recent case in which the U.S. Supreme Court struck an appropriate balance between ensuring the availability of potentially live-saving medical devices and protecting patient safety.
At issue in the case was the meaning of the pre-emption clause contained in the Medical Device Amendment (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.
David notes that while many patient advocates have criticized the decision, the court's ruling stems the tide against the establishment of an alternative regulatory system situated in the courts that operates outside the federal Food and Drug Administration (FDA), a system that would neither advance the availability of new treatments nor make patients any safer.