McGuan v. Endovascular Technologies, Inc

In McGuan v. Endovascular Technologies, Inc. (2010) 182 Cal.App.4th 974, after the FDA granted premarket approval of the device, serious problems arose and the manufacturer recalled and stopped marketing the device. (Id. at pp. 978-979.) As a result of what was later shown to be false information, the FDA subsequently reapproved the device. (Id. at p. 979.) The McGuan court determined that because "the FDA gave its approval of the device's design, testing, intended use, manufacturing methods, performance standards, and labeling" through the PMA process, the plaintiffs' allegations that the device "was unsafe and its warnings were inadequate" sought to "impose requirements that are '"different from, or in addition to"' the MDA." (McGuan, supra, at p. 983.) For that reason, it determined the plaintiffs' claims were preempted. (Ibid.)