The United States Court of Appeals for the Fifth Circuit issued an opinion in Bass v. Stryker that is a significant victory for victims injured by defective medical devices approved by the FDA under the pre-market approval process (PMA). The Court reinstated claims based on violations of federal safety laws. The case was brought by a man injured by a medical device that was approved by the FDA under the PMA process.
The Court analyzed the pleading requirements for claims premised on violations of federal safety laws that survive preemption under the Medical Device Amendments of the Food and Drug Act.
In its analysis, the Court determined that manufacturing defect claims, if properly plead as alleging violations of federal regulations which give rise to parallel claims under state law, could be allowed to go forward despite a product receiving PMA from the FDA. In this decision, the Fifth Circuit specifically found that state law claims premised upon violations of the Current Good Manufacturing Practice (“CGMP”) are capable of being enforced by a jury without placing requirements on a manufacturer that are in addition to those placed upon them by the FDA’s approval of their PMA.
Monica C. Vaughan from the firm Houssiere, Durant & Houssiere, LLP, who argued the appeal on behalf of Mr. Bass, believes, “This opinion is important because it allows those injured by medical devices to seek compensation in the courts which I believe has the added affect of improving the overall safety of medical devices for everyone.”