Under the Supreme Court’s 2008 decision in Reigel v. Medtronic making the FDA the final arbiter of medical device safety, if a medical device receives premarket approval from the FDA, the manufacturer cannot be sued for damages by any individuals injured by the device. Following that decision, lower courts threw out 1,400 lawsuits against device manufacturers.
Ironically, drug manufacturers do not enjoy the same immunity. Under the Supreme Court’s March 2009 decision in Wyeth v. Levine, FDA approval of a drug does not shield its manufacturers from lawsuits commenced by injured patients.
Now Congress is considering rectifying that inconsistency with the Medical Devices Safety Act of 2009, which would provide injured parties with legal recourse if they are injured by an implanted medical device.
For arguments for and against the passage of the legislation, see this article recently appearing on MedPage Today.