Can plaintiffs sue medical device manufacturers for defrauding the FDA?
This is a general order applying to all of the cases in the multi-district litigation against the manufacturers of spinal fixation devices by patients who allege that they have been injured by the devices either breaking or bending, or a afraid that they will be in the future. The order deals with whether the plaintiffs can maintain civil conspiracy charges against the defendants and whether the defendants’ presentations in educational seminars is entitled to First Amendment protection. The civil conspiracy claims are based on plaintiffs’ belief that defendants banded together to falsify data about the safety of their devices in order to fraudulently induce the FDA to change the risk classification of the devices and to approve their use. While plaintiffs presented substantial circumstantial evidence to support their claims, the court found that they did not satisfy the underlying requirement that the conspiracy be based on some otherwise actionable conduct, i.e., if the underlying con
