Medical Devices

Can plaintiffs sue medical device manufacturers for defrauding the FDA? - In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781 (3rd Cir. 1999)

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 conduct is not actionable, then conspiring to do it cannot be actionable as a civil conspiracy. A detailed review of the applicable law in all the states involved in the litigation did not find any state law that created a private right of action for defrauding the FDA. The court also reviewed the FDA enabling law and found that it did not create any private causes of action. Since plaintiffs could not sue for the underlying conduct of misleading the FDA, the court reasoned that they could not sue for a conspiracy to mislead the FDA and dismissed that part of their action. (While the court did not discuss it, plaintiffs can still use evidence of misrepresentation of the FDA as evidence of bad faith and notice of a problem with the product as part of their products liability claim against the manufacturers.)

There were remaining issues based on fraud and misrepresentation of surgeons and others involved in the selection and implantation of the devices, which might support private action, but the defendants argued that these should be preempted by their First Amendment free speech rights. After a review of the applicable law, the court found that defendants' conduct was likely commercial speech, which is subject to regulation for accuracy. The court overruled defendant's motion to strike charges related to their participation in medical education seminars and ruled that the jury should decide the extent that this was commercial speech was thus potentially actionable as a fraud. This case has a good review of civil conspiracy law and FDA medical device classification, as well as a useful discussion of commercial speech in the medical context.