This post is from the non-Reed Smith side of the blog.
We’ve been updating you regularly on the equally regular dismissal of the majority of claims in the Infuse litigation on the grounds of preemption and TwIqbal. Well, here’s a quick reminder that preemption isn’t the only arrow in device manufacturers’ quivers. All those allegations of off-label promotion that Infuse plaintiffs rely upon to avoid dismissal? It looks like they may have severe problems proving them. On the eve of trial and after several days of pretrial motions, summary judgment was entered in Medtronic’s favor in what was scheduled to be the first Infuse case to go to trial. Cabana v. Medtronic, Inc., No. BC465313 (Cal. Super. Apr. 4, 2014). Significantly, the court ruled, and plaintiff in the end did not even dispute, that plaintiff lacked both sufficient evidence of causation to support any of her claims and sufficient evidence that the device caused her any injury.
That’s not all. Even without the causation ruling, the court granted several significant in limine rulings: (1) excluding any evidence that Medtronic allegedly violated any federal law or regulation; (2) that the Infuse device was misbranded; (3) that off label promotion was expressly prohibited; or (4) that any warning other than the FDA approved warning should have been given. Together these seem to signal that the case would ultimately have been barred by preemption. Without such evidence we don’t see how plaintiff could establish a parallel claim. No parallel claim, no escaping Riegelpreemption.