We’ve blogged recently about good preemption decisions in the Filshie Clips litigation from the Southern District of Texas (per Bexis, “as good a PMA medical device preemption decision as a defendant has a right to expect”) and the Northern District of Georgia. Today we add another preemption win in the same litigation from the Middle District of Florida. Rebando v. Coopersurgical, Inc., 2024 WL 6816971 (M.D. Fla. Sept. 3, 2024). As a quick refresher, Filshie Clips are medical devices that underwent the FDA’s premarket approval process. The defendants have been successfully relying on the express and implied preemption provisions under the Medical Device Amendments to the Food Drug and Cosmetics Act. Rebando follows that trend. It’s a short and sweet decision flatly rejecting claims based on alleged failures to report adverse events.
Plaintiffs in Rebando premised their failure to warn claim on allegations that the defendants failed to submit adverse event reports to the FDA. But the Eleventh Circuit has directly addressed these types of “failure to report” claims and held that they are impliedly preempted. Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017). Rather than trying to distinguish Mink, plaintiffs suggested that their “artful drafting” of the complaint to avoid preemption—which got them past the defendants’ motions to dismiss—should be enough to get them past summary judgment. Not so, said the court:
The Court agrees that Plaintiffs artfully drafted their Complaint to avoid dismissal—as evidenced by the fact that Defendants’ Motions to Dismiss were denied—however, this case is no longer at the motion to dismiss stage. At this point, Plaintiffs must actually present evidence that their failure to warn claims consist of more than a failure to report adverse events to the FDA. Plaintiffs have failed to do so.
Id. at *4 (which makes us think it’s a shame that defendants have to spend significant resources defending against preempted claims past the motions to dismiss stage based on “artful drafting” of initial pleadings).
Plaintiffs also argued that the Eleventh Circuit got it wrong on implied preemption. The court disagreed and held that failure to report claims are impliedly preempted. Since plaintiffs did not present any evidence to support their claims other than allegations of failure to report, the court granted summary judgment on the failure to warn claims.
Like their failure to warn claim, the plaintiffs design defect claim was premised on alleged failures to report adverse events. Plaintiffs claimed the defendants failed to disclose adverse events to the FDA when they were obtaining premarket approval and that proper disclosures would have resulted in the FDA requiring a design change. But this is “precisely the type of fraud-on-the-FDA claim that the Supreme Court determined was preempted.” Id., citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 343-44 (2001). Plaintiffs also tried to rely on their claim that defendants failed to submit post-market adverse events, claiming that would have resulted in the FDA requiring a design change. But the court recognized that for what it was—a failure to warn claim repackaged as design defect. The court’s reasoning for granting summary judgment on the failure to warn claim applied equally to the repackaged version characterized as design defect.
Plaintiffs remaining claims all sounded in either failure to warn or design defect, so the court entered judgment in favor of the defendants. We’ll gladly take another preemption decision rejecting failure to report claims (and as a reference, here’s a link to the blog’s prior, 50 state survey on failure to report claims).