If you’re a frequent visitor to the DDL blog, you’ll know all about products liability claims premised on defendants’ alleged failure to report adverse events to the FDA.  You’ll also be acutely aware of what we think of such claims—they are flat-out preempted. Much to our dismay, not every court agrees with us. But recently, the Northern District of Georgia had to decide the issue on a motion for summary judgment in Blevins-Ellington v. Coopersurgical, Inc., 2025 WL 2437387, slip op. (N.D. Ga. Aug. 8, 2025). Happily, this court saw things our way.

The case involves three seemingly unrelated plaintiffs (why they were allowed to proceed in a single suit is beyond us) who underwent tubal ligation procedures using defendants’ Filshie Clips—pre-market approved (“PMA”), Class III medical devices. Plaintiffs assert three theories of liability: defendants should have issued a more extensive warning (failure to warn), defendants marketing materials overstated the safety of the device (deceptive marketing), and defendants defectively designed or manufactured the clips (design/manufacturing defect).  Id. at 5-6. When defendants moved to dismiss the complaint as preempted in 2023 they lost. After the close of discovery, defendants renewed their preemption arguments as a motion for summary judgment.

Plaintiffs’ first mistake was in trying to argue that because the motion to dismiss was denied so too should be the summary judgment motion.  But that ignores that at the summary judgment stage, plaintiffs’ claims “are now subject to an evidentiary standard, not self-described careful drafting.” Slip op. at 11 (citation omitted). Any leniency afforded plaintiffs during the pleadings stage is no longer applicable and each claim must be evaluated based on the evidence before the court.  Id. at 12.

Getting to that evaluation, plaintiffs had no evidence that defendants’ warnings, manufacture, or design of the device in any way deviated from FDA’s requirements. Since the clips are PMA, any argument that defendants should have done something beyond what the FDA approved would have been asking the court to impose requirements that are different from or in addition to federal requirements. Such claims would be expressly preempted. Instead, plaintiffs premised their legal theories on the argument that defendants “robbed” the FDA of an opportunity to act by concealing data and failing to file adverse event reports. Id. at 13. Plaintiffs’ word; not ours or the court’s.

In other words, absent an actual defect, plaintiffs attempted to create liability based on a hypothetical chain of events: had the manufacturer reported X, the FDA might have done Y, which could have prevented Z. Such reasoning not only invites courts and juries to speculate about the internal workings of the FDA, but it also rests on an impermissible attempt at private enforcement of the FDCA. Allowing private lawsuits to barge into that space would turn medical device cases into armchair audits of the FDA. It would also open the floodgates to fifty states second-guessing how the FDA does its job. Chaos, anyone?

Those are mostly our musings on the issue, but they underlie the court’s conclusion that a failure to warn claim based on an allegation that “the FDA would have updated the warnings for Filshie clips,” if defendants had reported certain adverse events is impliedly preempted. Id. at 13-14.  The court relied on Eleventh Circuit precedent finding failure-to-report claims are close cousins to fraud-on-the-FDA, and also on Georgia law that does not recognize a state law duty to report to the FDA. The only case law plaintiffs relied on reflected the general principle that defendants owe a duty to warn users, not the FDA or any other third-party regulatory body.  Id. at 14. 

For the most part, plaintiffs’ deceptive marketing claim failed for the same reason as their failure to warn claim. But it also failed for lack of causation. Plaintiffs had no evidence that they or their physicians saw, reviewed, or relied on any Filshie Clip marketing materials. Id. at 16. Plaintiffs’ design and manufacturing defect claims were similarly premised on the argument that defendants “robbed” the FDA of the opportunity to “amend the specifications or remove the device from the market.” Id. at 17. Therefore, they were similarly preempted.   

The “robbed the FDA” claim is legally hollow.  Moreover, it’s pure speculation, and courts don’t deal in “what-ifs” when it comes to federal agencies. You can’t sue a manufacturer based on what might have happened in an alternate timeline. Let’s leave the multiverse to Marvel.