Bergdoll v. Coopersurgical, Inc., 2025 U.S. Dist. LEXIS 38300 (W.D. Mo. March 4, 2025), is a good Class III medical device preemption decision. The device was a Filshie clip, which is used to perform tubal ligations.  The claim in Bergdoll is the typical one that the clip migrated and caused adverse symptoms. Bergdoll is also typical of the trend of defendants in Filshie clip litigation doing better on premarket approval (PMA) preemption on summary judgment than on a motion to dismiss.  

The plaintiffs (wife and husband) brought claims for design defect, manufacturing defect, failure to warn, “strict liability negligence” (whatever that is), violation of consumer protection laws, gross negligence, and punitive damages. The plaintiffs’ main beef with the defendants seems to be a failure to report adverse events to the Food and Drug Administration (FDA), resulting in an alleged understatement of the rate of migration. 

Both sides filed summary judgment motions.  The plaintiffs lost and the defendants won. The court’s opinion makes clear why that had to be the result. 

It was undisputed that the FDA reviewed and audited the defendants’ complaint-handling procedures and never found noncompliance.  The plaintiffs claimed that “the FDA does not know about the vast numbers of ‘scientific articles’ and ‘hundreds of adverse event reports’ that Defendants have deemed not reportable.  In essence, Plaintiffs contend Defendants are failing to report information to the FDA and if the FDA had this information Defendants would not be found in compliance.”

The plaintiffs were obviously endeavoring to evade preemption, but they failed. PMA device express preemption is triggered when the federal government established requirements – which, of course, it did for the Filshie clips – and the plaintiffs’ claims would impose requirements “that are different from, or in addition to the federal ones, and that relate to safety and effectiveness.”  Check, check, and check. 

It is a wonder that the plaintiffs even bothered to file a design defect claim.  With a class III device, preemption of such claims is iron clad.  

The Bergdoll decision might be most helpful on preemption of the manufacturing defect claim. That is a cause of action where plaintiffs tend to raise the most dust (and by “dust” we mean confusion) over the scope of preemption.  The Bergdoll court held that to escape preemption of a manufacturing defect claim on summary judgment, the plaintiff must prove that the medical device “was manufactured in a way that violated the PMA requirements.”  Compliance with the manufacturing process matters. Malfunction by itself does not establish deviation from specs.  

Naturally, the plaintiffs attempted to avail themselves of the dreaded Riegel parallel claim exception, but, again, the plaintiffs offered no claims of design or manufacturing deviations from FDA requirements. 

The failure to warn claims were a goner because the defendants’ FDA-approved warnings stated the rate of symptomatic migration.  

Bergdoll appears to be a situation in which plaintiff lawyer advertising dredged up old cases like this one, where the insertion was at least 15 years before suit.  Here, the plaintiffs attempted to assert a warning defect by way of failure to report.  That failed.  The warning language was what the FDA approved.  Anything else would be “different from or in addition to.”  

The Bergdoll court delivered a one-two preemption punch to the plaintiffs’ case, because it also held that the failure to report claims amounted to private FDCA enforcement and were thus impliedly preempted under Buckman.  

Further, to the extent the plaintiffs’ theory would require device manufacturers to inform end users about a higher migration rate, that would counter or supplement the FDA requirement to send adverse event reports to the FDA only.  The variance that the plaintiffs identified between the lower reported migration rate and what plaintiffs assert is the actual, higher migration rate seems to be that asymptomatic migration claims are not reportable adverse events.  Fine. That variance is not the stuff of a product liability claim, no matter the cause of action. But it is the stuff of preemption of every cause of action. 

Various other claims, based on negligence and consumer fraud were based on the same facts and were similarly preempted.