Don’t stop us if you’ve heard this before, because you have. (Here and here, for example). Wilson v. Coopersurgical, Inc.,  (S.D. Illinois Sept. 9, 2025), is yet another case from the Filshie Clip litigation illustrating the power of premarket approval (PMA) preemption.  The defendant won dismissal on summary judgment after the case had survived initial motions to dismiss.  Indeed, this favorable summary judgment decision was a complete reversal of a bad 2023 preemption decision on the pleadings in the same case, which we blogged about here, and which we named the #6 worst case of 2023. This to-be-published decision is also significant in that it overcame the Seventh Circuit’s Bausch decision, which had distorted the parallel requirement exception to federal preemption. 

Filshie Clips are a form of contraception – tubal ligation, to be more specific. They are titanium clips with silicone linings.  Doctors implant them in a woman’s fallopian tube.  The Filshie Clip is a Class III medical device. That means it had to go through the rigorous PMA process, which it did in 1996. And that means that Filshie Clips enjoy express federal preemption of any claim seeking to impose “any requirement” that is “different from, or in addition to, any requirement” under the federal regulations. 

The claim in Wilson was the usual one: that the Filshie Clip had migrated and caused certain adverse health effects. The plaintiff claimed that such migration of Filshie Clips occurred 25% of the time in the overall patient population, that the defendants knew it, but did not warn her. The plaintiff also alleged that the defendants had failed to report adverse event complaints accurately to the Food and Drug Administration (FDA). Interestingly, the plaintiff’s doctor knew of the risk of migration, but apparently did not tell her. Also interestingly, the warnings and precautions section in the instructions accompanying the Filshie Clips discussed the importance of patient counselling and explicitly mentioned the risk of clip migration and expulsion. 

But, as with any failure to warn case, a plaintiff lawyer can always dream up an allegedly better warning. It is a vast waste of time and judicial resources.  Federal preemption should avoid or eliminate such waste. That is what happened in Wilson, though a bit later than we’d like. 

The plaintiff filed a 93 page complaint with a litany of multiple, redundant, and unnecessary claims. Here, those claims included strict product liability design defect, strict product liability failure to warn, negligence, gross negligence, and punitive damages. The defendants argued that the plaintiff’s claims were both implied and expressly preempted. The Wilson court agreed with the defense argument and dismissed the case. 

Implied preemption occurs under the Buckman Supreme Court case when plaintiffs seek to use state law to police statements that a defendant was required to make to the FDA under federal law.  The plaintiff’s design defect claims were expressly preempted because the design was FDA compliant.  

As is typical, the failure to warn claims demanded more detailed warnings. But to ask for warnings on a PMA device that are more detailed than what the FDA requires is foreclosed by express preemption.  The failure to report claims were both expressly and impliedly preempted.  The Wilson case rejected a prior adverse federal district court reporting precedent (Laverty) in light of the Norabuena appellate Illinois decision. The federal court in Laverty held that Illinois law imposed a parallel requirement of adverse event reporting, and therefore did not hold the claims preempted.  By contrast, the Norabuena court held that “there is no Illinois requirement that parallels” any federal adverse event reporting obligation. Illinois appellate decisions are entitled to great weight on Illinois law issues.  The federal court in Laverty had gotten Illinois law wrong.  If there was no Illinois requirement, there was no parallel requirement, and the implications of the wretched Bausch case were avoided.

Reporting claims are expressly preempted for imposing obligations different than those imposed by the FDA.  They are also impliedly preempted because, absent any recognized state-law claim, they improperly seek to enforce federal regulations.  

A variety of other claims, all based on alleged reporting violations, were similarly preempted. Here is how the Wilson court summed up disposition of those various and sundry claims:

“Plaintiff’s claims of negligence and gross negligence must suffer the same fate as her claims of strict liability. Those claims are largely based on the same allegations and theories of liability. And, as to the strict liability claims, the Court has already found the PMA for the Filshie Clip has never been suspended or withdrawn by the FDA, the design of the Filshie Clip has always conformed to the design approved by the FDA in the PMA process, the FDA determination that the Filshie Clip is safe and effective with a reported .13% migration rate remains intact as a matter of federal law, the FDA approved updated instructions for use of the Filshie Clip with the same migration rate of .13%, the record does not indicate the design of the Filshie Clip has deviated from the design approved by the FDA, the Filshie Clip inspections for use ‘w[ere] approved … by the FDA and adhere[] to the FDA-approved language,’ and Plaintiff did not raise a state requirement that parallels the federal FDA reporting requirements because ‘there is no [such] Illinois requirement.’”  

Preemption made all the substantive claims go away, which also eliminated the claim for punitive damages and eliminated the need for the court to address causation.