There is a documentary out on the actor Charlie Sheen and it reminded us that, long before the current denizen of the White House crowed about “winning,” that was a staple of many bizarre rants by Sheen.
We’re not ranting, whether bizarrely or sanely, but it is nice to post about yet another defense win in Filshie clip litigation. The case is Banet v. Cooper Co., 2025 U.S. Dist. LEXIS. 193141 (W.D. Kentucky Sept. 30, 2025). The plaintiff made the usual claim – that the Filshie Clip tubal ligation device migrated and caused an injury. The particular injury in Banet seemed serious. The clip could not be removed safely.
The plaintiff filed a complaint with three counts: strict liability design and marketing defect; (2) negligence; and (3) punitive damages. Of course, punitive damages is a form of relief, not a separate cause of action. The court pointed that out and – spoiler alert – the count was going nowhere. Why do plaintiff lawyers keep making this mistake? Anyway, the key issues in the Banet case were personal jurisdiction and federal preemption.
Personal Jurisdiction
A couple of entities escaped on personal jurisdiction grounds, because they were merely corporate affiliates that did not actually do anything in Kentucky and did not constitute alter egos of the main defendant. One entity (CSI) did not escape on jurisdictional grounds, and the court’s reasoning is a bit fishy. The court applied a version of Kentucky’s long-arm statute that has since been repealed and replaced, so maybe the ruling is no big deal. Still … while CSI had ceased being a distributor before the date of the plaintiff’s surgery, the court kept it in the case based on a “possible inference” that “by establishing a pre-existing sales arrangement with Twin Lakes, CSI caused Banet to be implanted with defective Filshie Clips. To wit, had CSI not regularly marketed and/or sold Filshie Clips to Twin Lakes, Utah would not have continued to provide Filshie Clips to the hospital and Banet’s medical provider would have used another contraception device.” That sounds less like reasoning than speculation. Indeed, it sounds like a judicial exercise in counterfactuality with all the plausibility of the glorious Hot Tub Time Machine movie franchise. But whatever, the case gets dismissed anyway, and now we’ll get to the good part.
Federal Preemption
The Filshie Clip is a class III medical device that received premarket approval (PMA) by the Food and Drug Administration (FDA), meaning that broad express preemption applies, barring claims for both design defect (a different design would require a new FDA approval) and inadequate warning (the proposed new warning would vary or add to the device’s FDA-approved warnings).
The plaintiff argued that she “sufficiently pleaded that the Defendants violated the requirements of the Filshie Clips’ PMA,” but the court pointed out that “nowhere in the paragraphs she cited in support of this contention (nor anywhere else in the Complaint) does she allege that the design for the Filshie Clip used in her surgery different from the design approved by the FDA.” Accordingly, adios to the design defect claim.
As is usual in Filshie Clip cases, the plaintiffs ultimately asserted a claim for failure to report adverse events to the FDA. (The “marketing defect” claim originally offered nine different theories, including, inter alia, “failing to disclose that the Filshie Clip was inadequately tested,” and failing to convey post-marketing warnings, but the plaintiff abandoned those theories and pushed all her chips in on the alleged failure to report adverse events. That claim was also preempted because it presupposed the insufficiency of the device’s FDA-approved warnings.
Any duty to warn physicians, whether directly or indirectly through the MAUDE database, is different from, or in addition to, the FDA-approved warnings. “Any claim that Defendants were required to provide additional ‘warnings’ via MAUDE necessarily presupposes that the FDA-approved warnings contained within the Filshie Clips labeling and marketing were themselves insufficient to ‘adequately guard against the inherent danger.’” Allowing a jury “to determine whether Defendants’ FDA-approved warnings were inadequate based on ‘any non-disclosed information is the kind of inter-branch meddling that concerned the court in Buckman … and would both usurp the agency’s role and go beyond the court’s institutional expertise.’” Just so.
Lately, in all sorts of litigation, this structural, separation of powers point seems to be packing a powerful punch. The intemperate and inaccurate political yammerings about abuse of judicial authority are regrettable, but it is possible that at least some courts have shown an increased sensitivity to accusations of judicial overreach. Incursions on executive branch authority are to be studiously avoided. Incursions on Congressional authority … well, actually, what is that, anyway, these days?
The negligence claims in Banet failed for the same reasons as the strict liability claim failed. Again, the squishy litany of allegations boiled down to failure to report adverse events and, again, preemption ruled the day. Moreover, a “laundry list” of negligence allegations was not specific enough to state a claim. The court dismissed the claims. Even without “tiger blood,” winning by the defense is always welcome news in this blog.