There has been a veritable pandemic of posts about Covid-19 regulations (vaccine mandates, restrictions on indoor gatherings, etc.) on the DDL blog as of late, so we thought we’d take a break from the craziness and report on a good, old-fashioned medical device preemption case. And yet we still found ourselves encountering a loathsome disease that has wrought much controversy and dysfunction: the Riegel “parallel claim” exception to medical device express preemption. Thankfully, like an efficacious vaccine or a non-horsey paste therapeutic, the Fifth Circuit prevented further spread of the malady. (Yes, we are aware that a Fifth Circuit panel recently stayed the federal vaccine mandate, so we’ll not push the disease-fighter analogy too far.)
The case under consideration today is Naquin v. Medtronic, Inc., 2021 U.S. App. LEXIS 31121 (5th Cir. Oct. 18, 2021). The plaintiff claimed that an implantable cardiac defibrillator (ICD) was defective. What was wrong with it? As James Bond muttered in the great pretitle sequence in Goldfinger, “Shocking. Positively shocking.” A shocking defibrillator is a bad thing. It needed to be replaced. The plaintiff sought damages under the Louisiana Products Liability Act (LPLA) under the theory of defective construction, defective design, failure to warn, and breach of express warranty. The plaintiff also alleged that the defendant breached a contract in which the defendant promised to provide reliable 24/7 service. So basically the plaintiff threw in every possible theory available under the Louisiana statute. And then some. Perhaps the plaintiff lawyers should be congratulated for not including trover and replevin.
The defendant filed a motion to dismiss based on express preemption via the Medical Device Amendments Act, which says that no state may impose safety requirements on a Class III medical device if such requirements are different from or in addition to the federal requirements. The ICD was a class III medical device that had undergone the rigorous premarket approval process. It was clear that the plaintiff’s complaint “would require a jury to decide whether there existed an alternative design for the product that was capable of preventing [the plaintiff’s] damage and whether the safety benefits of that design outweighed the burden on the manufacturer of adopting such alternative design.” The complaint also asked the jury to rewrite the federally approved warning. Such Louisiana “standards” (a jury verdict would amount to state “standards”) relate to safety and would be preempted to the extent that they are different from or in addition to the FDA’s requirements.
Inevitably, the plaintiff invoked the Riegel “parallel claim” exception, which calls off federal preemption if the claim is created by state law and perfectly parallels federal requirements. If the state requirements are truly parallel, nothing is in addition or different. The district court in Naquin was unimpressed by the invocation of the parallel claim exception and dismissed the complaint. The plaintiff appealed.
We are used to reading appellate court discussions of the parallel claim exception that focus on how a plaintiff must thread the needle by relying on state law – it cannot be a private cause of action premised on the federal requirements – while being completely consistent with federal law. But here, the Fifth Circuit’s analysis was simple because the complaint hardly said anything. A plaintiff must plead facts supporting what is, in essence, an exception to a defense. As the Naquin court held, “parallel state law claims fail if they are pleaded in an impermissibly conclusory and vague fashion.”
Why did the Naquin complaint fail this rather basic test?
First, the complaint “baldy asserts that the [ICD] lead was adulterated, defective, malfunctioned, and failed.” That is not good enough. And the complaint does not get any less conclusory even when it pretends to supply the requisite details.
Second, the complaint alleged that the defendant, in violation of FDA regulations, used “nonconforming material.” But the complaint nowhere stated “how a violation of federal regulations produced a manufacturing or design defect or how a specific defect caused [the plaintiff’s] alleged harms.”
Third, the failure to warn claim was conclusory, simply asserting that the products “are unreasonably dangerous because an adequate warning about the product has not been provided concerning the numerous problems, and malfunctions of these products and their component parts.” What warning? How did the lack of such warning cause anything?
Fourth, the plaintiff “failed to reproduce any specific warranty in his pleadings or specify its precise source.” All there was on warranty in the complaint was hollow bloviation, and the pleadings “failed to identify when, where, or how [the defendant] made the alleged warranty, instead listing a variety of alleged sources in conclusory fashion.” Relatively late in the proceedings, as part of an endeavor to fend off the motion to dismiss, the plaintiff referenced an advertisement on the defendant’s website, but still failed to “identify a specific web page or specific warranty terms.”
Finally, the plaintiff’s appeal of the dismissal of the breach of contract claim (which struck us as an inordinately silly claim) was a goner because the district court’s dismissal of that claim was accompanied by an invitation to replead it. The plaintiff never accepted that invitation. A failure to replead after being granted leave to replead constitutes a forfeiture of any such claim on appeal.
The Fifth Circuit affirmed dismissal of the complaint in Naquin. In doing so, it cut back on the parallel claim exception, demanding real substance and specificity. If you hold up the deficient allegations in Naquin against those in a case you are defending, you might find that you have a solid ground for dismissal. File a motion. Do your part to fight the craziness.