It’s time for the Mesh Case of the Week. In Dupere v. Ethicon, Inc., 2022 WL 523604 (S.D.N.Y. Feb. 22, 2022), the plaintiff filed a lawsuit claiming injuries from pelvic mesh that had been implanted in her to treat stress urinary incontinence. The court ended up dismissing many of the causes of action. That is yet another significant win for a mesh defendant.
The Dupere court’s background section includes a discussion of pelvic mesh used to treat pelvic organ prolapse. That is a different condition, the product is different, the science is different, and the FDA regulatory story is different. It strikes us as an unfortunate mixup by the court. When these stress urinary mesh cases go to trial, the defendant usually moves in limine to exclude evidence and arguments regarding pelvic organ prolapse mesh, and the courts usually grant at least parts of such motions. The distinction between stress urinary incontinence mesh and pelvic organ prolapse mesh is a difference that matters. We’ll cease our squawking for now, because in Dupere, at least for the issues decided in this particular decision, the difference made no difference. But we’d be on guard going forward.
The plaintiff’s causes of action are the usual potpourri: strict liability failure to warn, strict liability defective design, negligence, negligent misrepresentation, fraud, fraudulent concealment, constructive fraud, violation of the New York Consumer Protection Act (NYCPA), and gross negligence. The defendant moved to dismiss the portion of the negligence claim alleging negligent failure to test, as well as the entirety of the negligent misrepresentation, fraud, fraudulent concealment, constructive fraud, NYCPA, and gross negligence claims.
The Dupere opinion’s legal discussion begins with an unusually detailed discussion of duty to test, with the conclusion that New York does not recognize any such independent claim. New York, like pretty much all jurisdictions, divides product defects into the three areas of manufacturing flaw, design defect, and failure to warn. No decision by the New York Court of Appeals (the highest court in New York – the Supreme Court there is not so supreme) has recognized a cause of action for failure to test. But the Dupere court did not stop there. It found a federal district court decision rejecting a theory of negligent failure to test, and it found no support for duty to test in the Restatement (Third) of Torts, or treatises on New York law, or Am. Jur. 2d. The plaintiff pointed to a New York Pattern Jury Instruction (albeit an old, out of date one) for negligence in product liability cases that mentioned an “examination of whether the defendant exercised reasonable care in inspecting or testing the product.” Nice try. The Dupere court held that such mention at most made testing a possible factor, but not a separate cause of action. Moreover, the New York Pattern Jury Instructions contain no independent charge for failure to test. (Plaintiff efforts to harp on failure to test pelvic mesh products prior to marketing are particularly unfair, as such failure to test can be explained by the FDA 510(k) process — which the MDL court excluded from evidence. Some remand courts have spotted this unfairness and found ways to curtail the unfairness. Exclusion of the failure to test argument is one way.)
The Dupere court’s rejection of a separate cause of action for negligent failure to test might be the most noteworthy aspect of the opinion, and we have added the case to our duty to test cheatsheet.
The Dupere opinion next turns to the claim for gross negligence. Under New York case law, a claim for gross negligence will survive only if the plaintiff alleges facts plausibly suggesting that the defendant’s conduct “evinces a reckless disregard for the rights of others or smacks of intentional wrongdoing.” Such recklessness is shown if the defendant must have been aware of the dangers. The first amended complaint in Dupere fell short of this standard. It did not plead facts reflecting an extreme departure from standards of ordinary care.
None of the plaintiff’s deceit-based claims passed muster. Federal Rule of Civil Procedure 9(b) imposes a particularity requirement on fraud claims, meaning that such claims must lay out the fraudulent statements or omissions, identify the speaker, provide time and place of the statements, and explain precisely how the statements were fraudulent. As usual, the mesh complaint was bereft of any of the particularities. (The Dupere court helpfully dropped a footnote holding that Rule 9(b) applies to negligent misrepresentation.) Further, the first amended complaint offers only a conclusory allegation of fraudulent intent. Nor did it identify the source of any duty on the part of the manufacturer to disclose to the plaintiff. Merely being a medical device manufacturer is not enough to create a duty to disclose things to the ultimate consumer. The court observed that New York law typically limited this cause of action to statements by certain sorts of professionals, not product sellers. There might have been other cases in which a patient did have direct contacts and some sort of special relationship of trust with a manufacturer, but nobody said that happened in the Dupere case.
The NYCPA claim seems to have been mere makeweight. New York law prohibits “false advertising” and deceptive acts or practices.” The good news for the plaintiff is that the Dupere court said that such a claim is not subject to the Rule 9(b) particularity requirement. The bad news for the plaintiff is that the Dupere court said that such claim in this case failed “for the simple reason that she has failed to identify even one false advertisement or misleading consumer-facing statement” regarding the product.
Mesh plaintiffs contend that the mesh shrinks. We don’t think the science supports that contention. But Dupere is yet another example of a mesh lawsuit shrinking.