Transvaginal Mesh – Failure to Test as a Claim

Contemplating whether you have a potential transvaginal mesh case? The past decade has seen over 100,000 transvaginal lawsuits filed, with individual complications ranging from chronic pain, bleeding, infection, organ perforation and autoimmune problems.  These cases have settled for roughly $8 billion dollars, with many of them alleging negligence and failure to warn on the part of the drug manufacturer.

One recent case had most of its claims dismissed- including an allegation for failure to test- and yet still ultimately ended up settling only a week later.




Failure to Test as a Claim – Transvaginal Mesh Injury


In the case of Dupere v. Ethicon, Plaintiffs alleged negligence, negligent misrepresentation, fraud, fraudulent concealment, constructive fraud, and gross negligence. Dupere v. Ethicon, Inc., No. 21cv2605 (DLC), 2022 U.S. Dist. LEXIS 31096, at *4-5 (S.D.N.Y. Feb. 22, 2022). As part of the negligence claim, Plaintiffs alleged that the Defendants breached a duty to adequately test TVT for safety before and after launching the product, rendering the product unreasonably dangerous and defective. Id. at *6. However, New York does not recognize a stand-alone failure-to-test cause of action, and the court ultimately dismissed the claim. Id. at *8.

Several cases in Illinois have attempted to assert a failure to test claim as well with the overall consensus that failure to test cannot be a standalone claim. In the case of Lash-Perez v. Henkel Corp., Plaintiffs sued a chemical manufacturer, the Defendant, alleging that their product Loctite 620 was a cause of the birth defects of her son and that the company had, among other things, properly failed to adequately test the compound and evaluate its dangers. Lash-Perez v. Henkel Corp., 2013 IL App (1st) 120023-U,

Dupere alleged failure to test under a negligence claim, but Lash-Perez instead alleged failure to test under a strict liability claim. However, the outcome remained the same. Because the claim was plead under a strict liability standard rather than negligence, the Court found there is no evidence that testing would have revealed that Loctite 620 causes birth defects.



One Illinois case asserted a failure to test claim successfully, as it was intertwined with a duty to warn claim “couched in negligence,” Baylie v. Swift & Co., 283 Ill. App. 3d 421, 434 (1996). However, the failure to test claim was not a standalone claim instead made up part of the negligence claim, differentiating the claim from both Dupere and Lash-Perez. Another Illinois case asserted the same sentiment- failure to test is an incomplete tort on its own. The failure to test is not a negligent act in itself; rather, a failure to test leads to a failure to correct either a manufacturing defect or a failure to warn of harm resulting from the product. Patton v. Country Place Condo. Ass’n, No. 4-00-0008, 2000 Ill. App. LEXIS 1001, at *9 (July 7, 2000).

The duty to test does not cause injury by itself but is a subpart of designing a safe product, manufacturing it safely, and providing adequate warnings of dangers inherent in the use of the product. Id.


Requirements for Additional Claims – Transvaginal Mesh Case


Other claims alleged in the Dupere transvaginal mesh case met a similar fate to the failure to test claim and were ultimately dismissed. The Court found that the Defendants had not plead sufficient facts to meet the standards of the additional claims, including the claims of gross negligence.

The Defendants sought to dismiss the four additional claims, alleging that the Plaintiff’s failed to plead the causes of action with the particularly required for negligent misrepresentation, fraud, fraudulent concealment, and constructive fraud. All four claims of require the plaintiff to plausibly allege that the Defendants made a specific misrepresentation or omitted to state a material fact.

Dupere v. Ethicon, Inc., at *13-14. Further, for alleged frauds based on omissions of material fact, “a concealment of facts supports a cause of action for fraud only if the non-disclosing party has a duty to disclose.” Id. The Court further found that Plaintiff failed to assert other than in a conclusory manner that the Defendants acted knowingly and with fraudulent intent. Id.

Courts require specificity when bringing an allegation against a Defendant, and Dupere is an example of what happens when that does not happen. And yet, Dupere serves as an example that even with the Court dismissing the majority of the claims (with claims for failure to warn under a strict liability theory and defective design still standing), transvaginal mesh cases still bode well for the individual(s) bringing a cause of action.

Less than two weeks after the Court dismissed the above claims, the case settled. The terms of the settlement are unknown, but clearly the Defendants wanted the case to resolve as quickly as possible before going to trial.



Transvaginal Mesh Lawsuit Chicago


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