Photo of Stephen McConnell

Covid has altered how and where we practice law. Along the way, it has also improved our exercise regimen. Every couple of days, we receive bankers boxes of binders and documents and then tote them upstairs to what passes for our home office.

For some reason, that makes us think of hernia mesh litigation.

Cosh v. Atrium Med. Corp., 2021 U.S. Dist. LEXIS 59649 (SDNY April 2, 2021), is round two of a battle between mesh plaintiffs and the manufacturer. The plaintiff alleged that she experienced stomach injuries from implantation of hernia mesh. The complaint included the usual litany of causes of action – design defect, manufacturing defect, and failure to warn, among others. The defendant moved to dismiss the complaint and won. The plaintiff filed another complaint, the defendant again moved to dismiss the complaint, and again won.

Under New York law, a claim for design defect must be supported by a showing of a safer, feasible alternative product. The plaintiff made no such showing. The plaintiff alleged that the defendant “could have used heavyweight small-pore mesh instead of midweight mesh or non-woven mesh instead of a knitted or woven mesh,” but did “not allege facts showing this would be technically and economically feasible and result in a safer design.” Moreover, when the plaintiff suggested the use of entirely different materials, the court reasoned that “alleging that the product should not be used at all is insufficient to satisfy the feasible alternative design element.” Hmmmm. What if that reasoning applied to pelvic mesh litigation? In any event, the safer alternative requirement has doomed several other hernia mesh cases, and you can read about them here and here and in other posts on this blog site.

The manufacturing defect claim was originally tossed because the plaintiff had not identified anything specifically wrong with the manufacturing process. In the amended complaint, the plaintiff pointed to an FDA complaint and warning letter involving the factory where the hernia mesh was made. But other medical devices were made in the same factory. The FDA complaint and warning letter were not aimed at the specific unit making the hernia mesh, and there was no allegation as to what precisely the violations were and how they could conceivably have played a role with respect to the plaintiff’s injuries.

The failure to warn claim did not address any communications to the plaintiff or her doctor concerning safety or efficacy. Rather, it “merely reframed Plaintiffs’ design and manufacturing defect allegations.” The plaintiff added an allegation that the defendant had failed to follow up on some adverse events, but there was no suggestion that the plaintiff or her doctor had relied on that or anything else the defendant said or failed to say.

This time when the court dismissed the Cosh complaint, it did so for good, ordering that the case be closed. It was not a heavy lift.