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Failure to warn claims

   Claims of a failure to warn are common in connection with the implantation of transvaginal mesh. Generally, women have been told that it is an easy way to treat pelvic organ prolapse or stress urinary incontinence. They have not necessarily been told about the potential complications that can arise after surgery and the difficulty of fixing those complications.

    In a product liability claim that focuses on a warning or labeling defect, the plaintiff alleges that the product had some sort of inherent danger and that the manufacturer of those product had a legal duty to warn of this danger but failed to do so.

   In the Suzanne Emmett case, the jury found that the mesh manufacturer, Ethicon - a Johnson & Johnson subsidiary, negligently designed and manufactured the at-issue pelvic mesh product and failed to warn of the risks of that product.

   She also proved that the possibility and seriousness of the harm caused by the mesh product outweighed the burden or cost of making it safe, that the product failed to perform as a pelvic floor surgeon would have expected, and that failure was the factual causes of the harm she and her husband suffered.                Consequently, the jury awarded her $15 million in compensatory damages and $25 million in punitive damages, adding another $1 million for her spouse’s loss-of-consortium damages.

   Ms. Emmett, a then 45-year-old woman, experienced complications that necessitated several subsequent corrective surgeries. Despite those surgeries, she continued to experience symptoms such as infections, inflammation, bleeding, pain, and dyspareunia (pain or discomfort during sexual intercourse) due to erosion and exposure of the mesh.

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