By Georgia D. Koutouzos, J.D.
The jury found that the mesh manufacturer, a Johnson & Johnson subsidiary, negligently designed and manufactured the at-issue pelvic mesh products and failed to warn of the risks of those products.
A Philadelphia jury awarded a total of $41 million to a woman who had been implanted with pelvic mesh manufactured by Ethicon Women’s Health and Urology, consisting of $15 million in compensatory damages, $25 million in punitive damages, and $1 million in damages to the patient’s husband for loss of consortium (Emmett v. Ethicon Women’s Health and Urology, January 31, 2019, Powell, K.).
After having been implanted with a pelvic mesh product or products manufactured by one or more subsidiaries of Johnson & Johnson (J&J) to treat her pelvic organ prolapse and/or stress urinary incontinence, a then 45-year-old woman experienced complications that necessitated several subsequent corrective surgeries. Despite those surgeries, she allegedly 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.
The patient and her spouse filed suit against the J&J companies and others, alleging that the manufacturers misrepresented the safety and efficacy of their vaginal mesh products and underreported/withheld information about the propensity of their vaginal mesh products to fail and cause injury and complications. The plaintiffs’ complaint asserted causes of action for strict liability/defective manufacture and design; strict liability/failure to warn; negligence; gross negligence; common-law fraud; negligent misrepresentation; negligent infliction of emotional distress; breach of express and implied warranties; and violation of Pennsylvania consumer protection law. A loss-of-consortium claim also was pleaded on the husband’s behalf. "The J&J defendants have known, continue to know, and at all times had reason to know that their disclosures to the [U.S. Food and Drug Administration] were and are incomplete and misleading," the complaint stated.
The case was tried to a jury, and the jury concluded that the ailing woman proved by a preponderance of the evidence that the J&J defendants negligently designed, manufactured, and failed to warn of the risks of the at-issue pelvic mesh products. She also proved that the possibility and seriousness of the harm caused by the mesh products outweighed the burden or cost of making them safe, that the products failed to perform as a pelvic floor surgeon would have expected, and that those failures were 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.
The case is No. 01495.
Attorneys: Lee B. Balefsky (Kline & Specter, PC) for Suzanne M. Emmett and Michael Emmett.
Companies: Ethicon Women's Health & Urology; Ethicon, Inc.; Gynecare; Prodesco, Inc.; Secant Medical, LLC; Secant Medical, Inc.; Johnson & Johnson
MainStory: TopStory JuryVerdictsNewsStory DamagesNews WarningsNews DesignManufacturingNews CausationNews MedicalDevicesNews PennsylvaniaNews
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