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Vaginal Mesh Manufacturers Accused of Withholding Information About Product Risks

On July 13, 2012, a lawsuit was filed against Ethicon and other defendants in the U.S. District Court of Kentucky in Bowling Green. The plaintiff, Mary Emerson of Kentucky, alleged that Ethicon, et al deliberately withheld information about the dangers of their vaginal mesh products “actively and intentionally misleading the FDA, the medical community, patients, and the public at large.”

On August 28, 2012, it was transferred to the U.S. District Court, Southern District of West Virginia in Charleston.

Transvaginal mesh failure spurs a Kentucky resident to file suit

Plaintiff Emerson, according to her vaginal mesh attorney, had surgery to implant an unspecified pelvic mesh product to treat stress urinary incontinence and/or pelvic organ prolapse. The surgery was performed in Kentucky. As a result of being implanted with the vaginal mesh device, Emerson allegedly experienced failure of the device and complications that caused her significant physical and mental pain and suffering, permanent injury, and physical deformity. The lawsuit says she has undergone and will undergo corrective surgery, and has suffered financial loss including medical expenses and past, present, and future lost earnings.

Multiple counts are brought against numerous vaginal mesh companies

The defendants in the case, encompassed by “Ethicon et al” included Ethicon, Gynecare, Johnson & Johnson, American Medical Systems Inc., C.R. Bard Inc., Boston Scientific Corporation, Covidien, Inc., and others.

In her lawsuit alleging vaginal mesh complications, the plaintiff brings multiple counts including failure to warn, strict liability, negligence, breach of express warranty, violation of consumer protection laws, unjust enrichment, and more. She seeks compensatory damages, punitive damages, interest, attorneys’ fees, and costs of suit.

The defendants marketed their pelvic mesh products as “safer and more effective” than traditional methods for treating POP and SUI and competing mesh products, the lawsuit states, and Emerson relied on those assurances of safety when she underwent her surgery and was not expecting failure of pelvic mesh to impact her life.

Despite aggressive marketing to the contrary, vaginal mesh products have high failure rates

Although the defendants aggressively marketed their vaginal mesh devices to patients and the medical community as safe and effective, the products “have high failure, injury, and complication rates, fail to perform as intended, require frequent and often debilitating re-operations, and have caused severe and irreversible injuries … to a significant number of women, including the plaintiff.”

It goes on to say that the defendants failed to perform adequate research and testing to evaluate the risks of their mesh products, but that even the limited pre-market clinical testing that was done revealed that the products “had a higher risk of adverse effects” than other products.

The plaintiff’s attorney alleges that the defendants deliberately suppressed information about the risks of the mesh products, and “actively and intentionally misled and continue to mislead” the public. In doing so, the defendants acted “recklessly and maliciously” in order to advance their own financial interests, “with wanton and willful disregard for the rights and health of the plaintiff.”

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