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Woman Receives $13.5 Million in Damages in Johnson & Johnson Pelvic Mesh Trial

Filed February 11th, 2016 Fran Kelley

A Philadelphia jury awarded a woman $13.5 million in damages against Johnson & Johnson’s Ethicon division for pain and injuries she suffered because of in a case an Ethicon pelvic mesh implant.

The woman—who received the implant in 2005—alleges that the implant left her in near constant pain and discomfort and unable to have sex, Law360 reports. The jury agreed that the Ethicon transvaginal tape (TVT) was not reasonably safe, and, further, that the doctor would not have implanted the device if he had been adequately warned of the risks.This is the second damage award against Ethicon in series of nearly 180 cases consolidated in Philadelphia County’s Court of Common Pleas. In December 2015, in the first case to go to trial, the jury awarded the plaintiff $12.5 million in damages, agreeing that Ethicon’s Prolift pelvic mesh device was negligently designed and that the woman’s doctor did not receive adequate warnings about the device’s dangers, according to Law360.

The February 9 verdict consists of $10 million in punitive damages, $3.5 million in compensatory damages, and $250,000 to the woman’s husband for loss of consortium. The woman’s attorney had argued that the Ethicon’s TVT product was defectively designed and the company had offered inadequate warnings to physicians.

A number of doctors testified at the trial about the risks of the transvaginal mesh devices. The plaintiff received her TVT implant in 2005 to treat stress urinary incontinence (SUI). In SUI, physical movement or activity — coughing, sneezing, running or heavy lifting — puts pressure (stress) on the bladder, resulting in urine leakage, according to the Mayo Clinic. Two years after the device was implanted, the woman complained of a sharp feeling in her vagina. Her doctor discovered that the mesh had become exposed and she underwent surgery to remove the exposed mesh. Three years later, she needed additional surgery when another patch of exposed mesh caused her discomfort. In 2012, her attorney told the jury, she began feeling pulling sensations and more pain caused by scarring from the implant and from the prior surgeries, Law360 reports.

The U.S. Food and Drug Administration (FDA) says transvaginal mesh devices are associated with a variety of side effects including mesh erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. C.R. Bard, American Medical Systems, and Boston Scientific—transvaginal mesh device makers—also face litigation over their devices.

In his closing argument to the jury, the attorney said that the TVT product’s various design flaws “combine to lead to permanent pain,” according to Law360. Even after follow-up surgeries, “the pain remains or comes back or starts anew,” he explained.

Court records indicate that a third Ethicon trial was scheduled to start on Feb. 22, but that the case was settled, Law360 reports. Other trials in the mass tort program are scheduled to start beginning in November, according to court records.

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