A Philadelphia jury has returned a $13.5 million verdict against Johnson & Johnson’s Ethicon division in a case over Ethicon’s faulty pelvic mesh implants.
The plaintiff in the case 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 that the woman’s doctor would never have implanted the product had he been aware of its risks.This is the second damage award against Ethicon in a string of nearly 180 cases consolidated in Philadelphia County’s Court of Common Pleas. In the first case to go to trial, the jury returned a $12.5 million verdict in December, agreeing that Ethicon’s Prolift pelvic mesh product was negligently designed and that the physician who implanted the product received inadequate warnings about the risks, according to Law360.
The verdict returned on February 9 included $10 million in punitive damages, $3.5 million in compensatory damages, and $250,000 to the woman’s husband for loss of consortium. During trial, the woman’s attorney told the jury the TVT product was defectively designed and that the company had offered inadequate warnings to physicians.
During the two-week trial, the jury heard testimony from a number of doctors about the alleged risks of the transvaginal mesh product. The plaintiff was implanted with TVT in 2005 to treat her stress urinary incontinence (SUI). SUI happens when physical movement or activity — such as coughing, sneezing, running or heavy lifting — puts pressure (stress) on the bladder, according to the Mayo Clinic. Two years after she received the implant, 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 a portion of the implant. Three years after that, she needed another procedure when another patch of exposed mesh began causing her discomfort. In 2012, her attorney told the jury, she began feeling pulling sensations and more pain because of scarring from the mesh implant and from the prior surgeries.
The Food and Drug Administration (FDA) reports that the most common side effects associated with transvaginal mesh devices include mesh erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. In addition to cases against Ethicon, women have also filed lawsuits against a number of other transvaginal mesh device makers including C.R. Bard, American Medical Systems, and Boston Scientific.
In closing arguments, the attorney said that the mesh product’s design flaws “combine to lead to permanent pain.” Even after follow-up surgeries, “the pain remains or comes back or starts anew,” he explained, according to Law360.
A third trial had been scheduled to start on Feb. 22, but court records indicate that the case was settled. Law360 reports that additional trials in the mass tort program are scheduled to start beginning in November, according to court records.