Johnson & Johnson’s losing streak in pelvic mesh litigation in Philadelphia ended on Friday as a jury rejected claims that a defective implant had left a woman facing the prospect of a lifetime of chronic pain. J&J subsidiary Ethicon Inc. was represented by IADC member Chad Hutchinson of Butler Snow LLP.
Jurors agreed that Ethicon Inc. had both defectively designed its so-called TVT Secur pelvic mesh, which plaintiff Kimberly Adkins was implanted with in July 2010 to treat her urinary stress incontinence, and failed to provide adequate warnings about its risks, but declined to back claims that the Ohio resident had suffered any injuries as a result.
Ethicon’s victory comes after losses in four prior mesh-related cases dating back to December 2015 that have left the company facing nearly $50 million in damages.
The verdict came after an Ethicon attorney admitted during closing arguments that there was potentially troubling evidence that the company had rushed TVT Secur to market despite internal concerns regarding the potential for high failure rates and medical complications among women using the product.
“There’s some things that trouble you about this case, no question,” said William Gage, an attorney with Butler Snow LLP representing Ethicon.
But he stressed that there was clear evidence in Adkins’ medical record showing that her physician had clearly communicated the risk, as eventually happened, that the implant could erode into her vaginal canal.
“She was warned about erosion, and erosion is why she’s here,” he said. “You have no evidence [her doctor] didn’t know these risks.”
While Adkins claimed that erosion was not listed as a risk in the product’s instructions for use, or IFUs, Gage said that erosion was commonly understood in the medical community as a potential consequence from any pelvic mesh implant.
“The IFU is not the only source of risk information for doctors,” he said.
He also argued that Adkins had presented no evidence, as required under relevant law in her home state of Ohio, that there was a reasonable alternative design that would have prevented her injury.
Adkins filed suit in July 2013 seeking damages after a portion of the TVT Secur implant eroded into her vaginal canal, causing significant pain.
Trial in her case kicked off nearly three weeks ago.
The mesh erosion resulted in Adkins undergoing surgery to remove a portion of the implant in September 2012, but her attorney told jurors during closing arguments that she has continued to experience significant pain that has largely robbed her of the ability to have normal sexual relations with her partner.
“She cannot have normal sexual relations for the rest of her life with her partner of 20 years,” said Bryan Aylstock, an attorney with Aylstock Witkin Kreis & Overholtz PLLC representing Adkins. “Do you know how that makes her feel? She knows she cannot please the man she loves, and she knows the man she loves will never be able to please her.”
But Gage urged the jurors, even despite Adkins’ injuries, not to allow sympathy to taint their deliberations of the particular facts of her case.
“You can’t fill in the gaps with sympathy,” he said. “You have to apply the law.”
Aylstock responded that it wasn't sympathy he was interested in.
"We want justice," he told the jury.
Aylstock said that he was disappointed with the verdict.
"We're obviously disappointed with the end result, but we proved that this is a product that should have never been on the market and that Ethicon and Johnson & Johnson behaved irresponsibly in putting a defective product on the market," he said.
Ethicon spokeswoman Kristen Wallace stressed that mesh products were a safe means of treating urinary stress incontinence like that suffered by Adkins.
"We empathize with women suffering from stress urinary incontinence, which can be a serious and debilitating condition," she said. "There are various treatment choices for women with this condition seeking to improve their quality of life, including surgical treatment with implantable mesh, which is backed by years of clinical research and is considered by most doctors to be the gold standard treatment."
Ethicon was also represented by Kimberly Bueno of Scott Douglass & McConnico LLP, William Gage and Jordan Walker of Butler Snow LLP, and Kenneth Murphy, Melissa Merk, and Andrew Reeve of Drinker Biddle & Reath LLP.
This article was originally published with Law360.