A recent transvaginal mesh trial concluded with an $80 million judgment against Johnson & Johnson subsidiary Ethicon.
The multimillion dollar verdict included $50 million in punitive damages. The money was awarded to plaintiff Patricia M. after a jury determined that a transvaginal mesh device manufactured by Ethicon caused the plaintiff’s injuries.
Patricia reportedly received a Prolift implant in September 2018 to treat pelvic organ prolapse. Pelvic organ prolapse, according to the U.S. Department of Health & Human Services, occurs when the muscles supporting the uterus, bladder, or rectum start to weaken, resulting in the organs pressing into the vagina. In severe cases, the organs may press completely out of the vagina due to a lack of support in the pelvic floor.
Just a month after her pelvic organ prolapse surgery, Patricia says she began experiencing vaginal bleeding that ultimately required a second surgery–known as revision surgery–to repair. During the revision surgery, doctors found that a portion of the transvaginal mesh had punctured Patricia’s vagina.
Four years after the revision surgery, Patricia says she again experienced vaginal bleeding as well as pain during sex, according to her suit. Doctors eventually discovered that another piece of mesh had become exposed in two places of Patricia’s vagina. She underwent a third surgery to remove the Ethicon transvaginal mesh, followed by three additional surgeries to address “mesh erosions,” Law360 reports. During two of the treatments, Patricia suffered chemical burns during attempts to remove scar tissue.
Patricia’s attorney told jurors in closing arguments that in spite of the half-dozen surgeries, the defective Prolift mesh continues to cause Patricia pain and has “all but ended her sex life with her husband.”
The product reportedly uses a tight weave, causing tissues to surround the mesh in a scar capsule rather than integrating with the mesh as intended.
“Once again, a jury resoundingly found that the Prolift device, among many defective Johnson & Johnson transvaginal mesh devices, badly injured a woman, and that the conduct was such that punitive damages were warranted,” plaintiff’s counsel said in an interview with Law360.
Ethicon argued that Patricia’s lichen sclerosus–a condition involving abnormally thin skin in the genital area–was to blame for her complications, not the transvaginal mesh. The jury did not agree.
“We respect the legal process, but we want to reiterate that jury verdicts are not medical, scientific or regulatory conclusions about a product and Ethicon will appeal these verdicts,” an Ethicon spokesperson told MedTech Dive. “While Ethicon empathizes with women who experience medical complications, these verdicts and the damages awarded are inconsistent with the science and Ethicon’s actions.”
The Transvaginal Mesh Lawsuit is Case No. 140200399 in the Court of Common Pleas of Philadelphia County, Pennsylvania.
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