J&J Wins Appeal, Loses Civil Case Over Pelvic Mesh Implant
Two new court decisions leave Johnson & Johnson subsidiary Ethicon with a win and a setback in its ongoing nationwide pelvic mesh litigation. Though a U.S. Court of Appeals for the 4th Circuit upheld Ethicon’s win from a year ago, a California jury has awarded $5.7 million in damages the court says were caused by Ethicon’s Gynecare TVT Abbrevo (Abbrevo) device.
Abbrevo, a newer pelvic mesh product developed by Ethicon, was approved by the FDA in 2010 to treat stress urinary incontinence and pelvic organ prolapse.
According to the California court’s decision, Abbrevo has serious design defects and Ethicon failed to warn doctors about the implant’s problems, according to The National Law Journal. Reuters reports that a Kern County Superior Court jury awarded the plaintiff, Coleen Perry, $700,000 in compensatory damages and $5 million in punitive damages.
According to Perry’s lawyers, she began experiencing pain almost immediately following her surgery, as the device began to erode inside her body. The verdict, said the lawyers, “sent a clear message to Ethicon” about its “improper conduct in designing and marketing Abbrevo,” reported Reuters.
Ethicon spokesman Matthew Johnson told Bloomberg that his company stands by the safety of Abbrevo and feels there is enough evidence to support an appeal.
“The evidence showed the TVT Abbrevo midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research development and marketing of the product,” Johnson told Bloomberg.
Despite its loss in California, Ethicon did manage to hold onto its win in West Virginia, Reuters reports.
Last week, the Fourth Circuit upheld a decision from January of 2014 that plaintiff Carolyn Lewis did not have enough evidence to support her claim that a sufficient warning would have prevented her doctor from prescribing the device, Law360 reports.
“When a physician relies on her own experience and examination of a patient in deciding to prescribe a device, and not on the device’s warning, the warning is not the cause of the patient’s injury,” the appeals judges said.
Abbrevo is one of numerous similar devices from multiple high-profile device makers fighting and settling court battles over the past few years. Boston Scientific, Endo, C.R. Bard, and Covidien have all been in court to resolve pelvic mesh lawsuits.
Danish medical device manufacturer Coloplast recently agreed to a $16 million dollar settlement for 400 cases against its vaginal mesh insert, Bloomberg reported.
“It appears that momentum is building for some type of global resolution as more of these vaginal-mesh cases settle,” said Carl Tobias, product liability law professor at the University of Richmond, told Bloomberg.
Bloomberg projects that despite litigation the market for pelvic mesh devices is expected to exceed $1.7 billion by 2017.
Image Credit: “3D Judges Gavel” by Chris Potter. Licensed under CC BY 2.0 via Flickr.