Barbara Kaiser and her husband Anton Kaiser sued Ethicon in March 2012, after learning that the Prolift mesh her doctor implanted in 2009 to treat her pelvic organ prolapse might be causing her low pelvic pain.
The lawsuit accused J&J and Ethicon of concealing the problems with Prolift, which allegedly include high failure, injury, and complication rates and “frequent and often debilitating re-operations,” according to the Kaiser’s complaint. Prolift “caused severe and irreversible injuries, conditions, and damage to a significant number of women, including plaintiff,” according to the complaint.
“Defendants have consistently underreported and withheld information about their Prolift’s propensity to fail and cause injury and complications, and have misrepresented the efficacy and safety of the products through various means and media, actively and intentionally misleading the medical community, patients, and the public at large,” the Kaisers alleged. “Defendants actively and intentionally misled and continue to mislead the public, including the medical community, health care providers, and patients, into believing their Prolift is safe and effective, leading to the prescription for, and implantation of, their Prolift into plaintiff, Barbara Kaiser, and numerous other women.”
The U.S. District Court for Northern Indiana jury March 8 awarded Barbara Kaiser $10 million in damages and $25 million in punitive damages but gave nothing to Anton Kaiser, according to court documents.
“Ethicon defended an indefensible product and the jury stood up for Barbara Kaiser,” her attorney, Thomas Plouff, told Scotland’s Sunday Post. “They were asked to send a message to Ethicon to deter future wrongdoing, and they did.”
Johnson & Johnson plans to appeal the verdict, spokeswoman Mindy Tinsley told MassDevice.com via email, “as we believe it contradicts the evidence that the product was properly designed and that the company appropriately informed surgeons of pertinent complications.”
“Pelvic organ prolapse is a serious and debilitating condition with limited treatment options. Scientists from around the world who have conducted and reviewed independent research on pelvic mesh agree it is an important treatment option for some women. All surgeries to treat pelvic organ prolapse have risks. While we empathize with those who have experienced complications, many women with pelvic mesh see an improvement in their day to day lives,” Tinsley told us. “Ethicon stands by, and will continue to defend, our pelvic mesh products in litigation.”
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
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