A New Jersey jury ordered Johnson & Johnson (J&J) to pay a South Dakota woman $3.35 million for failing to adequately warn her doctor of the potential dangers of a vaginal mesh implant made by Ethicon, a subsidiary of the company, and for misrepresenting the product in brochures. According to Businessweek, the Feb. 25 verdict comes as the first of 2,100 lawsuits over New Jersey-based J&J’s vaginal mesh implants.
The lawsuit was brought by Linda Gross, a 47-year-old nurse from South Dakota. In 2006 her surgeon implanted a Gynecare Prolift vaginal mesh implant to treat pelvic organ prolapse.
WebMD explains that pelvic organ prolapse occurs when “a pelvic organ — such as your bladder — drops (prolapses) from its normal spot in your lower belly and pushes against the walls of your vagina. This can happen when the muscles that hold your pelvic organs in place get weak or stretched from childbirth or surgery.”
Mesh implants are made of porous synthetic or biologic material and are inserted vaginally, then implanted and tied to ligaments or bone to serve as a sling that lifts and supports the organ involved. Businessweek reports that doctors implanted more than 70,000 such devices in U.S. women in 2010 for organ prolapse and to treat stress incontinence.
For Linda Gross, implantation of the Prolift followed years of chronic pain and left her unable to sit comfortably. The device, made of a polypropylene mesh, hardened and required 18 surgeries to remove. Gross testified that she has had more than 400 visits to doctors and physical therapists for treatment, exams and tests, which she described as “horrific.”
The $3.35 million award is for compensatory damages for losses and injuries, including pain and suffering, lost wages, costs of past and future medical treatment, and her husband’s loss of conjugal affections. The judge ruled that she would also allow arguments on punitive damages, which punish for willful and wonton behavior. New Jersey state law caps punitive damages at five times the compensatory damages, which could mean an additional $16.75 million award to Gross.
In response to the verdict, Sherri Woodruff, a spokesperson for Ethicon, told Reuters, “While we are always concerned when a patient experiences medical conditions like those suffered by the plaintiff, all surgeries for pelvic organ prolapse present risks of complications.”
Last June, J&J stopped selling the Prolift vaginal mesh implant following mounting lawsuits.