Another Lawsuit Brought Against Johnson Johnson Ethicon Over Pelvic Mesh InjuriesAug 22, 2016
A civil lawsuit brought against Johnson & Johnson, as well as its medical device unit, Ethicon, includes allegations that Johnson & Johnson and Ethicon used deceptive marketing over its surgical transvaginal mesh.
Litigation over pelvic mesh devices continues to move forward, with women alleging that transvaginal mesh implants caused serious and often permanent injuries. In fact, pelvic mesh devices have become the subject of safety concerns in recent years amid reports that the mesh device may lead to serious, sometimes permanent and life changing injuries.
Pelvic mesh, or transvaginal mesh, is a net-like implant device that has been approved to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). While the pelvic mesh device is meant to reinforce the strength of a woman's pelvic walls to offset sagging organs, the product design and implantation technique may lead to serious complications, including erosion and organ perforation.
SUI causes the involuntary release of urine during physical activity. The device, allegedly, Instead of helping with this issue has, according to women's allegations, resulted in pain and persistent urinary problems in some cases. In many cases, plaintiffs had to undergo surgery to remove the device. Ethicon, a subsidiary of Johnson & Johnson, is one of several manufacturers facing 60,000 lawsuits over mesh implants.
Plaintiffs' lawsuits note that pelvic mesh devices were never clinically tested before they were sold and implanted in thousands of women. Due to a regulatory loophole known as 510(k), manufacturers only had to show that the slings were "substantially equivalent" to an older device.
A federal bellwether trial over Ethicon's TVT-O sling resulted in a $3.27 million verdict. The jury found for the plaintiff on all counts, which included strict liability, design defect, failure to warn, and negligence. In 2013, a New Jersey jury ordered J&J to pay $11.1 million to a woman allegedly injured from its Prolift transvaginal mesh. Meanwhile, in 2011, the U.S. Food and Drug Administration (FDA) warned that complications associated with transvaginal mesh devices are "not rare" and that these devices may be more harmful compared to other methods for treating pelvic organ prolapse.
In Kentucky, over 15,000 women were implanted with a transvaginal mesh that, according to allegations, were not released to market with sufficient information concerning appropriate information about known hazards associated with transvaginal mesh that would enable women and their doctors to make meaningful, informed treatment decisions, according to the lawsuits, according to WKYT.