Johnson & Johnson Loses First Ethicon Mesh Lawsuit; Faces 12,000 More Complaints

Healthcare giant Johnson & Johnson has been ordered to pay a damages award of $1.2 million to a sixty-four year old woman in the first verdict against the company over the use of the Ethicon line of vaginal surgical mesh. The plaintiff argued that she suffered pelvic pain when a TVT-O mesh sling, one of the Ethicon unit’s vaginal inserts, eroded inside her. The jury concurred with the plaintiff’s claims that the design of the sling, which she was using to combat incontinence, was flawed and awarded her compensatory damages. The same jury rejected the plaintiff’s claims that Ethicon did not provide proper warnings about the sling’s health risks and declined to award punitive damages.

How is transvaginal mesh designed to work?

Through a small incision in the vaginal wall, surgical mesh is implanted into spaces /compartments in the pelvis using specially designed instruments.  The mesh is held in place by sutures or tissue fixation devices to pre-determined points in the pelvic floor muscles and ligaments. In time, cells grow into the pores of the mesh to create a sling or hammock support system thus restoring normal anatomy. Transvaginal mesh has been used to treat abdominal wall hernia (since the 1950s), abdominal repair of pelvic organ prolapse (since the 1970s), and urinary stress incontinence (since the late 1990’s).

Johnson & Johnson agrees to stop selling vaginal mesh

Johnson & Johnson’s Ethicon division, however, has not had good luck with its line of vaginal inserts. In 2010 alone, there were 70,000 mesh devices inserted by physicians by various vaginal implant makers. The FDA has received reports of thousands of serious complications, including mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems.

Hit with a mountain of more than 12,000 Ethicon mesh lawsuits over its continued design difficulties with its vaginal insert products, Johnson & Johnson finally agreed to stop selling certain lines of the flawed inserts in 2012. The allegations follow a similar theme—the design of the inserts is flawed and the patients who received them are suffering as a result.

Ethicon mesh lawsuits consolidated in West Virginia

Because of the commonality among the allegations, the majority of the Ethicon mesh lawsuits have been consolidated before U.S District Court Judge Joseph Goodwin in Southern District of West Virginia in Charleston. The proceedings in this multidistrict litigation will be widely considered a barometer for how juries will respond to the evidence and arguments on both sides of the litigation.

Other trials are still taking place in state courts such as the Texas case.  In New Jersey last year, a state court ruled that Johnson & Johnson to pay a jury award of $11.1 million to a woman who blamed another Johnson & Johnson product, Prolift , for her injuries in the first case of any of the company’s implants to reach a jury.  The FDA has ordered Johnson & Johnson, C.R. Bard Inc. and 31 other vaginal-implant makers to conduct a study of the rates of organ damage and complications because of the extreme volume of complaints about the devices.

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