Sixth Circuit Revives A Woman's Case Over J&J's Pelvic Mesh

Last week, the 6th Circuit U.S. Court of Appeals panel reinstated an Ethicon pelvic mesh lawsuit, ruling that the trial court misjudged the claim as time-barred under Tennessee law.

Transvaginal mesh is a surgical net-like implant, manufactured by various companies such as Ethicon, C.R. Bard, American Medical Systems, Boston Scientific, Coloplast, Cook Medical, Neomedic. It is used in the form of a sling to treat stress urinary incontinence (SUI) and Pelvic organ prolapse (POP) in women since the 1990s. Abdominal hernias have also been treated with a surgical mesh since the 1950s. The insertion of this mesh or a bladder sling through the vagina is known as a transvaginal mesh. The Food and Drug Administration (FDA) approved the first surgical mesh specifically designed for SUI in 1996. Later, in 2004, the FDA approved the first surgical mesh specifically for use in POP.

According to the lawsuit filed, a Tennessee woman developed pelvic organ prolapse in 2002, which resulted in urinary incontinence, generalized pelvic pain, and pain during sexual intercourse. In 2008, the woman was implanted with a Prolift brand vaginal mesh to treat the condition, but her pain returned within a year.

A lawsuit was filed in 2018, against Johnson & Johnson (J&J), alleging that the pelvic mesh implant caused serious and possibly permanent injuries. The lower court ruled that the lawsuit was barred under Tennessee's statute of repose, which prevents product liability lawsuits filed more than six years after the date of injury, and although the claim testified pelvic pain after the implant, it didn't establish mesh as the cause.

The woman's testimony was the sole reason for the district court to grant summary judgment to the defendant; however, the 6th Circuit U.S. Court of Appeals panel reinstated the case after finding that the testimony did not establish that the woman knew of a connection between her pain and the device before September 2012. The panel also noted that the plaintiff was only qualified to testify about the pain and not its cause.

Around four million women have vaginal mesh implants, and more than 150,000 developed complications associated with it. There are in all 7 MDLs to handle Transvaginal Mesh Litigation, overseen by U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia for coordinated discovery and early bellwether trials.


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