Pharmaceutical

More than 100 additional Suits Resolved in Transvaginal Mesh MDL

2012 TVM serious complications More than 100 additional Suits Resolved in Transvaginal Mesh MDLLaw360 reports that Endo International plc unit American Medical Systems Inc. has settled approximately 135 more suits in the multidistrict litigation (MDL) in West Virginia against the seven manufacturers of transvaginal mesh implants. The seven MDLs have been consolidated into one giant litigation totaling around 70,000 pending cases. Last year AMS settled about 360 cases in April, another 108 in May and another 100 by July. The previous year according to Law360 Endo paid $830 million to settle 20,000 suits.

“In a joint motion to dismiss, AMS said it had compromised and settled claims in roughly 135 suits filed by women who said they had been injured by the the vaginal mesh devices. The devices included the Apogee and Perigee systems as well as the MiniArc Sling and the IntePro Y Sling, among other products,” Law360 reported.

The lawsuits in the MDLs allege that transvaginal mesh devices are defective and cause severe injuries such as chronic pain, organ perforation, pain during intercourse, incontinence, mesh eroding into surrounding tissue, and other injuries. The devices are used to treat relatively common disorders such as stress urinary incontinence and pelvic organ prolapse.

This January the U.S. Food and Drug Administration (FDA) reclassified transvaginal mesh as high risk devices and required manufacturers to prove the safety and effectiveness of their product by going through rigorous safety evaluations that would reassess these devices.

In March Endo announced that it was shutting down its Astora Women’s Health division in part to “reduce the potential for product liability related to future mesh implants.” According to the Philadelphia Business Journal, “In August, Endo said it had set aside $1.53 billion for potential litigation and settlement costs, and the company said Monday it took an additional $834 million pre-tax charge during the fourth quarter related to vaginal mesh cases.”

Sources
Law360
Philadelphia Business Journal