On April 30th, Endo International Plc (“Endo”) agreed to pay $830 million to resolve legal claims filed by women who have been injured by various transvaginal mesh devices. In its annual report filed with the U.S. Securities and Exchange Commission, Endo reported that as of February 2014, the company and its American Medical Systems (“AMS”) subsidiary faced approximately 22,000 lawsuits over the devices, and that in 2013, Endo agreed to pay $54.5 million to settle an undisclosed number of the cases.
This most recent settlement is aimed at resolving all of Endo’s pending legal claims across the country related to these devices; however, several other manufactures, including C.R. Bard, Inc. and Johnson & Johnson’s Ethicon unit manufacturer, remain pending and are not part of the announced settlement. At last count, nearly 44,000 cases filed by injured women were pending in the U.S. District Court for the Southern District of West Virginia, alleging varying injuries, including pain during intercourse, bleeding, and additional complications, many of which have required additional surgeries to remove the devices.
Transvaginal mesh devices are net-like implants used to treat various conditions, including pelvic organ prolapse and stress urinary incontinence – common conditions for women after a hysterectomy, menopause, or childbirth. However, over time and beginning in 2008, the U.S. Food and Drug Administration (“FDA”) began notifying manufacturers of reports of complications linked to the devices. This ultimately led to post-marketing safety studies mandated by the FDA to be conducted by AMS and other manufacturers to monitor the rate at which adverse events were being reported. The effect of these reports has been that at the beginning of May, the FDA announced that it is considering proposals which would tighten safety standards for mesh devices used to treat pelvic organ prolapse. These proposals, if adopted, would require manufacturers to submit data which proves the devices’ safety and efficacy before allowing the manufacturer to take the device to market.