Leverkusen, Germany-based Bayer reached agreements with plaintiff law firms on about 90% of the nearly 39,000 filed and unfiled U.S. Essure claims from women who allege device-related injuries, according to a news release. Settlements include all jurisdictions with significant volumes of Essure cases, and the company will pay approximately $1.6 billion to resolve the claims.
Settling claimants will be required to dismiss their cases or not file, according to the company, and there is no admission of wrongdoing or liability by Bayer in the agreements. The other terms of the settlements are confidential and the settlement amount is covered by existing provisions. The U.S. settlements have no impact on pending litigation in other countries.
Bayer said virtually all its U.S. Essure litigation is now resolved, adding that the company “sympathizes with all women who have experienced adverse health conditions, regardless of the cause, but the company continues to stand by the science supporting the safety and efficacy of Essure.”
The company said women with Essure can “continue to rely on the device for their reproductive health” and should contact healthcare providers with questions or concerns, while Bayer will continue to provide support services for the device.
Essure users had claimed a number of injuries related to the permanent birth control device, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy, according to the company.
Earlier this month, Bayer had announced that it set aside $1.4 billion at the end of the second quarter (June 30) for the potential settlements. Some of the provision was also for litigation defense costs and other pharmaceutical matters.
Essure has not been available for implantation in the U.S. since December 2019, having had U.S. sales for the device discontinued in December 2018. Recently released interim results of an Essure postmarket study found higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared with laparoscopic tubal ligation as permanent birth control.