Endo Pays $830M to Settle TVM Lawsuits
Endo International, a transvaginal mesh (TVM) manufacturer, has agreed to pay $830 million to settle nearly 20,000 TVM lawsuits involving the Apogee, Perigee, and Elevate implants sold by its subsidiary, American Medical Systems (AMS). According to TVM lawsuits, thousands of women have suffered from pain during intercourse, organ damage and bleeding, among other complications. Endo stated that it had previously set aside $520 million in a product liability reserve to cover all TVM lawsuits filed against the company.
Endo Reaches Settlement
Once final, the settlement will resolve a significant majority of the AMS transvaginal mesh-related claims, according to officials for Endo. The manufacturer will pay each complainant an average of $40,000, pending confirmation of the extent of injuries allegedly sustained based on an evaluation of the plaintiffs’ medical records, according to a report by Bloomberg Business Week. The plaintiffs may be entitled to request additional compensation if they can provide proof that they were required to undergo multiple procedures to remove the defective implants or if they suffered severe injuries as a result of the devices.
Plaintiffs File TVM Lawsuits
The announcement comes one day after the U.S. Food and Drug Administration (FDA) proposed reclassifying TVM products used for repair of pelvic organ prolapse from a mild risk (Class II) to high-risk (Class III), thus requiring manufacturers to obtain premarket approval.
TVM implants are used to treat stress urinary incontinence and pelvic organ prolapse, a condition in which pelvic organs sag or prolapse into the vaginal walls. In 2010 alone, surgeons in the U.S performed an estimated 70,000 TVM procedures. The U.S. Food and Drug Administration issued a safety communication in July 2011 to warn the public and medical communities about serious complications associated with transvaginal mesh products.
According to the agency, the FDA received more than 1,000 adverse event reports linked to TVM implants between 2005 and 2007 and another 2,874 between 2008 and 2010. The FDA’s 2011 safety communication states that the most common injuries reported by women affected by TVM implants include vaginal scarring, pain during sexual intercourse, urinary problems, organ perforation and mesh erosion.
As a result, women throughout the U.S. are working with attorneys who handle TVM lawsuits to pursue claims against several manufacturers of these products, including Johnson & Johnson, C.R. Bard, Boston Scientific, Ethicon and American Medical Systems. Almost all of the 40,000 pending TVM lawsuits have been consolidated into the federal court in the Southern District of West Virginia for pretrial proceedings. The first bellwether trial is scheduled to begin in September 2014 and will provide an opportunity for both parties to gauge the outcome of future TVM lawsuits.
Contact the TVM Info Center Today for More Information
The TVM Info Center provides free case evaluations to women in the U.S. who feel they have been injured by TVM implants. We can help determine if you have a case and answer your questions so you are informed of your legal rights in your unique situation. We can also connect you with an affiliated attorney experienced in handling TVM lawsuits who can help you pursue a claim and seek damages to which you may be entitled such as pain and suffering, lost wages and medical expenses.