Endo International has reached a settlement agreement that reportedly will resolve most outstanding American Medical Systems (AMS) transvaginal mesh lawsuits. The medical device manufacturer has agreed to pay an additional $400 million settle “substantially all” of the remaining lawsuits that claim the AMS vaginal mesh implants eroded in some women, leaving them in pain and injured.
The Dublin-based company will add $400 million to its $1.2 billion liability reserve to resolve claims over the vaginal mesh products sold by its AMS subsidiary, Endo said in a statement. The master settlement will resolve more than 10,000 outstanding AMS lawsuits in the U.S. at an average of about $48,000 a piece, Bloomberg reports. AMS expects to fund the payments under all settlements through 2017.
AMS is based in Minnesota and is a major manufacturer of transvaginal mesh medical devices, which were designed to correct pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women.
The U.S. Food and Drug Administration (FDA) received a number of adverse reports regarding AMS transvaginal mesh. These reports have resulted in thousands of lawsuits filed against the company by women who may have been implanted with the following AMS mesh:
- AMS Apogee Vault Suspension System
- AMS Elevate Prolapse Repair System
- AMS Monarc Sling System
- AMS Perigee System
- AMS Sparc Sling System
In July 2011 an FDA advisory panel reported that TVM mesh, including AMS transvaginal mesh, be re-classified from moderate risk to high risk (Class III) of harming patients if it fails, and required that more studies be done to determine if it is safe and effective, and also will require pre-market clinical testing for new mesh products. (Moderate risk devices need only show that they are “substantially equivalent” to existing products).
Earlier this year, Endo announced that it had reached agreements to settle more than 22,000 AMS cases for $830 million. This still left thousands of claims unresolved. Sources close to the Endo settlement stated that the company still faces 5,000 lawsuits related to its vaginal mesh implants. The first trial is scheduled in Texas state court early next year, according to court filings obtained by Bloomberg.
Other manufacturers of TVM devices face lawsuits of their own. In March, Danish device maker Coloplast said it would pay $16 million to settle lawsuits over vaginal mesh inserts, indicating a possible global settlement. Some of the cases, including Endo suits, have been consolidated in Charleston, WV before U.S. District Judge Joseph Goodwin to reduce duplicative discovery in the cases.
As we reported in our blog in September, Johnson & Johnson’s Ethicon unit was ordered to pay $3.27 million to a woman who claimed that the company’s transvaginal mesh device caused severe pain and serious side effects. Also in September, a jury in Texas found that Boston Scientific’s vaginal mesh implant was defectively designed and awarded a woman $73 million in damages.
At least half a dozen trials have resulted in multi-million dollar verdicts for plaintiffs, which could prove costly for the other manufacturers if transvaginal mesh settlements are not reached to resolve the litigation.
Judge Goodwin has indicated that he plans to speed up the vaginal mesh trial schedule over the next year, ordering that hundreds of individual cases against C.R. Bard, Boston Scientific and Ethicon be prepared and ready to go to trial by January 2015. If settlements are not reached, it is expected that he will begin remanding cases back to U.S. District Courts nationwide for trials to be scheduled throughout 2015.
If you or a loved one has been injured as a result of a transvaginal mesh implant device, you should contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878) to discuss your options.