Vaginal Mesh Settlements Top $2.6B in Payments by Endo to Resolve All Lawsuits

Endo Pharmaceuticals is setting aside another $775 million to settle vaginal mesh injury lawsuits, bringing the total amount to be paid by the manufacturer to more than $2.6 billion to resolve “virtually all known” claims. 

More than 100,000 product liability lawsuits have been filed against Endo and other manufacturers of transvaginal mesh products used for repair of pelvic organ prolapse and female stress urinary incontinence. Design defects associated with surgical mesh have been linked to severe complications among women, including infections, erosion of the mesh into the vagina, and organ punctures.

In May 2014, Endo became the first major manufacturer to resolve cases, agreeing to pay about $830 million in AMS vaginal mesh settlements. However, in August 2015 the company announced it was allocating $1.53 billion for litigation and settlement costs, and then later added another $834 million specifically for vaginal mesh litigation.

In a quarterly filing with the U.S. Securities and Exchange Commission earlier this month, the company indicates that an additional $775 million will be set aside to resolve another 22,000 mesh claims. While this is intended to resolve all known claims, the manufcturer indicates that it is possible further claims may be filed or asserted.

In 2016, Endo also announced it was selling off its Astora Woman’s Health division, a part of its American Medical Services (AMS) subsidiary, which manufactured vaginal mesh products for the company. The move ended Endo’s vaginal mesh manufacturing.

Vaginal Mesh Lawsuits

The litigation over vaginal mesh products was one of the largest mass torts in recent years, with tens of thousands of women filing cases nationwide.

Following several years of litigation, various different manufacturers have reached vaginal mesh settlements to resolve groups of claims involving problems with products manufactured by Endo’s AMS, C.R. Bard, Boston Scientific, Ethicon and others.

The number of cases began to increase rapidly after July 2011, when the FDA warned that it had received thousands of adverse event reports involving problems with vaginal mesh products between January 2008 and December 2010.

After a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse.

In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, and establish whether they pose an unreasonable risk of injury for women. Since then, a number of manufacturers have decided to stop making the devices to avoid the need to spend money studying the safety of products they have sold for years.