According to a recent announcement in the vaginal mesh litigation, Medtronic’s Covidien unit has reached an agreement that could potentially settle more than 11,000 vaginal mesh lawsuits. These claims were filed by women who experienced severe complications after using these vaginal mesh products.

Details of Covidien Vaginal Mesh Settlements

In a pretrial order recently filed in the federal multidistrict litigation (MDL) for all Bard Avaulta mesh lawsuits under U.S. District Judge Joseph Goodwin, Covidien has entered into a Confidential Master Settlement Agreement to resolve thousands of vaginal mesh lawsuits.

Judge Goodwin appointed a specific master to perform certain functions in the administration and implementation of the vaginal mesh settlement. While the order does not disclose the terms of the agreement, a recent filing with the U.S. Securities and Exchange Commission (SEC) by Medtronic (which acquired Covidien in January 2015), a settlement was reached on June 1 that could resolve 11,300 vaginal lawsuits.

Judge Goodwin currently presides over 80,000 vaginal mesh and bladder sling lawsuits, which have been centralized into seven different federal MDLs, respectively established for different mesh manufacturers: C.R. Bard, Ethicon, Boston Scientific, American Medical Systems (AMS), Coloplast, Cook Medical, and Neomedic. While Covidien is not named in any of the MDLs, Bard has previously indicated that Covidien had supplied them with mesh products and that they hold just as much accountability as Bard in some cases.

This settlement decision came after several bellwether trials were held and processed in the federal court system, which resulted in several multimillion dollar damage awards for women who allegedly experienced debilitating vaginal mesh side effects. After these settlements, Judge Goodwin has been aggressively pushing parties to enter good faith settlement negotiations in order to avoid tens of thousands of individual trials for these vaginal mesh lawsuits.

Unfortunately, the only major manufacturer to resolve a significant portion of the vaginal mesh lawsuits filed against them has been Endo International. In October 2014, Endo announced that it had agreed to pay approximately $1.6 billion to resolve almost all of the 20,000 vaginal mesh lawsuits pending against the company’s AMS subsidiary.

Due to the lack of settlement of progress by other major vaginal mesh corporations, like Johnson & Johnson’s Ethicon subsidiary, Judge Goodwin scheduled a consolidated trial for later this year. This will involve vaginal mesh complications claims filed by 26 different women and will be presented to the same jury sometime in November of this year.

Overview of Vaginal Mesh Complications

Vaginal mesh implants are considered one of the greatest medical innovations in recent history. Women who were either suffering from pelvic organ prolapse (POP) or stress urinary incontinence (SUI) now had a discrete treatment method for their embarrassing problems. Both POP and SUI occur when the woman’s pelvic region suffers physical trauma, from either an accident or childbirth. Made of a biologically-safe material, vaginal mesh acts as a hammock to support pelvic organs for the weakened muscles. Ideally, muscles would be able grow around the stem and act as a necessary strength placeholder for the woman’s pelvis.

Unfortunately, it was not long until women discovered that these vaginal mesh products could cause major complications and debilitating injuries. In July 2011, the FDA reported that it received nearly 4,000 vaginal mesh injury reports between 2005 and 2010. Based on the numbers, the FDA concluded that vaginal mesh complications are not rare.

The agency also stated that vaginal mesh products do not necessarily improve the quality of life for patients. The most devastating vaginal mesh complications reported are mesh erosion and organ perforation, which can lead to device failure and infection. Oftentimes, surgical removal of the vaginal mesh is the only way to absolve these injuries.

As of early 2015, it has been estimated that 70,000 women had filed legal action against vaginal mesh manufacturers after suffering these injuries.