Endo International has agreed to pay a $775 million settlement to cover approximately 22,000 vaginal mesh lawsuits in the United States, that were filed by women who complained the implants eroded into their body causing chronic pain, incontinence, and sexual dysfunction. The settlement comes out to an average of $35,000 per claim, which is essentially equivalent to Endo’s previous settlements, reports the Daily Hornet.
According to filings with the U.S. Securities and Exchange Commission (SEC), Endo has agreed to pay a total of $2.6 billion in vaginal mesh lawsuit settlements. Dublin-based Endo has shut down a subsidiary that makes mesh implants after being confronted with lawsuits worldwide over the flawed medical devices that had been designed to support internal organs or treat incontinence.
Endo agreed to pay $830 million in May 2014, to settle lawsuits involving its Elevate, Apogee, and Perigee Prolapse Repair Systems, which provided a base payout of $40,000 per claim. The terms of the settlement permitted women to seek higher compensation for serious injuries and multiple revision surgeries, according to the Daily Hornet.
The national personal injury law firm Parker Waichman LLP has extensive experience and success in medical device litigation. Attorneys at the firm are available to answer any questions about filing a mesh lawsuit.
The lawsuits have been dragging through courtrooms for years, with many multi-million jury verdicts in favor of women who had been injured allegedly due to the defective mesh implants.
Example of Mesh Lawsuit
An example describing a lawsuit had to do with a plaintiff from Philadelphia who began to experience pain and discomfort when the vaginal mesh, made of polypropylene, began to erode inside her body. The lawsuit filed in 2013, stated that the plaintiff experienced mesh erosion, a transvaginal mesh complication where the device moves through the tissues of the vagina. The woman had to have three additional surgeries, but even then, physicians were not able to completely remove the mesh. The plaintiff continues to suffer chronic vaginal pain, pelvic floor spasms, and has developed permanent urinary dysfunction, according to Law360.
Only a few device-makers have not at this point agreed to large-scale settlements. Johnson & Johnson (J&J) based in New Brunswick, New Jersey, still has 54,800 vaginal mesh lawsuits pending, and Boston Scientific, based in Marlborough, Massachusetts, still faces 43,000 vaginal mesh claims. American Medical Systems, a subsidiary of Endo was sold to Boston Scientific in 2015.
The consolidated litigation against Endo International involving its subsidiary, American Medical Systems (AMS), stopped selling vaginal mesh products after the U.S. Food and Drug Administration (FDA) ordered new safety studies. The lawsuits were consolidated in multidistrict (MDL) litigation in the U.S. District Court for the Southern District of West Virginia in Charleston.
Multidistrict litigations are frequently formed to streamline the judiciary process by consolidating cases with similar complaints to be tried in one court under one judge. This allows a faster outcome, lowers court costs, cuts down on personnel, and is typically more efficient.
The FDA increased regulatory restrictions on the mesh inserts after concluding in 2014 that they were high-risk. When products are cleared through the 510(k) expedited process, manufacturers are not required to perform the normally rigorous clinical testing to show that the device is safe and effective. The 510(k) “fast track” only requires that the new product is “substantially equivalent” to a product already FDA approved.
The FDA has since reclassified transvaginal mesh devices from “moderate-risk” to “high-risk,” meaning the products may no longer be approved through the 510(k), fast track process.
Over 100,000 transvaginal mesh lawsuits have been filed, making it one of the largest mass torts in history. Approximately 75 percent of mesh lawsuits are consolidated in West Virginia federal court through seven MDL cases. The rest are in state courts, including those in Pennsylvania and West Virginia.
Endo paid $150 million in legal settlements related to its vaginal mesh in the fourth quarter of 2016 and now more payments are due to be paid. Endo recorded an $834 million pretax charge to increase the estimated product liability accrual. It had already set aside $1.4 billion to cover the legal costs at the end of the previous settlements.
Ongoing Complaints Concerning Vaginal Mesh Devices
Vaginal mesh is designed to repair pelvic organ prolapse (POP) and treat stress urinary incontinence (SUI), but may cause serious adverse reactions that may require additional surgeries or hospitalizations. Women with vaginal mesh implants have been known to experience erosion, infection, scarring, bleeding, pelvic pain, recurrent incontinence or prolapse.
Legal Information for Medical Device Problems
If you or someone you know has been injured by a medical device, such as Endo’s vaginal mesh implant, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact the personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).