Dive Brief:
- BD has reached an agreement to settle the majority of its hernia mesh litigation, the company said Wednesday.
- BD said it did not admit to wrongdoing or liability in the settlement agreement, terms of which were kept confidential. “BD is confident in both the design of its products and fulfilling its obligation to provide information about both the risks and the benefits of its products,” the company said.
- The settlement will be paid out over a multi-year period. BD continues to dispute the allegations in the matter and will “vigorously defend itself” in cases not resolved in the settlement, according to the statement.
Dive Insight:
Surgical mesh is used in hernia repair surgery to help reduce the likelihood of a hernia developing again. Multiple medical device manufacturers faced lawsuits in the past decade from thousands of patients who alleged injuries or medical complications due to flawed surgical mesh products.
Companies recalled hundreds of thousands of hernia mesh devices in response to safety concerns.
In 2019, the Food and Drug Administration ordered a stop to sales of a type of mesh product indicated for transvaginal repair of pelvic organ prolapse.
The FDA, after analyzing adverse event reports going back more than two decades, released a safety update in 2023 to help patients make decisions about use of surgical mesh in hernia repair.
BD faced more than 33,000 product liability claims involving its line of hernia repair devices as of March 2023. In 2022, a jury ordered BD’s C.R. Bard subsidiary to pay $4.8 million to a patient who alleged severe injuries from the company’s Ventralex hernia mesh.
BD said its new settlement includes cases in consolidated litigation in Rhode Island and federal multidistrict litigation in Ohio. The amount to be paid is within the company’s product litigation reserve and has already been recorded as a liability on its balance sheets.
“BD believes this agreement is in the best interest of all parties and is structured to eliminate uncertainty for all stakeholders related to the settled cases,” wrote the company.