BD, a prominent medical device manufacturer, has entered into a settlement agreement to resolve the majority of its hernia mesh litigation, as announced by the company on Wednesday. While the specific terms of the agreement remain confidential, BD has clarified that it does not admit to any wrongdoing or liability. The company remains confident in the design of its hernia mesh products and its commitment to informing users about the potential risks and benefits associated with them. The financial obligations arising from the settlement will be dispersed over several years.
Despite the settlement, BD intends to continue fiercely defending itself against any unresolved allegations. The settlement specifically includes cases that were part of consolidated litigation in Rhode Island and federal multidistrict litigation in Ohio. BD believes that reaching this agreement serves the best interest of all involved parties by diminishing uncertainties connected to the settled cases. This has been statistically accounted for in the company’s product litigation reserve, already factored as a liability on its balance sheets.
Over the past decade, the use of surgical mesh in hernia repair surgeries has come under intense scrutiny. Surgical mesh is commonly utilized to strengthen the repair of a hernia and reduce the recurrence rate. However, this practice has faced critical challenges as numerous patients across different manufacturers claimed to have suffered injuries or medical complications due to defective mesh products. These adverse reports have led to the recall of hundreds of thousands of hernia mesh units due to safety concerns.
The scrutiny reached a significant point when, in 2019, the Food and Drug Administration (FDA) intervened by halting the sales of a specific type of mesh used for transvaginal repair of pelvic organ prolapse. Further analysis of adverse event reports spanning over twenty years prompted the FDA to release a safety update in 2023. This update was aimed at aiding patients in making informed decisions regarding the usage of surgical mesh for hernia repairs.
Particularly for BD, the litigation issues became prominently burdensome as the company faced over 33,000 product liability claims concerning its hernia repair devices by March 2023. One notable legal defeat occurred in 2022 when BD’s subsidiary, C.R. Bard, was ordered by a jury to pay $4.8 million to a patient who suffered severe injuries allegedly caused by the company’s Ventralex hernia mesh.
This settlement marks a crucial point for BD as it seeks to mitigate risks and move forward from the barrage of litigations it has faced in connection to its hernia mesh products. The agreement aims to alleviate the looming uncertainties for BD’s shareholders and potentially restore some confidence in the safety and efficacy of its medical devices.
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