Ethicon, Inc., a subsidiary of Johnson & Johnson and manufacturer of pelvic mesh products, advised the United States Food and Drug Administration (FDA) this week that it is recalling four of its mesh, pelvic floor repair products. Additionally, Ethicon is asking the FDA for 120 days to “cease commercialization” of its products, notify customers, and allow physicians and hospitals time to choose different treatments for patients. Ethicon also plans to stop or change its marketing materials and revise its product labeling, limiting the use of certain products to abdominal procedures. These devices, many of which were made of synthetic polypropylene, have been used previously to treat women with conditions known as pelvic organ prolapse and stress urinary incontinence. Our law firm has filed lawsuits on behalf of women who suffered injuries after being surgically implanted with such devices, alleging that these devices were ill-suited for use in a woman’s pelvic floor area. Ethicon’s decision to recall four of its devices and stop marketing them for use in treating pelvic organ prolapse and stress urinary incontinence is an important step for thousands of women who have suffered injuries and continue to suffer because of these products.
Lawsuits on behalf of women who were injured by transvaginal mesh products have been consolidated in the United States District Court for the Southern District of West Virginia before Judge Joseph R. Goodwin for pretrial proceedings. You can read the letter notifying the Court of Ethicon’s decision to recall its products. This litigation is what is known as multidistrict litigation (MDL), in which similar cases pending throughout the U.S. against a manufacturer or manufacturers are consolidated in one Federal Court for purposes of coordinating pretrial discovery and achieving consistency of rulings on evidentiary issues. The Court appoints a Steering Committee on behalf of the Plaintiffs and Defendants, who work together on resolving issues that come up during the course of the litigation. If an individual’s case is not settled or tried by a jury while it’s pending in the MDL Court, that individual lawsuit can be referred back to the United States District Court in the state where the Plaintiff resides or where the injury occurred, and be tried before a jury there.
Suthers & Thompson represents clients in pelvic mesh lawsuits against various manufacturers, including American Medical Systems, Inc. (AMS), C.R. Bard, Inc. (Bard), Boston Scientific, and Johnson & Johnson and its subsidiary, Ethicon. For more information regarding the pelvic mesh lawsuits, please see the Transvaginal Mesh and Bladder Slings page at our website.