On Friday a complaint was filed in the United States District Court for the Northern District of California by Dawn and Daniel Williams against Ethicon Women’s Health and Urology and Johnson & Johnson as its parent company. The case is a product liability case regarding the Gynecare TVT Sling Retropubic System and the damage that is, according to the complaint, negligently caused by this system.
Ethicon is a producer of internal implantable mesh products. These products are used to treat a number of conditions including hernias, pelvic organ prolapse, and stress urinary incontinence. The mesh products have been used with a variety of support devices and systems including the TVT system involved in this case.
The complaint reported that there are complications that can arise from the use of mesh, including the possibility of erosion of the mesh, moving it from the desired locations into the body cavity or into other organs. This results in a need for revision surgery, removals, or other complicated and painful procedures.
The plaintiffs accused the defendants of under-reporting the numbers and types of complications from use of the mesh to the FDA to avoid having the product recalled from the market and noted that the defendants did eventually remove the product from the market rather than undergo a new round of clinical trials ordered by the FDA. The plaintiffs also accused the defendants of designing the product to be difficult to remove instead of following the trends of competitors, who specifically designed their products to be removable.
The plaintiffs filed claims of strict liability, failure to warn; strict liability manufacturing defect; negligence; negligent misrepresentation; and loss of consortium. The plaintiffs are represented by the Dolan Law Firm.