The Rottenstein Law Group has learned that Johnson & Johnson, the parent company of Ethicon, defied an order issued by the FDA instructing the company to postpone marketing Ethicon’s Gynecare Prolift vaginal mesh product until the FDA had determined whether the device was substantially equivalent to other vaginal mesh products on the market.
According to a June 26 article that appeared on Bloomberg.com, the FDA told Johnson & Johnson in a letter dated August 24, 2007, to stop selling the Gynecare Prolift until the agency had decided whether the device should be considered “substantially equivalent” to other vaginal mesh devices on the market—a classification that would have allowed Ethicon to market the Gynecare Prolift without submitting another application to the FDA, according to the June 26 Bloomberg piece. Instead of waiting for the FDA to make that determination, Johnson & Johnson began selling the Gynecare Prolift in 2005.
The Prolift wasn’t approved by the FDA until May 2008, after the agency and Johnson & Johnson had discussed at length the FDA’s concerns about the Prolift, which included the device’s “potential[ly] high risk for organ perforation” when it was inserted transvaginally to help stabilize weakened pelvic muscles, the Bloomberg article reports.
Johnson & Johnson marketed the Prolift several years before the FDA cleared it for sale despite the fact that the FDA’s August 2007 letter stated, “If you market the device without conforming to…requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act,” the Bloomberg article states.
The FDA’s August 2007 letter was made public along with a group of documents previously submitted under seal by attorneys representing plaintiffs in vaginal mesh lawsuits brought before the New Jersey State Court in Atlantic City (In re Pelvic Mesh/Gynecare Litigation No. 6341-10 (N.J. Super Ct.), and In re Pelvic Mesh Litigation/Bard No. L-6339-10 (N.J. Super. Ct.)). As a law firm representing women in these vaginal mesh cases and others in West Virgina (MDL No. 2325, MDL No. 2326, MDL No. 2327), the Rottenstein Law Group sincerely hopes that Johnson & Johnson and other medical device manufacturers will take special pains to heed FDA communications and regulations from now on.