Many women in Rayne may have heard of Johnson & Johnson’s problems with their Gynecare Prolift vaginal mesh. There have been numerous reports that women who have had the mesh implanted have suffered significant pain and there has also been some organ perforation, which has led to scars and damage to women’s nervous system. These victims of dangerous products are fighting back and filing product liability lawsuits. But the people of Louisiana may be shocked to learn that Johnson & Johnson may not have had permission to sell these devices.
In 2007, Johnson & Johnson received a letter from the federal Food and Drug Administration, in which they were told that they needed to stop selling their vaginal mesh device until the FDA had determined that it was “substantially equivalent” to other devices that were previously approved. Though the company received this letter and was also warned about the serious risk that the mesh could pierce other organs, it appears that the company continued to sell the vaginal mesh.
By continuing to market the product, Johnson & Johnson may have violated the Federal Food, Drug and Cosmetic Act, which could expose them to the loss of illegally marketed products and orders against the company and its officials that absolutely prohibit the sale of unapproved devices. In addition, the company could face substantial fines for violating the FDA’s original letter.
Though action taken by the government is one part of holding this company responsible for the injuries their products have caused, the true punishment will be the product liability lawsuits filed by the victims of these dangerous products.