Nearly 50 percent of women over the age of 50 suffer from pelvic organ prolapse. This is a condition where the pelvic organs, including the bladder, bowel, uterus and rectum, drop from their secured physical location and bulge into the vagina. It is a very uncomfortable condition. It causes stress incontinence and makes sexual intercourse painful and difficult or impossible.
The only permanent cure to this condition is surgery. For many years, the surgical procedure of choice was to reattach the sagging organs. In the 1970s, surgeons began using a type of mesh that had been used for hernia repair to create a sling for the pelvic organs to hold them in place. The procedure was done through an abdominal incision.
In the late 1990s, surgeons began inserting mesh through the vagina and creating a sling without the abdominal incision. The mesh was referred to as transvaginal mesh. The procedure was initially thought to be an improvement over the more invasive abdominal surgical procedure.
In just a few years, transvaginal mesh was found to cause a number of serious side effects and permanent complications. As a result, many lawsuits have now been filed against the manufacturers of the mesh.
Grounds for the Transvaginal Mesh Lawsuits
Many companies, including Johnson & Johnson, still manufacture and market transvaginal mesh. The mesh manufacturers obtained approval from the FDA by taking advantage of a provision that allowed them to market the product without having done any human testing.
Within a few years of the first use of transvaginal mesh, severe complications were noted. Between 2005 and 2008, nine manufacturers reported to the FDA that they were receiving a multitude of complaints from patients who had received the mesh. In response, the FDA simply issued a notice to physicians to be aware of potential “rare” side effects.
In 2011, the FDA finally issued a warning to doctors including the information that:
- The side effects and complications from the use of transvaginal mesh are not rare.
- The use of transvaginal mesh provides no benefit over traditional methods of repairing pelvic organ prolapse.
- Transvaginal mesh should only be used as a last resort after all other methods of repair have failed.
The FDA has still not recalled the product and a few manufacturers are still marketing it. The foundation of the lawsuits is that the manufacturers were negligent and continued to market the product knowing that it would cause serious complications or death.
Types of Transvaginal Mesh Lawsuits
Class action, Multi-District Litigation or State Action
Thousands of lawsuits have been filed in state and federal court. There are three different types of litigation that are going forward.
Class Action Lawsuit
A class action lawsuit is a single lawsuit with a large number of plaintiffs. The case proceeds based on the similarities in the damages to the plaintiffs who were all harmed by the same defendants. One judgment is issued and the plaintiffs all share equally in the amount awarded. If plaintiffs join the class, they agree to be bound by the final judgment and waive their right to their own lawsuit.
The benefit to the plaintiffs is that they incur no costs for the litigation. The downside is that their individual damages are not considered and they have no input on any aspect of the litigation. They generally are unaware of the status of the litigation until it is over.
Multidistrict litigation (MDL)
Cases filed in federal court were transferred to the U.S. District Court for the Southern District of West Virginia or the U.S. District Court for the Middle District of Georgia. Each case proceeds individually on its own merit but one judge in each district oversees pretrial issues. This includes issues concerning discovery and pretrial motions. The purpose is to avoid confusion by different pretrial rulings by different judges.
It is possible that some cases will be consolidated for trial. Even if two or more cases proceed to trial together, they will each be determined on their own merits and damages will be awarded on an individual basis.
State Court Litigation
There is nothing to prevent a lawsuit from being filed in any state court. It will proceed to trial or settlement just as any other personal injury or product liability case.