A fifth transvaginal mesh multidistrict litigation (MDL) has been established in U.S. District Court, Southern District of West Virginia, this time involving Coloplast transvaginal mesh products. Coloplast has been named in at least 24 transvaginal mesh lawsuits alleging the devices caused serious complications.
The Coloplast transvaginal mesh multidistrict litigation will join four other MDLs already being overseen by U.S. District Judge Joseph R. Goodwin: Bard-Avaulta; Johnson & Johnson/Ethicon, Inc.; American Medical Systems, Inc.; and Boston Scientific Corp. Lawsuits involving the Mentor OB Tape have been consolidated in a fifth transvaginal mesh MDL underway in U.S. District Court, Middle District of Georgia. Both C.R. Bard and Johnson & Johnson are also named in transvaginal mesh lawsuits in state court in Atlantic City, New Jersey. American Medical Systems faces additional state lawsuits in Delaware and Minnesota state courts over its Perigee, Apogee and Elevate surgical mesh products.
Recently, a California couple won the first personal injury lawsuit over transvaginal mesh; the landmark verdict awarded the couple a total of $5.5 million in a suit alleging C.R. Bard’s Avaulta Plus transvaginal mesh caused serious complications. Many legal experts see the verdict as an indicator of how future juries will rule in similar cases.
Transvaginal Mesh Complications
It is estimated that 75,000 women annually receive transvaginal mesh devices during surgery to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). However, such devices have been the subject of a U.S. Food & Drug Administration (FDA) safety review since 2008. Last summer, the FDA warned that it had recieved thousands of reports of serious complications associated with the use of transvaginal mesh products in POP repair surgeries, including:
• Inflammation and infection
• Pain from mesh shrinkage
• Extrusion of mesh through the vaginal wall
• Pain during intercourse and urination
In January, the FDA asked transvaginal mesh manufacturers to conduct post-market safety studies of their products. The agency is considering moving transvaginal mesh for POP repair to a higher risk medical device category.
A multidistrict litigation like those established for transvaginal mesh lawsuits allows claims associated with a particular product to be coordinated under one judge for pretrial litigation to avoid duplicative discovery, inconsistent rulings and to conserve the resources of the parties, witnesses and the court. When lawsuits are consolidated as a multidistrict litigation, each retains its own identity. If the multidistrict litigation process does not resolve the cases, they are transferred back to the court where they originated for trial.
The first bellwether trial in the C.R. Bard Inc. Pelvic Repair System Products Liability Litigation is scheduled to begin in February 2013. Bellwether trials are used when a large group of plaintiffs have filed suit based on the same theories or claims. Verdicts in these key trials will help gauge how juries might rule in similar transvaginal mesh lawsuits pending in the Bard Avaulta litigation.