Developments in Transvaginal Mesh Litigation and Its Multi-District Litigation

Over the past year, lawyers who represent thousands of women injured by defective transvaginal mesh have faced difficult choices with regard to the proper venue for filing individual lawsuits.

These medical devices have been widely used (and perhaps overused) to treat women with stress urinary incontinence (SUI) or pelvic organ prolapse (POP).  As time passes,  a great deal of new safety information is being developed, including evidence uncovered in discovery proceedings, new medical literature, and a recent FDA inquiry into the significant risks associated with implantation of these medical devices. Manufacturers of these slings have been recently ordered by the FDA to conduct studies that address the safety and effectiveness of implantation of the devices in women; unfortunately, these studies are being instituted nearly two decades after approval of the products for sale in the United States.

Until recently, there were only a few coordinated court proceedings involving bladder slings and pelvic floor mesh products including:

• State court proceedings in New Jersey involving Johnson & Johnson and its Ethicon division as well as C.R. Bard and their respective transvaginal mesh and sling products;

• MDL No. 2004 (In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation)  based in federal court in Georgia which includes approximately 30 individual lawsuits filed by women who suffered injuries following implantation of Mentor’s ObTape product which was withdrawn from the market in March of 2006;

• MDL No. 2187 (In Re Avaulta Pelvic Support Systems Product Liability Litigation) based in federal court in West Virginia, which includes approximately 125 cases filed against C.R. Bard, Covidien, Sofradim Production, and Tissue Science Laboratories over  numerous vaginal mesh products:  Avaulta Classic, Avaulta Biosynthetic Support Systems, Avaulta Plus, Avaulta Solo, Align Urethral Support System, Pelvisoft, Pelvilace, Pelvicol, Uretex, and Pelvitex; and

• State court proceedings in Minnesota against Coloplast involving its TVM products.

On February 7, 2012, the Judicial Panel on Multidistrict Litigation (JPML) issued an order that will have a profound impact on the ability of injured women to prosecute their claims against several manufacturers of transvaginal mesh products.  This order transfers a number of cases involving transvaginal mesh pelvic surgical products to Judge Goodwin, an experienced judge who currently is assigned MDL No. 2187 involving the Avaulta products. This order not only transfers nearly 150 individual lawsuits pending in federal courts across the country, but it also consolidates three different multi-district proceedings (MDL NO. 2325, MDL No. 2326, and MDL 2327) involving three different TVM manufacturers (American Medical Systems, Inc., Boston Scientific Corp., and Ethicon, Inc.) before Judge Goodwin.  This coordination is believed to pave the way for hundreds if not thousands of additional individual lawsuits to be filed against these defendants.

During argument before the Judicial Panel on Multidistrict Litigation, the parties suggested several other venues for this new consolidated MDL including federal courts in New Jersey, Minnesota, Georgia, Nevada, California, Pennsylvania, Louisiana, and Oklahoma.  The manufacturers resisted having all of the products included in a single MDL, and instead urged the court to establish three different MDLs to be handled by three judges in three different jurisdictions.  The plaintiffs were able to convince the JPML that coordination before a single, experienced judge would promote efficiencies, especially with regard to the consideration of scientific issues since all of the products cause similar harm.  Also, it is not uncommon for injured women to have been implanted with multiple defective slings made by more than one manufacturer, so having a single forum for most of these cases will simplify the prosecution of those claims.

The transvaginal mesh products manufactured by Johnson & Johnson include:

• Ethicon TVT
• Gynecare TVT
• Gynecare Prosima
• Gynecare Prolift
• Gynemesh PS

Boston Scientific’s product line includes:

• Advantage Sling System
• Obtryx Mesh Sling
• Obtryx Curved Single
• Prefyx Mid U Mesh Sling System
• Prefyx PPS System
• Arise, Pinnacle
• Lynx
• Solyx devices

Boston Scientific is also the manufacturer for the ProteGen sling products, which were the subject of a different MDL in Baltimore many years ago.

The lawsuits filed or anticipated to be filed against American Medical Systems (AMS) include:

• SPARC
• BioArc
• MiniArc
• Elevate
• Monarc
• Perigree
• In-Fast
• Apogee mesh implants