A Pennsylvania state judge has ordered the creation of a mass tort to collect product liability lawsuits filed over transvaginal mesh implant products against some of the largest makers of medical devices.
On February 11, Judge Arnold New, who directs the Complex Litigation Center at the Philadelphia Court ordered that “all currently filed pelvic mesh matters shall be transferred to the Complex Litigation Center Pelvic Mesh Mass Tort Program” for coordination, according to MassDevice.com.
Court records show that 44 lawsuits await classification in the mass tort. The suits name makers of the female urinary incontinence and pelvic organ prolapse treatment products including C.R. Bard, Boston Scientific, and Ethicon, a subsidiary of Johnson & Johnson, according to MassDevice. These three, along with Endo Health Solutions, Cook Medical, and Coloplast face thousands of product liability and personal injury lawsuits over their pelvic mesh devices. Some of the cases have been consolidated into multidistrict litigation (MDL) before Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia.
Transvaginal mesh is supposed to correct urinary incontinence and pelvic organ prolapse by providing additional support to the pelvic walls. But the U.S. Food and Drug Administration (FDA) has said that complications linked to transvaginal mesh implants are “not rare” and the agency warns that the devices may prove more harmful than alternative methods for treating pelvic organ prolapse. Among the most common complications reported to the FDA are
• mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
• organ perforation
• urinary problems
In 2012, the FDA ordered 31 mesh implant manufacturers to study rates of organ damage and complications linked to the implants. The companies must conduct three years of safety studies, the FDA said.