U.S. District Judge Joseph R. Goodwin has set a February 5, 2013 trial date for the first of nearly 600 federally filed lawsuits alleging that Avaulta vaginal mesh implants, made by C.R. Bard, and used to treat pelvic organ prolapse and stress urinary incontinence, causes injury, including organ damage.
In 2011, the FDA released a report finding that vaginal mesh products should be categorized as high-risk based on the reported side effects of the devices. This past January, the FDA ordered 31 vaginal mesh makers to conduct three-year studies on the devices and the rates of complications and organ damage, as well as the safety and efficacy of the mesh.
All federally filed vaginal mesh lawsuits against Boston Scientific Corp., the American Medical Systems unit of Endo Pharmaceutical Holdings Inc., and C.R. Bard, have been consolidated in multidistrict litigation be Judge Goodwin in Charleston, West Virginia. In his ruling, Judge Goodwin wrote that the trials for the first Avaulta cases “will be determined after completion” after pretrial “information exchanges between Bard and the plaintiffs,” Bloomberg reported.
Bard, as well as the other vaginal mesh manufacturers, face a number of lawsuits filed on the state level also.