In 2011, the FDA issued a safety warning stating that “serious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare.” The FDA ordered surgical mesh manufacturers to submit additional studies of the safety and effectiveness of their products. C.R. Bard, Inc. was one of the manufacturers. Bard manufactured a line of Avaulta products, which is a medical device that is inserted surgically into women to treat pelvic organ prolapse. Symptoms of pelvic organ prolapse include urinary incontinence and pain.
Bard pulled its Avaulta products off the market in 2012. There are approximately 20,000 transvaginal mesh device federal court cases, which have been coordinated in multidistrict litigation (MDL) in Charleston, WV. Last Thursday, a jury in the first MDL transvaginal mesh bellweather trial awarded $2 million to a woman who alleged that Bard failed to warn about design defects in its Avaulta product that caused her bleeding and pain. The National Law Journal reports that the breakdown of the award was $$250,000 in compensatory damages and $1,750,000 in punitive damages. The plaintiff, Donna Cisson, was represented by Henry Garrard, III at Blasingame Burch Garrard & Ashley in Athens, GA. Bard was represented by Greenberg Traurig in Atlanta. Bard has already announced that it will appeal the Avaulta mesh verdict.
The federal litigation against Bard was coordinated for pretrial purposes in 2010 before U.S. District Judge Joseph Goodwin, who now is overseeing separate multidistrict litigation proceedings against five other manufacturers of transvaginal mesh devices. A second bellwether trial against Bard is scheduled for Monday. Bard, which is based in Murray Hill, N.J., also faces its first trial in state court coordinated litigation in Atlantic City, N.J., on September 23.
There have been two previous state court transvaginal mesh cases that went to verdict. A jury in Bakersfield, CA awarded a woman and her husband $5.5 million last year. Bard has appealed that verdict. Earlier in 2013, a jury in Atlantic City, NJ awarded over $11 million to a South Dakota woman who sued Johnson & Johnson and its Ethicon, Inc. division. The South Dakota woman had undergone 18 operations over six years after having implanted an allegedy defective Gynecare Prolift device. That award included $.76 million in punitive damages. Johnson & Johnson appealed that verdict.