A New Jersey Superior Court judge has upheld the $68 million verdict awarded to a woman who suffered serious injuries and complications from C.R. Bard, Inc.’s defectively-designed transvaginal mesh implants.
The case was the first involving Bard’s products to go trial in the pelvic mesh litigation currently underway in New Jersey’s Bergen County Superior Court.
Plaintiff Mary McGinnis, 70, received C.R. Bard’s Avaulta Solo Prolapse Repair System and its Align Transobturator Stress Urinary Incontinence Repair System in 2009. She has since been forced to undergo multiple corrective surgeries, including vaginal reconstruction, to treat tissue inflammation, scar tissue formation, and mesh shrinkage. Despite extensive treatment, transvaginal mesh complications continue to cause McGinnis chronic pain and discomfort.
In April, McGinnis was awarded $23 million in compensatory damages, after the jury hearing her transvaginal mesh lawsuit found that Bard’s Avaulta and Align transvaginal mesh implants were defectively designed and responsible for her suffering. Her husband also received $10 million for loss of consortium.
Jurors later added $35 million in punitive damages to the judgment.
In seeking to have the verdict tossed, Bard’s attorneys argued that the massive award was not supported by the evidence presented during trial. However, the trial court judge denied the company’s motions for a judgement notwithstanding the verdict, a new trial. and for remittitur on damages last Thursday.
Bard has promised to appeal.
C.R. Bard is just one of several medical device companies that have been caught up in the massive, nationwide litigation involving transvaginal mesh implants. In fact, well over 100,000 similar lawsuits have been filed on behalf of women who allegedly suffered debilitating injuries and complications following implantation of pelvic mesh devices manufactured by American Medical Systems, Inc., Boston Scientific Corp., and Ethicon, Inc.
In 2008, the U.S. Food & Drug Administration (FDA) issued its first of several public health alerts regarding transvaginal mesh complications.
Three years later, the agency warned that transvaginal mesh complications following prolapse repair were not rare, a marked change from its previous position on the issue. In 2016, the FDA reclassified pelvic mesh intended for prolapse repair as high risk (Class III) medical devices.
C.R. Bard pulled Avaulta transvaginal mesh from the market in 2012, while Align devices were withdrawn in 2016.