C.R. Bard, Inc. has been ordered to pay $33 million in compensatory damages to a transvaginal mesh lawsuit plaintiff and her husband, after a jury in New Jersey’s Bergen County Superior Court determined that the company’s Align and Avaulta pelvic mesh implants were defectively designed and responsible for her chronic pain. (Case No. BER-L-17543-14)
The case was the first involving C.R. Bard’s transvaginal mesh devices to go to trial in the state.
According to her complaint, Mary McGinnis, 70, received the Align and Avaulta devices in 2009 to treat stress urinary incontinence and pelvic organ prolapse. She has since undergone several corrective surgeries, including vaginal reconstruction, to treat her transvaginal mesh complications, including tissue inflammation, scar tissue formation, and mesh shrinkage, yet continues to cope with chronic pain and discomfort.
“You realize nobody can help me – I have to tough it through,” McGinnis told jurors when she took the stand on March 29th. “The pain is unending; the burning is horrible. It’s beyond debilitating. It hurts so much you can’t cry.”
The jury delivered its verdict yesterday, awarding McGinnis $23 million in compensatory damages, while her husband was awarded $10 million.
Jurors will reconvene today to consider punitive damages.
C.R. Bard took the Avaulta mesh device off the market in 2012, while the Align device was withdrawn in 2016. The company denied McGinnis’s allegations and asserted that her complications were the result of underlying medical conditions.
C.R. Bard is just one of several medical device manufacturers facing litigation over transvaginal mesh implants. In fact, more than 100,000 product liability claims have been filed on behalf of women who suffered debilitating injuries and complication following implantation of pelvic mesh implants manufactured by American Medical Systems, Inc., Boston Scientific Corp., C.R. Bard, and Ethicon, Inc.
Prior to the McGinnis trial, just two transvaginal mesh lawsuits involving C.R. Bard’s products had gone to trial. Two of those cases concluded with plaintiffs’ verdicts.
In recent years, C.R. Bard has reached agreements to confidentially settle hundreds of additional transvaginal mesh claims involving its devices.
In 2008, the U.S. Food & Drug Administration (FDA) began investigating an increasing number of adverse event reports involving transvaginal mesh implants. In July 2011, the agency warned that pelvic mesh complications following prolapse repair were not rare, a marked change from its previous position on the issue.
In 2016, the FDA reclassified transvaginal mesh implants indicated for prolapse repair as Class III (high risk) medical devices, which among other things, made such products ineligible for the agency’s 510(k) clearance program. This program allowed the implants to come to market without the benefit of human clinical trials because manufacturers were able to demonstrate that that transvaginal mesh was “substantially equivalent” to “predicate” devices that had already been subjected to the FDA’s more stringent premarket approval process.