New Jersey is preparing to try its fist transvaginal mesh lawsuit involving products marketed by C.R. Bard, Inc.
According to CVN.com, jury selection for the case got underway in Bergen County Superior Court on March 15th. Opening statements will likely begin shortly after a jury is empaneled.
The case selected for trial was filed on behalf of Mary McGinnis, who received C.R. Bard’s Avaulta and Align implants in 2009 to treat stress urinary incontinence and pelvic organ prolapse. She claims that the devices were defectively designed and manufactured and caused her to suffer from chronic pain.
McGinnis further asserts that C.R. Bard knew that the material used to manufacture the transvaginal mesh devices could interact adversely with vaginal tissue but failed to warn doctors and patients of this risk.
More than 100,000 women have filed suit in courts nationwide over injuries and complications allegedly caused by transvaginal mesh products marketed by C.R. Bard and other manufacturers, including American Medical Systems, Inc., Boston Scientific Corp., and Ethicon, Inc., among others.
While roughly 30 cases have gone to trial thus far, only three have involved New Jersey-based C.R. Bard:
In recent years, C.R. Bard has reached agreements to confidentially settle hundreds of additional transvaginal mesh claims involving its devices.
The U.S. Food & Drug Administration (FDA) began investigating an increasing number of reports linking transvaginal mesh to severe and life-changing complications in 2008. In July 2011, 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 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.