Bergen County Jury Awards $68 Million in New Jersey's First Bard Pelvic Mesh Trial, a Verdict the State Supreme Court Later Threw Out Over Excluded FDA Evidence

In March 2009, Mary McGinnis, a North Carolina resident, had two C.R. Bard mesh devices implanted at a Raleigh hospital, the Avaulta Solo and the Align TO, to treat pelvic organ prolapse and stress urinary incontinence. The mesh eroded and contracted inside her body. She went through multiple removal surgeries and a vaginal wall reconstruction, and was left with chronic pain, nerve damage, and the loss of her ability to be intimate with her husband.

She and her husband, Thomas Walsh McGinnis, sued Bard in Bergen County, where Bard was headquartered, and their case became the first to reach trial in New Jersey's Bard pelvic mesh mass tort program. The jury applied North Carolina product liability law, as the McGinnises were North Carolina residents and the surgery took place there. Adam Slater of Mazie Slater Katz & Freeman tried the case over several weeks in the spring of 2018. The jury found both devices defectively designed and found that Bard failed to warn of their risks. It awarded $23 million to Mary McGinnis and $10 million to her husband, then on April 13, 2018 added $35 million in punitive damages, bringing the total to $68 million. It was the largest verdict returned against Bard in the pelvic mesh litigation, and the trial court upheld it against post-trial challenges that fall.

The verdict did not survive appeal, and the reason matters as much as the number. Before trial, the court had barred Bard from telling the jury that the FDA cleared the devices for market through the 510(k) process, which lets a manufacturer sell a device based on substantial equivalence to an existing product rather than premarket clinical trials. In March 2021 the Appellate Division reversed, in a consolidated appeal with a companion Ethicon case captioned Hrymoc v. Ethicon, holding the blanket exclusion deprived the defense of a fair trial.

On July 25, 2023, the New Jersey Supreme Court agreed as to Bard. The Court held that 510(k) clearance evidence is generally inadmissible because clearance does not establish safety or efficacy, but that it carries real probative value where, as here, the plaintiffs attacked the reasonableness of Bard's decision to bring the devices to market without clinical trials. Because the jury judged that conduct without hearing the clearance evidence, Bard was denied a fair trial. The Court ordered a new trial on all issues, covering liability and punitive damages alike, with the scope of the 510(k) evidence to be sorted out through motions in limine.

That wiped out the entire $68 million judgment. The case returned to the Bergen County mass tort program, which was reassigned to Judge Gregg A. Padovano effective June 1, 2023. As of 2026, no retrial verdict has been publicly reported and no settlement of the McGinnis case has been disclosed. The Bard pelvic mesh multicounty litigation remains active in Bergen County under master docket BER-L-17717-14, with a discovery deadline extended to June 30, 2026.