Bergen County Jury Awards $15 Million Over Defective Pelvic Mesh Implant

In December 2017, a Bergen County jury awarded $15 million to Elizabeth Hrymoc, a 71-year-old former research technician from South River, New Jersey, over a defective pelvic mesh implant made by Johnson & Johnson's Ethicon subsidiary. Hrymoc received two Ethicon mesh devices in June 2008: the Prolift, a polypropylene mesh implant meant to treat pelvic organ prolapse, and a TVT-O sling. She testified the mesh contracted and eroded inside her, leaving her with chronic pelvic pain, pain during intercourse and unrelieved urinary incontinence.

Trial ran two and a half weeks before Judge Rachelle L. Harz in Hackensack. Adam Slater of Mazie Slater Katz & Freeman tried the case for Hrymoc and her husband, Tadeusz, building it around internal Ethicon records in which the company's own researchers questioned whether the mesh material could contract once implanted. Ethicon countered that a team of fifty researchers had spent thousands of hours developing and testing the device and that Hrymoc's symptoms stemmed from the underlying surgery, not a defective product. The case drew on more than a million pages of documents produced in discovery.

On December 14, 2017, the jury of six men and four women needed six hours to reach a verdict. It found the Prolift device defectively designed and found Ethicon failed to adequately warn Hrymoc of its risks. The jurors also found the TVT-O's warnings inadequate, but not a cause of her injury, and the Hrymocs did not appeal that part of the verdict. The jury awarded $4 million for pain and suffering, $1 million to Tadeusz Hrymoc for loss of consortium, and $10 million in punitive damages against Johnson & Johnson, a total of $15 million. Ethicon said immediately that it would appeal.

It did, and won a new trial rather than a reduction. In a consolidated opinion covering Hrymoc's case and a companion Bergen County verdict against C.R. Bard over similar mesh devices, the Appellate Division vacated both judgments on March 2, 2021. The panel held that the trial court's blanket exclusion of evidence that the FDA had cleared the mesh for market under its 510(k) process denied the defense a fair trial, since plaintiffs' lawyers had repeatedly told jurors that Ethicon never ran a clinical trial before selling the device. The court ordered a new trial preceded by a hearing on how much of that evidence should be allowed.

Both sides asked the New Jersey Supreme Court to review the ruling, and the Court agreed to hear it. By the time the case was argued in February 2023, Hrymoc had settled her claim against Ethicon on undisclosed terms and dropped out of the appeal. The Supreme Court's own opinion later noted that the parties in her case 'have since settled and are no longer parties to this matter.' The Court went on to decide the underlying legal question in the companion Bard case alone. On July 25, 2023 it affirmed the Appellate Division, holding that 510(k) clearance evidence is generally inadmissible but becomes relevant when a plaintiff's claim turns on the reasonableness of a manufacturer's decision not to run clinical trials, so the order for a new trial stood.

For Hrymoc, the $15 million verdict never took effect. What replaced it was a settlement whose terms have not been made public.