A New Jersey judge has refused to grant Ethicon, Inc.’s motion seeking to negate a $15 million verdict recently awarded to a woman who suffered serious and permanent injuries following implantation of the company’s Prolift and TVT-O transvaginal mesh devices to treat pelvic organ prolapse and stress urinary incontinence.
Elizabeth Hrymoc, 71, and her husband were awarded $15 million in compensatory and punitive damages last December, after a Bergen County Superior Court jury found the Prolift pelvic repair system was defectively designed. Jurors also agreed that Ethicon failed to adequately warn doctor and patients about the risks associated with the Prolift and TVT-O devices.
In awarding the plaintiffs punitive damages, the jury found that the Prolift design and warnings demonstrated willful and wanton disregard for Mrs. Hrymoc’s health and safety. (Case No. L-13686-14)
The case was the second Ethicon vaginal mesh trial convened in New Jersey. The first concluded in March 2013, when a Bergen County Superior Court jury awarded more than $11 million in compensatory and punitive damages to a woman injured by the Gynecare Prolift device.
Shortly after the Hrymoc transvaginal mesh lawsuit concluded, Ethicon motioned the Court for a judgement not withstanding the verdict, which would have reversed the jury’s decision.
Superior Court Judge Rachelle Lea Harz denied the motion on Monday, citing in her decision evidence that Ethicon did not warn about certain risks associated with its Prolift and TVT-O implants.
Since 2008, the U.S. Food & Drug Administration has issued several safety communications regarding transvaginal mesh devices, after the implants were tied to hundreds of injuries and complications, including:
Tens of thousands of women have since filed transvaginal mesh lawsuits against Ethicon and other device makers, including American Medical Systems, Boston Scientific, C.R. Bard, Inc., and Cook Medical, Inc., for injuries and complications caused by allegedly defective mesh.
More than 30 vaginal mesh trials have been convened over the past several years, with juries awarding plaintiffs multi-million verdicts in over 20 cases. A significant percentage of lawsuits have also been settled, though thousands remain pending in federal and state courts throughout the country.