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The New Jersey Supreme Court will evaluate whether a state appeals court was wrong to throw out verdicts totaling $83 million against Johnson & Johnson’s Ethicon unit and C.R. Bard Inc. due to the exclusion of evidence that the companies’ pelvic mesh products were cleared through the U.S. Food and Drug Administration’s 510(k) process.
The court approved requests by two women and their husbands and the companies to review the Appellate Division’s March decision tossing the verdicts over each woman’s injuries because trial judges barred evidence of 510(k) clearance showing the product is “substantially equivalent” to an older device already on the market.
At trials in 2017 and 2018, jurors sided with Elizabeth Hrymoc and Mary McGinnis in their respective suits over Ethicon’s Gynecare Prolift pelvic floor support mesh product and Bard’s Avaulta Solo Support System and Align Trans-Obturator Urethral Support System.
The verdict in Hrymoc’s case includes $10 million in punitive damages, $4 million in compensatory damages for Hrymoc and $1 million for her husband, Tad. The second jury awarded $33 million in compensatory damages in McGinnis’ case and then $35 million in punitive damages.
In both matters, the trial judges precluded Ethicon and Bard from presenting evidence about their products’ clearance through the 510(k) process.
Both judges noted that such evidence does not represent an FDA determination that devices are safe and effective. The FDA’s premarket approval process makes that evaluation, but the products at issue did not have to go through that process.
In tossing the judge’s ruling, the appeals court said that the phrase “would have prevented the harm” in the statute “logically must be read to mean ‘prevented the degree of harm’ caused by the defendant’s product, rather than total elimination of risk.”