In Elizabeth Hrymoc v. Ethicon, Inc., a case involving two pelvic mesh trial verdicts totaling $83 million against Johnson & Johnson’s Ethicon unit and C.R. Bard Inc., the New Jersey Supreme Court considered whether defendant C.R. Bard, Inc., was denied a fair trial by the trial court’s determination that defendant could not present 510(k) clearance evidence — evidence that, pursuant to 21 U.S.C. ? 360c, the devices were allowed to be marketed without premarket clinical trials — to counter the product liability claims. The Court also considered whether New Jersey’s Products Liability Act (PLA), which governed plaintiffs’ claims for damages in this case, precludes punitive damages in cases involving 510(k) clearance.
The NJ Supremes sided with the appellate court that the 510(k) evidence was improperly excluded by the trial court and affirmed the reversal in both cases. The Court stated: “510(k) evidence is generally inadmissible because the 510(k) clearance process solely determines substantial equivalency, and not safety and efficacy. However, in a products liability claim premised not only on principles of negligence, but particularly on the reasonableness of a manufacturer’s conduct in not performing clinical trials or studies, evidence of 510(k) clearance has significant probative value under N.J.R.E. 401 that is not substantially outweighed by the risk of prejudice and potential juror confusion under N.J.R.E. 403.”