“510(k)” Evidence Was Improperly Excluded in Products Liability Matters, Requiring New Trial

Hrymoc v. Ethicon, Inc., 254 N.J. 446 (2023). As explained in more detail here, this was a products liability case involving “pelvic mesh” devices. (Actually, there were two consolidated cases, one of which settled before the Supreme Court ruled). Juries in both cases ruled for plaintiffs. Defendants appealed, and the Appellate Division reversed in an opinion reported at 467 N.J. Super. 42 (App. Div. 2021). That court held that the trial courts had “erred by categorically excluding any proof that defendants had obtained what is known as ‘Section 510(k) clearance’ from the Food and Drug Administration (“FDA”), see 21 U.S.C. § 360c, for the devices implanted by plaintiffs’ surgeons.” Such clearance confirms only that a medical device is “substantially equivalent” to other devices currently on the market and, unlike FDA premarket approvals of medical devices, says nothing about a device’s safety or effectiveness. The panel ruled that the scope and admissibility of 510(k) clearance evidence should be addressed at an Evidence Rule 104 hearing.

On review, the Supreme Court affirmed that ruling, as modified. The Court agreed with the Appellate Division that “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. [New Jersey Rule of Evidence] 401 that is not substantially outweighed by the risk of prejudice and potential juror confusion
under N.J.R.E. 403. Therefore, under the specific facts and circumstances of this case,” which was governed by North Carolina law’s negligence standard based on reasonableness (unlike New Jersey’s strict liability law), the 510(k) evidence should have been admitted, and its exclusion required a new trial.

The Court parted ways with the Appellate Division, however, as to the procedure for addressing the admissibility of 510(k) evidence. Rather than using the vehicle of a Rule 104 hearing, the Court stated that a motion in limine was the proper means. In fact, that was how the trial courts here had handled the issue.

Finally, the Court agreed with the courts below that if the case reaches the punitive damages phase, the New Jersey Products Liability Act, N.J.S.A. 2A:58A-5(c), would not bar punitive damages. That provision precludes punitive damages awards if a device “was approved or licensed; or is generally recognized as safe and effective pursuant to conditions established by the [FDA].” Since 510(k) clearance is not an approval or a license, or a determination of safety or effectiveness, it does not bar punitive damages. And since the New Jersey Punitive Damages Act, N.J.S.A. 2A:15-5.12, requires the trier of fact in the punitive damages phase to consider “all relevant evidence,” 510(k) evidence is admissible in that phase even if it was properly excluded in the first stage of the trial.

This was a 5-0 decision. Justice Solomon wrote the Court’s opinion, in which Chief Justice Rabner and Justice Pierre-Louis joined. Judge Accurso, who was brought up from the Appellate Division to participate in this matter because Justices Patterson and Fasciale and Judge Sabatino all did not participate, wrote a concurring opinion that Justice Wainer Apter joined. The concurrence suggested that 510(k) evidence should be admissible in both the main trial stage and the punitive damages phase whether tried on a negligence theory or a strict liability cause of action.