In Hymoc v. Ethicon, Inc., the Appellate Division reversed two plaintiffs’ verdicts in similar products liability cases involving pelvic mesh medical medical devices. Both juries awarded the plaintiffs with substantial punitive damages. But the Law Division in each case precluded the defendants from offering proof that they had obtained “Section 510(k) clearance” from the Food & Drug Administration under 21 U.S.C. § 360c. Under that clearance, the medical devices made by the defendants were deemed to be substantially equivalent to other devices already on the market. The Appellate Division ruled that the evidence was relevant and should be subject to a Rule 104 hearing.