The plaintiffs appealed the Superior Court of New Jersey Appellate Division’s March 2, 2021, decision reversing a trial court’s ruling that evidence of a U.S. Food and Drug Administration (FDA) medical device 510(k) approval process, which determined a device is safe and effective, may be excluded from evidence in this product liability case seeking punitive damages. The NAM filed an amicus brief in the Appellate Division, arguing that Congress and the FDA established the 510(k) process to ensure the safety of medical devices and that evidence of a manufacturer’s conformance with the FDA’s safety standards is essential to a fair determination of product defects and punitive damages. The Supreme Court of New Jersey lodged the NAM’s brief on its docket as a part of the plaintiffs’ appeal. It held oral argument on February 27, 2023, during which it accepted argument from the NAM’s counsel.
The New Jersey Supreme Court affirmed the Appellate Division’s decision. The Court concluded that the "510(k) evidence is generally inadmissible because the 510(k)-clearance process solely determines equivalency, and not safety and efficacy, and could therefore mislead the jury." Nevertheless, the Court reasoned, the plaintiffs’ "opened the door" to the admission of 510(k) evidence in this case by their counsel’s reference to "Bard’s failure to conduct clinical trials" and "it was unfair for the trial court not to allow Bard to explain in response that it received 510(k) clearance to market the devices without clinical studies or trials." The Court further explained that such evidence is admissible in the punitive damages phase of a case where, as here, pertinent to a defendant’s state of mind to refute the accusation that a defendant acted willfully.
This case is important because manufacturers could be adversely impacted if courts reach liability decisions based on an improper understanding of the principles of safety and effectiveness that underlies each 510(k) clearance.