New Jersey Court Rules to Allow 510(k) Evidence in Medical Device Cases

The New Jersey Appellate Division has released a ruling categorically allowing evidence on FDA 510(k) clearance in medical device cases, reversing for new trials in two cases where that evidence was excluded. The court held that “evidence of such authorization does have probative value in evaluating the company's design and sale of the devices.”

“Although several courts in other jurisdictions have chosen in their discretion to exclude such 510(k) evidence from jury trials involving the design and safety of mesh devices, we adopt the approach of other courts that have deemed such proof admissible with appropriate limiting instructions,” the decision states. “We are persuaded there is sufficient probative value of such evidence under N.J.R.E. 401 to justify informing the jurors, without extensive elaboration, that the products were reviewed by the FDA under the 510(k) clearance process before defendants' sales in these cases. The complete ban of such proof was unfairly and repeatedly capitalized upon by plaintiffs' counsel at both trials, in a manner that easily could have given the jurors a skewed impression of the totality of circumstances.”

In an unusual move, the court invited amici to be part of the oral argument. Shook Partner Dan Rogers presented on behalf of the amici, which included the Advanced Medical Technology Association, the National Association of Manufacturers and the U.S. Chamber of Commerce. Rogers, who submitted an amici brief with Partners Phil Goldberg and Katie Mastrucci, argued that the 510(k) review is a safety review and that courts can manage the introduction of such evidence rather than ban it. The court seemed to be persuaded by the brief, noting in its decision, “We should not underestimate the intelligence and conscientiousness of jurors. . . . [W]e believe the revelation of the FDA’s 510(k) clearance of these devices can be conveyed to the jurors effectively and plainly without extensive elaboration. The subject need not devolve into a ‘mini-trial’ before the jury. . . . The playing field can be leveled without a dramatic alteration of the overall contest.”

In addition, the court said 510(k) evidence is particularly important for punitive damages, which were awarded in this case without the ability of the manufacturers to show why they decided to conduct or not conduct certain tests in response to FDA’s clearance process: “The inherent unfairness of the situation as it unfolded is perhaps most pronounced in connection with the punitive damages aspect of these cases.”