NJ Court Reverses Pelvic Mesh 510(k) Cases

The New Jersey Superior Court has reversed and remanded for new trials two consolidated cases in which plaintiffs sought damages from Ethicon and Bard over pelvic mesh medical devices. The court opinion says the devices were surgically implanted in the female defendants in each case and severe adverse complications ensued for them and their spouses.

In each case, separate New Jersey county courts found in favor of the plaintiffs and awarded them compensatory and punitive damages. The companies appealed the county court decisions, raising several evidentiary and substantive arguments. The Superior Court rejected all of the arguments except for concluding that the judges who heard the cases in the county courts erred by excluding any proof that the companies had obtained 510(k) clearance from FDA for their devices.

“We conclude the total disallowance of such proof had the patent capacity to deprive defendants of a fair trial, most poignantly with respect to the state-of-mind and venal conduct issues that underlie the punitive damages awards,” the court said.

The three-judge Superior Court panel said while some courts in other jurisdictions have chosen to exclude 510(k) evidence from jury trials involving the design and safety of mesh devices, they adopted the approach of other courts that have deemed such proof admissible with appropriate limiting instructions.

The opinion says the judges affirmed the trial courts in all other aspects of the cases. They remanded the cases for new trials at which the trial courts should first hold hearings to consider adopting measures such as explanatory jury instructions, reasonable time and witness limits, and prohibitions on misleading demonstrative aids about the 510(k) clearance process.

Attorney James Beck (Reed Smith) in an online Drug and Device Law post criticizes courts in multi-district pelvic mesh litigation that have “turned FDA medical device regulation, particularly concerning design defect, into an all-or-nothing game. Either FDA’s decision was preemptive, as with PMA medical devices, or such decisions weren’t admissible at all.”

Beck praises the New Jersey decision, saying that while it is true that 510(k) clearance is less rigorous than the more elaborate and time-consuming process for obtaining premarket approval, “it is hardly a rubber stamp or unconcerned with safety.” (Beck notes that his firm represented both defendants in the New Jersey case and has been involved in other pelvic mesh cases.)