A New Jersey appeals court yesterday threw out jury verdicts totaling $83 million in separate pelvic mesh lawsuits against Johnson & Johnson’s (NYSE:JNJ) Ethicon division and Becton Dickinson (NYSE:BDX) subsidiary C.R. Bard.
In both cases, Bergen County, N.J. judges erred by disallowing evidence showing that each company’s mesh product had received FDA 510 (k) clearance, according to the appeals court panel.
In the case against J&J’s Ethicon, a jury had awarded Elizabeth and Tadeusz Hrymoc $5 million in compensatory damages and $10 million in punitive damages after finding the companies liable for violating New Jersey laws on the defective design of their ProLift pelvic mesh and failing to warn patients of product risk.
The jury in the case brought by Mary McGinnis and Thomas Walsh McGinnis found Bard liable for design and failure-to-warn defects under the product liability laws of North Carolina, the plaintiffs’ home state. It awarded the couple $33 million in compensatory damages and $35 million in punitive damages.
The appeals court rejected all of the companies’ arguments on appeal except for the one concerning 510(k) clearance, which other courts have allowed into evidence in separate cases, and sent both cases back to state court for retrial.
“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 appeals court judges wrote in their order. “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.”
The appeals court affirmed the remainder of the trial courts’ decisions, including that:
- The Hrymocs met their burden of establishing the pelvic mesh devices’ defective design under New Jersey state law and presented to the jury sufficient evidence of reasonably safer alternatives.
- Ethicon failed to establish a viable “state-of-the-art” defense.
- Ethicon failed to produce “unequivocal” evidence that Mrs. Hrymoc’s surgeon would have implanted a pelvic mesh device in her anyway if the company had provided more complete material information about the product’s dangers.
The appeals panel addressed other issues raised on appeal in each case in an unpublished portion of its opinion.
Medtech trade group AdvaMed, which had filed an amicus brief with the appeals court, praised its decision in the McGinnis case.
“AdvaMed applauds the New Jersey Appellate Division for reversing the trial court order, which prevented the medical device manufacturer in the case from fully informing the jury about the process Congress and the FDA developed to assure the safety and effectiveness of medical devices,” said Pat Fogarty, assistant general counsel and director of the trade group’s civil justice policy, in a statement emailed to MassDevice.
“As the NJ Appellate Division clearly understood, blindfolding a jury from the 510(k) clearance process can easily lead to unjust results,” Fogarty added. “AdvaMed agrees with Appellate Division that it is better to give jurors this information and trust them to get it right. As the court stated, ‘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 playing field can be leveled without a dramatic alteration of the overall contest.’”