Recently, the New Jersey Superior Court Appellate Division remanded the case of McGinnis v. C.R. Bard for a new trial and Rule 104 hearing on 510(k) clearance evidence.
At the outset, the case involves Mary McGinnis, a North Carolina resident, who alleged that the pelvic mesh device that she had implanted to treat her pelvic organ prolapse and stress urinary incontinence caused her chronic pain. The mesh was also allegedly too large for her and led her body to attack the device, causing tissue damage to her body and leading to a difficult removal (McGinnis had to undergo three surgeries for the device to removed). After hearing testimony from both McGinnis and Bard, the maker of the mesh device, the jury ruled in favor of McGinnis, awarding $68 million in damages.
Bard appealed the ruling, noting that implantable medical devices always carry inherent risks (and clinical benefits) but that both of the mesh products at issue in the case went through a rigorous testing prior to approval and met all industry standards when they were put on the market. Lori Cohen, attorney for C.R. Bard, noted that “there was no malicious intent, no evil-minded act” on the part of the company, despite allegations by McGinnis’ counsel to the contrary.
Advanced Medical Technology Association (AdvaMed) filed an amicus brief in support of Bard, arguing that the trial court prevented the jury from hearing evidence of a surgical mesh manufacturer’s interactions with the United States Food and Drug Administration (FDA) and its compliance with the FDA clearance process for the device. AdvaMed, through its counsel, argued that without hearing evidence about the way the FDA clears the mesh devices for sale, the jury did not understand the manufacturer’s decision to sell the device and that is why it awarded such a large amount of damages to McGinnis.
The New Jersey Superior Court Appellate Division concluded that the judge who decided the “difficult, complex” McGinnis case (and one other with a similar fact pattern) “erred by categorically excluding any proof that defendants had obtained what is known as ‘Section 510(k) clearance’ from the [FDA], see 21 U.S.C. § 360c, for the devices implanted by plaintiffs’ surgeons.” Therefore, the court determined that 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.”
In the court’s decision to remand, it stated that “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.” Further, 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.”
AdvaMed applauded the remand, noting that the trial court order “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” and that by “blindfolding a jury from the 510(k) clearance process,” it “can easily lead to unjust results.”