Hrymoc v. Ethicon, Inc., 467 N.J. Super. 42 (App. Div. 2021). This lengthy opinion by Judge Sabatino reversed trial verdicts for plaintiffs in two product liability cases involving pelvic mesh medical devices. The two verdicts together totaled $83 million in compensatory and punitive damages.
Though defendants asserted many arguments for reversal, the Appellate Division rejected all but one. But that one contention won the day. Defendants successfully asserted that the two trial judges “erred by categorically excluding any proof that defendants had obtained what is known as ‘Section 510(k) clearance’ from the Food and Drug Administration (“FDA”), see 21 U.S.C. ยง 360c, for the devices implanted by plaintiffs’ surgeons.” The Appellate Division concluded 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.”
The trial judges had excluded that evidence because, in summary, Section 510(k) clearance confirms only that a device is “substantially equivalent” to other devices already on the market after the FDA granted premarket approval applications for those devices. Unlike premarket approvals, though, Section 510(k) clearance does not address the safety or effectiveness of a device. The trial judges believed that admitting that evidence would confuse the jury and would entail prejudice to plaintiffs that would outweigh any probative value of that evidence. In doing so, the judges followed pelvic mesh cases elsewhere that had excluded evidence of Section 510(k) clearance.
But the caselaw elsewhere was not uniform. Other decisions permitted that evidence to be admitted. To sum up a lengthy discussion in the opinion, Judge Sabatino and the panel found those cases more persuasive. The Section 510(k) clearance had probative value, the Appellate Division concluded, and jury confusion and the like could be avoided by an appropriate instruction at trial. Though a standard of review deferential to the trial judges’ discretion governed, the Appellate Division found that that discretion had been misapplied.
The high stakes in these cases, and the fact that courts elsewhere have split, make it likely that plaintiffs will seek review by the Supreme Court. Stay tuned for the next chapter in this saga.