510(k) Clearance Evidence Gains New Life After $83 Million Verdicts Overturned

On March 2, 2021, a New Jersey appellate court overturned two pelvic mesh jury verdicts totaling over $83 million dollars, holding that the trial courts committed reversible error by excluding all evidence related to the FDA clearance process.  This decision represents a substantial victory for medical device manufacturers, particularly in light of the staggering jury verdicts that have been handed down over the past few years.

This ruling represents two separate cases that were consolidated for purposes of appeal.  See Hrymoc et al., v. Ethicon Inc. et al., Docket No. A-005151-17, and McGinnis et al. v. C.R. Bard Inc. et al., Docket No. A-001038-18.  In both cases, the respective juries found the medical device defendants liable for design and failure-to-warn defects that caused injuries to plaintiffs. In Hrymoc, the jury awarded the plaintiff and her husband $5 million in compensatory damages, and $10 million in punitive damages.  Conversely, in McGinnis, the jury awarded the plaintiff and her husband $33 million in compensatory damages, and $35 million in punitive damages.

Although several issues were raised on appeal, the Court considered only whether the trial courts erred by excluding all evidence that defendants obtained 510(k) clearance from the FDA for the medical devices at issue.  The Hrymoc and McGinnis trial judges excluded this evidence on the basis that any probative value was substantially outweighed by the risk of unfair prejudice and potential juror confusion. The trial judges were concerned that the jury would confuse 510(k) clearance with premarket approval (“PMA”). Specifically, that jurors would equate clearance based on “substantial equivalence,” with FDA approval based on the device’s safety and effectiveness.

On balance, the appellate Court concluded that the complete exclusion of 510(k) clearance evidence was unfairly prejudicial to defendants.  This was nowhere more apparent than the punitive damages phase of trial, where exclusion “could have easily led some jurors to incorrectly presume that defendants recklessly sold their defective mesh products to the public without any restraint or oversight whatsoever.”  Such presumptions are even more dangerous during the COVID-19 pandemic, where an average juror is now more familiar with FDA regulations.  Ultimately, the appellate Court vacated the verdicts, and remanded the matters for new trials. The Court also directed that the new trials be preceded by N.J.R.E. 104 hearings, where limiting instructions and other judicial remedies should be considered.

This ruling has substantial implications for medical device manufacturers.   Evidence of 510(k) clearance demonstrates strict compliance with the FDA and aids manufacturer defendants in arguing that they acted reasonably to refute negligence claims.  Such evidence can also be used to refute any indicia of recklessness during consideration of punitive damages. This evidence also prevents plaintiffs’ counsel from capitalizing on the inference of noncompliance, and distorting the jury’s perception of the device manufacturer. This ruling not only protects medical device manufacturers from unfair and unjust verdicts, but it also lends credence to the legitimacy of the 510(k) clearance process itself.