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. Continue reading “510(k) Clearance Evidence Gains New Life After $83 Million Verdicts Overturned”