N.J. High Court Orders New Trial for Bard in Pelvic Mesh Action

TRENTON, N.J. — The New Jersey Supreme Court has upheld an intermediate court’s ruling overturning two verdicts totaling $83 million in pelvic mesh cases filed against Ethicon Inc. and C.R. Bard on the basis that FDA 510(k) clearance evidence was wrongfully excluded from both the liability and punitive damages portions of the trials.

In a July 25 opinion, the state high court explained that while 510(k) evidence is generally inadmissible because the 510(k) clearance process solely determines substantial equivalency, not safety and efficacy, the evidence has significant probative value where a products liability claim is based “not only on principles …