ELIZABETH HRYMOC, ET AL. VS. ETHICON, INC. ET AL MARY MCGINNIS, ET AL. VS. C.R. BARD, INC., ET AL. (L-13696-14 AND L-17543-14, BERGEN COUNTY AND STATEWIDE) (CONSOLIDATED) (A-5151-17/A-1083-18)
In these related appeals, the court overturns separate jury verdicts in favor of plaintiffs in two product liability actions involving pelvic mesh medical devices. The devices in question were designed and manufactured by the respective defendants. They were surgically implanted in the female plaintiffs in each case, and severe adverse complications ensued for them and their spouses. The juries in both cases found that defendants were liable under separate theories of design defect and inadequate warnings. They awarded each plaintiff and their spouses substantial compensatory and punitive damages.
The court concludes the judges who tried these difficult complex cases 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. § 360c, before marketing the devices to plaintiffs' surgeons. 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.
Although several courts in other jurisdictions have chosen in their discretion to exclude such 510(k) evidence from jury trials involving the design and safety of mesh devices, the court adopts the approach of other courts that have deemed such proof admissible with appropriate limiting instructions. There is sufficient probative value of such evidence under N.J.R.E. 401 to justify informing the jurors, without extensive elaboration, that the products were reviewed by the FDA under the 510(k) clearance process before defendants' sales in these cases. The complete ban of such proof was unfairly 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. Countervailing concerns under N.J.R.E. 403 about potential juror confusion and consumption of time, while legitimate, can be capably addressed by the trial court through appropriate means discussed in this opinion.
The matters are remanded for new trials to be preceded by N.J.R.E. 104 hearings, at which the trial court may consider adopting measures such as explanatory jury instructions, reasonable time and witness limits, and prohibitions on misleading demonstrative aids about the 510(k) clearance process.
Aside from this one point of reversal, the court affirms the trial court in all other respects in both cases. Among other things, the court upholds the Hrymoc judge’s rulings that: (1) plaintiffs at that trial met their burden of establishing defective design of the pelvic mesh devices under N.J.S.A. 2A:58C-2, and presented to the jury sufficient evidence of reasonably safer alternatives; (2) defendants failed to establish a viable "state-of-the-art" defense under N.J.S.A. 2A:58C-3(a), and thus no jury charge on that defense was warranted; and (3) plaintiffs adduced sufficient evidence of proximate causation arising from a defective warning, as there was not "unequivocal" evidence that Mrs. Hrymoc's surgeon would have implanted a pelvic mesh device in her anyway if defendants had provided more complete material information about the product's dangers.
The court addresses other issues raised on appeal in Hrymoc and McGinnis in an unpublished, latter portion of this opinion.
