The New Jersey Supreme Court stated in its July 25, 2023 opinion: “In this products liability matter involving “pelvic mesh” medical devices, the Court considers whether defendant C.R. Bard, Inc., was denied a fair trial by the trial court’s determination that defendant could not present 510(k) clearance evidence — evidence that, pursuant to 21 U.S.C. § 360c, the devices were allowed to be marketed without premarket clinical trials — to counter the product liability claims brought by plaintiffs Mary and Thomas Walsh McGinnis. The Court also considers whether New Jersey’s Products Liability Act (PLA), which governed plaintiffs’ claims for damages in this case, precludes punitive damages in cases involving 510(k) clearance.”
Background Facts
To treat plaintiff Mary McGinnis, North Carolina surgeon Dr. Elizabeth Barbee implanted Bard’s “Align TO” and “Avaulta Solo” pelvic mesh devices. In the months following surgery, McGinnis had to undergo numerous invasive surgeries to remove the mesh and repair internal damage, with limited success. In 2011, plaintiffs filed a complaint in Atlantic County asserting products liability claims against defendant Bard under North Carolina law. Counsel agreed that the
substantive issues would be tried under the law of North Carolina but that the issue of damages would be tried under New Jersey law. Plaintiffs moved in limine to bar defendant from presenting any evidence of the devices’ 510(k) clearance to the jury.
The trial court found the 510(k) evidence inadmissible. The New Jersey Appellate Division reversed, holding that the exclusion of any 510(k) evidence deprived defendant of a fair trial on the issue of negligence. 467 N.J. Super. 42 (App.
Div. 2021). The Appellate Division also determined that although punitive damages were not precluded by the PLA by the mere existence of 510(k) evidence, such evidence could be admissible in the punitive damages phase of a trial. The Appellate Division remanded the matter for a new trial to be preceded by a Rule 104 hearing on the Section 510(k) evidence. The New Jersey Supreme Court granted plaintiffs’ petition for certification, 248 N.J. 564 (2021), and defendant’s cross-petition, 248 N.J. 567 (2021).
New Jersey Supreme Court Opinion
The New Jersey Supreme Court held: “510(k) evidence is generally inadmissible because the 510(k) clearance process solely determines substantial equivalency, and not safety and efficacy. However, in a products liability claim premised not only on principles of negligence, but particularly on the reasonableness of a manufacturer’s conduct in not performing clinical trials or studies, evidence of 510(k) clearance has significant probative value under N.J.R.E. 401 that is not substantially outweighed by the risk of prejudice and potential juror confusion under N.J.R.E. 403. Therefore, under the specific facts and circumstances of this case, the Court affirms the judgment of the Appellate Division. However, the Court parts ways with the Appellate Division’s decision as to its suggestion that the scope and admissibility of 510(k) evidence should be determined in a Rule 104 hearing. Instead, the scope and admissibility of 510(k) evidence should be resolved at the hearing on a motion in limine, which is how the issue was and, presumably, will be raised. Section 5 of the PLA does not bar plaintiffs’ recovery of punitive damages, and because evidence of 510(k) clearance should have been admitted in the first stage of trial as relevant to the reasonableness of Bard’s conduct in not performing clinical trials or studies, it would also be admissible in the second, punitive damages stage.”
Source Elizabeth Hrymoc v. Ethicon, Inc. (A-21/23-21) (085547).
If you or a family member were implanted with pelvic mesh or other surgical mesh and suffered complications, injuries, or chronic pain afterwards, you should find a mesh claim lawyer in your U.S. state who may investigate your mesh claim for you and represent you or your family member in a claim against the manufacturer, distributor, and/or supplier of the mesh, if appropriate.
Visit our website or call us toll-free in the United States at 800-295-3959 to find mesh claim attorneys who may assist you.
Turn to us when you don’t know where to turn.