Hrymoc v. Ethicon, Inc.Annotate this Case
In this products liability matter involving “pelvic mesh” medical devices, the New Jersey Supreme Court considered 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. 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 suit 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 Appellate Division reversed, holding that the exclusion of any 510(k) evidence deprived defendant of a fair trial on the issue of negligence. The Supreme Court agreed that 510(k) evidence was generally inadmissible because the 510(k) clearance process solely determines substantial equivalency, and not safety and efficacy. However, in a products liability claim premised on the reasonableness of a manufacturer’s conduct in not performing clinical trials or studies, the Court held evidence of 510(k) clearance had significant probative value under N.J.R.E. 401 that was 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 Supreme Court affirmed the Appellate Division and remanded for a new trial. The Court disagreed with the Appellate Division’s decision regarding the scope and admissibility of 510(k) evidence and a Rule 104 hearing. To this, the Supreme Court believed the scope and admissibility of 510(k) evidence should be resolved at the hearing on a motion in limine, which was how the issue was and, presumably, would be raised.