297 A.3d 1245
N.J.2023Background:
- Mary McGinnis underwent implantation of C.R. Bard pelvic‑mesh devices (Align TO and Avaulta Solo) and suffered complications requiring multiple corrective surgeries.
- Plaintiffs sued Bard in New Jersey; parties agreed North Carolina law would govern substantive liability (negligence/reasonableness standard) and New Jersey law would govern damages (including punitive damages under the PLA/PDA).
- The trial court granted plaintiffs’ in limine motion excluding any evidence or mention of FDA 510(k) clearance (which permits marketing based on “substantial equivalence” without PMA/clinical trials), and also barred 510(k) evidence in the punitive phase.
- Plaintiffs repeatedly emphasized Bard’s failure to conduct clinical trials at trial; the jury returned a large verdict including compensatory and punitive damages.
- The Appellate Division reversed, finding the blanket exclusion of 510(k) evidence deprived Bard of a fair trial; the New Jersey Supreme Court affirmed in part, holding 510(k) evidence is generally inadmissible but is admissible when plaintiffs make Bard’s failure to conduct clinical trials central (i.e., plaintiffs “open the door”), and that PLA Section 5 does not bar punitive damages for 510(k) devices.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of 510(k) evidence at liability | 510(k) only shows substantial equivalence, not safety; admitting it would mislead jurors and cause mini‑trials | 510(k) is relevant to reasonableness when plaintiffs attack Bard for not doing clinical trials; exclusion deprived Bard of a fair trial | Generally inadmissible, but admissible here because plaintiffs repeatedly emphasized absence of clinical trials (opened the door); limiting instruction can cure confusion |
| Procedural vehicle for resolving admissibility | Trial court’s exclusion on 403 was proper; Appellate Division erred in remanding for Rule 104 | In limine motions were the operative mechanism below; admissibility should be litigated in limine | Scope/admissibility should be resolved on motions in limine (not necessarily a Rule 104 pretrial hearing); court should craft limits and instructions at that stage |
| Whether PLA §5 bars punitive damages for 510(k) devices | PLA precludes punitive awards where FDA has approved/licensed or device is generally recognized as safe — 510(k) clearance qualifies | 510(k) clearance is not FDA approval/licensure; it does not denote official approval or independent finding of safety/effectiveness | PLA §5 does not bar punitive damages for devices cleared via 510(k) |
| Admissibility of 510(k) evidence in punitive phase | Exclusion in liability phase justified; punitive phase evidence should be similarly limited | 510(k) bears on defendant’s state of mind and is relevant to punitive determination | 510(k) evidence is admissible in punitive phase if pertinent to state of mind; here admissible because it should have been admitted in liability phase |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (510(k) focuses on substantial equivalence and does not independently establish device safety/effectiveness)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (discussed in relation to federal regulatory preemption principles)
- In re C.R. Bard, Inc. (Cisson), 810 F.3d 913 (4th Cir. 2016) (upheld exclusion of 510(k) evidence as more prejudicial than probative under facts of that MDL)
- Eghnayem v. Boston Scientific Corp., 873 F.3d 1304 (11th Cir. 2017) (affirmed exclusion of 510(k) evidence due to risk of juror confusion and mini‑trials)
- In re Bard IVC Filters Prods. Liab. Litig. (Booker), 289 F. Supp. 3d 1045 (D. Ariz. 2018) (held 510(k) compliance is relevant to reasonableness and manageable with limiting instructions)