ELIZABETH HRYMOC VS. ETHICON, INC. MARY MCGINNIS VS. C.R. BARD, INC. (L-13696-14 AND L-17543-14, BERGEN COUNTY AND STATEWIDE) (CONSOLIDATED), A-5151-17/A-1083-18

Background

Two related product-liability trials involving transvaginal pelvic‑mesh devices (Ethicon: Prolift/TVT‑O; Bard: Avaulta Solo/Align TO) produced large jury verdicts: Hrymoc (N.J. law on liability) — $5M compensatory ($4M patient, $1M spouse) and $10M punitive; McGinnis (N.C. law on liability) — roughly $33M compensatory plus $35M punitive. Punitive issues were tried under New Jersey law in both cases.
Plaintiffs asserted design‑defect and failure‑to‑warn claims; defendants defended on design, warning adequacy, and regulatory compliance grounds.
Both trial judges precluded any evidence or argument that defendants obtained FDA 510(k) clearance for the devices (i.e., evidence the devices were cleared as "substantially equivalent" to predicate Class II devices).
Defendants appealed, arguing the categorical exclusion of 510(k) evidence deprived them of a fair trial, particularly on state of mind and punitive damages; other appeals contested sufficiency of plaintiffs’ proofs and damages amounts.
The Appellate Division held the blanket exclusion of 510(k) evidence was reversible error and vacated both judgments, ordering retrials preceded by N.J.R.E. 104 hearings to craft limited admissibility and limiting instructions; otherwise the courts’ rulings (including upholding plaintiffs’ design and warning proofs in Hrymoc) were affirmed.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Admissibility of FDA 510(k) clearance evidence	510(k) is not approval of safety/effectiveness; risk of juror confusion; exclude.	510(k) clearance is relevant evidence of regulatory review and bears on reasonableness, state of mind, and punitive damages.	Court: categorical exclusion was error; 510(k) evidence has probative value and may be admitted with appropriate limits and jury instructions after Rule 104 proceedings.
Use of 510(k) evidence in punitive‑damages phase	510(k) not equivalent to PMA; does not bar punitive damages and may prejudice jury if admitted.	Excluding 510(k) prevented defendants from countering plaintiffs’ theme that defendants acted without any regulatory oversight; state of mind evidence affected.	Court: limiting admission needed; full ban unfairly prejudiced defendants as to state of mind and punitive issues.
Whether 510(k) clearance bars punitive damages under N.J. PLA or N.C. statute	510(k) constitutes FDA approval/licensure or government standard that precludes punitive damages/immunity.	510(k) is a substantial‑equivalence clearance, not PMA, licensure, or a prescriptive government standard.	Court: 510(k) is not premarket approval/licensure nor a government design standard; does not automatically bar punitive damages.
Sufficiency of design‑defect proof (Hrymoc)	Plaintiffs: offered feasible, safer alternatives (e.g., Prolift without arms, different mesh).	Defendants: alternatives impractical; state‑of‑the‑art defense warranted.	Court: plaintiffs adduced sufficient evidence of feasible safer alternatives; state‑of‑the‑art instruction not warranted on this record.
Proximate causation on failure‑to‑warn (Hrymoc)	Plaintiffs: surgeon relied on IFU and would have counseled patient differently if warnings were adequate; patient would not have consented.	Defendants: learned intermediary (surgeon) would have used device regardless; warnings not proximate cause.	Court: evidence was not unequivocal; jury could find inadequate warnings were a substantial factor; proximate causation supported.

Key Cases Cited

In re C.R. Bard, Inc., 810 F.3d 913 (4th Cir. 2016) (upheld district court exclusion of 510(k) evidence as within trial court discretion under Fed. R. Evid. 403)
Eghnayem v. Bos. Sci. Corp., 873 F.3d 1304 (11th Cir. 2017) (affirmed exclusion of 510(k) evidence; emphasized difference between 510(k) and PMA)
Kaiser v. Johnson & Johnson, 947 F.3d 996 (7th Cir. 2020) (upheld exclusion of §510(k) evidence and discussed limits of 510(k) as "approval")
In re Bard IVC Filters Prods. Liab. Litig., 289 F. Supp. 3d 1045 (D. Ariz. 2018) (admitted 510(k) evidence with limiting instructions; recommended judicial management to avoid mini‑trial)
Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (federal preemption and differences in device regulatory pathways explained)
Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (discussed consequences of FDA premarket approval for federal preemption)
In re Pelvic Mesh/Gynecare Litig., 426 N.J. Super. 167 (App. Div. 2012) (New Jersey App. Div. decision addressing pretrial evidentiary matters in pelvic‑mesh litigation)