New Jersey Products Liability Act: Statutory Overview and Recent Case Law

New Jersey has been known as the “Medicine Chest of the World.” It is a title earned through generations of scientific breakthroughs, pharmaceutical and manufacturing innovation, and lifesaving discoveries. The one thing that goes hand-in-hand with innovation is litigation.

The New Jersey Products Liability Act (NJPLA or PLA), N.J.S.A. 2A:58C-1 to -11, stands as one of the most important ‒ and most litigated ‒ statutes in the state. As New Jersey courts and federal courts applying New Jersey law continue to test the statute’s boundaries, its reach, defences, and interplay with common law and federal regulatory regimes remain active areas of legal development. This article provides a brief overview of the NJPLA’s statutory framework before examining its recent treatment in five significant decisions that together illuminate the statute’s operation across a range of product types and legal contexts: vehicles, medical devices, cosmetics, and pharmaceutical products.

The New Jersey Products Liability Act: A Statutory Overview

The NJPLA was enacted as remedial legislation to establish clear rules in actions for damages caused by products. As New Jersey courts have repeatedly observed, the Legislature intended the Act to address matters that require clarification in the law of products liability, and to channel claims into a unified statutory framework. It was intended to be the singular statute to address all product liability litigation.

The core liability standard

The central provision of the NJPLA, N.J.S.A. 2A:58C-2, sets forth the standard for liability. Under this Section, a manufacturer or seller of a product is liable in a product liability action only if the claimant proves by a preponderance of the evidence that the product causing harm was not reasonably fit, suitable, or safe for its intended purpose because it:

• deviated from the design specifications, formulae, or performance standards of the manufacturer or from otherwise identical units manufactured to the same specifications (manufacturing defect);
• failed to contain adequate warnings or instructions (failure to warn); or
• was designed in a defective manner (design defect).

These three theories ‒ manufacturing defect, failure to warn, and design defect ‒ represent the exclusive statutory causes of action under the NJPLA.

Critically, the NJPLA is broadly pre-emptive. The statute defines a “product liability action” as any claim or action brought by a claimant for harm caused by a product, irrespective of the theory underlying the claim, except actions for harm caused by breach of an express warranty. N.J.S.A. 2A:58C-1(b)(3). New Jersey courts have consistently held that the NJPLA effectively creates an exclusive statutory cause of action for claims falling within its purview, subsuming common law product liability theories such as negligence, strict liability, and implied warranty. This exclusivity is one of the NJPLA’s most consequential features and regularly shapes motion practice in New Jersey and in federal courts sitting in diversity.

Definitions: harm, manufacturer, and seller

The statute defines “harm” broadly to include physical damage to property other than the product itself; personal physical illness, injury, or death; pain and suffering, mental anguish, or emotional harm; and any loss of consortium or services deriving from any of those categories. N.J.S.A. 2A:58C-1(b)(2).

Importantly, only “manufacturers” and “sellers” can be held liable under the NJPLA. A “manufacturer” encompasses any person who designs, formulates, produces, creates, makes, packages, labels, or constructs any product or component of a product, as well as domestic sales subsidiaries of foreign manufacturers holding a controlling interest. N.J.S.A. 2A:58C-8. A “product seller” includes any person who, in the course of a business conducted for that purpose, sells, distributes, leases, installs, assembles, blends, packages, labels, markets, repairs, maintains, or otherwise places a product in the line of commerce. N.J.S.A. 2A:58C-8.

Affirmative defences

Section 3 of the NJPLA, N.J.S.A. 2A:58C-3, establishes several affirmative defences available to manufacturers and sellers. Most significant among these is the “inherent characteristic” or “consumer expectations” defence under Section 3(a)(2), which bars liability where the harm was caused by an unsafe aspect of the product that is an inherent characteristic recognised by the ordinary consumer. This defence embeds a hybrid “consumer expectations” test into the statute, combining the consumer expectations doctrine with an obvious-danger component drawn from risk-utility analysis. The defence does not apply to industrial machinery used in the workplace, or to dangers that can feasibly be eliminated without impairing the product’s usefulness.

Other defences under Section 3 include the state-of-the-art defence ‒ where the product complied with the best available scientific knowledge at the time of manufacture ‒ and compliance with applicable government standards or mandatory specifications.

Punitive damages

The NJPLA addresses punitive damages in N.J.S.A. 2A:58C-5, which permits punitive damages in product liability actions but contains an important carve-out: punitive damages are precluded when the product was approved or licensed, or is generally recognised as safe and effective pursuant to conditions established by the U.S. Food and Drug Administration (FDA) or comparable regulatory body. This provision, as explored in the case law below, has been interpreted narrowly by New Jersey courts, particularly in the medical device context.

Recent Case Law Interpreting the NJPLA

The five decisions surveyed below span 2021 to 2025 and address the NJPLA’s application across a diverse range of products and legal issues. Together they define the outer boundaries of design defect liability, clarify the exclusivity and subsumption doctrines, address the admissibility of federal regulatory evidence, and identify who qualifies as a covered defendant under the statute.

Berkoski v Honda Motor Co., Ltd., 480 N.J. Super. 379 (App. Div. 2025)

The New Jersey Appellate Division’s January 2025 decision in Berkoski is a significant statement on the scope of design defect liability under the NJPLA, holding that a motor vehicle is not defectively designed merely because it lacks available driver-assistance technologies that are not mandated by law.

The case arose from a fatal 2018 car accident on Cape May County Road 657, in which a 2016 Honda CR-V crossed the centre line and struck a vehicle driven by Dr Ann Ramage, killing both drivers. Crash data established that for the five seconds before impact the steering torque on the Honda CR-V was zero, indicating the driver had applied no steering input. Plaintiff ‒ Dr Ramage’s widower and estate administrator ‒ argued that the 2016 Honda CR-V was defectively designed because it was not equipped with a lane departure warning (LDW) system or a lane keeping assist (LKA) system, both of which were available in 2016 and installed in Honda’s higher-end models.

The court affirmed summary judgment for Honda, holding as a matter of law that the absence of the available driver-assistance systems did not render the 2016 Honda CR-V defectively designed within the meaning of the NJPLA. The court’s analysis turned on the Section 3(a)(2) consumer expectations defence. Because ordinary consumers understand that a vehicle must be steered within its lane of travel, and because the inherent risk of lane departure is recognised by the ordinary person who drives a car, the court held that Honda was entitled to the statutory defence. The court further held that the feasibility exception did not apply: even if LDW and LKA systems were available and could have been added, those systems could not “feasibly eliminate” the inherent risk of driving because they are driver-assistance aids, not substitutes for driver control, and because drivers are well aware they bear responsibility for controlling their vehicles.

More broadly, Berkoski reaffirms that the NJPLA does not impose a duty on manufacturers to incorporate every available safety technology into every product. The court cited the long-standing principle that a manufacturer is not required to produce an accident-proof vehicle under New Jersey law and expressly rejected the proposition that a design-defect claim arises whenever a plaintiff can identify a feasible technology that might have prevented an injury. The decision draws an important line between products that are unsafe for their intended purpose and products that could, hypothetically, have been made even safer through optional features. The New Jersey Supreme Court declined certification on 8 April 2025.

Hrymoc v Ethicon, Inc., 254 N.J. 446 (N.J. 2023)

The New Jersey Supreme Court’s 2023 decision in Hrymoc addressed the admissibility of federal FDA Section 510(k) clearance evidence in a products liability trial and the availability of punitive damages under Section 5 of the NJPLA where such clearance is at issue. The case consolidated claims arising from pelvic mesh medical devices, including claims by plaintiffs Mary and Thomas Walsh McGinnis against C.R. Bard, Inc., whose Align TO and Avaulta Solo devices were surgically implanted and subsequently caused complications requiring multiple revision surgeries.

The threshold issue was whether Bard could present evidence at trial that it had received Section 510(k) clearance from the FDA to market its pelvic mesh devices without conducting clinical trials. The trial court had barred the evidence entirely. The case was tried under North Carolina substantive law ‒ which, unlike New Jersey, requires negligence-based rather than strict liability analysis ‒ but New Jersey law governed damages, making the NJPLA’s punitive damages provision squarely applicable.

The Supreme Court held that while 510(k) evidence is generally inadmissible because the 510(k) process determines only substantial equivalence to a predicate device and does not constitute an independent finding of safety and effectiveness, the calculus changes when a plaintiff makes the manufacturer’s failure to conduct clinical trials a central theme of the negligence case. Where plaintiff’s counsel had repeatedly emphasised Bard’s failure to test the devices as demonstrating unreasonableness, the court held that plaintiffs “opened the door” to 510(k) clearance evidence as probative of the reasonableness of Bard’s decision not to perform clinical studies. Excluding this evidence entirely, the court concluded, was an abuse of discretion that deprived Bard of a fair trial.

On the punitive damages question, the court held that Section 5(c) of the NJPLA ‒ which precludes punitive damages where a product was approved or licensed by the FDA ‒ does not apply to 510(k) clearance because 510(k) clearance does not constitute FDA “approval.” This is a plaintiff-favourable ruling of substantial importance in New Jersey medical device litigation: it means that a manufacturer who received only 510(k) clearance, rather than full premarket approval (PMA), cannot shield itself from punitive damages under the NJPLA’s regulatory compliance defence. The Hrymoc decision thus clarifies that the punitive damages exemption in the NJPLA must be read strictly and does not extend to the more permissive 510(k) clearance pathway.

In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices & Products Liability Litigation, 553 F. Supp. 3d 211 (D.N.J. 2021)

The District of New Jersey’s decision in the Johnson & Johnson Talcum Powder MDL provides an instructive examination of the NJPLA’s scope of covered defendants, holding that a trade association is neither a manufacturer nor a seller under the statute and therefore cannot be held liable under it regardless of its involvement in industry self-regulation.

The MDL consolidated thousands of claims alleging that Johnson & Johnson’s talcum powder products ‒ specifically Baby Powder and Shower to Shower ‒ caused ovarian cancer and mesothelioma through exposure to alleged asbestos and other carcinogens. Among the defendants was PCPC, a national trade association representing cosmetics and personal care product manufacturers, including the Johnson & Johnson defendants. Plaintiffs alleged that PCPC, through its Talc Task Force, had suppressed scientific data about the risks of talc and misrepresented the products’ safety to regulators and the public.

The court granted summary judgment to PCPC on all products liability claims, holding first that the NJPLA does not apply to PCPC because PCPC is neither a manufacturer nor a seller of talcum powder products. The court observed that PCPC had no role in designing, producing, packaging, labelling, or marketing the specific products at issue, and that control over the product is the touchstone under New Jersey law for determining whether a party qualifies as a product seller. A trade association’s general advocacy and self-regulatory activities on behalf of an industry do not constitute “marketing” of specific products within the meaning of the NJPLA.

The court further held that the plaintiffs’ common law claims against PCPC ‒ sounding in negligence, fraud, fraudulent concealment, and civil conspiracy ‒ were not subsumed by the NJPLA because those claims did not arise from the sale of a defective product but from PCPC’s alleged misrepresentations and concealment of risks. This aspect of the decision illustrates an important boundary of the NJPLA’s exclusivity doctrine: while the statute broadly pre-empts product liability claims cast in negligence or strict liability theories, it does not reach claims that are not, at bottom, product liability claims at all.

Lanzo v Cyprus Amax Minerals Co., 467 N.J. Super. 476 (App. Div. 2021)

The Appellate Division’s decision in Lanzo arose from one of the first talcum powder cases tried in New Jersey state court and produced a USD117 million judgment before the court ordered new separate trials. The case illustrates the NJPLA’s operation in high-stakes toxic tort litigation, particularly on the issues of expert testimony, punitive damages, and the procedural consequences of discovery misconduct.

Plaintiffs Stephen Lanzo III and his wife Kendra Lanzo asserted design-defect and failure-to-warn claims under the NJPLA against Johnson & Johnson Consumer Inc. (JJCI) and Imerys Talc America, Inc., alleging that Mr Lanzo developed mesothelioma from long-term use of Johnson’s Baby Powder and Shower to Shower talcum powder, both of which plaintiffs alleged contained asbestos. The trial court had dismissed all common-law claims and permitted only the NJPLA claims to proceed.

After a lengthy trial, a Middlesex County jury awarded USD30 million in compensatory damages to Mr Lanzo, USD7 million to Mrs Lanzo for loss of consortium, USD55 million in punitive damages against JJCI, and USD25 million in punitive damages against Imerys ‒ a total of USD117 million. The trial court had imposed an adverse inference instruction against Imerys as a sanction for discovery violations and spoliation of talc samples and test data.

The Appellate Division reversed and remanded for new, separate trials. The court found several reversible errors, including that the consolidated trial of JJCI and Imerys was prejudicial once the jury received an adverse inference instruction attributing misconduct to Imerys alone. The court also scrutinised the admission of expert testimony on causation and the adequacy of jury instructions on alternative causation, which the court held had improperly constrained the defendants’ ability to argue that something other than asbestos in Johnson & Johnson talc caused Mr Lanzo's mesothelioma.

For practitioners, Lanzo underscores the importance of spoliation issues, separate trial motions, and the standards governing expert testimony in NJPLA cases under New Jersey’s Rule 104 framework. It also demonstrates that even where the NJPLA’s failure-to-warn and design-defect theories are both viable, trial errors at the causation stage can unravel a large plaintiff’s verdict.

Vicente v DePuy Synthes Companies, 570 F. Supp. 3d 232 (D.N.J. 2021)

The District of New Jersey’s decision in Vicente is a useful illustration of the NJPLA’s pleading standards and its subsumption doctrine as applied in the medical device context. Plaintiff Brian Vicente brought claims arising from the alleged failure of orthopaedic hardware ‒ plates and screws manufactured by DePuy Synthes and used in surgeries following a motorcycle accident ‒ asserting design defect, manufacturing defect, inadequate warning, and breach of implied and express warranty under the NJPLA.

The court dismissed all claims with prejudice on the defendant’s second motion to dismiss under Rule 12(b)(6). On the implied warranty count, the court held that Vicente’s claim was subsumed by the NJPLA because the essence of the claim was personal injury from a defective product, regardless of how it was labelled. The court rejected Vicente’s argument that representation-based claims fall outside the NJPLA’s pre-emptive reach, observing that courts must look to the essence of the claim rather than its label. Where the theory, if accepted, would allow a claimant to repackage any design-defect claim as one for implied warranty, the NJPLA’s exclusivity provision controls.

On the express warranty count, the court found the claim independently deficient because the complaint failed to identify any specific affirmation, promise, or description that formed the basis of a bargain with Vicente. The court reaffirmed the New Jersey principle that general references to product safety “assurances” or marketing materials, without specific warranty language, cannot support an express warranty claim.

On the design-defect claim, the court applied the well-established pleading requirement that a plaintiff must allege either that the product's risks outweighed its utility or that a technologically feasible and practical alternative design existed that would have reduced harm without substantially impairing the product’s function. The court dismissed the claim because Vicente’s amended complaint still failed to identify a reasonable alternative design or provide a risk-utility analysis ‒ deficiencies the court had flagged in its prior dismissal without prejudice.

Together, Vicente and the broader body of District of New Jersey case law it reflects establish that NJPLA design-defect claims require more than conclusory allegations of defectiveness. Federal courts applying New Jersey law hold plaintiffs to a substantive pleading standard that mirrors the statute’s liability framework: a complaint must plausibly allege the elements of a specific NJPLA theory, not simply assert that a product was unsafe.

Conclusion

The New Jersey Products Liability Act continues to generate significant and consequential litigation across a wide range of product categories. The five decisions examined here reflect several durable themes in its interpretation. Courts consistently enforce the statute’s exclusivity as the sole vehicle for product liability claims sounding in personal injury, turning aside attempts to plead around it through implied warranty or negligence theories. The consumer expectations defence in Section 3(a)(2) remains a potent tool for manufacturers, particularly where the product's alleged risk stems from an inherent characteristic known to ordinary users ‒ as Berkoski confirms even in the context of modern automotive technology. The statute's scope of covered defendants is enforced rigorously, as the MDL ruling illustrates: no matter how closely a trade association is linked to a product’s risks, only manufacturers and sellers fall within the NJPLA’s liability framework.

In the medical device space, Hrymoc has clarified that the NJPLA’s punitive damages exemption for FDA-approved products does not extend to devices cleared only through the 510(k) process, a ruling with substantial implications for New Jersey-based device litigation. And in the MDL and appellate talcum powder cases, courts have confirmed that NJPLA claims require rigorous expert testimony and proper trial management, with significant penalties ‒ both procedural and substantive ‒ for discovery misconduct.

As New Jersey’s courts continue to develop these principles, practitioners on both sides of the docket should remain attentive to the statute’s evolving boundaries. The NJPLA’s blend of strict liability, affirmative defences, and regulatory interplay makes it one of the most dynamic products liability frameworks in the country.