USA – NEW JERSEY Trends and Developments Contributed by: Mark Silver, Thomas Cotton, Joseph Amoroso and Timothy Duffy, Schenck, Price, Smith & King, LLP
ed the proposition that a design-defect claim arises whenever a plaintiff can identify a feasible technol - ogy that might have prevented an injury. The deci - sion 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 liabil - ity 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 pel - vic mesh medical devices, including claims by plain - tiffs 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 gov - erned damages, making the NJPLA’s punitive dam - ages 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 predi - cate device and does not constitute an independ - ent 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 repeat - edly emphasised Bard’s failure to test the devices as demonstrating unreasonableness, the court held that plaintiffs “opened the door” to 510 (k) clearance evi - dence 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) clear - ance 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 permis - sive 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 instruc - tive examination of the NJPLA’s scope of covered defendants, holding that a trade association is nei - ther 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 design - ing, producing, packaging, labelling, or marketing the specific products at issue, and that control over the product is the touchstone under New Jersey law for
365 CHAMBERS.COM
Powered by FlippingBook