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February 3, 2026 | Legal Update

Massachusetts courts issued several important product liability decisions in 2025. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows:

1. MASSACHUSETTS APPEALS COURT

Woodley v. Philip Morris USA Inc.
250 N.E.3d 580 (Mass. App. Ct. Jan. 8, 2025)

Significant Holding: Appeals Court affirms jury verdict on failure to warn claim, emphasizing SJC authority that a jury may infer that a warning would have been heeded had it been given.

The plaintiff, a lifelong cigarette smoker, filed suit against Philip Morris after developing laryngeal cancer. He sued the manufacturer in state court for negligent design, breach of the implied warranty of merchantability for design defect and failure to warn, violation of Mass. Gen. L. ch. 93A, fraud and misrepresentation, and conspiracy to commit same. At trial, a jury found in the plaintiff’s favor on the failure to warn claim and the defendant appealed, arguing the trial court erred in denying the defendant’s motion for judgment notwithstanding the verdict for lack of evidence of warning causation. The defendant argued that no reasonable jury could have found the plaintiff would have stopped smoking if warned about the risk of cancer as the evidence showed that he was already addicted by another manufacturer’s cigarettes before switching to the defendant’s brand. The Appeals Court, however, noted that under SJC authority, a jury may infer that a warning would have been heeded had it been given. Because the plaintiff testified that he wished he had been told that if he continued to smoke that he could develop cancer, the jury was permissible in finding causation.

2. UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

Warner v. Amgen Inc.
No. 1:24-CV-10632-JEK, 2025 WL 490720 (D. Mass. Feb. 13, 2025)

Significant Holding: Failure to warn claims under state law for labels approved by the FDA are preempted by federal law unless risks were not considered by the FDA during the approval process or new data arises about risks after FDA approval.

The plaintiff, as personal representative of her son’s estate, filed suit in state court against Amgen, alleging that an injection manufactured by Amgen caused her son to suffer from a massive seizure, ultimately leading to his death. The plaintiff’s son suffered from an arteriovenous malformation and took the injection, which had been approved by the FDA just a month prior, for migraine relief. The plaintiff claimed that Amgen’s labeling failed to provide adequate warnings that individuals with a history of seizures and cerebrovascular disease were excluded from the clinical testing. Amgen removed the case to federal court and moved to dismiss, arguing that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted any state law duty to warn. The plaintiff opposed the motion, but also moved to amend her complaint, seeking to claim that the manufacturers could have modified the drug’s label in the month after approval via the FDA’s “changes being effected” (“CBE”) regulation.

The court granted Amgen’s motion to dismiss and denied the plaintiff’s motion to amend, holding that the plaintiff’s state law failure to warn claims were impliedly pre-empted by federal law because (1) the FDA was aware of the exclusion of certain people from clinical trials when it approved the warning label and (2) the relevant risks were considered before approval of the warning label. As for the plaintiff’s post-approval warning claim, the court found that the articles submitted by the plaintiff did not constitute newly acquired information, as they failed to link the drug to any adverse risk and did not contain information about cerebral risks that were unknown to the FDA when it approved the drug.

Sundaramurthy v. Abbott Vascular, Inc.
775 F. Supp. 3d 576 (D. Mass. Mar. 31, 2025)

Significant Holding: Summary judgment granted in manufacturing defect cases involving a complex medical device where the plaintiff failed to disclose an expert witness to support his defect claim.

The plaintiff filed suit in state court against Abbott Vascular, a coronary stent graft manufacturer, for negligence, based on a manufacturing defect theory, and breach of implied and express warranties. The plaintiff suffered a heart attack which caused his doctors to implant three stents in his arteries and the use of a GraftMaster device manufactured by Abbot. Due to certain complications, it had to be surgically removed. The plaintiff alleged that despite the removal of the device, the procedure caused adverse effects on his heart condition, decreased quality of life, and caused medical expenses. The defendant removed the case to federal court and on a motion to dismiss the court dismissed all but the negligence claim. Following the end of discovery, the defendants filed a motion for summary judgment, arguing that the plaintiff's failure to designate any expert as to the alleged defect and/or causation mandates summary judgment in its favor.

Applying Massachusetts law, the court stated that “expert evidence is required in the context of manufacturing defect claims when the nature of the alleged defect is complex enough such that it is outside the scope of lay knowledge.” The court relied on Laspesa v. Arrow Int'l, Inc., No. 07cv12370-NG, 2009 WL 5217030, at *6, 2009 U.S. Dist. LEXIS 121576, at *17-18 (D. Mass. Dec. 23, 2009) and Hunt v. Covidien LP, No. 22-10697-RGS, 2024 WL 2724144, at *9, 2024 U.S. Dist. LEXIS 94280 at *24 (D. Mass. May 28, 2024) to emphasize that in the cases of medical devices specifically, it is impossible for a jury to determine whether devices deviated from their intended design without expert testimony. Here, the court found that because the GraftMaster was a complex device similar to the epidural catheter in Laspesa, the plaintiff was required to disclose an expert. Given the lack of expert testimony, the court allowed the defendant’s motion for summary judgment. Lastly, the court rejected the plaintiff’s last-minute efforts to advance a res ipsa loquitur theory as untimely, noting that it would have been extremely difficult to prove a negligent defect relative to a complex medical device with just a res ipsa theory.

Citation Insurance Company v. Broan-NuTone LLC
2025 WL 2239266 (D. Mass. Aug. 6, 2025)

Significant Holding: Manufacturing defect claims require evidence that the particular product used deviated from its intended design, rather than general deficiencies with the overall product. To survive summary judgment, design defect claims require expert evidence of financially feasible, practical alternative designs that would ameliorate the alleged defect.

The plaintiff, Citation Insurance Company, on behalf of an insured property owner, filed suit against Broan-NuTone, a manufacturer of bathroom exhaust fans and motors, alleging manufacturing and design defects after a fire damaged the property owner’s home. Broan-NuTone moved for summary judgment on all counts.

The court granted Broan-NuTone’s motion for summary judgment, holding that Citation Insurance Company lacked admissible evidence to show either a manufacturing or design defect. On the manufacturing defect, the court found that the plaintiff’s expert reports failed to disclose a specific manufacturing defect and how any alleged defect caused the fire at the premises. On the design defect claim, the court found that the plaintiff’s expert reports did not address the availability of a technically feasible practical alternative design for the product that does not result in undue cost. Based on these reasons, the court found that the plaintiff violated Rule 26(a)(2)(B) and as sanctions precluded the expert testimony. The court further found that given the complexity of the product at issue, the plaintiff could not prevail on its manufacturing and design defect claims without expert testimony.  

PerkinElmer Health Scis., Inc. v. LabQ Clinical Diagnostics LLC
2025 WL 2663243 (D. Mass. Sept. 16, 2025)

Significant Holding: Manufacturing defect claims must allege facts that a deviation from the intended design rendered the product unreasonably dangerous.

During the COVID-19 pandemic, the FDA granted PerkinElmer Emergency Use Authorization (“EUA”) for COVID-19 tests, including their “New Covid Kits.” The EUA required PerkinElmer to report suspected false positive or negative results to the FDA as well as “significant deviations from the established performance characteristics of the product of which [PerkinElmer] becomes aware.”

By July 2022, PerkinElmer’s final invoice to LabQ reflected an outstanding balance of approximately $6.3 million dollars. PerkinElmer filed suit against LabQ, alleging breach of contract for not paying for the kits. LabQ denied liability and filed counterclaims, including a gross negligence counterclaim under a manufacturing defect theory. Both parties filed motions for summary judgment on their claims.

The court granted PerkinElmer’s motion and denied LabQ’s motion, holding that there was no evidence of a manufacturing defect supporting LabQ’s claim, despite reports from consumers of false positive tests. The court explained that LabQ did not allege any facts relating to the design of the New Covid Kits nor how the purported defect rendered the product unreasonably dangerous.

NOTE: LabQ has since appealed this decision to the First Circuit Court of Appeals.

Ryan, et al. v. The Newark Group, Inc., et. al.
4:22-cv-40089-MRG (D. Mass. Dec. 31, 2025)

Significant Holding: Defendants with minimal, unrelated contacts with a forum have not purposefully availed themselves of the forum sufficient to satisfy personal jurisdiction.

Residents of Westminster, MA brought a putative class action to recover damages for groundwater contamination caused by improper disposal of wastes containing per- and polyfluoroalkyl substances (PFAS) at the MassNatural recycling and composting facility. Certain defendants, collectively “DuPont Entities”, moved to dismiss based on Rule 12(b)(2) for lack of specific personal jurisdiction and Rule 12(b)(6) for failure to state a claim.

The court granted the motion, holding that DuPont lacked specific, forum-related contacts because the nexus of contacts with the forum was not sufficiently related to the conduct at issue. The DuPont Entities did not engage in marketing, sales, or distribution efforts in Massachusetts, and the facts set forth in the pleadings were too conclusory about the DuPont Entities’ involvement to properly state a claim.

This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.

This legal update was prepared by David Ferrera, Ritika Bhakhri, and Benjamin Fink.