Product Liability & Mass Torts Digest

The Supreme Court just opened the doors to civil RICO suits against defendants alleged to have caused personal injury. This ruling could have major implications for product manufacturers and sellers, which may now face RICO claims—and treble damages—alongside traditional state-law claims in product-liability cases.

A cert petition filed in March in the long-running In re Fosamax (Alendronate Sodium) Products Liability Litigation gives the Supreme Court a chance to clarify—for the second time—the Third Circuit’s restrictive application of the impossibility preemption defense.

The U.S. District Court for the Northern District of Illinois recently dismissed a putative class action complaint alleging the term “natural” on Fiji Water bottle labels is false and misleading due to alleged microplastics contained in the water, because the plaintiffs failed to provide specific evidence to plausibly establish such contamination.

In a February 20, 2025 order, the District Court for the Northern District of California partially granted a motion to dismiss product liability claims based on theories that the descriptions of baby and infant bottles and cups as “BPA Free” were an affirmative misrepresentation. Miller v. Philips N. Am. LLC, Civil No. 3:24-CV-03781-RFL (N.D. Cal. 20 Feb. 2025).

In the ongoing litigation involving the BioZorb device, the U.S. District Court for the District of Massachusetts recently ruled on defendant-manufacturer Hologic’s motion for summary judgment in the case of In re BioZorb Device Products Liability Litigation, No. 22-cv-11895-ADB, 2025 WL 509834, at *4 (D. Mass. Feb. 12, 2025). 

In a negligence and failure to warn case, a Florida district court granted the defendant Sherwin-Williams’s motion to exclude the testimony of the plaintiff’s expert after determining that his causation opinion was unreliable under Daubert. Monte v. Sherwin-Williams Dev. Corp., 2025 WL 90123 (M.D. Fla. Jan. 14, 2025).

Artificial intelligence (AI) is an emerging tool in healthcare settings, altering the relationships between drug manufacturers, physicians, and patients.

A recent Supreme Court decision strengthened plaintiffs’ ability to control whether their case will be litigated in state or federal court.

Amicus filings joined by more than 70 diverse entities ranging from manufacturers to patient advocacy groups highlight widespread concern that California courts will adopt an expansive new theory of liability based on a “duty to innovate” that filers say will upend existing products liability law, disincentivize innovation, increase drug prices, and harm patients.

On November 5, 2024, Danone Waters of America, LLC (Danone) achieved a notable legal victory, securing the dismissal of a putative class action alleging violations of Illinois and California consumer fraud statutes. The plaintiffs contended that Danone’s labeling of Evian bottled spring water as “natural” was deceptive due to the alleged presence of microplastics. The United States District Court for the Northern District of Illinois granted Danone’s motion to dismiss, finding the claims preempted by federal law.

“Reptile theory” is a litigation tactic used by plaintiffs’ lawyers to appeal to a jury’s survival instincts by casting defendants as threats to community safety. Popularized by Don C. Keenan and David Ball in their book, Reptile: The 2009 Manual of the Plaintiff’s Revolution, it builds on the “triune brain” neuroscience theory, which posits that the human brain is made up of three regions of increasing evolutionary complexity.

Under both strict product liability and negligence theories, plaintiffs must establish proximate causation where there is a reasonable certainty that the defendant’s acts caused the injury. Several recent cases have emphasized the Daubert requirement that expert testimony supporting proximate cause for product liability claims must be non-speculative and backed by reliable, reproducible, scientific methodologies.

Third-party litigation financing is a significant issue in the U.S. legal system, with its use playing an increasingly important role in litigation. Whether a party should be, or is, required to disclose litigation funding from a third party, and the terms of that funding, has been the subject of heated debate for some time.

In Colwell, the plaintiff was injured when a Sig Sauer P320 handgun allegedly discharged unintentionally into his thigh.  The P320 “functions as a single-action pistol,” and while it has internal safeties “designed to prevent inadvertent discharges,” it lacks external safeties, such as a manual thumb safety or tabbed trigger safety.

A series of recent opinions by Judge Denise Cote of the U.S. District Court for the Southern District of New York exemplifies the effective judicial gatekeeping contemplated by Federal Rule of Evidence 702 and Daubert v. Merrel Dow Pharmaceuticals. In In re Acetaminophen – ASD-ADHD Products Liability Litigation, Judge Cote repeatedly excluded the plaintiffs’ general causation experts even though each was “eminently qualified” because they did not reliably apply their methodologies. 

There are myriad examples of lawsuits ensuing after a regulatory body or other agency issues a statement or report on a particular substance. As things currently stand, however, statements by the U.S. Food and Drug Administration (FDA) may offer a defense to claims involving microplastics.  

After several decades as a curiosity among computer programmers and science fiction fans, artificial intelligence (AI) is igniting the global economy.  Among those enchanted by its seemingly limitless modern applications is the litigation finance industry—an unfortunate product of skyrocketing large-scale litigation costs following the ESI (Electronically Stored Information) Revolution, where third parties invest in litigation for a chance to share in equally inflated judgments and settlements.  

The California Supreme Court has recognized a new path for plaintiffs to prove causation in failure-to-warn cases against manufacturers of prescription drugs and medical devices. Under the learned intermediary doctrine, such manufacturers have a duty to warn physicians of the risks associated with their products but do not have a duty to warn patients.

As part of the wider multidistrict litigation over the breast cancer drug docetaxel (branded Taxotere), on May 24, 2024, the Fifth Circuit ruled that Food and Drug Administration (FDA) labeling requirements preempt certain state law failure-to-warn theories. Hickey v. Hospira, 102 F.4th 748 (5th Cir. 2024).

The Southern District of Illinois's decision in In re Paraquat Products Liability Litigation underscores the critical importance of rigorous, transparent, and repeatable expert methodologies in court. The exclusion of plaintiffs' causation expert due to methodological flaws, resulting in a summary judgment for the defendants, highlights the escalating judicial scrutiny on expert reliability following the recent amendments to Rule 702.