Product Liability & Mass Torts Digest

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.

The Food, Drug, and Cosmetic Act (FDCA or the Act) governs safety, efficacy, and labeling over drugs, cosmetics, dietary supplements, medical devices, and other consumer products. The FDCA grants the Food and Drug Administration (FDA) the primary power to enforce the Act, including whether drugs, cosmetics, dietary supplements, and medical device manufacturers properly label their products to avoid misleading their customers. 

In a case involving a plaintiff who lost his arm in a meat grinder, the Second Circuit recently affirmed the dismissal of his claims against the grinder’s manufacturer on a motion for summary judgment due to substantial modification of the meat grinder by the plaintiff’s co-workers. Khusenov v. Prokraft Inc., 2024 WL 959620 (2d Cir. Mar. 6, 2024).

The litigation involved claims that type 2 diabetes drugs containing saxagliptin caused heart failure. The genesis of the claims goes back to 2008 when the FDA urged additional clinical studies examining diabetes drugs and cardiovascular risks.

The December 18, 2023 Southern District of New York opinion In re Acetaminophen – ASD-ADHD Products Liability Litigation, notable for excluding all five of plaintiffs’ general causation experts under Federal Rule of Evidence 702, reaffirms the importance of the FDA’s conclusions on causation, along with those of other research and medical organizations.

The Southern District of New York’s recent opinion in the In re Acetaminophen MDL establishes strong guardrails regarding how expert witnesses can rely on studies and data in support of their opinions. By way of background, In re Acetaminophen involves more than 600 plaintiffs who allege that the manufacturer and retailers of acetaminophen products failed to warn that children may develop autism spectrum disorder (ASD) or attention-deficit hyperactivity disorder (ADHD) from in utero exposure to the drug. In an opinion issued on December 18, 2023, Judge Denise Cote of the Southern District of New York excluded all five of the plaintiffs’ general causation experts as unreliable.

A Bradford Hill analysis—a set of criteria first proposed by the British epidemiologist Sir Austin Bradford Hill in 1965 to evaluate the strength of evidence for a causal relationship between two variables[1]—often plays a critical role in causation opinions of plaintiff experts in product liability matters. 

A recent and thorough opinion in In re Acetaminophen – ASD-ADHD Products Liability Litigation reaffirms the need for parties’ general causation experts to meaningfully engage with known confounding factors to ensure the admissibility of their opinions. 

On October 3, 2023, a three-judge panel from the Superior Court of New Jersey Appellate Division reversed a jury verdict against Johnson & Johnson over accusations its asbestos-tainted talcum powder caused consumers to develop cancer. The crux of the decision: improper admission of unreliable expert opinions.

In forming an admissible opinion about whether exposure to or use of a defendant’s product caused a plaintiff’s disease or condition, the plaintiff’s expert must factor into their differential diagnosis the role played by potential alternative causes. Yet in many instances, plaintiffs’ experts do not rule out unknown or unexplained causes—also known as idiopathic causes—even when idiopathy is the most likely explanation for the disease or condition.

On September 30, 2023, U.S. District Judge Hector Gonzalez dismissed a proposed class action accusing McDonald’s Corporation and Wendy’s International, LLC of exaggerating the size of their hamburgers in advertisements, ruling that reasonable customers wouldn’t be misled by the companies’ advertisements.