Product Liability & Mass Torts Digest
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May 6, 2024
|3 min read
A Potential Shield: FDCA Preemption in Product Liability and Mass Torts Litigation
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.
March 28, 2024
|3 min read
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).
March 4, 2024
|3 min read
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.
February 23, 2024
|5 min read
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.
February 2, 2024
|4 min read
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.
January 12, 2024
|8 min read
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.
January 5, 2024
|4 min read
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.
December 5, 2023
|5 min read
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.
November 17, 2023
|5 min read
Beyond the Obvious: Does the Failure to Rule Out Idiopathic Causes Survive a Rule 702 Challenge?
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.
October 30, 2023
|5 min read
Reason Prevails for McDonald’s and Wendy’s in Burger Beef
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.
September 26, 2023
|3 min read
Second Circuit Applies Preemption to Bar Tort Claims With No Clear Federal Counterpart
August 11, 2023
|4 min read
Eleventh Circuit Affirms CoolSculpting Device Manufacturer Win on Warning and Defect Claims
In a recent decision, the Eleventh Circuit affirmed the summary judgment victory of Zeltiq Aesthetics, Inc. in a failure-to-warn and design defect lawsuit regarding its CoolSculpting medical device and found that a health care provider’s misunderstanding of an adverse effect did not bear on the adequacy of the product’s warning.
March 14, 2023
|4 min read
Cherry-Picking Epidemiological Data Proves Fruitless for Zantac MDL Plaintiffs
The plaintiffs in the Zantac MDL faced a challenge that is common in products liability cases: How to handle evolving science and conflicting epidemiological data.
March 8, 2023
|7 min read
A recent ruling by the District of Maryland in Garcia v. Sherril, Inc. demonstrates the ongoing struggle by courts to distinguish between when plaintiffs must produce expert testimony in product liability cases and the danger that courts may permit jurors to comment beyond their shoes in cases involving technical subject matter.
February 15, 2023
|7 min read
Zantac MDL Decision Highlights Need for Rigorous and Objective Approach in Bradford Hill Analyses
As part of our continuing commentary on the Zantac decision, this review examines the court’s rationale for doing so and highlights potential avenues for Daubert challenges to experts conducting Bradford Hill analyses.
February 14, 2023
|3 min read
The Zantac MDL Court recently reinforced the important role of general acceptance of an expert’s conclusions to a court’s Rule 702 admissibility analysis.
January 27, 2023
|4 min read
Florida Court Declines to Find Exculpatory Clauses Preclude Strict Products Liability Claims
In a matter of first impression, a Florida appeals court recently held that a retailer’s exculpatory clause does not apply to claims brought under a theory of strict products liability.
July 25, 2022
|4 min read
In a question of first impression certified to it by the U.S. Court of Appeals for the Second Circuit, the Supreme Court of Connecticut recently delivered a partial win for defendants facing state products liability and unfair trade practices claims arising from the same conduct.
July 18, 2022
|4 min read
Product & Mass Torts Summit 2022: Key Takeaways
Winston & Strawn LLP held its second-annual Product & Mass Torts Summit on June 7, 2022. The Summit harnessed the collective experience of Winston’s Product Liability & Mass Torts group as well as of esteemed in-house counsel guest speakers to explore effective strategies to capitalize on the changing legal landscape and combat common plaintiff tactics.
June 29, 2022
|4 min read
Don’t Say Daubert – Reviving Rule 702
For years, federal practitioners have referred to that standard as the “Daubert” standard, for the Supreme Court’s seminal decision in Daubert v. Merrill Dow Pharmaceuticals, 509 U.S. 579 (1993). Daubert made clear that judges must act as gatekeepers when it comes to expert testimony and articulated various factors that they are to consider when deciding whether particular expert testimony is admissible. Defendants generally like Daubert because it effectively raised the bar for expert testimony, making it harder for plaintiffs to rely on junk science to make their case.