Subject: Over-The Counter Drugs

California Supreme Court Rejects Duty to Innovate

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On August 3, 2026, the California Supreme Court issued its decision in the closely watched Gilead Tenofovir Cases, No. S283862, — Cal.5th —, 2026 WL 2223748 (Cal. Aug. 3, 2026), rejecting the so-called “duty to innovate.” The court held, in a 6-1 decision, that “a drug manufacturer has no duty of care when deciding whether and when to develop and commercialize an allegedly safer alternative drug” to replace an admittedly nondefective drug. The decision is a significant victory for pharmaceutical manufacturers and carries substantial implications for product liability litigation across industries.

Background

The case arose from a Judicial Counsel Coordination Proceeding comprising more than 30,000 plaintiffs — HIV patients who took Gilead’s tenofovir disoproxil fumarate (TDF). Plaintiffs did not claim TDF was defective; it is undisputedly a life-saving medication. Instead, they alleged Gilead unreasonably delayed bringing an alternative medication, tenofovir alafenamide (TAF), to market, depriving them of a purportedly safer option and allegedly causing kidney, bone, or tooth injuries.

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Message Received – Delaware Follows Federal Rule of Evidence 702

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The Delaware Superior Court took the mass tort world by surprise with its May 31, 2024, refusal to exclude the plaintiffs’ experts’ causation opinions in the Zantac litigation, breaking with the federal MDL court’s prior exclusionary order and applying Delaware Rule of Evidence 702 “with a liberal thrust favoring admission.” The ruling was so unexpected that some outlets questioned whether Delaware courts would become a new preferred venue for mass tort plaintiffs. But, in a rare move, the Delaware Supreme Court granted the defendants’ request for interlocutory appeal — despite the Superior Court’s refusal to certify the order — and has now restored order, reversing the Superior Court’s decision and remanding for further proceedings. In re Zantac (Ranitidine) Litig., — A.3d —, 2025 WL 1903760 (Del. July 10, 2025).

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Plaintiffs’ Second Bite at the General Causation Apple Fares No Better Than the First in Acetaminophen MDL

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In December 2023, back when the ink was still drying on the amendments to Federal Rule of Evidence 702, the Southern District of New York excluded all five general causation experts proffered by plaintiffs in the In re Acetaminophen MDL whose cases had been selected for trial.  We discussed that impressively detailed and painstaking decision here. Observing that all 50 states require proof of general causation in product liability cases and that the plaintiffs now had no experts to carry that water, the court instituted an order to show cause process that led to the dismissal of approximately 550 cases. However, over the defendants’ objections, the court permitted a small handful of new arrivals to the MDL to name their own general causation expert and try again. In yet another impressively meticulous opinion, the court recently doubled down on its Rule 702 “gatekeeping” role and excluded the new plaintiffs’ backup general causation expert in In re Acetaminophen – ASD-ADHD Prod. Liab. Litig., No. 22MC3043 (DLC), 2024 WL 3357608 (S.D.N.Y. July 10, 2024).

The plaintiffs in In re Acetaminophen allege that prenatal use of acetaminophen caused attention deficit hyperactivity disorder (ADHD) and/or autism spectrum disorder (ASD) in offspring. The plaintiffs’ first five proffered general causation experts were excluded in part because the court took issue with the experts’ “transdiagnostic” approach — combining literature of ADHD and ASD into a single analysis — because it merely “obscured limitations in the scientific literature.”   The new plaintiffs’ expert — number six overall — sidestepped the “transdiagnostic” issues and sought to opine solely on a supposed link between prenatal acetaminophen use and ADHD.  But the court, still mindful of acetaminophen’s critical role as the only pain reliever and fever reducer indicated for use during pregnancy and the FDA’s multiple reviews of its safety, remained vigilant in its Rule 702 obligation.

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Amended FRE 702 Arrives in MDL Practice: S.D.N.Y. Excludes Plaintiffs’ Experts in Acetaminophen MDL

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The Committee Notes to the newly implemented amendments to Federal Rule of Evidence 702 make clear that the “[j]udicial gatekeeping” of expert evidence is “essential.”  Federal courts in New York have played an important role in pioneering and developing this concept.  Indeed, the idea of courts as gatekeepers in the expert context finds its roots in the Eastern District of New York, with the late Chief Judge Weinstein coining the term in a 1985 opinion in In re Agent Orange Product Liability Litigation.  Three decades later, the Southern District of New York offered one of the most thorough illustrations of careful judicial gatekeeping in In re Mirena IUS Levonorgestrel-Related Prod. Liab. Litig. (No. II).  Now, New York can also call itself home to the first MDL-wide decision to exclude experts under Rule 702’s new formulation.

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The Zantac Rule 702 Order: TLBR (Too Long, But Read)

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On opening an opinion, lawyers habitually roll their eyes when they see a table of contents.  Even more so when they learn the opinion is over 300 pages.  The MDL order granting defense motions to exclude experts and for summary judgment in In re Zantac (Ranitidine) Products Liability Litig. (S.D. Fla. Dec. 6, 2022), however, is a worthwhile read.  The court’s analysis and prose is thorough, clearly reasoned, well-supported, … and highly readable.  It reveals a court willing to roll up its judicial sleeves, tackle and explain the fundamental science in detail, and rigorously apply Rule 702 to perform its essential gatekeeping function – to insulate the jury, and the defendants, from flawed advocacy masquerading as scientific evidence and holding retained experts to reasonable standards of intellectual rigor.

The Zantac litigation involves claims that the active ingredient in popular heartburn medication ranitidine breaks down to produce excessive levels of NDMA, a probable human carcinogen, under certain storage and biological conditions.  That sounds scary.  FDA has set a low daily intake limit of NDMA, a byproduct of, among other things, a common diet.

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FDA Finalizes Voluntary Recall Guidance Imploring Companies to Be “Recall Ready”

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FDA recently issued final guidance regarding the initiation of voluntary product recalls and its related suggestions on how to be “recall ready.” The guidance – covering voluntary recalls of food, drugs, devices, biological products, cosmetics, and tobacco – emphasizes the importance of a company’s recall readiness at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for and implement voluntary recalls. It also advises companies on best practices for working with FDA to initiate a timely voluntary recall.

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