Tylenol Autism Lawsuit: A Comprehensive Overview

56 Tylenol autism and ADHD lawsuits remain pending in federal court. 

In December 2023, a Manhattan federal judge ruled to exclude expert testimony asserting a link between prenatal Tylenol use and autism in children, citing insufficient evidence to support these claims. 

This decision likely signals the end of the federal multidistrict litigation involving approximately 500 lawsuits related to the widely used over-the-counter medication, unless the plaintiffs successfully appeal.

This ruling may result in the dismissal of the 56 Tylenol autism and ADHD lawsuits and other federal cases. However, similar lawsuits will continue to proceed in state courts.

The future of the Tylenol MDL largely depends on whether Judge Cote accepts Dr. Roberta Ness’ opinion. Dr. Ness, who has recently been deposed, believes that acetaminophen could cause autism and ADHD. She reached this conclusion after conducting a thorough analysis using the Bradford Hill criteria. While she did not perform a separate Bradford Hill analysis specifically for autism, she did so for ADHD and neurodevelopmental disorders in general.

The Bradford Hill criteria are a set of nine principles used to determine a causal relationship between a presumed cause and an observed effect in epidemiology. These principles include strength, consistency, specificity, temporality, biological gradient, plausibility, coherence, experiment, and analogy. They are essential in a Daubert challenge as they provide a scientifically accepted framework for evaluating the reliability and relevance of expert testimony regarding causation, ensuring that the testimony is based on sound scientific principles.

Judge Cota has agreed to hear evidence from a new expert on the topic of whether the prenatal use of Tylenol (acetaminophen) can be linked to a later autism diagnosis in children exposed during pregnancy. Defendants have until July to file any motions in opposition to this expert testimony.

Judge Cota has granted permission for the Mota plaintiffs to present testimony from Dr. Roberta Ness, an epidemiologist and public health specialist with extensive publications on the link between Tylenol usage and neurodevelopmental disorders in children.

Plaintiffs in the Tylenol MDL face a February 1 deadline to justify why their cases shouldn’t be dismissed, impacting 501 plaintiffs with cases issued before January 11, 2024. Following Judge Cote’s ruling, which led to the dismissal of Tylenol autism lawsuits, plaintiffs are considering appeals and exploring state court options for compensation.

Judge Cote’s ruling in the federal court dismissed all Tylenol autism litigation due to insufficient evidence linking prenatal Tylenol or generic acetaminophen use to autism spectrum disorder/ADHD. Following the pivotal Daubert hearing on December 7, 2023, this decision has led plaintiffs to focus on pursuing these cases in state courts.

The Tylenol autism MDL has grown to 441 cases, with a critical Daubert hearing scheduled for December 7, 2023, in federal court. Concurrently, Tylenol autism cases are also advancing in state courts, notably in Madison County, Illinois, with key legal deadlines set for December 2023 and January 2024.

The outcome of the Daubert hearing in federal court could significantly influence the trajectory of these lawsuits, potentially shifting the focus to state courts.

The number of lawsuits within the MDL has surged to 383, with a significant increase in new filings last month, leading up to the Daubert hearings, where expert testimonies will be scrutinized.

The defense and plaintiffs have proposed different approaches for these hearings to Judge Cote, who has a history of favoring more efficient legal processes.

Concurrently, recent research has shown that prenatal exposure to paracetamol, the active ingredient in Tylenol, might impact brain development by altering gene expression, potentially influencing litigation.

Judge Cote had invited the FDA to weigh in on the appropriateness of the plaintiffs’ proposed warning labels for Tylenol and generic acetaminophen products earlier this year.

The FDA was given until July 28th to respond but requested additional time, pushing the new deadline to September 15, 2023.

Interestingly, the FDA declined to submit a statement of interest, opting to stay neutral in the matter. This decision is considered a significant win for the plaintiffs, as an FDA recommendation against the warning could have led to the motion to dismiss on federal cases.

The absence of the FDA’s input keeps the lawsuits alive and allows them to proceed. Major legal events, including crucial Daubert motions, are expected in the coming month.

The fate of the Tylenol autism lawsuits hinges on the upcoming Daubert challenges, where Judge Cote will rule on the admissibility of the plaintiffs’ scientific evidence linking acetaminophen to autism

A favorable ruling for the plaintiffs could lead to settlements, while an unfavorable one would result in a motion to dismiss.

A record 64 new cases were added to the Tylenol autism MDL last month, bringing the total number of pending cases to 200. This surge suggests increased momentum, yet thousands of prospective plaintiffs remain cautious, awaiting the Daubert ruling.

Only six new cases were added to the MDL this month, with many potential plaintiffs holding off. The hesitancy is attributed to concerns over the upcoming Daubert ruling, which could dismiss all federal cases if the scientific evidence used is deemed inadmissible.

The judge overseeing the MDL dismissed failure-to-warn claims against retailers like CVS under Texas law but denied a similar motion under California law. This decision complicates the landscape for future cases, particularly those subject to Texas law.

Judge Cote denied J&J’s motion to dismiss based on federal preemption, holding that the company could have added warnings without violating federal rules. This follows a similar ruling against Walmart in November, bolstering the plaintiffs’ position in the lawsuits.

The Tylenol autism MDL in New York now has 107 pending cases, marking a growth of 37 cases since its inception four months ago. This indicates an accelerating trend in the litigation.