Judge Pulls Plug on Tylenol Lawsuits

The Tylenol lawsuits are now essentially dead (barring a successful appeal) in federal court after the judge in the Tylenol autism MDL ruled that none of the plaintiffs’ evidence establishing a link between autism and Tylenol met the standards for admissibility in court.

This effectively means that all of the cases in the Tylenol autism MDL will be dismissed, and no Tylenol autism lawsuits will be filed in federal courts moving forward. In this post, we will explain the basis for Judge Cote’s pivotal ruling and discuss the future of Tylenol autism lawsuits in state courts.

About the Tylenol Autism Lawsuits

The Tylenol (acetaminophen) autism lawsuits sprang up two years ago after a group of doctors and scientists published a statement letter in a medical journal warning the healthcare community about the possible link between prenatal exposure to Tylenol and high rates of autism. This prompted a growing number of parents to file lawsuits alleging that their child developed autism because the mother used high levels of  Tylenol during pregnancy.

The number of Tylenol autism lawsuits began to grow in 2022. In October of 2022, the Tylenol autism lawsuits pending in federal courts were consolidated into a new class action MDL assigned to Judge Denise Cote in the Southern District of New York.

Our national mass tort lawyers have been following the Tylenol autism litigation from the very beginning. Over the last few months, we have noted that the fate of the Tylenol autism lawsuits was going to turn on the outcome of the Daubert challenges regarding the admissibility of the plaintiffs’ scientific evidence on causation. That issue was resolved this week in favor of the defendants.

MDL Judge Excludes All of the Plaintiffs’ Causation Experts

On December 7, 2023, Judge Cote held a hearing on the Daubert motions. On Monday, Judge Cote issued a 148-page ruling that rejected all five of the plaintiffs’ expert witnesses on the issue of causation.

Judge Cote’s lengthy opinion (which she almost certainly began writing long before the hearing on December 7th) detailed what she found to be scientific flaws that made the opinions of the plaintiffs’ experts unreliable and not consistent with the scientific consensus. Judge Cote found that none of the five expert witnesses proposed by the plaintiffs had offered a sound scientific methodology to support their opinion that Tylenol’s active ingredient, acetaminophen, could cause autism or ADHD. Among other issues, Judge Cote accused the plaintiffs’ experts of “cherry picking” and results-oriented analysis. In describing the plaintiffs’ expert opinions, Judge Cote said:

The unstructured approach adopted by the plaintiffs’ experts permitted cherry-picking, allowed a results-driven analysis, and obscured the complexities, inconsistencies, and weaknesses in the underlying data.

Judge Cote, in her ruling, indicated that there is no established scientific consensus linking acetaminophen to causing autism or ADHD. She referenced assessments from the FDA and other evaluating entities that scrutinize ongoing research in this area.

While acknowledging the qualifications of the plaintiffs’ experts, the judge expressed that their analysis was flawed and presented a simplified view of the evidence. Consequently, she deemed their testimony inadmissible under federal rules of evidence.

The judge critiqued the plaintiffs’ analyses, noting that instead of clarifying, they obscured the weaknesses within the evidence they purportedly relied upon. She highlighted that major medical organizations and regulators have advised against drawing definitive conclusions from the existing scientific literature, which contradicted assertions made by some of the experts.

What Does Judge Cote’s Ruling Mean for the Tylenol Autism Lawsuits?

Judge Cote’s ruling basically means that the Tylenol autism lawsuits are dead, at least in federal court. Without admissible scientific evidence to prove the link between Tylenol and autism, the Tylenol plaintiffs will be unable to prove their claims. All of the cases in the Tylenol autism MDL will eventually be dismissed for lack of evidence.

The plaintiffs will appeal Judge Cote’s decision, but Daubert rulings are rarely overturned on appeal because the trial court is given wide discretion in evaluating the scientific reliability of the evidence.  So the net result of Judge Cote’s decision is that the Tylenol autism lawsuits are done —- at least in federal courts.

Immediately after issuing her ruling, Judge Cote issued another Order basically telling the plaintiffs that the litigation is over. She notes that her ruling leaves the plaintiffs with no “admissible evidence to demonstrate that prenatal exposure to acetaminophen causes autism.” The Order then instructs lawyers for both sides to meet and submit a joint letter by January 12, 2024, outlining a proposal for winding down the litigation.

What is the Future for Tylenol Lawsuits?

Judge Cote’s ruling basically ends the Tylenol autism lawsuits in federal courts. However, Tylenol autism lawsuits can still be brought in state courts and that is where the focus of this litigation will now shift. The legal standard for the admissibility of scientific evidence under state laws is often much more relaxed compared to the Daubert standard applied in federal court.

This means that the Tylenol autism plaintiffs have a better chance of getting their causation evidence admitted in state court. We are expecting a large number of Tylenol autism cases to get filed in New Jersey, Pennsylvania, and California state courts moving forward.

The conventional wisdom among most Tylenol autism and ADHD lawyers is – notwithstanding the opinion of one judge – strong.  We also think the evidence linking autism and ADHD will get stronger, as will plaintiffs’ experts’ ability to convey the strength of the studies we already have to juries.


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