Tylenol Autism Lawsuit 2026 Update February Federal Cases Dismissed But Appeal Pending As FDA Issues Pregnancy Warning

The Tylenol autism lawsuit alleges prenatal acetaminophen exposure increases autism and ADHD risk in children. Federal Judge Denise Cote dismissed approximately 500 lawsuits in August 2024 after excluding plaintiffs’ expert witnesses, but families are appealing. In September 2025, the FDA announced pregnancy warnings following Trump administration claims about the Tylenol-autism link, adding uncertainty to the litigation’s future.

What Is The Tylenol Autism Lawsuit About?

Families filed lawsuits in federal court claiming Johnson & Johnson, Kenvue (J&J’s spin-off that now owns Tylenol), and major retailers like Walmart, CVS, Target, Walgreens, Costco, and Rite Aid failed to warn that taking acetaminophen during pregnancy could cause autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD) in children.

The first lawsuit was filed in June 2023 by Tiffany Rutledge against Walmart on behalf of her two children who developed ADHD. According to court documents, Rutledge took acetaminophen throughout both pregnancies. One child was undergoing testing for autism at the time of filing.

All federal cases were consolidated into Multi-District Litigation (MDL) No. 3043 in the Southern District of New York under Judge Denise Cote. As of October 2025, approximately 500 lawsuits had been filed in the MDL.

The Federal Court Dismissal And Appeal

In late 2023, Judge Cote excluded plaintiffs’ expert witnesses on general causation, ruling they failed to provide sound scientific basis for claims that acetaminophen causes autism and ADHD. This exclusion dealt a fatal blow to the federal litigation.

On August 14, 2024, Judge Cote granted summary judgment in favor of all defendants, effectively dismissing the federal cases. The ruling hinged on the Daubert standard, which requires expert testimony to meet specific scientific reliability criteria.

Plaintiffs have appealed this decision to the U.S. Court of Appeals for the Second Circuit. As of February 2026, the Second Circuit has not yet issued a ruling. The appeal’s outcome will determine whether more than 500 federal lawsuits can proceed or whether state court cases become the primary path for families pursuing claims.

Law firms handling the litigation, including Keller Postman, continue accepting new cases while the appeal is pending.

Trump Administration FDA Warning September 2025

On September 22, 2025, President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. announced that the FDA would notify doctors about potential links between prenatal acetaminophen use and autism/ADHD risk. Trump repeatedly advised pregnant women not to take Tylenol during the press conference.

The FDA issued a “Dear Doctor” letter warning that studies show acetaminophen use during pregnancy “can be associated with a very increased risk of autism.” The FDA also began the process of updating Tylenol’s label to include autism and ADHD risk information.

Kennedy stated the FDA would advise healthcare providers that acetaminophen should be used during pregnancy only in cases of high fever, when fever itself may pose health risks. The announcement came as the Second Circuit prepared to hear oral arguments on plaintiffs’ appeal.

This development is significant because Judge Cote’s dismissal centered on whether plaintiffs’ expert witnesses met scientific standards. The FDA’s endorsement of the pregnancy warning potentially validates the very science the court excluded.

Scientific Evidence: Conflicting Studies

The litigation has been marked by conflicting scientific evidence. Studies cited by plaintiffs include a 2019 Johns Hopkins study finding children with the highest acetaminophen concentrations in umbilical cord blood were 2.86 times more likely to have ADHD and 3.62 times more likely to have autism later in life.

A 2018 American Journal of Epidemiology study concluded acetaminophen exposure during pregnancy is associated with 20-30 percent increased risk for neurodevelopmental disorders including ADHD and autism.

In August 2025, researchers from Mount Sinai’s Icahn School of Medicine reported that prenatal acetaminophen exposure may increase neurodevelopmental disorder risk.

However, a comprehensive February 2026 Lancet review analyzed 43 high-quality studies and concluded acetaminophen use during pregnancy is unlikely to confer clinically important increased risk of autism. The study found that after controlling for confounding factors like genetics and environment, purported associations fell apart.

Kenvue, Tylenol’s manufacturer, maintains that independent science shows acetaminophen does not cause autism. Medical organizations including the American College of Obstetricians and Gynecologists continue recommending acetaminophen as the safest over-the-counter painkiller during pregnancy.

Texas Attorney General Lawsuit October 2025

Texas Attorney General Ken Paxton filed a separate state lawsuit against Kenvue and Johnson & Johnson on October 28, 2025. Filed in Panola County, Texas, the suit alleges the companies deceptively marketed Tylenol as safe for pregnant women while knowing for decades that acetaminophen is dangerous to unborn children.

Paxton’s lawsuit cited the Trump administration’s FDA warning as confirmation of what defendants “knew for years.” The lawsuit asks the court to order companies to pay $10,000 for each Deceptive Trade Practices-Consumer Protection Act violation and destroy marketing materials representing Tylenol as safe for pregnant women and children.

Kenvue responded that acetaminophen is the safest pain reliever option for pregnant women and expressed concern about “perpetuation of misinformation” that could impact women’s and children’s health.

Who May Be Eligible To File Claims

Families may qualify if their child was diagnosed with ASD or ADHD after the mother took Tylenol or generic acetaminophen during pregnancy, particularly during the second or third trimester. Most law firms require acetaminophen use during pregnancy and subsequent autism or ADHD diagnosis in the child.

Related cases involving similar pharmaceutical liability claims include toxic baby food lawsuits, where families allege heavy metals in baby food caused autism. Some Tylenol attorneys are also investigating these alternative claims for affected families. Similar to product liability cases like the McDonald’s hot coffee lawsuit, injured parties can pursue compensation for medical expenses and pain through the civil court system.

What Compensation Could Be Available

No settlements have been reached in Tylenol autism lawsuits. Plaintiffs’ attorneys project potential settlement amounts between $50,000 and $600,000 depending on claim strength and case severity, though some believe jury verdicts could reach millions if cases go to trial.

Compensation sought in these lawsuits typically includes medical expenses for autism and ADHD treatment, therapy costs, special education expenses, lost wages for parents providing care, loss of earning capacity for the child, pain and suffering, emotional distress, and diminished quality of life.

These projections are estimates only and do not guarantee financial compensation or specific dollar amounts.

Current Status And Next Steps For Families

While the federal MDL faces dismissal pending appeal, lawsuits continue in state courts across the country. States with more permissive standards for admitting expert testimony may be more receptive to these claims, particularly following the FDA’s pregnancy warning.

Families interested in pursuing claims should consult product liability attorneys experienced in pharmaceutical litigation. Most attorneys offer free consultations and work on contingency, taking 33-40 percent of settlements or verdicts only if they win.

Required documentation typically includes proof of acetaminophen use during pregnancy, medical records showing autism or ADHD diagnosis in the child, details about dosage and frequency of acetaminophen use, and timeline of prenatal exposure.

Frequently Asked Questions

What Is The Tylenol Autism Lawsuit About?

The lawsuit alleges Tylenol manufacturers and retailers failed to warn that prenatal acetaminophen exposure increases autism and ADHD risk in children. Federal cases were dismissed in August 2024 but are under appeal.

Has The Tylenol Autism Lawsuit Been Settled?

No settlements have been reached. All federal cases were dismissed, but plaintiffs appealed to the Second Circuit Court of Appeals. State court cases continue while the appeal is pending.

Can I Still File A Tylenol Autism Lawsuit?

Yes, law firms continue accepting cases while the federal appeal is pending. State court lawsuits remain an option. Consult a product liability attorney to evaluate your specific situation and discuss statute of limitations in your state.

What Did The FDA Say About Tylenol And Autism?

In September 2025, the FDA issued a warning that studies show prenatal acetaminophen use may be associated with increased autism and ADHD risk. The FDA began updating Tylenol’s label to include this information.

What Evidence Links Tylenol To Autism?

Several studies show associations, including a 2019 Johns Hopkins study finding children with highest acetaminophen levels were nearly 3 times more likely to develop autism or ADHD. However, a February 2026 Lancet review found no causal link after controlling for confounding factors.

How Much Compensation Could I Receive From A Tylenol Lawsuit?

Attorneys project potential settlements between $50,000 and $600,000 depending on case strength. No guarantees exist, and these are estimates only. Compensation typically covers medical expenses, therapy costs, lost wages, and pain and suffering.

Who Are The Defendants In Tylenol Autism Lawsuits?

Defendants include Kenvue (which owns Tylenol after spinning off from Johnson & Johnson), Johnson & Johnson, and major retailers selling generic acetaminophen including Walmart, CVS, Target, Walgreens, Costco, Rite Aid, Family Dollar, Safeway, and Sam’s Warehouse.

Last Updated: February 8, 2026

Disclaimer: This article provides information about the Tylenol autism lawsuit based on publicly available court filings and news reports. It is not legal advice. Consult a qualified attorney for evaluation of your specific situation.

If you believe your child’s autism or ADHD resulted from prenatal acetaminophen exposure, consult a product liability attorney experienced in pharmaceutical litigation to discuss your legal options.

Stay informed, stay protected. — AllAboutLawyer.com

Meta Description: Tylenol autism lawsuit dismissed in federal court August 2024 but under appeal. FDA issued pregnancy warning September 2025. What families need to know about eligibility and compensation.

About the Author

Sarah Klein, JD, is a licensed attorney and legal content strategist with over 12 years of experience across civil, criminal, family, and regulatory law. At All About Lawyer, she covers a wide range of legal topics — from high-profile lawsuits and courtroom stories to state traffic laws and everyday legal questions — all with a focus on accuracy, clarity, and public understanding.
Her writing blends real legal insight with plain-English explanations, helping readers stay informed and legally aware.
Read more about Sarah