Tylenol Lawsuit Updates
Last updated: September 6, 2026
The people bringing these cases are mostly mothers who took Tylenol while pregnant and whose children were later diagnosed with autism or ADHD. Their claim is not that they did anything wrong. It is that the companies selling acetaminophen never told them there was a question about it.
For nearly two years this litigation looked finished. A judge had ruled the plaintiffs’ experts could not testify, and the federal cases were thrown out. In July 2026 an appeals court brought them all back.
This page is general legal education and reports on litigation that keeps moving. It is not legal or medical advice, it does not evaluate anyone’s claim, and it is not guidance about what to take during pregnancy. That belongs with your doctor.
Where the Litigation Stands Now
The federal cases sit together in one court as In re: Acetaminophen – ASD/ADHD Products Liability Litigation, MDL No. 3043, before Judge Denise L. Cote in the Southern District of New York. It was set up in October 2022. Roughly 550 cases were revived by the appeals court in July 2026 and sent back to her.
The main defendant is Kenvue, the company spun out of Johnson & Johnson that now makes Tylenol. Alongside it are around fourteen retailers who sold store-brand acetaminophen, including Walmart, CVS, Walgreens, Target, Kroger, Costco and Rite Aid. The claim against all of them is the same: that the label should have said something and did not.
The cases are alive again, but they are back at the same place they got stuck. The fight over whether acetaminophen can cause these conditions starts over, on a fresh record, in front of the same judge.
Cases are being filed again. Lawyers are reviewing new claims now the federal litigation has reopened.
Check Whether You May QualifyWhat the Appeals Court Decided
In December 2023 Judge Cote ruled that the experts the plaintiffs planned to call could not testify about whether acetaminophen causes autism or ADHD. Without them the cases could not be proven, and in August 2024 she entered judgment for the companies. That was the end of it at the federal level.
On July 13, 2026 the Second Circuit reversed, and all three judges agreed. In a 64-page opinion written by Judge Guido Calabresi, the panel held the district court had gone too far in shutting the experts out. It reinstated three of them: Andrea Baccarelli, dean of the Harvard T.H. Chan School of Public Health; Eric Hollander, a psychiatry professor at the Albert Einstein College of Medicine; and Brandon Pearson, a toxicologist at Columbia. The panel found their methods were ones other scientists use, and their reading of the evidence a permissible one on a question where qualified people disagree.
Here is the part that gets lost in the headlines. The court decided what a jury is allowed to hear. It did not decide that Tylenol causes autism. Nobody has decided that. The companies can challenge the experts again as the case rebuilds, and the science they will point to includes a large Swedish study from 2024 that compared siblings and found the apparent link disappeared once family factors were taken into account. That study is covered on The Tylenol Autism Studies, Explained.
What Happened in September 2025
The announcement had been building for months. In April 2025 the Health Secretary said his department would identify the causes of autism, with results promised for September. The night before the event, the President described it as one of the biggest medical announcements in the country’s history and said he thought they had found an answer to autism.
On September 22 the press conference was held in the Roosevelt Room, with the Health Secretary, the FDA Commissioner and the head of Medicare and Medicaid alongside the President. Two things were announced about acetaminophen. The FDA would begin the process of changing the label to mention autism and ADHD, and it would write to doctors nationwide.
The President went considerably further than that. He told pregnant women not to take Tylenol, repeating it around a dozen times. He said there was no downside, that they would be uncomfortable and it would not be as easy, but to tough it out. He said to avoid it for the whole pregnancy, and not to give it to the baby after birth either. At points he said he was giving his own opinion rather than reporting research.
That is not what his own agency published. The FDA wrote that a causal relationship has not been established and that there are contrary studies in the literature. It named the research it was relying on, chiefly the Nurses’ Health Study II and the Boston Birth Cohort. It said acetaminophen is the only over-the-counter drug approved to treat fever in pregnancy, that high fevers can themselves put a baby at risk, and that aspirin and ibuprofen carry documented harms.
The letter to doctors asked for something narrower still. It asked them to consider cutting back for routine low-grade fevers, on the view that most short-term fevers in pregnancy need no medication, and in the same paragraph called acetaminophen the safest over-the-counter option in pregnancy of any painkiller or fever reducer. The Commissioner said publicly that the choice belongs with parents and that taking it remains reasonable in some situations.
The main science behind the move was a review published weeks earlier that pooled 46 existing studies. Its own authors said publicly that their work did not show Tylenol causes autism, and did not advise pregnant patients to stop taking it.
The response was immediate. The American College of Obstetricians and Gynecologists said no change in clinical practice was warranted. The Society for Maternal-Fetal Medicine restated that acetaminophen is appropriate for pain and fever in pregnancy, and reaffirmed that again in June 2026. Kenvue said the science shows its product does not cause autism. Autism research organisations objected that the evidence was too thin to carry the claim.
The administration itself softened over the following weeks. By late October the Health Secretary was saying the link was not enough to say acetaminophen definitely causes autism, though he called it very suggestive.
There is a detail here that connects the announcement to the court case. The main piece of science behind the FDA’s move was that 46-study review, whose senior author is Andrea Baccarelli, dean of the Harvard T.H. Chan School of Public Health. He is also one of the three experts the appeals court reinstated in July 2026. The government’s headline evidence and the plaintiffs’ reinstated expert are the same scientist.
It goes further than that. At the press conference the FDA Commissioner said the Harvard dean had stated there is a causal relationship. Fact-checkers found he had said it, in written testimony prepared for a lawsuit in 2023. In a statement put out before the press conference he said only that a causal relationship was possible.
Often described as a government report, none of this was one. A comprehensive report on the causes of autism had been promised for September 2025 and was not delivered.
What Happened to the Label Change
Nothing, so far. Nearly a year on, the label has not changed. What the FDA announced was the start of a process, not the change itself, and the process has not finished.
The reason is duller than a conspiracy and more useful to know. By the FDA’s own count, acetaminophen is in more than 600 medicines. Some are prescription and some are sold over the counter, and those are not just different approval routes. They are different documents.
A prescription product carries a long structured insert with a numbered section on pregnancy. An over-the-counter box carries a Drug Facts panel, which has no such section at all. There is nowhere obvious on it to put a warning of this kind. The FDA never said which route it was taking, or whether it meant to cover both, and lawyers watching it called the proposal territory the agency had not been into before.
Kenvue also gets to argue. How the FDA structures the change decides when the company can formally contest it, and Kenvue has rejected the government’s description of its product from the start. A fight over it was expected.
Worth knowing what the word means, too. The label is the written safety and prescribing information that comes with a medicine, not the printing on the box. Plenty of people took the announcement to mean Tylenol packaging would carry an autism warning. That was never what was proposed.
Why the Politics Matter Here
It would be easy to treat a White House press conference as noise around a court case. In this litigation it is not. These are failure-to-warn claims. The whole argument is that the label should have said something and did not. That makes what a regulator does with the label a piece of evidence rather than background.
When the FDA moved to add a warning, it helped one half of the plaintiffs’ case, the half that says a warning was owed. It did nothing for the harder half, which is proving the drug causes the condition, and the agency said as much in the same documents.
There is a second reason it matters. Companies in cases like these often argue that federal law blocks state lawsuits about a label the government approved. That argument is strongest when the regulator has looked at the question and chosen not to warn. It gets weaker once the regulator starts moving toward a warning. The same argument decided the Supreme Court’s Roundup ruling in June 2026, which is covered on Monsanto v. Durnell.
It cuts both ways, though. The defence can hold up the same FDA documents saying causation is not established, and point to the obstetricians who publicly refused to change their advice. A government that moves toward a warning while stating it has proved nothing hands each side something.
And regulatory positions move. The FDA called this evidence inconclusive in 2015 and moved on it in 2025. Administrations change and so do agency positions, which means whatever weight a court gives the current posture may not be the weight it carries in a few years. That is worth remembering before reading any single announcement as a turning point.
Recent Developments
A unanimous Second Circuit panel reversed the exclusion of the plaintiffs’ experts and revived roughly 550 dismissed cases against Kenvue and the retailers. The litigation returns to Judge Cote.
The FDA started a label update covering autism and ADHD while stating that causation is not established. Obstetricians publicly disagreed about what it meant for practice, keeping acetaminophen as their recommended option in pregnancy.
With no expert allowed to testify on causation, the court entered judgment for the defendants and the federal cases ended. Plaintiffs appealed.
Judge Cote excluded the plaintiffs’ general causation experts, finding their methods did not hold up. A later opinion dealt separately with the ADHD side of the case.
Eighteen lawsuits from seven parts of the country were moved into one court in New York and MDL 3043 was created. The number grew into the hundreds.
What Has Not Happened
Plenty of sites will tell you a Tylenol payout is coming. As of today, none of the following exists.
- No settlement, no settlement fund, and no payments to anyone
- No trial date and no schedule for test cases
- No court finding that acetaminophen causes autism or ADHD
- No completed FDA label change
Anyone quoting you a Tylenol settlement amount is inventing it. The revival restored the cases; it did not put money on the table.
Filing deadlines run on state law, and they did not pause while the cases were dismissed. Whether a particular history still supports a claim is a question about your own facts.
Start a Free Case ReviewIf You Are Pregnant and Reading This
This page is about a lawsuit, not about what you should take. Do not stop treating a fever because of something you read here. A high fever in pregnancy carries its own risks, and acetaminophen is still what most doctors recommend for it.
If the news has worried you, the person to talk to is your doctor or midwife, who knows your situation. Is Tylenol Safe During Pregnancy? sets out what the medical guidance currently says.
What People Often Watch For Next
- Whether the reinstated experts survive a fresh challenge from the companies.
- Whether the court sets a schedule for test cases.
- Whether the FDA finishes the label change it started.
- What happens in the state court cases running alongside the federal ones.
- Whether filings pick up again now the litigation is open.
Related Lawsuit Topics
Tylenol Autism Lawsuits
The main overview of who is involved and what is alleged.
Does Tylenol Cause Autism?
What the research shows, and where it is contested.
The Studies, Explained
Why different studies reach different conclusions.
Is Tylenol Safe During Pregnancy?
What the medical guidance currently says.
Acetaminophen and ADHD
The ADHD side of the same litigation.
What Is a Mass Tort?
How litigation like this is organized.
Find Out If You May Have a Case
If you took acetaminophen during pregnancy and your child was later diagnosed with autism or ADHD, a free case review can look at two things. Whether that history supports a claim, and whether your state’s deadline still allows one to be filed.
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