Tylenol Lawsuit Updates

By David Meldofsky, California-licensed attorney

Last updated: September 14, 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.

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 the Tylenol manufacturer, named in the case as Johnson & Johnson Consumer Inc. and now known as Kenvue Brands LLC. Alongside it are about twenty retail companies that sold store-brand acetaminophen. The list in the court papers runs from the largest chains to the smallest. Walmart, Sam’s Club, Target, Costco, CVS, Walgreens, Rite Aid and Kroger are there. So are Albertsons, Safeway, Harris Teeter, Giant Food, Big Lots, 7-Eleven, Dollar General, Dollar Tree and Family Dollar. The claim against all of them is the same: that the label should have said something and did not.

Kenvue itself is being bought. Kimberly-Clark announced a deal for the company in November 2025, shareholders approved it in January 2026, and it is expected to close in the second half of this year. This litigation is one of the reasons analysts questioned the price. It does not change anyone’s claim, but it does mean the company answering for Tylenol may sit inside a different corporate parent by the time these cases move.

The cases are alive again, and they are back at the same place they got stuck. The fight over whether acetaminophen can cause these conditions runs again, in front of the same judge. The companies are expected to challenge the three reinstated experts a second time under the rule that governs expert testimony, and the appeals court suggested Judge Cote may want to have the parties and their experts address the studies published since 2023. That round of argument comes before anything resembling a trial.

One thing complicates that picture. In September 2026 the companies asked the appeals court to reconsider the ruling that revived the cases, so two courts are handling two different questions at the same time. Where the appeal sits now sets out who is deciding what.

What 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 U.S. Court of Appeals for the Second Circuit reversed her. That court sits in Manhattan and reviews decisions from the federal trial courts in New York, Connecticut and Vermont, which makes it the court directly above Judge Cote. Appeals there are heard by panels of three judges, and all three agreed here.

The consolidated appeals are Rutledge v. Walgreen Co. and Phippen v. Walgreen Co., and the 64-page opinion was written by Judge Guido Calabresi. The panel held that Judge Cote had gone too far in shutting the experts out.

She had excluded five. The panel put three of them back: 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 formerly at Columbia. It found that their methods are ones other scientists use, and that their reading of the evidence is a permissible one on a question where qualified people disagree. The exclusion of the other two stands. A separate group of ADHD-only cases went back to Judge Cote to take a second look at a fourth expert, Roberta Ness.

One of Judge Cote’s rulings survived the appeal, and that one helps the families. The companies had argued that federal drug labeling rules override claims like these. Both courts held otherwise. A manufacturer has to carry the standard pregnancy wording, and it remains free to add more.

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.

Where the Appeal Sits Now

Two courts are involved, and it helps to keep them apart. The lawsuits themselves are in the federal trial court in Manhattan, in front of Judge Cote, which is where the July ruling sent them. The July ruling is back in front of the Second Circuit, the appeals court that wrote it.

On September 10, 2026 the defendants filed a petition for rehearing or rehearing en banc. That is a request that the three judges who decided the appeal look at their own decision again, and failing that, a request that the full Second Circuit take the case up. The argument is about who screens expert testimony. The companies say the federal evidence rules make the trial judge the gatekeeper who decides whether an opinion is reliable enough for a jury to hear, and that the panel gave that role away by treating serious problems with an expert’s work as something for a jury to weigh rather than a reason to keep the expert out. They point to a 2023 rewrite of that rule, which was meant to strengthen the screening job, and argue the panel went the other way.

Their second argument is about how closely an appeals court may second-guess a trial judge. The panel was meant to leave Judge Cote’s ruling alone unless she got the law wrong or went outside the bounds of her discretion. The companies say it instead read the scientific studies for itself and reached its own conclusion, which is a different and much freer kind of review. Their narrower request is that the court hold the three reinstated experts are not “categorically admissible” and send that question back to Judge Cote.

The court can grant the request, deny it, or give the narrower relief. It answers on its own schedule, and it is free to deny without explaining why. Reconsideration is the exception rather than the rule, and the Second Circuit seldom revisits decisions it has already made.

What happens in each case

• The court denies it. The July ruling is final at the appeals level. The cases stay with Judge Cote, and the companies challenge the three experts again in front of her.
• The court gives the narrower relief. The experts go back to Judge Cote for a fresh examination under the evidence rules, with instructions from the appeals court about how to run it.
• The court agrees to rehear the appeal. The expert question reopens at the appeals level, in front of the same three judges or the full court. The cases stay on the docket while that runs, and the trial court is likely to wait for the answer.

Two of those three roads lead to the same place: a second argument in front of Judge Cote about whether Baccarelli, Hollander and Pearson may testify. That argument is the next real event in this litigation. Whoever loses it can appeal again, and whoever loses the rehearing question can ask the Supreme Court to hear the case, which the Supreme Court is free to decline. Each of those steps takes months rather than weeks.

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

Nearly a year on, the label still reads the way it did before. The federal label record for Tylenol Regular Strength carries one sentence about pregnancy in its warnings, telling anyone pregnant or breastfeeding to ask a health professional first. That is the same wording it carried before September 2025, and it survived a routine label revision filed in May 2026 without any neurodevelopmental language being added. 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, and it has. The company rejected the government’s description of its product from the start and filed a petition with the FDA disputing it. How the agency structures any change decides when a company can formally contest it, so a fight over this was expected and it arrived.

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. Some coverage went further and reported the label as already updated, which is where a lot of the confusion comes from. What the FDA announced was the start of a process.

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

Where Settlement and Trial Actually Stand

Plenty of sites will tell you a Tylenol payout is coming. Here is where each piece of that stands today.

• Settlement: nothing negotiated, no fund established, no payments to anyone
• Trial: no date set, and no schedule yet for the test cases
• Causation: no court has found that acetaminophen causes autism or ADHD
• Label: the FDA change is still in process
• Appeal: the companies have asked the appeals court to reconsider, and it has not ruled

Anyone quoting you a Tylenol settlement amount is inventing it. The revival put the cases back on the docket, which is where they are now. Money is a later question, if it comes at all.

If 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 Second Circuit grants the rehearing request the companies filed in September 2026.
• 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.

Sources

• U.S. Court of Appeals for the Second Circuit, opinion of July 13, 2026 in Rutledge v. Walgreen Co. and Phippen v. Walgreen Co. — the ruling on the experts, the panel that decided it, and the separate holding on federal labeling rules.
• Reuters, September 11, 2026, on the defendants’ September 10 filing in Rutledge v. Walgreen Co., No. 24-916 (2d Cir.) — what the companies asked the appeals court to do, the gatekeeping argument they made, the retailers named as defendants, and how rarely the court reconsiders its own decisions.
• Defendants-Appellees’ Petition for Rehearing and/or Rehearing En Banc, In Re: Acetaminophen — ASD-ADHD Products Liability Litigation, No. 24-916(L) (2d Cir. September 10, 2026), docket entry 292 — the filing itself: the two grounds the companies argue, the alternative relief they ask for, and the full list of defendants in the caption.
• Southern District of New York, Judge Cote’s December 2023 expert opinion in MDL 3043 — the ruling that excluded the plaintiffs’ causation experts and led to judgment for the companies.
• FDA news release, September 22, 2025 — the announcement itself, including the agency’s statement that a causal relationship has not been established and that there are contrary studies.
• FDA, Notice to Physicians on the Use of Acetaminophen During Pregnancy — the letter sent to doctors alongside the announcement.
• American College of Obstetricians and Gynecologists, practice advisory on acetaminophen in pregnancy — the response from the obstetricians’ professional body, and its guidance on clinical practice.
• Kenvue statement on the Second Circuit ruling — the company’s own position on the decision and on the science.

Figures and dates above should be confirmed against the original sources.

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About the Author

David Meldofsky is a California-licensed attorney and the founder of Lawsuit Informer, an educational platform focused on helping people understand lawsuits, consumer safety issues, and legal rights related to defective products and toxic exposures.

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Last Updated: September 14, 2026

Educational information only. Not legal advice. No attorney-client relationship is formed.