Parents across the United States have filed lawsuits alleging that prenatal exposure to acetaminophen-based medications, including Tylenol and store-brand generics, contributed to their children developing Autism Spectrum Disorder (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD). These cases raise important questions about product safety, warning labels, and what manufacturers and retailers knew – or should have known – about potential risks during pregnancy.U.S. District Court+1
Phillips Law Group is monitoring these developments closely and evaluating potential dangerous drugs claims for families in Arizona and nationwide.
Overview of the Acetaminophen Autism and ADHD Litigation
Beginning in 2022, hundreds of lawsuits were consolidated into a federal multidistrict litigation (MDL No. 3043) in the Southern District of New York. In that MDL, parents alleged that in utero exposure to acetaminophen caused their children to develop ASD and/or ADHD.U.S. District Court+1
Key points about the federal litigation include:
- The MDL centralized cases involving Tylenol and numerous store-brand acetaminophen products sold by major retailers.U.S. District Court+1
- In December 2023, the presiding judge excluded the plaintiffs causation experts and dismissed the MDL, finding their opinions unreliable under federal evidentiary standards.
- Plaintiffs appealed that ruling to the U.S. Court of Appeals for the Second Circuit. As of April 1, 2025, the appeal remained pending.
- In November 2025, a federal appeals panel questioned whether the MDL had been dismissed because expert evidence was improperly excluded, and more than 500 private lawsuits could potentially be revived.
At the same time, some families are pursuing related state-court lawsuits, and at least one state attorney general (Texas) has filed a case against Johnson & Johnson and Kenvue alleging deceptive marketing of Tylenol to pregnant women.
What These Lawsuits Allege
The core allegations in these acetaminophen/Tylenol autism and ADHD lawsuits are generally consistent:
- Defective and unsafe products: Plaintiffs allege that over-the-counter acetaminophen medications were defective when used during pregnancy because of an increased risk of ASD and ADHD in exposed children.
- Failure to warn: The lawsuits claim the manufacturer and major retailers failed to provide adequate warnings that prenatal use could increase the risk of neurodevelopmental disorders, even though they allegedly knew or should have known about emerging safety signals in the scientific literature.
- Design defects and negligent design choices: Some complaints allege acetaminophen products were defectively designed because safer alternative designs or different formulations were available or should have been considered for pregnant users.
- Negligent misrepresentation and omissions: Plaintiffs allege that marketing, labeling and promotional materials omitted material information about potential risks, misleading pregnant consumers into believing the products were completely risk-free.
- Breach of implied warranty and consumer protection violations: The claims often include breach of implied warranty of merchantability and violations of state consumer protection statutes, as well as references to federal product safety and labeling standards.
Many of these cases involve a mother suing on behalf of her minor children, alleging that consistent use of Tylenol or store-brand acetaminophen during pregnancy was followed by a later diagnosis of ASD, ADHD, or both.
Who Are the Defendants in Tylenol Lawsuits?
Defendants vary by case but typically include:
- The major manufacturer responsible for Tylenol and related brands (historically Johnson & Johnson, with current consumer product responsibilities now held by Kenvue).
- National retailers that sold store-brand acetaminophen products, such as big-box chains and pharmacy chains, depending on the particular lawsuit.
The lawsuits argue that these companies were in the best position to monitor emerging safety data, update warnings and communicate potential risks to physicians, pharmacists and pregnant consumers.
Evolving Scientific Evidence on Acetaminophen, Autism, and ADHD
The scientific evidence in this area is complex and still evolving, and it is important to understand that there is no universal consensus that acetaminophen use during pregnancy causes ASD or ADHD.
Some studies and reviews have suggested an association:
- A 2025 Harvard T.H. Chan School of Public Health analysis reported that prenatal acetaminophen exposure may be associated with a higher likelihood of certain neurodevelopmental disorders, including autism and ADHD.
- A 2025 paper in The BMJ reported small increases in autism and ADHD risk in some models, while acknowledging important limitations and potential confounding.
Other large studies and reviews have not found a causal link:
- A 2024 JAMA study involving sibling-control analyses found that acetaminophen use during pregnancy was not associated with an increased risk of autism, ADHD or intellectual disability when shared familial and genetic factors were controlled.
- A 2025 comprehensive review published in the British Medical Journal concluded there was no convincing evidence that acetaminophen use in pregnancy increases the risk of autism or ADHD, and that any apparent associations in earlier research may be due to genetics or other confounding factors.
Regulators and professional organizations are also responding:
- In September 2025, the U.S. Food and Drug Administration (FDA) issued a press release acknowledging evidence of a possible association between acetaminophen use during pregnancy and autism, initiating safety label updates and communications to health care professionals.
- The U.S. Department of Health and Human Services (HHS) has likewise highlighted potential risks in the context of expanding litigation and regulatory scrutiny.
- The Society for Maternal-Fetal Medicine (SMFM), however, continues to advise that acetaminophen remains an appropriate medication for treating pain and fever during pregnancy when used as directed, emphasizing that untreated high fever can itself pose risks to the fetus.
Because the medical science is mixed and still developing, decisions about medication use during pregnancy should always be made with a treating physician. This page is not medical advice.
Current Status of Tylenol Autism and ADHD Lawsuits
As of November 2025:
- The federal MDL in the Southern District of New York was dismissed in December 2023 after the judge excluded the plaintiffs expert witnesses on causation.
- Plaintiffs appealed that ruling to the Second Circuit, and oral argument took place in December 2024. The appellate court has not yet issued a final written decision, but recent reporting indicates that a panel of judges has questioned aspects of the dismissal, raising the possibility that over 500 lawsuits could be revived.
- Separate from the private lawsuits, the Texas attorney general filed a state-court lawsuit in October 2025 against Johnson & Johnson and Kenvue, alleging they misled pregnant consumers by failing to warn about alleged neurodevelopmental risks – claims that major medical organizations say remain unproven.
Because appeals and new filings are ongoing, the legal landscape surrounding Tylenol, acetaminophen, autism and ADHD is likely to continue evolving.
Legal Theories in Acetaminophen Product Liability Claims
Families bringing Tylenol/acetaminophen autism and ADHD lawsuits typically pursue several product liability and consumer protection theories, including:
- Strict liability – failure to warn: Alleging that labels and marketing failed to disclose known or knowable risks associated with prenatal exposure.
- Design defect: Claiming the product was unreasonably dangerous as designed for pregnant users, or that safer alternative designs or risk-mitigation measures should have been adopted.
- Negligence: Alleging that manufacturers and retailers failed to exercise reasonable care in researching, monitoring, testing and updating warnings as new evidence emerged.
- Negligent misrepresentation by omission: Asserting that companies omitted material facts or safety information that would have affected purchasing and usage decisions.
- Breach of implied warranty and consumer protection violations: Arguing that the products were not as safe as an ordinary consumer would expect and that marketing and labeling violated state consumer protection statutes and, in some cases, federal labeling standards.
The success of any individual case depends heavily on the specific facts, applicable state law, expert testimony and how courts ultimately treat the evolving scientific evidence.
What Evidence May Matter in a Tylenol or Acetaminophen Case
If a parent pursues a claim alleging that prenatal acetaminophen use contributed to a child’s ASD or ADHD, attorneys may review:
- Medical records documenting pregnancy, symptoms and recommended medications
- Records of acetaminophen/Tylenol use (prescription history, pharmacy records or purchase history where available)
- The childs pediatric and developmental records, including formal ASD or ADHD diagnosis
- Family and genetic history, which can be relevant both medically and legally
- Packaging, labeling or advertising relied upon during pregnancy
- Expert opinions in obstetrics, maternal-fetal medicine, pediatrics, neurology and epidemiology
An experienced product liability attorney can help families evaluate whether their circumstances may fit into the evolving Tylenol/acetaminophen litigation.
How Phillips Law Group Can Help
Product liability cases involving emerging science and large corporate defendants are complex. Phillips Law Group has decades of experience helping injured individuals and families hold manufacturers and other responsible parties accountable when defective products or inadequate warnings cause harm.
Our team can:
- Review your medical and product use history
- Evaluate whether your situation aligns with existing Tylenol/acetaminophen litigation theories
- Consult with qualified medical and scientific experts
- Explain your legal options under Arizona law and, where appropriate, coordinate with national litigation efforts
We handle product liability cases on a contingency fee basis. There are no upfront fees. You do not pay attorney fees unless we obtain compensation for you.
Talk With Our Team About Filing an Acetaminophen Lawsuit
If you used Tylenol or other acetaminophen-based medications during pregnancy and your child was later diagnosed with Autism Spectrum Disorder or ADHD, you may have questions about your legal rights.
Call Phillips Law Group at 602-222-2222 or contact us online to schedule a free, confidential consultation to discuss filing a tylenol, acetaminophen, autism, and AHDH lawsuit.
This page is for informational purposes only and is not medical advice. Always speak with your health care provider before making any decisions about medications during pregnancy.
(602) 222-2222 
