Texas Attorney General Ken Paxton filed a lawsuit on October 28, 2025, against Johnson & Johnson and Kenvue, the companies behind Tylenol, alleging that the manufacturers deceptively marketed the over-the-counter painkiller to pregnant women while concealing research that links prenatal and early childhood exposure to acetaminophen (paracetamol) with an increased risk of autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD).
The suit marks the first state-level litigation to assert a causal relationship between acetaminophen — the active ingredient in Tylenol — and neurodevelopmental conditions in children, and it arrives amid heightened public attention and political debate about the safety of acetaminophen during pregnancy. The complaint, filed in Panola County, Texas, accuses the companies of violating state consumer protection laws, misrepresenting product safety to expectant mothers, and attempting to shift liabilities between corporate entities to avoid accountability.
What Texas is alleging
The complaint paints a sweeping picture: for decades, the companies marketed Tylenol as safe for pregnant women and children without warning about the alleged long-term developmental risks of prenatal exposure, even though, the suit claims, the companies were aware of — or deliberately disregarded — scientific studies pointing to associations between acetaminophen use and higher rates of ASD and ADHD. It seeks civil penalties, damages under Texas consumer-protection statutes (including statutory damages of $10,000 per violation where applicable), and injunctive relief to remove or alter marketing claims that the state says are misleading.
Paxton’s office frames the case not only as a consumer-protection action but also as an effort to hold large pharmaceutical manufacturers accountable for public health consequences, arguing that some pregnant women relied on safety assurances when using Tylenol and that a lack of adequate warnings put unborn children at risk. The lawsuit also accuses Johnson & Johnson of attempting to shield itself by transferring the Tylenol business to Kenvue following the latter’s 2023 separation from J&J.
Scientific background — association versus causation
Central to evaluating the lawsuit is the distinction between association and causation. Over the past decade, multiple epidemiological studies have reported associations between maternal acetaminophen use during pregnancy and modestly elevated risks of neurodevelopmental outcomes such as ADHD or ASD in children. These studies rely largely on observational data — surveys of maternal medication use paired with follow-up of child developmental diagnoses — and while they raise questions, they cannot, by design, conclusively prove that acetaminophen causes autism. Confounding factors (for example, the underlying reason a pregnant person took the medication, genetic predisposition, environmental exposures, or inaccuracies in reporting) complicate interpretation. Major medical organizations and regulators have generally urged caution in interpreting the literature and have not concluded that acetaminophen is a proven cause of autism.
The Texas complaint cites scientific papers and an FDA press announcement that acknowledged ongoing review of evidence about a possible association between prenatal acetaminophen exposure and neurodevelopmental outcomes. But the weight of expert opinion from obstetrics and pediatric professional bodies — which typically advise that acetaminophen remains the preferred analgesic/antipyretic in pregnancy when needed — remains skeptical that current evidence establishes causality. The FDA itself, in recent messaging, has emphasized that evidence is still evolving and recommended that pregnant people consult with their health care providers about the benefits and risks of treatment for fever or pain.
Political and public context — why now?
The lawsuit did not arise in a vacuum. In September and October 2025, public figures including former President Donald Trump and Health Secretary Robert F. Kennedy Jr. renewed assertions suggesting a link between acetaminophen (and broader concerns posed by certain perinatal medical practices) and autism. Those high-profile statements amplified public concern and spurred policymakers and some legal actors to act. Paxton’s filing is explicitly timed amid that surge of attention, and his press release frames the case as protecting Texas families from “Big Pharma” misinformation. Critics of the lawsuit, including physicians and scientific societies, immediately characterized Paxton’s move as politically charged, cautioning that litigation based on unsettled science risks sowing confusion and deterring appropriate medication use during pregnancy.
The defendants’ response
Kenvue, which took over Tylenol’s consumer-health business following Johnson & Johnson’s corporate split, issued a swift denial, calling the lawsuit “legally and scientifically without merit.” Kenvue emphasized that acetaminophen is widely recommended by clinicians as the safest option for treating pain and fever in pregnancy when necessary, and that the company will vigorously defend itself in court. Johnson & Johnson, which previously manufactured Tylenol for decades, has highlighted that liability for the product rests with Kenvue following the corporate separation, and it declined to comment directly on aspects of the legal strategy.
Medical and professional groups also weighed in: the American College of Obstetricians and Gynecologists (ACOG) and other experts reiterated the need to treat fever in pregnancy and recommended that individuals discuss treatment options with clinicians rather than avoiding medically indicated medication out of fear. Public health communicators warned that headlines conflating association with causation could lead some pregnant people to avoid treatment for fever — a condition that itself can pose risks to fetal development if left untreated.
Legal strategy, hurdles, and what to expect in court
From a legal perspective, the Texas lawsuit blends consumer-protection claims (fraudulent or deceptive marketing) with product-liability-style allegations tied to harms allegedly traceable to a product’s use. To succeed, Texas will have to prove that the companies engaged in deceptive practices in how they marketed Tylenol and that those practices caused consumers to be misled in a way that violates state law. Establishing that acetaminophen causes autism — a complex neurodevelopmental condition with multifactorial origins — would be a tall evidentiary hill; courts typically rely on expert testimony and peer-reviewed science to resolve such causation issues in product-liability matters.
Defendants will almost certainly attack both the legal theory (arguing the state cannot harness consumer-protection statutes to litigate complex scientific debates) and the factual basis (challenging the causal link and emphasizing the consensus guidance of medical authorities). They will also likely move to dismiss on jurisdictional or procedural grounds, and Johnson & Johnson may contest allegations that it improperly shifted liabilities to Kenvue. If the case survives preliminary motions, the discovery process could force broad document production and depositions, potentially drawing out what may become a protracted legal battle.
Public health implications and risks of mixed messaging
One of the most consequential knock-on effects of the lawsuit is its potential influence on public behavior. Unclear or sensationalized reports can cause pregnant people to make medication decisions without clinical guidance. Fever is not benign in pregnancy — high maternal fever in the first trimester has been associated with certain birth defects — and acetaminophen has, until now, been widely promoted as a safer antipyretic than alternatives. Public health authorities worry that overreaction to preliminary or associative studies could discourage appropriate use, leading to worse outcomes that are directly preventable.
At the same time, the lawsuit highlights legitimate questions: should labeling for common over-the-counter medicines do more to reflect evolving science? How should manufacturers, regulators, and clinicians balance the risks of undertreatment against uncertain long-term associations? Those are complex policy issues that intersect with regulatory standards for warning labels, the threshold of evidence required to mandate warnings, and how to communicate risk transparently without causing undue fear. The case will test legal and regulatory boundaries about when the state can demand stronger warnings based on epidemiological associations that have not achieved consensus as causal.
Voices from clinicians, researchers, and families
Reactions among clinicians and researchers were mixed but largely cautious. Some epidemiologists say the body of literature linking prenatal acetaminophen exposure to neurodevelopmental changes deserves careful monitoring and further study, including better controlled studies that minimize confounding and use biomarkers to confirm exposure. Others stress that current observational data show modest relative risks and do not settle causality. Clinicians emphasize that treatment decisions during pregnancy should consider immediate risks (like high fever) and be made in consultation with a health professional.
Advocacy groups for families affected by autism reacted in varied ways — some welcomed a legal push that could increase research funding and corporate accountability, while others warned against scapegoating a single medication when autism’s causes are complex and multifactorial. Parents who believe environmental contributors played a role in their children’s developmental histories may see litigation as an avenue for answers, whereas many scientists caution that legal processes are not always the best forum for resolving nuanced scientific questions.
What this means for consumers
For now, major medical organizations still advise that acetaminophen remains the recommended option for fever and pain during pregnancy when clinically indicated, in the lowest effective dose for the shortest necessary duration. Pregnant people who are worried about any medication should speak with their obstetric provider to weigh benefits and risks in the context of their medical history and symptoms. Meanwhile, consumers should be aware that litigation is one piece of a broader dialogue — scientific studies, regulatory reviews, and clinical guidance will continue to evolve, and a court’s decision in Texas may be appealed and could ultimately join other litigation if more states pursue similar claims.
The road ahead
The Texas suit is likely to draw fierce litigation energy from both sides: expansive discovery requests could unearth internal industry documents and scientific communications, while defendants will marshal expert witnesses and epidemiological critiques to challenge causation. The outcome could hinge less on whether acetaminophen is definitively proven to cause autism and more on whether the state can convincingly show that marketing practices were misleading under Texas law. Regardless of the legal result, the case will amplify public debate about how society responds when observational science raises questions about widely used medications taken during sensitive developmental windows like pregnancy.
Conclusion
The lawsuit filed by Texas’s attorney general represents a high-profile, politically charged attempt to translate an unsettled scientific literature into a legal accountability claim against the manufacturers of one of the world’s most commonly used pain relievers. It forces an uncomfortable but necessary public conversation: how to responsibly communicate evolving scientific uncertainty to pregnant people who must balance immediate symptoms with potential long-term risks for their children. In the near term, clinicians, public health agencies, and families will watch the case closely — not only for legal precedent but for how it shapes the communication and regulation of medication safety during pregnancy.
