By Sofia Bennett, Staff Writer
On October 27, 2025, Ken Paxton, the Attorney General of Texas, filed a complaint on behalf of the state against Johnson & Johnson (J&J), Kenvue, Inc., and Kenzie Brands LLC., the manufacturers of Tylenol.[1] Texas alleged J&J made deceptive marketing claims about Tylenol.[2] Texas claimed J&J hid the risks of the drug’s active ingredient, acetaminophen, to small children and pregnant women, despite mounting scientific evidence.[3] Texas’ claim cited scientific research linking early and prenatal acetaminophen exposure with increased rates of autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD).[4] Texas further asserted J&J failed to make the necessary changes to Tylenol’s’ labelling to more accurately reflect Tylenol’s pregnancy risk factors.[5]
The main study cited in Texas’s complaint is the Harvard study, “Evaluation of the evidence on acetaminophen use and neurodevelopmental disorders using the Navigation Guide methodology.”[6] In this study, researchers analyzed results from 46 previous studies using the Navigation Guide Systematic Review methodology, a highly regarded analysis tool for evaluating environmental health data.[7] Of the studies, 25 yielded a positive association between acetaminophen exposure and neurodevelopmental disorders, such as ASD and ADHD. Additionally, 7 studies had null results, and 14 studies had mixed or inverse results.[8] The overarching study noted that while acetaminophen use should be limited in pregnancy, it is the only safe medication to treat pain and fever during pregnancy.[9]
J&J vociferously responded to Texas’s complaint on November 6, 2025, and insisted the claim lacked scientific evidence, and intended to take immediate legal action to prevent further reckless and unsound theories, such as those in Texas’s complaint.[10] J&J cited FDA evaluated research supporting a causal link between acetaminophen and neurodevelopmental disorders for over a decade, which repeatedly concluded no causation was present.[11] J&J insisted such legal action was unnecessary and would harm Texas women and children, as the risks of untreated fever are greater than an unproven causal relationship between acetaminophen and neurodevelopment disorders.[12]
Acetaminophen has long been declared safe for use during pregnancy by the American College of Obstetricians and Gynecologists (ACOG). This was recently confirmed in a statement from the president of ACOG, when he reiterated that,“[i]n more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children.”[13] The ACOG president also expressed that acetaminophen is the only safe available option to prevent pain, fever, headaches, and manage preeclampsia during pregnancy.[14]
Despite the FDA concluding there is no causal relationship between acetaminophen and neurodevelopment disorders, lawsuits such as this could challenge the marketing and labeling of acetaminophen, regardless of the FDA’s regulatory practices.[15] The FDA requires drug manufacturers to either make or not make certain statements regarding product labeling.[16] If this authority is challenged the FDA will have to provide statutory and constitutional justification for acetaminophen labeling requirements.[17] While the case is still in its early stages, if Texas prevails it will be able to pursue acetaminophen labeling enforcement, regardless of the FDA’s drug labeling requirements.[18] Potentially opening up the floodgates for other states to take similar action, even when the strength of the scientific evidence is questionable.[19]
[1] https://www.texasattorneygeneral.gov/sites/default/files/images/press/Lawsuit.pdf
[2] Id.
[3] Id.
[4] Id.
[5] Id.
[6] https://ehjournal.biomedcentral.com/articles/10.1186/s12940-025-01208-0
[7]https://hsph.harvard.edu/news/using-acetaminophen-during-pregnancy-may-increase-childrens-autism-and-adhd-risk/
[8] https://ehjournal.biomedcentral.com/articles/10.1186/s12940-025-01208-0
[9] Id.
[10] https://www.kenvue.com/media/statement-in-response-to-texas-ag-filing
[11] Id.
[12] Id.
[13] Id.
[14] Id.
[15] https://natlawreview.com/article/texas-sues-johnson-johnson-and-kenvue-over-tylenol-scientific-evidence-regulatory
[16] Id.
[17] Id.
[18] Id.
[19] Id.