Texas Attorney General Ken Paxton sued Kenvue, the manufacturer of Tylenol, and its former parent company, Johnson & Johnson (J&J). The lawsuit alleges that the companies misrepresented the safety of acetaminophen by failing to disclose potential risks related to neurodevelopmental disorders. The case, which was filed in one of the state courts in Texas, is the first state-level lawsuit of its kind and occurred only a few weeks after President Donald Trump warned pregnant women against taking Tylenol, even though health authorities confirmed that there is no definitive study that can connect the medication to autism.
Paxton, a Republican candidate for the U.S. Senate, framed the lawsuit within the “Make America Healthy Again” initiative, a health campaign associated with Robert F. Kennedy Jr. He stated, “By holding Big Pharma accountable for poisoning our people, we will help make America healthy again.”
Kenvue responded by dismissing the claims, referring to the case as baseless. The company reported that it was tremendously concerned by the misinformation that was being propagated over the safety of acetaminophen, which is the active ingredient in Tylenol, and it asserted that the drug was the safest analgesic medication to be used by pregnant women when taken in moderation. In its clarification, J&J explained that Tylenol is no longer in its possession since it sold its consumer health division to Kenvue with all the rights and liabilities.
The FDA announced last month that it would begin the process of revising Tylenol’s label, noting that the use of acetaminophen, the drug’s active ingredient, during pregnancy may be associated with an increased risk of neurodevelopmental disorders such as autism and ADHD, although no causal relationship has been established. The agency added, however, that no causal relationship has been proved, and that some studies had not found a causal relationship, as well as that acetaminophen is the only recognized over-the-counter fever drug that is safe to use during pregnancy.
Conversely, the lawsuit filed by Paxton states that the federal government has affirmed that prenatal use of acetaminophen is probably the cause of autism. The suit claims the companies breached the Texas law by selling Tylenol as a safe drug and hiding the dangers, and that J&J fraudulently assigned its liabilities to Kenvue. It further asserts that as early as 2014, when an internal audit allegedly discovered indications indicating the presence of causal relation between acetaminophen and autism/ADHD, J&J was aware of the potential risks.
The case is similar to the claims of many individual plaintiffs that were consolidated in federal court in New York in 2022. This case was dismissed last year by the judge who discovered the unreliability of the expert witnesses of the plaintiffs, but the case is on appeal. The J&J 2023 spin-off of Kenvue is also alleged in the lawsuit filed by Texas, and was timed to offload any legal risks associated with Tylenol. In November 2021, J&J had announced an intention to spin off its consumer arm, and in February 2023, it revealed that it faced lawsuits over its Tylenol, but investors were more concerned with its talc-related cancer claims.
Ashley Keller, a lawyer involved in the federal Tylenol litigation, is representing Texas in the case. He claimed that he was contacted by the state officials following a September 22 news conference where Trump and Kennedy warned about the alleged risks of acetaminophen. After the incident, Aaron Siri, a longtime Kennedy friend, submitted a citizen petition to the FDA requesting that the labeling be changed to reflect the possibilities of correlating with autism and ADHD. Kenvue disagreed with the petition, terming the allegations as unscientific.
Researchers have been conducting studies on whether the use of acetaminophen during pregnancy affects fetal brain development, but no causal relationship has been established. The FDA mentioned that the reasons, such as the presence of maternal fever itself, where Tylenol is commonly used, might affect neurodevelopment, and it was hard to separate the connection between the drug and such disorders as autism and ADHD.
Reference: Gilbert D., Texas, sues Tylenol, taking cues from Trump and RFK Jr. The Washington Post. Published October 28, 2025. Accessed October 30, 2025. Texas sues Tylenol, taking cues from Trump and RFK Jr. The Washington Post
