On October 28, 2025, Texas Attorney General Ken Paxton filed a sweeping lawsuit against pharmaceutical giants Johnson & Johnson and its spin-off Kenvue, alleging they concealed evidence that prenatal use of Tylenol (acetaminophen) may increase the risk of autism and ADHD in children. The lawsuit, filed in Texas state court, seeks damages estimated in the tens of billions of dollars and accuses the companies of violating consumer protection laws by marketing Tylenol as safe for pregnant women without adequate warnings.
This legal action marks the first successful state-level effort to pursue claims that had previously stumbled in federal courts. According to IBTimes, Paxton’s case is buoyed by recent public statements from former President Donald Trump and Health Secretary Robert F. Kennedy Jr., both of whom have repeatedly suggested a link between Tylenol use during pregnancy and autism—a claim lacking definitive scientific backing.
Paxton, a Republican currently running for the U.S. Senate, invoked Kennedy’s “Make America Healthy Again” (MAHA) agenda in his announcement, framing the lawsuit as part of a broader crusade against what he terms “Big Pharma.” “By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again,” Paxton stated, echoing the rhetoric of both Kennedy and Trump.
The Texas complaint is ambitious in scope. It alleges that Johnson & Johnson and Kenvue suppressed or ignored scientific signals linking prenatal acetaminophen exposure to neurodevelopmental disorders. The suit cites over 26 epidemiological studies, some demonstrating dose-response relationships, to argue that the evidence warrants both warning labels and liability. Additionally, it accuses Johnson & Johnson of fraudulently transferring liabilities to Kenvue during its 2023 spin-off to shield itself from future claims.
Despite the aggressive legal strategy, the scientific community remains divided. Many epidemiological studies show mixed or modest associations, often hampered by confounding factors and reliance on maternal recall data. In fact, dozens of related lawsuits were consolidated into a multi-district litigation (MDL) overseen by Judge Denise Cote, who dismissed the claims late last year, criticizing expert testimony as methodologically flawed, according to IBTimes.
Meanwhile, Kenvue responded swiftly to the Texas suit, dismissing the allegations as “baseless” and reaffirming the longstanding safety record of acetaminophen for pregnant women. “We stand firmly with the global medical community that acknowledges the safety of acetaminophen and believe we will continue to be successful in litigation as these claims lack legal merit and scientific support,” Kenvue said in a statement, as reported by Reuters and Axios.
The controversy intensified when, on October 29, 2025, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. partially walked back his earlier, more definitive claims about Tylenol’s risks. In a news conference, Kennedy struck a more moderate tone, stating, “The causative association between Tylenol given in pregnancy and the perinatal periods is not sufficient to say it definitely causes autism, but it’s very suggestive.” He added, “There should be a cautious approach to it. That’s why our message to patients, to mothers, to people who are pregnant and to the mothers of young children is: Consult your physician.”
This statement aligns more closely with guidance from reputable health agencies. The World Health Organization reiterated in September 2025 that “no consistent association has been established” between the medication and autism, despite “extensive research.” The U.S. Food and Drug Administration, in a news release initiating a label reassessment, echoed this stance, noting that while an association has been described in many studies, a direct link “has not been established and there are contrary studies in the scientific literature.”
Nevertheless, the claims made by Trump and Kennedy have had a tangible impact. In a September 22, 2025, news conference, President Trump asserted, “[Using] acetaminophen – is that OK? – which is basically, commonly known as Tylenol, during pregnancy can be associated with a very increased risk of autism. So taking Tylenol is not good. I’ll say it. It’s not good.” Earlier in October, Kennedy had gone further, saying, “Anyone who takes this stuff during pregnancy, unless they have to, is irresponsible.”
These high-profile statements have prompted efforts to limit Tylenol’s availability and fueled a wave of legal actions. According to Axios, the Texas lawsuit points to the Trump administration’s recent actions tying Tylenol use during pregnancy to autism and ADHD as validation of its claim, declaring that “the reckoning has arrived.” The suit specifically quotes Trump, Kennedy, and Food and Drug Administration Commissioner Marty Makary, asserting that a proposed safety label change addressing Tylenol use during pregnancy “was supported by ample scientific evidence.”
The legal and political context of this case cannot be ignored. As Axios notes, it is not new for lawsuits to allege, without solid proof, that certain drugs do harm. What is new is when they cite the president and the country’s top federal health official to make their case. Legal experts warn that while such rhetoric may sway public opinion, it is unlikely to hold up in court, where evidence is paramount. “I think any of [the] rhetoric that’s not grounded in science is concerning,” said Richard Hughes, a professor of vaccine law at George Washington University. “It lends itself to this environment where anyone who’s litigious could be incentivized to go out and bring a suit.”
Experts also caution that lawsuits like Texas’ can be damaging for pharmaceutical companies, even if they ultimately fail in court. “It just damages public confidence,” Hughes added. There are also concerns that such legal actions could incentivize further litigation, potentially driving vaccine manufacturers and other drug makers out of the U.S. market if liability protections are weakened.
The stakes are high. Should Texas succeed in its case, it could open the floodgates for similar state-led lawsuits, reshaping liability norms and risk assessments across the pharmaceutical industry. The American College of Obstetricians and Gynecologists, among other medical groups, has criticized the government’s messaging as potentially dangerous, warning that untreated fever and inflammation during pregnancy can pose real risks to fetal development.
Public trust in health messaging is already showing signs of erosion. A recent Kaiser Family Foundation poll found that confidence in health information has sharply declined following the administration’s warnings about Tylenol, leaving many pregnant women unsure whom to trust or what medications are safe.
As this high-profile legal and political battle unfolds, it underscores the growing intersection of health science, politics, and legal strategies—raising difficult questions about the future of medical regulation, corporate accountability, and public trust. The outcome of the Texas lawsuit could set a precedent for how scientific uncertainty and political rhetoric shape the legal landscape for drug manufacturers and the health decisions of millions of Americans.
For now, the best advice for expectant mothers remains the oldest: consult your physician before taking any medication, and weigh the risks and benefits with a trusted healthcare provider. The story of Tylenol, autism, and the power of political rhetoric is far from over.
