Kenvue’s Tylenol headache, predicated on dubious and unproven claims linking the popular OTC pain and fever drug to autism, just won’t let up.
On Tuesday, Texas Attorney General Ken Paxton unleashed a new lawsuit against Kenvue, alleging that the Johnson & Johnson consumer health spinoff “deceptively” marketed Tylenol to pregnant mothers despite knowing that early exposure to the drug’s active ingredient, acetaminophen, can cause a “significantly increased risk of autism and other disorders.”
Kenvue, which has already pushed back on the alleged Tylenol-autism link drawn by the Trump administration in September, wasted no time issuing a rebuttal.
“We are deeply concerned by the perpetuation of misinformation on the safety of acetaminophen and the potential impact that could have on the health of American women and children,” the drugmaker wrote in an Oct. 28 statement responding to the lawsuit.
Acetaminophen’s safety profile is well-established in pregnant women and without it, those expectant mothers would face a “dangerous” choice between suffering through fevers—which can be harmful to both the mother and baby—or turning to “riskier alternatives” for treatment, Kenvue warned.
In late September, President Donald Trump—flanked by HHS Secretary Robert F. Kennedy Jr. and other prominent leaders of the U.S. federal healthcare system—delivered the apparent fruits of an investigation into the country’s “autism epidemic,” laying the blame in part on the use of Tylenol by pregnant women.
As part of the findings, which have been roundly rejected by much of the medical community, the FDA said it had started the process to change the safety label of acetaminophen. About a week ago, Kenvue urged the regulator to refrain from making any label changes.
In the lawsuit (PDF), Texas AG Paxton accused Tylenol’s original manufacturer, J&J, of “willfully” ignoring and attempting to “silence the science” that prenatal and early-childhood exposure to Tylenol could be harmful to kids.
J&J officially spun off Kenvue as an independent consumer health company in the summer of 2023, which Paxton framed as part of the drug giant’s strategy to avert Tylenol liability.
“[S]eeing that the day of reckoning was coming, Johnson & Johnson attempted to escape responsibility by illegally offloading their liability onto a different company,” Paxton wrote in a press release announcing the lawsuit.
Kenvue, for its part, said it believes the lawsuit relies on a “deliberate distortion of the facts” and accused Paxton of attempting to “revive legal claims that have already been thrown out of federal court.”
Kenvue stressed that it plans to “vigorously defend” itself against the AG’s claims in court.
Paxton’s lawsuit comes roughly a week after Kenvue urged the FDA against potential acetaminophen label updates by laying out 42 pages of evidence supporting the safety of Tylenol.
Aside from furnishing the regulator with half a century’s worth of research on the drug, Kenvue also highlighted the FDA’s own long-held position on the use of acetaminophen during pregnancy. The company argued that at this point, a label change would mark an “unexplained departure” from the agency’s enduring position that Tylenol is safe for pregnant mothers when used correctly.