Texas Attorney General Ken Paxton is suing Johnson and Johnson, accusing the pharmaceutical company of failing to warn consumers about the risk of taking Tylenol while pregnant.
This lawsuit, the first of its kind from a state government, comes a month after President Donald Trump and U.S. Secretary of Health and Human Services Robert F. Kennedy, Jr. announced updated guidance discouraging pregnant women from taking acetaminophen, citing it as a possible cause of autism. The announcement set off a wave of controversy in the health care community, and confusion among pregnant women unsure how they should manage fever and pain during pregnancy.
The science around Tylenol and autism is uncertain. While suggest a correlation between taking Tylenol while pregnant and having a child with autism, have repudiated those findings. Major medical associations rejected Kennedy and Trump鈥檚 claims as overly generalized and potentially harmful.
鈥淭he conditions people use acetaminophen to treat during pregnancy are far more dangerous than any theoretical risks and can create severe morbidity and mortality for the pregnant person and the fetus,鈥� Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, .
But this issue has been bubbling up for far longer than Trump and Kennedy have been in office. Dozens of people have filed personal injury lawsuits against Johnson and Johnson, and its corporate spin-off, Kenvue, alleging adverse neurodevelopment outcomes for their children after taking Tylenol while pregnant.
Those cases have been consolidated into multi-district litigation, which is still making its way through the courts and being led by Ashley Keller of Chicago law firm Keller Postman. Keller has in litigation against Google and Meta, and has been contracted by the attorney general鈥檚 office to handle this new lawsuit against Johnson and Johnson.
鈥淸Paxton] figured I knew the science, I knew the history, I knew a lot of the moving parts,鈥� Keller said in an interview. 鈥淎nd so I鈥檇 be an obvious choice to pursue this for Texans.鈥�
Paxton, who is running in the GOP primary to unseat U.S. Sen. , said in a statement announcing the lawsuit that 鈥渂y holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.鈥�
What the science says
Autism affects approximately one in 31 American children, and the rate of diagnoses has increased almost 300% over the last 20 years. that rise to better screening and an expanded definition of the spectrum of behaviors that qualify for a diagnosis.
Kennedy, in contrast, has long blamed the that autism is caused by common childhood vaccines. Since becoming health secretary, Kennedy has vowed to figure out and eliminate the root causes of autism, putting .
Relabeling Tylenol was one of his first steps. Kennedy pointed to from the Harvard School of Public Health and Mount Sinai Hospital that found pregnant women who reported taking acetaminophen seemed to be slightly more likely to have a child diagnosed with autism, a conclusion other studies have reached over the years.
But one of the largest studies, which looked at the health records of 2.5 million children born in Sweden over 25 years, found that link went away when they looked at siblings where the parent took acetaminophen during one pregnancy but not the other.
It鈥檚 hard to get a 鈥�100% definitive case closed on any topic鈥� in epidemiology, Dr. Brian Lee, a Drexel University epidemiologist who authored that study, told . It would be unethical to give pregnant women Tylenol just to see if they have a child with autism, so researchers must rely on less definitive methods to determine how great the risk is.
While more research is needed, he said, right now, 鈥渢he needle is pointing strongly toward there being no causal effect of acetaminophen use during pregnancy on autism.鈥�
Kenvue, the maker of Tylenol, has refuted the claims of a connection.
鈥淚ndependent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with allegations that it does and are deeply concerned about the health risks and confusion this poses for expecting mothers and parents,鈥�
Keller, the lawyer leading the litigation against Johnson and Johnson, said it鈥檚 better to inform people about the potential risks, and the uncertainty around them, and let them make their own decisions based on that.
鈥淚t is mind boggling to me that these major medical organisations would say, 鈥榃e aren't sure, and therefore we should say nothing,鈥欌�� he said. 鈥淭he opposite is true: We are not sure, and therefore we should sound the alarm.鈥�
A federal judge recently excluded the expert witnesses that Keller had planned to present in the consolidated litigation against Johnson and Johnson, 鈥渟upposedly because the science wasn't strong enough,鈥� he said. That decision has been appealed to the 2nd U.S. Circuit Court of Appeals.
The lawsuit
Paxton鈥檚 lawsuit builds on these claims, saying Johnson and Johnson 鈥渨illfully ignored and attempted to silence the science鈥� around acetaminophen and autism. Paxton takes specific aim at a spin-off company, Kenvue, which the suit says was only created to shelter Johnson and Johnson鈥檚 main assets from liability.
鈥淕iven the prevalence of acetaminophen use and these conditions, there is little doubt that Defendants will have to pay tens of billions of dollars in damages to children who were permanently injured from acetaminophen use,鈥� the lawsuit said.
As attorney general, Paxton has a different avenue into court than an individual trying to prove that Tylenol caused their child鈥檚 autism. While those lawsuits focus on personal injury claims, this suit hinges on two state consumer protection laws, the Uniform Fraudulent Transfer
Act and the Deceptive Trade Practices Act.
鈥淭hat overlaps a lot with the science and with the argument that is going on about Tylenol right now, but it's ultimately a different burden of proof and different damages that we're going to be seeking,鈥� Keller said.
Texas has repeatedly sued Johnson and Johnson over the years, negotiating a $290 settlement over the company鈥檚 role in the opioid epidemic in 2021; tens of millions of dollars in settlements over medical devices; and $158 million for deceptive marketing of the .
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