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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 some studies suggest a correlation between taking Tylenol while pregnant and having a child with autism, others have repudiated those findings. Major medical associations rejected Kennedy and Trump’s claims as overly generalized and potentially harmful.
Kenvue, the corporate subsidiary that makes Tylenol, said in a statement that it would vigorously defend itself against Paxton’s claims in court.
“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,” the company said in a statement.
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 represented Texas in litigation against Google and Meta, and has been contracted by the attorney general’s office to handle this new lawsuit against Johnson and Johnson.
“[Paxton] figured I knew the science, I knew the history, I knew a lot of the moving parts,” Keller said in an interview. “And so I’d be an obvious choice to pursue this for Texans.”
Paxton, who is running in the GOP primary to unseat U.S. Sen. John Cornyn, said in a statement announcing the lawsuit that “by holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”
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. Researchers attribute 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 debunked theory 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 $50 million toward research.
Relabeling Tylenol was one of his first steps. Kennedy pointed to an August study 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’s hard to get a “100% definitive case closed on any topic” in epidemiology, Dr. Brian Lee, a Drexel University epidemiologist who authored that study, told the Johns Hopkins Bloomberg School of Public Health podcast. 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, “the needle is pointing strongly toward there being no causal effect of acetaminophen use during pregnancy on autism.”
Keller, the lawyer leading the litigation against Johnson and Johnson, said it’s better to inform people about the potential risks, and the uncertainty around them, and let them make their own decisions based on that.
“It is mind boggling to me that these major medical organisations would say, ‘We aren’t sure, and therefore we should say nothing,’” he said. “The opposite is true: We are not sure, and therefore we should sound the alarm.”
A federal judge recently excluded the expert witnesses that Keller had planned to present in the consolidated litigation against Johnson and Johnson, “supposedly because the science wasn’t strong enough,” he said. That decision has been appealed to the 2nd U.S. Circuit Court of Appeals.
The lawsuit
Paxton’s lawsuit builds on these claims, saying Johnson and Johnson “willfully ignored and attempted to silence the science” 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’s main assets from liability.
“Given 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,” the lawsuit said.
As attorney general, Paxton has a different avenue into court than an individual trying to prove that Tylenol caused their child’s 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.
“That 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,” Keller said.
Texas has repeatedly sued Johnson and Johnson over the years, negotiating a $290 settlement over the company’s 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 anti-schizophrenia drug, Risperdal.
by Eleanor Klibanoff, The Texas Tribune
This article first appeared on The Texas Tribune.
