Texas Attorney General Ken Paxton is suing Johnson & Johnson, accusing the pharmaceutical company of failing to warn consumers about the risks of taking Tylenol during pregnancy. This lawsuit—the first of its kind brought by a state government—follows a recent announcement from President Donald Trump and U.S. Secretary of Health and Human Services Robert F. Kennedy Jr., who issued updated guidance discouraging pregnant women from using acetaminophen, citing it as a possible cause of autism.
The announcement sparked widespread controversy within the healthcare community and confusion among pregnant women uncertain about how to manage pain and fever during pregnancy.
### The Science Behind Tylenol and Autism
The scientific evidence linking Tylenol (acetaminophen) use during pregnancy to autism remains uncertain. Some studies suggest a correlation between prenatal acetaminophen use and an increased risk of autism in children, while other research has refuted these findings.
Major medical associations have rejected the claims made by Kennedy and Trump, labeling them as overly generalized and potentially harmful. Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, stated:
> “The 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.”
### Ongoing Litigation and Legal Strategy
Concerns about Tylenol’s safety during pregnancy are not new. Numerous personal injury lawsuits have been filed against Johnson & Johnson and its corporate spin-off, Kenvue, alleging adverse neurodevelopmental outcomes in children whose mothers used Tylenol while pregnant. These cases have been consolidated into a multi-district litigation currently progressing through the courts, led by Ashley Keller of Chicago’s Keller Postman law firm.
Keller, who has represented Texas in lawsuits against Google and Meta, has been contracted by the Texas Attorney General’s office to handle this new lawsuit. Keller commented in an interview:
> “[Paxton] figured I knew the science, I knew the history, I knew a lot of the moving parts. And so I’d be an obvious choice to pursue this for Texans.”
Ken Paxton, currently running in the GOP primary to unseat U.S. Senator John Cornyn, stated in announcing the lawsuit:
> “By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”
### Autism: Rising Rates and Controversial Causes
Autism affects approximately one in 31 American children, with diagnoses increasing by nearly 300% over the last two decades. Researchers attribute this rise mainly to improved screening methods and a broader definition of autism spectrum disorders.
Robert F. Kennedy Jr. has long supported the debunked theory that common childhood vaccines cause autism. Since becoming health secretary, he has pledged to identify and eliminate the root causes of autism, allocating $50 million toward research. Relabeling Tylenol was one of his initial actions.
Kennedy referenced an August study by the Harvard School of Public Health and Mount Sinai Hospital, which found a slight increase in autism diagnoses among children whose mothers reported using acetaminophen during pregnancy—a conclusion echoed by several previous studies.
However, other large-scale studies have challenged this link. One notable study analyzing health records of 2.5 million children born in Sweden over 25 years found that the association disappeared when comparing siblings where acetaminophen use occurred during only one pregnancy.
Dr. Brian Lee, a Drexel University epidemiologist who authored the Swedish study, told the Johns Hopkins Bloomberg School of Public Health podcast:
> “It’s hard to get a 100% definitive case closed on any topic in epidemiology. It would be unethical to give pregnant women Tylenol just to see if they have a child with autism, so researchers rely on less definitive methods to determine the risk. While more research is needed, the needle is pointing strongly toward there being no causal effect of acetaminophen use during pregnancy on autism.”
### Johnson & Johnson’s Response and Legal Challenges
Kenvue, the maker of Tylenol, has strongly refuted claims of a connection to autism, stating:
> “Independent, 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.”
Keller believes it is better to inform the public about potential risks—even amid scientific uncertainty—and let individuals make informed decisions:
> “It is mind-boggling to me that these major medical organizations would say, ‘We aren’t sure, and therefore we should say nothing.’ The opposite is true: We are not sure, and therefore we should sound the alarm.”
Recently, a federal judge excluded the expert witnesses Keller planned to present in the consolidated litigation against Johnson & Johnson, citing insufficient scientific strength. Keller has appealed this decision to the 2nd U.S. Circuit Court of Appeals.
### Details of the Lawsuit
Paxton’s lawsuit accuses Johnson & Johnson of willfully ignoring and attempting to silence scientific evidence regarding acetaminophen and autism. The suit also targets Kenvue, alleging it was created to shield Johnson & Johnson’s main assets from liability.
The lawsuit claims:
> “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.”
Unlike individual personal injury lawsuits, Paxton’s case uses consumer protection laws—the Uniform Fraudulent Transfer Act and the Deceptive Trade Practices Act—as its basis. These laws present a different burden of proof and seek different damages than personal injury claims, Keller explained.
### Texas’ History with Johnson & Johnson
This is not Texas’ first legal battle with Johnson & Johnson. The state has previously sued the company multiple times, securing:
– A $290 million settlement related to Johnson & Johnson’s role in the opioid epidemic in 2021
– Tens of millions of dollars in settlements over medical device issues
– $158 million for deceptive marketing of the anti-schizophrenia drug Risperdal
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