Texas has taken a pioneering step as the first US state to file a lawsuit against the maker of Tylenol, claiming that using this pain reliever during pregnancy may be linked to autism.

The lawsuit was initiated by Ken Paxton, the state’s attorney general, targeting Johnson & Johnson and its offshoot, Kenvue. Paxton accuses these companies of neglecting to inform consumers about the potential risks associated with their product.

This legal action follows a recent warning from former President Donald Trump and his Health and Human Services Secretary, Robert F. Kennedy Jr. They advised pregnant women to avoid acetaminophen, Tylenol’s active ingredient, during a White House press briefing, citing concerns it might increase the likelihood of autism in their children.

During the briefing, the former president emphatically advised, “Don’t take Tylenol, don’t take it,” and encouraged expectant mothers to “fight like hell not to take it,” suggesting they should “tough it out.”

Research has indicated there could be a connection between acetaminophen use during pregnancy and the development of autism in offspring.

But experts stress that an association does not directly prove that the drug causes autism in children. They also highlight other large-scale research that has found no link between taking Tylenol during pregnancy and autism.

Paxton, who is also running in the GOP primary to unseat Republican US Senator John Cornyn, said in a statement that the lawsuit would help to ‘Make America Healthy Again’.

He said: ‘Big Pharma betrayed America by profiting off of pain and pushing pills regardless of the risks. These corporations lied for decades, knowingly endangering millions to line their pockets.

Texas Attorney General Ken Paxton filed a lawsuit against Tylenol this week, saying its maker  had failed to warn consumers over the risks posed by its drug (stock image)

‘By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.’

The case is being led by law firm Keller Postman, which is also fighting a separate lawsuit where dozens of parents are suing Johnson and Johnson and Kenvue, claiming that taking Tylenol during pregnancy caused their children to suffer from adverse neurodevelopmental outcomes.

In the lawsuit, Paxton accuses Johnson and Johnson and Kenvue of marketing Tylenol to pregnant women despite being aware that early exposure to acetaminophen can cause autism. 

He accused the companies of violating the state’s consumer protection laws, which make it illegal to conceal or fail to disclose information about a product.

And said they had violated the Texas Uniform Fraudulent Transfer Act, accusing Johnson and Johnson of fraudulently transferring its liabilities arising from Tylenol to a separate company, Kenvue, in order to shield its assets from lawsuits arising from the impact of Tylenol on children. 

A spokeswoman from Kenvue, which markets Tylenol, told Daily Mail: ‘Nothing is more important to us than the health and safety of the people who use our products. 

‘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.’

Shown above is Texas Attorney General Ken Paxton on March 20 this year. He has filed a lawsuit against Johnson and Johnson and its corporate spin-off Kenvue

She added: ‘Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. 

‘Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives. High fevers and pain are widely recognized as potential risks to a pregnancy if left untreated.

‘We will defend ourselves against these baseless claims and respond per the legal process. 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 spokeswoman said Kenvue was also encouraging all expectant mothers to speak to their health professionals before taking any over-the-counter medication, including acetaminophen.

Acetaminophen is used during pregnancy to bring down high fevers and reduce pain, which may also pose a risk to mother and baby, with studies showing expectant mothers struggling with high fevers are more likely to have babies with birth defects. 

The president and his health officials frequently cited a new study last month as the reason for their warnings.

The paper, from Mount Sinai and Harvard researchers, analyzed data from 46 previous studies and found that there was an association between taking acetaminophen during pregnancy and higher rates of neurodevelopmental disorders such as autism in their children.

But there are also numerous papers showing no association between the two, including a 2024 study by Swedish researchers on 2.4million children that found no link between taking acetaminophen in pregnancy and a higher risk of autism.

President Donald Trump is pictured above at a press conference last month, where he warned pregnant women that taking Tylenol, active drug acetaminophen, could cause their children to suffer from autism

The researchers behind the new study cited by the administration have also accused the president of ‘spreading misinformation’, telling Daily Mail that while they communicated with Trump officials and ‘appreciate their interest in the study’, acetaminophen ‘remains an important tool for pregnant patients and their physicians’. 

After warning pregnant women not to take Tylenol at a press conference on September 22, the president doubled-down on the advice four days later in a post on his social media platform Truth Social where he warned: ‘Pregnant women, DON’T USE TYLENOL UNLESS ABSOLUTELY NECESSARY.’

The president added: ‘DON’T GIVE TYLENOL TO YOUR YOUNG CHILD FOR VIRTUALLY ANY REASON.’

Yesterday, the president again warned pregnant women not to take Tylenol, writing on his social media platform Truth Social: ‘Pregnant women, DON’T USE TYLENOL UNLESS ABSOLUTELY NECESSARY, DON’T GIVE TYLENOL TO YOUR YOUNG CHILD FOR VIRTUALLY ANY REASON.’

Other members of his administration have said, however, that pregnant women should speak to their doctors before deciding whether to take acetaminophen.

Dr Mehmet Oz, the head of the Centers for Medicare and Medicaid Services, told TMZ in the days after Trump’s press conference that pregnant women should consider taking Tylenol if they had a high fever.

‘If you have a high fever… you ought to be talking to a doctor anyway,’ he said. ‘The doctor’s almost certainly going to prescribe you something. Tylenol might be one of the things they give.’

Vice President JD Vance added in an interview with NewsNation two day’s after Trump’s White House press conference: ‘So, my guidance to pregnant women would be very simple, which is: Follow your doctor.’

He added that ‘ultimately, whether you should take something is very context-specific’ and should be considered ‘case by case’.

Dr Jeff Singer, a senior fellow at the Cato Institute in the Department of Health Policy Studies, previously told Daily Mail: ‘This is an issue, and it is being looked at by academic and clinical researchers around the world. It is not an unreasonable question to ask, “Does acetaminophen cause autism?”.

‘But what I am asking is that they leave the question to the scientists, to the clinical researchers, and stay out of it. We are on it, and we are already taking care of it.’

Autism rates have surged in the US since the 1980s, prompting concerns from experts over the potential cause.

In the 1980s, about one in 2,000 children had autism, according to estimates. But rates have since exploded, with one in 31 now reported to have the condition.

Experts say the surge is largely down to a loosening of the definition of autism, allowing for children with milder symptoms to be diagnosed with the disease, and a more accepting attitude in the US toward people with the condition.