Listen to this articleThe basics:
- Texas AG Ken Paxton sues J&J and Kenvue over Tylenol pregnancy risks
- Lawsuit claims companies hid dangers of acetaminophen for unborn children
- J&J spun off consumer health business to Kenvue in 2023
- Companies deny claims, call lawsuit scientifically unfounded litigation’
Texas Attorney General Ken Paxton is suing Johnson & Johnson and its consumer health spinoff Kenvue. The claim alleges the companies failed to warn consumers about the risks of taking Tylenol while pregnant.
In an Oct. 27 lawsuit, Paxton accused the New Jersey-based companies of violating Texas’ consumer protection laws. He alleges they hid the danger to unborn and young children from Tylenol while marketing the drug as the only safe painkiller for pregnant women. He also repeated President Donald Trump’s unfounded claims that the active ingredient, acetaminophen, raises the risk of autism and other developmental disorders in children.
In a statement, the Republican 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.”
Paxton is a candidate in the GOP primary to unseat U.S. Sen. John Cornyn. He also pledged, “By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”
A defense tactic?
After Trump’s remarks stirred up controversy last month, numerous professional associations have reiterated the stance that no proven link has been found between acetaminophen use in pregnancy and neurodevelopmental disorders. Advocates include the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics.
Global health authorities, such as the World Health Organization and the European Medicines Agency, also quickly denounced the president’s comments.
New Brunswick-based J&J was the original seller of Tylenol, before it spun off its consumer health business in 2023 as a fully independent company. Besides Tylenol, the Summit-headquartered Kenvue’s product portfolio also includes Neutrogena, Lactaid, Visine, Zyrtec, Aveeno, Band-Aid, Listerine and Benadryl.
Paxton’s suit alleges that J&J fraudulently transferred its Tylenol-related liabilities to Kenvue to shield itself from litigation.
“Seeing that the day of reckoning was coming, Johnson & Johnson attempted to escape responsibility by illegally offloading their liability onto a different company,” said Paxton. He estimated that the companies “face tens of billions of dollars in damages to permanently injured children.” Because of “how widely acetaminophen is used and how prevalent these conditions are.”
The complaint filed in state court in Panola County, Texas, seeks a jury trial.
Relief sought by the AG includes ordering companies to destroy marketing materials that represent that Tylenol:
- Is safe for pregnant women and children, or
- Doesn’t cause autism or attention-deficit/hyperactivity disorder in children whose mothers take Tylenol during pregnancy, or in young children who take the drug.
‘Scientifically unfounded litigation’
A spokesperson for J&J said, “Johnson & Johnson divested its consumer health business years ago, and all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol (acetaminophen), are owned by Kenvue.”
In a statement, Kenvue described Paxton’s lawsuit as “scientifically unfounded litigation.”
“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,” Kenvue said.
We are deeply concerned by the perpetuation of misinformation … and the potential impact that could have on the health of American women and children.
— Kenvue
“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,” Kenvue stated.
“We will vigorously defend ourselves against these 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 company added.
