Texas Takes On Tylenol: Lawsuit Claims Companies Hid Autism Risks

Texas Attorney General Ken Paxton, a Republican, has filed a lawsuit against the manufacturers of Tylenol. The suit, announced Tuesday, claims these companies intentionally concealed potential risks of the popular pain medication regarding children’s brain development.

This legal action comes after former President Trump’s assertions last month, linking Tylenol use during pregnancy to autism – a connection that currently lacks scientific proof.

The lawsuit targets both Johnson & Johnson, the longtime seller of Tylenol, and Kenvue, the independent company spun off in 2023 that now markets the drug.

According to the Texas lawsuit, the companies knowingly kept consumers in the dark about Tylenol’s potential ties to autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD). Furthermore, the suit alleges that Kenvue was established specifically to protect Johnson & Johnson from potential legal responsibility concerning Tylenol-related claims.

Texas’s lawsuit marks the first time a state has formally adopted Mr. Trump’s claims that acetaminophen-based products, like Tylenol, might cause neurodevelopmental disorders when used during pregnancy. While this concern has long been voiced by some supporters of Robert F. Kennedy Jr., a prominent health official, Mr. Trump’s statements significantly amplified its public profile.

Kenvue has consistently asserted Tylenol’s safety, refuting Mr. Trump’s claims regarding a connection between the drug’s use in pregnancy and autism.

“We intend to vigorously defend against these unfounded allegations through the proper legal channels,” stated Melissa Witt, a Kenvue spokeswoman, on Tuesday. “We align with the global medical consensus affirming the safety of acetaminophen and are confident in our continued success in litigation, given these claims lack both scientific evidence and legal foundation.”

Separately, Johnson & Johnson has previously stated that it has always acted responsibly in informing consumers about Tylenol’s known risk of liver damage when the medication is misused or taken in excessive amounts.

Clare Boyle, representing Johnson & Johnson, clarified on Tuesday that the company divested its consumer health division years ago. All rights and liabilities related to the sale of its over-the-counter products, including Tylenol (acetaminophen), now belong to Kenvue.

In recent years, hundreds of lawsuits have been filed in state and federal courts by families alleging that their children developed autism or ADHD following Tylenol use during pregnancy.

The most significant of these cases, consolidated in federal court, were dismissed by a U.S. judge in New York due to insufficient reliable scientific evidence. The plaintiffs are currently appealing this ruling, with an appellate hearing set for November 17.

For an extended period, scientists have investigated a possible link between acetaminophen and neurodevelopmental disorders; however, research to date has yielded inconsistent results.

Last September, medical organizations countered the Trump administration’s warning, emphasizing that Tylenol remains the only pain reliever deemed safe for pregnant individuals to manage high fevers. Untreated fevers can pose significant health risks to both the mother and the developing baby.

Mr. Paxton, who will be challenging incumbent Senator John Cornyn in the upcoming Republican primary, has a history of initiating aggressive litigation that aligns with Mr. Trump’s political agenda. His past legal actions include disputing the 2020 election results, suing immigrant rights organizations, and attempting to oust Democratic lawmakers in Texas during redistricting disputes. While not all his legal endeavors have succeeded, they have garnered substantial support among Texas Republicans.

Just last month, the Food and Drug Administration (FDA) announced its intention to add a warning to Tylenol’s label concerning a potential link to neurodevelopmental disorders. Kenvue, however, has stated its opposition to these proposed changes, maintaining that they are “not supported by the existing science.”

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Both the Trump administration and Mr. Paxton’s lawsuit refer to a recent scientific review. This review, conducted by epidemiologists from Harvard’s T.H. Chan School of Public Health and the Icahn School of Medicine at Mount Sinai, synthesized existing research without generating new data. It indicated a potential link between acetaminophen use during pregnancy and the subsequent development of autism and ADHD in children.

Out of the 46 studies examined in the review, over half reported a positive correlation between the use of acetaminophen during pregnancy and neurodevelopmental disorders in offspring. However, scientists consistently warn that these studies do not definitively prove acetaminophen as a cause for autism, a condition recognized to stem from a complex interaction of genetic and environmental influences.

It’s possible that pregnant women who use acetaminophen may have significant differences, including genetic predispositions, compared to those who do not. A large-scale study involving almost 2.5 million children born in Sweden revealed no association between acetaminophen and neurodevelopmental disorders once the mother’s genetic factors were considered.

Leading health organizations, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, have also reviewed the available evidence and concluded that the results concerning this link are inconclusive.

On Sunday, Mr. Trump reiterated his concerns on his social media platform, Truth Social, advising: “Pregnant Women, DON’T USE TYLENOL UNLESS ABSOLUTELY NECESSARY.”

Keller Postman, the primary law firm representing plaintiffs in similar personal injury cases, is also acting as external counsel for Mr. Paxton’s lawsuit.

In those individual plaintiff cases, a high legal standard must be met to demonstrate that the drug directly caused neurodevelopmental disorders in children, thereby entitling families to financial compensation.

However, Mr. Paxton’s lawsuit takes an alternative approach, contending that Johnson & Johnson and Kenvue violated Texas law by failing to adequately inform consumers about the potential risks associated with Tylenol use during pregnancy.

Texas courts can often present difficulties for plaintiffs in personal injury litigation. Mr. Paxton’s choice to file this case in a conservative, rural county near the Louisiana border is seen by some as a strategic maneuver to secure a court more inclined to favor his arguments.

The lawsuit brought by Mr. Paxton suggests that Johnson & Johnson deliberately divested its consumer health segment, partly to insulate itself from liability in ongoing Tylenol-related cases. However, the complaint itself does not present evidence to substantiate this particular accusation.

Johnson & Johnson first announced its plans for the spinoff in 2021, with the separation completed in 2023. Kenvue subsequently took over many of Johnson & Johnson’s beloved and iconic consumer brands, including Tylenol, Band-Aid, and Johnson’s Baby Shampoo.

At the time of the split, Johnson & Johnson stated its intention to concentrate on its more lucrative and rapidly expanding pharmaceutical and medical device sectors. The company was also contending with significant lawsuits concerning its involvement in the opioid crisis and allegations that the talc in its baby powder had caused cancer in some users.

Wall Street analysts generally did not view the Tylenol litigation as the primary driver behind the spinoff, with the majority of Tylenol-related lawsuits gaining momentum in 2022.