Texas Tylenol Lawsuit Accuses J&J of Failing To Warn of Autism Risks

State’s attorney general alleges Johnson & Johnson intentionally hid and downplayed data linking pregnancy use of acetaminophen to a risk of developmental disorders.

Following recent warnings from U.S. drug regulators, the state of Texas has filed a lawsuit against the makers of Tylenol, alleging they failed to warn pregnant women that prenatal exposure to acetaminophen may increase the risk of autism and other developmental disorders in children.

The complaint (PDF) was brought by Texas Attorney General Ken Paxton in Texas District Court on October 27, naming Tylenol manufacturers, Johnson & Johnson and its spin-off, Kenvue Inc., as the defendants.

Tylenol is a common brand name for acetaminophen, which has been one of the most widely used painkillers in the United States for decades. Originally approved in 1951 and marketed as Tylenol beginning in 1955, the drug quickly became a household staple and remains an active ingredient in hundreds of over-the-counter cold, flu and combination pain medications.

However, in September, the U.S. Food and Drug Administration (FDA) announced plans to require updated warning labels on all acetaminophen products sold in the U.S., which will require manufacturers to add new language warning against use during pregnancy. The new warnings will also advise doctors to minimize prescribing Tylenol and other products containing acetaminophen to pregnant patients, indicating they could increase fetal brain development risks, like autism and attention deficit hyperactivity disorder (ADHD).

The label updates followed years of research linking prenatal acetaminophen use to an increased risk of neurological disorders in children. Even before the FDA’s announcement, drug makers were already facing a growing number of Tylenol autism lawsuits in federal courts, citing studies that associated the painkiller with higher rates of autism and ADHD.

In a press release issued on October 28, Paxton argues that Johnson & Johnson purposefully ignored and downplayed science that warned Tylenol use during pregnancy could cause autism and ADHD, resulting in deceptive marketing to pregnant mothers.

The lawsuit notes that while a causal relationship between acetaminophen use during pregnancy and developmental disorders has never been admitted by the manufacturer, there is enough scientific evidence that women should be warned of the risks. Instead, Paxton claims Johnson & Johnson, after realizing its liability, broke off its consumer drugs wing into Kenvue to protect the company’s assets from potentially large jury verdicts.

“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

The complaint accuses the drug manufacturers of violating the Texas Deceptive Trade Practices-Consumer Protection Act (DTPA) and violations of the Uniform Fraudulent Transfer Act (UFTA).

Tylenol Autism Lawsuits

All Tylenol autism lawsuits filed in federal courts nationwide were assigned to U.S. District Judge Denise Cote in the Southern District of New York in October 2022. However, in December 2023, Judge Cote issued a sweeping order excluding all of the plaintiffs’ expert witnesses under the federal Daubert standard, determining that the scientific methods used to link acetaminophen to autism were not reliable enough to present to a jury. This led to the entire MDL being dismissed before any bellwether trials could take place.

However, plaintiffs have appealed the decision to the Second Circuit Court of Appeals, arguing that the FDA’s new label requirement means that the scientific evidence is good enough for federal regulatory standards, and therefore must be good enough for the courts.

Johnson & Johnson and Kenvue claim the FDA’s warning had no scientific evidence to back it up. It is unclear when the appellate court will issue its decision.

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