Copyright Anchorage Daily News
Texas Attorney General Ken Paxton filed a lawsuit Tuesday against Tylenol-maker Kenvue and its former parent company, Johnson & Johnson, alleging the companies deceptively sold the painkiller despite knowing it could cause autism. The suit, filed in a Texas state court, comes barely a month after President Donald Trump repeatedly warned pregnant women not to take Tylenol - despite a lack of evidence, acknowledged by his own health officials, that the over-the-counter drug causes the neurodevelopmental disorder. Texas is the first state to file such a case. Paxton, a firebrand Republican running for U.S. Senate, directly invoked the MAHA movement led by Health and Human Services Secretary Robert F. Kennedy Jr. in filing the suit. “By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again,” he said in a statement. Kenvue said in a statement that it is “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.” It called the lawsuit “baseless” and said its medication “is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy.” Johnson & Johnson sold 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,” the company said in a statement. The Food and Drug Administration last month said it would initiate the process to change Tylenol’s label, noting that using acetaminophen - the drug’s active ingredient - “may be associated with an increased risk” of conditions such as autism and attention-deficit/hyperactivity disorder. Still, the agency added that “a causal relationship has not been established,” acknowledging that some studies have found no such association and that acetaminophen remains the only over-the-counter drug approved to treat fevers during pregnancy. While the FDA cited a “possible association” between acetaminophen used prenatally and autism, Paxton’s lawsuit claims that the federal government “confirmed” that such use “likely causes” the disorder.” The suit’s main contentions are that the companies violated Texas law by promoting Tylenol as safe while concealing key information and that Johnson & Johnson “fraudulently transferred” its liabilities to Kenvue. Paxton’s lawsuit claims that Johnson & Johnson knew about the risks of Tylenol but suppressed them, stating it had performed an internal assessment of the evidence in 2014 and found that it “implied a causal relationship between acetaminophen” and autism and ADHD. Much of the lawsuit echoes claims made by scores of individual plaintiffs, whose complaints were consolidated in U.S. District Court in New York in 2022. The judge overseeing the federal litigation dismissed it last year after rejecting the plaintiffs’ expert witnesses as unreliable. The decision is being appealed. While Kenvue has owned the Tylenol brand since it was spun off as a separate company in 2023, the Texas lawsuit also takes aim at Johnson & Johnson, claiming the pharmaceutical giant wanted to off-load a business weighed down by legal risk. Johnson & Johnson announced plans to spin off its consumer products business in November 2021, saying it had concluded the division would perform better as a stand-alone company. It disclosed the Tylenol lawsuits among its major legal risks in a securities filing in February 2023, but that received little attention while most analysts focused on the company’s liabilities over claims that its talc powder caused cancer. “The timing of when Kenvue was created, and when all the science was coming to a head vis-à-vis Tylenol, is far too coincidental to ignore,” said Ashley Keller, a personal injury lawyer for plaintiffs in the federal Tylenol litigation who is now representing Texas as an outside attorney. Keller said he was contacted by Texas officials soon after the Sept. 22 news conference where Trump, Kennedy and other officials warned about the risks of acetaminophen. He said the comments “brought this more to the front burner of [Paxton’s] awareness.” The same day of the of the news conference, Aaron Siri, a lawyer who long worked with Kennedy before he became the nation’s top health official, filed a citizen petition with the FDA seeking changes to acetaminophen products’ labels that would highlight the risk of autism and ADHD. Kenvue earlier this month filed a response opposing the changes sought by Siri’s group, the Informed Consent Action Network, saying they are “unsupported by the scientific evidence.” For decades, scientists have been studying whether acetaminophen is linked to autism and ADHD. But sorting out a connection has proved elusive, researchers say. For example, many pregnant individuals take acetaminophen to reduce a fever, which itself could affect a baby’s development, according to the FDA.
