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Texas Attorney General Ken Paxton is the companies behind Tyelnol, accusing them of deceptively marketing the medication to pregnant women without disclosing claims that acetaminopehn exposure could increase the risk of autism. “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,” said Attorney General Paxton. “Additionally, seeing that the day of reckoning was coming, Johnson & Johnson attempted to escape responsibility by illegally offloading their liability onto a different company. By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.” This lawsuit comes just a month after said that taking the pain relief drug acetaminophen during pregnancy can lead to a higher risk of autism for babies prior to birth. Trump said that Tylenol, also known as acetaminophen, taken during pregnancy, "can be associated with a very increased risk of autism." He described the announcement as "historic steps to confront the crisis of autism," which he called a "horrible, horrible crisis." Since 2000, autism rates have surged over 400%, Trump said, adding that now it affects 1 in 31 U.S. children today. "Taking Tylenol is not good. I'll say it. Not good," Trump said. He shared that the Food and Drug Administration is strongly recommending that women limit the use of Tylenol during pregnancy unless it is medically necessary. The FDA has already started to notify doctors of the potential ties between acetaminophen and an increased risk of autism. It will also start the process for a safety label change on acetaminophen concerning its link to autism. Kenvue, the manufacturer of Tylenol, said Monday it "strongly disagrees" with the administration's findings. It said in a statement that "sound science clearly shows that taking acetaminophen does not cause autism." The company pointed to scientific reviews by government regulators worldwide, including some published by the FDA. However, FDA Commissioner Marty Makary said the administration now has "data we cannot ignore." Makary cited a collection of studies from Mount Sinai-Harvard, the Boston Birth Cohort and the Nurses Health Study that have established a "causal relationship between prenatal acetaminophen use and neurodevelopmental disorders of ADHD and autism spectrum disorder." The lawsuit alleges that the companies violated Texas consumer protection laws by hiding the danger that acetaminophen, the active ingredient in Tylenol, posed to fetuses and young children and “deceptively marketed Tylenol as the only safe painkiller for pregnant women.” It also alleges that Johnson & Johnson fraudulently transferred liabilities arising from Tylenol to Kenvue to shield assets against lawsuits. In 2021, Johnson & Johnson announced that it would turn its consumer health business, which makes Tylenol and other products, into a separate company now known as Kenvue. It referenced that divestment in a statement Tuesday, saying “all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol (acetaminophen), are owned by Kenvue." Kenvue stressed in a statement Tuesday that acetaminophen is the safest pain reliever option for pregnant women, noting that high fevers and pain are recognized as potential risks to pregnancies if left untreated. The company said it would defend itself against the claims and expressed concern about the “perpetuation of misinformation” about acetaminophen's safety and the potential impact on the health of women and children. “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,” Kenvue said. Acetaminophen has long been one of the most popular pain relievers and fever reducers in the U.S., used by upward of 100 million Americans annually.
