Lawyers cite Trump autism warning in push to revive Tylenol lawsuits
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Class action lawyers are citing the White House’s warning linking Tylenol to autism as a basis to resurrect lawsuits seeking to hold manufacturer Kenvue liable for developmental disabilities.
President Donald Trump’s warning on Monday that pregnant women should not use Tylenol, a US brand of paracetamol, came as arguments are pending in Manhattan federal court to overturn the 2024 dismissal of hundreds of lawsuits alleging Kenvue and major retailers failed to warn pregnant mothers about the prenatal risks of using the painkiller.
Arguments on the matter had been scheduled for October 6 in Manhattan federal appeals court but were postponed until November after the president’s pronouncement earlier this week.
Analysts said the Trump administration’s position has raised added risks for Kenvue, whose shares have reeled since the government first linked paracetamol, known as acetaminophen in North America, earlier this month.
“The administration’s focus on autism may bolster plaintiffs’ ongoing appeal,” BNP Paribas said in a research note on Thursday. Morningstar said the government’s Tylenol warnings could prompt more plaintiffs to join the litigation.
A representative for the health department did not immediately respond to a request for comment.
Kenvue on Friday said: “We stand with the science and believe we will continue to be successful in litigation, as the claims lack legal merit and scientific support.”
A judge found testimony in the class action by an expert witness in the case, Andrea Baccarelli, the Dean of Harvard University’s public health school, could not be introduced because it did not “reflect a reliable application of scientific methods”.
However, the Trump administration cited Baccarelli’s work this week as the basis for his warning and a decision by the US Food and Drug Administration to add a warning label to the painkiller.
Trump’s autism comments drew strong opposition from the science community. The World Health Organization on Wednesday said there is no conclusive scientific evidence linking autism and paracetamol during pregnancy. The FDA’s statement said it remains “reasonable” for pregnant women to take Tylenol in certain circumstances.
The lawyers are appealing against the dismissal of more than 800 lawsuits filed in the past few years on behalf of parents and children. The cases were consolidated in Manhattan federal court, but were dismissed after Judge Denise Cote concluded the plaintiffs’ expert witnesses did not meet the required standards of evidence.
Baccarelli asserted a causal relationship between prenatal use of Tylenol’s active ingredient paracetamol and neurodevelopmental disorders. Plaintiffs are contesting the dismissal of his evidence, which is vital to their case. In the wake of Trump’s comments, a lawyer for the plaintiffs said in a court filing that continuing to exclude Baccarelli’s evidence would damage public trust.
Ashley Keller, a partner at Keller Postman in Chicago, wrote in the filing: “A decision holding that a jury may not hear the same expert evidence that the executive branch credited will badly damage the public trust required for the executive to take care that the public health laws are faithfully executed.”
A lawyer for Kenvue has opposed reinstating the testimony in a court filing. Jay Lefkowitz, a partner at Kirkland & Ellis, said: “The many instances of cherry-picking and mischaracterisations of evidence in Dr Baccarelli’s report, among other methodological flaws, still require the exclusion of his opinion.” Lefkowitz did not respond to requests for additional comment.
Trump’s health secretary, Robert F Kennedy Jr, was a trial attorney before running for president in 2024. He worked at plaintiffs firm Morgan & Morgan on a trial team that won a mass tort case against Monsanto in 2018, alleging its Roundup weed killer caused cancer. Morgan & Morgan is not listed as one of the plaintiffs firms in the Tylenol litigation.
Kenvue’s shares have plunged 20 per cent since the Trump administration linked Tylenol to autism and attention deficit disorders in early September. The company, which was spun out of Johnson & Johnson in 2023, has repeatedly argued Tylenol is safe.
Tylenol’s label includes a general warning for pregnant women: “Ask a health professional before use.” But plaintiffs have argued the label was not specific about autism and attention disorders.
Trump on Monday repeatedly claimed Tylenol was a risk to pregnant women and babies.
“Don’t take Tylenol. Don’t give Tylenol to the baby after the baby is born,” Trump said, adding the painkiller is “fine” for everyone else.
Mass tort cases that hinge on causation between a product and an illness often rely on scientific research and expert testimony. Judges have authority to exclude expert witnesses under a so-called Daubert standard if they find the testimony does not meet evidentiary requirements.
If an expert’s opinion has been knocked out by a judge it faces a high bar to be included back into litigation, said Paul Grimm, a professor at Duke University and a former judge.
“The judge is going to base the decisions on the experts’ evidence provided in the [evidence] file,” Grimm said.
