US pharmaceutical company Kenvue could face the revival of more than 500 private lawsuits alleging its Tylenol painkiller causes autism, after an appeals court panel on Monday questioned whether they were dismissed because a trial judge improperly excluded evidence, reports Reuters.
District Judge Denise Cote dismissed the lawsuits last December after criticising the methodology of expert witnesses offered by parents who said using Tylenol or its active ingredient – acetaminophen – during pregnancy caused their children to develop autism or attention deficit hyperactivity disorder.
Two judges of the three-judge panel of the 2nd US Circuit Court of Appeals in Manhattan suggested during a hearing that some of the testimony might have been admissible.
Monday’s hearing came nearly two months after President Donald Trump and his top health officials suggested a link between autism and Tylenol use during pregnancy.
There is no firm evidence of such a link. Medical groups, including the American Academy of Paediatrics and the American College of Obstetricians and Gynaecologists, have said acetaminophen is the recommended first-line medication for pain and fever during pregnancy, but should be taken at the lowest possible dose.
Kenvue has long maintained that Tylenol is safe and does not cause autism. “The science has not changed,” a Kenvue spokesperson said after the hearing.
Cote had said the proposed expert testimony “obscured the complexities, inconsistencies and weaknesses in the underlying data”.
But at Monday’s hearing, Circuit Judge Gerard Lynch said the plaintiffs’ primary expert, Harvard School of Public Health Dean Andrea Baccarelli, appeared to be “explaining at every step of the way what he is doing”.
“Even if some would disagree with each or every step he takes.”
Another judge suggested that perhaps a jury could have sorted it out.
The appeals court did not say when it will rule.
Impact on Kimberly-Clark deal unclear
It is unclear how reviving the lawsuits might affect Kimberly-Clark’s plan to pay more than $40bn to buy Kenvue, formerly part of Johnson & Johnson.
Kimberly-Clark and Kenvue told US regulators that any “condition, development or occurrence” related to the alleged link between Tylenol’s use in pregnancy and autism and ADHD would not be a reason for Kimberly-Clark to back out. The companies plan to close the deal in 2026.
Kenvue has also defended against a lawsuit by Texas Attorney-General Ken Paxton over Tylenol.
Last Friday, a Texas judge declined Paxton’s request to block Kenvue from paying a $398m shareholder dividend this month, and require Kenvue to change its marketing.
See more from MedicalBrief archives:
Texas AG sues makers of Tylenol for ‘hiding autism risks’
New FDA Tylenol advice a potential boost for autism lawsuits