A US federal appeals court has reopened more than 500 lawsuits against Kenvue, the maker of Tylenol, after ruling that expert testimonies linking the use of acetaminophen during pregnancy to an increased risk of autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in children can be admitted. This move brings the case back to the forefront of the American judicial system.
Admitting Expert Testimonies Despite Controversy
The 2nd US Circuit Court of Appeals in Manhattan overturned a previous lower court ruling that excluded the testimonies of three experts presented by the plaintiffs (parents of the children). The court reasoned that the scientific methodologies adopted by the experts are also used by other scientists, and that differing scientific interpretations should not preclude their presentation in court. At the same time, the court emphasized that it did not rule on a causal relationship between the drug’s use and the onset of autism or ADHD; its decision was strictly limited to the procedural aspects of evidence admissibility.
Kenvue Defends the Safety of Its Drugs
For its part, Kenvue stood its ground, asserting that Tylenol is completely safe when used according to approved medical guidelines. The company pointed out that reliable, independent scientific research has not established any link between taking acetaminophen during pregnancy and neurodevelopmental disorders. The company announced its intention to vigorously defend its position in court and work to demonstrate the unreliability of the plaintiffs’ experts’ opinions. Meanwhile, the company’s shares experienced a drop in trading following the decision.
Return to the Trial Court
This ruling sends the case back to the federal court in Manhattan for further proceedings, after it was dismissed in December 2024 following the exclusion of the expert testimonies. It is worth noting that acetaminophen, the active ingredient in Tylenol, remains the preferred choice among doctors and medical associations for treating pain and fever during pregnancy. The lawsuits involve, alongside Kenvue, a number of major US pharmacy chains and retailers, keeping the scientific and legal debate over the drug’s safety wide open, amid medical assurances that no conclusive evidence proves these claims to date.
