Judge Bars Expert Witnesses in Lawsuits Linking Tylenol to Autism: What You Need to Know
A recent ruling by U.S. District Judge Denise Cote in Manhattan federal court has barred expert witnesses from testifying that Kenvue’s painkiller Tylenol can cause autism if taken during pregnancy. The judge found that the plaintiffs’ expert witnesses failed to provide scientific evidence to support their conclusions. This ruling is likely to bring an end to the consolidated mass tort litigation of approximately 500 lawsuits against the popular over-the-counter drug, unless plaintiffs successfully appeal the decision.
The Lack of Scientific Methodology:
Judge Cote’s 148-page ruling highlighted that none of the five expert witnesses proposed by the plaintiffs had presented a sound scientific methodology to support their claim that Tylenol’s active ingredient, acetaminophen, could cause autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD). The judge criticized the unstructured approach adopted by the plaintiffs’ experts, which allowed for cherry-picking of data and a results-driven analysis. According to Judge Cote, this approach obscured the complexities, inconsistencies, and weaknesses in the underlying data.
Implications for Kenvue and Johnson & Johnson:
Kenvue, formerly Johnson & Johnson’s consumer health unit before its spin-off in August, has stated that it will move to dismiss all the cases following the ruling. The company’s shares rose approximately 4 percent in Tuesday trading after the decision was announced. Kenvue emphasized that Tylenol is one of the most extensively studied medications in history and is recommended by doctors as a safe option for pain relief and fever reduction during pregnancy.
The Importance of Treating Conditions During Pregnancy:
The lawsuits against Tylenol have raised concerns about the safety of the medication during pregnancy. However, Kenvue highlighted that not treating conditions such as fever or pain during pregnancy may have serious health consequences for both the mother and the baby. Acetaminophen is recommended by healthcare professionals as a first-line treatment option for pregnant women due to its established safety profile.
The Role of Expert Testimony in Product Liability Lawsuits:
Product liability lawsuits, including those involving Tylenol, rely on expert witnesses to establish whether a product is capable of causing harm. Federal judges determine the admissibility of expert testimony based on scientific standards outlined in the U.S. Supreme Court’s 1993 ruling in Daubert v. Merrell Dow Pharmaceuticals.
The Background of the Lawsuits:
The consolidated mass tort litigation against Tylenol began in October 2022 and involved approximately 500 lawsuits. Plaintiffs alleged that retailers, including CVS, Walgreens, and Walmart, failed to warn pregnant users about the neurological risks associated with acetaminophen products. However, CVS and Walgreens declined to comment on the recent ruling, while Walmart has not yet responded to requests for comment.
The Complexity of Studying Acetaminophen Use During Pregnancy:
While some studies have found an association between acetaminophen use during pregnancy and autism spectrum disorder and attention deficit hyperactivity disorder, researchers have cautioned that other underlying factors could be responsible. They emphasize the need for further study to better understand the potential risks and benefits of acetaminophen use during pregnancy.
Conclusion:
The recent ruling by Judge Cote barring expert witnesses from testifying about the link between Tylenol and autism highlights the importance of scientific evidence in product liability lawsuits. Kenvue, formerly Johnson & Johnson’s consumer health unit, plans to dismiss all the cases following the decision. The ruling underscores the need for comprehensive research to determine the potential risks and benefits of medication use during pregnancy.
