A judge barred expert witnesses from testifying that Tylenol can cause autism in a ruling that likely ends a mass tort litigation of 500 lawsuits over the popular painkiller. The expert witnesses failed to offer scientific support for their claims, and the decision is expected to result in the dismissal of the cases. Source: ARY News – Khabristan.PK
A judge has barred expert witnesses from testifying that Johnson & Johnson spin-off Kenvue’s painkiller Tylenol can cause autism if mothers take it during pregnancy, finding that they failed to support their conclusions with scientific evidence.
The ruling on Monday by U.S. District Judge Denise Cote in Manhattan federal court likely means the end of a consolidated mass tort litigation of about 500 lawsuits over the popular over-the-counter drug, unless plaintiffs get it reversed on appeal.
Cote, in a 148-page ruling, found that none of the five expert witnesses proposed by the plaintiffs had offered a sound scientific methodology to support their opinion that Tylenol’s active ingredient, acetaminophen, could cause autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD).
“Instead, the unstructured approach adopted by the plaintiffs’ experts permitted cherry-picking, allowed a results-driven analysis, and obscured the complexities, inconsistencies, and weaknesses in the underlying data,” she wrote.
Kenvue, which was Johnson & Johnson’s consumer health unit before it was spun off in August, in a statement said it will move to dismiss all the cases in light of the ruling. Its shares rose about 4% in Tuesday trading following the decision.
“These lawsuits have created confusion on the safety of one of the most studied medications in history,” the company said.”Acetaminophen is recommended by doctors as a first-line treatment option for people who have a fever or are experiencing pain during pregnancy. It is scientifically known that not treating these conditions may have serious health consequences for both mother and baby.”
Lawyers for the plaintiffs did not immediately respond to requests for comment.
The lawsuits also targeted retailers that sold their own generic versions of Tylenol, including CVS, Walgreens and Walmart. CVS and Walgreens declined to comment on the decision, and Walmart did not immediately respond to a request for comment.
Product liability lawsuits, like the ones over Tylenol, rely on experts to establish that the product is capable of causing the alleged harm. Federal judges decide what expert testimony is allowed, based on whether it meets scientific standards first laid out by the U.S. Supreme Court in its 1993 ruling in Daubert v. Merrell Dow Pharmaceuticals.
The multidistrict litigation was consolidated before Cote in October 2022. Plaintiffs had begun filing lawsuits earlier that year, claiming that the retailers failed to warn pregnant users of acetaminophen products about the neurological risks to the fetus.
Health experts advise pregnant women to take acetaminophen rather than aspirin or ibuprofen, which can cause fetal organ damage.
While some studies have found an association between the disorders and acetaminophen use in pregnancy, researchers have cautioned that other, underlying factors could be responsible and that more study is needed.
In recent years, there has been a growing concern about the purported link between Tylenol and autism. However, it is crucial to distinguish between unfounded rumors and scientifically supported evidence. Numerous rigorous studies conducted by reputable medical institutions have conclusively shown that there is no credible evidence to support the claim that Tylenol causes or exacerbates autism. It’s important to rely on evidence-based information and consult qualified healthcare professionals when making decisions about the use of medications. Misinformation can lead to unnecessary fear and anxiety. By educating ourselves and promoting accurate information, we can help dispel myths and focus on the well-being of individuals and communities.
Keywords: Tylenol, autism, pregnancy, lawsuit, expert testimony, scientific evidence, acetaminophen, Kenvue, mass tort litigation, plaintiff, ADHD, product liability, FDA, fetal organ damage
Summary:
A judge has prohibited expert witnesses from asserting that Tylenol can cause autism if used during pregnancy, resulting in the likely termination of a mass tort litigation of around 500 lawsuits. The ruling was based on the lack of sound scientific methodology in supporting the claim that Tylenol’s active ingredient, acetaminophen, could lead to autism spectrum disorder and attention deficit hyperactivity disorder. Kenvue, the former consumer health unit of Johnson & Johnson, plans to dismiss all cases following the decision, emphasizing acetaminophen’s safety and the serious health consequences of untreated conditions during pregnancy. Retailers such as CVS, Walgreens, and Walmart were also targeted in the lawsuits.
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