A federal judge in Manhattan delivered a blow Monday to over 400 consolidated lawsuits against Tylenol and generic acetaminophen manufacturers, saying claims that the drugs cause autism are unreliable.
U.S. District Judge Denise Cote ruled that the plaintiffs lack admissible evidence to substantiate claims that using the pain reliever during pregnancy heightens the risks of autism or attention-deficit hyperactivity disorder (ADHD) in children, The Wall Street Journal reported.
Cote ruled that the scientific claims forming the basis of the lawsuits are fundamentally untrustworthy. She criticized the plaintiffs' experts for adopting an unstructured approach that allowed "cherry-picking," a "results-driven analysis," and "obscured complexities, inconsistencies, and weaknesses in the underlying data."
The lawsuits, representing families with children affected by ADHD and autism, contended that drugmakers should have warned pregnant women about potential health risks associated with taking the pain reliever.
Attorneys for the plaintiffs did not immediately respond to requests for comment made by The Wall Street Journal.
Additional defendants, such as CVS Health, Walmart, and Walgreens, also refrained from providing immediate comments.
Acetaminophen, often regarded as the safest pain relief option during pregnancy, carries a label advising pregnant women to consult their doctors before use.
The defendant drug manufacturers, including Kenvue (a consumer-health company spun off from Johnson & Johnson), argued that autism and ADHD are genetic disorders. They emphasized a lack of conclusive evidence supporting claims that in-utero exposure to acetaminophen raises risks.
After the court ruling, Kenvue's shares saw a more than 3% increase in midday trading. The company expressed its intention to seek dismissal of the lawsuits, asserting that they have sown confusion about "the safety of one of the most studied medications in history."
"Acetaminophen is recommended by doctors as a first-line treatment option for people who have a fever or are experiencing pain during pregnancy," a Kenvue spokeswoman stated.
The lawsuits stemmed from a 2021 declaration in "Nature" Reviews Endocrinology, endorsed by over 90 scientists, urging increased awareness, stronger warnings, and research into potential prenatal medication risks.
Contrary to this consensus, several experts and major medical organizations hold different views.
The identical "Nature" journal published three rebuttals, signed by numerous professional groups, researchers, and clinicians, asserting that the consensus statement relied on flawed data, exaggerating the potential harms of acetaminophen while minimizing its crucial role in treating fever and pain, Spectrum News reported.
Johnson & Johnson (Kenvue) has utilized these criticisms in its defense.
Jim Thomas ✉
Jim Thomas is a writer based in Indiana. He holds a bachelor's degree in Political Science, a law degree from U.I.C. Law School, and has practiced law for more than 20 years.
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