Tylenol Autism Lawsuits May Get New Life After HHS Pregnancy Warnings

Hundreds of Tylenol autism and ADHD lawsuits were dismissed in 2023, after a federal judge found there was a lack of scientific evidence establishing that children were injured by use of acetaminophen during pregnancy.

Nearly two years after a federal judge dismissed hundreds of Tylenol lawsuits linking prenatal acetaminophen use to autism and ADHD, due to a lack of admissible expert evidence, health officials have announced that they will require manufacturers of the popular pain medication to add new warnings about the risks associated with use of acetaminophen during pregnancy.

The U.S. Food and Drug Administration (FDA) issued a press release announcing the upcoming label changes on September 22. The agency also issued a letter to physicians, noting that while a causal connection between acetaminophen, autism and ADHD has not been established, they should try to minimize pregnant patients’ use of the drug to reduce potential risks to the unborn.

For decades, Tylenol (acetaminophen) has been widely used by pregnant women, largely due to the widespread belief that it is safe for unborn children. However, a number of studies in recent years have found associations between taking the nearly ubiquitous drug during pregnancy and children being born with developmental disorders.

Now, the FDA says there is enough evidence to require the drugs to carry warning labels and caution against use, and the U.S. Department of Health and Human Services (HHS) has announced that it will invest in groundbreaking research to further explore whether Tylenol causes autism and other developmental disorders.

This latest warning comes more than a year after hundreds of Tylenol autism and ADHD lawsuits making very similar claims were dismissed by a federal judge due to a lack of reliable evidence.

In 2023, given common questions of fact and law over the adequacy of the Tylenol pregnancy warnings, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings, centralizing all claims brought throughout the federal court system before U.S. District Judge Denise Cote in the Southern District of New York, as part of a federal multidistrict litigation (MDL).

However, in December 2023, Judge Cote issued an opinion excluding plaintiffs’ expert witnesses from testifying, after determining the scientific approaches and existing studies used were not sound enough to allow the opinions to be presented to a jury. That ruling is currently facing an appeal by plaintiffs, but this latest decision by federal regulators raises questions about whether those claims could be revived in the future.

At this time, it is unclear what effect the ruling or future research now funded by the federal government may have on the appeals process, or on future Tylenol autism lawsuits that have not yet been filed, since many of the potential plaintiffs are still young children.

Tylenol Links to Autism, ADHD Explored in Recent Studies

Another press release issued by HHS on Monday pointed to a 2020 study in JAMA Psychiatry, which linked cord plasma biomarkers indicating in utero exposure to acetaminophen to an increased risk of autism and ADHD diagnosis during childhood.

“To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature. The association is an ongoing area of scientific debate and clinicians should be aware of the issue in their clinical decision-making, especially given that most short-term fevers in pregnant women and young children do not require medication.”

– FDA Commissioner Martin A. Makary, Notice to Physicians on the Use of Acetaminophen During Pregnancy

The announcement also comes after a study published last month in the medical journal Environmental Health, which looked at 46 past studies and found that 27 of them linked acetaminophen use during pregnancy to ADHD, autism and similar disorders.

Both that study, and the recent FDA and HHS announcements note that acetaminophen is the only safe fever reducer approved for use during pregnancy, indicating they believe Tylenol can still fill that role if used with caution.

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