Breaking: FDA Tylenol Warning Could Bolster Autism Lawsuits in 2025, Says Angelos Law Firm

The legal landscape surrounding Tylenol (acetaminophen) and its potential link to autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) is rapidly evolving. As of today, September 26, 2025, a new development has emerged that could significantly impact ongoing and future litigation: a potential warning from the FDA regarding Tylenol use during pregnancy. This development, according to Angelos Law Firm, could bolster autism lawsuits in 2025.

The Alleged Link Between Tylenol and Autism/ADHD: A Cause for Concern?

For years, studies have suggested a possible association between acetaminophen exposure in utero and an increased risk of neurodevelopmental disorders. A recent study from Mount Sinai researchers, published in August 2025 in BMC Environmental Health, applied a rigorous methodology to analyze 46 previous studies. The analysis indicated that higher-quality studies were more likely to show a link between prenatal acetaminophen exposure and increased risks of autism and ADHD. This research strengthens the argument that acetaminophen could disrupt fetal brain development, potentially leading to these disorders.

It’s important to note that while these studies suggest an association, they do not definitively prove that acetaminophen causes autism or ADHD. Other factors, such as genetics, underlying maternal conditions, and environmental influences, could also play a role. However, the growing body of evidence has raised enough concern to prompt further investigation and legal action.

The FDA’s Potential Warning: A Game Changer?

According to reports, President Trump announced in September 2025 that the FDA would notify doctors of a potential connection between Tylenol use during pregnancy and the development of autism and ADHD. The FDA published a notice warning doctors that some studies have shown that the drug could increase the risk of autism, particularly if it is used regularly throughout pregnancy. The FDA also noted that the potential connection between Tylenol and autism “should also be balanced with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics.” Additionally, the FDA has also begun the process of updating Tylenol’s label to include information on potential autism and ADHD risks.

If the FDA issues a warning about the potential risks of Tylenol use during pregnancy, it could have significant implications for ongoing litigation. Such a warning could be interpreted as an acknowledgment of the potential link between the drug and neurodevelopmental disorders, which could strengthen the plaintiffs’ case.

The Current Status of Tylenol Autism Lawsuits

Currently, hundreds of families have filed Tylenol autism lawsuits against manufacturers and retailers, alleging that they failed to warn about the potential risks of taking acetaminophen during pregnancy. These lawsuits claim that the companies knew or should have known about the risks and that their failure to warn the public caused their children to develop autism or ADHD.

These cases have been consolidated into a multidistrict litigation (MDL) in the Southern District of New York. However, in a setback for the plaintiffs, the judge in the MDL excluded the testimony of the plaintiffs’ expert witnesses, stating that they did not provide sufficient scientific evidence to support their claims. As a result, the judge granted summary judgment in favor of the defendants, effectively dismissing all cases in the MDL.

The plaintiffs have appealed this decision to the U.S. Court of Appeals for the Second Circuit, and oral arguments were heard in December 2024. As of September 2025, the appellate court has not yet issued a ruling.

State Court Actions: An Alternative Avenue for Justice?

While the federal MDL remains in limbo, some families have begun filing similar claims in state courts across the country. These state court actions could offer an alternative avenue for justice, as the rules for expert testimony may differ from the federal standards.

For example, California employs the Frye standard for admitting scientific evidence, which may be more permissive than the Daubert standard used in federal courts. This could make it easier for plaintiffs to present expert testimony linking prenatal acetaminophen exposure to autism and ADHD in California state courts.

The Angelos Law Firm’s Perspective

The Angelos Law Firm believes that the FDA’s potential warning regarding Tylenol use during pregnancy could significantly bolster autism lawsuits in 2025. The firm argues that such a warning would provide further evidence of the potential link between the drug and neurodevelopmental disorders, which could strengthen the plaintiffs’ case in both federal and state courts.

Navigating the Complex Legal Landscape

The legal landscape surrounding Tylenol and autism/ADHD is complex and constantly evolving. If you or a loved one took Tylenol during pregnancy and your child was subsequently diagnosed with autism or ADHD, it is essential to seek legal advice from an experienced attorney.

An attorney can help you understand your legal rights and options, evaluate the strength of your case, and navigate the complex legal process. They can also help you gather the necessary evidence to support your claim and represent you in court.

What to Do Next

If you believe that your child’s autism or ADHD may be linked to Tylenol use during pregnancy, consider the following steps:

Gather relevant documentation: Collect medical records, prescription information, and any other documents related to your Tylenol use during pregnancy and your child’s diagnosis.
Consult with an attorney: Contact an experienced attorney to discuss your case and understand your legal options.
Stay informed: Keep up-to-date on the latest developments in the Tylenol autism litigation.

The potential link between Tylenol and autism/ADHD is a serious issue that deserves careful consideration. If you have been affected by this issue, seeking legal advice and staying informed are crucial steps in protecting your rights and pursuing justice.