Nine months of carrying a child can involve some less-than-pleasant experiences for pregnant women. With options severely limited out of concern for fetal developmental issues, the use of acetaminophen, also known as paracetamol, may be the only pain reliever available for some expectant mothers. The active ingredient in Tylenol has been a go-to choice as a painkiller to help make pregnant women as comfortable as possible for a long time.
Recently, however, the Secretary of the Department of Health and Human Services (HHS) Robert F. Kennedy Jr.’s (RFK Jr.), has claimed there is a link between autism and the use of acetaminophen by pregnant women. On September 22, the FDA announced it was updating safety labels for products using acetaminophen. This has led to calls to renew litigation against Kenvue, the spin-off company of Johnson & Johnson responsible for making Tylenol.
Allegations are Not New
This is not the first time Kenvue has had the link between Tylenol and autism questioned. In 2022, several lawsuits alleging that Tylenol caused autism were consolidated in multidistrict litigation (MDL). However, those cases were dismissed in 2024, after a federal judge excluded the plaintiffs’ expert witnesses under the “Daubert standard.” The Daubert standard allows federal trial court judges to exclude expert testimony if the expert opinions are not based on reliable scientific evidence or are irrelevant to the case. The Supreme Court established the Daubert Standard in 1993 as a way for federal judges to act as gatekeepers to avoid juries hearing from unreliable experts.
Kenvue was awarded a summary judgment in 2024 after the court ruled the plaintiffs’ expert witnesses were using unreliable methodology, instead cherry-picking data that supported their position. Unsurprisingly, the plaintiffs disagreed and appealed this decision. The appeal is currently pending in the 2nd Circuit Court of Appeals. After the White House’s announcement, plaintiffs’ lawyers have asked the court to consider the FDA’s new warning label in determining their appeal.
Should the Second Circuit reverse the trial judge, the case would go back to litigation, with the plaintiffs' expert witnesses allowed to testify.
What Is Kenvue?
Originally part of Johnson & Johnson, Tylenol was spun off into Kenvue in 2023. Around 600 products make use of acetaminophen, an analgesic. It’s estimated that nearly 25% of all adult Americans use some form of acetaminophen weekly. Tylenol is by far the most successful and well-known acetaminophen medication.
What Are the Concerns About Prenatal Tylenol Use and Autism?
Plaintiffs in MDL, and now HHS Secretary RFK, JR., have suggested there is a causal link between prenatal Tylenol use and autism. Why?
The scientific literature regarding whether paracetamol use by pregnant women leads to an increased risk of autism goes back years. Several studies have shown a link between prenatal acetaminophen use and autism. However, there are several important caveats:
- Neurodevelopmental disorders are a complicated area of study.
- Existing studies have conflicting results.
- Even if they are linked, there's a question of whether Tylenol causes autism, or if Tylenol use increases because of complications arising from other factors that could lead to autism.
- Finally, as an over-the-counter medication, many studies regarding Tylenol rely on self-reporting, which can be unreliable.
The U.S. Food and Drug Administration (FDA) is now recommending that pregnant women use the lowest dose of acetaminophen possible. However, the FDA also acknowledges that there is no proof acetaminophen causes autism. In addition, the FDA still considers acetaminophen to be the safest over-the-counter medication for pregnant women, as other, better-documented complications exist with ibuprofen and aspirin.
The American College of Obstetricians and Gynecologists has stated that “not a single reputable study” has shown any link between a pregnant woman’s use of acetaminophen during any trimester and ADHD, intellectual disability, or autism in children.
Perhaps the largest and best-regarded study was published in last year’s Journal of the American Medical Association (JAMA). Researchers from Sweden conducted a population study, controlling for other factors through siblings. After examining millions of cases, they found no link between autism and prenatal Tylenol use.
What Does It All Mean for Pregnant Women?
We are not doctors at FindLaw, so we make no recommendations. What we can say is that pregnant mothers and doctors are free to agree or disagree with the FDA’s new public health stance. The Trump administration is not seeking to make Tylenol prescription-only at this time, and pregnant women will still be able to use Tylenol as they choose. Instead, the FDA is adding a warning label to Tylenol and other acetaminophen products and partnering with manufacturers to conduct further research.
New product liability lawsuits against Kenvue and other paracetamol-using drugmakers are likely to be filed soon. Whether existing MDL over acetaminophen is revived remains to be seen.
Related Resources
- Defamation and False Statements Under the First Amendment (FindLaw’s First Amendment)
- 5 Legal Tips for Parents of Autistic Children (FindLaw’s Law and Daily Life)
- Injury Claims Against the Government (FindLaw’s Accident and Injury Law)
