Kenvue Brands LLC, the maker of Tylenol®, issued the following statement related to the Second Circuit Court of Appeals ruling in the acetaminophen litigation today:
“The procedural ruling today does not change the fact that credible, independent science shows no proven link between taking acetaminophen and autism or attention deficit hyperactivity disorder (ADHD). Science matters, and we stand with the many public health and medical professionals who have reviewed the science on this topic and agree.
We now have another opportunity to show that the plaintiffs’ experts’ opinions are unreliable and should not be allowed. We are exploring all options regarding this decision. We stand behind the safety of our product and will continue to defend these cases.”
Key Points
- Does the ruling by the Second Circuit Court of Appeals mean that a court has found that Tylenol causes autism or ADHD? No. This was a procedural ruling on whether plaintiffs’ experts’ methods and testimony should be allowed to be considered by a jury. As the Court said in its ruling, “[It is] not deciding whether there is a general causal relationship between acetaminophen and ADHD and/or ASD.”
- Does this ruling mean the lower court will review the case again? The Second Circuit’s decision remanded the cases to the District Court for further review consistent with its opinion. Timing for this review is set by the District Court and potential further appellate review. We are exploring all options regarding this decision.
- Do consumers and healthcare professionals trust the Tylenol® brand? Yes. See commentary on our recent earnings release.
- Does acetaminophen cause autism or ADHD? No. Current scientific evidence does not support a causal relationship. Again, as the Court stated the appeal is not deciding “whether acetaminophen use during pregnancy has adverse effects on fetal development.”
- Do leading medical authorities recommend acetaminophen during pregnancy when medically indicated and used as directed? Yes.
- Is there guidance pregnant women should follow when taking acetaminophen? Yes. Pregnant women should follow the product label and consult a healthcare professional before taking acetaminophen or any over-the-counter medication.
What This Legal Procedural Ruling Means
The Second Circuit Court of Appeals was asked to review whether the District Court in the federal multi-district litigation (In re: Acetaminophen ASD-ADHD Product Liability Litigation) correctly applied legal standards when deciding which expert opinions should be allowed in this case.
Today, the Second Circuit Court of Appeals ruled that the District Court was within its discretion in excluding two of plaintiffs’ experts (affirming in part) but exceeded its discretion in excluding three other experts. The District Court’s judgments were vacated and remanded for further proceedings consistent with the Second Circuit’s opinion.
It is important to understand today’s ruling is on legal procedure. The decision is not about the science or merits of the case and plaintiffs have not proven that taking acetaminophen causes autism or ADHD.
Health Authority Perspective
Credible, independent scientific data continues to show no proven link between taking acetaminophen and neurodevelopmental disorders, including autism and ADHD.
We stand with the many public health and medical professionals who have reviewed the science and agree. This includes the positions of the World Health Organization, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, the Autism Science Foundation, the American Academy of Pediatrics, Health Canada, the Society of Obstetricians and Gynaecologists of Canada, and others.
Safety Guidance
Acetaminophen is one of the most studied medications in history. Medical experts worldwide have and continue to recommend acetaminophen as an option for pregnant women to treat pain and fever throughout an entire pregnancy.
There is no known safe alternative to acetaminophen for the treatment of pain and fever throughout pregnancy. Untreated fever in pregnancy is associated with serious adverse outcomes including the possibility of miscarriage, preterm birth, and fetal organ malformations, and untreated pain is linked to depression, anxiety, and hypertension in the mother.
When it comes to taking acetaminophen during pregnancy, it is important to follow the product label and talk to a healthcare professional before doing so. Healthcare professionals are best positioned to evaluate underlying medical conditions and recommend the best approach for both mother and child.
Kenvue Position
We stand firmly with the global medical community that acknowledges the safety of acetaminophen and will continue to vigorously defend ourselves against claims that suggest otherwise. We will continue to vigorously defend these cases as we believe these claims lack merit and scientific support.
Cautions Concerning Forward-Looking Statements
This statement contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, litigation related to acetaminophen. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kenvue Brands LLC and its affiliates.
A list and descriptions of risks, uncertainties and other factors can be found in Kenvue Inc.’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 28, 2025, and subsequent Quarterly Reports on Form 10-Q and other filings, available at www.kenvue.com or on request. Kenvue Brands LLC and its affiliates undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or developments or otherwise.