Tylenol Pregnancy Warnings About Autism and ADHD Risk Proposed By Plaintiffs in Federal MDL

Federal judge presiding over lawsuits brought by families nationwide asked plaintiffs' lawyers to propose Tylenol pregnancy warnings that should have been added to the painkiller acetaminophen

With Johnson & Johnson and other drug makers face a growing number of Tylenol lawsuits brought by families of children diagnosed with autism or ADHD after exposure to the pain medication before birth, the U.S. District Judge presiding over the litigation asked lawyers for the families to propose an example of the acetaminophen pregnancy warnings that should have been provided to expecting mothers.

In a letter (PDF) submitted last week, plaintiffs used some of the existing language that has been on the warning labels in Europe for years, indicating that defendants could have provided the following Tylenol pregnancy warnings about the risk of autism and ADHD:

Autism/ADHD: Some studies show that frequent use of this product during pregnancy may increase your child’s risk of autism and attention deficit hyperactivity disorder. If you use this product during pregnancy to treat your pain and/or fever, use the lowest effective dose for the shortest possible time and at the lowest possible frequency.


Lawyers indicate that this language is not the only way the defendants could have warned pregnant women about the Tylenol autism risks, arguing that different words also could have satisfied the drug makers’ duty to warn. However, plaintiffs argue that it is not necessary for families to provide any specific alternate language for the Tylenol pregnancy warnings, as a required element of their claims.

Tylenol Lawsuits Allege Failure to Warn Pregnant Women

Tylenol (acetaminophen) has been widely used by pregnant women for decades, largely due to the drug makers’ failure to disclose growing evidence that exposure in utero increases a child’s risk of developing autism or ADHD.

More than 100 families of children with ADHD or autism from Tylenol are now pursuing lawsuits against Johnson & Johnson, as well as major retailers who sold generic versions of the pain medication, including Walmart, CVS, Walgreens, Costco and others. However, it is widely expected that tens of thousands of claims will be brought in the coming months and years.

Each of the complaints raise similar allegations, indicating that information has been available to the manufacturers for decades about the link between autism and Tylenol, as well as attention deficit hyperactivity disorder (ADHD) and other developmental problems. However, rather than warning about the acetaminophen risks, the drug has been actively promoted as safe for use by pregnant women.

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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 late last year, centralizing all lawsuits 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).

Plaintiffs Propose Tylenol Pregnancy Warnings

In January, Judge Cotes ordered plaintiffs to submit proposed language that could have been added to the acetaminophen labels, showing what the drug makers could have done to warn women about the risks of using Tylenol during pregnancy.

Plaintiffs noted in their proposed Tylenol pregnancy warning that the last line, which indicates women should “use the lowest effective dose for the shortest possible time and at the lowest possible frequency,” comes directly from the European Union’s label for paracetamol, the European name for acetaminophen.

While the plaintiffs lawyers complied with the Court’s request that they propose warning language about the Tylenol autism and ADHD risks, they maintain the law is well settled that this is not a required element of their claim.

“In almost every state whose courts have considered the question, plaintiffs pursuing failure-to-warn claims need not provide the fact finder with specific, alternative language for the label,” the letter states. “Therefore, by filing this letter, Plaintiffs do not concede that Plaintiffs’ proposed label change is a required element of their claims.”

April 2023 Tylenol Lawsuit Update

While litigation continues to grow, Judge Cote has indicated the court will prioritize discovery and pretrial proceedings that examine the strength of the evidence that Tylenol causes autism and ADHD, and has appointed a special master to oversee discovery issues that arise.

In January, Judge Cote issued a court order detailing how the federal court will coordinate Tylenol lawsuit discovery proceedings with various state courts nationwide, where some families have filed their claims outside of the MDL.

As part of the coordinated pretrial proceedings, it is also expected that the court will establish a “bellwether” process where a small group of representative cases will be selected for early trial dates, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation. However, if the parties fail to negotiate Tylenol autism settlements or another resolution for the litigation in the MDL, each family’s lawsuit may eventually be remanded back to different U.S. District Courts nationwide for future trial dates.

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