Appeals Court Urged To Reinstate Tylenol Lawsuits Over Autism, ADHD Risks

Plaintiffs argue that not allowing them to present expert opinions that the U.S. government itself used to require Tylenol to carry new autism label warnings would undermine the public trust.

Hundreds of families whose Tylenol autism lawsuits were dismissed nearly two years ago are calling on the U.S. District Court of Appeals for the Second Circuit to reinstate the claims, pointing to the recent federal government warning linking pregnancy use of acetaminophen to the risk of developmental disorders.

In December 2023, U.S. District Judge Denise Cote issued a controversial decision that excluded plaintiffs’ expert witnesses from testifying about the link between Tylenol and autism, after determining that the scientific approaches and studies relied on were not sufficiently sound enough to allow a jury to consider the opinions. This decision led to the dismissal of the entire litigation.

An appeal of that ruling was already pending in the Second Circuit, when the U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) issued statements on September 22, announcing that manufacturers of Tylenol and other acetaminophen-containing medications must add label warnings cautioning women that there is evidence Tylenol pregnancy side effects can cause autism, as well as attention deficit hyperactive disorder (ADHD) and other developmental problems in unborn children.

The federal health officials urged doctors to advise women to use as little acetaminophen as possible while pregnant, also noting that it is still safe enough to be used as a fever-reducer when needed.

However, one of the key studies the government cited as evidence for the new label requirements was one Judge Cote had determined was insufficient for a federal jury to consider at trial.

Plaintiffs’ appeal seeks to overturn Judge Cote’s decision and reinstate the litigation, indicating she erred in her decision to toss out their evidence. They now say that the federal governments recent decision to require manufacturers to provide the very label warnings the lawsuits claim should have been added years ago, gives their arguments more weight.

In a letter (PDF) sent to the appellate court on September 24, plaintiffs’ attorneys noted that if the government indicates the scientific evidence is good enough to set federal policy, the court should consider it good enough evidence to bring before a jury.

“The executive branch safeguards public health from dangerous pharmaceutical interventions. A decision holding that a jury may not hear the same expert evidence that the executive branch credited will badly damage the public trust required for the executive to take care that the public-health laws are faithfully executed.”

– In Re: Acetaminophen – ASD-ADHD Products Liability Litigation

Defendants pushed back with a response (PDF) issued on the same day, indicating that even in the latest announcement, the government never says there is a causal relationship between Tylenol and autism, and in fact states that such a relationship has not been established.

At question is what the Second Circuit will use as a measuring stick. Plaintiffs argue that the Court should rely on the evidence being good enough to bring before a jury to argue for causation, even if it does not specifically state causation, and that the government’s reliance on that data should meet that bar.

It is uncertain when the court will render a decision. If they rule in plaintiffs’ favor the litigation would likely be sent back to Judge Cote for continuing pretrial proceedings and preparation for eventual bellwether early test trials.

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