A federal appeals court has revived hundreds of lawsuits claiming that acetaminophen (Tylenol) use during pregnancy increases the risk of autism and attention-deficit/hyperactivity disorder in children.
The U.S. Court of Appeals for the Third Circuit overturned a district court judge's dismissal of the cases, finding that plaintiffs presented enough scientific evidence to proceed to trial. The lower court judge had rejected the lawsuits based on concerns about the reliability of the underlying science. The appeals panel disagreed, concluding that questions about the strength of that evidence should be resolved by a jury rather than dismissed at the outset.
The ruling centers on epidemiological studies showing associations between prenatal acetaminophen exposure and neurodevelopmental disorders. Several observational studies, including research published in peer-reviewed journals, have documented potential links between the over-the-counter pain reliever and these conditions. However, the scientific community remains divided on whether these associations prove causation or reflect other confounding factors.
The FDA has not changed acetaminophen's pregnancy classification, which allows use for fever and pain relief when benefits outweigh risks. Major medical organizations including the American College of Obstetricians and Gynecologists have not issued warnings against typical acetaminophen use in pregnancy, though some experts recommend limiting unnecessary exposure.
The appeals court decision does not determine whether acetaminophen actually causes autism or ADHD. Instead, it allows lawsuits to move forward where juries can evaluate competing expert testimony about the evidence. Defendants in the cases include Johnson and Johnson and other manufacturers.
Pregnant people facing fever or pain should consult their healthcare providers about treatment options. Medical providers weigh individual risk factors when recommending acetaminophen use during pregnancy, considering the severity of symptoms and potential harms of untreated fever or pain. The litigation reflects ongoing scientific debate about drug