Could New FDA Warnings on Tylenol Revive Litigation Over Risks to Unborn Children?
For decades, Tylenol (acetaminophen) has been one of the most commonly used over-the-counter pain relievers for pregnant individuals. It’s long been viewed as the “safe” alternative to aspirin or ibuprofen during pregnancy. However, recent discussions within the U.S. Food and Drug Administration (FDA) may change how the public—and the courts—view Tylenol’s safety.
The MDL: A Brief Overview
An existing Multidistrict Litigation (MDL) has been underway, consolidating lawsuits from families who allege that prenatal exposure to acetaminophen increased the risk of autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) in their children. The claims argue that manufacturers failed to adequately warn consumers of these potential risks, despite growing scientific studies linking acetaminophen use during pregnancy to developmental concerns.
While the litigation gained momentum in 2022–2023, it stalled somewhat after recent court rulings questioned whether plaintiffs’ scientific evidence met legal admissibility standards. However, new regulatory actions could reignite these claims.
Why FDA Action Could Change Everything
If the FDA moves forward with updated warning labels or safety communications regarding Tylenol use during pregnancy, this could significantly bolster plaintiffs’ failure-to-warn arguments in court. A formal government warning would lend additional credibility to the claim that consumers were not adequately informed of potential risks.
Such a development could lead to:
- Renewed MDL activity, including reconsideration of dismissed claims.
- New lawsuits from families who were previously unaware of the litigation.
- Increased settlement pressure on manufacturers and retailers.
This pattern has been seen in other mass tort cases, where regulatory changes breathed new life into claims that had previously stalled.
What This Means for Families
For families who believe their child’s neurodevelopmental conditions may be linked to Tylenol use during pregnancy, any new FDA warnings could represent an important legal turning point. These developments may expand eligibility for claims or extend filing timelines depending on the jurisdiction.
VanDerGinst Law is Monitoring the Situation Closely
At VanDerGinst Law, we have extensive experience handling complex mass tort and MDL cases across the country. We are closely following the FDA’s actions and court developments surrounding Tylenol litigation. If the FDA issues new warnings, the legal landscape could shift rapidly—and families may have new opportunities to pursue justice.
If you have questions about potential Tylenol-related claims, contact VanDerGinst Law at 800-960-VLAW or reach out online for a free consultation.