Austin, Texas — In a landmark legal move, Texas Attorney General Ken Paxton has filed a civil lawsuit targeting Johnson & Johnson and its spin-off consumer-health unit Kenvue, alleging that the companies misled pregnant women about the safety of the over- the-counter pain reliever Acetaminophen (branded as Tylenol) and concealed emerging evidence linking its prenatal use to autism and attention-deficit/hyperactivity disorder (ADHD) in children.
The lawsuit, filed Tuesday in Panola County, Texas, asserts that the companies engaged in deceptive trade practices under Texas consumer-protection laws by marketing the drug as safe for pregnant women, while allegedly suppressing internal research suggesting neurodevelopmental risks.
Key allegations include:
- That Johnson & Johnson conducted an internal assessment in 2014 which “implied a causal relationship” between acetaminophen use during pregnancy and neurodevelopmental disorders, but chose not to warn consumers. The Washington Post+1
- That in 2023, Johnson & Johnson spun off its consumer-health division, assigning the rights and liabilities of Tylenol to Kenvue, a move the lawsuit claims was a “fraudulent transfer” designed to shield the parent company from future legal risk. AP News+1
- The complaint seeks statutory damages of $10,000 per violation of Texas’s Deceptive Trade Practices Act, and asks for injunctive relief ordering the companies to remove marketing claims that acetaminophen is safe for use during pregnancy or poses no risk of autism/ADHD in children. AP News
In its response, Kenvue strongly rejected the claims, stating that acetaminophen remains the safest pain-reliever option for pregnant women when used as directed, and that the lawsuit “lacks legal merit and scientific support.” TIME+1 Johnson & Johnson also emphasised that all rights and liabilities for its consumer-health business were transferred to Kenvue when the spin-off occurred. The Washington Post+1
The case comes amid a high-profile public campaign by Donald Trump and Robert F. Kennedy Jr., who have criticised Tylenol’s use during pregnancy over alleged autism risks—despite widespread expert consensus that the evidence does not establish causation. Leading medical associations, including the American College of Obstetricians and Gynecologists, have warned that discouraging acetaminophen use without clear evidence could result in untreated fevers and pain during pregnancy, which themselves carry risks.
Analysts say this marks the first time a U.S. state government has brought such a claim focused on prenatal acetaminophen use. The suit places Johnson & Johnson and Kenvue at the centre of a potentially costly litigation wave that may reshape how over-the-counter drugs are marketed to expectant mothers.
Why this matters
- With acetaminophen being one of the most widely used medications during pregnancy in the U.S., the lawsuit raises urgent questions about how drug safety information is handled in both research and marketing.
- If the court finds for Texas, it could open the door to similar lawsuits in other states, increasing pressure on OTC drug makers and potentially triggering label changes, marketing adjustments, or increased regulatory oversight by the Food and Drug Administration (FDA).
- The case also intertwines legal, public-health and political dynamics: Ken Paxton is a high-profile Republican candidate for the U.S. Senate, aligning himself with a populist “hold Big Pharma accountable” message.
What’s next
- The lawsuit will proceed in Panola County, a rural East-Texas jurisdiction, where a jury trial is requested.
- The medical community awaits how the FDA will respond; although the FDA has acknowledged a “possible association” between prenatal acetaminophen use and neurodevelopmental conditions, it emphasises causality is not established.
- Drug makers and liability insurers will be watching closely: the litigation may lead to changes in how over-the-counter drugs are labelled, marketed and indemnified.
For now, Kenvue and Johnson & Johnson maintain that acetaminophen is safe when used appropriately—even during pregnancy—and plan to vigorously defend themselves against a suit they say is grounded in speculation, not sound science. The coming weeks of filings and discovery promises to bring more details and perhaps a deeper view of how much these companies knew—or didn’t—about the risks they now face.
