As Risk Managers at one of the country’s best-known pharmaceutical companies, Erin Sheridan and Tim Mohn were probably already struggling to sleep easily - but breaking news will doubtlessly cause even more nocturnal restlessness.
Texas has filed a lawsuit against Kenvue, the maker of Tylenol, and its former parent company, self-insured Johnson & Johnson, alleging that the pain reliever was deceptively marketed as safe for pregnant women despite what the state describes as evidence of harm to fetal brain development. The claim, lodged by Attorney General Ken Paxton in state court, makes Texas the first jurisdiction in North America to formally assert that acetaminophen exposure in utero can cause autism — a conclusion not supported by leading medical authorities.
The action follows a series of public statements from President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr., both of whom have linked the widely used medication to autism without offering new scientific data. Their comments have prompted a wider political debate about corporate accountability, medical regulation, and the boundaries of evidence-based policymaking.
Kenvue said in a statement that it is “deeply concerned by the perpetuation of misinformation on the safety of acetaminophen and the potential impact that could have on the health of American women and children.” The company called the lawsuit “baseless” and maintained that acetaminophen remains the safest option for pain and fever relief during pregnancy when used as directed. Johnson & Johnson said it no longer holds responsibility for Tylenol-related liabilities after spinning off its consumer division in 2023.
The U.S. Food and Drug Administration recently announced plans to update the drug’s labeling to reflect that prenatal exposure “may be associated” with a higher risk of autism or attention-deficit/hyperactivity disorder, though it emphasized that “a causal relationship has not been established.” That distinction — between statistical association and proven causation — lies at the center of both the scientific and legal debate.
Paxton’s complaint contends that Johnson & Johnson knew of potential developmental risks as early as 2014 and failed to disclose internal findings. The filing mirrors earlier personal-injury suits consolidated in federal court in New York, which were dismissed last year after a judge ruled that the plaintiffs’ expert witnesses did not meet evidentiary standards. That case is currently on appeal.
Medical research on the subject remains inconclusive. Some studies have found correlations between higher acetaminophen use during pregnancy and later diagnoses of autism or ADHD, while others — particularly large, sibling-comparison studies — show no link once genetic and environmental factors are controlled for. Health agencies including the World Health Organization and the American College of Obstetricians and Gynecologists maintain that there is no credible proof of causation and continue to regard acetaminophen as appropriate for use during pregnancy when necessary.
For insurers, the Texas filing could mark the beginning of a complex wave of liability and regulatory uncertainty. Product-liability carriers and pharmaceutical underwriters are watching closely to see whether other states follow suit, or whether the case becomes another high-profile test of how far public officials can go in asserting unproven health risks. If the litigation broadens, questions could arise about the scope of coverage under existing policies, particularly for “failure to warn” and post-spin-off successor liability.
The lawsuit also touches on a broader challenge for underwriters and risk managers: how to assess exposure when scientific evidence is incomplete and politicized. The Tylenol case now sits at the intersection of public health, regulation, and the evolving boundary between data and ideology — a space where uncertainty itself may be the largest liability of all.
