Blog Post 08.07.25
Alert
Alert
10.24.25
In late September 2025, the Food and Drug Administration (FDA) initiated the process for a label change for acetaminophen to reflect that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions. The FDA also sent a letter to physicians to “consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers” while acknowledging that such consideration should be “balanced with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics.” President Donald Trump—with Secretary of Health and Human Services Robert F. Kennedy, Jr. at his side—amplified the FDA’s action, noting in a White House event that his administration “has determined that acetaminophen exposure during pregnancy causes autism.” The announcement conflicts with efforts by manufacturers, health professionals and industry groups to convince the public and regulators that common, over-the-counter pain medications can be used safely during pregnancy.
The announcement also has triggered scientific criticism and revived attention to an ongoing, multidistrict litigation alleging that prenatal acetaminophen exposure contributes to neurodevelopmental disorders. Even though professional bodies, including the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and the World Health Organization, have all emphasized that existing data remains inconclusive and observational studies show no causation, the announcement has resulted in a new wave of litigation—not just against Kenvue[1], the company most associated with acetaminophen, but also against other manufacturers and retailers.
Insurance and Risk Management Considerations
As acetaminophen-related litigation gains momentum, the cost of defending even unsubstantiated claims is expected to be significant. Multidistrict litigation, expert-intensive discovery and parallel regulatory inquiries can rapidly escalate legal expenses, often far exceeding any eventual settlement or judgment exposure. For companies across the supply chain—manufacturers, distributors, retailers and health care providers—insurance coverage for defense costs may be the most immediate and essential layer of financial protection.
Depending on how far the litigation extends and what actions regulators ultimately take, the types of insurance coverage that could come into play include:
Policyholders should take early steps to review their coverage portfolios, confirm notice obligations and preserve rights to defense-cost reimbursement. There are, however, many potential issues that can impact a company’s ultimate ability to maximize the value of its insurance assets. For example, wording differences can materially affect the scope of recovery, even when the differences appear slight—such as whether a policy covers costs incurred “for” or “because of” bodily injury, which has been an important distinction in the opioid coverage disputes. Choice of law and potential forum battles matter, too, and insurers often seek out opportunities to file a preemptive lawsuit to secure a jurisdiction they believe will be more favorable to them. The complexity of these issues can be elevated when, as likely will be the case with many acetaminophen claims, there are decades of alleged injuries triggering many different insurance policies.
Conclusion
Depending on what is behind the administration’s announcement, and the strength of the boost that may give plaintiffs seeking to recover for alleged injuries, the emerging acetaminophen claims could drive insurers to reevaluate coverage triggers and defense-cost obligations. Companies facing these suits should proactively engage coverage counsel to identify applicable policies, maximize defense protection, and coordinate strategies across insurers to manage both near-term costs and long-term risk.
The amplified uncertainty around one of the most widely used over-the-counter medications in the world warrants a cautious approach. While regulatory follow-through remains uncertain, manufacturers, retailers, distributors and health care providers should act now to evaluate their exposure, refresh compliance protocols, and prepare for intensified public and legal scrutiny.
Pillsbury will continue to monitor FDA actions, litigation developments and insurance-coverage implications as this issue unfolds.
[1] Acetaminophen was first sold in the United States in 1955 by McNeil Laboratories and is currently manufactured and sold by Kenvue Inc. under the Tylenol brand.