Kenvue is gearing up for a significant wave of lawsuits concerning its well-known pain reliever, Tylenol, following a notification from the Trump administration. This warning suggests that acetaminophen, the active ingredient in Tylenol, might be linked to autism.
This update from health officials could empower lawyers representing plaintiffs, who have previously faced setbacks in their legal battles claiming the medicine resulted in neurodevelopmental issues. Insiders predict that this could trigger a surge of new lawsuits in the near future.
On a press briefing, Trump and Health Secretary Robert F. Kennedy Jr. stressed that prenatal exposure to acetaminophen might be a potential factor in the emergence of autism, with Trump urging, “Don’t take it,” while somewhat qualifying it for dire circumstances where pregnant women might need it.
The FDA has alerted medical professionals regarding this apparent link, advising that pregnant women take the lowest possible dose for a minimal time, if deemed necessary. They plan also to revise warning labels for acetaminophen products.
Moreover, the FDA recognizes the existence of studies refuting any connection between acetaminophen and autism, while also acknowledging the possible risks associated with leaving fever untreated during pregnancy for both mothers and developing fetuses.
For context, Kenvue emerged as a standalone entity from Johnson & Johnson just last year. Tylenol, among the most widely used over-the-counter medicines, significantly contributes to Kenvue’s revenue, accounting for about 10% of its impressive $15 billion annual earnings, as noted by BNP Paribas analyst Navann Ty.
While officials believe the new warnings could influence sales negatively, it’s hypothesized that pregnant women represent a small fraction of Tylenol’s user base, so the overall impact may be limited.
However, the flood of potential lawsuits claiming that Tylenol caused autism in children whose mothers used it during pregnancy could be a heavier burden for Kenvue.
Since 2022, around 500 lawsuits have targeted J&J, Kenvue, and other brands tied to private-label acetaminophen products, alleging that prenatal exposure led to autism and ADHD. Kenvue had to handle these lawsuits once it split from Johnson & Johnson.
Thus far, Kenvue has been effectively countering these lawsuits. A federal judge already determined that there wasn’t enough evidence linking acetaminophen to autism, resulting in a dismissal of the claims.
Nonetheless, plaintiff lawyers are appealing this ruling with intentions to reinstate the lawsuits. The recent warning from the Trump administration will likely be a focal point in their appeal, aiming to challenge the previous lower-court decision. Originally, the appeal hearing was set for early October, but it’s now deferred until mid-November.
Even if the federal lawsuits don’t see a revival, the new federal advisory might still spark numerous claims across state courts. Attorneys representing families, whose autistic children haven’t filed suits yet, consist of tens of thousands, reveals Ashley Keller, a senior partner from Keller Postman law firm. Notably, legal timelines allow such claims to be on hold until minors turn 18, paving the way for potential future lawsuits.
“When public health directives change or a clarion call is issued, you bet plaintiffs’ lawyers will pay attention to these shifts and gauge if that sways their decisions regarding cases,” Keller noted.
With a product label likely to indicate these risks, Kenvue may face a tougher battle since it could empower plaintiffs to argue that the company did not properly disclose potential dangers.
In response, Kenvue insists that Tylenol is sufficiently safe, strongly disputing any correlations with autism: “Independent and reliable science clearly illustrates that acetaminophen does not cause autism. We are seriously concerned about the health implications these claims pose to expectant mothers.”
The company urges that acetaminophen is the safest pain relief option for pregnant women needing pain management, indicating overlooking it might lead to untreated fever — itself a risk for miscarriages, autism, or birth defects in their babies.
They reiterated, “We will pursue all possibilities to safeguard the health interests of American families.”
Kenvue’s stock dipped 7.5% on Monday trading, but later rebounded following Trump’s announcement. It had risen 5.2% in Tuesday morning trades.
The recovery likely stemmed from the more balanced tone in official releases from the Department of Health and Human Services and the FDA compared to Trump’s live briefing, mentioned analyst Ty. Notably, the FDA commissioner emphasized in correspondence to doctors that “a causal relationship remains unproven” and categorized acetaminophen as “the safest non-prescription option during pregnancy.”
Contact: Peter Loftus at Peter.Loftus@wsj.com
