A US appeals court has revived private lawsuits linking acetaminophen, the active ingredient in Tylenol, to autism spectrum disorder. The decision reinstates claims that had been dismissed in lower court, allowing plaintiffs to proceed with litigation against Johnson & Johnson's consumer health unit.
The Third Circuit Court of Appeals ruled that plaintiffs stated viable claims under federal law, clearing a procedural hurdle that had blocked the cases from advancing. The court found that the allegations met the threshold for plausibility required to survive a motion to dismiss. This decision does not determine whether acetaminophen actually causes autism, but rather whether the legal claims can move forward to discovery and potentially trial.
The lawsuits allege that prenatal and early childhood exposure to acetaminophen increases the risk of autism spectrum disorder. Plaintiffs argue that Johnson & Johnson failed to warn consumers about this alleged risk despite evidence the company possessed or should have known about the connection.
Johnson & Johnson faces mounting legal exposure on this front. The company already contends with lawsuits over talc products linked to ovarian cancer and opioid painkillers. The acetaminophen litigation joins a growing list of product liability cases targeting the healthcare conglomerate.
Epidemiological studies have suggested a potential link between acetaminophen use during pregnancy and later autism diagnosis in children. However, major health organizations, including the FDA and American Academy of Pediatrics, have not established a causal connection or changed recommendations regarding acetaminophen use in pregnancy and childhood.
The appeals court decision does not resolve the scientific question of causation. Instead, it clears a path for discovery, depositions, and expert testimony that could illuminate whether acetaminophen poses the risks plaintiffs claim. The litigation could extend years before reaching resolution.
The ruling affects Johnson & Johnson's legal and financial planning. Large product liability judgments or settlements could impact the company's earnings and financial position. Investors monitoring J&J should watch for developments in acetaminophen litigation alongside ongoing talc and opioid cases.