Ruling Over Acetaminophen Pregnancy Warnings
Ruling Over Acetaminophen Pregnancy Warnings
Consumers potentially harmed by acetaminophen have gained an early win against manufacturers and retailers that knew of the additional risks associated with the drug but failed to adequately warn unwary consumers. On Nov. 14, 2022, Senior U.S. District Judge Denise L. Cote denied Walmart’s motion to dismiss claims filed against the company in the ongoing Tylenol autism lawsuit regarding the lack of acetaminophen pregnancy warnings on their Equate painkillers. As Walmart had argued for dismissal on the basis of preemption two months earlier, Judge Cote countered that federal preemption does not apply in this case because of state-level failure-to-warn laws.
Since then, Walmart has requested an immediate appeal of the decision while asking for reconsideration of the motion. If Judge Cote grants the request, it will pass through the U.S. Court of Appeals for the Second District, delaying litigation in the meantime.
A failure to warn
The case against Walmart, which began in June, involves its Equate-brand acetaminophen. Two mothers, Robin Hatfield and Lisa Roberts, filed separate lawsuits, claiming their use of the medicine during pregnancy caused their children to develop autism and attention-deficit hyperactivity disorder (ADHD). They allege that Walmart failed to warn consumers that acetaminophen posed an elevated risk for these disorders.
Walmart attempted to have the lawsuits thrown out because of preemption, a legal doctrine stating that federal law holds control over state laws. With regard to these two cases in particular, the company argued that by complying with the minimal labeling requirements of the Federal Drug Administration (FDA), it had no further duty to warn pregnant women or parents of young children of the potential risks associated with the use of acetaminophen. The Court ultimately disagreed with Walmart, citing a litany of examples in which drug manufacturers could — and indeed routinely do — provide additional warnings beyond the minimal FDA requirements, either voluntarily or to comply with the laws of individual states.
Though Walmart is likely to appeal the Court’s decision, the strategy of these initial cases shows promise as the Court appears to be signaling that the protection of children through state-level failure-to-warn laws carries significantly more weight than over-generalized FDA labels created for the protection of manufacturers that instruct users to “consult with your physician before use.”
The Tylenol autism lawsuit
Walmart’s lawsuits are among many others against companies that have sold their own brands of acetaminophen without warnings aimed at pregnant users. These claims are part of a larger litigation that comprises numerous cases across the United States, collectively known as the Tylenol autism lawsuit.
Because they involve similar complaints and matters of law, the plaintiffs filed to combine them into a multidistrict litigation in October, over which Judge Cote is presiding. At the time of consolidation, the litigation involved 18 plaintiff actions. With further claims added since then, it has grown to include more than 100 lawsuits.
The early claims focused primarily on retailers. Aside from Walmart, the defendants have included the national brands Costco, CVS, Safeway, and Walgreens. In November, however, several new lawsuits named the pharmaceutical giant Johnson & Johnson, owner of the Tylenol brand of acetaminophen products.
A growing body of research
Acetaminophen is one of the most widely used medicines in the world. Sold under the brand name Tylenol, as a generic product, and as an ingredient in more than 600 other medications, it is a frequently used remedy for common pains, including those experienced by pregnant women.
However, a growing body of research suggests that acetaminophen use during pregnancy may increase the risk of autism and ADHD in children. Some of the most significant research includes a 2015 review by the FDA, a 2018 review published in the American Journal of Epidemiology, and a 2019 study published in JAMA Psychiatry. These and other papers indicate a greater risk associated with larger and more prolonged dosing.
The research may help to form the foundation of the claims in the Tylenol autism lawsuit, which center on the failure of companies to warn consumers of the drug’s long-term health impact. If you or a loved one has a child who is experiencing developmental disorders that may be related to acetaminophen usage during pregnancy, you are not alone. Find out whether you can join the fight for compensation.