A Texas district judge has declined to dismiss a lawsuit filed by Attorney General Ken Paxton against Kenvue, the manufacturer of Tylenol. The ruling, made by Panola County District Judge LeAnn Rafferty on Thursday, allows the case to move forward into the discovery phase. Paxton’s lawsuit alleges that Kenvue, along with its parent company Johnson & Johnson, misrepresented the safety of acetaminophen for children, particularly during pregnancy.
The brief order issued by Judge Rafferty did not elaborate on the reasoning behind her decision to keep the lawsuit alive. According to Reuters, the judge’s ruling directly counters Kenvue’s motion to dismiss the case, which was filed in late October 2023. The lawsuit invokes the Texas Deceptive Trade Practices Act and seeks civil penalties as well as injunctive relief, claiming that the companies have deceptively marketed Tylenol as safe for use by pregnant women.
Kenvue has strongly defended its position, asserting that acetaminophen is safe when used according to guidelines. The company contends that federal law and the authority of the U.S. Food and Drug Administration (FDA) take precedence over state regulations. Furthermore, Kenvue argues that restricting its marketing practices could infringe upon First Amendment rights, as reported by ABC News.
Regulatory Context and Scientific Concerns
In September 2023, the FDA initiated a review of acetaminophen labeling, prompting healthcare professionals to consider potential associations between prenatal exposure to the drug and neurodevelopmental issues. Although the FDA highlighted this association, it emphasized that no direct causation has been established. Leading medical organizations, including the American College of Obstetricians and Gynecologists (ACOG), have advised caution, stating that current evidence does not warrant significant changes in clinical practice surrounding acetaminophen use during pregnancy.
This case is reflective of broader legal challenges surrounding prenatal acetaminophen use. Kenvue is also awaiting a decision from an appellate court regarding the revival of hundreds of private lawsuits that were previously dismissed by a federal judge. Additionally, a prior attempt by the state to block a $398 million dividend payment to Kenvue was rejected by a Panola County judge, as noted by The Dallas Morning News.
Potential Legal Implications
If Judge Rafferty permits Paxton’s claims to proceed through the discovery phase, Texas could pursue remedies such as disgorgement and civil penalties, rather than individual damages. Legal experts suggest that this could lead to extensive company document disclosures. Kenvue is likely to rely on defenses related to federal preemption, FDA labeling authority, and First Amendment protections concerning truthful marketing, as discussed in court filings and analyzed by The Texas Lawbook.
As of now, the ruling leaves several procedural questions unanswered. The court’s lack of detailed reasoning and the absence of a clear schedule suggest that further motions and a potentially protracted discovery process lie ahead. Both sides are expected to sharpen their legal strategies as the case unfolds, highlighting the ongoing complexities surrounding this high-stakes litigation.
