Motion to dismiss lawsuit against Tylenol

PANOLA COUNTY — An East Texas district court held a hearing on Thursday to discuss the dismissal of a lawsuit filed by Texas Attorney General Ken Paxton against the companies that produce Tylenol. After the hearing, 123rd District Court Judge LeAnn Kay Rafferty did not make an immediate decision but indicated that she would ‘take under advisement‘ the arguments presented. The lawsuit, initiated by Paxton’s office, targets the pharmaceutical companies Johnson & Johnson and Kenvue Brands, according to our news partners at KETK. The lawsuit asserts that they unlawfully marketed Tylenol, or acetaminophen, to pregnant women, despite claims that the medication may pose risks to unborn babies.

“Big Pharma betrayed America by profiting off of pain and pushing pills regardless of the risks. These corporations lied for decades, knowingly endangering millions to line their pockets,” Paxton said in Oct. 2025.

Attorneys for Kenvue and Johnson & Johnson have requested the dismissal of Paxton’s lawsuit on several grounds. They argue that requiring the companies to label Tylenol as dangerous for pregnant women would violate their First Amendment rights and conflict with federal laws that prohibit misbranding drugs or providing misleading information on labels.
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Kenvue’s attorneys also claim that the Food and Drug Administration (FDA) has already determined that acetaminophen is safe for pregnant women. Therefore, the State of Texas requiring a label change would overstep the FDA’s authority to regulate medications.

In a letter dated Sept. 22, 2025, FDA commissioner Martin A. Makary said there has been a debate over the safety of acetaminophen during pregnancy, but he stressed that it is still the safest over-the-counter pain reliever.

“In the spirit of patient safety and prudent medicine, clinicians should consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers,” Makary said. “This consideration should also be balanced with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics; aspirin and ibuprofen have well-documented adverse impacts on the fetus.”

Kenvue’s motion noted that the FDA is doing its own in-house review of the Tylenol label. According to Kenvue, the fact that the FDA is doing its own review of the label is another reason to dismiss the lawsuit since the court should defer to the FDA’s expertise under the primary-jurisdiction doctrine.

Attorney Kim Bueno and State Senator Bryan Hughes appeared for Kenvue Brands at the hearing across from John Mission for the State of Texas on Thursday. Records show that Rafferty considered the motion to dismiss the case, but she’s only taking it under advisement for now.