Texas asks judge for restraining order against Tylenol maker to stop it from advertising that drug is safe
Texas Attorney General Ken Paxton has asked a federal judge to issue a restraining order against the makers of Tylenol to force them to immediately stop advertising to consumers that in consultation with a doctor the pain reliever is safe for pregnant women and young children to use.
Paxton made the request in a Thursday filing, one week after he sued the drug's makers, Johnson & Johnson and its corporate spin-off Kenvue, claiming that they deceptively marketed the over-the-counter medication to pregnant women despite alleged links to autism and other disorders.
In the new filing, Paxton alleges that Kenvue "continue[s] to falsely assure Texans that Tylenol is entirely safe -- contrary to the specific instructions of the federal health authorities and indeed the President of the United States."
Those instructions from President Donald Trump came during a September press conference in which he repeatedly urged pregnant women not to take Tylenol and to "tough it out," recommendations he acknowledged he gave based on "common sense," not scientific evidence.
He also urged parents not to give Tylenol to their young children.
The Food and Drug Administration, in a more measured notice to physicians the same day, told them to "consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers," citing several studies that suggest a correlation between use of acetaminophen during pregnancy and autism.
However, the agency noted that "there are contrary studies in the scientific literature" and that researchers have not established a causal relationship.
The FDA said nothing about restricting the use of Tylenol for young children, and studies have shown that the drug is safe for them when used as directed.
Major medical groups blasted the FDA's guidance, with one, the American College of Obstetricians and Gynecologists, calling it "highly concerning," "irresponsible" and "not backed by the full body of scientific evidence."
In a statement, Kenvue said "we are taking immediate legal action to stop the plaintiffs' attorneys representing the State of Texas from continuing to drive these reckless and scientifically unsound theories. These politically and financially motivated actions will have a detrimental impact on public health for our consumers in this state. We will do everything in our power to stand up for sound, credible science."
On its website, Kenvue says pregnant women "should follow the label and consult a healthcare professional before taking acetaminophen or any over-the-counter medication."
In Thursday's filing, Paxton argues that by continuing to run ads without a warning label, Johnson & Johnson and Kenvue are claiming that "Americans should ignore the President of the United States's repeated warnings about the drug."
"Injunctive relief is necessary to prevent Kenvue from engaging in further deceptive conduct intended to take advantage of Texas consumers by misrepresenting the dangers of Tylenol for pregnant women and young children," the lawsuit says.
Texas is also asking the judge to issue a temporary restraining order to prevent Kenvue from "issuing a dividend or otherwise distributing funds without receiving equal value in return," arguing that paying a "massive dividend" could keep Kenvue from paying the state or other plaintiffs who have sued the company over alleged injuries from its products.
Texas last week became the first state to sue Kenvue since the government issued its September guidance about pregnant women and Tylenol.
