Texas Seeks Restraining Order Against Tylenol Maker Over Safety Claims for Pregnant Women and Children

Texas – Texas Attorney General Ken Paxton has requested a federal judge issue a restraining order to halt the advertising practices of Tylenol’s manufacturer, Kenvue, alleging deceptive claims about the safety of the drug for pregnant women and children. The motion, filed Thursday, follows a lawsuit Paxton filed against Johnson & Johnson and its spin-off company Kenvue over the marketing of Tylenol, an over-the-counter pain reliever, to pregnant women and young children.

In his latest filing, Paxton accuses Kenvue of continuing to “falsely assure Texans” that Tylenol is entirely safe, despite contradicting warnings issued by health authorities, including statements from former President Donald Trump. The Texas Attorney General contends that these misleading assurances are endangering public health, particularly for vulnerable populations such as pregnant women and young children.

The Allegations Against Kenvue and Johnson & Johnson

The lawsuit stems from growing concerns over the potential risks associated with acetaminophen, the active ingredient in Tylenol, especially for pregnant women. Paxton claims the companies have misrepresented Tylenol as a safe choice for pregnant women, despite studies that suggest a potential link between acetaminophen use during pregnancy and developmental disorders like autism.

A key point of contention arises from a September press conference where former President Donald Trump, without citing scientific evidence, publicly advised pregnant women against taking Tylenol, suggesting they “tough it out” instead. Additionally, Trump recommended that parents avoid giving Tylenol to their children, an endorsement that raised questions about the medication’s safety.

At the same time, the Food and Drug Administration (FDA) issued a more cautious statement urging physicians to minimize the use of acetaminophen during pregnancy for “routine low-grade fevers.” While the FDA acknowledged studies linking the drug to autism, it clarified that these studies did not establish a direct causal relationship, and that further research was needed. However, the agency did not recommend restricting acetaminophen for children, confirming its safety when used according to the label instructions.

Kenvue Responds to the Lawsuit

In response to the allegations, Kenvue has vigorously defended its marketing practices. The company criticized the Texas lawsuit, calling it a politically-motivated attack that is “reckless” and “scientifically unsound.” Kenvue further argued that the legal action could have unintended consequences for public health by spreading misinformation that may deter consumers from using a drug that has been proven safe in appropriate doses.

In a statement, the company emphasized its commitment to providing accurate, science-backed information to consumers, noting that their official website includes a disclaimer advising pregnant women to consult a healthcare professional before taking acetaminophen. Kenvue also pledged to fight the lawsuit in court, saying they would not allow “reckless” theories to impact their business.

The State’s Legal Arguments and Request for Injunctive Relief

The Texas Attorney General’s office argues that Kenvue’s ongoing advertising campaign, which does not include sufficient warnings about the potential risks of Tylenol, constitutes false and misleading conduct. Paxton is seeking a temporary restraining order to prevent the company from continuing its advertisements until a final ruling is made on the matter. He claims that such deceptive practices are exploiting consumers in Texas, misleading them into believing the drug is entirely safe for pregnant women and children.

Additionally, Paxton is asking the judge to block Kenvue from issuing dividends or distributing funds to shareholders without receiving equal value in return. The state contends that paying out a “massive dividend” could prevent Kenvue from being able to pay for damages if the company is found liable for harm caused by its products.

Medical Community Voices Concerns

The debate over Tylenol’s safety during pregnancy has sparked broader discussions within the medical community. Some medical professionals have voiced concern about the FDA’s guidance to limit acetaminophen use during pregnancy, with the American College of Obstetricians and Gynecologists (ACOG) calling the recommendations “irresponsible” and “not backed by the full body of scientific evidence.”

At the same time, there is growing pressure from consumer advocacy groups, who argue that more transparency is needed regarding the potential risks of acetaminophen. Critics argue that drug manufacturers should be held accountable for misleading consumers and failing to provide adequate warnings about the potential dangers of long-term or frequent use of acetaminophen.

Broader Implications and Future Developments

Texas became the first state to file a lawsuit against Kenvue following the September guidance issued by federal health authorities regarding the use of Tylenol during pregnancy. However, the outcome of this case could have wider implications for the pharmaceutical industry, potentially setting a precedent for how companies market over-the-counter drugs and handle public health concerns.

For now, the court will consider the request for a temporary restraining order, with a hearing set to take place in the coming weeks. As the case unfolds, the broader questions of public health, corporate responsibility, and consumer protection will continue to make headlines.