(NewsNation) — Texas Attorney General Ken Paxton has filed a lawsuit against Johnson & Johnson and Kenvue, alleging “deceptive” marketing and failure to disclose the risk of taking Tylenol while pregnant.
The lawsuit, which is the first of its kind from a state government, comes five weeks after President Donald Trump said using Tylenol during pregnancy can cause autism in children. Trump’s claim is unproven and lacks scientific evidence.
Paxton argues that the pharmaceutical companies failed to disclose to pregnant women that the acetaminophen, the only active ingredient in Tylenol, is connected to “a significantly increased risk of autism and other disorders.”
“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 a statement. “By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”
The lawsuit also claims Johnson & Johnson and Kenvue violated the Texas Deceptive Trade Practices-Consumer Protection Act because they knew that acetaminophen “is dangerous to unborn children and young children” and “they hid this danger and deceptively marketed Tylenol as the only safe painkiller for pregnant women.”
In response to the lawsuit, Kenvue, which makes Tylenol, said it will “vigorously” defend Paxton’s claims.
“We stand firmly with the global medical community that acknowledges the safety of acetaminophen and believe we will continue to be successful in litigation as these claims lack legal merit and scientific support,” Kenvue said in a statement.
Trump’s warning on Tylenol during pregnancy
Trump has urged pregnant women not to take acetaminophen — one of the most widely used medications in the world — for pain relief because of a potential risk of autism, despite no new evidence proving the drug directly causes it.
Acetaminophen has been seen as the safest pain medication for pregnant women to take.
Both the World Health Organization and the European Union have refuted Trump’s assertion that acetaminophen may cause conditions like autism and ADHD when taken by pregnant women. The FDA acknowledged that “a causal relationship has not been established” in public statements following Trump’s initial plea.
Medical organizations have also backed acetaminophen as safe for pregnant women, including both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine.
However, Trump and Health and Human Services Secretary Robert F. Kennedy Jr. said in last month that the FDA would begin updating the label on acetaminophen and notifying physicians that Tylenol “can be associated with a very increased risk of autism.”
Tylenol maker Kenvue called on the FDA to pull back on the proposed safety label change. The current label instructs people who are pregnant or breastfeeding to “ask a health professional before use.”
The Hill contributed to this report.