WATCH LIVE: Health Secretary RFK Jr. announces new FDA move to speed up approvals of biosimilar drugs

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📂 Category: Robert F. Kennedy Jr

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Texas Attorney General Ken Paxton on Tuesday accused the companies behind Tylenol of deceptively marketing the painkiller to pregnant mothers in a lawsuit that asserted unproven claims that early exposure to acetaminophen increases the risk of autism and other disorders.

Health Secretary Robert F. Kennedy Jr. and Medicare Director Dr. Mehmet Oz are scheduled to hold a news conference at 1 p.m. ET. Watch in the player above.

Paxton, an ally of President Donald Trump and a Republican candidate for the US Senate, announced the lawsuit against Johnson & Johnson and Kenvio weeks after Trump and Health Secretary Robert F. Kennedy Jr. asserted an unproven link between the painkiller and autism while announcing a large-scale effort to study the causes of the complex brain disorder.

The lawsuit alleges that the companies violated Texas consumer protection laws by concealing the danger that acetaminophen, the active ingredient in Tylenol, posed to fetuses and young children and “deceptively marketed Tylenol as the only safe pain reliever for pregnant women.”

It also alleges that Johnson & Johnson fraudulently transferred liabilities arising from Tylenol to Kenvue to protect the assets from lawsuits.

In 2021, Johnson & Johnson, based in New Brunswick, New Jersey, announced it would spin off its consumer health business, which makes Tylenol and other products, into a separate company now known as Kenvue. It noted the divestment in a statement on Tuesday, saying “all rights and obligations associated with the sale of its over-the-counter products, including Tylenol (acetaminophen), are owned by Kenvue.”

“Big Pharma has betrayed America by profiting from pain and promoting drugs regardless of the risks,” Paxton said in a statement. “These companies have lied for decades, putting millions at risk to line their pockets.” “In addition, when Johnson & Johnson saw its day of reckoning coming, it attempted to escape liability by illegally offloading its liability to a different company.”

Acetaminophen has long been one of the most popular pain relievers and fever reducers in the United States, used by more than 100 million Americans annually. Some studies have raised the possibility that taking Tylenol during pregnancy might be linked to autism risk — but many other studies have found no link.

In a statement on Tuesday, Kinvio stressed that acetaminophen is the safest option for pain relief for pregnant women, noting that high fever and pain are potential risks to pregnancy if left untreated. The Summit, based in New Jersey, said it would defend itself against the claims and expressed concern about “persistent misinformation” about the safety of acetaminophen and the potential impact on the health of women and children.

“We stand firmly with the global medical community that recognizes the safety of acetaminophen and believe we will continue to be successful in litigation because these claims lack legal merit and scientific support,” Kinvio said.

Kenvue said it faces a lawsuit in federal court over the autism claims, noting earlier this year in an annual filing that many of those claims had been dismissed but were being appealed.

The lawsuit, filed in state court in rural Panola County, requests a jury trial in the Republican-leaning county of about 23,000 people in East Texas.

The state of Texas is asking the court to order businesses to pay the state $10,000 for each violation of the Deceptive Trade Practices and Consumer Protection Act. It also asks the court to order the companies to destroy marketing materials indicating that Tylenol is safe for pregnant women and children or that it does not cause autism or attention-deficit/hyperactivity disorder in children whose mothers take Tylenol during pregnancy or in young children who take the drug.

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