Texas AG Sues Tylenol Makers for Hiding Autism Risks, Misleading Pregnant Women

According to the filing, Johnson & Johnson “fraudulently transferred its Tylenol-related liabilities” to Kenvue to shield assets and avoid paying damages to affected families, in violation of Texas law.

“Big Pharma betrayed America by profiting off of pain and pushing pills regardless of the risks,” Paxton said in a press release. “These corporations lied for decades, knowingly endangering millions to line their pockets. By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”

The state is requesting a jury trial. It also seeks an injunction prohibiting the companies from engaging in deceptive or unfair trade practices or disposing of corporate assets. The state also wants the companies to destroy any marketing materials they have claiming that Tylenol is safe for pregnant women and children, or that the drug doesn’t cause autism or attention-deficit/hyperactivity disorder (ADHD).

The state also seeks civil penalties of $10,000 per violation, and for the companies’ assets gained through fraudulent practices to be seized and surrendered.

Lawsuit follows Trump administration announcement, warning about Tylenol

The lawsuit follows increased scrutiny of Tylenol’s safety during pregnancy after President Donald Trump warned last month that pregnant women should not take Tylenol, and the U.S. Food and Drug Administration (FDA) announced that it will add warnings to products containing acetaminophen.

The announcements sparked controversy in the legacy media and pushback from Kenvue, TikTok influencers and the American College of Obstetricians and Gynecologists, which issued a statement insisting that using Tylenol during pregnancy is safe.

Mainstream media also portrayed acetaminophen use during pregnancy as safe. Reports included a Reuters story, “Tylenol is safe, doctors tell worried pregnant moms,” and a BBC article stating that “US doctors face anxious Tylenol conversations after Trump’s autism announcement.”

Kenvue said in a statement reported by Reuters that it will fight Paxton’s lawsuit.

“Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy,” Kenvue said. “We are deeply concerned by the perpetuation of misinformation on the safety of acetaminophen.”

Johnson & Johnson did not respond to The Defender’s request for comment on the lawsuit. It said in a separate statement that Kenvue is responsible for “all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol.”

Attorney Ashley Keller, who represents hundreds of plaintiffs suing Kenvue and other acetaminophen manufacturers and retailers for selling the drug to pregnant women despite knowing the risks, told The Defender he was “extremely grateful that Attorney General Paxton is standing up for Texas’s women and children.”

“This important litigation will go a long way toward ensuring public health,” he said.

Manufacturers knowingly concealed evidence of Tylenol’s dangers

For decades, doctors have recommended acetaminophen as the primary pain reliever for pregnant women, considering it safer than ibuprofen, naproxen and aspirin.

However, a series of epidemiological and observational studies in the 2010s began flagging associations between acetaminophen use during pregnancy and subsequent neurodevelopmental disorders in children, including higher rates of autism and ADHD.https://www.lawfirm.com/dangerous-drugs/tylenol/?utm_source=chatgpt.com

A 2019 study published in JAMA Psychiatry found that children whose mothers had higher levels of acetaminophen metabolites in umbilical cord blood had increased odds of being diagnosed with autism or ADHD.

The lawsuit cited a 2021 consensus statement, signed by 91 scientists and published in the journal Nature Reviews Endocrinology, which said that growing research suggests prenatal exposure to the drug can alter fetal development and increase the risk of neurodevelopmental, reproductive and urogenital disorders.

The scientists noted that the drug had long been considered appropriate for pregnancy, but new evidence showed it may be time to revisit the issue.

They called for “precautionary action” around acetaminophen, suggesting pregnant women should be encouraged to avoid the drug. Women who need to take the drug should “minimize exposure by using the lowest effective dose for the shortest possible time,” they concluded.

Johnson & Johnson allegedly created Kenvue to avoid liability

According to the lawsuit, Johnson & Johnson engaged in a calculated scheme to shield itself from massive financial liability stemming from Tylenol’s link to autism and ADHD by restructuring its business to protect its assets.

In 2022, Johnson & Johnson formed a Delaware-based subsidiary, Kenvue Inc., to spin off its consumer health division, including Tylenol. Johnson & Johnson retained a majority stake until the company went public, then reduced its ownership to 9.5% of its shares.

The lawsuit argued that Johnson & Johnson committed a fraudulent conveyance under the Texas Uniform Fraudulent Transfer Act by offloading Tylenol’s legal liabilities to Kenvue without providing enough assets to cover them.

The company allegedly tried to shield itself from lawsuits by states and families claiming that prenatal acetaminophen exposure caused neurodevelopmental disorders. Hundreds of such cases have targeted Tylenol retailers and manufacturers.

If the lawsuits succeed, victims would have to seek damages from a corporate entity that lacks sufficient assets to pay them.

The lawsuit also noted that Johnson & Johnson used similar tactics to protect itself from talc-related liabilities after large verdicts found its talc caused cancer in women — a strategy that federal courts previously rejected.

Tylenol maker’s own researchers believed evidence suggested causal link

The lawsuit summarized the extensive scientific literature and cited over two dozen studies in top journals. Based on “compelling” evidence, it concluded:

“It is incumbent on Defendants to use their labels to warn pregnant women that the drug can cause ASD [autism spectrum disorder] and ADHD. Or at a minimum, they should warn pregnant women that many studies have found such an association.

“Yet Defendants have taken no steps to warn pregnant women of the dangers associated with prenatal ingestion of Tylenol. Instead, Defendants have continued marketing these products as completely safe for pregnant women.”

The manufacturer knowingly concealed scientific evidence showing that acetaminophen use during pregnancy could increase the risk of autism and ADHD, according to the complaint.

Internal company documents cited in the lawsuit show that as early as 2014, the company’s own researchers believed the “weight of the evidence” suggested a causal link. Despite this, the firm continued to market Tylenol as the safest option for pregnant women and ran public-relations campaigns to undermine independent studies that found harm.

The complaint said Johnson & Johnson used the popular parenting website BabyCenter — which it owned from 2001-2019 — to reinforce the misleading message, promoting Tylenol as safe while presenting the site as a source of impartial medical advice.

The lawsuit alleges the defendants engaged in deceptive trade practices, and they still “practically encourage women to disregard the warnings” of public health officials.