News|Articles|October 30, 2025

Tylenol Maker Sued While Kennedy Says No ‘Sufficient’ Evidence for Autism Link

Author(s)Mike Hollan
Listen
0:00 / 0:00

Key Takeaways

  • Texas AG Ken Paxton filed a lawsuit against Kenvue and Johnson & Johnson for deceptive marketing regarding Tylenol's alleged autism link.
  • HHS Secretary Kennedy stated there is insufficient evidence to link Tylenol to autism, conflicting with the Texas lawsuit.
SHOW MORE

Texas filed its lawsuit just days before Kennedy made his remarks.

Tylenol’s maker is facing a new lawsuit despite an admission from the government that there isn’t sufficient proof that the medication causes autism.

One of the most unexpected stories of the year continues to play out in a chaotic way. Earlier this year, President Trump shockingly announced that Tylenol, when taken by pregnant women, could increase the risk of autism.

Who is suing Tylenol's maker?

Since then, experts have weighed in and pushed back against the President’s claims. Meanwhile, foreign health agencies have refused to adjust their policies around recommending Tylenol to pregnant women.

This week, two major events occurred.

First, Texas Attorney General Ken Paxton filed a lawsuit against Johnson & Johnson and Kenvue.1 According to his claims, both companies participated in deceptive marketing by not disclosing links to autism.

Kenvue is the current manufacturer of Tylenol. The company was previously part of Johnson & Johnson, which is why the larger pharmaceutical company is also named in the lawsuit.

In a press release, Paxton stated, ““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. Additionally, seeing that the day of reckoning was coming, Johnson & Johnson attempted to escape responsibility by illegally offloading their liability onto a different company. By holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”

Paxton is also arguing that Johnson & Johnson violated Texas’ Uniform Fraudulent Transfer Act by transferring liabilities related to Tylenol to Kenvue to “shield their assets.”

The Texas AG’s statement directly references the White House’s statement on Tylenol and its potential link to autism.

However, later in the week, HHS Secretary Kennedy made public comments that seemed to take a less aggressive approach to the topic.2

During a press briefing to announce FDA’s new draft guidance for biosimilars, Kennedy took a question from a reporter regarding Tylenol. During his answer, Kennedy stated that there is not sufficient evidence to say that Tylenol causes autism.

He continued to say that his view was that people simply should be cautious.

These statements appear to conflict with Texas’ lawsuit against Kenvue and J&J. It is unclear what, if any, impact Secretary Kennedy’s comments will have on the lawsuit.

This latest chapter in the ongoing story likely won’t be the last. Since President Trump first made his comments, Kenvue has been actively working to fight the allegations. The company’s stock has dropped since rumors of the announcement first began to circulate, and the stock took a more significant plunge after the President’s comments.

Kenvue issued the following statement after the President first made his comments, “Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives. High fevers and pain are widely recognized as potential risks to a pregnancy if left untreated.”

At the time, FDA Commissioner Makary said in a statement, “The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen. Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.”

Sources

  1. Attor­ney Gen­er­al Pax­ton Sues Big Phar­ma Man­u­fac­tur­ers for Decep­tive­ly Mar­ket­ing Tylenol to Preg­nant Moth­ers Despite Known Dan­gers to Unborn Children. Attorney General of Texas. October 28, 2025. https://www.texasattorneygeneral.gov/news/releases/attorney-general-paxton-sues-big-pharma-manufacturers-deceptively-marketing-tylenol-pregnant-mothers
  2. Health Secretary RFK Jr. says there's 'not sufficient' proof to show Tylenol causes autism. USA Today. October 29, 2025. https://www.usatoday.com/story/news/politics/2025/10/29/health-chief-insufficient-data-tylenol-causes-autism/86972118007/

Newsletter

Lead with insight with the Pharmaceutical Executive newsletter, featuring strategic analysis, leadership trends, and market intelligence for biopharma decision-makers.