Inside the crisis at Tylenol

In the post, a promoter of Covid-19 misinformation was connecting autism with acetaminophen, the active ingredient in Tylenol.

The text was from the nation’s top health official, Robert F. Kennedy Jr.

At that moment, it was clear to CEO Kirk Perry that his efforts to convince Kennedy that there was no science behind such claims had failed.

On Monday, Perry faced a full-blown crisis. In an extraordinary public announcement that contradicted widespread medical consensus and even his own top health advisers, President Trump warned that acetaminophen is a potential cause of autism, and urged expecting mothers to “tough it out" without the drug if they could. “Taking Tylenol is not good," the president told the world as Kennedy, the Health and Human Services secretary, looked on.

That claim has sent the medical establishment into panic mode. And it’s thrown Kenvue, the company that makes Tylenol, into crisis—just 70 days into Perry’s tenure as CEO.

Tylenol set the gold standard for corporate crisis management in 1982 after people died from taking its pain medication that had been tampered with and laced with cyanide. In a case now studied by business students and companies everywhere, the brand won back public trust with a quick recall, a redesign of its bottles to be tamper-resistant, and lots of coupons.

A clerk pulls Tylenol from the shelves at a New York City pharmacy during its 1982 recall crisis.

The stakes this time may be even higher. A direct assault on the brand by the president of the U.S. could open up the company to legal challenges. That is one reason that Kenvue’s stock hit an all-time low this past week. Perry and his team are also grappling with the possibility that millions of pregnant women around the world will avoid Tylenol when they have fevers, infections or other symptoms. Leaving those ailments untreated could increase birth defects and could itself contribute to a rise in autism, according to leading medical organizations and regulators in other countries.

Perry has been talking with his friend, pastor Brian Tome of Crossroads Church in Cincinnati, regularly over the past few days. Tome has reminded Perry of Bible verses that can be encouraging in hard times, and that Jesus said that his followers should “take up his cross daily, and follow me."

“He doesn’t like what he’s going through," Tome says of Perry. “He certainly wishes it was different, but I’m not seeing any bitterness in him and I think that’s because of his faith."

Raised in Detroit by young parents who were assembly workers for Ford, Perry was the first in his family to graduate from college. He attended the University of Cincinnati after working at Wendy’s for about a year and a half to save up the tuition.

He met his wife, Jacki, at a Piggly Wiggly grocery store in Ohio when he was 18. They married in his senior year of college and have four children.

He has frequently said he leaned on religion when his then-6-year-old daughter was being treated for kidney cancer. When a doctor told him and his wife that their daughter’s emergency colon surgery was successful, he dropped to the floor and wept. He said he realized God wasn’t making his daughter suffer, but God was with them when bad things happened.

Perry, 59, retired earlier this year after a career in marketing that included stints at Google and Procter & Gamble. His last job had been as CEO of market-research firm Circana. He was excited to coach high-school football, do mission work with his wife and hunt elk with friends. Then Kenvue called.

“Quite possibly the shortest retirement ever," he wrote on LinkedIn this summer.

Kenvue became independent two years ago when Johnson & Johnson split off its consumer-health unit. In addition to Tylenol, the Summit, N.J., company includes other famous brands such as Band-Aid, Johnson’s Baby Shampoo and the Neutrogena and Aveeno lines of shampoos and creams. J&J said the name Kenvue signified knowledge and sight.

From the start, Kenvue fought attacks linking Tylenol to autism, but it didn’t get much attention. Some 500 lawsuits had been filed against Kenvue and other makers of acetaminophen products in federal courts, alleging that use of the drug during pregnancy caused autism and attention-deficit/hyperactivity disorder in children. The lawsuits were based on a series of studies suggesting an association between acetaminophen and autism, though other studies had found no association.

An expert witness for plaintiffs was Dr. Andrea Baccarelli, dean of the faculty of Harvard T.H. Chan School of Public Health. A federal judge in New York concluded that Baccarelli’s opinions about causation weren’t admissible in the litigation.

Kenvue argued in court that there was no credible evidence of a causal link.

The judge sided with Kenvue in December 2023 and the cases were dismissed, though plaintiffs are appealing and some lawsuits have been filed in state courts.

Tylenol continued to sell well, though Kenvue’s beauty division was floundering.

In July, the board ousted its CEO, a J&J veteran who had led the company since the spinoff, and brought in Perry while it searched for a permanent replacement.

Perry thought his challenge would be to turn around the beauty brands. On his first call with analysts to discuss quarterly results on Aug. 7, he said he needed to streamline the product portfolio because the company made too many items that were generating only a small fraction of its sales.

The company embarked on a review of strategic alternatives that some analysts say may include selling some assets—or even the entire company. The review is still under way.

A week later, there was an early sign of the trouble to come. A journal called BMC Environmental Research on Aug. 14 published the results of an analysis by researchers from Harvard’s public-health school and other institutions. They analyzed past studies on the topic and said a majority of the studies found an association between acetaminophen and neurodevelopmental disorders including autism, though they stopped short of saying there was definitive evidence of causation.

The study was co-authored by Baccarelli, the Harvard dean whose expert testimony had been thrown out in court.

Baccarelli discussed his findings in recent weeks with Kennedy and Dr. Jay Bhattacharya, the director of the National Institutes of Health, Baccarelli said in a statement provided by Harvard. Those phone calls took place in early September, a university spokeswoman added.

Kennedy reached out to Kenvue to set up a meeting with Perry. They arranged to meet the week of Sept. 8. Days before the meeting took place, The Wall Street Journal reported that Kennedy was also working on a report that would say pregnant women’s use of Tylenol was potentially linked to autism.

The Tylenol bottle says women who are pregnant should speak to a health professional before taking the medicine.

In the meeting with Kennedy, Perry and Kenvue’s chief scientific officer, Caroline Tillett, made their case that there was no clear evidence linking autism and acetaminophen, and that there weren’t good alternatives to acetaminophen during pregnancy.

Kennedy agreed that there weren’t safe alternatives, according to people familiar with the matter. He discussed doing additional research, and asked that the executives set up follow-up meetings with Dr. Mehmet Oz, the head of the Centers for Medicare and Medicaid Services, and Bhattacharya. Perry and Tillett came away from the meeting thinking it had gone well, and that Kennedy’s request to set up additional meetings with Oz and Bhattacharya was a good sign that they could work with the administration.

But days later, Kennedy texted Perry the link to a Substack written by Sayer Ji, the founder of an alternative-health information platform called GreenMedInfo who has spoken at events alongside prominent members of Kennedy’s Make America Healthy Again movement. Ji has contended that vaccinations, prenatal ultrasounds and “stressors" from cesarean sections are among other factors that can increase autism risk.

Perhaps the meeting hadn’t been as much of a success as they’d thought.

The Kenvue board of directors held a regularly scheduled meeting the week of Sept. 15. Perry and his management team briefed the board on Kennedy’s impending autism report, but there wasn’t much discussion, according to a person familiar with the matter. Certainly nothing that painted it as anything other than routine business.

Trump started to tee up his autism announcement a few days later, announcing on Friday, Sept. 19, that he was planning to hold a press conference. That Sunday, in a packed football stadium for the memorial service for assassinated conservative activist Charlie Kirk, Trump promised a Monday announcement about “an answer to autism."

The company issued a statement, worded more strongly than its prior public comments. Science clearly shows that taking acetaminophen doesn’t cause autism, it said. “We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers."

Kenvue on Monday canceled its meetings with Oz and Bhattacharya.

‘Taking Tylenol is not good,’ President Trump said Monday as Robert F. Kennedy Jr. and other officials looked on.

At just before 5 p.m. Eastern on Monday, at the start of his press conference televised from the White House’s Roosevelt Room, President Trump tripped up pronouncing acetaminophen as he said it was associated with a “very increased" risk of autism. The president switched to referring to it as Tylenol for the rest of the news conference. “So taking Tylenol is not good, all right, I’ll say it. It’s not good," he said, as Kennedy stood by.

The president acknowledged that he was diverging from the health leaders he chose to guide him: “Bobby wants to be very careful with what he says," Trump said, referring to Kennedy. “But I’m not so careful with what I say."

The U.S. Food and Drug Administration guidance on the link between acetaminophen and autism was far more nuanced. “To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature," according to the official notice Trump’s administration released Monday.

That nuance went out the window as social media blew up. A 2017 tweet from the Tylenol account that read: “We actually don’t recommend using any of our products while pregnant," was seized upon by advocates for Kennedy’s MAHA initiative. Official Health & Human Services social-media accounts shared the post with the note: “No caption needed." The White House social-media accounts also recirculated the post, with a photo of Trump holding a “Trump was right about everything" hat.

Tylenol’s own social-media posts have tried to counter the noise.

Tylenol posted a series of Instagram posts this week, directing people to its website’s FAQ page and reiterating that its position on acetaminophen for pregnant women hasn’t changed.

“We do not recommend pregnant women take any medication without talking to their doctor," Kenvue said in a statement, adding that the 2017 tweet was “incomplete and did not address our full guidance on the safe use of Tylenol."

Ji, the vaccine skeptic whose Substack Kennedy had texted to Perry, said in an email that his readership has grown with the increased interest in Tylenol-autism information. His Substack, which has 43,000 subscribers, is currently listed among the fastest-rising publications in the health politics category, according to Substack’s leaderboard.

Kenvue has a crisis communications firm. It is also evaluating its potential liability, in the event that the statements from Trump and his administration spark a new round of lawsuits. The statute of limitation is paused until a child reaches the age of 18 in personal-injury lawsuits. That means a mother who took Tylenol during pregnancy and has a child with autism could take years to file a suit.

Friday morning, Perry sent a memo to Kenvue employees. “Difficult as it has been, it is clear to me that this team is guided by science and passionate about caring for others," he wrote. “Moments like these are when you see true character and I’ve been incredibly proud of how each of you has shown up."

Write to Peter Loftus at Peter.Loftus@wsj.com, Alyssa Lukpat at alyssa.lukpat@wsj.com and Sara Ashley O’Brien at sara.obrien@wsj.com