Among the many unusual things Donald Trump has done in recent days is to make us feel some sympathy for a major drug company. Kenvue Inc., producer of Tylenol, had to stand by and watch as Trump used the bully pulpit of his office to issue what amounted to a condemnation of the widely used pain reliever.
Trump, who is not a doctor but likes to play one on television, made sweeping claims about links between Tylenol use during pregnancy and autism in children. In doing so, he went far beyond existing scientific research, which has not shown a conclusive connection between acetaminophen and neurological conditions.
This was not only bad news for Kenvue. Trump’s unsubstantiated statements angered many mothers of autistic children, who were made to feel guilty about their past use of Tylenol, as well currently pregnant women, who may now be reluctant to seek relief from pain and fever in the face of Trump’s admonition that they should “tough it out.”
There is one group that is pleased by Trump’s attack on Tylenol: plaintiffs’ lawyers. Even before Trump weighed in, there had been a widespread legal assault on acetaminophen. Starting about three years ago, numerous product liability lawsuits were filed against Johnson & Johnson, which produced Tylenol until spinning off its consumer businesses as Kenvue in 2023, as well as major retailers.
The cases, which were consolidated, faced an uphill battle in trying to prove a link between Tylenol and both autism and ADHD. In December 2023, a federal judge in New York barred all five of the plaintiffs’ expert witnesses, finding that they were offering a flawed analysis that oversimplified the scientific evidence. The plaintiffs appealed, and oral arguments are scheduled for later this year.
It is unlikely that Trump’s comments by themselves will have much influence over the appeals court. More significant is the statement issued by Trump’s Food and Drug Administration announcing the initiation of the process for a label change “to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children.”
Unlike Trump, the FDA exhibited some caution, adding: “It is important to note that while an association between acetaminophen and neurological conditions has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature.” It remains to be seen whether this is more than window dressing.
Even if one thinks Kenvue is being treated badly by Trump, it is worth noting that the businesses it took over from Johnson & Johnson have a checkered history. In 2017, for example, J&J Consumer Inc. had to pay $33 million to resolve litigation brought by more than 40 states alleging its manufacturing facilities were substandard, leading to recalls.
In 2015, what was then the J&J subsidiary McNeil-PPC Inc. pleaded guilty to federal charges of selling adulterated infants’ and children’s over-the-counter liquid medicines. The company paid a criminal fine of $20 million and forfeited $5 million.
There may or may not be a significant link between acetaminophen and autism, but a legitimate answer to that question will come, not from Kenvue or the Trump Administration, but from rigorous scientific research free from business considerations or political grandstanding.