Final Monday, President Trump mentioned Tylenol is linked to autism. He was joined by well being officers — from left: Dr. Jay Bhattacharya, director of the Nationwide Institutes of Well being, Dr. Marty Makary, Meals and Drug Administration commissioner, Well being and Human Providers Secretary Robert F. Kennedy Jr., and Dr. Mehmet Oz, administrator of the Facilities for Medicare & Medicaid Providers.
Francis Chung/Politico/Bloomberg/Getty Pictures
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Francis Chung/Politico/Bloomberg/Getty Pictures
President Trump’s announcement final week linking Tylenol with autism might play a task in ongoing authorized circumstances in opposition to the corporate that makes it.
One lawyer representing sufferers who say they had been harmed by the drug says his agency has gotten an inflow of greater than a thousand calls this week from potential new purchasers asking for info.
“Plenty of inbound calls have are available, as you’d count on now {that a} very shiny highlight has been placed on this situation,” says legal professional Ashley Keller, whose agency Keller Postman is representing individuals in a product legal responsibility lawsuit in opposition to the drugmaker Kenvue.
The Trump administration’s consideration to the problem has additionally given the agency new ammunition in its attraction of the lawsuit, although the courts had successfully shot it down nearly two years in the past.
The president, flanked by federal well being officers, declared that acetaminophen, the generic identify for Tylenol, “might be related to a really elevated threat of autism.”
Through the press convention, officers mentioned the Meals and Drug Administration would start the method of updating the protection label for Tylenol and acetaminophen.
“So taking Tylenol will not be good,” the president advised reporters. “All proper. I will say it. It is not good.” He went on to recommend that pregnant ladies might “powerful it out” if they’ve a fever and mentioned there was “no draw back” to not taking the ache remedy.
A later press launch from the FDA was extra measured and famous that though some research discovered an “affiliation” between the painkiller and autism, that they had not established whether or not the painkiller actually brought about autism. The press launch additionally mentioned that acetaminophen is the one protected over-the-counter ache remedy for pregnant ladies to take for fever, which might be dangerous for a growing fetus.
Keller says he filed what was among the many first lawsuits alleging that prenatal acetaminophen publicity brought about autism or ADHD. However in 2023, a choose dominated to exclude testimony from the specialists he and his colleagues had gathered to assist make their case. Decide Denise Cote of the Southern District of New York wrote that the specialists “cherry picked” and misinterpreted the information they had been counting on.
“I feel the choose’s different concern was that… the knowledgeable testimony was to assert that there was a causation, whereas the analysis itself by no means claims causation,” says Sonia Suter, a professor who teaches legislation and drugs on the George Washington College Faculty of Regulation and was not concerned within the case. “So there was an inconsistency between the testimony for functions of being an knowledgeable witness and precisely what the findings of the examine confirmed.”
However because the Trump administration cited a kind of specialists, Dr. Andrea Baccarelli, of their announcement this week, Keller and his staff are submitting a brand new letter with the court docket to assist their ongoing attraction.
“One factor that I feel is important is that his scientific evaluation was thought of dependable sufficient for our nation’s govt department officers to credit score,” Keller says of Baccarelli. “And that is a fairly good signal that his scientific experience was reliably utilized. And in order that might be a related consideration for the Courtroom of Appeals.”
The Harvard T.H. Chan Faculty of Public Well being, the place Baccarelli is the dean, mentioned he is not out there for interviews.
Oral arguments within the attraction start on Oct. 6, Keller says.
Nevertheless, authorized specialists aren’t so certain the administration’s announcement will make a lot distinction to a choose as a result of there isn’t any new knowledge.
“I do not assume it signifies that they’ve a greater probability,” says Dr. Aaron Kesselheim, a professor of drugs at Brigham and Girls’s Hospital and Harvard Medical Faculty, the place he created the Program on Regulation, Therapeutics and Regulation. “Nothing basically has modified in regards to the analysis. The science is identical as we speak because it was final week and earlier than all this nonsense.”
Product legal responsibility circumstances are powerful to show, he says. Finally, attorneys should show causation, which hasn’t but been established.
Nonetheless, that does not imply it will not trigger an enormous headache for Tylenol’s producer, Kenvue, which spun off from Johnson & Johnson in 2023.
“I feel there’s one thing very harmful in regards to the president utilizing his energy to make statements that aren’t supported within the science,” says Suter. “I feel that could be very harmful for public well being typically.”
As for Kenvue, it issued an announcement saying it disagrees with any suggestion that taking acetaminophen causes autism, as a result of many years of scientific analysis present that it’s protected. The assertion went on to notice that “excessive fevers and ache are well known as potential dangers to a being pregnant if left untreated.”
