Final Monday, President Trump stated 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 Photographs
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Francis Chung/Politico/Bloomberg/Getty Photographs
President Trump’s announcement final week linking Tylenol with autism may play a task in ongoing authorized instances towards 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 shoppers asking for data.
“A whole lot of inbound calls have are available in, as you’d count on now {that a} very shiny highlight has been placed on this situation,” says lawyer Ashley Keller, whose agency Keller Postman is representing individuals in a product legal responsibility lawsuit towards the drugmaker Kenvue.
The Trump administration’s consideration to the difficulty has additionally given the agency new ammunition in its enchantment of the lawsuit, although the courts had successfully shot it down virtually two years in the past.
The president, flanked by federal well being officers, declared that acetaminophen, the generic identify for Tylenol, “will be related to a really elevated danger of autism.”
In the course of the press convention, officers stated the Meals and Drug Administration would start the method of updating the security label for Tylenol and acetaminophen.
“So taking Tylenol just isn’t good,” the president advised reporters. “All proper. I will say it. It isn’t good.” He went on to recommend that pregnant ladies may “robust it out” if they’ve a fever and stated there was “no draw back” to not taking the ache treatment.
A later press launch from the FDA was extra measured and famous that though some research discovered an “affiliation” between the painkiller and autism, they’d not established whether or not the painkiller in truth brought on autism. The press launch additionally stated that acetaminophen is the one protected over-the-counter ache treatment for pregnant ladies to take for fever, which will be dangerous for a growing fetus.
Keller says he filed what was among the many first lawsuits alleging that prenatal acetaminophen publicity brought on 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. Choose 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 professional 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 professional witness and precisely what the findings of the research confirmed.”
However because the Trump administration cited a type of specialists, Dr. Andrea Baccarelli, of their announcement this week, Keller and his staff are submitting a brand new letter with the courtroom to help their ongoing enchantment.
“One factor that I feel is critical 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 reasonably good signal that his scientific experience was reliably utilized. And in order that may very well 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, stated he is not obtainable for interviews.
Oral arguments within the enchantment start on Oct. 6, Keller says.
Nevertheless, authorized specialists aren’t so positive 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 suppose it signifies that they’ve a greater likelihood,” says Dr. Aaron Kesselheim, a professor of drugs at Brigham and Ladies’s Hospital and Harvard Medical Faculty, the place he created the Program on Regulation, Therapeutics and Regulation. “Nothing essentially has modified in regards to the analysis. The science is identical at the moment because it was final week and earlier than all this nonsense.”
Product legal responsibility instances are robust to show, he says. Finally, legal professionals must show causation, which hasn’t but been established.
Nonetheless, that does not imply it will not trigger a giant 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 a press release saying it disagrees with any suggestion that taking acetaminophen causes autism, as a result of a long time of scientific analysis present that it’s protected. The assertion went on to notice that “excessive fevers and ache are widely known as potential dangers to a being pregnant if left untreated.”
