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President Donald Trump’s announcement this week that pregnant women should not take Tylenol may breathe new life into hundreds of lawsuits against Tylenol-maker Kenvue and several major pharmacy chains that sell Tylenol and other painkillers that contain acetaminophen.
The families involved in the lawsuits on Wednesday petitioned a federal court to hear testimony from expert witnesses supporting claims made by Trump and others, Reuters reported Thursday.
The lawsuits, combined in 2022, allege that Kenvue and the pharmacy chains were aware of the risks the pain medication posed to pregnant women but marketed the drugs as safe.
In August 2024, a federal court dismissed the cases after declining to hear the testimony of the plaintiffs’ expert witnesses. An appeal is pending before the 2nd U.S. Circuit Court of Appeals with a hearing scheduled for Oct. 6.
During Monday’s press conference, the U.S. Food and Drug Administration (FDA) said it will add warnings to products containing acetaminophen that they may be associated with a higher risk of neurological conditions, including autism and attention deficit/hyperactivity disorder, or ADHD, in children. The FDA said it will also warn physicians and the public about the risk.
In its letter to the 2nd Circuit on Wednesday, Ashley Keller, an attorney representing the families in the combined lawsuits, urged the court to reinstate the expert witnesses in the case in light of Monday’s announcement.
Keller told The Defender that Monday’s announcement “confirms that our experts’ scientific analysis was well grounded.” He added:
“Reasonable people can debate the scientific conclusions our experts came to, but it is not debatable that those conclusions were derived from reliably applied, transparent scientific methods.”
In his letter, Keller noted that the FDA relied, in part, on a paper co-authored by one of the plaintiffs’ expert witnesses, Andrea Baccarelli, M.D., Ph.D., dean of the faculty at the Harvard T.H. Chan School of Public Health.
The paper, published in the journal Environmental Health in August, reviewed the outcomes of 46 previous studies, finding that most of those studies identified a link between acetaminophen use during pregnancy and the onset of autism or ADHD.
Baccarelli, the paper’s senior author, said in a statement cited by The New York Times that he had discussed the paper’s findings with U.S. Health Secretary Robert F. Kennedy Jr. and the director of the National Institutes of Health, Dr. Jay Bhattacharya, before Monday’s announcement.
Keller’s letter urged the court to accept “expert opinion that is sound enough to persuade every Senate-confirmed federal scientist.”
Keller wrote that if the court refuses to accept expert testimony from scientists whose research contributed to current public health guidance, this would pose “grave separation of powers concerns” and would reduce trust in public health authorities.
Research scientist and author James Lyons-Weiler, Ph.D., said it was “gratifying to see that unfettered rational discourse might allow society to benefit from the fruits of our investment in science.”
He added:
“The thought that the judiciary might turn a blind eye to evidence itself provides evidence of the lack of impartiality. Those who are harmed by pharmaceutical products should be allowed to bring evidence to court without prejudice.”
Responding to widespread criticism of Monday’s announcement, which also highlighted a potential new treatment for autism symptoms and funding for new research studying the link between autism and vaccines, Keller asked, “Rather than disparaging the messenger, why not focus on the message?”
“It is simply a fact: dozens of studies have found a link between prenatal Tylenol use and neurodevelopmental harm in offspring. In response, we get a raft of knee-jerk soundbites that refuse to take the issue seriously,” Keller said.
Announcement on acetaminophen risk may lead to ‘wave of new lawsuits’
According to Reuters, “Product liability lawsuits, like the ones over acetaminophen, rely on experts to establish that a product is capable of causing the alleged harm.”
But in her ruling last year, Judge Denise L. Cote of the U.S. District Court for the Southern District of New York dismissed the lawsuits, citing a lack of scientific evidence to support the plaintiffs’ claims.
The ruling came after multiple efforts by the defendants to delay the lawsuit. In 2023 and 2024, the same court rejected the plaintiffs’ expert witnesses, finding that they did not base their findings on sound scientific methodologies.
Reuters, citing legal experts, suggested that “it would be unusual” if the appeals court gave the plaintiffs’ petition and Monday’s announcement “much weight.”
However, Governance-intelligence.com reported that, if the FDA adopts its proposed warnings regarding acetaminophen’s risks, “this would likely affect ongoing and future litigation.”
The Wall Street Journal reported Wednesday that Kenvue is preparing for a “wave of new lawsuits” following Monday’s announcement.
Keller said “a few hundred” plaintiffs continue to participate in the combined lawsuit.
Under federal laws, including the Securities Act of 1933 and the Securities Exchange Act of 1934, “public companies must disclose material risks that could impact their business or stock price.” Failure to do so “can lead to shareholder litigation and regulatory scrutiny,” Government-intelligence.com reported.
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Plaintiffs’ attorney refutes conflict-of-interest accusations for expert witness
While the 2nd Circuit considers the plaintiffs’ petition, the Times reported Tuesday that, during a 2023 court deposition, Baccarelli disclosed that he received $150,000 to serve as an expert witness for the plaintiffs. The Times suggested that this represents a possible conflict of interest.
Keller characterized the Times’ report as “slander,” adding:
“Of course he was paid. He made less than the experts Kenvue paid. It is routine for litigants to pay their experts, because people don’t invest 700 hours of work for free.
“But Dr. Baccarelli was not paid to submit his findings from the litigation to peer review for publication. He was not paid to talk with U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and FDA officials about his sincere concerns. He did that as a decorated scientist committed to truth.”
Investigative journalist Paul D. Thacker told The Defender that “it’s great that The New York Times and other legacy media outlets are finally reporting on conflicts of interest.”
However, Thacker suggested that such outlets are doing so selectively, ignoring the “well-documented conflicts of interest” of other experts who express perspectives more closely aligned to Big Pharma.
“That’s because these media outlets have a political agenda, not a news agenda,” Thacker said.
Baccarelli and a spokesperson for Harvard’s T.H. Chan School of Public Health declined requests for comment.
Related articles in The Defender- Media Claims ‘No Science’ Linking Tylenol to Autism — But Studies by Major Medical Institutions Raise Red Flags
- ‘Uncompromising and Relentless’: HHS to Study All Possible Causes of Autism, Including Vaccines
- Judge Rejects Testimony Linking Prenatal Use of Tylenol to ADHD
- Judge Refuses to Hear Expert Testimony on Tylenol Link to Autism, ADHD
- Exclusive: Hundreds of ‘Tylenol Lawsuits’ Allege Retailers, Manufacturers Knew Acetaminophen During Pregnancy Could Cause Autism, ADHD
