Toxic Exposures
Judge Rejects Testimony Linking Prenatal Use of Tylenol to ADHD
Five lawsuits against Tylenol and makers of generic acetaminophen alleging prenatal exposure to the drug can lead to ADHD are likely to be dismissed after a U.S. District Court rejected new evidence supporting a causal link, but a researcher told The Defender “overwhelming” evidence shows Tylenol administered to babies after birth can cause autism.
Five lawsuits against Tylenol and makers of generic acetaminophen alleging prenatal exposure to the drug can lead to attention-deficit/hyperactivity disorder (ADHD) are likely to be dismissed after a U.S. District Court rejected new evidence supporting a causal link.
U.S. District Judge Denise Cote in the Southern District of New York said Dr. Roberta Ness will not be allowed to speak before the court on a causal link between acetaminophen and ADHD, leaving the plaintiffs with no “admissible testimony.”
William Parker, Ph.D. — who for the last 10 years has researched acetaminophen risks — told The Defender a key problem with the “Tylenol lawsuits” is that they restricted the timeframe to prenatal exposure, rather than looking at what happens when babies and small children are exposed to the drug.
Parker said that watching the slow demise of the lawsuits due to lack of admissible evidence “was like watching a train wreck” that he could see coming because the research on prenatal exposure to acetaminophen is relatively limited — most studies employed the same kind of analysis — and doesn’t firmly show that the drug causes ADHD or autism.
Meanwhile, there’s more than a decade-worth of “compelling evidence” that the drug — when administered postnatally to a baby or child — can cause neurodevelopmental injury that can manifest as autism and perhaps other neurodevelopmental disorders, Parker said.
Cote’s ruling is the latest development in the ongoing legal battle over whether Tylenol’s warning label adequately warned the public about the possible neurodevelopmental risks to the unborn when the drug is taken during pregnancy.
Cote has been presiding over hundreds of cases brought by families who filed lawsuits in early 2023 alleging their child developed autism and/or ADHD as a result of the mother taking acetaminophen during the pregnancy.
She previously dismissed more than 500 suits in February, after rejecting other expert witnesses who alleged that prenatal acetaminophen exposure can cause ADHD and autism. The five plaintiffs involved in the latest ruling, who filed their cases after Jan. 12, proposed a different expert witness — Ness — and research not presented in the earlier cases.
In a March 15 order, Cote allowed the five plaintiffs to argue that Ness’ report is sufficiently reliable and sound science, and should be considered admissible evidence during a trial.
The defendants told the court that Ness’ opinion that acetaminophen causes ADHD should be excluded from the case. They questioned her experience and the evidence she used to conclude prenatal exposure to acetaminophen causes ADHD.
Cote agreed with the defendants and granted their motion to exclude Ness’ opinion from the case.
“The ruling again leaves these new plaintiffs without a means of proving causation, meaning additional Tylenol ADHD and autism lawsuits brought in the federal court system this year will likely be dismissed,” wrote Irvin Jackson in an article for AboutLawsuits.com.
“However,” Jackson added, “the ruling does not apply to lawsuits filed in various state courts nationwide, which have different evidentiary standards and are continuing to be pursued by lawyers.”
‘Overwhelming’ evidence Tylenol causes autism in babies, expert says
Parker and his colleagues in March 2024 published a peer-reviewed paper tracing “overwhelming evidence” that acetaminophen causes neurodevelopmental harm in babies and children who are predisposed — due to genetic, epigenetic and environmental factors — to process the drug in a way that creates toxicity in their body.
In the paper, he and his co-authors said that while there’s a “narrow range of evidence” on prenatal acetaminophen exposure, there’s a “preponderance of evidence” on post-natal exposure.
Parker said it was “nonsensical” to look only at the impact of taking the drug during pregnancy. “It’s like knowing that a robber broke in sometime during the night and only looking at what happened between 2 and 3 a.m.”
He said he is “very certain” that much, if not most, of the harm occurs after the umbilical cord is cut as the mother’s liver is no longer protecting the fetus.
In another peer-reviewed article published Jan. 11, Parker and his colleagues included a figure showing what they, based on the evidence they’ve seen, believe to be occurring. The figure shows that newborns are especially vulnerable to developing autism when exposed to acetaminophen (referred to in the figure as “APAP”) just after birth.
Parker said if he were to rewrite Tylenol’s warning label, he would have it say: “The best evidence available indicates that Autism Spectrum Disorder, which affects one in every 36 children in the United States, is caused by exposure to acetaminophen combined with other risk factors.”
He noted that there’s some question about whether the drug is linked to dementia or Alzheimer’s disease. “If that’s not the case, then it’s probably a really good drug for adults.”
But he and his co-authors said there’s “no valid rationale for controversy” over their assertion that the drug causes harm in susceptible babies and kids.
Parker said it’s been challenging to get that message out because it runs contrary to public beliefs about Tylenol.
Companies like Johnson & Johnson — the makers of Tylenol — over the years have spent billions of dollars in direct-to-consumer marketing telling parents, “This is your friend, this will make your baby happy,” Parker said.
“It was a tremendous money maker,” he added.
According to Parker, acetaminophen induces autism in susceptible babies and kids similar to how alcohol induces fetal alcohol spectrum disorders.
“The only difference for public awareness, really, between the fetal alcohol spectrum disorder and the autism spectrum disorder, is that people were so willing — as soon as the data came out that said, ‘Look, this condition is connected with alcohol’ — everybody just said, ‘Oh, wow. Okay. Yeah, that makes sense.’”
That didn’t happen with autism, he said. “The data that first showed us that autism spectrum disorder is connected with acetaminophen is now 15 years old.”
The link still largely goes unrecognized, he said, even as more studies have confirmed it.
New study detracts from research showing link between Tylenol and autism in babies, kids
Making matters worse, Parker said, is that a large study was recently published in JAMA that denied a link between the drug and neurological harm.
Although Parker mostly focuses on acetaminophen’s effect when administered postnatally, he took issue with the JAMA study — which looked at the drug’s possible impact on kids whose mothers took it while pregnant.
Parker said the authors designed their study in a way that obfuscated a possible association between acetaminophen use during pregnancy and a child’s risk of autism, ADHD or intellectual disability.
Parker and his colleagues have written a paper refuting its findings by showing mathematically that they are incorrect. The paper is currently under peer review and available as a preprint.
The JAMA study — funded by the National Institutes of Health — received lots of media attention and now is the first thing to show up in Google searches, Parker said. “It just captured the search engines.”
Cote cited the study 14 times in her opinion rejecting Ness’ report.
One of the study’s lead investigators — Brian Lee, Ph.D., an associate professor of epidemiology at Drexel University in Philadelphia — disclosed in the manuscript that he received “personal fees” from two law firms and a consulting firm called AlphaSights.
One of the firms, Beasley Allen Law Firm, has represented plaintiffs who sued Johnson & Johnson over health risks associated with its talc products.
The other firm, Patterson Belknap Webb & Tyler LLP, has represented the company in court in at least three patent lawsuits.
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A June 14 press release stated:
“Patterson Belknap obtained a significant victory on behalf of our clients, Johnson & Johnson (J&J) subsidiaries Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica NV (Janssen), in a Hatch-Waxman patent infringement litigation regarding drug maker Tolmar’s proposed generic versions of Janssen’s blockbuster long-acting-injectable antipsychotic drug Invega Sustenna.”
When Lee was asked by The Defender if his work for Patterson Belknap presented a conflict of interest, Lee said in an email that he and his team disclosed all potential conflicts of interest in the manuscript.
“These potential conflicts do not impact our study design or analyses,” he said.
Lee couldn’t publically disclose how much he was paid in personal fees due to confidentiality agreements, he said. “However, I can confirm that this work did not influence the study we performed.”
He also pointed out that he and his co-authors responded to comments about the study’s results both in The Transmitter and in JAMA’s letter section.
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