FDA Will Not Weigh in on Acetaminophen Pregnancy Warnings in Tylenol Autism/ADHD Lawsuits

FDA Will Not Weigh in on Acetaminophen Pregnancy Warnings in Tylenol Autism/ADHD Lawsuits

Tylenol has been a trusted household name for years. Many pregnant women have relied on it, believing that it’s a safe choice for both them and their unborn children. However, research has indicated a potential risk associated with in-utero exposure to acetaminophen, suggesting a possible link to autism and ADHD in children. Recently, a federal judge presiding over Tylenol ADHD and autism lawsuits invited the FDA to provide its position on pregnancy warnings for acetaminophen medications. In a surprising turn of events, the FDA declined the invitation from the federal judge. Instead, the agency suggested that the court rely on their existing epidemiological assessments. 

Acetaminophen ADHD/Autism Multidistrict Litigation 

Families have filed lawsuits alleging that taking acetaminophen while pregnant caused their babies to develop ADHD and autism. These acetaminophen ADHD/autism lawsuits accuse manufacturers of inadequate warnings regarding the potential link between acetaminophen exposure during pregnancy and neurodevelopmental conditions such as autism and ADHD in children. Since these claims explore Tylenol and its potential connection to developmental problems, they have been gathered in one court and assigned to one judge. This process is known as multidistrict litigation (MDL) 

Right now, this MDL is in the discovery stage. The discovery process involves gathering information and evidence related to Tylenol, its use during pregnancy, and whether there’s a link between its use during pregnancy and autism and ADHD.  

 Proposed Tylenol Warnings 

In April 2023, plaintiffs submitted a template of proposed Tylenol pregnancy warnings. These proposed warnings are supposed to help pregnant women make more informed choices about using Tylenol. 

 One of the key points highlighted in these proposed warnings is a recommendation that pregnant women should use Tylenol at the lowest effective dose and for the shortest possible time. This recommendation aims to minimize any potential risks to their unborn children.  

 It’s worth noting that the lawyers representing the plaintiffs didn’t insist on any specific alternate warning language. This flexibility is important because it recognizes that the focus should be on the safety information rather than getting bogged down in legal technicalities. 

FDA Refuses to Give Opinion on Acetaminophen Pregnancy Warnings  

Federal Judge Denise Cote, leading the MDL, asked the FDA to provide its stance on pregnancy warnings for acetaminophen medications. The U.S. Attorney for the Southern District of New York responded that the FDA needed more time.  

However, the Department of Justice sent a letter indicating that the FDA had chosen not to express its opinion on label warnings. This decision left many puzzled. The FDA, being the authority on medication safety, was expected to weigh in on the matter. 

We turn to the FDA’s literature review to understand the agency’s stance. This review, dated March 10, 2023, represents the FDA’s most recent evaluation of available epidemiological evidence. What it revealed was a key factor: “limitations and inconsistent findings” that couldn’t support a determination of causation. In simpler terms, the FDA found that the evidence available did not definitively prove a direct link between Tylenol and the mentioned health concerns. 

Response to FDA’s Decision Not to Chime in on Acetaminophen Pregnancy Warnings 

The plaintiffs haven’t wavered in their belief that there is ample evidence of a causal link between acetaminophen and autism.  

One of the ways the plaintiffs support their case is by emphasizing that scientific studies have carefully controlled for potential confounding factors. This means that researchers have taken great care to rule out other possible explanations for the link they’ve observed. For example, researchers have observed factors like a mother’s smoking habits or illnesses during pregnancy to ensure these aren’t the real culprits. 

Another strong argument made by the plaintiffs comes from specificity studies. These studies have shown that other medications, like ibuprofen and aspirin, don’t have the same link to autism and ADHD. This suggests that there may be something unique about acetaminophen that requires attention. 

October 2023: Acetaminophen ADHD/Autism Lawsuits  

One significant upcoming milestone for Tylenol ADHD/autism lawsuits is the Daubert hearings. These hearings will evaluate the strength and reliability of the expert testimony that will be presented by both sides. Daubert hearings determine whether the experts have solid evidence and reliable methods to back up their claims.  

The Lake Law Firm remains committed to helping these families seek the answers and justice they deserve. You may qualify for compensation if you took Tylenol while pregnant and your child has ADHD or autism. Call (888) 525-3529 today to speak with one of our team members to begin your potential claim.