FDA Stance on Acetaminophen and Developmental Disorder Risk in Tylenol Autism Lawsuits

September 14, 2023 | Attorney, Matthew Dolman
FDA Stance on Acetaminophen and Developmental Disorder Risk in Tylenol Autism Lawsuits

Tylenol autism lawsuits filed due to the connection between acetaminophen prenatal exposure and developmental disorder risk face a new development as the United States Food and Drug Administration (FDA) has declined to provide their opinion on the controversy. The litigation has posed questions regarding the necessity of pregnancy warnings on acetaminophen drugs which the FDA has decided to not provide an opinion on despite the important role they play in the regulation of these products. 

Tylenol and other acetaminophen-containing drugs are used regularly in homes across the United States with no negative effects. However, recent research has indicated that in-utero exposure to acetaminophen can cause infants to be at risk of suffering from certain developmental disorders such as autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD). 

Consider Contacting Dolman Law Group About Your Acetaminophen Autism Lawsuit

If your child has been diagnosed with these developmental disorders and acetaminophen use during pregnancy is a suspected factor then do not hesitate to contact Dolman Law Group about your case. Our Tylenol autism lawyers are ready to speak with you in a free no-obligation consultation on your case and provide you with information regarding the viability of a Tylenol autism lawsuit and what Dolman Law Group can do to help.

To schedule a free consultation you can either call our offices at 727-451-6900 or fill out a form on our site's contact page

FDA Declines Federal Judge’s Invitation to Provide Opinion on Tylenol Pregnancy Labeling

In April 2023, plaintiffs' lawyers provided examples of proposed acetaminophen pregnancy warning labels. While they supplied these templates, the lawyers would stipulate that providing these examples is not a required element of the Tylenol autism claims they are representing. 

Judge Denise Cote, the federal judge presiding over the Tylenol Autism multidistrict litigation (MDL), invited the FDA to provide their position on pregnancy warnings for acetaminophen products after questions of fact regarding the necessity of this labeling became central to the litigation. 

The FDA’s opinion was anticipated to hold great sway over the litigation. This is because the FDA has federal power to regulate these products which due to the supremacy clause, has priority over state laws regarding labeling that Tylenol autism lawsuits use as the basis of their product liability claims.

Defendants like Johnson & Johnson have unsuccessfully tried to use this preemption as an excuse to get the Tylenol autism lawsuits thrown out however, Judge Cote ruled that the FDA regulations did not impede retailers' ability to provide ample pregnancy warnings on over-the-counter acetaminophen medications. 

The FDA Response to the Request for an Opinion on the Acetaminophen Labeling  

The FDA responded to Judge Cote with a letter from the U.S. Attorney for the Southern District of New York, Damian Williams, that would state:

“The United States respectfully declines the Court’s invitation to submit a statement of interest in this matter, but attaches a copy of FDA’s literature review, dated March 10, 2023, providing FDA’s most recent review of available epidemiological evidence.”-

-“In that review, FDA’s Division of Epidemiology I (“DEPI-I”) concluded that the new “studies reviewed here are limited and do not change DEPI-I’s conclusions from its most recent review—the limitations and inconsistent findings of current observational studies of [acetaminophen] and neurobehavioral and urogenital outcomes are unable to support a determination of causality.”

In the letter, the FDA has elected to abstain from taking a stance on the issue but provides its own information regarding acetaminophen and autism risk that it says is not conclusive, at least based on the findings so far. While the FDA is not outright supporting Tylenol autism lawsuit plaintiffs with this move and says that their findings are not conclusive they also say that-

“Of course, it is for the Court, not this Office, to review the admissibility of expert or other evidence in these matters.”

Tylenol Autism Multidistrict Litigation

Due to the widespread use of Tylenol and acetaminophen medications by millions of pregnant women, the many lawsuits filed across the country after the discovered connection between acetaminophen and developmental disorders have been consolidated into a multidistrict litigation (MDL). 

These Tylenol autism lawsuits were consolidated in the Southern District of New York before U.S. District Judge Denise Cote. The U.S. Judicial Panel on Multidistrict Litigation (JPML) established pretrial proceedings after a slew of lawsuits were filed against over-the-counter acetaminophen retailers with common questions of fact regarding the necessity of labeling for pregnant women that might be at risk on the medication. 

Tylenol Autism Multidistrict Litigation Benefits

Multidistrict litigation allows for increased efficiency when it comes to the handling of many similar lawsuits involving the same product. Instead of having many similar lawsuits handled across multiple courts which can bog down the process, they are all brought together under one court overseen by one judge to alleviate strain and expedite the process. 

Plaintiffs and their lawyers can work together to share resources and information in pretrial proceedings. The overseeing judge also chooses cases that are exemplary of the many lawsuits in the MDL for bellwether trials to work as a test run of how most of the trials will go so both defendants and plaintiffs can make decisions regarding settlement negotiations or pursuing their respective trials. 

Even though the many Tylenol autism claims filed are part of the same MDL, plaintiffs still retain their personal product liability lawyers as their representation and the outcomes of their cases such as settlement negotiations and trials are still up to individual plaintiffs' personal decisions. 

Tylenol and Acetaminophen Medication Connection to Autism and ADHD

The current controversy involving Tylenol and other acetaminophen over-the-counter medication arose after a study discovered that prenatal exposure to acetaminophen could potentially increase the risk of developmental disorders. In 2018, the American Journal of Epidemiology published a paper that analyzed data from multiple studies and found a 34% and 19% higher risk of autism and ADHD in children whose mothers took acetaminophen during pregnancy compared with those whose mothers did not.

Another JAMA study in 2019 analyzed blood from umbilical cords and found that samples from children exposed to acetaminophen had a 3.62 times higher chance of an autism diagnosis and a 2.86 higher chance of an ADHD diagnosis.

In 2021, an international group of scientists issued a consensus statement in Nature Reviews Endocrinology that voiced concerns over the potential risks of acetaminophen exposure in utero and called for more research on the possible connection between acetaminophen and developmental disorder risk. 

It is important to note that while much research indicates that there is a connection between acetaminophen and developmental disorder risk, there is not yet conclusive evidence that shows it is a clear cause of these disorders. That, however, does not mean that these concerns should be disregarded and in fact, should lead to measures being taken among retailers and manufacturers to inform consumers of a risk that is possible. 

How a Product Liability Lawyer Can Help With Your Tylenol Autism Lawsuit

Hiring a product liability lawyer to represent your Tylenol autism lawsuit is not only encouraged but essential if you want to seek the full value of compensation potentially available through your claim. Getting the professional assistance of an experienced product liability lawyer can mean the difference between having your damages like medical bills and lost career opportunities adequately covered by a settlement or court award and possibly making a mistake that can eliminate any settlement at all.

Contacting a Tylenol autism lawyer as soon as possible is imperative to get the litigation process started. Your Tylenol autism lawyer can work with you through every step of your case and keep you appraised of the progress of your litigation.

A Tylenol autism lawyer will be able to investigate your case, determine the damages you can claim, represent your interests at the negotiating table or in court, and provide invaluable legal insight gathered from years of helping similar clients. 

Dolman Law Group provides award-winning and nationally recognized legal representation to clients across the country. Our case results and the testimonials of our satisfied clients speak to the efficacy of our product liability team. 

Contact Dolman Law Group for Help with Your Tylenol Autism Lawsuit

Dolman Law Group is a personal injury law firm that specializes in handling product liability lawsuits involving defective drugs that harm consumers. Our Tylenol autism lawyers are ready to listen to your story and advocate on your behalf for your right to receive fair compensation for damages related to autism, ADHD, and other developmental disorders related to prenatal acetaminophen exposure. 

Medical bills, lost career opportunities, mental anguish, and general loss of quality of life are all damages potentially claimable in a Tylenol autism lawsuit. With the assistance of Dolman Law Group, you can be confident knowing your case is in the hands of a firm that invests itself in the outcome of clients’ cases while providing empathetic and diligent service. 

To contact Dolman Law Group and schedule a free consultation on your Tylenol autism case then either call our office at 727-451-6900 or fill out a form on our contact page


Matthew Dolman

Personal Injury Lawyer

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has successfully fought for more than 11,000 injured clients and acted as lead counsel in more than 1,000 lawsuits. Always on the cutting edge of personal injury law, Matt is actively engaged in complex legal matters, including Suboxone, AFFF, and Ozempic lawsuits.  Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

Learn More