Tylenol Autism Lawsuits Proceed After Preemption Challenge by Manufacturers

Tylenol Autism Lawsuits Proceed After Preemption Challenge by Manufacturers

A challenge to the group of Tylenol autism lawsuits making its way through the court system has been dismissed. Recent medical evidence has revealed a link between using acetaminophen-based pain relievers, like Tylenol, during pregnancy and developmental disorders like autism and ADHD. Thousands of families across the country are now seeking compensation for medical bills, lost wages, and pain and suffering resulting from this defective medication.

The makers of Tylenol and other generic acetaminophen are facing product liability lawsuits as families attempt to recover these costs. These Tylenol autism lawsuits are being heard in the United States District Court for the Southern District of New York as a multi-district litigation to preserve court resources and standardize settlement outcomes. In a recent decision, District Judge Denise Cote has shut down an attempt by makers of acetaminophen drugs to have this group of product liability lawsuits dismissed.

Understanding a Preemption Defense in the Tylenol Autism Lawsuits

On November 14th, 2022, Walmart filed a motion to dismiss the product liability claims against them based on a principle called preemption, a common tactic in defective drug lawsuits. Walmart argued that it should not be held liable because current FDA requirements for warning labels didn’t allow them to update the labels on their generic brand of Tylenol, Equate. Although state laws may require a warning on the risks of using acetaminophen-based drugs during pregnancy, Walmart representatives contend that federal regulations issued by the FDA should overrule state regulations. 

The Food and Drug Administration is the federal agency that is “responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs”. They set the national rules for drug manufacturers like the acetaminophen makers named in the Tylenol autism lawsuits. In their motion to dismiss, Walmart representatives argued that the FDA’s authority should supersede state authority when it comes to regulation, which would render the plaintiffs’ claims invalid.  

Judge Rejects Request to Dismiss Tylenol Autism Lawsuits Due to Preemption

This motion was quickly rejected by District Judge Denise Cote in a court order. Judge Cote is presiding over the Tylenol autism lawsuits that have been consolidated into a multi-district litigation. In this court order, she lays out an argument for her dismissal. She states that the principle of preemption does not apply in this instance. 

Preemption is a concept enshrined in the Constitution that dictates that federal laws trump state laws. Judge Cote asserts that Walmart was in fact able to add additional warnings to their generic acetaminophen because this action was not prevented by the FDA. In fact, they had the legal responsibility to bolster the warning labels on their products.

Current FDA labeling laws would have allowed Walmart to add to the existing warning labels because there was a risk associated with the drug when taken during pregnancy. Based on Judge Cote’s ruling, the Tylenol autism claims will proceed, although the plaintiffs must still prove that the makers of these defective drugs are indeed liable for damages.

Tylenol Usage During Pregnancy Linked to Autism and ADHD 

There is a growing body of evidence that suggests a causal link between exposure to acetaminophen drugs in the womb and the development of health issues like Attention-Deficit/Hyperactivity Disorder (ADHD) and autism.

Expectant mothers were previously told that acetaminophen and Tylenol were the preferred alternatives to other types of pain-relief drugs because of their perceived safety. Tylenol was often recommended over aspirin and ibuprofen which are other over-the-counter drugs known to potentially cause issues when taken during pregnancy.

Unfortunately, several studies have shown a clear link between prenatal acetaminophen exposure and developmental issues. Nature Reviews Endocrinology would publish a consensus statement in their September 2021 issue where 91 medical experts would conclude that Tylenol and other drugs containing acetaminophen can increase the risk of autism of children that were exposed in utero.

Health Problems Associated with Tylenol Use During Pregnancy

The health conditions that have been linked to Tylenol use during pregnancy include:

The families of children who have been diagnosed with Autism Spectrum Disorder or ADHD after exposure to acetaminophen in utero claim that makers of these drugs are liable for their damages. These accusations have been leveled against several major pharmacies and retailers, including Walmart, CVS, and Walgreens.

Plaintiffs claim that drug makers had a duty of care to warn consumers that exposure to acetaminophen exposure in utero could cause autism and ADHD. Additionally, makers should have ensured that their products were not unreasonably dangerous. In the plaintiffs’ arguments, they claim this breach of duty allowed defective drugs to reach the market and harm the pregnancies of the women who used Tylenol and other over-the-counter acetaminophen pain-relief medications. 

In many cases, this has caused the children and their families significant hardship. If the plaintiffs are able to establish liability, they may be able to recover compensation for past and future costs related to their child’s autism or ADHD.

The Consequences of Developmental Disorders Caused by Prenatal Tylenol Exposure

As with other developmental disorders, ADHD and autism can negatively impact a child's ability to learn, socialize, and function independently. This can require therapy, medication, special facilities, and individualized care, like tutors or home health aides. These disorders have the potential to cause lifelong disadvantages that could have been avoided had proper labeling been provided.

Families may incur significant costs as they seek treatment for their children that they could have avoided, if not for the makers’ failure to warn consumers of the dangers of using Tylenol while pregnant. Product liability lawsuits part of the current multidistrict litigation against Walmart present an opportunity for those harmed by Tylenol to seek fair compensation for the damages they have suffered because of acetaminophen. The newest ruling in the Tylenol autism multi-district litigation is promising for plaintiffs, but there is still a long road ahead to recover compensation. 


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 represented over 11,000 injury victims and has served as lead counsel in over 1000 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.

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