by Trevor Rockstad at Davis & Crump

Recent studies published in scientific and medical journals suggest a connection between taking acetaminophen, the active ingredient in Tylenol, during pregnancy and the development of autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in children. This evidence has encouraged many doctors, scientists and clinicians to support the idea that guidelines and warnings for prenatal use of Tylenol and other acetaminophen products should be changed to more fully inform expecting mothers.

In light of the discovery of the possible link between acetaminophen use during pregnancy and the occurrence of developmental disorders in children, including ASD and ADHD, many parents are filing lawsuits against companies that sell and manufacture products containing acetaminophen.

Studies Suggest Acetaminophen Linked to Higher Risk of Autism and ADHD

Over the past few years, numerous studies have indicated that acetaminophen may potentially cause or trigger conditions like ASD and ADHD. A study in the National Library of Medicine first identified this connection in 2008, finding that acetaminophen use was significantly associated with autism in children aged five and under. According to the National Library of Medicine, a 2013 study of over 48,000 children in Norway showed that prenatal use of acetaminophen was associated with problems in the psychomotor, behavioral and temperamental development of children at three years of age. Critics point out that these studies have limitations. However, most studies of this nature have limitations that prevent a single study from conclusively establishing the cause of a disorder. As such, it is important to look at the totality of the evidence when examining whether or not a medication can cause an illness or condition.

A 2019 study funded by the National Institutes of Health (NIH) and Agency for Health Care Research and Quality found that there may be a link. Doctors at Johns Hopkins University Bloomberg School of Public Health and their colleagues conducted the study, which was published in JAMA Psychiatry. In this long-term study, researchers analyzed factors that influenced pregnancy and child development. They collected umbilical cord blood from 996 births and measured the amount of acetaminophen and its byproducts in each sample. The amount of acetaminophen and byproducts in each sample correlated to the prenatal level of exposure to acetaminophen and was classified into thirds, from lowest to highest.

By the time the children were nearly nine years old, approximately 25.8% of them were diagnosed with ADHD only, 6.6% were diagnosed with ASD only, and 4.2% were diagnosed with both conditions. The researchers compared the risks associated with the amount of acetaminophen and its byproducts in the blood samples. Compared to the group with the lowest exposure, the group with the middle level of exposure was 2.26 times more likely to have ADHD and 2.14 times more likely to have ASD. The group with the highest level of exposure had a 2.86 times higher risk for ADHD and a 3.62 times higher risk for ASD. Thus, children whose mothers used the highest amount of acetaminophen while pregnant were 3.62 times more likely to develop autism than children who had the lowest level of prenatal acetaminophen exposure. Children with the highest exposure were 2.86 times more likely to develop ADHD.

The lead investigator in the study, Xiaobin Wang, indicated that the study design does have limitations. Notably, cord blood provides only a short window of exposure to acetaminophen because the drug is metabolized within hours. As a result, the researchers did not get a complete picture of fetal exposure, which is important because fetal brain development begins early in pregnancy, according to experts. Ideally, blood levels of acetaminophen should be measured throughout pregnancy so that data can be analyzed over time. This has not been done because it would be expensive and difficult to do with a large group of women.

While the study authors underscored the need for additional research into this important question, they concluded that the study results supported earlier studies that linked acetaminophen exposure to ADHD and ASD.

Those who argue against the link between Tylenol and autism/ADHD indicate that some of the conditions treated by acetaminophen during pregnancy, including fever and severe infection, are themselves associated with autism and ADHD in children. Additionally, some researchers indicate that it’s important to account for the health and lifestyle differences between pregnant women who take acetaminophen and those who do not. However, this theory has been called into question by a 2016 study published by JAMA, which specifically looked at whether or not the association between acetaminophen and ASD and ADHD can be explained by parental factors. Again, it is important to examine all of the evidence when considering an association between a medication and disorders like ASD and ADHD. In the case of acetaminophen, the evidence strongly points toward an association between prenatal exposure and ASD and ADHD.

What Does the FDA Say About the Link to Tylenol?

In 2015, the FDA called evidence linking prenatal acetaminophen exposure and ADHD “inconclusive.” However, there has been significant information discovered since then, including recent medical literature about the link to ASD and ADHD.

What Is ASD?

Autism, also called autism spectrum disorder (ASD), is a complex developmental disorder that affects how a person behaves, interacts with others and learns. No specific characteristics indicate a person has autism. Rather, medical professionals typically use a combination of factors to diagnose the condition.

According to the U.S. Centers for Disease Control and Prevention (CDC), autism affects approximately 1 in 36 children in the United States. Signs of autism typically appear by age 2 or 3; however, some delays can be diagnosed as early as 18 months.

There is not one distinctive feature of autism. Instead, there are many subtypes, most of which are influenced by a combination of genetic and environmental factors. Autism is a spectrum disorder; thus, people who are impacted by it have sets of strengths and challenges. The ways people with autism learn, think and prob-lem-solve can range from highly skilled to severely challenged. Some people with ASD need support in their everyday lives, while others live entirely independently. There are many famous people who have ASD; however, very few are open about their condition.

What Is ADHD?

According to the CDC, ADHD is one of the most common neurodevelopmental disorders in children. The disorder is most often diagnosed in childhood and lasts into adulthood. Children with ADHD typically have trouble concentrating and controlling impulsive behaviors. They may act without thinking about the consequences. They often appear to be overly active or “hyperactive.”

Other Conditions Linked to Acetaminophen

In addition to ASD and ADHD, other conditions have been linked to the use of acetaminophen while pregnant. Those conditions include:

  • Undescended testicles (cryptorchidism)
  • Abnormal urethra opening (hypospadias)
  • Other reproductive disorders or birth defects

While these conditions are identified in children of mothers who took various levels of acetaminophen during pregnancy, they continue to affect people into adulthood.

That May Cause Autism, ADHD and Other Conditions

While Tylenol is the target of many of the lawsuits alleging acetaminophen causes ASD, ADHD and other conditions, there are other brands of products that may be included. Some popular products containing acetaminophen that pregnant women are known to take include:

  • Tylenol Sinus
  • Tylenol Cough and Cold
  • Excedrin
  • Theraflu
  • Robitussin Multi-Symptom
  • DayQuil
  • NyQuil
  • Coricidin
  • Advil Dual Action
  • Generic and store-brand products

Women who have taken these medications and have children diagnosed with ASD, ADHD and other conditions may have valid legal claims against those companies. Lawsuits are just beginning to work through court systems, and discovery is being conducted.

Has Tylenol Been Recalled by the FDA?

No. Despite studies possibly linking acetaminophen-containing drugs to birth defects and conditions like ASD and ADHD, the FDA has not issued a mandatory recall of Tylenol and other drugs. However, a large group of scientists, doctors and clinicians from various countries has issued a statement warning about the link between acetaminophen use during pregnancy and developmental problems in children. A recall is unlikely, but many in the legal and medical communities urge the addition of a warning on these medications about the risk of ASD and ADHD.

Do Doctors Recommend Taking Tylenol While Pregnant?

Tylenol was once considered one of the safest medications to take while pregnant. Most doctors and other medical providers suggested pregnant people take it when experiencing pain, fever or other symptoms that acetaminophen commonly treats. However, with recent studies indicating there may be a link between Tylenol and ASD and ADHD, many doctors no longer recommend the over-the-counter drug or at least suggest that its use be limited. Some studies have demonstrated that the risk of ASD and ADHD correlates to the level of prenatal exposure. Thus, it is important for pregnant women to understand that Tylenol and acetaminophen do carry serious risks.

Tylenol and Autism/ADHD Lawsuits: 2023 Update

As of early 2023, many lawsuits have been filed against the pharmaceutical company Johnson & Johnson, which manufactures Tylenol-brand acetaminophen. There are currently more than 100 lawsuits consolidated in a federal court multidistrict litigation filed by parents who took the product during pregnancy and claim it caused ASD or ADHD in their children. The litigation names Johnson & Johnson as well as more than a dozen retailers who sell the drug acetaminophen under various name brands. The Tylenol-ASD and ADHD lawsuits were filed in federal courts across multiple court districts, but they have been joined with similar claims and transferred to the U.S. District Court for the Southern District of New York under Judge Denise Cote. It is expected that many more lawsuits will be filed in this litigation.

In April, Judge Cote denied a motion to dismiss by Johnson & Johnson in one of the lawsuits against the company. The Tylenol lawsuits state that Johnson & Johnson and other manufacturers should have warned pregnant consumers about the possible neurodevelopmental effects of prenatal exposure to acetaminophen. Since studies have been ongoing, the company was aware of the dangers prior to the filing of the lawsuits. However, they chose not to issue a warning or properly label bottles warning pregnant individuals. Those who have filed the lawsuits indicate that they would not have taken the medication if they had been aware that acetaminophen was linked to ASD, ADHD and other conditions.

Acetaminophen, like other painkillers, does carry a warning that anyone who is pregnant should consult a doctor before use. The FDA, which regulates drug labels, requires this warning. Johnson & Johnson argued in its motion to dismiss that federal law and the FDA prohibited them from adding any additional warning about ASD or ADHD.

Judge Cote disagreed with this argument and denied multiple motions to dismiss from Johnson & Johnson and Walmart, another defendant in the litigation. In the Walmart case, the plaintiff similarly alleged that the company should have included an additional warning label about ASD and ADHD on the bottle. Ultimately, Judge Cote found that the defendants had the ability to add additional warnings, including warnings about ASD and ADHD. Although these rulings do not necessarily mean that the parents will win, it does indicate that there is a sufficient legal basis for the claims and represents a significant victory in the case.

What Is a Products Liability Case?

Products liability refers to the financial responsibility of parties along the chain of manufacturing for damage caused by a product. In this case, plaintiffs are accusing Johnson & Johnson, Walmart and other manufacturers and retailers of being responsible for damages, including causing ASD, ADHD and other health conditions in children by failing to provide sufficient warnings to pregnant mothers.

What Is a Failure to Warn Case?

A “failure to warn” case alleges that a manufacturer or seller of a product knew or should have known about a risk of the product and did not warn consumers about that risk. In the Tylenol-ASD and ADHD cases, plaintiffs allege that defendants should have added warning labels to the acetaminophen products that warned of the link between the drug and ASD and ADHD.

How Much Compensation Can Plaintiffs Get in a Tylenol Lawsuit?

Products liability cases are a type of personal injury case. Most personal injury cases against large companies like Johnson & Johnson allow plaintiffs to get a significant amount of compensation to cover their damages. While there is no way to know exactly how much money plaintiffs can get in the Tylenol-ASD and ADHD lawsuits, plaintiffs may be able to recover money for:

  • Past and future medical costs
  • Lost wages
  • Loss of earning capacity
  • Disability
  • Pain and suffering
  • Emotional distress
  • Mental anguish
  • Attorney fees
  • Court costs

Any damages or losses experienced by plaintiffs may be included in claims against the defendants.

Tylenol-Autism and ADHD Lawsuit Settlements

Large defendants like Johnson & Johnson are often willing to settle out of court instead of taking cases to trial. They do this because going to trial can be time-consuming and expensive.

Attorney fees for both plaintiffs and defendants can be extensive. Most personal injury attorneys who represent plaintiffs typically don’t charge upfront fees. Instead, they will take a portion of the settlement or verdict if one is obtained for their client. However, defendants will have to pay out of pocket to their lawyers, which can be a motivation for them to settle early. Unfortunately, large defendants like Johnson & Johnson generally are not hesitant to spend a lot of money on litigation costs in defense of their drugs.

Both plaintiffs and defendants should be represented by attorneys throughout the trial and settlement process. This ensures no one is taken advantage of and everyone respects the rights of the other side.

What Should I Do If I Think Tylenol Caused ASD or ADHD in My Child?

If you think Tylenol or another brand of acetaminophen caused autism, ADHD or another condition in your child, you should contact an attorney as soon as possible. An attorney will inform you about your rights as a plaintiff and help you get a case started.

There are many law firms taking Tylenol-ASD and ADHD cases. It’s best to work with an attorney who can do the legwork for you while you continue to focus on your life outside of the Tylenol-ASD and ADHD lawsuit. Once retained, an attorney will work with you to gather necessary evidence and formulate a strategy for pursuing your lawsuit.

Stay in contact with your attorney throughout the process. However, you should know that these types of cases can take years to resolve. Some cases may go to trial to test the waters and see who is more likely to win. If plaintiffs tend to prevail, Johnson & Johnson and other manufacturers may be more likely to reach settlement agreements.

Parting Words

The scientific evidence of an association between acetaminophen and ASD and ADHD is significant and continues to develop. The medical community is paying attention to this important issue, and we will likely see changes in the way doctors approach the use of acetaminophen during pregnancy. If you have a child with ASD or ADHD, and you used acetaminophen during your pregnancy, your child may be entitled to compensation. As such, it is worth talking with an attorney to determine whether your child has a potential claim.