Tylenol Autism Lawsuit
Hundreds of lawsuits have been filed throughout the United States alleging the manufacturer and retailers of Tylenol and generic equivalents failed to warn that acetaminophen use during pregnancy may increase the risk of autism spectrum disorder in children.
Legally Reviewed By: Evan Janush
Managing Attorney | New York
- Page Last Updated:
- September 2, 2024
Recent research has given rise to an influx of product liability lawsuits against Johnson & Johnson, the manufacturer of Tylenol, and several major retailers that carry their own brands of acetaminophen.
Acetaminophen has long been considered the safest over-the-counter (OTC) pain medication for pregnant women. Emerging research has called into question the safety of this product during pregnancy. The lawsuits allege the defendants failed to issue a warning that using the store-brand drug during pregnancy could cause the child to develop autism or ADHD.
If you regularly used Tylenol or acetaminophen (also called paracetamol) during pregnancy and your child developed autism or autism with ADHD, you may be eligible for compensation from the party responsible. The Lanier Law Firm has extensive experience and success in pharmaceutical liability litigation and is here to fight on your behalf.
“As one of the leaders in the MDL assisting on the discovery of this case, I can give you a little bit of a background of where we are right now in this litigation. Currently, we are in the process of conducting discovery against Johnson & Johnson Consumer Inc. and many of the retailers, such as Walmart, Walgreens, CVS, Costco, Sam’s Club, and many more. We are currently involved in phase one, general causation discovery. This is science-based, science-focused discovery, and the goal here is for plaintiffs to demonstrate to the court that our experts can appropriately testify that Tylenol and acetaminophen raises the incidence or risk ratio of causing autism spectrum disorder and attention deficit hyperactivity disorder.” – Evan M. Janush, Managing Attorney
Tylenol Autism Lawsuit Timeline
2023 Case Developments
December 18, 2023
Today, Judge Denise Cote issued a lengthy ruling finding that the plaintiffs’ scientific experts failed to provide credible evidence linking Tylenol to autism or ADHD. Although this was a setback for the federal MDL, there are still options for appeal as well as the potential to pursue Tylenol autism cases in state courts.
December 1, 2023
Both sides are preparing for the upcoming Daubert hearing next week. The sole focus of this hearing is to determine the admissibility of plaintiff’s expert testimony evidence.
The Managing Attorney for The Lanier Law Firm’s New York Office, Evan M. Janush, was also named to the MDL Plaintiffs’ Executive Committee for the Tylenol autism MDL.
There are now a total of 441 cases in the MDL.
November 11, 2023
Judge Cote scheduled the Daubert hearing for December 7, 2023. While both sides will present oral arguments, the judge will not be hearing testimony from the plaintiffs’ expert witnesses. A ruling on the matter is not expected until early 2024.
Meanwhile, other Tylenol autism lawsuits have been filed in state courts, including one in Illinois. The state lawsuits are still in their early stages.
October 18, 2023
Both the Plaintiffs and Defendants have filed briefs stating their objections to the other side’s experts. In federal court, those briefs are called Daubert challenges, and losing a Daubert challenge can be the end of a case. Each side will have the opportunity to respond to the other side’s Daubert briefing. Plaintiffs are expecting to hear rulings on the Daubert challenges by the beginning of 2024.
October 17, 2023
In a little less than a month, 118 cases were added, bringing the total number of cases in the Tylenol autism MDL to 383.
October 9, 2023
Judge Cote has asked both parties to submit their proposals for the upcoming Daubert hearings. The proposals were submitted last week to determine the logistics of the hearings.
The defendants have requested an extensive week-long hearing process to contest the scientific evidence provided. In contrast, the plaintiffs are advocating for a shorter process and have suggested that Judge Cote identify in advance which experts she needs to hear from, thereby narrowing down the scope of the hearings.
October 5, 2023
A recent study has found that taking paracetamol (acetaminophen) during pregnancy may affect a baby’s brain development. The study used stem cells that were turning into brain cells and exposed them to paracetamol.
The researchers discovered that the drug can affect certain genes important in brain development, including those controlling communication between brain cells and the type of cells they become. These findings align with previous discoveries in cord blood samples from babies exposed to paracetamol during pregnancy.
The plaintiffs in the case wanted to strengthen their medical experts’ testimony by submitting supplemental expert reports based on information from this study. The defendants objected, claiming the supplemental expert reports based on the new study are untimely.
October 2, 2023
The parties informed Judge Cote through a letter this morning that they have completed the newly revised versions of the Plaintiff Fact Sheets and uploaded them into the case administration system. Additionally, the parties agreed on new health record authorization forms to be completed and signed by incoming plaintiffs to make it easier to collect certain medical records.
September 20, 2023
There are currently 265 cases pending in the MDL.
September 11, 2023
In light of the FDA’s decision not to submit a statement of interest, the defendants submitted a letter to the court requesting a status conference. Judge Cote swiftly declined the request, upholding the scheduling order issued in February.
September 8, 2023
In a letter from the U.S. Attorney for the Southern District of New York, the FDA responded to Judge Cote’s request for a statement of interest regarding whether warning labels, as suggested by the plaintiffs, should be included on Tylenol and other acetaminophen products.
The FDA letter stated:
“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.”
August 21, 2023
Judge Cote has granted the defendants permission to submit a consolidated brief on the Daubert challenges regarding the admissibility of scientific expert evidence presented by the plaintiffs. The plaintiffs had requested Judge Cote to deny the request, arguing that separate briefs for each expert were necessary to ensure a fair outcome.
August 3, 2023
In Manhattan, U.S. District Judge Cote denied Kenvue’s request to immediately appeal an earlier decision to deny the defendant’s motion to dismiss based on a lack of scientific evidence. Kenvue is Johnson & Johnson’s consumer health spinoff.
The judge stated that Kenvue “has not pointed to any authority to suggest that there is any ground for a difference of opinion” and that the appeal could not proceed to the 2nd U.S. Circuit Court of Appeals.
July 17, 2023
There are currently 188 cases in the MDL. The litigation is still in the discovery process.
June 15, 2023
As of this date, 136 cases are pending in the MDL.
May 15, 2023
Judge Denise L. Cote ruled on two motions to dismiss claims against retailers.
In the first ruling, Judge Cote granted the motion to dismiss a lawsuit based in Texas due to a state statute giving drug manufacturers and retailers a safe harbor when drugs are labeled in accordance with federal regulations. This dismissal is significant because it impacts all Texas cases in the acetaminophen autism litigation.
The California case involved plaintiff Makesha Anderson, whose case against Johnson & Johnson was previously dismissed. The retailers argued that the plaintiffs’ case against them should also be dismissed because California law provides that compliance with federal law is a defense for not adding warnings to package labeling. The court disagreed and denied the motion.
In light of the previous dismissal of this plaintiff’s lawsuit against Johnson & Johnson, this ruling is good news for California residents because it means they still have a cause of action in the acetaminophen litigation.
May 15, 2023
There are currently 118 pending cases in the MDL.
April 28, 2023
Judge Cote dismissed a California claim against Johnson & Johnson filed by plaintiff Makesha Anderson because California product liability law requires a plaintiff to prove a manufacturer misrepresented facts rather than only omitting facts.
The court denied Johnson & Johnson’s motion to dismiss a Nevada claim because Nevada’s laws allow defendants to be held liable based on an omission.
April 20, 2023
The court denies Johnson & Johnson’s motion to dismiss all of the claims in the MDL.
April 17, 2023
To date, 108 cases are pending in the MDL.
April 12, 2023
Judge Cote reviewed the suggested label change submitted by the defendants and invited the Food and Drug Administration to submit its own opinion on the following questions:
- Should the plaintiffs’ proposed warning be added to acetaminophen labels?
- Does the science warrant adding such a warning to the labels?
The judge requested an answer from the FDA by July 28, 2023, or as soon as possible afterward. The FDA’s answer could weigh heavily on the case.
April 7, 2023
Plaintiffs submitted to the court their version of the new warning that should be included on acetaminophen packaging, which reads as follows:
“Autism/ADHD: Some studies show that frequent use of this product during pregnancy may increase your child’s risk of autism and attention deficit hyperactivity disorder. If you use this product during pregnancy to treat your pain and/or fever, use the lowest effective dose for the shortest possible time and at the lowest possible frequency.”
March 15, 2023
No new cases have been added to the MDL since last month, but this is likely a temporary pause as the case works through the inevitable barrage of motions to dismiss by defendants. Once there is a greater degree of certainty that these complaints will be allowed to move forward, the number of lawsuits is expected to grow significantly.
February 16, 2023
There are currently 107 cases pending in the MDL.
February 10, 2023
Johnson & Johnson filed a motion to dismiss all of the short-form (individual) complaints against it on the grounds that federal law pre-empted state laws requiring them to update the label.
January 27, 2023
Judge Cote issued an order directing how the discovery process will proceed in the case. All parties in the case will have access to documentation uncovered during the discovery process.
The parties are ordered to avoid duplicating discovery efforts. Individual plaintiffs are prohibited from obtaining written discovery separately that duplicates discovery obtained in the coordinated effort. The parties are ordered to avoid subjecting non-experts to more than one deposition.
The parties are ordered to confer about disputes and attempt to reach an agreement outside of court. If this is not possible, the parties may file a motion up to two pages long, which states that the dispute could not be resolved in conference.
These terms and conditions are common in MDL cases.
January 17, 2023
To date, 104 cases have been transferred to the MDL.
2022 Case Developments
December 16, 2022
The master complaint against Johnson & Johnson and the retailers is filed.
December 15, 2022
So far, 101 cases have been transferred to the multidistrict litigation.
December 2, 2022
Judge Cote authorizes cases that could be transferred to the MDL to be filed directly through the MDL to eliminate delays.
Judge Cote also ordered plaintiffs to file two master complaints in the MDL, covering all plaintiffs. One is to be filed against Johnson & Johnson Consumer, Inc., and the other against the retailer defendants.
November 17, 2022
The first pre-trial status conference was held, during which lawyers presented arguments on the procedures and guidelines related to the discovery process, court disputes, and bellwether trial selection.
A schedule was set for the filing of the two master complaints in the case, one against Johnson & Johnson Consumer, Inc., and one against retailer defendants.
A long-form master complaint will be required for the MDL, and individual plaintiffs are ordered to file short-form complaints. A master complaint is a detailed argument against the defendants, presenting the facts of the case and allegations common to all the plaintiffs.
A short-form complaint provides additional personal information for individual cases.
November 16, 2022
Mark Lanier is appointed as one of the three co-lead counsel in the MDL. This is an important role that essentially places Mark Lanier in the position of acting on behalf of all plaintiffs in the MDL. He was chosen because of his extensive experience in pharmaceutical liability litigation overall and his specific experience in litigation against Johnson & Johnson and the defendants in the case.
November 15, 2022
As of this date, 91 cases are pending in the MDL.
November 14, 2022
Judge Cote denies Walmart’s motions to dismiss the acetaminophen lawsuits.
October 5, 2022
The Judicial Panel of Multidistrict Litigation granted the motion to transfer the Tylenol cases to the MDL. The case was assigned to the Honorable Denise L. Cote in the Southern District of New York. The court has been notified of 47 related cases since the motion to transfer was initially filed, which brings the total to 66 cases.
September 29, 2022
The Judicial Panel of Multidistrict Litigation heard arguments on the motion to transfer the Tylenol cases to the MDL. The request seeks to consolidate 19 cases against retailers who sold store-brand acetaminophen products. More than 30 additional cases have been filed since the motion to transfer was first filed, bringing the total number of cases to 49. The following manufacturers have been named as defendants:
- Costco
- CVS
- Walgreens
- Rite Aid
- Safeway
- Target
- Walmart
September 6, 2022
Walmart files two motions to dismiss the acetaminophen litigation on the grounds that the FDA regulates drug labeling, and this preempts any state law that requires a retailer to add warnings to its product.
June 10, 2022
Plaintiff Aujenai Thompson filed a motion to transfer 19 cases in seven jurisdictions against retailers who sold store-brand acetaminophen. According to the motion, the complaints involve similar facts and allegations, which include the following:
- Failure to provide warnings about the risk of the baby developing autism or ADHD and autism
- Breach of warranty
- Unsubstantiated claims made during the marketing and sales of acetaminophen.
Can prenatal use of acetaminophen cause autism?
Acetaminophen is an active ingredient used in several OTC and prescription medicines. Studies show that acetaminophen from the mother’s blood can cross the placenta and enter the baby’s bloodstream.
Acetaminophen is known to change the function of the immune system and the inflammatory response. It may also make cells more sensitive to oxidative stress, which occurs as a result of normal cell metabolism. Researchers believe that these mechanisms could explain how acetaminophen affects fetal brain development.
Research Linking Tylenol and Autism
Over the past several years, research from high-level institutions, scientists, and health care professionals has revealed that using acetaminophen during pregnancy presents an increased risk of the child developing autism spectrum disorder.
Nature Reviews Endocrinology, 2021
In a consensus statement published in Nature Reviews Endocrinology, nearly 100 scientists and medical professionals shared their concerns about pregnant women using Tylenol. The research presented indicates that Tylenol is not safe to take during pregnancy, and that fetal exposure to acetaminophen could lead to a higher chance of the child developing ASD or ADHD.
The studies also suggest a correlation between the amount of acetaminophen used during pregnancy and the likelihood of the child developing a neurodevelopmental disorder.
The group of experts urged clinicians and agencies to change their guidelines for using acetaminophen during pregnancy while more research is conducted on the effects of the drug on fetal development.
Johns Hopkins, 2019
A team at Johns Hopkins analyzed data from the Boston Birth Cohort, a group of mothers and infants who were followed for 20 years after birth. They examined umbilical cord blood for levels of acetaminophen and substances formed by the metabolism of acetaminophen.
Children whose umbilical cord blood contained the highest levels of acetaminophen were approximately three times more likely to be diagnosed with autism than those with the lowest levels. This study relied on direct evidence of Tylenol exposure rather than on maternal self-reporting, which makes the findings more reliable.
American Journal of Epidemiology, 2018
In 2018, the American Journal of Epidemiology published an article reviewing studies on acetaminophen use during pregnancy and its effect on the fetus. The data included over 132,000 pairs of mothers and children. The results concluded that acetaminophen exposure leads to a 20 to 30 percent increased risk for neurodevelopmental disorders, including autism and ADHD.
Journal of Pediatrics, 2017
A study published by the Journal of Pediatrics in 2017 analyzed the association between acetaminophen and ADHD. Researchers found that the risk of ADHD increased with the duration of use. The findings were as follows:
- Any use of acetaminophen during pregnancy was associated with a “modest” increase in the risk of ADHD.
- The association more than doubled when acetaminophen was used for more than 29 days during pregnancy.
- When used for fevers and infections for 22 to 28 days, a six-fold increase in the risk was noted.
International Society for Autism Research, 2015
According to the Danish National Research Foundation, a 12.7-year study of 64,322 found an increased risk of autism spectrum disorders with hyperkinetic symptoms in children whose mothers used acetaminophen during pregnancy. The risk was almost double when used for longer durations, such as 20 weeks during pregnancy.
This information was published as far back as 2015, yet warnings labels still have not been updated.
Who can file a Tylenol autism lawsuit?
“What we are looking for in this litigation is women who were under 40 when they gave birth and who utilized Tylenol for greater than ten doses throughout the history of their pregnancy, and in fact, the higher the dose utilization, the better. We’re also looking for situations where the father was younger than 45 at the time of pregnancy. These are what we call exclusionary factors, where we are specifically not taking cases if the pregnant woman gave birth after age 40. We’re also looking for cases where there wasn’t a utilization of drugs or alcohol, or tobacco use during the pregnancy by the mother.” – Evan M. Janush, Managing Attorney
You may be eligible to file a Tylenol autism claim and pursue compensation if you used Tylenol or acetaminophen during your pregnancy and your child was subsequently diagnosed with ASD or ASD and ADHD.
However, additional information may be needed from you to prove and support your claim:
- Why was Tylenol or acetaminophen used?
- Was Tylenol or acetaminophen used during the second and third trimesters, and how frequently?
- What was the dose taken?
- How was the baby delivered (c-section, vaginal birth, etc.)?
- Did the childbirth result in a loss of oxygen?
- Did the childbirth result in any type of injury to the child?
- Is the child regularly taking medication for autism spectrum disorder?
- Does the child have an IEP, 504, or other accommodation for any condition other than autism?
- Has either parent been diagnosed with autism?
Factors That May Disqualify Someone from Filing a
Tylenol Autism Lawsuit
- No diagnosis of autism spectrum disorder or ASD in addition to ADHD
- Mother ingested fewer than ten doses of Tylenol or generic acetaminophen during pregnancy
- Mother suffered from any of the following: gestational diabetes, gestational hypertension, or any type of infection or fever during pregnancy that required hospitalization
- Mother used any type of SSRI (selective serotonin reuptake inhibitors, typically used as antidepressants) during pregnancy
- Mother was over the age of 39 at the time of giving birth
- Mother consumed alcohol, tobacco, or any illegal drug during pregnancy
- Mother has a previous child that was diagnosed with autism and did not use Tylenol or acetaminophen during that pregnancy
- Mother gave birth before 26 weeks of pregnancy
- Child was born before 2007 or after March 26, 2020
- Pregnancy and/or childbirth occurred in Oregon, Michigan, Florida, Texas or Connecticut
- Child has been diagnosed with any of the following: Down syndrome, Fragile X syndrome, Tourette syndrome, or tuberous sclerosis
How much is the Tylenol autism lawsuit worth?
The litigation in the Tylenol autism lawsuit has yet to resolve, so there is no historical data on settlements and verdicts. The outcome depends largely on how the court views the current research. As the case unfolds, new research will likely come to light, which will almost certainly play a role in the value of your Tylenol lawsuit.
Our law firm has extensive experience with pharmaceutical litigation, and we have seen these cases resolve for hundreds of thousands to millions for individual plaintiffs and billions in global settlements. We have seen individual plaintiffs receive hundreds of thousands or more in global settlements. Below are just a few examples of our pharmaceutical liability case results:
- $9 billion verdict against Takeda and Eli Lilly for the increased cancer risk associated with Actos, a diabetes drug
- $4.85 billion nationwide settlement against Merck for heart damage from the pain reliever Vioxx
- $4.69 billion verdict against Johnson & Johnson, one of the defendants in the Tylenol litigation, on behalf of 22 women who developed ovarian cancer after using asbestos-tainted baby powder
- $1.85 billion opioid settlement on behalf of the state of Texas
- $253 million in the first Vioxx verdict in the United States
“If you were below the age of 40 and you took acetaminophen or Tylenol and you believe that you may have a claim in this matter, please reach out to us and we can assist you to determine if you have a claim and how we can help.” – Alex Abston, Attorney
Contact The Lanier Law Firm Today
The pharmaceutical liability lawyers at The Lanier Law Firm are currently investigating Tylenol autism claims filed by parents of children who have developed autism spectrum disorder or ASD and ADHD after the mother’s use of Tylenol (or acetaminophen) while pregnant.
When you contact our experienced pharmaceutical liability lawyers at the Lanier Law Firm, you can rest assured that talented attorneys who truly care about you and your outcome will handle your case. Our successful track record results from hard work, passion, and experience. We know what it takes to defeat large corporations like Johnson & Johnson and Walmart.
Our lawyers have been recognized as some of the nation’s top trial lawyers, and our founder Mark Lanier has been designated as one of the most influential lawyers in America. We charge nothing upfront for our services because it matters to us that victims of corporate wrongdoing have access to justice regardless of finances.
Don’t risk leaving substantial compensation on the table. If your child was born with autism or autism and ADHD after you used acetaminophen during pregnancy, contact the Lanier Law Firm today for a free, confidential case evaluation.
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