The number of Tylenol autism lawsuits is growing around the United States, focusing on both the sellers and the makers of acetaminophen, the active ingredient in Tylenol. These lawsuits state that using the pain reliever during pregnancy may lead to developmental disorders like autism and attention-deficit hyperactivity disorder (ADHD) in children. Several studies seem to support the link between acetaminophen use and these disorders.
Acetaminophen is one of the most commonly used over-the-counter (OTC) medicines in the world. It’s available in pure form as a pain reliever, while hundreds of other medicines feature it as an ingredient. Acetaminophen use is common among pregnant women, who experience headaches, backaches, and other pains during pregnancy. Consumers have long believed it to be safe for general use, but some scientific studies have cast doubt on that belief.
Tylenol Autism Lawsuit Updates
- The Tylenol Controversy: A Legal and Scientific Perspective (12/19/2023)
- The Legal Tussle Over Tylenol: the Autism and ADHD Lawsuits (12/6/2023)
- Update on Tylenol Litigation: Initiation of Daubert Motions (9/25/2023)
- The Tylenol Autism Lawsuit and its Implications (9/19/2023)
- Tylenol Litigation Update: FDA’s Stance Reveals Complex Implications (9/11/2023)
- Kenvue’s Denied Appeal: Legal Impact in Tylenol Autism Cases (8/4/2023)
- Advancements in Acetaminophen Litigation and the Approach to Daubert Hearings (7/29/2023)
- Tylenol Litigation: Getting Closer to the Daubert Motions (7/29/2023)
- Court Approves Short-Form Complaint for Tylenol Autism (3/9/2023)
- Special Master to Oversee Census of Tylenol Autism Lawsuits (3/9/2023)
Is there a Tylenol autism lawsuit?
Yes, several Tylenol autism lawsuits are underway. Scientific research concerning the link between acetaminophen and developmental disorders has led to an increasing number of lawsuits against both retailers and manufacturers, including Johnson & Johnson, owner of the Tylenol brand. These are product liability lawsuits, which concern products that may hurt consumers.
The number of lawsuits began to increase in mid-2022, and by October, a group of plaintiffs filed to consolidate the cases into a multidistrict litigation in the Southern District of New York. This procedure combines all of the lawsuits into one action because they involve similar claims, concerns, or injuries. Multidistrict litigation can save time, money, and resources while helping to achieve consistent rulings across each matter.
At the time of consolidation, 18 plaintiff actions alleged that using Tylenol, generic acetaminophen, and other acetaminophen products during pregnancy led to their children developing autism. These initial actions were against five large retailers that sold acetaminophen products: Costco, CVS, Safeway, Walgreens, and Walmart. According to the plaintiffs, the retailers knew or should have known about the drug’s risks but failed to warn consumers about them.
Then, in late November 2022, new cases joined the multidistrict litigation. These new cases named Johnson & Johnson, the company that owns the Tylenol brand, as a defendant. Johnson & Johnson is the first manufacturer involved in these lawsuits, while previous cases focused on retailers.
The judge presiding over the multidistrict litigation is Honorable Denise L. Cote. She had previously presided over a multidistrict litigation concerning the blood thinner Eliquis in 2017. Finding that the Eliquis label sufficiently warned against health complications, she dismissed more than 50 of the lawsuits in the litigation.
To date, Walmart, one of the defendants, has tried to argue for dismissal based on preemption. The preemption argument relates to federal law having more authority than state laws. Walmart has argued that:
- The Federal Drug Administration’s (FDA’s) labeling laws have priority over other requirements.
- The warnings on its acetaminophen products meet FDA requirements.
Judge Cote has denied this defense several times as of early December 2022.
Tylenol linked to autism
Numerous studies and reports have suggested a possible link between acetaminophen use by pregnant women and the development of developmental disorders in their children. The earliest scientific publication about the link came in 2008, while more recent publications have arisen from 2014 to 2022. They come from trusted sources like the FDA and Johns Hopkins University, with articles published in well-respected journals like JAMA Psychiatry and the American Journal of Epidemiology.
The studies also suggest that the acetaminophen-associated risk of autism in children is dose responsive. This means that the amount of acetaminophen a pregnant mother takes, as well as when and for how long, may affect the risk. Large, prolonged dosing seems to increase the risk, while dosing in shorter duration or in minimal quantities may have limited risk .
Given these findings, a group of 91 medical experts published a consensus statement on the matter in 2021. In it, they declared that Tylenol and other acetaminophen products may not be safe for pregnant women, as the drugs could to lead autism, ADHD, and other developmental concerns in children.
2008 Autism study
Because this 2008 study concerns children who took acetaminophen after birth, it differs from later research. It is important, however, for being the first report linking acetaminophen use with autis
Published in the journal Autism, the study examined whether the national rise in autism had any connection to the increased use of acetaminophen among young children. The study looked at 163 children â 83 with autism and 80 without. By survey, the researchers determined whether the children used acetaminophen or ibuprofen to treat reactions after receiving the measles, mumps, and rubella (MMR) vaccine.
The results showed that children who used acetaminophen to treat their reactions were more likely to develop autism compared to those who used ibuprofen. Not only that, but ibuprofen use had no association with autism, suggesting the phenomenon doesn’t stem from pain relievers in general.
A 2009 review of the study supported its findings by pointing out that rates of autism declined when acetaminophen use declined in the 1980s. Specifically, in 1982 and 1986, acetaminophen sales dropped after consumers died from ingesting tampered pills. Subsequent years then saw “declines in the numbers of California children with autistic disorders born in 1984 and 1987.”
2014 JAMA Pediatrics study
One of the earliest recent studies, published in JAMA Pediatrics, arose in 2014. Though it doesn’t specifically relate to autism, it does strongly suggest a connection between acetaminophen use, brain development, and developmental disorders. Also, it reveals findings that later studies would reproduce or affirm.
In the 2014 study, researchers looked at 64,322 mother-child pairs who’d enrolled in the Danish National Birth Cohort from 1996 to 2002. The goal was to learn whether acetaminophen exposure in the womb increases the risk for ADHD or hyperkinetic disorders (conditions that cause hyperactivity and attention difficulty). The researchers assessed acetaminophen use for each mother through interviews during pregnancy and six months after birth. Then, to determine outcomes, they:
- Gathered reports from the parents about behavioral problems in their children at 7 years of age.
- Accessed the Danish National Hospital Registry or Danish Psychiatric Central Registry to retrieve diagnoses of hyperkinetic disorders.
- Accessed the Danish Prescription Registry to identify prescriptions for ADHD.
The researchers found that more than 50% of the mothers used acetaminophen during pregnancy, and the children of those mothers were more likely to:
- Receive diagnoses of hyperkinetic disorders.
- Use prescriptions for ADHD.
- Show “ADHD-like behaviors” at 7 years old.
Moreover, they observed “stronger associations” if the mothers used the pain reliever in more than one trimester or for more than 20 weeks during pregnancy. This suggested that larger and longer dosing could increase the risk of children having a developmental disorder.
The study went on to discuss that acetaminophen has properties that can disrupt the endocrine system, which is crucial for childhood development. If taken during pregnancy, acetaminophen can cross the placental barrier, which controls what materials the mother transmits to the fetus. As a result, the medicine may interrupt the healthy growth of the brain, possibly by affecting essential hormones or exposing the fetus to toxic substances.
2015 FDA drug safety communication
The FDA posts drug safety communications on its website to inform people about safety concerns related to medicine. In 2015, the FDA completed a review of studies about the use of pain medicine by pregnant women. The safety communication reported several key findings about acetaminophen:
- In the United States, 65%-70% of pregnant women said they used acetaminophen at some point during pregnancy.
- One study reported an “increased association between acetaminophen use in pregnancy and ADHD in children,” plus an increased risk of developing a hyperkinetic disorder.
- Using acetaminophen across several trimesters or for more than 20 weeks during pregnancy could increase these risks.
The FDA couldn’t make any recommendations about acetaminophen use, but it did suggest that pregnant women exercise caution.
2018 American Journal of Epidemiology review
The authors of this 2018 review in the American Journal of Epidemiology evaluated the risk for autism and ADHD in the children of women who used acetaminophen during pregnancy. They searched several databases and found seven long-term studies eligible for analysis. These studies ultimately involved 132,738 mother-child pairs monitored for three to 11 years.
The study points out two properties of acetaminophen that may relate to childhood development. One is that acetaminophen crosses the placental barrier, which affirms the findings of the 2014 JAMA Pediatrics study. The other is that it may block testosterone production and be toxic to cortical neurons, both of which are important for brain growth.
On completing their review, the authors concluded that acetaminophen use during pregnancy can increase the risk for autism and ADHD in children. Specifically, they found a 20%-30% increased risk for such disorders.
2019 JAMA Psychiatry study
The 2019 JAMA Psychiatry study looked at the relationship between acetaminophen exposure and the risk of developing autism or ADHD in children. From 1998 to 2018, the authors examined biological markers from 996 pregnant mothers. At birth, they measured acetaminophen metabolites in umbilical cord plasma samples. These showed whether and how much the women used acetaminophen during pregnancy. Later, when the children were around 8 to 9 years old, the authors referred to birth records to determine diagnoses of developmental disorders like autism and ADHD.
Their findings were enough to presume a link between developmental disorders and acetaminophen use in pregnancy. In fact, 669 of the children born to these mothers had diagnosed developmental disorders:
- 257 (25.8%) with ADHD only.
- 66 (6.6%) with autism only.
- 42 (4.2%) with both.
- 304 (30.5%) with other developmental disorders.
The authors compared these findings with the cord burdens (the amounts of acetaminophen metabolite) associated with the children. They found that higher cord burdens correlated with a higher potential for autism or ADHD. They separated the diagnosed population into thirds. The middle third, with the second-highest acetaminophen exposure, was 2.14 times more likely to develop autism, and the highest third was 3.62 times more likely. For ADHD, the likelihood was 2.26 and 2.86 times, respectively.
2021 European Journal of Epidemiology review
European researchers have also examined the relationship between acetaminophen use by pregnant women and developmental disorders in their children. In 2021, the European Journal of Epidemiology published a review of six long-term studies, which involved 73,881 mother-child pairs in total. These studies largely looked at developmental disorder symptoms when the children were 4 to 12 years old.
The results of the review showed that children exposed to acetaminophen in the womb were 19%-21% more likely to develop “borderline or clinical” autism and symptoms of ADHD. The researchers felt these findings supported previous reviews and studies, and they suggested that pregnant women be aware of the “potential long-term risks of acetaminophen use” before deciding to take the pain reliever during pregnancy.
2021 consensus statement
In 2021, a group of medical experts published a consensus statement about acetaminophen use during pregnancy in the journal Nature Review Endocrinology. Supported by “91 scientists, clinicians, and public health professionals from across the globe,” the statement included clear recommendations about acetaminophen. Specifically:
- Women at the beginning of pregnancy should not use the medicine unless necessary.
- To ensure safety, they should speak with a doctor or pharmacist to determine necessary use.
- If they must use it, they should take the lowest possible doses for the shortest possible times to “minimize exposure.”
A range of research formed the basis of the consensus. Notably, the statement points out that acetaminophen is an endocrine disruptor, another affirmation of the 2014 JAMA Pediatrics study. It also points to studies that “consistently suggest” acetaminophen exposure in the womb increases the risk of autism spectrum disorder and ADHD.
2022 Cureus review
One of the most recent reports came in July 2022 in the Cureus Journal of Medical Science. The authors conducted a systematic review of published papers about the use of acetaminophen during pregnancy and “its effect on the offspring’s neurodevelopment.” After searching online databases, they selected 16 “high-quality papers.” These comprised 13 long-term studies, two reviews, and one meta-analysis, which combines data from several studies to identify common findings.
Though they were specifically looking for links between acetaminophen and autism, the authors also found associations with several other “neurodevelopmental outcomes.” Aside from autism spectrum disorders, their findings suggested possible negative impacts on:
- Language and communication.
- Behavioral control.
- Psychomotor development (the relationship between the brain and movement).
As with other studies, they too found that longer, larger, and more frequent dosing of acetaminophen could lead to more severe outcomes. Also, like other researchers, they suggested caution to pregnant women who are considering using acetaminophen to relieve pain.
Projected Tylenol lawsuit settlement amounts
No one can say for certain how much the settlement amounts will be in the Tylenol autism lawsuit. As of December 2022, the case is still in its early stages. No one has received a settlement yet, and no trials are yet on the schedule so far.
However, some legal experts have estimated how much the plaintiffs may receive in a settlement. Lower estimates give a range of $300,000 to $600,000 per plaintiff. Higher estimates are in the $500,000 to $2 million range for cases with a large volume of evidence for liability.
Should the lawsuit go to trial, the payout could be even higher, at around $5 million. This is because juries often award large sums to plaintiffs in cases involving children suffering lifelong damages.
What factors influence settlement amounts?
Several factors go into arriving at these projected settlement amounts, including:
The amount of damage
In the Tylenol autism lawsuit, the plaintiffs can claim long-term consequences from autism. The damage may include emotional distress, negative impacts on relationships, compromised quality of life, and health care costs. The greater the damage, the higher the likely settlement amount.
The extent of acetaminophen use
Asking how much acetaminophen a mother used can help determine the amount of money a plaintiff deserves. Several studies discuss dose responsiveness, so mothers who took larger and more frequent doses would have a stronger argument for the drug giving rise to their children’s symptoms. This factor relies on whether plaintiffs can verify the amounts of acetaminophen they took during pregnancy.
The certainty of liability
If the retailers and manufacturers named in the lawsuit are liable, that means they’re responsible for the damage the plaintiffs have suffered. With a high certainty of liability, the plaintiffs are more likely to win at trial, so the defendants may want to minimize their financial loss by offering a settlement. The plaintiffs would be in a strong position to argue for a higher settlement amount as well.
The outcomes of similar cases
The plaintiffs can point to cases that involved the same or similar products, as well as similar damages, to receive comparable settlements. If those past cases featured large settlements, the chances of getting a similar amount are higher.
For example, Johnson & Johnson has faced federal lawsuits for Tylenol in the past. In the early to mid-2010s, more than 200 lawsuits alleged the company failed to provide adequate warnings about the risk of liver failure from using Tylenol. Ultimately, Johnson & Johnson decided to settle the lawsuits for an undisclosed amount. The average amount the plaintiffs received could be a gauge for the Tylenol autism lawsuit.
The absence of other potential causes
An absence of other causes means other risk factors couldn’t have contributed to a child’s development of autism. Common risk factors for autism include:
- Preterm birth before 26 weeks of gestation.
- Family history.
- Genetic disorders such as fragile X syndrome and Rett syndrome.
- Male sex.
If these risk factors are absent in a particular lawsuit, the plaintiff could have a strong case.
Do you qualify for a Tylenol autism lawsuit?
You may qualify for a Tylenol autism lawsuit if you:
- Used Tylenol or another acetaminophen product during pregnancy, particularly in large and frequent doses.
- Your child has a diagnosis of autism.
Bear in mind that the strength of such a lawsuit depends on the ability of litigators to establish causation between acetaminophen use and developmental disorders such as autism. As of December 2022, litigators are still examining the evidence, and evidence also continues to emerge.
If you feel that you qualify, join the growing number of people who are seeking relief from the harm potentially caused by a product intended to ease pain.