Parents are filing lawsuits that allege taking Tylenol and other acetaminophen-based drugs while pregnant increases the risk of attention-deficit hyperactivity disorder (ADHD) and autism spectrum disorder in children. Acetaminophen was once considered one of the only pain relievers safe for pregnant women. However, studies suggest in utero exposure to acetaminophen may affect the fetus’ neurological development.
About Tylenol ADHD and Autism Lawsuits
Acetaminophen is one of the most common active drug ingredients in the United States, with an estimated 60 million Americans taking acetaminophen on a weekly basis. The pain reliever and fever reducer is the primary ingredient in Tylenol, one of the most popular over-the-counter acetaminophen brands.
Although pregnant women still need their doctors’ approval to take acetaminophen, it is the most common pain reliever doctors allow pregnant women to take. Acetaminophen-based drugs are generally deemed the safer choice compared to non-steroidal anti-inflammatory drugs (NSAID), which may result in infants suffering kidney damage and other injuries. Previous reports estimate between 40% and 65% of pregnant women use acetaminophen.
However, studies have discovered a link between prenatal exposure to acetaminophen and developmental disorders like ADHD and autism. Tylenol lawsuits allege manufacturers and retailers failed to include a warning label regarding acetaminophen’s association with ADHD and autism, despite evidence suggesting a possible correlation dating back to 2008.
Companies Involved in Tylenol ADHD and Autism Claims
Lawsuits have been filed against major retailers, Johnson & Johnson, and generic acetaminophen manufacturers. The multidistrict litigation (MDL) initially focused on stores selling acetaminophen drugs. The following retailers are defendants in the acetaminophen ADHD and autism MDL:
- Family Dollar
- Rite Aid
- Sam’s Warehouse
Plaintiffs allege their children developed ADHD, autism, or both after prenatal exposure to over-the-counter generic acetaminophen drugs sold by these retailers. The MDL did not involve manufacturers of acetaminophen products at the time of its formation. But claims brought against Johnson & Johnson, the manufacturer of Tylenol, have since been added to the MDL.
Conditions Allegedly Linked to Prenatal Exposure to Acetaminophen
Using Tylenol or other acetaminophen-based drugs during pregnancy may heighten a child’s risk of developing ADHD, autism, or both.
Attention-Deficit Hyperactivity Disorder (ADHD)
ADHD is one of the most prevalent neurodevelopmental disorders. According to the CDC, the estimated number of children aged 3–17 years diagnosed with ADHD is 6 million (9.8%) using data from 2016-2019. Hyperactivity and impulsiveness are defining characteristics of ADHD. A child with ADHD may:
- Have extreme difficulty focusing
- Fidget or talk excessively
- Be highly disorganized
- Have trouble getting along with others
- Forget or lose things
- Act without thinking or take unnecessary risks
ADHD can have lifelong implications when left untreated. For example, children with untreated ADHD are more likely to fail a grade in school or not graduate high school compared to those without the disorder.
Unmanaged ADHD can affect all areas of life, impairing personal relationships, careers, personal success and satisfaction, and marriages. Adults with untreated ADHD may self-medicate through drugs and alcohol. A presentation from the Smart Kids with Learning Disabilities organization pointed out that 78% of unmedicated adults with ADHD are more likely to be addicted to tobacco, and 58% are more likely to use illegal drugs than those without ADHD.
Autism Spectrum Disorder (ASD)
Autism spectrum disorder (ASD) refers to a broad range of conditions that hinder the ability to interact and communicate. CDC data estimates that 1 in 44 children has been diagnosed with this developmental disorder. There is not one form of autism, but instead, several subtypes of autism that vary from person to person. The symptoms of autism can range from highly skilled to severely challenged, with some autistic individuals requiring lifelong care while others lead independent lives. The primary symptoms of autism are social communication challenges and restricted/repetitive behaviors. People with autism may:
- Not understand spoken language or social cues such as gestures, eye contact, facial expressions, and tone of voice
- Have difficulty expressing their emotions
- Feel overwhelmed in social situations
- Exhibit ritualistic behaviors
- Need unchanging routines
- Have repetitive body movements
Key Studies in Tylenol ADHD and Autism Lawsuits
The definitive cause and risk factors for ADHD and autism are still unknown, but current research points to genetics playing a significant role in developing these disorders. However, studies suggest a link between exposure to acetaminophen during pregnancy and ADHD and autism.
A study published in the Journal of Autism in 2008 was the first to discover a possible connection between acetaminophen and autism. The study examined the effects on children given acetaminophen versus ibuprofen after receiving the measles-mumps-rubella vaccination. It concluded that acetaminophen use after MMR vaccination was associated with autistic disorder. But rather than prenatal exposure, this study focuses on the effects of acetaminophen after birth.
Researchers studied 64,322 children and mothers enrolled in a Danish National Birth Cohort during 1996-2002 to ascertain whether prenatal exposure to acetaminophen increases the child’s risk of developing ADHD. The study, published in JAMA in 2014, observed an increased risk for ADHD behaviors in children whose mothers used acetaminophen during pregnancy. The likelihood of ADHD increased with a higher frequency of acetaminophen use. Scientists hypothesized that acetaminophen may cross the placental barrier and interrupt brain development by interfering with maternal hormones or via neurotoxicity, leading to ADHD.
Another study in the American Journal of Epidemiology analyzed 132,738 mother-child pairs and found that children whose mothers used acetaminophen during their pregnancy were at a 20% greater risk of autism and a 30% greater risk of ADHD.
Research conducted by John Hopkins University and released in 2019 looked at the umbilical cord plasma of 996 mother-infant groups to understand the relationship between acetaminophen and childhood ADHD and autism. Children with higher acetaminophen levels in cord blood were over three times more likely to be diagnosed with autism and nearly three times more likely to be diagnosed with ADHD.
More recently, in 2021, a study in the European Journal of Epidemiology assessed prenatal exposure to acetaminophen in relation to autism and ADHD symptoms in childhood by interviewing 73,881 mother-child pairs. Children whose mothers took acetaminophen during pregnancy were 19% more likely to have autism symptoms than non-exposed children. Also, the chance of developing ADHD symptoms was 21% higher among children prenatally exposed to acetaminophen compared to non-exposed children.
MDL Launched for Tylenol ADHD & Autism Lawsuits
In June 2022, plaintiffs’ attorneys requested that the Judicial Panel on Multidistrict Litigation centralize acetaminophen claims. The motion only named retailers that sold over-the-counter generic versions of acetaminophen. It did not include manufacturers of acetaminophen medications.
On October 5, 2022, the JPML launched MDL No. 3043 IN RE: ACETAMINOPHEN – ASD/ADHD PRODUCTS LIABILITY LITIGATION. The panel transferred 80 pending actions to the Southern District of New York, appointing Honorable Denise L. Cote to oversee the MDL. Judge Cote has previously presided over 8 MDLs.
Defendants opposed consolidating acetaminophen claims, citing the retailers’ differing labeling and sourcing practices. Since the retailers are competitors, delays will arise due to the need to protect confidential information. However, the JPML found that there was a substantial amount of factual overlap involving the retailers, necessitating the creation of a single MDL.
Also, the defendants argued the MDL was premature because indispensable parties – the manufacturers of their acetaminophen products – had not been sued. The JPML noted it did not have authority to determine whether manufacturers were responsible. Lawsuits against Johnson & Johnson, the manufacturer of Tylenol, have since joined the MDL.
Status of Tylenol ADHD and Autism Litigation
As of September 2023, 265 cases are pending under MDL-3043.
Walmart previously filed a motion to dismiss acetaminophen ADHD and autism cases, contending that federal law preempts the plaintiffs’ state law failure to warn claims. The company stated that the FDA regulates acetaminophen drugs and their labels, not the retailers. Judge Cote ultimately rejected Walmart’s motion in November 2022, but Johnson & Johnson filed a similar motion to throw out these cases in February 2023. Like Walmart, Johnson & Johnson posits that preemption applies because the FDA regulates warning labels on Tylenol, so the manufacturers and retailers cannot independently update the warning label without the federal agency’s approval. Judge Cote ruled against J&J’s preemption motion in April 2023, as she did with Walmart before.
Judge Cote is expected to rule on Daubert this fall.
Tylenol ADHD and Autism Claims Settlements and Verdicts
We are still in the early phases of this litigation. Therefore, there are no acetaminophen ADHD and autism verdicts or settlements currently.