Tylenol has been around for decades since its debut in 1955 as a pain reliever for headaches and fevers. As a staple in U.S. household medicine cabinets, consumers have considered acetaminophen as the safest over-the-counter medication for pregnant women.
However, lawsuits recently filed in 2022 and 2023 may show that this is not the case.
Parents have been filing lawsuits against Tylenol suppliers alleging that using the painkiller during pregnancy caused their children to develop autism spectrum disorder or ADHD.
A class action lawsuit is ongoing in New York as of 2023. The plaintiffs hope that the class action lawsuit will result in a global settlement. These lawsuits may lead to one of the biggest mass torts in U.S. history.
Tylenol autism lawsuit made into MDL
The increase in Tylenol lawsuits prompted a request to combine the cases into a multidistrict litigation (MDL). An MDL is similar to a class action lawsuit.
A class action lawsuit combines several plaintiffs into the lawsuit to speed up the process.
Unlike a class action lawsuit, MDL cases remain separate from one another. Similar cases are grouped to decide in one court instead of all the plaintiffs together in the same lawsuit.
Research of acetaminophen in unborn children
Parents are filing product liability lawsuits to push for a new warning label on Tylenol for the increased risk of autism if consumed during pregnancy.
The basis for the new Tylenol lawsuits is research studies showing that the more Tylenol an expectant parent consumes, the higher the risk of their child developing autism spectrum disorder (ASD) or ADHD.
The research surrounding the Tylenol autism lawsuits is still ongoing, but there have been some findings that lawsuits have utilized.
In the past several years, research from high-level institutions, scientists and health care professionals have shown that the use of acetaminophen during pregnancy increases the risk of the unborn child developing an autism spectrum disorder or ADHD.
According to Nature Reviews Endocrinology, nearly 100 scientists and medical professionals expressed concerns for pregnant women using acetaminophen.
In 2018, the American Journal of Epidemiology published an article about research studies on acetaminophen use during pregnancy. The data included over 132,000 pairs of mothers and children. The results of the study determined that acetaminophen exposure in the womb led to a 20 to 30 percent increase in neurodevelopmental disorder risk. These disorders include autism and ADHD.
Johns Hopkins Research
One of the most reliable research studies used in a Tylenol autism lawsuit is from Johns Hopkins in 2019. A team from this company analyzed data from the Boston Birth Cohort. The data followed mothers and infants up to 20 years after birth. The team examined the blood in umbilical cords for levels of acetaminophen and substances formed by metabolizing (consuming) acetaminophen.
The team discovered that children whose umbilical cord blood contained the most acetaminophen levels were three times more likely to be diagnosed with autism.
The Johns Hopkins study depended solely on evidence of Tylenol exposure rather than the mother’s self-reports, making it a more reliable source for the Tylenol autism lawsuits.
How can acetaminophen affect an unborn baby?
Acetaminophen is an active ingredient in many OTC and prescription medications. According to research studies, acetaminophen can pass from the mother’s blood, through the placenta, and enter the baby’s bloodstream.
In other cases, acetaminophen is known to change the function of the immune system and the inflammatory response. It could also make cells more sensitive to oxidative stress, meaning it could break down cell tissue and cause DNA damage.
These mechanisms could explain how acetaminophen affects the fetus and brain development.
Research about the influence of acetaminophen upon an unborn baby’s brain is still ongoing, and can take years for a complete understanding.
What is autism?
Autism is more common than people realize. Autism, or autism spectrum disorder (ASD), affects approximately one in 36 children in the U.S. today, according to the Center for Disease Control (CDC).
There are a broad range of conditions and subtypes that describe living with autism, almost too many to pinpoint. Individuals with autism each have unique challenges, repetitive behaviors, and methods of communication.
Since autism is a spectrum disorder, each person with autism has a set of strengths and challenges. A person with autism could struggle with specific social skills and/or excel in problem-solving.
Children typically show signs of autism by age two or three. While a few signs of autism can show up in children without autism, a professional evaluation is essential to provide an official diagnosis. The following describe some early signs of autism:
- Few joyful, engaging expressions
- Limited or no eye contact
- Little or no back-and-forth sharing of sounds, smiles or facial expressions
- Little or no babbling
- Little or no response to child’s own name
- Very few or no words
For more information about an autism diagnosis, consult the official Autism Speaks website.
What is ADHD?
Attention-deficit/hyperactivity disorder is a brain-based disorder that can interfere with a child’s everyday activities at home or school. Children with ADHD often have trouble paying attention or controlling their behaviors.
ADHD shows three common signs:
- Inattention: disorganized, problems staying on task, constant daydreaming, not paying attention when spoken to directly
- Impulsivity: spur-of-the-moment decisions without considering results, acts quickly, regularly interrupting
- Hyperactivity: squirming, fidgeting, tapping, talking, constantly moving (especially in inappropriate situations)
ADHD can be divided into three types:
- ADHD predominantly inattentive presentation (which used to be called ADD)
- ADHD predominantly hyperactive-impulsive presentation
- ADHD combined presentation (both inattentive and hyperactive-impulsive symptoms)
For more information about specific ADHD types and/or diagnosing, consult the Web MD webpage.
What are the Tylenol autism lawsuits alleging?
Parents have been filing lawsuits against Tylenol manufacturers Johnson & Johnson, CVS, Costco, Family Dollar, Rite Aid, Safeway, Sam’s Warehouse, Target, Walgreens and Walmart.
The lawsuits allege:
- Failure to warn
- General negligence
- Breach of express warranty
- Breach of an implied warranty
- Negligent misrepresentation
- Violation of consumer protection laws
On Aug. 9, 2022, the first development of the Tylenol autism lawsuit began. Plaintiffs in the acetaminophen lawsuit filed a request to consolidate all Tylenol autism lawsuits into a new MDL class action.
By Sept. 27, 2022, 87 lawsuits had been filed.
The class action began to move quickly by December 2022. Going into January 2023, appointed judge Hon. Denise L. Cote began to make filing lawsuits for Tylenol autism litigations easier.
On Apr. 9, 2023, the CDC released data stating that the rate of children in the U.S. diagnosed with autism spectrum disorder had increased in recent years.
By Apr. 13, 2023, plaintiffs began to ask for a warning to be added to Tylenol labels, citing the risk of autism, ADD, and ADHD in children during pregnancy.
On May 17, 2023, Target and Walmart lost a preemption motion. Judge Cote dismissed their arguments, saying that their compliance with federal law absolves them of a liability under state law.