For decades, doctors told pregnant women that Tylenol® (acetaminophen, paracetamol) and other acetaminophen-based products were safe to use. Acetaminophen-based products have long been marketed to expectant mothers as the only safe prenatal pain reliever and fever reducer.
Tylenol’s marketing was effective as studies show that at least 50% of pregnant women in the U.S. use acetaminophen-based medications during pregnancy.
Based on a growing body of scientific research, parents of autistic children have started filing product defect lawsuits against the manufacturers of Tylenol and other acetaminophen-based medicines.
These injury lawsuits claim that manufacturers and distributors of acetaminophen-based drugs knew, or should have known, of the link between prenatal acetaminophen use and the increased risk of neurological disorders such as autism but instead continued marketing the drugs without warning pregnant women of the dangers.
The primary injuries alleged in the Tylenol autism lawsuits are neurodevelopmental disabilities in which studies have shown an association with the prenatal use of Tylenol and acetaminophen.
Autism Spectrum Disorder (ASD) is the neurodevelopmental disorder most linked to prenatal Tylenol use.
The autism injury requirement may change as evidence is uncovered in the lawsuits and additional scientific studies are published.
Acetaminophen-Based Drugs in the Lawsuits
Although often called the “Tylenol lawsuits,” the growing litigation includes most over-the-counter medications containing acetaminophen or paracetamol, including:
- Tylenol® / acetaminophen
- Alka-Seltzer Plus®
- Coricidin HBP®
- Robitussin Maximum Strength®
- Store-branded acetaminophen products such as Walmart’s Equate® products
The above list is not exhaustive, as dozens of other acetaminophen and paracetamol-based medications exist.
Status of the Tylenol Autism Lawsuits
On October 5, 2022, the federal Judicial Panel on Multidistrict Litigation (JPML) consolidated all Tylenol lawsuits in the U.S. District Court for the Southern District of New York. The cases, now titled In Re: Acetaminophen-ASD/ADHD Products Liability Litigation (MDL No. 3403), were assigned to the Honorable Denise L. Cote.
As of January 17, 2023, over 100 individual lawsuits have been filed or transferred into MDL 3403. Hundreds of additional cases are expected to be filed in the next six months.
Judge Cote has extensive experience overseeing mass tort consolidations like the Tylenol autism lawsuits and has entered several necessary pre-trial orders that have rapidly moved the litigation forward.
Judge Cotes denied a significant motion to dismiss by Walmart, requesting the court dismiss all cases naming Walmart as a defendant on preemption grounds.
Studies Linking Tylenol Use During Pregnancy to Autism Risk
Since 2000, the number of U.S. children diagnosed with autism spectrum disorder has increased exponentially. In 2000, the CDC reported that the prevalence of autism was 6.7 cases out of every 1,000 children or 1 in 150 children. By 2010, the reported prevalence had more than doubled to 1 in 68 children. By 2018, it had grown to 1 in 44 children.
The increasing incidence of autism in U.S. children has led to significant scientific research into the potential cause.
In the past few years, several scientific studies have been published linking prenatal acetaminophen exposure to neurodevelopmental problems, including autism and ADHD.
Read more about these studies in an article by one of our attorneys.
A Consensus Statement Calling for Precautionary Action
Scientists and health professionals issued a call to action about the relationship between prenatal acetaminophen use and autism.
The Consensus Statement by 91 scientists, clinicians, and health professionals discussed the long list of scientific research on the link between acetaminophen use during pregnancy and autism and made several strong recommendations.
Based on existing scientific research, the Consensus Statement noted:
Prenatal exposure to paracetamol (APAP or acetaminophen) might alter fetal development, which could, in turn, increase the risks of certain neurodevelopmental, reproductive, and urogenital disorders.
…We recommend that pregnant women should be cautioned at the beginning of pregnancy to: forego APAP unless its use is medically indicated; consult with a physician or pharmacist if they are uncertain whether use is indicated and before using on a long-term basis; and minimize exposure by using the lowest effective dose for the shortest possible time. (Emphasis added)
These experts also made the following recommendations about Tylenol and acetaminophen use before and during pregnancy:
- Pregnant women should be counseled before or during pregnancy to avoid Tylenol or acetaminophen use unless medically necessary and to reduce their risk by using the lowest effective acetaminophen dosage for the shortest possible time. All acetaminophen-based medications, despite the country, should have warnings regarding use during pregnancy.
- The U.S. Food and Drug Administration and European Medicines Agency “should review the most recent research and issue an updated Drug Safety Communication” on acetaminophen use during pregnancy.
Our attorneys are litigating Tylenol autism lawsuits on behalf of the parents of children diagnosed with autism spectrum disorder, including Asperger’s Syndrome and PDD-NOS, after prenatal acetaminophen use.
The lawsuits over the prenatal use of Tylenol or acetaminophen and its link to autism involve complex product liability and failure to warn legal claims, which depend on the facts of each case.
If you have a child with autism and took Tylenol or acetaminophen during the pregnancy, get a free case review by an experienced attorney.