By  Michael Nevradakis, Ph.D.

Hundreds of “Tylenol lawsuits” already have been filed against retailers and manufacturers of acetaminophen — but that number could soon reach into the thousands, according to an attorney who spoke to The Defender.

Hundreds of “Tylenol lawsuits” already have been filed against retailers and manufacturers alleging they sold products containing acetaminophen to pregnant women knowing the medications could harm the developing fetus — but the number of lawsuits could soon reach into the thousands, according to an attorney who spoke to The Defender.

Attorney W. Mark Lanier described the lawsuits, which allege acetaminophen use during pregnancy can cause children to be born with autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD), “some of the most important health litigation pending in the United States right now.”

Lanier, founder and CEO of the Houston-based Lanier Law Firm involved in several high-profile product litigation lawsuits, told The Defender:

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The U.S. Judicial Panel on Multidistrict Litigation (JPML) late last year appointed Senior U.S. District Judge Denise Cote to oversee the growing number of lawsuits brought by families, resulting in all of the claims being transferred to the U.S. District Court for the Southern District of New York.

Judge Cote last month appointed a special master to preside over all federal Tylenol autism and ADHD lawsuits.

The lawsuits allege retailers, including Walmart, CVS, Walgreens and others, falsely advertised products that contain acetaminophen as being safe for pregnant women and did not warn them about the risks posed to fetal development.

Lawsuits also are expected against Johnson & Johnson for its alleged role in encouraging widespread acetaminophen use during pregnancy, which could send the number into the thousands.

Products that contain the drug include Tylenol, Alka-Seltzer Plus, DayQuil, Excedrin, Goody’s, Mucinex, NyQuil, Robitussin and some generic and store-brand equivalents.

The lawsuits allege the products have been marketed as safe for pregnant women since the 1950s, despite the existence of dozens of peer-reviewed studies showing acetaminophen poses serious risks to pregnant women and unborn children.

Lawsuits are being pursued on behalf of children under age 15 who were diagnosed with ASD between the ages of 1 and 10, and children under age 15 who were diagnosed with ADHD between the ages of 8 and 14.

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Lanier, one of the attorneys appointed as lead counsel in the Tylenol multidistrict litigation (MDL), told The Defender, “I think at this point we’re in the hundreds that have been filed. I think when all is said and done, we’ll be talking about thousands, tens of thousands” of cases.

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The growing number of lawsuits has captured the attention of renowned consumer advocate Erin Brockovich, spokeswoman for Autism Justice, who launched a project to help mothers sue the manufacturers and retailers of acetaminophen products.

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Studies clearly show link between acetaminophen and autism, ADHD

As previously reported by The Defender, referencing a JAMA Pediatrics research letter stating 1 in 30 children born in the U.S. in 2020 were diagnosed with autism, and there was a 53% increase in ASD among young Americans since 2017. The Centers for Disease Control and Prevention (CDC) reported similar statistics.

A growing number of scientific, peer-reviewed studies identified links between acetaminophen use by pregnant women and the onset of ASD and ADHD, and other developmental problems, in their children.

Acetaminophen became the preferred drug to treat fevers and pain in children in the early 1980s, after aspirin became associated with Reye’s syndrome. An increase in ASD has been documented as having begun during this time period.

In January 2015, the U.S. Food and Drug Administration (FDA) issued an acetaminophen pregnancy warning, stating expectant mothers should be cautious when using such products. The FDA, however, claimed there is “not enough research” to confirm safety risks for unborn children from acetaminophen exposure.

However, numerous peer-reviewed scientific studies appear to show such a link:

• Data from the ongoing Boston Birth Cohort Study, sponsored by the Johns Hopkins Bloomberg School of Public Health, has indicated that “exposure to acetaminophen in the womb may increase a child’s risk for attention deficit/hyperactivity disorder and autism spectrum disorder.”
• A July 2022 study of acetaminophen published in Minerva Pediatrics “offers 17 lines of evidence that the commonly used remedy for pain and fever may be contributing to the autism epidemic,” as previously reported by The Defender. Dr. William Parker, lead researcher on the study, told The Defender at the time that “acetaminophen would never be approved for pediatric use by today’s regulatory standards.”
• A February 2022 study published in the European Journal of Pediatrics found that acetaminophen use in infants and children has never been shown to be safe for their neurodevelopment.
• In September 2021, a consensus of 91 scientists, clinicians and public health professionals published in Nature Reviews Endocrinology journal called for the FDA’s 2015 recommendations to be updated. The consensus stated that “increasing experimental and epidemiological research suggests that prenatal exposure to [acetaminophen] might alter fetal development, which could increase the risks of some neurodevelopmental, reproductive and urogenital disorders.” This study also found that acetaminophen was, in fact, never assessed for impact on neurodevelopment.
• A June 2021 study published in the European Journal of Epidemiology found that children exposed to Tylenol and acetaminophen during pregnancy were significantly more likely to develop ASD and ADHD symptoms.
• A September 2020 study published in JAMA Pediatrics suggested that the use of Tylenol and acetaminophen during pregnancy may impair the brain of a developing fetus. This could result in ADHD symptoms and other neurological disorders.
• A January 2020 study published in European Psychiatry found that girls whose mothers took acetaminophen during pregnancy were six times more likely to suffer from delayed language development, and used fewer words than normal by the age of 30 months.
• An October 2019 Johns Hopkins study funded by the National Institutes of Health (NIH) found that exposure to acetaminophen during pregnancy may increase a child’s risk of developing autism and ADHD, as the children that had the highest acetaminophen metabolite levels in their blood showed the highest risk of developmental disorders. This study was published in JAMA Psychiatry.
• A November 2017 study published in Pediatrics, based on data from the Norwegian Mother and Child Cohort Study, found that there is a possible association between short-term acetaminophen use during pregnancy and the risk of giving birth to a child who will later develop ADHD.
• An October 2017 NIH study linked acetaminophen use by pregnant women to “lower performance intelligence quotient (IQ) … autism spectrum disorder, neurodevelopmental problems (gross motor development, communication), attention-deficit/hyperactivity disorder, poorer attention and executive function, and behavioral problems in childhood.”
• A 2017 study published in the Journal of International Medical Research by renowned autism researchers from Duke, Harvard and the University of Colorado found that “the long-term effects of acetaminophen exposure on neural development have never been evaluated in humans.” The study’s authors stated that even at very low doses, acetaminophen “triggers immune system activation and oxidative stress responses” — both potential warning signs of autism.
• An October 2016 study published in JAMA Pediatrics suggested that the side effects of acetaminophen, when used during pregnancy, may increase the risk of children being born with behavioral problems such as hyperactivity and emotional difficulties.
• A June 2016 study published in the International Journal of Epidemiology found that acetaminophen use during pregnancy was linked to a higher risk of autism among males, and an increased prevalence of ADHD cases among both boys and girls.
• An October 2013 study in the International Journal of Epidemiology found that children whose mothers took acetaminophen products during pregnancy for more than 28 days exhibited poorer than normal gross motor development, communication, externalizing behavior and internalizing behavior.
• A May 2013 study funded by the NIH found a link between circumcision-related acetaminophen use and the increased prevalence of autism.