Growing Concerns Over Links Between Acetaminophen Use During Pregnancy and Developmental Disorders
A federal class action lawsuit was certified in a New York district court on October 5, 2022. This class action lawsuit is intended to gather together the growing number of individual claims being filed in federal courts related to acetaminophen use during pregnancy and the later development of autism. Tylenol is the best-known version of the drug known generically as acetaminophen — also known as paracetamol or N-acetyl-p-aminophenol (APAP). Experimental studies and statistical research have produced an accumulating body of evidence suggesting links between prenatal use of Tylenol and autism, as well as other neurodevelopmental, neurological, and reproductive disorders.
What Science is Showing About Tylenol and Autism and Other Problems
The journal Nature Reviews Endocrinology published a paper in September 2021 calling for precautionary actions related to acetaminophen usage during pregnancy. This “consensus statement” supported by ninety-one experts including medical doctors, scientists, and public health professionals also summarized growing evidence linking prenatal use of Tylenol and autism, as well as increased risk of other disorders, including:
- Other cognitive, behavioral, and learning problems such as attention deficit hyperactivity disorder (ADHD), delayed language development in girls, and autism spectrum disorder.
- Male reproductive and urogenital malformations and disorders.
- Early puberty in females.
The journal article summarized animal studies showing that fetal exposure to acetaminophen in rodents disrupted important hormone-based neurodevelopmental and reproductive development processes. This disruption resulted in:
- Reduced testicular function, abnormal sperm, and decreased sexual behavior in males.
- Reduced ovarian development and reduced fertility in females.
- Altered brain neurotransmission function appearing as changed cognition, behavior, and movement.
This well-supported consensus statement also noted the observation of increased rates of developmental problems in recent years. This specifically included findings from the ongoing U.S. National Health Interview Survey, which reported an increase of 9.5% in the nationwide rate of diagnosed developmental disabilities in children between the period 2009-2011 and 2015-2017. Over that entire time period, roughly one out of every six children surveyed had some form of diagnosed developmental disability. The 2021 journal article summarized more than two dozen observational studies worldwide that looked at nearly a quarter million children and their mothers.
The Scope of the Potential Problem
Acetaminophen — for which Tylenol is the best-known brand name — is one of the world’s most widely used drugs for relief of fever and pain. About 1 in 5 people in the United States uses products containing acetaminophen once a week or more frequently, and an estimated two-thirds of pregnant women in the United States are believed to take the medication. Estimates are that more than two million women in the United States alone take an acetaminophen-containing product during pregnancy each and every year.
Past evidence showed the medication to be very safe and effective, except for known liver damage problems associated with acute overdose or long-term, chronic overuse. These recent experimental and epidemiological studies, however, suggest an approximately 20% increased risk of autism spectrum disorder or ADHD symptoms following fetal exposure to acetaminophen. Among the findings of these studies was that more than 2% of eight-year-olds in the U.S. were diagnosed with autism spectrum disorder in 2018, and nearly 9% of U.S. children had ADHD diagnoses as of 2019.
Legal Actions Related to Tylenol and Autism
The accumulation of evidence summarized in the September 2021 Nature article has led to an increasing number of lawsuits in recent months related to acetaminophen and autism. Although not a great many claims have been filed so far, the sheer number of people who have used acetaminophen during pregnancy — combined with the increased rate of childhood diagnoses — is expected to result in a very large number of lawsuits being brought, at least in the tens of thousands, perhaps many more. It is in anticipation of this wave of lawsuits that the federal Judicial Panel on Multidistrict Litigation decided to certify the class action multi-district litigation (MDL) for actions in federal courts. This consolidation is intended to make the legal process for the claims included in the class action speedier and more efficient in reaching resolution.
There is a long way yet to go, however, before any large-scale efforts at settlement may be reached. While the current evidence is compelling enough for the 2021 consensus statement authors to recommend intensive further study, the development of “evidence-based medical guidance” for the use of acetaminophen during pregnancy, and that acetaminophen “should be used by pregnant women cautiously at the lowest effective dose for the shortest possible time,” that scientific and clinical evidence has yet to be tested in court and presented to a jury. In the meantime, families who believe that their children may have developed one of these serious disorders or disabilities following exposure to Tylenol or other acetaminophen-containing products during pregnancy should consult with an experienced personal injury attorney about their rights and options for proceeding with a claim.
View this report from CBC News about the 2021 Nature article’s concerns over acetaminophen:
Personal Injury Lawyer in California
Hello, my name is Ed Smith, and I’m a personal injury attorney in California. Nothing is more important than our children, and potential dangers to them must be carefully evaluated to determine if they are actual dangers. While the evidence linking acetaminophen use during pregnancy to the subsequent development of autism and other neurological, reproductive, and developmental problems has yet to be tested in court, it is sufficient for a number of science and medical professionals to call for prompt additional studies and development of new evidence-based medical advice for pregnant women. If you believe a child in your family may have been injured due to fetal exposure to acetaminophen products, please contact our drug products liability lawyer today at (916) 921-6400 or toll-free at (800) 404-5400 for free, friendly advice. You can also reach us through our online contact form.
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