The Tylenol Autism Lawsuit - Can Using Acetaminophen During Pregnancy Cause Autism?

The purpose of this study is to review the published papers investigating maternal acetaminophen (AP) use during pregnancy and its effect on the offspring's neurodevelopment, particularly autism spectrum disorders (ASD). Acetaminophen is an over-the-counter analgesic and antipyretic considered safe in pregnancy. Recent studies have found an association between acetaminophen and immune system alterations like asthma and adverse neurodevelopmental outcomes. We used online databases (PubMed/Medline/PubMed Central, Science Direct, and Google Scholar) to search the studies relevant to our topic. We screened the papers by titles, abstracts, and then full-text availability. The screened articles were checked for eligibility using relevant quality assessment tools for each study design, extracting and analyzing the data. We finalized 30 studies after the screening; 14 were ineligible. Our final selection included 16 high-quality papers - 13 prospective cohort studies, two review articles, and one meta-analysis.

We found a wide range of neurodevelopmental outcomes in our data collection. So, we included autism spectrum disorders, intelligent quotient (IQ), attention-deficit/hyperactivity disorder (ADHD), isolated language, attention and executive function, communication, behavior, and psychomotor development. All studies showed an association between acetaminophen use and listed neurodevelopmental outcomes. Long-term use, increased dose, and frequency were associated with a stronger association. We extracted collective evidence from 16 studies suggesting acetaminophen's role in developing adverse neurodevelopmental outcomes. It is urgent to do more research on this association before pregnant women can be cautioned about the precise use of acetaminophen.
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Read more about the Tylenol autism lawsuits here: https://www.dolmanlaw.com/blog/settle... will remain perhaps the most current and up to date coverage of the Tylenol autism lawsuit. For a free legal consultation, call 833-552-7274. A podcast covering the Tylenol autism science and scientific studies with Epidemiologist Ann Bauer can be found here: https://www.youtube.com/watch?v=bi_MB...

Generic acetaminophen and Tylenol have now been the subject of twenty-six (26) epidemiological studies that demonstrate a clear association between the use of acetaminophen during pregnancy and autism spectrum disorder and often attention deficit hyperactivity disorder. Beginning in 2013, there are now six separate European birth cohort studies with over 70,000 mother child pairs that have been analyzed. These birth cohort studies also found an association between in utero exposure to acetaminophen/Tylenol and autism spectrum disorder.

In September of 2021, ninety-one (91) scientists and health professionals all signed a consensus statement calling for precautionary action relating to the use of acetaminophen while pregnant (and especially "regular use"). The authors state “call to action” because they could no longer ignore the overwhelming evidence that acetaminophen use during pregnancy could cause ASD and ADHD." Additionally they offered “the combined weight of animal and human scientific evidence is strong enough for pregnant women to be cautioned by health professionals against its indiscriminate use, both as a single ingredient and in combination with other medications.” This article can be found here: https://www.nature.com/articles/s4157...

The authors believe that women should minimize risk by using as little acetaminophen as possible for as short of a period as possible during pregnancy and only when necessary. Further, these scientists and health professionals agree that the use of acetaminophen negatively impacts fetal brain development.

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The makers of Tylenol and generic acetaminophen are facing product liability lawsuits alleging they negligently failed to warn pregnant women, doctors, and the public of the potential risk involved with using their products during pregnancy. Recent studies have tied the use of Tylenol during pregnancy to a greater incident rate and severity of autism spectrum disorder (ASD), ADHD (attention deficit hyperactivity disorder), complex developmental disorder, and other health issues. However, autism has been studied the most.

The Tylenol autism lawsuit is beginning to attract national attention. In this article, we will discuss lawsuits relating to the use of acetaminophen while pregnant, potential settlements relating to such lawsuits, and the science behind the link between Tylenol and autism, ADHD, and other neurodevelopmental disorders.
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A challenge to the group of Tylenol autism lawsuits making its way through the court system has been dismissed. Recent medical evidence has revealed a link between using acetaminophen-based pain relievers, like Tylenol, during pregnancy and developmental disorders like autism and ADHD. Thousands of families across the country are now seeking compensation for medical bills, lost wages, and pain and suffering resulting from this defective medication.
On November 14th, 2022, Walmart filed a motion to dismiss the product liability claims against them based on a principle called preemption, a common tactic in defective drug lawsuits. Walmart argued that it should not be held liable because current FDA requirements for warning labels didn’t allow them to update the labels on their generic brand of Tylenol, Equate. Although state laws may require a warning on the risks of using acetaminophen-based drugs during pregnancy, Walmart representatives contend that federal regulations issued by the FDA should overrule state regulations.

The Food and Drug Administration is the federal agency that is “responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs”. They set the national rules for drug manufacturers like the acetaminophen makers named in the Tylenol autism lawsuits. In their motion to dismiss, Walmart representatives argued that the FDA’s authority should supersede state authority when it comes to regulation, which would render the plaintiffs’ claims invalid.

Judge Rejects Request to Dismiss Tylenol Autism Lawsuits Due to Preemption
This motion was quickly rejected by District Judge Denise Cote in a court order. Judge Cote is presiding over the Tylenol autism lawsuits that have been consolidated into a multi-district litigation. In this court order, she lays out an argument for her dismissal. She states that the principle of preemption does not apply in this instance.

Preemption is a concept enshrined in the Constitution that dictates that federal laws trump state laws. Judge Cote asserts that Walmart was in fact able to add additional warnings to their generic acetaminophen because this action was not prevented by the FDA. In fact, they had the legal responsibility to bolster the warning labels on their products.

Current FDA labeling laws would have allowed Walmart to add to the existing warning labels because there was a risk associated with the drug when taken during pregnancy. Based on Judge Cote’s ruling, the Tylenol autism claims will proceed, although the plaintiffs must still prove that the makers of these defective drugs are indeed liable for damages.
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Tylenol during pregnancy does not necessarily cause autism. However, consuming Tylenol and other acetaminophen-containing products during pregnancy may, according to a study by the National Institutes of Health and the Agency for Health Care Research and Quality, increase the risk that the infant will go on to develop autism or ADHD.

Researchers divided the level of acetaminophen exposure at birth into three tiers. The middle tier of exposure had 2.14 times the risk of the lowest third, while the risk of developing ASD was 3.62 times higher for the children in the highest tier.

While that increase does rely on prolonged exposure, it can cause serious problems for many children and their families. Before this study, doctors recommended using acetaminophen during pregnancy to deal with headaches and other common aches and pains. Unfortunately, expectant mothers who used it regularly may have increased their children’s risk of developing ADHD or autism spectrum disorder.
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Tylenol use (or use of generic acetaminophen) by pregnant women has now been the subject of over twenty-six (26) epidemiological studies. All twenty six studies found an association between in utero acetaminophen exposure and a diagnosis of autism spectrum disorder or ADHD. In September of 2021, a consensus statement signed by ninety-one (91) scientists appeared in Nature Reviews Endocrinology called for pregnant women to exercise precaution in acetaminophen use during pregnancy. In this article we will discuss the body of scientific evidence and emerging research linking Tylenol use to autism spectrum disorder.

Medical Studies Linking Tylenol to Autism & ADHD
Consensus Statement Signed by 91 Scientists and Physicians
A consensus statement issued in 2021, was essentially a call to action as researchers could no longer ignore the overwhelming scientific evidence acetaminophen use during pregnancy could cause autism spectrum disorder or attention deficit hyperactivity disorder (ADHD). The authors stated “the combined weight of animal and human scientific evidence is strong enough for pregnant women to be cautioned by health professionals against its indiscriminate use, both as a single ingredient and in combination with other medications.”

Tylenol use during pregnancy is an issue that has not received proper attention despite consistent association demonstrated by study after study. This may have something to do with the anti-vaccine movement and the discredited and debunked science behind the vaccine-autism link. We fear the stigma associated with such has resulted in lack of attention to the danger of regular use of acetaminophen during pregnancy.
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A new study from researchers at the Johns Hopkins Bloomberg School of Public Health has found that exposure to acetaminophen in the womb may increase a child's risk for attention deficit hyperactivity disorder or autism spectrum disorder.

The researchers analyzed data from the Boston Birth Cohort, a 20-year study of early life factors influencing pregnancy and child development. They found that children whose cord blood samples contained the highest levels of acetaminophen—the generic name for the drug Tylenol—were roughly three times more likely to be diagnosed with ADHD or autism spectrum disorder later in childhood, compared to children with the lowest levels of acetaminophen in their cord blood.

Their findings were published last week in JAMA Psychiatry.

Previous studies have found an association between maternal use of acetaminophen during pregnancy and increased risks of adverse childhood outcomes, including neurodevelopmental disorders such as ADHD—which is marked by hyperactivity and difficulty paying attention or controlling impulsive behavior—and autism spectrum disorder, a complex developmental disorder that can affect how a person socializes, communicates, and behaves. Because these studies relied on mothers self-reporting their acetaminophen use, critics have said the findings may be affected by recall bias or lack an objective measure of in-utero exposure. As a result, the U.S. Food and Drug Administration has refrained from making recommendations regarding the use of acetaminophen during pregnancy.
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In this podcast we interview Ann Bauer, a nationally recognized Epidemiologist who served on the research team on multiple published studies linking Tylenol and autism. We discuss the body of science linking acetaminophen use during pregnancy to autism spectrum disorder, the potential weaknesses of the studies, why observational studies were utilized and the future of this science.

A research team including two Yale researchers have cautioned pregnant women against the use of the common pain reliever acetaminophen, brand name Tylenol. They cited the growing body of research that suggests the drug might alter fetal development.

In a consensus statement, the 13-member research team called for greater precaution against taking acetaminophen when pregnant and to forgo using the pain reliever unless its use is medically necessary. Lead author Ann Bauer, a researcher at University of Massachusetts Lowell Center for Autism Research and Education, was the primary contributor behind writing the statement. Zeyan Liew, assistant professor of epidemiology at the Yale School of Public Health, and Hugh S. Taylor, chair of Obstetrics, Gynecology and Reproductive Sciences at the Yale School of Medicine, both helped write the statement as well.

“The period of fetal development is a very vulnerable stage,” Taylor explained in an interview with the News. “Things are moving, changing quickly. The changes that occur during that time period are then programmed for the rest of our lives. Things that don’t affect adults may affect these crucial developmental windows.”

He said that up to 65 percent of women in the United States and more than 50 percent of women worldwide use acetaminophen when pregnant.

The consensus statement was published in Nature Reviews Endocrinology on Sept. 23, and was the result of reviewing currently available literature on the effects of acetaminophen in pregnant women. In addition, the statement included support by signatories from 91 researchers, clinicians and public health experts across the world.
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Question
What is the association between cord plasma biomarkers of in utero acetaminophen exposure and risk of childhood attention-deficit/hyperactivity disorder and autism spectrum disorder?

Findings
In this cohort study of 996 mother-infant dyads from the Boston Birth Cohort, cord plasma biomarkers of fetal exposure to acetaminophen were associated with significantly increased risk of childhood attention-deficit/hyperactivity disorder and autism spectrum disorder.

Meaning
These findings suggest in utero exposure to acetaminophen is associated with increased risk of attention-deficit/hyperactivity disorder and autism spectrum disorder in children and warrant additional investigations.

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Abstract
Importance
Prior studies have raised concern about maternal acetaminophen use during pregnancy and increased risk of attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) in their children; however, most studies have relied on maternal self-report.

Objective
To examine the prospective associations between cord plasma acetaminophen metabolites and physician-diagnosed ADHD, ASD, both ADHD and ASD, and developmental disabilities (DDs) in childhood.

Design, Setting, and Participants
This prospective cohort study analyzed 996 mother-infant dyads, a subset of the Boston Birth Cohort, who were enrolled at birth and followed up prospectively at the Boston Medical Center from October 1, 1998, to June 30, 2018.

Exposures
Three cord acetaminophen metabolites (unchanged acetaminophen, acetaminophen glucuronide, and 3-[N-acetyl-l-cystein-S-yl]-acetaminophen) were measured in archived cord plasma samples collected at birth.

Main Outcomes and Measures
Physician-diagnosed ADHD, ASD, and other DDs as documented in the child’s medical records.

Results
Of 996 participants (mean [SD] age, 9.8 [3.9] years; 548 [55.0%] male), the final sample included 257 children (25.8%) with ADHD only, 66 (6.6%) with ASD only, 42 (4.2%) with both ADHD and ASD, 304 (30.5%) with other DDs, and 327 (32.8%) who were neurotypical. Unchanged acetaminophen levels were detectable in all cord plasma samples. Compared with being in the first tertile, being in the second and third tertiles of cord acetaminophen burden was associated with higher odds of ADHD diagnosis (odds ratio [OR] for second tertile, 2.26; 95% CI, 1.40-3.69; OR for third tertile, 2.86; 95% CI, 1.77-4.67) and ASD diagnosis (OR for second tertile, 2.14; 95% CI, 0.93-5.13; OR for third tertile, 3.62; 95% CI, 1.62-8.60). Sensitivity analyses and subgroup analyses found consistent associations between acetaminophen buden and ADHD and acetaminophen burden and ASD across strata of potential confounders, including maternal indication, substance use, preterm birth, and child age and sex, for which point estimates for the ORs vary from 2.3 to 3.5 for ADHD and 1.6 to 4.1 for ASD.
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The potential etiological role of early acetaminophen exposure on Autism Spectrum Conditions (ASC) and Attention-Deficit/Hyperactivity Disorder (ADHD) is inconclusive. We aimed to study this association in a collaborative study of six European population-based birth/child cohorts. A total of 73,881 mother–child pairs were included in the study. Prenatal and postnatal (up to 18 months) acetaminophen exposure was assessed through maternal questionnaires or interviews. ASC and ADHD symptoms were assessed at 4–12 years of age using validated instruments. Children were classified as having borderline/clinical symptoms using recommended cutoffs for each instrument. Hospital diagnoses were also available in one cohort. Analyses were adjusted for child and maternal characteristics along with indications for acetaminophen use. Adjusted cohort-specific effect estimates were combined using random-effects meta-analysis. The proportion of children having borderline/clinical symptoms ranged between 0.9 and 12.9% for ASC and between 1.2 and 12.2% for ADHD. Results indicated that children prenatally exposed to acetaminophen were 19% and 21% more likely to subsequently have borderline or clinical ASC (OR = 1.19, 95% CI 1.07–1.33) and ADHD symptoms (OR = 1.21, 95% CI 1.07–1.36) compared to non-exposed children. Boys and girls showed higher odds for ASC and ADHD symptoms after prenatal exposure, though these associations were slightly stronger among boys. Postnatal exposure to acetaminophen was not associated with ASC or ADHD symptoms. These results replicate previous work and support providing clear information to pregnant women and their partners about potential long-term risks of acetaminophen use.
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Paracetamol (acetaminophen) is commonly used to treat fever and pain in pregnant women, but there are growing concerns that this may cause attention deficit hyperactivity disorder and autism spectrum disorder in the offspring. A growing number of epidemiological studies suggests that relative risks for these disorders increase by an average of about 25% following intrauterine paracetamol exposure. The data analyzed point to a dose-effect relationship but cannot fully account for unmeasured confounders, notably indication and genetic transmission. Only few experimental investigations have addressed this issue. Altered behavior has been demonstrated in offspring of paracetamol-gavaged pregnant rats, and paracetamol given at or prior to day 10 of life to newborn mice resulted in altered locomotor activity in response to a novel home environment in adulthood and blunted the analgesic effect of paracetamol given to adult animals. The molecular mechanisms that might mediate these effects are unknown. Paracetamol has diverse pharmacologic actions. It reduces prostaglandin formation via competitive inhibition of the peroxidase moiety of prostaglandin H2 synthase, while its metabolite N-arachidonoyl-phenolamine activates transient vanilloid-subtype 1 receptors and interferes with cannabinoid receptor signaling. The metabolite N-acetyl-p-benzo-quinone-imine, which is pivotal for liver damage after overdosing, exerts oxidative stress and depletes glutathione in the brain already at dosages below the hepatic toxicity threshold. Given the widespread use of paracetamol during pregnancy and the lack of safe alternatives, its impact on the developing brain deserves further investigation.

Paracetamol (N-acetyl-p-aminophenol (APAP), otherwise known as acetaminophen) is the active ingredient in more than 600 medications used to relieve mild to moderate pain and reduce fever. APAP is widely used by pregnant women as governmental agencies, including the FDA and EMA, have long considered APAP appropriate for use during pregnancy when used as directed. However, increasing experimental and epidemiological research suggests that prenatal exposure to APAP might alter fetal development, which could increase the risks of some neurodevelopmental, reproductive and urogenital disorders. Here we summarize this evidence and call for precautionary action through a focused research effort and by increasing awareness among health professionals and pregnant women. APAP is an important medication and alternatives for treatment of high fever and severe pain are limited. 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. We suggest specific actions to implement these recommendations. This Consensus Statement reflects our concerns and is currently supported by 91 scientists, clinicians and public health professionals from across the globe. A growing body of research suggests that prenatal exposure to paracetamol (APAP) might alter development and increase the risk of some reproductive, urogenital and neurodevelopmental disorders. This Consensus Statement calls for precautionary action, including a focused research effort, increasing awareness among health professionals and pregnant women and, whenever possible, minimizing use.

Can you take Tylenol during pregnancy? A renowned epidemiologist cautions pregnant people that acetaminophen may be linked to autism or ADHD.

Most researchers think the science isn't yet conclusive, but Roberta Ness doesn't want to wait.
"I believe that acetaminophen is a cause of autism and ADHD," said Ness, former dean of the University of Texas School of Public Health and a leading voice in women's health research. "That is a very big thing for an epidemiologist to say."

More than two dozen studies around the world have linked a pregnant person's frequent use of acetaminophen—brand name Tylenol—to autism and attention deficit hyperactivity disorder in their child. Lawsuits are pending.

As many as two-thirds of pregnant people take acetaminophen, the painkiller deemed safest during pregnancy. Roughly 10% take it for more than a month. Data suggests a "dose response"—meaning the more acetaminophen someone takes during pregnancy, the higher their risk of having a child with autism or ADHD.
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Acetaminophen (also called paracetamol) is the analgesic and antipyretic medication most commonly used during pregnancy (1–4). It is classified as category B for safety in pregnancy (no risks have been found in humans) by the US Food and Drug Administration and is widely considered the drug of choice for fever and pain in pregnant and lactating women (5–7). In recent years, exposure to acetaminophen during pregnancy and early infancy has been associated with potential harmful effects, even with exposure to therapeutic doses. Reported harmful effects have included predisposition to asthma (8, 9), in vitro testicular toxicity and an increased risk for cryptorchidism (10–12), and neurodisrupting properties and an increased risk for neurodevelopmental disorders (13–18).

Several studies have evaluated acetaminophen’s potentially neurodisruptive properties. Recent studies reported that acetaminophen has (in rats) direct neurotoxic toxic effects in cortical neurons and (in mice) inhibits fetal testosterone production, areas that are critical for brain development (10, 19). Moreover, acetaminophen crosses the human placental barrier (20), and an association between exposure to acetaminophen during pregnancy and neurodevelopmental impairment in humans has been reported (13, 21, 22).
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Roberta Ness is on a mission to warn pregnant people to use less acetaminophen. The epidemiologist who helped convince jurors that baby powder likely causes ovarian cancer is now equally convinced of the dangers of frequent acetaminophen use during pregnancy. Most researchers think the science isn't yet conclusive, but Ness doesn't want to wait."I believe that acetaminophen is a cause of autism and ADHD," said Ness, former dean of the University of Texas School of Public Health and a leading voice in women's health research. "That is a very big thing for an epidemiologist to say."More than two dozen studies around the world have linked a pregnant person's frequent use of acetaminophen – brand name Tylenol – to autism and attention deficit hyperactivity disorder in their child. Lawsuits are pending. As many as two-thirds of pregnant people take acetaminophen, the painkiller deemed safest during pregnancy. Roughly 10% take it for more than a month. Data suggests a "dose response" – meaning the more acetaminophen someone takes during pregnancy, the higher their risk of having a child with autism or ADHD."I'm not saying that acetaminophen is now the cause (of autism and ADHD). I'm saying that it's a cause," she continued. "This is our first opportunity to find an exposure that may be preventable and may be a cause.

A debate over pregnant women and Tylenol is heading to court. A study from the NIH finds that pregnancy exposure to acetaminophen, the main ingredient in Tylenol, may increase a child’s risk for autism and ADHD. Consumer advocate Erin Brockovich is spearheading a project where tens of thousands of mothers are suing the makers of Tylenol and generic acetaminophen.

A challenge to the group of Tylenol autism lawsuits making its way through the court system has been dismissed. Recent medical evidence has revealed a link between using acetaminophen-based pain relievers, like Tylenol, during pregnancy and developmental disorders like autism and ADHD. Thousands of families across the country are now seeking compensation for medical bills, lost wages, and pain and suffering resulting from this defective medication.

This motion was quickly rejected by District Judge Denise Cote in a court order. Judge Cote is presiding over the Tylenol autism lawsuits that have been consolidated into a multi-district litigation. In this court order, she lays out an argument for her dismissal. She states that the principle of preemption does not apply in this instance.

Preemption is a concept enshrined in the Constitution that dictates that federal laws trump state laws. Judge Cote asserts that Walmart was in fact able to add additional warnings to their generic acetaminophen because this action was not prevented by the FDA. In fact, they had the legal responsibility to bolster the warning labels on their products.

Current FDA labeling laws would have allowed Walmart to add to the existing warning labels because there was a risk associated with the drug when taken during pregnancy. Based on Judge Cote’s ruling, the Tylenol autism claims will proceed, although the plaintiffs must still prove that the makers of these defective drugs are indeed liable for damages.
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Tylenol autism lawsuits have experienced another development that can significantly benefit the process of this litigation. In a win for the plaintiffs seeking compensation for developmental disorders caused by prenatal Tylenol exposure, the presiding judge over the multidistrict litigation approved a Short-Form complaint to be used in the filing of future Tylenol autism cases.

These many Tylenol autism lawsuits come on the heels of studies that indicate a significant risk of developmental disorders among children exposed prenatally to Tylenol when their mothers took the common over-the-counter drug while pregnant. Plaintiffs claim that developmental disorders such as autism spectrum disorder and ADHD could have been avoided had Tylenol been properly labeled with warnings for use during pregnancy.

What is Short-Form Complaint?
The litigation involving Tylenol has come to involve thousands of plaintiffs that claim to have been harmed by the failure to label the drug properly. These massive numbers of plaintiffs present a problem for the justice system that is tasked with seeing these claims handled efficiently and fairly.

Numerous measures have been taken to consolidate and streamline these many Tylenol product liability lawsuits so that they do not overwhelm the courts among which, Short-Form complaints are included. Each case involved in this litigation is unique although they will often share many common threads that unite them together in this legal battle.

Master and Short-Form Complaints
It is common in large product liability lawsuits with vast numbers of plaintiffs for the Court to approve a Master and Short-Form Complaint. These give plaintiff’s the ability to file future lawsuits in the relevant large-scale litigation through an abbreviated form.

A Master Complaint is filed on behalf of all the plaintiffs in a large-scale lawsuit and gives a broad coverage of the complaints filed by the many plaintiffs involved. Individual plaintiffs looking to join the lawsuit in the future then file a Short-Form complaint which is an abbreviated and standardized version of the Master Complaint. Their Short-Form Complaints adopt certain allegations from the Master Complaint that suit the individual plaintiff’s case as well as a limited amount of case-specific information regarding details such as injuries and damages.

This simplifies the process and makes management of the various claims much easier so that the process is more streamlined and efficient so that litigation can proceed all the more smoothly.

Implementation of Short-Form Complaints in the Tylenol Autism Lawsuit
On Monday, January 9th, 2023, Judge Denise Cote, the presiding judge over the Tylenol multidistrict litigation (MDL), approved the Short-Form complaint proposed for families filing Tylenol autism lawsuits.

The order by Judge Cote that approved these Short-Form Complaints also stated that any plaintiff who has a case pending in the MDL must file a Short-Form Complaint by January 20, 2023. Plaintiffs seeking to file a Tylenol autism case in the future are to complete a Short-Form complaint within 14 days of bringing their case regardless of whether it was filed with the MDL or transferred from another district.
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