Women who used Tylenol or generic acetaminophen while pregnant and gave birth to babies with autism or ADHD are filing lawsuits against the drug manufacturers. Numerous studies have linked acetaminophen or paracetamol exposure to fetuses to an increased risk of autism and ADHD, among other neurodevelopmental disorders. These product liability lawsuits allege that the drug manufacturers should have warned about the risks involved in taking the drug during pregnancy. Tylenol manufacturer, Johnson and Johnson is the main defendant in the litigation among other generic manufacturers of the drug.
Tylenol has been known as the only safe over-the-counter painkiller medication to use during pregnancy. Studies have shown that two in every three pregnant women have used the drug during pregnancy. Also, the number of children in the US born with autism spectrum disorders and ADHD has been on the rise over recent years. 2018 statistics show that one in every 44 eight-year-old children in the US had autism, and 8.8% of children aged between three and eight years suffered from ADHD.
Tylenol MDL dismissed
Judge Cote Dismissed the Tylenol Autism Multidistrict Litigation involving about 500 liability claims. Following the Daubert hearings, Judge Denise Cote barred expert witnesses from testifying, stating that they did not support their conclusions with scientific evidence.
According to the ruling, the plaintiffs’ claims were legally untenable as their scientific experts could not establish credible connections between Tylenol and autism, attention-deficit issues, or hyperactivity. She explained that the experts lacked a reliable application of scientific methods to ascertain the causal relationships between Tylenol and the conditions. Some plaintiffs are appealing Judge Cote’s ruling as others seek compensation in state courts.
Tylenol lawsuit eligibility
Tylenol ADHD lawsuits are being filed for children currently under 15 years and diagnosed with ADHD or severe attention deficit hyperactivity disorder between the ages of 8 and 14 years. If you took the drug several times while pregnant and gave birth to a child with either of these developmental disorders, you might be liable for a claim. Unfortunately, the statute of limitation may prohibit some cases, among other factors. Contact us, and our Tylenol attorneys will review your case and advise you accordingly.
About the Tylenol Lawsuit
The recent increase in children born with autism and ADHD has been linked to prenatal neurotoxic exposure to acetaminophen. A consensus statement published by a group of 91 medical experts in the Journal of Nature Reviews and Endocrinology in September 2021 showed that the use of Tylenol during pregnancy increased the risk of autism by 20%. This study summarized growing epidemiological studies and animal testing linking prenatal acetaminophen exposure to an increased risk of neurodevelopmental disorders. The studies involved consistently showed a link between the use of acetaminophen during pregnancy and high rates of autism. According to the findings, the risk of developing the condition depends on the duration of acetaminophen exposure and the amount of drug taken. This study comprised 29 observational studies and over 220,000 mother-child pairs globally.
The consensus statement strongly recommended that medical and public health agencies take preventive actions by warning the public about the potential risks of using Tylenol during pregnancy. They also recommended the inclusion of a prenatal use warning label on all acetaminophen drugs. The consensus statement findings sparked the acetaminophen autism lawsuits being filed against the drug manufacturers. With the frequency of the use of the drug during pregnancy and the growing numbers of autistic children, this acetaminophen litigation might be the largest witnessed in US history.
On October 5, 2022, after hearing the oral arguments in St. Louis, the JPML approved the consolidation of Tylenol lawsuits filed in federal courts into a multidistrict litigation (MDL) class action lawsuit in the Southern District of New York. All the cases allege that Tylenol use during pregnancy led to the delivery of autistic children. A group of plaintiffs in the lawsuits had filed a motion to consolidate the cases. The defendants were against the motion, stating that it was too early and some of the defendants were not yet involved. The panel, however, stated that there was no legal basis for the defendants’ arguments. Honourable Judge Denise L. Cote was appointed to oversee the Tylenol autism class action MDL, which comprised 90 cases at the time.
In November 2022, the jury approved the proposed defense counsel committee. In this litigation, a Retailer Liaison Committee (RLC) consisting of selected attorneys for the retail company defendants will serve as the liaison counsel on the plaintiffs’ side.
In November 2022, Walmart filed a motion to dismiss the Tylenol autism lawsuit based on federal preemption. Walmart is alleged to have violated its duties under the state law to warn about the risks of the prenatal use of their acetaminophen brand “Equate”. In its preemption motion, the company argues that it was not legally permitted to change the warning labels since the FDA mandated the warnings of such products under federal law. The plaintiffs opposed this motion, stating that the FDA regulations would not have barred such warning changes informing about the risks of drug use during pregnancy. The judge denied Walmart’s motion, explaining that federal preemption did not apply because FDA labeling law is not exclusive. She further explained that FDA regulations allow companies to change warning labels and include additional information to ensure the labeling is adequate. Walmart also appealled for the Judge to reconsider the preemption, which was also denied.
During the December 2022 monthly Tylenol class action lawsuit status conference, Judge Cote ordered the direct filing of future Tylenol autism cases in the MDL. Both parties also submitted independently proposed discovery plans after disagreeing on various issues. The Judge chose the defendant’s proposal and ordered them to work things out before the January 2023 status conference.
In December 2022, Judge Cote also appointed Randi Ellis as the MDL special master in charge of the plaintiff census. Her roles entail collecting key information from all new plaintiffs for decision-making purposes on matters related to the litigation. She has been previously appointed in similar roles in two other mass torts in 2022.
In January 2023, the Tylenol MDL judge approved the use of Short Form Complaint by new plaintiffs filing autism and ADHD lawsuits. The form allows the direct filing of lawsuits in the MDL, streamlining the process.
The judge also introduced a discovery plan focusing on causation evidence linking acetaminophen prenatal exposure to autism and ADHD. The first phase of the consolidated discovery plan required Johnson and Johnson, the original developers of Tylenol, to produce documents relating to the risks of prenatal exposure to acetaminophen. The plaintiffs’ lawyers wanted the defendants to identify the documents’ custodians and produce them within 30 days. The process would help with the vetting of scientific evidence before the cases go to trial and offer plaintiffs an opportunity to seek answers to written questions.
The judge also issued an order outlining the coordination of discovery processes in the Tylenol autism MDL and similar ongoing cases in state courts. According to this order, the state courts have an option of piggybacking on the MDL discovery efforts for efficiency.
In February 2023, Judge Cote set the expert witness depositions on course by issuing a new case management order finalizing rules and protocol. The judge plans to rule on the admissibility of scientific causation evidence in the litigation in October 2023.
In February 2023, J&J consumers who are significant defendants in the Tylenol lawsuits filed a motion seeking the dismissal of all the cases based on federal preemption. They argued that under federal law, the FDA was mandated with the Tylenol warning label. Walmart had filed a similar motion earlier in December which was denied by the court. The J& Jmotion was also denied in April 2023.
In March 2023, the judge introduced a new 35-page fact sheet that new plaintiffs would complete and submit. The plaintiff fact sheet (PFS) requires information about the specific products the plaintiff used and the parent’s and child’s medical and genetic history.
In April 2023, the MDL judge asked plaintiff lawyers for their suggested acetaminophen warning, and they provided the following:
“Autism/ADHD: Some studies show that frequent use of this product during pregnancy may increase your child’s risk of autism and attention deficit hyperactivity disorder. If you use this product during pregnancy to treat your pain and/or fever, use the lowest effective dose for the shortest possible time and at the lowest possible frequency.”
The judge further invited the government to provide its views on whether the proposed warning should be included in the drug label and if science warrants the inclusion of such a warning. As of May, Tylenol autism MDL had over 100 cases, and it is expected to grow to thousands before going to trial. Also, in May 2023, the judge dismissed a case based on Texas law regarding the labelling of over-the-counter medications.
Tylenol autism ADHD lawsuit claims
- There was sufficient science linking utero exposure to acetaminophen and autism spectrum disorder and ADHD, and the drug manufacturers knew or should have known about these risks.
- Manufacturers should have warned the drug users about the risks of taking the drug during pregnancy.
- The drug manufacturers marketed acetaminophen as a safe OTC medication for pain relief during pregnancy, while research indicated otherwise. From this marketing, expectant women went for acetaminophen as the first painkiller choice, increasing the risk of having children with autism and ADHD.
Tylenol autism studies
Let us look at some studies linking autism/ADHD to acetaminophen prenatal exposure:
- A 2020 study by Yale University and Johns Hopkins University established that children born to mothers who took acetaminophen during pregnancy had a higher diagnosis of neurodevelopmental disorders such as autism and ADHD. 996 cohort blood samples analyzed in this study indicated a dose-dependent relationship between Tylenol in-utero exposure and autism. Autistic children and those with ADHD were found to have higher levels of acetaminophen in the umbilical cord blood samples, indicating a quasi-casual link between acetaminophen during pregnancy and fetal developmental disorders. In the study, it was established that children with the highest acetaminophen levels in their blood were three times more likely to be diagnosed with autism and ADHD. Since the drug has a short half-life (it is eliminated from the body faster), it is difficult to establish at what stage of pregnancy acetaminophen was most harmful to a developing fetus. Other studies have also shown that the higher the utero-acetaminophen exposure, the higher the risk of neurodevelopmental disorders.
- A 2015 Danish National Birth Cohort Study involving 64,322 mother-child pairs to establish the causes of diseases in children and delivery complications, where several factors were analyzed, showed a close link between prenatal use of acetaminophen and ADHD. The study established that prenatal exposure to Tylenol led to a 30% risk of developmental disorders.
- A 2016 observational study analyzing data from a Spanish birth cohort and published in the International Journal of Epidemiology entitled (Acetaminophen use in pregnancy and neurodevelopment: attention function and autism spectrum symptoms) showed a close link between prenatal exposure to acetaminophen and high rates of autism in males and ADHD in both male and female. The researcher analyzed a Spanish birth cohort of 2644 mother-child pairs to establish whether prenatal acetaminophen exposure led to neurodevelopmental disorders in children aged one to five years. Findings from this study showed that fetuses exposed to acetaminophen had a 34% risk of developing ADHD, a 19% risk of developing autism spectrum disorders, and a 24% risk of hyperactivity symptoms. The paper concludes that prenatal acetaminophen exposure was linked to a higher rate of autism spectrum disorder symptoms in males and ADHD in males and females.
- Another similar study published in the European Journal of Epidemiology in 2021 analyzed data from the 2015 Danish Birth Cohort study and established a link between in-utero exposure to acetaminophen and adverse neurodevelopmental disorders, including autism and ADHD.
- A 2020 study published in the Journal of JAMA Psychiatry found that umbilical cord “biomarkers of fetal exposure to acetaminophen were associated with significantly increased risk of childhood [autism] in a dose-response fashion.” And sensitivity and subgroup analyses established consistent associations between acetaminophen and autism spectrum disorders across strata of potential confounders, such as maternal indication, substance use, preterm birth, and child age and sex.
- A 2017 study to establish acetaminophen injuries to a fetal brain published in the Journal of International Medical Research discusses how acetaminophen causes neurodevelopmental disorders by interfering with fetal brain development. Researchers believe the drug may inhibit essential brain development enzymes such as the Cox-2 enzyme. Acetaminophen is also said to interfere with the firing of neurons in the hypothalamus. The authors also attribute the use of acetaminophen to a brain inflammatory disease.
- A study by the American Academy of Pediatrics linked moderate prenatal use of acetaminophen to an increased risk of ADHD. All the studies in this research showed consistently the same results, with the risk of ADHD from Tylenol exposure being higher than that of autism. This study contributed to the sprawling Tylenot autism lawsuits being witnessed across the country. It also made health professionals take notice of the effects of the drug during pregnancy.
- The 2021 consensus statement published in Nature Reviews Endocrinology linked acetaminophen fetal exposure to an increased risk of alteration of fetal development leading to neurodevelopmental reproductive and urogenital disorders.
Tylenol autism settlement amounts.
If the Tylenol autism lawsuits are successful, the defendants are likely to part with huge payouts in settlements. This is because the conditions involved in the lawsuits prevent people from living normal lives and are carried throughout their entire lives. On average, the settlements are likely to be between $200,000 and $500,000, while the whole payout per victim could be around $5M.
The settlements are likely to vary depending on the severity of the child’s autism, level of independence, and the need for personal and medical care. The payouts will also depend on the amount of acetaminophen the mother took during pregnancy and if the child was born preterm. Other factors, such as maternal health during pregnancy and if they suffered from conditions such as gestational diabetes and hypertension, and genetic dispositions of both parents will also be put into consideration.