Every year, more and more children are being diagnosed with Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), and other neurodevelopmental disorders. Many of these cases are being linked to the child’s exposure to Tylenol (acetaminophen) during pregnancy. Families of children with ASD and ADHD are working with mass tort lawyers to bring product liability lawsuits and recover compensation for financial losses associated with this Tylenol use.
As of September 2022, the product liability claims against Tylenol and other makers and retailers of acetaminophen have been consolidated into a multi-district litigation (MDL) lawsuit. As a result, all Tylenol lawsuits will be heard in one jurisdiction, in front of Judge Denise Cote, to consolidate court resources and promote litigation efficiency. The team at Lawsuit Legal News created this page to help interested people follow the Tylenol autism lawsuit updates as they happen.
Acetaminophen and Autism Claim Basic Information
Mass tort lawyers for the injured parties in these Tylenol cases must prove that manufacturers like Johnson & Johnson breached their duty of care to consumers when they failed to warn potential users about the risks associated with acetaminophen use during pregnancy.
The team at Lawsuit Legal News believes manufacturers and retailers were both negligent by ignoring a growing body of scientific evidence that shows how acetaminophen use during pregnancy increases the risk for a child’s diagnosis of autism spectrum disorders. Failure to warn is at the heart of the Tylenol pregnancy lawsuit.
Our goal at Lawsuit Legal News is to update this page as often as possible with the most recent news at the top. For a detailed explanation of the ongoing MDL lawsuit from the very start, our affiliated law firm has created an extensive explanation of the Tylenol Autism Lawsuit.
As Of January 2024, the Tylenol Autism MDL is Done
The team at Lawsuit Legal News is sorry to report that the federal multidistrict litigation related to Tylenol and autism was ended by Judge Cote in December 2023. After the Daubert hearing on December 8th, Judge Cote issued a ruling that found there was not sufficient scientific evidence to link Tylenol or acetaminophen use during pregnancy to the diagnosis of autism or other neurodevelopmental conditions in the child.
Lawyers for the heartbroken plaintiffs are considering an appeal, but we are not optimistic about the appellate chances in this case. If your child was diagnosed with autism after being exposed to Tylenol in utero, you may still have an opportunity to seek compensation through a state court filing against the manufacturers of Tylenol and other acetaminophen products. Contact the LLN team to learn more about your unique legal rights.
Also, if your child consumed certain brands of baby food and was later diagnosed with autism, ASD, or another related condition, you may be able to join the toxic baby food lawsuit currently pending in federal court. Again, reach out to the Lawsuit Legal News team to learn more about this alternative course of action.
Summary of the Tylenol Autism Lawsuit Updates in 2023
December 1, 2023 - 58 More Cases Added to the MDL, Critical Daubert Hearing Next Week
On December 7th, Judge Cote will hold a Daubert Hearing to decide if the plaintiffs' scientific evidence is strong enough to show that taking Tylenol, or generic acetaminophen, during pregnancy can lead to the child being diagnosed with autism, ADHD, or other neurodevelopmental disorders.
With the addition of 58 cases in the past month, the Tylenol autism MDL now has 441 pending claims. If the Daubert evidence is admissible, we expect the number of cases to grow quickly.
November 3, 2023 - Briefing Completed for Daubert Hearings, Which May Occur in December
After three rounds of motions and briefs, both sides have completed their arguments related to the admissibility of expert testimony needed to show a link between the prenatal use of Tylenol (acetaminophen) and diagnoses of autism and ADHD in the child. With several thousand pages to review, we expect Judge Cote will take most of November to consider the upcoming hearings and decide if she will require expert testimony at that time.
October 17, 2023 - Daubert Proposals Submitted, New Cases Continue to be Added to the MDL
Lawyers for both sides of these cases submitted proposals to Judge Cote suggesting how the expert evidence hearings (known as Daubert hearings) should be run. While the defense counsel proposed a full week of hearings, the plaintiffs' lawyers requested a narrower focus to limit the experts involved. We hope the judge agrees with the plaintiffs for the sake of efficiency and fairness.
With the addition of 111 new cases, the MDL has jumped to 383 pending claims as we look forward to the all-important Daubert hearings.
October 3, 2023 - Plaintiffs Disclose Medical Experts, New Plaintiff Fact Sheets Created
In mid-September, plaintiffs' counsel disclosed the top five expert witnesses they intend to call to establish a causal link between Tylenol (acetaminophen) use during pregnancy and later diagnoses of autism, ADHD, and other neurodevelopmental conditions in the child. The expert witnesses include:
- Dr. Andrea Baccarelli, MD, PhD
- Dr. Robert Cabrera, Ph.D.
- Dr. Eric Hollander, MD
- Dr. Stan G. Louie
- Dr. Brandon Pearson, PhD
Also, new Plaintiff Fact Sheets have been added to the case administration system as well as health record authorization forms that each plaintiff must complete to provide the information necessary for the MDL.
September 8, 2023 -
The first week of September has been exciting. This Spring, Judge Cote reached out to the Food & Drug Administration (FDA) for guidance about the warning language that should appear on Tylenol and other acetaminophen products. Surprisingly, the FDA originally requested more time to provide an official statement, but we just learned the FDA has decided it won't provide any guidance about warning labels.
If the FDA had taken the position that the makers of Tylenol and similar products did not need to warn pregnant women about the potential dangers of having an autistic child if they used the drug during pregnancy, the plaintiffs' cases could have been devastated. Without any official position, plaintiffs are moving forward with expert testimony and scientific evidence that the manufacturers failed to warn consumers and should be held liable for their losses. We'll find out whether the judge agrees later this month.
August 2023 -
Among the record-setting number of new case filings last month, three new retailer defendants have been included in the Tylenol autism MDL. Current lawsuits now name Dollar Tree, Family Dollar, and 7-Eleven as responsible parties for selling acetaminophen without warnings about the potential link to autism and ADHD.
July 2023 -
During July, 64 new Tylenol autism lawsuits joined the multi-district litigation (MDL) based in the Southern District of New York. This was the largest number of new cases in any 30-day period from the beginning of the MDL. The total number of cases filed is now up to 200.
Many potential cases are waiting on the sidelines to see what happens with the scientific evidence challenges currently being scrutinized. If Judge Cote accepts and admits the expert testimony linking acetaminophen use during pregnancy to autism, we expect thousands of lawsuits to flood into the MDL. We also expect a hearing on this key issue before year's end.
If the judge rules there is a sufficient link between Tylenol use and ASD diagnoses, the federal cases in the MDL will keep moving forward. If not, state court litigation will grow as more cases are filed at the state level. If the expert testimony is rejected, the federal cases will likely be dismissed and they will not be eligible for state court filing.
June 2023 -
Johnson & Johnson (the maker of Tylenol) requested an immediate appeal when Judge Cote denied its motion to dismiss. If this interlocutory appeal is granted (which we believe is highly unlikely), the pending litigation could be delayed by a year or more. J&J is also trying to delay the MDL by subpoenaing nine expert witnesses. We are waiting for the judge to rule on these stall tactics.
May 2023 -
Different state laws are affecting potential Tylenol autism claims. A Texas case filed against CVS and other drug retailers was dismissed under a Texas law known as a "safe harbor" law. These laws protect retailers of over-the-counter drugs from being named in lawsuits claiming they failed to warn users.
Under Tex. Civ. Prac. & Rem. Code Ann. § 82.007(a), if product’s label meets the standards established by the FDA, retailers cannot be held liable. In California, which also has a safe harbor law, similar cases were not dismissed.
Two retailers, Walmart and Target filed motions to dismiss hoping to be let out of the MDL. Judge Cote denied both of those motions. J&J also filed a motion to dismiss, which was denied in June, so it filed a motion for an immediate, mid-trial interlocutory appeal. Our team of legal professionals expect that motion will be denied as well.
In an unusual move, Judge Cote sent two questions to the Food and Drug Administration (FDA):
- Should acetaminophen products carry a warning as proposed by the plaintiffs' counsel?
- Do current scientific studies warrant adding a label to warn users about acetaminophen use while pregnant and the risk of ASD or ADHD?
Considering the resolution of one of the biggest mass torts in history may hinge on these questions, we do not expect the FDA to answer.
April 2023 -
The Centers for Disease Control and Prevention (CDC) released an Autism Spectrum Disorder report that studied ASD diagnoses in eight-year-old children in 2020. The study showed that 1 in 36 American children is diagnosed with ASD by the age of eight. This report does not specifically address Tylenol use during pregnancy, but it does show increased numbers of children receiving ASD diagnoses by age eight. Studies like this may provide substantial support for the ongoing Tylenol Autism MDL lawsuit.
The Tylenol Multidistrict Litigation judge asked both sides of the MDL to create proposed warning language that could be added to bottles of acetaminophen. The plaintiffs' counsel suggested:
"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."
This month, Judge Cote denied J&J’s motion to dismiss based on the argument that FDA preemption prohibits J&J from changing a medication warning without prior approval from the FDA. In her Order, Judge Cote ruled there is no federal law that prohibits Johnson & Johnson from adding a warning about risks associated with taking Tylenol while pregnant. This was essentially the same outcome as her Walmart decision in mid-November 2022.
March 2023 -
Judge Cote recently adopted a uniform Plaintiff Fact Sheet (PFS) that every new and current plaintiff must complete. The PFS is a 35-page long document that requests more information than most mass tort lawsuit fact sheets. The form requires genetic and medical history from the parents and affected child which is probably to identify any plaintiffs who might have genetic risk factors that could cause autism or ADHD as opposed to only acetaminophen use.
The plaintiffs’ lawyers have received an internal Johnson & Johnson document from 2014 that directly contradicts J&J’s public stance. In the past, J&J has repeatedly stated it is "unaware of conclusive evidence to support a causal link between use of acetaminophen during pregnancy and the risk of adverse fetal outcomes."
A second document uncovered through the discovery process is even more disturbing. In that document, a Johnson & Johnson scientist stated that another study had been processed "implicating a causal relationship between acetaminophen use and ADHD like symptoms and behaviors."
The FDA has also acknowledged a consistent association between prenatal acetaminophen exposure and developmental disorders and noted a dose-dependent relationship (which likely will help establish causation).
February 2023 -
Judge Cote ordered the consolidation of both federal and state Tylenol autism cases to ensure judicial efficiency and avoid unfair burdens on third parties and redundancy issues. Out team expects more than 150,000 individuals to file a Tylenol autism lawsuit over the next two years. In the meantime, J&J filed a motion to dismiss claiming FDA preemption (this motion was denied in April).
Numerous studies now support the causal link between Tylenol exposure in utero and developmental disorders. Of course ethical concerns prevent researchers from researching pregnant women in depth, animal studies consistently show fetal brain developmental delays when there is acetaminophen exposure in-utero. After reviewing 26 epidemiological studies along with the animal studies, we believe plaintiffs will easily have sufficient evidence to establish a causal link and succeed on the merits of this lawsuit.
January 2023 -
Since the MDL is still youn, this month saw a lot of procedural progress. A short form complaint was created to ease the process of joining the MDL. Short-Form Complaints provide a uniform format that new plaintiffs must use when they want to join a large legal proceeding. This makes the process more efficient and manageable, and these claim forms help streamline the process of bringing cases into the MDL.
Judge Cote also ordered an evidence discovery plan initially focusing solely on causation and whether prenatal acetaminophen exposure causes autism spectrum disorder (ASD) or attention deficit hyperactivity disorder (ADHD).
For a full run-down of the Tylenol autism MDL’s procedural history up to 2023, be sure to check out the comprehensive summary page link above.
Count on Lawsuit Legal News to Be Your Top Resource for Tylenol Autism Lawsuit Updates
Whether you are already a part of the Tylenol autism MDL or considering joining the lawsuit, you can depend on Lawsuit Legal News to keep you informed. Our experienced team of mass tort and dangerous drug legal professionals is here to help. Call 866-467-0943 or fill out our online contact form for a free consultation anytime.