Tylenol Autism Lawsuit – Settlement & Claims (December 2024)

November 22, 2024 | Attorney, Matthew Dolman
Tylenol Autism Lawsuit – Settlement & Claims (December 2024)

The Tylenol autism lawsuit is attracting national attention. Also known as the Acetaminophen Autism Lawsuit, this nationwide legal action had the potential to be the biggest mass tort in U.S. history.

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What Is The Tylenol Autism Lawsuit?

The Tylenol Autism Lawsuit is a nationwide legal action brought by parents who took Tylenol during pregnancy and gave birth to a child diagnosed with autism, ADHD, or other neurodevelopmental disorders. In this article, we share the basic information you need to know to determine if you are eligible for a potential Tylenol-autism claim settlement.

Tylenol Autism Lawsuit

The makers of Tylenol and generic acetaminophen (also called Paracetamol, its chemical name) are facing numerous product liability lawsuits.

These mass tort lawsuits claim the product's makers and retailers negligently failed to warn pregnant women, doctors, and the general public about a potential risk that arises when the products are used during pregnancy.

Using acetaminophen during pregnancy has been linked to a 20% to 30% increase in children diagnosed with autism spectrum disorder (ASD), ADHD (attention deficit hyperactivity disorder), hyperactivity, and other conduct-related disorders.

The link between Tylenol and autism is the most studied. The size of the studies, the consistent methodology, and the studies' designs (described as "robust") provide solid evidence and a strong argument that paracetamol use during pregnancy leads to an increased risk of neurodevelopmental disorder diagnosis in children.

A summary of the most important scientific reports is included at the end of this page for more details about these studies.

In this article, we will discuss:

  • The latest updates from the pending multidistrict litigation involving these claims.
  • The foundation of Tylenol-autism claims relating to the use of acetaminophen while pregnant,
  • Potential Tylenol-autism settlement amounts,
  • The science supporting the link between Tylenol use and autism, ADHD, and other similar disorders

How Did The Tylenol Autism Lawsuit Begin?

The proposed link between Tylenol use during pregnancy and children born with ASD or other conditions has grown into a nationwide concern. As a result, beginning in September 2022, similarly to the toxic baby food autism lawsuit, numerous Tylenol autism lawsuits have been filed claiming damages related to the various manufacturers’ and merchants’ failures to warn about the potential problems this over-the-counter medicine can cause.

In October 2022 alone, Tylenol lawyers spent $1.85 million in mass tort advertising to notify potential claimants about their legal rights. This was the third biggest expenditure for any mass tort after mesothelioma and Camp Lejeune injury claims. Families affected by Tylenol-related issues are filing mass tort lawsuits throughout the United States. 

Rather than clogging multiple federal court systems, an ever-growing number of lawsuits have been consolidated in the Southern District of New York before Judge Denise Cote. These consolidated lawsuits are officially known as In Re: Acetaminophen – ASD/ADHD MDL No. 3043 Products Liability Litigation and are informally called the “Tylenol autism lawsuit.”

The Tylenol autism lawsuit encompasses all lawsuits filed in Federal Courts throughout the United States against manufacturers and retailers of generic acetaminophen products and Tylenol. This form of litigation is called Multi-District Litigation (MDL) because it includes potentially injured parties nationwide.

Read on to learn how the Tylenol autism lawsuit came to be, the present status of litigation, and what we can expect going forward.

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Tylenol and Autism or ADHD Lawsuit Updates - December 2024

The product liability claims against Tylenol and other makers of acetaminophen have been consolidated into a multi-district litigation class action lawsuit. This means all Tylenol lawsuits will be heard in one jurisdiction to consolidate court resources, even if the plaintiffs are located across the U.S. It also allows plaintiffs to share the burden of expenses like court fees.

Tylenol autism lawyers for injured parties must convince a jury that manufacturers like Johnson & Johnson breached their duty of care to consumers by failing to warn them of the risks associated with acetaminophen.

We believe manufacturers and retailers were both negligent by ignoring a growing body of scientific evidence illustrating acetaminophen use during pregnancy increases the risk for autism spectrum disorders. Failure to warn is at the heart of the Tylenol pregnancy lawsuit.

Our law firm can assist in accurately calculating the value of your damages so that you can make a claim for compensation against acetaminophen or Tylenol drug makers like Mallinckrodt or Johnson and Johnson and retailers such as Walmart and Costco.

We aim to update this page as often as possible, with the most recent news at the top. We will not only provide timely updates on the Tylenol autism ADHD lawsuit but also share any new scientific developments linking acetaminophen use during pregnancy and autism, along with any coverage this issue earns in the mainstream media.

Be sure to bookmark this page and come back often for the most up-to-date information on the Tylenol autism lawsuit.

December 1, 2024 - Plaintiffs' Appeal is Still Pending

After the MDL judge dismissed all pending federal claims based on her rejection of the plaintiffs' expert testimony, the plaintiffs filed an appeal. We don't expect a decision from the appellate court until sometime in 2025. In the meantime, families of children diagnosed with autism continue to file lawsuits in state courts around the nation.

Also, some children may have developed autism from consuming certain baby foods that contain toxic heavy metals. If your child has been diagnosed with autism, you probably have questions about your potential legal rights. The compassionate legal team at Dolman Law Group can answer your questions during a free consultation. Contact us today!

November 1, 2024 - Plaintiffs Appeal Judge’s Rejection of Expert Testimony that Led to MDL Dismissal

The team at Dolman Law Group has obtained new information on the pending appeal challenging the recent MDL dismissal. Judge Cote had excluded testimony from all plaintiffs’ expert witnesses regarding the possible link between prenatal Tylenol use and later diagnoses of autism or ADHD in children. The appeal contends that the judge improperly applied the Daubert standard by overstepping the role of gatekeeper and effectively acting as the ultimate decision-maker on scientific matters rather than simply filtering evidence.

In layman's terms, the Daubert standard requires courts to ensure that technical evidence presented to a jury is reliable, methodologically sound, and founded on recognized principles. In this case, plaintiffs’ attorneys introduced five reputable experts to illustrate how prenatal exposure to acetaminophen could impact fetal development.

The appellate brief argues that Judge Cote misused the Daubert standard by disregarding established scientific practices and assuming a conclusive stance on the scientific issues at hand. It further suggests that the judge appeared to prioritize concerns about the public policy implications of acetaminophen warnings over the scientific rigor applied by the experts—an issue outside the scope of a Daubert hearing.

Because the appeals process can be lengthy, we don't anticipate a ruling until early next year. We’ll continue to share updates as new information surfaces.

October 1, 2024 - State Court Tylenol Lawsuits Continue

When Judge Cote dismissed the federal MDL in August, counsel for the injured plaintiffs filed an appeal. As we learn more about the appellate filing, we will update this page. At the same time, Tylenol cases are still pending in several states, including several in Illinois and California. Defendant Johnson & Johnson continues to file motions to dismiss, claiming federal law preempts the plaintiffs' arguments. As each court rules on this issue, we will report the rulings here. However, at least one California lawsuit has been set for trial beginning in April 2025.

September 1, 2024 - Federal Multidistrict Litigation is Dismissed by Judge Cote

Based on her ruling in July, Judge Cote has officially dismissed all pending cases in the Tylenol Autism Multidistrict Litigation as of August 20, 2024. The plaintiffs' counsel has filed an appeal, but if they are unsuccessful, all federal cases will be considered resolved in favor of the defendant drug manufacturers.

August 1, 2024 - Judge Excludes Plaintiff's Expert Testimony, MDL is at Risk Again

We are sorry to report that on July 10th, Judge Cote granted the defendant's motion to exclude Dr. Roberta Ness as an expert witness for the plaintiffs. The 321 pending lawsuits in the MDL are again at risk of being dismissed due to insufficient medical and scientific evidence to support the allegations that Tylenol is responsible for causing autism in children who were exposed to acetaminophen during pregnancy.

The court will convene again on August 29, 2024, to consider various motions that could have a significant impact on the future of this MDL. Our team is keeping a close eye on this litigation, and we'll update this post as new information is released.

July 2, 2024 - Excluded Expert Testimony Could Lead Cases to State Courts

By July 2024, the multidistrict litigation (MDL) had accumulated 56 active cases. These lawsuits, collectively known as MDL 3043, are currently under the jurisdiction of Judge Denise L. Cote in the Southern District of New York.

Judge Cote previously

ruled to exclude expert testimony claiming that Tylenol usage during pregnancy can result in autism in babies. The judge determined that the experts did not provide sufficient scientific evidence to substantiate their assertions.

This ruling will significantly impact the federal multidistrict litigation involving around 500 lawsuits related to the widely used over-the-counter medication unless the plaintiffs can successfully appeal the decision; however, Tylenol autism lawsuits are anticipated to continue in state courts.

June 20, 2024 - Plaintiffs Present New Medical Testimony That Could Breathe New Life Into the Tylenol MDL

When Judge Cote rejected the plaintiffs' offered medical testimony and dismissed the pending federal multidistrict litigation last year, the MDL was over.

However, Dr. Roberta Ness has now provided new evidence that supports the plaintiffs' legal claims that taking Tylenol during pregnancy may cause autism or other neurodevelopmental disorders in the child. Last month, Dr. Ness was deposed, and her opinions could relaunch this MDL.

The MDL judge dismissed the first scientific evidence because she decided it contained certain methodological errors or analysis flaws.

In her deposition, Dr. Ness addressed each of the judge's concerns while supporting her opinion that the use of acetaminophen could lead to diagnoses of autism and ADHD. To form her opinion, Dr. Ness utilized a generally accepted protocol and followed Bradford Hill's criteria, a respected analysis method.

The defense tried to discredit Dr. Ness since the plaintiffs paid for her involvement in these cases. However, she completed her analysis before becoming a potential testifying witness in this MDL. She testified that her initial goal was to help the general public by challenging the scientific accuracy of other studies and data.

When she was asked to be a witness, Dr. Ness augmented her original studies by performing the Bradford Hill analysis. As a result, she addressed each of Judge Cote's prior concerns. Her testimony must meet the legal relevance and reliability standards needed to reinstate the MDL.

The next step is another Daubert hearing to see if the new evidence is legally sufficient to support the plaintiffs' arguments that Tylenol harmed their children. The team at Dolman Legal Group will keep you posted about this important litigation as it evolves.

May 7, 2024 - We are Still Waiting to See Whether New Expert Testimony Will Be Allowed in Tylenol Autism Claims

The court gave the defendants until July to file an objection to the recently proposed medical expert testimony. If the new evidence is allowed, it may breathe new life into the Tylenol autism MDL that was dismissed in December. Until we know whether the court finds the expert testimony is sufficient to connect prenatal Tylenol use to child autism diagnoses, our team is not accepting any new autism Tylenol cases.

April 1, 2024 - Defendants Given July Deadline to Object to New Expert Testimony

When Judge Cote agreed to hear evidence from a new plaintiff's expert about whether the prenatal use of Tylenol (acetaminophen) can be scientifically linked to a diagnosis of autism in the exposed child, she also gave the defendant drug manufacturers until July to file any opposing motions. The Dolman Law Group mass tort team expects this important ruling by the end of the summer or the start of autumn. In the interim, we are only accepting child autism cases that can be tied to toxic baby food.

March 18, 2024 – New Medical Expert May Revive the Tylenol MDL

Judge Cote has agreed to consider the evidence proposed by the Mota plaintiffs' expert, Dr. Roberta Ness. To learn more about this complicated scientific and legal process, see our February 22nd update below. The defendant drug manufacturers now have until July to object to this new expert and her testimony. In the meantime, our team at Dolman Law Group is not accepting any new Tylenol Autism cases until we hear whether Dr. Ness will be allowed to help support the litigation.

However, our dedicated mass tort attorneys are still actively accepting cases involving parents with children who were diagnosed with autism after eating baby foods that contain unsafe levels of heavy metals. To answer your questions, we created a page about the connection between toxic baby food and autism.

February 22, 2024 - A Glimmer of Hope with the Mota Plaintiffs in Tylenol Autism Lawsuits

Remember December 2023? We do. Federal Judge Cota dismissed most lawsuits claiming Tylenol use during pregnancy caused autism due to her opinion that there was a lack of solid scientific evidence and concerns about data manipulation by the plaintiff's expert witnesses. All five of them.

However, something unexpected happened in the last few weeks. A group of families who filed their own case against Tylenol manufacturer Johnson & Johnson, known as the Mota plaintiffs, have been granted permission by Judge Cota to have their expert witness heard in a Daubert hearing after they successfully argued their case was not part of the MDL when the December decision was made. Their expert witness will be Dr. Roberta Ness.

Dr. Ness is a public health expert who has been on a mission for years to teach women and the public at large about research—29 studies to be exact—that suggests a connection between Tylenol use and neurodevelopmental disorders in children. Now, she's taking this knowledge to federal court.

The Mota plaintiffs' case is a small slice of hope for those seeking answers and accountability about whether their child's autism or ADHD was caused by taking Tylenol while they were pregnant.

If Dr. Ness's testimony is allowed and their case progresses, it could reignite the debate about Tylenol's safety during pregnancy. The Daubert hearing to decide if Dr. Ness's testimony will be considered valid enough to move forward is scheduled for February 23, 2024.

When Judge Cote dismissed the Tylenol autism federal MDL in December, many parents with children on the Autism Spectrum feared they had no legal right to receive compensation for their child's condition. The team at Dolman Law Group expects many state court actions against Tylenol and acetaminophen makers will be filed this Spring throughout the country. Lawyers on the MDL plaintiff steering committee will be spearheading these state lawsuits, and we'll be keeping a close eye on this turn of events and sharing timely updates.

Also, parents whose children ate certain brands of baby food and were later diagnosed with autism or other neurodevelopmental conditions may have a viable legal claim against some baby food manufacturers. Our team is also participating in the pending baby food autism lawsuits, so reach out for more information and to learn if you qualify to bring a claim.

January 11, 2024 - Options for Parents of Children Diagnosed With Autism or ASD After Federal MDL Dismissed

The crushing ruling by Judge Cote after the Daubert hearing in December probably means the end of the federal Tylenol Autism MDL. So what can parents of children who were diagnosed with autism after being exposed to acetaminophen during pregnancy do now? Although the plaintiffs' lawyers are considering an appeal, the dangerous drug team at Dolman Law Group is not optimistic about the chances of a successful appeal.

Instead, we are meeting with these parents to discuss the possibility of filing state claims against the manufacturers of Tylenol and acetaminophen products. If you would like to learn more about your legal right to bring a state claim, contact our legal team right away.

Also, if your child was diagnosed with autism after consuming certain brands of baby food, you may be eligible to join the toxic baby food autism lawsuit currently pending in federal court. Our product liability lawyers are involved in this litigation and can explain more during a free consultation. Reach out to learn more today.

January 3, 2024 - Johnson & Johnson Spin-Off Enjoys Fleeting Stock Market Bump After Tylenol Autism Multidistrict Litigation is Dismissed

Judge Cote’s decision to deem expert witness testimony inadmissible in federal court translated into a brief stock market success for Kenvue, which recently became independent from acetaminophen manufacturer Johnson & Johnson. The company’s shares rose about 4% before returning to where they were immediately prior to Judge Cote’s ruling on the Daubert hearings. The momentary spike in Kenvue’s stock reflects traders’ reaction to a single favorable ruling, rather than a sustained or growing confidence in Johnson & Johnson’s former Consumer Healthcare division. 

Kenvue issued a statement emphasizing the established medical benefits of Tylenol and accusing the Tylenol autism claims of unfairly casting doubt on the safety of their product. At this point, Kenvue has been the only party to provide an official comment on the dismissal of the Tylenol autism multidistrict litigation. The lack of comments from plaintiffs and defendants indicates both parties may believe that the issue is not completely settled. The path forward for plaintiffs is undoubtedly narrower than it was prior to the Daubert hearings, but they may yet have success in state courts.

December 19, 2023 - Judge Cote Dismisses Tylenol Autism Multidistrict Litigation

Plaintiffs in the Tylenol autism lawsuits have just experienced a major setback. Following the Daubert hearings, Judge Denise Cote ruled to dismiss the product liability claims against the makers of acetaminophen-based drugs. A successful appeal is highly unlikely, which means the Tylenol autism lawsuits are probably finished in federal court. Judge Cote's ruling and subsequent dismissal have undeniably damaged the credibility of the Tylenol autism claims, although plaintiffs may be able to file again at the state level.

This disappointing decision is the result of the Daubert hearings, where five expert witnesses for the plaintiffs explained how their scientific findings supported the existence of a causal relationship between prenatal exposure to acetaminophen and the development of autism or ADHD. Based on their testimony, Judge Cote remained unconvinced. In her ruling, she found fault with the expert witnesses' methodologies, as well as their tendency to emphasize results that supported their position while neglecting to acknowledge information that would weaken their conclusions.

She also noted that there was a lack of scientific consensus on the issue, as researchers are still evaluating the validity of a connection between exposure to acetaminophen in utero and certain neurodevelopmental disorders. Ultimately, Judge Cote found that expert witnesses' testimony did not meet the criteria for admissibility for scientific evidence in federal court, also known as the Daubert standard. Without evidence that autism and ADHD can be caused by prenatal exposure to acetaminophen, the plaintiffs' case falls apart, hence the dismissal.

December 17, 2023 - Judge to Rule on Admissibility of Scientific Evidence Presented On Behalf of Plaintiffs

The acetaminophen autism MDL held their Daubert hearing in United States District Court for the Southern District of New York on December 7th.  I personally attended this hearing presided over by Judge Denise Cote.  In the context of a mass tort, a Daubert hearing tests the admissibility of expert testimony, whether such experts possess the necessary level of expertise and their findings are based on reliable methodologies.  Several media reports indicated that the hearing went well for the defense and the plaintiffs may not have met their burden. 

However, I am reticent to say it went poorly for the plaintiffs.  Judge Cote appeared perplexed that the plaintiffs utilized the same methodologies to examine whether prenatal exposure to acetaminophen increases the risk of autism and ADHD.  Autism and ADHD are two distinct neurodevelopmental disorders and Judge Cote questioned Ashley Keller as to why the two disorders were combined in a single study. 

We believe it remains possible that Judge Cote may dismiss the ADHD claims and allow autism claims to get past Daubert.  However, her ultimate decision remains a guess by all interested parties.  At the conclusion of the Daubert hearing, Judge Cote affirmatively stated she expects to issue an order over the coming weeks. 

December 1, 2023 - Pending MDL Cases Total 441, Crucial Daubert Hearing Approaches

In the past month, 58 new Tylenol autism cases were filed in the pending MDL, bringing the total number of pending claims to 441. If the court denies the defendants' challenges to the medical and scientific evidence offered by the plaintiffs after the Daubert hearing scheduled for December 7th, we expect new case filings to jump dramatically.

November 14, 2023 - Daubert Hearing Set for December 7, Illinois Case Also Moving Along

In a surprise move, Judge Cote has scheduled the Daubert hearing for December 7, 2023. This hearing is exclusively focused on whether the plaintiffs have sufficient expert evidence to support their claim that the use of Tylenol (or generic acetaminophen) during pregnancy can be linked to subsequent diagnoses of autism, ADHD, or other neurodevelopmental conditions in the child who was exposed in-utero.

The surprise is that the judge will NOT hear any testimony from the plaintiffs' expert witnesses during the hearing. Instead, the parties will present arguments in support of their positions. Attorneys for the injured plaintiffs are optimistic that this means the judge will deny the defendants' requests to strike the expert evidence, and the cases will proceed in federal court. We don't expect to receive the judge's ruling until January 2024 at the earliest.

In the meantime, other Tylenol autism lawsuits have been filed in various state courts, including one in Illinois, which is proceeding, although more slowly than the federal MDL. That lawsuit is still in the motion pleading and arguing stage, and we don't expect any substantial decisions until sometime in 2024 at the earliest. We are monitoring all of these cases and hoping for some good news soon.

November 3, 2023 - Daubert Briefing Completed, Expert Evidence Hearing Expected in December

Both plaintiffs and defendants have finally completed three rounds of motions and briefs regarding the admissibility of expert testimony about the potential link between Tylenol use and autism diagnoses. The MDL judge now has several thousand pages to review before deciding how the actual Daubert hearing will proceed. This hearing is crucial for both sides since it will determine whether and which experts will be allowed to testify in support of a causal link between acetaminophen use and subsequent autism or ADHD diagnoses. The Daubert hearing is scheduled for December.

October 16, 2023 - Another Study Supports Plaintiffs' Causation Theories, Use in the Upcoming Daubert Hearing Already Contested

Another new study provides more support for the causal link between prenatal acetaminophen use and impaired neurodevelopment in children exposed to Tylenol and other similar products. The scientists exposed special test cells in a laboratory to acetaminophen in similar amounts that a woman may use during pregnancy. The findings matched the results seen in umbilical cord samples of babies who were exposed to Tylenol before birth in support of the conclusion that Tylenol use can lead to neurodevelopmental issues such as autism and ADHD.

Of course, plaintiffs want to use this latest study to support their medical experts' testimony. The defendants objected, claiming the information was untimely. Obviously, the defendants are worried about the latest study and/or determined to object to all evidence offered by the plaintiffs.

With the Daubert hearing quickly approaching, both sides submitted proposals detailing how the hearing should proceed. Defendants suggested a week-long, comprehensive hearing so they can contest all of the plaintiffs' proposed expert testimony. Plaintiffs, on the other hand, want the judge to narrow the scope of the hearings by identifying which witnesses must present evidence at this stage to meet the plaintiffs' burden of proof.

October 3, 2023 - New Plaintiff Fact Sheets Submitted, Plaintiffs' Experts Disclosed

The parties have submitted revised Plaintiff Fact Sheets to the case administration system. All plaintiffs must complete these forms to ensure similar data is submitted by every participant in the Tylenol Autism Lawsuit MDL. Plaintiffs entering the litigation must also complete and sign health record authorization forms to help gather important medical information.

Also, near the end of last month, the plaintiffs disclosed the five main expert witnesses who will be called upon to support the link between Tylenol/acetaminophen use during pregnancy and conditions such as autism and ADHD. Those expert witnesses are:

As of mid-September, the MDL contained 265 cases. This number is misleading because thousands of potential claimants are waiting on the sidelines to see what happens before joining the litigation.

September 8, 2023 - FDA Refuses to Submit a Position on Adequate Labeling

Earlier this year, the judge in charge of the pending Tylenol Autism MDL asked the Food and Drug Administration (FDA) to submit an official statement about whether Tylenol and all acetaminophen products, should bear a warning about potential autism dangers for the children of pregnant women who use these drugs. Recently, the FDA requested more time to submit its statement, but now it appears it will not be involved in this matter.

We have learned the FDA will not offer its opinion about warning labels and provide no guidance for the judge and the MDL in general. This is an important victory for the plaintiffs as they move forward with providing expert testimony and evidence in support of their claims later this month.

September 1, 2023 - Scientific Causation Depositions Continue, Plaintiffs are Optimistic

Expert witness depositions related to the question of whether Tylenol causes autism or other neurodevelopmental conditions are ongoing. This evidence will be crucial this month as the court accepts the parties' initial Daubert motions related to scientific causation issues. In general, the plaintiffs' attorneys are optimistic that the court will admit the strong scientific evidence in the MDL and the pending cases will move forward. If the court rejects the proof, state court proceedings are still a viable alternative.

If the court rules in favor of the plaintiffs, we doubt Johnson & Johnson and the other named defendants will want to risk going to trial because potential jury verdicts could reach the millions. We are watching the Daubert proceedings very closely and our team is ready to react regardless of the outcome.

August 15, 2023 - The FDA Will Submit an Opinion About Tylenol Warning Labels, Expert Testimony Motions at the Forefront, and Some Claims Dismissed

In a surprise move, the government requested more time to file the FDA's opinion about the plaintiffs' proposed warning labels for Tylenol packaging. The government must now file a statement of interest on September 15, 2023, just four days before both sides must submit their initial Daubert motions regarding expert testimony and evidence. Both sides must also file letters to the judge, recommending how she should handle defendants' motions to exclude expert reports and which motions should be combined because of similar subject matters.

Judge Cote's decision about the Daubert expert issues with either make or break this MDL. If she allows the plaintiffs' experts' testimony and reports, the MDL will move forward. If she rejects the evidence, state court matters can still proceed, but federal plaintiffs' cases will be affected.

Lastly, both sides have agreed that certain legal claims for negligent misrepresentation are not allowed in some states and therefore, those claims should be dismissed. Fifteen states are involved, but the dismissal of these claims will have little effect on the pending MDL.

August 4, 2023 - J&J's Motion for Interlocutory Appeal Denied

When Johnson & Johnson's motion to dismiss based on federal law preemption was denied, it filed for certification of an interlocutory (immediate) appeal which would have delayed the MDL for at least a year. That motion was denied because the company did not show the necessary factors that would allow an immediate appeal. This is another big win for the plaintiffs in this MDL.

August 1, 2023 - More Retailer Defendants Named in Tylenol Autism MDL Cases

Among the record number of new cases filed in June, more retailers are being named as defendants. In recent filings, Family Dollar, Dollar Tree, and 7-Eleven are now included as defendants in the MDL as injured plaintiffs hope to recover compensation from those responsible for selling acetaminophen without proper warnings.

July 18, 2023 - Record Number of New Tylenol Autism Lawsuits Filed in the Past 30 Days

In the past month, 64 new Tylenol autism lawsuits joined the multi-district litigation located in the Southern District of New York. This reflects the largest number of new cases in any 30-day period since the beginning of the MDL and brings the total number of cases filed to 200.

However, this small number of cases does not reflect the true impact of acetaminophen use during pregnancy and how many children were later diagnosed with autism or ADHD. We believe thousands of cases are ready to be filed, but plaintiffs' counsel are waiting to see how the court rules on certain scientific evidentiary issues before officially joining the MDL.

July 10, 2023 - MDL Judge Advances Litigation, Focus on Expert Testimony Intensifies

Judge Cote has issued Orders to Show Cause in a few cases where the plaintiffs have not met discovery deadlines in order to keep all Tylenol autism lawsuits on track. Also, expert testimony deadlines have been established. Defendants must disclose their scientific experts by July 21st, and the plaintiffs' rebuttal reports are due by July 28th. The defendants must make their experts available for depositions between August 25 and September 12, 2023.

At this point, there are still fewer than 150 cases filed in the MDL. While thousands of injured plaintiffs have retained lawyers, they are waiting on the sidelines to see what happens with the scientific evidence and to preserve the right to bring a state court lawsuit. If the federal judge accepts and admits the expert testimony linking acetaminophen use to autism, we expect thousands of lawsuits to flood into the MDL. If the expert testimony is rejected, the federal cases will likely be dismissed and won't be eligible for filing as state court actions.

July 5, 2023 - What We Expect to Happen in the Tylenol Autism Litigation During the Second Half of 2023

The current focus of the MDL is the expert testimony addressing whether there is a valid scientific link between acetaminophen exposure and autism. The plaintiffs have presented expert reports, the defendants will submit their experts' counter-positions, and the plaintiffs may provide rebuttal expert opinion to help Judge Cote decide. We expect a hearing on this key issue before year's end. If the judge finds a sufficient link, the federal cases will keep moving forward. If not, state court litigation will expand.

Some state court cases are already in the works. For example, a mother recently filed a Tylenol autism lawsuit against Walgreen, Co. on behalf of her daughter in Illinois State Court. Because the plaintiff is an Illinois resident and Walgreens is headquartered in Illinois, there is no diversity jurisdiction and federal court is not an option.

June 5, 2023 - Johnson & Johnson Trying to Delay Case, Plaintiffs Fighting Back

J&J is trying to stall the ongoing multi-district litigation with two legal maneuvers. First, the huge corporation requested an immediate appeal when its motion to dismiss was denied. If an interlocutory appeal is granted (which we believe is highly unlikely), the pending litigation could face a year-long delay.

Also, J&J has issued deposition subpoenas against nine scientists who have linked Tylenol use with autism. The plaintiffs' counsel have opposed both moves and argued this is not how the litigation process should work. Instead, the scientific evidence will be decided at a Daubert hearing in the next few months, and immediate appeals should only be allowed in rare situations. We expect Judge Cote to rule on both issues fairly soon.

May 22, 2023 - Texas Cases at Risk, California Case Still Pending

When deciding the two motions to dismiss filed by the retailers who sold Tylenol and acetaminophen products to pregnant women without warning labels, the MDL judge reached different conclusions based on state laws. A Texas case brought against CVS and other retailers was dismissed under Texas' "safe harbor" law that protects retailers of over-the-counter drugs from lawsuits claiming they failed to warn users. Under Tex. Civ. Prac. & Rem. Code Ann. § 82.007(a), if product labels meet the FDA-approved label standards (monographs), retailers cannot be held liable.

However, a similar motion to dismiss was filed in a California case, but the judge denied that motion even though California also has a safe harbor law. At this point, Texas Tylenol autism lawsuits are at risk of being dismissed, while California cases remain viable. We are still reviewing cases from all states as the MDL unfolds.

May 17, 2023 - Walmart and Target Remain as Defendants. Thousands of Potential Plaintiffs are Watching

Both Target and Walmart have attempted to avoid liability for the Multidistrict Lawsuit (MDL) that claims they should have placed warnings on their acetaminophen products advising pregnant women that using the product could lead to their child being diagnosed with autism. Like her ruling against J&J (see below), Judge Cote denied their motions to dismiss and held the FDA does not preempt the retailers' responsibility to warn about dangerous products. However, one case filed against CVS Pharmacy, Inc. resulted in a different outcome because it fell under Texas law.

Although the MDL has been pending for months, we haven't seen a large number of new lawsuits as previously expected. We suspect thousands of potential plaintiffs are watching and waiting to see how the court rules on the Daubert challenges which will set the standard for expert testimony connecting Tylenol use during pregnancy to autism diagnoses. If Judge Cote decides the scientific evidence is not strong enough, the waiting plaintiffs can file their cases in state courts rather than the MDL. If the science is admitted by the court, we expect a rush of new case filings in this MDL.

May 9, 2023 - J&J Requests Interlocutory Appeal

Last month, MDL Judge Cote denied Johnson & Johnson's motion to dismiss based on the argument it could not unilaterally change medicine warning labels because they are controlled by the FDA. In light of the judge's denial, J&J has requested an interlocutory appeal that asks for an appellate court ruling about the denied motion. Usually, cases are appealed after a final decision is rendered. However, J&J is asking for an appellate decision while the case is still pending. If this request is granted, the pending litigation will be delayed until the higher court issues a ruling.

Since Judge Cote has been diligent about moving this case along fairly quickly, we believe she will deny J&J's appeal request and keep the MDL on track. However, she has requested a complete briefing on the matter, so we'll keep you informed as more information is released.

May 1, 2023 - Judge Asks for FDA Opinion

In an unusual move, Judge Cote sent two questions to the Food and Drug Administration:

  1. Whether acetaminophen products should carry the proposed warning suggested by the plaintiffs' counsel?
  2. Whether the current scientific studies warrant adding a label to warn about acetaminophen use while pregnant and the risk of ASD or ADHD?

Considering the outcome of one of the biggest mass torts in history may hinge on these questions, we will be surprised if the FDA answers. On one hand, if the FDA answers, there is a chance that they may say that they would never have approved any labeling warning of ASD or ADHD, which would negatively affect the plaintiff's claims. However, it is significantly more likely that they will simply refrain from responding, which will serve to benefit the plaintiffs in this litigation.

The FDA's reluctance to weigh in on this has been discussed in the litigation before when plaintiffs opposed Johnson & Johnson’s motion to dismiss the lawsuit. Basically, the FDA was concerned that a warning would generate panic among consumers since there would be no safe over-the-counter pain relievers available for use by women during pregnancy.

Time will tell how the FDA chooses to respond, if at all, which is why we are paying careful attention to any developments.

April 2023 – Another Big Month for Plaintiffs as Defendants' Motions to Dismiss are Denied, and New Autism Study Reports Soaring Incidence of Autism

Expert Witness Disclosures are in the Spotlight

To be successful in a complicated product liability lawsuit such as this, it's necessary to have expert witnesses connect the dots. Beyond showing the use of acetaminophen during pregnancy and the later diagnosis of neurodevelopmental conditions, the plaintiffs will have to prove the connection, or causal link, between the two.

The MDL was created to consolidate discovery which is the gathering of evidence before a trial. The plaintiffs have disclosed six areas where experts will be needed to prove a causal link. The defense raised another potential area—maternal-fetal medicine. Rather than naming an expert on this topic, the plaintiffs want the defense to go first. The court ordered the plaintiffs to disclose if they will have a maternal-fetal medicine expert by April 4 to preserve their right to name a rebuttal witness after the defense discloses their expert.

Shocking Autism Study Released

The Centers for Disease Control and Prevention released an Autism Spectrum Disorder (ASD) report that studied the prevalence of ASD in eight-year-old children in 2020. The study revealed that 1 in 36 children born in America is diagnosed with ASD by age eight.

This report does not address Tylenol use during pregnancy, but it does show an overall increase in the number of children diagnosed with ASD by age eight. Studies like this may become an important factor in the ongoing Tylenol Autism lawsuit.

Proposed Warning Label Suggested

The Tylenol Autism Multidistrict Litigation judge requested proposed warning language that could be placed on bottles of acetaminophen. The plaintiffs' attorneys suggested 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."

It will be interesting to see the final version of a warning related to Autism and ASD.

Johnson & Johnson’s Motion to Dismiss is Denied

As we previously predicted, Judge Cote denied Johnson & Johnson’s motion to dismiss based on preemption.  Johnson & Johnson argued they should be immune from any state law failure to warn claim based on the doctrine of preemption.  Essentially, they alleged they could not change a warning for the medication without prior approval from the FDA.  

In her Order, Judge Cote states there is no federal law that prohibits Johnson & Johnson from adding a warning about risks associated with taking Tylenol while pregnant. This was a very similar ruling to her ruling against Walmart in mid-November.  However, Johnson & Johnson’s motion was simply much better written.

Retailers, including Costco, CVS, Koger, Sam’s West, and Rite Aid, filed a similar motion to dismiss based on the same argument and asked to be removed from the Tylenol Autism MDL. The court order addressing these defendants is essentially the same as the previous day's order when she denied Johnson & Johnson’s motion.  Judge Cote denied the retailers’ motion to dismiss but also stated that all further motions to dismiss should be against a particular complaint and not the master complaint.  

March 2023 - J&J's Motion is Still Pending, and a Plaintiff Fact Sheet is Necessary to Remain in the MDL

In March, Judge Cote adopted a uniform Plaintiff Fact Sheet (PFS) that every new and current plaintiff must complete. This 35-page long document requests more information than most mass tort lawsuit fact sheets. As expected, plaintiffs must disclose the products used during pregnancy and when they were used, but the form also requires the genetic and medical history of the parents and affected child, probably to identify plaintiffs with genetic risk factors that could cause autism or ADHD.

Also, the Motion to Dismiss filed by Johnson & Johnson in February should be fully briefed by both sides and ready for Judge Cote to issue her decision. We expect the judge will deny the motion, and we will report the Judge's ruling once it is issued.

In early March, counsel for plaintiffs filed a memorandum in opposition to Johnson & Johnson's motion to dismiss.  This is essentially very similar to Walmart's motion to dismiss that argued for preemption, which was soundly rejected by Judge Denise Cote back in November. The plaintiffs' memorandum is interesting for several reasons. 

Johnson & Johnson's Internal Documents Contradict Their Public Stance on Tylenol Autism Link

The plaintiffs are in possession of an internal Johnson & Johnson document from 2014 that directly contradicts their public stance that repeatedly stated they are "unaware of conclusive evidence to support a causal link between use of acetaminophen during pregnancy and the risk of adverse fetal outcomes."  

Internal documents recently uncovered say quite the opposite.  Following a 2014 study (published in JAMA Psychiatry) that found children born to mothers who used acetaminophen during pregnancy had a much higher risk for developmental disorders, a Johnson & Johnson scientist complimented the strength of this study's design and "the strength and robustness of the association" (acetaminophen to autism).  Further, this same scientist complimented the study's ability to control for confounding factors that could also cause developmental disorders, which lends support to the findings.

A second document uncovered during early discovery is even more troubling.  A Johnson & Johnson scientist states that another study has been processed "implicating a causal relationship between acetaminophen use and ADHD-like symptoms behaviors."  While Johnson & Johnson's lawyers take the public stance that correlation does not equate to causation, their own internal documents and scientists tell a completely different story.  

Johnson & Johnson Mislead Court About FDA's Stance on Tylenol Autism Link

Plaintiff's memorandum goes on to dissect Johnson & Johnson's assertion the FDA  has rejected the link between acetaminophen use during pregnancy and developmental disorders.  In fact, the FDA has acknowledged a consistent association between prenatal acetaminophen exposure and developmental disorders and noted a dose-dependent relationship (which likely indicates causation).  Plaintiffs contend the FDA's failure to act as of date has everything to do with the lack of a pain or fever reducer available to pregnant women and their fear that such women will be deterred from taking acetaminophen when the benefit (reducing maternal fever) would exceed potential risks (developmental disorder).  

In 2016, the FDA's own internal epidemiologists urged the FDA to alert pregnant women that the data displays a potential risk of neurodevelopmental harm to the fetus.  In fact, these epidemiologists requested the FDA share this information with healthcare providers and pregnant women to counter the perception that the use of acetaminophen was risk-free.

We look forward to more internal Johnson and Johnson documents being uncovered as discovery progresses.  It is worth noting the documents discovered during this early stage of discovery already discredit and contradict their public stance.  Further, we anticipate the plaintiffs will prevail by year's end in the Daubert hearings to determine the validity of scientific evidence illustrating a link between in-utero acetaminophen exposure to autism and ADHD. 

When the Tylenol Autism MDL was created in September 2022, 80 cases were consolidated across the nation. As of the beginning of March, 107 cases were included in the litigation.

February 2023 - Procedurally, the Tylenol Autism MDL is Moving Forward

Coordinating the MDL with State Acetaminophen Autism Cases

In late January, Judge Denise Cote entered an order to coordinate the federal Tylenol autism lawsuit MDL with state court acetaminophen autism lawsuits. For judicial efficiency and to avoid redundancy or an unfair burden on third parties, Judge Cote is requiring parties in the MDL to take the lead on discovery matters. 

More than 150,000 individuals are expected to file a Tylenol autism lawsuit over the next two years. Only state courts and parties who have agreed to this coordination order will receive discovery from the Tylenol autism MDL. All plaintiffs' lawyers in state court cases must sign a protective order and agree to coordinated discovery within the Tylenol multidistrict litigation. 

We anticipate at least two hundred more Tylenol autism lawsuits will be added to the MDL by April. The Tylenol class action lawsuit is one of the fastest-growing mass torts in the U.S. Advertising continues to expand for Tylenol autism cases as momentum for this lawsuit continues to grow. 

Johnson & Johnson Files a Motion to Dismiss With a Familiar Theme

Johnson & Johnson filed a motion to dismiss all plaintiff claims, stating they are preempted under federal law. Johnson & Johnson argues it should be immune to any state law failure-to-warn claims because it cannot independently change a drug's warning label without approval from the FDA.

Judge Cote previously rejected Walmart's motion to dismiss based on a similar argument. Johnson & Johnson tried to distinguish its argument from Walmart's by stating Judge Cote arrived at the wrong decision because she didn’t have all the relevant issues at the time.

Johnson & Johnson also asked the Court to dismiss the master complaint filed on behalf of all plaintiffs. They argue the master complaint did not contain sufficient plausibility because the scientific studies that form the basis of the plaintiff's claims fail to show a causal link between the use of acetaminophen and neurodevelopmental disorders such as autism spectrum disorder. Johnson & Johnson requested oral arguments concerning its motion to dismiss.

We expect Judge Cote will deny Johnson and Johnson's Motion to Dismiss because it appears to be more of the same argument, and she has already decided that preemption did not apply to this lawsuit.  We also expect similar motions and results involving other acetaminophen manufacturers in the Tylenol MDL. 

While ethical concerns prevent researchers from going much further in researching pregnant women, animal studies consistently demonstrate a delay in fetal brain development with acetaminophen exposure in-utero. After reviewing all 26 epidemiological studies along with the animal studies, we believe plaintiffs will easily establish the causation evidence needed to succeed on the merits of this lawsuit. 

January 2023 - Setting Schedules for the Tylenol Autism Lawsuits

Short-Form Complaints Make it Easier to Join the Tylenol Autism MDL

In many situations, a Master Complaint is filed on behalf of all plaintiffs involved in a large-scale lawsuit to provide broad coverage of the general claims that relate to all plaintiffs. On January 9th, 2023, the presiding judge in the Tylenol autism multidistrict litigation (MDL) approved Short-Form Complaint forms for families filing Tylenol autism lawsuits. 

Short-form complaints provide a uniform claim format for new plaintiffs to 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. 

Plaintiffs with pending MDL cases were required to file a Short-Form Complaint by January 20, 2023. Future plaintiffs wanting to file a Tylenol autism case must 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. Joining the Tylenol autism MDL just became easier. 

Discovery Begins With a Focus on Causation

Judge Cote also ordered a discovery plan initially focusing solely on causation and whether prenatal acetaminophen exposure causes autism spectrum disorder (ASD) or attention deficit hyperactivity disorder (ADHD). Discovery will require responses to questions concerning the link between in-utero exposure to acetaminophen and ASD or ADHD, along with exchanging certain documents. 

Johnson & Johnson was given one week to designate five records custodians and specify how each individual custodian is relevant to the overall causation issue of whether taking acetaminophen while pregnant increases the risk of autism spectrum disorder or ADHD.

Judge Cote also gave the parties a deadline to propose a phase one discovery schedule and until April 7, 2023, to submit a proposed label change on all products that include acetaminophen as an active ingredient.

December 2022 – Walmart Tries to Leave the Acetaminophen Autism MDL Again, but Litigation Moves Onward

Walmart (one of the many defendants in the acetaminophen autism MDL) filed a motion for the Judge to reconsider her November 14th order denying its preemption defense Motion to Dismiss, which would have removed Walmart from the MDL.  

Walmart had claimed that federal law preempted the plaintiff’s arguments that Walmart failed to warn them against using acetaminophen while pregnant. Now, Walmart is asking Judge Cote for the right to raise the argument in the United States Court of Appeals for the Second Circuit (interlocutory appeal) or to reconsider her denial of the Motion to Dismiss.

The plaintiffs were given time to file any opposition to Walmart’s requests. The judge’s ruling is crucial to the future of the Tylenol pregnancy lawsuit. If the Second Circuit Appellate Court were to determine that federal law preempts plaintiffs’ claims, “such a decision would likely dispose of all claims inside the MDL (Walmart’s motion).” In other words, this could literally end the Tylenol autism lawsuit before it gets off the ground.

It was highly unlikely Judge Cote would grant Walmart’s motion for reconsideration because there has been no change in the controlling law. Further, we did not believe Judge Cote would certify an interlocutory appeal at this stage. (Spoiler Alert: Judge Cote denied both of Walmart’s requests as we expected)

The Second Circuit might entertain this appeal two to three years down the road, assuming plaintiffs succeed at the expected Daubert hearings. These procedures are conducted by the trial Judge to determine whether an expert’s testimony and current science are admissible. We also expect various motions for summary judgment and likely multiple bellwether trials to set the stage for all remaining cases.

Next Procedural Steps in the Tylenol Autism MDL Lawsuits

All counsel were required to file a proposed short-form complaint that will allow new plaintiffs a streamlined method to file new Tylenol autism lawsuits in this MDL. The court also requested a joint discovery plan from both sides. However, the plaintiffs and defense counsel could not agree on a joint discovery plan.  The defendant’s discovery plan was temporarily accepted, but the judge requested both parties to work together to create a joint plan before January 4, 2023.

Judge Cote also set quick deadlines for plaintiffs to file two proposed master complaints–one against the manufacturers of generic acetaminophen and Tylenol and the other against the retailers. Master short-form complaints are common in mass torts and allow new cases into the MDL by using the specific allegations in an abbreviated complaint. This will allow a large number of Tylenol lawsuits to enter the MDL in the coming months, and all plaintiffs with a pending complaint in the MDL must submit a short-form complaint by January 20, 2023.

November 2022 – A Big Month In Favor of Injured Plaintiffs in the Tylenol Autism Lawsuit MDL  

Walmart Filed a Motion to Dismiss in an Attempt to Leave the Tylenol Autism MDL 

Walmart's Motion to Dismiss the cases filed against it was based on the legal theory of federal preemption. Walmart argued that it could not be responsible for failing to warn consumers about acetaminophen because the warning labels were regulated by the FDA, and Walmart could not unilaterally change the labels in any way to include warnings. The plaintiffs’ lawyers disagreed.

Judge Cote Denied Walmart’s Preemption Defense

Walmart’s motion to dismiss was denied, and the judge flatly rejected its preemption argument. In the U.S. Supreme Court case of Merck v. Albrecht, the Supreme Court ruled that preemption is ultimately a question of law and must be decided by a judge, not a jury. The Merck court ruled that a defendant can prevail only if they prove they provided full justification to the FDA of a need for a label change, and the FDA informed the defendant they would not approve the labeling change.

Judge Cote’s decision will now impact all acetaminophen autism lawsuits pending in the Southern District of New York. In her order, Judge Cote analyzed two cases related to the defendant’s motion to dismiss; Hatfield et al. v. Wal-Mart Stores, Inc., 22cv9011, and Roberts et al. v. Wal-Mart Stores, Inc., 22cv9012.

In both cases, pregnant women took Walmart’s Equate brand over-the-counter equivalent acetaminophen, which is only sold at Walmart. Both mothers now allege their children have been diagnosed with autism and ADHD due to acetaminophen use during pregnancy. The mothers also claim that Walmart violated State law by failing to warn of the elevated dangers associated with prenatal acetaminophen exposure.

In her ruling, Judge Cote stated that “a manufacturer is responsible for the adequacy of the warnings on its drug label. The regulation of acetaminophen generally and the Pregnancy Warning regulation, in particular, do not alter that responsibility.” 

This was a huge victory for all plaintiffs and the overall acetaminophen or Tylenol autism lawsuit. Acetaminophen autism ADHD lawsuits are no longer subject to a preemption defense by any manufacturer or retailer of generic acetaminophen products.

Judge Names Leadership Team in the Tylenol Autism MDL

Next, the initial status conference in the Tylenol Autism lawsuit occurred on November 19th. Judge Cote appointed leadership in this emerging multidistrict litigation involving lawsuits alleging acetaminophen use during pregnancy causes autism or attention deficit hyperactivity disorder in children.

Attorneys Mark Lanier of The Lanier Law Firm, Mikel Watts of Watts Guerra, and Ashley Keller of Keller Postman will serve as lead plaintiffs’ counsel and are also members of the plaintiff’s executive committee along with five other lawyers; Zoe Littlepage of Littlepage Booth, Eric Holland, Holland Law Firm, Roger Smith, Beasley Allen, Sean Tracey, Tracey Fox King & Walters, and Ashley Barriere, Keller Postman. Judge Cote also listed ten members of the Tylenol autism class action lawsuit plaintiff’s steering committee.

Media Draws Attention to the Tylenol Autism MDL and the Dangers of Acetaminophen Use By Pregnant Women

Significant media attention continues to increase related to the Tylenol autism ADHD lawsuit as well as the dangers related to the consumption of acetaminophen during pregnancy. USA Today published an article discussing the increased risk posed by Tylenol use during pregnancy which was widely shared on social media.

The USA Today article quoted Roberta Ness, an epidemiologist (former Dean of the University of Texas School for Public Health) who served as an expert witness in the talc powder causing ovarian cancer lawsuits. Ness believes acetaminophen is a cause of both autism and ADHD, which she noted is “very big for an epidemiologist to say.” Further, she believes 1 in 7 children who developed autism may have avoided such diagnoses if the mother had avoided using acetaminophen during pregnancy, leading to the baby’s in-utero exposure to acetaminophen. In this article, Ness estimated that 20% of children diagnosed with either autism or ADHD have in-utero exposure to high levels of acetaminophen. 

“Johnson & Johnson Tylenol Lawsuit”

Lastly, four separate lawsuits have been added to the MDL naming Johnson & Johnson as a defendant. The vast majority of pending lawsuits were filed against acetaminophen retailers and not manufacturers. The floodgate of lawsuits against Johnson & Johnson (parent company of the manufacturer of Tylenol) and the manufacturers of generic acetaminophen products began. These lawsuits claimed that Johnson & Johnson failed to warn of the potential dangers of using acetaminophen during pregnancy.

At this point, commercials began referring to this litigation as “The Johnson & Johnson Tylenol Lawsuit.” This is very similar to the marketing behind the talc powder ovarian cancer mass tort lawsuits. 

At the end of November, counsel for the plaintiffs and defendants sent an agreed-upon list of potential special masters to serve as a mediator in any settlement discussions in these Tylenol autism cases.

October 2022 – The First Acetaminophen or Tylenol Autism Lawsuits Were Consolidated

Approximately 90 acetaminophen autism lawsuits were transferred and consolidated before the Honorable Judge Denise L. Cote (transfer order from JPML on acetaminophen autism lawsuits) in the Southern District of New York.

We expected hundreds, if not thousands, of Tylenol Autism lawsuits would be filed over the next several months alleging Tylenol/acetaminophen exposure in pregnant women greatly increased autism spectrum diagnosis in their children. 

Vying for Leadership

In MDL situations, the court appoints specific attorneys to act as lead counsel on behalf of the parties. Applications for leadership positions were open until November 14, 2022, and objections to such applications were required by November 16, 2022. The first status hearing was scheduled for November 17, 2022. 

MDL Judge Denise Cote issued an order on October 24, 2022, requesting that plaintiffs’ counsel file a joint letter by November 3, 2022, spelling out a proposed structure for all leadership positions on the acetaminophen autism MDL, including both lead and liaison counsel as well as all members of plaintiffs’ steering committee. 

The success of the Tylenol lawsuit hinges on establishing causation based on strict scientific criteria that plaintiff lawyers must meet. The Court must agree that the most recent scientific studies show a dose-dependent link between prenatal acetaminophen exposure and the incidence of autism spectrum disorder diagnosis, including its severity. The strength of each individual Tylenol lawsuit will depend on the amount of acetaminophen used and the severity of the child’s diagnosis of autism or ADHD.

With hundreds of Tylenol autism lawsuits being filed around the country, the courts and attorneys involved realized the potential for conflicting results and sluggish trial schedules. The need for a consolidated court process became apparent, and plaintiffs’ attorneys filed a motion to gather all federal cases in one place.

On September 29, 2022, the Joint Panel on Multidistrict Litigation (JPML) heard and granted the plaintiff’s motion to consolidate all acetaminophen lawsuits that had been filed in Federal Court into a single MDL (multidistrict litigation). The purpose of an MDL is to consolidate all cases with a single Judge to promote consistency in discovery, streamline all litigation, and increase the odds of a global settlement.

Tylenol Pregnancy Lawsuit is Based on a Failure to Warn

At no point have the manufacturers of Tylenol or the generic form of medication offered a disclaimer to pregnant mothers of existing indications (medical literature and clinical studies) that acetaminophen exposure in utero creates a higher risk of your unborn child developing autism spectrum disorder. Tylenol lawsuits allege that manufacturers and retailers knew of the growing scientific research and failed to provide any warning whatsoever. A number of published studies now indicate Tylenol use during pregnancy is causally related to ADHD diagnosis, autism spectrum disorders, and other health risks.

Tylenol and manufacturers of generic acetaminophen are now being accused of promoting their products as safe pain-relief alternatives during pregnancy when in fact, they may be responsible for causing neurological damage to babies in utero. Health professionals warn of the potential link between Tylenol and autism. The health issues or conditions that may be correlated with significant or prolonged prenatal acetaminophen exposure or Tylenol usage during pregnancy include:

  • Autism spectrum disorder (ASD)
  • ADHD (Attention Deficit Hyperactivity Disorder)
  • Neurodevelopmental problems later in life
  • IQ level deficits
  • Behavioral issues
  • Sleep problems
  • Early puberty in girls
  • Male fertility problems
  • Undescended testicles

Health Issues Associated With Tylenol Usage Can Have a Significant Cost

Tylenol Autism ADHD Lawsuit Settlement Amounts

While these conditions are not life-threatening, some of these issues can significantly impact a person's quality of life and ability to learn, develop social skills, and work. Parents may endure extreme stress while caring for their children impacted by these issues. Additionally, there is often an economic cost for parents of children with these health concerns, especially neurological disorders.

For example, a child with ASD may require therapy, medication, and additional tutoring. In some cases, they may require life-long personal care. Parents may be forced to miss work to take their children for treatment, forfeit job opportunities to care for their children, or substantially reduce their standard of living to afford treatment.

Costs like these may be eligible for compensation in the Tylenol class action lawsuit if we can establish that acetaminophen exposure during pregnancy resulted in a diagnosis of autism or attention deficit hyperactivity disorder (ADHD).

Since Tylenol Use is Linked to Autism – Do You Have a Tylenol Autism Claim?

If you believe that you or your child have been exposed to significant amounts of Tylenol or generic acetaminophen in utero and your child has been diagnosed with Autism Spectrum Disorder or ADHD, you may have a product liability claim against the manufacturers of generic acetaminophen (Mallinckrodt) or Tylenol (McNeil Consumer Products Co., a wholly-owned subsidiary of Johnson & Johnson). At Dolman Law Group, we are also investigating claims and potential Tylenol and/or acetaminophen lawsuits against retailers such as CVS, Walgreens, Costco, and Walmart.

These claims are often resolved through out-of-court settlements, but these settlements can vary depending on many factors. The amount of fetal exposure to acetaminophen coupled with your child’s clinical presentation and diagnosis will play a large role in determining the potential value of your claim. 

If you aren't sure whether you are eligible to bring a Tylenol-Autism Claim, how much your settlement could be worth, or if you have any other questions about this important legal action, please reach out today by calling 866-271-9007.

Why Choose Dolman Law Group to Be Your Tylenol Autism Claim Lawyer?

The Dolman Law Group is a nationally recognized law firm that has recovered hundreds of millions of dollars in compensation for injury victims in serious personal injury, mass tort claims, catastrophic injury, and product liability lawsuits. 

Our team has over 130 years of combined personal injury legal experience. Our national product liability lawyers have the financial resources to challenge any sized corporate defendant. We have also played a major role in mesothelioma, Uber sexual assault, and Camp Lejeune mass tort claims and protected hundreds of people injured by careless and negligent companies. 

Our law firm has the financial resources to accept a claim of this magnitude and the experience to handle it effectively. We have been investigating claims and reviewing Tylenol autism lawsuits since the beginning to gear up for this project. In fact, we are among the first law firms to begin investigating claims linking acetaminophen exposure of pregnant women to a child who was subsequently diagnosed with Autism Spectrum Disorder or ADHD. We currently represent plaintiffs in over two hundred acetaminophen autism cases.

Dolman Law Group Has the Resources to Handle Your Tylenol Autism Claim and Fight For the Maximum Payout

Acetaminophen and Autism

The Tylenol autism lawyers at Dolman Law Group do not back down from a challenge. You can depend on us to leverage expert witness testimony, collect medical evidence to support your claim and negotiate strategically to maximize your compensation. We have recovered millions of dollars in damages for clients who were injured by another party's negligence, and we are prepared to do the same for you. We are constantly staying on top of the medical and legal issues concerning Tylenol use during pregnancy.

As testimonials from former clients will attest, our team goes above and beyond to protect your right to compensation. This includes keeping in close contact with you, thoroughly explaining the implications of your options, and answering any questions you may have. If you have reason to believe that your child's autism or ADHD diagnosis is linked to Tylenol usage, call us today for a free consultation.

We handle each Tylenol lawsuit on a contingency basis and only get paid if we obtain a financial recovery on your behalf. Dolman Law Group offers a free case review for any family whose child received an autism diagnosis relating to acetaminophen use during pregnancy. If you want more information about a potential Tylenol autism lawsuit, feel free to email me directly at: matt@dolmanlaw.com

For a free legal consultation anytime, call 866-271-9007.

Tylenol Autism Settlement Amounts: How Much Can I Recover in a Tylenol and Autism Claim?

While it is too early to determine the full settlement value of a Tylenol acetaminophen autism lawsuit, we can certainly speculate and estimate based on prior mass tort projects. Before rendering our estimates, keep in mind that it is too early to determine how strong the scientific evidence in this MDL will be and the amount of fetal exposure to acetaminophen in your unique circumstances.

Most plaintiff trial lawyers agree we are dealing with strong science behind an ever-growing body of published studies linking autism spectrum disorder to acetaminophen or Tylenol use during pregnancy. However, it will be some time before we know whether the science concerning the impact acetaminophen has on fetal development and developmental disorders is strong enough to reach a jury trial. However, based on the current scientific research conducted, we feel confident about the pending Tylenol lawsuits and those that will be filed over the next few years.

Remember, in a civil case, the burden of proof is not “absolute certainty.” Rather, we must establish that the use of generic acetaminophen or Tylenol during pregnancy makes it “more likely than not” that the baby will be subsequently diagnosed with autism or ADHD.

To prevail in these lawsuits, we must establish through scientific research and evidence that the use of acetaminophen during pregnancy established an increased risk of a child being subsequently diagnosed with a developmental disorder.

Factors That Will Affect Tylenol Autism Settlement Payouts

Tylenol Autism Settlements

The main factors are the severity of autism spectrum disorder or ADHD and the amount of acetaminophen the mother used while pregnant. The severity of autism is measured in three different grades, where ASD level 1 is the least severe, and ASD level 3 is the most severe form of autism spectrum disorder.

Since we believe settlements will be based on the severity of the autism spectrum disorder diagnosis (ASD), Children with a level one autism diagnosis will most likely receive the lowest value settlements, while level three (ASD level 3) autism cases will have the most significant value.

We also base our Tylenol autism settlement projections on our assumption the science is strong enough to survive scientific causation hearings (Daubert hearings) and allow these cases to proceed to settlement or trial. 

We project the average jury verdict could be in excess of $2 million for individuals with an autism diagnosis who experience significant autism spectrum symptoms in their most severe form. 

For a free legal consultation, call 866-458-3982.

Projected Tylenol Autism ADHD Lawsuit Settlement Amounts

The majority of Tylenol lawsuits will never reach trial. In fact, very few mass tort cases are selected by Court for a bellwether trial. Thus, the vast majority of these claims will eventually be settled. After reviewing Tylenol autism lawsuits that have been filed over the past eight months, we are developing early estimates for settlement value.

Our very early projection for settlement value is:

  • $50,000.00 to $225,000.00 for ASD level 1 claims
  • $250,000.00-$500,000.00 for ASD level 2 claims
  • and in excess of $500,000.00 for ASD level 3 claims

Keep in mind these are simply early settlement projections for the Tylenol class action lawsuit. We based these projections partly on costs related to the support and treatment that will be required over a lifetime for a child with different levels of autism.

Autism Spectrum Disorder Level 1: $50,000 – $225,000 Range

Level 1 is the mildest form of autism. It is often referred to as “high-functioning autism” and is defined as a child who often speaks in complete sentences but has difficulty understanding social cues. Further, a child with level 1 autism may have challenges conversing and with organizational and planning skills. Another hallmark of level one autism is difficulty in moving from one task to the next. We believe children diagnosed with attention deficit hyperactivity disorder (ADHD) would fall into a similar range as those with level 1 autism.

Autism Spectrum Disorder Level 2: $225,000 – $500,000 Range

Children with level 2 autism have more obvious verbal and non-verbal communication issues. Another hallmark of level 2 autism spectrum disorder is engaging in repetitive behavior. Additionally, children with level 2 autism are challenged by changes in routine and coping with deviating.

Autism Spectrum Disorder Level 3: $500,000+

Children with level 3 autism face many of the same challenges and issues that those with level 1 and level 2 exhibit. However, these similar traits are much more severe in level 3. Level 3 children will often be non-verbal or make use of just a few select words. Further, they will have extreme difficulties in coping with changes to routines. Those with level 3 autism may only seek social contact to meet their immediate needs.

Keep in mind these classifications are not rigid. Every Tylenol autism lawsuit will be valued differently based on not only the classification of autism spectrum disorders but the extent of exposure to generic acetaminophen or Tylenol, along with compounding factors involving both parents and the child in question. Also, since the litigation is ongoing, these estimates could be affected by recent court decisions.

Does Tylenol Cause Autism?

We do NOT believe Tylenol is the primary cause of autism. In fact, autism has a heavy genetic component. Rather, we strongly believe that the use of acetaminophen during pregnancy—specifically in-utero exposure to acetaminophen—greatly increases the probability of a child being subsequently diagnosed with autism or ADHD. 

Autism, ADHD, and other neurodevelopmental disorders predate acetaminophen. However, we subscribe to the growing body of science that demonstrates a causal link between in-utero exposure to acetaminophen and a diagnosis of autism spectrum disorder in the child that was exposed.

Genetics are known to play a very large role in autism and ADHD. Environmental factors lead to a greater incidence rate, and numerous studies indicate not only an association between the use of acetaminophen and the incidence of autism; but a dose-dependent relationship. In other words, the greater the level of acetaminophen, the higher the incidence rate and severity of autism and ADHD.

Tylenol has long been marketed as a safe over-the-counter drug for pregnant women to utilize as a pain reliever. Recent studies analyzing umbilical cord blood samples illustrated a dose-dependent relationship between acetaminophen and autism. Study after study shows a consistent association between acetaminophen and autism. A vast number of studies all conclude that using Tylenol while pregnant leads to elevated risks of autism and negative neurodevelopmental outcomes for the developing fetus.

It is important to note that Autism rates began to soar in the 1980s after Tylenol replaced aspirin for routine use due to public fear of aspirin-related Reyes Syndrome. It is also important to draw a delineation between those who believe vaccinations cause autism vs. in-utero exposure to acetaminophen. The vaccination autism link has been debunked time and again. However, the science behind whether Tylenol causes autism is significant.

It will be interesting to see what the discovery process, including depositions in the autism class action lawsuit, will reveal about Johnson & Johnson's knowledge concerning the dangers associated with using Tylenol while pregnant. 

How Tylenol Usage During Pregnancy is Connected to Neurodevelopmental Disorders Like Autism and ADHD

Tylenol is a common over-the-counter drug used to treat pain and reduce fever. Unfortunately, in some cases, it may be doing more harm than good, and health risks can no longer be ignored. Recent studies indicate that in-utero acetaminophen exposure can impact fetal brain development.

How Prevalent is Acetaminophen Use During Pregnancy?

More than 65% of pregnant women in the U.S. turn to acetaminophen as their pain reliever choice during pregnancy. Health professionals have told pregnant women, and specifically by their obstetricians, that among the available over-the-counter medications, acetaminophen was safe for consumption. 

However, in 2021, a consensus statement on acetaminophen use during pregnancy was issued by 91 scientists, researchers, and physicians. These health professionals warned against acetaminophen use during pregnancy unless it is medically necessary. They cautioned pregnant women that a growing body of research indicates acetaminophen use may alter fetal brain development and result in neurodevelopmental disorders. More specifically, they warned about using Tylenol regularly during pregnancy.

Scientists Take a Stand to Warn About Autism and Tylenol Use During Pregnancy

In 2021, 91 American and European scientists became alarmed about data showing a consistent association between acetaminophen use by pregnant women and autism or ADHD diagnoses in their children. This group of scientists signed a consensus statement urging pregnant women to minimize their use of acetaminophen during pregnancy.

Autism and Tylenol Use During Pregnancy

The 2021 consensus statement, which was published in Nature Reviews Endocrinology, warned pregnant women that the use of acetaminophen during pregnancy could spike the rates of autism.

In fact, the authors say that “increasing experimental and epidemiological research suggests that prenatal exposure to APAP (Acetaminophen) might alter fetal development, which could increase the risks of some neurodevelopmental, reproductive, and urogenital disorders.”

Based on the new research and existing body of prior scientific evidence, these experts recommend women avoid taking acetaminophen during pregnancy.

Scientific evidence suggests a strong causal link between the use of acetaminophen during pregnancy and a higher risk of your child presenting with or obtaining a diagnosis of autism spectrum disorder or ADHD. This discovery has led many families to pursue legal action against the makers of these medical products and the retailers who have earned substantial profits selling these over-the-counter medications without warning of the potential health risks. This is the causal link that must be proven for the Tylenol lawsuit to be successful.

Medical Community Finally Takes Note of Tylenol Autism Link

It took far too long for health professionals to take notice. The Tylenol autism lawsuit will only serve to draw more attention to an emerging body of research that establishes how acetaminophen use during pregnancy is among the risk factors for adverse neurodevelopmental outcomes.

Based on the studies discussed below, the general recommendation for pregnant women is to avoid extended use of acetaminophen during pregnancy. Basically, pregnant women should only take Tylenol products when necessary, using the lowest possible dosage and for the least amount of time to protect their unborn child. Here's a quick summary of the most relevant and impactful studies supporting the Tylenol autism lawsuit.

Johns Hopkins University Boston Birth Cohort Study (2020)

Based on emerging research on acetaminophen conducted by both Yale University and Johns Hopkins University, this study found a link between mothers who took Tylenol during their pregnancies and the diagnosis of neurodevelopmental conditions, including autism, in their children. There now exist multiple studies (see this analysis of multiple studies on acetaminophen use during pregnancy) illustrating a potential causal link between higher rates of autism and acetaminophen use during pregnancy. 

More specifically, the cord blood samples analyzed in the Johns Hopkins study demonstrated a dose-dependent relationship between Tylenol and autism based on in-utero exposure to acetaminophen. Further acetaminophen use during pregnancy is among the risk factors for a host of other developmental disorders and can also increase a child’s risk for ADHD.

Acetaminophen use During Pregnancy

What makes the Johns Hopkins University study significant is the illustration of a dose-dependent relationship between Tylenol or generic acetaminophen use during pregnancy and a subsequent diagnosis of autism or ADHD.  The Johns Hopkins study sheds light on how acetaminophen impacts child development via the presence of the chemical in umbilical cord blood samples.

Umbilical Cord Blood Samples Measured For Acetaminophen

Researchers evaluated umbilical cord blood samples and noted those with a higher concentration of acetaminophen exposure showed a dose-dependent greater incidence of autism. This displayed a quasi-causal link at a minimum between acetaminophen use during pregnancy and developmental disorders. 

The higher the concentrations of acetaminophen in umbilical cord blood samples, the greater the incidence of autism spectrum disorder and ADHD. In fact, babies whose cord blood samples contained the highest amounts of acetaminophen were approximately three times more likely to be diagnosed with autism or ADHD.

Acetaminophen has a short half-life (the amount of time it remains active in the bloodstream). The fact that cord blood samples contained different amounts of acetaminophen tells us little about whether the use of this over-the-counter drug is dangerous in earlier periods of pregnancy (first or second trimester). However, there is scientific evidence that the greater the use of acetaminophen during pregnancy, the greater the risk of neurodevelopmental disorders.

Danish National Birth Cohort Study (2015)

In the Danish National Birth Cohort Study, 64,322 mother-child pairs were analyzed to study the causes of diseases in children and complications sustained by the mother during birth. A number of factors and health conditions were analyzed. The researchers noted an association between prenatal use of acetaminophen and a diagnosis of ADHD.

International Journal of Epidemiology (2016)

In 2016, the International Journal of Epidemiology published a study (this research paper analyzing data from a Spanish birth cohort) entitled Acetaminophen use in pregnancy and neurodevelopment: attention function and autism spectrum symptoms. The authors analyzed a Spanish birth cohort of 2644 mother-child pairs to determine whether prenatal exposure to acetaminophen resulted in adverse neurodevelopmental conditions at age 1 and age 5. The authors concluded that prenatal acetaminophen exposure was associated with a higher rate of autism spectrum disorder symptoms in males and ADHD symptoms in both sexes.

European Journal of Epidemiology (2021)

The European Journal of Epidemiology published a study where researchers analyzed all the data collected from the 2015 Danish Birth Cohort study. (Read this published study analyzing data from the Danish Birth Cohort study). Researchers determined that in-utero acetaminophen exposure was associated with adverse neurodevelopmental conditions, such as a clear increase in a child’s risk for autism and ADHD.

2017 Study Indicates How Acetaminophen Injures the Fetal Brain

The Journal of International Medical Research published a study (how Tylenol impacts fetal brain development) that discussed the likely mechanism for how generic acetaminophen and Tylenol caused autism by impacting fetal brain development.

Scientists believe it may inhibit essential enzymes in brain development like the Cox-2 enzyme. Further, it is also believed to alter or interfere with the firing rate of neurons in the hypothalamus. There is also believed to be a causal link between the use of acetaminophen and inflammatory diseases. This tells scientists that acetaminophen use during pregnancy may result in inflammation of the brain.

American Academy of Pediatrics Study

A study published in the American Academy of Pediatrics showed that even moderate use of acetaminophen during pregnancy created an increased risk for attention deficit hyperactivity disorder. It is important to note that Tylenol use during pregnancy was linked to ADHD in every Tylenol autism study. In fact, the link between Tylenol and ADHD slightly outpaces the incident rate of Tylenol and autism in study after study. 

Dolman Law Group is Carefully Watching These Tylenol ADHD Lawsuits

A 2014 study published by the Journal of the American Medical Association involved 64,322 mother-child pairs and found that children with prenatal exposure to acetaminophen showed close to a 30% increase in developmental disorders diagnoses such as ADHD (attention deficit hyperactivity disorder).

While the Tylenol autism link has received more media attention of late, we have seen very little attention focused on ADHD diagnosis linked to acetaminophen. The 2014 study demonstrated that acetaminophen crosses the placental barrier. Further, the study also found that using acetaminophen in more than one trimester created a greater incidence rate of ADHD or increased the child’s risk of other developmental disorders.

A 2021 study published by the European Journal of Epidemiology found that a child with in-utero acetaminophen exposure was 21% more likely to be diagnosed with ADHD. There is a growing body of scientific and epidemiological studies that the use of acetaminophen impacts fetal brain development. It is theorized that acetaminophen disrupts neurodevelopment and, in turn, child development.

We believe the science linking Tylenol to ADHD is very strong and also shows a dose-dependent causal relationship. The team at Dolman Law Group is monitoring these Tylenol ADHD claims and hope the MDL is reinstated so all injured children and families receive the justice and compensation they deserve.

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Contact Dolman Law Group for Help With Your Tylenol Autism Lawsuit

Tylenol Autism Lawsuit Attorney
Matt Dolman, Tylenol Autism Attorney

Learning that medicine you thought was harmless could have negatively impacted your child can be overwhelming news. However, you should not let this prevent you from taking action to seek compensation for your damages, including medical bills, emotional distress, and lost wages. The personal injury lawyers at Dolman Law Group are prepared to handle your Tylenol autism claim and support you through every step of the litigation process.

If the makers of Tylenol and other acetaminophen drugs are unwilling to compromise on a fair settlement offer, we won't hesitate to take your bad drug lawsuit to trial. Our team of personal injury attorneys will work tirelessly to maximize compensation on your behalf.

If you or your child has been diagnosed with autism, ADHD, or other neurodevelopmental conditions after significant exposure to Tylenol or acetaminophen use while in utero, our lawyers are here to speak with you as soon as possible. We urge you to contact a Tylenol autism lawyer at Dolman Law Group to learn how much your potential Tylenol autism settlement might be worth and the strength of your case.

You can reach out to us at 866-271-9007 or through our online contact form. We offer free consultations at our numerous office locations or virtual appointments. Our Tylenol attorneys are able to investigate your claim immediately.

The Dolman Law Group works with local counsel in any jurisdiction outside Florida for the purpose of filing lawsuits in jurisdictions wherein we are not licensed. Thus, we will follow each State's ethical rules to ensure a local attorney is involved.

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Matthew Dolman

Personal Injury Lawyer

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has successfully fought for more than 11,000 injured clients and acted as lead counsel in more than 1,000 lawsuits. Always on the cutting edge of personal injury law, Matt is actively engaged in complex legal matters, including Suboxone, AFFF, and Ozempic lawsuits.  Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

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