Tylenol Autism Lawsuit – Settlement & Claims (March 2026)

We are beginning to participate in state court Tylenol autism lawsuits in Florida, Illinois, and Pennsylvania. Over the coming weeks, we plan on filing state court cases while we await the Second Circuit’s ruling on the Tylenol appeal.

Assuming the appeal is successful, we will still continue filing cases in state court. We expect the state court acetaminophen lawsuits to gain significant momentum in the second half of 2026.

A lawsuit filed by Texas Attorney General Ken Paxton survived a motion to dismiss from Johnson & Johnson and its spinoff company Kenvue (the current owner of Tylenol).

Judge LeAnn Rafferty filed a one-sentence order, but this is great news for plaintiffs.

This lawsuit alleges that Kenvue, along with Johnson & Johnson, violated the deceptive trade practices act of Texas by marketing their pain reliever as safe, ignoring a wide body of scientific literature illustrating the danger of Tylenol to pregnant women.

The Texas Attorney General has argued that Kenvue/Johnson & Johnson has a non-delegable duty to warn pregnant mothers about the known dangers of exposing their unborn fetus to acetaminophen. Essentially, the defendant ignored twenty-six epidemiological studies demonstrating a link between in utero exposure to acetaminophen and autism spectrum disorder. 

This is yet another example of Johnson & Johnson ignoring an abundance of research linking acetaminophen to autism and developmental disorders. The defendants had a clear duty to warn that Tylenol exposure during gestation significantly increases the risk of autism.

Families watching the Tylenol Autism litigation finally have new reasons to feel encouraged. After many quiet months, both the appellate court and federal regulators have taken important steps that could impact whether these lawsuits move forward again.

A Promising Turn in the Federal Appeal

On November 17, 2025, the Second U.S. Circuit Court of Appeals heard arguments on whether the federal lawsuits should be revived. During the hearing, two of the three judges openly questioned whether the trial court acted too aggressively when it excluded the plaintiffs’ expert testimony last year—a decision that ultimately led to the dismissal of the entire MDL.

According to Reuters, some of the comments from the judges were especially notable:

• One judge said the plaintiffs’ lead expert, Dr. Andrea Baccarelli of Harvard, seemed to clearly explain his scientific reasoning.
• Another judge suggested that a jury should have been allowed to hear the evidence rather than having it stopped at the preliminary stage.

While no decision has been issued yet, these comments offer a genuine sense of hope for many families who want the chance to present their evidence in court.

Federal Health Officials Acknowledge Possible Risks

As we reported last month, the U.S. Food and Drug Administration (FDA) announced it is beginning the process of adding a pregnancy warning to acetaminophen products, including Tylenol. While the FDA stressed that a causal link has not been proven, the agency noted a growing body of studies showing a possible association between prenatal acetaminophen use and later diagnoses of autism or ADHD.

The FDA also alerted doctors nationwide so they can counsel expectant parents with better information. For many families who have long suspected a connection, this acknowledgment from federal health officials holds deep meaning.

What This Means for Parents and Caregivers

The past few years have been filled with uncertainty for families who used Tylenol during pregnancy and now wonder whether it played a role in their child’s autism diagnosis. These new developments—from federal warnings to judges signaling that the evidence may deserve to be heard—could mark a turning point in the litigation.

If the appellate court rules in favor of the plaintiffs, the federal lawsuits may be reinstated, giving families the opportunity to pursue justice and accountability.

At Dolman Law Group, we know how overwhelming it can feel to navigate questions about your child’s health while also trying to understand complex legal issues. Our attorneys are closely following the Tylenol Autism litigation, and we remain committed to helping families understand their options.

After months of uncertainty, families involved in the Tylenol Autism litigation finally have reason to feel hopeful again. New government actions and an upcoming appellate court hearing could change the direction of this complex and closely watched case.

Federal Agencies Acknowledge Possible Risks of Tylenol Use During Pregnancy

In a major development, the U.S. Food and Drug Administration (FDA) has taken the first steps toward updating the safety label for acetaminophen, the active ingredient in Tylenol and many other over-the-counter medications. The agency’s announcement noted a growing body of evidence suggesting a potential connection between prenatal Tylenol use and neurodevelopmental conditions such as autism and ADHD.

While the FDA emphasized that this does not yet establish a causal link, the decision to move forward with a warning label marks a significant shift in how federal regulators are approaching the science. For many parents who have long believed their child’s condition may be connected to Tylenol use during pregnancy, this acknowledgment feels like long-awaited validation.

Renewed Momentum in the Tylenol Autism MDL Appeal

These federal actions have also breathed new life into the ongoing appeal in the Tylenol Autism multidistrict litigation (MDL No. 3043). The case has been on hold since Judge Denise Cote excluded the plaintiffs’ expert witnesses in 2023 and entered summary judgment in favor of the defendants the following year.

Now, the Second U.S. Circuit Court of Appeals is set to hear oral arguments on November 17, 2025, where a three-judge panel will decide whether the lower court’s decision should stand or if the lawsuits deserve another chance to move forward.

The plaintiffs recently filed a letter urging the appellate judges to consider the government’s recent findings. They noted that the FDA and other federal agencies relied on the same scientific research presented by their lead expert, Dr. Andrea Baccarelli, a Harvard public health dean who has studied the connection between acetaminophen exposure during pregnancy and autism risk.

This new validation from federal health authorities strengthens the plaintiffs’ position that their evidence is credible and deserves to be heard by a jury.

Why This Matters for Families Affected by Autism

For families who used Tylenol during pregnancy and later received an autism diagnosis for their child, these developments may represent a turning point. The fact that national health agencies are now acknowledging the clinical evidence offered by the plaintiffs could help restore momentum to the litigation and open the door for renewed legal action.

While no appellate decision has been issued yet, the coming months will be critical. If the Second Circuit allows the expert testimony back into the case, the Tylenol Autism lawsuits could move forward once again in federal court, potentially paving the way for trials or settlements in the future.

Dolman Law Group Is Standing Ready

At Dolman Law Group, we understand how deeply parents want answers and accountability. Our attorneys are closely following every development in the Tylenol Autism litigation and are committed to helping families explore their legal rights.

Families affected by autism may soon have important new information to consider. According to recent reporting in The Wall Street Journal, the U.S. Department of Health and Human Services (HHS) is preparing to release a report suggesting a possible link between prenatal Tylenol (acetaminophen) use and autism. 

The FDA is also starting the process for a warning label change and advising doctors about the possible link between taking acetaminophen during pregnancy and later autism diagnoses. This news comes at a pivotal time, as the 2nd U.S. Circuit Court of Appeals is scheduled to hear arguments in October that could decide whether federal Tylenol Autism lawsuits are revived.

The federal litigation has been stalled since Judge Denise Cote excluded the plaintiffs’ expert witnesses in 2023 and later granted summary judgment to the defendants in 2024. But the upcoming appeal, combined with the anticipated HHS report and FDA action, has renewed hope for families seeking accountability and answers.

At Dolman Law Group, we understand how deeply parents want clarity when it comes to their child’s health and development. If you used Tylenol during pregnancy and your child has been diagnosed with autism, you may have legal options. Our attorneys are closely following this litigation and are here to guide you through your rights, your choices, and the path forward.

We are Also Accepting Toxic Baby Food Autism Cases

If your child has been diagnosed with autism or another neurodevelopmental condition, you likely have questions and want to learn more about whether you may qualify for a claim. The Dolman team is also working with families whose children were diagnosed with autism after eating certain baby food products that tested positive for excessive heavy metals. 

If your child was diagnosed with a medical condition you believe is related to Tylenol use or baby food consumption, you may have legal rights against the product manufacturers. We encourage you to contact Dolman Law Group today for a free consultation.

The Second Circuit Court of Appeals has not yet ruled on the appeal filed by plaintiffs in the Tylenol Autism MDL. The appeal stems from Judge Denise Cote’s December 2023 decision to dismiss the litigation after excluding expert testimony connecting prenatal Tylenol use to autism and ADHD.

Oral arguments took place in December 2024, but the appellate court has yet to issue a decision. For now, the matter remains under review.

Plaintiffs in the federal MDL are still hoping for good news while waiting for the appellate court to decide whether the dismissal entered last year will stand. In the meantime, families with children who were diagnosed with autism or ADHD are bringing state-based cases, and some have qualified to join the toxic baby food MDL. If you have questions about a state law lawsuit or baby food-related claim, reach out to the dangerous product team at Dollman Law Group today.

If your child was harmed by exposure to Tylenol or acetaminophen during pregnancy, you may have the right to bring a state court claim for compensation to help pay for expenses related to autism or ADHD. Reach out to the Dolman Law Group team for more information during a free consultation.

As we reported in August, the federal MDL was dismissed, but the appeal is still pending. We will report the Appellate Court’s decision as soon as it is released.

Unfortunately, we have not received the appellate court’s ruling regarding the plaintiffs’ challenge of Judge Cote’s dismissal. While the future of the MDL is still in limbo, parents of children with autism-related conditions, including ADHD, are filing state court claims. Some states, like Pennsylvania, Delaware, California, and New Jersey, have seen a rise in acetaminophen claims since the MDL was dismissed.

Also, more families are bringing claims against baby food makers, alleging toxic heavy metals in the food have caused neurodevelopmental issues for their children. The Dolman Law Group team is working with these families while we wait for news from the appellate court. We’ll keep you posted.

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!

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The acetaminophen autism MDL held their Daubert hearing in United States District Court for the Southern District of New York on December 7^th.  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. 

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.

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.

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.

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.

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:

• Dr. Andrea Baccarelli, MD, PhD
• Dr. Robert Cabrera, Ph.D.
• Dr. Eric Hollander, MD
• Dr. Stan G. Louie
• Dr. Brandon Pearson, PhD

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 theprevalence 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.  

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.

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. 

Numerous Research Studies Support a Causal Link Between Tylenol and Autism

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. 

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.

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.

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

The initial case management 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. We expect this will open the floodgates on federal Tylenol lawsuits.

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 litigation 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.

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