Close this search box.

The Tylenol Autism Lawsuit: A Comprehensive Overview and Update

The Tylenol Autism Lawsuit has emerged as a significant class action lawsuit within the United States, driven by parents who utilized Tylenol during their pregnancies and subsequently gave birth to children diagnosed with autism or other neurodevelopmental disorders. In this exclusive article, our personal injury attorneys aim to breakdown the case for you.

A Closer Look at the Tylenol Autism Lawsuit Manufacturers of Tylenol and generic acetaminophen, also known as Paracetamol, find themselves embroiled in a series of product liability lawsuits. These mass tort claims assert that the manufacturers and retailers displayed negligence by failing to adequately warn pregnant women, medical professionals, and the general public about potential risks associated with the use of their products during pregnancy.

Research has indicated a correlation between acetaminophen use during pregnancy and a heightened 20% to 30% likelihood of children being diagnosed with autism spectrum disorder (ASD), hyperactivity, and other behavior-related disorders. Among these disorders, the association between Tylenol and autism has been extensively studied. The robust nature of these studies, characterized by their size, consistent methodology, and well-designed frameworks, has produced compelling evidence supporting the argument that the usage of paracetamol during pregnancy increases the risk of neurodevelopmental disorders in children.

December 21, 2023 Update

In a critical legal decision, Judge Denise Cote in Manhattan federal court dismissed expert testimonies claiming Tylenol’s link to autism and ADHD during pregnancy, citing a lack of scientific evidence and methodology. This ruling likely signals the end of a consolidated litigation involving around 500 lawsuits against Kenvue, formerly Johnson & Johnson’s consumer health unit. The judge criticized the experts’ methodologies as unstructured and prone to selective analysis.

Kenvue responded to the ruling by planning to dismiss all related cases, emphasizing Tylenol as a well-studied medication and highlighting its safety and recommendation by doctors for treating pain and fever during pregnancy. The ruling also affected retail giants CVS, Walgreens, and Walmart, which faced similar lawsuits for selling generic versions of Tylenol.

The case underscores the critical role of scientific evidence in product liability lawsuits and the judicial standards for expert testimonies. The multidistrict litigation, consolidated in 2022, reflects the ongoing debate over acetaminophen’s safety during pregnancy, with health experts advising its use over aspirin or ibuprofen despite some studies suggesting potential risks.

September 1, 2023 Update

FDA Decision In a peculiar turn of events earlier this year, Judge Cote extended an uncommon invitation to the FDA. The invitation sought to garner the FDA’s evaluation of a critical issue at the heart of the Tylenol autism class action lawsuits: whether the proposed warnings by the plaintiffs should be affixed to acetaminophen labels. Additionally, the court sought the FDA’s expert opinion on whether existing scientific evidence substantiated these warnings or advisories concerning the risks of autism or ADHD in pregnant women. The question loomed: should the manufacturers have disclosed these risks to expectant mothers to safeguard their unborn children?

In response to this intriguing invitation, the FDA requested an extension through its legal representative, the U.S. Attorney for the Southern District of New York (akin to Chuck Rhoades in the television series Billions). Consequently, the deadline for this report now looms on September 15, 2023, just a few weeks away. The content of the FDA’s report (or its absence) to Judge Cote carries significant weight as the Daubert motions draw near. Once again, the plaintiffs maintain their unwavering belief in the robustness of the scientific foundation underpinning their lawsuits.

September 8, 2023 Update

The FDA’s stance, unveiled on September 8, 2023, stands as a pivotal moment in this legal saga. From the FDA’s official statement:

“In response to the Court’s invitation, the United States respectfully declines to submit a statement of interest in this matter,” although the missive does allude to the FDA’s recent scrutiny of the epidemiological data. The FDA’s assessment concluded with a resounding note that “the limitations and inconsistent findings of current observational studies of acetaminophen and its potential neurobehavioral and urogenital outcomes fail to substantiate a causal link.”

Concluding with a firm declaration of non-involvement in drug litigation, the FDA’s statement reaffirms its general policy against engaging in third-party litigation. However, it underscores its role in monitoring the safety of drug products and maintains various administrative channels for the submission of new safety and effectiveness information related to over-the-counter acetaminophen products.

For the plaintiffs, this declaration stands as a significant victory.

September 12, 2023 Update

As the sun rose on September 12, 2023, a pivotal moment in the courtroom drama unfolded. Following a recent pronouncement from the FDA, the defendants wasted no time, dispatching a letter to the court precisely at 9:11 a.m. Their intention was clear: a fervent plea for a status conference, seemingly with the aspiration of mounting an argument for the dismissal of the case. The crux of their argument appeared to hinge on the FDA’s stance, contending that the absence of a causal link, as per the FDA’s pronouncement, should necessitate the case’s immediate dismissal.

This maneuver bore the hallmark of a “best defense is a good offense” strategy, presumably devised by the legal minds representing Tylenol. However, the assertion that the FDA’s decision not to submit a statement of interest should validate their position struck a chord of illogicality. In a swift response, Judge Cote, in less than two hours since the request was made, declined the entreaty and affirmed that the previously established deadlines, including those for Daubert motions, would remain unchanged.

Tylenol Autism Lawsuit Update: August 2023

August 29th Tylenol Autism Lawsuit Recap

What’s the current status of the ongoing Tylenol legal dispute and when might we anticipate some form of resolution?

Presently, a multitude of expert testimonies and other witness statements are being collected regarding the fundamental question of general causation – specifically, whether Tylenol holds the potential to contribute to ADHD and autism.

Attorneys representing the plaintiffs are notably optimistic about the trajectory of these testimonies. To such an extent, there exists a prevailing belief that (1) Judge Cote will issue a favorable Daubert ruling, given the robust scientific basis, and (2) even if such a ruling is not granted, these claims retain their potency and validity within the realm of state jurisdiction.

Should the Daubert hearings achieve success during the upcoming fall season, it becomes arduous to envision J&J and its co-defendants being inclined to subject any of these cases to trial. This hesitance primarily stems from the fact that the projected average verdict for successful cases stands to easily reach the multimillion-dollar range.

August 21st Tylenol Autism Lawsuit Update

In an interesting turn, Judge Cote has granted permission for the defendants to amalgamate their arguments into a single comprehensive brief regarding the Daubert challenges. These challenges revolve around the admissibility of scientific expert testimony presented by the plaintiffs. Contrary to this consolidation, the plaintiffs had expressed their preference for distinct briefs for each expert. Their reasoning was anchored in the belief that individual briefs would be instrumental in ensuring an equitable resolution. The trajectory of the Tylenol autism class action rests on the outcome of these Daubert challenges. Should Judge Cote determine that the plaintiff’s evidentiary support for causation lacks admissibility, it is foreseeable that all ongoing cases will eventually face dismissal.

August 14th Tylenol Autism Lawsuit Update

In a concerted communication forwarded to Judge Cote, both the defendants and plaintiffs embroiled in the Tylenol autism MDL have concurred that certain states will not entertain plaintiffs’ pursuit of negligent misrepresentation claims predicated on omissions. The roster of states where such claims hold no legal ground encompasses: Arkansas, California, Colorado, Idaho, Indiana, Kentucky, Nebraska, New Hampshire, North Carolina, North Dakota, Ohio, South Dakota, Tennessee, Texas, and Wyoming. Despite this development, the overarching impact on the eventual case outcomes is anticipated to be marginal, if not inconsequential.

August 4th Autism Tylenol Lawsuit Update

In a noteworthy development last April, J&J found their hopes dashed as their motion to dismiss the cases implicating acetaminophen’s potential link to ASD-ADHD faced denial on the grounds of preemption. This ruling, while anticipated, marked a significant victory for the plaintiffs involved. Undeterred, J&J pursued a strategic move by seeking certification for an interlocutory appeal, aiming to challenge the decision immediately.

However, the tables turned when their request for certification of the interlocutory appeal met with denial. The court was not convinced that all the essential criteria for an immediate appeal were satisfied by the company’s presentation. This turn of events added yet another twist to the ongoing legal battle.

August 1st Autism Tylenol Lawsuit Update

Due to the record number of new Tylenol autism lawsuit cases that were filed in the month of June and the circumstances behind those cases, on August 1, 2023, there were additional retailers that have now been named as defendants in this case. 7-Eleven, Family Dollar and Dollar Tree are now formally named as defendants in this matter.

In addition, earlier this year, an interesting turn of events unfolded as Judge Cote sought the FDA’s expert opinion regarding the potential addition of warning labels to Tylenol and acetaminophen products, as proposed by the plaintiffs. The significance of this development cannot be understated, as it may influence the course of the ongoing litigation substantially.

In a recent update, Judge Cote has acceded to the FDA’s request for an extension of the deadline to submit their statement of interest. The new deadline for the FDA to provide their opinion is set for September 15, 2023. The clock is ticking, and this statement could hold the key to the future of the case.

Adding to the complexity, Daubert motions challenging the admissibility of causation evidence are scheduled to be filed just four days after the FDA’s submission deadline. The outcome of these Daubert challenges will undoubtedly play a pivotal role in shaping the course of the entire litigation.

All eyes are now on Judge Cote’s ruling, as the fate of the case largely hinges on how she addresses the Daubert challenges. The FDA’s stance on the warning labels could also prove to be a game-changer, influencing the overall outcome of this high-stakes litigation. As the legal proceedings unfold, the parties involved are closely watching these crucial developments with great anticipation.

Tylenol Autism Lawsuit Update: July 2023

In an exciting Tylenol autism lawsuit update, the Tylenol autism class action MDL has witnessed a surge in new cases during the previous month. With a record-breaking influx of 64 lawsuits, these claims assert that autism resulted from prenatal exposure to acetaminophen products. This surge in filings marks the highest monthly volume since the commencement of the Tylenol autism lawsuit, elevating the total number of pending cases to 200. While numerous prospective plaintiffs remain on the sidelines, their decision to participate hinges on the MDL Judge’s ruling regarding the admissibility of scientific causation evidence.

As summer progresses and further Tylenol autism lawsuit updates emerge, the litigation process remains on a fast-paced trajectory. Subject to Judge Cote’s approval, new deadlines have been established. The defendants’ expert designation deadline is set for July 21, requiring them to identify their expert witnesses. Consequently, the plaintiffs now have until July 28 to submit their rebuttal expert report. Additionally, the defendants will continue to depose the plaintiffs’ experts. Upon designation on July 21, the defendants have committed to making their experts available for deposition between August 25 and September 12.

June 2023 Tylenol Class Action Lawsuit Update

As of June 4, 2023, J&J has taken an aggressive stance against the scientists who reached conclusions regarding the alleged link between Tylenol and autism. The company has issued nine subpoenas to these scientists, seeking to challenge their findings. However, the plaintiffs are not taking this move lightly and have moved to quash the subpoenas. They argue that the company’s late and burdensome demands for nine depositions without sufficient notice do not align with the fair process of litigation.

The past actions of Judge Cote, known for her prompt rulings, suggest that she will swiftly address this discovery dispute, adding further anticipation to the unfolding legal drama.

Looking back to June 1, 2023, only six new cases were recently added to the Tylenol autism class action MDL, bringing the total filed lawsuits to 124. Despite the massive potential plaintiff pool in this litigation, the MDL’s size has remained relatively small.

The reason behind this discrepancy lies in the majority of potential plaintiffs adopting a cautious approach, waiting on the sidelines to observe how the MDL judge, Judge Cote, rules on the admissibility of causation evidence. If she deems the scientific evidence presented by the plaintiffs as inadmissible, all MDL cases could be dismissed without the possibility of refiling. To mitigate this risk, some plaintiffs are opting to refrain from filing at the federal level and, instead, keep their cases reserved for state court if the Daubert hearing doesn’t favor them.

Plaintiffs’ lawyers are particularly aware of this strategy due to their experience with the Zantac class action. In that instance, lawyers rushed to join the MDL, only to see their cases dismissed by a single federal judge, leaving them with no recourse. Conversely, those who refrained from the MDL process can still pursue their claims in state court. This approach is expected to work more effectively in the Tylenol lawsuits, given that the statute of limitations is less restrictive in most cases, allowing potential plaintiffs greater flexibility in their legal decisions.

Unveiling the Link Between Tylenol and Autism: Assessing Your Potential Tylenol Autism Lawsuit

If you suspect that you or your child has been exposed to substantial amounts of Tylenol or generic acetaminophen during pregnancy, and your child has received a diagnosis of Autism Spectrum Disorder you might possess a viable product liability claim against the manufacturers of generic acetaminophen (Mallinckrodt) or Tylenol (McNeil Consumer Products Co., a wholly-owned subsidiary of Johnson & Johnson). Our team at HHJ Trial Attorneys is diligently investigating claims and potential lawsuits pertaining to Tylenol and/or acetaminophen, encompassing prominent retailers such as CVS, Walgreens, Costco, and Walmart.

Typically, these claims find resolution through settlements reached outside the courtroom; however, the specific settlement amounts can vary significantly based on numerous factors. The extent of fetal exposure to acetaminophen, combined with your child’s clinical presentation and diagnosis, will substantially influence the potential value of your claim.

Why HHJ Trial Attorneys Stands Out as Your Trusted Tylenol Autism Claim Attorney

When it comes to securing legal representation for your Tylenol autism claim, HHJ Trial Attorneys stands apart as a nationally renowned law firm with an impressive track record of securing substantial compensation for injury victims in cases involving serious personal injury, mass tort claims, catastrophic injury, and product liability lawsuits.

Looking Into the Potential Settlement Amounts for Tylenol and Autism Claims: Estimating Your Recovery

While it remains premature to ascertain the precise settlement values in Tylenol acetaminophen autism lawsuits, we can make informed speculations and estimates based on previous mass tort endeavors. However, it is important to note that determining the strength of scientific evidence within this MDL (Multidistrict Litigation) and evaluating the level of fetal exposure to acetaminophen in your unique circumstances is still an ongoing process.

Numerous plaintiff trial attorneys concur that we are dealing with compelling scientific evidence stemming from an ever-expanding body of published studies connecting autism spectrum disorder to the usage of acetaminophen or Tylenol during pregnancy. Nevertheless, it will require some time to ascertain if the scientific research on the impact of acetaminophen on fetal development and developmental disorders is robust enough to proceed to a jury trial. Nonetheless, based on the current state of scientific research, we hold a positive outlook on the pending Tylenol lawsuits, as well as those anticipated to emerge in the coming years.

It is essential to remember that, in a civil case, the burden of proof does not demand “absolute certainty.” Instead, we must establish that the utilization of generic acetaminophen or Tylenol during pregnancy makes it “more likely than not” that the child will subsequently receive a diagnosis of autism.

To succeed in these lawsuits, our objective is to present compelling scientific research and evidence demonstrating that the use of acetaminophen during pregnancy escalates the risk of a child being diagnosed with a developmental disorder in a statistically significant manner.

Initial Estimations for Tylenol Autism Settlement Amounts: A Preliminary Outlook

It’s important to remember that these are preliminary settlement estimations for the Tylenol class action lawsuit and should be regarded as such. Our projections draw upon the anticipated costs associated with supporting and providing lifelong treatment for children with varying degrees of autism.

The primary factors influencing settlement amounts include the severity of the autism spectrum disorder (ASD) or and the quantity of acetaminophen used by the mother during pregnancy. The severity of autism is assessed across three levels, with ASD Level 1 denoting the mildest form and ASD Level 3 representing the most severe manifestation of autism spectrum disorder.

Considering settlements are expected to align with the severity of the autism spectrum disorder diagnosis (ASD), individuals diagnosed with Level 1 autism are likely to receive settlements of relatively lower value, while cases involving Level 3 autism (ASD Level 3) are anticipated to command higher settlement values.

Our Tylenol autism settlement estimations hinge upon the assumption that the scientific evidence will withstand rigorous scientific causation hearings (such as Daubert hearings) and allow these cases to progress toward settlement or trial.

We project that the average jury verdict for individuals diagnosed with autism, specifically those experiencing pronounced symptoms of autism spectrum disorder in its most severe form, could potentially surpass $2 million.

Determining Factors Impacting Tylenol Autism Settlement Payouts

Various factors come into play when assessing the potential settlement payouts for Tylenol-related autism cases. The key determinants include the severity of the autism spectrum disorder (ASD) and the extent of acetaminophen usage by the mother during pregnancy. Severity levels of autism are categorized into three grades, with ASD Level 1 representing the mildest form, while ASD Level 3 signifies the most severe manifestation of the disorder.

Our belief is that settlement amounts will primarily hinge on the severity of the autism spectrum disorder diagnosis (ASD). Consequently, individuals diagnosed with Level 1 autism are likely to receive settlements of relatively lower value, whereas cases involving Level 3 autism (ASD Level 3) may command higher settlement amounts.

Furthermore, our Tylenol autism settlement projections are based on the assumption that the scientific evidence supporting causation will prove robust enough to withstand scientific scrutiny, including hearings like Daubert hearings. This confidence in the scientific foundation of the cases allows us to anticipate the progression of these claims towards settlement or trial.

Our projections indicate that the average jury verdict could potentially exceed $2 million for individuals diagnosed with autism who exhibit significant symptoms across the autism spectrum, particularly in its most severe form.

Estimated Settlement Amounts for Tylenol Autism Lawsuits

It is important to note that the majority of Tylenol lawsuits are expected to settle rather than go to trial, as only a small fraction of mass tort cases proceed as bellwether trials. Based on our review of Tylenol autism lawsuits filed in the past eight months, we are formulating early estimates for settlement values.

Our initial projections for settlement amounts are as follows:

  • ASD Level 1 claims: $50,000.00 to $225,000.00
  • ASD Level 2 claims: $250,000.00 to $500,000.00
  • ASD Level 3 claims: Exceeding $500,000.00

These are preliminary settlement projections for the Tylenol class action lawsuit, taking into account the long-term costs associated with supporting and providing necessary treatment throughout the child’s lifetime, depending on the severity of their autism. The following is just an overall estimation when it comes to a Tylenol autism lawsuit payout:

  • Autism Spectrum Disorder Level 1: $50,000 – $225,000 Range Level 1 autism represents the mildest form, often referred to as “high-functioning autism.” These children typically speak in complete sentences but struggle with social cues, conversation skills, organizational abilities, and transitioning between tasks.
  • Autism Spectrum Disorder Level 2: $225,000 – $500,000 Range Children with Level 2 autism exhibit more noticeable communication difficulties, both verbal and non-verbal. Repetitive behaviors are common, and they face challenges with changes in routines and coping with deviations.
  • Autism Spectrum Disorder Level 3: $500,000 and above Level 3 autism entails severe manifestations of the traits observed in Levels 1 and 2. Children with Level 3 autism may be non-verbal or have limited speech, struggle greatly with routine changes, and primarily seek social contact to fulfill immediate needs.

It is essential to remember that these classifications are not absolute and each Tylenol autism lawsuit will be assessed individually, considering the specific autism spectrum disorder classification and the extent of exposure to generic acetaminophen or Tylenol. Other factors, such as the involvement of both parents and the unique circumstances of the child, can also influence the valuation. Additionally, recent court decisions may impact these estimates as the litigation progresses.

Tylenol and the Association with Autism: Exploring the Evidence for a Tylenol Autism Lawsuit

At our firm, we do not attribute Tylenol as the primary cause of autism. We recognize that autism has a strong genetic component. However, we firmly believe that the use of acetaminophen during pregnancy, particularly exposure in utero, significantly increases the likelihood of a subsequent autism diagnosis in the child.

It is important to acknowledge that autism and other neurodevelopmental disorders existed prior to the use of acetaminophen. Nevertheless, we align ourselves with the growing body of scientific research that establishes a causal link between in-utero exposure to acetaminophen and the diagnosis of autism spectrum disorder in the exposed child.

While genetics play a major role in autism environmental factors contribute to an increased incidence rate. Numerous studies have indicated not only an association between acetaminophen use and the prevalence of autism but also a dose-dependent relationship. In other words, higher levels of acetaminophen usage correspond to increased incidence rates and severity of autism.

Tylenol has been widely marketed as a safe over-the-counter pain reliever for pregnant women. However, recent studies examining umbilical cord blood samples have demonstrated a dose-dependent relationship between acetaminophen and autism. Consistent associations between acetaminophen and autism have been observed across numerous studies. The collective evidence strongly suggests that the use of Tylenol during pregnancy elevates the risk of autism and leads to negative neurodevelopmental outcomes in the developing fetus.

It is worth noting that the rise in autism rates began in the 1980s, coinciding with the replacement of aspirin with Tylenol for routine use due to public concerns about aspirin-related Reyes Syndrome. It is crucial to differentiate between the belief that vaccinations cause autism, which has been repeatedly debunked, and the association between in-utero acetaminophen exposure and autism. The scientific evidence supporting the link between Tylenol and autism is significant.

The ongoing discovery process, including depositions in the autism class action lawsuit, will be intriguing to uncover any information regarding Johnson & Johnson’s awareness of the risks associated with Tylenol use during pregnancy.

The Connection Between Tylenol Usage During Pregnancy and Neurodevelopmental Disorders: Unveiling the Risks and Strengthening Your Tylenol Autism Lawsuit

Tylenol, a commonly used over-the-counter pain reliever and fever reducer, has long been considered a safe option. However, recent findings have shed light on potential risks associated with its use during pregnancy, particularly concerning the development of neurodevelopmental disorders such as autism.

The prevalence of acetaminophen use during pregnancy is striking, with over 65% of pregnant women in the United States relying on it for pain relief. Obstetricians and healthcare professionals have traditionally reassured expectant mothers about the safety of acetaminophen among the available over-the-counter medications.

Nevertheless, in 2021, a consensus statement issued by a group of 91 esteemed scientists, researchers, and physicians raised concerns about acetaminophen use during pregnancy. They advised against its use unless medically necessary, citing a growing body of research indicating potential alterations in fetal brain development and an increased risk of neurodevelopmental disorders. Specifically, they highlighted the regular use of Tylenol during pregnancy as a cause for concern.

As we delve deeper into understanding the relationship between Tylenol usage during pregnancy and neurodevelopmental disorders, it becomes imperative to reevaluate the assumption of its safety. The well-being of both the mother and the developing fetus should be carefully considered, taking into account the potential risks associated with in-utero acetaminophen exposure.


Reach Out to Us Today To Learn More About the Tylenol Autism Lawsuit

If you or someone you know has been impacted by the effects of Tylenol, we encourage you to reach out to us. Our team of experienced mass tort attorneys will provide you with the legal support and guidance that you need and deserve during these troubling times.


Response time within minutes