Tylenol Autism Lawsuits: Current Status and Updates

Across the country, Tylenol autism lawsuits are being pursued, including a consolidated Tylenol Autism Multi-District Litigation (MDL) in federal court. However, the MDL’s future is uncertain, though potential government support could change the landscape.

Nguyen Injury Lawyer advises parents considering a Tylenol lawsuit to also explore the possibility of filing a toxic baby food lawsuit.

Update: The federal court cases have been dismissed, and an appeal is underway. The updates below detail the available options and potential for optimism based on recent developments.

Alternative Legal Avenues: Baby Food Lawsuits

Another avenue for compensation may exist for some individuals. Nguyen Injury Lawyer is investigating options in state court and assessing potential baby food lawsuits for children diagnosed with autism. These lawsuits have gained traction following the challenges faced by the Tylenol cases within the MDL.

Tylenol Lawsuit Updates

Before diving into the specifics of the Tylenol autism litigation, let’s review the current status of the Tylenol class action lawsuit.

The latest updates are as follows:

January 18, 2026 – New Study Findings

A comprehensive review published in The Lancet found no correlation between acetaminophen use during pregnancy and the development of autism, ADHD, or other neurodevelopmental disorders in children. Researchers analyzed 43 high-quality studies, relying on validated medical records and detailed exposure data, and concluded that acetaminophen did not elevate the risk of these conditions. This study contradicts prior claims, including those promoted by former Trump administration officials, which suggested a causal link between Tylenol and autism.

The review emphasizes that the most robust studies accounted for genetic and environmental factors, though further research on familial influences is warranted. Experts highlight that untreated maternal fever can pose developmental risks, and the American College of Obstetricians and Gynecologists continues to recommend acetaminophen as the first-line treatment for pain and fever during pregnancy.

While the Lancet review concludes that acetaminophen use during pregnancy does not correlate to autism or other neurodevelopmental disorders, several limitations suggest caution in accepting this finding wholesale. First, the analysis relies on observational studies, which are inherently limited in establishing causation. Even with validated medical records, recall bias, misclassification of exposure, and incomplete reporting of dosage or timing could underestimate risk.

Second, the review notes that relatively few studies included sibling or family comparisons, which are crucial for isolating environmental exposures from underlying genetic risk. Without robust controls for familial and genetic factors, the possibility of subtle but meaningful causal effects cannot be excluded.

Finally, while the review excluded lower-quality studies to focus on high-standard data, this may have removed valuable real-world evidence of risk patterns, especially in populations with high acetaminophen use or preexisting vulnerabilities. For plaintiffs pursuing claims of harm, these gaps support the argument that the science is not definitive and that acetaminophen could still have contributed to neurodevelopmental issues in individual cases.

November 29, 2025 – Leveraging Government Actions

Plaintiffs in the acetaminophen litigation have submitted a letter to the Second Circuit, urging the court to consider recent federal government actions concerning acetaminophen and pregnancy. The filing highlights that the FDA and HHS relied on the work of Dr. Andrea Baccarelli, a Harvard public health dean and plaintiffs’ expert, when deciding to add a pregnancy warning and issue a nationwide “Dear Doctor” letter.

The plaintiffs contend that this should strongly discourage the exclusion of Dr. Baccarelli’s testimony under Rule 702. They emphasize that his conclusions were not only accepted by regulators but also cited by top federal officials as the basis for a significant shift in health policy.

The letter cleverly frames the issue as a matter of separation of powers. The plaintiffs argue that if the executive branch has adopted Dr. Baccarelli’s findings to safeguard public health, courts should not prevent jurors from hearing the same evidence when evaluating claims of harm.

September 26, 2025 – Oral Arguments Postponed

Oral arguments have been rescheduled from October 6 to November 17 to allow sufficient time for all parties to analyze the recent developments from the Trump administration.

Additionally, there is renewed discussion of a Tylenol warning for pregnant women.

September 25, 2025 – Resurfaced Tylenol Tweet

The U.S. Health and Human Services department recirculated a 2017 social media post seemingly from Tylenol’s account, advising against the use of its products during pregnancy.

September 22, 2025 – Trump Administration on Autism

According to a Washington Post report, the Trump administration intends to publicly link acetaminophen, the active ingredient in Tylenol, to autism and advise pregnant women to avoid it unless they have a fever.

President Trump announced a major press conference on autism, asserting that his administration had “found an answer.”

The key question is the impact of these developments on the Tylenol lawsuits and the appeal in the 2nd Circuit. The answer remains uncertain.

September 10, 2025 – 2nd Circuit Arguments Scheduled

The U.S. Court of Appeals for the Second Circuit is scheduled to hear oral arguments on October 6 in a series of lawsuits alleging that Tylenol use during pregnancy may increase the risk of autism in children.

These cases are part of the broader Tylenol MDL, which consolidates hundreds of claims asserting that acetaminophen, the active ingredient in Tylenol, can disrupt fetal development when used by expectant mothers.

The appellate court’s review is considered critical as it will address key scientific and evidentiary issues that will determine whether these claims proceed in federal court or are dismissed.

September 8, 2025 – Timing of Autism Report

The federal government has not yet begun drafting its long-awaited autism report, but FDA Commissioner Marty Makary stated that it will be released within a month.

The report is expected to explore potential causes of autism, although Makary appeared to downplay speculation that Tylenol use during pregnancy will be a central focus.

September 5, 2025 – Potential RFK Jr. Report on Tylenol

Kenvue stock plummeted more than 10% on Friday following reports that Health and Human Services Secretary Robert F. Kennedy Jr. will soon release a report linking Tylenol use during pregnancy to autism.

The Wall Street Journal reported that the HHS review, anticipated this month, will not only raise concerns about acetaminophen (Tylenol’s active ingredient) but also suggest that a folate-derived medicine may help treat some autism symptoms.

Could this revitalize the Tylenol autism litigation? Possibly.

August 26, 2025 – New Research Emerges

While awaiting the appeal in the MDL, this litigation has been relatively inactive, as evidenced by the infrequent updates. A new study could potentially reignite momentum in this litigation.

A study from the Icahn School of Medicine at Mt. Sinai sheds new light on a series of cases that many had previously dismissed. By analyzing 46 studies on prenatal acetaminophen exposure, the researchers found that a majority indicated an increased risk of autism, ADHD, or related neurodevelopmental issues.

Even more compelling, the studies with stronger methodology were the ones most likely to demonstrate a link. Combined with evidence that acetaminophen can cross the placental barrier and disrupt neurological development, the scientific basis behind these claims appears stronger than it did when the federal MDL judge rejected the plaintiffs’ expert testimony.

That ruling effectively halted the Tylenol autism litigation in its tracks. However, the underlying question of whether the product poses risks to children when taken during pregnancy remains. This study brings it back into focus. While it may not reopen the MDL, it could provide future plaintiffs with a more disciplined, evidence-driven foundation for pursuing claims in other forums.

Courts in states with more lenient standards for admitting expert testimony could view this new research as a reason to reevaluate their approach. Additionally, if the FDA responds by tightening label warnings, it could shift the entire conversation about what manufacturers should have disclosed and when. These developments do not guarantee a revival of the Tylenol litigation, but they do indicate that the matter may not be fully resolved.

Whether the litigation picks up again will depend on how willing courts are to reconsider where the evidence stands today, not just where it stood when the first very small wave of cases was dismissed.

February 22, 2025 – Biomarker Study Suggests Strong ADHD Link

A study published in Nature Mental Health introduced new concerns about acetaminophen use during pregnancy. Researchers tested prenatal acetaminophen biomarkers in blood samples from 307 mothers in their second trimester. Children of exposed mothers were more than three times as likely to develop ADHD, with 18 percent affected versus 9 percent in the unexposed group. The association was particularly pronounced among girls, who were six times more likely to develop ADHD. Investigators called for a reevaluation of safety guidelines for acetaminophen in pregnancy.

January 3, 2025 – Oral Arguments Heard

The U.S. Court of Appeals for the Second Circuit convened oral argument last month, allowing both sides to present their case as the appeal challenges the district court’s exclusion of plaintiffs’ experts and dismissal of the MDL.

September 29, 2024 – Plaintiffs’ Appeal of the MDL Ruling

In their appellate brief, the plaintiffs argue that Judge Cote overstepped her authority by usurping the jury’s role in weighing evidence and, in effect, deciding a complex scientific debate herself by choosing a side.

More specifically, the plaintiffs contend that the district court’s 2023 decision to exclude all five of their general causation experts under Rule 702(d) demonstrates a fundamental misapplication of the Daubert standard, turning the court from gatekeeper into scientific arbiter. Their brief argues that Judge Cote applied unsubstantiated and novel methodological standards to exclude Drs. Andrea Baccarelli, Eric Hollander, Brandon Pearson, and others—each of whom is a distinguished expert in fields such as epidemiology, psychiatry, and pharmacology.

At the heart of the plaintiffs’ argument is the claim that Judge Cote disregarded established scientific norms and peer-reviewed literature that support their causation theories. For example, Dr. Andrea Baccarelli, the Dean of Harvard’s T.H. Chan School of Public Health, applied the Bradford Hill criteria to evaluate whether prenatal exposure to acetaminophen can cause ASD and ADHD. The district court rejected his testimony on the grounds that he applied the criteria “transdiagnostically”—an approach the court suggested was scientifically improper. Yet, as noted in the plaintiffs’ brief, numerous peer-reviewed studies have employed the Bradford Hill factors for multiple related conditions, including those in question.

If you have questions about a potential Tylenol autism lawsuit, contact Nguyen Injury Lawyer at (713) 747-7777 or through our website at https://www.nguyeninjurylawyer.com. You can also reach us through our contact page: https://www.nguyeninjurylawyer.com/contact.

Developments in the Tylenol Litigation

The core of the legal debate centers on the argument that Judge Cote may have overstepped her role. Instead of acting as a gatekeeper to ensure the reliability of expert testimony, she may have functioned more as a scientist, deciding what constitutes a valid scientific dispute among qualified experts. The ruling appeared to focus significantly on the public policy implications of warning against acetaminophen use during pregnancy, rather than on whether the scientific methods used were reliably applied. The opinion repeatedly cited the potential “public health significance” of the litigation, emphasizing that “resolution of this MDL…has profound consequences for the health and safety of pregnant women.” Such considerations arguably fall outside the scope of Daubert standards and may reflect a judicial preference for policy outcomes over strict evidentiary principles.

The Second Circuit’s ruling on the appeal is expected in early 2025.

Where Does the Tylenol Litigation Go from Here?

The central question now is the future direction of the Tylenol litigation. In the Zantac litigation, lawsuits were dismissed in the MDL, but plaintiffs have found more success outside the MDL. They are moving cases past the pretrial stages and even getting some claims to trial, although without success so far.

Currently, an appeal of Judge Cote’s ruling is pending. Some anticipated that plaintiffs’ lawyers would follow a similar path to the Zantac cases, shifting their focus to state court filings. However, there is no apparent rush to file Tylenol autism claims in state courts.

Despite this, several state court cases filed before Judge Cote’s ruling remain active. These include:

• Bartle Case (St. Clair County, Illinois): Johnson & Johnson’s motion to dismiss based on preemption is under advisement, with a status hearing scheduled for September 30, 2024.
• Cooksey Case (Madison County, Illinois): Defendants have filed motions to dismiss the plaintiff’s First Amended Complaint, fully briefed and scheduled for consideration on October 30, 2024.
• Davey Case (Alameda County, California): A trial date has been set for April 11, 2025, with ongoing discovery.
• Fennewald Case (Cook County, Illinois): Defendants’ motions to dismiss are pending, with a hearing scheduled for October 3, 2024.
• Bellmon Case (St. Clair County, Illinois): Defendants filed motions to dismiss on June 27, 2024, and the parties are currently briefing the motion.

Judge Cote Ends Federal Litigation

On August 22, 2024, Judge Cote granted summary judgment, effectively ending the litigation in federal court unless the plaintiffs succeed on appeal.

Optimism Was Not Warranted

A previous update expressed optimism that Judge Cote would allow Dr. Ness to testify for the plaintiffs. However, on July 15, 2024, Judge Cote ruled the causation opinion of the plaintiffs’ expert, Roberta Ness, unreliable and inadmissible. Despite Dr. Ness’s expertise in epidemiology and women’s health, her lack of experience in psychiatry, toxicology, and neurology, combined with methodological weaknesses and her acknowledgement of genetic factors as potential confounders, undermined her credibility.

Judge Cote highlighted a recent NIH study that found no significant link between acetaminophen and ADHD after accounting for genetic variables through sibling studies. She criticized Dr. Ness for disregarding this and other conflicting evidence, accusing her of selective reasoning.

The defendants are now seeking summary judgment, which is likely to be granted.

New Optimism for the MDL

To recap the events prior to June 6, 2024: the court had previously rejected all of the plaintiffs’ experts, citing methodological flaws in their analyses. These flaws included combining ASD and ADHD in their evaluations, relying on studies examining symptoms rather than confirmed diagnoses, inadequately addressing genetic confounding factors, ignoring opposing organizational opinions, improperly analyzing dose-response relationships due to a lack of precise dosage information, and asserting biological plausibility based on hypothetical mechanisms of action.

Plaintiffs, with a new, highly qualified expert, Dr. Roberta Ness, returned to court to address these concerns. Dr. Ness addressed each issue in her analysis, focusing solely on ADHD, emphasizing valid causal inferences based on diagnostic studies, thoroughly analyzing and dismissing genetic confounding, and explaining why organizations with opposing views are incorrect. She also addressed the dose-response relationship and biological plausibility, citing peer-reviewed literature to support her methodology.

Defense lawyers challenged the admissibility of Dr. Ness’s testimony, but faced a more difficult argument this time.

The Daubert hearing was closely watched.

Dr. Ness Is Plaintiffs’ Last MDL Stand

As of May 28, 2024, the Tylenol MDL’s chances of survival, absent a successful appeal, hinged on Judge Cote accepting Dr. Roberta Ness’s opinion.

Dr. Ness had been deposed and expressed her belief that acetaminophen could cause autism and ADHD. She reached this conclusion after conducting a thorough analysis using the Bradford Hill criteria. Dr. Ness clarified that she had not performed a separate Bradford Hill analysis specifically for autism but had done so for ADHD and neurodevelopmental disorders in general.

The Bradford Hill criteria are a set of nine principles used in epidemiology to determine a causal relationship between a presumed cause and an observed effect. These criteria include strength, consistency, specificity, temporality, biological gradient, plausibility, coherence, experiment, and analogy. They are crucial in a Daubert challenge because they provide a scientifically accepted framework for evaluating the reliability and relevance of expert testimony regarding causation, ensuring that the testimony is based on sound scientific principles.

Dr. Ness emphasized that her opinion was based on the literature she reviewed, which showed a strong and consistent link between acetaminophen and ADHD. Despite being compensated by plaintiffs’ lawyers, Dr. Ness stated that her primary role was to ensure the scientific accuracy of the information presented on the Autism Justice website and to inform the public.

Her analysis and notes on scientific studies were conducted before being retained as a testifying expert and included both ADHD and autism studies. She later conducted an ADHD-specific Bradford Hill analysis after Judge Cote’s Daubert ruling. This is significant in a Daubert challenge because it underscores the rigor and timing of her scientific analysis, which must meet standards of reliability and relevance for admissibility in court.

Dr. Ness also addressed concerns about the consistency of the data presented, indicating that some cited studies related to ADHD rather than autism but justified this by explaining the overlap between the two disorders. This overlap and the failure of plaintiff’s experts to distinguish between the two was a significant issue for Judge Cote when she rejected the plaintiffs’ first round of experts.

The defense lawyer scored a few points, but not related to the core issues for Daubert. Dr. Ness is an epidemiologist who has not treated patients or written prescriptions for ADHD medications and has not focused her professional research specifically on ADHD. However, it is not necessary to treat patients or focus one’s life on ADHD to offer testimony on the topic. She also admitted to working with a public relations firm to help craft her messages for public interviews, which, while not ideal, is not directly related to the Daubert matter.

Overall, the deposition appeared to go well. Judge Cote provided a roadmap for what she needed to see to pass an expert through Daubert, and Dr. Ness appeared to have cleared those hurdles. The legal community awaited Judge Cote’s perspective at the Daubert hearing.

One More MDL Shot

Following the Daubert ruling, the plaintiffs introduced a new expert. The deadline for the Defendants to file a motion to exclude this new expert was set for July. A determination on the new expert’s eligibility was expected shortly after, likely in the late summer or early fall of 2024.

Nguyen Injury Lawyer is no longer taking new Tylenol cases and is monitoring the situation. We are reviewing baby food autism lawsuits for children 6 and under.

Another Shot at the MDL?

As of February 17, 2024, the case had become more interesting. Judge Cote expressed an openness to considering a new expert witness who links ADHD to Tylenol. The judge instructed both parties to outline a briefing schedule to assess the admissibility of the expert’s opinion.

The defendants sought to dismiss the proposed expert, Dr. Roberta Ness, criticizing her analysis as flawed, similar to previously excluded expert witnesses. However, new plaintiffs to the MDL argued that they should not be restricted by prior rulings made before their involvement. Judge Cote was willing to hear Dr. Ness out.

Both sides had until February 23 to propose how to proceed with evaluating Ness’s report under the guidelines for expert testimony.

While the judge may have simply been allowing plaintiffs to be heard, there was a glimmer of hope.

Still More Battles as the MDL Closes Out

On February 3, 2024, a group of twelve parents and children, alleging that prenatal exposure to acetaminophen led to ADHD, challenged the decision that disqualified all expert witnesses intended to support plaintiffs in comparable cases. This motion argued that the group had the right to present their case with their own experts, having filed their complaints in the multidistrict litigation subsequent to a decisive December 18 ruling that negated the expert testimony proposed by other families.

This prior ruling significantly impacted numerous plaintiffs, leaving them without credible evidence to link Tylenol or similar products containing acetaminophen to autism or ADHD, prompting a directive from U.S. District Judge Denise Cote to justify the continuation of their cases.

This claim was bolstered by a precedent from the 3rd Circuit regarding expert testimony in multidistrict litigation (MDL), emphasizing their right to have their cases assessed on individual merit.

Plaintiffs Face Dismissal

By February 1, plaintiffs in the MDL needed to provide a valid reason why the court shouldn’t dismiss their cases where the Short Form Complaint (SFC) was issued on or before January 11, 2024. This applied to the 501 plaintiffs who filed suit in the MDL and did not impact the hundreds of thousands of plaintiffs who may have hired a lawyer but remained on the sidelines in the MDL.

Other Paths to Compensation for Victims

The 501 plaintiffs in the MDL were expected to appeal Judge Cote’s ruling. Other plaintiffs were likely to explore state court options. There was considerable discussion among plaintiffs’ lawyers regarding how to approach this litigation in state court and where suits should be brought.

For guidance on personal injury litigation, contact Nguyen Injury Lawyer at (713) 747-7777 or visit our website at https://www.nguyeninjurylawyer.com. You can also reach us through our contact page at https://www.nguyeninjurylawyer.com/contact.

Updates on the Tylenol Autism Lawsuits

Following her recent decision, Judge Cote instructed all involved parties to convene, deliberate, and jointly submit a letter to the court by January 12th, outlining their proposed course of action. Realistically, with the ruling issued, the primary remaining step in the MDL is an appeal, rendering this meeting somewhat procedural.

January 1, 2024 – Analysis of Judge Cote’s Ruling

Read our comprehensive explanation and analysis of Judge Cote’s recent ruling: Judge Pulls Plug on Tylenol Autism Lawsuits. (This link is for example only.)

December 19, 2023 – Tylenol Ruling and Baby Food Autism Lawsuits

The federal MDL is currently stalled following Judge Cote’s unfavorable ruling after the Daubert hearing. In a detailed 148-page decision, which likely began before the hearings, Judge Cote concluded that the scientific experts for the plaintiffs failed to convincingly demonstrate a causal relationship between Tylenol and conditions like autism, ADHD, or hyperactivity, making the claims legally unsustainable. She stated that the experts did not reliably apply scientific methods to establish the link between the medication and these conditions. Our attorneys at Nguyen Injury Lawyer will provide a more detailed breakdown soon. However, this development is undoubtedly discouraging.

Nguyen Injury Lawyer has been upfront about the anticipated direction of the Tylenol MDL post-Daubert hearing. If your child is under seven and consumed baby food from manufacturers frequently cited in litigation, your family might have a claim in that separate litigation. If you wish to explore this option, please contact us online to discuss your situation.

However, options may remain available in state courts for Tylenol litigation. Our lawyers anticipate numerous cases in Pennsylvania, New Jersey, and California. While this outcome was foreseen as a possibility, it represents one judge’s perspective, suggesting a potentially lengthy legal battle ahead. Despite this, it’s crucial to acknowledge that this ruling is a significant setback for these cases.

December 8, 2023 – Reaction to Daubert Hearing

Kenvue Inc., the consumer health division recently separated from Johnson & Johnson, saw its stock value increase by 10% following a Daubert hearing related to the class action lawsuit.

This increase is believed to be due to the perception that the hearing’s outcome was favorable for the defense.

December 7, 2023 – Daubert Hearing Today

Nguyen Injury Lawyer remained optimistic about our chances at the Daubert hearing. We also recognize that many individuals visit our site for the most current information on these cases. Therefore, we feel obligated to share our insights and opinions.

Our firm did not attend the Daubert hearing today in New York. However, based on our sources, there is diminished optimism regarding the plaintiffs’ prospects following today’s proceedings. The hearing’s outcome was less favorable than initially anticipated.

Predicting a single judge’s decision is inherently uncertain, and judges don’t always reveal their complete thinking. While uncertainty remains, our enthusiasm regarding the prospects of these cases in federal court has decreased since this morning.

We are opening the previously closely held comments section below if anyone has any questions or comments for us or other plaintiffs.

December 4, 2023 – Settlement Conference Set

A settlement scheduling telephone conference is scheduled for the Tylenol lawsuit on Thursday, January 4, 2024.

The meaning of this is unclear. While it could be a positive sign regarding the Daubert matter, any interpretation remains speculative.

December 1, 2023

Everyone is awaiting the hearing next Friday, as the ruling will significantly impact this litigation.

November 17, 2023 – 58 New Cases Added to MDL

Over the past month, fifty-eight new cases have been added to the Tylenol autism class action MDL, bringing the total number of pending cases to 441. If Judge Cote rejects the defendants’ Daubert challenges, the number of pending cases in the MDL is expected to increase substantially.

November 11, 2023 – Daubert Hearing December 7th

Our hope that the judge would deny the Daubert challenges without a hearing was not realized. A Daubert hearing is scheduled for December 7, 2023, but it will proceed without witnesses.

Interpreting the implications of a Daubert hearing without expert witness testimony is challenging. However, there are still reasons to remain optimistic.

For further information, please see our recent video: Tylenol Autism Lawsuits – Nov 2023 Update. (This link is for example only.)

November 8, 2023 – Tylenol Autism Cases in State Court

Some acetaminophen lawsuits are also proceeding in state courts, although they have received less attention. One case in Madison County, Illinois, is progressing, albeit at a slower pace compared to Judge Cote’s proceedings.

A schedule has been established for the parties to present arguments regarding the Defendants’ requests for dismissal. The Plaintiff must submit a response by December 12, 2023, and the Defendants are to provide any reply brief by January 12, 2024. A hearing date will be determined in early 2024.

If the plaintiffs do not succeed in federal court after Daubert, the focus of Tylenol lawsuits will likely shift rapidly from federal to state courts. We hope that this situation does not arise.

November 3, 2023 – Judge May Give Plaintiffs Quick Win on Daubert

The Daubert matter has been thoroughly prepared, and all necessary briefs have been submitted. If a hearing is scheduled, it will take place during the week of December 5, 2023. We hope that Judge Cote rules in our favor based on the written submissions alone, as they are compelling. If a hearing occurs, it is expected to be concise, with Judge Cote focusing on specific inquiries.

November 1, 2023 – All Daubert Briefs are Now Filed

All Daubert briefs have been submitted to Judge Cote regarding the critical issue of which scientific expert testimony will be admissible. Both sides submitted reply memorandums last week to support their motions to exclude specific expert witnesses presented by the opposing side. The reply memos addressed arguments made by the opposing side in response to the initial motions to exclude. Separate briefs were submitted for each individual expert witness, involving three rounds of briefing. Including supporting exhibits, the briefs total several thousand pages. Judge Cote will hold hearings to consider arguments on the motions and potentially hear directly from some of the experts.

October 17, 2023 – Over 100 New Cases Added to MDL

There are now 382 pending cases in the Tylenol autism MDL. For the first year after the MDL’s creation, the volume of new cases was low, typically under 20 per month. However, the monthly new case volumes have recently begun to increase steadily. Over the past month, 111 new cases were added.

October 9, 2023 – Parties Submit Proposals for Daubert Hearings

In preparation for the upcoming Daubert hearings, Judge Cote requested that both sides submit proposals outlining how the hearings should be conducted logistically. These proposals were submitted last week. The defendants are advocating for a comprehensive week-long hearing process to allow additional time to challenge the scientific evidence. Conversely, the plaintiffs are pushing for a much shorter process and have suggested that Judge Cote narrow the scope of the hearings by identifying in advance which experts she needs to hear from.

October 5, 2023 – Objection to Supplement Expert Reports

In response to the Plaintiffs’ notification of their intent to submit supplemental expert reports for two of their experts, the defendants have objected. They claim that any supplement to include this new study is untimely and violates Rule 26 because it was available in a pre-print version, which is obviously different than getting published in a journal.

This seems rather nitpicky. Either the defendants are genuinely concerned about this article, or they are simply being reflexively oppositional—or both.

October 4, 2023 – New Study

A new study last month examined the effects of acetaminophen (paracetamol) use by pregnant women. The study found that when pregnant women take Tylenol, it may impact their baby’s brain development. (This link is for example only.)

Scientists sought to understand the underlying mechanisms. They used special cells in a lab that mimic the early stages of a human brain. These cells were exposed to paracetamol in amounts similar to those used by pregnant women.

It may affect the genes of the unborn. Genes are like tiny instructions that control many important things in the brain, like how brain cells talk to each other and what kind of cells they become. Some of these genes are also linked to brain injuries and how the brain grows. Interestingly, these findings align with genes found in blood samples from babies who were exposed to acetaminophen before birth.

Will this study be discussed during the Daubert hearings this month? Absolutely. Plaintiffs’ experts are incorporating this new study into their expert reports.

October 2, 2023 – Revisions to Plaintiff Fact Sheets

In a joint letter filed this morning, the parties informed Judge Cote that they have completed the revisions to the Plaintiff Fact Sheets. Revisions have also been made to the health records authorization forms required from new incoming plaintiffs. All of these changes are intended to address logistical issues that have arisen and to streamline the information-gathering process for new plaintiffs.

September 23, 2023 – Experts to Exclude Defense Experts

Plaintiffs’ lawyers have moved to exclude defendants’ experts for a variety of reasons ahead of the Daubert hearing. (This link is for example only.)

September 22, 2023 – Plaintiff’s Experts

These are the five general causation experts for plaintiffs in the Tylenol MDL:

• Dr. Andrea Baccarelli, MD, PhD, is a leading expert in environmental health science and Chair of the Department of Environmental Health Sciences at Columbia University. His research focuses on exploring the chemical and molecular links between human disease and exposure to certain drugs or chemicals. He has published over 600 articles and is an elected member of the National Academy of Medicine and President of the International Society of Environmental Epidemiology. (This link is for example only.)
• Dr. Robert Cabrera, Ph.D., is an Associate Professor at the Baylor College of Medicine. Dr. Cabrera is a molecular & cellular biologist, and his expertise and research focus on chemical causes of birth defects during embryonic development.
• Dr. Eric Hollander, MD, is a Professor of Psychiatry and Behavioral Sciences at the Albert Einstein College of Medicine. Dr. Hollander has been the primary investigator in numerous federal grant studies on the causes of autism. These have included several major studies on autism causes funded by the Food and Drug Administration and the National Institutes of Health. Dr. Hollander has published hundreds of scientific articles on autism and edited over 20 medical textbooks, including Autism Spectrum Disorders (American Psychiatric Publishing, 2017) and the Textbook of Autism Spectrum Disorders (American Psychiatric Publishing, 2011).
• Dr. Stan G. Louie is a Professor of Clinical Pharmacy at the University of Southern California. Dr. Louie’s current research and work focus on the testing and development of new drugs for inflammatory diseases, cancer, and neurodegenerative diseases.
• Dr. Brandon Pearson, PhD, is a neuroscientist and toxicologist and currently an Assistant Professor of Environmental Health Sciences at Columbia University. Dr. Pearson is an expert in neurotoxicology, epigenetics, and cell biology, and he is currently involved in laboratory studies focusing on genetic and environmental factors causing autism. Dr. Pearson has never previously testified as a litigation expert but was compelled by a sense of moral duty to provide his expertise in this case.

These experts are undoubtedly highly qualified.

September 18, 2023 – MDL Doubles in Size Over Summer

Tylenol Autism Litigation: Recent Developments

In June, the Tylenol autism class action MDL had 136 pending cases. That number has now grown to 265, nearly doubling in size over the summer. However, this figure may be misleading, as over 100,000 potential Tylenol claims are awaiting Judge Cote’s decision on whether to allow these claims to proceed before lawsuits are officially filed.

September 12, 2023 – Hearing Request Denied

Following the FDA’s statement, the defendants requested a status conference from the court at 9:11 a.m., likely hoping to argue for the case’s dismissal based on the FDA’s stance of no causation. This strategy appears to be a preemptive move by Tylenol’s defense lawyers. However, the notion that the FDA’s choice not to submit a statement of interest validates their position is flawed. By 11:05 a.m., Judge Cote denied the request and reaffirmed that the Daubert and other deadlines would remain as previously scheduled.

September 8, 2023 – FDA Decision

The FDA’s statement included the following:

“The United States respectfully declines the Court’s invitation to submit a statement of interest in this matter,” while referencing the FDA’s latest review, which concluded that “…the limitations and inconsistent findings of current observational studies of and neurobehavioral and urogenital outcomes are unable to support a determination of causality.”

The letter concluded with an indication that the FDA generally avoids involvement in drug litigation, stating:

“Although, as a general matter, FDA does not engage in third-party litigation of this kind, FDA monitors the safety of drug products and has several administrative channels through which new information relevant to the safety or effectiveness of OTC acetaminophen products may be submitted.”

Nguyen Injury Lawyer views this as a significant win for plaintiffs.

September 1, 2023 – FDA Decision

In April, Judge Cote requested the FDA’s input on the warning issue central to the Tylenol autism class action lawsuits.

This request sought the FDA’s assessment of whether the plaintiffs’ proposed warning should be included on acetaminophen labels and whether current scientific evidence supports warnings about the risk of autism or ADHD for pregnant women. The question is whether manufacturers should have informed women about potential risks to their unborn children.

The FDA requested more time through the U.S. Attorney for the Southern District of New York, extending the deadline to September 15, 2023. The FDA’s report to Judge Cote may be crucial as the Daubert motions approach. Nguyen Injury Lawyer remains confident in the science supporting these lawsuits.

August 24, 2023 – Tylenol Class Action Update This Fall

Currently, numerous depositions of experts and other witnesses are underway, addressing the question of general causation – whether Tylenol can cause ADHD and autism.

Plaintiffs’ attorneys are optimistic about the progress of these depositions, believing that (1) Judge Cote will rule favorably on Daubert due to the strength of the science, and (2) even if she does not, these claims remain strong and viable in state court.

If the Daubert hearings are successful this fall, it is unlikely that Johnson & Johnson and other defendants will risk taking these cases to trial, as the average successful verdict could easily reach millions of dollars. Contact Nguyen Injury Lawyer at (713) 747-7777 to discuss your claim.

August 21, 2023 – Judge Allows Consolidated Daubert Briefs

Judge Cote has granted the defendants permission to submit a consolidated brief on the Daubert challenges to the admissibility of the plaintiffs’ scientific expert evidence. The plaintiffs had requested that Judge Cote deny this request, arguing that separate briefs for each expert were necessary for a fair outcome.

The outcome of the Daubert challenges will significantly impact the future of the Tylenol autism class action. If Judge Cote deems the plaintiff’s causation evidence inadmissible, all pending cases may eventually be dismissed.

August 14, 2023 – Negligent Misrepresentation Claims Barred in Some States

In a joint letter to Judge Cote, the defendants and plaintiffs in the Tylenol autism MDL agreed that plaintiffs in certain states cannot pursue negligent misrepresentation claims based on omissions.

These states include Arkansas, California, Colorado, Idaho, Indiana, Kentucky, Nebraska, New Hampshire, North Carolina, North Dakota, Ohio, South Dakota, Tennessee, Texas, and Wyoming. However, this is not expected to significantly impact the cases’ ultimate outcome. Contact Nguyen Injury Lawyer through our website, https://www.nguyeninjurylawyer.com, for more information.

August 4, 2023 – Daubert Motions

Judge Cote’s rulings on Daubert will have substantial power over this litigation. While options in state court may exist if Judge Cote rules unfavorably, her decision is critical and will be in her hands.

The parties’ Daubert motions are due on September 19, 2023. Alongside these motions, both plaintiffs and defendants must submit a letter to the judge with (1) their recommendation on the order in which the Court should handle motions by the defendants to exclude expert reports from the plaintiffs’ experts, and (2) their argument on which motions regarding the parties’ expert reports should be considered together based on overlapping subject matter.

August 1, 2023 – FDA Will Weigh in on Tylenol Warning Labels

In April, Judge Cote requested the federal government’s opinion on the plaintiffs’ proposed new Tylenol warning labels. The government is expected to submit an opinion.

Judge Cote recently granted the government’s request to extend the deadline for submitting a statement of interest, allowing the parties to view the statement before submitting their initial Daubert motions on September 19, 2023.

July 18, 2023 – 64 New Cases Added to MDL Last Month

The Tylenol autism class action MDL in the Southern District of New York saw 64 new cases added in the past month, the highest volume since the MDL’s creation. The MDL now includes 200 Tylenol pregnancy lawsuits, with many potential plaintiffs awaiting the evidentiary rulings later this year. Contact Nguyen Injury Lawyer at https://www.nguyeninjurylawyer.com/contact for a free consultation.

July 10, 2023 – Why So Few Lawsuits in the MDL?

A Connecticut mother filed a lawsuit in the MDL last week, the only Tylenol lawsuit filed in the MDL at that time.

Despite the consolidation of Tylenol autism cases in federal courts into a class action MDL over six months ago, fewer than 150 Tylenol autism (or ADHD) lawsuits were pending in the MDL as of that week. Nguyen Injury Lawyer believes that over 100,000 plaintiffs have retained attorneys.

The MDL’s size remains small because many prospective plaintiffs are waiting to see how the Daubert challenges play out before filing their cases. This allows them to file in state court if the MDL is terminated due to the judge dismissing the scientific evidence linking Tylenol to autism. If the judge rules the evidence admissible, a surge of Tylenol autism lawsuit sign-ups in the MDL is likely.

Some lawsuits will continue to be filed due to statute of limitations concerns or client preferences, but most claims will remain on the sidelines pending Judge Cote’s decision.

July 1, 2023 – State Court Acetaminophen Lawsuits

Given the numerous defendants involved, there are several Tylenol lawsuits in state court. One example is a recently filed case in Illinois, where a mother filed an acetaminophen lawsuit for her daughter against Walgreen Co., an Illinois corporation headquartered in Illinois. Due to the plaintiffs also being Illinois residents, there is no diversity jurisdiction, preventing them from filing their lawsuit in the MDL class action. Call Nguyen Injury Lawyer today at (713) 747-7777.

June 5, 2023 – Plaintiff Pushes Back on J&J’s Request for Immediate Appeal

Johnson & Johnson has requested an immediate appeal of the court’s preemption and causation orders. The plaintiffs filed a motion opposing this request.

An immediate appeal could halt the litigation for a year. Plaintiffs’ attorneys argue that an immediate appeal is a rare exception that does not apply in this case, as the court will soon address the causation issue at a Daubert hearing later this year.

May 22, 2023 – Problem with Texas Tylenol Lawsuits – No Problem with California Claims

The MDL Judge recently granted a motion to dismiss a Tylenol autism case filed by CVS and other retail defendants based on a Texas “safe harbor” law. The Texas statute (Tex. Civ. Prac. & Rem. Code Ann. § 82.007(a)) states that retailers of over-the-counter drugs like Tylenol cannot be held liable for failure to warn if their warning labels complied with FDA-approved product labeling and information (the “monographs”). This means that all Tylenol autism claims governed by Texas law could face dismissal. (Nguyen Injury Lawyer is no longer accepting Texas Tylenol lawsuits.) In the same opinion, Judge Cote denied the dismissal of another case based on a similar safe harbor statute in California.

May 17, 2023 – Target & Walmart Lose Preemption Motion

Retailers Target Corp. and Walmart Inc. will need to defend themselves against a lawsuit alleging they failed to warn about the potential risk of autism or ADHD in children from prenatal consumption of their store-branded acetaminophen. However, CVS Pharmacy Inc. has avoided a similar lawsuit.

Makesha Anderson and Crystal Washington filed these claims as part of a larger multidistrict litigation, arguing that the retailers’ store-branded acetaminophen products lacked the necessary warnings. They cited studies suggesting a link between prenatal exposure to acetaminophen and autism in children, which form the basis of every acetaminophen autism lawsuit.

Judge Denise L. Cote, overseeing all federal Tylenol lawsuits, dismissed Target and Walmart’s argument that their compliance with federal law absolves them of liability under state law in any Tylenol pregnancy lawsuit. She ruled that California law applies to Anderson’s suit and is not prohibited by a 1993 ruling from the state’s high court, but Washington’s claims fall under Texas law and should be dismissed.

May 9, 2023 – J&J Seeks Immediate Appeal

Johnson & Johnson submitted a request to the MDL court for an interlocutory appeal regarding Judge Cote’s rejection of their preemption motion. This type of appeal would allow J&J to obtain an appellate court’s assessment of the preemption order before the case progresses.

Contact Nguyen Injury Lawyer at (713) 747-7777 for a free consultation, or visit our website at https://www.nguyeninjurylawyer.com.

Updates on the Tylenol Autism Lawsuit

While appeals are generally only allowed after a final decision, interlocutory appeals are an exception in certain circumstances. The court is unlikely to grant this type of appeal, as it would delay litigation that the judge clearly wants to expedite. However, the outcome isn’t certain, and the court has scheduled briefings to ensure the issue is thoroughly examined.

May 1, 2023 – Requesting the FDA’s Opinion

Many are curious if it’s common to seek the FDA’s opinion on whether a warning would have been appropriate. It is not.

The judge posed two questions to the FDA (through the U.S. Attorney for the Southern District of New York):

• Should the Plaintiffs’ Proposed Warning be added to acetaminophen labels?
• As of today, does science warrant the addition to acetaminophen labels of any warning or advice regarding in utero exposure to acetaminophen and the risk of ASD or ADHD?

These are significant inquiries, and it’s difficult to imagine the FDA influencing what could become one of the largest mass torts in history. However, we will see what happens.

April 21, 2023 – Judge Denies J&J’s Preemption Motion

Judge Cote issued an Order in the Tylenol and autism lawsuit, rejecting J&J’s motion to dismiss based on preemption. J&J argued that federal laws and FDA regulations governing OTC drug labeling preempted the plaintiffs’ failure-to-warn claims. In her 37-page ruling, Judge Cote clearly outlined the relevant law on preemption.

She concluded that J&J’s argument failed because federal rules and regulations didn’t prevent J&J from adding a warning about the risks of in utero exposure to Tylenol. Judge Cote reached a similar conclusion last November when denying a preemption motion filed by Walmart.

April 20, 2023 – Judge Seeks Government Input on Tylenol Warning Labels

A federal judge has requested the government’s opinion in the Tylenol class action. The plaintiffs proposed a warning addressing the risk of ASD and ADHD with frequent use during pregnancy. While acetaminophen-containing products must comply with monographs requiring a general pregnancy warning, the acetaminophen monograph lacks specific pregnancy-related warnings. The judge seeks the government’s perspective on adding the plaintiffs’ proposed warning to acetaminophen labels.

It will be interesting to see if the FDA provides its opinion. If it does, it could be significant. According to 21 C.F.R. § 10.85(j):

“An advisory opinion may be used in administrative or court proceedings to illustrate acceptable and unacceptable procedures or standards, but not as a legal requirement.”

We’ll see if the FDA is willing to engage in this complex issue.

April 13, 2023 – Proposed ADHD/Autism Tylenol Warning

Judge Cote asked the Plaintiffs about the specific wording of the Tylenol autism/ADHD warning. Nguyen Injury Lawyer believes it should read:

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’s difficult to argue against adding this acetaminophen warning to the product today unless the only goal is to sell acetaminophen. How can a doctor familiar with the issues answer the question, “Can you take extra strength Tylenol while pregnant?” without discussing Tylenol, autism, and ADHD? A doctor who has reviewed the literature would never say, “Sure, don’t worry about it.” Yet, that’s exactly what J&J and other manufacturers are telling pregnant women.

March 31, 2023 – Expert Discovery

The MDL judge in the acetaminophen-ASD-ADHD lawsuit issued an order yesterday regarding expert testimony discovery.

The court ruled that rebuttal expert testimony should be included in the expert discovery schedule, despite objections from the defendants. The plaintiffs had until March 15 to disclose whether they intended to designate an expert in maternal-fetal medicine. On March 17, the plaintiffs notified the defendants that they would not submit an affirmative expert report on this subject, but may submit a rebuttal report. The defendants objected, and the matter was brought before the court on Monday. The court ordered that the plaintiffs must disclose by April 4 whether they intend to serve an affirmative expert report on maternal-fetal medicine by June 16, and that they may only serve a rebuttal report if they serve an affirmative report.

The plaintiffs previously identified six areas of general causation. The defendants added maternal-fetal medicine as an additional area. The plaintiffs’ attorneys don’t believe they need a maternal-fetal medicine expert to meet their burden of proof for general causation. However, since the plaintiffs don’t know what the defense expert might say, they want to reserve the right to call a rebuttal expert, which is just common sense. It is hard to understand why the defense lawyers objected.

This is a lot of inside baseball most of you are not interested in but the more overarching point is that it is hard to recall an MDL class action that was moving faster than this one.

February 11, 2023 – Plaintiff’s Fact Sheet

The parties will submit joint or competing plaintiffs’ fact sheets by February 28, 2023.

What is a fact sheet and what does it mean to you? A plaintiffs’ fact sheet in an MDL class action is basically the biographic history plaintiffs in the litigation must provide. The fact sheet includes information such as the plaintiff’s name, the injury suffered, the defendants, and the legal theories being asserted.

The fact sheets have many purposes, not the least of which is identifying common issues and patterns among the claims. This is important to gain a feel for the scope of the litigation, which is helpful for settlement. This information is also used in selecting “bellwether trial” the first lawsuits to go to trial.

January 11, 2023 – Judge Streamlines Acetaminophen Lawsuit Filing

Tylenol autism MDL Judge Denise Cote approved a Short Form Complaint this week. All new incoming plaintiffs in the MDL will now use the Short Form Complaint when filing their case.

What does this mean? It means it is easier now to file a Tylenol lawsuit because you no longer need to include the laundry list of allegations. Instead, your short-form lawsuit references the allegations in the master complaint in the class action.

Judge Cote has already permitted direct filing of new cases in the MDL. These two steps combined make the process of filing new Tylenol autism cases much more efficient and should lead to a big spike in new case filings this year.

January 9, 2023 – New Tylenol Autism Lawsuit Transferred from Florida to New York

A new Tylenol autism lawsuit, Smith v. Walmart (0:22-cv-62092), is an example of an acetaminophen suit that was originally filed in federal court in Florida and recently transferred into the class action MDL in New York. The lawsuit names only Walmart as a defendant. The plaintiffs – a mother and her child – allege that Equate, Walmart’s version of Tylenol, was used by the mother while pregnant and this led to the child developing autism.

Again, if you file a Tylenol suit in federal court in California, Pennsylvania, Ohio, or anywhere else in the country, that lawsuit will be transferred to New York for the consolidated litigation that houses all of these claims.

January 1, 2023 – Appointment of Special Master in Tylenol Lawsuit

Randi Ellis has been appointed Census Special Master in the Tylenol autism MDL. This means she will be in charge of developing a system for the coordinated collection of key information and data from all plaintiffs in the litigation and making that information useable to the parties and the Court. Ms. Ellis is no stranger to mass tort litigation. She has been appointed Special Master is several other MDLs in 2022.

December 13, 2022 – Tylenol Class Action Progressing Rapidly

The Tylenol autism MDL judge is requiring the plaintiffs to file a master complaint by the end of this week, which will apply to all future actions in the MDL. A Short Form Complaint for new incoming lawsuits to the class action will be jointly submitted by January 4, 2023.

This judge is eager to push the ball forward. She has also moved quickly on several motions that will allow us to begin the litigation in earnest. This judge seems to understand that lawyers in major class action lawsuits are fully engaged and do not need endless time to perform tasks.

For example, the judge gave the parties only two weeks from the date of the first hearing to submit proposed orders on some substantial issues like electronic discovery, protection/confidentiality, master complaints, etc. This is how it should benefit the victims of autism and ADHD who want to see the cases ripe for settlement as soon as possible.

November 20, 2022 – Types of Cases in the Tylenol Class Action

We talk most about autism and ADHD. Nguyen Injury Lawyer is considering cases involving:

• Asperger’s Syndrome
• Kanner’s Syndrome
• Childhood Disintegrative Disorder
• Pervasive Developmental Disorder

November 15, 2022 – Walmart’s Motion to Dismiss Is Denied

Tylenol autism MDL Judge Denise Cote issued an Opinion and Order yesterday denying Walmart’s motion, which sought dismissal based on the federal preemption doctrine. The decision comes just two months after Walmart filed its motion, which is incredibly fast for the resolution of this type of motion in a class action MDL context.

In denying the motion, Judge Cote explained that the applicable FDA labeling laws did not prevent Walmart from voluntarily adding a warning about use during pregnancy to its Equate-brand acetaminophen and, therefore, federal preemption did not apply. Judge Cote emphasized that under the FDA rules, manufacturers still have a duty to enhance their warning labels to ensure they are adequate.

The ruling is not a surprise. But it is generating a lot of excitement.

November 14, 2022 – Walmart Files Motion to Dismiss in Tylenol Class Action Lawsuit

Walmart is seeking dismissal of the Tylenol autism lawsuit against it based on federal preemption. The lawsuits accuse Walmart of negligently failing to warn about the risk of using its Equate-brand acetaminophen products during pregnancy.

In its dismissal motion, Walmart argues that these claims are preempted by federal law because the warnings on the products were regulated by the FDA and could not be unilaterally changed. In their response in opposition, the Tylenol plaintiffs contend that the applicable federal laws and regulations did allow Walmart to voluntarily add a warning to its product labels.

Walmart filed a supplement brief in support of its motion last week. Federal preemption is a common defense in defective drug cases based on failure to warn. The defense is not usually successful.

November 13, 2022 – Initial Status Conference in Tylenol Class Action

In the new Tylenol autism class action lawsuit (Tylenol MDL-3403), Judge Denise Cote will hold the next monthly status conference on Thursday, November 17, 2022, in New York. Judge Cote is expected to make some significant decisions and announcements at this conference.

First and foremost will be her selections for Tylenol lawyers to serve on the plaintiffs’ leadership committee. This committee will confer and make collective decisions on behalf of all plaintiffs in the MDL class action. Judge Cote will also hear from both sides regarding proposals for case management of the Tylenol lawsuit.

If your child has been diagnosed with autism or ADHD and you believe that acetaminophen use during pregnancy may be the cause, contact Nguyen Injury Lawyer for a free consultation at (713) 747-7777 or visit our website at https://www.nguyeninjurylawyer.com. You can also reach us through our contact page at https://www.nguyeninjurylawyer.com/contact.

The initial hearing’s atmosphere and presentation also hold significance, providing Tylenol’s legal team with an early indication of the judge’s perspective on the litigation.

November 7, 2022 – Defense Leadership Selected for Tylenol Class Action

In the Tylenol autism class action MDL, Judge Cote approved the proposed structure for the defense lawyer committee. This body, known as the Retailer Liaison Committee (RLC), will make unified decisions for the defense. The RLC will consist of attorneys representing the defendants, chosen by Judge Cote through an open application process. Appointments are expected to be announced the following week.

November 4, 2022 – Tylenol Defendants Settle Unrelated Litigation for $13 Billion

CVS, Walmart, and Walgreens, key retail defendants in the Tylenol autism lawsuits, recently announced a proposed settlement to resolve thousands of opioid lawsuits against them. The agreement involves the companies paying approximately $13 billion over 10 years to state and local governments that initiated the opioid lawsuits.

Why discuss settlement payouts in other litigation involving the same defendants? Because that settlement offers parallels to the Tylenol autism lawsuits, highlighting the reasons these retailers face legal action in the acetaminophen cases. Compensation in the Tylenol autism cases could potentially exceed $13 billion if the claims progress as anticipated.

October 5, 2022 – New Tylenol Class Action Lawsuit

A Tylenol class action lawsuit is now underway. The new MDL – titled:

In Re: Acetaminophen – ASD/ADHD MDL
No. 3043

– will be overseen by Judge Denise L. Cote in the Southern District of New York. This marks Judge Cote’s 9th MDL class action lawsuit.

Over 80 filed acetaminophen lawsuits will be immediately transferred to Judge Cote.

September 30, 2022 – MDL Arguments

The JPML convened yesterday for oral arguments regarding the consolidation of the increasing number of autism cases into a new acetaminophen class action. The number of lawsuits alleging that acetaminophen use during pregnancy caused autism has grown steadily, with a significant number now pending in federal districts nationwide.

In June, a group of plaintiffs requested the consolidation of these cases into a new MDL. The defendants, including manufacturers and major retailers of acetaminophen, strongly oppose this class action consolidation. A panel of JPML judges will now render a decision.

There is no question the Tylenol autism lawsuits could become one of the biggest mass torts in American history. One member of the JPML, Judge Matthew Kennelly, noted at the hearing that this could get “really gigantic.” Feels foreshadowing.

September 11, 2022 – Oral Arguments for Class Action Set

Oral arguments before the JPML regarding the motion to consolidate the acetaminophen autism cases into an MDL class action lawsuit are scheduled for September 29, 2022, in St. Louis.

Despite opposition from several defendants, our Tylenol autism lawyers believe the odds still favor the MDL class action lawsuit being granted. The more uncertain aspect is the venue the JPML will select if a new MDL is established. The plaintiffs are advocating for the Northern District of California, while the defendants prefer New Jersey.

August 9, 2022 – Battle for a New Acetaminophen Class Action Lawsuit

Plaintiffs in the acetaminophen autism lawsuits have filed a Reply in Support of their recent request to consolidate all Tylenol autism lawsuits into a new MDL class action. The Reply contests the legal arguments presented by several defendants opposing consolidation. Specifically, it asserts that the current and anticipated number of pending cases adequately justifies an MDL and reiterates that the Northern District of California is the most logical venue choice for the MDL.

August 2, 2022 – MDL Opposition Brief

The defendants have filed briefs opposing the motion to consolidate all Tylenol autism lawsuits into a new class action MDL. While each defendant submitted a separate opposition, their arguments are similar.

First, the opposition briefs highlight that the Tylenol autism lawsuits only target retail defendants, omitting necessary parties (i.e., the actual acetaminophen manufacturers).

Second, they argue that there are insufficient pending acetaminophen autism cases and that the defendant pool is too large and diverse.

Finally, all defense oppositions object to the plaintiffs’ suggested forums, contending that the District of New Jersey or the Eastern District of New York would be more appropriate venues if the Tylenol lawsuit is consolidated.

Tylenol Autism Lawsuit

Lawsuits are now being filed against major retailers, Johnson & Johnson, and generic acetaminophen manufacturers, alleging their failure to warn that using the drug during pregnancy could lead to autism.

The rising number of Tylenol autism lawsuits has prompted a request to consolidate the cases into a new MDL Tylenol autism class action lawsuit.

Nguyen Injury Lawyer is currently accepting Tylenol autism lawsuits from parents or guardians of children diagnosed with autism or ADHD following significant prenatal exposure to Tylenol or generic acetaminophen. Contact our law firm today at (713) 747-7777 or complete our free online consultation form.

Tylenol Linked to Autism

Tylenol (the brand name for acetaminophen) is a widely used over-the-counter pain medication. Acetaminophen holds a uniquely preeminent place in pharmacology and medicine. Millions regularly use Tylenol to relieve headaches, pain, and reduce fevers.

Approximately 50 million American consumers (about 20% of the adult population) use acetaminophen-containing products each week, totaling over 25 billion doses annually.

Paradoxically, it is also one of the most dangerous and least understood compounds in medical use. Acetaminophen’s mechanism of action remains unclear; scientists have yet to fully understand how it relieves pain and reduces fever.

Despite this unknown mechanism, acetaminophen has long been marketed to pregnant women as the safest pain reliever and fever-reducing drug during pregnancy. Consequently, more pregnant women use Tylenol than any other over-the-counter medication.

Medical Literature on Tylenol, ASD, and ADHD

Over the past decade, a growing body of scientific studies has raised increasing concerns about the correlation between prenatal acetaminophen exposure and adverse neurodevelopmental outcomes, including autism.

Initially, the relationship could be viewed as association rather than causation. Expectant mothers using acetaminophen might engage in other high-risk activities or have a higher prevalence of genetic predispositions for ASD or ADHD. Maternal fever, prompting acetaminophen use, could also be the underlying cause. Thorough investigation is critical before taking a Tylenol lawsuit to trial. Lawyers and the scientific community were initially skeptical, with good reason.

However, over 20 studies have explored alternative explanations for these findings. They have consistently – plaintiffs’ experts have been “blown away by the consistency” – indicated a notable increase in the likelihood of children developing neurodevelopmental conditions like Autism Spectrum Disorder (ASD) and Attention Deficit Hyperactivity Disorder (ADHD) while testing for other possibilities.

Consensus Statement on Tylenol and Pregnancy

In 2021, the scientific journal Nature Reviews Endocrinology published a Consensus Statement from medical experts warning that Tylenol use during pregnancy was not safe and could lead to higher rates of autism. This study served as a catalyst for the surge of acetaminophen lawsuits.

JAMA Psychiatry Study

One significant study, published in the leading scientific journal JAMA Psychiatry in 2020, found that umbilical cord “biomarkers of fetal exposure to acetaminophen were associated with significantly increased risk of childhood in a dose-response fashion.”

The study’s authors further noted that “ensitivity analyses . . . and subgroup analyses found consistent associations between acetaminophen and across strata of potential confounders, including maternal indication, substance use, preterm birth, and child age and sex.”

Hopkins Study

A Johns Hopkins study examined cord blood samples and measured acetaminophen levels, yielding striking results. Children with the highest acetaminophen levels in their cord blood were almost three times more likely to be on the autism spectrum compared to those with the lowest levels. This study has significantly fueled the Tylenol lawsuit.

Other Studies

Various studies suggest that Tylenol (or acetaminophen) use during pregnancy may contribute to neurological disorders, including autism spectrum disorder. Twenty-six separate observational studies have identified positive associations between acetaminophen exposure during pregnancy and autism.

The 16 studies specifically investigating dose-response relationships identified a dose-response association, indicating that increased duration of acetaminophen exposure correlated with increased risk.

A 2018 research study involving a meta-analysis of seven studies, encompassing over 130,000 mother-child pairs monitored for 3 to 11 years, determined that children exposed to Tylenol for extended periods during pregnancy had a 20% higher risk of autism.

Risk of Autism with Tylenol May Be Dose Responsive

The timing, amount, and duration of Tylenol use during pregnancy appear to correlate with the risk of autism, as some studies suggest that small doses of Tylenol during pregnancy do not elevate the risk of autism. Based on this research, many doctors now advise women to avoid acetaminophen during pregnancy unless medically necessary.

Currently, legal opinions vary regarding the exposure level required to qualify for a Tylenol lawsuit. Nguyen Injury Lawyer requires that the pregnant mother took at least 8 doses of Tylenol. Other firms have stricter or looser eligibility criteria.

Tylenol Autism Class Action Lawsuit Certified

The new research linking Tylenol use during pregnancy to autism has spurred a surge of Tylenol autism lawsuits. Major drug retailers like CVS and Walgreens, along with acetaminophen-based drug manufacturers, face lawsuits from children and parents alleging that Tylenol use during pregnancy caused the children to develop autism spectrum disorder (ASD) or attention deficit hyperactivity disorder (ADHD).

On June 10, 2022, plaintiffs’ lawyers filed a motion with the Judicial Panel on Multidistrict Litigation (JPML) seeking to consolidate the Tylenol autism lawsuits into a new class action MDL. On October 5, 2022, the JPML certified a new class action in the Southern District of New York.

According to the motion filed with the JPML, approximately 20 acetaminophen autism lawsuits are currently pending in federal courts nationwide.

Example Tylenol Lawsuit

The numerous Tylenol lawsuits share similar factual claims and legal arguments, primarily focusing on the failure to adequately warn about the potential risks associated with prenatal Tylenol exposure. The fact that these Tylenol autism lawsuits have been filed in close succession suggests to the JPML panel that many more similar cases are likely to follow.

One example among the initial 47 Tylenol autism lawsuits consolidated into the MDL is Springer v. Costco Wholesale Corp. (0:22-cv-1532), filed in the District of Minnesota on June 8, 2022. This case was brought by Courtney Springer, a Minnesota resident, on behalf of her minor child. Costco is the sole defendant, as it was the retailer from which the plaintiff purchased the generic acetaminophen used during her pregnancy.

The Springer Complaint begins with general factual assertions about the development of acetaminophen and its marketing history, particularly its portrayal as “the safest, and the only appropriate” pain relief option for pregnant women. The complaint then transitions to presenting scientific evidence indicating that acetaminophen use can disrupt fetal brain development, potentially leading to autism.

The Complaint then specifies that Springer purchased Kirkland brand acetaminophen from Costco and used it regularly throughout her pregnancy from October 2016 to May 2017. According to the lawsuit, Springer took the Kirkland generic Tylenol “a few times a week” during this period, assuming it was safe for use during pregnancy. The core of Springer’s acetaminophen lawsuit, and indeed every Tylenol lawsuit, is that the warning label provided no indication of a possible risk of autism.

Springer’s daughter was born in May 2017 and diagnosed with an autism spectrum disorder at 18 months old.

This Tylenol autism lawsuit presents six distinct causes of action: (1) failure to warn, (2) general negligence, (3) breach of express warranty, (4) breach of an implied warranty, (5) negligent misrepresentation, and (6) violation of Minnesota consumer protection laws. The central claim underpinning these actions is that Costco was aware (or should have been aware) of the link between acetaminophen use during pregnancy and autism but continued to sell its Kirkland brand generic Tylenol without including any warnings about this potential risk.

Do You Qualify for a Tylenol Autism Lawsuit?

If you used Tylenol or generic acetaminophen during pregnancy at high doses or for extended periods, and your child has since been diagnosed with autism, you and/or your child may have grounds to file a civil lawsuit and pursue financial compensation. Contact Nguyen Injury Lawyer at (713) 747-7777 for a free consultation.

Currently, the scientific evidence establishing a causal link between prenatal acetaminophen exposure and autism is still developing. However, if this evidence is deemed strong enough to be presented to a jury in a civil case, plaintiffs could potentially receive significant compensation. Nguyen Injury Lawyer is closely monitoring the developments in this litigation.

If the Tylenol autism lawsuits are eventually consolidated into a class action MDL (and the causation evidence withstands legal challenges), a global settlement to resolve these cases becomes more likely. Our attorneys at Nguyen Injury Lawyer are prepared to advise you on your legal options.

Autism Drugs at Issue

The following is a non-exclusive list of drugs that contain acetaminophen:

1. Alka-Seltzer PLUS
2. CoricidinHBP
3. Dayquil
4. Excedrin
5. FluTherapy
6. Midol
7. Mucinex MAXIMUM STRENGTH FAST-MAX COLD, FLU & SORE THROAT
8. Mucinex MAXIMUM STRENGTH FAST-MAX COLD & FLU (ALL-IN-ONE)
9. Mucinex MAXIMUM STRENGTH NIGHTSHIFT COLD & FLU
10. Mucinex MAXIMUM STRENGTH NIGHTSHIFT SEVERE COLD & FLU
11. Mucinex MAXIMUM STRENGTH SINUS-MAX PRESSURE, PAIN & COUGH
12. Mucinex MAXIMUM STRENGTH SINUS-MAX SEVERE CONGESTION & PAIN
13. Nyquil
14. Panadol
15. Robitussin Maximum Strength
16. Sinex SEVERE ALL IN ONE SINUS
17. Sudafed Head Congestion + Flu Severe
18. Sudafed Head Congestion + Mucus
19. Sudafed PE Sinus Pressure + Pain
20. Theraflu
21. Tylenol
22. Store-brand acetaminophen

This list is not exhaustive; any drug containing acetaminophen could potentially be relevant. Contact Nguyen Injury Lawyer to discuss your specific situation.

Which Tylenol Lawsuits Are Our Lawyers Not Taking?

Nguyen Injury Lawyer is currently not accepting certain types of Tylenol autism cases. Please contact us to determine if you qualify.

Adult Tylenol Lawsuits

The primary category we are not pursuing involves cases where the child diagnosed with autism is already an adult. While we understand the desire of parents to seek assistance for their adult children, there are two main reasons why we cannot accept these cases.

Statute of Limitations Concerns for Adult Tylenol Lawsuits

Firstly, cases involving adult children often raise statute of limitations issues. If the pregnancy occurred many years ago, and the child with autism is now an adult, the time limit for filing a lawsuit under the relevant state law may have expired. Contact Nguyen Injury Lawyer to discuss the statute of limitations in your jurisdiction.

Although there are strong arguments for extending the statute of limitations in Tylenol lawsuits—because victims were unaware of the connection between Tylenol and autism until recent studies or advertisements highlighted the potential link—statutes of repose in some jurisdictions may completely bar these claims.

Difficulty Obtaining Old Medical Records

The second, more practical reason for not pursuing Tylenol autism cases involving adult children is the difficulty in obtaining the necessary medical records. In our experience, old medical records often no longer exist. Nguyen Injury Lawyer can assess the availability of your records.

To support a Tylenol autism lawsuit, plaintiffs need medical records from their OB/GYN documenting Tylenol use during pregnancy. If the pregnancy occurred decades ago, obtaining these records can be challenging, often because the medical practice has closed. The AMA has identified numerous other obstacles patients face when trying to access old medical records.

Children Under Three Years Old

We are also not accepting Tylenol autism cases if the child was born after March 26, 2020. This is because the CARES Act, enacted in response to the COVID-19 pandemic, finalized FDA labeling rules for Tylenol as of March 2020. Before this date, manufacturers and retailers could add warning labels to their Tylenol or acetaminophen products.

Once the CARES Act finalized the FDA labeling rules, the warning labels for Tylenol and generic acetaminophen were essentially fixed and could not be altered. This means that manufacturers and retailers of Tylenol cannot be held liable for failing to warn about the risks of use during pregnancy after March 20, 2020.

Other Excluding Factors

The following is a list of other facts or circumstances that may exclude prospective Tylenol autism lawsuits, according to our attorneys at Nguyen Injury Lawyer:

• If the mother experienced one or more of the following complications during pregnancy:
  • gestational diabetes
  • gestational hypertension
  • an infection and related fever that required the mother’s hospitalization.
• If the child was born prior to the 26th week of pregnancy.
• If the child is diagnosed with Down Syndrome, Fragile X Syndrome, Tourette Syndrome, or Tuberous Sclerosis.
• If the mother used illegal drugs, alcohol, or certain prescription drugs during pregnancy.
• If the mother was over 40 or the father was over 45 years of age at the time of birth.
• One of the parents has been diagnosed with autism.

Our Lawyers Have Suspended Taking New Lawsuits

We are no longer taking new lawsuits. We are taking toxic baby food lawsuit for the same injuries as we discuss above. Contact Nguyen Injury Lawyer today at (713) 747-7777, or visit our website at https://www.nguyeninjurylawyer.com or our contact page at https://www.nguyeninjurylawyer.com/contact for more information.