Tylenol Autism Lawsuit

Tylenol autism lawsuits are being filed nationwide with a new Tylenol Autism class action lawsuit – technically an MDL, as we explain below – now certified in federal court. But, as we discuss below, that MDL is on the thinnest of ice.

We are encouraging parents interested in bringing a Tylenol lawsuit to consider bringing a toxic baby food lawsuit.

Update: The federal court cases are dismissed. There is an appeal. See the update below that discusses your options moving forward.

Another Path For Victims – Baby Food

There may be another path to compensation for some victims.  Plaintiffs’ Tylenol lawyers are exploring options in state court (and looking at potential baby food lawsuits for children with autism.. Those lawsuits are gaining new currency after the Tylenol cases faltered in the MDL.

Tylenol Lawsuit Updates

Before we discuss the substance of the Tylenol autism lawsuit, let’s understand where we are with the Tylenol class action lawsuit.

Below are the latest updates in this litigation:

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

In their appellate brief, plaintiffs allege that Judge Cote overstepped by usurping the jury’s role to weigh evidence and, in effect, deciding a complex scientific debate herself by picking 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 for 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 (can you get more impressive than that?) 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.

Really, the core of the argument is that Judge Cote was not functioning as a gatekeeper to filter out unreliable expert testimony, but as a  makeshift scientist who decided what is an scientific dispute among qualified experts.  The judge did seem to talk a lot in the ruling of the public policy implications of warning against acetaminophen use during pregnancy, rather than whether the scientific methods were applied reliably. The opinion repeatedly invoked 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.”  Certainly, such considerations are beyond the scope of Daubert and arguably reflect a judicial preference for policy outcomes over evidentiary principles.

The Second Circuit’s ruling is anticipated in early 2025.

September 4, 2024 – Where Does Tylenol Litigation Go from Here?

The big question now is what happens next in the Tylenol litigation.  In the Zantac litigation, the lawsuits were dismissed in the MDL and plaintiffs are having more success than they did in the MDL, getting those cases past the pretrial stages and getting a few claims to trial (albeit unsuccessfully so far).

Of course, there is an appeal of Judge Cote’s ruling pending. Some thought this would be the path plaintiffs lawyers would take in this litigation would mirror the Zantac cases where attorneys changed gears and started filing in state court. But there is clear no race to the courthouse steps to file Tylenol autism claims in state court.

Still, there are state court cases that were filed before Judge Cote’s ruling that are still active. Here are five of those case:

• Bartle Case (St. Clair County, Illinois): The motion to dismiss by Johnson & Johnson based on preemption is still 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, and parties continue to exchange discovery information.
• Fennewald Case (Cook County, Illinois): Defendants’ motions to dismiss are pending, with a hearing on these motions set 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 that motion.

August 22, 2024 – Judge Cote Ends Federal Litigation

Judge Cote granted summary judgment yesterday.  This ends this litigation in federal court unless plaintiffs prevail on appeal.

July 15, 2024 – Optimism Not Warranted

The last post expressed optimism that Judge Cote would allow Dr. Ness to testify for plaintiffs.  That optimism was in error.  Judge Cote ruled the causation opinion of the plaintiffs’ expert, Roberta Ness, unreliable and inadmissible. Despite Ness’s expertise in epidemiology and women’s health, her lack of experience in psychiatry, toxicology, and neurology, combined with methodological weaknesses and her admission of genetic factors as potential confounders, undermined her credibility.

Judge Cote emphasized the importance of a recent NIH study, which found no significant link between acetaminophen and ADHD after accounting for genetic variables through sibling studies, and criticized Ness for ignoring this and other contrary evidence, accusing her of selective reasoning.

The defendants will now seeks summary judgment and it will be granted.

June 6, 2024 – New Optimism for MDL

To recap, last year the court rejected all the plaintiffs’ experts in this litigation last year,  citing several 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.

So plaintiffs, with a new extremely qualified expert, Dr. Roberta Ness, have come back to court to address all of the concerns that were raised. Dr. Ness has addressed each of these issues 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 in support of her methodology.

Of course, the defense lawyers challenged the admissibility of Dr. Ness’s testimony. But their argument is much tougher this time.

We will see how it goes at the Daubert hearing but there is a new optimism in this litigation.

May 28, 2024 – Dr. Ness Is Plaintiffs’ Last MDL Stand

Any chances the Tylenol MDL has of surviving absent a successful appeal is if Judge Cote accepts Dr. Roberta Ness’ opinion.

Dr. Ness has now been deposed.  Dr. Ness expressed her belief that acetaminophen could cause autism and ADHD, a conclusion she reached 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.

What is Bradford Hill? The Bradford Hill criteria are a set of nine principles that help determine a causal relationship between a presumed cause and an observed effect in epidemiology. 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 had reviewed, which showed a strong and consistent link between acetaminophen and ADHD. Despite being compensated for her work 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.

I think this part is important:  her analysis and notes on scientific studies were conducted before being retained as a testifying expert and included both ADHD and autism studies. She did go back and do a ADHD-specific Bradford Hill analysis after Judge Cote’s Daubert ruling. But that just makes sense, right?  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 studies cited were 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 big isssue for Dr. Cote when she rejected plaintiffs’ first round of experts.

The defense lawyer scored a few hits but not really related to the core issues for Daubert. She is an epidemiologist who not treated patients or written prescriptions for ADHD medications and has not focused her professional research specifically on ADHD.  You certainly don’t need to treat patients or focus your life on ADHD to offer testimony on the topic.  She also admitted, for example, to working with a public relations firm to help craft her messages for public interviews.  There is nothing wrong with this but not a great look for a scientist. But, still not a big deal and totally unrelated to the Daubert matter at hand.

Overall, this deposition seemed to go well.  Judge Cote gave a roadmap of what she need to see to get an expert passed Daubert and Dr. Ness appears to have climbed those hurdles.  It will be interesting to get Judge Cote’s take at the Daubert hearing.

March 18, 2024 – One More MDL Shot

Following the Daubert ruling, the plaintiffs introduced a new expert. They were allowed to do this for the reasons articulated below. The deadline for the Defendants to file a motion to exclude this new expert is set for July. It is expected that a determination on the new expert’s eligibility will be made shortly after, likely occurring in the late summer or early fall of this year.

Again, we are no longer taking new Tylenol cases. We are waiting to see how this all flushes out.  We are reviewing baby food autism lawsuits for children 6 and under as we discuss above.

February 17, 2024 – Another Shot at the MDL?

Well, this at least makes the case 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’ had sought to dismiss the proposed expert, Dr. Roberta Ness – who has a resume as long as your arm – criticizing her analysis as flawed, similar to previously excluded expert witnesses Judge Cote knocked out last year. However, new plaintiffs to the MDL argue that they should not be restricted by prior rulings made before their involvement. We talked about this in the February 3rd update. I was not confident this argument would succeed. But Judge Cote is willing to hear Dr. Ness out.

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

It could just be the judge allowing plaintiffs to be heard when she knows full well she just does not buy the science. But there is some hope here.

February 3, 2024 – Still More Battles as the MDL Closes Out

A group of twelve parents and children, alleging that prenatal exposure to acetaminophen led to ADHD, are seeking challenging the decision disqualified all expert witnesses intended to support plaintiffs in comparable cases. This motion argues that the group has 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 is 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.

January 18, 2024 – Plaintiffs Face Dismissal

By February 1, plaintiffs MDL need 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. (Plaintiffs’ lawyers had argued the date should be June 16, 2023.)  This applies to the 501 plaintiffs who filed suit in the MDL.  This does not impact the hundreds of thousands of plaintiffs who may have hired a lawyer but sat on the sidelines in the MDL.

January 15, 2024 – Other Paths to Compensation for Victims

The 501 plaintiffs in the MDL will appeal Judge Cote’s ruling.  Other plaintiffs will look to state court options. There is a lot of discussion among plaintiffs’ lawyers as to how to attack this litigation in state court – and where suits should be brought.

January 8, 2024 – Conference This Week

Judge Cote ordered the parties to meet, discuss, and submit a joint letter to the court by January 12th, outlining their proposed next steps following her recent decision.

There is not really much more to do in the MDL except appeal the ruling. So this is a non-event.

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

See our full explanation and analysis of Judge Cote’s recent ruling: Judge Pulls Plug on Tylenol Autism Lawsuits

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

The federal MDL is dead for now.  Judge Cote ruled against us in the Daubert hearing. In a 148-page ruling the judge likely began before the Daubert hearings, Judge Cote determined that the plaintiffs’ scientific experts were unable to establish credible connections between Tylenol and conditions such as autism, attention-deficit issues, or hyperactivity, rendering the claims legally untenable.  She concluded that the experts did not employ a “reliable application of scientific methods” to ascertain the causal relationships between the medication and these conditions. We will break all of this down in a later post.   But this is horrible news.

We have been pretty transparent about where we thought the Tylenol MDL was going after the Daubert hearing. If your child is under seven and used baby food from the usual suspect manufacturers, there is the possibility your family could have a claim in that litigation.  If this is something you want to explore, contact us online and tell us about your situation. It may be something you want to explore.

But… this does not mean you do not have options in the Tylenol litigation in state courts.  Our lawyers expect a lot of cases in Pennsylvania, New Jersey, and California.  Everyone knew this was a possibility.  This is one judge’s take. So there is a long fight ahead.  But there is no silver lining here: this ruling is a real blow for these cases.

December 8, 2023 – Reaction to Daubert Hearing

Kenvue Inc., the consumer health company separated from Johnson & Johnson earlier this year, experienced a 10% increase in its stock value following a Daubert hearing related to a class action lawsuit.

The stock’s rise is attributed to the perception that the hearing went favorably for the defendants.

December 7, 2023 – Daubert Hearing Today

Our firm has been bullish on our Daubert chances.  We also know many people come here to get the latest information on these cases.  So we have an obligation to tell you what we know and what we think.

Our firm did not attend the Daubert hearing today in New York.  But from our sources, there is less excitement about the plaintiffs’ chance after today.  The hearing did not go as well as hoped.

This is all predicting what a single judge will do and judges do not always show all of their cards. So who knows?  But are we less excited about the prospects of these cases in federal court than we were this morning?  Yes.

We are opening the previously closely 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 set in the Tylenol lawsuit for Thursday, January 4, 2024.

What does this mean? Is it a Daubert tea leaf?  We want to think so. But it is all just guessing.

December 1, 2023

Everyone is waiting for next Friday’s hearing. The ruling will be the biggest thing to happen to this litigation.

November 17, 2023 – 58 New Cases Added to MDL

Fifty-eight new cases were added to the Tylenol autism class action MDL over the last month. That brings the total number of pending cases up to 441. If Judge Cote denies the defendants’ Daubert challenges, the number of pending cases in the MDL will increase dramatically.

November 11, 2023 – Daubert Hearing December 7th

Our quiet hope that the judge would simply deny the Daubert challenges with a hearing is dashed.  There will be a Daubert hearing on December 7, 2023, but without witnesses.

How do you read the tea leaves of a Daubert hearing without expert witnesses testifying?  It is hard to say.  But there is still every reason to be optimistic.

For more on this, see our recent video: Tylenol Autism Lawsuits – Nov 2023 Update

November 8, 2023 – Tylenol Autism Cases in State Court

There are also some acetaminophen lawsuits in state court that are getting scant attention.   One case in Madison County, Illinois, is moving forward, albeit leisurely compared to Judge Cote.

A timeline has been set for the parties to present their arguments on the Defendants’ dismissal requests. The Plaintiff is due to submit a response by December 12, 2023, while the Defendants are scheduled to provide any reply brief by January 12, 2024. A hearing date will be established sometime in early 2024, but it is still to be decided.

In the unlikely event that plaintiffs do not get past Daubert in federal court, you will see the epicenter of Tylenol lawsuits move quickly from federal court to state court.  Let’s hope it does not come to that.

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

The Daubert matter has been thoroughly prepared, with all necessary briefs submitted. Should a hearing be scheduled, it would be the week of December 5, 2023. The hope is that Judge Cote rules in our favor on the written submissions alone. They are strong.  If a hearing takes place, it’s anticipated to be brief, with Judge Cote focusing on specific inquiries.

November 1, 2023 – All Daubert Briefs are Now Filed

All Daubert briefs have now been submitted to Judge Cote on the critical issue of what scientific expert testimony will be admitted. Both sides submitted reply memorandums last week in support of their motions to exclude specific expert witnesses who either side has put up. The reply memos address arguments made by the opposing side in response to the initial motions to exclude. Separate briefs have been submitted for each individual expert witness, with 3 rounds of briefing. Including supporting exhibits, the briefs total several thousand pages. Next up, Judge Cote will hold hearings in which she will 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 this MDL was created the volume of new cases was very low, typically under 20 per month. That has changed recently as we are starting to see monthly new case volumes increase steadily. Over the last month, 111 new cases were added.

October 9, 2023 – Parties Submit Proposals for Daubert Hearings

In preparation for the upcoming Daubert hearings, Judge Cote asked both sides to submit proposals for how the hearings should be handled logistically. Those proposals were submitted last week. The defendants are calling for a comprehensive week-long hearing process to give them extra time to contest the scientific evidence. The plaintiffs, however, are pushing for a much shorter process, and they 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, that we reported on yesterday (see below), the defendants have objected.   They claim any supplement to include this new study is untimely and in violation of Rule 26 because it was available in a pre-print version, which is obviously different that getting published in a journal.

Seems pretty nitpicky. So either the defendants are really scared of this article, or they are just reflexively oppositional.  Or both.

October 4, 2023 – New Study

A new study last month looked at what happens when pregnant women take acetaminophen (paracetamol). When pregnant women take Tylenol, the study found, it may have an impact on their baby’s brain development.

Scientists wanted to understand how this happens, of course. So 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 what pregnant women might use.

It may impact 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. What’s interesting is that these findings match with genes found in babies’ blood samples who were exposed to acetaminophen before they were born.

Will this study come up in the Daubert hearings this month?  Of course.  Plaintiffs’ experts are adding to their expert reports in light of this new study.

October 2, 2023 – Revisions to Plaintiff Fact Sheets

In a joint letter filed this morning, the parties advised Judge Cote that they have finished 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 designed to deal with logistical issues that have arisen and to make the process of information gather for new plaintiffs more streamlined.

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.

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 the field of environmental health science. Dr. Baccarelli is Chair of the Department of Environmental Health Sciences at Columbia University. His research focuses primarily on exploring the chemical and molecular links between human disease and exposure to certain drugs or chemicals. He has published over 600 articles, if you can imagine. Dr. Baccarelli is an elected member of the National Academy of Medicine and he is also President of the International Society of Environmental Epidemiology
  • 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 focuses 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 focuses 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.

There is no doubt these are very formidable experts.

September 18, 2023 – MDL Doubles in Size Over Summer

Back in June, there were only 136 pending cases in the Tylenol autism class action MDL. As of now, however, that number has increased to 265, which means that this MDL has nearly doubled in size over the summer.  This number is widely misleading, however.  There are over 100,000 Tylenol claims out there waiting to see whether Judge Cote allows these claims to go forward before filing suit.

September 12, 2023 – Hearing Request Denied

After the FDA statement, the defendants sent a letter to the court at 9:11 a.m. seeking a status conference, presumably hoping to argue that the case should be dismissed.  The argument, I guess, would be that given the FDA’s stance on no causation, this case should be dismissed.

It is a “best defense is a good offense” strategy Tylenol defense lawyers must have come up with over the weekend.  But the idea that the FDA’s choice not to submit a statement of interest validates their stance is illogical.  By 11:05 a.m., in under two hours, Judge Cote declined the request and affirmed that the Daubert and other set deadlines would stand as previously determined.

September 8, 2023 – FDA Decision

From the FDA statement:

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

The letter closes with a “we don’t want to get involved in drug litigation.”

“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.”

This is a huge win for plaintiffs.

September 1, 2023 – FDA Decision

In April, Judge Cote asked the FDA to Judge Cote to give its thoughts on the warning issue that goes to the core of the Tylenol autism class action lawsuits.

This unconventional invitation aimed to gather the FDA’s assessment of whether the plaintiffs’ suggested warning should be included on acetaminophen labels. Additionally, the court sought the FDA’s opinion on whether current scientific evidence justifies these warnings or advice concerning the risk of autism or ADHD for pregnant women.  Should the manufacturers have told women about the risk to protect their unborn children?

The FDA asked for more time via its lawyer, the U.S. Attorney for the Southern District of New York (Chuck Rhoades’s job if you watched Billions).  So the deadline is now September 15, 2023. We are a few weeks away. What the FDA reports (or does not report) to Judge Cote may be very important as the Daubert motions approach.  Again, we believe the science behind these lawsuits is very strong.

August 24, 2023 – Tylenol Class Action Update This Fall

Where are we right now in the Tylenol litigation and when can you begin to expect some sort of resolution?

Right now, there are tons of depositions of experts and other witnesses on the question of general causation – can Tylenol cause ADHD and autism?

Plaintiffs’ lawyers are bullish on how these depositions are going.  So much so that there is a belief that (1) Judge Cote will rule favorably on Daubert because the science is strong and, (2) even if she does not, these are still strong and viable claims in state court.

If the Daubert hearings are successful in the fall, it is hard to imagine J&J and the other defendants being willing to take one of these cases to trial because the average successful verdict in these cases will easily be in the millions.

August 21, 2023 – Judge Allows Consolidated Daubert Briefs

Judge Cote has agreed to allow the defendants to submit a consolidated brief on the Daubert challenges to the admissibility the scientific expert evidence being presented by the plaintiffs. The plaintiffs had submitted a letter asking Judge Cote to deny the request, claiming that the submission of separate briefs for each individual expert was necessary to ensure a fair outcome.

The future of the Tylenol autism class action will hinge on the outcome of the Daubert challenges. If Judge Cote rules that the plaintiff’s causation evidence is not admissible in court, all of the pending cases will eventually get dismissed.

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

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

The states where these claims are not recognized include Arkansas, California, Colorado, Idaho, Indiana, Kentucky, Nebraska, New Hampshire, North Carolina, North Dakota, Ohio, South Dakota, Tennessee, Texas, and Wyoming. This will probably have little or no impact on the ultimate outcome of the cases.

August 4, 2023 – Daubert Motions

It is amazing how much power a single judge has over litigation like this.  The MDL boils down to how Judge Cote rules on Daubert.  Again, there will be options in state court if Judge Cote goes the wrong way.  But that ruling is a huge deal and it will all be in the hands of one person.

The parties’ Daubert motions are scheduled to be due on September 19, 2023. Along with those motions, both the plaintiffs and the defendants are to write the judge a letter that includes: (1) their recommendation concerning the sequence in which the Court should handle any motions by the defendants to exclude an expert report from the plaintiffs’ experts; and (2) their argument regarding which of the motions pertaining to the parties’ expert reports should be considered together, based on their overlapping subject matter.

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

Back in April, Judge Cote asked the federal government to submit a statement of interest giving the FDA’s opinion on new Tylenol warning labels proposed by the plaintiffs. It looks like the government is actually going to submit an opinion.

Just last week, Judge Cote granted the government’s request to extend the deadline for submitting a statement of interest, which will give the parties a chance to view the statement just before submitting their initial Daubert motions, which are due on September 19, 2023.

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

Over the last 30 days, 64 new cases were added to the Tylenol autism class action MDL in the Southern District of New York. That is actually the highest volume of new filings since the MDL was created. There are now 200 Tylenol pregnancy lawsuits in the MDL, but a very large group of potential plaintiffs have yet to file and are waiting to see how things play out with evidentiary rulings in the MDL later this year.

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

A Connecticut mother filed a lawsuit in the MDL last week.  It was the only Tylenol lawsuit filed in the MDL.

It has been over six months since the Tylenol autism cases in federal courts were consolidated into a class action MDL, but as of this week, there were less than 150 Tylenol autism lawsuits (or ADHD) pending in the MDL. So why aren’t hundreds more cases being filed in the MDL?  Our lawyers believe that over 100,000 plaintiffs have hired an attorney.

The MDL has remained so small because thousands of prospective plaintiffs are waiting on the sidelines to see how the Daubert challenges play out in the MDL before filing their case. This allows these plaintiffs the opportunity to file their cases in state court if the MDL gets terminated because the judge throws out the scientific evidence linking Tylenol to autism. If the MDL judge rules that the scientific evidence is admissible, we will likely see a flood of Tylenol autism lawsuit sign-ups in the MDL.

Some lawsuits will continue to be filed because of statute of limitations concerns or because the clients simply want to file suit now.  But you will continue to see the lion’s share of claims sitting on the sideline waiting to see what Judge Cote decides.

July 7, 2023 – Show Cause Orders

The Tylenol lawsuits in federal court are not the place where any of the parties will be permitted to drag their feet.  Judge Cote is issuing show cause orders to plaintiffs in two cases (Jackson v. Walmart and Swindell v. Johnson and Johnson) who have not completed a fact sheet.  This requires parties who have not complied to tell the court why their case should not be dismissed for failing to meet their discovery obligations.

July 1, 2023 – State Court Acetaminophen Lawsuits

With so many different defendants in this litigation, there are also a number of Tylenol lawsuits in state court.  One example is a recently filed case in Illinois.  In this case, a mother filed an acetaminophen lawsuit for her daughter against Walgreen Co., an Illinois Corporation headquartered in Illinois.  Because the plaintiffs are also Illinois residents, there is no diversity jurisdiction so the plaintiffs cannot file their lawsuit in the MDL class action.

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

J&J has sought an immediate appeal of the court’s preemption and causation orders. The plaintiffs filed a motion last week opposing an immediate appeal.

Why do you care about this if your family has filed a Tylenol autism lawsuit or intends to bring a claim?  An immediate appeal would likely grind this litigation to a halt for a year.  Plaintiffs’ attorneys argue that an immediate appeal is a rare exception that does not apply in this case and 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

Last week, the MDL Judge 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 at issue (Tex. Civ. Prac. & Rem. Code Ann. § 82.007(a)) mandates that retailers of over-the-counter drugs like Tylenol cannot be held liable for failure to warn if their warning labels complied with the FDA-approved product labeling and information (the “monographs”). This means that all Tylenol autism claims governed by Texas law could face dismissal.  (Our law firm is no longer taking 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 did not warn about the potential risk of autism or ADHD in children from prenatal consumption of their store-branded acetaminophen. CVS Pharmacy Inc., however, has managed to avoid a similar lawsuit.

Makesha Anderson and Crystal Washington made these claims as part of a larger multidistrict litigation, arguing that the retailers’ store-branded acetaminophen products did not carry the necessary warnings. They pointed to studies that are the foundation of every acetaminophen autism lawsuit that suggest a link between prenatal exposure to acetaminophen and autism in children.

Judge Denise L. Cote, who is overseeing all federal Tylenol lawsuits, dismissed the argument by Target and Walmart 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 the claims by Washington fall under Texas law and should be dismissed

May 9, 2023 – J&J Seeks Immediate Appeal

J&J submitted a request to the MDL court for an interlocutory appeal concerning Judge Cote’s rejection of their preemption motion. This type of appeal would enable J&J to obtain an appellate court’s assessment of the preemption order prior to the case progressing.

While appeals are generally permitted only after a final judgment, interlocutory appeals serve as an exception in specific situations. The court is unlikely to approve the interlocutory appeal, as it would halt litigation that the judge is evidently determined to expedite. But that outcome is not certain and the court has set a schedule to ensure the issue is fully briefed.

May 1, 2023 – Asking for the FDA’s Opinion

A lot of people are asking if it is common to ask the FDA’s opinion in whether a warning would have been appropriate.  It is not.

There were two questions the judge asked the FDA (technically, she asked the U.S. Attorney for the Southern District of New York to ask the agency):

1. 1. 1. Should the Plaintiffs’ Proposed Warning be added to acetaminophen labels?
      2. 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?

Those are big questions and it is hard to image the FDA wanting to put its thumb on the scales of what may end up being one of the biggest mass torts in history.  But we will see.

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

Judge Cote issued an Order yesterday in the Tylenol and autism lawsuit denying J&J’s motion to dismiss based on the preemption doctrine. The J&J motion argued that the failure to warn claims asserted by the plaintiffs are preempted by the various federal laws and FDA regulations that govern the labeling of OTC drugs. In her 37-page opinion, Judge Cote starts out by crisply laying out the relevant law on the doctrine of preemption.

She then explains that J&J’s preemption argument fails because nothing in the federal rules and regulations actually prevented J&J from adding a warning to Tylenol about the risks of in utero exposure. Judge Cote reached the same conclusion last November when she denied a preemption motion filed by Walmart.

April 20, 2023 – Judge Asks Government to Weigh in on Tylenol Warning Labels

A federal judge has requested the government’s opinion in the Tylenol class action lawsuit. The plaintiffs have proposed a warning that includes the risk of ASD and ADHD with frequent use during pregnancy. Labels for acetaminophen-containing products must comply with monographs that require a general pregnancy warning, but the monograph for acetaminophen contains no additional warning related to pregnancy. The judge wants the government to provide its views on whether the plaintiffs’ proposed warning should be added to acetaminophen labels.

It will be interesting to see if the FDA is willing to offer its opinion. If the FDA does offer an opinion, it may be more than just interesting.  Under 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.”

But we’ll see if the FDA is willing to put its toe in that vast pool.

April 13, 2023 – What an ADHD Autism Tylenol Warning Would Look Like

Judge Cote asked the Plaintiff what the Tylenol autism/ADHD warning should look like.  This is what Tylenol autism lawyers say it should be:

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 is hard to conjure up an argument against this acetaminophen warning going on the product today… unless your sole focus is to sell acetaminophen. How could a doctor who understands the issues answer a question like “Can you take extra strength Tylenol while pregnant?” without talking about Tylenol and autism and ADHD?  Any doctor who read the literature would never say, “Sure, don’t worry about it.”  And that is exactly what J&J and other manufacturers are telling pregnant women.

April 9, 2023 – Autism

According to recently released data from the CDC, the rate of children in the U.S. diagnosed with autism spectrum disorder has increased in recent years. The new research suggests that 1 out of every 36 children in the U.S. are diagnosed with autism or ASD.

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 history is last month the plaintiffs revealed six areas of general causation. The defendants added an additional area, maternal-fetal medicine. The plaintiffs’ lawyers don’t think they need a maternal-fetal medicine expert to meet their burden of proof for general causation.  But plaintiffs have no clue what the defense expert might say so 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.

March 10, 2023 – Number of Lawsuits

As of March 1st, there are 107 pending cases in the acetaminophen ADHD/autism class action litigation. There were 80 cases when the class action MDL was created a few months ago.

February 25, 2023 – Quick Moving Litigation

The logistical matters in the early stages of the Tylenol autism class action continue to get finalized swiftly by MDL Judge Denise Conte. Just last week, Judge Conte issued a new Order finalizing the protocol, rules and schedule for depositions and fact discovery of expert witnesses. Those depositions can now begin and they will play a key role in October when Judge Conte plans to rule on the admissibility of the plaintiffs’ causation evidence. That ruling will determine the future of the litigation unless overturned on appeal.

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 Makes It Easier to File an Acetaminophen Lawsuit

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 26, 2022 – Filing a Lawsuit Directly in the Class Action Lawsuit

Before Christmas, the plaintiffs and defendants submitted separate proposed discovery plans to MDL Judge Denise Cote, after they were unable to agree on a joint plan.

Last week, Judge Cote issued an Order preliminarily adopting the plan drafted by the defendants and urging both parties to collaborate on a joint submission before the January status conference.

December 15, 2022 – Filing a Lawsuit Directly in the Class Action Lawsuit

The judge in the Tylenol autism class action MDL have until the end of this week to file a “master complaint.”

The allegations in the master complaint will apply to all future cases filed or transferred into the MDL. Moving forward, new incoming cases will use a Short Form Complaint (SFC). The MDL judge has given the parties until January 4, 2023, to submit a joint SFC.

December 13, 2022 – Tylenol Class Action Moving Quickly

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 acetaminophen autism and ADHD victims who want to see the cases ripe for settlement as soon as possible.

December 1, 2022 – Walmart Tries Again

Just 2 weeks ago, the Tylenol autism MDL Judge denied Walmart’s motion to dismiss based on federal preemption. Now Walmart is asking Judge Cote to reconsider that ruling based on essentially the same arguments raised in the initial motion.

Moreover, Walmart is also asking Judge Cote to put the claims on hold while Walmart immediately appeals the decision. It is very unlikely that Judge Cote will grant either of these requests.

The court’s denial of Walmart’s preemption motion was supported by a strong, well-reasoned opinion. Walmart’s attorneys will not change her mind by simply rephrasing their arguments. The request for an immediate appeal is also a long shot. Motions to dismiss based on preemption get denied in mass tort cases all the time and immediate appeals are never allowed.

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

We talk most about autism and ADHD.  But our law firm 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 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.

The optics and vibe from the first hearing also matters. It will give Tylenol attorneys a first look at how the judge intends to approach the litigation.

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

In the Tylenol autism class action MDL, Judge Cote approved the proposed structure for the defense lawyer committee. The committee will be called the Retailer Liaison Committee (RLC) and it will make collective decisions for the defense. The RLC will be comprised of lawyers for the defendants, selected by Judge Cote via an open application process. Appointments should be announced next week.

November 4, 2022 – Tylenol Defendants Pay $13 Billion Settlement in Unrelated Litigation

A few of the primary retail defendants in the Tylenol autism lawsuits, CVS, Walmart, and Walgreens, recently announced a proposed settlement that will resolve thousands of opioid lawsuits pending against them. Under the proposed settlement, the three companies will pay around $13 billion over the next 10 years to thousands of state and local governments who brought the opioid lawsuits.

Why are we talking about settlement payouts in other litigation with these same defendants?  That settlement has parallels to the Tylenol autism lawsuits and underscores why these same retailers are being sued in the acetaminophen lawsuits. Tylenol autism compensation could potentially be a lot more than $13 billion if these claims go as expected.

November 2, 2022 – Tylenol Lawyers Coming  Out of the Woodwork

Just three months ago, few lawyers were taking Tylenol lawsuits seriously.  Now the television commercials are rivaling Camp Lejeune ads.  If you have minor children, Facebook knows and is flooding you with acetaminophen lawsuit ads. The Tylenol autism class action lawsuit may become the biggest mass tort in U.S. history.

October 5, 2022 – New Tylenol Class Action Lawsuit

We now have a Tylenol class action lawsuit. The new MDL – titled In Re: Acetaminophen – ASD/ADHD MDL No. 3043 – will be in the Southern District of New York under Judge Denise L. Cote.  This will be Judge Cote’s 9th MDL class action lawsuit.

More than 80 filed acetaminophen lawsuits will be immediately transferred to Judge Cote

September 30, 2022 – MDL Arguments

Yesterday, the JPML heard oral arguments at a hearing on the motion for consolidation of the growing number of autism cases into a new acetaminophen class action. The number of lawsuits alleging that acetaminophen use during pregnancy caused autism has been steadily growing and there is now a large number pending in federal districts across the country.

In June, a group of plaintiffs filed a request asking for the cases to be consolidated into a new MDL. The defendants, manufacturers, and major retailers of acetaminophen, are strongly opposed to class action consolidation. A panel of JPML judges will now decide.

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 the hearing that this could get “really gigantic.”  Feels foreshadowing.

September 11, 2022 – Oral Arguments for Class Action Set

Oral argument before the JPML on the motion to consolidate the acetaminophen autism cases into an MDL class action lawsuit has been set for September 29, 2022, in St. Louis.

The MDL consolidation request has faced opposition from various defendants. But our Tylenol autism lawyers think the odds still favor the MDL class action lawsuit being granted. What is more in doubt is what venue the JPML will select if a new MDL is created. The plaintiffs are pushing 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 file a Reply in Support of their recent request for consolidation of all Tylenol autism lawsuits into a new MDL class action. The Reply brief contests the legal arguments made by several defendants in their opposition to consolidation. Specifically, the Reply asserts that the number of pending cases and future pending cases are more than adequate to justify an MDL. The Reply also reasserts that the Northern District of California would be the most logical choice of venue for the MDL.

August 2, 2022 – MDL Opposition Brief

The defendants filed briefs in opposition to the motion seeking consolidation of all Tylenol autism lawsuits into a new class action MDL. Each defendant filed its separate opposition, but all four briefs make similar arguments.

First, the opposition briefs point out that the Tylenol autism lawsuits have only been filed against retail defendants and necessary parties (i.e., the actual acetaminophen manufacturers) have been left out.

Second, they contend that there are not enough acetaminophen autism cases pending and that the field of defendants is too large and diverse.

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

Tylenol Autism Lawsuit

Tylenol lawsuits are now being brought against major retailers, Johnson and Johnson, and generic acetaminophen makers claiming that they failed to warn that using the popular drug during pregnancy could lead to autism.

The growing number of Tylenol autism lawsuits has recently prompted a request for the cases to be consolidated into a new MDL Tylenol autism class action lawsuit.

Our firm is currently accepting Tylenol autism lawsuits from parents or guardians of children who were diagnosed with autism or ADHD after significant prenatal exposure to Tylenol or generic acetaminophen. Contact our law firm today at 800-553-8082 or get a free online consultation.

Tylenol Linked to Autism

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

Around 50 million American consumers (roughly 20% of the adult population in the United States) use products containing acetaminophen each week, with more than 25 billion doses being used annually.

At the same time, it is, paradoxically, probably one of the most dangerous and least understood compounds in medical use. Acetaminophen’s mechanism of action remains unclear. Scientists have yet to figure out how acetaminophen relieves pain and reduces fever.

Despite the drug’s unknown mechanism of action, acetaminophen has long been marketed to pregnant women as the safest pain reliever and fever-reducing drug for use during pregnancy. As a result, Tylenol is used by more pregnant women than any other over-the-counter drug.

Medical Literature on Tylenol ASD and ADHD

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

At first glance, this could be association and not causation, right?  It’s possible that expectant mothers who use acetaminophen may also partake in some other high-risk activities that could be the real causative relationship. Or it could have been that pregnant women who use Tylenol might have a higher prevalence of genetic predispositions for ASD or ADHD. Another consideration is that maternal fever, which prompts acetaminophen use, could be the real underlying cause.  If you want to take a Tylenol lawsuit to trial, you better first make sure that there is not some other reason for a connection.  Lawyers and the scientific community were skeptical at first with good reason.

But now over 20 studies have explored various 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 their 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 the use of Tylenol during pregnancy was not safe and could lead to higher rates of autism.  This study was the final straw that led to the avalanche of acetaminophen lawsuits.

JAMA Psychiatry Study

One of the most significant studies, 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 [autism] in a dose-response fashion.”

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

Hopkins Study

A Johns Hopkins study looked at cord blood samples and measured acetaminophen levels.  The results were stunning.  The highest levels of acetaminophen found in the cord blood were almost three times as likely to be on the autism spectrum compared to children with the lowest levels in their cord blood.  This study has fueled the Tylenol lawsuit more than any other study.

Other Studies

Various studies have found that the use of Tylenol (or acetaminophen) during pregnancy may lead to the development of various 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 that specifically investigated dose-response identified a dose-response association, meaning an increased duration of exposure to acetaminophen was associated with increased risk.

A research study published in 2018, involved a meta-analysis of seven other studies that included more than 130,000 pairs of mothers and children. The mother-child pairs were monitored for 3 to 11 years, depending on the study. The study determined that children who were exposed to Tylenol for prolonged periods during pregnancy had a 20% higher risk of autism.

Risk of Autism with Tylenol May Be Dose Responsive

The timing, amount, and length of Tylenol use during pregnancy appear to correlate with the risk of autism because other studies have indicated that using small doses of Tylenol during pregnancy does not increase the risk of autism. Based on this new research, many doctors now recommend that women avoid taking acetaminophen during pregnancy unless medically indicated.

At this point, different lawyers have different opinions on how much is enough to make you eligible for a Tylenol lawsuit.  Our law firm is requiring that the pregnant mother take at least 8 doses of Tylenol.  Other firms has stricter and looser eligibility requirements.

Tylenol Autism Class Action Lawsuit Certified

The new research linking Tylenol use during pregnancy to autism has prompted a growing wave of Tylenol autism lawsuits. Major drug retailers such as CVS and Walgreens and manufacturers of acetaminophen-based drugs are being sued by children and parents alleging that the use of Tylenol during pregnancy caused children to develop autism spectrum disorder (ASD) or attention deficit hyperactivity disorder (ADHD).

On June 10, 2022, the plaintiffs’ lawyers filed a motion with the Judicial Panel on Multidistrict Litigation (JPML) seeking to have the Tylenol autism lawsuits consolidated 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, there are currently about 20 acetaminophen autism lawsuits pending in federal courts across the country.

All the Tylenol lawsuits raise similar factual allegations and assert claims based on failure to warn about the risks of prenatal exposure to Tylenol. Each Tylenol autism lawsuit has been filed within a very short time frame. This tells the JPML panel that many more Tylenol lawsuits are likely going to be filed.

Example Tylenol Lawsuit

One of the 47 Tylenol autism lawsuits that were initially transferred into the new MDL is the case of Springer v. Costco Wholesale Corp. (0:22-cv-1532), which was filed in the District of Minnesota on June 8, 2022. The case was filed by a Minnesota woman, Courtney Springer, on behalf of her minor child. The sole defendant named in the case is Costco, which is where the plaintiff purchased the generic acetaminophen she used during pregnancy.

The Springer Complaint starts with general factual allegations about the development of acetaminophen and how it has been marketed as “the safest, and the only appropriate” pain reliever for pregnant women. These general allegations then move on to lay out the scientific evidence showing that the use of acetaminophen interferes with fetal brain development which can lead to autism.

Next, the Complaint gets more specific and states that Springer purchased Kirkland brand acetaminophen from Costco and regularly used it throughout her pregnancy from October 2016 to May 2017. According to the Complaint, Springer took the Kirkland generic Tylenol “a few times a week” during that time frame. Springer’s acetaminophen lawsuit claims that she took the drug based on the assumption that it was safe to use during pregnancy.  Her suit points to what is the core of every Tylenol lawsuit:  there was nothing on the warning label to suggesting a possible risk of autism.

Springer’s daughter was eventually born in May 2017. At 18 months old, Springer’s daughter was diagnosed with an autism spectrum disorder.

This Tylenol autism lawsuit asserts six separate 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 general allegation underlying all of these claims in this Tylenol lawsuit is that Costco knew (or should have known) about the connection between acetaminophen use during pregnancy and autism, but continued to sell its Kirkland brand generic Tylenol without any warnings about that 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 was subsequently diagnosed with autism, you and/or your child may be able to bring a civil lawsuit and seek financial compensation.

Right now, the scientific evidence establishing causation between prenatal exposure to acetaminophen and autism is still emerging. If this evidence of causation is considered strong enough to be presented to a jury in a civil case, however, plaintiffs could receive significant compensation for these cases.

If the Tylenol autism lawsuits are eventually consolidated into a class action MDL (and the causation evidence survives legal challenges), it will be more likely that these cases could be resolved in some type of global settlement.

Autism Drugs at Issue

The non-exclusive list of drugs:

a. Alka-Seltzer PLUS
b. CoricidinHBP
c. Dayquil
d. Excedrin
e. FluTherapy
f. Midol
g. Mucinex MAXIMUM STRENGTH FAST-MAX COLD, FLU & SORE THROAT
h. Mucinex MAXIMUM STRENGTH FAST-MAX COLD & FLU (ALL-IN-ONE)
i. Mucinex MAXIMUM STRENGTH NIGHTSHIFT COLD & FLU
j. Mucinex MAXIMUM STRENGTH NIGHTSHIFT SEVERE COLD & FLU
k. Mucinex MAXIMUM STRENGTH SINUS-MAX PRESSURE, PAIN & COUGH
l. Mucinex MAXIMUM STRENGTH SINUS-MAX SEVERE CONGESTION & PAIN
m. Nyquil
n. Panadol
o. Robitussin Maximum Strength
p. Sinex SEVERE ALL IN ONE SINUS
q. Sudafed Head Congestion + Flu Severe
r. Sudafed Head Congestion + Mucus
s. Sudafed PE Sinus Pressure + Pain
t. Theraflu
u. Tylenol
v. Store-brand acetaminophen

This list is NOT exhaustive and any drug containing acetaminophen qualifies.

Which Tylenol Lawsuits Are Our Lawyers Not Taking?

There are certain types of Tylenol autism cases that our firm is currently not accepting.

Adult Tylenol Lawsuits

The biggest category is cases in which the child born with autism has already reached the age of adulthood. It is often heartbreaking when a parent calls looking to find a path to help their adult child and our team has to say we cannot help them.  There are two primary reasons why we are not accepting Tylenol autism cases involving adults.

Statute of Limitations Concerns for Adult Tylenol Lawsuits

First, cases involving adult children may present statute of limitations issues. If the pregnancy happened 20 years ago and the child with autism is now an adult, it might simply be too late to file a lawsuit under the applicable state law.

There are strong arguments in many jurisdictions that the Tylenol lawsuit statute of limitations should be extended because victims did not know or have reasons to know of the connection to autism and their injuries until very recent studies (or television commercials) alerted them to a possible association.  But there are also statutes of repose in some jurisdictions that may completely bar many claims.

Getting Old Medical Records Often Proves Impossible

The second and more practical reason that we are not pursuing Tylenol autism cases involving adult children is that in most circumstances it will be very difficult, if not impossible, to obtain the medical records necessary to support the case.  Our lawyers have learned from experience in other lawsuits we have handled – old medical records often no longer exist.

To support a Tylenol autism lawsuit, plaintiffs will need medical records from their OB/GYN evidencing the Tylenol use. If the pregnancy happened two decades ago, getting those records will be very difficult. One of the primary reasons for this is that the medical practice has since closed. The AMA has identified a number of other challenges for patients attempting 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. The reason for this is that the CARES Act, which was passed in response to the COVID-19 pandemic, made FDA labeling rules for Tylenol final as of March 2020. Prior to that date, manufacturers and retailers were free to add warning labels to their Tylenol or acetaminophen products.

Once the CARES Act made the FDA labeling rules final, the warning labels for Tylenol and generic acetaminophen were essentially fixed and could not be amended. 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 our lawyers have that may exclude prospective Tylenol autism lawsuits.

• If the mother suffered one or more of the following complications during pregnancy:
  • gestational diabetes
  • gestational hypertension
  • an infection and related fever that required 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 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 not longer taking new lawsuits.  We are taking toxic baby food lawsuit for the same injuries as we discuss above.