Tylenol Autism ADHD Lawsuit | Acetaminophen During Pregnancy Linked to Birth Defects

July 2024

New York federal court currently has 56 pending lawsuits related to Tylenol and autism/ADHD, all consolidated under MDL No. 3043.

Judge Denise L. Cote is yet to decide on granting the defendants’ motion to exclude the expert opinions of Dr. Roberta Ness. As per the MDL docket, a ruling on the admissibility of this testimony is still pending. The outcome of this decision holds significant weight in determining the course of the litigation and whether it can proceed. The MDL case is currently ongoing, awaiting further developments from the court.

June 6, 2024

In the ongoing litigation, a significant development has emerged. Following the court’s previous rejection of all the plaintiffs’ experts due to methodological flaws, including combining ASD and ADHD in their evaluations, reliance on symptom studies rather than confirmed diagnoses, and other shortcomings, a positive turn has taken place.

Responding to the court’s concerns, the plaintiffs have enlisted the expertise of Dr. Roberta Ness, a highly qualified expert. Dr. Ness has meticulously addressed each issue raised by the court, focusing exclusively on ADHD, ensuring valid causal inferences from diagnostic studies, thoroughly debunking genetic confounding factors, and effectively countering opposing organizational opinions. Furthermore, she has provided a comprehensive analysis of the dose-response relationship and biological plausibility, underpinned by peer-reviewed literature to support her methodology.

Although the defense lawyers have challenged the admissibility of Dr. Ness’s testimony, their argument faces a tougher challenge this time around. As the case progresses to the Daubert hearing, there is a renewed sense of optimism surrounding the litigation’s outcome.

May 7, 2024

The Tylenol autism and ADHD lawsuits are in a phase where the court awaits a decision on the admissibility of new expert testimony in the claims. The defendants have until July to submit any objections to the proposed testimony. The potential acceptance of this new evidence could potentially revive the Multi-District Litigation (MDL) that was previously dismissed in December.

In a significant development, Dr. Roberta Ness has been deposed as the final expert witness for the plaintiffs in the MDL. During her deposition, Dr. Ness articulated her belief that acetaminophen could contribute to the development of autism and ADHD. This conclusion was drawn after Dr. Ness analyzed ADHD and neurodevelopmental disorders in a broader context using the Bradford Hill criteria.

April 29th, 2024:

As of now, there are no additional updates for April. However, we’ll continue to monitor the situation closely for any developments or changes in the ongoing legal proceedings.

March 18th, 2024;

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.

February 5th, 2024:

A group of twelve parents and children, alleging prenatal acetaminophen exposure caused ADHD, seeks to challenge the disqualification of expert witnesses. They argue for the right to present their own experts in multidistrict litigation, following a ruling that nullified expert testimony for similar cases.

This prior decision left many plaintiffs without credible evidence linking Tylenol or similar products to autism or ADHD. U.S. District Judge Denise Cote demands justification for the continuation of their cases. The claim is supported by a 3rd Circuit precedent affirming the right to individual assessment of cases in MDLs.

January 15th, 2024:

In the ongoing saga of the MDL, the 501 plaintiffs involved have decided to appeal Judge Cote’s ruling. Additionally, some plaintiffs are exploring alternative options by turning to state court avenues. Among plaintiffs’ lawyers, there is a significant discourse regarding strategies to approach the litigation in state courts, including deliberations on the most favorable jurisdictions for filing suits.

December 21st, 2023:

A decision by U.S. District Judge Denise Cote has barred expert witnesses from testifying that the consumption of Tylenol, produced by Kenvue, a spin-off of Johnson & Johnson, can lead to autism during pregnancy due to a lack of credible scientific evidence to substantiate these claims.

This ruling is likely to bring an end to a large-scale mass tort litigation comprising approximately 500 lawsuits against Tylenol.

Judge Cote concluded that the expert witnesses for the plaintiffs failed to provide a solid scientific foundation for their assertion that the active ingredient in Tylenol, acetaminophen, could result in autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD).

In response to this decision, Kenvue plans to dismiss all pending cases, and its stock has experienced a roughly 4% increase following the ruling.

The lawsuits also targeted retailers selling generic versions of Tylenol, but these retailers have not issued any statements regarding the verdict.

These lawsuits hinged on the use of expert testimony, emphasizing the importance of adhering to scientific standards when presenting such evidence.

While some studies have suggested a potential connection between the use of acetaminophen during pregnancy and the mentioned disorders, researchers caution that other variables may be contributing factors, necessitating further investigation.

Health experts recommend acetaminophen over aspirin or ibuprofen for pregnant women due to potential fetal organ damage associated with the latter two medications.

December 6th, 2023:

If Judge Cote does not reject the defendants’ Daubert challenges soon, it could result in a significant increase in the backlog of cases within the Tylenol autism MDL.

In just the past month, an additional 58 cases have been added, bringing the total count to 441.

Additionally, there is a conference scheduled for January 4, 2024, at 4:30 p.m. to address the potential settlement arrangement in the Tylenol class action lawsuit.

November 17th, 2023:

In the past month, fifty-eight new cases have been incorporated into the Tylenol autism class action MDL, bringing the total number of pending cases to 441.

Should Judge Cote reject the defendants’ Daubert challenges, the quantity of pending cases within the MDL is anticipated to undergo a substantial increase.

November 11th, 2023:

a Daubert hearing is scheduled for December 7, 2023, but it will proceed without the inclusion of witnesses.

November 6th, 2023:

All briefs under Daubert, focusing on the acceptance of scientific expert testimony, have been presented to Judge Cote.

Both sides have submitted additional memorandums backing their requests to disqualify specific expert witnesses proposed by the other party.

These reply documents address the arguments raised by the opposing side in response to the initial motions for exclusion.

Each expert witness has their own extensive brief, along with supporting exhibits, amounting to several thousand pages throughout three rounds of briefings.

Judge Cote is preparing to conduct hearings to review these motions and might directly interact with some of the experts.

A hearing is scheduled for the week commencing December 5, 2023.

November 1st, 2023:

Daubert briefs regarding the admissibility of scientific expert testimony have been filed with Judge Cote. Both parties submitted reply memorandums last week to support their motions to exclude specific expert witnesses.

These replies respond to arguments made by the opposing side in response to the initial exclusion motions. Separate briefs were filed for each expert witness, totaling several thousand pages with supporting exhibits.

The next step involves hearings in which Judge Cote will evaluate the arguments and may directly engage with some of the experts.

October 27th, 2023:

Rite-Aid Corporation has filed for Chapter 11 bankruptcy protection due to the significant costs of opioid epidemic lawsuits and recent revenue losses.

The bankruptcy petition was submitted to the U.S. Bankruptcy Court for the District of New Jersey, as Rite-Aid is facing unresolved lawsuits related to its involvement in the opioid abuse crisis.

Rite-Aid is also entangled in Tylenol lawsuits, where it is alleged that over-the-counter acetaminophen products used during pregnancy can increase the risk of autism or ADHD.

Plaintiffs plan to confer with the company’s bankruptcy counsel to discuss how the bankruptcy proceedings will affect the ongoing litigation.

The remaining cases are anticipated to go through a bellwether process to assess how juries might react to specific evidence, potentially influencing future Tylenol settlements.

October 11th, 2023:

In a joint letter submitted today, the involved parties have notified Judge Cote that they have completed updates to the Plaintiff Fact Sheets.

Furthermore, they have revised the health records authorization forms required for new plaintiffs joining the case.

These adjustments are intended to address logistical challenges that have arisen and to simplify the information-gathering process for new plaintiffs.

In response to the Plaintiffs’ intention to submit additional expert reports from two of their experts, the defendants have raised objections.

The defendants argue that such supplementation, involving a new study, is untimely and violates Rule 26 because it was only available in a pre-print version, which differs from being formally published in a journal.

In preparation for the upcoming Daubert hearings, Judge Cote has requested that both parties present logistical plans for the hearings.

The defendants are advocating for an extended, week-long hearing to allow them additional time to challenge the scientific evidence.

On the other hand, the plaintiffs are advocating for a more streamlined process and have proposed that Judge Cote identify in advance the experts she deems essential to hear from.

October 2nd 2023:

Both parties have informed Judge Cote in a joint letter this morning that they have finished revising the Plaintiff Fact Sheets and health records authorization forms for new plaintiffs. These changes aim to streamline the information gathering process and address logistical issues.

September 22nd, 2023:

In the Tylenol autism class action lawsuit, the outcome hinges on Daubert challenges related to the admissibility of expert witnesses on causation. If the plaintiffs’ causation experts are excluded, the lawsuits may end in federal courts. Both sides have filed objections to each other’s experts.

These objections focus on issues like methodology, qualifications, and relevance. The Daubert hearings will determine whether these experts’ testimonies are admissible, with the aim of discrediting the opposing side’s experts.

September 18th, 2023: 

The Tylenol autism class action MDL had 136 pending cases in June 2023, but it has since grown to 265, nearly doubling in size over the last several months. However, this number does not accurately represent the situation, as there are more than 100,000 Tylenol claims awaiting a decision from Judge Cote before proceeding with lawsuits.

September 11, 2023:

Earlier in the year, Judge Cotes, presiding over the Tylenol Autism litigation, requested the FDA’s input on the plaintiffs’ proposal to add new cautionary labels to Tylenol containers. The decision was scheduled for September 15, but the FDA released a statement a week early expressing its reluctance to get involved in pharmaceutical litigation. Consequently, the FDA will not provide its perspective on the plaintiffs’ request for warning labels.

This development could have had a significant impact on the plaintiffs’ legal case. If the FDA had supported their request, it would have presented a strong indication in court that the government concurs with the idea that Tylenol can lead to autism in infants. Conversely, if the FDA had opposed the plaintiffs’ request, it would have signaled a contrary viewpoint, potentially leading Judge Cote to consider dismissing all of the cases.

September 1st, 2023:

Judge Cote sought input from the FDA in April regarding the warning issue at the core of the Tylenol autism class action lawsuits. The objective being to assess if the warnings proposed by the plaintiffs should be incorporated into acetaminophen labels, considering the validity of these warnings based on current scientific evidence regarding the risk of autism or ADHD in children.

Represented by the U.S. Attorney for the Southern District of New York, the FDA asked for an extension, moving the response deadline to September 15, 2023.

August 30, 2023

Judge Cote, presiding over the Tylenol Autism MDL, will decide on the Daubert motions by September 19. This decision could greatly affect which direction the legal proceedings go.

Daubert motions involve requests to exclude expert testimonies in court. If Judge Cote rules favorably for the plaintiffs and allows the admission of their expert testimonies, it would strengthen the plaintiffs’ arguments.

In addition to the Daubert decision forthcoming,  the FDA is obligated to soon disclose its stance on the litigation concerning warning labels for Tylenol. This disclosure has been extended to September 15, four days before the Daubert decision is due.

August 14th, 2023: 

In a collective letter presented to Judge Cote, the defendants and plaintiffs within the Tylenol autism MDL have agreed that plaintiffs residing in select states will be precluded from pursuing negligent misrepresentation claims centered on omissions. Those states include the following: Arkansas, California, Colorado, Idaho, Indiana, Kentucky, Nebraska, New Hampshire, North Carolina, North Dakota, Ohio, South Dakota, Tennessee, Texas, and Wyoming.

July 18th, 2023

In the past month, the Tylenol autism class action MDL in the Southern District of New York saw a significant increase with 64 new cases filed, marking the highest number of new filings since the creation of the MDL.

Currently, there are 200 pending cases in the MDL.

However, a substantial number of potential plaintiffs have yet to file, observing developments closely, particularly how evidentiary rulings unfold later in the year within the MDL.

These rulings are expected to shape the course of the litigation and may influence the decision of other potential plaintiffs to join the MDL.

July 7th, 2023

Judge Cote is taking a proactive approach to ensure timely progress in the Tylenol lawsuits.

Show cause orders have been issued to plaintiffs in two cases, namely Jackson v. Walmart and Swindell v. Johnson and Johnson, who have not completed required fact sheets.

These orders demand an explanation from the non-compliant parties as to why their cases should not be dismissed for failing to fulfill their discovery obligations

July 1st,  2023

As the Tylenol class action progresses through 2023, several key steps lie ahead.

Currently, the plaintiffs have submitted their expert reports, with the defendants expected to file their reports in response.

Subsequently, the plaintiffs might present rebuttal experts, followed by expert depositions.

Towards the end of the year, a critical hearing will take place, where Judge Cote will assess the scientific evidence linking acetaminophen to autism and ADHD.

Depending on her determination, the case may proceed in federal court or be transferred to state court.

The outcome of this hearing will play a significant role in shaping the course of the litigation going forward.

June 5, 2023:

A plaintiff has strongly objected to Johnson & Johnson’s (J&J) request for an immediate appeal of the court’s preemption and causation orders.

The plaintiffs’ motion emphasizes that granting J&J’s plea for an immediate appeal would bring the litigation to a grinding halt for approximately a year.

Moreover, the plaintiffs argue that this type of appeal should be considered a rare exception, and is not applicate in this specific case.

May 9th, 2023:

Johnson & Johnson (J&J) has requested an interlocutory appeal in the Tylenol autism class action MDL regarding the rejection of their preemption motion by Judge Cote.

This appeal would allow J&J to seek an appellate court’s assessment of the preemption order before the case progresses further.

Interlocutory appeals are exceptions to the general rule of appealing only after a final judgment and are granted in specific situations.

Although the court is unlikely to approve the interlocutory appeal, as the judge aims to expedite the litigation, the issue will be fully briefed as per the set schedule.

May 16th, 2023:

Despite the consolidation of the Tylenol autism cases into a class action MDL over six months ago, there are currently only 124 pending cases in the MDL.

The relatively low number can be attributed to thousands of potential plaintiffs waiting on the sidelines to observe the outcome of Daubert challenges in the MDL.

By doing so, these plaintiffs can gauge whether the scientific evidence linking Tylenol to autism will be dismissed by the judge.

If the evidence is deemed admissible, a surge of new cases is expected to be filed in the MDL.

This cautious approach allows prospective plaintiffs the option to file their cases in state court if the MDL gets terminated.

New data from the CDC indicates that the number of children in the U.S. diagnosed with autism spectrum disorder (ASD) has increased in recent years.

The research suggests that 1 out of every 36 children in the U.S. is now diagnosed with autism or ASD.

The judge overseeing the Tylenol Autism Multidistrict Litigation asked for proposed warning language that could be added to acetaminophen bottles.

The plaintiffs’ attorneys have proposed a warning that states that using this product frequently during pregnancy may increase the risk of autism and attention deficit hyperactivity disorder in children.

They recommend that pregnant women use the lowest effective dose for the shortest possible time and at the lowest possible frequency.

March 1st, 2023

There were 107 pending cases in the acetaminophen ADHD/autism class action litigation, an increase from the 80 cases that were pending when the class action MDL was created a few months ago.

March 9th, 2023

March 9th, the plaintiffs filed a memorandum opposing the motion to dismiss filed by J&J last month.

J&J is seeking dismissal of the Tylenol lawsuits on the grounds that the federal preemption doctrine precludes them, arguing that the warning labels on Tylenol are regulated by the FDA and governed by federal law.

However, this same argument was already rejected by Judge Cote when Walmart’s motion to dismiss was filed back in December.

J&J will have an opportunity to file a supplemental brief in support of its motion next week, but it is expected that Judge Cote will rule quickly based on her previous decision.

February 3rd, 2023:

Judge Cote issued an order to increase cooperation between state and federal court cases involving Tylenol autism lawsuits, as there are related cases filed in state courts that are not included in the MDL class action lawsuit.

February 11th, 2023:

The parties were instructed to submit joint or competing plaintiff’s fact sheets by February 28, 2023, which will help identify common issues and patterns among the claims and select the first lawsuits to go to trial.

February 25th, 2023:

Judge Conte issued a new order finalizing the protocol, rules, and schedule for expert witness depositions and fact discovery, allowing the depositions to begin and leading up to a ruling on the admissibility of the plaintiffs’ causation evidence in October.

The Tylenol litigation is ongoing, and major steps are being made by the court and Judge Cote to make it easier for those potentially impacted by Tylenol use during pregnancy to file claims directly into the MDL with the help of their attorney.

The court is also establishing a discovery plan:

A series of hearings and depositions that aim to establish the scientific basis of the argument that Tylenol use during pregnancy may increase the risk for certain developmental disorders.

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