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

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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