Update on Tylenol Litigation: Initiation of Daubert Motions

Daniela P on September 25, 2023

Insightful Update on the Tylenol Litigation’s Daubert Hearing Proceedings

The judicial examination concerning the admissibility of general causation expert testimony in the Tylenol litigation has formally begun. On September 19, 2023, Johnson & Johnson, along with co-defendants representing retail entities, submitted a trilogy of motions intent on precluding the testimonies of the plaintiff’s general causation experts. The defense has raised questions about the scientific reliability of claims that acetaminophen consumption during pregnancy: (1) increases the risk of autism spectrum disorders, (2) elevates the risk of Attention-Deficit/Hyperactivity Disorder (ADHD), and (3) is backed by biological plausibility. Conversely, the plaintiff’s legal team has presented a series of motions aiming to exclude all expert testimonies put forth by the defense regarding general causation.

At this nascent stage of proceedings, it is challenging to predict the rulings on these motions. Opposition briefs and corresponding evidentiary materials will be filed by both parties on October 10, 2023. Subsequently, each will have an opportunity for rebuttal with reply briefs due on October 20th. A clearer understanding of the possible judicial directions will likely emerge only after the comprehensive briefing of each motion.

Further insights into the methodology of the presiding Judge Cote may be ascertained from a public telephonic status conference scheduled for early October. During this session, Judge Cote will delineate the expectations and specifics of the Daubert hearings set to commence on December 4th. This discussion may involve directives on witness examination procedures, the sequencing of testimonies, and potential limitations on the duration of oral arguments. Additionally, substantive comments from Judge Cote on the current briefs may signal her areas of interest.

It is also within the realm of possibility that Judge Cote will either request or mandate a set of questions for the counsel to address during the hearings in December, drawing parallels to the approach taken by Judge Rosenberg in the Zantac MDL Daubert proceedings of September 2022. Such an inquiry would likely underscore the issues Judge Cote deems pivotal in formulating her factual and legal conclusions.

To date, there is no record of any Daubert ruling from Judge Cote in similar product liability or mass tort cases, nor has either party cited such precedent in their filings. It is anticipated that Judge Cote will render a considered verdict on the motions, with a determination expected by mid to late January 2024.

Should the motions by the defendants be overruled, the litigation is expected to proceed to a subsequent phase, entailing: (1) the selection of bellwether plaintiffs and related discovery, (2) further Daubert motions and hearings focused on specific causation experts, and (3) the setting of bellwether trials, anticipated to be led by noted trial attorneys Mark Lanier and Mikal Watts, contingent upon the plaintiff’s causation experts prevailing against exclusion.

We will continue to provide updates as further developments arise.

Judicial Update 10.6.23: Judge Cote’s Status Conference on Daubert Hearing Procedures

In a concise telephonic status conference lasting merely 11 minutes, Judge Cote conferred with counsel regarding the logistics for the forthcoming Daubert hearings scheduled for the week of December 4th. Judge Cote immediately remarked on the uncommon nature of live expert testimonies during such hearings, indicating her preference for engaging with these testimonies only if they clarify issues arising from their written reports, depositions, or referenced scientific studies, thereby assisting her understanding.

Judge Cote assured that should she deem it necessary to solicit further explanations from specific experts during the proceedings, she will inform the parties accordingly. She emphasized efficiency in testimony, expressing her intention to conduct a thorough review of not only the briefs and reports but also the foundational studies referenced therein.

Although Judge Cote refrained from imposing oral argument constraints during the call, she signaled her willingness to hear counsel’s arguments and indicated that more concrete plans for the hearing would be forthcoming.

Upon querying the parties for their input on her preliminary views, the defendants’ counsel drew a parallel to a precedent where Judge Wolfson found live testimony beneficial after initial hesitation. Judge Cote responded by underscoring her current focus on the written briefs, indicating a readiness to request further expert testimony if necessary after the conclusion of the briefing process.

With the defense’s proposal for comprehensive witness testimony and the plaintiff’s call for a more streamlined approach, Judge Cote’s stance could be interpreted as leaning towards the plaintiffs. However, a more accurate assessment of her position will likely be available after further communication post-October 20th. Insights may also be enhanced should Judge Cote decide to present the parties with specific questions or topics to be addressed during the December hearings.

Legal Brief 10.20.23: Tylenol Case Progress

Following the submission of the final briefs on October 20th concerning the parties

’ Daubert motions, anticipation builds for further instructions from Judge Cote. Ahead of the December 4th Daubert hearing, there are several key considerations: the potential for Judge Cote to call upon specific expert witnesses, the allotment of time for each side’s oral arguments, the sequence of these arguments, and the possibility of receiving direct questions from the Judge. These forthcoming directives will offer significant insight into Judge Cote’s judicial approach and the trajectory of the hearings.

Tylenol Litigation Update: FDA’s Stance Reveals Complex Implications

Daniela P on September 11, 2023

FDA’s Response in Tylenol Autism/ADHD Litigation: An Overview

In the unfolding Tylenol litigation, the U.S. Food and Drug Administration (FDA) has provided a nuanced response to inquiries concerning the potential risks associated with acetaminophen use during pregnancy. In late April 2023, the presiding Judge Cote solicited the agency’s perspective on whether warnings about the risk of autism and Attention-Deficit/Hyperactivity Disorder (ADHD) should be explicitly stated on acetaminophen labels for pregnant women. Although the FDA’s feedback was initially due by the end of July, the deadline was extended at the request of the U.S. Government to September 15th.

Ahead of schedule, on September 8th, the U.S. Attorney for the Southern District of New York, on behalf of the FDA, submitted a letter and an accompanying report. This submission occurred 11 days before the deadline for the parties to present their initial Daubert briefs, which are intended to challenge and aim to exclude their opponents’ general causation experts.

The disclosure from the Department of Justice (DOJ) indicated that the FDA currently views the post-2015 scientific studies it has reviewed as inconclusive regarding causality. This perspective is seen as unfavorable by those who advocate for a definitive link between acetaminophen use during pregnancy and developmental disorders.

However, there is an aspect of the FDA’s position that may be perceived positively by the plaintiffs. According to the DOJ letter, the FDA has chosen not to assert a position within the ongoing litigation, aiming not to impede Judge Cote’s evaluative process of expert testimony during the Daubert hearings. Notably, the FDA has refrained from commenting on potential alterations to the current warning labels, thus abstaining from influencing the judicial procedures directly.

This development prompted Johnson & Johnson and Walmart to consider additional legal maneuvers, anticipating that Judge Cote might be persuaded to reassess her previous rulings that dismissed their preemption claims. In response to a subsequent request from Johnson & Johnson for a status conference to deliberate on the implications of the FDA’s stance, Judge Cote promptly declined, reasserting her focus on the upcoming September 19 Daubert motions.

The future implications of the FDA’s position remain to be fully understood. Defendants are expected to leverage the FDA’s findings in the Daubert motions and may seek to inform juries of the agency’s stance in future bellwether trials. Conversely, the plaintiffs’ representatives are likely to contend that unless FDA officials are subject to deposition and cross-examination, the disclosure of the FDA’s views could unfairly prejudice the jury against the plaintiffs.

Following the FDA’s response, the plaintiffs’ leadership has made public a previously submitted letter to the FDA, arguing that recent scientific studies do indeed establish a causal link. This public disclosure suggests an increased probability that subsequent filings from both parties, including the September 19 Daubert motions and the October 10 opposition briefs, may also enter the public domain rather than being filed confidentially.

While the FDA’s current position on the recent studies does not endorse causality, the agency’s non-interventionist approach to the warning label debate and the Daubert process presents a complex tableau. The litigation community now eagerly awaits the impending exchange of Daubert motions, expert reports, and briefs due for submission on September 19, 2023.

Tylenol Litigation: Getting Closer to the Daubert Motions

William V on July 29, 2023

Judge Cote has largely ruled in plaintiffs’ favor to date on most of the defendants’ initial motions — e.g., denying Walmart’s preemption motion twice and J&J’s preemption motion, and various other motions to dismiss claims on other grounds. Most recently she denied J&J’s motion seeking her permission to file an immediate (interlocutory) appeal from her preemption ruling to the Second Circuit Court of Appeals.
Plaintiffs’ leadership have filed amended master complaints against J&J and separately, against the various retail chain defendants who had manufactured and sold their own house brands of acetaminophen (i.e., Walmart, and other major retailers). These master complaints reflect the narrowing of plaintiffs’ causes of action in accordance with Judge Cote’s rulings.

In further efforts to focus the litigation, parties have agreed to dismiss without prejudice complaints where Texas law clearly governs, since Cote previously dismissed certain claims against retailers under a Texas statutory “safe harbor” preemption clause for retailers. The parties asked Judge Cote to resolve the parties’ dispute over whether certain additional plaintiffs’ complaints are governed by Texas choice of law (and thus dismissible) or a different state’s law (and thus remaining viable).

As previously written, she has also scheduled a “rocket docket” deadline, with special attention for Daubert motions to be filed on September 19^th and a Daubert hearing on the motions during the week of December 4^th. The parties will continue the process of exchanging initial and rebuttal expert reports in the weeks leading up to September 19, 2023.

On July 28, 2023, the Department of Justice asked Judge Cote for a time extension until September 15^th to respond to Cote’s unusual invitation to the federal government to weigh in on whether the label for acetaminophen should be changed to provide additional warnings of risk to pregnant women taking the drug. She likely granted the DOJ’s request to obtain a glimpse of how relevant regulatory agencies (especially the FDA) view this dispute in the context of their interpretation of public health and safety requirements.

Watch this space for links to the September 15^th and 19^th filings — to the extent they are public and not sealed.

Court Approves Short-Form Complaint for Tylenol Autism

CopyPress Inc. on March 9, 2023

Court Approves Short-Form Complaint for Tylenol Autism

Families looking to take legal action against distributors and manufacturers of acetaminophen-based pain medications gained a small victory on Jan. 11, 2023, when a U.S. District Judge approved a short-form complaint. This complaint allows families to submit ADHD and Tylenol autism-related lawsuits in the federal multidistrict litigation (“MDL”) Court, which will help the parties involved evaluate each individual claim. Judge Denise Cote made the decision because more families are seeking to file lawsuits, saying that the active ingredient found in Tylenol resulted in ADHD or autism in their children and that the drug maker or distributor failed to warn or adequately disclose the potential pregnancy dangers.

History of acetaminophen-based medications and pregnancy lawsuits

For many years, pregnant women used Tylenol, along with other acetaminophen-based medications, believing that they were safe. Now, however, some families allege that there is an active ingredient in these drugs that causes autism and ADHD and that the drug makers knew of this risk but didn’t adequately inform pregnant women. Back in November 2022, the Court established a federal MDL, creating a centralized location for all of these Tylenol autism lawsuits. Since these claims raise almost identical factual allegations, the Court decided to include them all in one MDL.

Managing similar cases

As of now, many of the current complaints are against drug retailers, such as CVS, Walgreens, and Walmart. This stems from the retailers selling these drugs without pregnancy warnings. It’s expected that several thousand lawsuits will also be filed against Johnson & Johnson for its alleged role in the extensive use of acetaminophen-based medications during pregnancy.

The short-form complaint was proposed by lawyers of the existing claimants, as it will allow for a standardized complaint form for potential future litigants. They can then use this to adopt specific allegations from the master complaint, then provide limited information on a case-by-case basis about acetaminophen-based drugs and any injuries suffered by their children.

Judge Cote was appointed by the U.S. Judicial Panel on Multidistrict Litigation (JPML) to oversee the growing number of cases. She will manage these cases in the Southern District of New York, allowing the different parties to coordinate discovery related to all claims. As part of this process, the Court expects to create what is known as a “bellwether” process, which is a small group of representative claims prepared in advance for earlier trial dates. The parties involved can then assess how these cases performed in front of a jury and decide on further actions needed.

Determining if you have a case

If you believe your child was injured during pregnancy because of Tylenol or another acetaminophen-based medication, you may have a claim. To proceed, you should speak with a lawyer who will assist you in determining whether you qualify to join the MDL. If you do, the lawyer can then work with you throughout the rest of the process to help ensure you receive the best possible outcome.

While these Court cases can take some time, it’s still important to join as early as possible if you think you are eligible. Doing so will help you avoid any deadlines and give you more insight into the progress of the litigation. Speak with one of our lawyers today to learn more about potentially joining the MDL and beginning the process of filing a short-form complaint.

Motion Filed To Consolidate Increase in Tylenol Autism/ADHD Lawsuits

CopyPress Inc. on March 9, 2023

Motion Filed To Consolidate Increase in Tylenol Autism/ADHD Lawsuits

Lawsuits from 20 parents covering the link between autism and the prenatal use of Tylenol or acetaminophen will likely consolidate into one Court. Plaintiffs claim their children developed autism or ADHD due to using the drug during pregnancy. The Tylenol autism lawsuits are against Johnson & Johnson — the company that first developed acetaminophen — and other brands that make generic versions of the product, such as Walmart, CVS, and Walgreens. All Plaintiffs feel that they were not provided warnings of the potential dangers of taking acetaminophen during pregnancy and are seeking compensation for a variety of relate issues.

Why Has a Motion Been Filed To Consolidate Tylenol Autism Lawsuits?

Bottle and carton box of tylenol pills

Recent research indicates that there is a 19% and 21% increase in the chance that a child may develop autism or ADHD, respectively, when prenatally exposed to acetaminophen. Because of this research, many experts and legal professionals anticipate the number of cases being filed against Johnson & Johnson and other companies that manufacture the drug will increase.

In an effort to provide a more prudent, efficient, and speedy pretrial process, consolidation of said cases is being sought in New York through the filing for an MDL where a judge could potentially hear many of the cases and establish rules for discovery, thresholds for evidence, and recoverable damages.

What Is the Risk of Autism or ADHD With Tylenol Use?

A National Institute of Health study states that the more exposure a pregnant mother has to Tylenol, the higher the risk there will be of the child developing autism or ADHD. Using umbilical cord blood from 996 babies, the study found that by the time the children reached about eight years old, 25.8% developed ADHD, 6.6% developed autism, and 4.2% were diagnosed with both. In this study, it was found that the longer a pregnant woman uses acetaminophen and the higher the dose, the more likely it is that the child will develop autism or ADHD.

This represents a significant increase in the occurrence of autism and ADHD in children over those who were not exposed to acetaminophen. These risks, combined with the failure of the manufacturers and distributors of acetaminophen to provide voluntary warnings even after they were aware of said risks may have unnecessarily exposed tens of thousands of children to an avoidable harm.

Who Can Qualify for a Tylenol Autism Lawsuit?

If a mother took acetaminophen during pregnancy or the postnatal period while nursing, and the child has developed autism or ADHD, she may qualify to pursue action against manufacturers of the drug. A child must be 17 years old or younger, and the mother has to have evidence that she took acetaminophen during pregnancy or while nursing.

This is possible through medical or pharmacy records, where a doctor may have instructed a pregnant patient to take Tylenol, or with receipts from purchasing one of hundreds of name and privately labeled acetaminophen products. This is especially true if mothers feel they weren’t properly informed of the risks associated with taking acetaminophen.

There have been no settlements yet for any Tylenol lawsuits. The studies linking Tylenol to autism and ADHD are also new, so it’s undetermined what the compensation might be for those seeking compensation for damages. Those who feel they qualify to join the Tylenol autism lawsuits should contact legal counsel to determine their eligibility.