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. 

Advancements in Acetaminophen Litigation and the Approach to Daubert Hearings

Michael S on July 29, 2023

Advancements in Acetaminophen Litigation and Daubert Hearing Strategies

The landscape of the ongoing acetaminophen litigation has seen a series of favorable rulings for the plaintiffs, as overseen by Judge Cote. Her judicial decisions have consistently dismissed the preemptive defenses posited by defendants, including two motions from Walmart and one from Johnson & Johnson (J&J). The motions aimed to invoke federal preemption, which were not only rebuffed once but in J&J’s case, the attempt to secure an interlocutory appeal to the Second Circuit Court of Appeals was also denied.

In a strategic move, the plaintiffs’ leadership team has taken steps to streamline their legal approach by filing revised master complaints against J&J and various retailers who produced and sold generic versions of acetaminophen. These updated complaints are directly responsive to the narrowing scope of actionable claims as determined by Judge Cote’s prior rulings. 

A notable decision to dismiss certain complaints where Texas law applies, without prejudice, illustrates a concerted effort to focus the litigation effectively. This decision arises from a prior judgment where Judge Cote recognized a Texas statutory “safe harbor” preemption provision favoring retailers. Current deliberations seek to ascertain the appropriate jurisdictional law applicable to additional complaints, distinguishing between those governed by Texas law and thus subject to dismissal, and those under alternate states’ laws which may remain in contention. 

In preparation for the critical phase of litigation, Judge Cote has instituted a “rocket docket,” specifying that Daubert motions be filed by September 19, 2023, followed by a dedicated Daubert hearing in the first week of December. This accelerated schedule underscores the urgency and significance of the expert testimony and reports that are to be exchanged in the lead-up to the September deadline. 

In a parallel development, the Department of Justice (DOJ) sought an extension from Judge Cote until September 15, 2023, to deliberate on the court’s request for federal insight into the potential amendment of acetaminophen labeling to caution pregnant women of associated risks. This extension likely serves to inform the court of the FDA’s stance on the matter, providing a regulatory perspective on the public health implications inherent in the labeling dispute. 

As the litigation proceeds towards these pivotal hearings, the transparency of the legal process will be maintained to the extent that the documents and filings are not sealed by the court. Legal scholars, practitioners, and the public alike await further developments and the potential impacts on regulatory practices and consumer safety standards. 

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 19th and a Daubert hearing on the motions during the week of December 4th. 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 15th 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 15th and 19th filings — to the extent they are public and not sealed.