Navigating the Camp Lejeune Water Contamination Litigation

Camp Lejeune Water Contamination Litigation: An Overview of Legal Progress 

The litigation concerning Camp Lejeune has reached a critical juncture, with significant developments promising a more expeditious pathway to resolution for the claimants affected by the contamination at the military base. There are three pivotal components currently underway: (1) the probable initiation of bellwether trials in the first half of 2024 for claimants with designated “Track 1” diseases; (2) the introduction of a “quick-pay” settlement program by the Navy as of September 2023; and (3) the prospective establishment of a standard settlement framework for those who either opt out of or do not qualify for the quick-pay option. 

For a considerable period following the enactment of the Camp Lejeune Justice Act (CLJA) by President Biden on August 10, there was a noticeable absence of progress within the judicial system. Prior to April 5, 2023, the legislation seemed stagnant, with no discernible movement in the form of court deadlines, status conferences, hearings, or indication of when the Eastern District of North Carolina’s federal judges would begin active management of the CLJA lawsuits, despite the legislation’s intent. Moreover, there was little evidence of the Department of Justice (DOJ) and Navy adequately addressing the influx of administrative claims or enhancing their staffing to cope with these demands. 

Momentum Shift Following Judge Dever’s Status Conference 

The stagnation was disrupted on April 5 when Judge James C. Dever III orchestrated an extensive status conference. He called for the Navy to expedite the processing of administrative claims and to initiate settlement offerings, as by that date, the Navy had approximately 20,000 claims yet to be resolved. Moreover, Judge Dever stressed the need for the litigation to progress, enabling plaintiffs to promptly have their cases tried against the Government. He emphasized the necessity of creating a comprehensive database detailing the specific contaminants at Camp Lejeune, their locations, and time frame of presence – information that would be instrumental in substantiating causation in the pending litigation. 

From this point, the trajectory of the Camp Lejeune lawsuits shifted dramatically, and the judicial approach adopted by the Eastern District of North Carolina’s four federal judges now mirrors the management typical of a Multidistrict Litigation (MDL): 

Key Developments and the Path Forward 

The subsequent months witnessed several noteworthy events: 

– On July 19, a prominent Plaintiffs’ Leadership Group was appointed, comprising notable attorneys with considerable experience in mass tort litigation. 

– July 28 saw the submission of a Joint Status Report and Joint Motion, proposing a Global Case Management Order that outlined a strategic approach to the consolidated lawsuits. 

– By August 18, the Plaintiffs’ Executive Committee reported on significant discussions focused on the scientific underpinnings of the case. 

– The end of August marked the filing of a Joint Status Report and a draft Case Management Order. 

Central to these developments was the classification of diseases for the upcoming trials into “Track 1,” which includes serious conditions such as bladder cancer and leukemia. The DOJ’s alternative proposal suggested a narrower selection and a timeline extending the bellwether trials to 2025. However, the Judges’ Order reflected an alignment with the Plaintiffs’ suggestions, setting the stage for trials to commence in 2024 – a major victory for the plaintiffs. 

On September 6, the Navy announced a “Quick Pay” settlement option, presenting a tiered structure of compensation based on the severity of diagnosis and duration of exposure. While the attractiveness of these terms to the victims remains to be assessed, there is anticipation for a more comprehensive settlement framework to be developed in 2024. 

Further revisions were introduced on September 15 regarding attorneys’ fees, triggering a potential confrontation between Plaintiffs’ Leadership and the DOJ/Navy over these caps. 

By October 26, detailed discussions on the path to a “Global Resolution” were outlined, and contentious issues, such as the DOJ’s attorneys’ fees caps, were poised for debate. 

With the events of the past 14 months culminating in a series of strategic legal advancements, claimants impacted by the Camp Lejeune water contamination stand on the cusp of potentially receiving due recompense through a structured settlement program. The shift in the judicial approach and the proactive measures of the court now reflect the gravity and urgency with which this matter is being addressed, signifying a profound change from the previous standstill. The dedication to advancing the litigation with alacrity and fairness suggests that 2024 could be a pivotal year for achieving justice for the victims of Camp Lejeune. 

Update on Tylenol Litigation: Initiation of Daubert Motions

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

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. 

Tepezza Litigation Updates: Establishment of a Multidistrict Litigation

Tepezza Litigation: MDL Establishment and Updated FDA Warnings 

Significant advancements have transpired in the ongoing Tepezza litigation. 

Formation of an MDL: On June 2, 2023, the Judicial Panel on Multidistrict Litigation (JPML) mandated the formation of multidistrict litigation (MDL) concerning Tepezza. The JPML selected the Honorable Judge Thomas Durkin of the Northern District of Illinois to preside over the MDL, which, as of August 15, 2023, comprises 46 individual cases. 

FDA Warning Label Update: After this, on July 24, the U.S. Food and Drug Administration (FDA) revised the warning label guidelines for Tepezza, mandating the inclusion of a warning pertaining to the risk of hearing impairment or hearing loss. This update reflects concerns regarding the potential adverse effects associated with the medication. 

Plaintiffs’ Allegations: The plaintiffs have presented allegations suggesting that Horizon Therapeutics, the manufacturer of Tepezza, was cognizant of the substantial risks associated with the drug, particularly in relation to hearing loss and tinnitus, but did not adequately communicate these risks to the FDA prior to or following the drug’s approval, nor did they sufficiently update the drug’s labeling to inform healthcare providers and patients. They contend that this omission constitutes a “failure to warn” and also assert that the drug possesses inherent safety issues, aligning with the “design defect” theory of liability. 

Horizon’s Stance: Horizon Therapeutics has countered, asserting that the warnings provided upon FDA approval in 2020 were adequate and that the subsequently identified concerns regarding hearing loss and tinnitus were not substantial enough to warrant an immediate change to the drug’s labeling. 

Impact of FDA Label Change: The FDA’s decision to modify the label on July 24, 2023, to include the exact warnings regarding hearing loss and the necessity for vigilant physician monitoring that the plaintiffs argued should have been included initially, is noteworthy. The revised labeling now clearly states the risks of severe hearing impairment, potentially altering the landscape of ongoing and future claims associated with the drug’s use. 

The updated label is available for review at: Tepezza Prescribing Information. 

The change in labeling is likely to have a dual effect: it may limit new “failure to warn” claims post-July 24, 2023, and it is expected to prompt more thorough discussions between physicians and patients about the risks associated with Tepezza. Moreover, this amendment fortifies the position of individuals who used Tepezza prior to these warnings, challenging Horizon’s defense against “failure to warn” claims before the label change. 

Horizon’s legal strategy regarding these preemption defenses remains unchanged as the briefing period continues. Upcoming oral arguments will be pivotal in discerning Judge Durkin’s perspective on these preemption issues and Horizon’s approach considering the updated warning. 

Progress Toward Bellwether Plan: According to a Joint Status Report filed on July 24th, the involved parties have expressed their intention to convene and forge a path toward a mutually agreeable Bellwether/Briefing Plan. This plan will encompass motions to dismiss and the initial selection of bellwether discovery cases. The subsequent status conference is scheduled with Judge Durkin on August 31, 2023. 

Amgen’s Proposed Acquisition of Horizon: In a related development, Amgen has expressed an intent to purchase Horizon for $27.8 billion (about $86 per person in the US). The transaction was initially deferred due to a lawsuit filed by the Federal Trade Commission (FTC) aimed at blocking the acquisition. Following a settlement with the FTC, the companies are now progressing toward finalizing the acquisition. The outcome of this purchase is anticipated to have a significant influence on the Tepezza litigation and its potential resolution. 

Potential Claimant Pool: Current data indicates that the pool of potential claimants is relatively limited, with only 14,500 patients having undergone treatment with Tepezza, as stated on the official product website. The treatment involves a series of infusions over approximately five months. The smaller number of potential claimants may influence the average settlement amount in any prospective collective settlement arrangement. 

Navigating the Complexities of Baby NEC Multidistrict Litigation

Navigating the Baby NEC Mass Tort Litigation Landscape 

  • Overview of the Baby NEC Multidistrict Litigation 
  • Judge Pallmeyer’s Pivotal Decisions in NEC MDL 
  • The Science Behind Baby NEC Claims 
  • Anticipating the Bellwether Trials in Baby NEC Litigation 
  • State Law Applications and Their Impact on NEC Cases 
  • Corporate Ethics and Its Influence in Baby NEC Litigation 
  • Procedural Milestones and Their Impact on the Litigation Timeline 
  • The Complexities of Document Management in Mass Tort Litigation 

The multidistrict litigation (MDL) encompassing claims related to baby necrotizing enterocolitis (NEC) is evolving with critical judicial activities that could establish important legal precedents for analogous litigations in the future. 

Key Developments in the NEC MDL Proceedings 

The MDL, which centralizes approximately 200 baby NEC claims, is advancing towards significant judicial milestones. The presiding judge, Honorable Judge Pallmeyer, has been instrumental in delineating the discovery and motions schedule, which is vital for dictating the pace of the ongoing litigation. 

Notably, the judicial proceedings such as the Science Day and the selection of bellwether trials are set to significantly shape the trajectory of the MDL. These selections will play a crucial role in informing settlement discussions and subsequent trial strategies. 

The application of disparate state laws to individual claims further underscores the complexity and heterogeneity inherent in these cases. Additionally, corporate behavior investigations into prominent companies like Abbott and Mead Johnson add an extra layer of intricacy and ethical considerations to the legal challenges presented. 

Current Status and Anticipated Progression 

As of mid-August 2023, the MDL’s progression reflects the invested interest of the parties involved in resolving these multifaceted disputes. Although the MDL is at an early stage, Judge Pallmeyer’s balanced approach to adopting a discovery and motions schedule from proposals by both plaintiffs and defendants, while leaving essential deadlines open, marks a significant step in the litigation process. 

The confidential Science Day held on May 3 provided a platform for discussing general causation issues, emphasizing the scientific underpinnings essential to the claims’ success. 

Further decisions on the procedural timelines are expected to emerge from the status conference scheduled for September 8, 2023. These rulings will likely affect the timing of bellwether trials, tentatively set for late 2024 or early 2025. 

The intricate analysis required by Judge Pallmeyer in her rulings reflects a nuanced approach to the legal standards and the individuality of claims under various state laws, highlighting the depth of the litigation. 

Implications of External Corporate Investigations 

While the FTC’s investigation into the defendant companies for potential collusion and misconduct is separate from the NEC litigation, the outcome could potentially sway juror opinions and influence the legal strategies of the parties involved. 

Outlook for Settlement and Trial Proceedings 

With the first bellwether trials not expected until at least late 2025, the MDL is indicative of a protracted legal engagement, with all parties bracing for an extended period of litigation. The extension of bellwether trial selections and the substantial volume of document production by the defendants point to the ongoing challenges in managing large-scale litigations such as this. 


The baby NEC MDL exemplifies the intricate dynamics of mass torts, with the judiciary’s discretionary powers playing a critical role. Each procedural advancement brings the legal fraternity closer to discerning the full implications for all stakeholders.