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. 

Paraquat Legal Developments: Daubert Hearings Are Over

The hearings on the Daubert motions took place from August 21-24 before MDL Judge Nancy Rosenstengl. The oral arguments were, as expected, very contentious and at a very high level. The sole live witness at the hearing, specifically requested by the Judge, was Dr. Michael Wells, plaintiffs’ only general causation expert.  The parties’ arguments on their respective motions to exclude other expert witnesses did not generate anywhere near the same time and heat as the arguments over Dr. Wells — which only makes sense since he is the linchpin of plaintiffs’ case.

Dr. Wells did a meta-analysis of seven (7) prior epidemiological studies of the causal link between exposure to Paraquat and Parkinson’s Disease, and he concluded that the odds ratio was 2.8. Syngenta and Chevron argued that he failed to properly consider let alone give proper weight to three more recent and much larger epidemiological studies, which did not show a causal link between Paraquat and Parkinson’s Disease — and used defendant boilerplate words such as “cherry-picking” to characterize his analysis as unreliable and thus warranting exclusion.  Dr. Wells and plaintiffs’ counsel Eric Kennedy strongly rebutted those attacks, emphasizing Dr. Wells did consider the other studies but gave them no weight in his analysis because they were lower quality and designed differently than the particular studies he relied upon.

Defendants also cited three prior litigations where Dr. Wells’ expert opinions had been allegedly excluded but plaintiffs’ counsel Kennedy seemed to adequately rebut those assertions as gross mischaracterizations.

In her questioning of counsel during the hearings, Judge Rosenstengl brought up the Seventh Circuit’s Manpower ruling (where that Court had reversed a district court judge for improperly excluding an expert on a Daubert motion). The language in that Seventh Circuit opinions warns district court judges not to overstep their limited role as “gatekeeper” on Daubert motions and intrude on the exclusive province of the jury as sole arbiter of the credibility and weight of expert witnesses’ opinions The Judge’s references to Manpower seemed somewhat heartening, signaling that she intends to tread carefully while wrestling with the critical question of allowing or excluding Dr. Wells and the other experts (on both sides).

At her request the parties filed 20-page post-hearing briefs on September 8, 2023.

She warned that she had much additional reading, and rereading, to do and, consequently, booted the upcoming October date for the first bellwether trial to some as-yet-unknown future date – all premised of course on her denying the Daubert motions aimed at excluding Dr. Wells (and excluding plaintiffs’ other expert witnesses) This is the third rescheduling of the trial.

It’s extremely hard to handicap the outcome of the Daubert motion aimed at Dr. Wells. The Judge did not appear to be anywhere close to making up her mind, or even leaning in one direction, by the end of the hearings.

Rulings on all the Daubert motions will hopefully be issued before year end.

Recent Judicial Proceedings in Paraquat Multidistrict Litigation Await Decision by Judge Rosenstengl

Awaiting Judge Rosenstengl’s Determination on Daubert Hearings in Paraquat Litigation 

The series of Daubert hearings, pivotal in the ongoing multidistrict litigation concerning Paraquat, concluded after intensive deliberations from August 21 to 24, under the adjudication of MDL Judge Nancy Rosenstengl. The proceedings, marked by vigorous debate, centered predominantly on the testimony of Dr. Michael Wells, the plaintiffs’ principal general causation expert. His appearance was at the behest of Judge Rosenstengl, indicating the weight his testimony held in the litigation. 

Dr. Michael Wells’ Testimony: A Focal Point of the Daubert Hearings 

Dr. Wells’ testimony involved a meta-analysis of seven epidemiological studies that examined the potential link between Paraquat exposure and Parkinson’s Disease, with his findings suggesting an odds ratio of 2.8. The defendants, Syngenta and Chevron, challenged his methodology, claiming an oversight of three larger, more recent studies that contradicted his conclusions. They used critical language, implying that Dr. Wells selectively reported data to support his position, thus questioning the reliability of his analysis. 

In response, Dr. Wells, supported by plaintiffs’ counsel Eric Kennedy, contended that the newer studies were of inferior quality and methodologically distinct, thereby justifying their exclusion from his analysis. Furthermore, the defense’s citation of past instances where Dr. Wells’ expert testimony was purportedly disregarded was met with firm refutations from counsel Kennedy, who insisted these references were misrepresented. 

Defense Challenges and Plaintiff Rebuttals in Paraquat Case

Throughout the hearings, Judge Rosenstengl was discerning, alluding to the Seventh Circuit’s Manpower decision which admonished lower courts against exceeding their ‘gatekeeping’ mandate on Daubert motions, reminding them of the jury’s exclusive role in determining the veracity and significance of expert testimony. Her allusions to this precedent appeared to indicate a meticulous approach in her pending decisions concerning the admissibility of Dr. Wells’ and other experts’ testimonies. 

Following the conclusion of the hearings, Judge Rosenstengl requested additional post-hearing briefs from the parties, extending to 20 pages, which were filed on September 8, 2023. She acknowledged the extensive review that lay ahead, leading to the deferment of the first bellwether trial, originally scheduled for October, to an undetermined later date. This rescheduling is contingent on her potential denial of the Daubert motions seeking to exclude Dr. Wells and other expert witnesses offered by the plaintiffs, marking the third postponement of the trial. 

Given the complexities of the arguments presented, the anticipation of the outcomes of the Daubert motions has become increasingly challenging. Judge Rosenstengl exhibited no clear inclination towards a decision at the hearings’ conclusion, underscoring the unpredictability of the ruling. 

A definitive judgment on the Daubert motions is expected before the close of the year, a decision that will have significant implications for the direction of the litigation. 

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. 

Significant Progress in Bard Hernia Mesh Litigation: Confirmation of Upcoming Stinson Bellwether Trial

Bard Hernia Mesh Update: Stinson Bellwether Trial Advances Despite Defense Motion 

In a noteworthy advancement within the Bard multidistrict litigation (MDL), the presiding court has confirmed that the Stinson bellwether trial, designated as the third of its kind, is scheduled to proceed on October 16, 2023.

On May 24, 2023, the defendants submitted a legal memorandum asserting that both plaintiff Aaron Stinson and Jacob Bryan, the fourth bellwether trial plaintiff scheduled for January 2024, no longer serve as suitable “representative” bellwether plaintiffs. The defendants posited that the forthcoming jury trials involving these plaintiffs would no longer yield substantial insights applicable to the broader MDL case pool, recommending their complete substitution with new plaintiffs. The defendants’ argument highlighted that Mr. Stinson’s additional surgery in May, involving the removal of a second Bard hernia device and subsequently his right testicle and spermatic cord, presented “new facts” that were not emblematic of the majority of MDL cases. They also stated that Mr. Bryan’s potentially evolving medical condition, with additional treatment and possible surgery on the horizon, rendered his case a “moving target.” 

On June 20, MDL Judge Edward Sargus ruled against this motion. The Plaintiffs’ Steering Committee (PSC) contended regarding Mr. Stinson that they plan to demonstrate that all subsequent injuries, including the Bard Mesh surgical removal and orchiectomy, stemmed from the initially defective PerFix Plug implant. The Committee asserted no claims against the Bard Mesh implanted in 2017 and removed in May 2023. Judge Sargus set limitations on the PSC from disclosing certain information regarding the Bard Mesh, while permitting the defense to propose that the recent surgery and Bard Mesh could be the intervening causes of Mr. Stinson’s orchiectomy. 

Furthermore, Judge Sargus dismissed the defense’s characterization of Mr. Bryan’s symptoms as “new injuries,” noting that Mr. Bryan had reported groin and testicular pain in a 2019 deposition, thereby the defense was already aware of these complaints. 

This effectively undermined what appeared to be the defense’s strategy to delay the impending bellwether trials. 

Subsequent to these developments, on July 13, Judge Sargus sanctioned a joint stipulation that established deadlines for the submission of additional post-operative medical records for Mr. Stinson, further depositions, the delivery of the parties’ revised expert reports, supplemental expert depositions, as well as additional Daubert motions and motions in limine. 

The next Case Management Conference in this ongoing MDL is slated for August 29, 2023, where the parties will continue to prepare for the trials ahead.