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

Daniela P on September 19, 2023

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

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.

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.