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. 

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. 

Paraquat Litigation Progresses Towards Daubert Hearing and Trial Set for October

Paraquat Litigation Advances: Daubert Hearing and October Trial Insight

The litigation process involving the herbicide Paraquat advances as key procedural hearings are scheduled. Notably, the legal teams involved have concluded their detailed briefings on two significant motions—the Daubert motion and the motion for partial summary judgment. A Daubert hearing, a critical juncture in the proceedings, is slated to commence on August 21, 2023, where expert testimonies will be pivotal. 

Key Points: 

  •  Daubert Hearing and Trial Dates Set: A crucial Daubert hearing for the Paraquat litigation is scheduled to begin on August 21, 2023, with the outcome expected to significantly affect the first bellwether MDL trial due on October 16, 2023. Furthermore, a California state court trial has been rescheduled to January 8, 2024, with pre-trial hearings set for October 10, 2023.  
  • Expert Witness Testimonies: The court has ordered plaintiffs’ expert Dr. Martin Wells to testify and face both direct and cross-examination in the upcoming Daubert hearing, as per Judge Rosenstengl’s July 28th order, which also allows for post-hearing briefs by September 8th. 
  • Precedent Settlement: Syngenta and Chevron, in 2021, settled numerous cases in Illinois and 16 cases in California for $187.5 million, which might indicate the potential strength of the plaintiffs’ cases and could influence future litigation outcomes.  
  • Public Disclosure of Settlement: Details of the previous settlement were made public through Syngenta’s 2021 Annual Report, revealing a strategic move to settle high-profile cases, thereby limiting negative publicity and further large-scale litigations.  
  • Ongoing Litigation Volume: The litigation encompasses a significant number of cases, with 4,384 active cases in the MDL, 298 in California state courts, and additional actions in Pennsylvania, Illinois, Florida, Washington, and Delaware as of July 20, 2023. 

A court filing by the defense on June 9th, the only one not sealed, delineates a strategic stance suggesting that the scientific evidence at hand fails to substantiate the expert causation theories proposed by the plaintiffs. 

Presiding Judge Rosenstengl issued a mandate on July 28th requiring the plaintiffs’ expert witness, Dr. Martin Wells, to provide testimony and undergo examination by the legal representatives of both parties. Additionally, the order permits the submission of post-hearing briefs by both sides, to be filed by September 8th at the latest. 

The rulings on these motions will have a direct influence on the inaugural bellwether trial of the Multidistrict Litigation (MDL), which is on the court’s docket for October 16, 2023. 

The first state court trial in California, initially scheduled for September 6th, has been postponed to January 8, 2024, in Contra Costa County. Pre-trial hearings concerning Sargon motions—California’s equivalent to Daubert hearings—and motions for summary judgment are expected to proceed on October 10, 2023. Syngenta’s Annual Report also indicates a concurrent trial scheduled in a Florida state court for January 8, 2024. 

Notably, Syngenta and Chevron, in a strategic move during 2021, settled several Illinois state court cases, including 16 in California, for a total of $187.5 million. This decision, seemingly a preemptive measure, may have been influenced by the desire to limit the exposure of these cases to public scrutiny and to curtail further litigations led by Stephen Tillery, especially in high-profile jury trials in St. Clair County and across Illinois. Based on the disclosed settlement figures by Syngenta, the financial compensation to each plaintiff appears to be substantial, especially if the number of claimants was limited. 

This previous settlement bears significant relevance as plaintiffs advance towards the forthcoming trials in October and January. 

From Syngenta’s 2021 Annual Report: 

“Settlement: On June 1, 2021, Syngenta, along with a co-defendant, reached an agreement to settle with claimants represented by the leading counsel in the Hoffmann cases scheduled for trial in St. Clair County, Illinois, and in a majority of the cases pending in California state courts at that time. The settlement, which was contingent upon the dismissal of all active cases and a comprehensive release from the plaintiffs, involved a payment of $187.5 million by Syngenta. The company allocated its share to the Qualified Settlement Escrow Fund on July 21, 2021, which allows for third-party verification and apportionment amongst the claimants. The incurred settlement expenses are reflected within ‘Other general and administrative’ costs in the financial statements.” 

As of July 20, 2023, the MDL has 4,384 active cases pending. Additionally, there are 298 active cases in various California state courts, with 244 consolidated in a Judicial Council Coordination Proceeding (JCCP). Separate actions are also underway in multiple jurisdictions including Pennsylvania, Illinois, Florida, Washington, and Delaware.