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.