Delaware Supreme Court to Review Key Legal Challenges in Massive Zantac Cancer Case

Dover, Delaware — Home to more than two-thirds of Fortune 500 companies, Delaware is a beacon of corporate incorporation. The state’s reputation as a legal hub for business is now under the spotlight as the Delaware Supreme Court considers a pivotal appeal that could redefine its approach to mass-tort litigation.

Delaware recently came to the forefront of legal discussions due to a substantial case involving over 75,000 plaintiffs. These individuals allege that ranitidine, often sold under the brand name Zantac, is carcinogenic. They argue that the drug breaks down into N-nitrosodimethylamine (NDMA), a substance believed to cause cancer.

In handling such cases, Delaware Superior Court holds hearings to ascertain if the substance in question, NDMA in this instance, causes the harm claimed by plaintiffs—this is known as determining “general causation.” Both parties presented expert testimonies, which the court considered under the guidelines of Delaware Rule of Evidence 702. This rule aligns closely with its federal counterpart, which illustrates the rigor with which such evidence is scrutinized.

On May 31, 2024, the court decided in favor of the plaintiffs by rejecting the defendants’ challenge to the expert testimony presented by those affected. This ruling diverged from a decision by a federal court in Florida, which had previously dismissed similar claims based on a lack of consistent evidence linking ranitidine to cancer. The federal ruling referenced conclusions by both the U.S. Food and Drug Administration and its European counterpart, which found no significant risk of cancer from ranitidine.

Despite the federal ruling, the Delaware judge acknowledged the similarities in legal standards but noted key differences in the cases, particularly in terms of the scope of cancers considered and the experts involved. The Delaware ruling pointedly illustrated the complexities and nuances of legal standards in mass-tort cases.

However, the Delaware court’s approach did not go without criticism. Legal analysts pointed out potential missteps in the court’s handling of the evidence. Specifically, there was a contentious decision to consider studies on NDMA beyond ranitidine and a failure to define a threshold dose of the substance necessary to establish causation. Critics argue that without establishing such a threshold, plaintiffs could attribute ordinary, everyday exposures to NDMA—such as those from consuming smoked meats or certain beverages—as grounds for their claims.

Recognizing the significance of these issues, the Delaware Supreme Court agreed to review the case on interlocutory appeal, noting that the findings on NDMA studies and the lack of a threshold dose requirement pose crucial questions about the application of the Daubert standard—a framework used to determine the admissibility of expert witness testimony in federal courts.

This ongoing litigation not only affects the parties involved but also has broader implications for Delaware’s stature in the legal landscape for business and mass-tort cases. The Supreme Court’s decision has the potential to either reinforce Delaware’s strong corporate governance reputation or make it a more attractive venue for plaintiff bars handling mass tort claims.

As Delaware’s highest court delves into these complex legal issues, the legal community and businesses alike await a ruling that will set precedents for how similar cases might be handled in the future. This case serves not only as a test of Delaware’s legal mettle but also as a potential turning point in the intricate balance between corporate interests and public health concerns in mass-tort litigation.