Zantac Ruling in California Creates “Hybrid Claim”

In recent litigation over Ranitidine, sold under the brand name Zantac, the California court presiding over the coordinated proceedings declined to grant summary judgment on plaintiffs’ manufacturing defect claims (In re Ranitidine Cases).

Eric Alexander, blogging on Drug & Device Law, argues that in doing so, the court introduced a new “hybrid” claim theory that combined elements of design and manufacturing defects rather than applying the established summary judgment framework.

Alexander writes that this approach departed from the expected evaluation of the complaint, its allegations, and the sufficiency of evidence in the record. Instead, it allowed plaintiffs to attempt a novel path forward despite prior rulings that traditional theories were preempted or unsupported.

The case arose after plaintiffs repeatedly attempted to plead a manufacturing defect claim that could withstand California law and federal preemption challenges.

Plaintiffs conceded that they could not demonstrate that individual products deviated from design specifications, and the court had already ruled that design defect claims were preempted.

Nonetheless, at summary judgment, rather than assessing whether plaintiffs met their evidentiary burden, the court crafted a new claim theory that effectively reopened litigation, creating a pathway not grounded in the existing complaint or procedural norms.

This new hybrid theory rested on plaintiffs’ assertion that all Ranitidine pills contained excessive NDMA, a purported carcinogen, due to the defendants’ failure to prevent its presence. Yet plaintiffs lacked admissible evidence of an applicable specification, any showing of deviation from manufacturing processes, or proof that the alleged excess NDMA caused cancer in specific individuals.

Alexander claims the ruling sidestepped clear requirements under California law and pattern jury instructions, which define manufacturing defects strictly as departures from intended design or specifications.

Attorneys can determine for themselves whether the decision constitutes a significant procedural irregularity. Arguably, by allowing a hybrid theory unsupported by the record, the ruling prolongs litigation and creates uncertainty in product liability law, potentially setting up further disputes and appeals.