A recent decision by the California Supreme Court underscores why courts should be hesitant to grant class certification in cases in which the learned intermediary doctrine applies.
In Himes v. Somatics, LLC, 2024 WL 3059637 (Cal. June 20, 2024), the Court considered the appropriate causation standard to be applied to failure-to-warn claims involving prescription drugs or medical devices. In such cases, the learned intermediary doctrine instructs that manufacturers owe a duty to warn physicians, but not the physicians’ patients, about certain risks accompanying the use of their prescription drugs and many medical devices. For purposes of establishing causation in these cases, the Court held that a plaintiff need not show that a stronger risk warning provided to the physician would have altered the physician’s decision to prescribe the product in the first place. Instead, under California law, a plaintiff may establish causation by showing that the physician would have communicated the stronger risk warning to the patient, and that an objectively prudent person in the patient’s position would have declined the treatment after receiving that stronger risk warning (notwithstanding that the patient’s physician still would have recommended the treatment).
Though Himes was not a class action, the Court’s discussion of the causation standard highlights several individualized questions of causation that may defeat certification in class actions in which the learned intermediary doctrine applies. As the Court explained, whether causation exists may depend on factors like the following, which may differ on an individual-by-individual or case-by-case basis:
- what the physician would have communicated to the patient regarding the treatment and the allegedly undisclosed risks;
- whether the physician, after weighing and assessing the risks and benefits, would have still recommended the treatment even if the manufacturer had provided an adequate warning of the alleged risks; and
- whether a patient would have declined the treatment despite the physician’s assessment. On this question, the Court observed that the answer might in turn depend on factors such as:
- whether the treatment was novel or was instead an established method for addressing the patient’s condition;
- the availability and utility of alternative treatments and the degree to which they have previously been tried in an effort to address the patient’s condition;
- the severity of the patient’s condition;
- the likelihood that the treatment would have resulted in more than marginal benefits to the patient; and
- other personal characteristics of the patient or circumstances unique to the patient.
Class certification discovery and arguments designed around these inherently patient- and physician- specific issues could prove valuable for defending against class certification.