Product Liability & Mass Torts Digest

The California Supreme Court has recognized a new path for plaintiffs to prove causation in failure-to-warn cases against manufacturers of prescription drugs and medical devices. Under the learned intermediary doctrine, such manufacturers have a duty to warn physicians of the risks associated with their products but do not have a duty to warn patients.

As part of the wider multidistrict litigation over the breast cancer drug docetaxel (branded Taxotere), on May 24, 2024, the Fifth Circuit ruled that Food and Drug Administration (FDA) labeling requirements preempt certain state law failure-to-warn theories. Hickey v. Hospira, 102 F.4th 748 (5th Cir. 2024).

The litigation involved claims that type 2 diabetes drugs containing saxagliptin caused heart failure. The genesis of the claims goes back to 2008 when the FDA urged additional clinical studies examining diabetes drugs and cardiovascular risks.

The plaintiffs in the Zantac MDL faced a challenge that is common in products liability cases: How to handle evolving science and conflicting epidemiological data.

As part of our continuing commentary on the Zantac decision, this review examines the court’s rationale for doing so and highlights potential avenues for Daubert challenges to experts conducting Bradford Hill analyses.

The Zantac MDL Court recently reinforced the important role of general acceptance of an expert’s conclusions to a court’s Rule 702 admissibility analysis.

Several recent decisions have shed light on the courts’ willingness to dismiss a product liability action where the plaintiff lacks sufficiently reliable evidence of general causation—that is, evidence that the product can cause the purported negative outcome.

In the wake of the U.S. Supreme Court’s decisions in Wyeth v. Levine and Merck Sharp & Dohme Corp. v. Albrecht, drug manufacturers face challenges in establishing a preemption defense when they receive “newly acquired information” about a drug’s side effects without clear evidence that the U.S. Food and Drug Administration would have rejected a label change adding a warning of the risk of harm.