Product Liability & Mass Torts Digest

There are myriad examples of lawsuits ensuing after a regulatory body or other agency issues a statement or report on a particular substance. As things currently stand, however, statements by the U.S. Food and Drug Administration (FDA) may offer a defense to claims involving microplastics.  

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

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.

Manufacturers and distributors of COVID-19 products (or countermeasures) necessary to combat the spread of infectious disease are understandably concerned about potential liabilities. Online advertisements are already offering legal services to pursue product liability and other claims related to COVID-19 treatments.