Question

2. Bensing manufacturers generic drugs for the treatment of heart disease. A federal law requires generic drug makers to use labels that are identical on brand-name versions of the drugs. Hunter purchased Bensing's generic drugs in Ohio and wants to sue Bensing for defective labeling based on its failure to comply with Ohio state common law (rather than the defective labeling requirement). What defense might Bensing assert to avoid liability under state law?

Answer 1

Bensing can claim the defense of preemption. An injured party may not be able to sue the manufacturer of defective products that are subject to comprehensive federal regulatory schemes. If the federal government has a comprehensive regulatory scheme (such as it does with medical devices and vaccines), then it is assumed that the rules were designed to ensure a product’s safety and the federal rules will preempt any state regulations. Therefore, Bensing could not be held liable under state law if it complied with the federal drug-labeling requirements.