仿製藥警示缺陷和設計缺陷責任──以美國法為例

Generic Drugs and Liability for Labeling or Design Defect: The Case of American Law

The Hatch-Waxman Act of USA creates a unique mode of regulation for generic drugs, balancing the availability of generic drugs and concerns for their safety and effectiveness. The “sameness” requirement under the Act does not allow generic drug manufacturers to change labeling unilaterally and independently. Does that preempt generic drug consumers’ labeling or design defect claims? In the cases of Mensing and Bartlett, the Supreme Court of USA answered that question affirmatively. As a result, unlike those of brand-new drugs, manufacturers of generic drugs enjoys the immunity from liability for labeling or design defect, therefore depriving suffering patients of state tort remedies. The USA is still struggling to keep a balance between low cost and easy access of generic drugs and increasing remedial possibilities available for generic drug victims.