ciary. Each country of interest to the committee faces different challenges in its own product liability system and civil justice institutions, as well as in its regulatory agencies.

This review provides a general historical and conceptual introduction, primarily from the perspective of the U.S. and European experience. Because legal systems are rooted in particular historical and cultural contexts, the determination of the appropriate scope of tort and administrative responsibility with respect to food and medical products in a specific country depends on a detailed examination of the social context there. The key variables identified in this discussion may serve as a starting point for such a detailed examination.


Food and medicines have been regulated since ancient times through criminal and civil mandates.2 In the Western world, Roman law prescribed quality and other requirements for food and drink, enforceable by the state. It also provided for civil liability, which could be pursued through private legal action in some instances. Early English history also reflected public and private enforcement of food standards. Under old English law, the Crown established basic quality systems such as uniform weights and measures, bread and grain standards, and officials to ensure compliance. At the same time, the common law permitted a buyer to sue a seller of substandard food for damages.3 Owners of restaurants were subject to strict liability for sales of food and drink.4 Nevertheless, before industrialization, at least in common law countries, tort suits based on product quality were few, perhaps in part because the costs of litigation outweighed the benefits.5

Beginning in the mid-19th century, the development of mass production, industrialization, science, and national markets led to changes in both how the state oversaw food and medical products. In the United States, the rise of the modern regulatory agency in the first half of the 20th century also coincided with expansion of the scope of product liability. Today’s U.S. Food and Drug Administration itself grew from its niche in the Bureau of


2 Peter Barton Hutt and Peter Barton Hutt II, A History of Government Regulation of Adulteration and Misbranding of Food, 39 Food Drug & Cosm. L.J. 2 (1984). The following historical discussion is drawn from the authors’ discussion at pages 1-26.

3 Id., at 22.

4 James M. Guiher & Stanley C. Morris, Handling Food Products Liability Cases, 1 Food Drug Cosm. L.Q. 115 (1946).


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