The general rule, under both negligence principles and strict products liability, is that a producer or supplier is required to warn users or consumers of its products. In most cases, this duty can be satisfied by placing a warning label on the product itself or by providing safety information in an owner's manual or in other literature attached to or enclosed with the product. However, there are some situations where it is difficult or impracticable to provide a direct warning to the ultimate user or consumer. In such cases, producers and suppliers should be able to satisfy their duty to warn by providing safety information to intermediaries who may be expected to pass this information along to the ultimate users or consumers of the product.
The drafters of the Restatement (Second) of Torts ("Restatement") have acknowledged the legitimacy of warning through intermediaries in section 388. This, in turn, has given rise to a number of specialized doctrines, such as the learned intermediary rule and the sophisticated user doctrine, which permit product producers and suppliers to warn through intermediaries in certain situations. The learned intermediary doctrine, though often criticized by legal commentators, seems to work well in the relatively narrow domain of pharmaceutical products. The sophisticated user doctrine, and related concepts commonly applied to suppliers of component parts and bulk products, is less satisfactory. Some courts employ a duty-oriented approach, which allows producers and suppliers to rely on intermediaries to convey warnings to product end users. Other courts utilize a balancing approach, but this provides little guidance to producers and suppliers about when reliance on intermediaries is appropriate and when it is not.
This article proposes a "general rule" to cover most situations where warning through intermediaries is feasible. This proposed rule would allow producers and suppliers to rely on intermediaries in virtually all cases to transmit warnings to users and consumers of products. Part I provides a brief overview of the duty to warn under negligence and strict products liability. Part II examines the caselaw on warning through intermediaries, focusing on pharmaceutical products, products designed for industrial use, component parts and bulk products. Part III discusses the feasibility of a general rule on warning through intermediaries and evaluates the advantages and disadvantages of a duty-oriented approach and a balancing approach. Finally, part IV introduces a specific proposal based on a duty-oriented approach.
Richard C. Ausness, Learned Intermediaries and Sophisticated Users: Encouraging the Use of Intermediaries to Transmit Product Safety Information, 46 Syracuse L. Rev. 1185 (1996).