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Learned Intermediaries

Products are designed for specific uses and users. Some products, such as can openers and lawn mowers, are designed for unsophisticated users. Others, such as airplanes, are designed for highly trained users. The learned intermediary problem arises when engineers and lawyers disagree over whether a device is designed for a sophisticated or an unsophisticated user. For example, both engineers and lawyers agree that airplanes should only be operated by trained pilots. They also agree that lawnmowers are usually operated by untrained users. However, they disagree over complex medical equipment such as anesthesia machines. Engineers assume that complex medical devices will be used by trained, competent users, analogous to pilots. The law frequently assumes that they will be used by persons more analogous to lawnmower users.

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