Learned Intermediaries : Warnings

Learned Intermediaries

Biotech, Medical Device Companies Encounter Prop. 65
John E. Carlson and Mary L. Walker of Brobeck Phleger & Harrison LLP

This article explains how biotech and medical device companies can be affected by California's Prop. 65.
The Intersection of Madison Avenue and the Learned Intermediary Doctrine
David J. Cooner of McCarter & English, LLP

The learned intermediary doctrine emerged from the development of strict product liability law, including the recognition of a cause of action for failure to warn. At its core, the doctrine is pragmatic: it recognizes that the warnings and instructions which accompany medicines and medical devices are directed not to ultimate consumers or the end users of those products, but to the physicians who prescribe them and who are in the best position to evaluate the risks associated with their use.