Mark Herrmann[*] & Pearson Bownas[**]
Introduction
The FDA approves prescription drugs and medical devices for only the specific uses indicated in the product labeling that the manufacturer submits in the approval process. A physician may determine, however, that a use not indicated in the FDA-approved labeling—an “off-label” use—would benefit a patient. This Article argues that in medical malpractice cases involving an off-label use, the product’s label should not be admitted as evidence of either the standard of care or the physician’s alleged breach of that standard.
