Learning Objectives:

1. Recognize the impact that post-marketing surveillance can ultimately have on the potential for liability on the part of the drug's manufacturer and others in the chain of drug distribution.

2. Review potential liability and defenses associated with injury from gadolinium-
based contrast agents.

The Food and Drug Administration (FDA) has issued several alerts in recent years requesting that manufacturers of Gadolinium-based contrast agents include certain warnings in the drug's labeling, primarily related to the development of nephrogenic systemic fibrosis in a narrow category of patients. This session will examine this class of drugs, the history and substance of the FDA alerts and how FDA actions such as this impact potential liability in tort actions. Likely defenses to such tort actions and the likely injury claims also will be discussed.