Nephrogenic systemic fibrosis and gadolinium-based contrast: medico-legal implications.

The epidemiologic link between exposure to gadolinium-based contrast (GBC) agents and the development of nephrogenic systemic fibrosis (NSF) in patients with moderate to severe end-stage renal disease (ESRD) has caused concern among physicians, particularly radiologists and nephrologists. The concerns of manufacturers of GBC agents and the U.S. Food and Drug Administration (FDA) have led to the publication of product label warnings and a Public Health Advisory. As more cases of NSF associated with GBC agent exposure have surfaced, manufacturers and physicians have become increasingly concerned about the potential for litigation. To date, litigation has been directed primarily at manufacturers of GBC agents and has focused on package warnings. Thus, physicians should stay abreast of FDA warnings, keep an open line of communication with manufacturers of GBC agents, and review package warnings.