Nephrogenic Systemic Fibrosis Lawsuit Scheduled For Trial in San Francisco

A date has been set for the start of what could be the first trial of a lawsuit involving nephrogenic systemic fibrosis (NSF), a severe and sometimes fatal condition caused by use of gadolinium based MRI contrast agents.

The NSF lawsuit was filed by Peter Gerber against Bayer Healthcare Pharmaceuticals, over problems caused by exposure to their Magnevist MRI contrast agent.  On Monday, a trial date was scheduled for January in the San Francisco Superior Court before Judge Curtis Karnow.

Unless a settlement is reached before the trial, the case is expected to be the first submitted to a jury out of hundreds of other similar cases that have been filed in state and federal courts throughout the United States against Bayer and the makers of other gadolinium-based contrast agents.  Many of the nephrogenic systemic fibrosis lawsuits against against Bayer have already settled, with most of the remaining cases pending against GE Healthcare over problems caused by their Omniscan MRI contrast agent.

Nephrogenic systemic fibrosis (NSF), which is sometimes referred to as nephrogenic fibrosing dermopathy (NFD), is a rare condition that is only known to occur after exposure to a gadolinium-based contrast agent (GBCA) among individuals with impaired kidney function.  The painful and disfiguring condition causes a hardening and thickening of the skin and other tissue throughout the body, severely restricting movement.  There is no cure for the progressive disorder, and no consistently successful treatments are available.

The FDA ordered the manufacturers of all types of gadolinium MRI contrast agents to add a “black box” warning in 2007, indicating that individuals with severe kidney problems could develop NSF.  This week, an FDA advisory panel of medical experts met to review the risk of NSF, and recommended that the warnings for Bayer’s Magnevist and GE’s Omniscan should be strengthened to indicate that they should not be used by patients with moderate to severe kidney problems.  Although the FDA is not bound to follow the recommendations of their advisory panel, they usually do.

In addition to the Gerber NSF lawsuit and other cases filed in state courts, there are about 350 cases consolidated for pretrial litigation in federal court in the Northern District of Ohio as part of a multidistrict litigation (MDL).  The first trial in the MDL is expected to begin next year.