Nephrogenic Systemic Fibrosis (NSF) Lawsuit Set For Trial January 2011

Trial has been schedule to begin early next year for a lawsuit involving allegations that a gadolinium-based MRI contrast agent led to the development of nephrogenic systemic fibrosis (NSF), a severe and debilitating injury. 

The trial could be the first NSF lawsuit to reach a jury out of hundreds of complaints filed against manufacturers of gadolinium contrast agents in the United States. A number of settlements have reportedly been reached in other cases that were being prepared for trial.

According to an order issued by U.S. District Judge Dan A. Polster, who is presiding over pretrial litigation for all federal lawsuits over nephrogenic systemic fibrosis from MRI contrast agents, trial will begin on January 24, 2011 in a case filed by Loralei and Donald Knase against GE Healthcare over its Omniscan MRI contrasting agent.

The case was originally selected as the third bellwether trial, which are designed to help the parties gauge how juries will respond to evidence that is likely to be similar to what would be offered in other cases pending in the MDL.

Lorelei Knase was given Omniscan several times between March 2003 and October 2005 for enhanced MRI scans, according to the complaint. The gadolinium-based contrast agent is used to help improve the images obtained from an MRI, but Knase alleges that neither she nor her physicians were warned about the potential side effects of Omniscan, which have been linked to an increased risk of nephrogenic systemic fibrosis.

Knase developed NSF following the MRIs and developed fibrosis in her hands, feet, arms, legs, and associated joints. The lawsuit describes the injuries as serious, progressive, incurable and potentially fatal.

Sometimes referred to as nephrogenic fibrosing dermopathy (NFD), the painful and rare condition that Knase developed is only known to occur after exposure to a gadolinium-based contrast agent (GBCA) among individuals with impaired kidney function. There is no cure for the painful and debilitating disorder, and in many cases it results in death.

Although all types of gadolinium MRI contrast agents have been linked to nephrogenic systemic fibrosis, reports have suggested that the risk of NSF associated with Omniscan may be higher than other with contrast agents.

In 2007, the manufacturers of gadolinium-based contrast agents were required by the FDA to add a “black box” warning to their products, indicating that individuals with severe kidney problems could develop NSF.

Approximately 350 lawsuits over nephrogenic systemic fibrosis have been filed in the United States by individuals who developed the condition after receiving a gadolinium-based contrast agent. Out of the five approved contrast agents, Omniscan has been associated with the most cases of NSF, outnumbering the other drugs in proportions that far exceed their market share. It has been estimated that about 75% of all NSF lawsuits involve cases where the plaintiff developed the condition after use of Omniscan, even though GE’s contrast agent only accounts for about 30% of the market share.