The first trial over nephrogenic systemic fibrosis (NSF) from Omniscan, a gadolinium-based MRI contrast agent manufactured by GE Healthcare, was settled in a last minute deal reached the night before trial was set to begin in federal court in Cleveland on Monday.
Although terms of the agreement have not been disclosed, a settlement was reached late Sunday night according to a report by ProPublica. The Omniscan settlement allows GE Healthcare to avoid another highly anticipated trial over their gadolinium contrast agent.
The lawsuit involved a claim brought by Loralei Knase, who was given Omniscan several times between March 2003 and October 2005 for enhanced MRI scans, according to the complaint. She subsequently developed nephrogenic systemic fibrosis (NSF), a rare and debilitating disease, which she alleges was caused by GE Healthcare’s MRI contrast agent.
Knase alleges that neither she nor her physicians were warned that she faced an increased risk of NSF from Omniscan. The condition is only known to occur after exposure to gadolinium-based contrast agents (GBCA) among individuals with impaired kidney function, and a black box warning was not added until 2007.
Sometimes referred to as nephrogenic fibrosing dermopathy (NFD) or gadolinium associated systemic fibrosis, NSF is a painful and debilitating disorder that causes a hardening and thickening of the skin and other tissue in the body. There is no known cure for the disease and it often leads to death.
Knase’s NSF trial was scheduled to begin on Monday in the U.S. District Court for the Northern District of Ohio, where several hundred similar lawsuits have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation.
The case was originally selected to be the last of three bellwether trials, which were selected for early trials 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. However, the two previous bellwether cases also settled before trial.
General Electric has worked hard to keep certain corporate documents regarding Omniscan discovered during the litigation confidential, saying that they contain trade secrets. As long as the company can settle with plaintiffs before their cases reach trial, there is a chance the documents will not become public.
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 GE Healthcare’s Omniscan may be higher than with other contrast agents.
Several hundred 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.