An Ohio jury has determined that GE Healthcare failed to provide proper warnings about the potential side effects of its MRI imaging contrast dye, Omniscan, and ordered the company to pay $5 million to a man diagnosed with a rare, debilitating, and often deadly skin disorder known as nephrogenic systemic fibrosis (NSF).
The verdict came following the trial of a lawsuit brought by Paul Decker, 61, who alleged that he developed the debilitating disease after being injected with the gadolonium-based contrast agent in 2005. Decker’s skin has hardened as a result, causing difficulty in moving his limbs.
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.
Gadolinium-based MRI contrast agents are the only known cause of NSF, and several different companies make similar products that have also been associated with the condition. New warnings were added to the products in 2007.
Several hundred lawsuits over nephrogenic systemic fibrosis have been filed against GE Healthcare and manufacturers of other gadolinium-based contrast agents, but the Decker case is the only one to reach a jury so far.
In response to the jury award, GE Healthcare has issued a statement indicating that they are disappointed in the jury’s decision and plan to appeal the verdict on several grounds. The company also pointed out that the jury found that Omniscan was not defective, and that GE was the first company to warn practitioners about the potential risk of NSF from gadolinium-based contrast agents.
GE has settled hundreds of those Omniscan lawsuits. The details of those settlements have been kept confidential.
3/28/2013: Updated to reflect response from GE Healthcare to the verdict.