Gadolinium, or gadodiamide, is a contrast agent that was used to increase the contrast of blood vessels during MRI procedures so they can better be distinguished from surrounding tissue.
While gadolinium served its purpose for MRI procedures, it is clear that nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NFD) can result from the use of a gadolinium contrast MRI in patients with kidney failure. First recognized as a disease in 1997, nephrogenic systemic fibrosis/ nephrogenic fibrosing dermopathy causes thickening or tightening of the skin and connective tissues, which inhibits the patient’s ability to move, and it also causes pain, muscle weakness, scarring of internal organs, and difficulty bending joints.
More than 215 cases of NSF/NFD have been documented in the last decade, but despite ongoing research, the cause of the disease was not entirely clear. Now, as many suspected, gadolinium-containing contrasting agents used for Magnetic Resonance Angiography (MRA) in patients with kidney failure is the culprit. In June 2006, the FDA first reported its belief that nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy can be caused by the use of gadolinium contrast MRI.
Last year, on May 23, 2007, FDA asked manufacturers to include a new black box warning on gadolinium contrast MRIs stating that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing (NSF/NFD). Additionally, the warning states that patients with liver problems are also at risk for developing (NSF/NFD) if they use a gadolinium based MRI.
There are five gadolinium-based contrast agents identified: Bayer’s gadopentetate dimeglumine (Magnevist); GE Healthcare’s gadodiamide, (Ominiscan, which seemed to have a good bit of market share);Mallinckrodt’s gadoversetamide (or OptiMARK); MultiHance’s gadobenate dimeglumine, (MultiHance), and Bracco Diagnostics’s gadoteridol (ProHance).
Gadolinium MRI NSF/NSD lawyers allege that these companies had superior knowledge and information regarding gadolinium and, accordingly, knew (or should have known) that gadolinium is toxic and harmful and would lead to serious injury and, accordingly, should have properly designed and tested the gadolinium MRI contrast.
We have settled the our client's cases in this litigation. Our last case settled in 2013.