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Spangenberg Shibley & Liber, LLC | Jan 5, 2014

Nephrogenic Systemic Fibrosis

Categories: News

Nephrogenic Systemic Fibrosis (NSF) is a horribly debilitating and sometimes fatal fibrosing disease first identified in 1997. NSF's relationship with certain gadolinium based contrast agents (GBCAs) was first described in 2006 when a group of patients at a Danish Hospital developed NSF after receiving Omniscan (Grobner, T). The overwhelming consensus among scientists and physicians who have studied NSF is that a toxic heavy metal, gadolinium, is released from certain unstable GBCAs, especially GE Healthcare's Omniscan in patients with severe renal impairment. This inappropriate release of "free" gadolinium causes an abnormal fibrotic response in the human body. Patients with NSF have been shown by biopsy to have "free" gadolinium deposited in their skin and several other body organs. Fibrotic lesions resembling scar tissue develop in the arms, legs and trunk and may severely restrict mobility. These fibrotic lesions may also occur in muscles and organs, such as the lungs and heart.
NSF's discovery as a new disease entity in 1997 corresponds with the use of GBCAs in higher dose procedures and in patients with severe renal impairment. The FDA has received no new reports of NSF in association with Omniscan since September, 2007 when it required the inclusion of a black box warning against use of this and other GBCA products in renally impaired patients. In September 2010, the FDA strictly contraindicated the use of Omniscan and two other GBCAs for this same group of patients.
As attorneys representing numerous individuals with NSF, we believe that evidence uncovered in the litigation against GE Healthcare (GEHC) demonstrates that important safety information about Omniscan has long been withheld from the FDA and the medical profession, leading to an unreasonable delay in enacting FDA labeling changes. At least one Court who has considered the matter concluded that "[Plaintiffs'] evidentiary exhibits, if proven at trial, could persuade the jury that in GEHC's effort to obtain FDA approval and desire to market Omniscan, it ignored mounting evidence from 1989 through 2007 that Omniscan was dangerous to renally impaired patients."

To read more about the case and a decision reached in Cook County, Illinois CLICK HERE

Grobner T., Gadolinium-a specific trigger for development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis. Nephrol Dial Transplant; 21:1104-8.

To find out if you have a case Contact one of these a gadolinium lawyers.