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Lawsuit Claims GE Omniscan Caused Nephrogenic Systemic Fibrosis

Mar 6, 2008 | Parker Waichman Alonso LLP

General Electric Company has been named in a lawsuit over its Omniscan gadolinium contrast dye.   The lawsuit alleges that Omniscan caused a Philadelphia man to develop Nephrogenic Systemic Fibrosis (NSF), a debilitating and often fatal disease. The plaintiff in the Omniscan lawsuit is represented by the law firm of Parker Waichman Alonso LLP.

NSF is a devastating condition that affects people with pre-existing kidney problems. There is currently no cure for NSF and no one understands its specific cause. However, the evidence that gadolinium contrast agents play a role in its development is fast becoming irrefutable. Dutch scientists made the first connection between NSF and gadolinium in 2006. Since then, researchers at Yale University have reported that 95-percent of those with NSF had undergone a Magnetic Imaging Resonance (MRI) procedure that involved a gadolinium contrast dye two to three months before their symptoms appeared. Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with gadolinium  contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.

In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents.

According to his lawsuit, Zbigniew Marcinczyk received two injections of Omniscan  contrast dye in September and December 2005. Shortly after the administration of Omniscan, Marcinczyk developed NSF.  The complaint states that Marcinczyk continues to suffer from the severe, debilitating and progressive fibrotic changes associated with NSF.  NSF is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

The Omniscan lawsuit, which was filed in US District Court for the Eastern District of Pennsylvania, alleges that the chemical make-up of Omniscan makes it more likely that gadolinium will become free within the bodies of recipients, thereby making it more likely that  kidney patients will develop NSF.  The lawsuit further alleges that Omniscan is defective, and that the defendants, including General Electric,  failed to adequately test Omniscan and failed to warn patients about its potential to cause NSF.

So far, around 68 lawsuits have been filed against the makers of gadolinium contrast dyes by victims of NSF and their families.  Last month, the U. S. Judicial Panel on Multidistrict Litigation designated the U.S. District Court for the Northern District of Ohio as the venue for the many lawsuits that have been filed against the makers of gadolinium contrast dyes.