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Woman with NSF Sues Over Magnevist

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Bayer-Schering has been named in a lawsuit filed by a woman who claims its Magnevist gadolinium contrast dye caused her to develop Nephrogenic Systemic Fibrosis (NSF). According to the lawsuit, the plaintiff received an injection of Magnevist gadolinium contrast dye on March 23, 2001. The Brooklyn Center, Minn. woman was diagnosed with NSF in February 2007.

The lawsuit, which also  names Bayer-Schering subsidiary Berlex Laboratories as a defendant, says that the plaintiff continues to suffer from the severe, debilitating and progressive fibrotic changes associated with NSF. This has permanently disabled, disfigured and severely impaired the plaintiff.

The lawsuit alleges that Magnevist is defective, and that the defendants failed to adequately test Magnevist and failed to warn patients about its potential to cause NSF. The lawsuit further alleges that the chemical make-up of Magnevist 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.

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. The disorder 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 evidence that gadolinium contrast agents play a role in the development of NSF 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.

The plaintiff in the Magnevist lawsuit is represented by the law firm of Parker Waichman LLP.

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