Bayer AG has settled some lawsuits involving its gadolinium contrast dye, Magnevist. Plaintiffs in the lawsuits claimed that Magnevist had caused Nephrogenic Systemic Fibrosis (NSF), a potentially fatal condition that develops in people with pre-existing kidney disease.
Gadolinium contrast dyes like Magnevist are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. In addition to Bayer’s Magnevist, these dyes include: Omniscan by GE Healthcare; OptiMARK by Mallinckrodt/Tyco Healthcare; ProHance by Bracco Diagnostics and MultiHance by Bracco Diagnostics.
In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the products’ labels regarding their association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents.
NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It 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.
According to Bloomberg.com, as of February Bayer faced 241 lawsuits over Magnevist. The company confirmed that it had entered into settlement discussions for about 40 of those.
“We can confirm that we have reached agreements in principle with several of the plaintiffs in the U.S. to settle without admission of liability”, a Bayer spokesperson told Bloomberg.com
An attorney for NSF plaintiffs told Bloomberg.com that the settlements at this time were tentative, and that dollar amounts could not be disclosed. A second plaintiffs’ attorney said that for now, Bayer was settling cases in which a biopsy confirmed a diagnosis of NSF, and Magnevist was the only contrast agent used.
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