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NSF Lawsuit Names Missouri Hospital

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A kidney disease patient has filed a lawsuit against St. Luke’s Hospital in Chesterfield, Mo., claiming the hospital was negligent in administering contrast dyes to him during MRI and MRA procedures.   The plaintiff was diagnosed with  nephrogenic systemic fibrosis (NSF), a deadly disorder that affects people with kidney impairment who have been exposed to gadolinium agents.

According to the lawsuit,  the plaintiff was administered a gadolinium agent at St. Luke’s Hospital in Chesterfield, Mo. in January 2005 in conjunction with an MRI.  The plaintiff was administered a contrast agent and underwent magnetic resonance angiography (MRA) on Oct. 10, 2007, at St. Luke’s. On Nov. 6, 2007, another MRA, again requiring the use of a contrast agent, was performed on the plaintiff at the hospital.

The lawsuit alleges that the hospital was negligent when it administered gadolinium contrast dyes to a patient with renal failure. The suit also asserts that the unknown makers of the dyes are strictly liable for the patient’s injury because they defectively designed the contrast agents and knowingly failed to warn consumers about the health risks. Finally, the suit alleges, the products were negligently designed and that the companies negligently and fraudulently represented to patients that they were safe.

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.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s. There are currently five such agents sold in the U.S.: Covidien’s OptiMARK; Prohance and Multihance, both by Bracco Diagnostics; Bayer Healthcare’s Magnevist; and GE Healthcare’s Omniscan.

It appears that NSF only develops in people with pre-existing kidney disease who are exposed to the gadolinium agents. In September 2007, the U.S. Food & Drug Administration (FDA) asked the manufacturers of all 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, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided

Earlier this month, an FDA review had found that OptiMARK, Magnevist and Omniscan carried a higher risk of NSF than other gadolinium agents on the market. Though the agency’s drug safety unit said the risk associated with the gadolinium contrast dyes “does not compel removal of specific (imaging agents) from the U.S. market”, it has recommended that the drug labels note the varying levels of risks with each product. An outside panel of experts will take up the issue in December.

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