St. Luke’s Hospital in Chesterfield, Mo. faces a lawsuit filed by a victim of nephrogenic systemic fibrosis (NSF). The plaintiff was administered a gadolinium based contrast dye at St. Luke’s several times starting in 2005, and was diagnosed with NSF in early 2007.
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
According to the St. Luke’s Hospital lawsuit, the plaintiff, who suffered from kidney disease, was administered a contrast dye 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, MRA, again requiring the use of a contrast agent, was performed on the plaintiff at the hospital.
Following these procedures, the plaintiff began to suffer symptoms typical of NSF, and was diagnosed with the disorder in early 2007.
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.
This lawsuit is just one of hundreds filed in the past couple of years by victims of NSF. Since the FDA mandated the black box warning for all gadolinium contrast dyes in 2007, evidence of a link between the products and NSF has only grown stronger.
Earlier this month, we reported that the FDA is still looking into the association between gadolinium agents and NSF. 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.
Following the news from the FDA, Covidien announced it would be modifying the label on OptiMARK to contraindicate its use in patients with severe kidney impairment. Mallinckrodt Inc., a Covidien company, has submitted this label change to the FDA and says it is implementing the new label in the U.S. effective immediately. Covidien also will update its educational materials to help physicians make informed decisions regarding the appropriate use of OptiMARK.
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