Lawsuits continue to mount over gadolinium use

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Patients fight overexposure to gadolinium-based contrast agents. Source: University of Pittsburgh School of Medicine  

The law firm of Parker Waichman Alonso has filed suit on behalf of a man who was diagnosed with nephrogenic systemic fibrosis (NSF) after receiving two injections of Omniscan, a gadolinium contrast agent manufactured by General Electric, its subsidiaries and Novation.

The plaintiff, Zbigniew Marcinczyk, a resident of Philadelphia and a patient with pre-existing kidney disease, received two injections of the gadolinium contrast agent in September and December 2005.

NSF, also known as nephrogenic fibrosing dermopathy (NSD) causes bodily impairment, disfigurement and scarring, as well as fibrosis and contractures in the extremities. NSF has been shown to occur in patients presenting with renal insufficiency who undergo an MRI exam that employs a gadolinium-based contrast agent.

According to a statement from Marcinczyk’s lawyers, representatives from Holy Redeemer Hospital and the University of Pennsylvania Hospital in Philadelphia have confirmed that the gadolinium contrast agent administered to Marcinczyk was Omniscan.

The lawsuit 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 patients with kidney disease will develop NSF. The lawsuit further alleges that Omniscan is defective, and that the defendants failed to adequately test Omniscan and failed to warn patients about its potential to cause NSF.

In September 2007, the FDA instructed gadolinium contrast agent manufacturers 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.

On Feb. 29, 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, and those that will be filed in federal district court, against the makers of gadolinium contrast agents, according to Marcinczyk’s lawyers.

The suit was filed in the U.S. District Court for the Eastern District of Pennsylvania (Docket Number: 2:08-cv-1060).