Omniscan NSF Lawsuit Settled

What would have been the first <"">Omniscan lawsuit to go to a jury trial was settled at the last minute. The terms of the settlement are confidential, according to a report on ProPublica.

Omniscan is gadolinium contrast dye that is used to enhance images in MRI procedures. Gadolinium contrast dyes are sold under the names Ablavar, Eovist, Magnevist, Multihance, Omniscan, Optimark, and Prohance.

Gadolinium contrast dyes are believed to be associated with <"">nephrogenic systemic fibrosis (NSF), an often fatal disease marked by the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs. Evidence suggests that NSF is most likely to occur in people with severe kidney disease who have been exposed to a gadolinium contrast dyes. In 2007, the U.S. Food & Drug Administration (FDA) mandated that all gadolinium agents sold in the U.S. carry a black box warning – the agency’s strongest safety notice – regarding the risk of NSF. This past September, the FDA ordered the warning be strengthened, and use of Omniscan and other gadolinium contrast dyes are now banned in patients with severe kidney disease.

The now-settled lawsuit was brought by Loralei Knase, 68, from Coon Rapids, Minnesota. According to her lawsuit, Knase, who suffered from kidney disease, was injected with Omniscan several times between 2003 and 2005. Her entire body became stiff and swollen, and she has since had a kidney transplant. Knase is now disabled and must rely on a wheelchair. Her lawsuit alleged General Electric and its health care division hid Omniscan’s risks and failed to protect patients after its problems became apparent.

According to ProPublica, had it gone to trial, the Knase lawsuit could have provided the first public evidence that the owners of Omniscan (GE acquired the drug with the 2004 purchase of the pharmaceutical company Amersham) failed to disclose its risks.

In a written statement, officials with GE Healthcare said the Omniscan settlement “does not represent an admission of wrongdoing by the company.”

“The Knase matter has been resolved to the mutual satisfaction of both parties,” the company said. “Patient safety is our number one priority at GE Healthcare. The company remains committed to improving the quality and efficiency of healthcare around the world.”

The Knase lawsuit was seen as a potential bellwether for the similar cases filed against the makers of gadolinium contrast dyes. Prior to the announcement of the settlement, roughly 300 such cases had been consolidated in a multidistrict litigation before Judge Dan Aaron Polster in U.S. District Court in Cleveland, Ohio.

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