A Diagnostics & Imaging Week

Greta Carolus, a former nurse and citizen of Loveland, Colorado, has filed a lawsuit in U.S. District Court for the District of Colorado against General Electric (Fairfield, Connecticut), GE Healthcare (Waukesha, Wisconsin), and GE Healthcare Bio-Sciences, claiming that their imaging agent, Omniscan, caused a debilitating skin and joint disease known as Nephrogenic Systemic Fibrosis (NSF).

The suit seeks damages for 15 separate causes of action and her attorney says it may be the first against GE stemming from the effects of Omniscan, also known as gadodiamide. Omniscan is injected into patients prior to MRI or MR angiograms (MRA) to help distinguish blood vessels from nearby tissues.

Peter Burg, a partner with Burg Simpson Eldredge Hersh & Jardine (Denver), said that a few days after she was injected with Omniscan, Carolus developed symptoms associated with NSF/NFD, formally diagnosed in November 2005, and progressing to widespread fibrosis and edema in her arms, legs, and “associated joints.” He said the disease “has caused permanent effects ... and could lead to death.”

Carolus, wheelchair-bound, was forced to leave her employment as a nurse as a result of her injuries.

Last year, the FDA acknowledged that there were 200 reports worldwide of Nephrogenic Systemic Fibrosis sometimes called Nephrogenic Fibrosing Dermopathy (NFD), the law firm said, adding that in 2006 that FDA issued Public Health Advisory alerts about the development of serious, sometimes fatal, NSF/NFD following patient exposure to several contrast agents, including Omniscan.

The suit claims that GE was aware, or should have been aware, of the risks of Omniscan and that there were reports demonstrating NSF/NFD in connection with the use of gadodiamide contrast agents, including Omniscan.