Former Nurse Sues GE for Disease Caused By Omniscan

Greta Carolus, a former nurse, resident and citizen of Loveland, Colorado, recently filed a lawsuit in U.S. District Court for the District of Colorado against General Electric Company, GE Healthcare, Inc. and GE Healthcare Bio-Sciences Corporation claiming that their drug caused her a debilitating skin and joint disease known as Nephrogenic Systemic Fibrosis (NSF).

The suit seeks damages for fifteen separate causes of action and may be the first against GE stemming from the effects of Omniscan(TM) also known as gadodiamide. Omniscan is injected into patients prior to magnetic resonance angiograms (MRA) or magnetic resonance imaging (MRI) to help distinguish blood vessels from nearby tissues.

"Within days after being administered Omniscan(TM), Ms. Carolus developed symptoms associated with NSF/NFD, which was formally diagnosed in November 2005, and which has progressed to widespread fibrosis and edema in areas including, but not limited to, her arms, legs, and associated joints," says Peter W. Burg, a partner in the Denver litigation law firm of Burg Simpson Eldredge Hersh & Jardine, who filed the suit.

"This disease has caused Ms. Carolus to suffer this condition and has caused permanent effects affecting her throughout her lifetime and could lead to death," said Burg, whose firm handles complex product liability and medical malpractice cases. Ms. Carolus is now wheelchair bound with limited extension of her legs, several fingers and elbows. Ms. Carolus was forced to leave her employment as a nurse as a result of her debilitating
injuries.

Last Year the U.S. Food and Drug Administration (FDA) acknowledged that there were 200 reports worldwide of Nephrogenic Systemic Fibrosis sometimes called Nephrogenic Fibrosing Dermopathy (NFD).

The suit also notes that in 2006 the FDA issued Public Health Advisory alerts about the development of serious, sometimes fatal, NSF/NFD following patient exposure to several contrast agents, including Omniscan(TM).

The suit claims that GE was aware or should have been aware of the risks of Omniscan(TM). And that "during the years that defendants have manufactured, marketed and sold Omniscan(TM), there have been numerous reports, studies, assessments, papers and other clinical data describing or demonstrating NSF/NFD in connection with the use of gadodiamide contrast agents, including Omniscan(TM).

"Despite this, defendants have repeatedly failed to take prompt, reasonable, and effective measures to alert the appropriate members of the health care community and its patients, including but not limited to, renal patients, nephrologists and other physicians, radiologists, administrations, technicians, and hospital/radiology supply personnel, to
the serious adverse health risks presented by Omniscan(TM) (gadodiamide) administration."

The suit asserts that in the course of being evaluated for a renal transplant at Poudre Valley Hospital in Fort Collins, Colorado, Carolus was administered Omniscan(TM) (gadodiamide) in connection with magnetic resonance angiogram (MRA). Carolus was formally diagnosed with NSF/NFD in November 2005.

"Neither Greta Carolus nor her prescribing physician, nor the performing radiologists or technicians were warned or cautioned by defendants about the serious health risks presented by the administration of Omniscan(TM)," states the suit.

Much has been made public recently about the relationship between gadodiamide contrast agents and NSF. In its Public Health Advisory last December, the FDA said it was notifying health care providers that patients with moderate to end-stage kidney disease that receive an MRI with a gadodiamide contrast agent may get NSF. The FDA called NSF "debilitating"
and added "it may cause death."

The Clinical Journal of the American Society of Nephrology reported on NSF in its February issue. "NSF is a fibrosing disorder that involves predominantly the skin but also affects systemic organs, such as the liver, heart, lungs, diaphragm, and skeletal muscles," said the publication.

The U.S. Centers for Disease Control (CDC) also has been investigating illnesses related to metallic dyes containing gadodiamide used in MRI scans. "When possible, use of gadodiamide contrast agents should be avoided in patients with advanced renal failure, particularly in patients who are undergoing peritoneal dialysis," the CDC concluded in its late February
Morbidity and Mortality Weekly Report.

The American College of Radiology, in a Guidance Document for Safe Practices, recently recommended that gadodiamide contrast agents not be administered to patients with advanced kidney disease unless the benefits clearly outweigh the risks. Even more strongly, the European Agency for the Evaluation of Medicinal Products issued a recent advisory against the use of Omniscan(TM) and one other gadodiamide contrast agent for patients with
severe renal disease.

Carolus' husband, Jim, is also a plaintiff. He contends that he has been deprived of the comfort, "society, aid, services, consortium and support of his wife." The Caroluses live in Loveland, Colorado.

Burg Simpson is currently involved in the representation of more than 20 individuals with Nephrogenic Systemic Fibrosis (NSF). -Burg Simpson Eldredge Hersh & Jardine, P.C.