A jury has ruled against GE Healthcare in the first jury trial regarding the company’s Omniscan dye. The jury awarded $5 million to a sixty-one-year-old retiree who was stricken with nephrogenic systemic fibrosis after receiving just one dose of Omniscan.
Gadodiamide, commonly marketed under the trade name Omniscan, is among a small group of drugs administered to patients before an MRI scan. Called contrast agents, the drugs enhance the differences between fluids and structures in the body when they appear on scans, making diagnosis easier. Omniscan is sold by a unit of General Electric called GE Healthcare.
Omniscan includes gadolinium, a substance that researchers have found can cause nephrogenic systemic fibrosis (NSF). The U.S. Food and Drug Administration ordered in May 2007 that U.S. makers of products containing gadolinium include a black-box warning on labels about the dyes’ risks.
Nephrogenic systemic fibrosis, or NSF, is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. NSF, patients develop large areas of hardened skin with fibrotic nodules and plaques. NSF can also cause joint pain and limitation in range of motion. In its most severe form, NSF may cause severe systemic fibrosis affecting internal organs including the lungs, heart and liver.
According to Decker’s lawsuit, he developed nephrogenic systemic fibrosis, or NSF, after receiving only one dose of Omniscan. Paul Decker received the Omniscan dye during 2005 tests on his heart. NSF left him immobile and dependent on 24-hour care.
Decker alleged that GE officials knew patients with impaired renal function (i.e., a history of kidney ailments) were at a higher risk for developing NSF from Gadolinium-based contrast agents. Over the course of a 17-day trail, Decker’s attorneys introduced evidence that GE Healthcare withheld important studies and FDA evidence that chronicled the dangers of Omniscan. In the end, the jury agreed with Decker and found that the company had failed to provide reasonable and adequate warnings to doctors and patients about those risks.
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