A federal jury in Ohio has awarded $5 million in the first case to go to trial in the multidistrict litigation (MDL) involving patients who were injured from the body scan contrast agent “gadolinium.” The jury found that GE Healthcare failed to provide adequate warnings of the health risk posed to those with impaired kidney function from Omniscan.
The GE product is a gadolinium-based contrast dye used in MRIs and other imaging scans.
Paul Decker contracted a debilitating skin disease, nephrogenic systemic fibrosis (NSF) after being injected with Omniscan for a magnetic resonance angiogram in 2005. Decker was also undergoing dialysis for end-stage kidney disease at the time.
Drug makers GE Healthcare, Bayer and Covidien have face hundreds of lawsuits claiming injuries from gadolinium-based contrast agent products. In June 2006, the FDA issued its first warning about the risk of NSF as a result of gadolinium exposure. The risk is unique to people already suffering from renal failure.
Nephrogenic systemic fibrosis is a progressive and sometimes fatal disease that involves the hardening of the skin and tissue growth along joints, eyes and internal organs. Unfortunately, there is currently no treatment for NSF.
The Federal Drug Administration first issued its warning about the risk of NSF in 2006. The risk is specific as to those who are suffering from a renal disease.
Mr. Decker experienced locking of his arms at the elbow joints, and the contraction of his hands, wrists and fingers. His lower extremtiies became basically like stone or wood and he now requires 24-hour care.
In February 2012, this product liability lawsuit against GE Healthcare became one of the nearly 1,000 federal cases consolidated in multidistrict litigation before Judge Evan Polster in the U.S. District Court for the Northern District of Ohio in Cleveland. At one time, there were almost 1,000 cases in the gadolinium MDL, but most of the cases have been settled, including each of the cases set for bellwether trials. There were only about 10 unresolved cases left in the MDL. GE Healthcare was unable to settle Decker’s case, making it the first to go to trial.
The jury found GE Healthcare liable for providing inadequate warnings, but rejected design defect and misrepresentation claims. The jury awarded Decker $1 million for economic losses and $3.5 million for non-economic losses. His wife received $500,000 for loss of consortium.
GE Healthcare understood the risk since 2005. GE had studies revealing that that this was a toxin and once it entered the body, and stayed there, it would cause unimaginable effects. Unfortunately, GE chose not to share that information with physicians.
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