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GE failed to adequately warn about dangers of its MRI dye, Jury finds

A jury awarded $5 million to a patient and his wife after it found GE Healthcare did not adequately warn patients and doctors about the risk of its imaging dye, Omniscan. It was the first case involving the dye to go to trial

In a setback for GE Healthcare, a jury on Friday found that the company failed to adequately warn patients and doctors about the dangers of its medical imaging dye. The jurors awarded $5 million to the plaintiff and his wife.
 

The verdict, after a two week trial in federal court in Cleveland, marks the first time a jury has examined whether the dye, injected into patients to sharpen MRI scans, can cause a rare but debilitating disease in which large areas of the skin become thick and hard. ProPublica investigated the dye in 2009 and 2010, revealing that GE ignored the advice of its own safety experts to "proactively" restrict its use.
 

GE has settled out of court a few hundred cases involving its dye, marketed as Omniscan. Other manufacturers of similar imaging agents have also resolved cases before trial. All the settlements are confidential.
 

Plaintiff Paul Decker, 61, was diagnosed with the disease, nephrogenic systemic fibrosis, in 2010, and he claimed it was caused by an injection of Omniscan he received during an MRI in 2005. GE acquired the drug in 2004.
 

A key question for the jury was whether the risks of the dye for patients such as Decker — who suffered from severe kidney disease, known to increase the risk of Omniscan side effects — had been adequately disclosed by the drug's manufacturer, not only GE but also the predecessor companies that had previously owned the dye.
 

At the opening of the trial, arguments were made — and disputed by GE­­ — that data was ordered destroyed and that research was not shown to a key scientist who co-authored a study finding the dye was safe.
 

GE maintained it had properly and promptly disclosed the dye’s dangers and that it had been the first to warn about the disease. But the jury rejected the company’s defense and awarded $4.5 million to Decker and $500,000 to his wife, Karen Decker. The jury also denied GE’s claim that Decker filed his case too late.
 

GE, in a statement, said it “was disappointed in the jury’s decision” and plans to appeal the verdict on “several grounds.” The statement pointed out that the jury had rejected Decker’s claims that Omniscan’s design was defective and that the company’s representations about the dye’s quality and safety were not accurate.
 

Omniscan and similar dyes manufactured by other companies contain a toxic metal, gadolinium, which is bonded with a protective coating to keep it inert. In the vast majority of patients, the drug is filtered out through the kidneys without causing harm.
There have been no new cases of the disease in recent years.

Only a few Omniscan cases are still in litigation.
 

Courtesy: http://www.propublica.org/

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