In a setback for GE
Healthcare, a jury today 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
weren’t 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.
