GE Hid Risks of MRI Dye Injury Alleges Omniscan Injury Lawsuit
Allegations of a cover-up in a groundbreaking GE Omniscan MRI Dye injury trial surround questions of whether GE Healthcare endangered patients by failing to protect them from a potential fatal skin disease.
While hundreds of Omniscan MRI Dye injury lawsuits have been filed against GE Healthcare, most have been settled under confidential terms. This week however, opening statements were heard in the first trial to reach federal court amongst allegations that GE failed to protect patients from a potentially life threatening disease called Nephrogenic Systemic Fibrosis (NSF) and whether the company did indeed cover-up studies that showed problems with the dye, including telling one researcher in 1994, to “burn the data” of a study that had unfavorable results. (https://www.propublica.org/article/burn-the-data-did-a-company-try-to-hide-risks-of-ges-mri-dye)
The case, brought by 61-year-old Paul Decker, alleges that Deck developed NSF after receiving an injection of the Omniscan dye in 2005. NSF is a potentially fatal disease that causes the skin to become swollen and hard. NSF can affect internal organs also, including the heart and lungs. While the disease has no known definitive cause or cure, it has been associated with MRI dyes like Omniscan when given to patients with kidney problems.
According to 2010 ProPublica article, about 500 injury lawsuits had been filed across the country against GE over Omniscan, though almost all the cases have been settled out of court. According to that article, documents unsealed during a lawsuit show that GE was warned during a May 10, 2006 drug safety meeting that they needed to “proactively propose to restrict the use of Omniscan in patients with severely impaired renal function.” The court order also referred to evidence that indicated that the FDA and physicians had not seen company research that questioned the chemical breakdown of Omniscan in the body and its potential to release the toxic metal gadolinium before being expelled. (https://www.propublica.org/article/ges-own-safety-team-urged-company-to-restrict-mri-drug-041510)
In 2007, the FDA required GE to update the Omniscan warning label to include the risks the dye posed to patients with kidney disease, and in 2010 the federal agency banned the use of Omniscan in patients with kidney disease. However, Decker alleges that at the time of his MRI scan, and well after issues with the dye were already being seen, GE continued to fail to protect patients with an inadequate warning that simply stated “caution should be exercised in patients with renal impairment.”
GE maintains that it didn’t hide evidence, tell the researcher to burn data, and that the company has always acted in an “ethical and responsible” manner regarding the dangers of the MRI dye.
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