Medical products giant GE Healthcare (NYSE:GE) noted wins and losses in its imaging agents this month, landing FDA clearance for its new AdreView cardiac imaging agent after losing a $5 million jury decision over its Omniscan MRI dye.
An Ohio jury ruled in favor of a patient, who claimed that GE Healthcare failed to warn doctors and patients about the potential risks of the Omniscan MRI imaging agent, especially for use in patients with kidney disease who are greater risk of contracting a rare disease called nephrogenic systemic fibrosis. Source:www.kidneyatlas.org
GE promised to appeal the decision on “several grounds,” the company told ProPublica. The trial took some dramatic turns prior to the jury’s decision, including the plaintiff’s claims that the company ordered one of its scientists to burn potentially troubling research about the Omniscan dye.
The Cleveland, Ohio, jury awarded $4.5 million to patient Paul Decker and another $500,000 to his wife after rejecting GE’s arguments that it had promptly and appropriately warned doctors and patients about the dangers of the Omniscan dye.
Many MRI contrast agents, including Omniscan, contain a chemically coated metal called gadolinium, which is considered toxic on its own. Healthy patients are able to expel the agent via the kidneys without serious harm, but the process may take longer in patients with kidney disease, increasing the risk that the toxic element may become un-bonded from its protective coat.
The FDA in 2010 banned the use of Omniscan and 2 similar imaging dyes in patients with severe kidney disease. The federal watchdog agency said that gadolinium-based contrast agents Omniscan, Magnevist and Optimark were associated with a greater risk of NSF and that enhanced screening to identify NSF risk was necessary, advising doctors to report cases of the syndrome.
No new cases of NSF have been reported in the past few years, according to ProPublica.
In 2006, the watchdog agency began warning the public in about cases of NSF in GBCA-treated patients. The following year, the agency began requiring the addition of a boxed warning about the risk of NSF to the labeling of GBCA drugs. In December 2009, an FDA advisory panel recommended that the watchdog agency tighten restrictions on the drugs.
Amid the recent legal kerfuffle, GE noted FDA approval for its new AdreView cardiac imaging agent, the 1st and only such product approved molecular imaging dye providing physicians with insight into a patient’s mortality risk by evaluating the function of the cardiac nerves.
The AdreView dye was approved with indication to assess cardiac nerve activity and help identify 1 and 2-year morality risk in patients diagnosed with Class II or Class III heart failure and left ventricular ejection fraction of less than or equal to 35%.
“Predicting disease progression in heart failure patients can be difficult, and there are currently a limited number of prognostic tools available to help clinicians understand the likelihood for heart failure progression,” Brown University associate professor Dr. James Arrighi said in prepared remarks on behalf of the company. “Now, with AdreView, we have a tool that will provide clinicians with a numeric score to help stratify mortality risk, and may help to promote more informed clinical decision-making.”