MRI Contrast Agents Face First Trial Over Link to Skin Disorder
Next month, the first of many lawsuits filed against makers of medical imaging contrast agents linked to a potentially fatal skin-thickening disorder called nephrogenic systemic fibrosis (NSF) is scheduled to begin.
Legal watchers figure to keep a close eye on the case against Bayer Healthcare Pharmaceuticals and its Magnevist contrast agent, since the outcome of the trial in a San Francisco courtroom figures to shape future litigation on the same issue. A win for plaintiff Peter Gerber could open the door for other victims of NSF caused by the use of gadolinium-based contrast agents to receive financial compensation for their injuries.
Gerber’s lawsuit accuses Bayer of negligence for designing, testing, and marketing Magnevist, a chemical agent used in MRI scans to make the results easier for doctors to read. His is the first of many pending lawsuits to be assigned to trial.
NSF is a progressive disease which results in thickening and hardening of the skin, particularly in the arms, legs and other extremities. In the most serious cases, NSF can be fatal.
Attorneys who have sued Bayer and manufacturers of other brands of gadolinium-based contrast agents say there is a direct link between exposure to the chemical agents during MRI scans and the severe skin disorder.
“When you have a case of NSF, it’s pretty much a certainty that person was exposed to one of these agents,” said Gerber’s lawyer, Lawrence Gornick, according to a report on Law.com.
As of October 15, Bayer has been named in about 350 lawsuits involving Magnevist, Law.com reports.
About two dozen NSF lawsuits filed in California have been consolidated for pre-trial rulings by the same judge. Many more suits alleging injuries from MRI contrast agents have been filed in federal court and consolidated in the Northern District of Ohio, Law.com reports.
In 2007, the Food and Drug Administration asked makers of gadolinium-based agents such as Magnevist include boxed warnings about the risk of contracting nephrogenic systemic fibrosis for patients with kidney problems.
Just this week, an FDA advisory panel said the use of gadolinium-based contrast agents should be restricted for patients with advanced kidney disease, since they are more likely to suffer fatal or severe complications from their use.
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