An Ohio woman has filed a lawsuit against Bayer Healthcare Pharmaceuticals of Wayne, New Jersey claiming the drug Magnevist, a contrast agent containing the heavy metal gadolinium, caused her 24-year-old son’s death in August 2004. Trevor Drake of Norwalk, Ohio was injected with Magnevist at the Cleveland Clinic prior to a magnetic resonance imaging (MRI) procedure for his advanced kidney disease. Contrast agents like Magnevist that contain gadolinium are injected into patients prior to some tests to help diagnosticians visualize the body’s internal organs and blood vessels.
Drake’s mother, Beverly Rockwell, is seeking compensatory and punitive damages on behalf of her son. The lawsuit specifically claims that Magnevist caused Nephrogenic Systemic Fibrosis (NSF), a skin and joint disease which proved to be fatal to the young man. NSF, also known as Nephrogenic Fibrosing Dermopathy (NFD), is a condition that only develops in patients with kidney disease. Patients with NSF/NFD have swelling and tightening of the skin, usually only involving the extremities but sometimes affecting the torso. The thickening and swelling of the skin inhibits flexion and extension of the arms and legs, and severely affected patients may even be unable to walk.
In 2006, the Food and Drug Administration (FDA) reported that there were 200 reports worldwide of NSF/NSD cases that had developed following patient exposure to gadolinium-based contrast agents; many of these cases were fatal. In mid-May 2007, the FDA advised the makers of gadolinium-based contrast agents to place a “Boxed Warning” about the risks of developing NSF/NFD after being injected with Magnevist. A boxed warning is also referred to as a black label warning and means that medical studies indicate the drug carries a significant risk of serious and even life-threatening side effects. A black label warning is the strongest warning the FDA issues prescription drugs.