A number of product liability lawsuits have been filed by individuals who allege they were poisoned by MRI contrast agents that contain the chemical gadolinium, indicating that the injections used to provide doctors with clearer images are leaving individuals with a debilitating condition known as “gadolinium deposition disease (GDD)”.
Bayer Healthcare, GE Healthcare and other manufacturers of gadolinium-based MRI contrast agents have been named as defendants in more than a dozen complaints filed in recent weeks in California state court and the federal court system.
According to allegations raised in the MRI contrast agent poisoning lawsuits, gadolinium contained in products like Magnevist, Gadavist, and Ominscan may leave patients with persistent headaches, bone and joint pain, reduced cognitive function, tendon and ligament pain, thickening of soft tissues and other complications.
The condition is known known as gadolinium deposition disease (GDD), and it is considered incurable and progressive, meaning that the symptoms worsen over time.
The most high-profile claim to date was filed on November 1 by action star and martial artist Chuck Norris, alleging that his wife, Gena Norris, suffered gadolinium MRI contrast agent poisoning that has left her with severe pain and burning sensations.
A number of similar complaints were filed in last week in the U.S. District Court or the Southern District of California, indicating that individuals now suffering from gadolinium deposition disease had no other factors that may explain the symptoms.
Gadolinium MRI Contrast Agent Side Effects
Gadolinium contrast agents are commonly used during magnetic resonance imagine (MRI) scans, to provide a detailed and clearer picture of internal organs, helping doctors identify abnormal tissue in the body.
Although the MRI dyes are generally believed to be safe, several years ago concerns emerged about a link between MRI gadolinium contrast agents and a severe and life-threatening skin condition, known as nephrogenic systemic fibrosis (NSF), which was found to occur among patients with impaired kidney function, causing their skin to thicken and harden, severely restricting movement.
Sometimes referred to as gadolinium associated systemic fibrosis, NSF is a painful disorder that has no known cure and often results in confinement to a wheelchair and then death.
In 2007, the FDA limited gadolinium contrast doses in most patients and contraindicated it for others, which limited the risk of NSF. In September 2010, the FDA went even further and banned the use of Bayer’s Magnevist on patients with kidney problems, due to the heightened risk of NSF.
The agency also required label changes for all gadolinium agents, warning healthcare professionals to screen patients before injecting gadolinium to identify those suffering from acute kidney injury or chronic, severe kidney disease.
However, the new lawsuits indicate that the plaintiffs or family members who suffered gadolinium poisoning suffered no reduced kidney function, raising questions as to whether the gadolinium contrast agent side effects are limited to those with kidney problems.
Recently, there have also been growing concerns over signs of gadolinium build-up in the body. In September, the FDA’s Medical Imaging Drugs Advisory Committee voted to recommend the FDA require new MRI contrast agent warnings about the risk of gadolinium build up in the brain. However, in May the FDA concluded that gadolinium in the brain appeared to carry no threat of health effects.
The FDA is continuing to assess their safety, and its National Center for Toxicological Research is currently conducting a study on gadolinium brain retention in rats.