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Gadolinium used in MRI, or Magnetic Resonance Imaging, is linked to life-threatening illnesses that occurred in those with kidney disease, eventually causing their death. These illnesses are NFD, or Nephrogenic Fibrosing Dermopathy, and NSF, or Nephrogenic Systemic Fibrosis. This guideline details information regarding gadolinium lawsuits, compensation, and the possible serious side effects stemming from gadolinium contrast agents.
Gadolinium
Gadolinium is defined as a chemical metallic element. This element is utilized as a contrast agent during medical imaging tests like MRIs and MRAs, or Magnetic Resonance Angiographies. As an agent, gadolinium temporarily alters the manner in which an imaging tests interacts with the human body in order to locate abnormalities. Prior to receiving an MRI, the patient is injected with this agent. Magnevist and Multihance by Bayer Healthcare, Omniscan by GE Healthcare, OptiMARK by Covidien/Mallinckrodt, and ProHance by Bracco Diagnostics are all approved as gadolinium agents by the FDA.
Risks
Gadolinium use is now known to have links to major health complications for those who have kidney disease. These agents cause NSF, which involves fibrosis, or scarring of the organs and skin within people with certain kidney problems like renal failure. NSF is rare, yet potentially fatal. NSF is swift to immobilize the body, rendering patients unable to walk after only several weeks. Currently, no consistently effective NSF treatment exists. Sometimes, a kidney transplant can slow the disease’s progression.
The Gadolinium-and-NSF Link
The year 1997 earmarked the first NSF case. In 2000, the disease was considered independent. However, a link was made between gadolinium agents and NSF in 2006. Afterward, Omniscan, OptiMARK, Magnevist, and Multihance were implicated in NSF cases.
NSF Symptoms
Those who have been injected with a gadolinium agent for an MRA or MRI should contact their doctor immediately if they experience any NSF symptoms. The various NSF symptoms include raised, yellow spots on the white of the eye, skin tightening, skin swelling, skin hardening, muscle weakness, dark or red skin patches, joint stiffness, deep hip bone or rib pain, itching or burning skin, and difficulty moving the arms, hands, legs and feet. NSF can eventually lead to death.
FDA Warnings
In June 2006, the FDA’s first warning to healthcare professionals and the public about gadolinium agent risks occurred. The FDA stated it was aware of 25 NFD and NSF cases involving those who had kidney failure that received a gadolinium agent injection of Omniscan before undergoing an MRI. The FDA requested that all gadolinium agent manufacturers post black-box warnings on their products’ labels as of May 2007.
Lawsuits Involving Gadolinium
Individual and class action suits have been filed by those affected against the manufacturers of gadolinium agents due to the lack of warning about the agents’ possible life-threatening effects. Most of the lawsuits involve Omniscan; however, there are filed lawsuits against other contrast agents. Those who are diagnosed with NFD or NSF may have a claim for compensation in the form of expenses such as pain and suffering, lost wages and medical costs.