Investigation and pending lawsuits against manufacturers of MRI and MRA Contrast Dye containing Gadolinium as it can cause rare disease NSF/NSD.
Gadolinium is a heavy metal found deep in the earth. It is highly toxic in its free (uncovered) form. MRI and MRA contrast agents containing gadolinium are supposed to be secreted out of the body quickly, but some people, especially those with impaired kidney function, may not be able to secrete it as quickly as necessary. On May 23, 2007, the FDA required a Black Box Warning on all MRI contrast dyes containing gadolinium, warning caution in using them in people with impaired kidney function. The brand names of MRI contrast dyes containing gadolinium include Omniscan, OptiMARK, Magnevist, MultiHance, and ProHance.
A MRI (Magnetic Resonance Imaging) is a diagnostic test that doctors use to obtain images of internal organs and tissue through the use of powerful magnets and radio waves. An MRA (Magnetic Resonance Angiography) is used to take a detailed picture of a patient's blood vessels. Sometimes in MRIs and always in MRAs, a contrast dye is injected into the body intravenously to help detect abnormal tissue.
MRIs are very common procedures. 23 million were done worldwide in 2005 alone, 10 million of them in the U.S. Unfortunately, MRI and MRA contrast dye containing the heavy metal gadolinium has been the cause of a disease called Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermotherapy (NFD), a serious condition that starts in the skin of the arms and legs and spreads to other parts of the body.
People who undergo an MRI-especially those with kidney disease-in which this contrast dye is used are particularly at risk for developing this disease. Nephrogenic Systemic Fibrosis (NSF), sometimes referred to as Nephrogenic Fibrosing Dermotherapy (NFD), is a disease that starts in the skin of the arms and legs and spreads to other parts of the body and internal organs. It causes the skin to change color, often to pink or orange and then brown, and causes the skin to stiffen and develop a 'woody' or hard texture. The skin can also lose its hair and pigment. It is a painful condition, and the limbs affected become difficult to move. It can spread to other parts of the body, including internal organs, and eventually can lead to death. A kidney transplant might be necessary to treat NSF/NFD.
This condition could start in as little as a few days or even several months after the patient was injected with a contrast agent during an MRI or MRA. Symptoms of NSF/NFD include burning of the skin, Itching, Swelling, Hardening or tightening of the skin, Red or dark patches on the skin, Yellow spots on the whites of the eyes, Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet, Pain deep in the hip bones or ribs, Muscle weakness.
Gadolinium is a heavy metal found deep in the earth. It is highly toxic in its free (uncovered) form. MRI and MRA contrast agents containing gadolinium are supposed to be secreted out of the body quickly, but some people, especially those with impaired kidney function, may not be able to secrete it as quickly as necessary. On May 23, 2007, the FDA required a Black Box Warning on all MRI contrast dyes containing gadolinium, warning caution in using them in people with impaired kidney function. The brand names of MRI contrast dyes containing gadolinium include Omniscan, OptiMARK, Magnevist, MultiHance, and ProHance.
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Defendant Details
Name (Stock Symbol)
Brief Description
Bayer AG
Bayer AG manufactures pharmaceuticals and consumer products.
General Electric Company (GE)
General Electric Company operates as a technology, media, and financial services company worldwide.
Bracco Diagnostic, Inc.
Bracco Diagnostic, Inc., a subsidiary of The Bracco Group, is a pharmaceutical company.