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Nephrogenic Systemic Fibrosis (NSF) and Omniscan Gadolinium Contrast Dyes Claims Attorneys

Accepting Cases Nationwide

What is Nephrogenic Systemic Fibrosis (NSF)?

Nephrogenic systemic fibrosis (NSF), was first diagnosed in 1997. Originally it was called nephrogenic fibrosing dermopathy or NFD but, as the total body manifestations of the disorder become recognized, the name was changed to NSF. NSF was not known to the medical community before March 1997 and some medical authors suggest that the sudden occurrence of the disease in the last 8 years makes it likely that a new agent or technique of examination causes it.

In whom does NSF occur?

Currently, little is known about NSF. Thus far, the condition has been observed to occur only in patients with advanced kidney dysfunction although some patients who have had, or who are awaiting, liver transplantation are also thought to be at increased risk of developing this disease. In a pivotal study in 2006 conducted by Dr. T. Grobner¹ it was noted that 5 of their 9 patients diagnosed with NSF had received a MRI involving use of Omniscan Contrast Dye, a gadolinium-based contrast agent manufactured by GE. This study was followed shortly by other studies and case reports showing a similar strong association. This resulted in both the FDA and General Electric sending out warnings about the use of gadolinium-containing contrast in patients with advanced kidney disease.

At this time, there are no known cases of NSF in patients with normal kidney function.

What is Magnetic resonance imaging (MRI)?

Magnetic resonance imaging (MRI) is a modern technology that allows doctors to have a detailed view of various parts of the body such as the brain, spinal cord, and heart. Occasionally, the exam will involve the intravenous injection of a contrast dye further allowing the physicians to 'see' inside of the body. Contrast dyes like Omniscan may also be used during a 'CT' scan, which is similar to a MRI.

What is Gadolinium?

Gadolinium is a contrast agent that helps distinguish between normal and abnormal tissue in the body when used with magnetic resonance imaging (MRI) and/or CT scans. It is the approved contrast agent for people with chronic kidney disease. Most cases of NSF have been associated with agents Omniscan and OptiMARK4. A small number of cases have been associated with Magnevist.

What are the symptoms of NSF?

At the current time, NSF is believed to develop over a period of days to several weeks. The first signs of the disorder may be red or dark patches or 'papules' developing on the skin. In time, the skin may feel "woody" and the surface may resemble the texture of the peel of an orange. The skin lesions are commonly symmetrical, with zones between the ankles and thighs most commonly involved, followed by involvement between the wrist and upper arms. Hand and foot swelling with blister-like lesions has also been reported. Some patients have reported yellow papules or plaques on or near the eyes. Rapid, new onset fluctuating high blood pressure has been described prior to the onset of the skin lesions.

Patients with NSF describe swelling and tightening of the skin, usually limited to the extremities, but sometimes involving the trunk. In many cases, the skin thickening inhibits the flexion and extension of joints, resulting in contractures. Severely affected patients may be unable to walk, or fully extend the joints of their arms, hands, legs, and feet. Complaints of muscle weakness are common.

Other organs might be affected, including the lungs, liver, muscles, and heart. About 5% of patients have very rapid and progressive disease development, and some patients may die.

How is NSF treated?

Currently, there is no effective treatment available for NSF. However, several different types of treatment options are being investigated.

What is the risk that I might get NSF?

According to a recent study, the overall risk of NSF was estimated at 4.3 cases per 1,000 dialysis patients per year or about 2.4 percent for each time a patient with advanced kidney disease was exposed to gadolinium. This means that approximately 1 in 40 gadolinium-based MRI scans resulted in NSF in the renal population. There was no risk when MRI scans were done without gadolinium. Approximately 200 cases of NSF have been associated with gadolinium-containing contrast agents worldwide.

Is Gadolinium still being used?

Yes, Gadolinium is still being used. However, pending further studies, experts are recommending that gadolinium-based MRI scans be avoided in patients with advanced kidney disease until more is known about the true causal link between gadolinium and NSF.

Should I contact an attorney?

If you believe you have developed NSF, we strongly advise you to contact your physician for an examination that may involve a skin biopsy. If you are, in fact, diagnosed with NSF then you may want to talk with an attorney in order to protect your legal rights. Burg Simpson is here to help you. We take cases on a contingency basis, which means that we are paid only if we bring about a recovery for our clients. We have already retained national experts in assist us with your case.

Contact us now to schedule your free confidential consultation with our experienced defective product attorneys.

View our NSF brochure for more information

¹Grobner T. Gadolinium - a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant. 2006 Apr;21(4):1104-8. (Grobner, 2006). Erratum 2006 Jun;21(6):1745.

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Burg Simpson Eldredge Hersh & Jardine, P.C. is a law firm serving the Rocky Mountain Region. The firm has offices in Denver, Colorado, Cody, WY, Cincinnati, Ohio, & Phoenix, AZ. The Firm is responsible for the content on the website,this information is not to be interpreted as providing legal services,
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