NSF, NFD, Kidney Failure and Renel Failure Lawsuit

Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy Lawsuits

Our law firm is representing clients that have suffered kidney failure or been diagnosed with Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD), after having a MRI or MRA that contained a gandolinium-based dye or contrast agent. Recent medical studies indicate that these dyes may be linked to patients with NSF and NFD. If you believe that your NSF, NFD, kidney, or renal failure may have been caused by MRI or MRA's that used a gandolinium-based dye or contrast agent, then please call and talk to us about a potential product liability lawsuit. You may reach us Toll Free at 1-800-883-9858 for a free case evaluation. If you prefer email, you may contact us by filling out our short online form:

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Information for Healthcare Professionals
Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging Scans
(marketed as Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance)

FDA ALERT [6/2006, updated 12/2006]: Development of Serious, Sometimes Fatal Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy following exposure to Gadolinium-based Contrast Agents

Since June 2006, the FDA has been reviewing reports about patients who developed a new disease --Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD)--after they received a gadolinium-based contrast agent during a magnetic resonance imaging scan (MRI) or magnetic resonance angiography (MRA). As of December 21, 2006, 90 individuals with NSF/NFD had been reported to the FDA; all had moderate (GFR<60 mL/min/1.73m2) to end-stage renal disease (GFR<15 mL/min/1.73m2) prior to their MRI or MRA with a gadolinium-based contrast agent. Their clinical characteristics are described in more detail below. Physicians should carefully assess the need for gadolinium-based contrast agents in patients with moderate to end-stage renal disease when performing an MRI or MRA.

Recommendations and Considerations for Health Care Professionals:

For patients with moderate (GFR<60 mL/min/1.73m2) to end-stage renal disease (GFR<15 mL/min/1.73m2): When recommending or performing an MRI or MRA, carefully weigh the benefits and risks associated with using a gadolinium-based contrast agent in light of recent reports of NSF/NFD observed following administration of these agents. Choose an alternative imaging method and/or contrast agent whenever possible.
Although there are no published data to determine the utility of dialysis to prevent or treat NSF/NFD, consider prompt dialysis of patients with moderate to end-stage renal disease who undergo a MRI or MRA with a gadolinium-based contrast agent. Prompt dialysis of these patients will eliminate circulating gadolinium-based contrast agent. From the first to the third hemodialysis sessions, average gadolinium-based contrast clearance rates were 78%, 96%, and 99%, respectively.

Information for the patient:

Physicians who are requesting an MRI or MRA with a gadolinium-based contrast agent for a patient with moderate to end-stage kidney disease should discuss the following issues with their patient.

Because the patient has moderate to end-stage kidney disease, they may develop NSF/NFD after receiving an MRI or MRA scan with a gadolinium-based contrast agent. NSF/NFD is a debilitating and potentially fatal disease.
The signs and symptoms of NSF/NFD include:

For the skin—burning or itching, reddened or darkened patches; and/or skin swelling, hardening and/or tightening
For the eyes—yellow raised spots on the whites of the eyes
For the bones, joints and muscles—joint stiffness; limited range of motion in the arms, hands, legs, or feet; pain deep in the hip bone or ribs; and/or muscle weakness

No studies have evaluated the role of dialysis on the chance of developing NSF/NFD in patients at risk. However, performing prompt dialysis to reduce the patient’s gadolinium-based contrast agent body burden following an MRA or MRI may be appropriate.
Patients at risk for NSF/NFD require close monitoring and clinical follow-up after having an MRI or MRA with a gadolinium-based contrast agent.

Background Information and Data

First identified in 1997, NSF/NFD has occurred in patients with moderate to end-stage renal disease. Patients with this condition develop fibrosis of the skin and connective tissues throughout the body. The skin thickening may inhibit flexion and extension of joints resulting in contractures. In addition, patients may develop widespread fibrosis of other organs. A skin biopsy is necessary to make a definitive diagnosis. The disease is progressive and may be fatal. Its cause is unknown.

As of December 21, 2006 the FDA has received reports to its Adverse Events Reporting System of 90 patients who developed NSF/NFD after they received a gadolinium-based contrast agent for an MRI or MRA; all had moderate to end-stage renal disease and many have been described in the scientific literature. 2,3 Their NSF/NFD began two days to 18 months after undergoing their contrast enhanced MRI or MRA. Many of these patients received a dose of gadolinium-based contrast agent exceeding that recommended in product labeling. Some patients developed NSF/NFD after receiving only one dose. Researchers have detected gadolinium deposits in skin biopsies from patients with NSF/NFD.

Five gadolinium-based contrast agents (Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance) are approved in the U.S. for magnetic resonance imaging (MRI). None are FDA-approved for MRA. The administered dose of gadolinium-based contrast with magnetic resonance angiography (MRA) is often higher (up to three times) than the approved dose for MRI. Though NSF/NFD has been reported following administration of three of the FDA approved gadolinium-based contrast agents (Magnevist, Omniscan, and OptiMARK), the FDA believes that there is a potential for NSF/NFD to occur in patients at risk following administration of any of the approved gadolinium-based contrast agents.

Worldwide, about 215 cases of NSF/NFD have been reported to the International Center for NSF/NFD Registry. In 75 of the 215 cases reviewed in detail, all had received gadolinium-based contrast agents for MRA or MRI.

MRI Lawsuits Gadolinium Poisoning - Free Case Evaluation

If you or a loved one had a MRI or a MRA, and a contrast dye or agent was used to enhance the MRI image, and you or a loved developed NFS/NFD, kidney failure or renal failure, then you may be eligible to collect money damages for your injuries and damages. Please fill out our Free Case Evaluation Form to better help us assist you, or call us Toll Free at 1-800-883-9858.