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What is NSF / NFD?

NSF / NFD refers to a disease called nephrogenic systemic fibrosis / nephrogenic fibrosing dermopathy. This rare, life-threatening condition develops in some patients after undergoing gadolinium-assisted MRI/MRA scans. While researchers have yet to find the exact cause of NSF / NFD, it appears that exposure to gadolinium is responsible for the onset of this debilitating condition in some patients. In 2006, the U.S. Food and Drug Administration (FDA) received reports of 90 patients who became ill with NSF / NFD after undergoing gadolinium-assisted MRI/MRA scans.

The very first case of NSF / NFD was reported in 1997 in a patient with renal insufficiency (kidney malfunction) who received a gadolinium injection as part of the MRI scan. However, the medical community began to recognize NSF / NFD as a distinctive condition only in 2000, when it was first described in medical literature. Since then, several hundred NSF / NFD cases have been reported in the United States, the vast majority of which have occurred in people with serious kidney conditions. Other NSF / NFD risk factors include recent liver transplant, recent surgery and thrombosis.

Symptoms of NSF / NFD

Patients usually notice the first symptoms of NSF / NFD one to six months after undergoing gadolinium-assisted MRI/MRA. The most notable signs are hardening and tightening of the skin, which might be accompanied by itching and swelling. These symptoms usually appear on the arms and legs, although patients might also notice skin changes on the trunk of the body.

Since NSF / NFD is a progressing disease affecting the whole body, the afflicted persons might also experience a combination of other symptoms:

  • Skin — reddened or darkened patches (in addition to hardening and swelling)
  • Eyes — yellow raised spots on the whites of the eyes and / or near the eyes
  • Bones and Joints — stiffness, limited range of motion, deep bone pain
  • Muscles — pain and/or weakness.

Dangers of NSF / NFD

NSF / NFD is a dangerous disease because, in addition to skin hardening, it can also cause hardening and scarring of internal tissues. The affected areas often include the diaphragm, abdomen and lungs. Scarring inside the lungs is especially dangerous, because it might result in restricted breathing, which in turn can cause death. In addition, NSF / NFD patients are prone to falling and sustaining major injuries due to their limited range of motion. Since their bodies are weakened by NSF/ NFD, recovery from such injuries is complicated.

NSF / NFD is a progressive condition. Depending on the course of the patient’s disease and overall health status, he or she might be rendered wheelchair-dependent within weeks after the onset of NSF / NFD. If the disease progresses rapidly and causes failure of vital internal organs, the outcome is usually fatal. Currently, there is no cure for NSF / NFD. Improving a patient’s kidney function has been shown to slow the progress of the disease, but not to stop it completely. Other therapies, such as ultraviolet light treatments and steroids, have had a similar effect.

Legal Recourse

The FDA has asked manufacturers of gadolinium-based MRI contrast agents to put black box warning on their respective products. This is the strongest warning the FDA can issue short of a complete product recall. Currently, several studies are being conducted to determine if the use of gadolinium as an MRI contrast agent should be continued. In the meanwhile, several NSF / NFD patients or their relatives have sued the manufacturers of gadolinium-based contrast agents. Gadolinium lawsuits seek compensation for medical expenses, lost income and physical and emotional suffering caused by the manufacturers’ harmful products. If it can be proved that pharmaceutical companies fell short of their obligation to protect their customers and/or warn them properly, the NSF / NFD victims might be entitled to compensation.

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