Parker, Waichman, Alonso LLP

Home » Topics » Diseases » NSF

Nephrogenic Systemic Fibrosis (NSF) Associated with Gadolinium-based Contrast Agents

Keywords:  NSF | Gadolinium | Lawyer | MRI | Kidney | Nephrogenic Systemic Fibrosis | Information | Contrast | Attorney

Nephrogenic Systemic Fibrosis (NSF / NFD) and Gadolinium Contrast Dyes

The lawyers and attorneys at our firm are representing victims of the rare disorder Nephrogenic Systemic Fibrosis (NSF).  NSF, a relatively new disease, is seen in people with pre-existing kidney disease who have been exposed to gadolinium contrast agents used in magnetic resonance imaging (MRI) procedures.

Gadolinium contrast dyes are used in MRI procedures because they make it far easier for a diagnostician to differentiate between normal and abnormal tissue. While the tests can be done without the gadolinium based contrast agent, they are nowhere near as effective. Unfortunately, there are not yet any alternatives to gadolinium based contrast agents.  Currently, there are five gadolinium contrast dyes approved for use in the US: Omniscan by GE Healthcare; OptiMARK by Mallinckrodt/Tyco Healthcare; Magnevist by Bayer/Schering AG/Berlex; ProHance by Bracco Diagnostics and MultiHance by Bracco Diagnostics. 

 
The first known diagnosis of NSF occurred in 1997, but it wasn't until September 2000 that details of the disease were published in the medical journal Lancet.  Even then, the disorder did not have a name.  Because it is rare, not much is known about NSF, but what studies have been done have consistently shown an association between NSF and gadolinium contrast agents used in MRI procedures.  Our NSF lawyers have already filed lawsuits against the makers of gadolinium contrast agents on behalf of NSF victims and their families.  If you or a loved one suffers from this devastating disorder, we urge you to contact one of our experienced NSF lawyers for a free evaluation of your case.

Nephrogenic Systemic Fibrosis (NSF)

NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. 

There is currently no cure for NSF and no one understands its specific cause.  Photopheresis, a treatment where blood is temporarily removed from the body and exposed to ultraviolet light before being re-injected into the patient, has been shown to help in some cases of NSF.  However, the treatment is expensive - costing about $8000 every two weeks.  Kidney transplants have also been shown to slow the progression of NSF.

 The evidence that gadolinium contrast agents play a role in the development of NSF is fast becoming irrefutable. In 2006, Dutch researchers where the first to link NSF with the use of gadolinium contrast dyes. In 2007 researchers at Yale University reported that 95-percent of those with NSF had an MRI that involved a gadolinium MRI contrast dye two to three months before their symptoms appeared.  Around the same time, researchers at Massachusetts General Hospital found that kidney patients who had undergone MRIs with gadolinium contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents.

A Scottish NSF study published in October 2007 looked at 1,826 patients who underwent renal replacement therapy at two Glasgow hospitals between January 1, 2000 and July 1, 2006. Of those patients, 421 underwent an MRI that involved the use of a gadolinium based contrast agent. Fourteen were diagnosed with NSF, and of those, 13 had been exposed to gadolinium during an MRI. The researchers also found that the patients with NSF had received far higher doses of gadolinium than those patients who were exposed to gadolinium but did not develop the disorder.

In that NSF study, the time between gadolinium-based contrast dye exposure and presentation with NSF ranged between 2 days and 6 years (median time, 76 days). Five patients developed NSF more than 90 days after exposure to gadolinium contrast agents. Of these, three had a time to onset of more than 1 year. Six patients in the NSF group had undergone previous gadolinium-enhanced MRI without apparent complication, and eight went on to undergo further exposure after presentation with NSF.

FDA Warnings

In June 2006,  the Food & Drug Administration (FDA) issued what would be the first of three warnings on gadolinium contrast dyes. Following the publication of the Dutch NSF study in 2006, the FDA issued an alert to healthcare providers that gadolinium based agents had been tied to multiple cases of NSF. Although these cases were not limited to one gadolinium based contrast agent, three were most often associated with the onset of NSF. Those three were Ominiscan, Magnevist and OptiMark. At that time the FDA warned physicians to screen patients for kidney problems prior to using gadolinium based contrast agents during MRIs.

In December of 2006, the FDA issued its second public health advisory regarding gadolinium based contrast dyes.  At that time, the FDA said it had received  90 reports of patients with moderate to end-stage kidney disease who developed NSF after being exposed to gadolinium based contrast agents. At the time of this alert, the FDA said about 215 patients worldwide were known to have NSF. Of those whose medical history were known, all had been exposed to gadolinium contrast agents prior to diagnosis.

In May 2007, the FDA requested that the manufacturers of the five gadolinium based contrast agents used in MRIs include a boxed warning – the FDA’s strongest possible safety warning – on product labels highlighting the risk they posed to patients with kidney problems. The FDA warned that patients who are at risk for NSF should be monitored by their doctors, and told to report any symptoms associated with the condition immediately. The FDA has also set up a reporting program so that healthcare providers can report instances of NFS caused by Gadolinium based contrast agents.

Legal Help for NSF Sufferers and Their Families

Our NSF lawyers are already actively involved in lawsuits against the makers of gadolinium contrast dyes.  If you or a loved one are suffering from NSF, and were exposed to a gadolinium contrast dyes prior to diagnoses, you have valuable legal rights.  Please fill out our online form or call us at 1-800-LAW-INFO (1-800-529-4636) for a free evaluation of our case.