Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) is a man-made disease that was first recognized in 1997. The cause was unknown until recently: it has now been attributed to current gadolinium-based contrast agents used in MRI procedures in patients with kidney failure.
The use of the heavy metal gadolinium during an MRI (a non-invasive diagnostic procedure that enables physicians to visualize internal organs through magnetic interactions) or MRA (Magnetic Resonance Angiography) improves the visibility of internal structures.
More than 215 cases of NSF/NFD linked with gadolinium have been documented in the last decade. This debilitating and sometimes fatal disease causes discoloration and thickening or tightening of the skin and connective tissues that inhibits the ability to move and may result in broken bones. It causes muscle weakness and difficulty bending joints, which can lead to scarring of internal organs that inhibit their ability to function properly.
In 2006, The U.S. Food and Drug Administration (FDA) acknowledged that there were 200 reports worldwide of NSF/NFD due to patients exposed to various gadolinium- based contrast agents. The report conceded many of these were serious and some fatal. Since that time, it is believed that there are many more people with this man-made disease than previously assumed--potentially many sufferers have not yet be diagnosed with this disease.
On May 23, 2007 the FDA asked the manufacturers of gadolinium-based contrast agents to issue a black box warning. The label now warns patients with severe kidney insufficiency who receive gadolinium-based agents that they are at risk for developing NSF/NFD. As well, the label states that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.
In a Wall Street Journal article on May 24 regarding the warning, an FDA spokesperson estimated that the risk of NSF for a person with severe kidney failure is about four in 100 patients.
Approved Gadolinium-based contrast agents
Five gadolinium-based contrast agents have been approved for use in the United States: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine);and Prohance (gadoteridol). Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents, with Omniscan as the most commonly reported agent, followed by Magnevist and OptiMARK.
Bayer Schering Pharma, Berlin, Germany, manufactures Magnevist; GE Healthcare, Chalfont St. Giles, U.K., is the maker of Omniscan; OptiMARK is manufactured by Mallinckrodt, Inc., Hazelwood, Mo.; and ProHance and Multihance are made by Bracco Diagnostics Inc., Princeton, N.J.
MRI Health Risk Lawsuits
Just a few weeks after the FDA’s black box warning was issued, the mother of a 24-year-old Norwalk, Ohio man who died in August 2004, shortly after receiving his second injection of the drug Magnevist, filed a lawsuit in U.S. District Court against Bayer, the manufacturer, claiming the gadolinium-based contrast agent caused her son’s death.
Another lawsuit was filed on behalf a 71-year-old suburban Cleveland man who was diagnosed with NSF/NFD. At University Hospitals in 2006 prior to kidney dialysis, he was injected with Optimark, a product of Tyco Healthcare Group. His NSF/NFD has since caused him serious debilitating joint injuries.
Health professionals advise patients to be screened for kidney problems prior to receiving one of these imaging agents. The recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again. To date, there is no successful treatment for this condition.
According to Missouri Lawyers Weekly, almost 400 gadolinium cases have been filed across the U.S. As of June 30, 2009, Bayer had been served in a total of 317 lawsuits involving Magnevist, its gadolinium-based contrast agent. Four other contrast agents are also involved in gadolinium litigation.
Bayer has reached agreements in principle with many plaintiffs in the U.S. to settle their claims and the company says it will continue to consider the option of settling individual lawsuits on a case-by-case basis. Bayer has taken accounting measures and is insured against product liability risks to the extent customary in the industry.
Bayer's 2008 annual report states the following: "All cases pending in federal courts have been consolidated in a multidistrict litigation (mdl) proceeding for common pre-trial management. Bayer believes that it has meritorious defenses and intends to defend itself vigorously. Based on the information currently available, Bayer has taken accounting measures for anticipated defense costs."
MRI Health Risk Legal Help
If you or a loved one has suffered health problems as a result of gadolinium given during an MRI or MRA, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.
Posted on May-24-07
Updated on Dec-15-09
Athens, AL: Among the health risks associated with MRIs are burns that can result during the procedure. Such was the case with a 21-month-old boy from Alabama who was injured during an MRI scan at Children's Hospital. [ 
San Francisco, CA: At the nation’s first Nephrogenic Systemic Fibrosis (NSF) trial in January, attorney Larry Gornick intends to prove that Bayer Healthcare Pharmaceuticals, Inc., the maker of Magnevist, could have made a safer and more stable product but chose not to bring it the US purely for financial reasons. [ 
San Francisco, CA: The nation's first trial of a Nephrogenic Systemic Fibrosis (NSF) case was assigned today for trial before the Honorable Curtis E. A. Karnow of the San Francisco Superior Court. NSF is debilitating and incurable condition caused by exposure to gadolinium-based contrast agents (GBCAs), which contain a toxic heavy metal and are sometimes used by radiologists during magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) procedures. [ 
