LAWSUITS NEWS & LEGAL INFORMATION

MRI Gadolinium Lawsuit FAQ

What are the concerns regarding MRI health risks?

The concerns regard gadolinium-based contrast agents being linked to an increased risk of developing nephrogenic systemic fibrosis (NSF). A gadolinium-based MRI contrast agent is used to provide a clearer picture of the patient's organs and tissues. Since the use of gadolinium-based contrast agents began, more than 200 cases of NSF have been reported. It is believed that the actual number may be much higher because of underreporting of the condition or because patients have not been properly diagnosed.

What is nephrogenic systemic fibrosis (NSF)?

Nephrogenic systemic fibrosis (also known as nephrogenic fibrosing dermopathy or NFD) is an MRI contrast side effect that involves a thickening of the skin around the patient's joints. The skin around the joints becomes so thick that the joints cannot move normally. Furthermore, tissue around the patient's internal organs can also be affected, preventing those organs from operating properly.

According to an editorial in the Annals of Rheumatic Diseases (10/19/10), "The presences of skin changes of NSF [including tightening and hyperpigmentation] has been associated with a nearly threefold increased risk of death within 24 months."

Who is at risk of developing MRI contrast side effects such as NSF?

Patients who are most susceptible to MRI health risks are those who are administered a gadolinium-based contrast agent and have acute kidney insufficiency or chronic, severe kidney disease are at risk of developing NSF.

What are symptoms of NSF?

Symptoms of NSF include hardening, tightening or scaling of the skin, changes in skin pigmentation and stiffness.

What causes NSF?

Gadolinium is an extremely toxic heavy metal that is excreted from the body through the kidneys. Because people with kidney insufficiency do not expel the gadolinium as quickly, the gadolinium remains in the patient's system longer than it should, causing the development of NSF.

Is there a cure for NSF?

There is currently no cure and no consistently effective treatment for NSF.

Have there been MRI contrast agent lawsuits or NSF lawsuits filed yet?

Yes, lawsuits have been filed against the makers of gadolinium-based contrast agents, alleging those MRI contrast agents are responsible for the plaintiffs developing NSF/NFD. Some lawsuits against the makers of gadolinium-based contrasted agents have been settled; however, there are still lawsuits pending.

Lawyers are still accepting patients related to MRI gadolinium-based contrast agents.

What does the FDA say about gadolinium-based MRI contrast agent side effects?

The FDA has issued warnings about the risk of NSF/NSD. In 2006, the FDA acknowledged reports about NSF/NFD in patients exposed to gadolinium-based contrast agents. On May 23, 2007, the FDA requested a black box warning on gadolinium-based contrast agents. That warning was to alert patients with kidney insufficiency about the risk of developing NSF/NFD.

On September 9, 2010, the FDA required a label change to gadolinium-based contrast agents. The label change includes recommending against using Magnevist, Omniscan and OptiMARK (three gadolinium-based contrast agents) in patients with acute kidney insufficiency, or chronic, severe kidney disease; screening patients prior to administering a gadolinium-based contrast agent to identify patients with kidney problems; and monitoring for signs and symptoms of NSF after a gadolinium-based contrast agent is administered.

Which gadolinium-based MRI contrast agents are linked to NSF

The following MRI contrast agents have been linked to NSF:

• Magnevist, made by Bayer Schering Pharm;
• Omniscan, made by GE Healthcare; and
• OptiMARK, made by Mallinckrodt, Inc.
• ProHance and Multihance made by Bracco Diagnostics Inc.

What should I do if I have a kidney insufficiency and I have been exposed to a gadolinium-based MRI contrast agent?

If you are concerned about the risk of developing NSF, speak to your doctor about your concerns. If you have kidney insufficiency, were exposed to a gadolinium-based contrast agent and were diagnosed with scleroderma or sclerodeema, there is a chance you were misdiagnosed. You may want to visit your doctor to determine if there is a possibility you have NSF.

NSF can develop anywhere from days following exposure to the contrast agent up to a year and a half later.