Nephrogenic Systemic Fibrosis Lawsuit

Gadolinium based contrast agents used during MRI and MRA tests could cause nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD) for individuals with moderate to severe kidney problems. The devastating condition could have been avoided by hundreds of people throughout the United States if the manufacturers of these contrast agents had warned about the potential MRI problems.

NEPHROGENIC SYSTEMIC FIBROSIS LITIGATION STATUS: MRI lawsuits are pending throughout the United States for individuals diagnosed with NSF or NFD. All federal lawsuits have been consolidated in a Multidistrict Litigation (MDL) in the Northern District of Ohio.

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DEFENDANTS: There are five different gadolinium based contrast agents which have been associated with the development of nephrogenic systemic fibrosis:

• Omniscan (gadodiamide) – Manufactured by GE Healthcare, a subsidiary of General Electric
• MultiHance (gadobenate dimeglumine) – Manufactured by Bracco Diagnostic, Inc.
• Magnevist (gadopentetate dimeglumine) – Manufactured by Bayer Healthcare Pharmaceuticals
• Prohance (gadoteridol) – Manufactured by Bracco Diagnostic, Inc.
• OptiMARK (gadoversetamide) – Manufactured by Mallinckrodt, Inc.

OVERVIEW: Nephrogenic systemic fibrosis (NSF), which is also often referred to as nephrogenic fibrosing dermopathy, is a progressive disorder associated with scarring of the skin and connective tissue throughout the body, known as fibrosis. It results in a thick and hard skin, which becomes rigid and coarse, especially around the joints. This results in severe restrictions on movements, and can also impact other organs.

It is primarily known to occur in those with chronic kidney problems or impaired renal function, who have undergone an MRI (magnetic resonance imaging) or MRA (magnetic resonance angiography), with a gadolinium contrast agent.

NSF AND MRI CONTRAST AGENTS: The development of NSF has been directly linked to the use of gadolinium based contrast agents which may be injected before an MRI or MRA test to help the doctor differentiate blood vessels from the surrounding tissue.

Gadolinium is a paramagnetic metal which is attracted to the magnetic field of an MRI or MRA. The contrast agent is injected directly into the vein, and the gadolinium is designed to be eliminated through the kidneys after an exam. However, individuals with impaired kidney function could have the prolonged exposure to the gadolinium, and the protect coating which is supposed to prevent the toxic free gadolinium from being released into the body could break down.

NEPHROGENIC SYSTEMIC FIBROSIS DIAGNOSIS: There is no known treatment for NSF which is consistently successful and the condition can progress for different people at different rates. Nephrogenic systemic fibrosis symptoms could include:

• Burning, itching, swelling of the skin
• Development of "thick skin" or "hard skin" which appears shiny
• Red or dark patches of skin
• Yellow spots on the whites of the eyes
• Stiff joints which cause trouble straightening or moving the limbs
• Deep pain in the hip bones or ribs
• Generalized muscle weakness.

If symptoms of NSF appear after an MRI or MRA with contrast in an individual with impaired kidney function, a dermatologist will often recommend a punch biopsy to take a sampling of the skin so that a diagnosis of NSF can be determined.