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MRI Injury

Magnetic Resonance Imaging (MRI) and Gadolinium

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Gadolinium based contrast material has been routinely used for many years in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) procedures. The use of these contrast agents enhances the visualization of organs and tissue.

In 2006, the FDA began evaluating a link between gadolinium based contrast agents and development of diseases in patients. Two related types of diseases have been related to gadolinium; Nephrogenic Systemic Fibrosis (NSF) and Nephrogenic Fibrosing Dermopathy (NFD). These are systemic disorders that cause severe and debilitating injuries; including swelling of the skin, cracking of the skin surface, burning sensations in the skin, skin thickening, contractures and, in some cases, death.

The patients most at risk for developing NSF or NFD are patients with pre-existing kidney or liver diseases who were subjected to MRI studies using gadolinium based contrast agents.

NSF and NFD are relatively new diagnoses and they are diagnoses that are sometimes missed in favor of more common diseases. The first diagnosis of NSF was made in the late 1990’s, but the first relationship with kidney patients was in a 2000 Lancet article; Cowper SE, Robins HS, Steinberg HM, Su LD, Gupta S, Leboit PE; Scleromyxedema-like cutaneous diseases in renal-dialysis patients. Lancet 2000. The early connection between gadolinium exposure in kidney patients and NSF was not made until 2006; Marckmann P, Skov L, Dupont A, Damholt MB, Heaf JG, Thomsen HS; Nephrogenic systemic fibrosis: suspected causative role of gadodiamide used for contrast- enhanced magnetic resonance imaging. J Am Soc Nephrol, 2006.

Several companies manufacture gadolinium based or gadolinium derivative contrast agents, including: General Electric Co; GE Healthcare, Inc; GE Healthcare Bio-Sciences Corp.; Bayer Healthcare Pharmaceuticals, Inc; Bayer Healthcare, LLC, Bayer Pharmaceuticals Corp; Bayer Corp.; Mallinckrodt, Inc.; Tyco International Ltd.; Tyco Healthcare, Ltd.; Tyco Holdings, Ltd.; Ytco Healthcare Group LP; and Covidien Ltd. The trade names of the U.S. approved gadolinium-containing contrast agents are: Omniscan, OptiMARK, Magnevist, ProHance, and  MultiHance.

Lawsuits have been filed in over 20 states, including: New Jersey, Missouri, Wisconsin, West Virginia, Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Kansas, Missouri, North Carolina, New York, Ohio, Maryland, Oklahoma, and Pennsylvania. In February of 2008, the Untied States Judicial Panel on Multidistrict Litigation transferred 12 actions to Judge Dan A. Polster, in the Northern District of Ohio, for coordinated proceedings.

In 2007, the FDA requested that all manufacturers of gadolinium based contrast agents add the following new warnings:

Boxed Warning:

  • Exposure to GBCAs increases the risk for NSF in patients with:
    • Acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
    • Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. 
  • NSF is a debilitating and sometimes fatal disease affecting the skin, muscle, and internal organs.
  • Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI).
  • Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. 
  • When administering a GBCA, do not exceed the dose recommended in product labeling.  Allow sufficient time for elimination of the GBCA prior to any readministration.

 Additional New Warnings:

  • Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA.
  • For patients receiving hemodialysis, healthcare professionals may consider prompt hemodialysis following GBCA administration in order to enhance the contrast agent's elimination.  However, it is unknown if hemodialysis prevents NSF.
  • Determine the renal function of patients by obtaining a medical history or conducting laboratory tests that measure renal function prior to using a GBCA.
  • The risk, if any, for developing NSF among patients with mild to moderate renal insufficiency or normal renal function is unknown.
  • Post-marketing reports have identified the development of NSF following single and multiple administrations of GBCAs.  These reports have not always identified a specific agent.  Where a specific agent was identified, the most commonly reported agent was Omniscan, followed by Magnevist and OptiMARK.  NSF has also developed following the sequential administration of Omniscan and MultiHance and Omniscan and ProHance.  The distribut­­ion of the number of reports for the individual GBCAs may relate to multiple factors, including more limited use of some GBCAs, under-reporting of NSF, characteristics of the agent and a lack of patients’ complete GBCA exposure history. 

We expect that the defendants will make the typical defense arguments to the allegations against them. They will likely argue that they gave sufficient warnings in the use of their contrast agents. Given the literature existing before 2006, together with the studies we expect to discover, we believe the defendants’ warnings will be proved to be inadequate.

Often, defendants in these types of cases attempt to shift the blame for injuries to physicians. Either the physicians used more contrast agent than was necessary or the physicians should have demonstrated better judgment in “this particular patient” and not used the contrast agent at all. This defense is called the “learned intermediary” defense.

The defendants will likely blame the patient, by claiming that their problems were actually caused by progression of their own health problems; or the cause is idiopathic—a fancy term for no one really knows what caused the patient’s tragic injuries.

We further expect the defendants will wage exhaustive battles to keep their internal documents away from public disclosure and scrutiny. It can be expected that the defendants will not want to litigate these cases in the open; where consumers can see what “they knew and when they knew” about the dangers presented by gadolinium based agents. We intend to vigorously fight these unwarranted efforts at secrecy.


Additional informational web links:
FDA - Warning Label
MDL - Confidentiality Order
Bayer Healthcare - Nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy
“Learned Intermediary” - Direct marketing to consumers limits the learned intermediary defense