Gadolinium, the contrast agent used in MRIs (magnetic resonance imaging) and MRAs (magnetic resonance angiography), has been linked to a disease known as NSF/NFD (Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy). Several hundred people have already been injured and lawsuits over what manufactures knew, and when they knew it, continue to be filed in 2009.
Hundreds of NSF/NFD injuries
Hundreds of people have developed NSF/NFD, a disease that affects skin and connective tissue, can cause patients’ skin to thicken to the point that they cannot move. The condition, which can spread to other parts of the body, is often fatal. The disease was not discovered until approximately 12 years ago and the medical community has limited information on how it can be treated – if at all. Symptoms include:
- Burning of the skin
- Hardening or tightening of the skin
- Itching
- Muscle weakness
- Pain deep in the hip bones or ribs
- Red or dark patches on the skin
- Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet
- Swelling
- Yellow spots on the whites of the eyes
Manufacturers of gadolinium are Bayer HealthCare Pharmaceuticals, Bracco Diagnostics, GE Healthcare and Mallinckrodt and the products involved are OmniScan (gadodiamide), OptiMark (gadoversetamide), Prohance (gadoteridol), Magnevist (gadopentate dimeglumine) and MultiHance (gadobenate dimeglumine).
The U.S. Food & Drug Administration (FDA) issued a black box warning (the harshest warning given by the FDA) on gadolinium products in 2007 and lawsuits continue to be filed alleging that manufacturers failed to 1) adequately test these products and 2) warn consumers of the possibility of contacting the disease once known.
Allegations of off-label use
Benjamin Locklar, an Alabama attorney whose practice represents clients injured by drugs such as gadolinium, explained that lack of testing and failure to warn aren’t the only allegations against manufacturers. “There also seems to be off-label uses of the product. Our research has determined that the FDA approved the use of the gadolinium contrast agents in MRIs, but that they were never approved for MRAs. It appears that they’re used far more widely in MRAs than MRIs. We don’t know who made the decision to them in MRAs; however, we suspect what we’re going to find, based upon past pharmaceutical litigation, that the drug companies were telling radiologists that the agents were okay to use for that purpose.”
Gadolinium lawsuits continue
While lawsuits continue to be filed in 2009, approximately 250 lawsuits already filed have been consolidated in multidistrict litigation (MDL) in the U.S. District Court for the Northern District of Ohio before Judge Dan Polster. Trials may begin by the end of this year. An experienced attorney will be able to determine if you have a lawsuit and how the MDL may affect your case.
If you’ve been injured due to gadolinium, contact an experienced attorney to discuss your situation and evaluate your options. Consultations are free, without obligation and are strictly confidential.
