Gadolinium is a metal found in contrast agents (dyes) that are used in magnetic resonance imaging (MRI) procedures, including a procedure called magnetic resonance angiography (MRA). Since 1988, five gadolinium-based contrast agents (GBCAs) have been approved by the FDA. Although these agents were never specifically approved for use in MRAs, they have been used extensively for this legitimate "off-label" purpose. Unfortunately, patients with compromised kidney function are often unable to filter gadolinium from their bloodstreams following this procedure. This has led to numerous cases of a potentially fatal condition called nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD).
In May 2007, the Food and Drug Administration (FDA) issued a Public Health Advisory warning patients with diminished kidney function to avoid undergoing magnetic resonance angiographies with gadolinium-based contrast agents. In addition, the FDA required the manufacturers of these defective treatments to add "black box warnings" to the packaging of their products. Although the GBCA manufacturers complied with this mandate, they are still liable for the harm caused by their products. Many gadolinium lawsuits have been filed alleging negligence and violation of pharmaceutical statutes and product liability laws.
If you or someone you know has been harmed by a gadolinium contrast dye, a gadolinium lawyer can evaluate your situation, advise you of your legal rights and discuss the possibility of compensation.
Gadolinium-based Contrast Agents
Gadolinium-based contrast agents are used in a variety of MRI-based procedures. Gadolinium is easy to see due to its bright appearance, allowing doctors to identify certain bodily tissues. During a magnetic resonance angiography, the agent is injected into one of the patient's veins so that the doctor can distinguish blood vessels from nearby tissues.
Five gadolinium contrast agents have been approved by the FDA for use in MRIs:
- Omniscan (gadodiamide), produced by GE Healthcare
- Magnevist (gadopentetate dimeglumine), produced by Bayer Healthcare
- OptiMARK (gadoversetamide), produced by Mallinckrodt
- ProHance (gadoteridol), produced by Bracco
- MultiHance (gadobenate dimeglumine), produced by Bracco
Many of the gadolinium lawsuits filed claim that the manufacturers of these agents failed in their duty to warn doctors and the general public of the potential dangers associated with gadolinium-based contrast agents in patients with kidney conditions.
Gadolinium Side Effects
The side effects of gadolinium contrast agents came to light in 1997, when the Danish Medicines Agency reported 25 cases of nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD) a scarring condition that can lead to organ failure and death in patients with kidney problems.
Symptoms of NSF/NFD may include:
- Joint stiffness
- Pain in the hip bones and/or ribs
- Swollen, tight or hardened skin
- Raised yellow spots on the whites of the eyes
NSF/NFD can affect connective tissues, joints, muscles, lung vessels, the abdomen and the diaphragm. In serious cases, the condition can cause the skin of the lungs and diaphragm to harden, which can affect a patient's ability to breathe and, in extreme cases, lead to death. Families of victims who have succumbed to the side effects of gadolinium should contact a lawyer for death claim filing to learn more about their legal rights.
Gadolinium lawyers and their clients claim that the five gadolinium contrast dyes have caused Nephrogenic Systemic Fibrosis (NSF) in patients who had kidney problems prior to undergoing their MRAs.
Drug manufacturers have a duty to inform doctors and patients of potential side effects of their products. Failure to do so may make them liable for any harm that occurs. The manufacturers of gadolinium contrast agents have been accused of failing to inform doctors and their patients of the potential dangers. Some gadolinium lawsuits also maintain that the manufacturers of GBCAs failed to adequately test their products for serious gadolinium side effects. Death resulting from gaolinium side effects may be negligent and grounds for legal action. Contact a lawyer for neligent death claim filing information.
Depending on the state in which you reside, a personal injury attorney may cite one of many legal theories or state statutes in presenting your case. Some states have statutes relating to pharmaceutical liability, including certain wrongful death laws. In others, your gadolinium lawyer may use product liability theories or cite negligence on the part of the gadolinium contrast agent's manufacturer.
For more information on gadolinium lawsuits, contact a gadolinium lawyer who is familiar with the laws in your state.
A recent scientific study at the University of Pennsylvania found that patients with advanced kidney disease are 27 times more likely to develop NSF when exposed to gadolinium.
Source: Nephrology Dialysis Transplantation
Black box warnings are FDA-mandated warnings on the packaging of potentially dangerous drugs, including gadolinium-based contrast agents (GBCAs).