Gadolinium-Based Contrast Agents (GBCAs) is a term given to a category of pharmaceuticals derived from rare earth metals that are administered in conjunction with certain types of medical imaging. Recently, many patients have come forward with claims of serious adverse health effects after administration of GBCAs. Below are some frequently asked questions that patients who have come in contact with these agents may have.
What Are Gadolinium Based Contrast Agents?
GBCAs are used during diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA). These medications are typically administered intravenously through the arm. Contrast is used to highlight blood vessels and to enhance the structure of organs like the brain, spine, liver, and kidney. Once the contrast is injected into the blood, it circulates throughout the body. When the test is finished, the kidneys and liver quickly eliminate the contrast from the body.
What Are the Side Effects of Gadolinium Based Contrast Agents?
For many years, it was accepted that for patients with renal issues, GBCAs may pose some risks, as the kidneys aren't able to eliminate gadolinium from the body as efficiently as those with functioning kidneys, which could lead to deposits remaining in the body. The full extent of potential adverse health outcomes caused by gadolinium deposits remains unclear, but in 2006, multiple reports convincingly linked the rare but serious disease nephrogenic systemic fibrosis to the administration of gadolinium-based contrast agents in patients with severe renal failure. In response, new policies on GBCA administration were put in place, which has virtually resulted in the elimination of the disease.
However, in the past few years, many patients with healthy kidneys are asserting that they have experienced adverse health outcomes following GBCA administration, raising questions about toxicity. The most high profile cases involving these type of complaints is a lawsuit filed by actor Chuck Norris. Mr. Norris brought a claim against a contrast vendor and the contrast distributor for allegedly poisoning his wife Gena. Mrs. Norris had several contrast MRI exams and alleges numerous adverse health effects began after these exams, including burning pain throughout her body, violent shaking, numbness, tingling, weakness, cognitive deficits, kidney damage and trouble breathing. The couple is seeking $10 million in damages.
Other patients who received GBCA have suffered adverse health effects similar to those reported by Mrs. Norris. These patients have grouped the following as symptoms of Gadolinium Deposition Disease:
- Pain in the joints, tendons, ligaments, and bones
- Skin tingling, numbness, or burning
- Cognitive issues, such as confusion
- Chronic headaches
- Kidney damage
Has There Been a Recall or Other FDA Action Related to Gadolinium Based Contrast Agents?
In 2018, Bayer, Bracco, GE, and Guerbet, manufacturers of the GBCAs issued updated warnings about Gadolinium retention.
This warning informed patients that: "Gadolinium is retained for months or years in several organs. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (e.g. brain, skin, kidney, liver, and spleen). Consequences of gadolinium retention in the brain have not been established."
"While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions."
This warning was in reference to the following Gadolinium Based Contrast Agents:
- Dotarem (Gadoterate Meglumine) injection
- Eovist (Gadoxetate Disodium) injection
- Gadavist (Gadobutrol) injection
- Magnevist (Gadopentetate Dimeglumine) injection
- MultiHance (Gadobenate Dimeglumine) injection
- Omniscan (Gadodiamide) injection
- Optimark (Gadoversetamide) injection
- ProHance (Gadoteridol) injection
Were My Symptoms Caused by Gadolinium Based Contrast Agents?
At this time, most of the definitive research on the negative effects of GBCAs has focused on nephrogenic systemic fibrosis in patients with preexisting renal issues. The pharmaceutical companies are only recently beginning to acknowledge the symptoms which could be present in patients without renal problems, and extensive research has not yet been conducted on this population. Therefore it is extremely difficult to ascertain if symptoms are directly linked to a particular GBCA drug.
However, with the amount of lawsuits being filed by not only patients suffering from nephrogenic systemic fibrosis, but also other symptoms (such as Mrs. Norris), GBCAs are coming under greater scrutiny and we will likely see more research on patients who suffer such adverse health outcomes. Additionally, it is important to note that in the manufacturers' warning, they specified that certain individuals may be at a higher risk - including those patients who received multiple lifetime doses of GBCAs, pregnant women, pediatric patients, and patients with inflammatory conditions.
Could I Bring a Lawsuit for Gadolinium Deposition Disease?
Many patients are bringing lawsuits against the manufacturers of Gadolinium Based Contrast Agents for symptoms that may have been brought on by these agents. If you or a loved one received GBCA as part of medical testing and experienced what you think might be symptoms stemming from Gadolinium, you may be entitled to compensation. An experienced attorney can review your medical history, the parties responsible for your treatment, and further advise you on the best course for pursuing legal action.
Gadolinium Based Contrast Agent Legal Representation
It is evident from the history of Gadolinium Based Contrast Agents that litigation involving these types of potentially defective pharmaceuticals can be incredibly complex. Research into potential adverse health effects often does not begin until there have been widespread reports. By the time a manufacturer takes action, thousands of victims may have already been injured, have prognoses significantly impacted, or even lost their lives. The team at Gilman & Bedigian have decades of legal experience and extensive resources necessary to investigate these types of claims. Contact our team for a free consultation to discuss the specifics of your case.