Gadolinium-Based Contrast Agents are intravenous drugs injected into a patient's vein before a magnetic resonance imaging (MRI) or a magnetic resonance angiography (MRA) scan to improve visualization of internal organs, blood vessels, tumors, and tissues.
The lawsuit involving gadolinium-based contrast agents claims the use of these drugs can result in gadolinium toxicity, Gadolinium Deposition Disease, and Nephrogenic Systemic Fibrosis.
What Do We Know About the Gadolinium Lawsuits?
During the period 2008 - 2015, more than 1,000 lawsuits were filed against the manufacturers of Gadolinium-Based Contrast Agents (GBCA). These lawsuits involved patients who experienced Nephrogenic Systemic Fibrosis injuries after undergoing a magnetic resonance imaging (MRI) or a magnetic resonance angiography (MRA) scan that used GBCA.
When these lawsuits occurred, healthcare providers were told that only patients with renal and kidney issues could suffer injuries from the use of gadolinium-based contrast agents. This has proven to be wrong. Severe injuries have now been found in patients with normal kidney function who underwent an MRI or MRA scan where a Linear GBCA was used.
Within minutes to up to two months after having an MRI or MRA where a Linear GBCA is utilized, patients with normal kidney and renal function can develop symptoms consistent with gadolinium toxicity. The manufacturers of these GBCAs failed to warn healthcare providers of this danger until May 21, 2018.
Gadolinium Injuries & Side Effects
The most common side effects caused by gadolinium-based contrast agents are headaches, nausea, dizziness, and allergic reactions. These symptoms generally occur within minutes of a gadolinium injection, if they do occur.
The most serious injuries caused by the use of gadolinium-based contrast agents are Gadolinium Deposition Disease and Nephrogenic Systemic Fibrosis.
Nephrogenic Systemic Fibrosis (NSF) is a debilitating and deadly disease that causes the skin to harden, and causes a patient’s joints to contract. The areas between the ankles and the thighs and the wrists and the upper arms are most commonly affected. Symptoms develop slowly over a few weeks to a few months after exposure to gadolinium-based contrast agents, and can result in chronic pain and loss of mobility.
Gadolinium Deposition Disease (GDD) causes patients to suffer fibrosis (thickening and scarring of connective tissue) in an organ, bone, and skin, and gadolinium to be retained in the neuronal nuclei of the brain. Symptoms start within minutes up to two months after an MRI or MRA where a linear gadolinium-based contrast agent was utilized.
Patients suffering from Gadolinium Deposition Disease often experience chronic headaches, bone and joint pain, and clouded mental acuity. They also can experience subcutaneous soft-tissue thickening that appears somewhat spongy or rubbery. Tendons and ligaments may also become painful and have a thickened appearance.
Symptoms of Gadolinium Deposition Disease
- Intense burning of the skin, described as pins and needles
- Intense pain in bones, joints, tendons, and ligaments
- Mental confusion or brain fog
- Tingling or numbness in the skin
- Severe and persistent headaches
- Kidney damage
- Skin that appears spongy or rubbery
Gadolinium retention and toxicity is a progressive disease. Several treatments are available if the condition is caught early, but often the disease is not curable.
Gadolinium retention only occurs in patients who have received a gadolinium-based contrast agent. Gadolinium does not occur naturally in the body and there is no known environmental source.
Gadolinium toxicity pain can be excruciating, often occurring in the arms and legs. Symptoms can progress to a patient’s inability to use his/her arms, legs, hands, feet, and other joints.
A simple 24-hour urine test can be performed to determine whether a patient is retaining gadolinium. This test should be performed 30 days or more after the most recent GBCA administration.
Compensation in Gadolinium Lawsuits
If you suffered from gadolinium toxicity after having an MRI or MRA where a linear gadolinium-based contrast agent was utilized, you might be entitled to the following damages:
- Past and future medical expenses that result from your injuries.
- Past and future pain and suffering (physical and mental) caused by the injuries, and the treatment and recovery process.
- Past and future wage loss.
- Past and future loss of earning capacity.
- Past and future loss of enjoyment of life.
- Punitive damages, if appropriate.
Gadolinium Lawsuit Settlement Amounts
As of this time, there have been no large mass tort settlements involving gadolinium toxicity injuries and the link to linear gadolinium-based contrast agents. However, these specific types of injuries have just recently become publicly known. Lawsuits are now just beginning. Large groups of settlements do not generally occur until such time as a few bellwether trials occur and the manufacturers are able to more thoroughly understand their financial risk.
In 2008, hundreds of lawsuits were filed in federal court claiming Gadolinium-Based Contrast Agents had caused Nephrogenic Systemic Fibrosis (NSF) injuries in patients suffering from kidney or renal issues who then underwent an MRI. The cases were consolided before one judge in federal court in Ohio. The cases eventually settled for large sums of money, and the FDA required the manufacturers to place detailed warnings on their labels. Our law was the co-lead counsel for all plaintiffs in this litigation.
Gadolinium Recalls & Warnings
In December 2017, the FDA began requiring a warning to be included with gadolinium-based contrast agents. This warning is intended to notify physicians that gadolinium can remain in a patient’s body, including the brain, for months to years after the patient is injected with this drug. Additionally, a Medication Guide is to be provided to patients educating them on this potential danger.
On May 21, 2018, the four manufacturers of linear Gadolinium-Based Contrast Agents issued a joint warning to patients with normal kidney function. The manufacturers warned that gadolinium from linear GBCAs could remain in a patient’s body for months to years after injection. They warned that the highest concentrations of retained gadolinium were being found in a patient’s bones, followed by organs (such as the brain, skin, kidney, liver, and spleen). This occurred even with patients who had normal kidney function before having their MRI or MRA.
Patients at highest risk of gadolinium toxicity were pregnant women and pediatric patients. Healthcare providers were warned that the retention was greater when patients were injected with linear GBCA versus macrocyclic GBCA.
What is the Purpose of Gadolinium-Based Contract Agents?
Gadolinium-Based Contrast Agents (GBCA) are intravenous drugs injected into a patient's vein before a magnetic resonance imaging (MRI) or a magnetic resonance angiography (MRA) scan to improve visualization of internal organs, blood vessels, tumors, and tissues.
GBCAs have been used in America since 1988, and now are utilized in almost 33% of all MRIs. There are two types of GBCAs, linear and macrocyclic.
Linear GBCAs are less stable in terms of their tendency to release Gadolinium ions. Macrocyclic GBCAs tend to stay intact because the molecule offers better protection through stronger binding of the metal ions.
Manufacturers have claimed that linear GBCAs are supposed to quickly clear the kidneys through urine, and not impact patients with normal to near-normal kidney function. Healthcare providers have been told that GBCA has a half-life of 90 – 120 minutes in patients with normal kidney function. This has proven to be false, and the manufacturers of linear GBCA issues a joint warning in 2018 regarding the potential retention of gadolinium after the use of GBCA.
There are four main manufacturers of linear GBCA: (1) Bayer Healthcare, which produces Magnevist & Eovist; (2) GE Healthcare, which produces Omniscan; (3) Bracco Diagnositics, which produces MultiHance; (4) Guerbet, which produces Optimark; and (5) Mallinckrodt, which produces OptiMARK.
Gadolinium Lawsuit News
Chuck Norris, FDA And Gadolinium - Untangling The Lawsuit:
Chuck and Gena Norris are suing manufacturers and distributors of a contrast agent used in Magnetic Resonance Imaging (MRI) for ill effects on Gena’s health. Gena Norris is claiming that she developed Gadolinium Deposition Disease (GDD) after undergoing three contrast-enhanced MRIs in a one week period. Reported in The American Council on Science and Health
FDA & Scientific Studies Regarding Gadolinium Use
Gadolinium deposition disease: Initial description of a disease that has been around for a while:
Gadolinium toxicity appears to arise following GBCA administration, which appears to contain clinical features seen in Nephrogenic Systemic Fibrosis, but also features not observed in that condition. Reported in Magnetic Resonance Imaging
Gadolinium in Humans: A Family of Disorders:
“Gadolinium deposition disease” is the name we propose for a disease process observed in subjects with normal or near normal renal function who develop persistent symptoms that arise hours to 2 months after the administration of GBCAs. In these cases, no preexistent disease or subsequently developed disease of an alternate known process is present to account for the symptoms. Reported in American Journal of Roentgenology
FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings:
To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure. We have also received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established. Reported in FDA Safety Communication
FDA requires new class warning and additional research on retention in the body of gadolinium from gadolinium-based contrast agents used in magnetic resonance imaging:
The FDA is requiring a new class warning for all GBCAs about gadolinium remaining in the body for months or years after receiving the drug. Manufacturers of GBCAs must also conduct human and animal studies to further assess the safety of these contrast agents. The FDA is also requiring a patient medication guide providing educational information that every patient will be given before receiving a GBCA. Reported in FDA Brief
FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue:
An FDA review to date has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Reported in FDA Drug Safety Communication 2017
Intracranial Gadolinium Deposition after Contrast-enhanced MR Imaging:
Intravenous GBCA exposure is associated with neuronal tissue deposition in the setting of relatively normal renal function. Additional studies are needed to investigate the clinical significance of these findings and the generalizability to other GBCAs. Reported in Radiology
New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction:
The U.S. Food and Drug Administration (FDA) is requiring changes in the drug label for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction. Reported in FDA Drug Safety Communication 2010