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When patients are receiving a magnetic resonance imaging scan, they are often injected with a substance that is administered in order to enhance the MRI image and make it clearer. This substance is called gadolinium and it is a chemical element that can be found on the periodic table. The problem is that gadolinium does not always leave the body once it enters and if it is retained, it can cause severe side effects. In a worst-case scenario  Gadolinium poiosning complications impact kidney function and can cause death. Generally, retention of this product caused debilitating symptoms. There have been multiple Gadolinium toxicity lawsuits filed against the manufacturers of gadolinium. These  MRI DYE lawsuits  and Gadolinium toxicity lawsuits are still pending and new lawsuits are being filed.

What is Gadolinium and Why is it Used in MRIs? 

Gadolinium is an element with the atomic number of 64 and is a rare-earth metal. The element has many different uses including in microwave applications and in color television tubes. Its variety of uses is due to its metallic properties.

With regard to MRIs, gadolinium acts as a dye. When a patient receives an MRI, gadolinium is injected into the body. The same properties that make it effective in color televisions act to improve and enhance the MRI pictures for the doctor’s viewing. Doctors will not inject pure gadolinium into a patient’s body. Instead, the gadolinium will be mixed with other substances. One of these additives is an agent that is intended to counteract the toxicity of gadolinium since the pure substance could never be injected directly into a patient’s body.

Gadolinium is used in about 30 percent of MRIs. It is used when the scan needs to diagnose some sort of inflammation or tumor. It is administered intravenously either before or during an MRI. The compound is supposed to only temporarily be in the patient’s body. The intention is that the gadolinium is passed out of the body through the patient’s urine within a day of receiving the injection.

Side Effects of Gadolinium 

When any naturally occurring element is injected directly into the patient’s body, there is a possibility of an adverse reaction. While the gadolinium is only supposed to remain inside the patient for only a day, that does not always happen. This is the major side effect of gadolinium. The immediate reaction to an injection is most often minimal, although subsequent reactions are usually more severe than the first. In addition, gadolinium can have a severe impact on a patient who is already suffering in any way from reduced kidney function. In those instances, patients can contract nephrogenic systemic fibrosis which can lead to death.

Gadolinium complications

The real danger that is commonly posed to those receiving gadolinium occurs is that the substance is retained in the body. When the body fails to expel all of the gadolinium, it is holding onto a toxic substance that can interfere with normal body function. This results in Gadolinium Deposition Disease which is both painful and incurable. In a worst-case scenario, gadolinium can remain in the patient’s body for years. While the symptoms are not necessarily fatal, they can degrade the patient’s quality of life. The symptoms can include joint pain, fatigue, memory loss and general confusion. Other symptoms include a burning sensation and heart palpitations. These health issues can become debilitating and ongoing.

FDA Warning | MRI dye lawsuit

The FDA had long been concerned about gadolinium elimination, but the early concern was for patients with known problems eliminating drugs. Recently, that concern has been expanded. In December 2017, the FDA issued a safety announcement regarding gadolinium. The FDA’s announcement was issued after undertaking a review. After review and consultation, the FDA required several actions pertaining to gadolinium. Now, patients must receive additional education about the substance before they can agree to receive it as part of the MRI. This includes receiving a Medication Guide that details information about possible side effects. In addition, the FDA directed the manufacturers of gadolinium to conduct a new series of tests on both humans and animals. In Europe, some of these products can no longer be used after a decision from the European Medicines Agency.

Gadolinium Toxicity Lawsuits | Gadolinium poisoning lawsuit

In 2016, the first lawsuit was filed against a gadolinium manufacturer. Thereafter, numerous lawsuits have been filed regarding the retention of the substance in the body. These lawsuits have proceeded under product liability theories.

The manufacturers of gadolinium are alleged to have knows about the issue with retention since shortly after the substance was approved for use in MRIs. Their knowledge of this potential condition dates as far back to 1998. While much of the focus on gadolinium retention focused on people who already had kidney conditions, the manufactures allegedly knew of other issues with the substance that would cause retention. According to the complaints, the knowledge about gadolinium retention further increased this decade to the point where manufacturers definitely should have known there was an issue. Nevertheless, the substance was continuing to be sold without any product warnings.

In addition to the failure to warn, the lawsuits have generally alleged that gadolinium makers have been negligent in their design and manufacture of the product. These manufacturers have the obligation to design a safe product that is free from defects. Instead, they have designed and sold a product that is retained in the bodies of some patients and has caused long-term health problems. Reasonable care and testing could have detected such problems. In addition, some of these lawsuits have accused the manufacturers of fraud and misrepresentation when they claimed that gadolinium-based agents were safe for use in MRIs. The manufacturers are alleged to have actively concealed information that this substance could be harmful. Since the first cases were filed in 2016, none of these lawsuits have yet proceeded to trial and have received a decision on the merits.

If you have received gadolinium in conjunction with your MRI and suffer from any of these side effects, you should immediately consult a Gadolinium toxicity lawsuit lawyer. An  MRI dye attorney can advise you of your legal rights and your prospects for obtaining compensation for any harm  or  Gadolinium poisoning that you may have suffered as a result of receiving gadolinium.

Sources:

https://cutterlaw.com/app/uploads/2018/06/Chuck-and-Gena-Norris-Filed-Complaint.pdf 

https://www.ema.europa.eu/en/medicines/human/referrals/gadolinium-containing-contrast-agents 

http://www.mrisafety.com/SafetyInfov.asp?SafetyInfoID=245 

https://www.mayoclinic.org/diseases-conditions/chronic-kidney-disease/expert-answers/gadolinium/faq-20057772 

https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm