Every year in the United States, millions of MRI (magnetic resonance imaging) scans are performed to diagnose a wide variety of injuries and diseases. The images provided have helped saved countless people whose afflictions would not have been identifiable otherwise.
However, more patients are claiming gadolinium-based contrast agents are putting patients at risk of potentially deadly side effects. The substance injected before MRIs may affect the kidneys and result in a condition known as nephrogenic systemic fibrosis (NSF). Some have reported side effects to other organs as well.
As a result of the rise in complications, hundreds of patients have filed lawsuits against the makers of gadolinium-based contrast agents over allegations that they failed to warn the public about their risks.
A gadolinium contrast medium, also known as an MRI contrast agent or dye, is a chemical substance injected into the body before an MRI to enhance the images. The enhancement allows the radiologist to better analyze the images to report the findings to a doctor.
GBCAs are composed of molecules held together by chemical bonds, according to Inside Radiology.1 The gadolinium is bonded to a chelating agent to counter the toxicity of the chemical element while maintaining its magnetic properties.
There are several types of dyes containing gadolinium. These are the GBCAs approved for use by the U.S. Food and Drug Administration, according to Medscape:
The dye is typically injected intravenously near the site of the scan and is later naturally removed from the body through the kidneys.
One out of every three MRI scans requires gadolinium dyes, according to Inside Radiology.1 Gadolinium agents have been used in roughly 300 million patients around the world. In some cases, certain cancers or diseases may be undetectable if an MRI is performed without a dye.
A doctor will typically inform the radiologist whether a contrast dye is needed before an MRI. Occasionally, the radiologist might determine that a gadolinium injection would greatly improve the quality of the images.
Before gadolinium dye is administered, a patient will be asked several questions to find out if they can receive an injection. For example, if a patient is pregnant or suffers from severe kidney disease, it may be recommended that the scan is done without the dye.
However, depending on the nature of the problem, a second scan may be performed using a GBCA.
Side effects can occur in patients injected with gadolinium contrast media. Although side effects are rare, some of the most common complaints include (but are not limited to):
Aside from the common side effects, gadolinium contrast agents have been connected to more serious complications. One of the most dangerous side effects is a condition called nephrogenic systemic fibrosis (NSF). It is a disease of the skin and internal organs caused by exposure to gadolinium in those with poor kidney function.
According to the National Organization of Rare Diseases,2 the severity and progression of the disease varies by case. Although it often develops slowly following exposure to GBCAs, progression can be rapid and debilitating.
Symptoms will usually manifest themselves on the skin. For example, darkened patches may appear on extremities. Eventually, the skin will harden and cause severe pain. Sometimes NSF will affect multiple organ systems.
Studies have linked NSF with exposure to gadolinium through contrast agents. One study from 2015 found that higher doses of gadolinium contrast agents were linked to the development of NSF.3 Researchers recommended a minimum dosage and careful documentation of usage.
Other studies have made similar discoveries.
Thanks to reports from patients, the FDA launched an investigation into NSF from gadolinium exposure in 2006. By 2007, the FDA added a black box warning — the strongest warning for a label — to recommend those with renal issues avoid using gadolinium agents.
In 2010, the FDA required a label change to GBCAs to minimize the risk of NSF in patients with kidney dysfunction.4 The agency recommended against the usage of three GBCAs — Magnevist, Omniscan, and Optimark — in patients with severe kidney disease.
The potential complications surrounding GBCAs became even more apparent when the FDA warned that gadolinium may remain in the brain of patients who undergo multiple MRI scans in 2015. A follow-up safety communication in 2017 issued a more general warning that all GBCAs may be associated with gadolinium retention in the body for long periods of time.5
Around the same time, the European Medicines Agency recommended a suspension of certain types of gadolinium agents after a review similarly found gadolinium deposits remained in the brain after MRI scans.
The FDA’s most recent December 2017 announcement said that it was adding new warnings of long-term gadolinium retention to labels of GBCAs.6
With millions of people taking gadolinium-based dyes, countless people have experienced serious and unexpected side effects. As a result, thousands have filed lawsuits against the makers of GBCAs.
One patient named Paul Decker sued GE Healthcare after developing NSF following an injection with Omniscan (gadodiamide). His lawyers claimed GE Healthcare knew of the risks but deliberately hid them from the public. In fact, one woman said that a boss told her to “burn the data” about troubling scientific findings related to the gadolinium agent.7
The jury found GE had failed to adequately warn its patients about the risks and awarded Decker $5 million in 2013. It was the first dye case to go to trial.8
Most lawsuits related to gadolinium and NSF have either been settled out of court or are still pending.
However, the latest evidence of gadolinium deposits in the brain could mean a new upcropping of lawsuits from patients who have suffered cognitive decline after being injected with GBCAs.
Anyone who has suffered an unexpected injury from gadolinium dyes — whether NSF or neurological effects — is encouraged to reach out to a qualified attorney to find out more about possible legal options.
Fill out this form for a FREE, immediate, Case Evaluation
Please read these Terms and Conditions ("Terms", "Terms and Conditions") carefully before using the https://www.kbaattorneys.com/ website (the "Service") operated by KBA Attorneys ("us", "we", or "our").
Your access to and use of the Service is conditioned on your acceptance of and compliance with these Terms. These Terms apply to all visitors, users and others who access or use the Service.
By accessing or using the Service you agree to be bound by these Terms. If you disagree with any part of the terms then you may not access the Service. The materials contained in this web site are protected by applicable copyright and trade mark law.
The materials and information contained within the Service is of a general, informational nature but does not constitute legal or professional advice and should not be constituted as such. Use of the Service in any way, does not establish an attorney-client relationship.
Except as required by law, neither KBA Attorneys nor its affiliated firms or businesses accept any responsibility and shall not be liable for any damages (direct, indirect, incidental, special, consequential or exemplary), resulting from the use of this Service. This includes, but is not limited to, damages (for loss of profits, goodwill, use, data or other intangible losses) resulting from the use of or inability to use the Service or its contents or from any interruption or delay in access to the Service for whatever reason.
Note also that sending an e-mail to our office does not create a lawyer-client relationship, and none will be formed unless there is an expressed agreement between the firm and the client. Therefore, we strongly advise you against sending confidential or privileged information to us until you can establish such a relationship.
Our Service may contain links to third-party websites or services that are not owned or controlled by KBA Attorneys
KBA Attorneys has no control over, and assumes no responsibility for, the content, privacy policies, or practices of any third party websites or services. You further acknowledge and agree that KBA Attorneys shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with use of or reliance on any such content, goods or services available on or through any such websites or services.
We strongly advise you to read the terms and conditions and privacy policies of any third-party websites or services that you visit.
These Terms shall be governed and construed in accordance with the laws of Maryland and Virgina, United States, without regard to its conflict of law provisions.
Our failure to enforce any right or provision of these Terms will not be considered a waiver of those rights. If any provision of these Terms is held to be invalid or unenforceable by a court, the remaining provisions of these Terms will remain in effect. These Terms constitute the entire agreement between us regarding our Service, and supersede and replace any prior agreements we might have between us regarding the Service.
We reserve the right, at our sole discretion, to modify or replace these Terms at any time. If a revision is material we will try to provide at least 30 days notice prior to any new terms taking effect. What constitutes a material change will be determined at our sole discretion.
By continuing to access or use our Service after those revisions become effective, you agree to be bound by the revised terms. If you do not agree to the new terms, please stop using the Service.
If you have any questions about these Terms, please contact us.