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Gadolinium Lawsuit

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.


What Are Gadolinium-Based Contrast Agents (GBCAs)?

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:

                                                                                                                                                                                                                                                                                                                                           
Generic NameTrade NameStructure
GadodiamideOmniscanLinear nonionic        
GadoversetamideOptimarkLinear nonionic
Gadopentetate dimeglumineMagnevistLinear ionic
Gadobenate dimeglumineMultiHanceLinear ionic
Gadoxetate disodiumEovist/PrimovistLinear ionic
Gadofosveset trisodiumAblavarLinear ionic
Gadoterate meglumineDotaremMacrocyclic ionic
GadoteridolProHanceMacrocyclic nonionic


The dye is typically injected intravenously near the site of the scan and is later naturally removed from the body through the kidneys.


When is Gadolinium Dye Necessary?

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.


Gadolinium Side Effects

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):

  • Dizziness
  • Headaches
  • Nausea
  • Vomiting
  • Difficulty breathing
  • Itchiness
  • Pain
  • Malaise
  • Sensations at the injection site


Gadolinium Linked to Nephrogenic Systemic Fibrosis

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.


FDA Takes Action Against Gadolinium Toxicity

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


Thousands File Gadolinium Lawsuits

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.

References
  1. Dr Nick Ferris, Prof Stacy Goergen. "Gadolinium Contrast Medium (MRI Contrast agents)", Inside Radiology, https://www.insideradiology.com.au/gadolinium-contrast-medium/. Accessed Mar 9th, 2018.
  2. NORD. "Nephrogenic Systemic Fibrosis", National Organization for Rare Disorders, https://rarediseases.org/rare-diseases/nephrogenic-systemic-fibrosis/#symptoms. Accessed Mar 9th, 2018.
  3. Aurang Z. Khawaja, Deirdre B. Cassidy, Julien Al Shakarchi, Damian G. McGrogan, Nicholas G. Inston, and Robert G. Jones. "Revisiting the risks of MRI with Gadolinium based contrast agents—review of literature and guidelines", US National Library of Medicine National Institutes of Health, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4569598/. Accessed Mar 9th, 2018.
  4. FDA. "FDA Drug Safety Communication: New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction", U.S. Department of Health and Human Services, https://www.fda.gov/Drugs/DrugSafety/ucm223966.htm. Accessed Mar 9th, 2018.
  5. FDA. "Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention", U.S. Department of Health and Human Services, https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm559709.htm. Accessed Mar 9th, 2018.
  6. Media and Public Relations. "PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations", European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2017/03/WC500223209.pdf. Accessed Mar 9th, 2018.
  7. FDA. "U.S. Department of Health and Human Services", U.S. Department of Health and Human Services, https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm589580.htm. Accessed Mar 9th, 2018.
  8. Jeff Gerth. "'Burn the Data': Did a Company Try to Hide Risks of MRI Dye Omniscan?", ProPublica, https://www.propublica.org/article/burn-the-data-did-a-company-try-to-hide-risks-of-ges-mri-dye. Accessed Mar 9th, 2018.
  9. Jeff Gerth. "GE Failed to Adequately Warn about Dangers of its MRI Dye, Jury Finds", ProPublica, https://www.propublica.org/article/ge-failed-to-adequately-warn-about-dangers-of-its-mri-dye-jury-finds. Accessed Mar 9th, 2018.