Gadolinium Lawsuit
A gadolinium lawsuit may be an option for patients suffering from gadolinium retention and related complications. Gadolinium, used in dyes to increase the clarity of magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) scans, has been alleged to create gadolinium retention in the body, thereby increasing patients’ risk of developing gadolinium deposition disease and nephrogenic systemic fibrosis. These conditions are accompanied with symptoms that include severe physical pain and cognitive difficulties. Affected patients and their loved ones may be able to file a lawsuit and recover damages with the help of a dangerous drug lawyer.
For more information, contact Attorney Group. We offer free, confidential, no obligation consultations, during which, we will help answer your questions and, if you decide to pursue a case, we will connect you with an affiliated gadolinium lawsuit attorney who can assist you throughout the legal process.
Have You Seen a Gadolinium Lawsuit Commercial?
You may have seen a gadolinium lawsuit commercial and wondered whether your symptoms, or those of a loved one, are the result of an MRI you underwent. You may also have questions as to whether you are eligible to pursue a claim against the manufacturer of the gadolinium-based dye or others. The purpose of this article is to provide you information concerning gadolinium, lawsuits that have been filed and what your legal options may be.
What is Gadolinium?
Gadolinium is a chemical compound naturally found in minerals such as bastnasite, monazite and gadolinite. The metal was first identified in 1880 by Jean Charles Galissard de Marignac and Paul-Émile Lecoq de Boisbaudran. It received its name from gadolinite, which was discovered by a Finnish chemist named Johan Gadolin eighty years prior. Described as a soft metal that is silver in color, Gadolinium is primarily used in the manufacturing of color television phosphors, garnets for microwave technology and nuclear reactor rods. The chemical compound is often mixed with other metals, like chromium and iron, to give those substances more resistance to oxidation and high temperatures. It also increases these metals’ workability. Today, gadolinite is primarily produced in China, Russia and Malaysia.
The National Center for Biotechnology Information, U.S. National Library of Medicine, states that gadolinium was first presented as a potential contrast agent for MRI scanning in 1982. Further research with the chemical indicated that gadolinium-based dyes produced enhanced MRI images, thereby giving medical professionals the ability to detect the presence of cancer; benign tumors; infectious diseases of the spine, brain, soft tissues and bone; and heart abnormalities. By 1988, Bayer Healthcare, formerly Schering AG, had created gadopentetate dimeglumine, received approval for the contrast agent to be used in clinical settings, and launched it to the medical community.
Today, there are several contrast agents, referred to as gadolinium contrast medium, used in coordination with MRI and MRA scans. These are:
- Omniscan (gadodiamide)
- Dotarem (gadoterate meglumine)
- ProHance (gadoteridol)
- Magnevist (gadopentetate dimeglumine)
- Eovist (gadoxetate disodium)
- OptiMARK (gadoversetamide)
- MultiHance (gadobenate dimeglumine)
- Ablavar (gadofosveset trisodium)
- Gadavist (gadobutrol)
Also referred to as an MRI dye, the medium is injected into the patient through the bloodstream prior to the scanning process. Gadolinium leaves the body after the MRI or MRA through urination – usually within 24 hours. The decision to use gadolinium is left to the discretion of the patient’s doctor, technologist or nurse, and is based on the patient’s condition. Today, a patient who is pregnant or who has severe kidney disease would not be given gadolinium.
Are there risks associated with gadolinium?
Used throughout the world as an MRI contrast dye, gadolinium does not pose any health risks for most people. However, it has been reported that some patients may experience an immediate response to the drug that includes the following: skin rash, anaphylactic reactions, nausea, dizziness or headache. Others have experienced gadolinium retention, which has developed into NSF/NFD or gadolinium deposition disease.
As the name implies, gadolinium retention happens when the metal does not leave the body through the kidneys and urination. Instead, the metal settles in the brain, bone and tissues. The person does not have to have any kidney issue or renal problems for this condition to occur, and recent studies concerning the brain indicate that gadolinium deposits occur in more people than originally thought. The effects of gadolinium in the brain are still unknown, but future studies are planned. Additionally, there is no known treatment for those with gadolinium retention.
Gadolinium lawsuits filed against manufacturers claim that patients developed NSF/NFD after a gadolinium injection. NSF/NFD is a rare disease that affects internal organs and the skin. People with kidney problems, including transplants with renal function issues, are the highest at risk for NSF/NFD.
Those diagnosed with NSF/NFD suffer from symptoms including the following:
- Pain in the bone
- Tightening and hardening of skin
- Tightening of muscles
- Blood clots
- Itching or burning
- Reduced internal organ function
The condition can be fatal for some people or lead to severe disability. Currently, there is no cure for NSF/NFD, according to the Mayo Clinic, and the treatments that are available, are not effective for everyone.
Gadolinium deposition disease is diagnosed when people experience problems that will not go away, after receiving an injection of the metal contrast agent. These problems have involved brain fog, burning, sharp or cutting body pain, joint and bone pain, a headache that persists and cognitive impairment. Patients with gadolinium deposition disease include those with no renal failure as well as with moderate renal failure. Medical researchers are just beginning to acknowledge the existence of gadolinium-related disorders and so there is no known or established treatment for gadolinium deposition disease at this time.
Is there an FDA warning on gadolinium?
The U.S. Food and Drug Administration has issued a couple of warnings concerning gadolinium. In 2009, the agency began requiring manufacturers to place a box warning label to alert radiologists and healthcare professionals that there was a risk of NSF for patients with acute or chronic severe renal insufficiency and for patients with acute renal insufficiency due to hepato-renal syndrome or liver transplant. The label instructed medical staff to screen their patients to identify those with renal failure and avoid the use of gadolinium unless it is deemed absolutely necessary.
On December 19, 2017, the FDA issued a public safety announcement, stating it is “requiring several actions to alert health care professionals and patients about the gadolinium retention.” These actions include written material concerning gadolinium that patients will be given and additional human and animal testing by manufacturers concerning gadolinium safety. The agency also announced it was requiring a new class warning on all contrast agents containing gadolinium and that NSF is related to the injection of the metal. According to the public safety announcement, gadolinium can be retained in the body, including the brain, for months and years after injection.
Lauren A. on May 16, 2016
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Why a gadolinium lawsuit may be the right option
A gadolinium lawsuit may be the right option for patients who have been diagnosed with gadolinium deposition disease, NSF/NFD or gadolinium storage condition, following a gadolinium injection. In lawsuits that have already been filed, plaintiffs allege that manufacturers of gadolinium-based contrast dye agents for MRIs and MRAs failed to test the agent for its potential to cause NSF before it was launched for medical use. Other allegations state that:
- The dye is defective; it “causes the gadolinium to become free in the body.”
- Dangerous to patients with kidney problems
- Harmful for those who have renal failure
- Manufacturers failed to warn about the increased risk of NSF for patients with kidney issues, even though they were aware of it.
Plaintiffs also claim the metal stays in the body longer than the stated 24 hours
Gadolinium Lawsuit News
- 2007First known gadolinium lawsuit is filed.
- February 2008Gadolinium lawsuit multi-district litigation is consolidated before the United States District Court for the Northern District of Ohio, Judge Dan Polster presiding.
- April 2009Bayer AG reaches settlement with several plaintiffs who were harmed by its gadolinium contrast agent, Magnevist.
- 2009The FDA requires manufacturers to place a warning in gadolinium contrast agent labels that people with acute or severe renal failure were at risk for NSF.
- January 2011A bellwether product liability suit involving GE Healthcare is settled after the company and plaintiff reach an agreement. The terms are not disclosed.
- July 2013A $5 million jury award is issued in a gadolinium lawsuit. The plaintiff, a 61-year-old man in kidney failure, was left severely disabled from NSF after receiving gadolinium just once in 2005. The jury agreed with the man’s claim that the manufacturer, GE Healthcare, was aware that their product called Omniscan posed a risk for NSF to people with impaired renal function, but deliberately withheld that information from patients and doctors.
- April 2015GE Healthcare’s appeal of the $5 million award is denied by the Sixth Circuit of the U.S. Court of Appeals.
- April 2017A $33.9 million settlement is reached between manufacturers of gadolinium-based dyes and plaintiffs.
- November 2017Action film star Chuck Norris and his wife filed the first lawsuit concerning gadolinium deposition disease, asking for $10 million in damages from 11 medical companies. The gadolinium lawsuit alleges that Mrs. Norris developed gadolinium deposition disease after being injected with the metal for several MRI scans. Court filings claim the disease has left her with kidney damage. Furthermore, she experienced breathing problems, violent shaking, muscle weakness, burning pain and cognitive deficits. Mrs. Norris and her husband state they were not told about the risks of gadolinium, and had they known, they would not have consented to its use.
- December 2017the FDA issues a new safety alert on gadolinium, requiring manufacturers to issue warnings to doctors and patients about the risk for gadolinium retention.
How can a gadolinium lawsuit help?
Many people assert that a lawsuit is a way to get money out of a company, but that is not accurate. The purpose of a gadolinium lawsuit is to seek financial reparation, or compensation, for the damages alleged victims have suffered. These damages include physical, emotional and mental anguish; the costs of current and future medical care; and loss of income caused by the injury/illness. If a family has lost a loved one, they may be able to seek financial compensation to cover funeral and burial costs.
For example, people diagnosed with NFS/NFD in relation to a gadolinium injection, often suffer intense physical pain. They are unable to hold down a job or perhaps even return to work, making it difficult to provide financial support for themselves or their families. Since NFS requires ongoing medical treatment, patients may find themselves overwhelmed with rising healthcare bills.
Subsequently, they worry over how they will be able to pay their debts, struggle with accepting their physical limitations and may even develop depression as they battle constant pain, day and night. The physical and emotional stress may lead to other health conditions like high blood pressure.
In cases involving corporate negligence, patients have the right to ask a court for punitive damages. Punitive damages are intended as a financial punishment against the company for its misconduct and as a deterrent. Through punitive damages, the courts send a loud message to other companies that such actions will not be tolerated. Since withholding information from the public about the risks and dangers of a product is not a criminal act, civil litigation is the only method available to hold negligent companies responsible.
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