2018 Gadolinium Lawsuit News: Earlier this year, the FDA published new medical guides for patients and doctors with updated information about the dangers of gadolinium. If you have received a gadolinium-based contrast agent (GBCA) and developed severe complications, talk to an attorney now to get a free case review and learn about your legal rights.
Gadolinium is a rare earth element used in intravenous contrast dyes for imaging technologies like magnetic resonance imaging (MRI) scans, X-rays, and CT scans. The FDA has issued multiple drug safety communications about the dangers of gadolinium, including a 2007 requirement to add a black box warning to the drug label. As a result of the serious side effects of gadolinium, many people have filed lawsuits against pharmaceutical companies like Bayer and GE Healthcare, among others.
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Why Are People Filing Gadolinium Lawsuits?
Contrast dyes are often used to increase the visibility of blood vessels, organs, and soft tissues in the body during MRI scans and other imaging scans. Since the late 1980s, Gadolinium has been used in some contrast dyes because of its strong paramagnetic properties, which react to the magnetic resonance of MRIs and make parts of the body easier to see.
Unfortunately, gadolinium can also cause a wide variety of side effects, some of which are quite severe. Two of the most dangerous complications are nephrogenic systemic fibrosis and gadolinium deposition disease.
Nephrogenic Systemic Fibrosis (NFS) was first discovered in patients with kidney disease who were given gadolinium-based contrast agents. The condition causes the skin to thicken and become discolored, typically in the arms and legs though it can happen elsewhere as well. Thickening of the skin can lead to problems with mobility and flexibility. Other tissues can start to thicken as well, including cardiac tissue around the heart, pleural tissue around the lungs, neural tissue in the brain, the gastrointestinal tract, and skeletal muscles. As the disease progresses over a few weeks or months, it can increase the likelihood of death.
Gadolinium Deposition Disease (GDD) is caused when gadolinium deposits build up in certain parts of the body. The most common places for gadolinium deposits to form are the bones, liver, and the brain. Unlike NSF, which occurs only in patients with kidney problems, GDD has been observed in people with normal renal function. GDD symptoms can occur in as soon as a few hours or da ys. Because gadolinium deposition disease (sometimes called gadolinium retention) has been recognized fairly recently, no standard treatment exists yet, though anti-inflammatory drugs may help with some of the symptoms.
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Gadolinium Side Effects
- Bone and joint pain
- Chronic headaches
- Brain fog
- Cognitive problems
- Pins and needles
- Burning sensation
- Skin thickening
- Itching or rashes
- Kidney damage
Note: Many of these side effects may be signs of NFS or GDD. If you experience any of these after receiving a gadolinium-based contrast agent, contact your doctor right away.
FDA Warnings About Gadolinium Toxicity
Since the U.S. Food and Drug Administration (FDA) approved the first gadolinium agent, gadopentetic acid, in 1988, the agency has issued a number of warnings about the potential for gadolinium toxicity. These safety communications are based on various studies and adverse event reports reported to the FDA by patients, doctors, and drug companies.
June 2006 – The FDA published a safety communication about the discovery of 25 cases of nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD) in patients with kidney failure who had been given gadolinium contrast dye. A follow-up communication was sent in December 2006, with additional information about the risks of NSF/NFD. Read the safety communication »
May 2007 – The FDA requested that drugmakers add a new black box warning on labels for all gadolinium-based contrast agents informing patients, doctors, and others about the potentially deadly occurrence of NSF/NFD in patients with kidney problems. Read the safety communication »
September 2010 – The FDA required pharmaceutical companies to add even more warnings on gadolinium contrast dyes related to the risks of NSF in those who have kidney disease. The new warnings provided health care professionals with guidance around properly screening patients who have kidney disease and monitoring for signs of NSF. Read the safety communication »
July 2015 – The FDA announced an investigation into the possibility of gadolinium deposits in the brain, based on several recently released medical studies. These brain deposits can form even in people who have normal kidney function, according to the studies. Read the safety communication »
December 2017 – The FDA required a new set of warnings for gadolinium-based contrast agents around the formation of brain deposits. Although the agency previously declared that the buildup of gadolinium deposits in the brain was not correlated with any negative effects, the new warning came with additional guidance for doctors and patients who use gadolinium dyes. Also, the agency required GBCA manufacturers to conduct new clinical studies to determine whether gadolinium brain deposits were harmful to patients. Read the safety communication »
May 2018 – The FDA published medication guides for healthcare professionals and patients around the side effects of gadolinium.
MRI Contrast Agents Containing Gadolinium
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Current Gadolinium Litigation
About ten years ago, people started filing lawsuits against subsidiaries of General Electric – specifically, GE Healthcare, Inc. and GE Healthcare Biosciences Corp. – due to problems with gadolinium. These cases were managed as part of a multidistrict litigation case in United States District Court for the Northern District of Ohio, under MDL No. 1909.
Gena and Chuck Norris Lawsuit
In November 2017, problems with gadolinium came to light when a gadolinium lawsuit was filed by Gena Norris, the wife of famous action star Chuck Norris. The Norrises’ lawsuit claims that gadolinium deposits have caused a host of problems with Gena’s health, including overall weakness and fatigue, with periods of intense pain and a burning sensation. While their lawsuit acknowledges that there is no officially recognized link between gadolinium and symptoms, the couple claims that urine tests for gadolinium have only been implemented recently, and that conditions like those Gena suffers from are greatly underdiagnosed.
The Norrises are seeking $10 million in damages from multiple makers and distributors of gadolinium contrast agents, including McKesson Corporation, Acist Medical Systems, and the Italian pharmaceutical company, Bracco S.P.A.
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Gadolinium Verdicts and Settlements
There have been a number of verdicts for the plaintiff in gadolinium lawsuits, bringing compensation to those who filed the suits. To date, there have been no known settlements in gadolinium cases.
Illinois Lawsuits: In April 2010, a circuit judge in Cook County, Illinois, opened the door for punitive damages in more 500 lawsuits filed by patients who developed NSF after receiving gadolinium. The ruling came after the judge reviewed evidence that GE Healthcare’s own safety experts urged the company to restrict the use of Omniscan.
Decker Lawsuit: in March 2013, an Ohio jury found in favor of Paul Decker, awarding him $5 million for side effects suffered after receiving Omniscan, a gadolinium-based contrast dye made by GE Healthcare. At the time he was given the contrast agent, Decker had been diagnosed with renal failure, and the administration of gadolinium triggered nephrogenic systemic fibrosis. Decker and his wife, Karen Decker, sued GE Healthcare for failing to properly warn them of the potential risks of gadolinium. The lawsuit was ultimately successful for the Deckers, with the Sixth Circuit Court of Appeals unanimously upholding the ruling after GE Healthcare appealed the verdict.
Gadolinium Lawsuit FAQs
Get answers to some of the most frequently asked questions about gadolinium lawsuits below.
Can I File a Gadolinium Lawsuit?
If you or a loved one has developed Nephrogenic Systemic Fibrosis (NFS), Gadolinium Deposition Disease (GDD), or other severe symptoms of gadolinium toxicity after receiving a contrast agent containing the rare earth metal, you could be eligible for compensation. You should discuss your situation with a product liability lawyer right away to find out what options you have.
What Compensation Can a Gadolinium Lawsuit Lead To?
There have been a number of multimillion dollar verdicts in the past, and Chuck Norris and his wife are currently seeking $10 million in their gadolinium lawsuit against McKesson, Bracco and others.
In general, medical-related lawsuits over drug side effects seek damages for a number of economic and noneconomic factors, including:
- The cost of the initial treatments using the defective drug
- The cost of follow-up care to treat severe side effects
- Duration of both the initial care and side effects
- Loss of income or inability to work, whether temporary or permanent
- Loss of companionship with your partner
Some people may be able to see punitive damages, as well, depending on whether the company was aware of the potentially harmful effects of their drug. Your lawyer should be able to explain what damages you can see in your lawsuit when you meet for a free consultation.
How Much Does a Gadolinium Lawsuit Cost?
If you are eligible to file a gadolinium lawsuits, you will not need to pay anything up front. Your lawyers will take the case on contingency, meaning that they will only receive payment if they help you recover money through a verdict or settlement.
During your free case evaluation, always be sure to ask your lawyer about what expenses or fees may be taken out of your compensation. You will have a chance to talk about the payment before you sign up with a law firm.
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