Gadolinium lawsuits claim manufacturers failed to warn patients of severe side effects like nephrogenic systemic fibrosis, gadolinium deposition disease, skin thickening and kidney damage. Dozens of gadolinium lawsuits have been filed in state and federal courts, including a well-known lawsuit filed by Gena Norris, the wife of actor Chuck Norris.
Why Are People Filing Gadolinium Lawsuits?
Contrast agents are used to increase the visibility of blood vessels, internal organs, and soft tissues in the body during magnetic resonance imaging (MRI) scans. They are also used with other imaging technologies like X-rays, CT scans and magnetic resonance angiography (MRA). 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, use of gadolinium can also cause a wide variety of adverse 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. 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 weeks or months, it can increase the likelihood of death.
Gadolinium Deposition Disease (GDD) occurs 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 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 days.
Because gadolinium deposition disease (sometimes called gadolinium retention or gadolinium storage condition) has been recognized fairly recently, no standard treatment exists yet, though anti-inflammatory drugs may help with some of the symptoms. A recently published study indicates chelation therapy (using other agents to bind and help expel substances from the body) may help remove gadolinium deposits. Unfortunately symptoms did not improve proportionately with removal of gadolinium.
Gadolinium Side Effects
- Bone and joint pain
- Persistent 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 in 1988, the agency has issued a number of warnings about the risk of gadolinium toxicity for certain patients. These safety communications are based on various studies and adverse event reports reported to the FDA by patients, doctors, and drug companies. Other regulatory agencies, such as the European Medicines Agency, have also issued warnings about gadolinium.
May 2018 – The FDA published medication guides for healthcare professionals and patients around the side effects of gadolinium.
December 2017 – The FDA required new class warnings for gadolinium-based contrast agents (GBCAs) around the formation of brain deposits. Although the agency previously declared that gadolinium retention 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 »
July 2015 – The FDA announced an investigation into the possibility of gadolinium retention 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 »
September 2010 – The FDA required pharmaceutical companies to add even more warnings to GBCA prescribing information detailing 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 »
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 »
MRI Contrast Agents Containing Gadolinium
|Company||Brand Name||Generic Name|
|Lantheus||Ablavar (formerly Vasovist)||gadofosveset trisodium|
Current Gadolinium Litigation
GBCA lawsuits have been filed in both state and federal courts across the country. Though some cases have been centralized under multidistrict litigation, there are currently no class-action lawsuits related to gadolinium.
Gena and Chuck Norris Lawsuit
In November 2017, problems with gadolinium came into the public eye when a 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 muscle 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 certain symptoms, the couple claims that urine tests for gadolinium have only been implemented recently, and that conditions like those Gena suffers from are often undiagnosed.
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.
MDL 2868 – In re: Linear Gadolinium-Based Contrast Agents Products Liability Litigation
In 2018, more than 21 plaintiffs petitioned the Judicial Panel on Multidistrict Litigation (JPML) to centralize proceedings for their linear GBCA lawsuits in either the Northern District of California or the District of Massachusetts. However, the JPML ultimately denied the request for centralization, even though the cases might involve some common factual issues related to the development, regulation, and labeling and marketing of the GBCAs named in the actions. The JPML noted that “the injuries alleged in each case appear to be highly plaintiff-specific,” and that the various GBCAs involved in the lawsuits had different formulations. The panel also noted the unusual circumstance that many of the plaintiffs were represented by the same law firm, making consolidation unnecessary for the most part.
Although the JPML has declined to centralize this group of lawsuits, it’s possible that as more lawsuits are filed, the panel will re-evaluate its decision. For the time being, the current lawsuits will still move forward in the district courts in which they were filed.
MDL 1909 – Northern District of Ohio
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 the United States District Court for the Northern District of Ohio, under MDL 1909. According to court records, the cases in MDL 1909 were settled, but the details of that settlement were sealed.
Gadolinium Settlements and Verdicts
There have been a number of verdicts for the plaintiff in gadolinium lawsuits, bringing compensation to those who filed the suits. Though MDL 1909 did settle, the details of that settlement have not been disclosed.
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 complications 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
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 lawsuit against McKesson, Bracco and others.
In general, medical-related lawsuits over drug adverse 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 receive 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 lawsuit, 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.