More than 1,000 gadolinium users have filed gadolinium lawsuits in US courts. Many of the lawsuits were consolidated in an Ohio court, where drug makers have regularly reached gadolinium settlements with people who have developed side effects. The gadolinium based contrast agents used during MRI’s have been directly linked to nephrogenic systemic fibrosis (“NFS”); a painful, progressive, and sometimes fatal condition of the skin and connective tissue.
“With all the doctors, the FDA, and the makers of the gadolinium contrast agents claiming to know what’s best for the patient- more and more MRI patients are left to their own devices after discovering that their NSF was caused by the MRI itself. That’s when they need a Gadolinium lawyer,” says David Eisbrouch, a partner at Balkin & Eisbrouch.
Most patients who have contacted a gadolinium lawyer and filed a lawsuit have cases that involve the gadolinium-based contrast agent Omniscan, which is manufactured by GE Healthcare. Omniscan has been named in nearly 75 percent of gadolinium lawsuits despite accounting for just 30 percent of the GBCA market.
Some experts have suggested that certain GBCAs are more prone to breaking down in the body than others, posing a greater risk to not just patients with renal insufficiency, but all gadolinium users. Gadolinium, a rare earth metal, is toxic to humans.
A relatively small-scale study presented at the 2011 annual meeting of the Society of Critical Care Medicine appears to contradict the long-held belief that the side effects of gadolinium-based contrast agents (GBCAs) can be especially dangerous for people with renal insufficiency. With this new information, it’s unclear as to how the lawsuits will progress, though the GBCA used in the study was Multihance and not Omniscan, the majority shareholder in the lawsuits.
According to the National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC), 11.5 percent of Americans suffer from some form of chronic kidney disease. Many do not know they have the condition. This new study may only shorten the list of CBCA’s that have caused the disease and keep the 11.5 percent of Americans with potential renal failure safe in the future.
Wednesday, May 4, 2011
Friday, April 1, 2011
Gadolinium Lawsuits on the Rise
Gadolinium-based contrasting agents were first approved by the Food and Drug Administration in 1988, and between 1988 and 2004 five different brands of the product were introduced into the market – ProHance, OptiMARK, Omniscan, MultiHance, and Magnevist. During clinical trials of the product, patients whose kidney function was compromised or who were on dialysis were not included, because gadolinium is excreted through the kidneys. However, this did not exclude these patients from being administered gadolinium in its commercial use, as a MRI contrasting agent. Patients with renal insufficiency were somewhat likely to develop a disease called nephrogenic systemic fibrosis, which doctors believe that exposure to gadolinium could be a risk factor.
Because of this, many patients are considering gadolinium lawsuits, and many members of the public want to know how these contrasting agents work. Gadolinium is a rare-earth metal that is only magnetic when external magnetic force is applied, and a magnetic resonance imaging, or MRI, machine is a device which uses magnetic force to allow doctors to see inside a patient’s body in some detail, but for the most accurate results a contrasting agent must be used. Gadolinium-based contrasting agents are either swallowed or injected into the patient’s body, depending on the body part being imaged. Although gadolinium-based products are not the only ones used in MRI scanning, they are among the most common.
Gadolinium products were likely approved by the Food and Drug Administration because the only side effects noted in pre-marketing studies were allergic reactions, which ranged from mild to severe and potentially fatal. However, some plaintiffs are claiming that the testing done was incomplete because it did not include those with serious kidney problems, while gadolinium is being used on these patients despite a lack of proper testing. It remains to be seen whether lawsuits against any of the gadolinium distributors will be successful.
Because of this, many patients are considering gadolinium lawsuits, and many members of the public want to know how these contrasting agents work. Gadolinium is a rare-earth metal that is only magnetic when external magnetic force is applied, and a magnetic resonance imaging, or MRI, machine is a device which uses magnetic force to allow doctors to see inside a patient’s body in some detail, but for the most accurate results a contrasting agent must be used. Gadolinium-based contrasting agents are either swallowed or injected into the patient’s body, depending on the body part being imaged. Although gadolinium-based products are not the only ones used in MRI scanning, they are among the most common.
Gadolinium products were likely approved by the Food and Drug Administration because the only side effects noted in pre-marketing studies were allergic reactions, which ranged from mild to severe and potentially fatal. However, some plaintiffs are claiming that the testing done was incomplete because it did not include those with serious kidney problems, while gadolinium is being used on these patients despite a lack of proper testing. It remains to be seen whether lawsuits against any of the gadolinium distributors will be successful.
Thursday, March 31, 2011
Gadolinium Settlement Amounts: A Windfall for Some
Defendants, especially large corporations involved in a lawsuit surrounding their products, often opt to settle with plaintiffs out of court to avoid what is involved in the legal process – a divulgence not only of settlements but also of other important and sensitive information, such as trade secrets, manufacturing and testing processes, and other documents the public is not usually privy to. This is the case with the major manufacturers of gadolinium-based contrasting agents, chemicals used in MRI scans to help doctors better see parts of the body.
These chemicals have been found to cause nephrogenic systemic fibrosis, a debilitating disease that is permanent and sometimes fatal. There is no cure. Although in a settlement the defendant does not have to disclose the amount of money that is given to a plaintiff, experts are estimating that gadolinium settlements could be between $50,000 and $200,000 – however, some are probably much higher. Millions of dollars have already changed hands in gadolinium-related cases.
It isn’t clear how many gadolinium lawsuits are still standing in courts across the country and how many have been dealt with out of court with a settlement for the plaintiff. However, in many cases, many plaintiffs decide to agree to a settlement – and many do not. In similar cases, many defendants have chosen to see their case through court, as there is a chance of a higher payoff from a jury trial against the corporation responsible for the damaging product. However, this is always a gamble – if the jury decides against him or her, they may receive no payoff whatsoever.
Because the first three trials were settled out of court, lawyers no longer have a way to gauge the kind of gadolinium settlement possible in these cases. This may mean that even more trials will be settled this way, and those with outstanding lawsuits may soon reach settlements.
These chemicals have been found to cause nephrogenic systemic fibrosis, a debilitating disease that is permanent and sometimes fatal. There is no cure. Although in a settlement the defendant does not have to disclose the amount of money that is given to a plaintiff, experts are estimating that gadolinium settlements could be between $50,000 and $200,000 – however, some are probably much higher. Millions of dollars have already changed hands in gadolinium-related cases.
It isn’t clear how many gadolinium lawsuits are still standing in courts across the country and how many have been dealt with out of court with a settlement for the plaintiff. However, in many cases, many plaintiffs decide to agree to a settlement – and many do not. In similar cases, many defendants have chosen to see their case through court, as there is a chance of a higher payoff from a jury trial against the corporation responsible for the damaging product. However, this is always a gamble – if the jury decides against him or her, they may receive no payoff whatsoever.
Because the first three trials were settled out of court, lawyers no longer have a way to gauge the kind of gadolinium settlement possible in these cases. This may mean that even more trials will be settled this way, and those with outstanding lawsuits may soon reach settlements.
Friday, March 11, 2011
Gadolinium Contrasting Agents can be Dangerous
Magnetic resonance imaging, or MRI, scans are used worldwide in hospitals to help with the diagnosis and treatment of patients. Often when a patient needs to undergo an MRI scan, he or she must ingest or be administered a dye, called a contrasting agent, which will allow the doctor a clearer view of his or her insides on the scan – as well as increase the chances that a doctor will spot a problem area or discrepancy and be able to treat it quickly and successfully. However, many contrasting agents – the brands Magnevist, ProHance, OptiMARK, MultiHance, and Omniscan – contain gadolinium, which comes with a risk of side effects.
The Food and Drug Administration offered a gadolinium-related warning to healthcare providers in June of 2006 after the Danish Health Authority provided evidence of 25 gadolinium-related cases of nephrogenic systemic fibrosis, or NSF – a condition that causes hardening of the skin, organs, and other tissues in the body. This condition is permanent, debilitating, and there is no known cure. Patients who are experiencing renal failure or have other kidney problems are especially at risk for developing gadolinium-related NSF, leading the Food and Drug Administration to issue a warning to doctors, urging them to know the warning signs and to determine whether or not it is safe to use a gadolinium product on a patient based on his or her current health.
The Food and Drug Administration also required that manufacturers of gadolinium-based contrasting agents, or GBCAs, include a warning label on both the packaging and inner label of their products, warning users of the risks associated with NSF, especially in the cases of patients with kidney problems and renal failure. These warnings go into more detail about potential Gadolinium side effects and are specific about the risks associated with the product, allowing doctors to make careful decisions about who they treat with gadolinium-based products and who they do not allow to be treated with these products.
The Food and Drug Administration offered a gadolinium-related warning to healthcare providers in June of 2006 after the Danish Health Authority provided evidence of 25 gadolinium-related cases of nephrogenic systemic fibrosis, or NSF – a condition that causes hardening of the skin, organs, and other tissues in the body. This condition is permanent, debilitating, and there is no known cure. Patients who are experiencing renal failure or have other kidney problems are especially at risk for developing gadolinium-related NSF, leading the Food and Drug Administration to issue a warning to doctors, urging them to know the warning signs and to determine whether or not it is safe to use a gadolinium product on a patient based on his or her current health.
The Food and Drug Administration also required that manufacturers of gadolinium-based contrasting agents, or GBCAs, include a warning label on both the packaging and inner label of their products, warning users of the risks associated with NSF, especially in the cases of patients with kidney problems and renal failure. These warnings go into more detail about potential Gadolinium side effects and are specific about the risks associated with the product, allowing doctors to make careful decisions about who they treat with gadolinium-based products and who they do not allow to be treated with these products.
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