Gadolinium Toxicity & Deposition Disease Lawsuit

One of the 17 rare-earth elements, gadolinium (Gd) is part of the “lanthanide” series of metals. A large percentage of rare-earth metals have a toxic effect on human beings.

Also known as Magnetic Resonance Imaging, or MRI, dye, gadolinium has paramagnetic properties, meaning that there is a slight increase in its temperature when it moves through a magnetic field, like an MRI. It is these properties that make it useful in enhancing the quality of images in MRI scans.

Gadolinium is administered to patients via an injection through the bloodstream before they go through the MRI and MRA scanning process. The medium leaves the body after the scan through urination – in most cases, within 24 hours.

Deciding whether or not to use gadolinium for this type of scanning process is left to the discretion of the patient’s physician, nurse, or radiologist or radiographer, and is based on the condition of the patient. Nowadays, a patient with severe kidney disease or who is pregnant would not be given this medium due to gadolinium toxicity and the risks that come with it.

While it does not have any known biological properties and does not occur in the human body naturally, gadolinium has molecules that are similar in size and shape to calcium, which is a nutrient that has many biological functions. As free gadolinium ions act like calcium in the body, it interferes with the effects of processes that are dependent on calcium.

Gadolinium can produce a variety of effects, including oxidative stress, inflammation, damage to your DNA or genes, and neurological damage. The cell damage from gadolinium is exacerbated when you are exposed to the magnetic fields of MRI scanners.

Brands of Gadolinium Contrast Dyes

Brands of contrast dyes containing some formulation or level of gadolinium include the following:

• Ablavar (gadofosveset trisodium)
• Eovist (gadoxetate disodium)
• Dotarem (gadoterate meglumine)
• Magnevist (gadopentetate dimeglumine)
• Gadavist (gadobutrol)
• Omniscan (gadodiamide)
• MultiHance (gadobenate dimeglumine)
• ProHance (gadoteridol)
• OptiMARK (gadoversetamide)

Side Effects of Gadolinium

Gadolinium retention occurs when the element is not eliminated from the body through the kidneys and urination. Instead, it settles in the tissues, bones, and brain. It is not necessary for the person to have renal problems or kidney issues to develop this condition. You should bear in mind that there is no known treatment for people with this condition.

Gadolinium side effects may occur in some people, but in most cases, they are mild and do not last long. The medium should not be used in patients who have reduced kidney function or hepatorenal syndrome, which is a condition that involves the reduced function of the kidneys and liver. This is because it results in nephrogenic systemic fibrosis in patients with kidney function that is severely reduced.

You should remember to inform the radiologist or radiographer if you have any history of kidney issues before the scan is performed. You should also let them know if you have had gadolinium allergy or an allergic reaction to any contrast agent in the past.

Some of the more common gadolinium toxicity symptoms include the following:

• Itching
• Nausea
• Vomiting
• Pain on the injection site
• Facial swelling
• Temporary hypertension
• Rapid breathing
• Headache
• Rashes
• Paresthesia – abnormal sensation in the skin, such as tingling, burning or prickling

As mentioned earlier, patients with kidney problems should not be injected with gadolinium because the kidney plays the primary role in eliminating chemical particles through urine excretion. In patients who suffer from kidney issues, the substance is not eliminated completely from their body, which leads to an increased risk of gadolinium deposition disease.

There are some long-term side effects that patients experience due to the accumulation of gadolinium in their body resulting from undergoing MRI scans more than once. These include the following:

• A small percentage of patients who undergo an MRI experience breathing problem, swelling of the lips or mouth, or an allergic-like reaction in the skin. It is important for these adverse reactions to be treated immediately.
• Radiologists advise that pregnant patients inform their doctors before going through an MRI so that they can communicate the risks of the scan for mother and child. In addition, patients who are breastfeeding should bear in mind that there is a likelihood of a fraction of the particles could be transmitted through breast milk.
• Nephrogenic systemic fibrosis (NSF) may be another long-term side effect of gadolinium particles. NSF is a disease which causes the skin to become thick and tight as well as damage to internal organs. Although the likelihood of its occurrence is very slim, it is a little more likely to occur in patients with kidney problems.

Allergic Reactions

Serious gadolinium allergy reactions are uncommon but they do occur. In most cases, the reactions occur during administration of the substance or within the first hour after administration. However, it is critical to bear in mind that some reactions can occur up to a few days after administering gadolinium.

You should seek immediate medical attention if you experience any of the following:

• Swelling of the mouth, face, throat, hands, or feet
• Fainting
• Difficulty breathing or swallowing
• Irritation of the eyes
• Hives or itchy red skin
• Sneezing, coughing, or wheezing

Preventing the Side Effects of Gadolinium

Doctors cannot predict the occurrence of minor side effects like sweating, itching, facial swelling, nausea, rapid breathing, localized pain, temporary hypertension, etc. before an MRI scan is performed. Therefore, these patients are usually advised to take medication only if it does not settle down within 48 hours. Albeit, when it comes to long-term side effects, doctors advise patients to reveal their complete medical history.

If a patient has a history of severe allergic reactions to gadolinium or has a kidney problem, the physician will take appropriate steps accordingly before the MRI is done to make sure that the patient is safe from reactions.

Radiologists may recommend a pre-medication before the gadolinium contrast medium is injected into the patient’s body. However, this step can only minimize gadolinium risks of allergic reactions, not eliminate it completely.

Minor allergic reactions to gadolinium can occur in patients when the medium is injected prior to an MRI, and they can be easily treated. However, the long-term gadolinium toxicity symptoms can result in more significant side effects if they are not treated in a timely manner with proper medical care.

As mentioned already, it is imperative that you seek medical attention immediately if you experience any of the symptoms of the side effects of gadolinium so that your condition can be prevented from getting worse and causing potentially serious complications.

Testing for Gadolinium Toxicity

With the current status of understanding gadolinium toxicity by the medical community, there is no known or verified methods to know with absolute certainty if you are gadolinium toxic or have symptoms that are caused by the element.

There is not any medical institution or provider you can go to find out whether or not your symptoms are caused by gadolinium that has been retained in your body from contrast MRIs, and you should know that there is no medical diagnosis of “gadolinium toxic”.

However, if you suspect that your symptoms are a result of gadolinium, there are gadolinium toxicity testing procedures that may be helpful in determining the cause of your symptoms. Urine and blood testing, as well as dermal tissue biopsies, can be done.

On top of this, no published history of results for patients who have normal kidney function exist. The current diagnostic criteria for dermal tissue biopsies are based on what has been seen in patients with NSF along with severe kidney disease.

Urine Testing: While urine testing may not be the definitive test to determine whether or not you are gadolinium toxic, it is believed that test results for gadolinium that are consistently high are a positive indicator for gadolinium toxicity. The test can be periodically repeated for progress monitoring.

It is important to note that having elevated gadolinium levels in urine will not get you a gadolinium-related diagnosis – it is only proof that your body has retained the element.

Going past this, having lower gadolinium levels in your urine long after you have gotten a contrast MRI done does not mean that you did not have a much higher level at an earlier period of time. For anyone who suspects that they may have gadolinium toxicity, they can get some insight from a 24-hour unprovoked urine test.

Blood Testing: Also called serum testing, blood testing for gadolinium poisoning or toxicity can also be done. However, the plasma half-life of the element is roughly 90 minutes. According to specialists, elevated gadolinium levels in the blood drawn over 4 days after the administration of GBCA is not typical of most patients who have normal renal function. In many cases, blood tests report undetectable levels when urine tests show elevated gadolinium levels.

Biopsy Testing: This is a more complex topic that includes two types of tests – dermal or skin biopsies for histological features that are similar to those found in patients with NSF, and testing skin tissues for the presence of gadolinium.

A majority of dermatopathology labs can conduct dermal biopsy tests for the histopathological features that are observed in NSF. However, most patients with normal function of the kidneys do not present with the same severe skin manifestations following retention of gadolinium. If you have changes in your skin and plan to have skin tissue testing done for NSF, it should be taken from an area where there are skin changes similar to what has been observed with NSF. Before a biopsy is done, you should make sure that your dermatologist and their lab are familiar with the requirements for biopsy specimen and the histopathological evaluation that is necessary to make a diagnosis for NSF. It is extremely important to make sure that the biopsy is deep enough, taken from the affected skin and has adequate volume.

Gadolinium Toxicity in the Brain

Gadolinium toxicity in the brain is an occurrence that can take place in patients who have undergone contrast-enhanced MRI exams multiple times, according to new research. It is suggested that some types of popular contrast agents used in MRIs may remain in the brain for a number of years, but that the long-term effects are not yet known.

Some patients who have received contrast agents like gadolinium and other similar types have reported a decline in thought and cognitive processes, but manufacturers have claimed that studies that confirm brain residue did not show actual “brain injury”.

Companies that manufacture gadolinium-based contrast agents have denied liability, but a large number of patients have filed lawsuits against these manufacturers for medical injuries, including injuries from gadolinium toxicity of the brain.

Recent studies concerning the brain indicate that gadolinium retention occurs in more people than originally believed. More studies in the future are planned to find out how gadolinium deposits affect the brain since the effects are still not fully known.

Gadolinium-Based Contrast Agents Associated with Brain Hypersensitivity

A recent study revealed that gadolinium may not be eliminated from the body immediately and instead, may persist in different parts of your body, including your brain.

When brain images of patients who had gone through 6 or more contrast-enhanced MRI scans of the brain were compared to those of patients who had undergone 6 or fewer unenhanced scans, areas of hyperintensity, or high intensity, in two regions of the brain – the Globus pallidus (GP) and the dentate nucleus (DN) – were found. The hyperintensity correlated with the number of MRIs enhanced with gadolinium-based contrast agents.

At this time, it is not yet known what the brain hyperintensity may mean. However, DN hyperintensity is associated with multiple sclerosis. There are now suggestions that this hyperintensity may be due to the large number of enhanced MRI scans that patients with multiple sclerosis often receive. Meanwhile, hyperintensity of the GP is associated with liver dysfunction.

Warning on Gadolinium Contrast Agents

The US Food and Drug Administration (FDA) recently stated that all gadolinium contrast agents used in MRIs are required to carry a warning about their retention in the body, which is known to have adverse renal effects.

The agency reviewed available data about gadolinium retention from GBCAs as part of its role in monitoring the safety of drugs after they have been marketed. As a result of that review, the FDA recommended that medical professionals consider each agent’s retention characteristics when they choose a GBCA for patients who may be at a higher risk for gadolinium poisoning, such as those who might have to go through GBCA MRI scans multiple times to monitor a chronic condition.

In addition to the new requirement for warnings on labels, the FDA also stated that manufacturers are required to develop a Patient Medication Guide that healthcare professionals can provide to patients to read before they undergo MRI scans that use gadolinium agents.

The FDA explained that gadolinium agents are normally metabolized and excreted in urine but there can be trace amounts left in the body for long periods of time. This retention of the agents has been linked to nephrogenic systemic fibrosis (NSF) in patients who already suffer from renal failure. The agency indicated that although this is an effect that appears to be rare, it is serious enough to warrant an advisory to all healthcare professionals as well as patients.

The FDA made the announcement more than 2 years after the agency said that it was investigating reports of negative effects that were linked to gadolinium contrast agents.

What is Gadolinium Deposition Disease?

As mentioned already, gadolinium element is used to make gadolinium-based contrast agents (GBCA) used in MRIs. GBCAs were considered to be safe until reports in recent times indicated that they are retained in the body and have adverse side effects in some cases.

One such toxic side effect is gadolinium deposition disease (GDD) which is caused by the accumulation of the element in the body. The pathophysiology of GDD is hypothesized as the host immune response which destroys the host and causes genetic abnormality in the metabolism of elements such as gadolinium

Patients who have gone through a series of MRI scans were found to retain the deposits of gadolinium in their brain and bones. The body can retain the gadolinium deposits for months, and in some cases, even years, after it receives GBCAs following MRI scans. It is linear GBCAs that remain in the body rather than macrocyclic GBCAs.

GDD affects patients with gadolinium accumulation who have normal kidney function and then experience painful symptoms within a few hours to two months after being administered or exposed to GBCAs. The symptoms of the disease are similar to nephrogenic systemic fibrosis (NSF) but less severe.

It is important to note that gadolinium storage condition (GSC) is different from GDD and occurs as a result of the accumulation of gadolinium deposits that are inert. The condition does not show symptoms that are observed in GDD.

Symptoms of Gadolinium Deposition Disease

As already mentioned, exposure to GBCAs comes with a number of adverse side effects. Patients with Gadolinium Deposition Disease often complain about acute and chronic symptoms that are similar but not identical to NSF. These symptoms include the following:

• Pain and a burning sensation in the lower arms and lower limbs – patients often describe the pain as burning or cutting
• Pain in the bones or joints
• Tightness of the hands and feet – a feeling similar to being fitted with gloves or socks that are extremely tight
• Mental confusion also described as brain fog
• Persistent headaches
• Itchy skin
• Loss of hair
• Problems with vision and hearing
• In later stages, skin problems such as progressive thickening of soft tissues under the skin as well as discoloration
• Other symptoms include nausea, vomiting, breathing problems, and diarrhea

It is only recently that medical researchers have begun to acknowledge that gadolinium-related disorders exist. Therefore, there is no established or known treatment for gadolinium deposition disease at this time.

Treatment for Gadolinium Deposition Disease

Treatment for gadolinium deposition disease can be expansive and very costly. It involves combining immune system modulation and chelation. Chelation is a medical process that involves administration of chelating agents to bond with metal ions so that a more chemically stable compound can be formed to excrete GBCA safely from the patient’s body.

It is should be noted that this process has not been approved by the FDA. The chemicals used in the process are approved by the FDA only for the removal of lead from the body. Many people do not realize that important nutrients like calcium and zinc are also removed in this process.

Additionally, research has shown that the process does not eliminate all the gadolinium in the body anyway. It can also cause symptoms to worsen.

Oral Chelation

In most cases, oral chelation is a pill taken under a doctor’s advisement. Supplements are usually required to counteract the elimination of good minerals as the chelating agent removes the toxic heavy metals. Sublingual

powders are also used under the tongue rather than going through the digestive process.

IV Chelation

This is the strongest approach to treating Gadolinium Deposition Disease. Patients undergo a urine test to determine the burden of different toxic substances in their body. Their doctor will then determine the appropriate chelating agents and recommend a course of treatment.

Usually, treatments are done between 1 and 3 times a week for a total of over 20 sessions. A lot of people have had 50 treatments. Each treatment session costs from $100 to $250 and they are not usually covered by insurance.

Gadolinium Deposition Disease Lawsuits

When people develop conditions such as NSF or Gadolinium Deposition Disease after being given a gadolinium injection prior to undergoing an MRI scan, they may be able to file a gadolinium deposition disease lawsuit. They can also do so if they have lost a loved one to any gadolinium-related complication or disorder.

A number of people are suing manufacturers of gadolinium-based contrast agents, alleging that the companies did not provide adequate warnings about the risks that are associated with gadolinium retention. These lawsuits are filed in state and federal courts across the United States. Some lawsuits have been settled while there are a number of others that are still pending.

In recent times, there has been a focus on the damage that may be caused by gadolinium-based contrast agents, such as Omniscan and Magnevist, and there have been patients who have reported that they suffered significant cognitive decline which has resulted in the loss of jobs and various personal difficulties.

Investigators have indicated that additional studies need to be conducted to further examine the effects of these drugs, and a large number of patients who have suffered cognitive and other neurological effects due to these drugs may be filing lawsuits against manufacturers like GE, Bayer, and others.

It is important to keep in mind that filing a gadolinium deposition disease lawsuit may be a long and tedious process as companies that manufacture GCBAs have stated that studies showed that there is no confirmation of any clinical effect such as brain injury. These manufacturers have denied liability, although it should be noted that only autopsy reports were addressed by the reports.

Needless to say, these companies will fight tooth and nail to avoid liability for any injuries or damages suffered by patients after the drugs in question were administered before they underwent MRI scans for their conditions. You need to be well-prepared for a lengthy fight against these companies.

You should make sure that you hire a lawyer who has knowledge and experience in handling cases involving gadolinium or similar drugs so that you have the best chance of obtaining financial compensation for the damages brought on by the drugs.

You should find a lawyer who is as committed as you are to making sure that the manufacturers are held liable for their negligence and failure to warn patients about the risks that come with their products.

Filing a Gadolinium Toxicity & Deposition Disease Lawsuit

The purpose of filing a gadolinium deposition disease lawsuit is to seek financial compensation, or reparation, for the damages that victims have suffered as a result of GCBAs.

These damages include physical pain, the costs of current and future medical treatment and care, mental and emotional anguish, etc. – all of which are caused by the injury or illness.

If a family has lost a loved one, they may also be able to file a lawsuit to seek financial compensation for the aforementioned, as well as, funeral and burial costs, loss of consortium, and other damages.

Gadolinium poisoning can cause serious damage to your health and it is important to make sure that the manufacturer pays for the suffering you and your loved ones have gone through.

If you or a loved one suspects that you have Gadolinium Deposition Disease, you should consult a gadolinium lawyer to find out what legal options are available to you. Gadolinium lawyers will be able to give you the best advice as they have knowledge about the element and the possible risks that are associated with it.

They will review your case and determine if you have a viable case and can file a lawsuit against the manufacturer of the GCBA you were given.

Once your lawyer determines that you have a solid case and can file a lawsuit against the manufacturer, they will protect your rights and make sure that you receive the financial compensation you deserve for the injury/illness and other damages you have suffered as a result of gadolinium poisoning.

Your lawyer will make the entire process easier for you and make sure that the company pays for the devastating impact that their drug has had on your life as well as your family’s.