Gadolinium MRI contrast agents have been linked to a rare disease. Now, hundreds are filing lawsuits claiming that the makers hid the risks from the public.
Gadolinium MRI Toxicity
Millions of people around the world have used MRI (Magnetic Resonance Imaging) scans to look for or diagnose diseases and injuries. But, mounting evidence suggests that contrast agents containing gadolinium used to enhance the images may put patients at risk for developing potentially lethal side effects.
Although the only known health effects related to gadolinium exposure is a condition that affects the kidneys called nephrogenic systemic fibrosis (NSF), patients also claim the contrast agents have led to problems with other organ systems as well.
Now patients are fighting back against the makers of gadolinium-based contrast agents through lawsuits.
What is an MRI?
An MRI is an imaging technique used in radiology to create accurate pictures of the body. Unlike CT scans, MRI scanners do not use X-rays. Instead, they use magnetic fields and radio waves to examine internal body structures.
A person is placed inside a large machine and must remain still while the imaging is processed. The typical MRI scan lasts anywhere between 30 to 60 minutes. However, some scans may take longer.
MRI scans are most commonly used for taking images of knees and shoulders to detect injuries. They can also be used on the head and neck to detect brain tumors, stroke, dementia, multiple sclerosis, aneurysms, spinal tumors, and more.
How Does Gadolinium Work with MRIs?
Gadolinium is a chemical element — a heavy metal found on the periodic table with the symbol Gd — that is combined with other chemicals to enhance the image quality of MRI scans.
According to Inside Radiology, a Gadolinium contrast medium is used in roughly 1 out of every 3 MRI scans. It is injected near the site of the scan and may be recommended by the doctor or radiologist.
Several different manufacturers make gadolinium contrast media, but they generally work by shortening spin-lattice relaxation time (T1) to increase the contrast of the MRI imaging.
According to The American College of Radiology, more than 300 million patients around the world have used gadolinium-based contrast agents for diagnosis and treatment since it was first approved by the U.S. Food and Drug Administration in 1988.
Gadolinium Side Effects
Side effects can occur in those injected with gadolinium-based contrast agents. However, they are often mild. The most common side effects are headaches, nausea, itchiness, dizziness, vomiting, and inflammation.
In some cases, patients may have allergic reactions to gadolinium that ranges from mild to severe. Reactions may manifest itself as itchy eyes, hives, skin irritation, breathing issues, and chest tightness.
Nephrogenic Systemic Fibrosis Side Effect
The most severe side effect connected to gadolinium is a condition called nephrogenic systemic fibrosis (NSF). NSF is a rare disease that develops in some people with reduced kidney function after exposure to gadolinium-based contrast agents.
According to the National Organization for Rare Disorders, the disease may develop slowly over a period of time. The severity and progression of the disease vary by person but can come on rapidly and lead to potentially life-threatening complications.
Symptoms of NSF included (but are not limited to):
- Swelling or tightening of the skin
- Darkened patches, especially on extremities
- Skin hardening
- Loss of flexibility
- Chronic pain on the skin
- Muscle weakness
- Bent joints
- Blood clots
So far, the disease has not yet been reported in individuals with normal kidney functions. NSF may also affect multiple organ systems, depending on the person, and may include complications involving the kidney or heart.
FDA Warns of Gadolinium Toxicity
Nephrogenic systemic fibrosis was first identified in 1997, but researchers now believe that the rise in NSF since then is directly related to the increased use of gadolinium-based contrast agents.
It wasn’t until 2006 when European investigators identified a possible association between NSF and gadolinium dyes did the public become aware of the dangers of gadolinium. That same year, the U.S. Food and Drug Administration issued a public health advisory of the potential risks.
In a review of post-marketing reports, the FDA found reports of patients who developed the rare disease after being exposed to the five gadolinium-based contrast agents currently approved in the U.S. for MRI scans. With the information, the FDA began requiring the makers of the gadolinium drugs to include a boxed warning about the risk of NSF.
Over the years, the FDA has continued highlighting the dangers of the contrast agents in patients with renal insufficiency by updating and adding warnings to the labels.
In December 2017, the FDA started requiring a new class warning for all gadolinium-based contrast agents over concerns that the chemical agent stays in patients’ bodies years after receiving the drugs.
The latest requirements feature actions to alert health care professionals and patients about gadolinium retention. Those who may be pregnant, have had repeat scans with the agent, or have kidney problems may also be at greater risk.
Patients File Gadolinium MRI Lawsuits
Since the news about the connection between NSF and gadolinium has become public, patients have started to file lawsuits against the makers of the agents for a failure to warn of complications.
In one case, plaintiff Paul Decker claimed he contracted NSF after being injected with one of the gadolinium dyes in 2005 and sued GE Healthcare. During the trial in 2013, damaging information about GE came out suggesting that the company may have been trying to hide problems with the drug.
Decker and his family were awarded $5 million by a jury.
Companies like GE Healthcare have settled hundreds of cases out of court over the last several years from people claiming they were negligent in selling the drugs to the public. However, more lawsuits continue being filed every month.
In November 2017, actor Chuck Norris and his wife, Gena, filed a lawsuit against three companies for $10 million over claims that their gadolinium agents nearly cost Gena her life.
“Unfortunately, litigation is the only course of action we can take to hold the drug companies accountable for threatening the lives of so many innocent people who undergo MRIs,” Gena said in a statement. “These companies continue to say that there is no link between gadolinium and adverse events, even though the evidence is overwhelming that this heavy metal stays in the body for years, rather than hours.”
Advocates are hoping to get the FDA to follow the lead of the European Medicines Agency, which restricted the use of gadolinium agents and suspended the approval of others in July 2017.
Why File a Gadolinium Lawsuit?
For years, the makers of gadolinium-based contrast agents may have been aware of the risks associated with the MRI drug but failed to warn the public. As a result, people have been diagnosed with a rare disease that could lead to unexpected complications and even death.
Drug manufacturers need to be held accountable for their actions and take steps toward paying back those they harmed with their negligence.