Patients who say they were harmed by gadolinium-based contrasting agents used as dye in MRIs and other medical imaging tests are filing lawsuits against the makers of the drugs. Lawsuits say the gadolinium is retained in the body and is causing serious, life-altering injuries.
Lawsuits say patients can experience gadolinium toxicity after having an MRI scan with a linear gadolinium-based contrast agent (GBCA). Gadolinium is a metal used in MRI contrast dyes to help produce better images for doctors.
Patients who experienced side effects from gadolinium toxicity after having an MRI — and who had no known kidney issues before the scan — have filed lawsuits seeking compensation for serious injuries they sustained.
In 2018, the U.S. Food and Drug Administration approved updated prescribing information to include warnings about gadolinium retention. Side effects from gadolinium retention are progressive and can be life-threatening.
- Gadolinium toxicity
- Gadolinium deposition disease (GDD)
- Nephrogenic systemic fibrosis (NSF)
Chuck Norris Lawsuit
Perhaps the highest profile lawsuit involving gadolinium was filed by actor Chuck Norris and his wife, Gena, in 2017. The couple claimed Gena developed gadolinium deposition disease after undergoing three MRIs in which the substance was used to enhance images.
The Norrises said they spent almost $2 million for Gena’s treatment over five years. She had to be hospitalized repeatedly with debilitating pain.
She also says she is suffering other effects, including problems with thinking, kidney damage and loss of energy. She says her ribs were damaged, and she has trouble breathing. They are seeking $10 million in damages.
Part of the costs were because the couple says Gena Norris has had to seek treatment outside mainstream medicine.
“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,”
“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,” she added.
As of October 2018, the case was still pending in San Francisco.
Another California man, Jeffrey Steiner, filed a lawsuit in federal court in June 2018 claiming he was seriously injured after being injected with gadolinium during multiple MRI tests. He claimed he retained gadolinium in the neurons of his brain. His lawsuit was dismissed on July 30, 2018 by U.S. District Judge Edward J. Davila, who cited jurisdictional problems.
Federal Case Consolidation Request
After 21 federal lawsuits were filed in 12 courts on behalf of patients around the country who say they were injured by gadolinium contrasting dye, lawyers filed a motion in July 2018 with the Judicial Panel on Multidistrict Litigation. The lawyers asked the court to consolidate the cases to be managed by a single judge. Attorneys said in the motion that they expect that ultimately, hundreds of such cases will be filed.
Lawyers are asking that the cases be assigned to a judge in the Northern District of California, where there were five cases pending at the time of the motion. Two of the defendants named in lawsuits are also headquartered there. In the alternative, the lawyers suggested a court in Massachusetts.
The plaintiffs say they had normal or near-normal kidney function when they underwent MRI or MRA procedures in which a gadolinium-based contrasting agent was injected into them. They then developed symptoms consistent with the known toxic effects of gadolinium that is retained in the body.
Gadolinium-based contrasting agents are used in 33 to 50 percent of all MRIs, translating to 1.5 million procedures a year.
Consolidation of Federal Cases Denied
Two companies, Guerget and Liebel-Flarsheim, filed a response to the motion, arguing that consolidation of the cases in a multidistrict litigation (MDL) is not warranted. The companies said plaintiffs suffered different injuries, and “different combinations of unique symptoms.”
Moreover, they argued, “The overwhelming weight of scientific and regulatory findings demonstrate that there is no sound scientific or medical basis on which to conclude that GBCAs cause any adverse health effects in patients, such as plaintiffs, with normal kidney function.”
On Oct. 10, 2019, the panel denied the motion for an MDL. “We find movants have failed to demonstrate that any common questions of fact and law are sufficiently complex or numerous to justify centralization,” the panel wrote in its order. “In particular, the injuries alleged in each case appear to be highly plaintiff-specific, and the actions involve GBCAs manufactured by one or more of four different defendant groups, involving different formulations.”
In 2009, another group of gadolinium contrast dye products lawsuits was organized into an MDL that was centralized in Ohio. That MDL closed in 2015. Those lawsuits involved patients with abnormal kidney function who were given gadolinium contrasting agents and developed nephrogenic systemic fibrosis. The FDA later required a black box warning against using the dyes for patients with abnormal kidney function.
People who filed lawsuits claim GBCAs caused them to develop gadolinium deposition disease (GDD). Plaintiffs had normal kidney function at the time they developed the disease.
Gadolinium deposition disease is progressive and has no known cure.
- Persistent headaches
- Weight loss
- Kidney impairment
- Body aches and stiffness
- Bone and joint pain
- Brain fog
- Thickening of the skin that appear spongey or rubbery
- Thick, painful ligaments and tendons
- Cutting, burning pain in arms, legs and the torso
There are two basic types of GBCAs: linear and macrocyclic. These agents surround the gadolinium ions when injected into the body. This lowers toxicity levels.
Linear agents do not fully surround the gadolinium ions, and macrocyclic agents do, according to lawsuits. So, linear agents are more likely to cause gadolinium toxicity.
Settlements & Verdicts
Because lawsuits involving patients with normal kidney function are so new, there are not yet any settlements or verdicts.
But, in 2013, a jury ordered GE Healthcare to pay $5 million in a lawsuit that claimed an Ohio man, Paul Decker, developed nephrogenic systemic fibrosis (NSF) after being injected with the gadolinium-containing product Omniscan. That trial was conducted after GE had settled several hundred gadolinium cases.
Decker was retired after working 30 years at a tire company. At the time of the verdict, he was being cared for by his wife.
A federal appeals court later upheld the award and denied a defense motion to grant a new trial.
NSF is a rare condition that affects the skin and organs. The skin becomes thick and hard. As the condition progresses, multiple organs may fail. The condition may be fatal.
According to a report by ProPublica, Decker’s lawyer told jurors during the trial that Decker’s skin “feels like wood or granite.”
Decker, attorney Christopher Tisi added, “has a really hard time doing most anything.”
The case was the first to go to trial in a multidistrict litigation (MDL) in Cleveland, Ohio, involving gadolinium nephrogenic systemic fibrosis lawsuits. The patients in those cases had abnormal kidney function when they were injected with the contrasting dye.
Most of the other cases in the MDL were settled.
Please seek the advice of a medical professional before making health care decisions.