Gadolinium Lawsuits Filed by Patients with Gadolinium Deposition Disease
UPDATED: June 21, 2018
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Gena Norris and her famous husband, Chuck Norris, filed a high-profile lawsuit in November 2017 alleging that Gena Norris is suffering from gadolinium deposition disease (GDD) as the result of multiple MRI scans that used a gadolinium-based contrast agent (GBCA) to enhance the quality of MRI images. Gena and Chuck Norris hope to use that lawsuit to shine a spotlight on a condition that is afflicting increasing numbers of patients who have undergone repeated MRIs using a GBCA. In the wake of their lawsuit, other lawsuits may follow.
The GBCA Controversy
A contrast agent is sometimes referred to as a “dye,” but it is actually a chemical compound that a radiologist injects into a patient’s body prior to an MRI scan. Not all MRIs use a contrast agent and not all contrast agents are gadolinium-based. However, GBCAs are the most common contrast agents, and radiologists routinely use them to improve the visibility of tissues and organs during certain kinds of MRIs, including brain scans and scans of blood vessels. A GBCA is administered in about 30% of MRI scans.
A Food and Drug Administration (FDA) review of scientific literature in May 2017 determined that all GBCAs “may be associated with some gadolinium retention in the brain and other body tissues.” Gadolinium is a heavy metal. While heavy-metal poisoning involving lead, mercury, arsenic and a variety of other heavy metals is well-documented, the FDA initially declined to impose limits on the use of GBCAs because it found “no evidence to date that gadolinium retention in the brain from any of the GBCAs, including GBCAs associated with higher retention of gadolinium, is harmful.”
Just seven months later, after further review of the evidence, the FDA expressed less certainty about the risks associated with gadolinium retention. Noting that gadolinium remains “in patients’ bodies, including the brain, for months to years after receiving” GBCAs, the FDA decided to require “manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.” The FDA is also requiring radiologists to provide a Medication Guide to patients who are asked to submit to an MRI using a GBCA, so that patients can make an informed choice about the risks and benefits of having a GBCA injected into their bodies.
Gadolinium Deposition Disease
The FDA is often notoriously slow to act when confronted with evidence that it has approved the medical use of drugs that turn out to be harmful. Concern about gadolinium has been rising since 2006, when researchers in Europe determined that GBCAs were probably responsible for causing a rare condition known as nephrogenic systemic fibrosis (NSF) in patients with kidney disease. Four years later, the FDA required warnings to be added to GBCA labels. Among other warnings, the FDA urged doctors not to use three GBCAs — Magnevist, Omniscan, and OptiMARK — in patients with a severe kidney disease.
A 2015 editorial published in the medical journal Radiology pointed to “clear evidence that the administration of various GBCAs results in notably varied levels of accumulation of residual gadolinium in the brain and bones of patients, even those with normal renal function.” While noting that the clinical significance of gadolinium retention in brains and bones is unclear, the editorial recognized that the widespread use of GBCAs was based on the assumption that the risks of administering a GBCA had been well-established. The editorial urged radiologists to be cautious about GBCA use until studies are undertaken to confirm or rule out “any toxic effects of residual gadolinium in organs where it is detectable, including the brain.” The editorial emphasized that studies should examine whether gadolinium deposits in the brain cause cognitive impairments.
The evidence is stronger now than it was in 2015 that gadolinium deposits in the brain are, in fact, harmful. Widely reported symptoms of GDD include bone pain, overall body pain, skin thickening, burning pain in the skin, and cognitive impairments that patients describe as “brain fog.” Evidence suggests that white women of European heritage are more susceptible to GDD than men or patients of other racial or ethnic backgrounds. Two of the GBCAs mentioned above — Omniscan and OptiMARK — are the kind of GBCAs that are most closely associated with GDD, although the European Agency for the Evaluation of Medicinal Products has also described Magnevist as a “high risk” agent.
While the pharmaceutical industry is quick to point out that no definitive study has established that gadolinium retention has harmful long-term effects, researchers have identified “four major gadolinium disorders” potentially caused by GBCAs, including GDD. While acknowledging the need for further research to strengthen the proof of a causal link between GBCAs and GDD, the researchers conclude that the symptoms of GDD are “consistent with the known toxic effects of gadolinium.” They also cite the absence of any other disease condition in patients suffering from GDD as evidence that GBCAs are responsible for GDD symptoms.
Gena and Chuck Norris Lawsuit
Patients who acquire GDD from MRI scans have the opportunity to seek a legal remedy. One example that has received widespread publicity is the lawsuit filed by Gena Norris and her husband. The lawsuit was filed against companies that manufacture and distribute the GBCAs that were administered to Ms. Norris.
The lawsuit describes Gena Norris as “a model, actress, business owner, CEO, and former deputy sheriff” who “always lived an active and athletic lifestyle before being stricken with Gadolinium Deposition Disease.” The lawsuit alleges that repeated MRIs have poisoned her body with gadolinium, leading to debilitating bouts of pain throughout her body, cognitive deficits, kidney damage, loss of mobility and energy, and difficulty breathing due to rib damage.
Gena Davis has had to pay for chelation treatments out of her own pocket because the FDA has not approved chelation as a treatment for GDD. Despite its belated recognition that GBCAs can cause gadolinium retention in the human body, the FDA has not acknowledged the existence of GDD, leaving insurance companies with an excuse to avoid paying for chelation, the most common treatment for heavy metal poisoning.
Lawsuits Provide Remedies for Patients with GDD
Hundreds of lawsuits were filed by patients who acquired NSF as a result of having an MRI using a GBCA. While NSF only afflicts patients who already have a kidney disease, patients with a healthy kidney can acquire GDD, particularly after repeated MRIs. The potential population of injury victims is so large that thousands of lawsuits against manufacturers and distributors of GBCA are expected to be filed by patients who acquire GDD. Lawsuits have already been filed by patients who were treated in Arizona, Pennsylvania, California, and many other states.
Lawsuits may provide compensation for pain and suffering, emotional distress, past and future wage loss, and the cost of past and future treatment of GDD and its symptoms. In appropriate cases, a court may permit an award of punitive damages, particularly if pharmaceutical companies continue to market GBCAs in the United States that have been deemed unsafe by regulators in Europe and Japan.
Lawsuits against pharmaceutical companies are usually based on product liability laws, negligence, and the failure to warn doctors and patients of the risk of using a drug. They are typically filed by law firms that have experience handling product liability cases involving drugs and medical devices. Patients who experience the symptoms of GDD after having an MRI that used a contrast agent should seek legal advice from a firm that is accepting cases involving GDD.
This Article is Sponsored by Advocate Law Group, P.C.
If you or a family member developed pain, skin problems, “brain fog,” or any of the symptoms described by Gena Davis after having an MRI using a gadolinium-based contrast agent (GBCA), you might have Gadolinium Deposition Disease (GDD). Patients who had an MRI can contact the medical records department of the clinic or hospital where it was performed to find out whether and what kind of gadolinium-based contrast agent was administered. A urine test can determine the presence of gadolinium in the patient’s body.
The Advocate Law Group network represents patients nationwide who are suffering from GDD in claims against the manufacturers and distributors of GBCAs. With years of experience bringing gadolinium-related claims, lawyers in the Advocate Law Group network understand the unique needs and fears of patients who suffer from GDD. You may be entitled to compensation if you have GDD, but there are strict time limits to file claims. Contact Advocate Law Group, P.C. promptly to avoid losing your right to seek a legal remedy for your condition.