Cases

Gadolinium Toxicity Lawsuit

Magnetic resonance imaging (MRI) scans of the body often include the use of a contrast dye, such as the rare, heavy metal Gadolinium, to improve the quality of the image and give doctors a better view of potential abnormalities. However, this contrast dye may pose deadly and serious side effects to patients. Concerns have been raised by regulators regarding the safety of Gadolinium, which, in some cases, can remain in the body for months or even years after an MRI is completed.

The U.S. Food and Drug Administration announced in December 2017 a new warning label for all Gadolinium-based agents and that it would require manufacturers of Gadolinium-based contrast agents (GBCAs) to conduct human and animal studies to examine risks to the kidneys and other potential effects.

Motley Rice is reviewing claims of harm involving GBCAs, including those manufactured by Bayer HealthCare Pharmaceuticals Inc., Bracco Diagnostics Inc., GE Healthcare, Guerbet LLC, and Guerbet subsidiary Liebel-Flarsheim Companny LLC.  

Contact an attorney

If you or a loved one had several MRIs with the contrast dye Gadalinium and suffered serious side effects, you may have a claim. Contact medical attorney Carmen Scott by email or call 1.800.768.4026 for more information or to discuss your potential claim.

If you believe that you may have a claim, consider contacting an attorney as soon as possible.  A statute of limitations (SOL) may limit the time you have to file a claim. If you do not file your claim within the SOL, you may lose it forever.

Gadolinium side effects

While the effects of Gadolinium retention continue to be studied, potential serious side effects to the brain, bone, skin, kidney, liver, or spleen are being investigated.  

The FDA also reports that the metal contrast agent can cause nephrogenic systemic fibrosis (NSF) in patients with pre-existing kidney failure. Symptoms of NSF may include:

  • Swelling, tightening or hardening of the skin
  • Burning, itching or severe sharp pain
  • Blisters or ulcers
  • Muscle weakness
  • Limitation of joint motion
  • Bone pain
  • Reduced internal organ function
  • Yellow plaques on the white surfaces of the eyes
  • Blood clots

In some patients, severe disability or death may result from NSF.

The FDA has also received reports of adverse effects to multiple organ systems in patients with normal kidney function. Patients at higher risk include those requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions.

Gadolinium retention background

In December 2017, the FDA announced that it would require a new class warning and additional safety measures addressing Gadolinium retention. In May 2018, manufacturers Bayer, Bracco, GE and Guerbet issued a warning to healthcare providers notifying them of updated Warnings and Precautions on product labels. Labels now warn that Gadolinium can be retained for months or years in several organ systems throughout the body. The warnings go on to state that “consequences of gadolinium retention in the brain have not been established.” The notifications also instruct physicians to provide patients with medication guides detailing the risks of Gadolinium retention prior to receiving a GBCA.