Gadolinium MRI contrast agent has been linked to serious complications in patients who say they were never given a proper warning.

Alleged complications have also spurred legal action against GE Healthcare Inc. and other pharmaceutical companies, with patients claiming the companies knew that gadolinium would be difficult for the human body to process.

One of the most recent lawsuits was filed by a woman alleging she developed gadolinium deposition disease as a direct result of gadolinium contrast dye. Plaintiff Marcia S. reportedly underwent six MRI procedures in New York and four in Florida, each of which required her to use a gadolinium based IV contrast agent.

Marcia says she was provided the Magnevist, MultiHance, and Omniscan IV contrast agents for MRI image scans. GE Healthcare allegedly marketed these gadolinium MRI contrast products as safe. The company told patients and the medical community that they would harmlessly exit the body shortly after being administered, she says.

This was allegedly not the case for patients like Marcia, who says that the gadolinium remains inside her body even years after it was used. Marcia claims she developed severe multiple organ damage due to gadolinium deposition disease — a progressive condition with no known cure.

According to her lawsuit, Marcia suffered gadolinium toxicity effects in her brain, heart, liver, kidney, bones, and skin, with the heavy metal reportedly crossing the blood brain barrier and depositing metal particles in the nuclei of the brain.

Marcia opted to file legal action against the companies arguing that GE Healthcare allegedly knew about the dangers of gadolinium deposition disease but failed to warn her and the medical community because she had normal kidney function at the time.

Overview of Gadolinium Deposition Disease

Gadolinium is a rare heavy earth metal, which is widely utilized for MRI contrast. This is because the metal reacts to the magnetism of the medical imaging device, which makes it easier for organs, bones, and blood vessels to appear on scans.

Overall gadolinium MRI contrast is supposed to help make accurate diagnoses, but its recent association with gadolinium deposition disease is very troubling.

According to advocates at the Lighthouse Project, the FDA issued a warning stating that gadolinium contrast could stay inside patients months to even years after implementation. The FDA stated that the metal contrast could lead to nephrogenic systemic fibrosis in patients with pre existing kidney problems. However, the FDA has also received reports of multiple organ failure in previously healthy patients.

The FDA recently issued an update to this warning on May 16, 2018, stating that all MRI centers should provide a Medication Guide for first time outpatients who are set to receive a gadolinium based contrast. This is so patients understand the risks associated with gadolinium IV contrasts, which will hopefully help prevent further incidents of gadolinium deposition disease.

Along with GE Healthcare, Bayer Healthcare has been named as a defendant in the gadolinium MRI lawsuit for manufacturing, producing, and selling Magnevist contrast dye.

Marcia alleges she was never warned about the dangers of gadolinium retention because she had normally functioning kidneys. She alleges that GE Healthcare had only chosen to disclose this information to patients with compromised renal function.

This Gadolinium MRI Lawsuit is Case No. 1:18-cv-11169, in the U.S. District Court for Southern New York.