Lawsuit Alleges Gadolinium Retention from Optimark, Multihance Resulted in Severe Injuries

Published on March 8, 2019 by Sandy Liebhard

A new MRI contrast dye lawsuit claims gadolinium retention from Optimark and Multihance caused an Arizona woman to suffer severe injuries, including fibrosis in her organs, bones, and skin.

Plaintiff Had Healthy Kidneys During Gadolinium MRIs

According to a complaint filed in Arizona federal court on February 5^th, Candice Drescher received Optimark prior to an MRI on January 19, 2013. She subsequently received Multihance before additional scans on August 11, 2015 and November 8, 2016.

The toxic heavy metal did not leave Drescher’s body as expected. She continues to retain gadolinium in multiple organs, soft tissue, and her brain, allegedly resulting in permanent physical injuries. Because Dresher did not suffer from chronic kidney disease or acute kidney injury when she received Optimark and Multihance, she never received a warning regarding gadolinium retention.At the time, gadolinium contrast dye labels indicated this was only a risk for people with impaired kidney function.

However, Dresher claims that the defendants were aware for years that gadolinium retention could also occur in patients with healthy kidneys. But rather than issue appropriate warnings, they misrepresented the products’ safety and concealed this information from doctors and patients.

“Had Plaintiff and/or her healthcare providers been warned about the risks associated with linear gadolinium-based contrast agents, she would not have been administered linear gadolinium-based contrast agents and would not have been afflicted with gadolinium retention resulting in fibrosis in her organs, skin, and bones, retained gadolinium in her brain, and related injuries,” the complaint states.

History of Gadolinium Retention Warnings

Optimark and Multihance are linear gadolinium-based contrast dyes injected before an MRI to enhance the appearance of blood vessels, organs, tumors, and other images on the resulting scan. Other linear contrast dyes include Eovist, Magnevist, and Omniscan. Three macrocylic contrast dyes – Dotarem, Gadavist, and Prohance – are also on the market.

In 2007, the U.S. Food & Drug Administration (FDA) ordered gadolinium MRI dye manufacturers to add a Black Box Warning to their product labels, after gadolinium retention in kidney-impaired patients was linked to a debilitating disease called Nephrogenic Systemic Fibrosis, or NSF. However, the warnings for patients with healthy renal function remained unchanged.

The FDA ordered another update in December 2017, after subsequent studies suggested gadolinium retention also occurred in patients with healthy kidneys.

In a joint letter to healthcare providers the following May, the drugs’ manufacturers finally warned that:

• Gadolinium may be retained in the body long after injection, including the bones, brain, and other organs.
• Linear agents cause more retention than macrocylic agents.
• Pathological skin changes, as well as adverse events involving multiple organ systems, had been reported in patients with normal kidney function.
• Certain patients are at higher risk for gadolinium retention, including those who receive multiple lifetime doses, pregnant women, children, and patients with inflammatory process.