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.
According to a complaint filed in Arizona federal court on February 5th, 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.
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: