The manufacturer of MultiHance is facing yet another lawsuit over Gadolinium Deposition Disease, an incurable and debilitating disorder that allegedly occurs after the administration of gadolinium-based MRI contrast agents.
According a complaint filed in the U.S. District Court, Western District of Louisiana, on April 17th, Jay Thomas unknowingly developed Gadolinium Deposition Disease shortly after he underwent several MRIs with Bracco Diagnostics’ MultiHance. Thomas had healthy kidneys when he received the gadolinium agent, but subsequently developed a range of debilitating symptoms, including a burning sensation, cloudy mental state, confusion, weakness, fatigue, difficult and painful movement, inflammation, muscle cramps, numbness, tingling sensation, aching joints, and lumps and rashes on his body. (Case No. 3:19-cv-00493)
“These symptoms are consistent with the known toxic effects of retained gadolinium,” his MultiHance lawsuit states. “Gadolinium is a highly toxic heavy metal. It is not found naturally in the human body. The only known route for gadolinium to enter the human body is injection of a GBCA.”
By the time Thomas underwent his MRIs, Bracco was allegedly aware of multiple case reports, assessments, papers, peer-reviewed studies, and other clinical data that had demonstrated a potential for gadolinium retention in patients with healthy kidneys. According to his MultiHance lawsuit, people suffering from Gadolinium Deposition Disease had also made a significant number of publicized complaints.
“Defendant has repeatedly and consistently failed to advise consumers and/or their healthcare providers of the causal relationship between gadolinium-based contrast agents and GDD. Defendant knew or should have known of the risk of GDD posed by GBCAs (including MultiHance) to individuals with normal or near-normal kidney function,” the complaint charges. “Had Plaintiff and/or his healthcare providers been warned about the risks associated with GBCAs (including MultiHance) he would not have been administered GBCAs and would not have been afflicted with GDD.
Gadolinium contrast dyes help improve the visibility of images on an MRI scan. The U.S. Food & Drug Administration (FDA) has approved eight of these agents for use in the United States:
They are currently contraindicated for patients with impaired kidneys, as their inability to eliminate toxic gadolinium from their bodies can cause to a life-threatening disease call Nephrogenic Systemic Fibrosis. Until recently, however, it was assumed gadolinium would be eliminated fairly quickly when the kidneys functioned normally.
In December 2017, the FDA warned that multiple recent studies had suggested gadolinium could also accumulate in the brain, tissue, organs, and skin, even in patients with healthy kidneys. The agency has yet to link gadolinium retention to any adverse health effects, but noted that pathological skin changes and adverse events involving multiple organ systems been reported in patients with normal kidney function.
Linear gadolinium agents, including MultiHance, Eovist, Magnevist, MultiHance, Ominiscan, and OptiMark, appear to be associated with the higher rates of retention than their macrocylic counterparts. Patients who’ve received multiple lifetime doses of gadolinium, pregnant women, children, and those with inflammatory process face the greatest risk.