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According to allegations raised in a recently filed product liability lawsuit, side effects of the gadolonium MRI contrast dye MultiHance make it not fit for human use, indicating that it can cause individuals to suffer painful and debilitating fibrosis in the organs, skin and bones following an examination.
The complaint (PDF) was filed by Reginald Brown in the U.S. District for the Northern District of California on August 28, indicating that Bracco Diagnostics, Inc. never should have introduced or marketed MultiHance for injection in humans undergoing an MRI without proper warnings and directions about the dangers associated with its use.
Brown indicates that gadolinium contained in MultiHance remained in his body after receiving the MRI contrast dye, resulting in fibrosis throughout his body and retention of the toxic gadolinium in his brain. The lawsuit notes that Brown did not have any kidney condition that would have prevented his body from filtering the gadolinium out of his system.
“Gadolinium is a highly toxic heavy metal and rare earth element. It does not occur naturally in the human body. The only known route for gadolinium to enter the human body is by injection of a gadolinium-based contrast agent,” the lawsuit states. “Plaintiff maintains that Defendant’s GBCA is defective, dangerous to human health, unfit and unsuitable to be marketed and sold in commerce, and lacked proper warnings and directions as to the dangers associated with its use.”
In recent years, these complications from MRI/MRA contrast dyes have come to be known as gadolinium deposition disease (GDD), which has been linked to reports of persistent headaches, reduced cognitive function, bone and joint pain, thickening of soft tissues and other complications. Similar side effects have been reported among individuals who received Omniscan, Magnevist, Optimark and other linear gadolinium contrast agents during MRI and MRA exams
Brown’s claim joins a growing number of MRI gadolinium contrast lawsuits filed in recent months, each raising similar allegations that the manufacturers knew, or should have known, about the risks associated with their products, but failed to provide adequate warnings for patients or the medical community.
Gadolinum Toxicity Problems
Warnings about risks associated with gadolinium retention were previously issued for individuals with an acute kidney injury or chronic kidney disease about 10 years ago. However, gadolinium deposition disease is seen among patients with normal kidney function, who are not warned about the risk of these problems before agreeing to undergo an MRI with contrast.
Several studies have found evidence that gadolinium from MRI contrast dyes may build up in the brain, leading the FDA to require more thorough research to help determine whether further restrictions need to be placed on the use of the contrast agents.
In December 2017, the FDA issued a drug safety communication for Omniscan and other gadolinium-based contrast agents, including Gadavist, OptiMark, Magnevist and others, providing new information about the risk of gadolinium retention and potential side effects, even for individuals with normal kidney function.
The manufacturers were required to provide new warnings and information in a Medication Guide, which all patients receiving an MRI contrast dye will be asked to read.
The FDA also recommended that health care professionals consider the fact that the body retains gadolinium when deciding whether to give it to patients that may be at higher risk of health problems. These include women who are pregnant or think they may be pregnant, patients with kidney problems, children, and patients when inflammatory conditions. The recommendations also suggest that repeated use of the contrast agents be minimized where possible, particularly when MRIs are scheduled closely together.
Patients are now urged to tell their health care professionals whether they are pregnant or may be pregnant, whether they have kidney problems, and the date of their last MRI with gadolinium, or whether they have had repeated MRI scans that involved the use of gadolinium contrast agents.
In the coming months, as more individuals contact lawyers about problems that may be the result of gadolinium allergic reactions or toxicity, the size and scope of the litigation is expected to increase dramatically.