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Bayer and General Electric face a product liability lawsuit over MRI/MRA contrast agents Magnevist and Omniscan, alleging that the gadolinium-based dyes caused a Georgia woman to develop persistent pain and fibrosis in the body’s skin and organs.
According to a complaint (PDF) filed by Kimberly Ann Viruet in the U.S. District Court for the District of Massachusetts on July 31, gadolinium retained in the body after MRI/MRA contrast injections caused her to suffer a toxic condition, which is progressive and has no known cure.
Viruet indicates that Bayer’s linear gadolinium-based contrast agent (GBCA) Magnevist was injected during a magnetic resonance angiogram (MRA), and General Electric’s Omniscan was injected during a magnetic resonance imaging (MRI) scan.
“Plaintiff Kimberly Ann Viruet had normal kidney function at the time she was injected with these GBCAs,” the lawsuit states. “The gadolinium that Ms. Viruet was injected with was retained in her body and resulted in fibrosis in her organs, skin, and bones, retained gadolinium in the neuronal nuclei of her brain, and related injuries.”
In recent years, these problems from MRI/MRA contrast dye have come to be known as gadolinium deposition disease (GDD), and similar side effects have been reported among individuals who received MultiHance, Optimark and other linear gadolinium contrast agents during MRI and MRA exams
Viruet’s claim joins a growing number of MRI/MRA 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.
Concerns About Gadolinium Retention
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 MRI contrast problems that may be the result of gadolinium allergic reactions or toxicity, the size and scope of the litigation is expected to increase dramatically.