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According to allegations raised in a lawsuit filed last week against Bayer Healthcare, side effects of a gadolinium MRI contrast dye caused a California man to suffer painful and debilitating health problems, after the toxic metal was retained in his body.
In a complaint (PDF) filed in the U.S. District Court for the Northern District of California on July 11, Joseph Lewis indicates that he continues to suffer symptoms associated with retained gadolinium, which causes fibrosis in organs, bone, and the skin.
Lewis indicates that he was injected with Magnevist contrast dye before undergoing magnetic resonance imaging (MRI), in order to enhance the results. However, the gadolinium-based injection allegedly caused a toxic reaction in his body, resulting in painful and debilitating symptoms.
“The type of gadolinium retention sustained by Plaintiff Joseph Lewis occurs in patients with normal or near-normal renal function that develop persistent symptoms that arise hours to months after the administration of a linear gadolinium-based contrast agent,” the lawsuit states. “People suffering from gadolinium retention experience symptoms consistent with the known toxic effects of retained gadolinium. Typical clinical features include persistent headaches, bone and joint pain, and clouded mental activity.”
The lawsuit presents claims of negligence and failure to warn, joining a growing number of similar of MRI contrast dye lawsuits filed in recent months. Each of the complaints allege 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 Retained Following MRI With Contrast
Warnings about risks of gadolinium side effects among individuals with an acute kidney injury or chronic kidney disease were previously issued 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.
In recent years, 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 Magnevist and other gadolinium-based contrast agents, including Gadavist, OptiMark, Omniscan 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.