OptiMark Side Effects Caused Fibrosis In Skin, Organs and Bones from MRI Dye Injection, Lawsuit Claims
A lawsuit filed against the makers of the gadolinum-based contrast agent (GBCA) OptiMark alleges that side effects of the MRI dye injection caused fibrosis of the skin, organs and bones, resulting in permanent injuries.
John Carney filed the complaint (PDF) in the U.S. District Court for the Eastern District of Missouri last week, naming Guerbet, LLC, Mallinckrodt, LLC, and Liebel-Flarsheim Company as defendants.
According to the lawsuit, Carney received a dye injection of OptiMark before undergoing a magnetic resonance imaging (MRI) scan. He now claims that the injection left residue of the toxic metal gadolinium in his body for years, resulting in gadolinium retention and fibrosis of skin, bones and organs.
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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, and other linear gadolinium contrast agents during MRI and MRA exams in recent years.
Carney’s claim joins a growing number of MRI dye injection 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.
“Plaintiff’s primary injuries alleged herein are related to gadolinium retention in multiple organs (brain, heart, liver, kidney, bones, and skin). The gadolinium, a toxic heavy metal, causes fibrosis in organs, bone, and skin, and crosses the blood-brain barrier and deposits in the neuronal nuclei of the brain,” the lawsuit states. “Plaintiff was never warned about the risks of gadolinium retention because he had normal renal function and the GBCA manufacturers chose to only provide warnings to patients with reduced renal function.”
Gadolinum Toxicity Problems
Warnings about risks associated with gadolinium first emerged about 10 years, among individuals with an acute kidney injury or chronic kidney disease. However, gadolinium deposition disease is seen among patients with normal kidney function, who are not currently warned that the toxic metal may remain in their body and cause fibrosis of the skin, bones and organs after an MRI
Several studies have found evidence that gadolinium from MRI contrast dyes may build up in the brain or other parts of the body, 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 become 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.
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