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The makers of Omniscan and Multihance face a new product liability lawsuit, which alleges side effects of gadolinium in the MRI contrast agents caused an Illinois woman to develop painful and debilitating injuries after the toxic metal was retained in her body.
The complaint (PDF) was filed by Pearl Pierik and her husband, John, in the U.S. District Court for the District of Massachusetts on August 13, indicating that GE Healthcare, Bracco Diagnositics, Inc. and McKesson Corporation failed to adequately warn about the risk that individuals may be left with gadolinium deposits long after undergoing an MRI or MRA with contrast.
Pierik indicates that she was injected with Omniscan before receiving magnetic resonance imaging (MRI) scans twice in August 2013, and was injected with MultiHance in March 2010, twice in September 2014, and again in August 2016.
Although she had normal kidney functions, and representations were made by the manufacturer that the gadolinium would pass safely out of her body, the lawsuit indicates that gadolinium deposits have resulted in fibrosis of her organs, skin and bones, and other problems.
“The gadolinium from Omniscan and MultiHance does not wash out of a patient’s body as readily as promised, and instead can be retained indefinitely or permanently in multiple organs and soft tissues (e.g., brain, heart, liver, kidney, bones, and skin) in patients with normal renal function,” Pierik’s lawsuit states. “This gadolinium, a toxic heavy metal, causes fibrosis in organs, bone, and skin, other adverse reactions, and crosses the blood-brain barrier and deposits in the neuronal nuclei of the brain.”
In recent years, these complications from MRI/MRA contrast dyes have come to be known as gadolinium deposition disease (GDD), and similar side effects have been reported among individuals who received Magnevist, Optimark and other linear gadolinium contrast agents during MRI and MRA exams
Pierik’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.
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 problems that may be the result of gadolinium allergic reactions or toxicity, the size and scope of the litigation is expected to increase dramatically.