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As a growing number of gadolinium toxicity lawsuits continue to be filed throughout the federal court system against the manufacturers of MRI contrast dyes, alleging that the toxic metal left individuals with painful and debilitating injuries, a panel of federal judge has agreed to hear oral arguments next month to evaluate whether all of the cases should be centralized before one judge for coordinated pretrial proceedings.
The makers of linear gadolinium-based contrast agents, such as Magnevist, Omniscan, MultiHance and others, currently face nearly two dozen complaints filed in various different U.S. District Courts nationwide. However, it is widely expected that hundreds of additional cases may be filed in the coming months by individuals who suffered toxic side effects from the MRI contrast dyes.
Each of the lawsuits raise similar allegations, indicating that the manufacturers provided false and misleading information about the safety of the contrast agents used to enhance MRI and MRA exams. While individuals with normal kidney function are told that the dye passes out of the body following the exam, recent studies have found that toxic gadolinium deposits may accumulate in the brain, organs and body.
Plaintiffs claim that they would not have agreed to undergo an MRI or MRA with contrast if warnings had been provided about the risk that gadolinium may result in the development of persistent headaches, bone and joint pain, mental acuity problems, skin thickening and other symptoms of the toxic reaction, now commonly referred to as gadolinium deposition disease.
Last month, a group of plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML), requesting that all MRI contrast dye cases be centralized before one judge in the Northern District of California. Known as a federal multidistrict litigation, or MDL, transferring the cases is designed to reduce duplicative discovery into common issues in the litigation, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and court system.
In a notice of hearing session (PDF) issued on August 16, the U.S. JPML indicated that oral arguments will be heard on the matter at the Phillip Burton United States Courthouse in San Francisco, California on September 27.
Gadolinium Toxicity Concerns
About ten years ago, manufacturers of the MRI contrast dyes faced a number similar lawsuits over toxic side effects of gadolinium for individuals with pre-existing kidney injuries, who did not properly process the dye out of their system. However, the new cases involve claims for individuals with normal kidney function, who claim they were not adequately warned about the risk that gadolinium may build up in their body.
In recent years, several studies have found evidence that gadolinium from MRI contrast dyes may accumulate 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 linear gadolinium-based contrast agents, including Omniscan, 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 are now required to provide new warnings and information in a Medication Guide, which all patients receiving an MRI contrast dye will be asked to read.
In the coming months, as more individuals contact lawyers about toxic MRI dye problems that resulted in pain or other problems, the size and scope of the litigation is expected to increase dramatically.