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According to allegations raised in a recently filed product liability lawsuit, a Louisiana woman suffered severe, disabling and disfiguring injuries due to an allergic reaction to a gadolinium dye IV injection administered during CT scans and an MRI with contrast.
The complaint (PDF) was filed late last month in the U.S. District Court for the Eastern District of Louisiana by Bobby Jo Robichaux, naming GE Healthcare, Bayer, Tyco Healthcare, Mallinckrodt, Inc., and Bracco Diagnostics as defendants.
According to the lawsuit, Robichaux suffered an allergic reactions after being injected with various gadolinium-based contrast agents in July 2018, which were administered as part of a lumbar spine MRI and CT scans of her abdomen and pelvis. The defendants are the manufacturers of the gadolinium-based contrast dye’s administered, including Omniscan, Magnevist, Gadavist, MultiHance, Dotarem, ProHance, OptiMARK, Eovisst and Ablavar.
“Plaintiff has been re-admitted to the hospital several times due to ongoing complications from the IV dye,” the lawsuit notes. “Upon information and belief, the GBCAs produced by Manufacturing Defendants and used by Petitioner, is defective in its design or formulation in that it is not reasonably fit, suitable, or safe for its intended purpose and/or its foreseeable risks exceeded the benefits associated with its design and formulation.”
Gadolinium Dye Problems
In recent years, several studies have found evidence that gadolinium dye from MRI contrast dyes may build up in the brain, potentially causing users to experience an allergic reaction and other problems following an MRI with contrast. As a result of the potential risk, the FDA has required more thorough research to help determine whether restrictions may need to be placed on the use of the contrast agents.
In December 2017, the FDA issued a drug safety communication for certain types of contrast agents, providing new information about the risk of gadolinium retention and potential side effects. As a result, 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.
The case filed by Robichaux joins a growing number of gadolinium dye allergic reaction lawsuits filed in courts nationwide, and the side of the litigation is expected to continue to increase over the coming months and years.