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After receiving injections of the gadolinium-based MRI contrast dye MultiHance, a recently filed product liability lawsuit indicates that a Louisiana man developed painful and debilitating side effects, known as Gadolinium Deposition Disease (GDD).
The complaint (PDF) was filed by Jay Thomas in the U.S. District Court for the Western District of Louisiana on April 17, indicating that Bracco Diagnositics, Inc. manufactured and sold the MRI dye with full knowledge of its dangerous and defective nature, yet withheld warnings from patients and the medical community.
Thomas indicates that he had normal kidney function before undergoing several MRIs, at which time he was injected with the gadolinium-based contrast agent (GBCA) MultiHance, which was designed to enhance the images resulting from the exam. Although Bracco represented that MultiHance was safe for use in conjunection with MRIs, Thomas later developed Gadolinium Deposition Disease, which was caused by a build up of the toxic metal in his body, resulting in burning sensations, clouded thinking, confusion, weakness, fatigue, difficult and painful movement, inflammation, muscle cramps, numbness, tingling sensations, aching joints, and lumps and rashes on the body.
“These symptoms are consistent with the known toxic effects of retained gadolinium,” the lawsuit states. “Gadolinium is a highly toxic heavy metal. It is not found naturally in the human body. The only known route for gadolinium to enter the human body is injection of a GBCA.”
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.
Thomas presents charges of failure to warn, negligence, negligent misrepresentation, negligence per se, breach of warranty, fraudulent misrepresentation and concealment and civil battery. His complaint joins a growing number of MRI dye gadolinium deposit lawsuits filed in courts nationwide, and the size of the litigation is expected to continue to increase over the coming months and years.