Gadolinium Mass Tort Review
Gadolinium Mass Tort
Gadolinium is a chemical element, discovered in 1880 that is silvery-white in color. It has some paramagnetic properties because of which it is used intravenously in diagnostic imaging procedures to better the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA). The first GBCA, Magnevist by Bayer, was approved in the U.S. in 1988.
Magnetic Resonance Imaging (MRI) is a medical imaging procedure used for making images of the internal structures of the body. MRI scanners work by making images using strong magnetic fields and radio waves (radiofrequency energy). Gadolinium-Based Contrast Agents (GBCA) are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA).
FDA has mostly approved all the GBCAs for an intravenous (IV) administration in radiology imaging as they can provide greater contrast between normal and abnormal tissues within the body. Gradually, it came to notice that these contrast agents do not leave the body immediately as they were supposed to. Gadolinium excretes out of the body through the kidneys, but due to its deposition in the body, it causes Gadolinium Deposition Disease (GDD) to give permanent injuries to kidneys. GDD is incurable, and symptoms can begin anytime from hours to months after the application of GBCA.
The five linear forms of the contrast agents include Magnevist manufactured by Bayer-Schering; MultiHance developed by Bracco Diagnostics; Omniscan created by GE Healthcare; OptiMARK manufactured by Mallinckrodt Inc.; and ProHance also manufactured by Bracco Diagnostics.
SERIOUS ALLEGED INJURIES MAY INCLUDE:
FDA SAFETY WARNINGS:
Defendants: Bayer Healthcare; GE Healthcare; Covidien, McKesson, Bracco Diagnostics, Inc., Guerbet, LLC, Mallinckrodt Inc., Liebel Flarsheim Company LLC, and other defendants
Defendants’ Lead Counsel:
Defendants' Liaison Counsel: Charna Sherman, Esq. - Squire, Sanders & Dempsey LLP
Allegations: Allegations made in the gadolinium lawsuits are that the makers of the contrast agents did not warn patients about the health risks associated with the use of gadolinium-based contrast agents.
Plaintiff Steering Committee
2008: Over 250 Nephrogenic Systemic Fibrosis (NSF) lawsuits filed in federal courts throughout the US were consolidated and centralized for pretrial litigation in an MDL No. 1909 in the U.S. District Court for the Northern District of Ohio before Judge Dan Polster. Allegations included the makers failed to adequately test their products or warn that individuals could face a risk of developing NSF, a rare progressive condition which leads to the hardening and thickening of the skin, severely restricting movements and ultimately resulting in death in many cases.
2009: Bayer Healthcare initiated settlement negotiations with several plaintiffs to settle NSF lawsuits after receiving the gadolinium-based Magnevist MRI contrast agent.
2018: A growing number of lawsuits over GDD continue to be filed in courts nationwide.
On October 10, 2018, the U.S. Judicial Panel on Multidistrict Litigation (JPML), rejected a centralization motion for new GDD MDL No. 2868 against the manufacturers of gadolinium-based MRI contrast dyes stating the plaintiffs failed to demonstrate sufficient common questions of law and fact existed to justify the creation of an MDL.
The lawsuits would move forward in the U.S. District Court, where they were initially filed.
Medical Record Review and claim validation of Gadolinium case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.