Four plaintiffs have filed a lawsuit against Bayer, GE Healthcare, McKesson Medical-Surgical and Bracco Diagnostics, alleging gadolinium toxicity. The complaint was filed in San Francisco on May 28, 2019.

Plaintiffs Tatsiana D., Tamara T., Gilberto L. and Bonnie W. claim to have suffered “severe and life altering injuries” they say are “debilitating, permanent, and excruciating, and have ruined Plaintiffs’ ability to enjoy normal and productive lives” due to exposure to gadolinium in the course of undergoing medical scans.

Plaintiffs’ Allegations

Each of the four plaintiffs underwent a magnetic resonance imaging procedure, during which they were injected with a gadolinium-based contrast agent (GBCA). All four of the plaintiffs say they had normal kidney function at the time they were injected which, according to manufacturer claims, indicated that the heavy metal substance should have passed out of their bodies through urination.

Instead, each of the four plaintiffs state that gadolinium was retained in their systems, causing them to suffer from gadolinium deposition disease, also known as GDD according to the Mayo Clinic. In addition, plaintiffs claim they have suffered from symptoms of a serious condition known as nephrogenic systemic fibrosis (NSF), which, says the Mayo Clinic, is normally a rare disease occurring in patients with end-stage kidney disease.

The defendants stand accused of failure to warn, fraudulent misrepresentation and concealment, and negligence pertaining to their gadolinium products.

About GBCAs

GBCAs are sold under various brand names, including Magnevist (Bayer Healthcare), MultiHance (Bracco) and Ominscan (GE Healthcare). These agents are injected into a patient’s bloodstream prior to undergoing medical imaging; the purpose is to enable the imaging equipment to obtain clearer, more detailed images of internal organs and other bodily systems.

There are two distinct GBCAs. One of these is known as “linear”, and the other macrocyclic. With linear GCBA, the chemical structure does not completely surround the gadolinium ion, making it more likely to come apart, leaving gadolinium in the tissues. The other type, macrocyclic, completely encloses the gadolinium ion, and is considered a safer alternative – making gadolinium toxicity less likely.

What Was Known About Gadolinium Toxicity?

Magnevist was the first GBCA to gain FDA approval in 1988. However, the risk of gadolinium toxicity, demonstrated in laboratory test animals, has been known since 1984.

The first study of gadolinium retention in humans was published in 1998, which focused on subjects suffering from kidney failure. Six years later, in 2004, a second study was completed showing the same gadolinium deposition in humans with healthy kidney function.

The potential dangers of gadolinium toxicity resulting from the use of less stable, linear contrast agents were disregarded by the industry, who claimed these agents were eliminated from the body before gadolinium could be released. Later research found that under some conditions, the contrast agents could be retained in the body for a prolonged amount of time, resulting in the release of higher levels of gadolinium into the tissues – even in patients with normal renal function.

Health Consequences of Gadolinium Toxicity

Gadolinium is meant to leave the system with 24 hours to a couple of days, but toxicity shows it remaining in the body. Symptoms of gadolinium toxicity include bone and joint pain, thickening of the skin surface due to NSF, headaches, convulsions, cognitive impairment, numbness, and generalized weakness.

The current Gadolinium Toxicity Lawsuit is Case No. 3:19-cv-2932, filed in the US District Court, Northern District of California.