A number of recent lawsuits against global pharmaceutical giant Bayer AG cite Magnevist, a gadolinium-based contrast agent (GBCA), as the cause of action. One of them, filed by a widower and now pending in federal court, claims that the plaintiff's spouse died eight years after she was injected with Magnevist in order to undergo an MRI. The cause of death was fibrosis, cognitive impairment, and kidney failure due to the toxic metal remaining in her system. The plaintiff, like others who have filed gadolinium lawsuits, allege that manufacturer Bayer was aware of those risks before his wife was administered Magnevist in 2009.
This most recent spate of gadolinium lawsuits is not the first time Bayer has faced legal problems over its product.
The very first Magnevist lawsuit in the US was filed by a woman who had been injected with Bayer's GBCA product in the course of an MRI scan in 2001. Several years later, she was diagnosed with nephrogenic systemic fibrosis, which left her permanently disabled. The following year, Bayer settled a substantial number of the Magnevist claims against the company – but as is standard procedure in settlements, it was not required to acknowledge liability.
In 2006, the FDA issued a public health advisory, noting that a number of reports had been received suggesting a link between the use of GBCAs and NSF. The following year, the FDA recommended that Magnevist and other GBCAs should carry a strong warning about the risk of NSF. In 2010, the FDA finally mandated a change in the product labeling. At that time, it was recommended that gadolinium should not be administered to patients with impaired kidney function unless there are no alternatives and a clear image is otherwise unobtainable.
Since then, studies have found that GBCAs can accumulate in brain tissues even if the patient has fully functioning, healthy kidneys.
NSF was first identified in the late 1990s. The disorder initially presents as a skin condition, characterized by thickening and redness. Eventually, it begins to affect the internal organs, including the heart, kidneys, and lungs. NSF can also cause muscles and tendons to contract. There is no cure, although a few patients have been able to delay the progression of the disease with a kidney transplant. For patients suffering from gadolinium toxicity, however, a transplant is not an option unless the gadolinium can be removed from the patient's system.
Unfortunately, removing gadolinium from the body has proven to be difficult. Chelation has been of limited success and there are questions about its effectiveness. Dialysis can remove up to 90 percent of gadolinium if administered immediately after exposure – and requires 10 – 15 cycles.
In the meantime, the question remains whether or not Bayer and other manufacturers of GBCAs were aware of the dangerous side effects of their products, and if so, why they failed to inform the medical community and the general public.