Lawsuit Filed Against Manufacturers of MRI Contrast Agents

Bayer and GE named in suit

11/02/07

On October 30, 2007, the Associated Press reported that an elderly man filed a lawsuit against several major health companies involved in making, distributing, and using dyes used in magnetic resonance imaging (MRI) and X-Rays for diagnostic purposes. The lawsuit names medical centers as well as manufacturers, including Bayer Healthcare Pharmaceuticals Inc. and GE Healthcare Inc.

72-year-old Peter Gerber underwent imaging before undergoing a kidney transplant. Gerber contends that injection of contrasting agents containing gadolinium, a paramagnetic metal ion, caused him to develop nephrogenic systemic fibrosis (NSF).

Contrasting agents are injectable solutions which improve the resolution of interior body images. Contrast agents improve image resolution by increasing the level of brightness in parts of the body where the agent is injected. Contrasting agents help to create clear pictures of the brain, spine, heart, tissues of joints, and the inside of bones.

Impaired kidneys can not properly eliminate gadolinium from the renal system, which leads to the development of NSF. NSF is a serious skin disease that can thicken the skin, stiffen the joints, restrict movements, and potentially lead to death if it affects internal organs.

“There is only one identified cause of NSF, and that’s gadolinium,” said Gerber’s personal injury attorney *. “And there is only one way *gadolinium gets into the human body, and that’s through these contrasting agents.”

In May 2007, the U.S. Food and Drug Administration (FDA) requested a boxed warning on all gadolinium-based contrast agents, considered the agency’s most severe warning of serious injury or death, due to the risk of NSF. The agency advised physicians and patients that patients with moderate to “end-stage” kidney disease avoid magnetic imaging scans using gadolinium-based contrast agents.

As of September 12, 2007, more than 250 cases of NSF have been reported. All of these patients had kidney disease and were given gadolinium-based contrast agents.

“Mr. Gerber was never warned that there was any kind of risk associated with gadolinium, let alone NSF,” said Gerber’s attorney. “Because of that, he developed a life-threatening disease that will most likely take his life in a horrible way.”

There is no cure for NSF. Some patients have seen improvement after treatment to improve their kidney function.

Sources: “NorCal man blames MRI dyes for illness,”Associated Press, October 30, 2007; U.S. Food and Drug Administration Release P07-90, May 23, 2007; “Important drug warning for gadolinium-based contrast agents,”, September 12, 2007.

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