An elderly man has sued several major health companies, claiming the dyes used to scan his failing kidneys caused a rare, painful and incurable disease.
Peter Gerber, 72, of San Rafael, contends that injections of dyes containing the heavy metal gadolinium caused him to develop nephrogenic systemic fibrosis, or NSF. Also known as nephrogenic fibrosing demopathy, the disease can thicken the skin, stiffen joints, restrict movement and potentially lead to death if it affects internal organs.
Only about 215 cases have been reported worldwide, all involving people with kidney disease. No cures have been reported but some patients have seen improvement after treatment to improve their kidney function, according to the International Center for Nephrogenic Fibrosing Dermopathy Research.
Gerber's lawsuit claims that people with impaired kidney function can't properly eliminate the gadolinium from their system.
Last year, the U.S. Food and Drug Administration issued an advisory that patients with moderate to "end-stage" kidney disease should avoid having medical scans that use gadolinium-based contrast dyes, such as magnetic resonance images and magnetic resonance angiographies. If the imaging is done, "prompt dialysis" following the procedure should be considered, the FDA said.
Gerber had such imaging before he underwent a kidney transplant.
His lawsuit, filed Friday in San Francisco Superior Court, names medical centers and companies involve in making, distributing and using the dyes, including Bayer Healthcare Pharmaceuticals Inc. and GE Healthcare Inc.
Both companies have added warning labels to their dyes.
"Mr. Gerber was never warned that there was any kind of risk associated with gadolinium, let alone NSF," Gerber's attorney, Lawrence J. Gornick, told the Los Angeles Daily Journal. "Because of that, he developed a life-threatening disease that will most likely take his life in a horrible way."
"There is only one identified cause of NSF, and that's gadolinium," Gornick said. "And there is only one way gadolinium gets into the human body, and that's through these contrasting agents."
Gornick said he expected to seek millions of dollars in damages.
Bayer spokeswoman Marcy Funk said Tuesday that the company could not comment on pending litigation.
"There are warning labels on the product," she said. "Patient safety is always the No. 1 priority of the company and we're working with the health authorities … on this particular issue."
GE Healthcare spokesman Brian McKaig said in a written statement that a "definitive causal relationship" between NSF and the use of gadolium-based dyes has not been established.
"GE Healthcare does not comment about ongoing lawsuits but the company is concerned for patients diagnosed with NSF "and continue to emphasize our commitment to patient care and safety," he wrote..
Gerber's is one of only a handful of lawsuits filed by people with the rare disease.