Gadolinium is linked to adverse health effects on patients with renal insufficiency or kidney failure, including Nephrogenic Systemic Fibrosis (NSF), which causes fibrosis of the skin and connective tissues and scarring of organs including lungs, heart, and liver and may lead to death.

Beasley Allen attorneys Andy D. Birchfield, Jr., and Benjamin L. Locklar filed the complaint in United States District Court, Northern District of Ohio Eastern Division under Judge Dan Aaron Polster on behalf of plaintiffs Caroll L. Jett, a resident of Fulton County, Illinois, and Malicia A. Moody, a resident of Wilcox County, Alabama.

This is a Multidistrict Litigation (MDL) against defendants Bayer Corporation; Bayer Healthcare LLC; Bayer Pharmaceuticals Corporation; Bayer Healthcare Pharmaceuticals, Inc.; Berlex Laboratories, Inc.; Berlex, Inc.; Bayer Schering Pharma AG; and Bayer AG.

The complaint alleges the defendants designed, manufactured and marketed the gadolinium-based contrast agent Magnevist, which is an injectable Paramagnetic contrast agent for magnetic resonance imaging (MRI), containing the metal gadolinium.

The lawsuit alleges the manufacturers of the gadolinium-containing products acted in a conscious, intentional, willful, wanton, reckless, fraudulent and inappropriate way with total disregard for the rights and safety of those persons who used their products, and as a result the plaintiffs suffered significant and lasting harm.

Official Complaints

Gadolinium Lawsuit – Malicia Moody v. Gadolinium

SOURCE: Gadolinium and NSF › Beasley Allen files two gadolinium lawsuits

When gadolinium is in the bloodstream, medical imaging devices produce clearer, more defined images of the patient’s blood vessels. Since gadolinium is extremely toxic to human tissue, it must first be coated with a benign chemical before being injected into the patient. Over the course of time, the body expels the metal through the kidneys.

Patients with poor kidneys, however, experience a buildup of the toxic metal in their body. The protective coating on the gadolinium eventually breaks down and the patient begins to experience the symptoms of Nephrogenic Systemic Fibrosis (NSF).

Currently, 391 lawsuits have been filed in state and federal courts against manufacturers of the gadolinium based contrast dyes. 287 cases pending in Multidistrict Litigation are now moving forward in the U.S. District Court for the Northern District of Ohio. The remaining 104 NSF lawsuits are pending in state courts. The U.S. Judicial Panel on Multidistrict Litigation designated the Northern District of Ohio to handle all NSF lawsuits pending in federal courts. Last week, the presiding judge established ground rules for the consolidated cases now moving forward.

Defendants named in the suits are GE Healthcare, Bayer Healthcare Pharmaceuticals, Bracco Diagnostics, and Mallinckrodt.

The very first cases of NSF were identified in 1997. NSF is a debilitating disease for which there is currently no known cure. Symptoms include fibrosis of the skin, eyes, joints, and internal organs, hardened skin, limited movement, high blood pressure, dark patches, redness, itchiness, burning, and swelling of skin, soreness of hips and ribs, muscle weakness and limited movement. Progression of the disease can lead to severe rigidity in the joints and death.

SOURCE: Gadolinium and NSF › Gadolinium federal lawsuits move ahead

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.

October 30th, 2007

SOURCE: Gadolinium and NSF › NorCal man blames MRI dyes for illness