Gadolinium Side Effects - Gadolinium Lawyer - Gadolinium Lawsuit - Gadolinium NSF - Nefrogenic Systemic Fibrosis -Gadolinium Attorney

Specter of MRI disease haunts GE

-ProPublica

10/20/2009 - In May 2006, medical regulators in Denmark issued a warning that signaled trouble for General Electric. Danish researchers noted that, over a four-year period, 25 patients in Denmark and Austria had suffered a rare and crippling disease after undergoing an MRI, the scanning procedure used to diagnose everything from brain tumors to blown knees. The patients had been injected with a GE dye that makes images more distinct. They all had weak kidneys before receiving the dye.

The GE product, Omniscan, has since been linked to other cases of the disease, which appears to affect only MRI patients who have kidney problems. Similar drugs made by Bayer and others have also been tied to the sometimes fatal ailment, nephrogenic systemic fibrosis (NSF).

Some regulators and researchers in the U.S. and Europe have found that a disproportionate number of NSF cases are associated with GE’s Omniscan. That threatens to create a costly liability mess for the company’s growing $17 billion health-care division, which GE promotes heavily with its "Healthymagination" ad campaign. The company’s diagnostic products generate about $1.8 billion in sales. GE doesn’t provide financial figures on Omniscan.

People with NSF, or relatives of those who have died, have filed more than 400 lawsuits in U.S. federal courts against GE, Bayer and two other makers of similar drugs in the past several years. About 100 cases don’t concern Omniscan. Of the roughly 300 that do involve the GE drug, about 70 percent relate exclusively to Omniscan, according to court records and lawyers on both sides. Bayer HealthCare has some 50 percent of the U.S. market, regulators estimate. GE is next, with about 30 percent.

While GE says it is investigating concerns about Omniscan, the company maintains there is no proof that the drug, known as a contrast agent, causes disease. "NSF is a complex disease with a number of contributing factors," GE said in a February 2009 position paper. It conceded that a critical ingredient in Omniscan and other agents may be one of those factors, "but not necessarily an essential" factor. Scientists concur that they don’t fully understand how the disease starts, although nearly all cases have involved patients with kidney problems who were injected with MRI contrast agents.

The U.S. Food and Drug Administration has required since May 2007 that makers of contrast agents use a stern "black box" warning cautioning physicians to weigh carefully the benefits and risks for patients with weak kidneys. Screening out people with kidney problems appears to eliminate the danger of NSF. But the FDA has not said that GE’s product is any more problematic than those of its competitors. The agency reached that conclusion even after two of its staff doctors — in findings disclosed here for the first time — determined that Omniscan is riskier than its rivals. GE had urged the FDA to treat all of the agents as equally risky.

Now one of the nation’s leading imaging-safety experts, Dr. Emanuel Kanal, a professor at the University of Pittsburgh Medical Center, says the FDA’s decision to lump all contrast agents together is "inappropriate and indefensible." Kanal warns that the government’s position potentially "endangers American citizens." The FDA, while defending its stance, says it will meet with Kanal to look at fresh data. (Kanal isn’t working for any of the parties in the lawsuits.)

A spokesman for GE Healthcare, Ryan Fitzgerald, declined to comment specifically on the litigation or the FDA’s position on contrast agents. GE is "confident" in its "legal positions," he added. On its corporate Web site, the company says Omniscan is superior to rival contrast agents because its "low viscosity" makes it easier to inject.

(GE Healthcare issued a response on Oct. 16, in which it said this story "unfairly characterizes GE’s relationships with its customers.")

The companies that have been sued deny liability. In recent months, Bayer HealthCare has settled more than 100 cases related to its contrast agent