In May 2006 medical regulators in Denmark issued a warning that signaled trouble for General Electric (GE). 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 (BAY) 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% relate exclusively to Omniscan, according to court records and lawyers on both sides. Bayer HealthCare has some 50% of the U.S. market, regulators estimate. GE is next, with about 30%.
snip
The companies that have been sued deny liability. In recent months, Bayer HealthCare has settled more than 100 cases related to its contrast agent, Magnevist, according to lawyers and court records.
snip
Omniscan and comparable products contain the potentially toxic metal gadolinium. During MRIs, the metal helps physicians see the brain and other parts of the body. Healthy kidneys filter out gadolinium. But patients with severely impaired kidneys can become victims of NSF, according to the FDA.
NSF starts with painful swelling in the legs and arms. It progresses to lesions in the skin and connective tissues, and it can attack organs, causing death. So far, there is no cure.
http://www.businessweek.com/magazine/content/09_43/b4152052049124.htm