The first civil trials involving gadolinium MRI contrast dyes are scheduled to begin early next year. Hundreds of lawsuits have been filed against the makers of gadolinium MRI contrast dyes by people who claim the agents caused them or a loved one to develop Nephrogenic Systemic Fibrosis (NSF). Gadolinium dye makers Bayer HealthCare Pharmaceuticals, Bracco Diagnostics, GE Healthcare and Mallinckrodt have all been named as defendants in the cases.
In February 2008, the U. S. Judicial Panel on Multidistrict Litigation designated the U.S. District Court for the Northern District of Ohio as the venue for NSF lawsuits pending in federal courts. The Judicial Panel on Multidistrict Litigation of the United States Courts was created in 1968. Since then, it has consolidated hundreds of thousands of lawsuits that involved high numbers of plaintiffs, including litigation over asbestos, breast implants and other matters.
Currently, there are just over 400 lawsuits pending in the Multidistrict Litigation. At a status conference held on March 6, Judge Dan Aaron Polster announced that the first trials will begin next January. The parties involved in the litigation have each selected 10 cases, known as Eligible Trial Pool Cases, which are currently undergoing early discovery in preparation for the first trials. Those 20 will be narrowed down to 10, with 5 chosen by the plaintiffs and 5 chosen by the defendants for the first trials. Defendants and plaintiffs will then select two from each sides’ list for the first four trials.
NSF is a devastating condition that affects people with pre-existing kidney problems. There is currently no cure for NSF and no one understands its specific cause. The disorder is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.
A growing mountain of evidence has linked NSF to gadolinium contrast dyes, and it is theorized that people with kidney problems may not be able to quickly eliminate gadolinium from their body. In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents if they must undergo an MRI or MRA procedure.