The Multidistrict Litigation in U.S. District Court established for hundreds of  lawsuits filed against the makers of gadolinium contrast dyes by victims of Nephrogenic Systemic Fibrosis (NSF) has reached a new phase.  At a September 24 conference, ground rules for the consolidated discovery phase of hundreds of cases were established by the judge overseeing the litigation.

For the next Multidistrict Litigation conference, lawyers must provide product identification in approximately 75% of the cases where a plaintiff fact sheet has been exchanged prior to October 1 before the case can be designated for an early trial pool.  By November, attorneys for both sides must also choose 10 cases each  to undergo discovery. The 20 cases will be reduced to 10 by May 2009 for the court to begin case-specific expert discovery.  By January 23, lawyers for plaintiffs must also submit expert reports limited to any generic experts they may call in the initial trials.

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.   As of September 24, there were 287 NSF lawsuits pending in the Multidistrict Litigation. Another 104 lawsuits have been filed in various state courts throughout the U.S.  Gadolinium dye makers  Bayer HealthCare Pharmaceuticals, Bracco Diagnostics,  GE Healthcare  and Mallinckrodt have all been named as defendants in the cases.

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.

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.