According to U.S. District Judge Dan Polster, Bayer Healthcare has initiated settlement negotiations with a number of plaintiffs who have filed Nephrogenic Systemic Fibrosis lawsuits after receiving the gadolinium-based Magnevist MRI contrast agent.

The cases have been filed against Bayer by individuals with pre-existing kidney issues who developed a rare condition known as Nephrogenic Systemic Fibrosis (NSF), which is associated with the progressive hardening and thickening of the skin and other tissues throughout the body.

About 400 gadolinium lawsuits have been filed in state or federal courts against Bayer and the makers of four other similar types of MRI contrast agents, including GE Healthcare’s Omniscan, Bracco Diagnostics’ MultiHance and ProHance, and Mallinckrodt’s OptiMARK.

The NSF lawsuits all allege that the manufacturers did not conduct adequate testing for their products and failed to warn consumers about the risk of developing the debilitating and potentially life-threatening disease.

Most of the lawsuits filed have involved the use of GE Healthcare’s Omniscan contrast agent. However, Bayer’s Magnevist has been identified as the contrast agent used in over 60 of the Nephrogenic Systemic Fibrosis lawsuits filed so far in federal court.

Although details of any gadolinium settlement negotiations have not been publicly released, during a recent status conference held on March 6, 2009, Judge Polster confirmed that discussions have taken place and suggested that several cases may settle in the near future.

The federal gadolinium litigation has been consolidated before Judge Polster in the United States District Court for the Northern District of Ohio for purposes of pretrial litigation. The Court has pushed for an aggressive trial schedule since many of the plaintiffs are very ill and may not survive lengthy litigation, which has put pressure on the manufacturers.

The parties have each selected 10 cases, known as Eligible Trial Pool Cases, which are currently undergoing early discovery in preparation for the first trials that are expected to begin next year.

Judge Polster has agreed to allow the parties to substitute any current Eligible Trial Pool Case that settles before April 6, 2009 with another lawsuit.

The final list of 20 cases will later be narrowed down to 10, with 5 chosen by the plaintiffs and 5 chosen by the defendants for the first trials. The parties will then attempt to agree on the first four which will be scheduled for trial, with two from each side’s list.

Tags: Bayer, Gadolinium, Magnevist, MRI, MRI Contrast Agent, Nephrogenic Systemic Fibrosis, NSF, Omniscan