Nephrogenic systemic fibrosis. Source: Mass General Hospital

The pretrial proceedings for the mounting federal gadolinium contrast dyes product lawsuits will be consolidated in the Northern District of Ohio, according to a transfer order from the U.S. Judicial Panel on Multidistrict Litigation (MDL).

Since January 2008, complaints have been filed on behalf of patients who allege that exposure to gadolinium-based contrast agents is directly related to nephrogenic fibrosing dermopathy (NSF/NSD), a disease diagnosed in each plaintiff.

NSF/NSD can occur in patients with kidney disease, who undergo an MRI or MRA, when a gadolinium-based contrast agent has been used.

Judge Dan A. Polster will oversee the discovery process for all federal lawsuits within the jurisdiction, to provide a central forum for the nationwide litigation.

The centralization will “serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation,” according to the panel’s order.

The Southern District of Ohio was originally considered as a transferee district; however, the defendants, GE Healthcare, Bayer Healthcare Pharmaceuticals, Novation and Tyco, suggested the Northern District of Ohio, according to the transfer order.

Bracco Diagnostics opposed the centralization of all claims against Bracco, the Tyco defendants, or the Bayer defendants, and instead suggested creating a separate MDL for each defendant group, or the District of Kansas as a transferee district.

Bracco argued against the centralization, saying:

• the actions do not share sufficient questions of fact because each of the contrast agents is chemically and pharmacologically different;
• because of the unique properties of each contrast agent, a global MDL will impinge upon due process rights of the separate defendant companies;
• when each different group is considered separately, there are too few actions to warrant MDL treatment for any claims other than those involving the GE defendants; and
• alternatives to centralization are available and sufficient to coordinate the small number of claims involving Bracco and the Tyco and Bayer defendants.

The panel was not persuaded by these arguments and instead wrote that the transfer order would “streamline pretrial proceedings in all actions while concomitantly directing the appropriate resolution of all claims.”

In May 2007, the FDA ordered a black box warning for all gadolinium-based contrast agents for MRI, detailing an increased risk of NSF with kidney disease patients. The warning was to be added to the labels of the five FDA-approved gadolinium-based contrast agents: gadopentetate dimeglumine (Magnevist), gadodiamide (Ominiscan), gadoversetamide (OptiMARK), gadobenate dimeglumine (MultiHance), and gadoteridol (ProHance).