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Lawyers involved in the federal litigation over gadolinium-based contrast agents, which have been linked to the development of a debilitating condition known as Nephrogenic Systemic Fibrosis, are scheduled to meet with the Court today to discuss the process for selecting the first NSF lawsuits for trial and the status of the plaintiffs’ ability to identify which of the five different gadolinium contrast agents were used in each case.
Gadolinium is a paramagnetic metal which is used during enhanced MRI and MRA scans to help doctors interpret the test. However, the use of gadolinium based contrast agents in patients with moderate to severe kidney impairment, has been linked to a rare condition which causes fibrosis or scarring of the skin and tissue throughout the body.
This devastating condition, which is known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD), causes a hardening and thickening of the skin which severely restricts movement and ultimately can be fatal.
Nearly 400 NSF lawsuits have been filed against the makers of the five different types of gadolinium contrast dyes.
In February 2008, the U.S. Judicial Panel on Multidistrict Litigation transferred all federal cases to Judge Dan Polster in the U.S. District Court for the Northern District of Ohio for coordinated and centralized handling during pretrial litigation. Nearly 300 of the lawsuits over gadolinium have been transferred to Judge Polster.
Plaintiffs’ lawyers representing individuals with NSF have been pushing the court for an aggressive trial schedule, since many of their clients are sick and may not survive a lengthy litigation.
The current scheduling plan calls for each side to designate 10 gadolinium lawsuits next month, which are supposed to be representative of the issues presented in the litigation. These 20 cases will be designated for the initial trial pool, and the parties will conduct limited discovery on those lawsuits. That group will later be narrowed down to 10 cases, which could be scheduled for trial by the middle of 2009.
Last month, gadolinium attorneys representing the manufacturers of the five different contrast agents argued that they are unable to make an informed selection of cases for the initial pool by next month, since many of the filed NSF lawsuits did not have records establishing which of the contrast agents was used in each case.
At a status conference before Judge Polster on September 24, 2008, the Court indicated that the plaintiffs’ lawyers will need to provide product identification in 75% of the cases where a plaintiff fact sheet has been exchanged before 10/1/2008. If product identification is not established in 75% of the cases, the Judge indicated that the schedule for discovery may have to be pushed back.
In advance of the hearing scheduled for today, the parties filed a joint status report listing out all of the cases involved in the gadolinium litigation where initial fact sheets have been exchanged. They indicated that approximately 500,000 pages of medical records, including 1,000 gadolinium-based contrast agent scans in over 250 NSF lawsuits, have been reviewed.
However, the parties have different views on the Court’s definition of the 75% threshold. The lawyers for the plaintiffs believe they have met the threshold for product identification, but lawyers for the defendants do not believe they have.