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Lawyers for the plaintiffs and lawyers for the manufacturers of gadolinium based MRI contract agents, have filed a joint list of 193 NSF lawsuits which are eligible to be among the first cases prepared for trial in the consolidated federal litigation.
There are over 350 NSF lawsuits that have been filed in federal and state courts throughout the United States alleging that the manufacturers of five different gadolinium MRI contrast agents failed to adequately test their products or warn that they could cause a progressive and potentially fatal condition associated with the hardening and thickening of the skin, severely restricting movement.
All of the federal cases have been consolidated in an MDL, or Multidistrict Litigation, in the United States District Court for the Northern District of Ohio, where they are being handled by Judge Dan Polster for pretrial litigation.
The 193 cases consist of those lawsuits where the parties have agreed that there has been a “good faith substantiation” of which of the five different gadolinium contrast agents were used and where the plaintiff alleges that they have been diagnosed with Nephrogenic Systemic Fibrosis (NSF). The list was narrowed down from over 250 cases which have been consolidated in the MDL.
Nephrogenic systemic fibrosis (NSF), which is also sometimes referred to as nephrogenic fibrosing dermopathy (NFD), is an extremely rare condition and the only known cause is the use of gadolinium based contrast agents during MRI and MRA examinations. There is no known cure for the condition, and it often results in reliance on a wheelchair and could eventually lead to death.
Judge Polster has agreed to an aggressive trial schedule in the gadolinium litigation, as the plaintiffs’ lawyers have stressed that many of the cases involve individuals who are in very poor health and may not survive lengthy litigation.
The Case Management Order issued by the Court calls for each side to select 10 cases out of the 192 Eligible Trial Pool cases by January 29, 2009. These 20 cases will then under go case-specific discovery next year before being narrowed down to 10 “bellwether” cases, which are expected to go to trial toward the end of 2009 or early 2010.
With five different types of gadolinium-based contrast agents manufactured by four different defendants, the process of narrowing down the list of cases which would be eligible for an early trial took longer than the Court and parties initially anticipated.
Most healthcare providers do not indicate in the medical records which type of gadolinium contrast agent was used with a particular examination, and many plaintiffs have received multiple MRIs and MRAs before the NSF diagnosis. As a result, many of the NSF lawsuits were filed against multiple manufacturers.
According to the most recent Case Management Order issued by Judge Polster, the defendants can request that they be dismissed from any cases on the list of Eligible Trial Pool cases where their product has not been identified as one received by the plaintiff.
GE Healthcare, which manufactures of Omniscan, the contrast agent most frequently associated with the development of NSF, has filed a notice that plaintiffs are required to dismiss them as a party in 32 of the gadolinium lawsuits. Bayer Healthcare, which manufactures Magnevist, indicates that they should be dismissed from 51 lawsuits. Mallinckrodt, which manufactures OptiMARK, indicates they should be dismissed from 70 cases and Bracco Diagnostics, which manufactures MultiHance and ProHance, indicates that they should be dismissed from 69 cases.