Judge Omniscan Ruling Good News for PlaintiffsMay 6, 2010
Attorneys representing hundreds of plaintiffs in Omniscan lawsuits have been given a wide berth by a judge overseeing the litigation. In a 58-page procedural ruling, U.S. District Judge Dan Polster restricted important parts of GE Healthcare’s case, but said most of the plaintiffs’ expert witnesses will be allowed to testify at trials.
GE Healthcare’s Omniscan is a gadolinium contrast agent used in MRI procedures. Such agents have been linked to a debilitating disease called nephrogenic systemic fibrosis (NSF). The disease leads to excessive formation of connective tissue in the skin and internal organs. It 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. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death.
While not much is known about the disease, a growing mountain of evidence indicates that NSF only occurs in people with severe kidney disease who have been exposed to a gadolinium contrast dyes like Omniscan. Since 2007, all gadolinium agents have carried the same black box warning – the Food & Drug Administration’s (FDA) strongest safety notice – regarding the risk of NSF.
GE Healthcare and the other makers of gadolinium agents are named in approximately 500 lawsuits filed by NSF patients, most of which have been consolidated in the U.S. District Court for the Northern District of Ohio as part of a multidistrict litigation (MDL) before Judge Polster.
GE Healthcare had attempted to exclude many of the plaintiffs’ theories and witnesses from the proceedings. But Judge Polster has rejected those attempts, including one that would have barred a plaintiff theory that Omniscan breaks down chemically, releasing a toxic metal that triggers the disease. He also ruled to allow the testimony of two medical school professors that the company failed to properly warn radiologists about Omniscan.
In addition, Judge Polster ruled that he would not permit GE Healthcare’s in-house expert to testify that NSF has occurred in the absence of exposure to gadolinium-based agents because the two studies that served as the basis for that opinion are “fundamentally flawed.” He also said GE Healthcare would not be allowed to introduce testimony by a former FDA official that the agency would have stopped the company from unilaterally changing its label to include stronger warnings on the NSF risk.
Judge Polster’s decision will likely make it easer for plaintiffs to present their case, and much more difficult for GE Healthcare to mount a defense.
The first trial in the multidistrict litigation, involving Omniscan, had been scheduled to start later this month, but that case has settled. The next Omniscan trial is slated for later this year.