Omniscan plaintiffs were bolstered by U.S. District Judge Dan Polster’s recent decision regarding their lawsuits. In a 58-page procedural ruling, the judge restricted key parts of GE Healthcare’s case, but said most of the plaintiffs’ expert witnesses will be allowed to testify at trials.

GE Healthcare tried to exclude many plaintiff’ theories and witnesses from the proceedings, but Judge Polster rejected those attempts, including one that would have barred a plaintiff theory that Omniscan breaks down chemically, releasing a toxic metal that triggers the debilitating disease called nephrogenic systemic fibrosis (NSF). He will also allow testimony by two medical school professors that the company failed to properly warn radiologists concerning Omniscan.

In addition, Judge Polster ruled that he would not permit GE Healthcare’s in-house expert to testify that NSF has occurred without exposure to gadolinium-based agents because the two base studies for that opinion are “fundamentally flawed.” He also said GE Healthcare cannot introduce testimony by a former FDA official that the agency would have prevented the company from changing its label to include stronger warnings on NSF risk.

GE Healthcare’s Omniscan is a gadolinium contrast agent used in MRI procedures. Such agents have been linked to NSF, a debilitating condition, that prompts excessive formation of connective tissue in the skin and internal organs. Symptoms are: high blood pressure, burning, itching, swelling and hardening of the skin. Other maladies include muscle weakness, red or dark skin patches, and pain deep in the hip bones or ribs. There is no effective treatment for the disease, which in a progressive state causes severe joint stiffness and sometimes death.

Although information is limited, growing evidence indicates that NSF occurs solely in persons with severe kidney disease who have been exposed to a gadolinium contrast dye such as 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 cited 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.

Judge Polster’s decision should make it easer for plaintiffs to present their case but more difficult for GE Healthcare to execute a defense.