A last-minute settlement has averted what would have been the first trial involving General Electric’s drug Omniscan and allegations that it has caused patients to contract a crippling disease.
The terms of the settlement, reached late Sunday night, are confidential, said lawyers involved in the case, which was scheduled to start today in U.S. District Court in Cleveland.
As ProPublica has reported, had it gone before a jury, the case could have provided the first public disclosure of evidence behind claims that Omniscan, a drug used to enhance MRIs, caused hundreds of kidney patients to suffer nephrogenic system fibrosis, a rare and potentially fatal condition, and that GE’s health care unit hid the drug’s risks.
The main plaintiff in the Cleveland case, Loralei Knase, 68, of Coon Rapids, Minn., was injected with Omniscan for several scans between 2003 and 2005. Knase had severe kidney disease that later necessitated a transplant. In the fall of 2005, her entire body became stiff and swollen, symptoms of nephrogenic system fibrosis, or NSF. She is now profoundly disabled.
GE has maintained that Omniscan has been used safely on tens of millions of patients and that it came with adequate warnings. The causes of NSF, are still undetermined, the company says.
In a written statement, officials with GE Healthcare, the unit that makes Omniscan, said Sunday’s settlement “does not represent an admission of wrongdoing by the company.”
"The Knase matter has been resolved to the mutual satisfaction of both parties,” the company said. “Patient safety is our number one priority at GE Healthcare. The company remains committed to improving the quality and efficiency of healthcare around the world."
Observers also were watching the Knase lawsuit closely as a possible window into hundreds of other cases filed against GE and makers of similar imaging agents.
Some manufacturers of such drugs, all of which contain the metal gadolinium, tended to settle cases early on. GE – facing far more lawsuits than any other company – was initially reluctant to do so, but has changed its posture in recent months, settling hundreds of cases, lawyers involved with the litigation say.
Last night, GE settled scores of similar cases in addition to the suit brought by Knase, according to one lawyer.
One byproduct of such deals: The veil on confidential GE documents remains in place. The company has persuaded courts to keep many documents under seal, arguing they contain trade secrets and other confidential information.
GE has declined to say how many lawsuits are still pending and how many have been settled. The exact number of settlements is hard to quantify, in part because plaintiff lawyers can negotiate for groups of clients, some of whom may opt out later if they are dissatisfied with their shares of the recovery.
GE faced more than 300 cases before last night’s negotiations, lawyers involved in the cases say.