Five years after scientists linked a rare disease to drugs used to enhance MRIs, General Electric goes to trial to rebut charges that its drug Omniscan caused an elderly Minnesota woman to contract the crippling and potentially fatal condition.
The case scheduled to start Monday in U.S. District Court in Cleveland would be the first Omniscan lawsuit to get before a jury. As such, it is a potential bellwether for hundreds of similar cases filed against GE and makers of similar imaging agents.
As ProPublica has reported, GE has steadfastly defended Omniscan, saying the cause of the disease, known as nephrogenic systemic fibrosis, or NSF, is undetermined and that its drug has been used safely by tens of millions of patients worldwide.
But plaintiffs' lawyers say GE hid Omniscan's risks and failed to protect patients after problems began to emerge. The U.S. Food and Drug Administration and European regulators have since banned its use in patients with advanced kidney disease, the group considered most at risk from exposure.
The main plaintiff is Loralei Knase, 68, from Coon Rapids, Minn. In the fall of 2005, soon after being injected with Omniscan, her entire body became stiff and swollen. Knase, who suffered from severe kidney disease and eventually had a transplant, is now profoundly disabled and relies on a wheelchair for mobility.
Knase is suing General Electric and its health care division, the maker of Omniscan. She was injected with the drug for several scans between 2003 and 2005.
An association between Omniscan and NSF was first publicly disclosed in early 2006, following reports of 25 cases in Denmark and Austria. NSF, by and large, has not been reported in patients with healthy kidneys. The disease is marked by scaling, hardening and tightening of the skin and can cause lethal fibrosis of internal organs.
Newly reported cases of NSF have virtually ceased. Still, the legal process is unfolding. Several manufacturers make similar drugs, but Omniscan was the first to be linked with the disease and is named more often in medical reports and lawsuits.
Other companies, including Bayer HealthCare, have confidentially settled most of the cases involving their drugs. GE initially resisted settlement but has now resolved scores of cases. Nonetheless, more than 300 remain unresolved, according to lawyers.
A GE Healthcare spokesperson said the company would not comment about the pending trial. GE has argued that it always conformed to regulatory requirements and that the company's practices for Omniscan were state of the art when Knase was exposed.
Mrs. Knase and her husband, Donald, who is also a plaintiff, contend the company long knew its drug was defective and more dangerous than the public realized and set about to actively conceal those risks from patients, regulators and doctors.
So-called contrast agents like Omniscan help radiologists obtain sharper images from MRI scans. The leading seller has been Bayer's Magnevist. Since the discovery of NSF, Omniscan's market share has dropped, according to public records and industry executives.
Omniscan was approved for sale in the United States in 1993. The drug has largely been the property of European firms, but GE acquired it with the 2004 purchase of the pharmaceutical company Amersham, based in the United Kingdom.
Much of the evidence in the Omniscan cases, including that of the Knases, has remained under court seal. As such, the trial may offer the first public disclosure of documents and depositions that plaintiffs' lawyers believe show GE's culpability.
Court filings suggest the case will turn on whether GE and its predecessors ignored warning signs about Omniscan's risk for kidney patients, as plaintiffs allege, or whether the company did what it reasonably could given available information.
Lawyers for the Knases, based on court filings, are likely to point to internal concerns voiced by employees working for Omniscan's owners, dating back to the 1990s, about the chemical stability of the drug and the possibility that patients with impaired kidneys might retain some of its active ingredient, the toxic metal gadolinium.
Like similar imaging agents, Omniscan is chemically bonded with a protective coating to keep the gadolinium inert and prevent it from exposing the body to toxicity. Normally, the drug is filtered out via the kidneys without breaking down.
Some of those internal corporate concerns focused on the possibility that Omniscan might be less stable than competitors, according to court and public records.
By 2002 and 2003, Amersham was aware that a few kidney patients exposed to Omniscan had developed severe skin problems and pain in their joints, court records show. In one case, the company learned in 2004, after it was acquired by GE, that the death of one patient, a woman in Copenhagen, was associated with Omniscan.
GE's likely defense is also sketched out in court filings.
The company says the causes of NSF remain to be scientifically determined and that its own studies of Omniscan were not what plaintiffs allege and did not show that any injury was likely to result from use of the drug.
Early reports of adverse reactions in renal patients were vague and inconsistent with NSF, the company says, so a connection couldn't be certain. Nor is there convincing proof that Omniscan poses greater risks than other drugs in its class, GE asserts.
The FDA initially agreed with the latter argument, ruling in 2007 that Omniscan and its competitors should all carry the same black-box label warnings about NSF.
But last year the FDA modified its stance and decided that Omniscan and two other drugs should be banned in severe kidney patients because they posed a greater risk.
District Judge Dan Aaron Polster will preside over the Knase case and is overseeing similar cases in federal courts elsewhere. A few hundred cases have also been filed in state courts.