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General Electric Faces First Jury Test in Omniscan Litigation

An elderly Minnesota woman and her husband claim General Electric hid the risks of the company’s MRI drug Omniscan, causing her to contract a crippling disease.

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(Brian Snyder/Reuters)

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.

Barry Schmittou

Jan. 21, 2011, 3:10 p.m.

To see more dangerous health care practices please go to :
http://www.extremelyurgentpresidentobama.blogspot.com

Numerous U.S. Judges have written that doctors’paid by insurance companies are ignoring life threatening medical conditions, including brain lesions of an MS patient, and a foot that was broken in 5 places after another patient developed a severe form of diabetes after having a baby.

dead_man_walking

Jan. 21, 2011, 6:47 p.m.

To see one the most dangerous regulatory healthcare loopholes in the FDA,,,research the GAO site and/or simply download the follwing GAO audit of the FDA Drug Post Marketing Division:

http://www.healthlawyers.org/News/Health Lawyers Weekly/Documents/HLW 12 11 09/gao-10-68.pdf

Drug Post Marketing Adverse Events in this country are NOT mandated by law (solely voluntary) to be reported to the FDA or the drug manufacturer. Meaning,,,,the patient population is being used as offical lab rats,,,,except that lab rats are afforded better attention than the patient population in this country, when toxic drugs (like linear gadolinium contrast have been proven to be) are recognized as causing/inducing life threatening conditions/even diseases,,like this articles discussion about unstable gadolinium contast (Omnsican)/NSF.
Got many more unpleasant truths/lethal flaws-laws or lack of,,,would love to provide them to the people/patient population,,,,only need provocation.

Yes,,,,,there are many patients that are being denied proper healthcare due to blood money staining many hands in many communities.

dead_man_walking

Jan. 21, 2011, 7:11 p.m.

Another little lethal fact,,,,the public admission by the co-inventor of another gaodlinium contrast (Magnivest)/Dr. Wienman - was Director of Contrast for Bayer Schering Pharma at the time of his statement for the record: “He & his collegaues had known (with clinical proof) there were “problems” with two particular gadolinium contrast formulations (GE-Omniscan/Bayer-Magnivest) since the 1980’s.

Google: “The train radiologist didn’t see coming”. To read many of my post and other links to this gadolinium contrast/NSF issue.

Here is the link to the article/pulic admission during a convention of radiologist in Europe.
http://www.diagnosticimaging.com/display/article/113619/1184977

Got plenty more,,,,,several GB more,,,,like the Danish Nycomed story…..University of Oslo papers,,,,,too numerous to mention peer reviewed studies linking gadolinium contrast to this systemic fibrosing disease (NSF/NFD or gadolinium associated systemic fibrosis)

It’s all about the money!  They should be required by law to disclose potentially deadling problems, however “rare.” 

Sad thing is is that the politicians are in bed with these big corporations and Big Pharma.  Patient beware—trust your gut. 

And Obama just chose the big wig at GE to be his “economic policy and advancement” or some other nonsense agency he created to “help spur growth in the economy.” God help us all!

And Jeffrey Immelt, GE’s CEO/CoB, who as recently as July 2010 criticized Obama for too much regulation, is now an adviser to the administration.  Obama has more than a tin ear when it comes to politics; he is absolutely stone cold deaf.  Either that or campaign donations are more important to than unethical conflicts of interest.

This article is part of an ongoing investigation:
Omniscan

Omniscan: Specter of MRI Disease Haunts General Electric

A rare disease linked to MRI scans has left GE fending off claims of liability.

The Story So Far

General Electric is in a liability fight over a rare and sometimes fatal disease that has been linked to a dye used for MRI scans, with a preponderance of cases involving a GE product called Omniscan.

The disease, nephrogenic systemic fibrosis, or NSF, isn’t fully understood, but nearly all cases have involved patients with kidney problems who were injected with MRI contrast agents.

More »

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