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Judge Opens Door to Case Against General Electric’s Omniscan

A ruling by a Cleveland judge will allow most of the plaintiffs' expert witnesses to testify about the MRI drug Omniscan. The ruling covers hundreds of lawsuits against General Electric’s health care unit.

A technician demonstrates an MRI machine in a GE Healthcare clinic at the Beijing Olympic Village (Getty Images file photo).In a key ruling covering hundreds of lawsuits against General Electric’s health care unit, a federal judge has given plaintiffs’ lawyers wide latitude to present evidence and expert testimony that GE’s Omniscan imaging drug caused a crippling disease in MRI patients.

The 58-page opinion by District Judge Dan Polster in Cleveland comes as the first cases head for possible trials and represents a setback for GE by making it easier for plaintiffs to present their positions and harder for the company to make its case before a jury.

Polster criticized GE Healthcare’s lawyers and witnesses for relying on misleading and flawed presentations as they sought to quash the plaintiffs’ theories, including one that Omniscan breaks down chemically, releasing a toxic metal that triggers the disease.

Omniscan has been linked to a rare but often crippling disease, called nephrogenic systemic fibrosis, or NSF, in patients with kidney problems. Lawyers for NSF victims claim the company failed to adequately warn doctors and patients about the dangers.

GE Healthcare, in denying the claims, says the causes of NSF remain unproven. The company maintains that Omniscan is safe and that when reports of NSF emerged it properly revised the label to reflect the small risks posed for some patients.

Polster is managing more than 500 cases filed in multiple states alleging that NSF was caused by imaging drugs from several manufacturers. Omniscan is named in about 400.

The judge’s ruling, made public late Tuesday, is procedural and sets parameters on expert testimony each side may present at upcoming trials. While restricting some important parts of GE’s case, he allowed most of the plaintiffs’ experts to testify.

Jeffrey DeMarrais, the spokesman for GE Healthcare, said in an e-mail the company sought to "exclude speculative testimony" by plaintiffs’ witnesses. The upshot of the order, DeMarrais said, is that "both sides now must present their theories in court."

DeMarrais noted, as did Polster in his ruling, that tens of millions of patients have safely been injected with Omniscan and contrast agents to help make MRI scans easier to read.

The first trial, involving Omniscan, had been scheduled to start later this month, but the judge said he was told the day before his order that the case had been settled. The terms were not disclosed. The next Omniscan trial is slated for later this year.

A central question in the litigation is whether the metal gadolinium, a key ingredient in Omniscan and other similar contrast agents, is the culprit behind NSF.

"Gadolinium, in its free state, is highly toxic to humans," Polster wrote. All the contrast agents are chemically constructed to render gadolinium inert by creating a protective shield. But, the judge noted, "many studies show that Omniscan is more prone" to have the gadolinium break away, making it available to bond with human tissue and blood.

GE Healthcare sought to block any presentation of the theory that this "free gadolinium" causes NSF, but Polster said testimony about the theory was admissible. The company can challenge the theory at trial.

An alternative theory, presented by GE Healthcare and used to discredit the "free gadolinium" theory, is that gadolinium in its protected state may well trigger NSF. This argument spreads the blame among all contrast agent manufacturers, but Polster wrote that the theory "does not explain why the incidence of NSF in patients administered Omniscan far exceeds the number indicated" by the drug’s market share.

Polster also said GE Healthcare did not "advance any explanation why there are virtually no documented NSF cases attributed" to patients administered a competing gadolinium-based drug "which has a different chemical configuration than Omniscan."

The judge allowed the company’s in-house expert to present his theory at trial, noting that all parties agree "the exact mechanism for NSF causation is uncertain." But Polster said 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."

GE Healthcare unsuccessfully tried to block the testimony of two medical school professors that the company failed to properly warn radiologists about Omniscan. In allowing the testimony, Polster criticized the company’s lawyers for objecting to one of the doctors based on "out-of-context statements" and other "flawed" arguments.

Polster also weighed in on another key argument in GE’s defense: that the company complied with all U.S. Food and Drug Administration requirements after reports of NSF emerged, including introduction of a "black box" warning about NSF risks on its label.

The FDA approved the labeling change in 2007 for all gadolinium-based imaging drugs despite findings by agency medical reviewers that Omniscan was the riskiest for NSF.

GE’s lawyers sought to introduce testimony by a former FDA official that the agency would have stopped the company from unilaterally changing its label. But Polster rejected it, saying the proposed testimony "is at best misleading and at worst directly contrary to the Supreme Court’s holdings."

In support, Polster cited a case in which the court rejected an argument by Wyeth, now part of Pfizer, that it could not have modified a warning label already approved by the FDA. The court said "it has remained a central premise of drug regulation that the manufacturer bears responsibility for the content of its label at all times."

Jeff DeMarrais

May 5, 2010, 2:36 p.m.

This is Jeff DeMarrais at GE. In response to ProPublica’s inquiries last night and Mr. Gerth’s interest in quoting Judge Polster’s motion I provided the following response.
—-
Judge Polster’s ruling was regarding a procedural motion, not a summary judgment motion.  The motion we submitted was intended to exclude speculative testimony. Both sides had items granted and denied - and the result means both sides now must present their theories in court.

I think there are some very important quotes from the order that you should include in your article. Judge Polster states:

“One of the few things Plaintiffs and GEHC agree upon is that no one knows exactly how NSF develops or why only a tiny percentage of renally-impaired patients who have been administered GBCAs have developed NSF.”

He later repeats:  “Additionally, about the only thing concerning NSF upon which all parties agree is that the exact mechanism for NSF causation is uncertain.”

Judge Polster also covers another point we have made with you on several occasions but has not been reported by ProPublica:

“Millions of people have received MRIs with GBCAs manufactured by GEHC and others. Not only have they had no complications, but they have avoided the risks associated with iodine, the magnetic contrast agent used prior to gadolinium.”
—-
One final note: ProPublica did finally admit that “tens of millions” of patients received MRIs with GCBAs - to clarify that point, over 100 million doses of GCBAs have been safely administered, giving doctors a valuable tool to help better see and interpret MRI findings; to diagnose a wide range of diseases and injuries, sometimes at a very early stage; and to determine appropriate treatment.

ProPublica’s editors respond:

Jeff DeMarrais of GE implies that ProPublica has never reported that millions of patients used gadolinium-based contrast agents like the company’s drug, Omniscan. In fact, our two most widely circulated stories about Omniscan did report that tens of millions of doses had been sold. They are “Specter of MRI Disease Haunts GE,” published in collaboration with BusinessWeek, and “GE Sues to Hush Scientist Critical of its MRI Drug,” published in collaboration with The Sunday Times of London. In addition, in a Dec. 2, 2009, story  about federal regulators considering restrictions on Omniscan and similar drugs, we reported the following: “About 8 million vials of gadolinium-based imaging agents are sold each year. So far, the number of NSF cases is in the hundreds.” Finally, our Dec. 9 follow-up story on an FDA advisory panel meeting reported: “The lengthy deliberations were, in some ways, a dry debate among two dozen doctors and safety experts about how to manage the business and regulatory risks of drugs that have been safely used tens of millions of times to help doctors diagnose many diseases and injuries.”

Jeff DeMarrais

May 10, 2010, 6:21 a.m.

Jeff DeMarrais from Healthcare - The Dec. 9 article did, indeed, reference “tens of millions” of safe doses of GBCAs. To provide further clarification, that number is really more than 100 million doses safely administered. The other 3 articles do not reference the use of GBCAs - they quote sales numbers, which is something very different.

From the editors:

We think the fact that many millions of doses of Omniscan and similar agents have been sold is indicative of the drug’s effectiveness in MRIs. Safety is a separate issue. Clearly regulators, GE and other manufacturers say the drugs should not be used in patients with impaired kidney function. The issue of whether gadolinium-based MRI agents may pose significant health risks beyond what is currently known remains a subject of professional and scientific discussion.

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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