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GE Failed to Adequately Warn about Dangers of its MRI Dye, Jury Finds

A jury awarded $5 million to a patient and his wife after it found GE Healthcare didn’t adequately warn patients and doctors about the risk of its imaging dye, Omniscan. It was the first case involving the dye to go to trial.

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Jeff Immelt, Chairman and CEO of GE, holds a portable ultrasound machine during a presentation on General Electric's strategy for global health in May 2009. (Photo: Immelt photo, Saul Loeb/AFP/Getty Images.)

In a setback for GE Healthcare, a jury today found that the company failed to adequately warn patients and doctors about the dangers of its medical imaging dye. The jurors awarded $5 million to the plaintiff and his wife.

The verdict, after a two week trial in federal court in Cleveland, marks the first time a jury has examined whether the dye, injected into patients to sharpen MRI scans, can cause a rare but debilitating disease in which large areas of the skin become thick and hard. ProPublica investigated the dye in 2009 and 2010, revealing that GE ignored the advice of its own safety experts to "proactively" restrict its use.

GE has settled out of court a few hundred cases involving its dye, marketed as Omniscan. Other manufacturers of similar imaging agents have also resolved cases before trial. All the settlements are confidential.

Plaintiff Paul Decker, 61, was diagnosed with the disease, nephrogenic systemic fibrosis, in 2010, and he claimed it was caused by an injection of Omniscan he received during an MRI in 2005. GE acquired the drug in 2004.

A key question for the jury was whether the risks of the dye for patients such as Decker — who suffered from severe kidney disease, known to increase the risk of Omniscan side effects — had been adequately disclosed by the drug's manufacturer, not only GE but also the predecessor companies that had previously owned the dye.

At the opening of the trial, arguments were made — and disputed by GE­­ — that data was ordered destroyed and that research was not shown to a key scientist who co-authored a study finding the dye was safe.

GE maintained it had properly and promptly disclosed the dye’s dangers and that it had been the first to warn about the disease. But the jury rejected the company’s defense and awarded $4.5 million to Decker and $500,000 to his wife, Karen Decker. The jury also denied GE’s claim that Decker filed his case too late.

GE, in a statement, said it “was disappointed in the jury’s decision” and plans to appeal the verdict on “several grounds.” The statement pointed out that the jury had rejected Decker’s claims that Omniscan’s design was defective and that the company’s representations about the dye’s quality and safety weren’t accurate.

Omniscan and similar dyes manufactured by other companies contain a toxic metal, gadolinium, which is bonded with a protective coating to keep it inert. In the vast majority of patients, the drug is filtered out through the kidneys without causing harm. There have been no new cases of the disease in recent years.

Only a few Omniscan cases are still in litigation.

The reason there are no new cases is because the diagnostic guidelines were paid for by among others GE.  Doctors want nothing to do with you if you are sick from these injections. Tell me that’s not a conflict.  According to what came out at trial a study showed 25% of the gadolinium in GE’s product Omniscan stays in the body.  Even in Judge Polster’s original ruling on expert witnesses he states “It is undisputed that gadolinium, in its free state, is highly toxic to humans”.  And generally if it is found in the body years later or even days later it is in its free toxic state.  [O]mniscan most likely causes NSF in renally impaired patients when, due to various processes (for example,
transmetalation), the gadolinium becomes dechelated, dissociated, released or freed from theIt is, as acknowledged by GEHC’s expert Ben B. Newton,Ph.D., the prevailing theory in the scientific community.”

So how is GE getting away with keeping this product on the market?  Does the FDA have any answers as to why this product is still on the market?

I have more than a dozen MRI dye injections without side effects

Does anyone see the irony here and with most malpractice actions?

In most instances procedures such as MRI and other scans can save your life and without them most plaintiff/patients would not survive and even be around to sue…

I had 12 and GE’s product 11 times.  I am sick with five autoimmune disorders, disorders that do not run in my family.  I was completely healthy until I received the toxic dye. I was being screened for breast cancer.  If you think that carrying around toxic metal is fun I can assure you it is not.  And they found gadolinium in my breast tissue long after it shouldn’t have been there.  I was of childbearing years.  And no I can’t sue due to people that listen to 30 second sound bites like you and think they know what they are talking about.  The FDA needs to do an investigation and this product needs to be removed from the market.  Of course I forgive you because gadolinium is a neurotoxin and you likely can’t help yourself.  Why did you get so many injections anyway?

Aw, when has poor widdle GE ever done anything that wasn’t in the public interest?  I mean instead of selling nuclear reactors they knew were faulty.  And manufacturing weapons.  And tax evasion.  Oh, and that time they bought NBC/Universal, then sold just over half the stake so they wouldn’t be seen as a majority shareholder.  Besides all that, when have they ever done anything bad…?

I thought so!

More seriously, how do these clowns stay in business without DA after DA coming after them?  It’s like everything they make, if you let it sit long enough, will kill you.

It’s not a dye. IT’s METAL for the magnets. See PMC 28224463.
They’ve known all along what this metal does to people. They are a disgrace to the nation and the world, intentionally harming people and children and animals.  the FDA just approved another METAL for MRI’s, Dotarem. STAY away from this metal.  when the MRI screening form asks if you have metal or metal implants in your body, no one would think that THEY would deliberately inject more metal into you that knowingly harms you, would they? The mfgr warning and the FDA warning on the clear fluid metal injection clearly states Warning, Risk of Nephrogenic Systemic Fibrosis! it affects the lungs, kidneys, immune system, vision, causes falls and breaks bones, deposits in the brain and breaks down to toxic Gd3+ in the presence of elevated alk phosphatase, calcium, zinc and copper. It causes BLOOD CLOTs and PULMONARY emboli, elevated D Dimers and doctors LIE about it all the time, Check the funding on these SOBs and read The Treatment by Martha Stephens, 2004, same tactics. Just as EVIL.

Mike McDermott

April 18, 2013, 4:59 p.m.

Mayo Clinic used this on me when I visited them in August of 2002.  I was there to determine the cause of pain in my kidney from a previous surgery 6 months earlier.  I was there alleging that the Urologist from the previous operation went into my kidney without authorization and without ever telling me that he did. Mayo then did a contrasted MRI using gadolinium.  Had my kidney been damaged from this first operation, I wouldn’t think that this contrast would be prescribed.  Since visiting Mayo Clinic, my feet feel cold and dead.  Gadolinium is one of the heaviest elements on the atomic chart.  Would it be the case that it would accumulate in the feet due to natural gravity? Incidentally, Mayo discovered a “new kidney stone” in my kidney in the exact spot that I had hurt since my original operation, where there hadn’t been one before.  I’m alleging that this Urologist had done what a nurse who worked for a Urologist boasted years before, that one day he boasted to the nurse that whenever he would get the chance, he would go up into the kidney and would scratch it to form a new kidney stone in the same way that an oyster forms a pearl.  With a damaged kidney, the contrast would enter the system.  The question should be, what did Mayo Clinic know of the contrast then, and why were they using it in cases of suspected damaged kidneys such as mine?

Mike McDermott

April 18, 2013, 5:09 p.m.

And by the way, the first question asked of me by the Mayo doctor was whether or not I was going to sue the original Urologist. The person who administered the Gadolinium asked me while I was on the exam table how much I weighed.  When I told her, she told me that I had to have a second “dose” of contrast.  I learned later that the contrast amount to be administered is determined in the lab, not at the side of the exam table relying upon the patient knowing what he weighed.  The world renowned Urologist berated me before telling me that the contrasted MRI had detected a “new kidney stone” in the very spot I had hurt in my kidney.  He failed to tell me that it was his invention used in the initial operation, one that was known to tear or “scratch” tissue if turned.

Hi Mike,

Have you joined the ProPublica’s Patient Harm Facebook group or filled out their questionnaire.  I think you should. 

The Mayo does testing for gadolinium in the tissue and urine but may have some reservations regarding helping those of us that have been injured from gadolinium based contrasting agents.

You are right to be concerned.

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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