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Gadolinium LawsuitGadolinium Contrast Agents Causing Rare Diseases

Gadolinium Lawsuit – Gadolinium Deposition Disease

Gadolinium is a contrast dye used to enhance MRI films. Its use has resulted in severe and debilitating injuries. Gadolinium-based contrast agents (GBCAs) used in MRI's can remain in the body and cause Gadolinium Deposition Disease (GDD). As a relatively new diagnosis, GDD can give rise to permanent injuries in individuals with normal to near normal renal function.

Litigation Updates

$5 Million Verdict in Gadolinium Case Proves Justice Can Occur with Persistence and Passion

March 22, 2013 - The first verdict in a gadolinium case resulted in a $5 million verdict for the Plaintiff. The case, Paul Decker and Karen Decker v. GE Healthcare, Inc. had been litigated by the lawyers at Ashcraft & Gerel, LLP and Spangenberg and Shibley & Liber LLP for over five years.

 

Paul Decker, an Ohio retiree, was catastrophically injured by a single dose of GE Healthcare's intravenous body-scan contrast agent, Gadolinium. As a result, Mr. Decker was diagnosed with a rare and debilitating disease called Nephrogenic Systemic Fibrosis (NSF) that rendered him immobile and dependent upon 24-hour care. There are very few effective treatments for NSF and there is no cure.

Like the hundreds of other plaintiffs, some of whom THL represented and continues to represent, Mr. Decker was in end-stage renal disease and contracted NSF as a result of the intravenous body-scan contrast agent he was given during an MRI.

Mr. Decker and his lawyers stayed the course in a battle against several of the largest defense firms in the Country.

The courageous plaintiffs and hard-working attorneys, in this case, proved that justice could be achieved in the face of a great obstacle if you are persistent and passionate enough.

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Punitive Damages Allowed by IL Court in NSF Lawsuit

April 2, 2010 - Cook County Circuit Judge Dooling granted an order allowing for punitive damages against GE based on the evidence she reviewed with regards to Robbie Booker v. GE, one of the approximate 500 lawsuits filed by NSF patients against GE. The decision opened the door for punitive damages in all 500 lawsuits filed by NSF patients, although it does not necessarily mean that each lawsuit will be granted punitive damages.

 What is Gadolinium?

Gadolinium (Gd) is a silvery-white, malleable and ductile rare-earth metal. Because of the extremely high neutron cross-section of Gadolinium, this element is very effective for use with X-ray, magnetic resonance imaging (MRI), computed tomography (CT), angiography, and occasionally ultrasound imaging. The chemical medium helps to provide clear and detailed pictures of internal organs that can then be used to “more accurately report on how your body is working and whether there is any disease or abnormality present.”

Gadolinium contrast dyes were approved for use in MRI scans in 1988. It is now the most commonly used chemical medium for MRI’s.

 

Why is Gadolinium Dangerous?

Gadolinium contrast agents, used to enhance MRI films, can be extremely dangerous.

Over the past several years it has become apparent that Gadolinium contrast dyes can cause two separate diseases: Gadolinium Deposition Disease (GDD) and Nephrogenic Systemic Fibrosis (NSF).

 

What is Gadolinium Deposition Disease?

Gadolinium Deposition Disease occurs in individuals with normal or near-normal renal function “who develop persistent symptoms that arise within a few hours to two months after the administration of Gadolinium-based contrast agents (GBCAs).” In order to diagnose individuals with the disease, a urine test must be administered that confirms the presence of Gadolinium in the body. This test should be administered 30 or more days after the most recent GBCA was used.

Until recently, a diagnosis for patients with normal to near normal renal function did not exist, making the disease a relatively new concept. It is unclear how many individuals actually suffer from Gadolinium Deposition Disease.

 

What are the Symptoms of Gadolinium Deposition Disease?

Symptoms are similar to NSF, but vary in a few notable ways:

  • A persistent headache;
  • Bone and joint pain;
  • “Brain fog;”
  • Subcutaneous soft tissue thickening (skin that appears spongy or rubbery, without hardness and redness observed in NSF);
  • Tendons and ligaments are painful and have thickened appearance;
  • Tightness in the hands and feet; and
  • Pain described as burning, cutting, or pins and needles in the arms or legs, and the torso.

If you have been injured as a consequence of Gadolinium dye used in an MRI, please contact our office at 1-888-508-6752 for a free, no-obligation Gadolinium lawsuit consultation.

 

What is Nephrogenic Systemic Fibrosis (NSF)?

TorHoerman Law is no longer accepting Gadolinium Nephrogenic Systemic Fibrosis (NSF) cases.

NSF is a disease also caused by Gadolinium, with the first diagnosis occurring in 1997. Currently, the Center for Disease Control has information about 315 patients with NSF. Sadly, at the present time, there are more questions than there are answers about the disease. There are very few effective treatments for NSF, and there is no cure.

 

What are the Initial Signs of NSF?

Originally thought to be a skin disorder, the diagnosis was termed Nephrogenic Fibrosing Dermopathy (NFD). Gradually, the diagnosis produced wider symptoms and it is now considered a systemic disorder referred to as Nephrogenic Systemic Fibrosis (NSF). Some of the initial signs of NSF/NSD are:

  • Development of tight, rigid skin in areas;
  • Scarring of body organs;
  • Burning, itching, swelling, hardening and tightening of the skin;
  • Red or dark patches on the skin;
  • Yellow spots on the whites of eyes;
  • Stiffness in joints with trouble moving or straightening the arms, hands, legs or feet;
  • Pain deep in the hip bones or ribs; and
  • Muscle weakness

 

Should I Worry about Developing NSF after an MRI or MRA Scan?

NSF is a rare diagnosis. There have been no reports of NSF in patients with normal kidney function or with those with mild-to-moderate kidney insufficiency. However, if you suspect you may have kidney issues, you should be screened prior to receiving one of these imaging agents. Furthermore, the recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again.

In May 2006, Danish Medicines Agency was one of the first groups to report NSF traces. The agency reported 25 cases of NSF occurring in Denmark and Austria alone.

In May 2007, Dr. Melanie Blank, an FDA kidney specialist, issued a report concluding that an “undeniable and strong association” existed between contrast agents containing Gadolinium and NSF.

 

Gadolinium Contrast Dyes on the Market

  • Omniscan by GE Healthcare;
  • OptiMARK by Mallinckrodt/Tyco Healthcare;
  • Magnevist by Bayer/Schering AG/Berlex;
  • ProHance by Bracco Diagnostics; and
  • MultiHance by Bracco Diagnostics

Timeline

FDA Approved Updated Drug Labels To Warn of Gadolinium Retention

July 25, 2018 - The FDA approved an updated label for Magnevist, a type of contrast agent. The label now warns of the risk of Gadolinium retention. In April 2018, the FDA also approved an updated label for Omniscan warning of the same risk.

FDA Issued Drug Safety Communication

December 19, 2017 - The FDA issued a Drug Safety Communication warning that Gadolinium-based contrast agents (GBCAs) are in fact retained in the body. As part of the warning, new class warnings are required.

FDA Panel Suggested Warning for Gadolinium Used in MRIs

September 8, 2017 - A Food & Drug Administration (FDA) panel recommended implementing a Gadolinium warning for Gadolinium Contrast Agents (GBCAs) used in magnetic resonance imaging (MRI).

The FDA's Medical Imaging Drugs Advisory Committee recommended that prescribing information should include a "warning for retention for all GBCAs with greater retention of all or some of the linear GBCAs compared to the macrocyclics in certain organs including the brain." If too much GBCAs are in the body, a patient can develop Gadolinium toxicity, which can inevitably lead to increased adverse side effects.

The updated Gadolinium warning resulted from previous research, warnings, and alerts that signify Gadolinium retention in the brain is linked to nephrogenic systemic fibrosis (NSF). In accordance with the updated warning, the committee also recommended the FDA consider requiring the GBCA industry to conduct further research on the safety of the product to determine if additional action is needed. If further research finds GBCAs used in magnetic resonance imaging prove to be too harmful to patients, the "withdrawal of approval and restriction of indicated populations" could be necessary.

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FDA Announced Investigating Risk Associated with Gadolinium Deposits in the Brain

July 27, 2015 - The FDA issued a drug safety communication alerting healthcare professionals and patients that the FDA was investigating the risk associated with gadolinium deposits in the brain.

Covidien Announced Support for FDA Labeling Changes

September 13, 2010 - Covidien, a leading global provider of healthcare products, announced it supported the U.S. Food and Drug Administration's (FDA) labeling changes for gadolinium-based contrast agents for patients with acute kidney injury or chronic, severe kidney disease.

FDA Required Label Change to Minimize NSF Risk

September 9, 2010 - The FDA required a change in the labeling for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF). In the safety alert, the FDA acknowledged that NSF is a rare but serious condition associated with the use of GBCAs in certain patients with kidney dysfunction.

FDA Mandated Black-Box Warning

May 23, 2007 – The FDA requested that all manufacturers of Gadolinium-based contrast agents place a black box warning on the product. The warning should disclose that "patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF)."

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FDA Issued Two Separate Health Advisories

December 22, 2006 - The FDA issued a second Public Health Advisory only months after the first health advisory was released warning healthcare professionals and the public of the risk of NSF due to Gadolinium. At the time, the FDA received reports of 90 additional patients with moderate to end-stage kidney disease who developed NSF after they had an MRI with a Gadolinium-based contrast agent.

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Reports of Gadolinium Injuries Arise

2006 - Danish medical authorities began receiving reports that patients with serious kidney problems who underwent a magnetic resonance scan using Omniscan, a Gadolinium-based contrast agent produced by GE Healthcare, had developed a rare, crippling and potentially fatal disease.

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+ - References

“Drug Safety and Availability - FDA Drug Safety Communication: FDA Evaluating the Risk of Brain Deposits with Repeated Use of Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging (MRI).” U.S. Food and Drug Administration Home Page, U.S. Department of Health and Human Services, www.fda.gov/Drugs/DrugSafety/ucm455386.htm.

“Drug Safety and Availability - FDA Drug Safety Communication: FDA Warns That Gadolinium-Based Contrast Agents (GBCAs) Are Retained in the Body; Requires New Class Warnings.” U.S. Food and Drug Administration Home Page, U.S. Department of Health and Human Services, www.fda.gov/Drugs/DrugSafety/ucm589213.htm.

Ferris, Nick, and Stacy Goergen. “Gadolinium Contrast Medium (MRI Contrast Agents).”InsideRadiology, 26 July 2017, www.insideradiology.com.au/gadolinium-contrast-medium/.

Fornell, Dave. “The Debate Over Gadolinium MRI Contrast Toxicity.” Imaging Technology News, 16 Feb. 2018, www.itnonline.com/article/debate-over-gadolinium-mri-contrast-toxicity.

"Gadolinium-Based Contrast Agents (GBCAs) and Nephrogenic Systemic Fibrosis (NSF)." DIVISION OF MEDICAL IMAGING AND HEMATOLOGY PRODUCTS MEMORANDUM TO THE FILE, s3.amazonaws.com/propublica/assets/omniscan/blank-melanie-review-omniscan2.pdf.

“Gadolinium Deposition Disease – Part of a Family of Disorders.” Gadolinium Toxicity, 30 May 2016, gadoliniumtoxicity.com/2016/05/30/gadolinium-deposition-disease-family-of-disorders/.

Goergen, Stacy. “Contrast Medium: Using Gadolinium or Iodine in Patients with Kidney Problems.” InsideRadiology, 26 July 2017, www.insideradiology.com.au/contrast-medium/.

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