Gadolinium

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Formerly known as Nephrogenic Fibrosing Dermopathy (NFD), Nephrogenic Systemic Fibrosis (NSF) is a condition that, to date, has occurred only in people with severe kidney disease who have undergone at least one MRI and were injected with a Gadolinium MRI contrasting agent.

NSF is a bizarre systemic disorder with its most prominent and visible effects manifesting itself in the skin. As hundreds of additional emerging cases are studied, it is becoming clear that kidney disease seems to be a prerequisite for developing NSF because all currently known cases of NSF involve patients suffering from severe kidney dysfunction. Nephrogenic means starting with the kidney, so NSF (as opposed to NFD) is accepted as the terminology most accurately reflecting the disease.

Gadolinium is chemical element found in the periodic table. It carries the atomic number 64, the atomic symbol Gd, and belongs to a group of elements called lanthanides. This is a rare earth element characterized as silvery white, malleable, and ductile.

Although the element is typically used in daily appliances like microwaves, color TV tubes and computer memory, gadolinium is an element widely used as a base for contrast agents or contrast dyes.

Also referred to as gadolinium-based contrast agents (GBCAs), this injectable is typically infused into the bloodstream of patients who will undergo magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) scans. However, the injectable is not approved by the United States Food and Drug Administration for the latter.

The contrast agent helps doctors easily trace the source of any problems found within the body. Although gadolinium was initially deemed safe for use in MRIs and MRAs, studies surfaced in 2006 linking gadolinium exposure to nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy (NFD).

The chemical can be highly toxic when in a free state. GBCAs are typicaly chelated for safe use in patients. However, the body can sometimes easily break down its chelated form, causing it to return to a free state before the element fully eradicates the body – which then leads patients with impaired renal function into developing NSF.

Some brands of GBCAs are safer than others, but that does not exempt them from posing an increased risk of developing NSF in patients who have kidney diseases. In fact, majority of lawsuits filed against GBCA manufacturers are against GE Healthcare, for their Omniscan brand (gadodiamide). Other brands and manufacturers facing lawsuits from patients who have developed NSF include:

  • Bayer Schering Pharma for Magnevist (gadopentetate dimeglumine)
  • Mallinckrodt, Inc. for OptiMARK (gadoversetamide)
  • Bracco Diagnostics, Inc. for ProHance (gadoteridol) and Multihance (gadobenate dimeglumine)

Patients can either file for a personal injury lawsuit, a product liability lawsuit, or a wrongful death lawsuit against these manufacturers for diseases or deaths sustained from gadolinium exposure.

What is Gadolinium?

Gadolinium is a chemical element carrying the atomic number 64 and the atomic symbol Gd. Belonging to a group of elements in the periodic table called Lanthanides, the chemical is a rare earth element described as silvery white, malleable, and ductile.

Typically used in microwave applications, color TV tubes, synthetic gemstones, compact discs, and computer memory, this chemical element is widely used as an injectable in patients as a contrast agent when undergoing magnetic resonance Imaging (MRI) and magnetic resonance angiography (MRA) scans.

Before undergoing an MRI or MRA, a gadolinium contrast agent is injected into the bloodstream, and is stored in the blood vessels and abnormal tissue so that doctors can easily detect and trace any problems found within the body.

Using this chemical element was initially perceived to be safe for use in MRIs and MRAs. In fact, the element is very toxic when in its “free” state, while the element becomes less toxic when it is chelated, due to its increased water solubility.

Patients suffering from existing kidney or renal conditions are at risk of developing nephrogenic systemic fibrosis (NSF) and nephrogenic fibrosing dermopathy (NFD), which are possible side effects from using the injectable.

After injection in the body, this chelated chemical element is expelled from the body through the kidneys. Patients with weak kidney functions as well as some patients with normal kidney functions can develop NSF or NFD simply because the chelated element is not expelled from the body in a timely fashion. The chelates eventually break down within the confines of the body, causing the “free” element to spread into the body.

However, not all contrast agents are made in the same way. Although contrast agents made with this specific chemical element can contribute or cause the development of NSF, some are less risky as compared to others. This is because of how the coating elements – called ligands – bond themselves to the element.

In fact, on report claims that the brand Prohance – manufactured by Bracco Diagnostics – is more stable than most. As compared to the Omniscan brand (the body has an easier time breaking down the chemical structure of this brand), Prohance clears from the body more completely.

Nephrogenic Systemic Fibrosis (NSF)

Nephrogenic systemic fibrosis, or nephrogenic fibrosing dermopathy is a progressive and potentially fatal disease. Fibrosis – or the thickening and scarring of connective tissue – occurs in the skin, joints, eyes, and internal organs. This results in patients having limited or restricted movements.

According to Medscape:

“Nephrogenic systemic fibrosis always occurs (with the exception of one report in 2 transplant patients whose organ donors’ histories were not noted[1] ) in patients with renal insufficiency who have had imaging studies (eg, magnetic resonance angiography) with gadolinium, a contrast agent used in imaging studies. Gadolinium can be found in tissue samples of nephrogenic systemic fibrosis. Evidence for a link between nephrogenic systemic fibrosis and gadolinium was first described in a case series of 13 patients, all of whom developed nephrogenic systemic fibrosis after being exposed to gadolinium.[2] Sometimes articles are published that state a patient with renal impairment developed nephrogenic systemic fibrosis, but these are likely instances when an inadequate history has been taken.[3] One case of nephrogenic systemic fibrosis developed 10 years after gadolinium exposure.[4]

Nephrogenic systemic fibrosis resembles scleroderma and eosinophilic fasciitis clinically and scleromyxedema histopathologically. Patients with nephrogenic systemic fibrosis may develop large areas of indurated skin with fibrotic nodules and plaques. Flexion contractures with an accompanying limitation of range of motion also can occur. Although most patients with nephrogenic systemic fibrosis have undergone hemodialysis for renal failure, some have never undergone dialysis and others have received only peritoneal dialysis.

Histopathologically, nephrogenic systemic fibrosis resembles scleromyxedema in that it manifests with a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers, and mucin deposition.”

Symptoms of NSF and NFD include swelling, thickening and hardening skin, in the extremities, and occasionally in the torso area. These symptoms typically manifest within two to 12 weeks following the injection.

Other symptoms of excessive exposure to the chemical element also include harm to connective tissues of the body, difficulty moving and in extreme cases, being unable to walk or extend joints, hardening of internal organs, muscle weakness, reddened or darkened skin patches, papules, or plaque, burning or itching of the skin, raised yellow spots on the whites of the eyes, and pain in the hip bones or ribs.

Currently, there are no “consistently effective treatment[s]” for this condition. Doctors are continuously exhausting efforts to treat the disease, including oral steroids (prednisone), topical dovonex (under occlusion), extracorporeal photopheresis (ECP), plasmapheresis, cytoxan, thalidomide, ultraviolet therapy, physical therapy (PT), pentoxifylline (PSF), high dose intravenous IG therapy, and renal transplantation.

It was only in 1997 when the first cases of NSF or NFD were identified. It was found that patients with compromised kidney functions developed areas in the skin described as thick and hard, which restricted movement. However, it was only in 2006 when the connection between the disease and gadolinium exposure was found.

Lawsuits and Litigation

More and more patients who have developed NSF/NFD are filing lawsuits against manufacturers of the contrast agent. Although a majority of lawsuits are filed against GE Healthcare for Omniscan, other manufacturers have also been facing lawsuits. The defendants of these cases are:

  • Bayer Schering Pharma – Berlin, Germany for Magnevist (gadopentetate dimeglumine)
  • GE Healthcare – Chalfront St. Giles, UK for Omniscan (gadodiamide)
  • Mallinckrodt, Inc. – Hazelwood, Montana for OptiMARK (gadoversetamide)
  • Bracco Diagnostics Inc. – Princeton, New Jersey for ProHance (gadoteridol) and Multihance (gadobenate dimeglumine)

In February 2008, the U.S. Judicial Panel on Multidistrict Litigations appointed the U.S. District Court for the Northern District of Ohio as the location for pending federal NSF lawsuits (MDL No. 1909), which is presided by Judge Dan Polster.

By the time September 2008 came, 287 NSF lawsuits were pending in the multidistrict litigation. 104 other lawsuits have also been filed in different state courts across the country – 53 in New Jersey, 14 in Pennsylvania, 25 in California, 3 in Alabama, 6 in Illinois, 1 in Missouri, 1 in Delaware, and 1 in New York. In the same month, manufacturers were facing 391 lawsuits in federal court.

By December 2008, over 350 NSF lawsuits were filed in both federal and state courts across the United States. Lawsuits claim that manufacturers of the chemical element-based contrast agent failed to properly test their products, and that the manufacturers knew about the link between the contrast agent and NSF/NFD for years and failed to inform the public.

Bayer Schering Pharma has settled a number of lawsuits involving Magnevist. According to Bloomberg, the drug manufacturer faced 241 lawsuits, wherein 40 of which were already settled by February 2009.

Come January 2011, lawsuits against GE Healthcare for Omniscan were settled the night before the trial was set in federal court in Cleveland. Details of the settlement agreement were not disclosed.

One of these settled lawsuits was filed by Loralei Knase, who was injected with Omniscan several times spanning March 2003 until October 2005 for MRI scans. Loralei Knase eventually developed NSF, which the plaintiff alleges was caused by the manufacturer’s contrast agent.

In addition, Knase also claims that she, along with her doctors, were not warned of the increased risks of developing NSF from the MRI contrast agent.

In 2013, 61-year-old retiree Paul Decker received an award of $5 million through a jury decision in a lawsuit against GE Healthcare for Omniscan. According to the lawsuit, Decker developed NSF after receiving just one dose of the contrast agent when tests were conducted on his heart in 2003.

Decker claimed that GE Healthcare officials knew about the increased risk of NSF in patients with impaired renal function. During the 17-day trial, Decker’s lawyer presented evidence showing that the manufacturer withheld studies, including FDA evidence stating the dangers associated with Omniscan.

The jury found that the company “failed to provide reasonable and adequate warnings to doctors and patients about the risks associated with the element-based contrast agent. Decker is now left immobile, in addition to requiring 24-hour care.

Plaintiffs who file personal injury lawsuits against MRI contrast agent manufacturers are may receive the following types of compensation:

  • Medical expenses
  • Loss of income
  • Pain and suffering
  • Lost prospects
  • Other related expenses

On the other hand, plaintiffs who file wrongful death lawsuits against the MRI contrast agent manufacturers may be able to receive the following types of compensation:

  • Medical and funeral expenses
  • Lost future financial aid (e.g. income, gifts, inheritances, other factors)
  • Non-economic damages such as loss of consortium
  • Punitive damages

FDA Recalls, Reports and Warnings

In June 2006, the FDA issued its first Public Health Advisory on the chemical element-based contrast dye. Because of a Dutch NSF study the same year, the FDA issued an alert to healthcare providers and the public noting that these agents have been linked with several cases of NSF. The three contrast agents noted in the report included Omniscan, Magnevist, and OptiMARK.

It was in December 2006 when the FDA issued another Public Health Advisory regarding these contrast dyes. The advisory reported that the FDA received 90 adverse event reports of patients with moderate to end stage kidney disease that contracted NSF after exposure to the element-based contrast agent.

At this time, the FDA also reported that approximately 215 patients across the globe reportedly developed NSF due to contrast agents that contained the chemical element.

In May 2007, the United States Food and Drug Administration required manufacturers of these contrast agents to include black box warnings into their labels, noting the links with NSF to patients with kidney problems. Additionally, the FDA also warned patients suffering from kidney disease to refrain from using these injectables.

First reports of links between NSF and the gadolinium-based contrast agents surfaced in May 2006, based on a press release by the Danish Medicines Agency and an April 2006 report by Grobner et. al in Nephrology, Dialysis and Transplantation.

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