Gadolinium Contrast Dyes Products Liability Litigation
Carter P. Spohn
Gadolinium, or gadodiamide, is a rare earth element that provides greater contrast between normal and abnormal tissue in the brain and body, causing abnormal tissue to appear brighter in Magnetic Resonance Imaging (MRI). Gadolinium is used as a contrast agent in an MRI; the clear non-radioactive substance is injected into the bloodstream and accumulates in abnormal tissue, highlighting small tumors and other abnormalities. In patients with normal kidney function, gadolinium is simply excreted from the body through the kidneys. However, for patients with poor kidney function, gadolinium has been linked to a severe, debilitating and incurable condition known as Nephrogenic System Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD).
Nephrogenic System Fibrosis (NSF) is a systemic disorder causing fibrosis or increased formation of the connective tissue in the skin. The most prominent and visible effect is on the skin, which thickens, hardens and becomes extremely coarse. Patients experience swelling and tightening of the skin, typically in the extremities, but occasionally involving the trunk of the body. Severely afflicted patients may be unable to fully extend their joints or walk. NSF may also cause fibrosis of the eyes and internal organs. Muscle fatigue and weakness are common symptoms of NSF. There is no known genetic basis for NSF; while the cause of NSF is not fully understood, it appears to be associated with exposure to gadolinium. There is no known treatment for NSF. Over time, the symptoms of NSF worsen and can lead to death.
According to the FDA, symptoms of the onset of NSF can include the following:
- Swelling, hardening or tightening of the skin
- Reddened or darkened patches of skin
- Burning or itching of the skin
- Stiffening of the joints
- Pain deep in the hip joints or ribs
- Muscle weakness
Gadolinium is marketed under several names, depending on the pharmaceutical company manufacturing it. Common brand names include Magnevist (Berlex Laboratories, Inc.), Omniscan (Nycomed Amersham, plc), OptiMARK (Covidien Imaging), Multihance and ProHance (Bracco Diagnostics, Inc.).
The FDA approved gadolinium for use in MRI in 1998. Gadolinium in its unbound (free) state is highly toxic, however, when chelated; its toxicity is reduced, rendering it safe for use in MRI procedures under most circumstances. Gadolinium is not naturally occurring in the human body and is present only when ingested or injected. Until recently, gadolinium was considered to be relatively safe in comparison to other MRI contrast agents.
The FDA has requested a labeling change by all manufacturers of gadolinium warning of the risks of developing NSF. In addition, the FDA has requested all manufacturers to collect data on patients with varying degrees of renal insufficiency exposed to gadolinium to determine the magnitude of the risk to patients with varying degrees of kidney disease. For further information from the FDA on the risks of gadolinium contrast agents, click here.
In February of 2008, the United States Judicial Panel on Multi-District Litigation issued a transfer order in the Gadolinium Contrast Dyes Products Liability Litigation. The panel found that upon review, the actions involve common questions of fact. The panel therefore ordered all federally filed gadolinium cases to be centralized in the Northern District of Ohio and assigned to Judge Dan A. Polster.
Magaña, Cathcart & McCarthy is currently investigating cases involving gadolinium contrasting agents and NSF. If you have been injured by gadolinium, contact our firm online, or call 800-742-1019 to speak with Carter P. Spohn. Initial inquiries and consultations are offered without charge or obligation.