Gadolinium, the contrast dye that is used in MRIs (magnetic resonance imaging) and MRAs (magnetic resonance angiography) has come under fire from the U.S. Food and Drug Administration (FDA) who issued a black box warning on the dye in 2007. Yet, it continues to be used – leaving injured consumers to ask why it hasn’t been recalled.

Warning issued, but no recall

According to Benjamin Locklar, an Alabama attorney whose practice represents clients injured by drugs such as gadolinium, there are four manufacturers and five contrast agents involved. “The first manufacturer is Bayer Health Corporation; their product is called Magnevist. The second manufacturer is Bracco Diagnostics Products. They have two products – Prohance and Multihance. The third manufacturer is GE Healthcare and their product is called Omniscan. The fourth manufacturer is Tyco Healthcare with a product called Optimark.”

However, none of these products have been recalled. He told us, “In May 2007, the FDA required a black box warning, the highest level of warning, on them with respect to the skin disorders.” When we asked him why the black box warning hasn’t been ‘upgraded’ to a recall, he explained, “These products are not unreasonably dangerous for everyone, only for patients with impaired renal function. Therefore, an appropriate warning should insure that patients at risk for these horrific injuries are not subjected to these agents.”

Injuries continue

The injuries caused by gadolinium, while not dangerous for everyone, are very dangerous for many. Gadolinium has been linked to very painful, and often deadly, diseases known as Nephrogenic Systemic Fibrosis (NSF) and Nephrogenic Fibrosing Dermopathy (NFD). These diseases, discovered in the past 10 years, cause skin disorders that thicken or harden the skin and may affect bodily organs as well. Since there hasn’t been a recall, injuries continue and litigation over gadolinium use has increased.

Allegations

Locklar explained what causes of action are being alleged in gadolinium litigation:

It certainly depends upon the venue in which the case is filed, but failure to warn would be one the causes of action. In other words, the drug company had some prior indication of the problem and didn’t undertake to warn physicians in a timely manner to prevent the cause or damage. Negligence and wantonness would be others.

There also seems to be off-label uses of the product. Our research has determined that the FDA approved the use of the gadolinium contrast agents in MRIs, but that they were never approved for MRAs. It appears that they’re used far more widely in MRAs than MRIs.

We don’t know who made the decision to them in MRAs; however, we suspect what we’re going to find, based upon past pharmaceutical litigation, that the drug companies were telling radiologists that the agents were okay to use them for that purpose.

If you or a loved one was given gadolinium and would like to discuss your situation with a qualified attorney whose practice focuses in this area of law, please click here. Consultations are free, without obligation and strictly confidential.