Makers of MRI contrast dyes are being sued by claimants who say they developed a skin hardening condition from exposure to a metal that is highly toxic in its free state.
In a product liability suit against General Electric Co. and others, plaintiffs claim they developed nephrogenic fibrosing dermopathy (NFD) after being injected with Omniscan and OptiMARK injectible paramagnetic contrast dyes, according to a lawsuit filed Aug. 5 in St. Clair County Circuit Court.
Attorneys for Randy McCallum and his wife Gwenolyn McCallum of East St. Louis and Antoinette Davis and her husband Elhajj Davis of Freehold, N.J. are Lloyd M. Cueto and Christopher Cueto of Belleville, as well as John J. Driscoll of St. Louis and Robert Salim of Natchitoches, La.
According to the complaint, the dyes contain the metal gadolinium, which is "highly toxic in its free state."
But, according to the International Center for Nephrogenic Fibrosing Dermopathy Research, "there is no convincing evidence that (NFD) is caused by a medication…There have been no cases identified prior to early 1997."
Nephrogenic Fibrosing Dermopathy, characterized by discoloration, thickening, tightening and swelling of the skin, develops only in patients with renal "insufficiency," the complaint states.
It "often progresses to painful inhibition of the ability to use the arms, legs, hands, feet, and other joints," the complaint states.
"The skin changes that begin as darkened patches or plaques progress to a 'woody' texture and are accompanied by burning, itching and severe pain in the area of involvement," the complaint states.
Also named as defendants in the 11-count lawsuit are Amersham Health, Tyco Healthcare Group, Covidien, Mallinckrodt and John/Jane Doe Corporations.
"At all times relevant to this action, defendants knew or should have known that in its free state and as injected into patients, gadolinium is highly toxic, harmful and dangerous to humans and causes severe injury," the complaint states.
"Defendants knew or should have known of the need to prevent the gadolinium contained in their products from becoming free in the body of humans injected with Omniscan and/or OptiMARK through the use of, among other things, proper design, testing and manufacturing."
The plaintiffs claim the chemical composition of Omniscan and OptiMARK makes it easier for the "toxic gadolinium" to become free in the bo of persons injected with the contrast agents. They also claim there were safer, alternative designs for imaging systems that do not use gadolinium-based contrast agents.
Randy McCallum claims he was injected with the products in April 2004 and in April 2006. In August 2006, McCallum was diagnosed with NFD, the suit claims.
Antoinette Davis claims she was injected with the contrast agents twice in August 2006. She was diagnosed with NFD in July 2007, the suit claims.
The lawsuit also claims the defendants made false representations that Omniscan and OptiMARK were safe for use.