Lawsuit: MRI dye linked to disease

A Warwick woman has joined 516 other plaintiffs in a massive lawsuit against pharmaceutical companies that make certain dyes used for magnetic resonance imaging (MRI).

The woman, who did not want to be identified, was diagnosed with nephrogenic systemic fibrosis (NSF) in 2006 after being injected with a contrast-agent made with gadolinium . It's a rare disease that affects people with renal failure, such as kidney disease.

The contrast-agent, or dye, is used during an MRI to help technicians and doctors examine tissue. Patients with healthy kidneys simply flush the gadolinium out. People diagnosed with NSF, however, describe their skin turning wood-like, eventually cracking. The disease can move to organs where it can be fatal.

"It's awful," says Dr. Leslie Robinson-Bostom, an Associate Professor of Dermatology at Brown University. "Some patients will have a rapidly progressive course, where they're fine. Three weeks later they're wheelchair-bound."

The attorney for the Warwick woman, Patrick Barry of Providence law firm Morowitz and Barry, tells The Target 12 Investigators his client's condition got so bad, she had to have a finger amputated.

"Imagine if you're wearing very tight gloves then you tried to bend your fingers," Barry says. "It's very tough to do and the skin will actually break down on the knuckles."

Gadolinium is still used in routine MRI's, but the U.S. Food and Drug Administration issued a warning in 2006 and 2007 not to administer the drug to those with kidney problems. The products are marketed as Magnevist, MultiHance, Omniscan, OptiMARK and ProHance, according to the FDA's website.

Now a class-action lawsuit against five pharmaceutical companies that make gadolinium-based contrasting agents is getting larger as more and more are diagnosed with NSF. Barry says his client was never warned about the possible side-effect because the medical community was in the dark at the time

"We want to uncover exactly what the manufacturers knew and when," Barry says. "How much information did they have and what did they do with it?"

Barry says his client was injected with a dye made by G.E. Healthcare . Company spokesperson Ryan Fitzgerald issued a statement that reads in part:

"...no definitive causal relationship between the administration of gadolinium-based contrast agents to patients with moderate to severe renal impairment and NSF has ever been found."

But Barry says the FDA researched 75 patients who were diagnosed with NSF and found each one had been administered gadolinium before their MRI.

Dr. Robinson-Bostom says she has diagnosed 11 patients from Rhode Island with NSF.

"We know that 10 of them definitely received gadolinium dye for MRI’s before they developed the disease," Dr. Robinson-Bostom says.

She says if caught early enough, NSF can be treated, but the prognosis is often poor.

Medical experts say healthy people have nothing to worry about when going in for an MRI and receiving a dye. But those with kidney problems need to talk to a doctor.