The potential lawsuit involves Silvia DeSilva, who underwent a series of scans in 2007 at Brigham Hospital and Women's Hospital in Boston. According to the Royal Gazette on 6/04/10, DeSilva was given a gadolinium-based dye prior to the scan. DeSilva was a dialysis patient and therefore at a higher risk of developing Nephrogenic Systemic Fibrosis (NSF), according to the US Food and Drug Administration (FDA).
Gadolinium is a dye that provides a clearer picture of the patient's internal structures. Because it is removed from the body via the kidneys, gadolinium carries a risk of NSF for patients with kidney problems—patients with impaired kidney function will not expel the gadolinium as quickly as those with normal kidney function.
In 2006, the FDA issued a warning about the risk of NSF in patients with moderate to chronic kidney problems. In 2007, the FDA updated the warning labels of gadolinium products to alert patients and physicians about the risk of NSF.
Nephrogenic Systemic Fibrosis is a progressive disease, characterized by the thickening of the skin and the hardening of the tissue around the patient's joints. As the disease progresses, the patient develops difficulty moving and may lose the ability to walk entirely. Patients also experience muscle weakness and pain in the areas affected and may lose some organ function.
DeSilva was diagnosed with NSF and is mainly bedridden. Some of her tissue has hardened and she finds daily activities exhausting.
READ MORE MRI HEALTH RISK LEGAL NEWS
DeSilva and her husband now want to know why the FDA's warnings were not followed in her situation. They are considering a medical malpractice lawsuit against the hospitals where the scans were performed. According to DeSilva's lawyer, there are safer products available that DeSilva could have been given prior to her scans, which would not have put her life at risk.
Nephrogenic Systemic Fibrosis is also known as nephrogenic fibrosing dermopathy (NFD).