Malpractice Lawsuit Over NSF From Gadolinium Considered Against Hospital

A Bermuda couple is planning to file a medical malpractice lawsuit against at U.S. hospital, claiming that doctors ignored FDA warnings and administered a gadolinium-based MRI contrast agent despite the wife’s known kidney problems, causing her to develop a rare and potentially life-threatening condition, known as nephrogenic systemic fibrosis (NSF). 

Silvia DeSilva, 70, contracted NSF from gadolinium after a trip to King Edward VII Memorial Hospital and Brighan and Women’s Hospital in Boston, Massachusetts, where she was given the MRI contrasting agent to help her doctors obtain better scan results in 2007. However, she and her husband, Allan DeSilva, 75, say that the doctors should have never given her the contrast agent, because she was a dialysis patient, which put her at risk for the painful, disfiguring and often fatal condition.

The DeSilva’s are now planning to take legal action over the medical negligence of the hospital. According to a report in the Royal Gazette, the hospital indicates they are attempting to work with the couple to resolve their complaints.

In 2006 and 2007, the FDA released warnings that gadolinium-based contrasting agents increase the risk of NSF for people with kidney problems. The warnings culminated in a NSF risk “black box” for all gadolinium-based contrasting agents in 2007. Black box warnings are the most stringent label warning the FDA can require.

NSF, which is sometimes referred to as nephrogenic fibrosing dermopathy (NFD), is only known to occur after exposure to a gadolinium-based contrast agent (GBCA) among individuals with impaired kidney function. The condition is associated with a hardening and thickening of the skin and other tissue throughout the body, severely restricting movement. There is no cure for the progressive disorder, and no consistently successful treatments are available.

Hundreds of product liability lawsuits have been filed against gadolinium-based contrasting agent by individuals diagnosed with NSF who were given a gadolinium contrast agent prior to prominent warnings being issued by the manufacturers. The nephrogenic systemic fibrosis lawsuits allege that the manufacturers failed to adequately research the side effects of the MRI contrast agents and warn about the risks for individuals with impaired kidney function.

For individuals diagnosed with NSF after receiving an MRI with contrast once it was well-known within the medical community that individuals with kidney problems are at risk, they may be able to pursue compensation through a medical malpractice lawsuit.