Radiologist Fights Back Against GE Healthcare Over Omniscan Side Effects

A Danish scientist is filing a counterclaim against GE Healthcare in response to libel charges originally brought by the company over critical statements the radiologist made about potential side effects of Omniscan, an MRI contrast agent that has been linked to a severe and debilitating injury among some patients, known as nephrogenic systemic fibrosis (NSF). 

Henrick Thomsen, a leading medical scientist and radiologist, has been an outspoken crusader against Omniscan, speaking at medical conferences and writing several papers about the risk of problems from the gadolinium-based contrast agent, which is used to improve magnetic resonance imaging (MRI) scan results.

Thomsen sounded the warning bell about potential risks with Omniscan after noticed that 20 of his patients were suffering from nephrogenic systemic fibrosis, which causes a hardening and thickening of the skin and other tissue throughout the body, severely restricting movement.

GE Healthcare attempted to silence Thomsen through use of British libel laws, but The Guardian reports that the Danish radiologist will file a counterclaim for libel in the ongoing battle

Although all types of gadiolinium MRI contrast agents have been linked to nephrogenic systemic fibrosis, multiple reports have suggested that the risk of NSF is increased with Omniscan.

Nephrogenic systemic fibrosis (NSF), which is sometimes referred to as nephrogenic fibrosing dermopathy (NFD), is a rare condition that is only known to occur after exposure to a gadolinium-based contrast agent (GBCA) among individuals with impaired kidney function. There is no cure for the painful and debilitating disorder, and in many cases it results in death.

The manufacturers of all types of gadolinium-based agents were required by the FDA to add the same “black box” warning in the United States in 2007, indicating that individuals with severe kidney problems could develop NSF. However, many have argued that the warnings about Omniscan side effects should be stronger than those on other available contrast agents, possibly calling for a ban on use of the product in some patients.

Approximately 350 nephrogenic systemic fibrosis lawsuits have been filed in the United States by individuals who developed the condition after receiving a gadolinium-based contrast agent. Out of the five approved contrast agents, Omniscan has been associated with the most cases of NSF, outnumbering the other drugs in proportions that far exceed their market share. It has been estimated that about 75% of all NSF lawsuits involve cases where the plaintiff developed the condition after use of Omniscan, even though GE’s contrast agent only accounts for about 30% of the market share.