GE Healthcare and a Danish scientist have reached a settlement in a libel lawsuit over statements made about the side effects of Omniscan, an MRI contrast agent that has been linked to nephrogenic systemic fibrosis (NSF), a severe and debilitating injury.
Neither party disclosed details of the settlement, but both GE Healthcare and Henrik Thomsen, Professor of Radiology at Herley Hospital in Copenhagen, made conciliatory statements last week. Thomsen has been an outspoken crusader against Omniscan, speaking at medical conferences and writing several papers about the risk of problems from the gadolinium MRI contrast agent, which is used to improve scan results.
Thomsen sounded the warning bell about potential risks with Omniscan after noticed that 20 of his patients were suffering from NSF, which causes a hardening and thickening of the skin and other tissue throughout the body, severely restricting movement. Sometimes referred to as nephrogenic fibrosing dermopathy (NFD), the rare condition 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.
GE hit Thomsen with a libel suit in British courts, and Thomsen responded with a counterclaim, saying that the company was trying to gag scientific debate over the issue. Now, both say that their reactions were due to a misunderstanding, according to a press release by GE Healthcare.
“My purpose was to share with fellow clinicians and healthcare professionals my experience in managing a serious problem at our hospital where we found 20 patients suffering from NSF. The cause was unknown, but in early 2006, it was clear to us that all of our nephrology patients with NSF had only one factor in common; they had all been exposed to Omniscan,” Thomsen said. “It was not my intention to suggest on the basis of the evidence then available to me that GE Healthcare had marketed Omniscan knowing that it might cause NSF.”
GE officials also said their actions were misunderstood.
“It was not the intention of GE Healthcare by bringing proceedings for libel against Professor Thomsen to stifle academic debate,” said Dr. Lynne Gailey, executive vice-president of GE Healthcare communications. “GE Healthcare objected to statements made by Professor Thomsen which it interpreted as suggesting that it had known from the outset that Omniscan caused NSF. GE Healthcare accepts, however, that Professor Thomsen’s concerns were expressed in good faith. GE Healthcare regrets that these proceedings were necessary to reach the common understanding described in this statement.”
Although all types of gadolinium MRI contrast agents have been linked to nephrogenic systemic fibrosis, multiple reports have suggested that the risk of NSF associated with Omniscan may be higher than other contrast agents.
In 2007, the manufacturers of all types of gadolinium-based agents in the United States were required by the FDA to add a “black box” warning to their products, indicating that individuals with severe kidney problems could develop NSF. However, many have argued that the warnings about the risk of NSF from Omniscan should be stronger, 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.