GE Healthcare has settled its libel lawsuit against Henrik Thomsen, the Danish radiologist who had raised questions about the safety of one of the company’s drugs used for magnetic resonance scans.
The two-year-old suit in London involved a 2007 presentation Thomsen made in Oxford and statements in an article published in his name by a European scientific journal in February 2008. Both contained descriptions of his experiences at a Copenhagen hospital in 2006, when 20 kidney patients, all of whom had been injected with the GE Healthcare drug, Omniscan, developed a crippling and sometimes deadly disease. The rare condition is called nephrogenic systemic fibrosis, or NSF.
The libel suit was first disclosed two months ago by ProPublica and The Sunday Times. The case quickly became a key exhibit in a running debate about whether England’s libel laws are so restrictive that they impede free speech, including the open exchange of scientific information.
Neither the company, a subsidiary of General Electric, nor Thomsen, who is director of diagnostic sciences at the University of Copenhagen, disclosed the terms of the settlement.
Dr. Lynne Gailey, the company’s spokeswoman, said in a statement (PDF) issued jointly with Thomsen that GE Healthcare never intended "to stifle academic debate" but objected to statements by Thomsen "which it interpreted as suggesting that it had known from the outset that Omniscan caused NSF." The company now believes Thomsen’s "concerns were expressed in good faith" and "regrets that these proceedings were necessary to reach the common understanding described in the statement."
Thomsen said in the statement that he had not intended "to suggest that on the basis of the evidence then available to me that GE Healthcare had marketed Omniscan knowing that it might cause NSF." The statement said his comments had been based on statements by other experts, including some at a Berlin conference in May 2007, "which indicated that it had been known for many years that there was a specific risk arising from the formulation of gadodiamide" – a uniquely structured chemical compound found only in Omniscan.
Omniscan is one of several contrast agents containing the metal gadolinium. Some of the gadolinium- based agents have been linked to NSF in patients with severe kidney disease. Some 500 lawsuits over gadolinium-based agents have been filed in U.S. federal courts by patients who contracted NSF; most involve Omniscan.
Thomsen’s statement said he continues to "stand by" his publicly expressed opinion that "there is an association between the chemical formulation of gadolinium-based contrast agents and NSF."
GE Healthcare, in its statement, repeated its long standing position that it is cooperating with authorities around the world as part of an effort to look at the safety of these agents "based on evidence and science." The company has previously said evidence isn’t sufficient to show (PDF) that the risks of NSF are greater for patients using Omniscan than for competing drugs.
GE is the only manufacturer that has not settled NSF lawsuits in federal courts. The first of those cases is scheduled to go to trial later this spring.
Thomsen's and GE’s statement (PDF).
