The U.S. District Court in Trenton, N.J. has ruled that GE Healthcare and its predecessor companies, including Amersham, engaged in a false and misleading advertising with a promotional campaign claiming that its x-ray contrast agent Visipaque was superior to Bracco's x-ray contrast agent Isovue.

Judge Freda L. Wolfson found GE liable for disseminating false messages in its advertising of Visipaque. The litigation is primarily related to a clinical study that was published in 2003 by the New England Journal of Medicine (the NEPHRIC study) comparing two GE products: Visipaque and Omnipaque. While the study only compared these two products, GE misrepresented the study in an attempt to claim that Visipaque was safer than other products that were not included in the study, including Bracco's Isovue.

As a result, the court permanently enjoined GE from making further false claims and ordered it to implement a number of corrective actions within 60 days of the ruling. including a press release and advertisements, to ensure that healthcare providers are correctly informed about the false claims.

GE's advertising must be limited to the procedures, contrast medium, patient types and circumstances that were used in the studies presented at trial. When citing studies in its advertising, GE must plainly identify, in same size print (and not in footnoted material), the contrast medium used in the study and that the findings of that study are limited to the studied contrast medium, according to the ruling.

The court also ordered GE Healthcare to pay Bracco $11.4 million in damages.

"We are pleased that the Court has demanded that GE Healthcare disclose the truth to healthcare professionals, many of whom have paid a significant premium for Visipaque over many years as a result of false statements that Visipaque was superior to Isovue," stated Carlo Medici, President and CEO of Bracco Diagnostics.

GE had also filed a counterclaim against Bracco, but "because Bracco has discontinued its use of advertisements GE alleged to be false in its counterclaim, GE is not entitled to injunctive relief," according to the court documents.

In a request for comment from GE, Eric Cantor, MD, head of medical and professional affairs, Americas, said that the company had a very different perspective on the ruling.

"We are actually fairly pleased with the outcomes," he said. "We lost in that we were asked to pay $11.4 million but that was compared to in excess of $1 billion initially being asked for." Cantor added that in looking at the details of the ruling, there were a lot of things brought out not in favor of Bracco.

He specifically mentioned that the court also ruled that Bracco failed to prove a good portion of their claims against GE, such as a loss of GPO contracts or other sales based on their allegations. Additionally, the accusation that GE had manipulated clinical trials was also found to be untrue. "The majority of GE's messages were in fact true and properly relied upon scientific studies to support them," Cantor quoted from the court documents.

Also, he cited the finding that Bracco sought to manipulate and conceal its results adverse to its marketing position, and that it had falsely promoted Isovue as less renally toxic than GE's products based on NEPHRIC.

"It really was much more of a mixed bag [of results]," Cantor concluded, adding that GE is working to follow the court's ruling.