A U.S. Federal court has ruled that Amersham plc (now an acquisition of General Electric Company for GE Healthcare) has engaged in actionable false and misleading advertising and promotion in claiming that its contrast medium, Visipaque, was superior to Bracco Diagnostics, Inc.'s (Bracco) contrast medium, Isovue.

The Hon. Freda L. Wolfson, U.S. District Judge for the District of New Jersey handed down the Opinion and Order on March 25 after a 39 day bench trial that featured many experts and witnesses testifying with regard to both parties' product lines and clinical studies featured in advertising.

The following information was obtained from the legal documents filed in the case: Bracco filed a federal Complaint against Amersham plc and its indirect wholly owned subsidiaries (Amersham) in 2003. Amersham was officially acquired by General Electric Company (GE) in 2004, after the Complaint was filed. Bracco's Complaint alleged false advertising by Amersham in violation of the Lanham Act (which permits business competitors to litigate one another for false advertising). Amersham had the iso-osmolar contrast medium known as Visipaque, and Bracco has a competing line of low osmolar, nonionic contrast medium (LOCM) known as Isovue. Bracco alleged that Amersham had falsely advertised the superiority of Vispaque over Isovue through statements suggesting Visipaque is better than a LOCM. Amersham then filed a Counterclaim against Bracco for alleged false advertising of its own line of products.

Amersham had advertised Vispaque as being superior in several different ways including renal and cardiovascular safety, pain, heat and discomfort, in part relying on a study in the New England Journal of Medicine. That study involved Visipaque and Omnipaque, Amersham's own LOCM. The Court found that only a fraction of the Visipaque ads were false and most of the other advertisements were true and based on reliable scientific studies. The advertising the Court found false were those representations that extrapolated beyond the studies' results. However, the Court noted that the limited false ads disseminated by Amersham were not willfully (deliberately) false because the company had relied on scientific studies that had not been disproved.

The Court issued an injunction forbidding GE from claiming (among other claims) that Visipaque is renally superior to all LOCM or performs better than all LOCM because of lower osmosality and associated costs, or that Visipaque causes less discomfort than all LOCM. The Court also ordered GE to issue a press release, including on its website, regarding the Court's decision and the placement of corrective ads. In addition, the Court ordered GE to re-train its sales and marketing personnel in accordance with the Court opinion. The Court ordered recovery of Bracco's costs associated with corrective advertising performed in response to GE's wrongful conduct, $11,376,500. Finally, the Court imposed an alternative dispute mechanism applicable to both parties for safeguarding against any future false advertisements.

In regards to the counterclaim against Bracco for false advertising, the Court held that the requested injunction against Bracco was not appropriate because GE could not demonstrate irreparable harm, and that Bracco had stipulated that it no longer uses the advertisements that the Court found false.

Source:
Based upon the legal documents filed in the case Civil Action No. 03-6025, Bracco Diagnostics, Inc., v. Amersham Health Inc., et al.

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