Bracco Diagnostics Inc. (“Bracco”) announced today that the United States District Court in Trenton, New Jersey has ruled in favor of Bracco and against GE Healthcare in one of the most significant false advertising cases to date. Today’s ruling validates Bracco’s position that GE Healthcare and its predecessor companies, including Amersham, engaged in a false and misleading advertising and promotional campaign in an attempt to make false claims that its x-ray contrast agent Visipaque™ was superior to Bracco’s market-leading x-ray contrast agent Isovue®.

In its ruling, the Court found GE Healthcare 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 Healthcare products: Visipaque™ and Omnipaque®. While the study only compared these two GE Healthcare products, GE Healthcare 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®. In addition, independent studies, Bracco studies, and GE Healthcare’s own clinical research demonstrated the inappropriateness of GE Healthcare’s false claims.

As a result of GE Healthcare’s misconduct, the Court permanently enjoined GE Healthcare from making further false claims and ordered them to implement a number of corrective actions, including a press release and advertisements, to ensure that healthcare providers are correctly informed about the false claims. The Court also ordered GE Healthcare to pay Bracco $11.4 million in damages.

Carlo Medici, President and CEO of Bracco Diagnostics, stated, “Today’s ruling highlights the importance of conducting pharmaceutical marketing in an ethically responsible manner and accurately presenting the results of clinical research to healthcare providers to ensure the best patient care. 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®.” In its ruling, the Court stated the following:

  • “Here, the Court is the fact-finder, and has found that GEH’s [GE Healthcare] conduct is in violation of the Lanham Act; accordingly, Bracco has demonstrated actual success of the merits and in turn, irreparable injury.”
  • “Finally, it is well within the public interest for this Court to enjoin GEH from disseminating false messages regarding Visipaque.”
  • “In connection with Bracco’s claim, the Court finds that an injunction and damages for post and future corrective advertising are appropriate remedies to prevent future violations of the Lanham Act.”

The Court has ordered GE Healthcare to take a series of corrective actions within 60 days, including, but not limited to:

  • Be permanently enjoined from making false claims about the comparative safety profile of Visipaque™;
  • Issue a press release that would also be posted on its website on the Court’s decision;
  • Issue corrective advertisements;
  • Re-train its sales and marketing staff in accordance with the Court’s decision;
  • When citing studies in its advertising, plainly identify which studies the findings relate to and refer to the comparator drugs by either their brand or scientific names.

GE Healthcare had also filed a counterclaim against Bracco, but the Judge granted GE Healthcare no relief whatsoever.

This litigation was originally filed in December 2003. The 39-day trial, taking place from May to December of 2007 and including the testimony of seven contrast agent experts, 34 other witnesses and the entry into evidence of over 1400 exhibits, was one of the most comprehensive examinations of false advertising claims in legal history. Kramer, Levin, Naftalis & Frankel, LLP served as legal counsel to Bracco.