A Medical Device Daily

Bracco Diagnostics (Princeton, New Jersey) reported that the U.S. District Court in Trenton, New Jersey has ruled in favor of Bracco and against GE Healthcare (Waukesha, Wisconsin). The 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.

Bracco said 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.

In other legalities:

The United States Patent & Trademark Office (USPTO) overruled Arthrex's (Naples, Florida) validity challenges to the claims of a medical device patent exclusively licensed to Smith & Nephew (London) by Dr. John Hayhurst of Portland, Oregon.

As part of its attempt to overcome the jury's verdict against it, Arthrex initiated a standard re-examination proceeding with the USPTO to try to declare the patent invalid. The USPTO ruling confirms the validity of the claims of the patent that are infringed by Arthrex.

A jury determined last June that Arthrex willfully infringed this patent and awarded Smith & Nephew Endoscopy $14.7 million for infringement through the end of 2005. That amount was later increased by the court for prejudgment interest and additional damages.

Four med-tech companies reported that the Deferred Prosecution Agreement (DPA) entered into with the U.S. Attorney's Office for the District of New Jersey (USAO) has expired. Biomet, Zimmer (both, Warsaw, Indiana) Smith & Nephew (London) and the DePuy Orthopaedics (Raynham, Massachusetts) unit of Johnson & Johnson (New Brunswick, New Jersey) all said that they had satisfied their obligations under the DPA and have received a Notice of Dismissal of the complaint filed against them in this matter in the U.S. District Court for the District of New Jersey.

A fifth company, Stryker (Kalamazoo, Michigan), also completed the terms of its agreement with the government. Stryker cooperated in the criminal investigation and was not the subject of a complaint.

Neither the DPA nor the complaint alleged that the companies' conduct adversely affected patient health or patient care. The 18-month agreements were entered into on Sept. 27, 2007, between the USAO and the five largest companies that manufacture and sell hip and knee replacement implants.

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