Two major players in the trocar market settled their legal dispute this week over tactics used in marketing products to surgeons and hospitals.

As part of the settlement, Applied Medical, based in Santa Margarita, Calif., dropped a lawsuit that had alleged Ethicon Endo-Surgery used false advertising to promote its XCEL bladeless trocar and to disparage Applied Medical's Separator trocars. In return, Ethicon Endo-Surgery, based in Cincinnati, Ohio, will stop making the disputed marketing claims.

"We believe that it will enhance hospitals' and providers' ability to rely on peer-reviewed scientific research and avoid unsubstantiated claims," says Karen Gibbs, vice president of litigation for Applied Medical, of the settlement.

The case had been in federal court in California for more than a year. In the complaint filed in May 2009, Applied Medical claimed that during clinical evaluation of its trocars at the Halifax Medical Center in Daytona Beach, Fla., and Hawaii Pacific Health outside Honolulu, Ethicon Endo-Surgery reps gave surgeons and other clinical staff false and misleading information about the Applied Medical trocars under evaluation.

According to court documents, when Ethicon reps learned of a trial of Applied Medical's Separator trocars at hospitals, they sent letters and promotional materials to surgeons that listed poorly supported clinical assertions and urged the surgeons to select "unacceptable" on evaluation forms. "Some surgeons at Halifax are seeing signs of skin necrosis at the puncture site," said a February 2009 letter from Ethicon Endo-Surgery to surgeons. In court documents, Applied Medical says that it sells 250,000 trocars a month and is aware of no reports of necrosis.

In March, Judge Percy Anderson of the U.S. District Court Central District of California dismissed several of Applied Medical's claims of false advertising, except those related to port site trauma, fascial closure and port site herniation, which were still included in the lawsuit. The settlement apparently dealt with those assertions.

In a statement, Ethicon Endo-Surgery said that it "is pleased with this previous judgment, and the resolution of outstanding claims through this settlement."

Kent Steinriede

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