With an Eye on Consulting Relationships, Sen. Grassley Probes Reporting Practices at Zimmer
BY LAUREN UZDIENSKI, AUGUST 2, 2010
Zimmer received a letter from Sen. Chuck Grassley requesting data on the company's processes for tracking failure rates of its large joint systems, specifically when safety issues are raised by company consultants. The inquiry stems from concerns over the company's NexGen CR-Flex, a cementless total knee, which were publicized by the New York Times in an article on Dr. Richard Berger's relationship with Zimmer.
In an interview with the Times conducted in June, Dr. Berger intimated that the company terminated his consulting contract, for which he'd been paid more than $8 million over a decade, based on his criticism of the NexGen knee and a study demonstrating its high failure rate. The story alleges that colleagues of Dr. Berger's reported similar problems with the NexGen, which Zimmer reportedly blamed on surgical technique, not the device.
For Sen. Grassley, this raised a number of questions pertaining to Zimmer's processes for addressing safety concerns raised by its consultants. The senator has asked for documentation on how Zimmer responds to safety issues raised by consultants; the number of consultants who have raised safety issues since January 2008; the number of issues refuted by the company; and whether the company voluntarily collects data on device performance.
