US Senator Wants Answers from Medical Device Company

After reading a June 20th article in the NY Times concerning Zimmer Holdings Inc.’s relationship with two medical consultants, Senator Charles Grassley (R-IA) decided he needed to ask the medical device manufacturer a few questions himself.
The Times’ article had told the story of Dr. Dorr and Dr. Berger, two prominent orthopedic surgeons and one-time consultants to Zimmer regarding the artificial hips and knees. The Times detailed the doctors’ concerns about the orthopedic products. Dorr had warned other surgeons that the Zimmer Durom Cup was failing at an unacceptable rate. Berger complained to Zimmer about its knee device the NexGen CR-Flex which, according to Berger, was experiencing a high failure rate. In both instances, Zimmer told the surgeons that any failures should be attributed to improper technique rather than device failure.
Senator Grassley, perhaps recognizing such a dispute between a medical device company and surgeons places the patient in an untenable position, wants to know how Zimmer makes such a determination. Specifically, Grassley wants to know how Zimmer tracks the long-term effectiveness of their medical devices. (Most countries maintain databases with this information. The United States has no such system in place.) Additionally, Grassley wants a list of complaints consultants, including Dorr and Berger, have made to the company as well as information concerning Zimmer’s response to the complaints.
This is an important move by Senator Grassley. Anyone who read the Times’ article should have found the present stand-off between doctors and Zimmer disconcerting. Unless this is resolved, it’s the patients who lose.