Recently, Senator Charles Grassley (R-IA) sent a letter to David C. Dvorak President and CEO of Zimmer Holdings Inc., regarding the company’s deferred prosecution agreement with the Department of Justice (DOJ).
As one of the requirements under the agreement, Zimmer has been posting on its website detailed information about the company’s financial relationships with certain healthcare professionals since 2008. In fact, on Zimmer’s corporate website, they assert their support for transparency initiatives relating to financial arrangements and collaboration between industry and healthcare professionals. It should be noted however, that you can only find their “transparency” report in the corporate website area. If you say you are a patient caregiver, or medical professional you can’t access the information.
In addition to posting its payments, the company asserts on its website that they “encourage efforts to enact Federal legislation that requires the reporting of physician payments in a way that protects the important collaboration between manufacturers and physicians.” In that regard, Zimmer believes that “such legislation should institute a uniform reporting requirement nationwide that will provide patients with relevant information concerning these financial arrangements.”
The company also acknowledged that “over the past year, Zimmer has supported the efforts of Senators Herb Kohl (D-WI) and Charles Grassley (R-IA) to enact such legislation, and even provided comments on the Physician Payments Sunshine Act of 2009 (S.301) introduced by Senators Kohl and Grassley.”
Consequently, the reason for Grassley’s letter was a response to an article he read in The New York Times, which reported that one of the surgeons with whom Zimmer had a financial relationship, Dr. Richard Berger, raised concerns to the company a few years ago about the premature failure of a Zimmer knee, the NexGen CR-Flex. Grassley focused his comments on the fact that Dr. Berger was a long-time consultant for Zimmer—a financial relationship that spanned more a decade—with Dr. Berger receiving more than $8 million during that time frame.
Mr. Grassley was also concerned that a second Zimmer consultant, Dr. Lawrence Dorr, alerted other doctors that Zimmer’s Durom hip device was failing a few years after they were implanted in patients. He also noted that these two doctors were not alone in their concerns about the device failures, according to The New York Times. Consequently, in both cases, Zimmer responded that it was the surgeons’ technique, not the devices that were flawed.
Accordingly, Mr. Grassley asked that Mr. Dvorak respond to the requests listed below by August 12, 2010, which include:
1) What process does Zimmer have in place to respond to allegations and concerns raised by its consultants or contractors regarding the safety of one of its products?
2) Since January 2008, how many Zimmer consultants or contractors have raised safety concerns or problems regarding Zimmer’s products? For each product for which concerns or problems were reported, please include the following:
a. The name and affiliation of the consultant or contractor and whether or not s/he is still a Zimmer consultant;
b. The name of the product;
c. The specific concern(s) or problem(s) reported to Zimmer;
d. Whether or not the reports of safety concerns or problems led to product changes/modifications; and
e. Whether or not the reports of safety concerns or problems led to product discontinuation.
3) Of the safety concerns or problems identified since January 2008, how many were refuted by Zimmer?
4) Although not required to track the long-term performance of its devices, does Zimmer voluntarily collect data on the performance of its hip and knee devices and other implantable devices? If so, how is that data collected? If not, has Zimmer considered putting in place a process for tracking and reviewing the performance of its devices?
It will be interesting to learn the response from Zimmer. The questions seem reasonable; though probably propagate by a trial attorney.