Zimmer Asked To Provide Details Of Safety Concerns
Posted
Daniel Riordan-driordan@timesuniononline.com
In a letter to Zimmer last week, U.S. Senator Charles E. Grassley asked the orthopedic company to provide information regarding concerns brought up by its consultants.
Zimmer also has been asked how it tracks the long-term performance of its products.
The inquires by the senator from Iowa came about after a June 20 New York Times article titled "Surgeon vs. Knee Maker: Who's Rejecting Whom?"The letter was addressed to Zimmer's President and Chief Executive Officer David C. Dvorak.
Grassley said he was troubled by the article and wrote the letter because of his status as ranking member of the U.S. Senate finance committee.
The article features Dr. Richard A. Berger, a surgeon and assistant professor at Rush University Medical Center in Chicago.
The New York Times reported that during a decade Berger earned more than $8 million from Zimmer for designing surgical tools, artificial joints and training "hundreds of doctors to use its products."
Berger told the New York Times the relationship between him and the world's larger maker of knee joints became strained over Zimmer's NexGen CR-Flex knee.
It was noted that Berger used an uncemented version of the CR-Flex and that in 2005 he put the device in 125 patients.
But in 2006, some patients complained of pain and x-rays showed that device was loose and hadn't fused completely.
The article stated Zimmer officials suggested the problem may be with Berger's techniques citing that no other surgeon had complained.
Berger and another surgeon presented a study at the American Association of Orthopedic Surgeons this year that the uncemented Zimmer knee failed nearly in about 9 percent of some 100 patients studied and looseness was shown in about half the patients.
For its part, the Times article reports that Zimmer noted in a filing with the Securities and Exchange Commission that the cement-free CR-Flex accounted for a small percentage of its total knee sales.
In that filing with the SEC, Zimmer noted both Berger's study and another study in Australia showing a low failure rate.
Another surgeon, Dr. Lawrence Dorr, of Los Angeles, was also featured in the New York Times article about the potential failure of a Durom cup in hips.
The Food and Drug Administration eventually closed an investigation into the hip component after Zimmer provided information from 12 surgical centers that showed the hip was working well.
While Berger no longer has a relationship with Zimmer, a representative from the orthopedic company couldn't confirm as of this morning whether Dorr still did.
At the end of Grassley's letter he asked for responses to several questions by Aug. 12.
The first question was what process does Zimmer have in place to respond to allegations by consultants or contractors.
Grassley also asked Zimmer to recount how many Zimmer consultants, since January 2008, have raised safety concerns or problems regarding Zimmer products.
Grassley asked for specifics including the name of the consultant, the product, specific concerns and whether or nor the reports led to product changes or modifications.
Grassley also asked Zimmer to provide how many concerns were refuted by the company.
Zimmer released a statement in response to Grassley's letter to Dvorak.
"Zimmer welcomes the opportunity to speak with Senator Grassley about The New York Times article of June 18, 2010 ('Surgeon vs. Knee Maker: Who's Rejecting Whom?')."
Zimmer's press release also addressed its relationship with its consultants.
"Beyond product development, Zimmer welcomes and seeks feedback from surgeons who use our products. This feedback can lead to modifications and improvements to products, their labeling and the manner in which we train and educate surgeons about our products."
The release also noted its compliance of ethics and compliance programs.
Zimmer also noted its support of the Sunshine Act co-sponsored by Grassley. The Sunshine Act, in part, requires companies like Zimmer to provide payment information to physicians.
