A top Senate Republican from Iowa has asked Zimmer Holdings Inc. to disclose information about its product complaint handling process. A July 29 letter sent by U.S. Sen. Charles E. Grassley, R-Iowa, asks Zimmer to list reports of “safety concerns or problems” reported by the company’s consultants or contractors since January 2008. The letter also asks officials at the Warsaw, Ind.-based firm to disclose the way they track the long-term performance of orthopedic devices.
Specifically, Grassley has given Zimmer until Aug. 12 to supply data about:
•The process it uses to respond to all product safety concerns raised by consultants or contractors;
•Product safety concerns raised by consultants and contractors since January 2008 (including the product name, nature of the safety concern, identities of the contractors/consultants that raised the concerns, any changes or modifications to the product, and whether the product was discontinued);
•The number of safety concerns refuted since January 2008; and
•The performance of hip, knee and other implantable devices (including how such data is collected, and whether the company has ever considered implementing a process for tracking and reviewing device performance)
Zimmer, in an emailed statement, said it welcomes the chance to discuss its complaint handling process with Grassley. “For decades, Zimmer engineers and health care professionals (HCPs) have worked closely to develop technologies that match patients’ needs and improve clinical outcomes in musculoskeletal care. Collaboration between HCPs and industry is an essential factor in the demonstrable success of orthopaedic implants compared to other medical therapies. 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 statement read.
Grassley’s requests were prompted by a June 18 story in The New York Times that detailed disputes in recent years between Zimmer and two of its top consultants. The disputes involved the failures of two different products—a hip component in one case and the NexGen CR-Flex knee in the other case. The consultants claimed the devices failed soon after they were implanted, but Zimmer officials blamed the surgeons’ techniques for the failure rather than the products’ design.
One of the surgeons, Richard Berger, M.D., was a consultant for Zimmer for more than a decade, receiving more than $8 million for his services. In the Times article, Berger said he implanted Zimmer’s NexGen CR-Flex device in about 125 patients in 2005. Though the device is supposed to last 15 years, Berger noticed that some X-rays showed lines where the implant met the thigh bone, an indication that the artificial knee had not fused completely. Patients were able to walk, but experienced pain, he told the Times. In a study he conducted with another doctor, Berger found the uncemented NexGen knee failed early in about 9 percent of 100 patients. In addition, the study concluded, Zimmer’s knee showed signs of loosening in about half of all patients and has been replaced in some of them.
Berger alerted Zimmer executives to the problem (including the company’s top scientist), but the company countered those failures in a filing with the U.S. Securities and Exchange Commission. In that filing, Zimmer noted the low failure rate of its NexGen knee among Australian orthopedic patients (the device, however, accounted for only 2 percent of its overall knee sales at the time).
Another consultant, Lawrence Dorr, M.D., discovered problems with Zimmer’s Durom cup hip component, the subject of numerous lawsuits from patients. Dorr, a Los Angeles, Calif.-based consultant, alerted his fellow surgeons that the Durom cup failed within a few years of being implanted. Zimmer officials, however, claimed the problem was with Dorr’s technique and to prove it, provided the U.S. Food and Drug Administration (FDA) with data from 12 surgical centers that showed the hip implant was working well. Based upon that information, the FDA closed its investigation of the device.
“Zimmer strives to protect patients by adhering to quality system requirements and diligently monitoring the performance of our products through a post-market surveillance program,” the company’s statement (to Grassley’s letter) read. “This program is similar to programs for other medical device manufacturers and is designed to ensure the well-being of patients and address the concerns of surgeons responsibly and appropriately. Our surveillance program includes vetting concerns from surgeons which may lead to investigations. In addition to Zimmer’s own processes, the clinical performance of implant products is subject to review by independently run national patient registries in many countries.”
Grassley and Sen. Herbert R. Kohl, D-Wis., have been on an 18-month quest to improve the transparency of physician-industry relationships. Last year, the pair introduced the Physician Payments Sunshine Act, which would require the disclosure of physician payments of all medical device, medical supply and pharmaceutical companies.
Though that legislation is still pending, several states have drafted their own legislation requiring disclosure. Massachusetts, for instance, passed a law requiring disclosure of gifts worth more than $50.