Who foots the bill when an artificial hip or other joint implant fails prematurely due to a defect? According to a report in The New York Times, itsâ€™ almost never the maker of the device.
An artificial hip or knee should last about 15 years. But sometimes, design defects or other problems cause a device to fail early. Just last month, for example, DePuy Orthopaedics, a unit of Johnson & Johnson, warned that its ASR artificial hip implant appears to have a high early failure rate in some patients. The warning from DePuy followed more than two years of reports that the device was failing in patients only a few years after implant, requiring costly and painful replacement operations. Since 2008, the Food & Drug Administration (FDA) has received about 300 reports of early replacement operations involving the ASR device.
But the ASR, like the million or so artificial hips and knees implanted each year in the U.S. donâ€™t come with any type of guarantee or warranty. Instead the Times said, when a device fails, the cost is borne by Medicare (i.e. the taxpayer), insurance companies and even the patient. At about $15,000 per implant, the cost to the healthcare system is huge, even if only a small percentage of implants fail because of a defect.
Even worse, some device makers may actually profit when an implant fails. In many cases, the manufacturer of the defective implant provides the replacement â€“ at full price.
The lack of warranties for joint implants is unusual in the industry. Other implant makers, such as those that manufacture defibrillators, have issued warranties for more than 30 years and have provided free or discounted replacements when devices fail prematurely, the Times said.
Arthur Levin, the executive director of the consumer advocacy group Center for Medical Consumers, told the time that the lack of warranties for joint implants borders on unethical behavior. â€śEither they do not have faith in their products, or they are just saying tough luck to patients,â€ť Levin said.
An official with implant maker Zimmer Holdings told the Times that that the success or failure of a joint implant depends on too many factors â€“ including a surgeonâ€™s skill, a patientâ€™s weight and a patientâ€™s adherence to postoperative restrictions on activity â€“ factors that are not under the manufacturerâ€™s control. This, according to the official, makes offering warranties impossible.
DePuy said in a statement that while it does not guarantee its devices with product warranties, it does â€śevaluate and address all complaints and issues on a case-by-case basis and take actions based on the specific circumstances.â€ť
According to the Times, when joint implant makers do pay for revision surgeries, it is often because they are facing product liability lawsuits over defective products.