Many car buyers are familiar with what’s known as a “lemon law”-the obligation of a car dealer to make good if the car you buy is defective. Consumers Union, the policy arm of the nonprofit that publishes Consumer Reports, is championing the idea of a lemon law-otherwise known as a warranty-for the artificial hips and knees implanted during replacement surgery.
Problems with these devices are well known: For example, see our blog about Consumers Union’s effort for more rigorous medical device testing. Joint replacements often fail, the organization notes, and patients and insurers get stuck with the bill, not the manufacturers.
Nearly 1 in 5 hip replacements and 1 in 10 knee replacements each year are revisions, says Consumers Union, and the re-dos are often necessary because the original device was defective. Those follow-up surgeries generally require longer hospital stays than the initial procedures, which means additional risks of infection, bed sores (pressure sores) and other problems that result from additional surgery and bed confinement.
They’re also more expensive for the patient, the insurance company and, where relevant, Medicare.
“[M]anufacturers of hip and knee implants should give patients warranties, guaranteeing to replace defective devices at no cost. That … is not only fairer to patients, but might encourage companies to make their devices safer and more durable,” says the Consumers Union policy statement.
The organization’s Safe Patient Project tapped into an FDA database on hip and knee implant recalls over the last 10 years, and learned that every major manufacturer had recalled a product or line of products.
It cited the approximately 750,000 Americans who received metal-on-metal hip implants since 2003 that were promoted as lasting longer than more traditional devices made with ceramic and plastic. But not only were such devices more likely to fail, as we’ve reported, some patients experienced debilitating symptoms from the metal debris that corrodes over time, including heart damage and neurological problems.
Knee implants, Consumers Union says, haven’t been as deficient or as dangerous, but still, according to the Safe Patient analysis, hundreds of knee-implant components have been recalled since 2003, often because they were shipped with the wrong part, a wrong size part, a missing part or a part built for the opposite side for which it was intended.
In what universe should these errors in management and manufacturing be the responsibility of the patient or insurer?
A Consumer Reports investigation last year on dangerous medical devices found that most hip and knee implants are approved for market without being reviewed for safety and effectiveness under the FDA’s 510(k) law, known as “fast track” clearance. That means manufacturers only have to demonstrate that a device is “substantially equivalent” to a product on the market-it doesn’t have to go through rigorous testing to which completely new devices are subject.
“Medical device companies claim that current law provides adequate protection for patients and that their implants are dependable and safe,” Lisa McGiffert, director of the Safe Patient Project, said in the policy statement. “If that’s the case, they should have no objection to offering warranties to back up those claims. Patients and taxpayers shouldn’t be on the hook for the cost of replacing devices when they fail.”
Safe Patient wants the makers of hip and knee implants, including Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc. and Zimmer Holdings Inc., to provide a 20-year warranty that:
- covers the full cost of revision surgery, including the device itself, the surgeon and hospital costs and patient out-of-pocket costs;
- establishes a clear system for patients to use, including a toll-free phone line and a registration number to track the claims process, with physicians charging the device company, not the patient; and
- does not eliminate the patient’s right to sue if he or she uses a warranty.
If you believe in your product, you should be willing to make such a promise to the people who buy it.