Defective Machinery: Can Warranty Systems Work for Medical Devices?

Your heart stops beating.

This is unwelcome news and doubly so because you underwent surgery three months ago to have a pacemaker installed. It was supposed to keep your heart beating, right?

If paramedics get to you and physicians are able to restart your heart, it’s most likely that you can have at least some of your costs covered through a warranty. Unlike hip and knee replacement devices, pacemakers generally come with warranties.

Now, this doesn’t mean that companies won’t argue about what a warranty covers or that patients won’t end up in court. But it does mean there’s a clear precedent for product warranties on medical devices. Consumers Union’s Safe Patient Project is launching a new campaign to push for warranties on hip and knee replacements with slogans that you never thought you would see on a bumper sticker: Equip That Hip! Guarantee That Knee!

How guaranteed are pacemakers right now?

It depends on the company. I found one-year, five-year, and seven-year warranties, all with variations on the same theme. If the failure of the device meets certain conditions, the company will replace it and, in some cases, cover elements of the related medical expenses.

BIOTRONIK Inc. offers a five-year warranty. The company will “extend a replacement credit equal to the original purchase price,” if the pacemaker malfunctions and will provide $2,500 to help cover surgical and hospitalization costs. There are some big caveats, though. In order for the warranty to apply, these conditions have to be met:

1. The implantable pulse generator was stored, handled, and implanted in accordance with BIOTRONIK’s specifications.

2. The explanted pulse generator was replaced with another BIOTRONIK unit, and the explanted unit was returned to BIOTRONIK within 30 days of explants to verify that the unit ceased to function because of malfunction. All devices returned become the property of BIOTRONIK. All available documentation of device malfunction should be included.

3. The Warranty shall apply only to the patient registered with BIOTRONIK. Receipt of the completed Patient Registration Form serves as verification of implantation.

In other words:

1. The hospital stored your pacemaker next to the boiler room (too hot) before your surgery, and so the warranty is voided.

2. You don’t want another BIOTRONIK unit because the first one failed. (Understandable.) So the warranty is voided.

3. You are dead. So your partner, children, parents, or anyone else who might have a reasonable claim on a warranty can’t make that claim. The warranty is voided.

I am not a warranty expert, but my experience has always been that if I have a device with a serial number on it, and it is within the warranty period, I can make a claim. I have never been asked to verify that I purchased the device. I brought my phone in for a fix the other day, for example, and nobody asked me to produce the product registration form.

The Safe Patient Project has a few suggested requirements for warranties for knees and hips. Note that the lifespan of the warranty is more in line with the typical lifespan of knee and hip replacements.

• Covers the implant for at least 20 years.
• Covers full replacement costs of a flawed device, including the device, surgeon and hospital costs as well as the related patient out of pocket costs.
• Does not require the failed device be replaced with the same product or a product from the original device maker if the product has been recalled by FDA or the company, is the subject of FDA warnings, is under investigation by the FDA or if the product is no longer being sold by the company.
• Establishes a clear system for patients to use, including a toll-free number and a registration number to track the claims process, with physicians charging the device company, not the patient.
• Does not require the patient pay out-of-pocket expenses; for example, the patient should not have to pay the device maker or surgeon first and get reimbursed later.
• Provides the patient with full information concerning a warranty claim denial and provides a process to allow the patient to appeal the decision.
• Does not limit or eliminate a patient’s right to sue if they use the warranty.
• Does not disqualify patients across the board because they have specific diseases or illnesses that are not related to the failure of a device.
• Does not disqualify patients for normal activities, including falls.
• Does not disqualify patients due to information that is not routinely available to them, such as information that is on the device packaging or placed into their medical records and not routinely provided directly to the patients in the course of getting the implant.

What do you think warranties on medical devices should cover? And do you think there’s a difference between pacemakers and other devices in terms of expectations for replacement costs?

Image by Bhakua via Flickr

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