The good news is that the FDA has recalled Guidant defibrillators. Here is the press release that discusses the recall and lists the models that are being recalled. Somewhere between 40,000 and 50,000 people are affected by the recall.
It is known that two people have died because of a malfunction in the device.
The bad news is that Guidant has not yet indicated that it will pay for the full cost of the replacement (including surgeon and hospital fees). Reportedly, it is only going to pay (i.e.not charge) for the cost of a new device. A hospital charges about $2000 for a device like this; the cost to Guidant is a fraction of this amount.
Patients: contact the surgeon who put in your device and find out if it has been recalled. Then, talk with your surgeon about the wisdom of having the device replaced. Feel free to seek a second opinion. Here is an article that gives you more information about the recall and the risks.
We have addressed this topic in previous posts (Go to Products Liability). Guidant should, at a minimum, pay all costs associated with the removal of the devices. It should also reimburse the patients for lost earnings during any period of incapacity because of the replacement of the device and it should be fully responsible for any complications of the replacement procedure. The taxpayers (who pick up the cost of Medicare and Medicaid funding) and those with health insurance (whose premiums are impacted by health care costs) should not pay one penny to fix a problem caused by Guidant.
I am confident that Guidant will appropriately address this issue sooner rather than later. Why? Why after all these months of not bringing the problem with the devices to the attention of regulators and patients? Well, because it’s code of ethics requires it. Here is an excerpt:
“Guidant is a leader in the medical technology industry. We believe that conducting our business in accordance with high standards of business conduct is fundamental to our ability to succeed in the marketplace. We are committed to being an innovative, unique, world-class corporation. The only way to achieve this commitment is by providing a high standard of leadership, along with unquestionable integrity. Continued honest and ethical business conduct will earn Guidant the trust of customers, patients, suppliers, investors, regulators and fellow employees, while sustaining our long-term commitment to our shareholders.”
For more on Guidant’s views on its ethics, click here. Let’s compare actions and words over the next few days.