Who is responsible for communicating defects?

Clancy Law

Medical devices, such as tiny defibrillators and artificial hearts, have given thousands of people new leases on life. But when these devices become defective and are subject to recall, whose duty is it to inform the patient?

This question vexed the parents of a nine-year-old Chicago girl who had a St. Jude defibrillator implanted in her chest to keep her heart going. (She has a condition called Long QT Syndrome, where the heart is prone to stop beating). According to an NBC Chicago.com report, her parents recently discovered that her device was subject to a recall, but they only did so out of happenstance.

They did not receive an official notice from St. Jude. Instead, they only found out through an online newsletter that St. Jude products had been subject to a recall.

They cross-referenced the information with the Food and Drug Administration’s (FDA) website, and discovered that their daughter’s device was on the list. However, they did not receive any letters or notification from the FDA before searching their site. When the parents asked questions about why they were not notified about the recall, St. Jude and the FDA started pointing fingers.

The FDA indicated that the device maker must notify health care providers and patients, while St. Jude said that the health care provider is responsible for informing patients about product recalls. A cardiologist familiar with the recall disagreed, and believed that the parents should have been notified by both the manufacturer as well as the physician. He also suggested that the parents were justified in being upset about how they were notified.

Fortunately, the blame game did not result in a life being lost.

Source: NBC Chicago.com, Girl, 9, learns of second recall connected to defibrillator, February 4, 2013

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Who is responsible for communicating defects?