Who informs Chicago patients about defective medical devices?

Chicago patients who suffer from life-threatening, chronic or disabling medical conditions may currently be using a variety of medical devices to keep their symptoms and health under control.

Although medical devices must meet certain requirements before the products can be approved for patient use, a number of problems could still occur after a device is approved and used by patients. Perhaps a manufacturing error causes a product to become defective. Or perhaps a product ends up causing patients to suffer serious injuries. When defects and dangerous side effects are discovered, the U.S. Food and Drug Administration may need to recall dangerous medical devices.

When a recall is finally issued, who informs patients that they may be using a dangerous product that could cause them to suffer serious or fatal injuries? The FDA says device makers have a responsibility to directly notify patients about recalls when patients may be affected by a specific device recall. But medical device makers claim that physicians are entirely responsible for passing the word along to their patients who may be using a recalled medical device.

So, who do you think is truly responsible for telling patients that they may be using dangerous, recalled products that could potentially cause more harm than good? Should only device makers take on this responsibility, or should doctors get involved and inform patients, too?

One Illinois woman is still trying to get this question answered. She recently learned that her 9-year-old daughter has been relying on an implantable defibrillator that was recalled by St. Jude Medical over one year ago. The device was recalled as a Class I recall because it is so defective that it could cause patients to suffer serious or fatal injuries. The Riata leads of the devices have been known to fail, which could prevent patients from being saved by the devices if or when their hearts suddenly stop working.

The woman learned that her daughter’s medical device had been recalled over a year ago after she recently received a newsletter in her email about a recalled St. Jude product. The name of the device manufacturer caught the woman’s attention and she realized that the recalled product is one that is currently implanted in her daughter’s chest.

The mother is upset and frustrated because St. Jude never directly informed her about the device recall, and neither did her daughter’s doctor. She has asked who is responsible for notifying patients when devices go bad, but the blame keeps getting passed between doctors and device makers.

Source: 5 NBC Chicago, “Girl, 9, Learns of Second Recall Connected to Defibrillator,” Lisa Parker, Feb. 4, 2013

  • Our firm provides legal counsel to patients and families who have been harmed by doctors’ mistakes and medical negligence. To learn more about protecting medical malpractice victims’ rights and seeking compensation for malpractice-related injuries and costs, please visit ourmedical malpractice solutions for people in Cook County page.

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