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Heart Device Flaws Raises Many Questions

The New York Times recently shared information about new concerns over defibrillator safety. As often happens in medical devices cases, individual stories of malfunction combined with research data indicates that certain devices may present unnecessarily high risks for patients. Each Illinois medical malpractice attorney appreciates that it is important for local community member to be aware of these issues-particularly if they recently had the device implanted or may be having it inserted in the future. According to the latest story the heart implant problem is particularly concerning because it presents extreme risks for those receiving the faulty devices.

The defibrillator in question was produced by St. Jude Medical-the Riata and the Riata ST. Researchers from Ireland have previously suggested that wires were protruding out of the casing of the implants in 15% of the devices used. The protruding wires were caused by failure of the cable connecting the device to the heart, with wires escaping their metal coating. This can result in the device firing wildly into the patient’s chest. Our Chicago medical malpractice lawyers appreciate that of particular concern is the consequences for the patient. Unfortunately, this error is no easy fix. Removing the wires pose very clear dangers, and keeping them in is risky as well.

This latest safety scare is leading to scrutiny of the heart device industry as well as the U.S. Food and Drug Administration. Serious questions are being asked about whether enough is being done to ensure that patients are not receiving devices that pose unnecessarily high levels of risk. Two of St. Jude’s other competitors in the heart device business (Guidant and Medtronic) also have had faulty device problems in recent years. Those problems led to injury and death for some patients, spurring the companies to adopt new safeguards intended to raise awareness before too many patients are injured.

It remains unclear if St. Jude properly warned doctors and patients about the risks of the potentially fault defibrillator. Medical malpractice attorneys know that one important factor in all potential legal actions stemming from these medical devices errors is the actions of the involved company when faced with any information about potential problems.

In this case, the Irish researchers have suggested that concerns were brought to the company’s attention as early as 2010 without the manufacturers properly responding to the information. The heart device expert suggested that the company should have provided more warning to doctors and consumers at that point. The company did send out a letter to doctors in late 2010 alerting them that silicone coating on the device could wear away. However, the letter estimated the abrasion rate at .47%, with exposed wires constituted only a subset of that group. This is far smaller than the rate of exposed wires found by the outside group-with some estimates running as high as 30% wire exposure.

Regardless, many observers have expressed concern that crucial data about the safety of the device did not come from St. Jude’s own safety protocols but from outside groups. This was the same situation faced by the previous heart device problems from Guidant and Medtronic. It suggested that perhaps these manufacturers are not providing as much monitoring or oversight as necessary to ensure that the products on which they are making money do not unnecessarily harm unsuspecting patients.

It is important to follow the developments of this story as more information is uncovered to ensure local patients are kept informed.

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