The New York Times published a troubling story on Tuesday regarding concerns by a leading cardiologist on the safety of one popular heart device. As experienced Chicago medical malpractice lawyers, we have seen the consequences all of sorts of medical errors, including those linked to problematic devices and equipment. It goes without saying that these concerns must be taken seriously, because there are obvious life and death consequences at stake.
The Problem The latest concerns were raised by a cardiologist amid the publishing of a study he completed on the safety of a component sold by St. Jude Medical. The study was published this week by the cardiology journal EP Eurospace. The component is a material used to coat wires in a heart defibrillator known as “Optim.” The doctor argues that the material breaks down too easily–ultimately causing the defibrillator to fail.
The cardiologist author suggests that several cases of failure have been identified and reported to the U.S. Food and Drug Administration (FDA). Those concerns are enough, he says, to avoid used the coating until more information is learned.
For their part, St. Jude rejects the safety concerns raised in the report. In fact, the company argues that Optim is actually fifty times more resistant to abrasion than the other standard coating, silicone. In addition, they claim that a monitoring system is already in place, tracking the leads on at least 11,000 patients.
Of course, our Illinois medical malpractice lawyers know that it is rarely reasonable to downplay legitimate safety concerns. That appears to be the approach taken by the FDA on this issue. For example, last week the FDA recommended that patients receiving the earlier version of the device get checked to determine its stability. On top of that the safety administration ordered the company to conduct studies on certain older leads. Yet, most of the increased FDA focus is on older leads–not Optim–and so disagreement reigns over the safety of the coating product.
The cardiologist making the strong calls for concerns notes that the main issue is not to suggest that all of these products will fail. Instead, he simply wants to warn the community about the unknowns and the need to investigate more. He notes of the at least 15 cases of failure so-far, “I think it is a red flag. I think we need more data. But fundamentally, I’m afraid that this material is not going to perform as advertised.”
All of this comes shortly after an older version of the St. Jude devices–Riata–were recalled last November over concerns of their safety. Over 128,000 people received those now-recalled devices.
The medical process it is immensely complex. However, that does not mean that all errors or problems which cause harm to a patient are unforeseen. In fact, the opposite is true–reasonable care is required at all times. That includes the conduct of the professionals themselves as well as of the manufacturers of the devices used in the process. If you suspect that errors with the care you received or the products used might have caused harm, be sure to get in touch with a medical malpractice attorney to share your story.
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