By Joe Messa
Medical malpractice attorneys report that Concerns about St. Jude Medical’s Riata heart device continue as doctors try to determine how to manage patients who have the defective defibrillators. The Riata leads as well as the Riata ST leads are both at issue. Both models are no longer being sold, but an estimated 128,000 patients worldwide have had the devices implanted. The Riata and Riata ST can both be removed, but that doctors say the procedure to remove the device can be dangerous.
The Riata device issue is the third safety concern involving the heart device industry in the last seven years. Both Medtronic and Guidant—its heart division has since been purchased by Boston Scientific— had trouble with defective devices. In both cases, patients were seriously injured or killed as a result of the defibrillator defects.
As a result, experts are questioning whether the Food and Drug Administration needs to become more involved in the heart device safety guidelines. Most of the device makers have already put procedures in place to alert them to problems before too many patients are injured. However, physicians still say they are not being warned quickly enough.
At least 20 Riata patients have died after the silicone coating of their defibrillator lead wore away, causing a short circuit when the device fires a life-saving jolt. An additional cause for concern with the Riata devices involves the internal wires working their way out of their casing. In most cases, the wires will continue to function; however, if they do not, they can lead to a variety of electrical malfunctions.
St. Jude has continued to market and sell another defibrillator lead, called Durata. The company insists that the device’s extra coating of insulation prevents the types of problems that have affected its Riata heart devices.
Critics of the Durata device say that the lead is likely to have the same problems as the Riata leads. St Jude has denied that claim; accusing Medtronic of trying to gain a competitive advantage over St. Jude by weakening sales of the Durata device.
Some doctors agree that the improved coating of the Durata device may solve the problem. There have been no reports of problems so far. Still other physicians are skeptical of the new lead and have already decided not to implant the Durata leads in patients.
The Philadelphia medical malpractice attorneys at Messa & Associates are experienced at handling cases resulting from medical errors. Our extremely skilled team of medical malpractice attorneys and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you or a loved one has suffered personal injuries as a result of a medical error, defective medical device or any other type of negligent care received by a medical provider, contact the medical malpractice attorneys of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More