New York Personal Injury Lawyers Represent Victims of Riata Defibrillators
Heart patients take note: St. Jude Medical’s Riata defibrillators have been recalled. These medical devices may have a serious defect that can put your health in danger.
The wire leads that connect St. Jude Medical’s Riata defibrillators to a patient’s heart have a higher failure rate than previously known. That has prompted the U.S. Food and Drug Administration to order a Class I recall of these medical devices. Class I recalls apply to products that pose a grave risk of serious injury or death.
If you or a loved one has a Riata defibrillator sold by St. Jude Medical, Inc., you should talk to your doctor about potential serious complications that can be caused by a faulty device.
You also should talk to a New York injury lawyer about your legal options. You may need follow-up heart surgery to replace the defective device. A legal action against the manufacturer can help you pay those medical bills and other expenses.
The medical device lawyers at Belluck & Fox, LLP represent people harmed by unsafe medical products and negligently manufactured medical devices. We provide personalized and professional representation to victims of unsafe medical devices.
For a free case evaluation, contact the New York attorneys of Belluck & Fox, LLP by calling 866-493-8986 or fill out our online contact form.
St. Jude’s Defibrillator Attorney Assists Patients Harmed by Unsafe Medical Device
Heart patients depend on defibrillators to jolt their heart back into a normal rhythm. Defibrillators are implanted in the chest and are attached to the heart by thin, insulated wires known as leads. The wires monitor the heart for irregular beats, occasionally sending an electrical shock that corrects the problem.
An improperly manufactured defibrillator can deliver shocks or short circuit and cause serious injury or death.
According to The New York Times report, several experts suggested that St. Jude Medical has been slow to warn of problems with the implantable defibrillator’s wire leads. Medical device manufacturers have a legal responsibility to make products that are safe and effective when used as intended and to warn of potential risks. When they fail to act, they may be legally liable.
The problems with the wire leads involve two models of heart defibrillator, the Riata and the Riata ST, according to the FDA’s recall notice in late 2011. The silicone insulation covering the defibrillator leads may wear off, allowing the wire leads to work through the insulation, develop electrical shorts and fail to deliver the high voltage, life-saving therapy needed if a patient has a heart rhythm abnormality.
New York Attorneys Fight For Patients Harmed by the Riata Defibrillator Recall
St. Jude Medical, based in St. Paul, Minn., is one of the nation’s biggest manufacturers of medical devices. In 2010, St. Jude Medical sent a letter to doctors notifying them about data showing that the silicone coating of the Riata lead could wear away, creating the risk of a short circuit when the defibrillator fires a life-saving jolt.
St. Jude Medical stopped selling the wire leads in December 2010 because of safety concerns. But the devices remain implanted in approximately 128,000 patients, including 79,000 patients in the United States.
In April 2012, St. Jude Medical announced that it would also stop selling its QuickFlex left-ventricular leads used to connect cardiac resynchronization therapy devices to the heart, after reports of wire wearing through the silicone coating.
A 2012 study published in the medical journal Heart Rhythm Journal, based on an analysis of a government database of device malfunctions, linked St. Jude’s Riata and Riata ST wire leads to 22 patient deaths. St. Jude has disputed the accuracy of the article.
The FDA’s Class I recalls are the most serious type of recall. They involve situations in which there is a reasonable probability that use of the medical devices will cause serious injury to the patient, or death.
Medical device manufacturers should fully understand the risks of products before putting them on the market. When manufacturers make and market devices that malfunction, they should be held accountable for the serious harm they cause.
Send Us Your Questions Regarding Defibrillators
If you have suffered complications after having a defibrillator implanted with St. Jude’s Riata defibrillator leads, or you suspect a loved one’s death was caused by defibrillator complications, discuss your concerns and know your rights with the help of a compassionate medical device injury attorney at Belluck & Fox, LLP.
Belluck & Fox, LLP is listed as one of America’s best law firms by U.S. News & World Report and Best Lawyers magazine. We provide personalized and professional legal representation. Our product liability lawyers have helped many clients injured by dangerous products and medical devices.