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Defibrillator Implant Lawsuit | Lawyer for Defective Heart Implant Recall
Some heart defibrillators may malfunction or stop working when patients need shock therapy the most. Some defibrillators may contain a defective sensing or pacing lead (implanted in patients). In addition to shocking people when they don’t need it – the defibrillator may also fail to provide shock therapy when needed the most. Both issues may result in pain and even death.
If you have experienced any of these potentially deadly side effects from a defective heart defibrillator implant, contact your doctor right away. Then call our law firm to schedule a free case review for a defibrillator implant lawsuit. At Baron & Budd, we’re committed to doing what’s right. That means holding the companies responsible for the dangerous heart defibrillator implants responsible.
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Some implanted heart defibrillators that are manufactured by St. Jude Medical have been shown to unnecessarily jolt the heart or fail to deliver lifesaving shocks to return patient’s erratic heart rhythms back to normal. These implants, known as the St. Jude Medical’s Riata and Riata ST were recalled on November 28, 2011. The St. Jude Medical Durata lead, while showing evidence of failure and fraying, has not been recalled by the company nor the FDA at this time. However, there are untold tens of thousands of patients who still have the recalled implants inside them or may have the Durata implant as well. It’s possible that these patients may not realize that anything is wrong with their implant until it is too late.
Most patients do not know the type of defibrillator implant they have. We advise that any patient who experienced jolting of the heart or who did not receive shock therapy from their defibrillator when they needed it contact us at 866-520-2755 or via email here to learn more and schedule a consultation with a defective defibrillator implant lawyer.
If you have spoken with your doctor and have been able to discover what defibrillator you have, then the ones to be particularly watchful of are St. Jude Medical’s Riata, Riata ST and the Durata.
With the recalled implants, defibrillators may send unnecessary — and very frightening and painful — jolts to the heart. Likewise, these defective defibrillators may fail to send these same jolts to the heart when the patient needs them — i.e., when the patient’s heart rhythm has become abnormally fast or slow. Because implanted heart defibrillators are put in patients in order to read their heart rhythms and send pulses of electricity to “Reset” the patient’s heart beat when it has becomes abnormal, this failure could be deadly — as it means that the entire purpose of the implanted heart defibrillator could be ineffective, or even unnecessarily dangerous, to the patient.
What’s worse, these implants may also be deadly.
In 2008 a doctor named Robert G. Hauser and his colleagues at the Minneapolis Heart Institute found 22 deaths caused by Riata’s lead failure reported on an FDA’s database — that’s over 75 percent more deaths than they found were caused by Riata lead’s popular competitor’s lead, the Quattro Secure lead.
The St. Jude Medical leads may have a unique inherent failure with its lead insulation. Leads often have layers of insulation that help protect the electrical conductor wires inside the lead. That’s important because these wires connect the implantable defibrillator to the patient’s heart. However, with the Riata and Riata ST lead recall, for instance, these electrical conductor wires inside the lead may have the unique problem of becoming exposed — aka, coming out through the protective insulation. This occurs because the lead insulation erodes prematurely. After exposure, these wires may cause the electrical problems that lead to inappropriate sensing or a failure to conduct shock therapy when the patient needs it. This problem is often termed “inside-out abrasion” — because the wires within the lead rub against one another creating friction which results in the wires protruding outside of the lead.
The faulty defibrillators, including the Riata, Riata ST and Durata, are manufactured by St. Jude Medical, a pharmaceutical company headquartered in St. Paul, Minnesota. St. Jude Medical develops medical technology and services having to do with specific problems relating to the brain and heart.
Here is where the really unfortunate news comes in: according to company documents, St. Jude Medical may have known of its premature erosion problem as early as October 2005. In fact, there are so many instances within the last decade that demonstrate that St. Jude Medical was aware of the problem and should have taken immediate action.
- 2006 (Part 1) — A physician was hired by St Jude Medical to examine a malfunction detailed in an FDA inspection report of a patient who received unneeded shocks from the Riata lead. This physician wrote a letter to St. Jude Medical in 2006 saying that the malfunction was due to an inside-out abrasion.
- 2006 (Part 2) — Starting in 2006 and spanning to 2009, physicians including Samir Saba, Director of the Cardiac Electrophysiology Section at the University of Pittsburgh Medical Center and Alan Cheng, directer of Johns Hopkins Medicine’s Arrhythmia Device Services, saw inside-out abrasion problems in their practice that they reported to St. Jude Medical. In these examples, the doctors were told that the inside-out abrasion problems they encountered were isolated.
- 2006 (Part 3) — After several reports of inside-out abrasions from doctors around the world, St. Jude Medical began a broad internal company audit of all insulation problems relating to their leads. This audit includes a special section on the inside-out abrasion problem as, according to the audit, there was already evidence of the problem in both lab testing and devices that were extracted from patients.
- 2008 — The internal St. Jude Medical insulation audit comes to a conclusion. After examining 246 leads dating from before April of 2008, the audit found that 32 of the 246 leads were damaged enough to have prevented crucial and lifesaving shock therapy. By this time, St. Jude Medical had sold more than 120,000 Riata leads in the United States alone.
- 2010 — Two years later, St. Jude Medical issued a warning letter to doctors in December stating that wires inside their Riata leads were sometimes coming through their insulation. It was at this time that St. Jude Medical stopped the distribution of both the Riata and Riata ST leads.
- 2011 — A cardiologist at Royal Victoria Hospital in Belfast, Northern Ireland told St. Jude Medical that he was encountering increasing numbers of exposed Riata lead wires in his patients. Because of this, he urged St. Jude Medical to warn cardiologists immediately regarding the seriousness of the inside-out abrasion problem.
November 28, 2011: St. Jude Medical Inc. finally recalled the Riata leads because of insulation failure, i.e., a premature erosion of the insulation around the electrical conductor wires.
Because of the insulation failure, St. Jude Medical had already refrained from selling these recalled Riata leads by the end of 2010. However, by that time over 227,000 Riata leads had been distributed around the world and by 2011, according to St. Jude Medical, approximately 79,000 Riata leads still remained in patients in the United States alone.
Unfortunately, physicians and medical experts say that had St. Jude Medical warned doctors of the premature erosion sooner, then doctors may have been able to identify the scope of the problem earlier. After all, the physicians who had reported the problem to St. Jude Medical had been told that the issue was isolated (meaning “very rare” in the medical field). However, once St. Jude Medical came forward and warned doctors of the problem beginning in 2010, doctors around the world were better able to identify the Riata leads’ failure to perform both proper sensing and shock therapy. Likewise, while the inside-out abrasion problem was well-identified thanks to St. Jude Medical’s own audit, more than 13,000 patients were implanted with the now recalled Riata leads following the audits completion in 2008.
One of the most well-known studies regarding the Riata lead recall was performed by Dr. Robert G. Hauser at the Minneapolis Heart Institute. Dr. Hauser found that the material used to coat the Riata lead wires broke down prematurely and that sometimes this breakdown led to a failure of the device. This report follows additional studies showing that the Riata lead recall may have internal wires come through the outer insulation coating, thus causing electrical problems such as unnecessary shocks to patients.
In another study performed at Vanderbilt, researchers found that of the recalled Riata leads they examined, around one third of the leads had signs of protruding wires — protruding wires that may, in turn, cause electrical problems.
The FDA has asked that manufacturers perform five-year post-market approval studies for new or very modified leads since 2008. Unfortunately, these post-market approval studies were not in place when the FDA approved both the Riata and the Riata ST leads.
In addition, the FDA has sent several warning notices concerning the Riata leads, and in 2011 the FDA issued a C lass 1 recall of the Riata and the Riata ST Silicone Endocardial Defibrillation Leads. The FDA’s Class 1 recall is the most serious type of recall and it is not to be taken lightly.
In 2012, the FDA issued a subsequent notice that stated: “The FDA is aware of an increase in frequency of reported Riata lead insulation failures, beginning approximately four years after implant. Insulation failure may cause some of the electrical conductors inside Riata leads to move within (migrate), or move entirely outside (externalize), the outer lead insulation. These changes may be detectable on X-ray or fluoroscopic imaging.”
The FDA has also recommended that patients contact their cardiac physicians in order to see if they have the recalled leads and has recommended that patients who received earlier generations of St. Jude Medical leads get imaging tests to see if their lead is starting to fail. This was an unusual measure taken by the FDA and again shows the severity of the St. Jude Medical recalled Riata, Riata ST and Durata risks.
If you or someone you know has experienced unnecessary jolting of the heart or another failure related to your implanted heart defibrillator, you may be suffering from the St. Jude Medical’s Riata, Riata ST or Durata defibrillator lead issue. Our experienced defibrillator recall lawyers can review your case to determine whether you have a potential claim. Patients who experienced unnecessary jolting of the heart, or who did not receive necessary shock therapy when they needed it likely do not know what defibrillator implant they have. That is why we encourage all patients who experienced a jolting of the heart or a lack of shock therapy when they needed it to contact our defective medical device lawyers at 866-520-2755 or contact us here to learn more.