St. Jude Riata Defective Devices Lead to Major Lawsuit; Evidence Shows St. Jude Knew of Problems Years Before
UPDATE: 4/4/2013: TorkLaw Files Lawsuits On Behalf of 30 in State and Federal Courts
The Torkzadeh Law Firm (TorkLaw) is currently involved in pursuing damages on behalf of their clients who have been injured by the defective St. Jude Riata defibrillators that have been installed in over 80,000 patients. As the litigation continues across the country, information that is already public is shining a bright light on what St. Jude Medical, Inc. knew years before the major recall and investigation by the FDA. TorkLaw has filed a lawsuit on behalf of victims of the St. Jude Riata Defibrillator and Silicone Endocardial Defibrillator Leads.
ST. JUDE MEDICAL, INC. KNEW OF LEAD PROBLEMS
As reported in the Wall Street Journal last month, evidence shows that St. Jude Medical heart-device flaws were known for years. The article cites several well-known physicans across the country who experienced problems with the St. Jude device and subsequently reported the problems to St. Jude. These doctors were told specifically by St. Jude Medical, Inc. that the problems they were experiencing were “isolated.”
Dr. Lau, in Belfast, first spotted inside-out abrasion of a Riata lead in November 2006, but believing it was an isolated event, discarded the broken lead, he said. He alerted the company through a field representative, but didn’t pursue the matter. After his clinic encountered three more cases in early 2010, he said he raised the cases with senior St. Jude officials. “We were repeatedly told these were isolated incidents,” said Dr. Lau, after raising the issue with various St. Jude officials beginning in June 2010.
TORKLAW FILES LAWSUIT ON BEHALF OF INJURED VICTIMS OF THE ST. JUDE DEFECTIVE MEDICAL DEVICES
As mentioned in our earlier announcement, TorkLaw has filed a lawsuit on behalf of injured victims and our involvement in the St. Jude Riata Medical Device litigation is ongoing. It is absolutely critical that we get answers to the many questions including what St. Jude Medical knew about its design failures and the steps they took to protect the more than 80,000 patients that have defective defibrillators.
FOOD & DRUG ADMINISTRATION (FDA) ANNOUNCES RECALL
On December14, 2011, the FDA announced a Class 1 Recall, for the St. Jude Riata Medical Devices. Given the circumstance and nature of the defective defibrillator, the FDA has continued their involvement into the investigations of this defective product.
The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction. As communicated in the Physician Advisory Letter, the clinical implications of externalized conductors in a defibrillation lead without electrical anomalies are not fully known or understood at this time. Externalized conductors can present as only a visual observation on x-ray or fluoroscopy without any associated clinical or device-related observations. If the electrical integrity of a lead were to be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur, and could lead to a serious adverse event or death. Reports to St. Jude Medical associated with extraction of a Riata lead with externalized conductors include two patient deaths and one serious injury (effusion requiring thoracotomy). In addition, one patient death and one serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors.
HELP FOR VICTIMS OF THE ST. JUDE RIATA DEFIBRILLATOR
If you or a loved one has been injured by a St. Jude Medical device, including the defibrillator, Riata Leads, Riata ST Silicone Endocardial Defibrillation Leads, you may be entitled to compensation and damages for your injuries. The Torkzadeh Law Firm currently represents victims against St. Jude Medical and is accepting cases. For a free consultation, please call (888) 845-9696.