TorkLaw Responds to FDA Warning Letter to St. Jude Medical Regarding Defective Heart Device
In December 2011, the Food and Drug Administration issued a Class 1 recall for the St. Jude Medical Riata leads after many adverse events were being reported in patients. Studies showed that the leads which connect the heart defibrillator to the heart were failing due to insulation problems referred to as externalization. A Class 1 Recall is the highest level recall that exists because the product poses a reasonable probability of serious adverse health consequences or death.
TorkLaw is now representing patients in fifteen states who have been affected by the recalled Riata leads and continues its ongoing investigation. "We are speaking with patients from all over the country who have suffered from life-threatening injuries as a result of the defects found in St. Jude Medicals's heart devices," said Reza Torkzadeh , Senior Partner at TorkLaw.
The wires in the St. Jude Riata leads were found to protrude or perforate through the insulation resulting in lead failure, errant shocks, migration and other injuries. Removal of leads is a very complex and potentially dangerous operation.
"We are seeing a wide range of injuries caused by the defective leads. All of these individuals have suffered a level of anxiety and pain that most of us will never understand," said Torkzadeh, who says his firm is committed to seeing that St. Jude is held accountable.
The latest FDA investigation into St. Jude Medical was focused on the newer Durata leads also manufactured by St. Jude. In an official FDA warning letter to St. Jude Medical, dated January 10, 2013, the government agency cites St. Jude Medical for multiple manufacturing and quality control problems at their facility in Sylmar, California.
"The latest warning letter from the FDA raises a lot of red flags. The FDA makes it very clear that their month-long inspection resulted in pinpointing the systematic failure of St. Jude Medical to follow approved manufacturing processes, proper monitoring, analysis, quality control and testing. That is not acceptable," said Torkzadeh.
TorkLaw is providing free legal consultations to those who have been affected by the St. Jude Medical heart defibrillator and Riata Leads. Call today for a free consultation 888.222.8286.
SOURCE The Torkzadeh Law Firm