While St. Jude Medical, Inc. has been the subject of major recalls, investigations and lawsuits over its defective Riata Leads, the US Food and Drug Administration (FDA) released a report today questioning the very testing, reporting and oversight that the company has been using over its new Durata electrical wires that uses Optim to insulate the wire that connects its implanted defibrillator to the patient’s heart.
11/20/2012 FDA REPORT: FDA St. Jude Report on the reporting flaws and testing that was released on Tuesday.
11/20/2012 NY Times Article: Report Raises Concerns Over St. Jude Heart Device
11/20/2012 Wall Street Journal: Report Cites Flaws in St. Jude’s Oversight of Device’s Design
In December 2011, the FDA announced a major recall of all St. Jude Riata Leads citing major problems with insulation of the leads that were eroding causing the device to fail. It is estimated that over 80,000 patients in the United States alone have the St. Jude Riata Defibrillator that have been recalled. Doctors have been told to test all patients for any signs of movement in the defibrillator and its leads. Most patients are opting to have the defective device replaced.
This latest news comes at a time when St. Jude is trying to fight off criticism about the way its handled its previous Riata lead failures. The NY Times reported today that:
Although the agency blacked out many details of the inspection, which took place in September and October at the company’s plant in Sylmar, Calif., the report appeared to focus on the methods St. Jude used to test the Durata, which was introduced in December of 2007. The agency inspectors found that the company failed to follow its own written protocols for testing the product, and did not properly evaluate some study results. The agency also concluded that St. Jude did not adequately follow up on problems it identified in the manufacturing process, and also did not properly investigate some complaints about the lead.
The Wall Street Journal, which published an investigative report in October entitled “St. Jude Riata Heart-Device Flaws Known for Years” found that doctors knew years before the recall in 2011, that the Riata leads were defective:
St. Jude had been tracking the problem for several years, according to company documents collected by the Food and Drug Administration and reviewed by The Wall Street Journal. Cases involving the so-called inside-out abrasion date to at least October 2005, the documents show. Inside-out abrasion became a focus of an internal St. Jude audit, which examined multiple cases of the failure before April 2008.
TorkLaw is currently representing victims of St. Jude Defective devices nationwide. For more information on the ongoing litigation or a free consultation on the St. Jude Riata Lawsuits, call our office at 888.222.8286