St. Jude Heart Device Maker Fights Back Against Reports Linked to Deaths and Injuries

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A problem has developed with the St. Jude implanted heart device: A wire or lead that connects a defibrillator to a patient’s heart has been failing, often with fatal results. The lead, a model called Riata, has been used by more than 128,000 patients worldwide.
The electrical wires within the Riata lead have been known to break through the insulation, causing shocks in some patients and other more serious injuries. More important, the Riata wire failure does not react to the need for a lifesaving jolt to keep a failing heart beating.
St. Jude stopped selling the Riata product in late 2010. In December 2011, The U.S. Food and Drug Administration (FDA) announced the voluntary physician recall of the Riata and Riata Silicone Defibrillation Leads as a Class I Recall. This means that the FDA believed there was potential risk of serious injury or patient death caused by the devices’ malfunction.

Reports to St. Jude included that of two patient deaths and the serious injury with extraction of a Riata lead with externalized conductors. St. Jude’s chief executive, Donald Starks, has defended St. Jude against reports of deaths and injuries linked to the Riata wiring problem.
Since 2005, two of St. Jude’s competitors, Medtronic and Guidant, have had similar problems with their heart implant devices. Lawsuits have been filed against all three of these companies for deaths and injuries to patients. In a New York Times article, Mr. Starks charged Medtronic of trying to undercut St. Jude to gain business from it by pointing out the defects of St. Jude’s heart implant devices. In the meantime, St. Jude has said it has introduced a new insulation sheath that may solve the lead problem.
Kreisman Law Offices has been handling medical device lawsuits for individuals and families for more than 40 years in and around Chicago, Cook County and its surrounding areas, including Addison, Chicago (Andersonville), Chicago (Calumet Heights), Cicero, Glen Ellyn, Glenview, Hoffman Estates and Mount Prospect, Illinois.
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