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By: Irvin Jackson | Published: July 30th, 2012
A New Mexico man has filed a product liability lawsuit against St. Jude Medical over its recalled Riata defibrillator lead, alleging that he received a defective lead that failed and had to be replaced.
The complaint (PDF) was filed by Joseph D. Houlette on July 23, in the U.S. District Court for the District of Minnesota.
Houlette claims he received an implantable cardiac defibrillator (ICD) in September 2003 that featured a Riata lead, which is a small wire that connects the device to his heart. Problems with the insulation on the wires ultimately led to the removal of the St. Jude Riata leads from the market after it had already been implanted in Houlette and thousands of other patients throughout the United States.
In April 2012, Houlette indicates that he learned of the Riata recall and that his lead was failing, resulting in the need for invasive surgery to remove and replace the lead.
The complaint is at least the second St. Jude Riata lawsuit filed by a patient who alleges that they had to have their leads replaced because of design defects. Earlier this month, a similar complaint was filed by Richard J. Pinsonneault in the U.S. District Court for the District of Minnesota.
Problems that Resulted in St. Jude Recall for Riata Defibrillator Lead
St. Jude Medical introduced the Riata defibrillator leads in 2002, selling more than 227,000 devices worldwide before removing the lead from the market amid reports of problems with the insulation that covers the wire. However, there are an estimated 79,000 Riata leads that remain active in patients in the United States.
The defibrillator lead is designed to monitor a patient’s heart rhythms and provide a life-saving electrical shock if necessary. However, many St. Jude Riata leads have been found to be prone to puncture or break through the insulation, resulting in an exposed wire inside the body. This could result in unnecessary shocks or failure of the device to deliver a life-saving jolt when needed.
In December 2010, St. Jude decided to “phase out” the Riata lead and sent a letter to doctors acknowledging that defects had been identified with the insulation. A second letter was sent in November 2011, which the FDA later determined constituted a Class I Medical Device Recall, which is the most serious categorization for a product removal.
The Houlette lawsuit accuses St. Jude Medical and and their Pacesetter, Inc. subsidiary of manufacturing a defective medical device and negligence. The lawsuit seeks compensation for compensatory damages, court costs and attorney fees.
Although the St. Jude Riata lead has been off the market for nearly two years, a number of individuals like Houlette are just now learning about the problems with their lead or experiencing problems. A number of product liability lawyers are now investigating potential claims and it is expected that the St. Jude Riata litigation will continue to grow in the coming months.