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By: Irvin Jackson | Published: July 19th, 2012
A Connecticut man has filed a product liability lawsuit alleging that he had to have his St. Jude Riata defibrillator lead replaced after it failed earlier this year, forcing him to undergo invasive heart surgery due to defects in the design of the small wire that connected an internal defibrillator to his heart.
The complaint (PDF) was filed by Richard J. Pinsonneault on July 17, in the U.S. District Court for the District of Minnesota. St. Jude Medical, Inc. and Pacesetter, Inc., a St. Jude subsidiary, are listed as the defendants.
According to allegations raised in the St. Jude Riata lawsuit, Pisonneault received the recalled lead as part of an implantable cardiac defibrillator in 2009. Just over three years later, in April 2012, Pisonneault learned that his Riata lead was failing and he was required to undergo invasive surgery last month to remove and replace the defective lead.
St. Jude Riata Recall Amid Reports of Failures
The St. Jude Riata Defibrillation Lead System was first introduced in March 2002, involving a small wire that connects a patient’s defibrillator to the heart to monitor heart rhythms and provide a life-saving electrical shock if necessary.
The lead wires are supposed to remain covered with insulation, but the St. Jude Riata has been found to be prone to puncture or break through the insulation, potentially resulting in an exposed wire inside the body. This could result in unnecessary shocks or a failure of the device to deliver a life-saving jolt when needed.
According to allegations raised in the complaint, the St. Jude Riata implanted in Pisonneault had a manufacturing defect, which resulted in inconsistent insulation diameters surrounding the electric conductors. This resulted in an increased risk of abrasion at thinner insulation sites and an risk of device failure.
During normal activities and movements, abrasion may occur with the insulation after the lead is implanted, and the defective Riata lead wires may protrude through the insulation, causing them to come into contact with materials and fluids that prevent the proper function of the ICD, which is known as “externalization.”
In December 2010, St. Jude Medical sent a “Dear Doctor” letter acknowledging that defects had been identified with the insulation in certain Riata Lead Models. Although they decided to “phase out” all Riata leads by the end of 2010, no formal recall was issued at that time.
In November 2011, St. Jude sent a second “Dear Doctor” letter updating previously published failure rates for the Riata leads. The next month, the FDA determined that the letter constituted a Class I Medical Device Recall, since there was a reasonable probability that use of the product would cause serious adverse health consequences or death.
Pisonneault alleges that St. Jude failed to manufacture the Riata Leads consistent with the processes approved by the FDA, seeking compensatory damages for severe physical injuries, emotional distress, mental anguish and economic losses.