Wrongful Death Lawsuit Filed Over Recalled St. Jude Riata Defibrillator Lead

The family of an Alabama woman who died after experiencing problems with a St. Jude Riata lead has filed a wrongful death lawsuit, alleging that there were manufacturing defects with the small wire used to connect an implantable cardioverter defibrillator (ICD) to the woman’s heart.

The complaint (PDF) was filed by Elizabeth W. McElroy, as administrator of the estate of Caroline Hall, alleging that Hall died due to injuries sustained from a St. Jude Riata defibrillator lead, which was recalled amid reports of problems with the insulation failing, allowing the wire to become exposed inside the body.

According to allegations raised in the St. Jude Riata wrongful death lawsuit, the defibrillator lead implanted in Hall possessed multiple manufacturing defects, which resulted in inconsistent insulation diameters surrounding the electric conductors. As a result of natural abrasion that occurs once the lead is implanted, the complaint indicates that the wires are prone to coming in direct contact with materials and fluids that prevent the proper functioning of the implanted defibrillator.

A St. Jude recall for the Riata leads was issued in December 2011, after the manufacturer sent several warning letters to doctors about reports of problems with the insulation. As a result of insulation failure, users have reportedly suffered unnecessary shocks and in some cases the defibrillator has failed to deliver a life-saving charge when needed.

McElroy indicates that St. Jude Medical appears to have known that there was a problem with the Riata lead insulation long before removing the product from the market. The company applied numerous times to the FDA to change how the insulation was applied to the leads, and the lawsuits suggests that if St. Jude thought the lead insulation was secure, it would not have repeatedly sought new manufacturing techniques for applying the insulation.

The lawsuit comes just weeks after the FDA announced that inspections of the manufacturing facility where St. Jude defibrillator leads are made uncovered numerous and serious manufacturing deficiencies.

St. Jude Riata Lead Problems Pose Risk for Thousands

Approximately 227,000 St. Jude Riata leads have been sold worldwide since the product was introduced in the United States in 2002. Estimates suggest that approximately 79,000 of the Riata leads remain active in patients in the United States, as the process of attempting to remove the lead is very risky and doctors usually recommend keeping the recalled lead in place unless there is evidence that it has failed.

In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude Riata or Riata ST leads, recommending that individuals undergo x-ray or other imaging exams to monitor the condition of the leads.

The agency also indicated at that time that it was ordering St. Jude to conduct additional studies on the potential risk of insulation failures and problems with the debrillator leads, including the newer versions sold under the Riata ST Optim and Durata names.

This wrongful death lawsuit joins an increasing number of St. Jude Riata lawsuits filed against the manufacturer by individuals who have experienced complications associated with the leads poking through the insulating materials.