|March 28, 2014|
Previously published on March 24, 2014
The latest personal injury lawsuit against St. Jude Medical for injuries due to its faulty Riata cardiac defibrillator leads was filed by Robert Loiseau of Southampton, Pennsylvania. Dozens of similar lawsuits have been filed against St. Jude.
Loiseau was implanted with a St. Jude-manufactured Riata lead in 2007. Five years later, he was compelled to undergo surgery to remove and replace the recalled lead. Upon the removal of the device, his surgeons discovered that the lead had fractured and would have malfunctioned had Loiseau needed an electrical shock from his defibrillator.
The removal of a heart lead requires invasive surgery, which some Riata patients have had to undergo under emergency circumstances. In 2012, the New York Times profiled Greg Jessee, who felt an unexpected jolt to his chest one day from his defibrillator, quickly followed by two more jolts, the last of which knocked him unconscious.
The journal Heart Rhythm also found in 2012 that at least 22 deaths were associated with electrical malfunctions in the wires of St. Jude Riata and Riata ST heart leads. The lawsuits against St. Jude allege that the erosion of the coating around the wiring of the Riata defibrillator leads was reported to St. Jude by physicians as early as 2006, and that St. Jude had been tracking problems with the leads for years while it continued to market and sell the leads to physicians and heart patients.
Back in 2010, St. Jude sent out a letter to doctors alerting them that the silicone coating of the Riata lead could wear away. They estimated that the overall rate of abrasion was only 0.47 percent, but after an initial report by a doctor investigating the issue in Belfast came out, other researchers undertook additional tests and found incidences of protruding wires at rates as high as 30 percent. The problem seems to develop only after several years, so the risk is increased the longer the devices have been impacted.