A federal judge ruled St. Jude may not dismiss a patient’s allegations over manufacturing-defects and negligence related to the company’s implantable cardiac defibrillator in a case filed with the U.S. District Court for the Northern District of California.
In an Aug. 23 court order, Judge Edward J. Davila concluded there was sufficient evidence for a “plausible connection” between the identified manufacturing defects related to the Riata Leads and the patient’s injuries.
The patient alleged he underwent cardiovascular surgery to have St. Jude’s Riata Leads implanted in 2003, 2007 and 2015, and in November 2016, he “was shocked an estimated sixteen to twenty times, causing irreparable harm to his heart, body, and mind” when the leads malfunctioned as he slept
An internal audit St. Jude conducted in 2005 on malfunctioning Riata Leads concluded that the defibrillators had “potentially serious insulation problems.” The FDA issued a Form 483 several years later flagging the company for potential violations.
However, it wasn’t until 2010 that St. Jude identified the problems with its ICDs in a “Dear Doctor” letter, which was reclassified by the FDA a year later as a product recall. Failures associated with lead insulation abrasion on the St. Jude Riata and Riata ST Silicone Endocardial Defibrillation Leads may cause the conductors to become externalized, the agency said. “If this occurs, the product may cause serious adverse health consequences, including death.”