FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Judge Rules Case Against St. Jude Defribrillators Can Go Ahead

Sept. 8, 2017
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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 (ICD) 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.

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