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Abbott Facing $9.9 Million Class Action Lawsuit Over St Jude Cardiac Defibrillators



Chicago, IL: Abbott and its subsidiary, St. Jude Medical, are facing a defective products class action lawsuit over allegations the companies were aware of a battery-depletion defect in some of its cardiac defibrillators, as early as 2011. However, the lawsuit asserts, the defendants failed to adequately report the risk and waited almost five years before issuing the recall.

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St Jude Defibrillator Recall

In the October 2016 defibrillator recall, the US Food and Drug Administration (FDA) and St. Jude state they had received reports “of rapid battery failure caused by deposits of lithium (known as “lithium clusters”), forming within the battery, and causing a short circuit. If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and able to have it replaced, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.”

The lawsuit was filed September 18, 2017 in northern Illinois and centers on several ICD and CRT-D device models powered by lithium-based batteries, including the Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura, and Unify Quadra.

"On November 11 and 12, 2014, St Jude Medical's management review and medical advisory boards were given two separate presentations on premature battery depletion," the complaint alleges. "During these meetings, St Jude failed to tell its own boards about the full scope of the battery issue, presented false or incomplete evidence of the defect, and concealed from the boards evidence of a known death related to this battery defect, stating instead that there were no serious injuries or deaths directly related to lithium cluster bridging."

Filed on behalf of ASEA/AFSCME Local 52 Health Benefits Trust and a collection of other third-party payers, the plaintiffs are seeking $9,999,000 in damages and medical costs related to their coverage of the defective implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices from 2011 to the 2016 recall.

Plaintiffs are represented by Adam Levitt of DiCello Levitt & Casey and Kim Stephens of Tousley Brain Stephens PLLC.

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ST JUDE CARDIAC DEFIBRILLATORS LEGAL ARTICLES AND INTERVIEWS

Criticism for Both St. Jude Medical and FDA over Defective St. Jude ICD Batteries
Criticism for Both St. Jude Medical and FDA over Defective St. Jude ICD Batteries
October 20, 2017
Washington, DC: A troubling report that ran in The New York Times back in April shed a dark shadow on defective St. Jude cardiac defibrillators and the batteries that powered them. St Jude ICD and CRT-D device lawsuits have alleged further than the original manufacturer of the medical devices, St. Jude Medical, downplayed reports of device failure for years. And it’s not just St. Jude lawsuit plaintiffs making that allegation; so too, is the US Food and Drug Administration (FDA), according to The New York Times (04/13/17) [READ MORE]

Were Defective St. Jude Cardiac Defibrillators Implanted Even After Recall?
Were Defective St. Jude Cardiac Defibrillators Implanted Even After Recall?
October 9, 2017
Washington, DC: The complaint in the ASEA/AFSCME Local 52 Health Benefits Trust defective St Jude cardiac defibrillator lawsuit contains shocking new allegations. The fact-finding that follows may give patients the information they need to seek redress [READ MORE]

St. Jude Battery Failure, Delayed Recall and it all comes down to Money
St. Jude Battery Failure, Delayed Recall and it all comes down to Money
September 28, 2017
Santa Cruz, CA: The battery seems to have run out, so to speak, on St. Jude’s recall process. The company made a change to its battery design back in 2015 but didn’t acknowledge the reasoning behind the design—until the lithium battery defects were confirmed internally [READ MORE]



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