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.

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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Last updated on Oct-13-17