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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

The FDA Warning Letter RE: St. Jude ICD Batteries One Year Later
The FDA Warning Letter RE: St. Jude ICD Batteries One Year Later
February 10, 2018
Sylmar, CA: We will soon be coming up to the one-year anniversary of the receipt by Abbott Laboratories of a scathing warning letter by the US Food and Drug Administration (FDA). At issue were various allegations and findings of non-compliance and failures to maintain good manufacturing practices determined during an inspection of its facility in Sylmar, California. Of interest to litigants bringing St. Jude ICD and CRT-D device lawsuits, are findings of non-conformity with regard to its cardiac defibrillator line - namely its Fortify, Unify, Assura and Quadra devices [READ MORE]

Canadian Class Action Launched Against Defective St. Jude Cardiac Defibrillators
Canadian Class Action Launched Against Defective St. Jude Cardiac Defibrillators
January 13, 2018
Toronto, ON: Imagine the panic one might feel when told the defibrillator relied upon to help keep you alive, could fail at any time and with little warning. In reality, that circumstance is one Canadian lawsuit plaintiff Shirley Houle didn’t have to imagine. Amongst the St. Jude ICD and CRT-D device lawsuits, is a Canadian class action launched this past May [READ MORE]

Alaskan Health Insurer Sues Abbott / St. Jude over Defective ICD Batteries
Alaskan Health Insurer Sues Abbott / St. Jude over Defective ICD Batteries
December 24, 2017
Chicago, IL: Chicago may be far removed from Alaska geographically, but Illinois serves as home base for a proposed St. Jude class action lawsuit brought by an Alaskan union-benefits fund against St. Jude manufacturer Abbott Laboratories (Abbott) [READ MORE]



READER COMMENTS

Posted by
Margaret Andrews
on
I have a St. Jude defibrillator implant from AGH Pittsburgh in 2011 and have received a letter from the Electrophysiology office to sign off on "Consent to treatment, release and acknowledgement, should I sign this?

I am concerned it is a way for St. Jude to protect themselves from a lawsuit, I have no problems with the device and get a yearly check up on it.

Posted by
MIKE
on
ANY settlements yet..Real tired of all this lawyer double talk... Dancing around my point. Worse then used car salesman. maybe its magic only they can doPlease read this on FB

Posted by
Delores Decker
on
I can remember having problems and went in to see the doctor who place the device in my chest 2011. After checking me out I had to get the device replace on March 15, 2017. He also stated that their was a recall for devices. I wondering will I be eligible to participate in the lawsuit.

Posted by
Michelle Eastman
on
I had this difficulty to replaced in November last year however I didn't have any issues with it it was just the fear from the time I received a letter saying it had been recalled until they could get me in to remove it. Will we be eligible to participate in the lawsuit?

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