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St. Jude Defibrillator Battery Settlement Resolves Class Action Lawsuit in Canada

  • Written by: Austin Kirk
  • 1 Comment

St. Jude Medical has agreed to pay $5 million to settle a class action lawsuit in Canada, resolving claims over battery failures in a number of its implantable cardiac defibrillators.

The problems impacted certain St. Jude Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra devices, and the manufacturer has faced a number of claims that allege the batteries may deplete prematurely due to a manufacturing defect that results in the formation of lithium clusters.

The St. Jude defibrillator battery settlement was approved by the Ontario Superior Court of Justice on August 7, allowing any person implanted with the affected devices in Canada to make a claim for compensation. Close family members can make wrongful death claims if they can establish the death was due to battery failure in the devices.

In the United States, a number of injury and wrongful death lawsuits following a St. Jude Implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) recall announced by the FDA in October 2016. That recall came after at least two deaths and dozens of adverse event reports have been linked to the St. Jude battery problem.

Months after the recall, the FDA sent a warning letter to St. Jude and it’s new parent company, Abbott Laboratories, warning that some devices were still shipped out after the recall, with at least seven patients implanted with defibrillators that were then known to be defective.

St. Jude has continued to have ICD battery problems in its devices. In April 2018, the company had to issue a firmware update to address additional battery issues, which the FDA declared a recall. Many of the same devices were affected.

In lawsuits over St. Jude defibrillator battery problems filed throughout the U.S., plaintiffs allege that the manufacturer knew about the potential risks associated with their product as early as 2011, but continued to distribute implants they knew could fail prematurely.

Nearly 9,000 Canadians received the implants and may be eligible for compensation for the settlement there. They can visit www.stjudeicdclaim.ca for more information.

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1 comment

  1. dennis Reply

    My name is Dennis Doss. I am 63 years old and on disability for heart problems.

    I had a St. Jude pacemaker replaced in December of 2017 that I later found out was on the recalled device list.

    It was placed in me in May of 2015 and replaced 2 ½ years later for battery problem.

    During that 2 ½ year time, I was hospitalized 6 times for pulmonary edema and subsequent cardiac ablations for ventricular tachycardia that my pacemaker could not pace me out of. During some of those visits, I was manually shocked to regain a normal heart rhythm.

    The 2015 St. Jude ICD was a three lead model. Apparently, there was a problem with one of the leads. (It was drawing too much power) I understand there are some known problems with leads as well.

    In 2017, the new pacemaker my doctor installed only required 2 leads, so the 3rd defective lead was left inside me and not used. My doctor said that it was more dangerous to me to remove it than to just leave it in and unused.

    I don’t know if any of this qualifies me for a case against St. Jude, but I had a very rough 2 ½ years while having that pacemaker in me.

    My new ICD is made by a German company, Biotronik. Since its installation, I have had no recurring problems with my heart at all.

    Thank you for your attention to this matter.

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