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.