Following a recall for St. Jude defibrillators, which may suffer sudden battery problems, a class action lawsuit has been filed on behalf of insurance carriers, alleging that that manufacturer knew or should have known about the issue for years, yet delayed issuing a recall, placing those implanted with the devices at risk.
The Alaska State Employees Association/AFSCME Local 52 Health Benefits Trust filed the complaint (PDF) in the U.S. District Court for the Northern District of Illinois on September 18, seeking class action status to pursue damages on behalf of all insurers who covered the costs of buying and removing St. Jude difibrillators recalled in October 2016, as well as additional medical costs for incidents where the devices failed.
According to the lawsuit, St. Jude deceived insurers by having them cover costs associated with a defective device, which it knew had problems since as early as 2011, but did not issue a recall until last year, continuing to sell the implantable defibrillators even as it received numerous reports of device failures. The St. Jude defibrillator battery class action lawsuit indicates that insurance companies paid millions of dollars buying devices known to be defective, then had to pay medical costs for when the devices failed and when patients decided to have them removed and replaced due to the risks.
On October 24, 2016, the FDA announced a St. Jude Implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) recall, affecting some Fortify, Unify and Assura heart implants. The recall came after it was determined that the devices could experience rapid battery failure. At least two deaths and dozens of adverse event reports have been linked to the St. Jude battery problem.
The lawsuit indicates that there were at least 42 reported incidents of premature battery failure in the devices between 2011 and 2014, including at least one patient death. It also details how St. Jude changed the battery design in May 2015, more than a year before the recall was announced.
“St. Jude Medical knew of the Battery Depletion Defect as early as 2011, but failed to take action to investigate and report this known risk, instead waiting nearly five years before issuing a recall of the defective devices,” the lawsuit states. “Despite the extensive evidence, and its clear knowledge of the premature battery depletion problem in its devices, St. Jude Medical failed to take prompt action, and knowingly ignored or concealed this evidence from its management boards, from the FDA, and from the public, including Plaintiff and the other Nationwide and Alaska Class members.”
St. Jude has defended its actions, saying that it did not confirm the problem until just before the recall was announced, and that the design changes were to make the device better; not because they believed there was a battery problem.
However, 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.