A class-action lawsuit has been filed against St. Jude Medical and parent company Abbott Laboratories, claiming St. Jude failed to act quickly on a defect that led to a 2016 recall of some of its cardiac defibrillator devices.
The complaint, filed in Chicago by law firms DiCello Levitt & Casey and Tousley Brain Stephens on behalf of third party insurance payers, alleges Minnesota-based St. Jude knew of a significant battery depletion defect as early as 2011, but failed to adequately investigate and report the risk, instead waiting nearly five years before issuing a recall of the defective devices.
The medical products -- the Implantable Cardiac Defibrillator and Cardiac Resynchronization Therapy Defibrillator -- provide pacing therapy to support slow heart rhythms and electrical shock or pacing therapy to treat fast heart rhythms. The products were recalled on Oct. 10, 2016 due to defects related to a fast depletion of its lithium-based battery.
The lawsuit claims that, between the time St. Jude discovered the defect and the time the devices were recalled, the brunt of the economic impact from the defective devices fell on the shoulders of public and private health insurance payers.
Several models of ICDs and CRT-Ds are at issue, including the Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra models, according to a statement from the law firms. The lawsuit, filed on behalf of ASEA/AFSCME Local 52 Health Benefits Trust and similarly-situated plaintiffs nationwide, seeks restitution and damages related to third party payers' coverage of these defective ICDs and CRT-Ds, and related medical costs.
"Physicians, patients and payers were deliberately kept in the dark by St. Jude with respect to ongoing battery issues," said Kim Stephens, a partner at Tousley Brain Stephens. "Defendants have purportedly agreed to reimburse patients for their out-of-pocket costs associated with the implantation of these devices, but what about the health insurance payers who have shelled out millions of dollars on these defective pacemakers?"
Libertyville Township-based Abbott acquired St. Jude in January for approximately $25 billion. While the acquisition was seen as a boost to Abbott's cardiovascular business portfolio, the recall occurred during the time Abbott began the acquisition process.
St. Jude at the time was also fighting a battle with investment firm Muddy Waters Capital, which claimed its devices could be targets of cyberattacks. St. Jude called the allegations "false and misleading."