Health Insurance Payors File Class Action Over Recalled Implantable Cardiac Defibrillators

Sep 19, 2017

St. Jude Medical, Inc. Accused of Concealing Lithium Battery Depletion Defects

CHICAGO, September 18, 2017—A nationwide class action lawsuit has been filed on behalf of third party insurance payors against St. Jude Medical, Inc. and its parent company Abbott Laboratories, related to the manufacture, sale and distribution of defective Implantable Cardiac Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices. The medical products in question, which provide pacing therapy to support slow heart rhythms and electrical shock or pacing therapy to treat fast heart rhythms, were officially recalled on October 10, 2016 due to defects related to lithium-based battery depletion.

The complaint alleges that St. Jude knew of a significant battery depletion defect as early as 2011, but failed to adequately investigate and report this known risk—instead waiting nearly five years before issuing a recall of the defective devices. During these intervening years, the overwhelming economic impact of St. Jude’s conduct fell on the shoulders of public and private health insurance payors.

Several models of ICDs and CRT-Ds are at issue in the case, including the Fortify™, Fortify Assura™, Quadra Assura™, Unify™, Unify Assura™ and Unify Quadra™ models. The class action lawsuit, filed jointly by law firms DiCello Levitt LLC and Tousley Brain Stephens PLLC, on behalf of ASEA/AFSCME Local 52 Health Benefits Trust, and similarly-situated plaintiffs nationwide, seeks restitution and damages related to third party payors’ coverage of these defective ICDs and CRT-Ds, and related medical costs.

Adam Levitt, a DiCello Levitt partner and co-counsel for plaintiffs, said “St. Jude concealed a serious—and potentially deadly—battery defect that was endemic in hundreds of thousands of its pacemakers. As a result, not only did St. Jude expose a significant segment of the American public to a severe health risk, but St. Jude’s conduct caused public and private health insurance payors to pay for defective devices or costly, second surgeries that patients should never have had to undergo.”

The defect, which ultimately led to the product recall, is caused by deposits of lithium known as “lithium clusters,” which can form within the battery and create abnormal electrical connections that cause the battery to short circuit, leading to rapid battery failure. The complaint alleges that, despite having knowledge of this substantial defect, defendants failed to adequately report and disclose the risk posed by ICDs and CRT-Ds, including to the FDA, the entity which initially approved the devices.

“Physicians, patients and payors were deliberately kept in the dark by St. Jude with respect to ongoing battery issues,” said Kim Stephens, partner at Tousley Brain Stephens and one of plaintiffs’ co-counsel. “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 payors who have shelled out millions of dollars on these defective pacemakers?”

Health insurance payors who have issued payments related to ICDs and CRT-Ds should call 888-778-8880 to determine their legal rights and learn more about the case.

The case is ASEA/AFSCME Local 52 Health Benefits Trust v. Abbott Laboratories, et al., No. 1:17-cv-6704 in the U.S. District Court for the Northern District of Illinois, Eastern Division. A copy of the complaint is available upon request.

About DiCello Levitt

DiCello Levitt is a different kind of law firm—one that combines excellence in commercial litigation, class action litigation, mass tort litigation, catastrophic injury litigation, medical malpractice litigation and civil rights litigation. Practicing nationwide—and internationally—from offices in Chicago and Cleveland, we are an aggressive, attentive, and creative plaintiffs’ firm whose work speaks for itself—billions of dollars in recoveries in some of the highest-profile matters in U.S. history. Revered by clients and respected by defense counsel, our team gets results.

About Tousley Brain Stephens PLLC

Tousley Brain Stephens PLLC is a Seattle law firm with a nationally recognized litigation practice and a renowned Pacific Northwest transaction practice. Having recovered billions for its class action clients, the firm is known for creative advocacy and practical advice.


Jason Milch

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