Abbott Hit With $9.9 Million Class-Action Over St Jude Devices

Patrice Wendling

September 21, 2017

CHICAGO, IL — A nationwide class-action lawsuit has been filed against St Jude Medical and parent company Abbott Laboratories, alleging that despite knowing about a battery-depletion defect in some of its cardiac defibrillators as early as 2011, St Jude failed to adequately report the risk and waited nearly 5 years before issuing a recall in October 2016.

The lawsuit was filed on behalf of ASEA/AFSCME Local 52 Health Benefits Trust and a collection of other third-party payers and seeks $9,999,000 in damages related to their coverage of the defective implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices during those intervening years and related medical costs.

"On November 11 and 12, 2014, St Jude Medical's management review and medical advisory boards were given two separate presentations on premature battery depletion," the complaint alleges. "During these meetings, St Jude failed to tell its own boards about the full scope of the battery issue, presented false or incomplete evidence of the defect, and concealed from the boards evidence of a known death related to this battery defect, stating instead that there were no serious injuries or deaths directly related to lithium cluster bridging."

"St Jude concealed a serious—and potentially deadly—battery defect that was endemic in hundreds of thousands of its pacemakers," cocounsel for the plaintiff Adam Levitt (DiCello Levitt & Casey) said in a statement[1]. As a result, Levitt adds, not only did the company "expose a significant segment of the American public to a severe health risk, but St Jude's conduct caused public and private health insurance payers to pay for defective devices or costly second surgeries that patients should never have had to undergo."

"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?" Kim Stephens (Tousley Brain Stephens), one of the plaintiffs' cocounsels, adds in the statement.

To | Medscape Cardiology, Abbott spokesperson Scott Stoffel said in an email only, "We believe the lawsuit is without merit."

The case, filed September 18, 2017 in northern Illinois and first reported by the local Daily Herald[2], involves several ICD and CRT-D models powered by lithium-based batteries including the Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura, and Unify Quadra.

In its 2016 recall, St Jude and the US Food and Drug Administration warned that lithium clusters had caused some batteries to run out within 24 hours of the patient receiving an elective replacement-indicator alert, instead of the normal 3-month lead time for device replacement.

At that time, 349,852 affected devices were actively implanted worldwide, but they noted that the true number of affected devices was not known because battery depletion may not always be reported to the manufacturer.

Abbott completed a $25 billion acquisition of St Jude in January 2017 and has been wrestling with ongoing cybersecurity vulnerabilities associated with some St Jude pacemakers. The latest software update was issued in August 2017 to help protect patients from hackers gaining access to their device, which could result in patient harm from rapid battery deletion or inappropriate pacing.

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