Lawsuit: St. Jude waited years before recalling faulty defibrillators

A collection of third-party insurance payers has filed a class-action lawsuit seeking $9.9 million from St. Jude Medical and parent company Abbott Laboratories, claiming St. Jude knew about a battery defect in its cardiac defibrillators nearly five years before issuing a recall.

Filed Sept. 18 in Chicago by law firms DiCello Levitt & Casey and Tousley Brian Stephens, the suit alleges St. Jude knew more than 250,000 devices sold in the U.S. between 2011 and October 2016 contained lithium batteries that could abruptly short out.

“Physicians, patients and payors were deliberately kept in the dark by St. Jude with respect to ongoing battery issues,” Kim Stephens, co-counsel for the plaintiffs, said in a statement. “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?”

The devices at issue include the Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra models. They were recalled in October 2016, and Abbott acquired St. Jude three months later.

The plaintiff in the case is the Alaska State Employees Association/AFSCME Local 52 Health Benefits Trust, but the lawsuit is seeking class-action status to represent other insurance companies affected by costs of the recalled devices.

An Abbott spokesperson told The Minneapolis Star-Tribune the lawsuit has no merit.

According to the Star-Tribune, St. Jude’s most recent data shows 616 of the 398,740 affected defibrillators worldwide had depleted batteries due to lithium shorting.

The devices were designed to alert patients at least three months before batteries needed to be replaced. But because of the defect, some batteries ran out within 24 hours of the alert, according to the FDA’s safety communication on the recall.

Two patients died after their defibrillators were no longer able to provide the necessary shocks to keep their hearts in rhythm. St. Jude offered to provide replacements for patients with potentially defective devices, but the FDA warned that comes with its own risks.

“The rate of complications following replacement surgery are higher than those associated with premature battery depletion,” the FDA safety communication said. “However, the FDA and St. Jude Medical recognize the need to weigh individual clinical considerations. If the decision is made to replace an affected device based on individual patient circumstances, St. Jude Medical has announced they will provide a replacement device at no cost.”

In the law firms’ statement on the case, plaintiff co-counsel Adam Levitt said insurance companies weren’t given the same break on replacement procedures.

“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,” he said.