An Alaska union-benefits fund is suing Abbott Laboratories over allegations that Minnesota-based medical device company St. Jude Medical, which is owned by Abbott, failed to warn the public and regulators for years that thousands of its implantable defibrillators contained defective lithium batteries.
The federal lawsuit, filed in northern Illinois late Monday, alleges that St. Jude knew more than 250,000 defibrillators it sold in the United States between 2011 and October 2016 contained batteries that could abruptly short out and cause the lifesaving devices to lose power with little or no warning. Abbott acquired St. Jude three months after the recall, so it has to deal with the litigation.
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 all self-insured and commercial insurance companies. The lawsuit estimates that those insurers collectively paid hundreds of millions of dollars for St. Jude Medical defibrillators with defective lithium batteries.
The suit also seeks punitive damages.
On Tuesday, an Abbott spokeswoman said the lawsuit has no merit. In the past, St. Jude officials have defended their decision to wait until October 2016 to recall hundreds of thousands of the implantable devices, saying executives and medical advisers worked as quickly as possible to confirm the rare but serious problem.
The federal lawsuit makes 10 claims, including failure to warn about known defects, breach of warranty, negligence, and unjust enrichment. The federal case also includes an allegation that St. Jude officials violated Minnesota’s Prevention of Consumer Fraud Act when they “deceptively omitted” long-known facts about the device batteries until last October.
“If defendants had not omitted … or misrepresented the defects in the recalled devices, physicians would not have used the recalled devices,” the lawsuit says. “Accordingly, plaintiff and the other nationwide class members would not have incurred costs for the recalled devices and the medical costs of device removal and replacement surgery and other related medical costs.”
The lawsuit says St. Jude received 42 reports showing evidence of premature battery depletion related to the lithium problem between 2011 and 2014; and in 2014 the company received a report that the problem had caused a patient death. A journal article documented the problem in December 2014.
The Star Tribune has reported that St. Jude Medical made a change to its battery design on May 23, 2015, in response to a problem that the company said it identified in 2014. Yet the company continued to sell defibrillators that contained the old batteries until early October 2016.
That meant that some patients received recall notices just weeks or months after surgery for a problem that St. Jude knew about for years.
St. Jude officials have said they didn’t consider the change in battery design in 2015 to be an acknowledgment that they knew at the time that the old devices were faulty; rather, they felt they were taking a device that was performing well and making it even better. The decision to recall the devices in 2016 happened only after enough cases of lithium battery defects were confirmed internally.
The FDA approved the 2015 design change. The agency didn’t call for an immediate recall because the rate of problems at the time appeared low and was consistent with rates of problems in other models on the market. The heightened rate of early battery depletions was realized only later, triggering the recall.
As of May 31, the most recent date available, 616 of the 398,740 affected defibrillators sold worldwide had depleted batteries with no other discernible cause than lithium shorting, St. Jude data show.
Two patients died after their defibrillators lost the ability to shock the heart back into a normal rhythm.
The voluntary recall that St. Jude announced in October does not call for all affected devices to be removed from patients. Rather, it recommends that patients consult with their physicians and use bedside remote-monitoring devices that analyze remaining battery life.
The devices affected by the recall include Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable defibrillators made before May 2015.
Some doctors have said they would consider immediate device replacements for patients who are dependent on their defibrillators to also act as pacemakers to keep their hearts beating in proper rhythm.
St. Jude and the Food and Drug Administration do not recommend “prophylactic” replacement of all recalled devices because the replacement surgery creates its own risks of complications.
“The rate of complications following replacement surgery are higher than those associated with premature battery depletion,” an Oct. 11 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.”