Alaskan Health Insurer Sues Abbott / St. Jude over Defective ICD Batteries

December 24, 2017, 8:00AM. By Gordon Gibb

While many St. Jude ICD and CRT-D device lawsuits relate to health issues when their batteries fail, there is another side to the issue: the cost to health insurers for purchasing medical devices that are alleged to be defective

Chicago, ILChicago may be far removed from Alaska geographically, but Illinois serves as home base for a proposed St. Jude class action lawsuit brought by an Alaskan union-benefits fund against St. Jude manufacturer Abbott Laboratories (Abbott).

According to a report carried by the Minneapolis Star Tribune (09/19/17) in September, the Alaska State Employees Association/AFSCME Local 52 Health Benefits Trust is protesting the outlay of millions of dollars for what are alleged to be defective devices. Factor in other commercial insurance and self-insured providers and the stake escalates to hundreds of millions of dollars.

Amongst unidentified damages, the St. Jude lawsuit is seeking punitive damages.

St. Jude issued recall five years after first learning of problems

It was in 2011, the lawsuit asserts, that St. Jude Medical (now owned by Abbott Laboratories), began receiving reports that the batteries in several units of their defibrillator line were depleting prematurely due to the formation of lithium crystals. Designed, under normal circumstances to provide ample warning of a battery nearing its end-of-life in order to facilitate battery replacement under optimum circumstances, defective batteries were seen to be failing prematurely and without warning, potentially leaving the patient in dire straits.

The proposed class action notes that St. Jude received some 42 reports that demonstrated evidence of premature depletion in the three years ending in 2014, the year St. Jude – according to the lawsuit – received a report the battery problem had contributed to the death of a patient.

According to the Star Tribune, St. Jude Medical undertook a change to its battery design as of May 23, 2015 in response to a problem St. Jude said it identified in 2014. And yet, according to the news report, the manufacturer continued to vend defective St. Jude cardiac defibrillators containing the problematic batteries until early October, 2016.

“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.”

Some patients received recall notices mere weeks after implantation: Star Tribune

The defective St. Jude devices were eventually recalled. However, according to the Star Tribune, some patients having received a St. Jude device would have received recall notices months, or even weeks after the initial implant procedure. The Star Tribune reported that St. Jude had characterized their change in battery design as making a well-performing device even better – rather than an acknowledgement of a defect.

The US Food and Drug Administration (FDA), in approving the battery design change in 2015, suggested it stopped short of issuing a recall after becoming aware of problems with the St. Jude batteries, because the rates for adverse events appeared low and consistent with failure rates associated with other devices on the market.

Both the FDA and St. Jude Medical agree that replacements – which will occur at no cost to the patient – would only be considered on a case-by-case basis given the heightened risks and complexities with replacement procedures v. the initial implantation. “The rate of complications following replacement surgery are higher than those associated with premature battery depletion,” according to an FDA safety communication released October 11 of last year, revealed by the Star Tribune. “However, the FDA and St. Jude Medical recognize the need to weigh individual clinical considerations.”

The Star Tribune noted that Abbott Laboratories acquired the assets and operations of St. Jude Medical some three months after the St. Jude recall was released in October 2016, and thus has inherited the problem and respective St. Jude ICD and CRT-D device lawsuits.

The proposed defective St. Jude cardiac defibrillators class action is ASEA/AFSCME Local 52 Health Benefits Trust et al., v. Abbott Laboratories et al., Case No. 1:17-cv-06704, filed September 19 of this year at US District Court for the Northern District of Illinois, Eastern Division. St. Jude Medical, Inc. is named as a co-defendant in the lawsuit.