Abbott (NYSE:ABT) is facing an investor suit from an Alaskan union-benefits fund over allegations that St. Jude Medical, which it closed its acquisition of in January, failed to notify regulators about defective lithium batteries in its implantable defibrillators.
In the lawsuit, plaintiffs allege that St. Jude was informed of the battery defect “as early as 2011”, but it failed to take action and would wait 5 years before issuing a recall for the devices.
St. Jude received 42 product reports which showed “evidence of premature battery depletion due to lithium cluster bridging,” court documents claim, but did not take action to correct the problems.
In December 2014, a study was published detailing that lithium cluster bridging was causing premature battery depletion in St. Jude’s ICDs and CRT-Ds, according to court documents.
The company eventually made changes to its battery design on May 23, 2015, according to a Minneapolis Star Tribune report, but continued to sell defibrillators containing old batteries until December the next year.
This resulted in some patients receiving recall notices only weeks or months after surgery for the problem, which St. Jude reportedly knew about, the Star Tribune claims.
Plaintiffs claim that St. Jude’s medical advisory and management review boards were informed of the depletion issue, but did not cover “the full scope of the battery issue” and presented “false or incomplete evidence of the defect, and concealed from the boards evidence of a known death related to the battery defect stating instead that there were no serious injuries or deaths directly related to lithium cluster bridging,” court documents report.
St. Jude also reportedly concealed the defect from the FDA and “allowed thousands of more defective devices to be implanted” across the US at investors expense.
The plaintiff, the Alaska State Employees Association Local 52 Health Benefits Trust, is seeking class-action status and damages incurred by paying for defective defibrillators, alongside punitive damages.
An Abbott spokesperson said yesterday the lawsuit had no merit, according to the Star Tribune report, saying that the company worked as quickly as possible to confirm and correct the problem.