Abbott Laboratories is the target of a lawsuit filed by the Alaska State Employees Association/AFSCME Local 52 Health Benefits Trust in which it is alleged that the device maker’s subsidiary, St. Jude Medical, negligently failed to provide warning to government regulators and the public at large about defective lithium batteries installed in the implantable defibrillators it sold.
Initiated in Illinois federal court, the complaint at issue argues that St. Jude Medical was aware that at least a quarter of a million defibrillators placed on the U.S. market contained lithium batteries known for shorting out and resulting in loss of power to the emergency tools used to save lives.
While the Alaska Union Benefits Fund is the named plaintiff in the lawsuit, class action certification is being sought on behalf of self-insured as well as commercial insurance firms. According to the complaint, the group of insurers in aggregate purchased millions upon millions of dollars worth of defibrillators made by St. Jude Medical containing defective batteries.
According to Abbott, there is no merit to the claims raised in the lawsuit. It should be noted that officials from the device maker have long justified the delay in issuing a recall of their implantable defibrillators, which did not occur until October of 2016. Spokespeople from the company asserted that its team of executive staff and medical consultants worked as promptly as they could to verify the existence of the battery issue.
There are ten distinct claims included in the complaint. Breach of warranty, failure to warn, unjust enrichment and negligence are among them. The plaintiff also alleges violations of the Minnesota Prevention of Consumer Fraud Act by way of the company’s decision to conceal knowledge of the risks posed by the lithium batteries until late last year. It is argued that if those facts had been publicized, physicians would have avoided the defibrillators made by St. Jude, and the massive expenses involved with the recall and potentially risky revision surgeries would not have been incurred.
The plaintiff argues further that St. Jude Medical was aware of no less than 42 studies that revealed a connection between unusual depletion of batteries and the lithium versions used in the defibrillators between the years of 2011 and 2014. The company, it is alleged, also knew of a patient death that had occurred due to the issue.
St. Jude eventually moved to a different battery design in the May, 2015, but kept selling products with the old battery until eventually stopping in October of 2016. Thus, patients were receiving notification of the product recall after having surgery to correct an issue that the company knew about for multiple years.
It has been argued by St. Jude that its officials did not view the 2015 shift in batteries as representing any sort of admission that the prior versions were indeed defective. Instead, they claimed that the switch was simply evidence of a product improvement from which everyone could benefit.
St. Jude Medical’s voluntary recall program does not suggest that every device containing the suspect battery needs to be removed from each patient. Instead, it urges close patient/doctor consultation and the use of remote-monitoring capabilities to keep tabs on battery strength.
The U.S. Food and Drug Administration does not advocate preventive replacement of recalled defibrillator models for the simple fact that the removal and replacement procedures themselves are hazardous in nature. Of course, if a patient and physician decide that replacement is in fact the best course of action under a given set of circumstances, St. Jude will provide a no cost a new defibrillator device.
Learn more about Medical Device Lawsuits.
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