Today it was announced that Medtronic has agreed to a $268 million settlement to facilitate an end to various US lawsuits and claims related to the Sprint Fidelis family of leads.
These are the wires that connect the human heart with medical devices such as pacemakers and defibrillators—wires that send electrical impulses to the heart to either control its rhythm, or to shock it back into submission. That operation is based on signals sent over those same wires from the heart to the medical device, in order to instruct it to perform the proper operation.
When the Sprint Fidelis lead was introduced, surgeons loved it. The thinner profile made it easier to thread to the heart and it was viewed as a milestone leap in the technology.
The euphoria was short-lived as some of the leads were prone to hairline cracks once implanted. Such cracking would impede the flow of information and response between the heart and device, often resulting in a lack of electronic stimulation when required, or stimulation when none was called for—both with devastating results.
Surgeons were reluctant to remove, and replace the leads unless absolutely necessary given that removing a lead from the heart muscle—once attached—carries certain risks that could lead to irreparable damage to the heart, or even death.
Thus, were a Sprint Fidelis customer not be in a position to have a lead replaced—or whose lead was functioning properly—the emotional toll related to the constant trepidation that a lead could fail at a moment's notice spurred many a lawsuit. To compound the problem, the recall announced three years ago proved frustrating for Sprint Fidelis patients whose surgeons were reluctant to replace them.
Medtronic, based in Minneapolis, indicated in a statement that the settlement will include attorney's fees and administrative costs, and would dismiss plaintiff's appeals pending in the US Court of Appeals for the Eighth Circuit and the Minnesota Court of Appeals.
It was reported in The New York Times October 14th that the parties, according to Medtronic, would also seek to dismiss Fidelis-related cases nationwide. The company plans on recording the settlement as a special charge in its second quarter.