In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation Lawsuit

In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation

Product and manufacturer

Medtronic is a large medical technology company headquartered in Minneapolis, Minnesota, with a broad portfolio of implantable cardiac devices. The product at the center of this litigation was not the defibrillator itself but the lead: the Sprint Fidelis family of defibrillation leads. A lead is a thin insulated wire that is implanted together with the pulse generator of an implantable cardioverter-defibrillator, or ICD. It performs two jobs. It senses the heart's electrical activity continuously, and when the device's logic determines that the rhythm has become dangerous, it conducts the corrective shock to the heart muscle. ICDs are typically implanted in patients who have already experienced, or are at high risk of, life-threatening ventricular arrhythmias, so the lead is a critical component of a system many patients depend on to avoid sudden cardiac death. Medtronic, as the manufacturer of the lead family, was the defendant.

Alleged harm

In October 2007 Medtronic issued a field action — the industry term for a post-market corrective measure — covering the Sprint Fidelis family of ICD leads. The defect that prompted the action was lead fracture: the wire could break, in some cases leaving fragments behind in the body. Fractures had been identified in roughly two thousand patients at the time of the field action. A fractured lead can fail in more than one way. It may stop sensing the heart correctly, so a dangerous rhythm goes undetected. It may fail to conduct the shock the patient actually needs. Or it may send spurious electrical noise to the device, causing it to deliver shocks that are not warranted. Every one of these failure modes exposes the implanted patient to the same practical consequence: a return to the operating room for a revision procedure to extract or replace the damaged lead, along with the period of vulnerability while the device is compromised. Patients who had received Sprint Fidelis leads and who were harmed by fractures, or who underwent revision surgery, brought product liability suits against Medtronic.

Litigation

The federal cases were centralized as Multi-District Litigation No. 1905, docket 0:08-md-01905, in the United States District Court for the District of Minnesota, before Judge Richard H. Kyle. More than a thousand cases were drawn into the centralized docket. Minnesota was the natural forum, as it is Medtronic's home district. The MDL structure allowed discovery, expert work on lead performance and fracture mechanisms, and pretrial rulings to proceed in a single court rather than in a scattered set of separate dockets.

Outcome

On October 14, 2010 Medtronic announced that it had agreed to settle all United States lawsuits and claims relating to the Sprint Fidelis leads that were pending as of October 15, 2010; the agreement also covered attorneys' fees and administrative expenses. The parties subsequently filed joint requests to terminate the MDL and the related Minnesota state court proceedings. The docket records the MDL as terminated on September 22, 2011. This entry records the settlement as the outcome; no financial terms are stated here.

This is an archived encyclopedia record; intake for new claims is closed and the entry is provided for historical reference only.