Over 16 months after Medtronic issued a Sprint Fidelis recall for small leads used to connect individuals’ defibrillators to their heart, new research suggests that the risk of the leads fracturing is higher than originally thought and is continuing to increase as time passes.
Thousands of individuals who received the leads now not only face more uncertainty about whether their lead will fracture in the future, but their ability to pursue compensation though a Medtronic lawsuit remains in jeopardy after a federal court ruling last month.
The Sprint Fidelis lead was recalled on October 15, 2007, after it was confirmed that they were prone to fracture or break. If a defibrillator lead fails, it could result in a massive electrical shock or cause a patient’s cardiac defibrillator not to work when it is needed to deliver a life-saving jolt.
At the time of the Medtronic recall, approximately 268,000 of the leads were already implanted in the patients. While Medtronic has suggested that the leads continue to work in about 95% of patients three years after they were implanted, new research finds that they are only working in 88% of the patients studied at three years.
The study, which was published on-line this week by the medical journal Heart Rhythm, looked at data for about 3,000 people who had a defibrillator implanted at Minneapolis Heart Institute or Mayo Clinic between 2004 and 2008. Medtronic Sprint Fidelis leads accounted for 848 of the leads implanted.
Researchers found that the annual Sprint Fidelis lead failure rate was 3.75%, compared with 0.6% for other types of leads. They also indicate that the failure rate for the Medtronic Sprint Fidelis lead was increasing as time passes, while it has remained stable for other types of leads.
Individuals who still have one of the Sprint Fidelis leads implanted in their chest face an uncertain future, as doctors are not removing or replacing the leads without evidence of a fracture. Attempting to remove the lead or insert a new one into the vein is a very risky procedure, which carries a substantial risk of complication or death.
Thousands of Medtronic Sprint Fidelis lawsuits have been filed throughout the country by individuals who have had their leads fracture and by individuals who are now required to obtain additional medical monitoring. However, Medtronic has taken the position that they are not liable for the damages caused by their faulty design, since the FDA approved their device.
In January 2009, U.S. District Judge Richard H. Kyle, who is overseeing the consolidated federal Medtronic lawsuits involving the Sprint Fidelis lead, issued an order that calls for the cases to be dismissed. He ruled that the federal law involving FDA approval of medical devices preempts the plaintiffs’ claims.
Legislation is currently being prepared in Congress which could nullify the preemption issue, potentially allowing the Medtronic Sprint Fidelis litigation to continue. However, it is unclear when or if the law will be passed.
Judge Kyle’s decision has also been questioned recently after it was reported that his son is a partner at a large law firm which represented Medtronic on a variety of matters.
While no evidence has surfaced that suggests Judge Kyle’s decision was influenced by the work of his son’s firm, serious questions have emerged about why the relationship was not disclosed before he agreed to hear the consolidated litigation and potentially save Medtronic billions of dollars in Sprint Fidelis lawsuit settlements and verdicts.