Nearly a quarter of a million Americans have pacemaker leads implanted in their hearts that may be defective. The leads are known as “Sprint Fidelis” leads, manufactured by Medtronic. The leads were recalled 2 years ago, but in this recall the potentially defective products have only been taken off the market, as the leads that have already been sold are implanted in patient's hearts. Replacing the leads carries a significant risk of death from the operation required to retrieve them. In the face of this quandary, evidence has surfaced indicating that as the Sprint Fidelis leads age, they are failing at a higher rate than previously expected.
According to an article published February 22, 2009 on the website for the journal Heart Rhythm, researchers analyzed the records of 3,000 patients and found that three years after implantation, only 88% of the Sprint Fidelis leads were still functioning. In a February 23, 2009 article in the New York Times, Medtronic disputed these new failure figures, and stated that 95% of the leads were still functioning after three years. Under either analysis, thousands of the leads have failed.
The Sprint Fidelis leads connect the heart to an implanted electronic defibrillator, which is designed to maintain normal heart rhythm by delivering an electric shock to the heart when a rhythm abnormality occurs. The electronic defibrillator keeps heart attacks from happening. The defect in the Sprint Fidelis leads causes the implanted defibrillator to either deliver shocks to the patient's heart when they are not needed, or (worse) fail to deliver shocks when they are needed. A number of patients have died as a result of failures of Sprint Fidelis leads, and hundreds of lawsuits have been filed against Medtronic.
Last month a Federal Judge in Minneapolis dismissed the lawsuits against Medtronic, citing “federal pre-emption” (a topic discussed in other postings on this blog). According to the New York Times article, some Congressional Democrats intend to introduce legislation to abolish federal pre-emption in medical device lawsuits and other product lawsuits. To date,the Bush administration has effectively shielded product manufacturers from lawsuits by injured consumers, but it is anticipated that the Obama administration will not continue to protect big corporate interests. At this point it is anyone's guess whether or not there will be any relief for the folks injured or killed by the Sprint Fidelis leads.