In 2007 Medtronic recalled their heart device, the Sprint Fidelis Cardiac Leads, which has caused the deaths of at least 13 people. Essentially the product, the Sprint Fidelis cardiac leads, connects the patient’s heart to a defibrillator. Along with deaths, the Federal Drug Administration (FDA) has received about 2,200 reports of serious injuries related to the leads.
The Sprint Fidelis lead is at the center of Riegel v. Medtronic, Inc., a medical device liability lawsuit that is receiving a lot of attention from the legal community because of the involvement of preemption issues.
Yet despite the FDA recall and the highly publicized Riegel lawsuit, around 150,000 people still have the leads from this device in their body and it is still in widespread use amongst Illinois residents. Typically doctors decide to leave a fractured heart device lead in place when implanting a new one. Doctors are faced with a difficult choice when confronted with the large number of people who rely on this product because of the high degree of injury associated with it.
Last week the FDA issued an advisory to physicians regarding patients that would benefit from having the failed leads extracted, which urged the physicians to ensure that the procedure is performed by a physician skilled in removing these type of failed leads.
The medical community has responded with skepticism to the FDA advisory board regarding Medtronic’s device. Dr. William H. Maisel, a cardiologist at Boston’s Beth Israel Deaconess Medical Center, stated, “In 2006 the company recognized there was a problem”, suggesting that Medtronic did not act on this information.
Records show that back in February 2007, a group of cardiologists met with Medtronic officials to inform them that patients with the Sprint Fidelis leads were fracturing at a troubling rate. Medtronic officials responded that it was not unusual for heart device leads to fracture and that they had no data to show that there was a significant difference in failure rates between their Spring Fidelis lead and other leads.
For over 30 years Chicago’s Kreisman Law Offices has been handling Illinois product liability lawsuits and Cook County medical device liability for clients in areas such as Hoffman Estates, Wheaton, Oak Lawn, and Chicago Heights.