Minnesota cardiologists have warned that Medtronic’s Sprint Fidelis defibrillator leads which were pulled from the market in 2007, represent an “increasing hazard” for patients. In a Wall Street Journal article, David L. Hayes, a cardiologist at the Minneapolis Heart Institute, and David L. Hayes, chairman of cardiology at the Mayo Clinic in Rochester Minnesota, state that the risks increase as the implanted wires age. The two cardiologists published a study in the journal HeartRhythm that reviewed leads implanted from 2004 to 2008. They found that of 3,000 leads implanted at their respective institutions during that period, 848 were the Sprint Fidelis leads. The failure rate of these leads was 3.75 % compared with 0.6 % of other leads. Further, the physicians determined that this failure rate was increasing.
The situation presents a dilemma for patients with the leads. Removal can be extremely risky but the risks of doing nothing increase with time. In one of our cases, a 33-year-old man died when a blood vessel was punctured during surgery to remove a fractured Medtronic Sprint Fidelis lead. His story was featured in a New York Times article about Medtronic lead lawsuits.
PritzkerOlsen represents many patients with the implanted Medtronic leads and is strongly advocating for legislative action that will allow cases against Medtronic to go forward. Right now, these cases are effectively blocked by the U.S. Supreme Court ruling in Riegel v. Medtronic, which holds that certain defective medical device cases are “preempted” by FDA action.
For more information on preemption, please contact PritzkerOlsen at 1-888-377-8900 or submit our free consultation form.
Sources:
1. New Concern is Raised about Medtronic Wires, The Wall Street Journal Online, February 23, 2009.
2. Study Finds More Failure of Heart Device, The New York Times Online, February 23, 2009.
