Medtronic Inc. has written a letter to doctors revising the number of deaths it believes are due to a faulty wire known as Sprint Fidelis.
When the cardiac defibrillation device was recalled for safety reasons in 2007, the company said five deaths were associated with the wire, which fractures in a small number of cases and shocks the patient or fails to work. On Friday, Medtronic wrote to doctors saying the death total is 13 — including four patients who died from complications of surgery to remove the device.1
Some experts believe the latest estimate by Medtronic is lower than the actual death toll. Regardless, the overall count clearly includes the tragic death of 33-year-old Mark Turnidge of Minnesota. Doctors at North Memorial Medical Center in Robbinsdale were removing a fractured Sprint Fidelis lead from Mark’s chest when a vessel was punctured. He died two days later, leaving a wife, Wendy, and two little boys.
With the help of attorney Fred Pritzker, Mark’s case has garnered national attention, including a recent feature story in the New York Times by journalist Barry Meier. Pritzker, founder and president of premier personal injury law firm PritzkerOlsen Attorneys, is considering filing a Sprint Fidelis lawsuit against Medtronic and the doctors who went to remove the fractured lead.
But as the Times story noted, there is a Supreme Court ruling in Reigel vs. Medtronic barring patients and survivors from suing the makers of devices that were approved for sale by the Food and Drug Administration. That makes it likely that a state judge would reject such cases. PritzkerOlsen already has a number of claims on file on behalf of Sprint Fidelis patients.
The ruling in Reigel vs. Medtronic has the affect of leaving patients and survivors legally powerless over spotty oversight by FDA, an agency that has proven incapable of keeping dangerous medical devices off the market. There is continued hope, however, that Congress will rectify the situation with new legislation in 2009.
Meanwhile, Medtronic is continuing to advise wearers of Sprint Fidelis (about 150,000 patients in the United States and 268,000 worldwide) not to have the device removed if it is faulty. That’s because the wires can become embedded in scar tissue. Now the company is saying that if a patient desires anyway to have the device removed, to rely on a surgeon with specialized experience in such removals.
We welcome your comments. Do you think Congress should step in with Legislation to overpower the Supreme Court ruling that cushions corporations from accountability when faulty devices are approved by the FDA?
Source: 1Star Tribune, By Janet Moore, March 14 2009.
