Medtronic Increases Estimate of Deaths from Sprint Fidelis
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.
Medtronic Sprint Fidelis Lead Lawsuits and Preemption
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.
Client Featured in New York Times Story
Mark Turnidge was like other wearers of the Medtronic Inc. Sprint Fidelis Lead, a heart defibrillation device that was recalled in 2007 over concerns that the product’s slender electrical cable, or lead, had a high rate of fracture.
But last month, when doctors at North Memorial Medical Center went to remove the fractured Fidelis lead in Mark, a vessel was punctured and he died two days later at age 33. He left behind a wife, Wendy, and their two young sons.
Even more tragic, Mark’s death highlights the difficulty that victims of faulty medical devices are now having all over the country in seeking justice from manufacturers. With the cooperation of Minneapolis attorney Fred Pritzker, who represents the Turnidge family, Barry Meier of the New York Times on Friday featured the family in a story about the growing national outrage over a recent U.S. Supreme Court ruling in Riegel v. Medtronic.
Pritzker told the Times he is considering suing Medtronic and the doctors who went to remove the fractured lead. But he said the Supreme Court ruling — which barred patients and survivors from suing the makers of devices that were approved for sale by the Food and Drug Administration — makes it likely that a state judge would reject such cases. Pritzker’s firm, PritzkerOlsen Attorneys, already has a number of claims on file on behalf of Sprint Fidelis patients.
The ruling 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.
The Times story said help could be on the way from Congress, where legislation is being prepared to overpower the Supreme Court decision. Democrats Henry Waxman and Frank Pallone Jr. are carrying the issue in the House while Sen. Ted Kennedy, D-Mass., and Sen. Patrick Leahy, D-Vermont, have supported a Senate version that could be reintroduced soon.
Most people assume any product approved by the FDA is safe. Wendy Turnidge and many others know this is not true. We ask that you support any efforts to nullify Riegel v. Medtronic. Wendy Turnidge is going to be raising her sons alone. She deserves justice.
