1.800.THE FIRM | 1.800.843.3476
The Cochran Firm Legal Blog
With Office Locations Nationwide
Tuesday, April 7, 2009
Who Should Bear the Cost of Medtronic's Defective Product?
When Medtronic introduced the Sprint Fidelis defibrillator lead, it was quickly adopted as the new standard in defibrillator leads. Over the next three years, more than a quarter-million people around the world, including over 150,000 Americans, had the leads implanted, until Medtronic abruptly stopped selling them in 2007 after five people with them died. Medtronic acknowledged that the breakage rate for this defective product was about 2.3 %, much higher than the original estimated 1%.
The failure rate continues to climb and now stands at 5% confirmed failure rate, with some studies showing Sprint Fidelis defibrillator lead failure rates ranging as high as 12%. Since the possibility exists that many of the leads will fail without warning signs until the defibrillator does not give a life-saving electric shock, the failure rate may actually be much higher. Now, people who have faulty leads must have them removed and replaced with more reliable leads. The operation is expensive, around $20,000, and potentially deadly. Already, at least four people have been killed during the operation. Who is responsible for these wrongful deaths and who should pay the cost of these operations?
Should the patient pay? Of course, the patient knew there was a risk the product would fail, but they were not told it would fail so quickly and in such great numbers. Should the implanting physician pay? The physician performed his or her job implanting the leads, and according to the company's data, selecting the Sprint Fidelis lead would not constitute medical malpractice. Should Medicare or a private insurer pay? Currently, they are the ones paying, but when they decided to cover the cost of Sprint Fidelis lead implantation, they were also not informed about the high failure rate. Should the manufacturer pay? Medtronic manufactured the defective medical product. They marketed the product, sold it, and collected profits from the product. They should be responsible for paying the price.
Unfortunately, the manufacturer is the one person who doesn't have to pay. According to the US Supreme Court decision in Riegel v. Medtronic, medical device manufacturers are immune to lawsuits based on FDA-approved devices that could make them pay the monetary and human costs of their defective product. Instead, Medtronic is offering only replacement leads for free. A replacement product is adequate when the product is a toaster or paddle-ball, but not when the defective product has such expensive and deadly consequences.
Hundreds of lawsuits over this defective medical device are on hold, but hope exists. Currently, Congress is considering legislation to overturn Riegel v. Medtronic and allow patients to receive compensation for their injuries. Schedule a free, no-obligation defective product lawsuit consultation with the product liability lawyers at The Cochran Firm today to learn whether you can pursue a lawsuit for your injuries related to this or other defective products.
The failure rate continues to climb and now stands at 5% confirmed failure rate, with some studies showing Sprint Fidelis defibrillator lead failure rates ranging as high as 12%. Since the possibility exists that many of the leads will fail without warning signs until the defibrillator does not give a life-saving electric shock, the failure rate may actually be much higher. Now, people who have faulty leads must have them removed and replaced with more reliable leads. The operation is expensive, around $20,000, and potentially deadly. Already, at least four people have been killed during the operation. Who is responsible for these wrongful deaths and who should pay the cost of these operations?
Should the patient pay? Of course, the patient knew there was a risk the product would fail, but they were not told it would fail so quickly and in such great numbers. Should the implanting physician pay? The physician performed his or her job implanting the leads, and according to the company's data, selecting the Sprint Fidelis lead would not constitute medical malpractice. Should Medicare or a private insurer pay? Currently, they are the ones paying, but when they decided to cover the cost of Sprint Fidelis lead implantation, they were also not informed about the high failure rate. Should the manufacturer pay? Medtronic manufactured the defective medical product. They marketed the product, sold it, and collected profits from the product. They should be responsible for paying the price.
Unfortunately, the manufacturer is the one person who doesn't have to pay. According to the US Supreme Court decision in Riegel v. Medtronic, medical device manufacturers are immune to lawsuits based on FDA-approved devices that could make them pay the monetary and human costs of their defective product. Instead, Medtronic is offering only replacement leads for free. A replacement product is adequate when the product is a toaster or paddle-ball, but not when the defective product has such expensive and deadly consequences.
Hundreds of lawsuits over this defective medical device are on hold, but hope exists. Currently, Congress is considering legislation to overturn Riegel v. Medtronic and allow patients to receive compensation for their injuries. Schedule a free, no-obligation defective product lawsuit consultation with the product liability lawyers at The Cochran Firm today to learn whether you can pursue a lawsuit for your injuries related to this or other defective products.
Labels: main
posted by Benjamin A. Irwin at 9:14 AM
<< Home