Minnesota based Medtronic Inc. is the world’s biggest maker of internal defibrillators and cardiac devices. Holding about 50% of all sales worldwide, Medtronic has been distributing a variety of devices throughout the country and abroad for use in patients with a variety of heart problems. Defibrillators, which are implanted under the skin and then attached to heart muscle with wires are responsible for regulating problem heart beats and correcting those that can be deadly. Unfortunately, it appears that the Medtronic devices themselves could be blamed in the deaths of at least 13 people after claims of faulty welding and design flaws led to malfunctions.
Manufactured in Puerto Rico, there are concerns that quality issues have resulted in tragedy. The implanted device Sprint Fidelis is the device in question and sales have been stopped since 2007 on the device. Medtronic is expected to shell out $268 million in damages–and a company spokesperson says that the amount should cover the majority of the 8,100 U.S. cases and will resolve cases filed in both federal and state courts.
With as many as 268,000 patients using the device at its manufacturing peak, Medtronic estimates that there are still around 170,000 individuals with the potentially faulty devices in place. Despite the seemingly-large settlement total, the actual payout is only around $33,000 per client–pocket change to a company this size. For those 170,000 who are still walking around with the device, a mere $33,000 seems minor in the scope of the issue. The company acknowledged in 2009 that the wires were likely contributing factor in 13 deaths.
A U.S. Federal judge in Minnesota dismissed all claims in 2009 citing a ruling by the U.S. Supreme Court that barred all medical devices that have undergone strict scrutiny by the Food and Drug Administration from going to court. The settlement announcement came not long after the judge’s ruling to throw out the cases went to a federal appeals court for review.
This is the second major settlement for Medtronic. In 2007 the company paid out $114 million to the users of the Marquis defibrillator which its users claimed were defective and just stopped working. When a patient undergoes a procedure to implant a defibrillator it is because the heart rhythm that they have is dangerous or even deadly. When hope and trust are placed into the hands of not only the doctors, but also the manufacturers of devices that need to be relied on, a life is on the line. Families trust that they are getting the best and that the quality will be enough to sustain a high quality of life from that point on. Defective devices have cost at least 13 families alone a loved one–and $33,000 will not bring them back.