Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, announced last week that it had reached a settlement agreement regarding another of its faulty medical devices. The company has agreed to pay out $114 million to settle product liability lawsuits. Consumers filed the lawsuits in response to injuries caused by its malfunctioning Marquis line of implanted cardiac defibrillators. Despite the huge settlement agreement, Medtronic said it does not admit liability in the litigation.
Thousands of Replacements
Implantable cardioverter defibrillators (ICDs) provide shocks to stop hearts from dangerously rapid beating. They treat patients at risk for sudden cardiac death, which is the leading natural cause of death in the U.S. In February 2005, Medtronic warned of a potential battery shorting problem in various Marquis-brand defibrillators. According to the Wall Street Journal, 11,000 machines were surgically removed and replaced with a different device in the U.S. 2,000 more such removals took place overseas. The Food & Drug Administration (FDA) classified Medtronic’s action as a Class II recall. In a Class II recall, there is a chance that the device will cause temporary or reversible health problems. There may also be a smaller chance that the device will cause serious health problems.
Plaintiffs in the suits against Medtronic argued that the company knew for years about the potential for product defects. Regardless, the company sold its stock of potentially defective devices and didn’t advise patients that safer devices were available. The company has argued that it fulfilled every obligation in terms of reporting the problem. It also points out that it obtained FDA approval in 2003 to implement battery design changes. In spite of its claims that it acted properly, Medtronic is now settling thousands of defective Marquis defibrillator lawsuits. The company will pay a total of $114 million. It settles the 2,682 cases for $95.6 million as well as $18.5 million in attorneys’ fees.
Other Medtronic Device Problems
Medtronic, the largest manufacturer of ICDs, has had other problems with many of its devices. In April 2004, Medtronic announced a recall of Micro Jewel II Model 7223Cx and Medtronic GEM DR Model 7271 ICDs. The devices had been linked to at least four deaths and one injury. Medtronic said some of the recalled defibrillators failed to charge properly. As a result, patients could receive late or no delivery of cardiac shock therapy. In January 2007, the FDA announced that the agency started an investigation into accusations from a former Medtronic engineer. The engineer stated that Medtronic didn’t sufficiently test its new Concerto cardiac device for patients with congestive heart failure. The Concerto device is one that can resynchronize the heartbeat of a patient and also provide backup defibrillator capability. Hopefully, this would save the patient’s life if their heart went into cardiac arrest.
In October 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead. The lead, a wire that connects the device to the heart, is a vital component in the implantable defibrillators. According to Medtronic, it could fracture inside a patient’s blood vessel, delivering a massive electrical jolt. This malfunction can cause extreme pain, or in the worst-case scenario, it can be fatal. At least 5 deaths have already been linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.