The complaint incorporates by reference the relevant portions of the Master Consolidated Complaint for Individuals on file with the Clerk of the Court for the United States District Court for the District of Minnesota in the matter In Re MEDTRONIC, INC., SPRINT FIDELIS LEAD PRODUCT LIABILITY LITIGATION.

According to the complaint, Lancaster received the Sprint Fidelis lead on May 10, 2007 at DCH Regional Medical Center in Tuscaloosa, Alabama. As a result of the lead, Landcaster suffered injury and damages.

On October 15, 2007, Medtronic suspended the sale of its Sprint Fidelis Defibrillator Leads after receiving reports of fatalities associated with the defibrillators. It was discovered that the Sprint Fidelis leads, or cables that connected to the devices, had fractured, causing the defibrillators to unnecessarily shock patients or fail to work all together. Since the initial recall, Medtronic has increased the number of fatalities associated with the faulty leads to 13.

Due to a Supreme Court ruling last year, manufacturers of medical devices that have been approved by the FDA are immune to lawsuits by victims harmed by those devices. Currently, consumer and patient safety groups are working to push the Medical Device Safety Act (MDSA), legislation that would restore the rights of patients who have been harmed by unsafe medical devices, such as Lancaster, to seek justice in state courts.

Read the complaint.

SOURCE: Sprint Fidelis Lead Recall › Alabama man injured by cardiac defibrillator sues manufacturer

Medtronic defended the Minnesota judge on Friday, saying that “this is clearly an effort to remove a well respected judge following rulings the plaintiffs’ lawyers do not like.”

Richard H. Kyle, Jr., works for a Minneapolis based law firm with offices in the Midwest, China, and Mexico. Kyle’s bio on the firm’s website states that he is “a shareholder in [the firm's] White Collar & Regulatory Defense, Health Care Fraud & Compliance and Litigation Groups.”

The website also says that Kyle “is one of the top 40 criminal defense lawyers in Minnesota by the Minnesota Journal of Law and Politics.” Medtronic says that Kyle is not a part of its legal defense and has never represented the company.

Medtronic is the world’s largest medical device manufacturer. Its Sprint Fidelis defibrillators were removed from the market in 2007 because of faulty wires that shocked patients unnecessarily. The defibrillators are blamed for numerous injuries and deaths.

According to the Associated Press, Judge Kyle is “not aware of any formal attempt to remove him from the case.” He also said that that he felt no need to disclose his son’s relationship with the law firm because his son practices criminal law and “would not work with a company like Medtronic.”

Judge Kyle claims that he threw out the lawsuits against Medtronic because the company’s faulty devices had been deemed safe and effective by the Food and Drug Administration. The doctrine of pre-emption, a legal premise that took shape during the Bush administration, allows federal laws to trump state laws. Therefore, since the federal government said that the Sprint Fidelis defibrillators were safe, people harmed by them cannot turn to state law and thus have little or no legal recourse.

Which begs the question: if judges, politicians, and FDA regulators are all attached to big corporations, can the FDA’s stamp of approval on medical devices and drugs ever be trusted to protect the American people?

SOURCE: Sprint Fidelis Lead Recall › Judge tosses medtronic lawsuits, doesn’t disclose son’s ties

Implantable cardioverter defibrillators, or ICDs, provide shocks to stop hearts from potentially dangerous 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 of the machines were surgically removed and replaced with a different device in the U.S. and 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 either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.

Plaintiffs in the suits against Medtronic argued that the company knew for years that there was a potential for product defects but 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, including seeking and receiving FDA approval in 2003 to implement battery design changes. Yet in spite 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, as it settles 2,682 cases for $95.6 million as well as $18.5 million in attorneys’ fee.

Medtronic, the largest manufacturer of ICDs, has had other problems with many of its devices. In April 2004 Medtronic announced that it was recalling its Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271 ICDs after they had been linked to at least four deaths and one injury. Medtronic said at the time that some of the recalled defibrillators failed to charge properly, resulting in the late delivery or no delivery of cardiac shock therapy. In January 2007 the FDA announced that the agency started an investigation looking into accusations by a former Medtronic engineer that the medical-device company 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 to save the patient’s life if the heart goes into cardiac arrest.

In October 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators. According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt. This malfunction can cause extreme pain, or in the worse 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.

January 1st, 2008 by Staff with NewsInferno.com

SOURCE: Sprint Fidelis Lead Recall › Medtronic settles defective defibrillator lawsuits for $114 Million