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

It was reported yesterday in the Wall Street Journal that the global medical device manufacturer acknowledged the federal investigations as part of a filing with the SEC (Securities and Exchange Commission).On October 15, 2007, a nationwide Medtronic recall was issued for all models of the Sprint Fidelis defibrillator lead. Defects in the lead could cause the thin electrical wire to fracture or break, resulting in electrical shock or device failure.

A lot of controversy has surrounded the approval of this device by the FDA, since no specific testing was required before it was introduced in 2004. In addition, many have expressed concerns about the timing of the defibrillator lead recall, as the Company delayed removal of the device from the market for many months, allowing thousands of people to receive the lead which was known to be dangerous and defective.

Medtronics indicates that the Senate Finance Committee has requested information regarding the defibrillator lead recall as well as information about alleged payments made to doctors by the company. Shortly after the recall, the company was also the subject of a letter from the U.S. Congressional Committee on Oversight and Government Reform, which was sent to the commissioner of the FDA inquiring about the Sprint Fidelis lead’s approval process and when the FDA first learned about the risk that the leads could fracture.

A separate Medtronic investigation has been initiated by the Justice Department, through the U.S. attorney’s office for the Eastern District of Pennsylvania. The U.S. attorney requested that the company provide information about payments made to doctors outside of the United States. The alleged payments could be in violation off the U.S. Foreign Corrupt Practices Act, which is designed to prevent companies from bribing foreign government officials.

Any defibrillators implanted since 2004 could have the Sprint Fidelis lead. To determine if you, a friend or family member may be impacted by the recall, contact your doctor for medical advice and contact our office for a free legal consultation.

December 6th, 2007 by Austin Kirk with Permalink

SOURCE: Sprint Fidelis Lead Recall › Medtronic investigations initiated by federal government

Following the recall, it was learned that Medtronic had been receiving reports that indicated the Sprint Fidelis Lead had a higher-than-normal fracture rate for months. The incident has raised questions about the Food & Drug Administration’s (FDA) regulation of medical devices, and of the Medtronic’s response to early reports of lead problems.

Medtronic has acknowledged in a Securities and Exchange Commission (SEC) filing that the Senate Finance Committee has requested information about ties between the medical-device industry and practicing physicians and information about Medtronic’s suspended distribution of its Sprint Fidelis family of defibrillation leads. The Senate panel is probing the FDA’s oversight of medical-device components.

Medtronic said in the same SEC filing that it is the subject of a Justice Department probe into illegal physician payments. The U.S. attorney’s office for the Eastern District of Pennsylvania asked for information on payments or gifts to physicians or physician’s groups related to the purchase of the company’s cardiac stents and cardiac-therapy devices.

The U.S. attorney also asked Medtronic to provide documents related to its relationship with a specific customer. The customer wasn’t identified in the SEC filing. In September, the SEC began an informal probe of Medtronic, seeking information about possible violations of the Corrupt Foreign Practices Act, which is meant to stop bribes to foreign officials.

This is not the first time Medtronic’s relationships with physicians has come under scrutiny. Earlier this year, Sen. Charles Grassley, R-Iowa, requested information from Medtronic about the company’s payments to orthopedic surgeons, and questioned whether they improperly influenced physician decisions about which products to use.

Monetary agreements with physician consultants are common in the medical device industry, where doctors are paid for their work developing products and then, in some cases, for helping to train other doctors in how to use the products. Medtronic insists that it only provides physicians with compensation that is fair, relative to current market values, and is compliant with the law.

December 6th, 2007 by Staff with NewsInferno.com

SOURCE: Sprint Fidelis Lead Recall › Medtronic faces investigations over defective Sprint Fidelis Defibrillator lead