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