Ron Albrecht

“I don’t trust the unit itself,” he told NWI.com. “You’ve got that fear you’re constantly going to get shocked. It’s very traumatic.”

Because of the faulty defibrillator, Albrecht had to quit his job because he was no longer able to lift heavy equipment. The defective device, he said, has changed his life for the worse.

In 1997, Medtronic suspended sales of its Sprint Fidelis Defibrillators after deaths were linked to the devices. The device’s leads were found to have fractured, which caused them to unnecessarily shock patients or fail to work altogether, putting patients’ lives at risk.

Albrecht was one of the many patients who tried to sue Medtronic over his faulty defibrillator leads but previous legislation prevented him and other victims from doing so. Earlier this week, Albrecht and several victims of malfunctioned heart devices converged in Washington, D.C. to lobby for support of the Medical Device Safety Act, which would allow consumers who have been hurt by defective medical devices to sue the device’s maker even if the devices have been approved by the Food and Drug Administration (FDA).

A spokesman with Medtronic says the industry as a whole is resistant to the proposed act, stating that a 1978 federal law was enacted to ensure that the FDA operates as the arbiter of safety.

SOURCE: Sprint Fidelis Lead Recall › Victim of defective defibrillator lobbies for Medical Device Safety Act

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