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

In Canada, 2,416 patients had the Medtronic defibrillators implanted as of February 2005, with 613 of them having been removed or replaced as of June 2007.

In 2005, Medtronic announced that it was recalling two heart defibrillators because they had been linked to at least four deaths and one injury. These devices are used to shock the heart into normal rhythm after patients suffer irregular heartbeat or fibrillation, which are rapid, life-threatening arrhythmia’s, originating in the lower chambers of the heart.

The defibrillators are implanted surgically in the chest. When a cardiac arrhythmia occurs, the capacitor is charged and the device delivers the appropriate shock. Medtronic said that some of the recalled defibrillators failed to charge properly, a defect which can result in the late delivery or no delivery of cardiac shock therapy. Medtronic had actually discovered the problem with its defibrillators in 2003, but did not disclose the problems immediately.

In October, Medtronic agreed to pay $130 million to settle U.S. claims it hid the defects in the defibrillators, $55 million more than it proposed in a July settlement, people familiar with the agreement said at the time. The company agreed to the higher amount after more claims were filed over the heart defibrillators than the parties expected, the people said.

But the October settlement was not the end of Medtronic’s defibrillator woes. That same month, Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart.

Just last week, lawyers for Medtronic went before the US Supreme Court to ask that people injured by defective medical devices and drugs should not be allowed to sue manufacturers if those products have been approved by the Food & Drug Administration.

December 10th, 2007 by Staff with NewsInferno.com

SOURCE: Sprint Fidelis Lead Recall › Medtronic dfibrillator cass ation lawsuit gets go ahead in Canada

“My pacemaker was implanted in 1999. It worked very nicely and it turned my life around,” Adams says. “But my heart was wearing out and I needed to have a defibrillator put in. After a discussion with my electrophysiologist I decided to have the defibrillator put in on the left side. I made that decision based on how long these devices are supposed to last and because the left side was a clear route to the heart. My pacemaker had been on the right-hand side, so I decided that the defibrillator should be on the left-hand side, which hadn’t been used.”

Adams’ defibrillator was implanted on July 6, 2006. Three months ago, Adams went swimming when her defibrillator gave her an unnecessary shock. She says that it was painful but the shock only happened one time so rather than seeking medical attention right away, she spoke to a Medtronic representative at her check in.

“I don’t know if people know this, but Medtronic’s people do the checking on you,” Adams says. “They do the hook-ups and the check-ins, so you deal with them a lot. When I mentioned the shock, they told me that the pool triggered it. But I swim in that pool all the time. It has never happened other than that one time. Now I’m worried because I don’t know if I have a faulty lead.”

Adams says she does not know what she is supposed to do now that her defibrillator has shocked her. “When I felt the zap, I thought maybe the leads can’t hold the power from the defibrillator,” Adams says. “Medtronic hasn’t made it clear why the leads fray. Is it the movement and extra exercise or is it the power from the defibrillator? Am I supposed to just continue on with the leads in my chest and once 30 months has passed we’ll know for sure if my leads are frayed?

“I’m scared of what the device is doing. I’m not comfortable with it. How do you know it is working? I feel so angry because I had a pacemaker in one side and now I’ve got a defibrillator in the other side and it might be messed up.”

Adams says that Medtronic representatives have not been helpful in answering her questions. In fact, some have been downright rude. “I went to one meeting with a Medtronic representative and there was a woman there who appeared to be with Medtronic, too.” Adams says. “I was talking about how worried I am and saying that if Medtronic knew about these problems, they shouldn’t have put the leads in. Then I said that I was happy that at least my devices have kept me alive so far. She said to me, ‘I’m glad you’re finally grateful about something.’ I just said to her, ‘It’s not in your chest. You have no idea. You’re not the one who has to be worried about it working.’

“Prior to this incident I felt safe with Medtronic. I would never have said anything bad about them. But after this I feel very let down and uncertain. I feel like they knew about the problems a long time before it came out. I think they know more than they say. They should step up to the plate and be honest about what’s going on. There has to be more to the story than just ‘five people are dead.’ I want to know the truth.

“No one has ever spoken to me about faulty leads. No one mentioned that it was a risk. It seems like they should have said something. How can they get by with not telling the truth?”

December 20th, 2007 by Heidi Turner with LawyersandSettlements.com

SOURCE: Sprint Fidelis Lead Recall › Medtronic should be honest about Sprint Fidelis leads