US District Judge Richard Kyle has dismissed all lawsuits pending against Medtronic for its faulty Sprint Fidelis Defibrillator leads citing Riegel v. Medtronic's Supreme Court case last year. In his broader opinion, Judge Kyle wrote in his 37 page opinion that consumers have no right to file lawsuits against medical device companies who've previously received FDA pre-market approval for the device.
While the case is a set back for consumer justice, a legislative solution is in the works. Congress will consider a measure that effectively makes the judicial decision moot if passed into law. One of the Senate sponsors last year was the current President-elect Barack Obama. The proposed legislation has bipartisan support and is expected to pass this year or at the latest in 2010.
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This is so scary for the consumer. Judge Kile wrote that he had to do it , despite what happened to the people. Hopeful they can fix this.
I encourage everyone who has been injured by the Sprint Fidelis lead to write to your Congressman and Senators. This is an outrage. Medtronic should be held accountable and not be allowed to "hide" under the blanket of the FDA.
Thanks for your comments, Jill and Michael. InjuryBoard is eager to bring this issue into public view. Considering the potential ramifications for public safety created by a broad legal immunity for drug and device manufacturers, I am amazed at how little coverage mainstream media have given the Riegel and Levine cases. Then again, I wonder how much of a surprise a lack of preemption news coverage is given the amount of money industries like big pharma spend on media: More ... Considering Auto media spending is dropping, maybe the networks are trying to keep their other customers happy?More ...
Well my dad past away last year and he had a defected pacemaker put in pryor and died as a result...I haven't had the chance to see a lawyer about it because im only 17 but today I got a letter explaining the information about the case... im a little confused about what this means for any case I might have...any suggestion
i have wrote and called, my congressman,senator lots of news station, talk shows and any one i can think of. my next stop is to lobby in front of congress and the,minnesota,courts.i'am going to scream until someone hear us, question? what would be the judge decison if it was his lawyer son uh?
I received a Medtronic/Sprint Fidelis ICD in May of 05. A month later I read about the recall in US News. Yep, my card shows 6949. My EP shrugged off most of my questions, reprogrammed it with the software fix, and I have the wireless set-up at home. Amazing technology and I am grateful for it. I am concerned about several things though. No human testing because the "smaller lead did not need it". Problems being reported but sales and implants continuing, including mine. Suddenly preemption is dclared from a judge whose son works for a law firm retained by Medtronic? Not sure what to think or what to believe anymore. I'm just worried.
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