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For some time now, members of the Injuryboard have been writing about the major impediment on medical device cases. They have been thrown out of court, because of federal preemption. There are tragic stories of people who are injured by these products who simply have no recourse. It’s one of the hardest things to do, when someone calls with a letter that says the product that they have in them is faulty, and they have to be told, sorry you have no protection, despite what the Constitution says about your civil rights.

The question is if Congress should reverse the 2008 US Supreme Court decision of Riegel v. Medtronic, Inc? That ruling granted immunity to medical devices that gain approval from the Food and Drug Administration under the Medical Devices Amendment of 1976. In affect silencing individual state’s consumer protections.

Last week, the U S Senate took testimony on the Medical Device Liability Bill:

Two Minnesota families testified concerning their children who died due to problems with Medtronic pacemakers and Medtronic implantable cardiac defibrillators.

Another Medtronic defibrillator user from Iowa testified that he received 22 electric shocks within a span of 53 minutes from a faulty implant . He said, “My hope is that no one else ever has to go through the pain and agony that I experienced with the fractured lead, and that Medtronic is held responsible for the injuries it has caused other patients like me.” He was asked to testify by Senator Tom Harkin (D-IA).

Also testifying were a Texas man who was shocked six times by a faulty pacemaker and a six year-old Illinois girl, who was also shocked by a faulty defibrillator.

William Maisel, MD, director of the Medical Device Safety Institute and a cardiologist who chairs an FDA advisory committee, testified that "the FDA does an ‘exceptional job’ of monitoring the safety of medical devices." But, he added, "the postmarketing data is an issue." Dr. Maisel "said it is ‘simply impossible’ for the FDA to continue to monitor the safety of every medical device it has approved."

Hopefully, the senate will listen. The question isn’t what these people should get. It is simply that they should have the right to make the claim. Let the system work with each case standing on it’s merits.


  1. Gravatar for Daniel 8791
    Daniel 8791

    This is a matter of protecting peoples civil rights. The movie "Mississippi Burning" has always got my blood stirring, and I certainly wouldn't want to bring that kind of rage when I'd have a faulty medical devise in me. I think Congress will make this right.

  2. Gravatar for Mike Bryant
    Mike Bryant

    Hope so, these people need some kind of remedy. Thanks for taking the time to read and comment.

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