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Tag Archives: Sprint Fidelis

FDA to Hold Public Hearings on Medical Device Approval Process

  • Written by: AboutLawsuits
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The FDA has scheduled a public meeting for late this month to review review the controversial process used to swiftly approve medical devices, which some say has been overused and allowed dangerous devices to be implanted in patients.…

Medtronic Sprint Fidelis Lawsuits in Minnesota State Court Dismissed

  • Written by: AboutLawsuits
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A Minnesota judge has dismissed all state court lawsuits against Medtronic over its recalled Sprint Fidelis defibrillator leads. The decision follows a similar dismissal of the federal Sprint Fidelis litigation in January, based on the argument that the medical device manufacturer is immune from liability for injuries caused by their defective defibrillator leads since the FDA approved the devices.…

Senate Hearing Held on Restoring Rights to Sue Medical Device Makers

  • Written by: AboutLawsuits
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A panel of U.S. Senators heard testimony on Tuesday from patients and medical experts about the potential dangers of defective medical devices and the impact of a recent Supreme Court ruling that insulates manufacturers from product liability lawsuits for injuries caused by certain defective products that were approved by the FDA.…

GAO: FDA Oversight of Medical Devices Inadequate

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A Government Accountability Office (GAO) review of FDA’s oversight of medical devices has found a number of deficiencies that could expose the public to potentially dangerous and defective medical devices. The report was submitted as testimony today at a congressional hearing regarding legislation that would restore patients’ ability to file product liability lawsuits against the manufacturers of medical devices.…