14 results

• 1.1M Medical Device Reports Involving Problems Staplers, Defibrillators and Other Products Hidden From Public: Report

  May 22, 2019

  Irvin Jackson

  A new report reveals the FDA has allowed manufacturers to hide more than a million reports of serious injury and medical device malfunction away from public view since 2016.

• St. Jude Riata Recall Sign of FDA Oversite Problems: Report

  February 21, 2012

  Staff Writers

  A recent editorial published in the New England Journal of Medicine suggests that last year’s recall of St. Jude Riata...

• Heart Defibrillators Often Implanted in Inappropriate Patients: Study

  January 5, 2011

  Staff Writers

  More than one out of every five heart defibrillators implanted in the United States may be unnecessary, or were implanted...

• Medtronic Sprint Fidelis Lead Failure Rates Reportedly As High As 9.2%

  February 8, 2010

  Staff Writers

  According to new research, the failure rate for recalled Medtronic Sprint Fidelis leads, which are small wires used to connect...

• FDA to Hold Public Hearings on Medical Device Approval Process

  February 1, 2010

  AboutLawsuits

  The FDA has scheduled a public meeting for late this month to review review the controversial process used to swiftly...

• Medtronic Sprint Fidelis Lead Failures Could Hit 30% in Four Years

  January 5, 2010

  AboutLawsuits

  A new analysis by UBS Investment Research warns that the failure rate for Medtronic Sprint Fidelis defibrillator leads could reach...

• Problems with FDA Medical Device Approval Process Identified in New Studies

  December 30, 2009

  AboutLawsuits

  Two new studies have been published that are highly critical of the way the FDA approves medical devices for human...

• Medtronic Sprint Fidelis Lawsuits in Minnesota State Court Dismissed

  October 26, 2009

  AboutLawsuits

  A Minnesota judge has dismissed all state court lawsuits against Medtronic over its recalled Sprint Fidelis defibrillator leads. The decision...

• Senate Hearing Held on Restoring Rights to Sue Medical Device Makers

  August 5, 2009

  AboutLawsuits

  A panel of U.S. Senators heard testimony on Tuesday from patients and medical experts about the potential dangers of defective...

• GAO: FDA Oversight of Medical Devices Inadequate

  June 18, 2009

  AboutLawsuits

  A Government Accountability Office (GAO) review of FDA’s oversight of medical devices has found a number of deficiencies that could...