48 results

• Medtronic Infuse Linked To Neck Problems In Data Kept From FDA For Years

  December 27, 2018

  Irvin Jackson

  For years, Medtronic sat on more than 1,000 reports of serious complications linked to its Infuse bone growth products, including life-threatening neck conditions.

• Medtronic Settlement Reached Over Claims Infuse Bone Graft Studies Were Manipulated

  July 24, 2018

  Austin Kirk

  A $43 million settlement agreement proposes to resolve an investor lawsuit against Medtronic over manipulating studies linked to its Infuse bone growth product.

• Medtronic Infuse Problems Hidden From Regulators, Report Claims

  April 12, 2016

  Irvin Jackson

  A new report indicates that Medtronic waited years to inform the FDA of 1,000 adverse event reports linked to complications with the Medtronic Infuse bone growth products.

• Medtronic Infuse Lawsuit Appealed to U.S. Supreme Court Over Off-Label Marketing

  September 21, 2015

  Irvin Jackson

  The Supreme Court has been asked to weigh in on whether Medtronic is protected by preemption laws if if illegally promoted the Infuse bone growth system for off-label use.

• Side Effects of Bone Graft Substitutes Linked to Child Health Risks, FDA Warns

  January 22, 2015

  Irvin Jackson

  The FDA is warning doctors to avoid regular use of bone growth products like Medtronics Infuse on children due to the risk of side effects to their still-growing bones.

• New Rules Proposed For Conducting Clinical Drug Trials

  December 30, 2014

  Irvin Jackson

  Newly proposed rules would greatly expand the amount of information the public must be given on clinical drug trials.

• Researchers Call For Open Access to Clinical Trial Data

  September 15, 2014

  Irvin Jackson

  More drug researchers are calling for open access to clinical trial data amid distrust for the pharmaceutical industry to police itself.

• Settlements for Medtronic Infuse Bone Growth Lawsuits Cut Into Q4 Profits

  May 22, 2014

  Irvin Jackson

  Medtronic saw a major drop in profits, in part because of Infuse settlements

• Bayer to Share Clinical Trial Data Amid Push for Transparency

  May 20, 2014

  Irvin Jackson

  Bayer has agreed to release some voluntary patient-level trial data amid growing concerns over corporate clinical trial data authenticity.

• Medtronic Infuse Settlement Agreement Reached For $22M

  May 7, 2014

  Irvin Jackson

  A $22 million Medtronic Infuse settlement has been reached that resolves 950 claims, but leaves hundreds more unresolved; a number likely to grow as more claims are filed.