49 results

• 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.

• Whistleblower Lawsuit Results in $10M Settlement by Medtronic

  May 30, 2014

  Irvin Jackson

  Medtronic has agreed to pay $10 million to settle allegations that it paid off doctors to implant its devices in patients.

• 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.

• Medtronic Infuse Lawsuits Over Bone Growth Complications Top 1,000

  March 5, 2014

  Irvin Jackson

  Medtronic says it faces 1,000 lawsuits over its Infuse bone growth product.

• European Regulators Call for Drug Companies to Release Clinical Trial Data

  October 28, 2013

  Irvin Jackson

  EMA officials say more clinical trial data transparency would help drug companies become more trustworthy.

• Medtronic Infuse Bone Graft Lawsuits Continue to Mount

  October 8, 2013

  Irvin Jackson

  Medtronic Infuse lawsuit has been filed on behalf of nearly 100 plaintiffs, joining a growing litigation.