36 results

• Medtronic Faces Investigations Worldwide Over Alleged Improper Conduct, Unsafe Medical Devices: “Implant Files” Report

  November 30, 2018

  Irvin Jackson

  A new report finds that Medtronic or its subsidiaries were responsible for one-fifth of all medical device recalls last year, and raises questions about the company's commitment to avoid unfair business practices which got it into trouble with the U.S. Justice Department in 2008.

• Medical Device Makers Could Just “Summarize” Malfunction Reports Under Proposed FDA Rule

  March 2, 2018

  Irvin Jackson

  A proposed rule by the FDA could allow medical device manufacturers to simply summarize malfunction reports quarterly, instead of providing full, detailed information.

• 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.

• 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.

• Clinical Trial Data to be Voluntarily Released by Additional Drug Makers

  December 6, 2013

  Martha Garcia

  Pfizer has agreed to change its policy for disclosure of clinical trial data, coming amid an increasing push for trial data transparency.

• Risperdal Safety Information from Clinical Trials Withheld by J&J: Records

  November 12, 2013

  Irvin Jackson

  The Justice Department has released documents suggesting Johnson & Johnson withheld clinical trial data on Risperdal, amid growing concern over drug company's use of clinical trial data that places their drugs in a bad light.

• 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.