Medtronic Infuse Problems Hidden From Regulators, Report Claims
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.
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.
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.
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.
Medtronic has agreed to pay $10 million to settle allegations that it paid off doctors to implant its devices in patients.
Medtronic saw a major drop in profits, in part because of Infuse settlements
Bayer has agreed to release some voluntary patient-level trial data amid growing concerns over corporate clinical trial data authenticity.
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 says it faces 1,000 lawsuits over its Infuse bone growth product.
EMA officials say more clinical trial data transparency would help drug companies become more trustworthy.
Medtronic Infuse lawsuit has been filed on behalf of nearly 100 plaintiffs, joining a growing litigation.