Medtronic Infuse Linked To Neck Problems In Data Kept From FDA For Years
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.
Tag Archives: Medtronic Infuse
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Medtronic Settlement Reached Over Claims Infuse Bone Graft Studies Were Manipulated
A $43 million settlement agreement proposes to resolve an investor lawsuit against Medtronic over manipulating studies linked to its Infuse bone growth product.
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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.
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Medtronic Infuse Lawsuit Appealed to U.S. Supreme Court Over Off-Label Marketing
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.
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Side Effects of Bone Graft Substitutes Linked to Child Health Risks, FDA Warns
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.
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New Rules Proposed For Conducting Clinical Drug Trials
Newly proposed rules would greatly expand the amount of information the public must be given on clinical drug trials.
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Researchers Call For Open Access to Clinical Trial Data
More drug researchers are calling for open access to clinical trial data amid distrust for the pharmaceutical industry to police itself.
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Settlements for Medtronic Infuse Bone Growth Lawsuits Cut Into Q4 Profits
Medtronic saw a major drop in profits, in part because of Infuse settlements
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Bayer to Share Clinical Trial Data Amid Push for Transparency
Bayer has agreed to release some voluntary patient-level trial data amid growing concerns over corporate clinical trial data authenticity.
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Medtronic Infuse Settlement Agreement Reached For $22M
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.
