- The Medtronic Infuse Bone Graft is a medical device that is intended to be implanted after lower-back (lumbar) spinal surgery. It works by stimulating bone-growth in this area. It was developed as an alternative to traditional bone grafting, which involves painful bone-harvesting from other areas of the body.
- On November 28, 2006, the MDL (Multi-district litigation) court denied a Medtronic motion to dismiss on the basis of preemption. The defibrillator battery failure MDL litigation is now proceeding in the discovery phase.
- Medtronic is facing three whistleblower lawsuits seeking damages on behalf of the U.S. Government. Medtronic is accused of paying 15 doctors more than $60 million to promote the Infuse and other Medtronic spine products, all while downplaying the risks of severe side effects.
- On March 30, 2012, Medtronic agreed to an $85 million settlement in a lawsuit by shareholders that accused the company of making misleading statements about the Infuse system.
Facts about Meddtronic:
- The Medical Device Safety Act was introduced in Congress to amend the Food, Drug and Cosmetic Act to make clear that it does not provide medical device makers total immunity from claims by patients that suffered grave injuries from a faulty device.
- Medtronic has reported five patient deaths associated with fractured Sprint Fidelis leads and the FDA has 599 reports of malfunctions and injuries associated with the Fidelis leads as of January, 2007.
- The FDA issued a class I recall of Medtronic ICDs Micro Jewel II Model 7223Cx and GEM DR Model 7271 defibrillators. The recall was issued because the batteries may short over a period of hours or several days causing the devices to fail.
- The FDA in 2008 issued a Public Health Notification to healthcare providers warning against the use of Infuse Bone Graft in cervical spinal fusions, citing nearly 40 reports of serious injury associated with that specific off-label use.
- Medtronic is also accused of engaging in illegal “off-label” promotion of the Medtronic Infuse Bone Graft.
- When the FDA approved the device in 2002, they only approved it for use in the lower-spine (lumbar) region following spinal surgery. However, there is evidence that the company marketed the device “off-label” for use in upper-spinal or cervical surgeries.
- The risk with such surgeries is that the product can cause massive tissue swelling in the neck and throat area, leading to suffocation and death.
- In a 2011 study, five of the six men who developed a condition called retrograde injection were Infuse recipients.
- A U.S. Senate Finance Committee raised disturbing questions about the integrity of the research used to gain FDA approval of Infuse.
- In a report released in October 2012, Senate investigators charged that Medtronic deliberately manipulated studies to downplay Infuse Bone Graft side effects and promote off-label use of the bone protein.
- The report also found that Medtronic paid out $210 million in royalties, consulting fees, and other payments to the doctors who co-authored the Medtronic-sponsored Infuse studies.
If you have a Medtronic device implanted and you have suffered injury or pain from that device, or have lost a loved one that had a Medtronic device implanted, find out how the Miller Firm LLC can help you. Fill out our case review form here on our website and submit it for a free consultation.