Medtronic Inc. is one of the largest medical product manufacturing companies in the United States, and is responsible for the widely used Infuse Bone Graft System.

Across the country, though, patients are complaining that they suffered severe and painful complications after using having surgeries involving the Infuse Bone Graft System. They have filed numerous Medtronic lawsuits and claim the company used deceptive marketing tactics to sell it.

Class action lawyers allege that Medtronic misrepresented the uses of the Infuse when presenting it to different healthcare facilities by stating that this device could be used for cervical spinal procedures, when it was only approved to be used on certain lower lumbar procedures.

Infuse was originally approved by the U.S. Food and Drug Administration (FDA) in 2002 to be an alternative option for spinal fusion surgery that would require the doctor to harvest bone marrow from another location. The Infuse Bone Graft is composed of synthetic proteins that promote bone growth, and would ideally allow the spine to heal itself without an invasive procedure.

It quickly became popular for being an economic and less invasive option. On average, a traditional spinal fusion surgery in the United States can cost as much as $34,000 while Infuse can cost between $2,500 and $5,000.

Medtronic has been facing extreme criticism from the public and medical community for allegedly practicing illegal marketing tactics. In 2011, Dr. Eugene J. Carragee and several colleagues published an editorial in The Spine Journal, which stated that a number of Medtronic-sponsored studies did not mention the possible side effects of the Infuse Bone Graft.

It also revealed that the researchers involved in these Medtronic studies had been paid by the company between $1 million and $23 million a year in royalties and consulting fees.

However, patients across the country are filing Infuse lawsuits against Medtronic for not only allegedly deceitful marketing practices, but for also misrepresenting the procedures Infuse was approved for. This misrepresentation has allegedly caused hundreds of back injuries, ectopic bone growth, and even device failure.

Overview of Medtronic Infuse Bone Graft

On April 30, 2011, the FDA revealed that it had received hundreds of Infuse Bone Graft injury reports, many of which required surgical intervention. The side effects patients have reported included:

• Inflammation
• Pain in back and legs
• Radiculitis (pain spreads through the spinal nerves)
• Implant displacement
• Retrograde ejaculation (occurs when semen enters the bladder)
• Male sterility
• Cancer
• Infection
• Osteolysis (bone tissue degeneration)
• Ectopic bone formation (unwanted bone growth in the spinal canal)
• Death

Currently, the Infuse Bone Graft is only approved to be used on certain lower lumbar procedures. However, Medtronic allegedly marketed this device to be a safe and effective method for these procedures.

While it is not illegal for doctors to use medical products for off-label purposes, it is illegal for manufacturing companies to advertise them for such uses.

Thousands of lawsuits have been filed throughout the country, with the plaintiffs alleging that the company exposed them to an unnecessary risk. The plaintiffs typically state that they never would have used the Infuse Bone Graft if they had known about the risks associated with the product.