The Medtronic Infuse Bone Graft is a new medical device that helps stimulate bone growth after lower-spinal surgery. Unfortunately, the device has been linked to hundreds of adverse event reports, including death. Nearly 75% of people who are implanted with the Infuse Bone Graft suffer from over-grown bones, which can cause severe nerve damage and other side effects. Medtronic is currently under Congressional investigation, because the company has been accused of engaging in illegal “off-label” promotion. They are also accused of paying physicians millions of dollars to produce studies favorable to the Infuse bone graft. The company is now facing Infuse Bone Graft lawsuits from people who were injured, permanently disabled, or died from side effects of this device.

What You Can Do & How a Medtronic Infuse Bone Graft Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting Medtronic Infuse Bone Graft induced injury cases in all 50 states. If you or somebody you know has been injured by Medtronic Infuse Bone Graft, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

What is the Infuse Bone Graft?

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. The device itself consists of two parts — a sponge-like substance, which is soaked in a biological agent. The biological agent is a synthetic liquid form of bone morphogenetic protein, or BMP. The device is implanted between vertebrae, and the BMP stimulates the bones to grow. The sponge dissolves and is absorbed into the body.

What’s the problem?

Medtronic is facing intense pressure regarding its Infuse Bone Graft. The FDA has issued safety warnings, the U.S. Department of Justice (DOJ) has begun a criminal investigation, and the company is currently facing a Congressional investigation. Recently, Medtronic admitted to paying a surgeon nearly $800,000. The surgeon is accused of falsifying the results of a study, which produced a favorable review of the Infuse Bone Graft, all while downplaying the risks of severe side effects.

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 problem is that when the Infuse Bone Graft is used in these upper-spinal areas, there is a risk that the product can cause massive tissue swelling in the neck and throat area, leading to suffocation and death.

 Medtronic is facing three whistleblower lawsuits seeking damages on behalf of the U.S. Government. The lawsuits were filed by former Medtronic employees, who allege that the company engaged in illegal marketing. This marketing allegedly involved 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. Although doctors are allowed to use medical devices for off-label purposes, the manufacturers of such devices are not allowed to engage in off-label promotion.

FDA Warns of Life-Threatening Complications

On July 1, 2008, the FDA published a Public Health Notification to warn of life-threatening complications of the Infuse Bone Graft. The agency received 38 reports of complications during the last 4 years, which included swelling of the throat and neck. Some patients suffered suffocation, compression of the airway, and/or nerve damage in the neck. The patients who suffered this side effect had difficulty breathing, swallowing, and speaking. Most of these complications occurred between 2 and 14 days after the operation.

Most of the patients who suffered this severe side effect were implanted with the Medtronic Infuse Bone Graft in the cervical spinal area, near their neck. The FDA never approved the Infuse Bone Graft for use in this area.

Off-Label Use & Promotion

The Wall Street Journal reports that “a number of patients say they have been harmed in off-label uses of Infuse, which is approved by the FDA only for a small section of the spine in the lower, lumbar region. At least 280 reports of side effects involving Infuse have been made to the FDA. About three-quarters of those reports involve off-label use. In July, the agency issued a safety alert about complications from the off-label use of Infuse in the neck, or cervical, area of the spine.”

Symptoms of Medtronic Infuse Bone Graft Complications

The FDA issued a safety alert regarding the complications from the off-label use of Infuse in the neck, or cervical area of the spine. These complications, which can be life threatening, include:

• Angioedema (swelling of the neck and throat, which can cause fatal suffocation)
• Cancer
• Male sterility
• Chronic pain that radiates into the arms and legs
• Respiratory depression
• Nerve damage
• Death

Several patients that were recipients of the Medtronic Infuse Bone Graft in off-label procedures required emergency treatment, including tracheotomies and the insertion of feeding tubes.

Do I have a Medtronic Infuse Bone Graft Lawsuit?

The Schmidt Firm, LLP is currently accepting Medtronic Infuse Bone Graft induced injury cases in all 50 states. If you or somebody you know has been injured by the Medtronic Infuse Bone Graft, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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