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From humble beginnings in a garage in suburban Minneapolis, Minnesota, Medtronic started in 1949 as a medical equipment repair shop, went on to pioneered the first battery-powered cardiac pacemaker and has grown to be the world's largest medical technology company.

Today, this multibillion-dollar company is facing intense scrutiny regarding its bone-growth product, Infuse Bone Graft. Even though federal regulators approved this bioengineered material in 2002 for repairing debilitating lower spinal problems, doctors have been using it for a host of other spinal ailments for years. While Medtronic denies any part in this off-label use, some medical professionals charge the company did nothing to discourage it. Patients worldwide have been suffering from a variety of diseases as a result.

By 2011, a prominent medical journal alleged that doctors were put on the Medtronic payroll to overstate the device's benefits and encourage off-label use. The U.S. Department of Justice, U.S. Food and Drug Administration and the U.S. Senate Finance Committee each launched investigations into the allegations.

Is this company yet another example of Big Pharma gone awry?


Created in 1999, Infuse is a manmade form of a human bone protein. In 2002, the FDA approved it for a specific type of low-back surgery. In its approved use, the bone-growth agent is soaked into a sponge-like material, encased in a thimble-sized titanium cage and surgically implanted between the vertebrae. It has been shown to grow bone and encourage spinal vertebrae fusion, which is helpful for many chronic back pain patients. It is also approved for specific types of oral surgery.

Despite the FDA restrictions on usage, scores of surgeons have used it for off-label procedures, including cervical (neck) spinal surgeries. This causes unwanted bone growth and severe nerve damage. Some charge that Medtronic encouraged some surgeons to sing the praises of the device's off-label use in medical journals, trade meetings and educational seminars. While Medtronic is bound by federal regulations that prohibit it from promoting off-label use, doctors on the Medtronic payroll are under no such constraints. Up to 85 percent of the Infuse usage is off-label, experts say.

After a U.S. Department of Justice investigation into the allegations came up empty, a group of spinal specialists came forward to levy their criticisms of the device. In the June 2011 issue of The Spine Journal, a prominent group of physicians questioned the extensive off-label use, suggesting that doctors with financial ties to Medtronic have been encouraged to skew clinical trial results in the device's favor. The articles said that many of the physicians received between $12 million and $16 million in financial support. The U.S. Department of Justice is continuing an investigation into the claims.

Medtronic Infuse Bone Graft Lawsuit

The Spine Journal articles also said that the Infuse clinical trials funded by Medtronic failed to disclose any serious side effects, but independent medical reviewers found a host of problems associated with Infuse, including infections, pain, abnormal bone growth, male infertility, a host of different types of cancer and death.

As a result, Infuse patients are now stepping forward with their personal stories of pain and suffering from side effects they never anticipated. Many have turned to the court system for help to pay for the mounting medical bills and daily living expenses that stem from the complications from Infuse surgery. Many feel duped by Medtronic and are seeking financial relief in court.

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