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Mark Favaloro
Mark Favaloro
Attorney • (800) 752-0042

CA Man Sues Medtronic for Off-Label Medical Device Use

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A man in California last month filed a lawsuit against Medtronic for its Infuse spine surgery product, which is shedding more light on the off-label uses of the company’s Infuse Bone Graft device.

The complaint of 85 pages was filed in LA Superior Court on June 19. The plaintiff alleges that the product is liable for his injuries and he is seeking punitive and compensatory damages.

Medtronic started to use its Infuse Bone Graft – a product that releases bone growth protein into the body during spinal fusion surgery – in 2002. FDA approved the medical device, but only for a certain type of procedure in one area of the spine.

The plaintiff’s suit alleges that Medtronic felt frustrated by the limited FDA approval and the low sales, so it started to go off label to increase sales of the device.

While it is not illegal to use a medical device for an off-label purpose, it is illegal for the company to promote that use or to offer financial benefits for that use. This lawsuit alleges that FDA informed Medtronic before approval that the Infuse Bone Graft could be hazardous for off-label uses. Some dangers include bone overgrowth issues, which can then damage nerve tissues, and in some neck surgeries, can even impede airways and threaten life.

The plaintiff had spinal surgery in September 2011. He states that Medtronic did not inform him or his doctor of the risks of off label use of the device. He developed serious bone overgrowth in the neck and had nerves compressed near his spine. Doctors could not find the source of the pain for over a year. By that time, the plaintiff had to have several painful surgeries to correct the problem.

The lawsuit is seeking compensatory damages for lost wages, medical bills and pain and suffering, as well as an undisclosed amount of punitive damages.

This is not the first lawsuit against Medtronic for one of its devices. In 2010, Medtronic was sued for problems with its heart defibrillators. These types of cases are why our Virginia law firm seeks the passage of the Medical Device Safety Act, which would ensure that customers have the right to hold device firms liable for causing serious injuries to patients.

HSInjuryLaw.com is a Virginia-based personal injury law firm that frequently provides commentary on medical device lawsuits.