Medtronic Lawsuit

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Medtronic Sued over Bone Growth Product

December 3rd, 2008 · No Comments

Medtronic has been sued by the family of a California woman who went into respiratory arrest and died following an off-label use of a bone growth promoter manufactured and marketed by Medtronic. 

The product, Infuse Bone Growth, is a fast-selling bone-growth protein. The product has been approved by the FDA to stimulate bone growth through a frontal approach to surgeries of the lower back. No other use has been approved by the FDA but there are a number of off-label uses. While it is not illegal for a doctor to use a drug or other item in an off-label way, the company making the product cannot market the product for off-label uses.

The lawsuit that was filed by the woman’s family alleges that Infuse Bone Growth was responsible for the woman’s death. The family argues that the Medtronic salesperson encouraged the surgeon performing the neck surgery to use Infuse in an off-label way. 

The case has come up as the Justice Department and a Senate Committee are looking into the product for uses not approved by the FDA. The suit echoes lawsuits filed in 2002 and 2003 by former Medtronic employees. It is, however, the first to allege that the product caused the death of an individual.

If you have been injured by a Medtronic product, contact the Medtronic lawsuit attorneys of Williams Kherkher at 1-866-950-9000 to discuss your case and to determine our legal options.

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