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Off-Label Use of Infuse Bone Graft Blamed for Woman’s Death

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A family in California has filed the first lawsuit involving off-label use of   Medtronic Inc.’s Infuse Bone Graft.  The lawsuit claims a woman died as a result of an off-label use of Infuse. Doctors are free to use approved medical devices in anyway they see fit.  However, manufacturers are forbidden from promoting any use that has not been approved by the Food & Drug Administration – a practice known as off-label use.

According to the Infuse Bone Graft lawsuit, Shirley Nesbitt received the graft during neck surgery, an off-label use of the product.  According to The Wall Street Journal, the lawsuit alleges that a Medtronic sales representative was in the operating room before and during Nesbitt’s surgery, and encouraged the doctor to use Infuse in the off-label procedure.

Nesbitt underwent her surgery on August 21, and suffered respiratory arrest on August 23, the lawsuit said.  According to the Journal, she was “kept alive by artificial means” until August 30.

In July, the FDA warned that the use of Infuse Bone Graft and similar devices had caused serious problems when they were used off-label in cervical spine (neck) surgeries.   Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the FDA involve off-label uses of Infuse Bone Graft.  The Journal said that most of these cases involved unwanted bone growths near nerves or in areas outside targeted fusion sites.

Last month, Medtronic revealed that off-label use of Infuse Bone Graft was the subject of a subpoena filed by the U.S. Department of Justice.  The company insists that it does not promote off-label use of Infuse, and claims  that if doctors were using the bone graft product in off-label procedures, it was because they had determined it was the best therapy for their patients.

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