FDA to Be Informed of Infuse Bone Graft DeathDec 12, 2008 | Parker Waichman LLP
Medtronic Inc. said it is going to inform the Food & Drug Administration (FDA) about the death of a patient treated with its Infuse Bone Graft product in an off-label procedure. The death occurred in August, but according to a report in The Wall Street Journal, Medtronic is claiming it did not learn of the fatality until it was named in a lawsuit filed by the victim's family earlier this month.
Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.
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. Doctors are free to use approved medical devices in anyway they see fit. However, manufacturers are forbidden from promoting any use that has not received FDA approval - known as off-label use.
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.
According to her family's Infuse Bone Graft lawsuit, Shirley Nesbitt received the graft during neck surgery, an off-label use of the product. 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.
Device makers are required to let the FDA know when a patient treated with one of their products suffers an adverse event. In August, Medtronic informed the FDA that Nesbitt had fallen into a coma following her Infuse Bone Graft Surgery, the Journal said. However, Nesbitt's death was never reported. According to The Wall Street Journal, the hospital where Nesbitt died did not report the death to Medtronic, and the company said it only learned of the incident when the lawsuit was filed.
However, the Journal reports that Medtronic has been cited by the FDA before for not reporting adverse events related to some of its products. Last year, the FDA issued a warning letter to Medtronic, saying it had failed to properly report adverse events related to devices in its neuromodulation business, the Journal said.