Medtronic Inc.’s Infuse Bone Graft has been blamed for the death of a California woman. A lawsuit filed by the victim’s family claims that use of Infuse Bone Graft in an off-label procedure caused her to suffer respiratory arrest, which proved fatal.
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.
In July, the Food & Drug Administration (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.
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.
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.
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.
But in a series of articles over the past several months, the Wall Street Journal has reported that doctors paid consulting fees by Medtronic have promoted off-label use of Infuse by, among other things, authoring articles that present unapproved uses in a favorable light.
The Journal also reported that employees of Medtronic have accused the company of paying kickbacks to doctors to get them to use its spinal products, including Infuse. Though it denied the allegations, Medtronic agreed to pay $40 million to settle claims made in two whistleblower lawsuits filed by former employees in 2002 and 2003, the Wall Street Journal said.
Such revelations have sparked a Congressional investigation into the possible promotion of off-label use of Infuse by Medtronic.
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