Medtronic could be facing more trouble over its Infuse Bone Graft product. According to a report on the website “Finance and Commerce”, a Texas woman is preparing to file a lawsuit that blames off-label use of Infuse for injuries she suffered after cervical spine surgery.
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 “Finance and Commerce”, a draft of a lawsuit being prepared on behalf of Mary Selke claims that use of Infuse during her cervical spine surgery caused bone to form in her neck, impeding her breathing and swallowing to the extent that she required emergency surgery. “Finance and Commerce” also reported that Selke’s lawyer said her physician will “provide testimony stating ways in which Medtronic has promoted the off-label use of the product among physicians”.
As we’ve previously reported, Medtronic already faces a lawsuit filed by the family of a woman who received Infuse during neck graft surgery, and later died. That lawsuit claims that a Medtronic sales representative was in the operating room before and during the patient’s surgery, and encouraged her doctor to use Infuse in the off-label procedure.
Off-label use of Infuse Bone Graft was also the subject of a subpoena filed by the U.S. Department of Justice in November. Medtronic 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.
According to “Finance and Commerce”, the Minneapolis Firefighters’ Relief Association has also filed a class-action shareholder lawsuit against Medtronic on Dec. 12, alleging that the company did not reveal that most of its revenue came from off-label use of Infuse, did not reveal that off-label use was causing major complications and did not disclose that it adopted an unlawful marketing campaign to promote its use.
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